Pilocarpine Hydrochloride
Brand names: Salagen
Drug class:
Antineoplastic Agents
Usage of Pilocarpine Hydrochloride
Radiation-induced Dry Mouth
Symptomatic treatment of radiation-induced dry mouth (xerostomia) in patients with head and neck cancer.
Dry Mouth Secondary to Sjögren Syndrome
Symptomatic treatment of dry mouth in patients with Sjögren syndrome.
There are few comparative studies of pilocarpine and cevimeline (a similar muscarinic agonist). Although both drugs can increase salivary flow and improve symptoms of dry mouth, adverse effects may differ based on differences in selectivity and affinity for muscarinic receptors. (See Actions.)
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How to use Pilocarpine Hydrochloride
Administration
Oral Administration
Administer orally 3–4 times daily.
Dosage
Available as pilocarpine hydrochloride; dosage expressed in terms of the salt.
Adults
Radiation-induced Dry Mouth OralInitially, 5 mg 3 times daily; titrate dosage based on therapeutic response and tolerance.
Usual dosage range is 15–30 mg daily given in divided doses (not to exceed 10 mg per dose).
Adverse effects are dose related; use lowest effective and tolerated dosage for maintenance therapy.
At least 12 weeks of continuous therapy may be necessary to achieve therapeutic benefit.
Dry Mouth Secondary to Sjögren Syndrome OralRecommended dosage is 5 mg 4 times daily. To minimize incidence of sweating, some clinicians recommend initiating therapy at a low dosage (e.g., 2 mg once or twice daily), then gradually increasing up to 5 mg 3 or 4 times daily.
In clinical studies, a therapeutic effect was observed by 6 weeks of treatment.
Prescribing Limits
Adults
Radiation-induced Dry Mouth OralDo not exceed 10 mg per dose.
Special Populations
Hepatic Impairment
Mild hepatic impairment: No dosage adjustment required.
Moderate hepatic impairment: Reduce initial dosage to 5 mg twice daily regardless of indication; adjust subsequent dosage based on response and tolerability. (See Hepatic Impairment under Cautions.)
Severe hepatic impairment: Use not recommended.
Renal Impairment
Manufacturer makes no specific dosage recommendations.
Geriatric Patients
Manufacturer makes no specific dosage recommendations.
Warnings
Contraindications
Warnings/Precautions
Warnings
Cardiovascular EffectsRisk of altered cardiac conduction and/or heart rate. Patients with clinically important cardiovascular disease may be unable to compensate for transient changes in hemodynamics or heart rhythm induced by pilocarpine.
Use with caution and under close medical supervision in patients with a history of cardiovascular disease (e.g., angina pectoris, MI).
Ocular EffectsBlurred vision reported with ophthalmic formulations. May result in impaired depth perception and decreased visual acuity, especially at night and in patients with central lens changes; may impair ability to drive at night or perform hazardous activities in reduced lighting. (See Advice to Patients.)
Pulmonary EffectsMay increase airway resistance, bronChial smooth muscle tone, and bronchial secretions. Use with caution and under close medical supervision in patients with controlled asthma, chronic bronchitis, or COPD.
General Precautions
Parasympathomimetic EffectsPossible exaggeration of parasympathomimetic effects (e.g., headache, visual disturbance, lacrimation, sweating, respiratory distress, GI spasm, nausea, vomiting, diarrhea, AV block, tachycardia, bradycardia, hypotension, hypertension, shock, mental confusion, cardiac arrhythmia, tremors).
Sweating is the most common adverse effect. Excessive sweating may cause dehydration. (See Advice to Patients.)
Biliary EffectsUse with caution in patients with known or suspected cholelithiasis or biliary tract disease.
Contraction of gallbladder or biliary smooth muscle could precipitate complications (e.g., cholecystitis, cholangitis, biliary obstruction) in patients with cholelithiasis.
Renal EffectsMay increase ureteral smooth muscle tone, and theoretically cause renal colic or ureteral reflux in patients with nephrolithiasis.
CNS EffectsDose-related CNS effects reported; use caution in patients with underlying cognitive or psychiatric disturbances.
Specific Populations
PregnancyNo adequate and well-controlled studies in pregnant women; fetotoxicity and developmental abnormalities reported in animal studies.
Use during pregnancy only if potential benefit justifies potential risk to the fetus.
LactationNot known whether pilocarpine is distributed into human milk; discontinue nursing or the drug.
Pediatric UseSafety and efficacy not established in children.
Geriatric UseIn patients ≥65 years of age with head and neck cancer, adverse effects generally similar to those observed in younger adults.
In patients ≥65 years of age with Sjögren syndrome, increased incidence of urinary frequency, diarrhea, and dizziness reported compared with younger patients.
Hepatic ImpairmentClearance decreased in patients with hepatic impairment. (See Special Populations under Pharmacokinetics.) Dosage reduction required in patients with moderate hepatic impairment. (See Hepatic Impairment under Dosage and Administration.)
Renal ImpairmentPharmacokinetics not substantially altered in patients with renal impairment (mean Clcr 25.4 mL/minute; range 9.8–40.8 mL/minute).
Common Adverse Effects
Radiation-induced dry mouth: Sweating, nausea, rhinitis, diarrhea, chills, flushing, urinary frequency, dizziness, asthenia, headache, dyspepsia, lacrimation, edema.
Dry mouth secondary to Sjögren syndrome: Sweating, urinary frequency, nausea, flushing, rhinitis, diarrhea, headache, flu syndrome, dyspepsia, dizziness.
What other drugs will affect Pilocarpine Hydrochloride
Specific Drugs
Drug
Interaction
Comments
Antimuscarinic agents (e.g., atropine, ipratropium)
Potential for antagonism of antimuscarinic effects
β-Adrenergic blocking agents
Possible cardiac conduction disturbances
Caution is advised if used concomitantly
Parasympathomimetic agents
Possible additive effects
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