On the basis of experience with a group of subjects with severely impaired renal function treated with ranitidine, the recommended dosage in patients with a creatinine clearance <50 mL/min is 150 mg every 24 hours. Should the patient’s condition require, the frequency of dosing may be increased to every 12 hours or even further with caution. Hemodialysis reduces the level of circulating ranitidine. Ideally, the dosing schedule should be adjusted so that the timing of a scheduled dose coincides with the end of hemodialysis.
Elderly patients are more likely to have decreased renal function, therefore caution should be exercised in dose selection, and it may be useful to monitor renal function (see CLINICAL PHARMACOLOGY: Pharmacokinetics: Geriatrics and PRECAUTIONS: Geriatric Use).
Ranitidine tablets, USP 150 mg (ranitidine HCl USP equivalent to 150 mg of ranitidine) are brown coloured, circular shaped, biconvex, beveled edge film-coated tablets debossed with “S on one side and plain on the other side. 429”
They are available in blister packs of 30 (NDC 58118-0803-8), bottles of 60 (NDC 64380-803-03), 100 (NDC 64380-803-06), 500 (NDC 64380-803-07) and 1000 (NDC 64380-803-08) tablets.
Ranitidine tablets, USP 300 mg (ranitidine HCl USP equivalent to 300 mg of ranitidine) are brown coloured, circular shaped, biconvex, beveled edge film-coated tablets debossed with “S on one side and plain on the other side. 430”
They are available in bottles of 30 (NDC 64380-804-04), 100 (NDC 64380-804-06) and 250 (NDC 64380-804-38) tablets.
Store at 20° to 25° C (68° and 77° F); excursions permitted between 15° and 30° C (59° and 86° F) [see USP Controlled Room Temperature]. Protect from light. Replace cap securely after each opening.
Strides Shasun Limited,
Unit II, R.S. No: 32, 33/11 and 34/2, PIMS Road,
Periyakalapet, Puducherry-605 014, India.
Revised: November 2016
Ranitidine Tablets, USP
Strides Shasun Limited
Puducherry – 605 014, India.
Mfg. Lic. No.: 16 13 4193
Strides Pharma Inc. East Brunswick, NJ 08816
Clinical Solutions Wholesale
Franklin, TN 37067
|RANITIDINE IMMEDIATE RELEASE ranitidine tablet|
|Labeler — Clinical Solutions Wholesale, LLC (078710347)|
|Registrant — Clinical Solutions Wholesale, LLC (078710347)|
|Clinical Solutions Wholesale, LLC||078710347||repack (58118-0803)|
Revised: 07/2019 Clinical Solutions Wholesale, LLC
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