Ranitidine Injection

What is Ranitidine Injection?

• Ranitidine Injection (Zantac) is a histamine H2-receptor antagonist used in people who are hospitalized to treat certain conditions in which the stomach produces too much acid or to treat ulcers.
• Ranitidine injection is also used on a short-term basis in people who cannot take oral medication.

Ranitidine

Ranitidine Structural Formulae

Ranitidine-B-3D-vdW

What are the uses of this medicine?

• Ranitidine Injection (Zantac) is used in some hospitalized patients with pathological hypersecretory conditions or intractable duodenal ulcers.

It is also used on a short-term basis in people who cannot take oral medication:

• to treat ulcers,
• to prevent ulcers from returning after they have healed,
• to treat gastroesophageal reflux disease (GERD, a condition in which backward flow of acid from the stomach causes heartburn and injury of the esophagus [tube between the throat and the stomach]),
• and to treat conditions where the stomach produces too much acid, such as Zollinger-Ellison syndrome (tumors in the pancreas and small intestine that caused increased production of stomach acid).

How does this medicine work?

• Ranitidine hydrochloride is a competitive, reversible inhibitor of the action of histamine at the histamine H2-receptors, including receptors on the gastric cells.
• Ranitidine hydrochloride does not lower serum Ca++ in hypercalcemic states.
• Ranitidine hydrochloride is not an anticholinergic agent.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• known to have hypersensitivity to the drug.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• anticoagulants ('blood thinners') such as warfarin (Coumadin), atazanavir (Reyataz, in Evotaz), delavirdine (Rescriptor), gefitinib (Iressa), glipizide (Glucotrol), ketoconazole (Nizoral), midazolam (by mouth), procainamide, and triazolam (Halcion).

Is this medicine FDA approved?

• Ranitidine was discovered in England in 1976, and came into commercial use in 1981.
• It is on the World Health Organization's List of Essential Medicines.
• It is available as a generic medication.

How should this medicine be used?

Recommended dosage: In Adults:

• 50 mg (2 mL) every 6 to 8 hours.

In Pediatric Use:

• The recommended dose in pediatric patients is for a total daily dose of 2 to 4 mg/kg, to be divided and administered every 6 to 8 hours, up to a maximum of 50 mg given every 6 to 8 hours.

Administration:

• Ranitidine injection comes as a solution to be mixed with another fluid and injected intravenously over 5 to 20 minutes.
• Ranitidine may also be injected into a muscle.
• It is usually given every 6 to 8 hours, but may also be given as a constant infusion over 24 hours.
• You may receive ranitidine injection in a hospital or you may administer the medication at home.
• If you will be receiving ranitidine injection at home, your healthcare provider will show you how to use the medication.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Ranitidine Injection, 25 mg/mL

This medicine is available in fallowing brand namesː

• Zantac

What side effects can this medication cause?

The most common side effects of this medicine include:

• pain at the site of IM injection
• local burning or itching has been reported with IV administration

Less common, side effects may include:

• Central Nervous System: Rarely, malaise, dizziness, somnolence, insomnia, and vertigo. Rare cases of reversible mental confusion, agitation, depression, and hallucinations.
• Cardiovascular: tachycardia, bradycardia, atrioventricular block, and premature ventricular beats.
• Gastrointestinal: Constipation, diarrhea, nausea/vomiting, abdominal discomfort/pain, and rare reports of pancreatitis.
• Hepatic: hepatocellular, cholestatic, or mixed hepatitis, with or without jaundice.
• Musculoskeletal: arthralgias and myalgias
• Hematologic: Blood count changes (leukopenia, granulocytopenia, and thrombocytopenia)
• Endocrine: gynecomastia, impotence, and loss of libido
• Integumentary: Rash, including rare cases of erythema multiforme.
• Respiratory: pneumonia
• Other: Rare cases of hypersensitivity reactions (e.g., bronchospasm, fever, rash, eosinophilia), anaphylaxis, angioneurotic edema, acute interstitial nephritis, and small increases in serum creatinine.

What special precautions should I follow?

• Symptomatic response to therapy with ranitidine hydrochloride does not preclude the presence of gastric malignancy.
• Caution should be observed in patients with hepatic dysfunction since ranitidine hydrochloride is metabolized in the liver.
• Elevations in SGPT have been observed when H2-antagonists have been administered intravenously at greater-than-recommended dosages for 5 days or longer.
• Bradycardia in association with rapid administration of ranitidine injection has been reported rarely, usually in patients with factors predisposing to cardiac rhythm disturbances. Recommended rates of administration should not be exceeded.
• Ranitidine hydrochloride may precipitate acute porphyric attacks in patients with acute porphyria. Ranitidine hydrochloride should therefore be avoided in patients with a history of acute porphyria.
• False-positive tests for urine protein with MULTISTIX may occur during therapy with ranitidine hydrochloride, and therefore testing with sulfosalicylic acid is recommended.
• Ranitidine is secreted in human milk. Caution should be exercised when ranitidine hydrochloride is administered to a nursing mother.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• Side effects mentioned above
• gait
• hypotension
• muscular tremors
• vomiting
• rapid respiration

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• When overdosage occurs, the usual measures to remove unabsorbed material from the gastrointestinal tract, clinical monitoring, and supportive therapy should be employed.

Can this medicine be used in pregnancy?

• Pregnancy Category B.
• There are, however, no adequate and well-controlled studies in pregnant women.
• Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Can this medicine be used in children?

• The safety and effectiveness of ranitidine injection have been established in the age-group of 1 month to 16 years for the treatment of duodenal ulcer.
• Safety and effectiveness in pediatric patients for the treatment of pathological hypersecretory conditions have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• RANITIDINE HYDROCHLORIDE

Inactive ingredients:

• PHENOL
• POTASSIUM PHOSPHATE, MONOBASIC
• SODIUM PHOSPHATE, DIBASIC

Who manufactures and distributes this medicine?

Manufactured by:

• Cadila Healthcare Ltd.
• Ahmedabad, India

Distributed by:

• Zydus Pharmaceuticals (USA) Inc.
• Pennington, NJ

What should I know about storage and disposal of this medication?

• Store at 20° to 25°C (68° to 77°F).
• Do not freeze.
• Protect from light.
• Exposure of pharmaceutical products to heat should be minimized.
• Avoid excessive heat; however, brief exposure up to 40°C does not adversely affect the product.
• Protect from freezing.

The antiulcer agents in clinical use

Proton Pump Inhibitors

• Dexlansoprazole
• Esomeprazole
• Lansoprazole
• Omeprazole
• Pantoprazole
• Rabeprazole

Selective Histamine Type 2 Receptor Antagonists or H2 Blockers

• Cimetidine
• Famotidine
• Nizatidine
• Ranitidine

• Dailymed label info on Ranitidine Injection
• FDA Ranitidine Injection

Ranitidine Injection Resources
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