Cimetidine (Page 5 of 5)
Erosive Gastroesophageal Reflux Disease (GERD)
The recommended adult oral dosage for the treatment of erosive esophagitis that has been diagnosed by endoscopy is 1600 mg daily in divided doses (800 mg twice daily or 400 mg four times daily) for 12 weeks. The use of cimetidine beyond 12 weeks has not been established.
Pathological Hypersecretory Conditions (such as Zollinger-Ellison Syndrome)
Recommended adult oral dosage: 300 mg four times a day with meals at bedtime. In some patients it may be necessary to administer higher doses more frequently. Doses should be adjusted to individual patient needs, but should not usually exceed 2400 mg per day and should continue as long as clinically needed.
Dosage Adjustments for Patients with Impaired Renal Function
Patients with severely impaired renal function have been treated with cimetidine. However, such dosage has been very limited. On the basis of this experience the recommended dosage is 300 mg every 12 hours orally. Should the patient’s condition require, the frequency of dosing may be increased to every 8 hours or even further with caution. In severe renal failure, accumulation may occur and the lower frequency of dosing comparable with an adequate patient response should be used. When liver impairment is also present, further reductions in dosage may be necessary. Hemodialysis reduces the level of circulating cimetidine. Ideally, the dosage schedule should be adjusted so that the timing of a scheduled dose coincides with the end of hemodialysis.
HOW SUPPLIED
Cimetidine tablets USP, 400 mg are dark-green, oval-shaped, film-coated tablets, debossed with N vertical bisect 204 on one side and partial bisect 400 on the reverse. They are supplied as follows:
NDC 33261 -0024-60 bottles of 60
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, with a child-resistant closure (as required).
* Theo-Dur® is a registered trademark of Key Pharmaceuticals Inc.
Manufactured In Canada By:
NOVOPHARM LIMITED
Toronto, Canada M1B 2K9
Manufactured For:
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960
Repackaged By :
Aidarex Pharmaceuticals LLC,
Corona, CA 92880
Rev. D 10/2010
PRINCIPAL DISPLAY PANEL
Cimetidine Tablets USP 400 mg 60s Label Text
NDC 33261-0024 -60
CIMETIDINE
Tablets USP
400 mg
Rx only
60 TABLETS
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Labeler — Aidarex Pharmaceuticals LLC (801503249) |
Revised: 12/2013 Aidarex Pharmaceuticals LLC
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