GLYCOPYRROLATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Leading Pharma, LLC

INN (International Name):

GLYCOPYRROLATE

Composition:

GLYCOPYRROLATE 1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Glycopyrrolate Tablets, USP are indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. Limitations of Use Glycopyrrolate Tablets, USP are not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established. Glycopyrrolate Tablets USP 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 - Glauco

Product summary:

Glycopyrrolate tablets USP, 1 mg are bisected, compressed white, round tablet debossed “EP” above the bisect and “139” below the bisect on one side of the tablet, and plain on the other side. Available in bottles of 100 (NDC 69315-139-01). Glycopyrrolate tablets USP, 2 mg are bisected, compressed white, round tablet debossed “EP” above the bisect and “140” below the bisect on one side and plain on the other side. Available in bottles of 100 (NDC 69315-140-01). Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature] Dispense in a tight, light-resistant container as defined in the USP, using a child- resistant closure.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GLYCOPYRROLATE- GLYCOPYRROLATE TABLET
LEADING PHARMA, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GLYCOPYRROLATE
TABLETS, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR GLYCOPYRROLATE
TABLETS, USP.GLYCOPYRROLATE TABLETS, USP FOR ORAL USE
INITIAL U.S. APPROVAL: 1961
INDICATIONS AND USAGE
Glycopyrrolate tablets, USP are 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 is not recommended for patients initiating treatment or
receiving maintenance
treatment with glycopyrrolate tablets, USP or another 1 mg dosage
strength of oral glycopyrrolate
tablets.
Recommended Dosage (2.2)
The recommended initial dosage of glycopyrrolate tablets, USP 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, USP 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, USP or another 1mg
oral tablet of glycopyrrolate.
DOSAGE FORMS AND STRENGTHS
Tablets: 1 mg and 2 mg (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 Acute Glaucoma: May increase intraocular pressure; if
symptoms occur, discontinue
use and promptly seek medical