Downoprazol 40/1100 mg 14 capsules

Downoprazol 40/1100 mg 14 capsules

Composition:
Active ingredients:
- Omeprazole - 20 mg or 40 mg (depending on strength)
- Sodium bicarbonate - 1100 mg per capsule.
Excipients:
Croscarmellose sodium, Magnesium stearate, Titanium dioxide, Gelatin, Methyl paraben, Propyl paraben.
Description:
DOWNOPRAZOL contains omeprazole combined with sodium bicarbonate and is used to suppress gastric acid secretion.
It reduces the production of stomach acid, relieves symptoms of acid-related conditions, and promotes healing of gastric and esophageal damage.
It is indicated for the treatment and maintenance of healing of erosive esophagitis, for therapy of duodenal ulcer and benign gastric ulcer, and for relief of symptoms of gastroesophageal reflux disease (GERD).
Indications for Use:
- Duodenal Ulcer
- Gastric Ulcer
- Gastroesophageal Reflux Disease (GERD)
- Maintenance of Healing of Erosive Esophagitis.
Dosage and Method of Administration:
- Take on an empty stomach, at least 1 hour before a meal.
Key dosing regimens:
- Duodenal ulcer: 20 mg once daily for 4 weeks.
- Benign gastric ulcer: 40 mg once daily for 4-8 weeks.
- Symptomatic GERD (no erosions): 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.
- Important: two 20 mg units are not interchangeable with one 40 mg unit due to differing sodium bicarbonate content.
- Capsules: swallow intact with water; do not use other liquids; do not open and sprinkle contents.
Contraindications:
- Hypersensitivity to any components of the formulation, including anaphylaxis, angioedema, bronchospasm, urticaria, acute interstitial nephritis.
Precautions:
- Presence of gastric malignancy may be masked by symptomatic response.
- Acute interstitial nephritis - discontinue if develops.
- Buffer/sodium content - consider in sodium-restricted diets; caution in Bartter’s syndrome, electrolyte disturbances; risk of milk-alkali syndrome with long-term bicarbonate+calcium; chronic sodium bicarbonate can cause systemic alkalosis, edema, weight gain.
- Clostridium difficile-associated diarrhea risk.
- Bone fracture risk with long-term, high-dose PPI therapy.
- Subacute cutaneous lupus erythematosus (SCLE) - rare cases.
- Interaction with clopidogrel - avoid concomitant use.
- Vitamin B12 (cyanocobalamin) malabsorption with prolonged acid suppression.
- Hypomagnesemia with prolonged therapy.
- Interactions with St. John’s wort and rifampin (CYP inducers) - avoid concomitant use.
- Interference with chromogranin A testing.
- Interaction with methotrexate (high dose) - may increase methotrexate levels.
- Fundic gland polyps with long-term use.
Side Effects:
All adverse reactions are reproduced exactly as listed, including:
- Headache
- Diarrhea
- Abdominal pain
- Nausea/vomiting
- Constipation
- Rash
- Dizziness
- Many organ-system-specific reactions
Additional reactions include hematologic, cardiac, gastrointestinal, hepatic, infectious, metabolic, musculoskeletal, neurologic/psychiatric, respiratory, dermatologic (including severe reactions such as TEN, SJS), and special senses (tinnitus, taste disturbances).
Pregnancy and Breastfeeding:
Pregnancy (Category C):
No adequate well-controlled studies; use only if potential benefit justifies potential fetal risk.
Nursing mothers: Omeprazole is excreted in human milk (<7% of peak serum concentration in milk); a decision should be made to discontinue nursing or discontinue the drug, considering the importance to the mother. Sodium bicarbonate should be used with caution in nursing mothers.
Storage Conditions:
Store at a temperature not exceeding 30°C in a dry place.
Keep out of reach of children.
Packaging:
Carton box containing one strip of 14 capsules and insert leaflet.