Prevacid NapraPAC

DRUG DESCRIPTION

PREVACID NapraPAC (lansoprazole) 500 is a combination package containing NAPROSYN 500 mg tablets and PREVACID 15 mg capsules.

NAPROSYN

Naproxen is a proprionic acid derivative related to the arylacetic acid group of NSAIDs. The chemical name for naproxen is (S)-6-methoxy-?-methyl-2-naphthaleneacetic acid and naproxen has the following structure:

Naproxen Structural Formula Illustration

Naproxen has a molecular weight of 230.26 and a molecular formula of C14H14O3.

Naproxen is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8.

NAPROSYN (naproxen tablets) is available as yellow tablets containing 500 mg of naproxen for oral administration. The inactive ingredients are croscarmellose sodium, iron oxides, povidone, and magnesium stearate.

PREVACID

The active ingredient in PREVACID Delayed-Release capsules 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:

Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166C. 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 and approximately 18 hours at pH 7.

PREVACID Delayed-Release capsules contain enteric-coated granules consisting of 15 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. 3, and FD&C Red No. 40.

What are the possible side effects of lansoprazole and naproxen (PREVACID NapraPAC 500)?

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.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with...

Read All Potential Side Effects and See Pictures of Prevacid NapraPAC

What are the precautions when taking lansoprazole (Prevacid NapraPAC)?

Consult your...

Read All Potential Precautions of Prevacid NapraPAC


Prevacid NapraPAC Consumer (continued)

SIDE EFFECTS: Consult your pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Consult your pharmacist.


Prevacid NapraPAC Patient Information Including Side Effects

Brand Names: PREVACID NapraPAC 500

Generic Name: lansoprazole and naproxen (Pronunciation: lan SOE pra zole and na PROX en)

  • What is lansoprazole and naproxen (Prevacid NapraPAC)?
  • What are the possible side effects of lansoprazole and naproxen (Prevacid NapraPAC)?
  • What is the most important information I should know about lansoprazole and naproxen (Prevacid NapraPAC)?
  • What should I discuss with my healthcare provider before taking lansoprazole and naproxen (Prevacid NapraPAC)?
  • How should I take lansoprazole and naproxen (Prevacid NapraPAC)?
  • What happens if I miss a dose (Prevacid NapraPAC)?
  • What happens if I overdose (Prevacid NapraPAC)?
  • What should I avoid while taking lansoprazole and naproxen (Prevacid NapraPAC)?
  • What other drugs will affect lansoprazole and naproxen (Prevacid NapraPAC)?
  • Where can I get more information?

What is lansoprazole and naproxen (Prevacid NapraPAC)?

Naproxen is in a group of drugs called NSAIDs (nonsteroidal anti-inflammatory drugs). It works by reducing substances in the body that cause inflammation, pain, and fever.

Lansoprazole is in a group of drugs called proton pump inhibitors. It decreases the amount of acid produced in the stomach.

The combination of lansoprazole and naproxen is used to treat symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. The lansoprazole in this medication helps reduce the risk of stomach ulcers in people who may be at risk for them while receiving treatment with an NSAID.

Lansoprazole and naproxen may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of lansoprazole and naproxen (Prevacid NapraPAC)?

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.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • swelling, rapid weight gain, feeling short of breath, even with mild exertion;
  • black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or
  • pale skin, easy bruising, weakness.

Less serious side effects may include:

  • mild stomach pain, constipation, nausea, heartburn;
  • headache, dizziness or drowsiness;
  • sweating, mild skin rash or itching; or
  • ringing in your ears.

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.

What is the most important information I should know about lansoprazole and naproxen (Prevacid NapraPAC)?

The naproxen in this medicine can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use naproxen. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

Naproxen can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking naproxen. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Call your doctor at once if you have symptoms of bleeding in your stomach or intestines. This includes black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Do not use any other over-the-counter pain or arthritis medication without first asking your doctor or pharmacist. Naproxen is contained in many medicines available over the counter. Read the label of any other medicine you are using to see if it contains naproxen.

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