Seclotil 20 mg (Capsule (Enteric Coated))

Indications

• Treatment of gastric and duodenal ulcer
• NSAID-associated duodenal and gastric ulcer
• Prophylaxis in patients with a history of NSAID-associated duodenal and gastric ulcer
• Gastro-esophageal reflux disease
• Long-term management of acid reflux disease
• Severe ulcerating reflux esophagitis
• Prophylaxis of acid aspiration during general anesthesia
• Zollinger-Ellison syndrome
• Helicobacter pylori-induced peptic ulcer

Pharmacology

• Inhibitor of gastric acid secretion
• Blocks hydrogen-potassium-adenosine triphosphatase (H+/K+ ATPase) enzyme system
• Onset of antisecretory effect within one hour
• Maximum effect within two hours
• Inhibition of secretion lasts up to 72 hours

Dosage

• 20 mg once daily for benign gastric and duodenal ulcer
• 40 mg daily for severe or recurrent cases
• 10-20 mg daily for prevention of relapse in duodenal ulcer
• 20 mg once daily for NSAID-associated duodenal or gastric ulcer
• 20 mg once daily for 4 weeks, continued if not fully healed
• 40 mg once daily for gastro-esophageal reflux disease refractory to other treatment
• 20-40 mg once daily for severe ulcerating reflux esophagitis
• 20 mg twice daily for Helicobacter pylori eradication regimen in peptic ulcer disease
• 10-20 mg daily for long-term management of acid reflux disease

Administration

• IV injection for prophylaxis of acid aspiration
• IV infusion over a period of 20-30 minutes
• Reconstitution of the injection and infusion
• Use within specific time frames after reconstitution

Interaction

• Decreased intragastric acidity affecting absorption of ketoconazole
• Metabolism through cytochrome P450 affecting elimination of certain medications
• Plasma concentration increase during concomitant administration with clarithromycin
• No evidence of interaction with numerous other drugs

Contraindications

• Known hypersensitivity to Omeprazole
• Suspicion of gastric ulcer without excluding the possibility of malignancy

Side Effects

• Mild and reversible adverse reactions
• Skin rash, urticaria, and pruritus
• Photosensitivity, bullous eruption, and erythema multiforme
• Diarrhea and headache
• Gastrointestinal reactions such as constipation, nausea, vomiting, and abdominal pain
• Dizziness, somnolence, and insomnia
• Mental confusion, agitation, and depression

Pregnancy & Lactation

• No adverse effects of Omeprazole on pregnancy or fetus/newborn child observed in studies
• Use during pregnancy considered safe
• No information available on passage into breast milk or effects on the neonate
• Discontinuation of breastfeeding if essential use of Omeprazole

Precautions & Warnings

• Avoid concomitant use of clopidogrel
• Increased risk for osteoporosis-related fractures
• Occasional atrophic gastritis noted in long-term treatment
• Potential for methotrexate toxicities during concomitant use with PPIs

Therapeutic Class

Proton Pump Inhibitor

Storage Conditions

Keep in a dry place away from light and heat

Related Brands

• Omimak 20 mg (Capsule (Enteric Coated)) - maks-drug-limited
• Seclogen 40 mg (Capsule (Enteric Coated)) - biogen-pharmaceuticals-ltd
• Seclotil 40 mg (Capsule (Enteric Coated)) - pristine-pharmaceuticals-ltd