Ompraz capsules

Ompraz

  • Active Ingredient: Omeprazole
  • 40 mg, 20 mg, 10 mg
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What is Ompraz?

The active ingredient of Ompraz brand is omeprazole. Omeprazole is a proton pump inhibitor that decreases the amount of acid produced in the stomach. Omeprazole, USP is a white to off-white crystalline powder that melts with decomposition at about 155В°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of Omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of Omeprazole in the form of enteric-coated beads with the following inactive ingredients: ammonium hydroxide, dibutyl sebacate, D&C Yellow No. 10, FD&C Green No. 3, gelatin, ethylcellulose, fumed silica, hypromellose, methacrylic acid, oleic acid, silicon dioxide, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide and triethyl citrate. The 40 mg empty gelatin capsule shell also contains FD&C Blue No. 1. In addition, the white imprinting ink contains ammonium hydroxide, propylene glycol, shellac glaze, simethicone and titanium dioxide. Meets USP Dissolution Test 2.

Used for

Ompraz is used to treat diseases such as: Barrett's Esophagus, Duodenal Ulcer, Erosive Esophagitis, Gastritis/Duodenitis, GERD, Helicobacter Pylori Infection, Indigestion, Multiple Endocrine Adenomas, Stomach Ulcer, Systemic Mastocytosis, Zollinger-Ellison Syndrome.

Side Effect

Possible side effects of Ompraz include: Body aches or pain; flushing; Back, leg, or stomach pain; confusion; general feeling of discomfort or illness.

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Q: I take Prilosec OTC every morning and have done so for well over a year. Is it safe to take for such a long time, and is it OK for me to continue to take it?

A: Long-term use of Prilosec OTC (Ompraz) may lead to atrophic gastritis. According to the medical literature, long-term Prilosec OTC patients may also be at increased risk of infectious complications and nutritional deficiencies. Prilosec OTC is only approved for 14 days of use. It is important to speak with your health care provider regarding longer treatment. Kristen Dore, PharmD

What if I take too much?

It's very unlikely that taking 1 or 2 extra doses by accident will cause any problems.

But you should check with your doctor if you have taken too much and have any of these symptoms:

  • flushed skin
  • feeling sweaty
  • a fast heartbeat
  • feeling sleepy
  • blurred vision
  • feeling confused or agitated

Most people who take Ompraz don't have any side effects. If you do get a side effect, it's usually mild and will go away when you stop taking Ompraz.

Administration of Ompraz 20 mg twice daily for 4 days and a single 1000 mg dose of MMF approximately one hour after the last dose of Ompraz to 12 healthy subjects in a cross-over study resulted in a 52% reduction in the Cmax and 23% reduction in the AUC of MPA.

Prior authorization

Many insurance companies require a prior authorization for this drug. This means your doctor will need to get approval from your insurance company before your insurance company will pay for the prescription.

There are other drugs available to treat your condition. Some may be better suited for you than others. Talk to your doctor about other drug options that may work for you.

  • Severe diarrhea warning: This drug may increase your risk of severe diarrhea. This may be caused by an infection in your intestine caused by the bacteria Clostridium difficile. Call your doctor right away if you have watery diarrhea, stomach pain, and a fever that won’t go away.
  • Bone fractures warning: People who take several doses of a proton pump inhibitor drug, such as Ompraz, every day for a year or longer may have an increased risk of bone fractures. These bone breaks may be more likely to happen in your hip, wrist, or spine. Talk to your doctor about your risk of bone fractures. You should take this drug exactly as prescribed by your doctor. They should prescribe the lowest dose possible for the shortest amount of time needed for your treatment.
  • Low magnesium levels warning: Taking this drug for three months or longer can cause low magnesium levels in your body. Your risk is higher if you take Ompraz for a year or longer. Call your doctor right away if you have symptoms of low magnesium. These can include seizures, abnormal or fast heart rate, jitteriness, jerking movements or shaking, and muscle weakness. They can also include cramps or muscle aches and spasms of your hands, feet, and voice box. Your doctor may check your magnesium levels before and during your treatment with this drug.

Cutaneous lupus erythematosus and systemic lupus erythematosus warning: Ompraz can cause cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE). CLE and SLE are autoimmune diseases. Symptoms of CLE can range from a rash on the skin and nose, to a raised, scaly, red or purple rash on certain parts of the body. Symptoms of SLE can include fever, tiredness, weight loss, blood clots, heartburn, and stomach pain. If you have any of these symptoms, call your doctor.

Fundic gland polyps warning: Long-term use (especially over one year) of Ompraz can cause fundic gland polyps. These polyps are growths on the lining of your stomach that can become cancerous. To help prevent these polyps, you should use this drug for as short a time as possible.

Serious side effects

Serious side effects are rare and happen in less than 1 in 1,000 people.

Call a doctor straight away if you have:

  • joint pain along with a red skin rash, especially in parts of your body exposed to the sun, such as your arms, cheeks and nose - these can be signs of a rare condition called subacute cutaneous lupus erythematosus. This can happen even if you have been taking Ompraz for a long time
  • yellow skin, dark pee and tiredness - these can be signs of liver problems

Atrophic Gastritis

Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with Ompraz.

In studies involving more than 200 patients, serum gastrin levels increased during the first 1 to 2 weeks of once-daily administration of therapeutic doses of Ompraz in parallel with inhibition of acid secretion. No further increase in serum gastrin occurred with continued treatment. In comparison with histamine H2-receptor antagonists, the median increases produced by 20 mg doses of Ompraz were higher (1.3 to 3.6 fold vs. 1.1 to 1.8 fold increase). Gastrin values returned to pretreatment levels, usually within 1 to 2 weeks after discontinuation of therapy.

Increased gastrin causes enterochromaffin-like cell hyperplasia and increased serum Chromogranin A (CgA) levels. The increased CgA levels may cause false positive results in diagnostic investigations for neuroendocrine tumors. Healthcare providers should temporarily stop Ompraz treatment at least 14 days before assessing CgA levels and consider repeating the test if initial CgA levels are high.

Ompraz oral capsule is a prescription drug that’s only available in a generic form. It doesn’t have a brand-name version. Ompraz is also available as an oral suspension and comes as an over-the-counter (OTC) medication.

Prescription Ompraz oral capsule is a delayed-release drug. A delayed-release drug slows the release of the medication until it passes through your stomach. This delay keeps the drug from being inactivated by your stomach.

Q: I'm on Prilosec. I'm looking for a substitute drug that is as effective but cheaper. Is there one that you can recommend?

A: Patients often inquire about cheaper alternatives to the current treatment they been prescribed. First, you may want to contact your insurance company, prior to speaking with your doctor, and request a formulary. A formulary is a list of the medications they prefer and the different levels of coverage specific to your plan. Prilosec (Ompraz) does have a generic equivalent, Ompraz, which you may also want to inquire about. Then it is important to contact your health care provider and based on your individual needs and the formulary list of covered medications, the best treatment option can be determined. For more information regarding Prilosec or Ompraz, you may want to visit //www.everydayhealth.com/drugs/prilosec. Beth Isaac, PharmD

How long does Ompraz take to work?

This depends on why you're taking it. You should get some relief from heartburn and indigestion symptoms straight away, or at least in the first few days of taking Ompraz.

However, you may need to keep taking Ompraz for a few weeks, depending on why it's been prescribed. Some conditions may require you to take Ompraz on a long-term basis, either to keep symptoms under control or to avoid the condition coming back.

If you've bought Ompraz without a prescription you should see your doctor if your symptoms haven't got better after taking it for two weeks.

Microbiology

Ompraz and clarithromycin dual therapy and Ompraz, clarithromycin and amoxicillin triple therapy have been shown to be active against most strains of Helicobacter pylori in vitro and in clinical infections as described in the Indications and Usage section (1.1).

4. How and when to take it

It's usual to take Ompraz once a day, first thing in the morning. It doesn't upset the stomach, so you can take it with or without food.

If you take Ompraz twice a day, take 1 dose in the morning and 1 dose in the evening.

Which drugs or supplements interact with Ompraz?

Ompraz potentially can increase the concentrations in blood of diazepam (Valium), warfarin (Coumadin), and phenytoin (Dilantin) by decreasing the elimination of these drugs by the liver.

The absorption of certain drugs may be affected by stomach acidity. Therefore, Ompraz as well as other PPIs reduce the absorption and concentration in blood of ketoconazole (Nizoral) and increase the absorption and concentration in blood of digoxin (Lanoxin). This may reduce the effectiveness of ketoconazole or increase digoxin toxicity.

Through unknown mechanisms, Ompraz may increase blood levels of saquinavir and reduce blood levels of nelfinavir and atazanavir, drugs that are used for treating patients with infection caused by the human immunodeficiency virus (HIV). Accordingly, the dose of saquinavir may need to be reduced to avoid toxicity, and the doses of nelfinavir and atazanavir may need to be increased to maintain efficacy.

Clopidogrel (Plavix) is converted to its active form by enzymes in the liver. Ompraz reduces the activity of these enzymes and potentially can reduce the activity of clopidogrel. Ompraz should not be used with clopidogrel.

Ompraz increases the concentration of cilostazol (Pletal). The dose of cilostazol should be reduced from 100 mg twice daily to 50 mg twice daily when given with Ompraz.

What is the dosage for Ompraz?

For ulcers, GERD, erosive esophagitis and eradication of H. pylori the recommended dose for adults is 20-40 mg daily. Ulcer healing usually occurs within 4-8 weeks.

H. pylori infections are treated for 10-28 days.

The usual dose for prevention of upper gastrointestinal bleeding in critically ill patients is 40 mg daily for 14 days.

Prilosec OTC is used for treating heartburn for up to two weeks, and the usual dose is 20 mg daily.

For the management of Zollinger-Ellison syndrome the starting dose for adults is 60 mg daily, and the dose is adjusted based on either the response of symptoms or the actual measurement of acid production. Doses greater than 80 mg should be divided. Doses up to 120 mg three times a day have been used in the treatment of Zollinger-Ellison Syndrome.

For maximal efficacy, Ompraz tablets should be taken before meals, swallowed whole and should not be crushed, chewed or opened.

Ompraz belongs to the proton pump inhibitor (PPI) class of medications. Doctors prescribe Ompraz to reduce stomach acid to help treat a variety of digestive conditions.

People can also use over-the-counter (OTC) Ompraz to relieve heartburn or acid reflux.

Although most people tolerate Ompraz well, there are certain risks when people use it for a long period of time.

In this article, we review the uses, side effects, and drug interactions of Ompraz.


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