Version May 2024
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 disease: 5 mg 4 times daily.
There are no dosage adjustments provided in the manufacturer's labeling.
Mild impairment (Child-Pugh score 5 to 6): No dosage adjustment necessary.
Moderate impairment (Child-Pugh score 7 to 9): Initial: 5 mg twice daily; adjust dose based on response and tolerability.
Severe impairment (Child-Pugh score 10 to 15): Use is not recommended.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults.
>10%:
Cardiovascular: Flushing (8% to 13%)
Dermatologic: Diaphoresis (29% to 68%)
Gastrointestinal: Nausea (6% to 15%)
Genitourinary: Urinary frequency (9% to 12%)
Nervous system: Asthenia (6% to 12%), chills (3% to 15%), dizziness (5% to 12%), headache (11%)
Respiratory: Rhinitis (14%)
1% to 10%:
Cardiovascular: Edema (5%), hypertension (3%), palpitations (1% to 2%), tachycardia (1% to 2%)
Dermatologic: Pruritus (1% to 2%), skin rash (1% to 2%)
Gastrointestinal: Constipation (1% to 2%), diarrhea (7%), dysgeusia (1% to 2%), dyspepsia (7%), dysphagia (1% to 2%), flatulence (1% to 2%), glossitis (1% to 2%), sialorrhea (3%), stomatitis (1% to 2%), vomiting (3% to 4%)
Genitourinary: Urinary incontinence (1% to 2%), urinary tract infection (1% to 2%), vaginitis (1% to 2%)
Hypersensitivity: Facial edema (1% to 2%), hypersensitivity reaction (1% to 2%)
Nervous system: Drowsiness (1% to 2%), pain (4%), tremor (1% to 2%), voice disorder (1% to 2%)
Neuromuscular & skeletal: Back pain (1% to 2%), myalgia (1% to 2%)
Ophthalmic: Amblyopia (4%), blurred vision (1% to 2%), conjunctivitis (1% to 2%), visual disturbance (1% to 2%)
Otic: Tinnitus (1% to 2%)
Respiratory: Epistaxis (1% to 2%), increased cough (1% to 2%), sinusitis (1% to 2%)
Miscellaneous: Fever (1% to 2%), laboratory test abnormality (1% to 2%; including abnormal urine test findings and hematologic abnormality)
Postmarketing:
Cardiovascular: Chest pressure (Aframian 2007)
Gastrointestinal: Abdominal pain (Felberg 2022), gastric distress (Farag 2019), gastritis (Aragona 2006), stomach cramps (Chainani-Wu 2006)
Genitourinary: Diuresis (Felberg 2022)
Nervous system: Fatigue (Farag 2019), paresthesia (Brito-Zeron 2019)
Renal: Interstitial nephritis (Fujii 2019)
Respiratory: Exacerbation of asthma (Farag 2019)
Hypersensitivity to pilocarpine or any component of the formulation; uncontrolled asthma; when miosis is undesirable (eg, acute iritis, angle-closure glaucoma)
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.
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 (indigo carm) aluminum lake]
Generic: 5 mg, 7.5 mg
Yes
Tablets (Pilocarpine HCl Oral)
5 mg (per each): $0.49 - $3.75
7.5 mg (per each): $2.00 - $4.55
Tablets (Salagen Oral)
5 mg (per each): $2.21
7.5 mg (per each): $2.71
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral, as hydrochloride:
Salagen: 5 mg
Generic: 5 mg
Avoid administering with high-fat meal. Ensure adequate water intake (dehydration may develop with use).
Xerostomia: Treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; treatment of symptoms of dry mouth in patients with Sjögren disease.
Salagen may be confused with selegiline
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Acetylcholinesterase Inhibitors: May enhance the adverse/toxic effect of Cholinergic Agonists. Specifically, cholinergic effects may be enhanced or increased. Risk C: Monitor therapy
Beta-Blockers: May enhance the adverse/toxic effect of Cholinergic Agonists. Of particular concern are the potential for cardiac conduction abnormalities and bronchoconstriction. Risk C: Monitor therapy
Cimetropium: Cholinergic Agonists may diminish the anticholinergic effect of Cimetropium. Risk C: Monitor therapy
Rivastigmine: Cholinergic Agonists may enhance the adverse/toxic effect of Rivastigmine. Specifically, cholinergic effects may be enhanced or increased. Rivastigmine may enhance the adverse/toxic effect of Cholinergic Agonists. Management: Use of rivastigmine with a cholinergic agonist is not recommended unless clinically necessary. If the combination is necessary, monitor for increased cholinergic effects. Risk D: Consider therapy modification
Sincalide: Drugs that Affect Gallbladder Function may diminish the therapeutic effect of Sincalide. Management: Consider discontinuing drugs that may affect gallbladder motility prior to the use of sincalide to stimulate gallbladder contraction. Risk D: Consider therapy modification
Fat decreases the rate of absorption, maximum concentration and increases the time it takes to reach maximum concentration. Management: Avoid administering with a high-fat meal.
Adverse events have been observed in some animal reproduction studies.
It is not known if pilocarpine is excreted in breast milk. Due to the potential for serious adverse reactions in the nursing infant, the manufacturer recommends a decision be made to discontinue nursing or to discontinue the drug, taking into account the importance of treatment to the mother.
Binds to muscarinic (cholinergic) receptors, causing an increase in secretion of exocrine glands (such as salivary and sweat glands) and increase tone of smooth muscle in gastrointestinal and urinary tracts
Onset of action: 20 minutes; Maximum effect: 1 hour
Duration: 3 to 5 hours
Half-life elimination: 0.76 to 1.35 hours; mild to moderate hepatic impairment: 2.1 hours
Time to peak, serum: 0.85 to 1.25 hours (increased to 1.47 hours with a high-fat meal)
Excretion: Urine
Hepatic function impairment: Clearance decreased ~30% in patients with mild to moderate impairment, resulting in an increase in Cmax and half-life.
Sex: Elderly women had Cmax and AUC approximately twice that of elderly and younger men.
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