Pilocarpine is indicated for:

• The treatment of symptoms of dry mouth (xerostomia) caused by salivary gland dysfunction following radiotherapy for head and neck cancer.
• The treatment of dry mouth symptoms in patients with Sjögren’s syndrome.

Pilocarpine is a cholinergic agonist with a broad range of pharmacological actions, mainly showing muscarinic effects. In appropriate doses, it stimulates secretion from exocrine glands such as salivary, sweat, lacrimal, gastric, pancreatic, intestinal glands, and mucous cells of the respiratory tract. It may also increase tone and motility of smooth muscles in the urinary tract, gallbladder, biliary ducts, and gastrointestinal system.

For Head & Neck Cancer Patients: The recommended initial dose of pilocarpine hydrochloride tablets is one tablet taken three times a day. Dosage should be titrated according to therapeutic response and tolerance. The maximum daily dose is 30 mg daily (Not to exceed 10 mg per dose). Therapy should be discontinued if no improvement is noted after 2-3 months of therapy.

For Sjogren’s syndrome: The recommended dose of Pilocarpine HCl tablets is one tablet (5 mg) four times a day. Efficacy was established by 6 weeks of use.

Pilocarpine tablet should be taken with a glass of water during or directly after meals. The last tablet should always be taken in conjunction with evening meal. Regardless of the indication, the starting dose in patients with moderate hepatic impairment should be one tablet twice daily, followed by adjustment based on therapeutic response and tolerability. Patients with mild hepatic insufficiency do not require dosage reductions.

Pilocarpine should be used with caution in patients receiving beta-adrenergic antagonists due to the risk of cardiac conduction disturbances. It may also reduce the effect of drugs with anticholinergic activity when used together.

Pilocarpine is contraindicated in patients with uncontrolled asthma, cardiovascular disease, known hypersensitivity to pilocarpine, and in conditions where pupil constriction is undesirable, such as acute iritis and narrow-angle (angle-closure) glaucoma.

Common adverse effects may include headache, visual disturbances, excessive tearing, sweating, respiratory difficulty, gastrointestinal cramps, nausea, vomiting, diarrhea, changes in heart rate (tachycardia or bradycardia), blood pressure changes (hypotension or hypertension), atrioventricular block, shock, mental confusion, cardiac arrhythmia, and tremors. Most reactions are due to excessive parasympathetic stimulation, are dose-dependent, and usually mild and self-limiting.

Pilocarpine should be used with caution in patients with suspected or known gallstones (cholelithiasis) or biliary tract disease. If excessive sweating occurs and the patient cannot maintain adequate fluid intake, medical advice should be sought immediately.

Pregnancy: Category C. Adequate and well-controlled studies in pregnant women are not available. It should be used during pregnancy only if the potential benefit outweighs the risk to the fetus.
Lactation: It is not known whether pilocarpine is excreted in breast milk. A decision should be made to either discontinue breastfeeding or discontinue the drug based on maternal need.
Pediatrics: Safety and efficacy in children have not been established.

Drugs affecting exocrine secretions