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PREVACID
(lansoprazole)
The active ingredient in PREVACID Delayed-Release Capsules and PREVACID SoluTab Delayed-Release Orally Disintegrating Tablets is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. PREVACID has the following structure:
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Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water.
Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0.
PREVACID is supplied in delayed-release capsules and in delayed-release orally disintegrating tablets for oral administration.
The delayed-release capsules are available in two dosage strengths: 15 mg and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: sugar sphere, sucrose, methacrylic acid copolymer, low substituted hydroxypropyl cellulose, starch, magnesium carbonate, talc, polyethylene glycol, titanium dioxide, polysorbate 80, hydroxypropyl cellulose, colloidal silicon dioxide, D&C Red No. 28, FD&C Blue No. 1, FD&C Green No. 31, and FD&C Red No. 40.
PREVACID SoluTab Delayed-Release Orally Disintegrating Tablets are available in two dosage strengths: 15 mg and 30 mg of lansoprazole per tablet. Each delayed-release orally disintegrating tablet contains enteric-coated microgranules consisting of 15 mg or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: mannitol, methacrylic acid, hydroxypropyl cellulose, lactose monohydrate-microcrystalline cellulose sphere, triethyl citrate, crospovidone, polyacrylate, magnesium carbonate, aspartame2, glyceryl monostearate, hypromellose, magnesium stearate, citric acid, titanium dioxide, talc, artificial strawberry flavor, polyethylene glycol, polysorbate 80 and ferric oxide.
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.
Less serious side effects may include:
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side...
Read All Potential Side Effects and See Pictures of Prevacid »
Before taking lansoprazole, tell your doctor or pharmacist if you are allergic to it; or to similar drugs (such as omeprazole, pantoprazole); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease.
Some symptoms may actually be signs of a more serious condition. Tell your doctor immediately if you have: heartburn with lightheadedness/sweating/dizziness, chest pain or shoulder pain (especially with trouble breathing, sweating, lightheadedness, pain spreading to arms/jaw/neck/shoulders), unexplained weight loss.
In addition, before you...
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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.
Less serious side effects may include:
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side...
Read All Potential Side Effects and See Pictures of Prevacid »
Before taking lansoprazole, tell your doctor or pharmacist if you are allergic to it; or to similar drugs (such as omeprazole, pantoprazole); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease.
Some symptoms may actually be signs of a more serious condition. Tell your doctor immediately if you have: heartburn with lightheadedness/sweating/dizziness, chest pain or shoulder pain (especially with trouble breathing, sweating, lightheadedness, pain spreading to arms/jaw/neck/shoulders), unexplained weight loss.
In addition, before you...
1 PREVACID 15-mg capsules only.
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.
Less serious side effects may include:
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side...
Read All Potential Side Effects and See Pictures of Prevacid »
Before taking lansoprazole, tell your doctor or pharmacist if you are allergic to it; or to similar drugs (such as omeprazole, pantoprazole); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease.
Some symptoms may actually be signs of a more serious condition. Tell your doctor immediately if you have: heartburn with lightheadedness/sweating/dizziness, chest pain or shoulder pain (especially with trouble breathing, sweating, lightheadedness, pain spreading to arms/jaw/neck/shoulders), unexplained weight loss.
In addition, before you...
2 Phenylketonurics: Contains Phenylalanine 2.5 mg per 15 mg Tablet and 5.1 mg per 30 mg Tablet.
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.
Less serious side effects may include:
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side...
Read All Potential Side Effects and See Pictures of Prevacid »
Before taking lansoprazole, tell your doctor or pharmacist if you are allergic to it; or to similar drugs (such as omeprazole, pantoprazole); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease.
Some symptoms may actually be signs of a more serious condition. Tell your doctor immediately if you have: heartburn with lightheadedness/sweating/dizziness, chest pain or shoulder pain (especially with trouble breathing, sweating, lightheadedness, pain spreading to arms/jaw/neck/shoulders), unexplained weight loss.
In addition, before you...
Last reviewed on RxList: 5/18/2012
This monograph has been modified to include the generic and brand name in many instances.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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