Oprezol capsules

Oprezol

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

The active ingredient of Oprezol 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

Oprezol 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 Oprezol include: sores, ulcers, or white spots on the lips, in the mouth, or on the genitals; increased sweating; unusual tiredness or weakness; unusual bleeding or bruising; redness, tenderness, itching, burning, or peeling of the skin; difficult, burning, or painful urination; sore throat.

How to Buy Oprezol capsules online?

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once daily

Researchers have not conducted studies on the efficacy of Oprezol past 12 months.

Doctors suggest taking Oprezol 30–60 minutes before a meal. If the doctor recommends taking Oprezol twice daily, the person should take it before breakfast and before supper.

The side effects of Oprezol include:

Side effects that children may report are similar to those that adults report, except that they tend to complain more about fever and breathing issues, such as pharyngitis and sinus infections.

Watermelon juice

Watermelon is a great alternative to Oprezol. There are plenty of ways to consume it like as a dessert or even as a drink. Drinking watermelon juice is an excellent way to take advantage of all of its properties.

What brand names are available for Oprezol?

Prilosec, Zegerid, Prilosec OTC, Zegerid OTC

H. pylori Eradication in Patients with Duodenal Ulcer Disease

Triple Therapy (PRILOSEC/clarithromycin/amoxicillin)— Three U.S., randomized, double-blind clinical studies in patients with H. pylori infection and duodenal ulcer disease (n = 558) compared PRILOSEC plus clarithromycin plus amoxicillin with clarithromycin plus amoxicillin. Two studies (1 and 2) were conducted in patients with an active duodenal ulcer, and the other study (3) was conducted in patients with a history of a duodenal ulcer in the past 5 years but without an ulcer present at the time of enrollment. The dose regimen in the studies was PRILOSEC 20 mg twice daily plus clarithromycin 500 mg twice daily plus amoxicillin 1 g twice daily for 10 days; or clarithromycin 500 mg twice daily plus amoxicillin 1 g twice daily for 10 days. In studies 1 and 2, patients who took the Oprezol regimen also received an additional 18 days of PRILOSEC 20 mg once daily. Endpoints studied were eradication of H. pylori and duodenal ulcer healing (studies 1 and 2 only). H. pylori status was determined by CLOtest®, histology and culture in all three studies. For a given patient, H. pylori was considered eradicated if at least two of these tests were negative, and none was positive.

The combination of Oprezol plus clarithromycin plus amoxicillin was effective in eradicating H. pylori.

Table 5 : Per-Protocol and Intent-to-Treat H. pylori Eradication Rates % of Patients Cured PRILOSEC +clarithromycin +amoxicillin Clarithromycin +amoxicillin Per-Protocol † Intent-to-Treat‡ Per-Protocol † Intent-to-Treat‡ Study 1 *77 *69 43 37 (n = 64) (n = 80) (n = 67) (n = 84) Study 2 *78 *73 41 36 (n = 65) (n = 77) (n = 68) (n = 83) Study 3 *90 *83 33 32 (n = 69) (n = 84) (n = 93) (n = 99) † Patients were included in the analysis if they had confirmed duodenal ulcer disease (active ulcer, studies 1 and 2; history of ulcer within 5 years, study 3) and H. pylori infection at baseline defined as at least two of three positive endoscopic tests from CLOtest®, histology, and/or culture. Patients were included in the analysis if they completed the study. Additionally, if patients dropped out of the study due to an adverse event related to the study drug, they were included in the analysis as failures of therapy. The impact of eradication on ulcer recurrence has not been assessed in patients with a past history of ulcer. ‡Patients were included in the analysis if they had documented H. pylori infection at baseline and had confirmed duodenal ulcer disease. All dropouts were included as failures of therapy. *(p

Oprezol and breastfeeding

Oprezol is safe to take while you're breastfeeding. It passes into breast milk, but only in small amounts that aren't harmful to the baby.

But if your baby is premature or has health problems, check with your doctor first.

How long will I take it for?

If you bought the medicine yourself from a pharmacy, tell your doctor if you feel no better after taking Oprezol for 2 weeks.

They may want to do tests to find out what's causing your symptoms or change you to a different medicine.

Depending on your illness or the reason you're taking Oprezol, you may only need it for a few weeks or months.

Sometimes you might need to take it for longer, even for many years.

Some people don't need to take Oprezol every day and take it only when they have symptoms.

Once you feel better (often after a few days or weeks), you can stop taking it.

But taking Oprezol in this way isn't suitable for everyone. Talk to your doctor about what's best for you.

PRILOSEC Delayed-Release Capsules contain an enteric-coated granule formulation of Oprezol (because Oprezol is acid-labile), so that absorption of Oprezol begins only after the granules leave the stomach. Absorption is rapid, with peak plasma levels of Oprezol occurring within 0.5 to 3.5 hours. Peak plasma concentrations of Oprezol and AUC are approximately proportional to doses up to 40 mg, but because of a saturable first-pass effect, a greater than linear response in peak plasma concentration and AUC occurs with doses greater than 40 mg. Absolute bioavailability (compared with intravenous administration) is about 30-40% at doses of 20-40 mg, due in large part to presystemic metabolism. In healthy subjects the plasma half-life is 0.5 to 1 hour, and the total body clearance is 500-600 mL/min.

Based on a relative bioavailability study, the AUC and Cmax of PRILOSEC (Oprezol magnesium) for Delayed-Release Oral Suspension were 87% and 88% of those for PRILOSEC Delayed-Release Capsules, respectively.

The bioavailability of Oprezol increases slightly upon repeated administration of PRILOSEC Delayed-Release Capsules.

PRILOSEC Delayed-Release Capsule 40 mg was bioequivalent when administered with and without applesauce. However, PRILOSEC Delayed-Release Capsule 20 mg was not bioequivalent when administered with and without applesauce. When administered with applesauce, a mean 25% reduction in Cmax was observed without a significant change in AUC for PRILOSEC Delayed-Release Capsule 20 mg. The clinical relevance of this finding is unknown.

The pharmacokinetics of Oprezol have been investigated in pediatric patients 2 to 16 years of age:

Table 3 : Pharmacokinetic Parameters of Oprezol Following Single and Repeated Oral Administration in Pediatric Populations Compared with Adults

Following comparable mg/kg doses of Oprezol, younger children (2 to 5 years of age) have lower AUCs than children 6 to 16 years of age or adults; AUCs of the latter two groups did not differ .

Summary

Oprezol, Oprezol/sodium bicarbonate (Prilosec, Zegerid, Prilosec OTC, Zegerid OTC) is a proton pump inhibitor drug (PPI) prescribed for the treatment of ulcers, gastroesophageal reflux disease (GERD), Zollinger-Ellison syndrome, duodenitis, erosive esophagitis, heartburn, and H. pylori infection. Side effects, drug interactions, warnings and precautions, and patient information should always be reviewed prior to taking any medication.

In patients with chronic renal impairment, whose creatinine clearance ranged between 10 and 62 mL/min/1.73 m², the disposition of Oprezol 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 Oprezol metabolites, their elimination slowed in proportion to the decreased creatinine clearance. No dose reduction is necessary in patients with renal impairment.

Oprezol 40 mg daily was given in combination with clarithromycin 500 mg every 8 hours to healthy adult male subjects. The steady state plasma concentrations of Oprezol were increased (Cmax , AUC0-24 , and T1/2 increases of 30%, 89% and 34% respectively) by the concomitant administration of clarithromycin. The observed increases in Oprezol plasma concentration were associated with the following pharmacological effects. The mean 24-hour gastric pH value was 5.2 when Oprezol was administered alone and 5.7 when co-administered with clarithromycin.

The plasma levels of clarithromycin and 14-hydroxy-clarithromycin were increased by the concomitant administration of Oprezol. For clarithromycin, the mean C max was 10% greater, the mean Cmin was 27% greater, and the mean AUC0-8 was 15% greater when clarithromycin was administered with Oprezol than when clarithromycin was administered alone. Similar results were seen for 14-hydroxy-clarithromycin, the mean Cmax was 45% greater, the mean C min was 57% greater, and the mean AUC0-8 was 45% greater. Clarithromycin concentrations in the gastric tissue and mucus were also increased by concomitant administration of Oprezol.

Table 2 : Clarithromycin Tissue Concentrations 2 hours after Dose 1

Q: Does Prilosec cause weight gain and severe night sweats? I have been on it for almost 2 months.

A: According to the package insert, the most common side effects reported in patients treated with Prilosec (Oprezol) were headache (6.9%), abdominal pain (5.2%), nausea (4.0%), diarrhea (3.7%), vomiting (3.2%), and gas (2.7%). Weight gain has been reported in clinical practice through voluntary reporting and surveillance systems. A review of medical literature found case reports of night sweats in patients with gastroesophageal reflux disease. The cause of the night sweats and effect of treatment is unknown. For more information, please consult with your health care provider and visit: //www.everydayhealth.com/drugs/prilosec. You are encouraged to report any negative side effects of prescription drugs to your health care practitioner and the U.S. Food and Drug Administration (FDA) by visiting www.fda.gov/medwatch, or by calling 1-800-FDA-1088. Michelle McDermott, PharmD

How should I take Oprezol?

Oprezol is usually taken before eating (at least 1 hour before a meal). Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Use Prilosec OTC (over-the-counter) exactly as directed on the label, or as prescribed by your doctor.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Shake the oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

If you cannot swallow a capsule whole, open it and sprinkle the medicine into a spoonful of applesauce. Swallow the mixture right away without chewing. Do not save it for later use.

You must dissolve Oprezol powder in a small amount of water. This mixture can either be swallowed or given through a nasogastric (NG) feeding tube using a catheter-tipped syringe.

Use this medicine for the full prescribed length of time, even if your symptoms quickly improve.

>OTC Oprezol should be taken for only 14 days in a row. It may take 1 to 4 days before your symptoms improve. Allow at least 4 months to pass before you start a new 14-day course of treatment.

Call your doctor if your symptoms do not improve, or if they get worse.

Some conditions are treated with a combination of Oprezol and antibiotics. Use all medications as directed.

Oprezol can affect the results of certain medical tests. Tell any doctor who treats you that you are using this medicine.

Store at room temperature away from moisture and heat.

On this page

  1. About Oprezol
  2. Key facts
  3. Who can and can't take Oprezol
  4. How and when to take it
  5. Side effects
  6. How to cope with side effects
  7. Pregnancy and breastfeeding
  8. Cautions with other medicines
  9. Common questions

Following single dose oral administration of a buffered solution of Oprezol, little if any unchanged drug was excreted in urine. The majority of the dose (about 77%) was eliminated in urine as at least six metabolites. Two were identified as hydroxyOprezol and the corresponding carboxylic acid. The remainder of the dose was recoverable in feces. This implies a significant biliary excretion of the metabolites of Oprezol. Three metabolites have been identified in plasma -the sulfide and sulfone derivatives of Oprezol, and hydroxyOprezol. These metabolites have very little or no antisecretory activity.

Interference With Antiretroviral Therapy

Concomitant use of atazanavir and nelfinavir with proton pump inhibitors is not recommended. Co-administration of atazanavir with proton pump inhibitors is expected to substantially decrease atazanavir plasma concentrations and may result in a loss of therapeutic effect and the development of drug resistance. Co-administration of saquinavir with proton pump inhibitors is expected to increase saquinavir concentrations, which may increase toxicity and require dose reduction.

Oprezol has been reported to interact with some antiretroviral drugs. The clinical importance and the mechanisms behind these interactions are not always known. Increased gastric pH during Oprezol treatment may change the absorption of the antiretroviral drug. Other possible interaction mechanisms are via CYP2C19.

Q: Does Prilosec OTC cause gas, bloating, and constipation?

A: Prilosec OTC (Oprezol) (//www.everydayhealth.com/drugs/prilosec) is in a class of medications called proton pump inhibitors used to treat heartburn and GERD. Prilosec may also be used short term to treat ulcers. (//www.everydayhealth.com/gerd/guide/) Common side effects associated with Prilosec include nausea and diarrhea, headache and stomach pain. A search of prescribing information did list gas and constipation as side effects of Prilosec OTC. This is not a complete list of the side effects associated with Prilosec OTC. Kimberly Hotz, PharmD

Q: I have read recently that Prilosec is not good to be taken on a regular basis. Is it safe to take occasionally? I know years ago there was a correlation between Prilosec and cancer. Now they are talking about it again.

A: Prilosec (Oprezol) is a proton pump inhibitor (PPI) used to treat ulcers, heartburn, and gastric reflux. Prilosec is now available over the counter. Patients who take Prilosec over the counter should not take it for longer than two weeks consistently without consulting their health care provider. This is due to the fact that if you have symptoms that last longer than two weeks, you may have a more serious condition that would need to be evaluated and treated by a physician. Long-term use of PPIs is generally considered safe under the direction of a doctor. There is some talk that long term use of PPI's could cause some problems, such as decreased immunity and osteoporosis, but this is yet to be proven. It is always best to avoid taking medication you do not need, but occasional use of Prilosec is likely to be safe, and long term use under the direction of a physician would also likely be safe for most patients. Please see the following Everyday Health link for more information on Prilosec. //www.everydayhealth.com/drugs/prilosec. Laura Cable, PharmD


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