Cimetidine: Package Insert and Label Information (Page 3 of 3)
DOSAGE AND ADMINISTRATION
Duodenal Ulcer
Active Duodenal Ulcer
Clinical studies have indicated that suppression of nocturnal acid is the most important factor in duodenal ulcer healing (see CLINICAL PHARMACOLOGY: Antisecretory Activity: Acid Secretion). This is supported by recent clinical trials (see CLINICAL TRIALS: Duodenal Ulcer: Active Duodenal Ulcer). Therefore, there is no apparent rationale, except for familiarity with use, for treating with anything other than a once-daily at bedtime dosage regimen.
In a U.S. dose-ranging study of 400 mg at bedtime, 800 mg at bedtime and 1600 mg at bedtime, a continuous dose-response relationship for ulcer healing was demonstrated.
However, 800 mg at bedtime is the dose of choice for most patients, as it provides a high healing rate (the difference between 800 mg at bedtime and 1,600 mg at bedtime being small), maximal pain relief, a decreased potential for drug interactions (see PRECAUTIONS: Drug Interactions) and maximal patient convenience. Patients unhealed at 4 weeks, or those with persistent symptoms, have been shown to benefit from 2 to 4 weeks of continued therapy.
It has been shown that patients who both have an endoscopically demonstrated ulcer larger than 1.0 cm and are also heavy smokers (i.e., smoke 1 pack of cigarettes or more per day) are more difficult to heal. There is some evidence which suggests that more rapid healing can be achieved in this subpopulation with 1,600 mg of cimetidine tablets at bedtime. While early pain relief with either 800 mg at bedtime or 1,600 mg at bedtime is equivalent in all patients, 1,600 mg at bedtime provides an appropriate alternative when it is important to ensure healing within 4 weeks for this subpopulation. Alternatively, approximately 94% of all patients will also heal in 8 weeks with 800 mg of cimetidine tablets at bedtime.
Other regimens of cimetidine tablets in the United States which have been shown to be effective are: 300 mg 4 times daily, with meals and at bedtime, the original regimen with which U.S. physicians have the most experience, and 400 mg twice daily, in the morning and at bedtime (see CLINICAL TRIALS: Duodenal Ulcer: Active Duodenal Ulcer).
Concomitant antacids should be given as needed for relief of pain. However, simultaneous administration of cimetidine tablets and antacids is not recommended, since antacids have been reported to interfere with the absorption of cimetidine.
While healing with cimetidine tablets often occurs during the first week or two, treatment should be continued for 4 to 6 weeks unless healing has been demonstrated by endoscopic examination.
Maintenance Therapy for Duodenal Ulcer
In those patients requiring maintenance therapy, the recommended adult oral dose is 400 mg at bedtime.
Active Benign Gastric Ulcer
The recommended adult oral dosage for short-term treatment of active benign gastric ulcer is 800 mg at bedtime, or 300 mg 4 times a day with meals and at bedtime. Controlled clinical studies were limited to 6 weeks of treatment (see CLINICAL TRIALS). A dose of 800 mg at bedtime is the preferred regimen for most patients based upon convenience and reduced potential for drug interactions. Symptomatic response to cimetidine tablets does not preclude the presence of a gastric malignancy. It is important to follow gastric ulcer patients to assure rapid progress to complete healing.
Erosive Gastroesophageal Reflux Disease (GERD)
The recommended adult oral dosage for the treatment of erosive esophagitis that has been diagnosed by endoscopy is 1,600 mg daily in divided doses (800 mg twice daily or 400 mg 4 times daily) for 12 weeks. The use of cimetidine tablets beyond 12 weeks has not been established.
Pathological Hypersecretory Conditions (such as Zollinger-Ellison Syndrome)
Recommended adult oral dosage: 300 mg 4 times a day with meals and 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 2,400 mg per day and should continue as long as clinically indicated.
Dosage Adjustment for Patients with Impaired Renal Function
Patients with severely impaired renal function have been treated with cimetidine tablets. However, such usage 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 lowest frequency of dosing compatible 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 tablets. 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 are available containing 200 mg, 300 mg, 400 mg or 800 mg of cimetidine, USP.
The 200 mg tablets are green, film-coated, five-sided, house-shaped, unscored tablets debossed with M on one side and 53 on the other side. They are available as follows:
NDC 0378-0053-01
bottles of 100 tablets
The 300 mg tablets are green, film-coated, five-sided, house-shaped, unscored tablets debossed with M on one side and 317 on the other side. They are available as follows:
NDC 0378-0317-01
bottles of 100 tablets
The 400 mg tablets are green, film-coated, five-sided, house-shaped, partially scored tablets debossed with M on one side and 372 on the other side. They are available as follows:
NDC 0378-0372-01
bottles of 100 tablets
The 800 mg tablets are green, film-coated, oval, partially scored tablets debossed with M 541 across the partial score. They are available as follows:
NDC 0378-0541-01
bottles of 100 tablets
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Protect from light.
Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.
Revised: 7/2019
CIM:R14
PRINCIPAL DISPLAY PANEL — 200 mg
NDC 0378-0053-01
Cimetidine
Tablets, USP
200 mg
Rx only 100 Tablets
Each film-coated tablet contains:
Cimetidine, USP 200 mg
Usual Dosage: See accompanying
prescribing information.
Keep this and all medication out of
the reach of children.
Store at 20° to 25°C (68° to 77°F). [See
USP Controlled Room Temperature.]
Protect from light.
Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.
Made in India
Mylan.com
RMXA0053A
Dispense in a tight, light-resistant
container as defined in the USPusing a child-resistant closure.
Keep container tightly closed.
Code No.: MH/DRUGS/AD/089
PRINCIPAL DISPLAY PANEL — 300 mg
NDC 0378-0317-01
Cimetidine
Tablets, USP
300 mg
Rx only 100 Tablets
Each film-coated tablet contains:
Cimetidine, USP 300 mg
Usual Dosage: See accompanying
prescribing information.
Keep this and all medication out of
the reach of children.
Store at 20° to 25°C (68° to 77°F). [See
USP Controlled Room Temperature.]
Protect from light.
Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.
Made in India
Mylan.com
RMXA0317A
Dispense in a tight, light-resistant
container as defined in the USPusing a child-resistant closure.
Keep container tightly closed.
Code No.: MH/DRUGS/AD/089
PRINCIPAL DISPLAY PANEL — 400 mg
NDC 0378-0372-01
Cimetidine
Tablets, USP
400 mg
Rx only 100 Tablets
Each film-coated tablet contains:
Cimetidine, USP 400 mg
Usual Dosage: See accompanying
prescribing information.
Keep this and all medication out of
the reach of children.
Store at 20° to 25°C (68° to 77°F). [See
USP Controlled Room Temperature.]
Protect from light.
Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.
Made in India
Mylan.com
RMXA0372A
Dispense in a tight, light-resistant
container as defined in the USPusing a child-resistant closure.
Keep container tightly closed.
Code No.: MH/DRUGS/AD/089
PRINCIPAL DISPLAY PANEL — 800 mg
NDC 0378-0541-01
Cimetidine
Tablets, USP
800 mg
Rx only 100 Tablets
Each film-coated tablet contains:
Cimetidine, USP 800 mg
Usual Dosage: See accompanying
prescribing information.
Keep this and all medication out of
the reach of children.
Store at 20° to 25°C (68° to 77°F). [See
USP Controlled Room Temperature.]
Protect from light.
Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.
Made in India
Mylan.com
RMXA0541A
Dispense in a tight, light-resistant
container as defined in the USPusing a child-resistant closure.
Keep container tightly closed.
Code No.: MH/DRUGS/AD/089
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| Labeler — Mylan Pharmaceuticals Inc. (059295980) |
Revised: 07/2019 Mylan Pharmaceuticals Inc.
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