Dehychol

Dehychol may be available in the countries listed below.

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Dehydrocholic Acid

Dehydrocholic Acid is reported as an ingredient of Dehychol in the following countries:

• Taiwan

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Ketofun

Ketofun may be available in the countries listed below.

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Ketoconazole

Ketoconazole is reported as an ingredient of Ketofun in the following countries:

• Bangladesh

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Solu Tet

In some countries, this medicine may only be approved for veterinary use.

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Tetracycline

Tetracycline hydrochloride (a derivative of Tetracycline) is reported as an ingredient of Solu Tet in the following countries:

• United States

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Bizolin

In some countries, this medicine may only be approved for veterinary use.

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Phenylbutazone

Phenylbutazone is reported as an ingredient of Bizolin in the following countries:

• United States

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Coax

Coax may be available in the countries listed below.

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Dihydroergotoxine

Dihydroergotoxine mesilate (a derivative of Dihydroergotoxine) is reported as an ingredient of Coax in the following countries:

• Japan

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Bevalex

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Betamethasone

Betamethasone 17α-valerate (a derivative of Betamethasone) is reported as an ingredient of Bevalex in the following countries:

• Indonesia

Neomycin

Neomycin sulfate (a derivative of Neomycin) is reported as an ingredient of Bevalex in the following countries:

• Indonesia

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Depakine Crono

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Valproic Acid

Valproic Acid sodium (a derivative of Valproic Acid) is reported as an ingredient of Depakine Crono in the following countries:

• Spain

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Soluric

Soluric may be available in the countries listed below.

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Allopurinol

Allopurinol is reported as an ingredient of Soluric in the following countries:

• Greece

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Clevidipine butyrate

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Clevidipine

Clevidipine butyrate (USAN) is known as Clevidipine in the US.

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USAN	United States Adopted Name

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Biostatik

Biostatik may be available in the countries listed below.

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Roxithromycin

Roxithromycin is reported as an ingredient of Biostatik in the following countries:

• Indonesia

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Orgy

Orgy may be available in the countries listed below.

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Cetirizine

Cetirizine dihydrochloride (a derivative of Cetirizine) is reported as an ingredient of Orgy in the following countries:

• Bangladesh

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Elpi Lip

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Bezafibrate

Bezafibrate is reported as an ingredient of Elpi Lip in the following countries:

• Argentina

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Respontin

Respontin may be available in the countries listed below.

UK matches:

• Respontin Nebules (SPC)

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Ipratropium

Ipratropium Bromide is reported as an ingredient of Respontin in the following countries:

• United Kingdom

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SPC	Summary of Product Characteristics (UK)

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D Cure

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Colecalciferol

Colecalciferol is reported as an ingredient of D Cure in the following countries:

• Belgium


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Fosinoprilnatrium Merck

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Fosinopril

Fosinopril sodium salt (a derivative of Fosinopril) is reported as an ingredient of Fosinoprilnatrium Merck in the following countries:

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Atropina

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Atropine

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Carvedilol

Carvedilol is reported as an ingredient of Carvedilol-corax in the following countries:

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Bentyl

Generic Name: dicyclomine hydrochloride

Dosage Form: capsule, tablet, syrup, injection
FULL PRESCRIBING INFORMATION

Indications and Usage for Bentyl

Bentyl® (dicyclomine hydrochloride) is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.

Bentyl Dosage and Administration

Dosage must be adjusted to individual patients needs.

Oral Dosage and Administration in Adults

The recommended initial dose is 20 mg four times a day. After one week treatment with the initial dose, the dose may be increased to 40 mg four times a day unless side effects limit dosage escalation.

If efficacy is not achieved within 2 weeks or side effects require doses below 80 mg per day, the drug should be discontinued. Documented safety data are not available for doses above 80 mg daily for periods longer than 2 weeks.

Intramuscular Dosage and Administration in Adults

Bentyl Intramuscular Injection must be administered via intramuscular route only. Do not administer by an other route. The recommended intramuscular dose is 10 mg to 20 mg four times a day. [see Clinical Pharmacology (12)]

The intramuscular injection is to be used only for 1 or 2 days when the patient cannot take oral medication.

Intramuscular injection is about twice as bioavailable as oral dosage forms.

Preparation for Intramuscular Administration

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Aspirate the syringe before injecting to avoid intravascular injection, since thrombosis may occur if the drug is inadvertently injected intravascularly.

Dosage Forms and Strengths

• Bentyl 10 mg capsules: blue, imprinted Bentyl 10


• Bentyl 20 mg tablets: compressed, light blue, round, debossed Bentyl 20
  


• Bentyl syrup 10 mg/5 mL
  


• Bentyl injection 20 mg/2 mL (10 mg/mL)
  

Contraindications

Bentyl is contraindicated in infants less than 6 months of age [see Use in Specific Populations (8.4)], nursing mothers [see Use in Specific Populations (8.3)], and in patients with:

• unstable cardiovascular status in acute hemorrhage


• myasthenia gravis [see Warnings and Precautions (5.4)]


• glaucoma [see Adverse Reactions (6.3) and Drug Interactions (7.1)]


• obstructive uropathy [see Warnings and Precautions (5.8)]


• obstructive disease of the gastrointestinal tract [see Warnings and Precautions (5.5)]


• severe ulcerative colitis [see Warnings and Precautions (5.4)]


• reflux esophagitis

Warnings and Precautions

Inadvertent Intravenousmuscular Administration

Bentyl solution for intramuscular administration only. Do not administer by any other route. Inadvertent intravenous administration may result in thrombosis, thrombophlebitis and injection site reactions such as pain, edema, skin colour change, and reflex sympathetic dystrophy syndrome [see Adverse Reactions (6.2)].

Cardiovascular Conditions

Dicyclomine hydrochloride needs to be used with caution in conditions characterized by tachyarrhythmia such as thyrotoxicosis, congestive heart failure and in cardiac surgery, where they may further accelerate the heart rate.  Investigate any tachycardia before administration of dicyclomine hydrochloride.  Care is required in patients with coronary heart disease, as ischemia and infarction may be worsened, and in patients with hypertension [see Adverse Reactions (6.3)].

Peripheral and Central Nervous System

The peripheral effects of dicyclomine hydrochloride are a consequence of their inhibitory effect on muscarinic receptors of the autonomic nervous system.  They include dryness of the mouth with difficulty in swallowing and talking, thirst, reduced bronchial secretions, dilatation of pupils (mydriasis) with loss of accommodation (cycloplegia) and photophobia, flushing and dryness of the skin, transient bradycardia followed by tachycardia, with palpitations and arrhythmias, and difficulty in micturition, as well as reduction in the tone and motility of the gastrointestinal tract leading to constipation [see Adverse Reactions (6)].

In the presence of a high environmental temperature heat prostration can occur with drug use (fever and heat stroke due to decreased sweating). It should also be used cautiously in patients with fever.  If symptoms occur, the drug should be discontinued and supportive measures instituted.  Because of the inhibitory effect on muscarinic receptors within the autonomic nervous system, caution should be taken in patients with autonomic neuropathy. 

Central nervous system (CNS) signs and symptoms include confusion, disorientation, short-term amnesia, hallucinations, dysarthria, ataxia, coma, euphoria, fatigue, insomnia, agitation and mannerisms, and inappropriate affect.  Psychosis has been reported in sensitive individuals given anticholinergic drugs. These CNS signs and symptoms usually resolve within 12 to 24 hours after discontinuation of the drug

Bentyl may produce drowsiness, dizziness or blurred vision. The patient should be warned not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery or performing hazardous work while taking Bentyl.

Myasthenia Gravis

With overdosage, a curare-like action may occur (i.e., neuromuscular blockade leading to muscular weakness and possible paralysis).  It should not be given to patients with myasthenia gravis except to reduce adverse muscarinic effects of an anticholinesterase [see Contraindications (4)]

Intestinal Obstruction

Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance, treatment with this drug would be inappropriate and possibly harmful [see Contraindications (4)].

Rarely development of Ogilvie's syndrome (colonic pseudo-obstruction) has been reported. Ogilvie's syndrome is a clinical disorder with signs, symptoms, and radiographic appearance of an acute large bowel obstruction but with no evidence of distal colonic obstruction

Toxic Dilatation of Intestinemegacolon

Toxic dilatation of intestine and intestinal perforation is possible when anticholinergic agents are administered in patients with Salmonella dysentery.

Ulcerative Colitis

Caution should be taken in patients with ulcerative colitis.  Large doses may suppress intestinal motility to the point of producing a paralytic ileus and the use of this drug may precipitate or aggravate the serious complication of toxic megacolon [see Adverse Reactions (6.3)].  Bentyl is contraindicated in patients with severe ulcerative colitis [see Contraindications (4)].

Prostatic Hypertrophy

BENYL should be used with caution in patients with known or suspected prostatic enlargement, in whom prostatic enlargement may lead to urinary retention [see Adverse Reactions (6.3)]

Hepatic and Renal Disease

Bentyl should be used with caution in patients with known hepatic and renal impairment.

Geriatic Population

Dicyclomine hydrochloride should be used with caution in elderly who may be more susceptible to its adverse effects.

Adverse Reactions

The pattern of adverse effects seen with dicyclomine is mostly related to its pharmacological actions at muscarinic receptors [see Clinical Pharmacology (12)].  They are a consequence of the inhibitory effect on muscarinic receptors within the autonomic nervous system.  These effects are dose-related and are usually reversible when treatment is discontinued. 

The most serious adverse reactions reported with dicyclomine hydrochloride include cardiovascular and central nervous system symptoms [see Warnings and Precautions (5.2,5.3)].

Clinical Studies 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. 

The data described below reflect the exposure in controlled clinical trials involving over 100 patients treated for functional bowel/irritable bowel syndrome with dicyclomine hydrochloride at initial doses of 160 mg daily (40 mg four times a day)

In these trials most of the side effects were typically anticholinergic in nature and were reported by 61% of the patients.  Table 1 presents adverse reactions (MedDRA 13.0 preferred terms) by decreasing order of frequency in a side-by-side comparison with placebo. 

Table 1: Adverse reactions experienced in controlled clinical trials with decreasing order of frequency

MedDRA Preferred Term	Dicyclomine Hydrochloride (40 mg four times a day) %	Placebo %
Dry Mouth	33	5
Dizziness	40	5
Vision blurred	27	2
Nausea	14	6
Somnolence	9	1
Asthenia	7	1
Nervousness	6	2

Nine percent (9%) of patients were discontinued from Bentyl because of one or more of these side effects (compared with 2% in the placebo group).  In 41% of the patients with side effects, side effects disappeared or were tolerated at the 160 mg daily dose without reduction.  A dose reduction from 160 mg daily to an average daily dose of 90 mg was required in 46% of the patients with side effects who then continued to experience a favorable clinical response; their side effects either disappeared or were tolerated. 

Postmarketing Experience

The following adverse reactions, presented by system organ class in alphabetical order, have been identified during post approval use of Bentyl.  Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their freqeuncy or establish a casual relationship to drug exposure. 

• Cardiac disorders: palpitations, tachyarrhythmias


• Eye disorders: cycloplegia, mydriasis, vision blurred


• Gastrointestinal disorders: abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, nausea, vomiting


• General disorders and administration site conditions: fatigue, malaise


• Immune System Disorders: drug hypersensitivity including face oedema, angioedema, anaphylactic shock


• Nervous system disorders: dizziness, headache, hallucinations insomnia, somnolence, syncope


• Psychiatric disorders: confusional state, nervousness


• Reproductive system and breast disorders: suppressed lactation


• Respiratory, thoracid and mediastinal disorders: dyspnoea, nasal congestion


• Skin and subcutaneous tissue disorder: dermatitis allergic, erythema, rash
  

Adverse Reactions Reported with Similar Drugs with Anticholinergic/Antispasmodic Action

Gastrointestinal: anorexia,

Central Nervous System: tingling, numbness, dyskinesia, speech disturbance, insomnia

Peripheral Nervous System: With overdosage, a curare-like action may occur (i.e., neuromuscular blockade leading to muscular weakness and possible paralysis).

Ophthalmologic: diplopia, increased ocular tension

Dermatologic/Allergic: urticaria, itching, and other dermal manifestations;

Genitourinary: urinary hesitancy, urinary retention in patients with prostatic hypertrophy

Cardiovascular: hypertension

Respiratory: apnea

Other: decreased sweating, sneezing, throat congestion, impotence.  With the injectable form, there may be temporary sensation of light-headedness.  Some local irritation and focal coagulation necrosis may occur following the intramuscular injection of Bentyl. 

Drug Interactions

Antiglaucoma Agents

Anticholinergics antagonize the effects of antiglaucoma agents. Anticholinergic drugs in the presence of increased intraocular pressure may be hazardous when taken concurrently with agents such as corticosteriods. Use of Bentyl in patients with glaucoma is not recommended [see Contraindications (4)].

Other Drugs with Anticholinergic Activity

The following agents may increase certain actions or side effects of anticholinergic drugs including Bentyl: amantadine, antiarrhythmic agents of Class I (e.g., quinidine), antihistamines, antipsychotic agents (e.g., phenothiazines), benzodiazepines, MAO inhibitors, narcotic analgesics (e.g., meperidine), nitrates and nitrites, sympathomimetic agents, tricyclic antidepressants, and other drugs having anticholinergic activity. 

Other Gastrointestinal Motility Drugs

Interaction with other gastrointestinal motility drugs may antagonize the effects of drugs that alter gastrointestinal motility, such as metoclopraminde.

Effect of Antacids

Because antacids may interfere with the absorption of anticholinergic agents including Bentyl, simultaneous use of these drugs should be avoided.

Effect on Absorption of Other Drugs

Anticholinergic agents may affect the gastrointestinal absorption of various drugs by affecting the gastrointestinal motility, such as slowly dissolving dosage forms of digoxin; increased serum digoxin concentration may result.

Effect on Gastric Acid Secretion

The inhibiting effects of anticholinergic drugs on gastric hydrochloric acid secretion are antagonized by agents used to treat achlorhydria and those used to test gastric secretion.

USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category B

Adequate and well-controlled studies have not been conducted with Bentyl in pregnant women at the recommended doses of 80 to 160 mg/day. However, epidemiologic studies did not show an increased risk of structural malformations amoung babies born to women who took products containing dicyclomine hydrochloride at doses up to 40 mg/day during the first trimester of pregnancy.

Reproduction studies have been performed in rats and rabbits at doses of up to 33 times the maximum recommended human dose based on 160 mg/day (3 mg/kg) and have revealed no evidence of harm to the fetus due to dicyclomine.  Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

Bentyl is contraindicated in women who are human milk feeding. Dicyclomine hydrochloride is excreted in human milk. Because of the potential for serious adverse reactions in human milk-fed infants from Bentyl, a decision should be made whether to discontine nursing or to discontinue the drug, taking into account the importance of the drug to the mother. [see Use in Specific Populations (8.4)].

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Bentyl is contraindicated in infants less than 6 months of age.  [see Contraindications (4)] There are published cases reporting that the administration of dicyclomine hydrochloride syrup to infants has been followed by serious respiratory symptoms (dyspnea, shortness of breath, breathlessness, respiratory collapse, apnea and asphyxia), seizures, syncope, pulse rate fluctuations, muscular hypotonia, and coma, and death, however; no causal relationship has been established.

Geriatric Use

Clinical studies of Bentyl 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. 

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.

Renal Impairment

Effects of renal impairment on PK, safety and efficacy of Bentyl have not been studied. Bentyl 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. Bentyl should be administered with caution in patients with renal impairment.

Hepatic Impairment

Effects of renal impairment on PK, safety and efficacy of Bentyl have not been studied. Bentyl should be administered with caution in patients with hepatic impairment.

Overdosage

In case of an overdose, patients should contact a physician, poison control centre (1-800-222-1222), or emergency room. 

The signs and symptoms of overdosage include: headache; nausea; vomiting; blurred vision; dilated pupils; hot, dry skin; dizziness; dryness of the mouth; difficulty in swallowing; and CNS stimulation including convulsion. A curare-like action may occur (i.e., neuromuscular blockade leading to muscular weakness and possible paralysis).

One reported event included a 37-year-old female who reported numbness on the left side, cold fingertips, blurred vision, abdominal and flank pain, decreased appetite, dry mouth, and nervousness following ingestion of 320 mg daily (four 20 mg tablets four times daily.) These events resolved after discontinuing the dicyclomine.

The acute oral LD50 of the drug is 625 mg/kg in mice.

The amount of drug in a single dose that is ordinarily associated with symptoms of overdosage or that is likely to be life-threatening, has not been defined. The maximum human oral dose recorded was 600 mg by mouth in a 10-month-old child and approximately 1500 mg in an adult, each of whom survived. In three of the infants who died following administration of dicyclomine hydrochloride [see Warnings and Precautions (5.1)] , the blood concentrations of drug were 200, 220, and 505 ng/mL.

It is not know if Bentyl is dialyzable.

Treatment should consist of gastric lavage, emetics, and activated charcoal. Sedatives (e.g., short-acting barbiturates, benzodiazepines) may be used for management of overt signs of excitement. If indicated, an appropriate parenteral cholinergic agent may be used as an antidote.

Bentyl Description

Bentyl is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following forms:

• Bentyl capsules for oral use contain 10 mg dicyclomine hydrochloride USP.  Bentyl 10 mg capsules also contain inactive ingredients: calcium sulfate, corn starch, FD&C Blue No. 1, FD&C Red No. 40, gelatin, lactose, magnesium stearate, pregelatinized corn starch, and titanium dioxide. 
  


• Bentyl tablets for oral use contain 20 mg dicyclomine hydrochloride USP.  Bentyl 20 mg tablets also contain inactive ingredients: acacia, dibasic calcium phosphate, corn starch, FD&C Blue No. 1, lactose, magnesium stearate, pregelatinized corn starch, and sucrose.


• Bentyl syrup for oral use contains 10 mg dicyclomine hydrochloride USP in each 5 mL (1 teaspoonful).  Bentyl syrup also contains inactive ingredients: citric acid, D&C Red No. 33, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, flavors, glucose, methylparaban, propylene glycol, propylparaben, saccharin sodium, and water.


• Bentyl injection is a sterile, pyrogen-free, aqueous solution for intramuscular injection (NOT FOR INTRAVENOUS USE) supplied as an ampule containing 20 mg/2 mL (10 mg/mL).  Each mL contains 10 mg dicyclomine hydrochloride USP in sterile water for injection, made isotonic with sodium chloride. 
  
  
  Bentyl (dicyclomine hydrochloride) is [bicyclohexyl]-1-carboxylic acid, 2-(diethylamino) ethyl ester, hydrochloride, with a molecular formula of C19H35NO2•HCl and the following structural formula:

Molecular weight: 345.95


Dicyclomine hydrochloride occurs as a fine, white, crystalline, practically odorless powder with a bitter taste.  It is soluble in water, freely soluble in alcohol and chloroform, and very slightly soluble in ether. 

Bentyl - Clinical Pharmacology

Mechanism of Action

Dicyclomine relieves smooth muscle spasm of the gastrointestinal tract.  Animal studies indicate that this action is achieved via a dual mechanism:

• a specific anticholinergic effect (antimuscarinic) at the acetylcholine-receptor sites with approximately 1/8 the milligram potency of atropine (in vitro, guinea pig ileum); and
  


• a direct effect upon smooth muscle (musculotropic) as evidenced by dicyclomine's antagonism of bradykinin- and histamine-induced spasms of the isolated guinea pig ileum. 
  

Atropine did not affect responses to these two agonists. In vivo studies in cats and dogs showed dicyclomine to be equally potent against acetylcholine (ACh)- or barium chloride (BaCl2)-induced intestinal spasm while atropine was at least 200 times more potent against effects of ACh than BaCl2.  Tests for mydriatic effects in mice showed that dicyclomine was approximately 1/500 as potent as atropine; antisialagogue tests in rabbits showed dicyclomine to be 1/300 as potent as atropine.

Pharmacodynamics

Bentyl can inhibit the secretion of saliva and sweat, decrease gastrointestinal secretions and motility, cause drowsiness, dilate the pupils, increase heart rate, and depress motor function.

Pharmacokinetics

Absorption and Distribution

In man, dicyclomine is rapidly absorbed after oral administration, reaching peak values within 60-90 minutes.  Mean volume of distribution for a 20 mg oral dose is approximately 3.65 L/kg suggesting exentsive distribution in tissues.

Elimination

The metabolism of dicyclomine was not studied. The principal route of excretion is via the urine (79.5% of the dose).  Excretion also occurs in the feces, but to a lesser extent (8.4%). Mean half-life of plasma elimination in one study was determined to be approximately 1.8 hours when plasma concentrations were measured for 9 hours after a single dose.  In subsequent studies, plasma concentrations were followed for up to 24 hours after a single dose, showing a secondary phase of elimination with a somewhat longer half-life. 

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been conducted to evaluate the carcinogenic potential of dicyclomine.  In studies in rats at doses of up to 100 mg/kg/day, dicyclomine produced no deleterious effects on breeding, conception, or parturition. 

Clinical Studies

In controlled clinical trials involving over 100 patients who received drug, 82% of patients treated for functional bowel/irritable bowel syndrome with dicyclomine hydrochloride at initial doses of 160 mg daily (40 mg four times daily) demonstrated a favorable clinical response compared with 55% treated with placebo (p<0.05).

How Supplied/Storage and Handling

Bentyl Capsules

10 mg blue capsules, imprinted Bentyl 10, supplied in bottles of 100. Store at room temperature, preferably below 86°F (30°C).

NDC number: 58914-012-10.

Bentyl Tablets


20 mg compressed, light blue, round tablets, debossed Bentyl 20, supplied in bottles of 100. To prevent fading, avoid exposure to direct sunlight. Store at room temperature, preferably below 86°F (30°C).


NDC 58914-013-10.


Bentyl Syrup

10 mg/5 mL pink syrup, supplied in 16 ounce bottles. Store at room temperature, preferably below 86°F (30°C). Protect from excessive heat.

NDC 58914-015-16.

Bentyl Injection

20 mg/2 mL (10 mg/mL) injection supplied in boxes of five 20 mg/2 mL ampoules (10 mg/mL). Store at room temperature, preferably below 86°F (30°C). Protect from freezing.

NDC 58914-080-52.

Patient Counseling Information

Inadvertent Intravenous Administration

Bentyl injection is for intramuscular administration only. Do not administer by any other route. Inadvertent administration may result in thrombosis or thrombophlebitis and injection site such as pain, edema, skin colour change and even reflex sympathetic dystrophy syndrome [see Adverse Reactions (6.2)].

Use in Infants

Inform parents and caregivers not to administer Bentyl in infants less than 6 months of age [see Use in Specific Populations (8.4)] .

Use in Nursing Mothers

Advise lactating women that Bentyl should not be used while human milk feeding their infants [see Use in Specific Populations (8.3, 8.4)] .

Peripheral and Central Nervous System

In the presence of a high environmental temperature, heat prostration can occur with Bentyl use (fever and heat stroke due to decreased sweating). If symptoms occur, the drug should be discontinued and a physician contacted. Bentyl may produce drowsiness or blurred vision.  The patients should be warned not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery or to perform hazardous work while taking Bentyl.  [see Warnings and Precautions (5.3)].

Manufactured for:

Axcan Pharma US, Inc.

22 Inverness Center Parkway

Suite 310

Birmingham, AL 35242 USA

www.axcan.com

Bentyl® is a registered trademark owned by Axcan Pharma Inc., an affiliated company of Axcan Pharma US, Inc.

Principal Display Panel

Bentyl Capsules:

Bentyl Injection, Ampule:

Bentyl Injection, Box:

Bentyl, Syrup:

Bentyl, Tablets:

Bentyl  dicyclomine hydrochloride  capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 58914-012 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dicyclomine hydrochloride (Dicyclomine) Dicyclomine hydrochloride 10 mg

Inactive Ingredients Ingredient Name Strength Lactose monohydrate   Calcium sulfate   Starch, corn   Magnesium stearate

Product Characteristics Color blue Score no score Shape CAPSULE Size 10mm Flavor Imprint Code Bentyl;10 Contains

Packaging # NDC Package Description Multilevel Packaging 1 58914-012-10 100 CAPSULE In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA007409	05/11/1950

Bentyl  dicyclomine hydrochloride  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 58914-013 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dicyclomine hydrochloride (Dicyclomine) Dicyclomine hydrochloride 20.6 mg

Inactive Ingredients Ingredient Name Strength Acacia   Dibasic calcium phosphate dihydrate   Starch, corn   Lactose monohydrate   Magnesium stearate   Sucrose

Product Characteristics Color blue (Light blue) Score no score Shape ROUND (Compressed round) Size 10mm Flavor Imprint Code Bentyl;20 Contains

Packaging # NDC Package Description Multilevel Packaging 1 58914-013-10 100 TABLET In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA007409	05/11/1950

Bentyl  dicyclomine hydrochloride  syrup

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 58914-015 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dicyclomine hydrochloride (Dicyclomine) Dicyclomine hydrochloride 10 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength Anhydrous citric acid   Saccharin sodium   Methylparaben   Propylparaben   Propylene glycol   Water

Product Characteristics Color pink Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 58914-015-16 473 mL In 1 BOTTLE, GLASS None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA007961	04/30/1951

Bentyl  dicyclomine hydrochloride  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 58914-080 Route of Administration INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dicyclomine hydrochloride (Dicyclomine) Dicyclomine hydrochloride 20 mg  in 2 mL

Inactive Ingredients Ingredient Name Strength Sodium chloride   Water

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 58914-080-52 5 AMPULE In 1 BOX contains a AMPULE 1 2 mL In 1 AMPULE This package is contained within the BOX (58914-080-52)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA008370	08/13/1952

Labeler - Axcan Pharma Inc. (787651231)

Revised: 07/2011Axcan Pharma Inc.

More Bentyl resources

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

• Bentyl Concise Consumer Information (Cerner Multum)


• Bentyl Monograph (AHFS DI)


• Bentyl MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Bentyl with other medications

• Irritable Bowel Syndrome

Zofran ODT

In the US, Zofran ODT (ondansetron systemic) is a member of the drug class 5HT3 receptor antagonists and is used to treat Alcohol Dependence, Gastroenteritis, Nausea/Vomiting, Nausea/Vomiting - Chemotherapy Induced, Nausea/Vomiting - Postoperative, Nausea/Vomiting - Radiation Induced, Obsessive Compulsive Disorder, Postanesthetic Shivering and Pruritus.

US matches:

• Zofran ODT Orally Disintegrating Tablets


• Zofran ODT


• Zofran ODT Oral, Oromucosal

Ingredient matches for Zofran ODT

Ondansetron

Ondansetron is reported as an ingredient of Zofran ODT in the following countries:

• United States

International Drug Name Search

Acido Valproico ratiopharm

Acido Valproico ratiopharm may be available in the countries listed below.

Ingredient matches for Acido Valproico ratiopharm

Valproic Acid

Valproic Acid is reported as an ingredient of Acido Valproico ratiopharm in the following countries:

• Italy

Valproic Acid sodium (a derivative of Valproic Acid) is reported as an ingredient of Acido Valproico ratiopharm in the following countries:

• Italy

International Drug Name Search

Diloxide

Diloxide may be available in the countries listed below.

Ingredient matches for Diloxide

Diloxanide

Diloxanide ester with 2-furoic acid (a derivative of Diloxanide) is reported as an ingredient of Diloxide in the following countries:

• Bangladesh

International Drug Name Search

Beapizide

Beapizide may be available in the countries listed below.

Ingredient matches for Beapizide

Glipizide

Glipizide is reported as an ingredient of Beapizide in the following countries:

• Singapore

International Drug Name Search

Fenemal SAD

Fenemal SAD may be available in the countries listed below.

Ingredient matches for Fenemal SAD

Phenobarbital

Phenobarbital is reported as an ingredient of Fenemal SAD in the following countries:

• Denmark

International Drug Name Search

Amoxicilline Farmaprojects

Amoxicilline Farmaprojects may be available in the countries listed below.

Ingredient matches for Amoxicilline Farmaprojects

Amoxicillin

Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Amoxicilline Farmaprojects in the following countries:

• Netherlands

International Drug Name Search

rilonacept Subcutaneous

ril-ON-a-sept

Commonly used brand name(s)

In the U.S.

• Arcalyst

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Immunological Agent

Pharmacologic Class: Interleukin-1 Inhibitor

Uses For rilonacept

Rilonacept is used to treat cryopyrin-associated periodic syndromes (CAPS), including familial cold autoinflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS). Rilonacept can help lessen the signs and symptoms of CAPS, such as rash, joint pain, fever, and tiredness .

rilonacept is available only with your doctor's prescription .

Before Using rilonacept

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 rilonacept, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to rilonacept 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 rilonacept in children below 12 years of age. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of rilonacept in the elderly. However, specific side effects may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of rilonacept .

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 rilonacept, 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 rilonacept 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.

• Adalimumab


• Adenovirus Vaccine Type 4, Live


• Adenovirus Vaccine Type 7, Live


• Anakinra


• Bacillus of Calmette and Guerin Vaccine, Live


• Etanercept


• Infliximab


• Influenza Virus Vaccine, Live


• Measles Virus Vaccine, Live


• Mumps Virus Vaccine, Live


• Poliovirus Vaccine, Live


• Rotavirus Vaccine, Live


• Rubella Virus Vaccine, Live


• Smallpox Vaccine


• Typhoid Vaccine


• Varicella Virus Vaccine


• Yellow Fever Vaccine

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

• Asthma or


• Diabetes or


• Immune system problems—Patients with these conditions will have an increased risk of infection .

• Serious infections (e.g., HIV, hepatitis B or C, tuberculosis)—Rilonacept may decrease the body's ability to fight infection .

Proper Use of rilonacept

rilonacept is given as a shot under your skin. Rilonacept may sometimes be given at home to patients who do not need to be in the hospital. If you are using rilonacept at home, your doctor will teach you how to prepare and inject the medicine. Be sure that you understand exactly how the medicine is prepared and injected .

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

Use a new needle and syringe each time you inject your medicine .

You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections. Do not inject into skin areas that are bruised, red, tender, or hard .

This powder medicine must be mixed with the liquid provided in your dose kit. Mix the medicine only when you are ready to use it. Do not use if it is cloudy or has specks floating in it .

Dosing

The dose of rilonacept 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 rilonacept. 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 injection dosage form (vial):
  
  • For cryopyrin-associated periodic syndromes:
    
    • Adults—At first, 320 milligrams (mg) given as two, 2-milliliter (mL) doses of 160 mg injected under the skin on the same day at two different sites. Your dose will be adjusted to 160 mg once a week, given as a single, 2 mL injection.
    
    
    • Children and teenagers 12 to 17 years of age—At first, 4.4 milligrams (mg) per kilogram (kg) of body weight up to 320 mg given as one or two, 2-milliliter (mL) doses injected under the skin. Your dose will be adjusted to 2.2 mg per kg of body weight up to 160 mg once a week, given as a single, 2 mL injection.
    
    
    • Children below 12 years of age—Use and dose must be determined by your doctor .
    
    
  
  

Missed Dose

If you miss a dose of rilonacept, 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 in the refrigerator. Do not freeze.

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.

Once the powder medicine has been mixed with the liquid, this mixture may be stored at room temperature, away from direct light. You must use this mixture within 3 hours. Throw away any leftover mixture .

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets .

Precautions While Using rilonacept

It is important that your doctor check your progress at regular visits to make sure that rilonacept is working properly. Blood tests may be needed to check for unwanted effects (e.g., increased amount of cholesterol or fats in the blood) .

Your body's ability to fight infection may be reduced while you are being treated with rilonacept. It is very important that you call your doctor at the first signs of any infection (such as fever or chills; cough or hoarseness; lower back or side pain; or painful or difficult urination) .

While you are being treated with rilonacept, do not have any immunizations (vaccinations) without your doctor's approval. Rilonacept may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. Tell your doctor about any vaccinations you have received in the past. Ask your doctor whether you should receive any vaccinations, including pneumonia and flu shots, before receiving rilonacept .

You will need to have a skin test for tuberculosis before you start using rilonacept. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis test .

Using rilonacept may increase your risk of certain types of cancer. Talk with your doctor about this risk .

Rilonacept may cause a serious allergic reaction. Check with your doctor right away if you have a rash; itching; swelling of the face, tongue, and throat; trouble with breathing; or chest pain after you get the injection .

Do not take adalimumab (Humira®), anakinra (Kineret®), etanercept (Enbrel®), or infliximab (Remicade®) while you are being treated with rilonacept, unless your doctor says it is okay .

rilonacept 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

• Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at site


• body aches or pain


• chills


• cough


• difficulty in breathing


• ear congestion


• fever


• headache


• loss of voice


• nasal congestion


• runny nose


• sneezing


• sore throat


• unusual tiredness or weakness

Incidence not known

• Bloody or black, tarry stools


• constipation


• cough producing mucus


• lower back or side pain


• pain or tenderness around eyes and cheekbones


• painful or difficult urination


• severe stomach pain


• shortness of breath or troubled breathing


• tenderness


• tightness of chest or wheezing


• vomiting of blood or material that looks like coffee grounds

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, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

Less common

• Stomach discomfort

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: rilonacept Subcutaneous 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 rilonacept Subcutaneous resources

• Rilonacept Subcutaneous Side Effects (in more detail)
• Rilonacept Subcutaneous Use in Pregnancy & Breastfeeding
• Rilonacept Subcutaneous Drug Interactions
• Rilonacept Subcutaneous Support Group
• 1 Review for Rilonacept Subcutaneous - Add your own review/rating

Compare rilonacept Subcutaneous with other medications

• Cryopyrin-Associated Periodic Syndromes
• Familial Cold Autoinflammatory Syndrome
• Gout
• Muckle Wells Syndrome

Pocillin

Pocillin may be available in the countries listed below.

Ingredient matches for Pocillin

Benzylpenicillin

Benzylpenicillin procaine (a derivative of Benzylpenicillin) is reported as an ingredient of Pocillin in the following countries:

• Ethiopia

Benzylpenicillin sodium (a derivative of Benzylpenicillin) is reported as an ingredient of Pocillin in the following countries:

• Ethiopia

International Drug Name Search

Butasona Fabra R.L.

Butasona Fabra R.L. may be available in the countries listed below.

Ingredient matches for Butasona Fabra R.L.

Betamethasone

Betamethasone 21-acetate and 21-(disodium phosphate) (a derivative of Betamethasone) is reported as an ingredient of Butasona Fabra R.L. in the following countries:

• Argentina

International Drug Name Search

Betatar Gel Topical

Generic Name: coal tar (Topical route)

kole tar

Commonly used brand name(s)

In the U.S.

• Betatar Gel


• Cutar Emulsion


• Denorex


• DHS Tar


• Doak Tar


• Duplex T


• Fototar


• Ionil-T Plus


• Medotar


• MG 217


• Neutrogena T/Derm


• Neutrogena T/Gel

In Canada

• Estar


• Liquor Carbonis Detergens


• Psorigel


• Spectro Tar Skin Wash


• Tar Distillate

Available Dosage Forms:

• Liquid


• Shampoo


• Lotion


• Solution


• Cream


• Gel/Jelly


• Soap


• Kit


• Ointment


• Bar


• Foam


• Emulsion

Therapeutic Class: Keratolytic

Uses For Betatar Gel

Coal tar is used to treat eczema, psoriasis, seborrheic dermatitis, and other skin disorders.

Some of these preparations are available only with your doctor's prescription.

Before Using Betatar Gel

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

Coal tar products should not be used on infants, unless otherwise directed by your doctor. Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of this medicine in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of this medicine in the elderly with use in other age groups.

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. 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.

Proper Use of coal tar

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

Use this medicine only as directed. Do not use more of it and do not use it more often than recommended on the label, unless otherwise directed by your doctor. To do so may increase the chance of side effects.

After applying coal tar, protect the treated area from direct sunlight and do not use a sunlamp for 72 hours, unless otherwise directed by your doctor, since a severe reaction may occur. Also, make sure you have removed all the coal tar medicine from your skin before you go back into direct sunlight or use a sunlamp.

Do not apply this medicine to infected, blistered, raw, or oozing areas of the skin.

Keep this medicine away from the eyes. If you should accidentally get some in your eyes, flush them thoroughly with water at once.

To use the cream or ointment form of this medicine:

• Apply enough medicine to cover the affected area, and rub in gently.

To use the gel form of this medicine:

• Apply enough gel to cover the affected area, and rub in gently. Allow the gel to remain on the affected area for 5 minutes, then remove excess gel by patting with a clean tissue.

To use the shampoo form of this medicine:

• Wet the scalp and hair with lukewarm water. Apply a generous amount of shampoo and rub into the scalp, then rinse. Apply the shampoo again, working up a rich lather, and allow to remain on the scalp for 5 minutes. Then rinse thoroughly.

To use the nonshampoo liquid form of this medicine:

• Some of these preparations are to be applied directly to dry or wet skin, some are to be added to lukewarm bath water, and some may be applied directly to dry or wet skin or added to lukewarm bath water. Make sure you know exactly how you should use this medicine. If you have any questions about this, check with your health care professional.


• If this medicine is to be applied directly to the skin, apply enough to cover the affected area, and rub in gently.


• Some of these preparations contain alcohol and are flammable. Do not use near heat, near 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 eczema, psoriasis, seborrheic dermatitis, and other skin disorders:
  
  • For cleansing bar dosage form:
    
    • Adults—Use one or two times a day, or as directed by your doctor.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For cream dosage form:
    
    • Adults—Apply to the affected area(s) of the skin up to four times a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For gel dosage form:
    
    • Adults—Apply to the affected area(s) of the skin one or two times a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For lotion dosage form:
    
    • Adults—Apply directly to the affected area(s) of the skin or use as a bath, hand or foot soak, or as a hair rinse, depending on the product.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For ointment dosage form:
    
    • Adults—Apply to the affected area(s) of the skin two or three times a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For shampoo dosage form:
    
    • Adults—Use once a day to once a week or as directed by your doctor.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For topical solution dosage form:
    
    • Adults—Apply to wet the skin or scalp, or use as a bath, depending on the product.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For topical suspension dosage form:
    
    • Adults—Use as a bath.
    
    
    • 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

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.

Precautions While Using Betatar Gel

If this medicine is used on the scalp, it may temporarily discolor blond, bleached, or tinted hair.

Coal tar may stain the skin or clothing. Avoid getting it on your clothing. The stain on the skin will wear off after you stop using the medicine.

Betatar Gel Side Effects

In animal studies, coal tar has been shown to increase the chance of skin cancer.

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 as soon as possible if any of the following side effects occur:

Rare

• Skin irritation not present before use of this medicine


• skin rash

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

• Stinging (mild)—especially for gel and solution dosage forms

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.

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 Betatar Gel Topical resources

• Betatar Gel Topical Use in Pregnancy & Breastfeeding
• Betatar Gel Topical Support Group
• 0 Reviews for Betatar Topical - Add your own review/rating

Compare Betatar Gel Topical with other medications

• Dermatitis
• Psoriasis
• Seborrheic Dermatitis

Bruxel

Bruxel may be available in the countries listed below.

Ingredient matches for Bruxel

Proglumetacin

Proglumetacin is reported as an ingredient of Bruxel in the following countries:

• Argentina

International Drug Name Search

Amadol

Amadol may be available in the countries listed below.

Ingredient matches for Amadol

Tramadol

Tramadol hydrochloride (a derivative of Tramadol) is reported as an ingredient of Amadol in the following countries:

• El Salvador


• Germany

International Drug Name Search

Gesin

Gesin may be available in the countries listed below.

Ingredient matches for Gesin

Chlormadinone

Chlormadinone 17α-acetate (a derivative of Chlormadinone) is reported as an ingredient of Gesin in the following countries:

• Japan

International Drug Name Search

Destone

Destone may be available in the countries listed below.

Ingredient matches for Destone

Potassium Citrate

Potassium Citrate is reported as an ingredient of Destone in the following countries:

• Taiwan

International Drug Name Search

Xabine

Xabine may be available in the countries listed below.

Ingredient matches for Xabine

Capecitabine

Capecitabine is reported as an ingredient of Xabine in the following countries:

• India

International Drug Name Search

Flurandrenolone

Flurandrenolone may be available in the countries listed below.

Ingredient matches for Flurandrenolone

Fludroxycortide

Flurandrenolone (BAN) is also known as Fludroxycortide (Rec.INN)

International Drug Name Search

Glossary

BAN	British Approved Name
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.

Nixal Spray

Nixal Spray may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Nixal Spray

Oxytetracycline

Oxytetracycline hydrochloride (a derivative of Oxytetracycline) is reported as an ingredient of Nixal Spray in the following countries:

• Germany


• Italy

International Drug Name Search

Dicloxacilina MK

Dicloxacilina MK may be available in the countries listed below.

Ingredient matches for Dicloxacilina MK

Dicloxacillin

Dicloxacillin is reported as an ingredient of Dicloxacilina MK in the following countries:

• Colombia


• Ecuador

International Drug Name Search