Ranitidine Hydrochloride 300 mg/1
Ranitidine Hydrochloride · CAPSULE · Dr. Reddy's Laboratories Limited
Ranitidine hydrochloride is an oral capsule used to treat conditions caused by excess stomach acid, such as heartburn and ulcers. This medication works by reducing the amount of acid your stomach produces.
Key Facts
- Brand Name
- Ranitidine Hydrochloride
- Generic Name
- Ranitidine Hydrochloride
- NDC Code (Product)
55111-130- Manufacturer
- Dr. Reddy's Laboratories Limited
- Strength
- 300 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA075742
- Marketing Start
- 04/01/2001
Recall History
Sandoz, Inc
CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
Sandoz, Inc
CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
Spectrum Laboratory Products
CGMP Deviations: Presence of NDMA impurity detected in product.
AVKARE Inc.
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
AVKARE Inc.
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Dr. Reddy's Laboratories, Inc.
Microbial Contamination of Non-Sterile Products: A lot of raw material used in the manufacture of Ranitidine was positive for Pseudomonas sp.
PD-Rx Pharmaceuticals, Inc.
CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
Sandoz, Inc
CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Ranitidine is indicated in: 1. Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks. 2. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative studies have been carried out for periods of longer than 1 year. 3.The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis). 4. Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks. 5.Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studies have been carried out for 1 year. 6.Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with ranitidine 150 mg two times a day. 7. Treatment of e…
Dosage & Administration
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 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 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 …
Contraindications
CONTRAINDICATIONS Ranitidine is contraindicated for patients known to have hypersensitivity to the drug or any of the ingredients (see PRECAUTIONS ).
Drug Interactions
Drug Interactions Ranitidine has been reported to affect the bioavailability of other drugs through several different mechanisms such as competition for renal tubular secretion, alteration of gastric pH, and inhibition of cytochrome P450 enzymes. Procainamide: Ranitidine, a substrate of the renal organic cation transport system, may affect the clearance of other drugs eliminated by this route. High doses of ranitidine (e.g., such as those used in the treatment of Zollinger-Ellison syndrome) have been shown to reduce the renal excretion of procainamide and N-acetylprocainamide resulting in increased plasma levels of these drugs. Although this interaction is unlikely to be clinically relevant at usual ranitidine doses, it may be prudent to monitor for procainamide toxicity when administered with oral ranitidine at a dose exceeding 300 mg per day. Warfarin: There have been reports of altered prothrombin time among patients on concomitant warfarin and ranitidine therapy. Due to the narrow therapeutic index, close monitoring of increased or decreased prothrombin time is recommended during concurrent treatment with ranitidine. Ranitidine may alter the absorption of drugs in which gastric…
Adverse Reactions
ADVERSE REACTIONS The following have been reported as events in clinical trials or in the routine management of patients treated with ranitidine. The relationship to therapy with ranitidine has been unclear in many cases. Headache, sometimes severe, seems to be related to administration of ranitidine. Central Nervous System Rarely, malaise, dizziness, somnolence, insomnia, and vertigo. Rare cases of reversible mental confusion, agitation, depression, and hallucinations have been reported, predominantly in severely ill elderly patients. Rare cases of reversible blurred vision suggestive of a change in accommodation have been reported. Rare reports of reversible involuntary motor disturbances have been received. Cardiovascular As with other H 2 -blockers, rare reports of arrhythmias such as tachycardia, bradycardia, atrioventricular block, and premature ventricular beats. Gastrointestinal Constipation, diarrhea, nausea/vomiting, abdominal discomfort/pain, and rare reports of pancreatitis. Hepatic There have been occasional reports of hepatocellular, cholestatic, or mixed hepatitis, with or without jaundice. In such circumstances, ranitidine should be immediately discontinued. These e…
Frequently Asked Questions
What is Ranitidine Hydrochloride used for?
Ranitidine hydrochloride is an oral capsule used to treat conditions caused by excess stomach acid, such as heartburn and ulcers. This medication works by reducing the amount of acid your stomach produces.
Is Ranitidine Hydrochloride a controlled substance?
Ranitidine Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Ranitidine Hydrochloride?
The generic name for Ranitidine Hydrochloride is Ranitidine Hydrochloride. There are 1 other brand versions of Ranitidine Hydrochloride.
What is the NDC code for Ranitidine Hydrochloride 300 mg/1?
The NDC (National Drug Code) for Ranitidine Hydrochloride 300 mg/1 is 55111-130, listed by Dr. Reddy's Laboratories Limited.