Evoxac (Page 3 of 3)

MANAGEMENT OF OVERDOSE

Management of the signs and symptoms of acute overdosage should be handled in a manner consistent with that indicated for other muscarinic agonists: general supportive measures should be instituted. If medically indicated, atropine, an anti-cholinergic agent, may be of value as an antidote for emergency use in patients who have had an overdose of cevimeline. If medically indicated, epinephrine may also be of value in the presence of severe cardiovascular depression or bronchoconstriction. It is not known if cevimeline is dialyzable.

DOSAGE AND ADMINISTRATION

The recommended dose of cevimeline hydrochloride capsules is 30 mg taken three times a day. There is insufficient safety information to support doses greater than 30 mg tid. There is also insufficient evidence for additional efficacy of cevimeline hydrochloride at doses greater than
30 mg tid.

HOW SUPPLIED

EVOXAC® is available as white, hard gelatin capsules containing 30 mg of cevimeline hydrochloride. EVOXAC® capsules have a white opaque cap and a white opaque body. The capsules are imprinted with “EVOXAC” on the cap and “30 mg” on the body with a black bar above “30 mg”. It is supplied in child resistant bottles of:

100 capsules (NDC 63395-201-13).

Store at 25°C (77°F) excursion permitted to 15°-30°C (59°-86°F)

Rx only

Manufactured for :
Daiichi Sankyo, Inc.
Basking Ridge, NJ 07920

Revised 04/2018 Printed in U.S.A.

USPI-EVO-0418-r100

PRINCIPAL DISPLAY PANEL — 30 mg Capsule Bottle Label

NDC 63395-201-13

Evoxac®
(cevimeline HCl)
30 mgCapsules

Rx only

100 Capsules

PRINCIPAL DISPLAY PANEL -- 30 mg Capsule Bottle Label
(click image for full-size original)
EVOXAC cevimeline hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63395-201
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEVIMELINE HYDROCHLORIDE (CEVIMELINE) CEVIMELINE HYDROCHLORIDE ANHYDROUS 30 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
MAGNESIUM STEARATE
Product Characteristics
Color WHITE (WHITE OPAQUE) Score no score
Shape CAPSULE (CAPSULE) Size 15mm
Flavor Imprint Code EVOXAC;30;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63395-201-13 100 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020989 01/12/2000 08/31/2025
Labeler — Daiichi Sankyo, Inc. (844277256)

Revised: 06/2022 Daiichi Sankyo, Inc.

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