Downoprazol 40/1680 mg 7 sachets

Downoprazol 40/1680 mg 7 sachets

Composition:

Each sachet contains Omeprazole 40 mg and Sodium Bicarbonate 1680 mg.
Excipients include aspartame, sodium carboxymethylcellulose, orange flavor, menthol flavor, and sucrose.

Product Description:

Downoprazole is a fixed-dose combination antiulcer medication containing omeprazole and sodium bicarbonate.
Omeprazole inhibits the gastric hydrogen-potassium ATPase enzyme ("proton pump") within the parietal cells of the stomach, blocking the final step of hydrochloric acid production and effectively reducing gastric acidity.
Sodium bicarbonate acts as an immediate antacid, rapidly neutralizing stomach acid and elevating intragastric pH; this protects omeprazole from acid-induced degradation, allowing rapid systemic absorption and prompt therapeutic onset.

Indications for Use:

• Acute and maintenance treatment of gastric and duodenal ulcers.
• Gastroesophageal reflux disease (GERD), including erosive esophagitis.
• Treatment and prevention of NSAID-induced gastric and duodenal erosions and ulcers.
• Management of acute stress-induced gastrointestinal mucosal lesions.
• Eradication of Helicobacter pylori in patients with peptic ulcer disease (as part of combination antibacterial therapy).
• Hypersecretory conditions, including Zollinger-Ellison syndrome.

Method of Administration and Dosage:

• The product is intended for oral administration once daily in the morning, 1 hour before a meal.
• Empty the contents of one sachet into a glass containing 20 ml of water, stir thoroughly, and drink the resulting suspension immediately. 
• Do not use liquids other than water.
• For adults over 18 years of age with acute gastric ulcer or erosive esophagitis, the recommended dosage is 20 to 40 mg daily for 4 to 8 weeks. 
• For Helicobacter pylori eradication, 20 mg once daily is administered for 7 days in combination with appropriate antibacterial agents. 
• For Zollinger-Ellison syndrome, the initial dosage is usually 60 mg daily, adjusted individually up to 80–120 mg daily (divided into two doses if exceeding 80 mg).

Contraindications:

• Pediatric patients under 18 years of age.
• Pregnancy.
• Breastfeeding (lactation) period.
• Known hypersensitivity to omeprazole, sodium bicarbonate, or any of the excipients in the formulation.

Precautions:

Caution should be exercised in patients with renal or hepatic impairment. In patients with severe hepatic impairment, the daily dose of omeprazole should not exceed 20 mg.
Prior to initiating therapy, gastric malignancy must be excluded, particularly in patients with gastric ulcers, as symptomatic relief under treatment may mask clinical manifestations and delay diagnosis.
Due to the high sodium bicarbonate content, total daily sodium intake must be monitored in patients adhering to a low-sodium diet.

Adverse Reactions / Side Effects:

• Gastrointestinal Disorders: diarrhea or constipation, nausea, vomiting, flatulence, abdominal pain, dry mouth, taste disturbances, stomatitis; in patients with pre-existing severe liver disease — hepatitis (with or without jaundice) and hepatic dysfunction.
• Nervous System Disorders: headache, dizziness, agitation, somnolence, insomnia, paresthesia, depression, hallucinations; in severely ill patients or those with liver failure — encephalopathy.
• Musculoskeletal and Connective Tissue Disorders: muscle weakness, myalgia, arthralgia.
• Blood and Lymphatic System Disorders: leukopenia, thrombocytopenia; rarely — agranulocytosis, pancytopenia.
• Skin and Subcutaneous Tissue Disorders: pruritus, rash; rarely — photosensitivity, erythema multiforme, alopecia.
• Immune System Disorders: urticaria, angioedema, bronchospasm, interstitial nephritis, anaphylactic shock.
• General and Other Disorders: visual disturbances, peripheral edema, hyperhidrosis, fever, gynecomastia; benign gastric glandular cysts during prolonged treatment (reversible consequence of sustained acid suppression).

Pregnancy and Lactation:

Downoprazole is strictly contraindicated during pregnancy and breastfeeding.
If treatment is required during the lactation period, breastfeeding must be discontinued.

Storage Conditions:

Store in a dry, dark place at a temperature not exceeding 30 °C.
Keep out of reach of children.

Packaging:

The cardboard box contains 7 sachets of 6 g each and a medical instruction insert.