Source: FDA, National Drug Code (US) Revision Year: 2022
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 FORTE is not recommended for patients in whom a lower dosage strength of oral glycopyrrolate (e.g., 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.
The recommended dosage of ROBINUL FORTE for adults is 2 mg two or three times daily at equally spaced intervals.
The maximum recommended daily dosage of glycopyrrolate 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.
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.
Management of glycopyrrolate overdosage is based upon presenting signs and symptoms, including close observation for severe or life-threatening complications which may require respiratory and cardiovascular monitoring and support. Consider administration of activated charcoal and/or use of a reversible anticholinesterase as appropriate or recommended by Poison Control.
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.
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