Cosec

Description

Indications: Cosec is indicated for the treatment of the following conditions:

• Gastric and duodenal ulcers
• NSAID-associated gastric and duodenal ulcers
• Prophylaxis for patients with a history of NSAID-associated ulcers
• Gastro-esophageal reflux disease (GERD)
• Long-term management of acid reflux disease
• Acid-related dyspepsia
• Severe ulcerating reflux esophagitis
• Prophylaxis against acid aspiration during general anesthesia
• Zollinger-Ellison syndrome
• Helicobacter pylori-induced peptic ulcers

Use as directed by a registered medical professional.

Pharmacology: Omeprazole, a substituted benzimidazole, acts as a potent inhibitor of gastric acid secretion. It works by blocking the hydrogen-potassium-adenosine triphosphatase (H+/K+ ATPase) enzyme system in the gastric parietal cells, thereby reducing gastric acid production. Following oral administration, the antisecretory effect begins within one hour, with peak efficacy occurring within two hours. The inhibition of acid secretion can last up to 72 hours. After discontinuation, secretory activity gradually returns within 3 to 5 days.

Dosage:

Oral Administration:

• Benign Gastric and Duodenal Ulcer:

  • 20 mg once daily for 4 weeks for duodenal ulcers, 8 weeks for gastric ulcers.
  • In severe or recurrent cases, increase the dose to 40 mg daily.
  • For recurrent duodenal ulcers, a maintenance dose of 20 mg daily is recommended.
  • To prevent relapse of duodenal ulcers, 10-20 mg daily may be prescribed.

• NSAID-Associated Gastric or Duodenal Ulcer:

  • 20 mg once daily for 4 weeks, and continue for another 4 weeks if not fully healed.
  • 20 mg once daily as prophylaxis for patients with a history of NSAID-related ulcers.

• Gastro-esophageal Reflux Disease (GERD):

  • 20 mg once daily for 4 weeks, and if not fully healed, extend for another 4-8 weeks.
  • 40 mg once daily for 8 weeks in cases of GERD refractory to other treatments.
  • Maintenance dose: 20 mg once daily.

• Long-term Acid Reflux Management:

  • 10-20 mg daily.

• Acid-Related Dyspepsia:

  • 10-20 mg once daily for 2-4 weeks.

• Prophylaxis of Acid Aspiration during Surgery:

  • 40 mg on the evening prior to surgery, and then 40 mg 2-6 hours before surgery.

• Zollinger-Ellison Syndrome:

  • Initially, 60 mg once daily. The usual dose range is 20-120 mg daily. If the daily dose exceeds 80 mg, split into two doses.

• Helicobacter pylori Eradication Regimen (Peptic Ulcer Disease):

  • Omeprazole 20 mg twice daily, combined with the following antibiotics for one week:
    • Amoxicillin 500 mg and Metronidazole 400 mg, both taken three times a day, OR
    • Clarithromycin 250 mg and Metronidazole 400 mg, both taken twice a day, OR
    • Amoxicillin 1 g and Clarithromycin 500 mg, both taken twice a day.

• Pediatric Use (Severe Ulcerating Reflux Esophagitis, Children >1 year):

  • For children weighing 10-20 kg, administer 10-20 mg once daily for 4-12 weeks.
  • For children over 20 kg, administer 20-40 mg once daily for 4-12 weeks.

IV Injection:

• Prophylaxis of Acid Aspiration:

  • 40 mg administered slowly over 5 minutes, one hour before surgery.

• Duodenal Ulcer, Gastric Ulcer, or Reflux Esophagitis:

  • 40 mg once daily via IV for patients unable to take oral medication.

• Zollinger-Ellison Syndrome:

  • Start with 60 mg once daily intravenously. Higher doses may be required and should be administered in divided doses if exceeding 60 mg daily.

Administration Instructions for IV Injection:

• Reconstitute Omeprazole lyophilized powder with 10 ml of water for injection.
• Administer as a slow intravenous injection over a period of 2 to 5 minutes at a maximum rate of 4 ml/minute.
• Use freshly prepared solution and administer within 4 hours of reconstitution.

Administration Instructions for IV Infusion:

• Reconstitute Omeprazole powder with 100 ml saline or 5% dextrose for infusion.
• Infuse over 20-30 minutes or more.
• The solution should be used within 12 hours when dissolved in saline and within 6 hours when dissolved in 5% dextrose.
• Do not mix or co-administer with any other drugs in the same infusion set.

Use as directed by a registered medical professional.

Interactions:

• Cosec may reduce the absorption of ketoconazole and other medications that require an acidic environment.
• Since Cosec is metabolized by the liver via the cytochrome P450 system, it can delay the elimination of drugs like diazepam, phenytoin, and warfarin. Monitoring of these drugs may be necessary.
• Co-administration with Cosec and clarithromycin increases plasma levels of both drugs, which is useful during H. pylori eradication therapy.
• Alcohol and food do not affect Cosec absorption.
• Cosec does not interact with piroxicam, diclofenac, naproxen, or other listed medications.

Contraindications:

• Omeprazole is contraindicated in patients with known hypersensitivity to it.
• In cases of suspected gastric ulcers, malignancy must be ruled out before initiating treatment, as omeprazole can alleviate symptoms and delay diagnosis.

Side Effects: Cosec is generally well tolerated, and adverse effects are typically mild and reversible. Common side effects include:

• Skin rash, urticaria, and pruritus
• Photosensitivity, erythema multiforme, angioedema, and alopecia (in rare cases)
• Diarrhea, headache, abdominal pain, constipation, nausea/vomiting
• Dry mouth, stomatitis, candidiasis, paraesthesia
• Dizziness, somnolence, insomnia, and vertigo
• Reversible mental confusion, agitation, and hallucinations in severely ill patients
• Arthritic and myalgic symptoms

In rare cases, more severe effects may occur, such as blurred vision, taste disturbance, peripheral edema, increased sweating, and hepatic issues.

Pregnancy & Lactation: Omeprazole appears to have no adverse effects during pregnancy based on three prospective studies, and it can be used during pregnancy. However, there is insufficient data on its excretion in breast milk, so breastfeeding should be discontinued if omeprazole is necessary.

Use in Children & Adolescents: The safety and effectiveness of Omeprazole in children under 18 years have not been established.

Precautions & Warnings:

• Avoid concurrent use of clopidogrel with Cosec as it reduces the pharmacological activity of clopidogrel.
• Long-term use of PPIs like Cosec may be linked to an increased risk of osteoporosis-related fractures.
• Caution is advised when using Cosec alongside methotrexate, as it may increase methotrexate toxicity.

Therapeutic Class: Proton Pump Inhibitor

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