Drug Catalog - Product Detail
GLYCOPYRROLATE 1MG TB 100
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 23155-0606-01 | AVET PHARMACEUTICALS | 100 | 1MG | TABLET |
PACKAGE FILES
Generic Name
GLYCOPYRROLATE
Substance Name
GLYCOPYRROLATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA207201
Description
11 DESCRIPTION Glycopyrrolate tablets contain synthetic anticholinergic glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentyl hydroxyphenylacetyl)oxy]-1,1-dimethylpyrrolidinium bromide. The molecular formula for glycopyrrolate is C 19 H 28 BrNO 3 , the molecular weight is 398.3 g/mol, and the structural formula is: Each glycopyrrolate tablets, USP contains glycopyrrolate, USP 1 mg or 2 mg as the active ingredient. The inactive ingredients are dibasic calcium phosphate, lactose, magnesium stearate, povidone, and sodium starch glycolate. glycco-structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Glycopyrrolate Tablets USP, 1 mg are white to off-white, round, flat beveled edge tablet debossed with “MCR 117” separated by break line on one side and plain on other side. Packaged in bottles of 100 tablets. Glycopyrrolate Tablets USP, 1 mg in bottles of 100 (NDC 23155-606-01). Glycopyrrolate Tablets USP, 2 mg are white to off white, round, flat beveled edge tablet debossed with “AC 108” separated by break line on one side and plain on other side. Packaged in bottles of 100 tablets. Glycopyrrolate Tablets USP, 2 mg in bottles of 100 (NDC 23155-607-01). Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° C to 30°C (59° F to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children. Dispense in tight container.
Indications & Usage
1 INDICATIONS AND USAGE Glycopyrrolate is indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. Limitations of Use Glycopyrrolate is not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established. Glycopyrrolate is anticholinergics indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. Limitations of Use: Not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Important Dosing Information ( 2.1 ) Glycopyrrolate tablets 2 mg are not recommended for patients initiating treatment or receiving maintenance treatment with glycopyrrolate tablets 1 mg or another 1 mg dosage strength of oral glycopyrrolate tablets. Recommended Dosage ( 2.2 ) The recommended initial dosage of glycopyrrolate tablets 1 mg is 1 mg three times daily (in the morning, early afternoon, and at bedtime). Some patients may require 2 mg at bedtime to assure overnight control of symptoms. For maintenance, a dosage of 1 mg twice a day is frequently adequate. The recommended dosage of glycopyrrolate tablets 2 mg for adults is 2 mg two or three times daily at equally spaced intervals. The maximum recommended daily dosage is 8 mg. Use the lowest effective dosage of glycopyrrolate to control symptoms. If patients can be titrated to a lower dose, switch from glycopyrrolate tablets 2 mg to glycopyrrolate tablets 1 mg or another 1 mg oral tablet of glycopyrrolate. 2.1 Important Dosing Information Glycopyrrolate tablets 2 mg are not recommended for patients in whom a lower dosage strength of oral glycopyrrolate (e.g., 1 mg tablet strength) is appropriate for initial or maintenance treatment because the dosage strength of glycopyrrolate tablets 2 mg may exceed the recommended initial and maintenance dosage of oral glycopyrrolate tablets. 2.2 Recommended Dosage The recommended initial dosage of glycopyrrolate tablets 1 mg for adults is 1 mg three times daily (in the morning, early afternoon, and at bedtime). Some patients may require 2 mg at bedtime to assure overnight control of symptoms. For maintenance, a dosage of 1 mg twice a day is frequently adequate. The recommended dosage of glycopyrrolate tablets 2 mg for adults is 2 mg two or three times daily at equally spaced intervals. The maximum recommended daily dosage of glycopyrrolate is 8 mg. Use the lowest effective dosage of glycopyrrolate to control symptoms. If patients can be titrated to a lower dose, switch from glycopyrrolate tablets 2 mg to glycopyrrolate tablets 1 mg or another 1 mg oral tablet of glycopyrrolate.