Famotidine (Page 5 of 5)
Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)
The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.
Concomitant Use of Antacids
Antacids may be given concomitantly if needed.
Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency
In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient’s clinical response.
Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.
HOW SUPPLIED
Famotidine Tablets USP (white round tablets) containing 20mg of famotidine and engraved with
.
Bottle of 1,000 (NDC 42291-281-10)
Famotidine Tablets USP (white round tablets) containing 40mg of famotidine and engraved with
.
Bottles of 1,000 (NDC 42291-282-10)
STORAGE
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478
Mfg. Rev. 06/12
AV Rev. 11/15 (P)
AvKARE
NDC
42291-281-10
Famotidine Tablets USP
20 mg
1000 Tablets Rx Only
Each tablet contains: Famotidine 20 mg.
Usual dosage: See accompanying infomration.
Dispense in a well-closed container.
Store at 20
o to 25
o C (68
o to 77
o F). [See USP Controlled Room Temperature.]
Keep out of the reach of children.
Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478
Mfg. Rev. 11/12 AV 09/13 (P)
N 3 42291-281-10 3
AvKARE
NDC 42291-282-10
Famotidine Tablets USP
40 mg
1000 Tablets Rx Only
Each tablet contains: Famotidine 40 mg.
Usual dosage: See accompanying information.
Dispense in a well-closed container.
Store at controlled room temperature, 20° to 25°C (68° to 77°F). [See USP.]
Keep out of the reach of children.
Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478
Mfg. Rev. 05/10 AV 11/15 (P)
N 3 4229128210 0
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| FAMOTIDINE famotidine tablet | ||||||||||||||||||||
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| Labeler — AvKARE (796560394) |
Revised: 01/2022 AvKARE
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