Ranitidine

What is Ranitidine?

• Ranitidine (Zantac; Tritec) is a histamine H2-receptor antagonist which is widely used for treatment of acid-peptic disease and heartburn.

Ranitidine

Ranitidine Structural Formulae

Ranitidine-B-3D-vdW

What are the uses of this medicine?

Ranitidine (Zantac; Tritec) is used for:

• Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks.
• Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers.
• The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis).
• Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated.
• Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers.
• Treatment of GERD.
• Treatment of endoscopically diagnosed erosive esophagitis.
• Maintenance of healing of erosive esophagitis.

Concomitant antacids should be given as needed for pain relief to patients with active duodenal ulcer; active, benign gastric ulcer; hypersecretory states; GERD; and erosive esophagitis.

How does this medicine work?

• Ranitidine (ra ni' ti deen) was the second H2 blocker introduced into clinical practice in the United States and remains a commonly used agent for treatment of duodenal and gastric ulcer and gastroesophageal reflux disease.
• A member of the class of histamine H2-receptor antagonists with antacid activity.
• Ranitidine is a competitive and reversible inhibitor of the action of histamine, released by enterochromaffin-like (ECL) cells, at the histamine H2-receptors on parietal cells in the stomach, thereby inhibiting the normal and meal-stimulated secretion of stomach acid.
• In addition, other substances that promote acid secretion have a reduced effect on parietal cells when the H2 receptors are blocked.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• known to have hypersensitivity to the drug or any of the ingredients.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention any of the following:

• anticoagulants ('blood thinners') such as warfarin (Coumadin); and triazolam (Halcion).

Is this medicine FDA approved?

• Ranitidine was first approved for use in the United States in 1983 and is now used widely both by prescription and over-the-counter. The listed indications for ranitidine are duodenal and gastric ulcer disease, gastroesophageal reflux and prevention of stress ulcers.
• Ranitidine is available by prescription in capsules of 150 and 300 mg in several generic forms, and in both oral and parenteral forms under the brand name Zantac.
• Over-the-counter formulations of ranitidine are usually tablets of 75 mg each.

How should this medicine be used?

Recommended dosage:

Adults:

In 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.
• Antacid should be given as needed for relief of pain.

In Maintenance of Healing of Duodenal Ulcers:

• The current recommended adult oral dosage is 150 mg at bedtime.

In 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 four times daily.

Maintenance of Healing of Erosive Esophagitis:

• The current recommended adult oral dosage is 150 mg twice daily.

Pediatric Use (agegroup of 1 month to 16 years): 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.

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.

Treatment of GERD and Erosive Esophagitis:

• Dosage of 5 to 10 mg/kg/day, usually given as two divided doses.

Dosage Adjustment for Patients With Impaired Renal Function:

• The recommended dosage in patients with a creatinine clearance <50 mL/min is 150 mg every 24 hours.

Administration:

• Ranitidine comes as a tablet, an effervescent tablet, effervescent granules, and a syrup to take by mouth.
• It is usually taken once a day at bedtime or two to four times a day.
• Over-the-counter ranitidine comes as a tablet to take by mouth.
• It is usually taken once or twice a day.
• To prevent symptoms, it is taken 30 to 60 minutes before eating or drinking foods that cause heartburn.
• Dissolve ranitidine effervescent tablets and granules in a full glass of water before drinking.
• Do not take over-the-counter ranitidine for longer than 2 weeks unless your doctor tells you to.
• If symptoms of heartburn, acid indigestion, or sour stomach last longer than 2 weeks, stop taking ranitidine and call your doctor.

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

This medicine is available in fallowing doasage form:

• As a tablet, an effervescent tablet, effervescent granules, and a syrup

This medicine is available in fallowing brand namesː

• Tritec
• Zantac
• Zantac 75
• Zantac EFFERdose
• Zantac Syrup

What side effects can this medication cause?

The most common side effects of this medicine in Chemotherapy-Induced Nausea and Vomiting Studies may include:

• diarrhea, constipation, fatigue, drowsiness, headache and muscle aches

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 does not preclude the presence of gastric malignancy.
• Caution should be observed in patients with hepatic dysfunction since ranitidine is metabolized in the liver.
• Ranitidine may precipitate acute porphyric attacks in patients with acute porphyria. Ranitidine should therefore be avoided in patients with a history of acute Porphyria.
• False-positive tests for urine protein with MULTISTIX may occur during ranitidine therapy, and therefore testing with sulfosalicylic acid is recommended.
• Ranitidine is secreted in human milk. Caution should be exercised when ranitidine is administered to a nursing mother.
• Ranitidine has been linked to rare instances of clinically apparent acute liver injury.

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 effetiveness of ranitidine have been established in the agegroup of 1 month to 16 years for the treatment of duodenal and gastric ulcers, gastroesophageal reflux disease and erosive esophagitis, and the maintenance of healed duodenal and gastric ulcer.
• Safety and effectiveness in pediatric patients for the treatment of pathological hypersecretory conditions or the maintenance of healing of erosive esophagitis have not been established.
• Safety and effectiveness in neonates (less than one month of age) have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• RANITIDINE HYDROCHLORIDE

Inactive ingredients:

• CASTOR OIL
• CELLULOSE, MICROCRYSTALLINE
• CROSCARMELLOSE SODIUM
• HYPROMELLOSE
• MAGNESIUM STEARATE
• SILICON DIOXIDE
• TALC
• TITANIUM DIOXIDE

Who manufactures and distributes this medicine?

Manufactured by:

• Wockhardt Limited
• Mumbai, India.

Distributed by:

• Wockhardt USA LLC.
• 20 Waterview Blvd.
• Parsippany, NJ
• USA.

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

• Store between 20° and 25°C (68° and 77°F) in a dry place.
• Protect from light.
• Replace cap securely after each opening.

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
• FDA Ranitidine

Ranitidine Resources
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