Proceptin 40

Indications

Proceptin is used for the treatment of:

• Gastric and Duodenal Ulcers: Effective for both types of ulcers and associated conditions.
• NSAID-Associated Ulcers: Prophylaxis and treatment for ulcers linked to NSAID use.
• Gastro-esophageal Reflux Disease (GERD): Long-term management of acid reflux.
• Acid-Related Dyspepsia: Relief from acid-induced digestive discomfort.
• Severe Ulcerating Reflux Esophagitis: Management of severe cases.
• Acid Aspiration Prophylaxis: Prevention during general anesthesia.
• Zollinger-Ellison Syndrome: Control of excessive stomach acid production.
• Helicobacter Pylori-Induced Peptic Ulcers: Part of eradication therapy for H. pylori infections.

Pharmacology

Proceptin contains Omeprazole, a substituted benzimidazole that inhibits gastric acid secretion. It works by blocking the H+/K+ ATPase enzyme system in the stomach’s parietal cells, leading to reduced acid production. Its effects begin within one hour of administration, peak in about two hours, and can last up to 72 hours. Acid secretion gradually resumes within 3 to 5 days after discontinuation.

Dosage

Oral Administration:

• Gastric and Duodenal Ulcers: 20 mg daily for 4-8 weeks; increase to 40 mg if severe or recurrent.
• NSAID-Associated Ulcers: 20 mg daily for up to 8 weeks; also used for prophylaxis.
• GERD: 20 mg daily for 4-8 weeks; 40 mg if resistant.
• Acid-Related Dyspepsia: 10-20 mg daily for 2-4 weeks.
• Prophylaxis of Acid Aspiration: 40 mg the evening before surgery and 40 mg before surgery.
• Zollinger-Ellison Syndrome: 60 mg daily, with adjustments as needed.
• H. pylori Eradication: 20 mg twice daily with specific antibiotics.

IV Injection:

• Acid Aspiration Prophylaxis: 40 mg IV one hour before surgery.
• Ulcers and Esophagitis: 40 mg IV daily if oral administration is not feasible.
• Zollinger-Ellison Syndrome: Initial 60 mg IV daily, with possible higher doses.

Administration

• IV Injection: Reconstitute powder with 10 ml water; administer slowly over 2-5 minutes.
• IV Infusion: Dissolve in 100 ml saline or 5% dextrose; administer over 20-30 minutes.

Interaction

Proceptin may reduce the absorption of ketoconazole and delay the elimination of drugs like diazepam and warfarin. Monitoring and dose adjustments may be required. There are no significant interactions with other common medications or food.

Contraindications

Contraindicated in patients with known hypersensitivity to Omeprazole. Malignancy should be ruled out in suspected gastric ulcers before starting treatment.

Side Effects

Generally well-tolerated, with mild and reversible reactions such as skin rash, headache, and gastrointestinal discomfort. Rare effects include serious conditions like liver damage or anaphylaxis.

Pregnancy & Lactation

• Pregnancy: Omeprazole is considered safe during pregnancy based on studies.
• Lactation: No specific data on breast milk; caution advised.

Use in Children & Adolescents

Safety and efficacy in children under 18 years have not been established.

Precautions & Warnings

Avoid using Proceptin with clopidogrel, as it may reduce clopidogrel’s effectiveness. Long-term use may increase fracture risk and lead to atrophic gastritis.

Therapeutic Class

Proton Pump Inhibitor

Storage Conditions

Store in a dry, cool place away from light and heat. Keep out of reach of children.