Ranitidine

yes; OTC (Zantac 75 and 150 mg)

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• procainamide
• warfarin (Coumadin)
• triazolam (Halcion)
• midazolam
• glipizide (Glucotrol)
• ketoconazole (Nizoral)
• atazanavir (Reyataz)
• delavirdine (Rescriptor)
• gefitinib (Iressa)

This is not a complete list of ranitidine drug interactions. Ask your doctor or pharmacist for more information.

Ranitidine tablets, USP is contraindicated for patients known to have hypersensitivity to the drug or any of the ingredients (see PRECAUTIONS).

Active Duodenal Ulcer:
The current recommended adult oral dosage of Ranitidine tablets 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 Trials: Active Duodenal Ulcer). Smaller doses have been shown to be equally effective in inhibiting gastric acid secretion in US trials, and several foreign trials have shown that 100 mg twice daily 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 daily. 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/day have been employed in patients with severe disease.

Benign Gastric Ulcer: The current recommended adult oral dosage is 150 mg twice daily.

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 daily.

Erosive Esophagitis: The current recommended adult oral dosage is 150 mg 4 times daily.

Maintenance of Healing of Erosive Esophagitis: The current recommended adult oral dosage is 150 mg twice daily.

Pediatric Use:

The safety and effectiveness of Ranitidine have been established in the age-group of 1 month to 16 years. There is insufficient information about the pharmacokinetics of Ranitidine in neonatal patients (aged younger than 1 month) to make dosing recommendations.
The following 3 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 trials 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 trials 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/day, usually given as 2 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 <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 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.

Manufactured by:
Strides Shasun Limited,
Unit II, R.S. No: 32, 33 & 34, PIMS Road,
Periyakalapet, Puducherry-605 014, India.

Revised: June 2016

Rx only

NDC 64380-803-03

Ranitidine Tablets, USP
150 mg

60 Tablets

Manufactured by:

Strides Shasun Limited
Puducherry – 605 014, India.
Mfg. Lic. No.: 16 13 4193

Distributed by:
Strides Pharma Inc.
East Brunswick, NJ 08816

Alterations in half-life, distribution, clearance, and bioavailability are minor but clinically insignificant.

False-positive urine protein using Multistix.

Frequency not defined.

Cardiovascular: Asystole, atrioventricular block, bradycardia (with rapid IV administration), tachycardia, vasculitis, ventricular premature contractions

Central nervous system: Agitation, confusion, dizziness, depression, drowsiness, hallucination, headache, insomnia, involuntary motor activity, malaise, vertigo

Dermatologic: Alopecia, erythema multiforme, injection site pruritus (transient), skin rash

Endocrine & metabolic: Acute porphyria, increased serum prolactin

Gastrointestinal: Abdominal distress, abdominal pain, constipation, diarrhea, nausea, necrotizing enterocolitis (very low weight neonates; Guillet 2006), pancreatitis, vomiting

Hematologic & oncologic: Agranulocytosis, aplastic anemia, granulocytopenia, hemolytic anemia (immune; acquired), leukopenia, pancytopenia, thrombocytopenia

Hepatic: Cholestatic hepatitis, hepatic failure, hepatitis, jaundice

Hypersensitivity: Anaphylaxis, angioedema, hypersensitivity reaction (eg, bronchospasm, eosinophilia, fever)

Local: Burning sensation at injection site (transient), pain at injection site (transient)

Neuromuscular & skeletal: Arthralgia, myalgia

Ophthalmic: Blurred vision

Renal: Acute interstitial nephritis, increased serum creatinine

Respiratory: Pneumonia (causal relationship not established)

Ranitidine crosses the placenta (Armentano 1989). Histamine H2 antagonists have been evaluated for the treatment of gastroesophageal reflux disease (GERD) as well as gastric and duodenal ulcers during pregnancy. If needed, ranitidine is the agent of choice (Cappell 2003; Richter 2003). Histamine H2 antagonists may be used for aspiration prophylaxis prior to cesarean delivery (ASA 2007).

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience nausea, vomiting, constipation, diarrhea, or injection site edema or irritation. Have patient report immediately to prescriber signs of liver problems (dark urine, feeling tired, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin or eyes), severe dizziness, passing out, confusion, angina, tachycardia, arrhythmia, severe headache, urinary retention, bruising, or bleeding (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.