Prilosid capsules


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

The active ingredient of Prilosid 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

Prilosid 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 Prilosid include: general feeling of discomfort or illness; sores, ulcers, or white spots on the lips, in the mouth, or on the genitals; dizziness; pain; joint pain; chest pain.

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In patients with chronic renal impairment, whose creatinine clearance ranged between 10 and 62 mL/min/1.73 m², the disposition of Prilosid was very similar to that in healthy volunteers, although there was a slight increase in bioavailability. Because urinary excretion is a primary route of excretion of Prilosid metabolites, their elimination slowed in proportion to the decreased creatinine clearance. No dose reduction is necessary in patients with renal impairment.

Q: What are the long term effects of using drugs like Prilosec for acid reflux? I have to take it every day.

A: PPIs (proton pump inhibitors), such as Prilosec (Prilosid), Prevacid (lansoprazole), Nexium (esPrilosid), Protonix (pantoprazole), and Aciphex (rabeprazole), were initially created to help treat ulcers in the GI (gastrointestinal) tract over a few weeks, and they are used for GERD (gastroesophageal reflux disease), and other acid related conditions. However, many doctors have authorized their patients to keep taking them past the initial set timeframes, and in general, they are still considered to be safe. Complications can occur while taking any medications, and this is also the case with PPIs. The body makes stomach acid to digest food and the acidic environment can also prevent bacteria from growing. When a PPI, such as Prilosec (Prilosid) is used over the longterm, an abundance of gastrin, an important stomach hormone, can cause a rebound effect of extra large stomach acid secretion if the PPI is stopped. The PPIs can interfere with the processing of the blood thinner Plavix (clopidogrel), which may not thin the blood enough, with vitamin B-12 (cyanocobalamin) and calcium, as they need the acidic environment to be absorbed. There have been some studies which showed higher results of hip-fractures, due to the low calcium absorption, especially if the person had been taking a PPI over a long period of time. Calcium citrate is a good form of calcium to take, as it does not need the acid that other versions do, and since the body does not absorb much more than 500mg at a time, it should be divided in dosing throughout the day. Pneumonia was also more likely, as a low acidic environment could allow bacteria to grow in the stomach. When people are lying flat to sleep, small amount of stomach contents can travel up the esophagus to the throat and go down the trachea to the lungs. This is called aspiration. A bacteria called C. difficle can also grow better in the stomach if there is less acid, and it can cause life-threatening diarrhea and conditions such as colitis, and inflammation of the lining of the colon. The PPIs are considered safe for long term use, but a patient should always be monitored for the complications. If a person only has occasional reflux that an antacid, such as Rolaids/Tums (calcium) can neutralize, it may be a better option, or avoiding foods, such as chocolate, coffee, and fatty foods, can help. If the problem is at night, the head of the bed being elevated may be a good answer as well. PPIs, such as Prilosec (Prilosid) have their place, but you should ask your doctor what regimen is best for you. Patti Brown, PharmD

What is Prilosid?

Prilosid is a medicine that reduces the amount of acid that your stomach produces. It's prescribed for stomach ulcers, but you can also buy it over the counter from pharmacies to relieve heartburn associated with acid reflux.

Prilosid comes as capsules, tablets and dispersible tablets. These are all available in 10mg, 20mg and 40mg strengths. In hospital Prilosid is sometimes given by injection or drip into a vein.

Losec, Losec MUPS, Mepradec and Mezzopram are all brand names for Prilosid. It's also called Prilosec in the USA.

Prilosid side effects

Get emergency medical help if you have signs of an allergic reaction to Prilosid: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using Prilosid and call your doctor at once if you have:

severe stomach pain, diarrhea that is watery or bloody;

new or unusual pain in your wrist, thigh, hip, or back;

kidney problems - little or no urination, blood in your urine, swelling, rapid weight gain;

low magnesium - dizziness, irregular heartbeats, feeling jittery, muscle cramps, muscle spasms, cough or choking feeling; or

new or worsening symptoms of lupus - joint pain, and a skin rash on your cheeks or arms that worsens in sunlight.

Taking this medicine long-term may cause you to develop stomach growths called fundic gland polyps. Talk with your doctor about this risk.

If you use Prilosid for longer than 3 years, you could develop a vitamin B-12 deficiency. Talk to your doctor about how to manage this condition if you develop it.

Common Prilosid side effects may include:

stomach pain, gas;

nausea, vomiting, diarrhea; or

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 other drugs will affect Prilosid?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your current medicines. Many drugs can interact Prilosid, especially:

This list is not complete and many other drugs may affect Prilosid. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

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

Prescription Prilosid 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.

2. Key facts

  • It's usual to take Prilosid once a day in the morning.
  • For severe illness, you can take it twice a day - in the morning and in the evening.
  • Common side effects include headaches, diarrhoea and stomach pain. These tend to be mild and go away when you stop taking the medicine.
  • If you're self-treating with Prilosid, do not take it for longer than 2 weeks without checking with a doctor.
  • Prilosid is also called by the brand names Losec and Losec MUPS.

Storage And Handling

PRILOSEC Delayed-Release Capsules, 10 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 606 on cap and PRILOSEC 10 on the body. They are supplied as follows:

NDC 0186-0606-31 unit of use bottles of 30

PRILOSEC Delayed-Release Capsules, 20 mg, are opaque, hard gelatin, amethyst colored capsules, coded 742 on cap and PRILOSEC 20 on body. They are supplied as follows:

NDC 0186-0742-31 unit of use bottles of 30 NDC 0186-0742-82 bottles of 1000

PRILOSEC Delayed-Release Capsules, 40 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 743 on cap and PRILOSEC 40 on the body. They are supplied as follows:

NDC 0186-0743-31 unit of use bottles of 30 NDC 0186-0743-68 bottles of 100

PRILOSEC For Delayed-Release Oral Suspension, 2.5 mg or 10 mg, is supplied as a unit dose packet containing a fine yellow powder, consisting of white to brownish Prilosid granules and pale yellow inactive granules. PRILOSEC unit dose packets are supplied as follows:

NDC 0186-0625-01 unit dose packages of 30: 2.5 mg packets NDC 0186-0610-01 unit dose packages of 30: 10 mg packets

Drugs you should not use with Prilosid

Do not take these drugs with Prilosid. Doing so can cause dangerous effects in the body. Examples of these drugs include:

  • Atazanavir, rilpivirine, and nelfinavir. Prilosid may greatly decrease the effects of these drugs and could make them less effective over time. You shouldn’t take these drugs with Prilosid.
  • Clopidogrel. Prilosid may reduce the effects of clopidogrel, causing your blood to clot. You shouldn’t take this drug with Prilosid.

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