Norma 20

Description

Norma 20 Capsule: Uses, Dosage, and Side Effects

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

Key Information

• Generic Name: Omeprazole
• Strength: $20\text{mg}$
• Manufacturer: Deurali Janta Pharmaceuticals Pvt. Ltd.
• Pack Size: $225$ capsules
• Retail Price: $4.00\text{ NPR}$ (per capsule)

Indications

Norma 20 Capsule is prescribed for:

• Peptic Ulcers: Sores in 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 excessive stomach acid production due to tumors.
• 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.

Dosa

Adults (Oral):

• Peptic Ulcer: $20\text{mg}$ or $40\text{mg}$ per day for $4$ weeks (duodenal ulcer) or $8$ weeks (gastric ulcer) in severe cases.
  • 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 needed.
  • Refractory Oesophagitis: $40\text{mg}$ per day.
  • Maintenance: $20\text{mg}$ per day (after healing oesophagitis); $10\text{mg}$ per day (for 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 given in $2$ divided doses.
• Prophylaxis of Acid Aspiration (during general anesthesia): $40\text{mg}$ 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):

• GERD; 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 over $60\text{mg}$ 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: Take on an empty stomach, at least $1$ hour before meals. Swallow whole; do not chew or crush. If swallowing is difficult, 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: Take 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.

Contraindications

Do not use Norma 20 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 before starting treatment 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 fractures (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.

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.