Pilocarpine (Systemic)

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• Pilocarpine HCl
• Pilocarpine Hydrochloride

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral, as hydrochloride:

Salagen: 5 mg

Salagen: 7.5 mg [contains fd&c blue #2 aluminum lake]

Generic: 5 mg, 7.5 mg

Xerostomia: Oral:

Associated with head and neck cancer: Initial: 5 mg 3 times daily; may titrate dose based on response and tolerability; usual dosage range: 15 to 30 mg/day; maximum: 10 mg/dose

Sjögren syndrome: 5 mg 4 times daily

Refer to adult dosing.

There are no dosage adjustments provided in the manufacturer’s labeling.

Store at 15°C to 30°C (59°F to 86°F).

>10%:

Cardiovascular: Flushing (8% to 13%)

Central nervous system: Chills (3% to 15%), dizziness (5% to 12%), headache (11%)

Gastrointestinal: Nausea (6% to 15%)

Genitourinary: Urinary frequency (9% to 12%)

Neuromuscular & skeletal: Weakness (2% to 12%)

Respiratory: Rhinitis (5% to 14%)

Miscellaneous: Diaphoresis (29% to 68%)

1% to 10%:

Cardiovascular: Edema (<1% to 5%), facial edema, hypertension (3%), palpitation, tachycardia

Central nervous system: Pain (4%), fever, somnolence

Dermatologic: Pruritus, rash

Gastrointestinal: Diarrhea (4% to 7%), dyspepsia (7%), vomiting (3% to 4%), constipation, flatulence, glossitis, salivation increased, stomatitis, taste perversion

Genitourinary: Vaginitis, urinary incontinence

Neuromuscular & skeletal: Myalgias, tremor

Ocular: Lacrimation (6%), amblyopia (4%), abnormal vision, blurred vision, conjunctivitis

Otic: Tinnitus

Respiratory: Cough increased, dysphagia, epistaxis, sinusitis

Miscellaneous: Allergic reaction, voice alteration

<1% (Limited to important or life-threatening): Abnormal dreams, alopecia, angina pectoris, anorexia, anxiety, arrhythmia, body odor, bone disorder, cholelithiasis, colitis, confusion, dry eyes, dry mouth, ECG abnormality, myasthenia, photosensitivity reaction, nervousness, pancreatitis, paresthesia, salivary gland enlargement, sputum increased, taste loss, tongue disorder, urinary impairment, urinary urgency, yawning

Disease-related concerns:

• Cardiovascular disease: Use with caution in patients with significant cardiovascular disease; may have difficulty compensating for transient changes in hemodynamics or rhythm induced by pilocarpine.

• Cholelithiasis: Use with caution in patients with cholelithiasis or biliary tract disease.

• Hepatic impairment: Use with caution in patients with moderate impairment; dosage adjustment recommended; use is not recommended in patients with severe impairment.

• Nephrolithiasis: Use caution in patients with a history of nephrolithiasis; may induce smooth muscle spasms, precipitating renal colic or ureteral reflux in patients with nephrolithiasis.

• Respiratory disorders: Use with caution in patients with controlled asthma, chronic bronchitis, or COPD; may increase airway resistance, bronchial smooth muscle tone, and bronchial secretions.