Composition:

Pilogen Tablet: Each tablet contains Pilocarpine Hydrochloride BP 5 mg.

Pharmacology:

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.

Indications:

Pilocarpine hydrochloride tablets are indicated for

1. the treatment of symptoms of dry mouth from salivary gland dysfunction caused by radiotherapy for cancer of the head and neck and
2. the treatment of symptoms of dry mouth in patients with Sjogren’s syndrome.

Dosage & Administration:

For Head & Neck Cancer Patients: The recommended initial dose of pilocarpine hydrochloride tablets is 5 mg 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) taken 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. The starting dose in patients with moderate hepatic impairment should be 5 mg twice daily regardless of the indication, followed by adjustment based on therapeutic response and tolerability. Patients with mild hepatic insufficiency do not require dosage reductions.

Contraindications:

Pilocarpine hydrochloride tablets are 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.

Precautions:

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

Side effects:

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. However, severe adverse experiences might occasionally occur and therefore careful monitoring of the patient is recommended.

Drug interactions:

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.

Use in special group:

Use in pregnancy:

Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Pilocarpine HCl should be used during pregnancy only if the patient’s benefits justified 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.

Packing:

Pilogen Tablet: Each box contains 30’s tablets in blister pack.