Pilocarpine Hydrochloride (Oral)

• Sjogren’s syndrome

Pilocarpine is indicated for: The treatment of symptoms of dry mouth from salivary gland dysfunction caused by radiotherapy for cancer of the head and neck. The treatment of symptoms of dry mouth in patients with Sjogren’s syndrome.

N/A

Pilocarpine is contraindicated in patients with uncontrolled asthma, cardiovascular disease, known hypersensitivity to pilocarpine and when miosis is undesirable, e.g. in acute iritis and in narrow-angle (angle closure) glaucoma.

Pilocarpine is a cholinergic agonist exerting a broad spectrum of pharmacologic effects with predominant muscarinic action. Pilocarpine, in appropriate dosage, can increase secretion by the exocrine glands such as sweat, salivary, lacrimal, gastric, pancreatic, and intestinal glands and the mucous cells of the respiratory tract. The tone and motility of urinary tract, gallbladder and biliary duct, smooth muscle may be enhanced.

Pilocarpine should be administered with caution to patients taking beta adrenergic antagonists because of the possibility of conduction disturbances. Pilocarpine might antagonize the anticholinergic effects of drugs used concomitantly.

Headache, visual disturbance, lacrimation, sweating, respiratory distress, gastrointestinal spasm, nausea, vomiting, diarrhea, atrioventricular block, tachycardia, bradycardia, hypotension, hypertension, shock, mental confusion, cardiac arrhythmia, and tremors etc may occur. Most of the adverse experiences observed during pilocarpine treatment were consequences of exaggerated parasympathetic stimulation. These adverse experiences were dose-dependent and usually mild and self-limited.

Pilocarpine should be administered with caution to patients with known or suspected cholelithiasis or biliary tract disease. If a patients sweats excessively while taking pilocarpine hydrochloride and can not drink enough liquid, the patient should consult a physician.

Use in pregnancy: Pregnancy Category C. There is no adequate and well controlled studies in pregnant women. Pilocarpine HCl should be used during pregnancy only if the potential benefits justify the potential risk to the fetus.Use in nursing mother: It is not known whether the drug is excreted in human milk. However, decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Use in children: Safety and effectiveness in pediatric patients have not been established.