RANITIDINE HCL

Ranitidine hydrochloride (HCl) is a histamine H2-receptor antagonist. Chemically it is N-[ 2-[[[5-[(Dimethylamino)methyl]-2-furanyl] methyl]thio]ethyl]-N'-methyl-2-nitro-1,1-ethenediamine, HCl. It has the following structure:

The empirical formula is C₁₃H₂₂N₄O₃S·HCl, representing a molecular weight of 350.87. Ranitidine HCl is a white to pale yellow, granular substance that is soluble in water. It has a slightly bitter taste and sulfur-like odor. Each tablet, for oral administration, contains 168 mg of ranitidine HCl equivalent to 150 mg of ranitidine, or 336 mg of ranitidine HCl equivalent to 300 mg of ranitidine. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium bicarbonate, synthetic red iron oxide, synthetic yellow iron oxide, talc, titanium dioxide and triethyl citrate.

Ranitidine HCl is a white to pale yellow, granular substance that is soluble in water. It has a slightly bitter taste and sulfurlike odor.

Each ZANTAC (ranitidine hcl) 150 Tablet for oral administration contains 168 mg of ranitidine HCl equivalent to 150 mg of ranitidine. Each tablet also contains the inactive ingredients FD&C Yellow No. 6 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, titanium dioxide, triacetin, and yellow iron oxide.

Each ZANTAC (ranitidine hcl) 300 Tablet for oral administration contains 336 mg of ranitidine HCl equivalent to 300 mg of ranitidine. Each tablet also contains the inactive ingredients croscarmellose sodium, D&C Yellow No. 10 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin.

Before using this medication, tell your doctor if you are allergic to any drugs, or if you have kidney disease, liver disease, or porphyria.

Using ranitidine may increase your risk of developing pneumonia. Symptoms of pneumonia include chest pain, fever, feeling short of breath, and coughing up green or yellow mucus. Talk with your doctor about your specific risk of developing pneumonia.

Ranitidine granules and effervescent tablets must be dissolved in water before you take them.

Your doctor may recommend an antacid to help relieve pain. Carefully follow your doctor's directions about the type of antacid to use, and when to use it.

Avoid drinking alcohol. It can increase the risk of damage to your stomach.

It may take up to 8 weeks of using this medicine before your ulcer heals. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 6 weeks of treatment.

Heartburn can be confused with early symptoms of heart attack. Seek emergency medical attention if you have chest pain or heavy feeling, dizziness, pain spreading to the arm or shoulder, sweating, nausea or vomiting, and a general ill feeling.

Side effects of ranitidine?
Stop using ranitidine and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• chest pain, fever, feeling short of breath, coughing up green or yellow mucus;
• easy bruising or bleeding, unusual weakness;
• fast or slow heart rate;
• problems with your vision;
• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or
• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

• headache (may be severe);
• drowsiness, dizziness;
• sleep problems (insomnia);
• decreased sex drive, impotence, or difficulty having an orgasm; or
• swollen or tender breasts (in men);
• nausea, vomiting, stomach pain; or
• diarrhea or constipation.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.