Hasalbu

Hasalbu may be available in the countries listed below.

Ingredient matches for Hasalbu

Salbutamol

Salbutamol is reported as an ingredient of Hasalbu in the following countries:

• Vietnam

International Drug Name Search

Leucovorin Kalbe

Leucovorin Kalbe may be available in the countries listed below.

Ingredient matches for Leucovorin Kalbe

Calcium Folinate

Calcium Folinate is reported as an ingredient of Leucovorin Kalbe in the following countries:

• Indonesia

International Drug Name Search

Carafate

Generic Name: sucralfate

Dosage Form: oral suspension
Carafate (sucralfate) Suspension

Carafate Description

Carafate Suspension contains sucralfate and sucralfate is an α-D-glucopyranoside, β-D-fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex.

Carafate Suspension for oral administration contains 1 g of sucralfate per 10 mL.

Carafate Suspension also contains: colloidal silicon dioxide NF, FD&C Red #40, flavor, glycerin USP, methylcellulose USP, methylparaben NF, microcrystalline cellulose NF, purified water USP, simethicone USP, and sorbitol solution USP. Therapeutic category: antiulcer.

Carafate - Clinical Pharmacology

Sucralfate is only minimally absorbed from the gastrointestinal tract. The small amounts of the sulfated disaccharide that are absorbed are excreted primarily in the urine.

Although the mechanism of sucralfate’s ability to accelerate healing of duodenal ulcers remains to be fully defined, it is known that it exerts its effect through a local, rather than systemic, action. The following observations also appear pertinent:

1. Studies in human subjects and with animal models of ulcer disease have shown that sucralfate forms an ulcer-adherent complex with proteinaceous exudate at the ulcer site.


2. In vitro, a sucralfate-albumin film provides a barrier to diffusion of hydrogen ions.


3. In human subjects, sucralfate given in doses recommended for ulcer therapy inhibits pepsin activity in gastric juice by 32%.


4. In vitro, sucralfate adsorbs bile salts.

These observations suggest that sucralfate’s antiulcer activity is the result of formation of an ulcer-adherent complex that covers the ulcer site and protects it against further attack by acid, pepsin, and bile salts. There are approximately 14 to 16 mEq of acid-neutralizing capacity per 1-g dose of sucralfate.

Clinical Trials

In a multicenter, double-blind, placebo-controlled study of Carafate Suspension, a dosage regiment of 1 g (10 mL) four times daily was demonstrated to be superior to placebo in ulcer healing.

Results From Clinical Trials Healing Rates for Acute Duodenal Ulcer

* P=0.016 † P=0.001 ‡ P=0.0001
Treatment	n	Week 2 Healing Rates	Week 4 Healing Rates	Week 8 Healing Rates
Carafate Suspension	145	23(16%)*	66(46%)†	95(66%)‡
Placebo	147	10(7%)	39(27%)	58(39%)

Equivalence of sucralfate suspension to sucralfate tablets has not been demonstrated.

Indications and Usage for Carafate

Carafate (sucralfate) Suspension is indicated in the short-term (up to 8 weeks) treatment of active duodenal ulcer.

Contraindications

There are no known contraindications to the use of sucralfate.

Precautions

Duodenal ulcer is a chronic, recurrent disease. While short-term treatment with sucralfate can result in complete healing of the ulcer, a successful course of treatment with sucralfate should not be expected to alter the posthealing frequency or severity of duodenal ulceration.

Episodes of hyperglycemia have been reported in diabetic patients. Close monitoring of glycemia in diabetic patients treated with sucralfate suspension is recommended. Adjustment of the anti-diabetic treatment dose during the use of sucralfate suspension might be necessary.

Special Populations: Chronic Renal Failure and Dialysis Patients

When sucralfate is administered orally, small amounts of aluminum are absorbed from the gastrointestinal tract. Concomitant use of sucralfate with other products that contain aluminum, such as aluminum-containing antacids, may increase the total body burden of aluminum. Patients with normal renal function receiving the recommended doses of sucralfate and aluminum-containing products adequately excrete aluminum in the urine. Patients with chronic renal failure or those receiving dialysis have impaired excretion of absorbed aluminum. In addition, aluminum does not cross dialysis membranes because it is bound to albumin and transferrin plasma proteins. Aluminum accumulation and toxicity (aluminum osteodystrophy, osteomalacia, encephalopathy) have been described in patients with renal impairment. Sucralfate should be used with caution in patients with chronic renal failure.

Drug Interactions

Some studies have shown that simultaneous sucralfate administration in healthy volunteers reduced the extent of absorption (bioavailability) of single doses of the following: cimetidine, digoxin, fluoroquinolone antibiotics, ketoconazole, l-thyroxine, phenytoin, quinidine, ranitidine, tetracycline, and theophylline. Subtherapeutic prothrombin times with concomitant warfarin and sucralfate therapy have been reported in spontaneous and published case reports. However, two clinical studies have demonstrated no change in either serum warfarin concentration or prothrombin time with the addition of sucralfate to chronic warfarin therapy.

The mechanism of these interactions appears to be nonsystemic in nature, presumably resulting from sucralfate binding to the concomitant agent in the gastrointestinal tract. In all cases studied to date (cimetidine, ciprofloxacin, digoxin, norfloxacin, ofloxacin, and ranitidine), dosing the concomitant medication 2 hours before sucralfate eliminated the interaction. Because of the potential of Carafate to alter the absorption of some drugs, Carafate should be administered separately from other drugs when alterations in bioavailability are felt to be critical. In these cases, patients should be monitored appropriately.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Chronic oral toxicity studies of 24 months’ duration were conducted in mice and rats at doses up to 1 g/kg (12 times the human dose).

There was no evidence of drug-related tumorigenicity. A reproduction study in rats at doses up to 38 times the human dose did not reveal any indication of fertility impairment. Mutagenicity studies were not conducted.

Pregnancy

Teratogenic effects. Pregnancy Category B.

Teratogenicity studies have been performed in mice, rats, and rabbits at doses up to 50 times the human dose and have revealed no evidence of harm to the fetus due to sucralfate. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when sucralfate is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies of Carafate Suspension did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the 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. (See DOSAGE AND ADMINISTRATION)

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. (See PRECAUTIONS Special Populations: Chronic Renal Failure and Dialysis Patients) Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Adverse Reactions

Adverse reactions to sucralfate tablets in clinical trials were minor and only rarely led to discontinuation of the drug. In studies involving over 2700 patients treated with sucralfate, adverse effects were reported in 129 (4.7%).

Constipation was the most frequent complaint (2%). Other adverse effects reported in less than 0.5% of the patients are listed below by body system:

Gastrointestinal: diarrhea, dry mouth, flatulence, gastric discomfort, indigestion, nausea, vomiting

Dermatological: pruritus, rash

Nervous System: dizziness, insomnia, sleepiness, vertigo

Other: back pain, headache

Postmarketing reports of hypersensitivity reactions, including urticaria (hives), angioedema, respiratory difficulty, rhinitis, laryngospasm, and facial swelling have been reported in patients receiving sucralfate tablets. Similar events were reported with sucralfate suspension. However, a causal relationship has not been established.

Cases of hyperglycemia have been reported with sucralfate

Bezoars have been reported in patients treated with sucralfate. The majority of patients had underlying medical conditions that may predispose to bezoar formation (such as delayed gastric emptying) or were receiving concomitant enteral tube feedings.

Inadvertent injection of insoluble sucralfate and its insoluble excipients has led to fatal complications, including pulmonary and cerebral emboli. Sucralfate is not intended for intravenous administration.

Overdosage

Due to limited experience in humans with overdosage of sucralfate, no specific treatment recommendations can be given. Acute oral studies in animals, however, using doses up to 12 g/kg body weight, could not find a lethal dose. Sucralfate is only minimally absorbed from the gastrointestinal tract. Risks associated with acute overdosage should, therefore, be minimal. In rare reports describing sucralfate overdose, most patients remained asymptomatic. Those few reports where adverse events were described included symptoms of dyspepsia, abdominal pain, nausea, and vomiting.

Carafate Dosage and Administration

Active Duodenal Ulcer. The recommended adult oral dosage for duodenal ulcer is 1 g (10 mL/2 teaspoonfuls) four times per day. Carafate should be administered on an empty stomach.

Antacids may be prescribed as needed for relief of pain but should not be taken within one-half hour before or after sucralfate.

While healing with sucralfate may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination.

Elderly: 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. (See PRECAUTIONS Geriatric Use)

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

How is Carafate Supplied

Carafate (sucralfate) Suspension 1 g/10 mL is a pink suspension supplied in bottles of 14 fl oz (NDC 58914-170-14).

SHAKE WELL BEFORE USING. AVOID FREEZING.

Store at controlled room temperature 20-25°C (68-77°F)[see USP].

Rx Only

Prescribing Information as of December 2010

Axcan Pharma US, Inc.

22 Inverness Center Parkway

Birmingham, AL 35242

USA

www.axcan.com

Principal Display Panel

Carafate Suspension, Box

Carafate Suspension, Foil

Carafate Suspension, Bottle

Carafate   sucralfate  suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 58914-170 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sucralfate (Sucralfate) Sucralfate 1 g  in 10 mL

Inactive Ingredients Ingredient Name Strength FD&C RED NO. 40 0.004 mg  in 10 mL Glycerin 87.92 mg  in 10 mL Methylparaben 1.78 mg  in 10 mL Sorbitol 177.62 mg  in 10 mL Water 618.006 mg  in 10 mL

Product Characteristics Color pink Score      Shape Size Flavor CHERRY (Maraschino Cherry Artificial Flavor #2359) Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 58914-170-14 414 mL In 1 BOTTLE None 2 58914-170-60 6 CUP In 1 BOX contains a CUP, UNIT-DOSE 2 295.7 mL In 1 CUP, UNIT-DOSE This package is contained within the BOX (58914-170-60)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019183	12/16/1993

Labeler - Axcan Pharma Inc. (787651231)

Establishment
Name	Address	ID/FEI	Operations
Sanofi Aventis US, Inc.		783243835	MANUFACTURE, pack, analysis

Revised: 01/2011Axcan Pharma Inc.

More Carafate resources

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

• Carafate Monograph (AHFS DI)


• Carafate Consumer Overview


• Carafate Advanced Consumer (Micromedex) - Includes Dosage Information


• Carafate MedFacts Consumer Leaflet (Wolters Kluwer)


• Sucralfate Professional Patient Advice (Wolters Kluwer)

Compare Carafate with other medications

• Duodenal Ulcer
• Duodenal Ulcer Prophylaxis
• GERD
• Hyperphosphatemia of Renal Failure
• Stomach Ulcer
• Stomatitis
• Stress Ulcer Prophylaxis

Transient Ischemic Attack Medications

Definition of Transient Ischemic Attack:

A transient ischemic attack (TIA) is an episode in which a person has stroke -like symptoms for up to 1-2 hours. A TIA is often considered a warning sign that a true stroke may happen in the future if something is not done to prevent it.

Drugs associated with Transient Ischemic Attack

The following drugs and medications are in some way related to, or used in the treatment of Transient Ischemic Attack. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Learn more about Transient Ischemic Attack

Micromedex Care Notes:

• Transient Ischemic Attack

Medical Encyclopedia:

• Transient ischemic attack

Harvard Health Guide:

• Symptoms and treatment for Transient Ischemic Attack (TIA)

Drug List:

Arthritis-Pain

Aspergum-Gum

Aspir-81

Aspir-Low

Aspirin-Lite-Coat

Aspirin-Low-Dose

Aspiritab

Bayer

Bayer-Plus

Bayer-Low-Adult-Strength-Controlled-Release-Tablets

Bayer-Children-S-Chewable-Tablets

Bayer-Aspirin-With-Calcium

Buffered-Aspirin

Bufferin

Bufferin-Arthritis-Strength

Bufferin-Extra-Strength

Easprin

Ecotrin-Delayed-Release-Tablets

Ecotrin-Adult-Low-Strength

Ecotrin-Maximum-Strength

Empirin

Fasprin

Genacote

Halfprin

Litecoat-Aspirin

Medi-Seltzer-Effervescent-Tablets

Norwich-Aspirin

Plavix

St-Joseph-Aspirin-Adult-Ec

St-Joseph-Aspirin-Adult-Chewable

St-Joseph-81-Mg-Adult-Chewable-Tablets

Stanback-Analgesic

Tri-Buffered-Aspirin

Ysp-Aspirin

Zorprin-Controlled-Release-Tablets

Clobex

Generic Name: clobetasol (Topical application route)

kloe-BAY-ta-sol PROE-pee-oh-nate

Commonly used brand name(s)

In the U.S.

• Clobevate


• Clobex


• Cormax


• Embeline


• Embeline E


• Embeline Scalp Application


• Olux


• Olux/Olux-E Complete Pack


• Olux-E


• Temovate


• Temovate E

In Canada

• Clobetasol Propionate


• Dermovate


• Dermovate Scalp Application


• Med Clobetasol Scalp Application


• Ratio-Clobetasol

Available Dosage Forms:

• Cream


• Ointment


• Gel/Jelly


• Spray


• Solution


• Foam


• Emollient Cream


• Lotion


• Shampoo

Therapeutic Class: Corticosteroid, Very Strong

Pharmacologic Class: Clobetasol

Uses For Clobex

Clobetasol topical is used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions. The solution and foam are used for scalp problems, the lotion and spray are used for moderate to severe plaque psoriasis, and the shampoo is used for moderate to severe scalp psoriasis. This medicine is a corticosteroid (cortisone-like medicine or steroid).

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

Before Using Clobex

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of clobetasol topical gel, foam, cream, ointment, or scalp solution in children 12 years of age and older. However, because of this medicine's toxicity, it should be used with caution. Children may absorb large amounts through the skin, which can cause serious side effects. If your child is using this medicine, follow your doctor's instructions very carefully. Safety and efficacy have not been established in children younger than 12 years of age and the use of clobetasol topical gel, foam, cream, ointment, or scalp solution is not recommended. The safety and efficacy of clobetasol topical spray, lotion, or shampoo have not been established in children and use is not recommended.

Geriatric

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

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:

• Cushing's syndrome (adrenal gland disorder) or


• Diabetes or


• Hyperglycemia (high blood sugar) or


• Intracranial hypertension (increased pressure in the head)—Use with caution. May make these conditions worse.

• Infection of the skin at or near the place of application or


• Large sores, broken skin, or severe skin injury at the place of application—The chance of side effects may be increased.

• Perioral dermatitis (skin problem) or


• Rosacea (skin problem)—Should not be used in patients with these conditions.

Proper Use of clobetasol

This section provides information on the proper use of a number of products that contain clobetasol. It may not be specific to Clobex. 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 is for use on the skin only. 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.

This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other 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.

Do not use this medicine on the face, groin, or underarms unless directed to do so by your doctor.

To use the cream, foam, gel, lotion, ointment, or spray:

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


• Apply a thin layer of this medicine to the affected area of the skin. Rub it in gently.


• With the lotion, protect the skin from water, clothing, or anything that causes rubbing until the medicine has dried. Also, shake the lotion well before using it.


• Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.

To use the foam, scalp solution, or shampoo:

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


• Apply a thin layer of this medicine to the affected area of the scalp. Rub it in gently.


• Do not cover the scalp (e.g., shower cap, bathing cap) while it is being treated.


• Do not use the shampoo for more than 4 weeks, the foam and scalp solution for more than 2 weeks unless your doctor has told you to.

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

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 redness, itching, and swelling of the skin:
  
  • For topical dosage forms (cream, gel, or ointment):
    
    • Adults—Apply to the affected area of the skin two times per day.
    
    
    • Children 12 to 17 years of age—Apply to the affected area of the skin two times per day.
    
    
    • Children younger than 12 years of age—Use is not recommended.
    
    
  
  
  • For topical dosage form (lotion):
    
    • Adults—Apply to the affected area of the skin two times per day.
    
    
    • Children—Use is not recommended.
    
    
  
  


• For plaque psoriasis:
  
  • For topical dosage form (foam):
    
    • Adults—Apply to the affected area of the skin two times per day, once in the morning and once at night.
    
    
    • Children 12 to 17 years of age—Apply to the affected area of the skin two times per day, once in the morning and once at night.
    
    
    • Children younger than 12 years of age—Use is not recommended.
    
    
  
  
  • For topical dosage form (spray):
    
    • Adults—Spray to the affected area of the skin two times per day.
    
    
    • Children—Use is not recommended.
    
    
  
  


• For scalp problems:
  
  • For topical dosage form (foam or scalp solution):
    
    • Adults—Apply to the affected area of the scalp two times per day, once in the morning and once at night.
    
    
    • Children 12 to 17 years of age—Apply to the affected area of the scalp two times per day, once in the morning and once at night.
    
    
    • Children younger than 12 years of age—Use is not recommended.
    
    
  
  
  • For topical dosage form (shampoo):
    
    • Adults—Apply to the affected area of the scalp once a day.
    
    
    • Children—Use is not recommended.
    
    
  
  

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.

Store the foam can at room temperature, away from heat and direct light. Do not keep this medicine inside a car where it could be exposed to extreme heat. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Precautions While Using Clobex

It is very important that your doctor check the progress of you or your child at regular visits for any unwanted effects that may be caused by this medicine.

If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and patients who use large amounts for a long time. Talk to your doctor right away if you or your child have more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; a fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.

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

Make sure your doctor knows that you are using clobetasol gel. You may need to stop using this medicine several days before having surgery.

Do not use cosmetics or other skin care products on the treated areas.

Clobex 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

• Burning or stinging at the application site

Less common

• Burning sensation of the skin


• dry skin


• flushing or redness of the skin


• itching, scaling, severe redness, soreness, or swelling of the skin


• skin irritation


• skin rash, encrusted, scaly and oozing


• thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (e.g. between the fingers)

Incidence not known

• Burning, itching, and pain in hairy areas, or pus at the root of the hair


• hair loss


• redness and scaling around the mouth


• thinning of the hair


• thinning, weakness, or wasting away of the skin

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

• Cough


• sore throat

Less common

• Burning, itching, and pain in hairy areas, or pus at the root of the hair


• changes in skin coloring


• body aches or pain


• congestion


• cough


• dryness or soreness of the throat


• fever


• headache


• hoarseness


• raised, dark red, wart-like spots on the skin, especially when used on the face


• skin discomfort


• stuffy or runny nose


• tender, swollen glands in the neck


• trouble with swallowing


• unusual tiredness or weakness


• voice changes

Incidence not known

• Acne or pimples


• burning and itching of the skin with pinhead-sized red blisters


• increased hair growth on the forehead, back, arms, and legs


• lightening of normal skin color


• lightening of treated areas of dark skin


• reddish purple lines on the arms, face, legs, trunk, or groin


• softening of the skin

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: Clobex side effects (in more detail)

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More Clobex resources

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

• Clobex Prescribing Information (FDA)


• Clobex Lotion MedFacts Consumer Leaflet (Wolters Kluwer)


• Clobex Concise Consumer Information (Cerner Multum)


• Cormax Prescribing Information (FDA)


• Embeline Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Olux Prescribing Information (FDA)


• Olux Foam MedFacts Consumer Leaflet (Wolters Kluwer)


• Olux-E Prescribing Information (FDA)


• Olux-E Emollient Foam MedFacts Consumer Leaflet (Wolters Kluwer)


• Temovate Prescribing Information (FDA)

Compare Clobex with other medications

• Atopic Dermatitis
• Dermatitis
• Lichen Planus
• Lichen Sclerosus
• Psoriasis

mitotane

MYE-toe-tane

Oral route(Tablet)

Mitotane should be temporarily discontinued immediately following shock or severe trauma since adrenal suppression is its prime action. Exogenous steroids should be administered in such circumstances, since the depressed adrenal may not immediately start to secrete steroids .

Commonly used brand name(s)

In the U.S.

• Lysodren

Available Dosage Forms:

• Tablet

Therapeutic Class: Adrenocortical Suppressant

Uses For mitotane

Mitotane is used to treat some types of cancer in the adrenal glands. mitotane acts on a part of the body called the adrenal cortex. Mitotane reduces the amount of steroids (cortisone-like hormones) that are produced by the adrenal cortex. These hormones are important for various functions of the body, including growth. However, too much of these hormones can cause problems.

mitotane is available only with your doctor's prescription.

Before Using mitotane

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 mitotane, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to mitotane 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 mitotane 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 mitotane in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require an adjustment in the dose for patients receiving mitotane.

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. When you are taking mitotane, 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 mitotane 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.

• Rotavirus Vaccine, Live

Using mitotane 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.

• Adenovirus Vaccine Type 4, Live


• Adenovirus Vaccine Type 7, Live


• Bacillus of Calmette and Guerin Vaccine, Live


• Influenza Virus Vaccine, Live


• Measles Virus Vaccine, Live


• Mumps Virus Vaccine, Live


• Rotavirus Vaccine, Live


• Rubella Virus Vaccine, Live


• Smallpox Vaccine


• Sunitinib


• Typhoid Vaccine


• Varicella Virus Vaccine


• Yellow Fever Vaccine

Using mitotane 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.

• Midazolam


• Warfarin

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 mitotane. Make sure you tell your doctor if you have any other medical problems, especially:

• Injury, serious or


• Shock or


• Trauma, severe—Should not be used in patients with these conditions.

• Liver disease—The effects may be increased because of slower removal of the medicine from the body.

Proper Use of mitotane

Medicines used to treat cancer are very strong and can have many side effects. Before receiving mitotane, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

Take mitotane only as directed by your doctor. Do not take more or less of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Do not stop taking mitotane without first checking with your doctor. To do so may increase the chance of unwanted effects.

Swallow the tablet whole. Do not crush, break, or chew it. If contact with broken or crushed tablets occurs, wash your hands immediately.

Dosing

The dose of mitotane 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 mitotane. 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 oral dosage form (tablets):
  
  • For cancer of the adrenal glands:
    
    • Adults—At first, 2 to 6 grams (g) per day, given in divided doses three or four times a day. Your doctor may adjust your dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of mitotane, take 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. Do not double doses.

Storage

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

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.

Precautions While Using mitotane

It is very important that your doctor check you at regular visits for any problems or unwanted effects that may be caused by mitotane.

Your doctor may want you to carry an identification card or wear a bracelet stating that you are taking mitotane.

Check with your doctor right away if you get a serious injury, infection, or illness of any kind. mitotane may weaken your body's defenses against infection or inflammation.

Adrenal insufficiency may develop in patients using mitotane. Check with your doctor right away if you have more than one of the following symptoms: darkening of the skin; diarrhea; dizziness; fainting; loss of appetite; mental depression; nausea; skin rash; unusual tiredness or weakness; or vomiting.

mitotane will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates or medicine for seizures; tricyclic antidepressants (medicine for depression); muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using mitotane.

mitotane may cause some people to become dizzy, drowsy, or less alert than they are normally. Make sure you know how you react to mitotane before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

mitotane may cause some people to have changes in their behavior or memory, or to become depressed. This usually occurs in people who take mitotane for more than 2 years. If you or your caregiver notice any changes in behavior while you are taking mitotane, talk to your doctor right away.

mitotane 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

• Darkening of the skin


• diarrhea


• dizziness or lightheadedness


• drowsiness


• loss of appetite


• mental depression


• nausea or vomiting


• skin rash


• unusual tiredness or weakness

Less common

• Blood in the urine


• blurred vision


• double vision

Rare

• Shortness of breath


• wheezing

Incidence not known

• Chills


• cloudy urine


• cold sweats


• confusion


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


• feeling of warmth


• fever


• frequent urination


• headache


• lower abdominal cramping


• nervousness


• painful urination


• pounding in the ears


• redness of the face, neck, arms, and occasionally, upper chest


• slow or fast heartbeat


• vision changes


• white area over the eye

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

• Feeling of constant movement of self or surroundings


• indigestion


• passing of gas


• sensation of spinning


• sleepiness


• stomach pain, fullness, or discomfort


• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Less common

• Aching muscles


• flushing or redness of the skin


• muscle twitching

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: mitotane 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 mitotane resources

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

• mitotane Concise Consumer Information (Cerner Multum)


• Mitotane Professional Patient Advice (Wolters Kluwer)


• Mitotane MedFacts Consumer Leaflet (Wolters Kluwer)


• Mitotane Monograph (AHFS DI)


• Lysodren Prescribing Information (FDA)

Compare mitotane with other medications

• Adrenal Cortical Carcinoma

Clomiphene Citrate

Class: Estrogen Agonists-Antagonists
ATC Class: G03XC
VA Class: HS400
CAS Number: 50-41-9
Brands: Clomid, Serophene

Introduction

Estrogen agonist-antagonist; a nonsteroidal ovulatory stimulant.^{a b}

Uses for Clomiphene Citrate

Female Infertility

Used to induce ovulation in appropriately selected anovulatory women desiring pregnancy in whom ovulatory dysfunction has been demonstrated.^{a b} (See General under Dosage and Administration and also see Contraindications under Cautions.)

Optimum results obtained in patients with adequately functioning anterior pituitary gland, adrenals, ovaries, and thyroid, including women with polycystic ovary syndrome, amenorrhea-galactorrhea syndrome, psychogenic amenorrhea, post-oral-contraceptive amenorrhea, and certain cases of secondary amenorrhea of unknown etiology.^{a b} Better results usually obtained in patients with adequate serum estrogen concentrations; however, reduced serum estrogen concentrations do not always preclude successful therapy.^{a b}

Use recommended only in women who are not pregnant, without ovarian cysts or ovarian enlargement (unless enlargement is due to polycystic ovarian syndrome), with normal liver function, and with no abnormal vaginal bleeding.^{a b} (See General under Dosage and Administration and also see Contraindications under Cautions.)

Ineffective in patients with primary pituitary or ovarian failure;^{a b} not a substitute for appropriate therapy of other conditions that may cause ovulatory dysfunction (e.g., thyroid or adrenal disease).^b

Manufacturer states that clomiphene is not recommended to induce ovulation associated with in vitro fertilization programs.^a

Clomiphene Citrate Dosage and Administration

General

• 
  

  Should be prescribed by clinicians experienced in management of gynecologic and endocrine disorders.^a

  
  


• 
  

  Carefully evaluate patient prior to each course of therapy to exclude pregnancy, ovarian enlargement, or ovarian cyst formation.^a (See the following sections under Cautions: Ovarian Enlargement and Cyst Formation, and Ovarian Hyperstimulation Syndrome, and Adequate Patient Evaluation and Monitoring, and Contraindications.)

  
  


• 
  

  Prior to initiating therapy, carefully evaluate patient for adequate endogenous estrogen levels, for primary pituitary or ovarian failure, and for the presence of endometriosis, endometrial carcinoma, or uterine fibroids.^{a b} Exclude or treat all impediments to achieving ovulation and conception (e.g., thyroid disorders, adrenal disorders, hyperprolactinemia, male partner infertility).^{a b} (See Adequate Patient Evaluation and Monitoring and also see Uterine Fibroids, under Cautions.)

  
  


• 
  

  Therapy may be started at any time in patients with no recent uterine bleeding.^b If progestin-induced bleeding is planned, or if spontaneous uterine bleeding occurs prior to therapy, initiate regimen on the fifth day of the menstrual cycle.^b Once ovulation has been established, initiate each subsequent course of therapy on the fifth day of the menstrual cycle.^b Reevaluate patient if ovulatory menses does not occur.^a

  
  


• 
  

  Majority of responding patients will ovulate after the first course of therapy, generally within 5–10 days.^{a b}

  
  


• 
  

  Prolonged amenorrhea may be less responsive and may require ≥2 cycles of therapy. ^b

  
  


• 
  

  Likelihood of conception decreases with each succeeding course of therapy.^b

  
  

Administration

Oral Administration

Administer orally once daily.^b

Dosage

Available as clomiphene citrate; dosage expressed in terms of the salt.^{a b}

Adults

Female Infertility

Oral

Initially, 50 mg once daily for 5 days.^{a b}

If ovulation occurs after initial course of therapy, continue with initial dosage of 50 mg once daily for 5 days starting on the fifth day of the menstrual cycle in subsequent treatment cycles.^{a b} If 3 ovulatory responses occur, but pregnancy is not achieved, further treatment not recommended.^a

If ovulation does not occur after initial course of therapy, increase to 100 mg daily for 5 days, starting ≥30 days after previous course of therapy.^{a b} If ovulation does not occur after 3 courses of therapy, further treatment not recommended; reevaluate patient.^{a b}

≥6 cycles of therapy (including 3 ovulatory cycles) not recommended.^a

Prescribing Limits

Adults

Female Infertility

Oral

Maximum 100 mg daily for 5 days.^{a b}

Maximum 6 cycles of therapy (including 3 ovulatory cycles); safety of long-term cyclic use not conclusively demonstrated.^{a b}

Special Populations

No special population dosage recommendations at this time.^{a b}

Cautions for Clomiphene Citrate

Contraindications

• 
  

  Pregnancy.^{a b} (See Fetal/Neonatal Morbidity and Morality under Cautions.)

  
  


• 
  

  Liver disease or history of liver dysfunction.^{a b}

  
  


• 
  

  Abnormal uterine bleeding of undetermined origin.^{a b}

  
  


• 
  

  Ovarian cysts or enlargement (unless due to polycystic ovarian syndrome).^{a b} (See Ovarian Hyperstimulation Syndrome under Cautions.)

  
  


• 
  

  Uncontrolled thyroid or adrenal dysfunction.^a

  
  


• 
  

  Presence of an organic intracranial lesion (e.g., pituitary tumor).^a

  
  


• 
  

  Known hypersensitivity to clomiphene or any ingredient in the formulation.^a

  
  

Warnings/Precautions

Warnings

Fetal/Neonatal Morbidity and Mortality

May cause fetal harm; teratogenicity and fetotoxicity demonstrated in animals.^{a b}

Contraindicated in pregnant women.^{a b} Carefully observe patients to determine if ovulation occurs; record basal body temperature throughout all treatment cycles, and discontinue therapy if pregnancy is suspected.^{a b} Exclude pregnancy, ovarian cyst, or ovarian enlargement between treatment cycles.^a

Ocular Effects

Dose-related adverse ocular effects (i.e., blurring of vision, scotomata, electroretinographic changes in retinal function, phosphenes, diplopia, photophobia, decreased visual acuity) reported;^{a b} adverse ocular effects generally disappear a few days to weeks following discontinuance of therapy.^{a b}

Visual symptoms may result from intensification and prolongation of after-images and may be precipitated by a brightly lit environment.^{a b}

Discontinue therapy if visual symptoms occur; prompt ophthalmologic evaluation recommended.^a

Ovarian Enlargement and Cyst Formation

Risk of uncomplicated ovarian enlargement and cyst formation; may be accompanied by abdominal or pelvic pain, or distension.^{a b} Generally regresses within days or weeks after discontinuing therapy.^{a b}

Monitor for signs and symptoms of excessive ovarian stimulation (e.g., pelvic pain).^b If ovarian enlargement or cyst development occurs, withhold therapy until ovaries return to pretreatment size; maximum enlargement of ovaries may not occur until several days after therapy is discontinued.^a If benefits of continuing therapy outweigh risks, reduce dosage or duration of the next course of therapy.^a

Ovarian Hyperstimulation Syndrome (OHSS)

Risk of potentially severe OHSS; may progress rapidly and is initially manifested by abdominal pain and distension, nausea, vomiting, diarrhea, and weight gain.^a Other symptoms include gross ovarian enlargement, ascites, dyspnea, oliguria, and pleural effusion.^a Pericardial effusion, anasarca, hydrothorax, acute abdomen, hypotension, renal failure, pulmonary edema, intraperitoneal and ovarian hemorrhage, deep-venous thrombosis, torsion of the ovary, acute respiratory distress, elevated urinary steroid levels, electrolyte imbalances, and hypoproteinemia may occur.^a Fatalities due to hypovolemia, hemoconcentration, and thromboembolism reported.^a

Transient liver function test abnormalities, which may be accompanied by morphologic changes (as detected by liver biopsy) have been reported.^a

If ovaries are abnormally enlarged, discontinue therapy until ovaries return to pretreatment size; reduce dosage or duration of the next course of therapy.^{a b} Perform abdominal and pelvic examinations with caution due to fragility of enlarged ovaries.^a

Hepatic Effects

Increased retention of sulfobromophthalein has occurred.^b One case of jaundice (due to bile stasis) has been reported.^b

Polycystic Ovary Syndrome

Potential for exaggerated response (e.g, ovarian hyperstimulation) to usual dosages of clomiphene in patients with polycystic ovary syndrome who are overly sensitive to gonadotropin.^{a b} (See Ovarian Hyperstimulation Syndrome under Cautions.) Initially, administer lowest recommended dose and shortest treatment duration.^a (See Dosage under Dosage and Administration.)

Ovarian Cancer

Risk of borderline or invasive ovarian tumors; may be associated with prolonged therapy.^a Careful evaluation to rule out ovarian cancer recommended if ovarian cysts do not regress spontaneously.^a

General Precautions

Adequate Patient Evaluation and Monitoring

Prior to initiating therapy and each subsequent course of therapy, perform a thorough pelvic examination and rule out pregnancy, ovarian enlargement, or ovarian cyst.^a (See Contraindications under Cautions.)

Prior to initiating therapy, evaluate for adequate endogenous estrogen levels (e.g., from vaginal smears, endometrial biopsy, urinary estrogen assay, and bleeding response to progesterone).^a

Prior to initiating therapy, evaluate liver function.^a

If abnormal vaginal bleeding is present, evaluate carefully to rule out neoplastic lesions.^a

Perform endometrial biopsy prior to initiating therapy in women with increased risk of endometriosis or endometrial carcinoma (e.g., older women).^a

Uterine Fibroids

Possible enlargement of existing uterine fibroids; use with caution in women with uterine fibroids.^a

Plural Gestation

Risk of multiple ovulations with resulting plural gestations, including bilateral tubal pregnancy and coexisting tubal and intrauterine pregnancy;^a may be associated with higher dosages.^b (See Prescribing Limits under Dosage and Administration.)

Specific Populations

Pregnancy

Category X.^a (See Fetal/Neonatal Morbidity and Mortality and also see Contraindications, under Cautions.)

Lactation

Not known whether clomiphene is distributed into milk. ^a Caution if used in nursing women.^a Clomiphene may reduce lactation in some women.^a

Men

Testicular tumors and gynecomastia reported; however, causal relationship between testicular tumors and clomiphene not determined.^a

Common Adverse Effects

Ovarian enlargement; abdominal or pelvic discomfort including distention, bloating, or pain; hot flushes (flashes).^b

Interactions for Clomiphene Citrate

No known drug interactions.^a

Clomiphene Citrate Pharmacokinetics

Absorption

Bioavailability

Well absorbed following oral administration.^{a b}

Elimination

Metabolism

Exact metabolic fate not clearly established; drug appears to be metabolized in the liver.^b

Elimination Route

Excreted in the feces (42%) and urine (8%).^{a b}

Half-life

5 days;^b however, radioactivity detected in feces up to 6 weeks following oral administration of radiolabeled drug.^{a b}

Stability

Storage

Oral

Tablets

Tight, light resistant containers at 15–30°C; protect from heat and excess humidity.^{a b}

ActionsActions

• 
  

  Exhibits estrogenic and anti-estrogenic properties;^{a b} precise mechanism of action in ovulation induction of anovulatory women unknown.^b

  
  


• 
  

  Interacts with estrogen-receptor containing tissues (e.g., hypothalamus, pituitary, ovary, endometrium, vagina, cervix).^a May compete with estrogen for estrogen-receptor-binding sites and may delay replenishment of estrogen receptors.^a

  
  


• 
  

  Appears to stimulate release of the pituitary gonadotropins, FSH and LH, which results in development and maturation of the ovarian follicle, ovulation, and subsequent development and function of the corpus luteum.^{a b} May also directly affect the biosynthesis of ovarian hormones.^b

  
  


• 
  

  No known progestational, androgenic, or antiandrogenic effects; does not appear to affect pituitary-adrenal or pituitary-thyroid function.^{a b}

  
  

Advice to Patients

• 
  

  Importance of discussing purpose and risks of therapy and required monitoring procedures.^a

  
  


• 
  

  Risk of multiple pregnancy; importance of informing patients about potential complications and risks associated with multiple pregnancies.^{a b}

  
  


• 
  

  Importance of properly timed sexual intercourse (i.e., coinciding with expected time of ovulation).^a Importance of using a basal body temperature graph or an appropriate ovulation predicting test to determine if ovulation has occurred.^{a b}

  
  


• 
  

  Risk of visual disturbances (e.g., blurring, diplopia, photophobia);^{a b} importance of informing clinicians if any adverse visual symptoms occur.^{a b} Use caution when driving or operating machinery, particularly under conditions of variable lighting.^{a b}

  
  


• 
  

  Importance of informing clinicians if pelvic or abdominal pain, weight gain, discomfort, or distention occurs.^a

  
  


• 
  

  Importance of advising women of risk of fetal harm if administered during pregnancy; importance of excluding pregnancy before each course of treatment.^a

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.^{a b}

  
  


• 
  

  Importance of informing patients of other important precautionary information.^{a b} (See Cautions.)

  
  

Preparations

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

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Clomiphene Citrate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets	50 mg*	Clomid (scored)	Sanofi-Aventis
			Serophene (scored)	Serono

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 04/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Clomid 50MG Tablets (SANOFI-AVENTIS U.S.): 5/$89.39 or 10/$160.89

ClomiPHENE Citrate 50MG Tablets (PAR): 30/$84.99 or 90/$251.98

Serophene 50MG Tablets (SERONO): 5/$55.99 or 10/$105.97

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 November 01, 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

a. Sanofi-aventis. Clomid (clomiphene) prescribing information. Bridgewater, NJ; 2006 Jun.

b. AHFS drug information 2007. McEvoy GK, ed. Clomiphene. Bethesda, MD: American Society of Health-System Pharmacists; 2007: 3107-3108.

More Clomiphene Citrate resources

• Clomiphene Citrate Side Effects (in more detail)
• Clomiphene Citrate Dosage
• Clomiphene Citrate Use in Pregnancy & Breastfeeding
• Drug Images
• Clomiphene Citrate Support Group
• 10 Reviews for Clomiphene Citrate - Add your own review/rating

• Clomid Prescribing Information (FDA)


• Clomid Consumer Overview


• Clomid Advanced Consumer (Micromedex) - Includes Dosage Information


• Clomid MedFacts Consumer Leaflet (Wolters Kluwer)


• Clomiphene Prescribing Information (FDA)


• Serophene Prescribing Information (FDA)

Compare Clomiphene Citrate with other medications

• Female Infertility
• Lactation Suppression
• Oligospermia
• Ovulation Induction