Ranitidine (Page 3 of 3)
Overdosage
There has been limited experience with overdosage. Reported acute ingestions of up to 18 g orally have been associated with transient adverse effects similar to those encountered in normal clinical experience (see ADVERSE REACTIONS). In addition, abnormalities of gait and hypotension have been reported.
When overdosage occurs, the usual measures to remove unabsorbed material from the gastrointestinal tract, clinical monitoring, and supportive therapy should be employed.
Studies in dogs receiving dosages of ranitidine in excess of 225 mg/kg per day have shown muscular tremors, vomiting, and rapid respiration. Single oral doses of 1,000 mg/kg in mice and rats were not lethal. Intravenous LD50 values in mice and rats were 77 and 83 mg/kg, respectively.
DOSAGE AND ADMINISTRATION
Active Duodenal Ulcer: The current recommended adult oral dosage of ranitidine for duodenal ulcer is 150 mg twice daily. An alternative dosage of 300 mg once daily after the evening meal or at bedtime can be used for patients in whom dosing convenience is important. The advantages of one treatment regimen compared to the other in a particular patient population have yet to be demonstrated (see CLINICAL PHARMACOLOGY, Clinical Trials: Active Duodenal Ulcer). Smaller doses have been shown to be equally effective in inhibiting gastric acid secretion in US studies, and several foreign trials have shown that 100 mg b.i.d. is as effective as the 150 mg dose.
Antacid should be given as needed for relief of pain (see CLINICAL PHARMACOLOGY: Pharmacokinetics).
Maintenance of Healing of Duodenal Ulcers: The current recommended adult oral dosage is 150 mg at bedtime.
Pathological Hypersecretory Conditions (such as Zollinger-Ellison syndrome): The current recommended adult oral dosage is 150 mg twice a day. In some patients it may be necessary to administer ranitidine 150-mg doses more frequently. Dosages should be adjusted to individual patient needs, and should continue as long as clinically indicated. Dosages up to 6 g per day have been employed in patients with severe disease.
Benign Gastric Ulcer: The current recommended adult oral dosage is 150 mg twice a day.
Maintenance of Healing of Gastric Ulcers: The current recommended adult oral dosage is 150 mg at bedtime.
GERD: The current recommended adult oral dosage is 150 mg twice a day.
Erosive Esophagitis: The current recommended adult oral dosage is 150 mg four times a day.
Maintenance of Healing of Erosive Esophagitis: The current recommended adult oral dosage is 150 mg twice a day.
Pediatric Use: The safety and effectiveness of ranitidine have been established in the age-group of one month to 16 years. There is insufficient information about the pharmacokinetics of ranitidine in neonatal patients (less than one month of age) to make dosing recommendations.
The following three subsections provide dosing information for each of the pediatric indications.
Treatment of Duodenal and Gastric Ulcers: The recommended oral dose for the treatment of active duodenal and gastric ulcers is 2 to 4 mg/kg twice daily to a maximum of 300 mg/day. This recommendation is derived from adult clinical studies and pharmacokinetic data in pediatric patients.
Maintenance of Healing of Duodenal and Gastric Ulcers: The recommended oral dose for the maintenance of healing of duodenal and gastric ulcers is 2 to 4 mg/kg once daily to a maximum of 150 mg/day. This recommendation is derived from adult clinical studies and pharmacokinetic data in pediatric patients.
Treatment of GERD and Erosive Esophagitis: Although limited data exist for these conditions in pediatric patients, published literature supports a dosage of 5 to 10 mg/kg per day, usually given as two divided doses.
Dosage Adjustment for Patients with Impaired Renal Function: 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 less than 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).
HOW SUPPLIED
Ranitidine Tablets USP, 150 mg and 300 mg for oral administration are available as:
150 mg tablets —
White to off-white, round, biconvex, film-coated tablets with “G” on one side and “00” over “30” on the other side.
Bottles of 60- NDC # 55530-030-06
Bottles of 100- NDC # 55530-030-35
Bottles of 500- NDC # 55530-030-05
Bottles of 1000- NDC # 55530-030-10
300 mg tablets –
White to off-white, capsule shaped, film-coated tablets with “G” on one side and “0031” on the other side.
Bottles of 30- NDC # 55530-031-03
Bottles of 100- NDC # 55530-031-01
Bottles of 250- NDC # 55530-031-25
Store at controlled room temperature between 15°C and 30°C (59°F and 86°F) in a dry place.
Protect from light. Replace cap securely after each opening. Dispense in a tight, light-resistant container as defined in the USP.
Rx only.
Manufactured for:
GENPHARM, L.P.
NAPA, CA 94558
Manufactured by:
GENPHARM INC.
Toronto, Ontario
Canada M8Z 2S6
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| Labeler — GENPHARM, L.P. |
Revised: 11/2006 GENPHARM, L.P.
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