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MedsAcross

Molecule

Pilocarpine

Also known as pilocarpine hydrochloride
Available on requestOrphanCold chainNeurologyOphthalmology
Presentations
9
Brands
2
Manufacturers
2
Available from stock
0

Pilocarpine is a cholinergic receptor agonist. It is available as tablets, eye drops and ophthalmic solution for oral use. MedsAcross supplies Pilocarpine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Cholinergic Receptor Agonist, Cholinergic Agonists, Cholinergic Muscarinic Agonists
ATC classification
N07AX01 Pilocarpine · Parasympathomimetic drug, subgroup N07AXS01EB01 Pilocarpine · Eye medicines, subgroup S01E, subgroup S01EB
US FDA first approval
29 July 1974
EU status
Not recorded
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Ophthalmic, Oral
Dosage forms
Tablet, Eye drops, Ophthalmic solution
Identifiers
UNII 01MI4Q9DI3RxCUI 8328CAS 92-13-7DrugBank DB01085Q411461

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

SALAGEN ® Tablets are indicated for 1) the treatment of symptoms of dry mouth from salivary gland hypofunction 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.

Source: US FDA prescribing information

Dosing overview

Regardless of the indication, the starting dose in patients with moderate hepatic impairment should be 5 mg twice daily, followed by adjustment based on therapeutic response and tolerability. Patients with mild hepatic insufficiency do not require dosage reductions. The use of pilocarpine in patients with severe hepatic insufficiency is not recommended. If needed, refer to the Hepatic Insufficiency subsection of the Precautions section of this label for definitions of mild, moderate and severe hepatic impairment. Head & Neck Cancer Patients: The recommended initial dose of SALAGEN ® Tablets is 5 mg taken three times a day. Dosage should be titrated according to therapeutic response and tolerance. The usual dosage range is up to 15-30 mg per day.

Source: US FDA prescribing information

Contraindications

SALAGEN ® Tablets are contraindicated in patients with uncontrolled asthma, known hypersensitivity to pilocarpine, and when miosis is undesirable, e.g., in acute iritis and in narrow-angle (angle closure) glaucoma.

Source: US FDA prescribing information

Warnings and precautions

Cardiovascular Disease: Patients with significant cardiovascular disease may be unable to compensate for transient changes in hemodynamics or rhythm induced by pilocarpine. Pulmonary edema has been reported as a complication of pilocarpine toxicity from high ocular doses given for acute angle-closure glaucoma. Pilocarpine should be administered with caution in and under close medical supervision of patients with significant cardiovascular disease. Ocular: Ocular formulations of pilocarpine have been reported to cause visual blurring which may result in decreased visual acuity, especially at night and in patients with central lens changes, and to cause impairment of depth perception. Caution should be advised while driving at night or performing hazardous activities in reduced lighting.

Source: US FDA prescribing information

Side effects

Head & Neck Cancer Patients: In controlled studies, 217 patients received pilocarpine, of whom 68% were men and 32% were women. Race distribution was 91% Caucasian, 8% Black, and 1% of other origin. Mean age was approximately 58 years. The majority of patients were between 50 and 64 years (51%), 33% were 65 years and older and 16% were younger than 50 years of age. The most frequent adverse experiences associated with SALAGEN ® Tablets were a consequence of the expected pharmacologic effects of pilocarpine. Adverse Event Pilocarpine HCl Placebo 10 mg t.i.d. (30 mg/day) 5 mg t.i.d.

Source: US FDA prescribing information

Interactions

Pilocarpine should be administered with caution to patients taking beta-adrenergic antagonists because of the possibility of conduction disturbances. Drugs with parasympathomimetic effects administered concurrently with pilocarpine would be expected to result in additive pharmacologic effects. Pilocarpine might antagonize the anticholinergic effects of drugs used concomitantly. These effects should be considered when anticholinergic properties may be contributing to the therapeutic effect of concomitant medication (e.g., atropine, inhaled ipratropium).

Source: US FDA prescribing information

Storage

Store up to 25°C (77°F), excursions permitted to 15°-30°C (59°-86°F). They are supplied as follows: NDC 59212-775-10 bottles of 100 Store up to 25°C (77°F), excursions permitted to 15°-30°C (59°-86°F).

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

9 presentations of Pilocarpine, sorted by availability.

MedicineManufacturerRegisterAvailability
Pilocarpine 5 mg tabletOralGeneric name—US FDAAvailable on request
Pilocarpine 10 mg/mL eye dropsOphthalmicGeneric name—US FDAAvailable on request
Pilocarpine 20 mg/mL eye dropsOphthalmicGeneric name—US FDAAvailable on request
Pilocarpine 40 mg/mL eye dropsOphthalmicGeneric name—US FDAAvailable on request
Pilocarpine 7.5 mg tabletOralGeneric name—US FDAAvailable on request
Qlosi 4 mg/mL ophthalmic solutionOphthalmic Cold chainOrasis PharmaceuticalsUS FDAAvailable on request
Pilocarpine 12.5 mg/mL eye dropsOphthalmicGeneric name—US FDAAvailable on request
Salagen 5 mg tabletOralAdvanz PharmaUS FDAAvailable on request
Salagen 7.5 mg tabletOralAdvanz PharmaUS FDAAvailable on request

Brands by market

2 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 29 July 1974Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Pilocarpine in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Pilocarpine available for export from India?

Yes, on request. MedsAcross lists 9 presentations of Pilocarpine and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Pilocarpine have?

The catalogue lists 2 brand names for Pilocarpine, including Qlosi, Salagen.

Is Pilocarpine approved by the US FDA?

Yes. The US FDA first approved Pilocarpine on 29 July 1974, according to Drugs@FDA.

Does Pilocarpine need cold chain shipping?

At least one listed presentation of Pilocarpine must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.

Which ATC class is Pilocarpine in?

Pilocarpine is classified under ATC code N07AX01 (Pilocarpine).

References

  1. Salagen prescribing information (Advanz Pharma). U.S. National Library of Medicine, DailyMed. Retrieved 5 December 2024

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