Linked Life Data

Bentyl (Capsule)

Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3390

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PredicateObject
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Bentyl (Capsule)
dailymed-instance:clinicalP...
Dicyclomine relieves smooth muscle spasm of the gastrointestinal tract. Animal studies indicate that this action is achieved via a dual mechanism: (1) 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 (2) a direct effect upon smooth muscle (musculotropic) as evidenced by dicyclomine's antagonism of bradykinin- and histamine-induced spasms of the isolated guinea pigileum. 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 (BaCI)-induced intestinal spasm while atropine was at least 200 times more potent against effects of ACh than BaCI. 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. In man, dicyclomine is rapidly absorbed after oral administration, reaching peak values within 60-90 minutes. The principal route of elimination 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 concentration were measured for 9 hours after a single dose. In subsequent studies, plasma concentrations were followedfor up to 24 hours after a single dose, showing a secondary phase of elimination with a somewhat longer half-life. Mean volume of distribution for a 20 mg oral dose is approximately 3.65 L/kg suggesting extensive distribution in tissues. 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 q.i.d.) demonstrated a favorable clinical response compared with 55% treated with placebo (p<.05). In these trials most of the side effects were typically anticholinergic in nature (see table) and were reported by 61% of the patients. Nine percent (9%) of patients were discontinued from the drug 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.
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10 mg blue capsules, imprinted BENTYL 10, NDC 58914-012-10: bottles of 100. Store at room temperature, preferably below 86��F (30��C). 20 mg compressed, light blue, round tablets, debossed BENTYL 20, NDC 58914-013-10: bottles of 100. To prevent fading, avoid exposure to direct sunlight. Store at room temperature, preferably below 86��F (30��C). 10 mg/5 mL pink syrup, NDC 58914-015-16: 16 ounce bottle. Store at room temperature, preferably below 86��F (30��C). Protect from excessive heat. 20 mg/2 mL (10 mg/mL) injection (for intramuscular use only, NOT FOR INTRAVENOUS USE) NDC 58914-080-52: Boxes of five 20 mg/2 mL ampules (10 mg/mL). Store at room temperature, preferably below 86��F (30��C). Protect from freezing. Rx only Rev. March 2005 Bentyl Capsules, Bentyl Tablets and Bentyl Syrup Manufactured by: Patheon Pharmaceuticals Inc. Cincinnati, OH 45215 Bentyl Injection Manufactured by: Akorn Inc. Decatur, IL 62522 Manufactured for: Axcan Scandipharm Inc. Birmingham, AL 35242 www.axcan.com
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dailymed-instance:genericMe...
dicyclomine hydrochloride
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Bentyl (Capsule)
dailymed-instance:adverseRe...
Controlled clinical trials have provided frequency information for reported adverse effects of dicyclomine hydrochloride listed in a decreasing order of frequency. (See CLINICAL PHARMACOLOGY.) Not all of the following adverse reactions have been reported with dicyclomine hydrochloride. Adverse reactions are included here that have been reported for pharmacologically similar drugs with anticholinergic/antispasmodic action. Gastrointestinal: dry mouth, nausea, vomiting, constipation, bloated feeling, abdominal pain, taste loss, anorexia Central Nervous System: dizziness, light-headedness, tingling, headache, drowsiness, weakness, nervousness, numbness, mental confusion and/or excitement (especially in elderly persons), dyskinesia, lethargy, syncope, speech disturbance, insomnia Ophthalmologic: blurred vision, diplopia, mydriasis, cycloplegia, increased ocular tension Dermatologic/Allergic: rash, urticaria, itching, and other dermal manifestations; severe allergic reaction or drug idiosyncrasies including anaphylaxis Genitourinary: urinary hesitancy, urinary retention Cardiovascular: tachycardia, palpitations Respiratory: dyspnea, apnea, asphyxia Other: decreased sweating, nasal stuffiness or congestion, sneezing, throat congestion, impotence, suppression of lactation With the injectable form, there may be temporary sensation of light-headedness. Some local irritation and focal coagulation necrosis may occur following the I.M. injection of the drug.
dailymed-instance:indicatio...
For the treatment of functional bowel/irritable bowel syndrome.
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dailymed-instance:name
Bentyl