Prazo20 mg

Prazo is a proton pump inhibitor (PPI) approved and guideline-supported for the following uses:

Established / FDA-approved uses

• Treatment of gastroesophageal reflux disease (GERD), including erosive esophagitis
• Maintenance of healing of erosive esophagitis
• Treatment of active duodenal ulcer
• Treatment of active benign gastric ulcer
• Treatment and reduction of risk of NSAID-associated gastric ulcer
• Treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome

Combination-therapy use

• Helicobacter pylori eradication to reduce the risk of duodenal ulcer recurrence, used together with antibiotics (e.g. clarithromycin and amoxicillin) as part of standard triple or quadruple therapy regimens — Prazo alone does not eradicate H. pylori

Over-the-counter use

• Short-term relief of frequent heartburn (occurring 2 or more days per week) in adults, as a self-directed 14-day treatment course

Each capsule/tablet of Omeprazole Magnesium contains omeprazole as the magnesium salt, delayed-release (enteric-coated), commonly available in strengths equivalent to omeprazole 10 mg, 20 mg, or 40 mg. The enteric coating protects the acid-labile omeprazole from degradation by gastric acid until it reaches the small intestine for absorption.

Prazo is the magnesium salt formulation of omeprazole, a substituted benzimidazole that belongs to the proton pump inhibitor (PPI) class of gastric acid-suppressing agents. It is a prodrug that is activated within the acidic environment of the gastric parietal cell to irreversibly inhibit acid secretion.

Prazo is used to treat conditions caused or worsened by excess stomach acid, including gastroesophageal reflux disease, peptic ulcer disease, and (in combination with antibiotics) Helicobacter pylori infection.

Prazo belongs to the Proton Pump Inhibitor (PPI) therapeutic class of anti-secretory, acid-suppressing agents.

Omeprazole Magnesium is a prodrug that, after absorption, diffuses into the acidic canaliculi of gastric parietal cells where it is protonated and converted to its active sulfenamide form. This active form covalently and irreversibly binds to the hydrogen-potassium ATPase (H+/K+-ATPase, the "proton pump") on the parietal cell surface, blocking the final common step of gastric acid secretion.

Because the inhibition is irreversible, acid secretion resumes only after new proton pump molecules are synthesized, giving Omeprazole Magnesium a duration of acid suppression that outlasts its plasma half-life. Onset of significant acid suppression typically occurs within 1 hour, with maximal effect after several days of once-daily dosing.

Prazo delayed-release capsules or tablets should be swallowed whole with water, ideally at least 1 hour before a meal (commonly before breakfast). Do not crush or chew the capsule/tablet, as this destroys the delayed-release (enteric) coating that protects the drug from stomach acid.

For patients who have difficulty swallowing capsules, the contents of some formulations may be sprinkled on a small amount of soft food (such as applesauce) and swallowed immediately without chewing, per product-specific instructions — confirm with a pharmacist or physician before doing so.

Prazo has the following clinically significant drug interactions:

• Clopidogrel: Prazo inhibits CYP2C19, the enzyme that converts clopidogrel to its active metabolite, reducing clopidogrel's antiplatelet effect. Concomitant use should generally be avoided; if acid suppression is needed, an alternative agent with less CYP2C19 inhibition may be considered.
• Rilpivirine-containing products: Contraindicated (see Contraindications).
• Methotrexate: With high-dose methotrexate regimens, Prazo may elevate and prolong methotrexate (and its metabolite) blood levels, increasing toxicity risk. Temporary discontinuation of Prazo may be considered during high-dose methotrexate therapy.
• Warfarin: Prazo may potentiate the anticoagulant effect; monitor INR more closely when starting or stopping therapy.
• pH-dependent absorption drugs: By raising gastric pH, Prazo can reduce absorption of drugs requiring an acidic environment, such as ketoconazole, itraconazole, and atazanavir, and can increase absorption of others such as digoxin.
• CYP2C19/CYP3A4 interactions: Strong inducers (e.g. rifampin, St. John's Wort) can reduce omeprazole levels; strong inhibitors (e.g. voriconazole) can increase them.

Common side effects of Prazo include:

• Headache
• Abdominal pain
• Nausea and vomiting
• Diarrhea
• Flatulence

Less common but clinically important effects associated with long-term use of Prazo and other PPIs include:

• Increased risk of bone fracture of the hip, wrist, or spine, particularly with high-dose or long-duration (≥1 year) use
• Hypomagnesemia, which can be severe and may require magnesium supplementation or discontinuation of therapy
• Vitamin B12 deficiency with prolonged use (typically ≥3 years)
• Increased risk of Clostridioides difficile-associated diarrhea
• Rare acute interstitial nephritis, which can occur at any point during therapy
• Fundic gland polyps with long-term use

Prazo should be used during pregnancy only if clearly needed and if the potential benefit justifies the potential risk to the fetus; a physician should be consulted before use. Among available data on PPIs in pregnancy, omeprazole is among the more extensively studied agents, but this does not constitute a guarantee of safety, and use should still be individualized under medical supervision.

Omeprazole is excreted in breast milk in small amounts. Prazo should be used during breastfeeding only after consulting a physician, weighing the benefits of treatment against any potential risk to the nursing infant.

The following precautions apply to Prazo:

• Bone fracture risk: Long-term and high-dose use is associated with an increased risk of hip, wrist, and spine fractures; use the lowest effective dose for the shortest duration appropriate to the condition.
• Hypomagnesemia: May occur, especially after 3 months to 1 year of therapy; can be severe and, rarely, symptomatic (tetany, arrhythmia, seizures). Consider monitoring magnesium levels in patients on prolonged therapy or on concomitant medications that also lower magnesium (e.g. diuretics, digoxin).
• Vitamin B12 deficiency: May occur with prolonged use due to reduced absorption; monitor in patients on long-term therapy.
• Clostridioides difficile-associated diarrhea: PPI use, including Prazo, is associated with increased risk; consider this diagnosis in patients who develop persistent diarrhea.
• Masking of gastric malignancy: Symptomatic response to Prazo does not exclude gastric malignancy; consider further evaluation in patients with alarm symptoms (e.g. weight loss, recurrent vomiting, dysphagia, hematemesis) or those not responding adequately.
• Acute interstitial nephritis: Has been reported at any time during therapy; discontinue if it occurs.
• Cutaneous and systemic lupus erythematosus: New onset or exacerbation has been rarely reported with PPI use.

Reported symptoms of Prazo overdose include confusion, drowsiness, blurred vision, tachycardia, nausea, diaphoresis, flushing, headache, dry mouth, and other mild-to-moderate symptoms; serious toxicity is uncommon. There is no specific antidote.

In case of suspected overdose, seek immediate medical attention or contact a poison control center. Treatment should be supportive and symptomatic; hemodialysis is not effective for enhancing elimination given the drug's high protein binding.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children.

Pediatric use: Prazo is approved for treatment of GERD and erosive esophagitis in children 1 year of age and older, and for short-term treatment (up to 6 weeks) in children 2–16 years, using weight-based dosing. Safety and efficacy in children under 1 year of age have not been established.

Elderly: No dosage adjustment is generally required based on age alone; elderly patients may be at higher relative risk of the long-term effects described under Precautions (e.g. fracture, hypomagnesemia).

Hepatic impairment: Because omeprazole is extensively metabolized by the liver, dose reduction (e.g. to a maximum of 20 mg daily) should be considered in patients with severe hepatic impairment.

Renal impairment: No dosage adjustment is generally required, as omeprazole is not significantly renally eliminated.

Duration of treatment with Prazo depends on the indication: typically 4 weeks for GERD without esophagitis, 4–8 weeks for erosive esophagitis or gastric ulcer, up to 4 weeks for duodenal ulcer, 10–14 days for H. pylori eradication regimens, and longer-term or indefinite maintenance therapy for hypersecretory conditions or recurrent erosive esophagitis, as directed by a physician. OTC self-treatment courses are limited to 14 days, repeatable every 4 months if needed.

Proton Pump Inhibitor (PPI); substituted benzimidazole class of gastric acid-suppressing agents.

Omeprazole Magnesium acts as a prodrug activated in the acidic environment of gastric parietal cells, where it irreversibly binds and inhibits the H+/K+-ATPase proton pump, the final step in gastric acid secretion, resulting in profound and long-lasting suppression of both basal and stimulated gastric acid output.

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Prazo is approved for the treatment of GERD and erosive esophagitis in pediatric patients 1 year of age and older, dosed by body weight. It is also approved for short-term (up to 6 weeks) treatment of GERD symptoms in children 2 to 16 years of age.

Safety and efficacy of Prazo have not been established in children younger than 1 year of age, and it is not approved for OTC use in children under 18 years.