HYOSCYAMINE SULFATE SL- hyoscyamine sulfate tablet
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Hyoscyamine Sulfate Extended-Release Tablets contain 0.375 mg hyoscyamine sulfate in a formulation designed for oral b.i.d. dosage.
Hyoscyamine Sulfate Sublingual Tablets 0.125 mg are white, round, flat beveled edge tablets debossed “644? on one side. Plain on the other side.
Hyoscyamine Sulfate Sublingual tablets contain 0.125 mg hyoscyamine sulfate formulated for oral administration. Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The molecular formula is (C17 H23 NO3 )2 •H2 SO4 •2H2 O and the molecular weight is 712.85. Chemically, it is benzeneacetic acid, ?-(hydroxymethyl)-, 8-methyl-8-azabicyclo [3.2.1] oct-3-yl ester, [3(S)-endo ]-, sulfate (2:1), dihydrate.
Each tablet also contains as inactive ingredients: mannitol, croscarmellose sodium and magnesium stearate.
Hyoscyamine sulfate 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. 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. At therapeutic doses, it is completely devoid of any action on autonomic ganglia. Hyoscyamine sulfate inhibits gastrointestinal propulsive motility and decreases gastric acid secretion. Hyoscyamine sulfate also controls excessive pharyngeal, tracheal and bronchial secretions. Hyoscyamine sulfate is absorbed totally and completely by sublingual administration as well as oral administration. Once absorbed, hyoscyamine sulfate disappears rapidly from the blood and is distributed throughout the entire body. The half-life of hyoscyamine sulfate is 2 to 3½ hours. Hyoscyamine sulfate is partly hydrolyzed to tropic acid and tropine but the majority of the drug is excreted in the urine unchanged within the first 12 hours. Only traces of this drug are found in breast milk. Hyoscyamine sulfate passes the blood brain barrier and the placental barrier.
Hyoscyamine Sulfate SL Indications and Usage
Hyoscyamine sulfate is indicated whenever antispasmodic or anticholinergic therapy is desired. The high degree of purity allows effective action at very low dosage, with a minimal incidence of unwanted side effects.
May be contraindicated in glaucoma, prostatic hypertrophy and some cases of cardiac disease.
Excessive dryness of the mouth, blurred vision, urinary difficulty and tachycardia may indicate overdosage.
DOSAGE AND ADMINISTRATION
Dosage may be adjusted according to the conditions and severity of symptoms. Hyoscyamine Sulfate Sublingual Tablets, 0.125 mg must be placed under the tongue when it will dissolve in seconds, then swallow with saliva. Administering with liquid is not necessary.
Adults and pediatric patients 12 years of age and older
1 to 2 tablets every four hours or as needed. Do not exceed 12 tablets in 24 hours.
Pediatric patients 2 to under 12 years of age
½ to 1 tablet every four hours or as needed. Do not exceed 6 tablets in 24 hours.