Baclofen (Page 2 of 2)
DOSAGE AND ADMINISTRATION
The determination of optimal dosage requires individual titration. Start therapy at a low dosage and increase gradually until optimum effect is achieved (usually between 40 to 80 mg daily).
The following dosage titration schedule is suggested:
5 mg t.i.d. for 3 days
10 mg t.i.d. for 3 days
15 mg t.i.d. for 3 days
20 mg t.i.d. for 3 days
Thereafter additional increases may be necessary but the total daily dose should not exceed a maximum of 80 mg daily (20 mg q.i.d.).
The lowest dose compatible with an optimal response is recommended. If benefits are not evident after a reasonable trial period, patients should be slowly withdrawn from the drug (see WARNINGS, Abrupt Drug Withdrawal).
HOW SUPPLIED
Baclofen Tablets USP, 5 mg are available as a white round convex tablet debossed with “LCI” on one side and “1333” on the other side. Available in bottles of 90 (NDC 62135-472-90).
Baclofen Tablets USP, 10 mg are available as a white round flat-faced beveled edge bisected tablet debossed with “LCI” over “1330” on one side and plain on the other side, containing 10 mg Baclofen USP. Available in bottles of 90 (NDC 62135-473-90) and 500 (NDC 62135-473-05).
Baclofen Tablets USP, 20 mg are available as a white round flat-faced beveled edge bisected tablet debossed with “LCI” over “1337” on one side and plain on the other side, containing 20 mg Baclofen USP. Available in bottles of 90 (NDC 62135-474-90) and 500 (NDC 62135-474-05).
PHARMACIST: Dispense in a well-closed container as defined in the USP, with a child-resistant closure (as required).
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Manufactured for:
Chartwell RX, LLC.
Congers, NY 10920
L71279
Rev. 02/2023
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Baclofen Tablets, USP 5 mg- NDC 62135-472-90 — 90s-bottle label
Baclofen Tablets, USP 10 mg- NDC 62135-473-90 — 90s-bottle label
Baclofen Tablets, USP 10 mg- NDC 62135-473-05 — 500s-bottle label
Baclofen Tablets, USP 20 mg- NDC 62135-474-90 — 90s-bottle label
Baclofen Tablets, USP 20 mg- NDC 62135-474-05 — 500s-bottle label
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Labeler — Chartwell RX, LLC (079394054) |
Revised: 06/2023 Chartwell RX, LLC
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