ROBINUL® ROBINUL® FORTE
Indications And Clinical Uses: The management of gastrointestinal disorders amenable to anticholinergic therapy, such as: duodenal ulcer, duodenitis, pylorospasm; gastric ulcer, gastritis, hiatal hernia, hyperchlorhydria, pyrosis, aerophagia, gastroenteritis; esophagitis; cholecystitis, chronic pancreatitis; spastic and irritable colon, ulcerative colitis, functional bowel distress, diverticulitis, acute enteritis, diarrhea; and splenic flexure syndrome, neurogenic gastrointestinal disturbances.
Contra-Indications: Glaucoma, urinary bladder neck obstruction, pyloric obstruction, stenosis with significant gastric retention, prostatic hypertrophy, duodenal obstruction, cardiospasm (megaesophagus), achalasia of the esophagus.
Manufacturers’ Warnings In Clinical States: Pregnancy and Lactation: Use of the drug in pregnancy, lactation or in the childbearing years requires that the potential benefits of the drug be weighed against the possible hazards to mother and child.
In the presence of a high environmental temperature, heat prostration can occur (fever, heat stroke due to decreased sweating) with all anticholinergic agents.
Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance, treatment with this drug would be inappropriate and possibly harmful.
Occupational Hazards: Glycopyrrolate may produce drowsiness or blurred vision. In this event, the patients should be warned not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery, and not to perform hazardous work while taking this drug.
Precautions: Investigate any tachycardia before giving anticholinergic, (atropine-like) drugs since they may increase the heart rate.
The use of anticholinergic drugs in the treatment of gastric ulcer may produce a delay in gastric emptying and may complicate such therapy (antral stasis). The use of an indwelling nasogastric tube should be considered whenever more than 2 doses in succession are to be administered.
Do not rely on the use of the drug in the presence of complications of biliary tract disease.
Adverse Reactions: Dry mouth, blurring of vision, constipation, urinary hesitancy, rash, urinary difficulties, nausea, bitter taste, nervousness, abdominal cramps; tachycardia, palpitation, dilatation of the pupil, increased ocular tension, weakness, vomiting, headache, dizziness, drowsiness, dysuria.
Symptoms And Treatment Of Overdose: Symptoms and Treatment: Symptomatic and supportive.
Empty the stomach as quickly as possible by emesis followed by gastric lavage. Following gastric lavage activated charcoal (30 g) may be administered every four to six hours during the first 24 hours after ingestion.
Monitor cardiac function for any signs of dysrhythmia.
Maintain an open airway and adequate fluid intake; regulate body temperature.
Use standard medical measures to manage circulatory shock and metabolic acidosis. Cardiac arrhythmias may be treated with neostigmine, pyridostigmine, or propranolol. If signs of cardiac failure occur, consider the use of a short acting digitalis preparation. Close monitoring of cardiac function for not less than 5 days is advisable.
Anticonvulsants may be given to control seizures.
Dialysis is of no value because of low plasma concentrations of the drug.
Physostigmine given i.v. can be used to reverse the symptoms of anticholinergic poisoning. Give physostigmine 1 to 3 mg slow i.v. (over 2 minutes). If no clinical changes or cholinergic signs occur within 15 to 30 minutes, an additional 1 to 2 mg may be administered. Repeat doses of 1 to 2 mg i.v. every 30 minutes up to two hours.
Physostigmine is not innocuous and carries the risk of inducing seizures and cholinergic crisis. It should not be used routinely. If excessive sweating, nausea or vomiting occur, reduce dosage of physostigmine. Atropine in a dose of 50% of the amount of injected physostigmine should be kept on hand and administered if excessive cholinergic symptoms develop.
Dosage: Average Recommended Adult Dose: 1 to 2 tablets 3 times daily (morning, mid-afternoon, and bedtime). To obtain optimum results, dosage should be adjusted to the individual patient’s response. After the more severe symptoms associated with acute conditions have subsided, the dose may be reduced to the minimum required to maintain symptomatic relief. For maintenance, a dosage of 1 mg twice a day will frequently afford adequate control.
Availability And Storage: Robinul: Each pink, scored, compressed tablet, engraved “AYERST”, contains: glycopyrrolate 1 mg. Nonmedicinal ingredients: calcium phosphate dibasic dihydrate, FD&C Red No. 3 Aluminum Lake, lactose, magnesium stearate, povidone and sodium starch glycolate. Energy:
Robinul Forte: Each pink, scored, compressed tablet, engraved “AYERST”, contains: glycopyrrolate 2 mg. Nonmedicinal ingredients: calcium phosphate dibasic dihydrate, FD&C Red No. 3 Aluminum Lake, lactose, magnesium stearate, povidone and sodium starch glycolate. Energy:
ROBINUL® ROBINUL® FORTE Wyeth-Ayerst Glycopyrrolate Anticholinergic