Downoprazol 20/1100 mg 14 capsules

Downoprazol 20/1100 mg 14 capsules

Composition:
Each capsule contains:
- Omeprazole 20 mg
- Sodium bicarbonate 1100 mg.
Excipients:
Croscarmellose sodium, magnesium stearate, titanium dioxide, gelatin, methyl paraben, propyl paraben, Brilliant Blue (for 20 mg only).
Description:
Downoprazol is a combined anti-ulcer and anti-reflux medicine that contains omeprazole, a proton pump inhibitor (PPI), and sodium bicarbonate, an antacid.
It works by reducing the production of stomach acid and neutralizing excess gastric acidity, which helps relieve symptoms such as heartburn, acid reflux, and stomach pain and promotes the healing of gastric and duodenal ulcers.
Omeprazole acts by blocking the acid-producing enzyme (H+/K+-ATPase) in the stomach lining, while sodium bicarbonate protects omeprazole from acid destruction and provides rapid relief by neutralizing existing acid.
The medicine provides quick symptom relief and long-lasting protection against excessive stomach acid and acid-related damage to the stomach and esophagus.
Indications for Use:
Downoprazol is indicated for the treatment of the following conditions:
- Duodenal ulcer: short-term treatment (4 weeks; may extend to 8 weeks if needed).
- Gastric ulcer: short-term treatment (4-8 weeks) of active benign gastric ulcer.
- Gastroesophageal reflux disease (GERD):
Symptomatic GERD (heartburn and related symptoms) - up to 4 weeks.
Erosive esophagitis - short-term treatment for 4-8 weeks.
- Maintenance of healing of erosive esophagitis: to prevent recurrence (controlled studies up to 12 months).
Dosage and Method of Administration:
For oral use.
Capsules should be swallowed whole with water, on an empty stomach at least one hour before meals.
- Duodenal ulcer: 20 mg once daily for 4 weeks.
- Gastric ulcer: 40 mg once daily for 4-8 weeks.
- Symptomatic GERD: 20 mg once daily for up to 4 weeks.
- Erosive esophagitis: 20 mg once daily for 4-8 weeks.
- Maintenance of healing: 20 mg once daily.
Do not take two 20 mg capsules instead of one 40 mg capsule, as both contain the same sodium bicarbonate content (1100 mg).
Contraindications:
- Hypersensitivity to omeprazole, sodium bicarbonate, or any excipient.
- History of hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, bronchospasm).
Precautions:
- Gastric malignancy: symptomatic response does not exclude malignancy; further evaluation may be required.
- Acute interstitial nephritis: discontinue treatment if suspected.
- Sodium content: each capsule contains 304 mg sodium; use with caution in patients on sodium-restricted diets, or with Bartter’s syndrome, hypokalemia, or metabolic alkalosis.
- Difficile-associated diarrhea: possible with long-term PPI use.
- Bone fracture: prolonged use (>1 year) may increase risk of osteoporosis-related fractures.
- Subacute cutaneous lupus erythematosus (SCLE): discontinue if lesions occur.
- Hypomagnesemia: monitor during long-term therapy or concomitant use with diuretics or digoxin.
- Vitamin B12 deficiency: possible with prolonged acid suppression (>3 years).
- Interactions: avoid concomitant use with clopidogrel, St. John’s Wort, rifampin, and high-dose methotrexate.
- Elderly: no dose adjustment needed, but bioavailability may increase.
Side Effects:
Common adverse effects (≥1%):
- Gastrointestinal: diarrhea, constipation, abdominal pain, nausea, vomiting, flatulence.
- Nervous system: headache, dizziness, somnolence.
General:
Fatigue, back pain, rash.
Less common or rare effects:
- Hepatic: elevated liver enzymes, hepatitis (rare).
- Skin: rash, pruritus, urticaria, alopecia, photosensitivity, rare severe reactions (TEN, Stevens–Johnson syndrome).
- Musculoskeletal: myalgia, arthralgia, fractures.
- Hematologic: anemia, leukopenia, thrombocytopenia (rare).
- Renal: interstitial nephritis, elevated creatinine.
- Metabolic: hypomagnesemia, hyponatremia, hypocalcemia.
- Psychiatric: agitation, confusion, depression, hallucinations (rare).
Pregnancy and Breastfeeding:
- Pregnancy: Category C - use only if potential benefit justifies potential risk.
- Breastfeeding: Omeprazole is excreted in breast milk; use with caution or discontinue nursing.
Storage Conditions:
Store at a temperature not exceeding 30°C in a dry place.
Keep out of reach of children.
Packaging:
Carton box containing strip of 14 hard gelatin capsules with an insert leaflet.