Pilocarpine Hydrochloride (Page 4 of 4)

MANAGEMENT OF OVERDOSE

Fatal overdosage with pilocarpine has been reported in the scientific literature at doses presumed to be greater than 100 mg in two hospitalized patients. 100 mg of pilocarpine is considered potentially fatal. Overdosage should be treated with atropine titration (0.5 mg to 1.0 mg given subcutaneously or intravenously) and supportive measures to maintain respiration and circulation. Epinephrine (0.3 mg to 1.0 mg, subcutaneously or intramuscularly) may also be of value in the presence of severe cardiovascular depression or bronchoconstriction. It is not known if pilocarpine is dialyzable.

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.

Head & Neck Cancer Patients: The recommended initial dose of pilocarpine hydrochloride tablets, USP 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. (Not to exceed 10 mg per dose.) Although early improvement may be realized, at least 12 weeks of uninterrupted therapy with pilocarpine hydrochloride tablets, USP may be necessary to assess whether a beneficial response will be achieved. The incidence of the most common adverse events increases with dose. The lowest dose that is tolerated and effective should be used for maintenance.

Sjogren’s Syndrome Patients: The recommended dose of pilocarpine hydrochloride tablets, USP is 5 mg taken four times a day. Efficacy was established by 6 weeks of use.

HOW SUPPLIED

Pilocarpine Hydrochloride Tablets USP, 5 mg are round, white film coated, biconvex, beveled edge tablet, debossed with “I” on one side and “116” on the other. They are supplied as follows:

Bottles of 100 NDC 1035-0680-01

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Manufactured for & Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

PRINCIPAL DISPLAY PANEL

NDC 10135-0680-01
Pilocarpine
Hydrochloride
Tablets, USP
5 mg
Rx Only
100 TABLETS

PRINCIPAL DISPLAY PANEL
NDC 10135-0680-01
Pilocarpine
Hydrochloride
Tablets, USP
5 mg
Rx Only
100 TABLETS
(click image for full-size original)
PILOCARPINE HYDROCHLORIDE
pilocarpine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10135-680(NDC:69292-274)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PILOCARPINE HYDROCHLORIDE (PILOCARPINE) PILOCARPINE HYDROCHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
STEARIC ACID
HYPROMELLOSE, UNSPECIFIED
POLYDEXTROSE
POLYETHYLENE GLYCOL, UNSPECIFIED
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code I;116
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10135-680-01 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076963 02/01/2019
Labeler — Marlex Pharmaceuticals Inc (782540215)

Revised: 03/2019 Marlex Pharmaceuticals Inc

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