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Pilocarpine Hydrochloride Tablets
5 mg
Rx only
DESCRIPTION: Pilocarpine Hydrochloride Tablets contain pilocarpine hydrochloride, a cholinergic agonist for oral use. Pilocarpine hydrochloride is a hygroscopic, odorless, bitter tasting white crystal or powder, which is soluble in water and alcohol and virtually insoluble in most non-polar solvents. Pilocarpine hydrochloride, with a chemical name of (3 S-cis )-2 (3 H )-Furanone, 3-ethyldihydro-4-[(1-methyl-1 H -imidazol-5-yl)methyl] monohydrochloride, has a molecular weight of 244.72.
Each pilocarpine hydrochloride tablet for oral administration contains 5 mg of pilocarpine hydrochloride. In addition, it also contains the following inactive ingredients: hypromellose, microcrystalline cellulose, polyethylene glycol, propylene glycol and stearic acid.
CLINICAL PHARMACOLOGY
Clinical Studies:
INDICATIONS AND USAGE: Pilocarpine hydrochloride 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.
CONTRAINDICATIONS: Pilocarpine hydrochloride 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.
WARNINGS:
PRECAUTIONS:
Pregnancy : Teratogenic Effects
Geriatric Use:
ADVERSE REACTIONS
DOSAGE AND ADMINISTRATION
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.
HOW SUPPLIED:
Pilocarpine hydrochloride tablets 5 mg are supplied as white, round, film coated tablets, debossed cor over 137 on one side and other side is plain.
They are supplied as follows:
Bottles of 100 (NDC 0781-5100-01)
Store at 20 - 25°C (68 - 77°F) (See USP Controlled Room Temperature).
Dispense in tight, light-resistant containers as defined in the USP.
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
Rev. 03-2006
MF # 352-02
Manufactured by
Corepharma LLC
Middlesex, NJ 08846
Distributed by
Sandoz Inc.
Princeton, NJ 08540