Drug Catalog - Product Detail
GLYCOPYRROLATE FORTE TB 2MG 100
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 64980-0273-01 | RISING PHARMACEUTICALS | 100 | 2MG | TABLET |
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Description
DESCRIPTION Glycopyrrolate tablets contain the synthetic anticholinergic glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethylpyrrolidinium bromide. Its empirical formula is C 19 H 28 BrNO 3 , its molecular weight is 398.33, and its structural formula is: Each 1 mg tablet contains: Glycopyrrolate, USP.................1 mg Each 2 mg tablet contains: Glycopyrrolate, USP.................2 mg Inactive Ingredients: Dibasic Calcium Phosphate, Lactose, Magnesium Stearate, Povidone, Sodium Starch Glycolate. Structural Formula
How Supplied
HOW SUPPLIED Glycopyrrolate tablets 1 mg are bisected, compressed white, round tablets debossed “K” above the bisect and “400” below the bisect on one side of the tablet, and plain on the other side. Available in bottles of 100 (NDC 64980-272-01). Glycopyrrolate tablets 2 mg are bisected, compressed white, round tablets debossed “K” above the bisect and “401” below the bisect on one side of the tablet, and plain on the other side. Available in bottles of 100 (NDC 64980-273-01). Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Keep out of reach of children. Dispense in tight container. * Dopram ® is a registered trademark of Baxter Healthcare Corporation. Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401 U.S.A. Product of Finland Manufactured by: Par Formulations Private Limited, 9/215, Pudupakkam, Kelambakkam - 603 103. Made in India from Active Pharmaceutical Ingredient made in Finland Mfg. Lic. No.: TN00002121 Iss. 08-2017 OS272R-01-74-02
Indications & Usage
INDICATIONS For use as adjunctive therapy in the treatment of peptic ulcer.
Dosage and Administration
DOSAGE AND ADMINISTRATION The dosage of glycopyrrolate should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse reactions. The presently recommended maximum daily dosage of glycopyrrolate is 8 mg. Glycopyrrolate Tablets 1 mg. The recommended initial dosage of glycopyrrolate for adults is one tablet three times daily (in the morning, early afternoon, and at bedtime). Some patients may require two tablets at bedtime to assure overnight control of symptoms. For maintenance, a dosage of one tablet twice a day is frequently adequate. Glycopyrrolate Tablets 2 mg. The recommended dosage of glycopyrrolate for adults is one tablet two or three times daily at equally spaced intervals. Glycopyrrolate tablets are not recommended for use in pediatric patients under the age of 12 years.