ROBINUL- glycopyrrolate_tablet
Function and Efficacy
Glycopyrrolate, an anticholinergic (antimuscarinic) agent, inhibits the action of acetylcholine on parietal cells in the stomach and decreases the volume and acidity of gastric secretions. No formal pharmacodynamic studies have been conducted with ROBINUL and ROBINUL FORTE. Patients with Renal Impairment see Use in Specific Populations (8.
Indication
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 anticholinergics indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. (1) Limitations of Use: (1).
Usage and Dosage
Important Dosing Information (2. 1) Recommended Dosage (2. 2) ROBINUL FORTE is not recommended for patients in whom a lower dosage strength of oral glycopyrrolate (e. , ROBINUL or another 1 mg tablet strength) is appropriate for initial or maintenance treatment because the dosage strength of ROBINUL FORTE may exceed the recommended initial and maintenance dosage of oral glycopyrrolate tablets. The recommended initial dosage of ROBINUL for adults 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.
Label
Adverse Reactions
The following serious or otherwise important adverse reactions are discussed elsewhere in the labeling: see Warnings and Precautions (5. 1) see Warnings and Precautions (5. 2) see Warnings and Precautions (5. 3) see Warnings and Precautions (5. 4) see Warnings and Precautions (5. 5) see Warnings and Precautions (5. 6) see Warnings and Precautions (5. 7) Cardiac Disorders: Endocrine Disorders: Eye Disorders: Gastrointestinal Disorders: Immune System Disorders: see Contraindications (4) Nervous System Disorders: Respiratory Disorders: Renal and Urinary Disorders: Reproductive System and Breast Disorders: Vascular Disorders: Adverse reactions include blurred vision, drowsiness, decreased sweating, flushing, vomiting, constipation, dry mouth, tachycardia, and urinary retention. (6) To report SUSPECTED ADVERSE REACTIONS, contact Casper Pharma LLC at 1-844-5-CASPER (1-844-522-7737) or FDA at 1-800-FDA-1088 or www. gov/medwatch.
Precautions
ROBINUL and ROBINUL FORTE are contraindicated in: see Warnings and Precautions (5. 1) see Warnings and Precautions (5. 2) see Warnings and Precautions (5. 3) see Adverse Reactions (6) Description (11) Patients at risk for anticholinergic toxicity due to various underlying medical conditions.
Special Population Medication
Renal Impairment 8. 6 Risk Summary see Data Data Animal Data see Nonclinical Toxicology (13. 1) Risk Summary Safety and effectiveness in pediatric patients have not been established. Geriatric patients 65 years of age and older may be more sensitive to the anticholinergic adverse reactions of glycopyrrolate leading to complications of urinary retention, bowel obstruction, heat prostration, arrhythmias, delirium, and falls or fractures; therefore, ROBINUL and ROBINUL FORTE are not recommended in geriatric patients and may be contraindicated in some geriatric patients with underlying medical conditions [ see Contraindications (4) Warnings and Precautions (5) Glycopyrrolate is substantially excreted by the kidney [ see Clinical Pharmacology (12. 3) Monitor patients with renal impairment for anticholinergic adverse reactions [ see Adverse Reactions (6).
Drug Interactions
Other Anticholinergic Drugs 5. 1 Drugs with Altered Absorption due to Decreased GI Motility 7. 2 GI Toxicity with Solid Oral Dosage Forms of Potassium Chloride 7. 3 There is potential for an additive interaction between glycopyrrolate and concomitantly used anticholinergic drugs (e. , tricyclic antidepressants, anti-epileptics, class I antiarrhythmics, antispasmodics, amantadine) resulting in increased anticholinergic adverse reactions. Co-administration of antipsychotics with glycopyrrolate may lead to worsening of tardive dyskinesia. ROBINUL and ROBINUL FORTE are not recommended in patients taking other anticholinergic drugs [ see Warnings and Precautions (5. 6 Decreased gastrointestinal motility by glycopyrrolate may impact absorption of other drugs leading to increased or decreased drug exposure. ROBINUL and ROBINUL FORTE are not recommended in patients taking other drugs that are affected by altered gastrointestinal motility [ see Warnings and Precautions (5. Oral glycopyrrolate may worsen gastrointestinal mucosal injury reported with solid oral dosage forms of potassium chloride due to decreased gastric motility and increased transit time, leading to prolonged contact with the gastrointestinal mucosa. ROBINUL and ROBINUL FORTE are not recommended in patients taking solid oral dosage forms of potassium chloride.
Other Information
OVERDOSAGE
Signs and symptoms of glycopyrrolate overdosage are related to excessive anti-muscarinic anticholinergic activity and are generally peripheral (e.g., flushing, hyperthermia, tachycardia, ileus, urinary retention, loss of ocular accommodation, and light sensitivity due to mydriasis), but central nervous system toxicity (agitation, seizures, hyperthermia) may also occur. If over-exposure occurs, call the Poison Control Center at 1-800-222-1222 for current information on the management of glycopyrrolate poisoning and overdosage.
NONCLINICAL TOXICOLOGY
Reproduction studies in rats resulted in diminished rates of conception in a dose-related manner. Studies in dogs suggest that diminished rates of conception may be due to diminished seminal secretion, which is evident at high doses of glycopyrrolate.
Manufacturer
ROBINUL FORTE- glycopyrrolate_tablet