![]() ![]() ![]() Levsin® inhibits gastrointestinal propulsive motility and decreases gastric acid secretion. At therapeutic doses, it is completely devoid of any action on autonomic ganglia. These peripheral cholinergic receptors are present in the autonomic effector cells of the smooth muscle, cardiac muscle, the sinoatrial node, the atrioventricular node, and the exocrine glands. Levsin® inhibits specifically the actions of acetylcholine on structures innervated by postganglionic cholinergic nerves and on smooth muscles that respond to acetylcholine but lack cholinergic innervation. Hyoscyamine Sulfate, USP.0.3111 mgĪtropine Sulfate, USP.0.0582 mg If indicated, one tablet every eight (8) hours may be given.Įach Donnatal Extentabs® tablet contains: The usual dose is one tablet every twelve (12) hours. IT HAS NOT BEEN SHOWN CONCLUSIVELY WHETHER ANTICHOLINERGIC /ANTISPASMODIC DRUGS AID IN THE HEALING OF A DUODENAL ULCER, DECREASE THE RATE OF RECURRENCES OR PREVENT COMPLICATIONS.ĭosing (Adult): Usual: The dosage of Donnatal Extentabs® should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse reactions. May also be useful as adjunctive therapy in the treatment of duodenal ulcer. ![]() INDICATIONS: Based on a review of this drug by the National Academy of Sciences - National Research Council and/or other information, FDA has classified the following indications as "possibly" effective: For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. ![]() Syrup, as hydrochloride: 10 mg/5 mL (480 mL) Injection, solution, as hydrochloride: 10 mg/mL (2 mL) In these trials, most of the side effects were typically anticholinergic in nature (see table) and were reported by 61% of the patients.įor the treatment of functional bowel/irritable bowel syndrome.ĭosing (Adult): Usual: 10-20 mg orally or IM four times daily (up to 40 mg orally four times daily). 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. Mean volume of distribution for a 20 mg oral dose is approximately 3.65 L/kg suggesting extensive distribution in tissues. 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 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. Excretion also occurs in the feces, but to a lesser extent (8.4%). The principal route of elimination is via the urine (79.5% of the dose). In man, dicyclomine is rapidly absorbed after oral administration, reaching peak values within 60-90 minutes. 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 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. Atropine did not affect responses to these two agonists. 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 pig ileum. Dicyclomine relieves smooth muscle spasm of the gastrointestinal tract. ![]()
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