ROBINUL- glycopyrrolate tablet ROBINUL FORTE- glycopyrrolate tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Casper Pharma LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ROBINUL and ROBINUL FORTE are indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. Limitations of Use ROBINUL and ROBINUL FORTE are not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established. ROBINUL and ROBINUL FORTE are contraindicated in: • Patients at risk for anticholinergic toxicity due to an underlying medical condition, including:       o Glaucoma [see Warnings and Precautions (5.1) ]       o Obstructive uropathies, including prostatic hypertrophy       o Mechanical obstructive diseases of the gastrointestinal tract (e.g., pyloroduodenal stenosis, strictures) [see Warnings and Precautions (5.2) ]       o Gastrointestinal motility disorders (e.g., achalasia, paralytic ileus, intestinal atony) [see  Warnings and Precautions (5.3) ]       o Bleeding gastrointestinal ulcer       o Active inflammatory or infectious colitis which can lead to toxic megaco

Product summary:

ROBINUL (glycopyrrolate) tablets, 1 mg are white, round, flat-faced, beveled-edge tablet, debossed “CS” and “007” on one side and functionally scored on the other side. Available as • Bottles of 30  NDC 70199-007-30 • Bottles of 90  NDC 70199-007-90 ROBINUL FORTE (glycopyrrolate) tablets, 2 mg are white, round, flat-faced, beveled-edge tablet, debossed “CS” score “008” on one side and plain on the other side. Available as • Bottles of 30  NDC 70199-008-30 • Bottles of 90  NDC 70199-008-90 Store at controlled room temperature, 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children. Dispense in a tight container.

Authorization status:

New Drug Application

Summary of Product characteristics

ROBINUL - GLYCOPYRROLATE TABLET
ROBINUL FORTE - GLYCOPYRROLATE TABLET
CASPER PHARMA LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ROBINUL AND ROBINUL
FORTE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ROBINUL AND ROBINUL
FORTE.
ROBINUL® AND ROBINUL® FORTE (GLYCOPYRROLATE) TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1961
INDICATIONS AND USAGE
ROBINUL and ROBINUL FORTE 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)
• ROBINUL FORTE is not recommended for patients initiating treatment
or receiving maintenance
treatment with ROBINUL or another 1 mg dosage strength of oral
glycopyrrolate tablets.
Recommended Dosage (2.2)
• The recommended initial dosage of ROBINUL 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 ROBINUL FORTE for adults is 2mg 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 ROBINUL FORTE to ROBINUL or another 1 mg oral
tablet of glycopyrrolate.
DOSAGE FORMS AND STRENGTHS
• Tablets: 1 mg (functionally scored) 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 s