Calcium Acetate Capsules

FULL PRESCRIBING INFORMATION

Indications and Usage for Calcium Acetate Capsules

Calcium Acetate Capsules are a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD).

Calcium Acetate Capsules Dosage and Administration

The recommended initial dose of Calcium Acetate Capsules for the adult dialysis patient is 2 capsules with each meal. Increase the dose gradually to lower serum phosphorus levels to the target range, as long as hypercalcemia does not develop. Most patients require 3 to 4 capsules with each meal.

Dosage Forms and Strengths

Capsule: 667 mg calcium acetate capsule.

Contraindications

Patients with hypercalcemia.

Warnings and Precautions

Hypercalcemia

Patients with end stage renal disease may develop hypercalcemia when treated with calcium, including calcium acetate. Avoid the use of calcium supplements, including calcium based nonprescription antacids, concurrently with calcium acetate.

An overdose of calcium acetate may lead to progressive hypercalcemia, which may require emergency measures. Therefore, early in the treatment phase during the dosage adjustment period, monitor serum calcium levels twice weekly. Should hypercalcemia develop, reduce the calcium acetate dosage, or discontinue the treatment, depending on the severity of hypercalcemia.

More severe hypercalcemia (Ca >12 mg/dL) is associated with confusion, delirium, stupor and coma. Severe hypercalcemia can be treated by acute hemodialysis and discontinuing calcium acetate therapy.

Mild hypercalcemia (10.5 to 11.9 mg/dL) may be asymptomatic or manifest as constipation, anorexia, nausea, and vomiting. Mild hypercalcemia is usually controlled by reducing the calcium acetate dose or temporarily discontinuing therapy. Decreasing or discontinuing Vitamin D therapy is recommended as well.

Chronic hypercalcemia may lead to vascular calcification and other soft-tissue calcification. Radiographic evaluation of suspected anatomical regions may be helpful in early detection of soft tissue calcification. The long term effect of calcium acetate on the progression of vascular or soft tissue calcification has not been determined.

Hypercalcemia (>11 mg/dL) was reported in 16% of patients in a 3 month study of solid dose formulation of calcium acetate; all cases resolved upon lowering the dose or discontinuing treatment.

Maintain the serum calcium-phosphorus (Ca x P) product below 55 mg2/dL2.

Concomitant Use with Medications

Hypercalcemia may aggravate digitalis toxicity.

Adverse Reactions

Hypercalcemia is discussed elsewhere [see Warnings and Precautions (5.1)]

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In clinical studies, calcium acetate has been generally well tolerated.

Calcium acetate was studied in a 3 month, open-label, non-randomized study of 98 enrolled ESRD hemodialysis patients and an alternate liquid formulation of calcium acetate was studied in a two week double-blind, placebo-controlled, cross-over study with 69 enrolled ESRD hemodialysis patients. Adverse reactions (>2% on treatment) from these trials are presented in Table 1.

Table 1: Adverse Reactions in Patients with End-Stage Renal Disease Undergoing Hemodialysis

Preferred Term	Total adversereactionsreported forcalcium acetateN=167 N (%)	3 month, open label study ofcalcium acetateN=98 N (%)	Double blind, placebo-controlled,cross-over study of liquid calciumacetate N=69
			Calcium acetate N (%)	Placebo N (%)
Nausea	6 (3.6)	6 (6.1)	0 (0)	0 (0)
Vomiting	4 (2.4)	4 (4.1)	0 (0)	0 (0)
Hypercalcemia	21 (12.6)	16 (16.3)	5 (7.2)	0 (0)

Mild hypercalcemia may be asymptomatic or manifest itself as constipation, anorexia, nausea, and vomiting. More severe hypercalcemia is associated with confusion, delirium, stupor, and coma. Decreasing dialysate calcium concentration could reduce the incidence and severity of calcium acetate-induced hypercalcemia. Isolated cases pruritus have been reported, which may represent allergic reactions.

Postmarketing Experience

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or to establish a causal relationship to drug exposure.

The following additional adverse reactions have been identified during post-approval of calcium acetate: dizziness, edema, and weakness.

Drug Interactions

The drug interaction of calcium acetate  is characterized by the potential of calcium to bind to drugs with anionic functions (e.g., carboxyl, and hydroxyl groups). Calcium acetate  may decrease the bioavailability of tetracyclines or fluoroquinolones via this mechanism.

There are no empirical data on avoiding drug interactions between calcium acetate and most concomitant drugs. When administering an oral medication with calcium acetate  where a reduction in the bioavailability of that medication would have a clinically significant effect on its safety or efficacy, administer the drug one hour before or three hours after calcium acetate. Monitor blood levels of the concomitant drugs that have a narrow therapeutic range. Patients taking anti-arrhythmic medications for the control of arrhythmias and anti-seizure medications for the control of seizure disorders were excluded from the clinical trials with all forms of calcium acetate.

Ciprofloxacin

In a study of 15 healthy subjects, a co-administered single dose of 4 calcium acetate tablets, approximately 2.7g, decreased the bioavailability of ciprofloxacin by approximately 50%.

USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category C

Calcium Acetate Capsules  contains calcium acetate. Animal reproduction studies have not been conducted with calcium acetate, and there are no adequate and well controlled studies of calcium acetate use in pregnant women. Patients with end stage renal disease may develop hypercalcemia with calcium acetate treatment [see Warnings and Precautions (5.1)]. Maintenance of normal serum calcium levels is important for maternal and fetal well being. Hypercalcemia during pregnancy may increase the risk for maternal and neonatal complications such as stillbirth, preterm delivery, and neonatal hypocalcemia and hypoparathyroidism. Calcium acetate  treatment, as recommended, is not expected to harm a fetus if maternal calcium levels are properly monitored during and following treatment.

Labor and Delivery

The effects of calcium acetate  on labor and delivery are unknown.

Nursing Mothers

Calcium Acetate Capsules  contains calcium acetate and is excreted in human milk. Human milk feeding by a mother receiving calcium acetate  is not expected to harm an infant, provided maternal serum calcium levels are appropriately monitored.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies of calcium acetate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Overdosage

Administration of Calcium Acetate Capsules  in excess of the appropriate daily dosage may result in hypercalcemia [see Warnings and Precautions (5.1)].

Calcium Acetate Capsules Description

Calcium Acetate Capsules acts as a phosphate binder. Its chemical name is calcium acetate. Its molecular formula is C4H6CaO4, and its molecular weight is 158.17. Its structural formula is:

Each white opaque/blue opaque capsule contains 667 mg of calcium acetatee, USP (anhydrous; Ca(CH3COO)2; MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium, and 10 mg of the inert binder, polyethylene glycol 8000 NF and the following inactive ingredients: FD&C blue #1, FD&C red #3, gelatin, magnesium stearate, polyethylene glycol 8000 and titanium dioxide. In addition to the ingredients listed above, each capsule contains Opacode (Black) monogramming ink. Opacode (Black) contains ethanol, FD&C blue #2, FD&C red #40, FD&C yellow #6, iron oxide black, N-butyl alchol, propylene glycol and shellac.

Calcium Acetate Capsules are administered orally for the control of hyperphosphatemia in end-stage renal failure.

Calcium Acetate Capsules - Clinical Pharmacology

Patients with ESRD retain phosphorus and can develop hyperphosphatemia. High serum phosphorus can precipitate serum calcium resulting in ectopic calcification. Hyperphosphatemia also plays a role in the development of secondary hyperparathyroidism in patients with ESRD.

Mechanism of Action

Calcium acetate, when taken with meals, combines with dietary phosphate to form an insoluble calcium phosphate complex, which is excreted in the feces, resulting in decreased serum phosphorus concentration.

Pharmacodynamics

Orally administered calcium acetate from pharmaceutical dosage forms is systemically absorbed up to approximately 40% under fasting conditions and up to approximately 30% under nonfasting conditions. This range represents data from both healthy subjects and renal dialysis patients under various conditions.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

No carcinogenicity, mutagenicity, or fertility studies have been conducted with calcium acetate.

Clinical Studies

Effectiveness of calcium acetate in decreasing serum phosphorus has been demonstrated in two studies of the calcium acetate solid oral dosage form.

Ninety-one patients with end-stage renal disease who were undergoing hemodialysis and were hyperphosphatemic (serum phosphorus >5.5 mg/dL) following a 1 week phosphate binder washout period contributed efficacy data to an open-label, non-randomized study.

The patients received calcium acetate 667 mg tablets at each meal for a period of 12 weeks. The initial starting dose was 2 tablets per meal for 3 meals a day, and the dose was adjusted as necessary to control serum phosphorus levels. The average final dose after 12 weeks of treatment was 3.4 tablets per meal. Although there was a decrease in serum phosphorus, in the absence of a control group the true magnitude of effect is uncertain.

The data presented in Table 2 demonstrate the efficacy of calcium acetate in the treatment of hyperphosphatemia in end-stage renal disease patients. The effects on serum calcium levels are also presented.

Table 2: Average Serum Phosphorous and Calcium Levels at Pre-Study, Interim, and Study Completion Time Points

Parameter	Pre-Study	Week 4a	Week 8	Week 12	p-valueb
Phosphorus (mg/dL)c	7.4 ± 0.17	5.9 ± 0.16	5.6 ± 0.17	5.2 ± 0.17	≤0.01
Calcium (mg/dL)c	8.9 ± 0.09	9.5 ± 0.10	9.7 ± 0.10	9.7 ± 0.10	≤0.01

There was a 30% decrease in serum phosphorus levels during the 12 week study period (p<0.01). Two-thirds of the decline occurred in the first month of the study. Serum calcium increased 9% during the study mostly in the first month of the study.

Treatment with the phosphate binder was discontinued for patients from the open-label study, and those patients whose serum phosphorus exceeded 5.5 mg/dL were eligible for entry into a double-blind, placebo-controlled, cross-over study. Patients were randomized to receive calcium acetate or placebo, and each continued to receive the same number of tablets as had been individually established during the previous study. Following 2 weeks of treatment, patients switched to the alternative therapy for an additional 2 weeks.

The phosphate binding effect of calcium acetate is shown in the Table 3.

Table 3: Serum Phosphorous and Calcium Levels at Study Initiation and After Completion of Each Treatment Arm

* ANOVA of calcium acetate vs. placebo after 2 weeks of treatment. † Values expressed as mean ± SEM.
Parameter	Pre-Study	Post-Treatment		p-value*
		Calcium Acetate	Placebo
Phosphorus (mg/dL) †	7.3 ± 0.18	5.9 ± 0.24	7.8 ± 0.22	<0.01
Calcium (mg/dL) †	8.9 ± 0.11	9.5 ± 0.13	8.8 ± 0.12	<0.01

Overall, 2 weeks of treatment with calcium acetate statistically significantly (p<0.01) decreased serum phosphorus by a mean of 19% and increased serum calcium by a statistically significant (p<0.01) but clinically unimportant mean of 7%.

How Supplied/Storage and Handling

Calcium Acetate Capsules are supplied as white opaque/blue opaque capsules imprinted with “54 215” on the cap and body.

0054-0088-26 667 mg, white opaque/blue opaque capsule, bottle of 200

STORAGE

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Patient Counseling Information

Inform patients to take Calcium Acetate Capsules with meals, adhere to their prescribed diets, and avoid the use of calcium supplements including nonprescription antacids. Inform the patients about the symptoms of hypercalcemia [see Warnings and Precautions (5.1)andAdverse Reactions (6.1)].

Advise patients who are taking an oral medication where reduction in the bioavailability of that medication would have clinically significant effect on its safety or efficacy to take the drug one hour before or three hours after Calcium Acetate Capsules.

 

10003705/02

Revised April 2011

© RLI, 2011

Package Label

Calcium Acetate Capsules, 667 mg

Roxane Laboratories, Inc.

Rx Only

CALCIUM ACETATE  calcium acetate  capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0054-0088 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM ACETATE (CALCIUM) CALCIUM ACETATE 667 mg

Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1   FD&C RED NO. 3   GELATIN   MAGNESIUM STEARATE   POLYETHYLENE GLYCOL 8000   TITANIUM DIOXIDE   ALCOHOL   FD&C BLUE NO. 2   FD&C RED NO. 40   FD&C YELLOW NO. 6   FERROSOFERRIC OXIDE   PROPYLENE GLYCOL   SHELLAC

Product Characteristics Color WHITE (Blue Opaque) Score no score Shape CAPSULE Size 1mm Flavor Imprint Code 54215 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0054-0088-26 200  In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077728	02/26/2008

Labeler - Roxane Laboratories, Inc (833490464)

Registrant - Roxane Laboratories, Inc (833490464)

Establishment
Name	Address	ID/FEI	Operations
Boehringer Ingelheim Roxane Inc		058839929	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Kemira Chem Solutions B.V.		403364669	API MANUFACTURE

Revised: 04/2011Roxane Laboratories, Inc

More Calcium Acetate Capsules resources

• Calcium Acetate Capsules Side Effects (in more detail)
• Calcium Acetate Capsules Dosage
• Calcium Acetate Capsules Use in Pregnancy & Breastfeeding
• Drug Images
• Calcium Acetate Capsules Drug Interactions
• Calcium Acetate Capsules Support Group
• 0 Reviews for Calcium Acetate - Add your own review/rating

Compare Calcium Acetate Capsules with other medications

• Hyperphosphatemia

Calcitrene Topical

Generic Name: calcipotriene (Topical route)

kal-si-poe-TRYE-een

Commonly used brand name(s)

In the U.S.

• Calcitrene


• Dovonex


• Sorilux

Available Dosage Forms:

• Cream


• Foam


• Ointment


• Solution

Therapeutic Class: Antipsoriatic

Pharmacologic Class: Vitamin D3, Synthetic

Uses For Calcitrene

Calcipotriene is used on the skin and scalp to treat plaque psoriasis. It is a form of vitamin D that works by changing how the skin cells are made in the areas affected by psoriasis.

This medicine is available only with your doctor's prescription.

Before Using Calcitrene

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of calcipotriene in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of calcipotriene in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Hypercalcemia (high calcium in the blood)—Should not be used in patients with this condition.

• Skin irritation in psoriasis areas—May make this condition worse.

Proper Use of calcipotriene

This section provides information on the proper use of a number of products that contain calcipotriene. It may not be specific to Calcitrene. Please read with care.

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.

This medicine should only be used on the skin. Do not get it in your eyes, nose, mouth, or vagina. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

To help clear up your skin problem completely, it is very important that you keep using calcipotriene for the full time of treatment. Do not miss any doses.

This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other skin conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.

To use the cream or ointment:

• Wash your hands with soap and water before and after using this medicine. If the skin on your hands is being treated with the medicine, only wash the skin that is not affected.


• Apply a thin layer to the affected area of the skin. Rub it in gently until it disappears into the skin.


• Do not get any medicine on your face or in your eyes.

To use the scalp solution:

• Wash your hands with soap and water before and after using this medicine.


• Before using the medicine, comb your dry hair to remove any skin flakes. Part your hair so you can see the scalp lesions.


• Apply the solution only to the scalp lesions. Rub it in gently until it disappears into the scalp.


• Do not get any medicine on your forehead or in your eyes.


• Do not use this medicine near heat, an open flame, or while smoking.

To use the foam:

• This medicine comes with a patient information insert. Read and follow the instructions carefully.


• Wash your hands with soap and water before and after using this medicine. If the skin on your hands is being treated with the medicine, only wash the skin that is not affected.


• Break the tiny plastic piece on the nozzle of the foam can.


• Shake the can before each use.


• Turn the can upside down and place a small amount into the palm of your hand.


• Apply a thin layer to the affected area of the skin. Rub it in gently until it disappears into the skin.


• Do not use the medicine in or near your eyes, mouth, or vagina. If the foam does get in your eyes, wash them right away with water.


• Do not use this medicine near heat, an open flame, or while smoking.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For topical dosage form (cream, foam, ointment, scalp solution):
  
  • For plaque psoriasis:
    
    • Adults—Apply to the affected area of the skin or scalp once per day or two times per day as directed by your doctor.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

The scalp solution and foam are flammable. Keep them away from an open flame or heat. Do not smoke when you are applying the medicine. Do not poke holes in the foam canister or throw it into a fire, even if the canister is empty. Do not keep the foam inside a car where it could be exposed to extreme heat.

Precautions While Using Calcitrene

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for any unwanted effects.

Stop using this medicine and check with your doctor right away if you have a skin rash, burning, stinging, redness, swelling, or irritation on the skin.

If your psoriasis does not improve within a few weeks or becomes worse, check with your doctor.

Calcipotriene may make your skin more sensitive to sunlight. Use a sunscreen and wear protective clothing, including a hat, when you are outdoors. Avoid sunlamps and tanning beds.

Do not use cosmetics or other skin care products on the treated areas unless directed to do so by your doctor.

Calcitrene Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Skin redness, swelling, or itching


• skin rash


• worsening of psoriasis

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Burning, dryness, irritation, peeling, or redness of the skin

Less common or rare

• Darker color in treated areas of the skin


• pus in the hair follicles

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Calcitrene Topical side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

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More Calcitrene Topical resources

• Calcitrene Topical Side Effects (in more detail)
• Calcitrene Topical Use in Pregnancy & Breastfeeding
• Calcitrene Topical Drug Interactions
• Calcitrene Topical Support Group
• 0 Reviews for Calcitrene Topical - Add your own review/rating

Compare Calcitrene Topical with other medications

• Psoriasis

Caldolor

Generic Name: ibuprofen (Intravenous route)

eye-bue-PROE-fen

Intravenous route(Solution)

NSAIDs increase the risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Ibuprofen is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. NSAIDs can also cause an increased risk of serious gastrointestinal adverse events especially in the elderly, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal .

Commonly used brand name(s)

In the U.S.

• Caldolor


• Neoprofen

Available Dosage Forms:

• Solution

Therapeutic Class: Analgesic

Pharmacologic Class: NSAID

Chemical Class: Propionic Acid (class)

Uses For Caldolor

Ibuprofen injection is a nonsteroidal antiinflammatory drug (NSAID) that is used alone or together with other medicines (e.g., opioid analgesics) to relieve mild to severe pain. It is also used to treat fever in adults.

This medicine is available only with your doctor's prescription.

Before Using Caldolor

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of ibuprofen injection in children and teenagers below 17 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ibuprofen injection in the elderly. However, elderly patients are more likely to have age-related kidney, liver, heart, or stomach problems, which may require an adjustment in the dose for patients receiving ibuprofen injection.

Pregnancy

	Pregnancy Category	Explanation
1st Trimester	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
2nd Trimester	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
3rd Trimester	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Ketorolac


• Pentoxifylline

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abciximab


• Ardeparin


• Argatroban


• Beta Glucan


• Bivalirudin


• Certoparin


• Cilostazol


• Citalopram


• Clopidogrel


• Clovoxamine


• Dabigatran Etexilate


• Dalteparin


• Danaparoid


• Desirudin


• Dipyridamole


• Enoxaparin


• Escitalopram


• Femoxetine


• Flesinoxan


• Fluoxetine


• Fluvoxamine


• Fondaparinux


• Ginkgo


• Heparin


• Lepirudin


• Methotrexate


• Nadroparin


• Nefazodone


• Parnaparin


• Paroxetine


• Pemetrexed


• Protein C


• Reviparin


• Rivaroxaban


• Sertraline


• Sibutramine


• Tacrolimus


• Ticlopidine


• Tinzaparin


• Tirofiban


• Vilazodone


• Zimeldine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol


• Acetohexamide


• Alacepril


• Alprenolol


• Amikacin


• Amiloride


• Arotinolol


• Aspirin


• Atenolol


• Azilsartan Medoxomil


• Azosemide


• Befunolol


• Bemetizide


• Benazepril


• Bendroflumethiazide


• Benzthiazide


• Betaxolol


• Bevantolol


• Bisoprolol


• Bopindolol


• Bucindolol


• Bumetanide


• Bupranolol


• Buthiazide


• Candesartan Cilexetil


• Canrenoate


• Captopril


• Carteolol


• Carvedilol


• Celiprolol


• Chlorothiazide


• Chlorpropamide


• Chlorthalidone


• Cilazapril


• Clopamide


• Cyclopenthiazide


• Cyclosporine


• Delapril


• Desipramine


• Desvenlafaxine


• Dilevalol


• Duloxetine


• Enalaprilat


• Enalapril Maleate


• Eprosartan


• Esmolol


• Ethacrynic Acid


• Fosinopril


• Furosemide


• Gliclazide


• Glimepiride


• Glipizide


• Gliquidone


• Glyburide


• Hydrochlorothiazide


• Hydroflumethiazide


• Imidapril


• Indapamide


• Irbesartan


• Labetalol


• Landiolol


• Levobetaxolol


• Levobunolol


• Lisinopril


• Lithium


• Losartan


• Mepindolol


• Methyclothiazide


• Metipranolol


• Metolazone


• Metoprolol


• Milnacipran


• Moexipril


• Nadolol


• Nebivolol


• Nipradilol


• Olmesartan Medoxomil


• Oxprenolol


• Penbutolol


• Pentopril


• Perindopril


• Phenytoin


• Pindolol


• Piretanide


• Polythiazide


• Propranolol


• Quinapril


• Ramipril


• Sotalol


• Spirapril


• Spironolactone


• Tacrine


• Talinolol


• Tasosartan


• Telmisartan


• Temocapril


• Tertatolol


• Timolol


• Tolazamide


• Tolbutamide


• Torsemide


• Trandolapril


• Triamterene


• Trichlormethiazide


• Valsartan


• Venlafaxine


• Voriconazole


• Xipamide


• Zofenopril

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia or


• Bleeding problems or


• Congestive heart failure or


• Edema (fluid retention) or


• Heart attack, history of or


• Hypertension (high blood pressure) or


• Kidney disease or


• Liver disease or


• Stomach ulcers or bleeding, history of or


• Stroke, history of—Use with caution. May make these conditions worse.

• Aspirin-sensitive asthma or


• Aspirin sensitivity, history of—Should not use in patients with these conditions.

• Heart surgery (e.g., coronary artery bypass graft [CABG])—Should not use for pain right before or after surgery in patients with this condition.

• Systemic lupus erythematosus (SLE)—May cause side effects to become worse.

Proper Use of ibuprofen

This section provides information on the proper use of a number of products that contain ibuprofen. It may not be specific to Caldolor. Please read with care.

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins.

Drink extra fluids so you will pass more urine while you are using this medicine. This will keep your kidneys working well and help prevent kidney problems.

Precautions While Using Caldolor

It is very important that your doctor check your progress while you receive this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it. Blood tests may be needed to check for unwanted effects.

This medicine may increase your risk of having a heart attack or stroke. This is more likely to occur in people who already have heart disease. People who use this medicine for a long time might also have a higher risk.

This medicine may cause bleeding in your stomach or intestines. This problem can happen without warning signs. This is more likely to occur if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, are over 60 years of age, are in poor health, or are using certain other medicines (such as steroids or a blood thinner).

Liver problems may occur while you are using this medicine. Stop using this medicine and check with your doctor right away if you are having more than one of these symptoms: abdominal pain or tenderness; clay-colored stools; dark urine; decreased appetite; fever; headache; itching; loss of appetite; nausea and vomiting; skin rash; swelling of the feet or lower legs; unusual tiredness or weakness; or yellow eyes or skin.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after you get the injection.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin; red skin lesions; a severe skin rash or acne; sores or ulcers on the skin; or fever or chills while you are using this medicine.

Using this medicine while you are pregnant can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after you receive this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Call your doctor right away if you have confusion, drowsiness, fever, a general feeling of illness, a headache, loss of appetite, nausea, stiff neck or back, or vomiting. These could be symptoms of a serious condition called meningitis.

Tell your doctor if you have unexplained weight gain or edema (fluid retention or body swelling) with this medicine.

Caldolor Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Abdominal or stomach pain


• black, tarry stools


• bleeding gums


• blurred vision


• chest pain


• confusion


• convulsions


• cough


• coughing up blood


• decreased urine


• diarrhea


• difficulty in breathing or swallowing


• dizziness


• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly


• dry mouth


• fast heartbeat


• fat in the stool


• fever or chills


• headache


• increased menstrual flow or vaginal bleeding


• increased thirst


• irregular heartbeat


• irritability


• loss of appetite


• lower back or side pain


• mood changes


• muscle pain or cramps


• muscle twitching


• nausea or vomiting


• nervousness


• nosebleeds


• numbness or tingling in the hands, feet, or lips


• pain, warmth, or burning in the fingers, toes, and legs


• painful or difficult urination


• pale skin


• paralysis


• pounding in the ears


• problems with vision or hearing


• prolonged bleeding from cuts


• rapid breathing


• red or black, tarry stools


• red or dark brown urine


• restlessness


• seizures


• shortness of breath


• slow or fast heartbeat


• sneezing


• sore throat


• sores, ulcers, or white spots on the lips or in the mouth


• sweating


• swelling of the feet or lower legs


• swollen glands


• tightness in the chest


• troubled breathing with exertion


• unusual bleeding or bruising


• unusual tiredness or weakness


• weakness


• wheezing

Less common

• Bloating or swelling of the face, arms, hands, lower legs, or feet


• decrease in frequency of urination


• decrease in urine volume


• difficulty in passing urine (dribbling)


• rapid weight gain


• unusual weight gain or loss

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Excess air or gas in the stomach or intestines


• full feeling


• passing gas

Less common

• Abdominal or stomach discomfort


• acid or sour stomach


• belching


• heartburn


• indigestion


• stomach discomfort, upset, or pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Caldolor side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Caldolor resources

• Caldolor Side Effects (in more detail)
• Caldolor Use in Pregnancy & Breastfeeding
• Caldolor Drug Interactions
• Caldolor Support Group
• 0 Reviews for Caldolor - Add your own review/rating

• Caldolor Prescribing Information (FDA)


• Caldolor Injection MedFacts Consumer Leaflet (Wolters Kluwer)


• Caldolor Consumer Overview


• Ibuprofen Monograph (AHFS DI)


• Ibuprofen Professional Patient Advice (Wolters Kluwer)


• Ibuprofen Prescribing Information (FDA)


• Advil Consumer Overview


• Advil MedFacts Consumer Leaflet (Wolters Kluwer)


• Advil Prescribing Information (FDA)


• Advil Childrens Prescribing Information (FDA)


• Advil Migraine Prescribing Information (FDA)


• IBU MedFacts Consumer Leaflet (Wolters Kluwer)


• Ibutilide Fumarate Monograph (AHFS DI)


• Motrin Consumer Overview


• Motrin Prescribing Information (FDA)


• Motrin IB Prescribing Information (FDA)


• Motrin Junior Strength Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• NeoProfen Prescribing Information (FDA)

Compare Caldolor with other medications

• Fever
• Pain
• Spondylolisthesis

Cortizone-10 Anal Itch Cream cream, ointment, suppository

Generic Name: hydrocortisone rectal (cream, ointment, suppository) (hye dro KORT i zone REK tal)

Brand Names: Anucort-HC, Anumed-HC, Anusol-HC, Cortizone-10 Anal Itch Cream, Hemorrhoidal HC, Hemril-30, Hemril-HC Uniserts, Preparation H Hydrocortisone, Procto-Kit 1%, Procto-Kit 2.5%, Procto-Pak 1%, Proctocort, Proctocream-HC, Proctosert HC, Proctosol-HC, Proctozone HC, Proctozone-H, Recort Plus, Rectasol-HC, Tucks HC

What is hydrocortisone rectal?

Hydrocortisone is a steroid medicine that reduces inflammation in the body.

The information in this medication guide is specific to hydrocortisone rectal cream, ointment, or suppository.

Hydrocortisone rectal is used to treat itching or swelling caused by hemorrhoids or other inflammatory conditions of the rectum or anus.

Hydrocortisone rectal is also used together with other medications to treat ulcerative colitis, proctitis, and other inflammatory conditions of the lower intestines and rectal area.

Hydrocortisone rectal may also be used for purposes not listed in this medication guide.

What is the most important information I should know about hydrocortisone rectal?

The information in this medication guide is specific to hydrocortisone rectal cream, ointment, or suppository.

Do not take hydrocortisone rectal by mouth. It is for use only in your rectum.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions. You may need to use this medication for up to 8 weeks.

Call your doctor at once if you have any bleeding from your rectum, feeling short of breath (even with mild exertion), swelling of your ankles or feet, or rapid weight gain.

There may be other drugs that can interact with hydrocortisone rectal. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Call your doctor if your symptoms do not improve or if they get worse after using this medicine for a few days.

What should I discuss with my health care provider before using hydrocortisone rectal?

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have:

• 
  

  congestive heart failure;

  
  


• 
  

  a history of tuberculosis;

  
  


• 
  

  stomach ulcer or diverticulitis;

  
  


• 
  

  a colostomy or ileostomy;

  
  


• 
  

  fever or any type of infection;

  
  


• 
  

  kidney disease;

  
  


• 
  

  high blood pressure; or

  
  


• 
  

  myasthenia gravis.

  
  

Also tell your doctor if you have diabetes. Steroid medicines may increase the glucose (sugar) levels in your blood or urine. You may also need to adjust the dose of your diabetes medications.

FDA pregnancy category C. It is not known whether hydrocortisone rectal will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether hydrocortisone passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use hydrocortisone rectal?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Do not take hydrocortisone rectal by mouth. It is for use only in your rectum.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions. You may need to use this medication for up to 8 weeks.

Wash your hands before and after using this medicine.

Try to empty your bowel and bladder just before using hydrocortisone rectal.

Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands. The rectal suppository can stain clothing or other fabrics it comes into contact with.

For best results from the suppository, lie down after inserting it and hold in the suppository. The suppository will melt quickly once inserted and you should feel little or no discomfort while holding it in.

For best results from the cream, use only the applicator provided with the medication. Otherwise, follow the directions provided with your rectal cream.

Avoid using the bathroom for one to three hours after inserting the cream or suppository.

Apply the ointment to the rectum and surrounding skin of the rectal area as directed on the package label.

Call your doctor if your symptoms do not improve or if they get worse after using this medicine for a few days.

Store the rectal cream at room temperature away from moisture and heat. Store the rectal suppositories at cool room temperature away from moisture and heat. Do not refrigerate or freeze them.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose of hydrocortisone rectal is not expected to produce life-threatening symptoms. However, long-term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while using hydrocortisone rectal ?

Avoid getting a vaccine during your treatment with hydrocortisone rectal. Vaccines may not work as well while you are using a steroid medicine.

Hydrocortisone rectal side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• 
  

  feeling short of breath, even with mild exertion;

  
  


• 
  

  swelling of your ankles or feet;

  
  


• 
  

  muscle weakness;

  
  


• 
  

  rapid weight gain, especially in your face and midsection;

  
  


• 
  

  severe rectal pain or burning;

  
  


• 
  

  bleeding from your rectum;

  
  


• 
  

  severe stomach pain;

  
  


• 
  

  sudden and severe headache or pain behind your eyes; or

  
  


• 
  

  seizure (convulsions).

  
  

Less serious side effects may include:

• 
  

  mild rectal pain or burning;

  
  


• 
  

  acne;

  
  


• 
  

  changes in your menstrual periods;

  
  


• 
  

  increased sweating; or

  
  


• 
  

  increased facial or body hair growth.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect hydrocortisone rectal ?

Before using hydrocortisone rectal, tell your doctor if you also use insulin or take oral diabetes medication.

There may be other drugs that can interact with hydrocortisone rectal. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Cortizone-10 Anal Itch Cream resources

• Cortizone-10 Anal Itch Cream Side Effects (in more detail)
• Cortizone-10 Anal Itch Cream Use in Pregnancy & Breastfeeding
• Cortizone-10 Anal Itch Cream Drug Interactions
• 0 Reviews for Cortizone-10 Anal Itch - Add your own review/rating

Compare Cortizone-10 Anal Itch Cream with other medications

• Anal Itching
• Aphthous Stomatitis, Recurrent
• Atopic Dermatitis
• Dermatitis
• Eczema
• Gingivitis
• Proctitis
• Pruritus
• Psoriasis
• Seborrheic Dermatitis
• Skin Rash

Where can I get more information?

• Your pharmacist can provide more information about hydrocortisone rectal cream, ointment, or suppository.

See also: Cortizone-10 Anal Itch side effects (in more detail)

Cortisporin-TC Drops

Pronunciation: koe-LIS-tin/hye-droe-KOR-ti-sone/nee-oh-MYE-sin/thon-ZOE-nee-um
Generic Name: Colistin/Hydrocortisone/Neomycin/Thonzonium
Brand Name: Examples include Cortisporin-TC and Coly-Mycin S

Cortisporin-TC Drops are used for:

Treating infections of the ear caused by certain bacteria. It may also be used for other conditions as determined by your doctor.

Cortisporin-TC Drops are a combination of 2 antibiotics and a corticosteroid. The antibiotics work by killing sensitive bacteria. The corticosteroid reduces inflammation.

Do NOT use Cortisporin-TC Drops if:

• you are allergic to any ingredient in Cortisporin-TC Drops, to other aminoglycosides (eg, gentamicin), or to other corticosteroids (eg, prednisone)


• you have a viral infection of the ear (eg, herpes simplex, chickenpox, shingles)


• you have a perforated ear drum

Contact your doctor or health care provider right away if any of these apply to you.

Before using Cortisporin-TC Drops:

Some medical conditions may interact with Cortisporin-TC Drops. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have the blood disease porphyria

Some MEDICINES MAY INTERACT with Cortisporin-TC Drops. Because little, if any, of Cortisporin-TC Drops are absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Cortisporin-TC Drops may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Cortisporin-TC Drops:

Use Cortisporin-TC Drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Cortisporin-TC Drops are only for the ear. Do not get it in your eyes, nose, or, mouth. If you get Cortisporin-TC Drops in your eyes, rinse immediately with cool tap water.


• Wash your hands before and after using Cortisporin-TC Drops.


• Wash and dry the outer ear with a sterile cotton applicator.


• Shake well before each use.


• Before using, hold the ear drop container in your hand for 1 or 2 minutes to avoid dizziness that may result from putting cold drops into the ear. Do not heat Cortisporin-TC Drops by any other method because it could decrease its effectiveness.


• Lie down or tilt your head so that the affected ear faces up. For adults, gently pull the earlobe up and back to straighten the ear canal. For children, gently pull the earlobe down and back to straighten the ear canal. Drop the medicine into the ear canal. Keep the ear facing up for several minutes so the medicine can run to the bottom of the ear canal. A clean cotton plug may be gently inserted into the ear canal to prevent medicine from leaking out.


• To prevent germs from contaminating your medicine, do not touch the applicator to any surface, including the ear. Keep the container tightly closed.


• To clear up your infection completely, use Cortisporin-TC Drops for the full course of treatment. Keep using it even if you feel better in a few days.


• If you miss a dose of Cortisporin-TC Drops, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Cortisporin-TC Drops.

Important safety information:

• Cortisporin-TC Drops are only works against bacteria; it does not treat fungal or viral infections.


• Be sure to use Cortisporin-TC Drops for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.


• Long-term or repeated use of Cortisporin-TC Drops may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.


• Do NOT take more than the recommended dose or use for longer than 10 days without checking with your doctor.


• Do not use Cortisporin-TC Drops for other ear conditions at a later time.


• Tell your doctor or dentist that you take Cortisporin-TC Drops before you receive any medical or dental care, emergency care, or surgery.


• PREGNANCY and BREAST-FEEDING: It is not known if Cortisporin-TC Drops causes harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Cortisporin-TC Drops while you are pregnant. It is not known if Cortisporin-TC Drops are found in breast milk after topical use. If you are or will be breast-feeding while you are using Cortisporin-TC Drops, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Cortisporin-TC Drops:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Mild, temporary burning or stinging.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); acne-like rash; changes in hearing; decreased urination; dry, scaly, or peeling skin at the application site; continued burning or stinging; excessive hair growth; inflamed hair follicles; inflammation around the mouth; loss of hearing; pain, redness, itching, irritation, or swelling not present when you began using Cortisporin-TC Drops; thinning, softening, or discoloration of the skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Cortisporin-TC side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Cortisporin-TC Drops:

Store Cortisporin-TC Drops between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Keep the container tightly closed. Keep Cortisporin-TC Drops out of the reach of children and away from pets.

General information:

• If you have any questions about Cortisporin-TC Drops, please talk with your doctor, pharmacist, or other health care provider.


• Cortisporin-TC Drops are to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Cortisporin-TC Drops. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Cortisporin-TC resources

• Cortisporin-TC Side Effects (in more detail)
• Cortisporin-TC Use in Pregnancy & Breastfeeding
• Cortisporin-TC Drug Interactions
• Cortisporin-TC Support Group
• 0 Reviews for Cortisporin-TC - Add your own review/rating

Compare Cortisporin-TC with other medications

• Acute Otitis Externa
• Chronic Otitis Media
• Otitis Externa
• Otitis Media

Cortisporin Solution

Pronunciation: HYE-droe-KOR-ti-sone/NEE-oh-MYE-sin/POL-ee-MIX-in
Generic Name: Hydrocortisone/Neomycin/Polymyxin B
Brand Name: Examples include Cortisporin and Cortomycin

Cortisporin Solution is used for:

Treating infections of the ear caused by certain bacteria. It may also be used for other conditions as determined by your doctor.

Cortisporin Solution is a combination of 2 antibiotics and a corticosteroid. The antibiotics work by slowing the growth of, or killing, sensitive bacteria. The corticosteroid reduces inflammation.

Do NOT use Cortisporin Solution if:

• you are allergic to any ingredient in Cortisporin Solution, to other aminoglycosides (eg, gentamicin), or to other corticosteroids (eg, prednisone)


• you have a viral infection of the ear (eg, herpes simplex, chickenpox, shingles)


• you have a perforated ear drum

Contact your doctor or health care provider right away if any of these apply to you.

Before using Cortisporin Solution:

Some medical conditions may interact with Cortisporin Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have asthma

Some MEDICINES MAY INTERACT with Cortisporin Solution. Because little, if any, of Cortisporin Solution is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Cortisporin Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Cortisporin Solution:

Use Cortisporin Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Cortisporin Solution is only for the ear. Do not get it in your eyes, nose, or mouth. If you get Cortisporin Solution in your eyes, rinse immediately with cool tap water.


• Wash your hands before and after using Cortisporin Solution.


• Wash and dry the outer ear with a sterile cotton applicator.


• Lie down or tilt your head so that the affected ear faces up. For adults, gently pull the earlobe up and back to straighten the ear canal. For children, gently pull the earlobe down and back to straighten the ear canal. Drop the medicine into the ear canal. Keep the ear facing up for several minutes so the medicine can run to the bottom of the ear canal. A clean cotton plug may be gently inserted into the ear canal to prevent medicine from leaking out. To prevent germs from getting into your medicine, do not touch the applicator to any surface, including the ear. Keep the container tightly closed.


• To clear up your infection completely, use Cortisporin Solution for the full course of treatment. Keep using it even if you feel better in a few days.


• If you miss a dose of Cortisporin Solution, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Cortisporin Solution.

Important safety information:

• Cortisporin Solution only works against bacteria; it does not treat fungal or viral infections.


• Be sure to use Cortisporin Solution for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.


• Long-term or repeated use of Cortisporin Solution may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.


• If your symptoms do not get better within 7 days or if they get worse, check with your doctor.


• Do NOT take more than the recommended dose or use for longer than 7 days without checking with your doctor.


• Do not use Cortisporin Solution for other ear conditions at a later time.


• Some of these products contain sulfites. Sulfites may cause an allergic reaction in some patients (eg, asthma patients). If you have ever had an allergic reaction to sulfites, ask your pharmacist if your product has sulfites in it.


• Tell your doctor or dentist that you take Cortisporin Solution before you receive any medical or dental care, emergency care, or surgery.


• Cortisporin Solution should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Cortisporin Solution while you are pregnant. It is not known if Cortisporin Solution is found in breast milk after topical use. If you are or will be breast-feeding while you use Cortisporin Solution, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Cortisporin Solution:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Mild, temporary burning or stinging.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); acne-like rash; changes in hearing; decreased urination; dry, scaly, or peeling skin at the application site; continued burning or stinging; excessive hair growth; inflamed hair follicles; inflammation around the mouth; loss of hearing; muscle weakness; pain, redness, itching, irritation, or swelling not present when you began using Cortisporin Solution; thinning, softening, or discoloration of the skin; unusual weight gain, especially in the face.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Cortisporin side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Cortisporin Solution:

Store Cortisporin Solution between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Keep the container tightly closed. Keep Cortisporin Solution out of the reach of children and away from pets.

General information:

• If you have any questions about Cortisporin Solution, please talk with your doctor, pharmacist, or other health care provider.


• Cortisporin Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Cortisporin Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Cortisporin resources

• Cortisporin Side Effects (in more detail)
• Cortisporin Use in Pregnancy & Breastfeeding
• Cortisporin Drug Interactions
• Cortisporin Support Group
• 0 Reviews for Cortisporin - Add your own review/rating

Compare Cortisporin with other medications

• Otitis Externa
• Otitis Media

Chantix

Generic Name: Varenicline tartrate
Class: Autonomic Drugs, Miscellaneous
Chemical Name: 7,8,9,10-tetrahydro-6,10-methano-6H-pyrazino[2,3- h][3]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1)
Molecular Formula: C₁₃H₁₃N₃•C₄H₆O₆
CAS Number: 375815-87-5

Special Alerts:

[UPDATED 07/22/2011] FDA has approved an updated drug label for Chantix (varenicline) to include information about the efficacy and safety of the drug in two patient populations who may benefit greatly from giving up smoking—those with cardiovascular disease and those with chronic obstructive pulmonary disease (COPD). The updated label now also includes alternative directions for patients to select a quit smoking date. For more information visit the FDA website at: and .

[Posted 06/16/2011] ISSUE: FDA notified healthcare professionals and patients that the Prescribing Information for this drug product will be strengthened to inform the public that use of varenicline (Chantix) may be associated with a small, increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease. This safety information will be added to the Warnings and Precautions section and the patient Medication Guide.

BACKGROUND: FDA reviewed a randomized, double-blind, placebo-controlled clinical trial of 700 smokers with cardiovascular disease who were treated with varenicline or placebo. While cardiovascular adverse events were infrequent overall, certain events, including heart attack, were reported more frequently in patients treated with varenicline than in patients treated with placebo. The events included angina pectoris, nonfatal myocardial infarction, need for coronary revascularization, and new diagnosis of peripheral vascular disease or admission for a procedure for the treatment of peripheral vascular disease. FDA is continuing to evaluate the cardiovascular safety of varenicline and is requiring the manufacturer to conduct a large, combined analysis (meta-analysis) of randomized, placebo-controlled trials. FDA will update the public when additional information is available.

RECOMMENDATION: See the Data Summary section of the Drug Safety Communication for additional information.

Healthcare professionals should be aware that smoking is an independent and major risk factor for cardiovascular disease, and smoking cessation is of particular importance in this patient population. The known benefits of varenicline should be weighed against its potential risks when deciding to use the drug in smokers with cardiovascular disease.

Patients are encouraged to read the Medication Guide they receive along with their varenicline prescription. For more information visit the FDA website at: and .

REMS:

FDA approved a REMS for varenicline tartrate to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of varenicline tartrate and consists of the following: medication guide. See the FDA REMS page () or the ASHP REMS Resource Center ().

• Neuropsychiatric Symptoms and Suicide Risk


• 
  

  Serious neuropsychiatric symptoms (e.g., depression, suicidal ideation, suicide attempt, completed suicide) have been reported in patients receiving varenicline for smoking cessation.^{1 10 11 12 13} (See Neuropsychiatric Symptoms and Suicidality under Cautions.)

  
  


• 
  

  Such effects have occurred in patients with or without psychiatric illnesses.^{1 10 11 12 13} Safety and efficacy of varenicline not established in patients with serious psychiatric illness (e.g., schizophrenia, bipolar disorder, major depressive disorder); such patients may experience recurrence or worsening of symptoms during varenicline therapy.^{1 10 12}

  
  


• 
  

  Depressed mood may be a symptom of nicotine withdrawal; however, some symptoms occurred in varenicline-treated patients who continued to smoke.¹

  
  


• 
  

  Most symptoms occurred during varenicline therapy, but some were reported following discontinuance of drug.^{1 10 13}

  
  


• 
  

  Monitor all patients receiving varenicline for neuropsychiatric symptoms, including changes in behavior, hostility, agitation, depressed mood, and suicide-related events (including ideation, behavior, and attempted suicide).^{1 10 12}

  
  


• 
  

  Patient should discontinue varenicline and immediately contact clinician if agitation, hostility, depressed mood, or changes in thinking or behavior not typical for the patient occur, or if patient develops suicidal ideation or behavior.^{1 10 11 13}

  
  


• 
  

  Symptoms resolved upon drug discontinuance in many cases, but persisted in some.^{1 10 12} Provide ongoing patient monitoring and supportive care until symptoms resolve.^{1 10}

  
  


• 
  

  Weigh risks of varenicline therapy against benefits of its use for smoking cessation.^{1 7 10 13}

  
  

Introduction

Nicotinic acetylcholine receptor partial agonist.¹

Uses for Chantix

Smoking Cessation

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Adjunct in the cessation of cigarette smoking.^{1 3 4 5 7 8}

Urge to smoke was less severe in individuals receiving varenicline than in those receiving placebo.^{1 3 4 5}

Efficacy and safety of varenicline given in conjunction with other smoking cessation therapies (e.g., bupropion, nicotine replacement therapy) have not been established.¹

Chantix Dosage and Administration

Administration

Oral Administration

Administer tablets orally after eating, with a full glass of water.^{1 3 4 5 7}

Dosage

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Available as varenicline tartrate; dosage expressed in terms of varenicline.¹

Adults

Smoking Cessation

Oral

0.5 mg once daily on days 1–3, followed by 0.5 mg twice daily on days 4–7, and then 1 mg twice daily from day 8 through the end of 12 weeks of treatment.¹ Initiate 1 week before the target smoking cessation date.¹

Titrate dosage during the initial week of treatment to reduce the incidence of drug-related nausea.¹ Dosage may be reduced temporarily or permanently in patients who experience intolerable adverse effects.¹

In patients who have successfully stopped smoking by the end of 12 weeks of initial treatment, consider an additional 12 weeks of therapy to increase the likelihood of long-term abstinence.¹

Patients unable to quit smoking during 12 weeks of treatment or those who have relapsed after varenicline therapy should make another attempt to quit smoking once factors responsible for such failure have been identified and addressed.¹

Prescribing Limits

Adults

Oral

1 mg twice daily.¹

Special Populations

Hepatic Impairment

No dosage adjustment is needed in patients with hepatic impairment.¹

Renal Impairment

No dosage adjustment needed in patients with mild to moderate renal impairment.¹

If Cl_cr is <30 mL/minute, initially administer 0.5 mg once daily; titrate dosage as needed to a maximum of 0.5 mg twice daily.¹

In patients with end-stage renal disease undergoing hemodialysis, maximum dosage is 0.5 mg once daily.¹

Geriatric Patients

Select dosage carefully and monitor renal function.¹

Cautions for Chantix

Contraindications

No known contraindications to the use of varenicline.¹

Warnings/Precautions

Warnings

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Neuropsychiatric Symptoms and Suicidality

Serious neuropsychiatric symptoms, including changes in mood (e.g., depression, mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, hostility, agitation, aggression, anxiety, panic, and suicidality (e.g., suicidal ideation, attempted and completed suicides), reported.^{1 10 11 12 13} (See Neuropsychiatric Symptoms and Suicide Risk in Boxed Warning.)

While some patients who stopped smoking have experienced these symptoms as a result of nicotine withdrawal, others who had not yet discontinued smoking also experienced such symptoms.¹

Monitor all patients for neuropsychiatric symptoms or for worsening of preexisting psychiatric conditions.^{1 10 12} Discontinue varenicline in patients who develop agitation, hostility, depressed mood, or changes in behavior or thinking that are not typical for the patient or who develop suicidal ideation or suicidal behavior.^{1 10 11 13}

Symptoms resolved after varenicline discontinuance in many cases but persisted in some despite discontinuance.^{1 10 12} Provide ongoing patient monitoring and supportive care until symptoms resolve.^{1 10}

Risk of worsening preexisting psychiatric illness.¹ Safety and efficacy of varenicline in patients with serious psychiatric illness (e.g., schizophrenia, bipolar disorder, major depressive disorder) not established.¹

Discuss risk of developing serious neuropsychiatric effects with patients prior to use of varenicline.^{1 10} (See Advice to Patients.) Weigh such risks against health benefits of smoking cessation (e.g., reduction in the risk of developing pulmonary disease, cardiovascular disease, or certain types of cancer).^{1 7 10 13}

Dermatologic Effects

Serious dermatologic reactions, including Stevens-Johnson syndrome and erythema multiforme, reported; potentially life-threatening.¹ Instruct patients to discontinue varenicline and immediately contact healthcare provider at first appearance of rash with mucosal lesions or any signs of hypersensitivity.¹

Sensitivity Reactions

Angioedema and Hypersensitivity Reactions

Hypersensitivity reactions, including angioedema, reported.¹ Manifestations included swelling of the face, mouth (tongue, lips, and gums), extremities, and neck (pharynx and larynx).¹ Life-threatening angioedema requiring emergent medical attention because of respiratory compromise infrequently reported.¹

Instruct patients to discontinue varenicline and immediately seek medical attention if such symptoms occur.¹

General Precautions

Nausea

Nausea is most commonly reported adverse effect; usually mild or moderate, dose related, and often transient (although may persist for several months).^{1 3 4 8}

Initial titration of varenicline dosage reduces incidence of nausea (see Dosage under Dosage and Administration).¹ Consider dosage reduction in patients experiencing intolerable nausea.¹

Accidental Injury

Traffic accidents, near-miss incidents in traffic, or other accidental injuries reported.¹ In some cases, somnolence, dizziness, loss of consciousness or difficulty concentrating was reported.^{1 7} (See Advice to Patients.)

Specific Populations

Pregnancy

Category C.¹

Lactation

Distributed into milk in animals; not known whether varenicline is distributed into human milk.¹ Discontinue nursing or the drug.¹

Pediatric Use

Safety and efficacy not established in children <18 years of age.¹

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.¹

Modification of dosage may be necessary because of age-related decreases in renal function.¹

Renal Impairment

Caution in patients with moderate to severe renal impairment and in patients with end-stage renal disease undergoing hemodialysis.¹ Exposure to the drug was increased in patients with such impairment.¹ Dosage adjustment is recommended for patients with Cl_cr<30 mL/minute.¹ (See Special Populations under Dosage and Administration.)

Common Adverse Effects

Nausea,^{1 3 4 8} abdominal pain,¹ flatulence,^{1 3 4} dyspepsia,^{1 3} vomiting,^{1 3} constipation,^{1 3 4} dry mouth,^{1 3 4} insomnia,^{1 3 4} abnormal dreams,^{1 3 4} sleep disorders,^{1 3 4} headache,^{1 3 4} dysgeusia,¹ fatigue/malaise/asthenia,^{1 3} upper respiratory tract disorders.^{1 9}

Interactions for Chantix

Physiologic changes resulting from smoking cessation (with or without varenicline) may alter the pharmacokinetics or pharmacodynamics of some drugs (e.g., insulin, theophylline, warfarin); dosage adjustment may be required.¹

Does not inhibit CYP isoenzymes 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, 3A4/5 in vitro; does not induce CYP isoenzymes 1A2 or 3A4 in vitro.¹ Pharmacokinetic interactions with drugs metabolized by or affecting these isoenzymes unlikely.¹

Specific Drugs

Drug	Interaction	Comments
Bupropion	Pharmacokinetic interaction unlikely1	Safety of combined use not established1
Cimetidine	Possible increased plasma concentration of varenicline secondary to a reduction in renal clearance1
Digoxin	Pharmacokinetic interaction unlikely1
Nicotine	Pharmacokinetic interaction unlikely;1 increased incidence of adverse effects (nausea, headache, vomiting, dizziness, dyspepsia, fatigue) and increased rate of discontinuance of combination (varenicline and transdermal nicotine replacement) therapy compared with those receiving transdermal nicotine and placebo1	Safety and efficacy of varenicline in combination with other smoking cessation therapies not established1
Warfarin	Pharmacokinetic interaction unlikely;1 warfarin pharmacokinetics may be affected by smoking cessation1

Chantix Pharmacokinetics

Absorption

Bioavailability

Well absorbed following oral administration, with peak plasma concentration usually attained within 3–4 hours.¹ Time of dosing does not appear to affect oral bioavailability.¹

Food

Food does not appear to affect oral bioavailability.¹

Distribution

Plasma Protein Binding

≤20%; independent of age and renal function.¹

Elimination

Metabolism

Undergoes limited biotransformation.¹

Elimination Route

Excreted in urine principally (92%) as unchanged drug.¹

Half-life

24 hours.¹

Special Populations

No evidence of gender-, age-, race-, smoking status-, or concomitant drug-related pharmacokinetic differences.¹

In patients with moderate (Cl_cr ≤50 mL/minute) to severe (Cl_cr <30 mL/minute) renal impairment or end-stage renal disease undergoing hemodialysis, exposure to the drug was increased. ¹ (See Special Populations under Dosage and Administration.)

Stability

Storage

Oral

Tablets

25°C (may be exposed to 15–30°C).¹

Actions

• 
  

  Binds with high affinity and selectivity to α₄β₂ nicotinic acetylcholine receptors located in the brain to stimulate receptor-mediated activity, but at a substantially lower level than nicotine.^{1 6}

  
  


• 
  

  Stimulation and subsequent moderate, sustained release of mesolimbic dopamine are thought to reduce craving and withdrawal symptoms associated with smoking cessation.^{1 4 6}

  
  


• 
  

  Blocks the ability of nicotine to activate α₄β₂ receptors by preventing nicotine-induced stimulation of the mesolimbic dopaminergic system and thus reducing the reinforcement and reward effects of cigarette smoking.^{1 6}

  
  

Advice to Patients

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

• 
  

  Importance of providing educational materials and counseling to support attempt to quit smoking.¹ Patients should be instructed to read the patient medication guide before initiation of varenicline therapy and every time the prescription is refilled since the information may have been revised.^{1 7}

  
  


• 
  

  Advise patients to set a date to quit smoking and to start varenicline therapy 1 week prior to the quit date.^{1 7}

  
  


• 
  

  Importance of taking varenicline after eating and with a full glass of water.^{1 7}

  
  


• 
  

  Importance of instructing patients how to titrate varenicline tartrate dosage, starting with a dosage of 0.5 mg daily.^{1 7} (See Smoking Cessation under Dosage and Administration.)

  
  


• 
  

  Advise patients to take the drug exactly as prescribed by clinician.⁷

  
  


• 
  

  Advise patients not to take varenicline while using other smoking cessation treatments.⁷ Importance of informing clinician if using other smoking cessation treatments.⁷

  
  


• 
  

  Advise patients to notify clinician if nausea or insomnia persistently occur; consideration of dosage reduction may be necessary.¹

  
  


• 
  

  Importance of encouraging patients to continue to attempt to quit smoking if they have early lapses after the set quit date.¹

  
  


• 
  

  Importance of informing patients that quitting smoking, with or without use of varenicline, may be associated with symptoms of nicotine withdrawal (e.g., depression, agitation, urge to smoke, difficulty sleeping, irritability, frustration, anger, anxiety, difficulty concentrating, restlessness, decreased heart rate, increased appetite, weight gain) or exacerbation of preexisting psychiatric illness.^{1 7 10 13}

  
  


• 
  

  Importance of advising patients and their caregivers that changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, agitation, aggression, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide, have been reported in patients attempting to quit smoking while receiving varenicline.^{1 7 10 11 12 13} Importance of advising patients to discontinue varenicline and notify a clinician if they or their caregivers observe agitation, depressed mood, or changes in behavior or thinking that are not typical for the patients, or if the patient develops suicidal ideation or suicidal behavior.^{1 7 10 11 13} Importance of informing clinicians of preexisting psychiatric illness.^{1 7}

  
  


• 
  

  Importance of immediately discontinuing varenicline and contacting a clinician at first sign of rash with mucosal lesions (e.g., peeling skin, mouth blisters) or other skin reactions or symptoms of angioedema (e.g., swelling of the face, mouth [lips, gums, tongue], throat).^{1 7}

  
  


• 
  

  Importance of informing clinicians about development of symptoms associated with previous attempts to quit smoking (with or without varenicline).⁷

  
  


• 
  

  Importance of informing patients that they may experience vivid, unusual, or strange dreams during varenicline treatment.^{1 7}

  
  


• 
  

  Somnolence, dizziness, or difficulty concentrating reported.^{1 7} Importance of advising patients to use caution while driving, operating machinery, or engaging in other potentially hazardous activities until the effects of varenicline on the individual are known.^{1 7}

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹ Advise women who are or plan to become pregnant or plan to breast-feed of risks of smoking and risks and benefits of using varenicline to aid in smoking cessation.¹

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses (e.g., depression or other psychiatric illness, renal disease).^{1 7} Some concomitantly administered drugs may require dosage adjustment due to effects of smoking cessation.^{1 7}

  
  


• 
  

  Importance of informing patients of other important precautionary information. (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Varenicline Tartrate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Kit	11 Tablets, film-coated, Varenicline Tartrate 0.5 mg (of varenicline) (Chantix) 42 Tablets, film-coated, Varenicline Tartrate 1 mg (of varenicline) (Chantix)	Chantix Pack (available as dose/cards for first month of therapy)	Pfizer
	Tablets, film-coated	0.5 mg (of varenicline)	Chantix	Pfizer
		1 mg (of varenicline)	Chantix (available as 4 cards of 14 tablets and regular packaging)	Pfizer

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 10/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Chantix 0.5MG Tablets (PFIZER U.S.): 56/$177.65 or 168/$499.17

Chantix 1MG Tablets (PFIZER U.S.): 56/$179.00 or 168/$506.96

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions October 27, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Pfizer Labs. Chantix (varenicline) tablets prescribing information. New York, NY; 2009 Jul.

2. Kuehn BM. FDA speeds smoking cessation drug review. JAMA. 2006; 295:614. [PubMed 16467225]

3. Jorenby DE, Hays JT, Rigotti NA et al. Efficacy of varenicline, an α4β2 nicotinic acetylcholine receptor partial agonist, vs placebo or sustained-release bupropion for smoking cessation: a randomized controlled trial. JAMA. 2006; 296:56-63. [PubMed 16820547]

4. Gonzales D, Rennard SI, Nides M et al. Varenicline, an α4β2 nicotinic acetylcholine receptor partial agonist, vs sustained-release bupropion and placebo for smoking cessation: a randomized controlled trial. JAMA. 2006; 296:47-55. [PubMed 16820546]

5. Tonstad S, Tonnesen P, Hajek P et al. Effect of maintenance therapy with varenicline on smoking cessation: a randomized controlled trial. JAMA. 2006; 296:64-71. [PubMed 16820548]

6. Coe JW, Brooks PR, Vetelino MG et al. Varenicline: an α₄β₂ nicotinic receptor partial agonist for smoking cessation. J Med Chem. 2005; 48:3474-7. [PubMed 15887955]

7. Pfizer Labs. Medication Guide: Chantix (varenicline) tablets. New York, NY; 2009 Jul.

8. Klesges RC, Johnson KC, Somes G. Varenicline for smoking cessation: definite promise, but not panacea. JAMA. 2006; 296:94-5. [PubMed 16820552]

9. Pifzer Inc., Morris Plains, NJ: Personal communication.

10. Food and Drug Administration. FDA Alert: Information for healthcare professionals: varenicline (marketed as Chantix) and bupropion (marketed as Zyban, Wellbutrin, and generics). Rockville, MD; 2009 Jul 1. From the FDA web site: . Accessed 2009 Sep 24.

11. Food and Drug Administration. FDA MedWatch alert: varenicline (marketed as Chantix) and bupropion (marketed as Zyban, Wellbutrin, and generics). Rockville, MD; 2009 Jul 1. From the FDA web site: . Accessed 2009 Sep 25.

12. Pollock M, Lee JH. The smoking cessation aids varenicline (marketed as Chantix) and bupropion (marketed as Zyban and generics): suicidal ideation and behavior. Drug Safety Newsletter. 2009; 2:1–4. From the FDA web site: . Accessed 2009 Sep 25.

13. Food and Drug Administration. Public Health Advisory: FDA requires new boxed warnings for the smoking cessation drugs Chantix and Zyban. Rockville, MD; 2009 Jul 1. From the FDA web site: . Accessed 2009 Sep 25.

More Chantix resources

• Chantix Side Effects (in more detail)
• Chantix Use in Pregnancy & Breastfeeding
• Drug Images
• Chantix Drug Interactions
• Chantix Support Group
• 369 Reviews for Chantix - Add your own review/rating

• Chantix Prescribing Information (FDA)


• Chantix Consumer Overview


• Chantix Advanced Consumer (Micromedex) - Includes Dosage Information


• Chantix MedFacts Consumer Leaflet (Wolters Kluwer)


• Varenicline Professional Patient Advice (Wolters Kluwer)

Compare Chantix with other medications

• Smoking Cessation