PPI Capsule (Enteric Coated) 20 mg contains Omeprazole 20 mg. It is manufactured by The ACME Laboratories Ltd. in Bangladesh.  

Indications:

Omeprazole is a widely used medication that works by decreasing the amount of acid produced in the stomach. It is indicated for the treatment of various acid-related conditions, including: 

• Benign gastric and duodenal ulcers: Including those associated with Helicobacter pylori infection (often used in combination with antibiotics) and NSAID (Non-Steroidal Anti-inflammatory Drug)-associated ulcers. 
• Gastro-oesophageal Reflux Disease (GERD): This includes erosive esophagitis (inflammation and damage to the esophagus caused by acid reflux) and long-term management of healed reflux esophagitis. 
• Zollinger-Ellison Syndrome: A rare condition where the stomach produces excessive acid. 
• Prevention of acid aspiration syndrome: To reduce gastric acid during general anesthesia. 
• Acid-related dyspepsia: Indigestion characterized by symptoms like heartburn, belching, and sour stomach. 
• Heartburn: Especially frequent heartburn occurring 2 or more days a week. 

Pharmacology:

Omeprazole is a proton pump inhibitor (PPI). It acts by irreversibly blocking the H+/K+-ATPase (hydrogen-potassium-adenosine triphosphatase) enzyme system, often called the "proton pump," located in the parietal cells of the stomach. This pump is responsible for the final step in gastric acid secretion. By inhibiting this pump, Omeprazole significantly reduces both basal and stimulated gastric acid production, leading to a profound and long-lasting reduction in stomach acid. 

Dosage and Administration:

PPI Capsule (Omeprazole) should be taken orally before a meal, preferably in the morning. The capsule should be swallowed whole and not chewed, crushed, or opened, as this would compromise the enteric coating. 

Typical dosages for adults and adolescents (15 years and older) include: 

• Duodenal Ulcer: 20 mg once daily for 4 weeks; in severe or recurrent cases, can be increased to 40 mg daily. Maintenance for recurrent duodenal ulcer: 20 mg once daily. 
• Gastric Ulcer: 20 mg once daily for 8 weeks; in severe or recurrent cases, can be increased to 40 mg daily. 
• GERD/Reflux Esophagitis: 20 mg once daily for 4-8 weeks. For severe or refractory cases, 40 mg once daily has been given for 8 weeks. Maintenance therapy: 10-20 mg once daily. 
• Heartburn: 20 mg once daily for 14 days (for frequent heartburn, not for immediate relief). Can be repeated every 4 months if needed, but not for more than 14 days or more often than every 4 months unless directed by a doctor. 
• H. pylori Eradication: 20 mg twice daily, usually in combination with two antibiotics (e.g., Amoxicillin and Clarithromycin) for 7-14 days, as part of a triple therapy regimen. 
• Zollinger-Ellison Syndrome: Initially 60 mg once daily; dosage adjusted based on response, usually ranging from 20-120 mg daily (doses above 80 mg daily typically given in two divided doses). 

Use in Children: For children over 2 years with severe ulcerating reflux esophagitis, a dose of 0.7-1.4 mg/kg daily, up to a maximum of 40 mg daily, may be prescribed under strict medical supervision. 

Side Effects:

Omeprazole is generally well-tolerated. Most side effects are mild and transient. 

Common side effects (may affect up to 1 in 10 people):

• Headache 
• Abdominal pain, constipation, diarrhea, flatulence, nausea/vomiting 
• Benign stomach polyps (fundic gland polyps) 

Uncommon side effects (may affect up to 1 in 100 people):

• Dizziness, lightheadedness, somnolence (drowsiness), insomnia 
• Paresthesia (pins and needles sensation) 
• Vertigo (spinning sensation) 
• Increased liver enzymes 
• Dermatitis, pruritus (itching), rash, urticaria (hives) 
• Malaise, peripheral edema (swelling of ankles/feet) 
• Fractures of the hip, wrist, or spine (especially with long-term, high-dose use) 

Rare or very rare serious side effects (seek medical attention if experienced):

• Blood disorders (e.g., leukopenia, thrombocytopenia, agranulocytosis) 
• Hypersensitivity reactions (fever, angioedema, anaphylaxis) 
• Hyponatremia (low sodium levels), hypomagnesemia (low magnesium levels, especially with prolonged use, can lead to muscle spasms, irregular heartbeat, seizures) 
• Psychiatric disturbances (agitation, confusion, depression, aggression, hallucinations) 
• Blurred vision, taste disturbance 
• Bronchospasm 
• Hepatitis (with or without jaundice), hepatic failure 
• Severe skin reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) 
• Interstitial nephritis (kidney inflammation) 
• Myalgia (muscle pain), arthralgia (joint pain), muscular weakness 
• Gynecomastia (breast enlargement in men) 
• Clostridium difficile-associated diarrhea (severe, watery, bloody stools). 

Contraindications:

• Known hypersensitivity to Omeprazole, substituted benzimidazoles, or any component of the formulation. 
• Concomitant use with Nelfinavir or Atazanavir (antiretroviral drugs for HIV) due to significant reduction in their plasma concentrations. 

Precautions and Warnings:

• Malignancy Exclusion: Symptomatic response to Omeprazole does not rule out the presence of gastric malignancy. If gastric ulcer is suspected, the possibility of cancer should be excluded before starting treatment, as Omeprazole may mask symptoms and delay diagnosis. 
• Long-term Use: Prolonged use (over 1 year) may lead to an increased risk of bone fractures (hip, wrist, spine) and hypomagnesemia. Regular monitoring of magnesium levels may be necessary. It may also lead to vitamin B12 deficiency (with very long-term use). 
• Acute Interstitial Nephritis: Has been observed with PPIs; discontinue if suspected. 
• Clostridium difficile-associated diarrhea: PPIs may increase the risk of this infection. 
• Lupus Erythematosus: Cases of cutaneous and systemic lupus erythematosus have been reported; discontinue if symptoms occur. 
• Driving/Operating Machinery: Omeprazole may cause dizziness or visual disturbances, which could affect the ability to drive or operate machinery. 
• Children: Use in children should be under strict medical supervision. 

Pregnancy and Lactation:

• Pregnancy: While available data generally suggest no increased risk of major birth defects, Omeprazole should be used during pregnancy only if clearly needed and after careful consideration of risks and benefits by a physician. 
• Lactation: Omeprazole is excreted into breast milk. Caution should be exercised, and a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the mother. 

Drug Interactions:

Omeprazole is metabolized by CYP enzymes (primarily CYP2C19 and CYP3A4) and can affect the metabolism of other drugs. 

• Antiretrovirals (Nelfinavir, Atazanavir, Rilpivirine): Concurrent use is contraindicated due to reduced absorption of these drugs, leading to decreased efficacy. 
• Clopidogrel: Omeprazole may reduce the antiplatelet effect of clopidogrel by inhibiting its activation; concomitant use is generally discouraged. 
• Warfarin: Increased INR and prothrombin time with increased bleeding risk. Close monitoring is required. 
• Digoxin: Increased absorption of digoxin, potentially leading to toxicity. 
• Methotrexate: May increase and prolong serum concentrations of methotrexate and its metabolite, potentially leading to toxicity. Consider temporary withdrawal of Omeprazole during high-dose methotrexate administration. 
• Tacrolimus, Diazepam, Phenytoin, Cilostazol: Omeprazole can increase the systemic exposure of these drugs, potentially increasing their side effects. 
• CYP2C19 inhibitors/inducers: Drugs that inhibit (e.g., Citalopram, Voriconazole) or induce (e.g., Rifampicin, St. John's Wort) CYP2C19 may alter Omeprazole levels. 
• Drugs requiring gastric acidity for absorption: (e.g., Ketoconazole, Itraconazole, Posaconazole, Erlotinib) - Omeprazole reduces gastric acidity, which can decrease the absorption and efficacy of these drugs. 

Storage Conditions:

Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children. 

Note: This information is for general knowledge and informational purposes only and does not substitute professional medical advice. Always consult your doctor or pharmacist for specific instructions and guidance regarding your medication.