Dicyclomine Hydrochloride (Capsule)

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DOSAGE MUST BE ADJUSTED TO INDIVIDUAL PATIENT NEEDS.<br/>Adults: The only oral dose clearly shown to be effective is 160 mg per day (in 4 equally divided doses). Since this dose is associated with a significant incidence of side effects, it is prudent to begin with 80 mg per day (in 4 equally divided doses). Depending upon the patient's response during the first week of therapy, the dose should be increased to 160 mg per 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.

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 bradykininand histamine-induced spasms of the isolated guinea pig ileum. Atropine didnot 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 (BaCl)-induced intestinal spasm while atropine was at least 200 times more potent against effects of ACh than BaCl. 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 to 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 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. 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<0.05). 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.

Dicyclomine Hydrochloride Capsules are provided containing 10 mg of dicyclomine hydrochloride. The 10 mg capsule is a hard shelled gelatin capsule with a light turquoise blue opaque cap and a light turquoise blue body axially printed with MYLAN over 1610 in black ink both on the cap and the body. The capsule is filled with white to off-white powder. They are available as follows: NDC 0378-1610-01bottles of 100 capsules NDC 0378-1610-05bottles of 500 capsules STORE AT ROOM TEMPERATURE 15��TO 30��C (59��TO 86��F). Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

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Dicyclomine Hydrochloride

Controlled clinical trials have provided frequency information for reported adverse effects of dicyclomine hydrochloride listed in a decreasing order of frequency. 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.

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Dicyclomine Hydrochloride