Cevimeline Hydrochloride (Page 3 of 3)
MANAGEMENT OF OVERDOSAGE
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 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
Cevimeline Hydrochloride Capsules are available as hard gelatin capsule with tan opaque cap and tan opaque body imprinted with “NL 999” on the cap and “30 mg” on the body with black ink, filled with white to off white granular powder.
It is supplied in:
Child-resistant bottles of 30 Capsules (NDC 40032-999-03)
Child-resistant bottles of 100 Capsules (NDC 40032-999-01)
Bottles of 500 Capsules (NDC 40032-999-05)
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].
Dispense in a tight, light resistant container as defined in the USP/NF.
Rx Only
Manufactured by:
Novel Laboratories, Inc.
Somerset, NJ 08873
Iss. 02/2016
PI9990000101
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
30 Count
CEVIMELINE HYDROCHLORIDE cevimeline hydrochloride capsule | ||||||||||||||||||||||||||||||||
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Labeler — Novel Laboratories, Inc. (793518643) |
Registrant — Novel Laboratories, Inc. (793518643) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Novel Laboratories, Inc. | 793518643 | ANALYSIS (40032-999), MANUFACTURE (40032-999), PACK (40032-999) |
Revised: 02/2016 Novel Laboratories, Inc.
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