Robinul Forte

— THERAPEUTIC CATEGORIES —
  • Hyperacidity, GERD, and ulcers
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Robinul Forte Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Glycopyrrolate 2mg; dye-free tabs.

    Pharmacological Class

    Anticholinergic.

    See Also

    How Supplied

    Tabs—30, 90

    How Supplied

    Robinul (glycopyrrolate) Tablets, 1 mg

    • Supplied as white, round, flat-faced, beveled-edge tablets, debossed “CS” and “007” on one side and functionally scored on the other side. 

    • Available in 30- and 90-count bottles.

    Robinul Forte (glycopyrrolate) Tablets, 2 mg

    • Supplied as white, round, flat-faced, beveled-edge tablets, debossed “CS” score “008” on one side and plain on the other side. 

    • Available in 30- and 90-count bottles.

     

    Storage

    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].

    Manufacturer

    Casper Pharma

    Generic Availability

    YES

    Mechanism of Action

    Glycopyrrolate, like other anticholinergic agents, inhibits the action of acetylcholine on structures innervated by postganglionic cholinergic nerves and on smooth muscles that respond to acetylcholine but lack cholinergic innervation. These peripheral cholinergic receptors are present in the autonomic effector cells of smooth muscle, cardiac muscle, the sino-atrial node, the atrioventricular node, exocrine glands, and, to a limited degree, in the autonomic ganglia. Thus, it diminishes the volume and free acidity of gastric secretions and controls excessive pharyngeal, tracheal, and bronchial secretions. Glycopyrrolate antagonizes muscarinic symptoms (eg, bronchorrhea, bronchospasm, bradycardia, and intestinal hypermotility) induced by cholinergic drugs such as the anticholinesterases.

    Robinul Forte Indications

    Indications

    Adjunct in peptic ulcer.

    Limitations of Use

    Not indicated as monotherapy for treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established.

    Robinul Forte Dosage and Administration

    Adult

    Use lowest effective dose. 2mg 2–3 times daily in divided doses; max 8mg daily. Not recommended for patients in whom a lower dosage strength of oral glycopyrrolate is appropriate for initial or maintenance treatment.

    Children

    Not established.

    Robinul Forte Contraindications

    Contraindications

    Glaucoma. Obstructive uropathies, including prostatic hypertrophy. Mechanical obstructive diseases of the GI tract (eg, pyloroduodenal stenosis, strictures). GI motility disorders (eg, achalasia, paralytic ileus, intestinal atony). Bleeding GI ulcer. Active inflammatory or infectious colitis. Toxic megacolon. Myasthenia gravis.

    Robinul Forte Boxed Warnings

    Not Applicable

    Robinul Forte Warnings/Precautions

    Warnings/Precautions

    Precipitation of acute glaucoma. IOP. Partial or complete mechanical intestinal obstruction. Ileostomy. Colostomy. Monitor for decreased GI motility. Cognitive or visual impairment. Conditions exacerbated by anticholinergic effects (eg, autonomic neuropathy, hyperthyroidism, cardiac disease, hiatal hernia due to reflux esophagitis). Avoid exposure to hot or very warm environmental temperatures. Renal impairment: monitor. Increased risk of anticholinergic adverse reactions in elderly (≥65yrs): not recommended. Pregnancy. Nursing mothers.

    Warnings/Precautions

    Precipitation of Acute Glaucoma

    • Glycopyrrolate may cause increased IOP in patients with glaucoma and may reduce the effects of antiglaucoma agents.

    • Discontinue use and seek medical care immediately if symptoms of acute angle-closure glaucoma develop.

    Partial or Complete Mechanical Intestinal Obstruction 

    • Glycopyrrolate may worsen intestinal mechanical obstruction. Diarrhea may be an early symptom of an incomplete intestinal obstruction (esp in patients with ileostomy or colostomy).

    • Discontinue use and evaluate for potential intestinal obstruction if partial or complete intestinal obstruction is suspected.

    Gastrointestinal Adverse Reactions Due to Decreased Gastrointestinal Motility

    • Glycopyrrolate reduces GI motility and may result in delayed gastric emptying, constipation, and intestinal pseudo-obstruction and may precipitate or aggravate paralytic ileus and toxic megacolon.

    • Monitor for symptoms of decreased GI motility.

    • Concomitant use of Robinul with other anticholinergics or other drugs that decrease GI peristalsis: not recommended.

    Cognitive and Visual Adverse Reactions 

    • Glycopyrrolate may produce drowsiness and blurred vision and impair the mental and/or physical abilities required for the performance of hazardous tasks such as driving a motor vehicle, operating machinery, or performing other hazardous work.

    • Do not operate motor vehicles or other dangerous machinery or perform other hazardous tasks until they are reasonably certain that does not affect them adversely.

    • Discontinue if signs or symptoms of cognitive or visual impairment develop.

    Heat Prostration at High Environmental Temperatures

    • Avoid exposure to hot or very warm environmental temperatures.

    • Robinul and Robinul Forte are not recommended in geriatric patients.

    Other Conditions Exacerbated by Anticholinergic Adverse Reactions 

    • Robinul and Robinul Forte are not recommended in patients with other conditions exacerbated by anticholinergic adverse reactions (eg, autonomic neuropathy, hyperthyroidism, cardiac disease, and hiatal hernia associated with reflux esophagitis) and in patients taking other anticholinergic medications.

    Increased Risk of Anticholinergic Adverse Reactions in Geriatric Patients

    • Geriatric patients 65 years of age and older are at increased risk of anticholinergic adverse reactions that may lead to complications of urinary retention, bowel obstruction, heat prostration, arrhythmias, delirium, and falls or fractures. 

    • Robinul and Robinul Forte are not recommended in geriatric patients and may be contraindicated in some geriatric patients with underlying medical conditions. 

    Pregnancy Considerations

    Risk Summary

    • There is an absence of published data on orally administered glycopyrrolate in pregnant women, including an absence of any reports of a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.

    • The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

    Nursing Mother Considerations

    Risk Summary

    • There are no data on the presence of glycopyrrolate in either human or animal milk, the effects on the breastfed infant, or the effects on milk production.

    • Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for Robinul and Robinul Forte and any potential adverse effects on the breastfed infant from Robinul and Robinul Forte.

    Pediatric Considerations

    • Safety and efficacy have not been established.

    Geriatric Considerations

    • Robinul and Robinul Forte are not recommended in geriatric patients and may be contraindicated in certain geriatric patients with underlying medical conditions.

    Renal Impairment Considerations

    • Monitor patients with renal impairment. Discontinue if anticholinergic adverse reactions occur.

    Robinul Forte Pharmacokinetics

    Metabolism

    Hepatic.

    Elimination

    Renal. Half-life: 3 hours.

    Robinul Forte Interactions

    Interactions

    Additive anticholinergic effects with other anticholinergics (eg, tricyclics, antiepileptics, class I antiarrhythmics, antispasmodics, amantadine) or other medications that decrease GI motility: not recommended. Concomitant use with solid oral dosage forms of potassium chloride may worsen GI mucosal injury due to decreased gastric motility and increased transit time: not recommended.

    Robinul Forte Adverse Reactions

    Adverse Reactions

    Blurred vision, drowsiness, decreased sweating, flushing, vomiting, constipation, dry mouth, tachycardia, urinary retention.

    Robinul Forte Clinical Trials

    See Literature

    Robinul Forte Note

    Not Applicable

    Robinul Forte Patient Counseling

    Patient Counseling

    Precipitation of Acute Glaucoma

    • Discontinue use and seek medical care immediately if symptoms of acute angle-closure glaucoma (pain and reddening of the eyes accompanied by dilated pupils) develop.

    Partial or Complete Mechanical Intestinal Obstruction 

    • Contact your healthcare provider if diarrhea occurs esp in patients with ileostomy or colostomy.

    Gastrointestinal Adverse Reactions Due to Decreased Gastrointestinal Motility

    • Advise patients that treatment with Robinul and Robinul Forte may cause reduced GI motility and contact their healthcare provider if vomiting, early satiety, abdominal distention, or constipation occur.

    Cognitive and Visual Adverse Reactions 

    • Advise that cognitive or visual impairment may occur and to avoid operate motor vehicles or other dangerous machinery or perform other hazardous tasks until they are reasonably certain that treatment does not affect them adversely. Discontinue if signs or symptoms of cognitive or visual impairment develop.

    Heat Prostration at High Environmental Temperatures

    • Avoid exposure to hot or very warm environmental temperatures.

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