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

IMAGE LABEL
(click image for full-size original)

Cimetidine Tablets USP 400 mg 60s Label Text

NDC 33261-0024 -60

CIMETIDINE

Tablets USP

400 mg

Rx only

60 TABLETS

CIMETIDINE
cimetidine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:33261-024(NDC:0093-8204)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CIMETIDINE (CIMETIDINE) CIMETIDINE 400 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONES
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
CARNAUBA WAX
HYPROMELLOSES
POLYETHYLENE GLYCOLS
POLYSORBATE 80
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
ALUMINUM OXIDE
Product Characteristics
Color GREEN (dark green) Score 2 pieces
Shape OVAL Size 16mm
Flavor Imprint Code N;204;400
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:33261-024-60 60 TABLET, FILM COATED (60 TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074151 02/02/2004
Labeler — Aidarex Pharmaceuticals LLC (801503249)

Revised: 12/2013 Aidarex Pharmaceuticals LLC

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