Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
GLYCOPYRROLATE (UNII: V92SO9WP2I) (GLYCOPYRRONIUM - UNII:A14FB57V1D)
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
GLYCOPYRROLATE
GLYCOPYRROLATE 1 mg
ORAL
PRESCRIPTION DRUG
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 tablets are contraindicated in: - Patients at risk for anticholinergic toxicity due to an underlying medical condition, including: Glaucoma [see Warnings and Precautions (5.1) ] Obstructive uropathies, including prostatic hypertrophy Mechanical obstructive diseases of the gastrointestinal tract (e.g., pyloroduodenal stenosis, strictures) [see Warnings and Precautions (5.2) ] Gastrointestinal motility disorders (e.g., achalasia, paralytic ileus, intestinal atony) [see Warnings and Precautions (5.3)] Bleeding gastrointestinal ulcer Active inflammatory or infectious colitis which can lead to toxic megacolon History of or current toxic megacolon Myasthenia gravis - Glaucoma [see Warnings and Pre
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, 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. 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.
Abbreviated New Drug Application
GLYCOPYRROLATE - GLYCOPYRROLATE TABLET HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE GLYCOPYRROLATE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GLYCOPYRROLATE TABLETS. GLYCOPYRROLATE TABLETS FOR ORAL USE INITIAL U.S. APPROVAL: 1961 INDICATIONS AND USAGE Glycopyrrolate is anticholinergics indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. (1) Limitations of Use: Not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established. (1) 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. DOSAGE FORMS AND STRENGTHS Tablets: 1 mg (functionally scored) and 2 mg (functionally scored) (3) CONTRAINDICATIONS Patients at risk for anticholinergic toxicity due to various underlying medical conditions. (4, 5.1,5.2, 5.3) Hypersensitivity to glycopyrrolate or the inactive ingredients. (4) WARNINGS AND PRECAUTIONS Precipitation of Acut Preberite celoten dokument