Omfil

Description

Omfil Capsule: Uses, Dosage, and Side Effects

Omfil Capsule ($20\text{mg}$ Omeprazole) is a proton pump inhibitor (PPI) manufactured by Fourrts India Laboratories Pvt Ltd. It’s available in Nepal and is used to reduce stomach acid and treat various related conditions.

Key Information

• Generic Name: Omeprazole
• Strength: $20\text{mg}$
• Manufacturer: Fourrts India Laboratories Pvt Ltd
• Pack Size: $100$ capsules
• Retail Price: $7.12\text{ NPR}$ (per capsule)

Indications

Omfil Capsule is prescribed for:

• Peptic Ulcer: Sores that develop on the lining of the esophagus, stomach, or small intestine.
• H. pylori Infection: A bacterial infection that can cause stomach ulcers.
• Gastro-oesophageal Reflux Disease (GERD): Chronic acid reflux that irritates the food pipe.
• Zollinger-Ellison Syndrome: A rare condition causing tumors that release large amounts of gastrin, leading to excess stomach acid.
• Oesophagitis: Inflammation of the esophagus.
• Acid-related Dyspepsia: Indigestion caused by excess stomach acid.
• NSAID-associated Ulceration: Ulcers caused by the use of non-steroidal anti-inflammatory drugs.

Dosage

Adults (Oral):

• Peptic Ulcer: $20\text{mg}$ or $40\text{mg}$ per day in severe cases for $4$ weeks (duodenal ulcer) or $8$ weeks (gastric ulcer).
  • Maintenance: $10\text{–}20\text{mg}$ per day.
  • All doses are taken once in the morning.
• NSAID-associated Ulceration: $20\text{mg}$ once in the morning.
• Gastro-oesophageal Reflux Disease (GERD): $20\text{mg}$ per day for $4$ weeks; may continue for another $4\text{–}8$ weeks if necessary.
  • Refractory Oesophagitis: $40\text{mg}$ per day.
  • Maintenance: $20\text{mg}$ per day (after healing of oesophagitis); $10\text{mg}$ per day (acid reflux).
  • All doses are taken once in the morning.
• Zollinger-Ellison Syndrome: Initially, $60\text{mg}$ once in the morning, adjust as required. Dose Range: $20\text{–}120\text{mg}$ per day. Doses exceeding $80\text{mg}$ are administered in $2$ divided doses.
• Prophylaxis of Acid Aspiration (during general anaesthesia): $40\text{mg}$ given in the evening and another $40\text{mg}$ $2\text{–}6$ hours pre-operation.
• Acid-related Dyspepsia: $10\text{mg}$ or $20\text{mg}$ once in the morning for $2\text{–}4$ weeks.
• Erosive Oesophagitis: $20\text{mg}$ per day for $4\text{–}8$ weeks.
  • Maintenance of Healing: $20\text{mg}$ per day for up to $12$ months.
  • All doses are taken once in the morning.
• H. pylori Infection:
  • Triple Therapy ($7$ or $10$ days): $20\text{mg}$ twice daily OR $40\text{mg}$ once daily combined with specific antibiotic regimens (e.g., amoxicillin $500\text{mg}$ and metronidazole $400\text{mg}$ both three times daily; or clarithromycin $250\text{mg}$ and metronidazole $400\text{mg}$ (or tinidazole $500\text{mg}$) both twice daily; or amoxicillin $1\text{g}$ and clarithromycin $500\text{mg}$ both twice daily).
  • $2$-week Dual Therapy: $20\text{mg}$ twice daily OR $40\text{mg}$ per day combined with either amoxicillin $750\text{mg}$ to $1\text{g}$ twice daily or with clarithromycin $500\text{mg}$ three times daily.

Adults (Intravenous):

• Gastro-oesophageal Reflux Disease; Gastric and Duodenal Ulcers; NSAID-associated Ulceration: $40\text{mg}$ once daily infused over $20\text{–}30$ minutes or slow injection over $5$ minutes until oral administration is possible.
• Zollinger-Ellison Syndrome: Initially, $60\text{mg}$ per day, adjust according to response. Daily doses exceeding $60\text{mg}$ per day should be given in $2$ divided doses.

Elderly: No dosage adjustment is typically needed.

Hepatic Impairment: $10\text{–}20\text{mg}$ per day.

Children (Oral):

• GERD:
  • $>1$ year:
    • $5\text{–}10\text{kg}$: $5\text{mg}$ orally once daily
    • $10\text{–}20\text{kg}$: $10\text{mg}$ orally once daily
    • $>20\text{kg}$: $20\text{mg}$ orally once daily
• Erosive Esophagitis:
  • $1$ month to $<1$ year:
    • $3$ to $<5\text{kg}$: $2.5\text{mg}$ once daily
    • $5$ to $<10\text{kg}$: $5\text{mg}$ once daily
    • $>10\text{kg}$: $10\text{mg}$ once daily (May treat for up to $6$ weeks)
  • $1\text{–}16$ years:
    • $5$ to $<10\text{kg}$: $5\text{mg}$ orally once daily
    • $10$ to $<20\text{kg}$: $10\text{mg}$ orally once daily
    • $>20\text{kg}$: $20\text{mg}$ orally once daily (May treat for $4\text{–}8$ weeks)
• Safety and efficacy have not been established for children under $1$ year for GERD or under $1$ month for erosive esophagitis.

Renal Impairment: No dosage adjustment is typically needed.

Administration

• Delayed-release capsules: Should be taken on an empty stomach, at least $1$ hour before meals. Swallow whole; do not chew or crush. For patients with difficulty swallowing, the capsule may be carefully opened, and its entire contents sprinkled into a spoonful of applesauce. Swallow this mixture without chewing immediately after preparation. Do not store the drug/food mixture for later use.
• Powder for oral suspension: Should be taken on an empty stomach, at least $1$ hour before a meal.
• MUPS tablets: May be taken with or without food.
• Capsules (general): Should be taken with food, immediately before a meal.

Contraindica

Do not use Omfil Capsule if you have a known hypersensitivity (allergy) to omeprazole or any of its components.

Precautions

• Gastric malignancy (stomach cancer) should be ruled out before initiating treatment.
• Use with caution during pregnancy and lactation.
• Not recommended for children under $1$ year.
• Monitor magnesium concentrations prior to initiation and periodically thereafter.
• Omeprazole distributes into human breast milk; use caution if breastfeeding.

Interactions

• Increased risk of hypomagnesaemia with diuretics.
• May increase INR and prothrombin time with warfarin.
• Increased risk of digoxin-induced cardiotoxic effects.
• May increase plasma concentration of benzodiazepines (e.g., diazepam), clarithromycin, and methotrexate.
• Decreased absorption of itraconazole, ketoconazole, posaconazole, dasatinib, and iron salts.
• May prolong elimination of diazepam, cilostazol, phenytoin, and ciclosporin.
• May reduce the antiplatelet effect of clopidogrel.
• Potentially Fatal: May decrease plasma concentrations and pharmacological effects of rilpivirine, nelfinavir, and atazanavir.

Side Effects

Common side effects (occurring in $1\text{–}10\%$ of patients) include:

• Headache ($7\%$), abdominal pain ($5\%$), diarrhea ($4\%$), nausea ($4\%$), vomiting ($3\%$), flatulence ($3\%$), dizziness ($2\%$), upper respiratory infection ($2\%$), acid regurgitation ($2\%$), constipation ($2\%$), rash ($2\%$), cough ($1\%$).

Less common or rare side effects (frequency not defined) include:

• Bone fracture (including hip fracture), osteoporosis-related issues, hepatotoxicity (rare), agranulocytosis, anorexia, gastric polyps, alopecia (hair loss), atrophic gastritis, interstitial nephritis (rare), pancreatitis (rare), rhabdomyolysis, taste perversion, abnormal dreams, and toxic epidermal necrolysis (rare).

Potentially Fatal: Anaphylaxis (severe allergic reaction).

Mechanism of Action

Omeprazole is a proton pump inhibitor (PPI). It blocks the final step in gastric acid secretion by specifically inhibiting the H+/K+ ATPase enzyme system, which is located on the secretory surface of the gastric parietal cell. This action effectively inhibits both basal (resting) and stimulated acid production in the stomach.

Important Note

The information provided here is for general knowledge and informational purposes only and should not be considered medical advice or a substitute for professional medical judgment. Always consult with a qualified healthcare professional for any health concerns or before making any decisions related to your health or treatment.