GLYCOPYRROLATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GLYCOPYRROLATE (UNII: V92SO9WP2I) (GLYCOPYRRONIUM - UNII:A14FB57V1D)

Available from:

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

INN (International Name):

GLYCOPYRROLATE

Composition:

GLYCOPYRROLATE 1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GLYCOPYRROLATE - GLYCOPYRROLATE TABLET
HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.
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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