Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
GLYCOPYRROLATE (UNII: V92SO9WP2I) (GLYCOPYRRONIUM - UNII:A14FB57V1D)
Casper Pharma LLC
ORAL
PRESCRIPTION DRUG
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
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.
New Drug Application
ROBINUL - GLYCOPYRROLATE TABLET ROBINUL FORTE - GLYCOPYRROLATE TABLET CASPER PHARMA LLC ---------- 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 Διαβάστε το πλήρες έγγραφο