Omez FF

Description

Omez FF Capsule, containing Omeprazole, is a medication used to treat various conditions caused by excessive stomach acid. As a Proton Pump Inhibitor (PPI), it effectively reduces the amount of acid your stomach produces. Omez FF is manufactured by Dr. Reddy’s Laboratories and is available in Nepal.

What Omez FF Capsule Treats

Omez FF is prescribed for a range of acid-related problems in your digestive system, including:

• Peptic Ulcers: This covers ulcers found in the small intestine (duodenal ulcer) and the stomach (gastric ulcer).
• H. pylori Infection: It’s used as part of a combination therapy to eliminate Helicobacter pylori, a common bacteria that can lead to ulcers.
• Gastro-oesophageal Reflux Disease (GERD): Often called acid reflux, this condition causes symptoms like heartburn and regurgitation.
• Zollinger-Ellison Syndrome: A rare condition where the stomach produces abnormally high levels of acid.
• Oesophagitis: Inflammation of the esophagus, frequently caused by acid reflux, including more severe forms like erosive oesophagitis.
• Acid-related Dyspepsia: General discomfort, pain, or indigestion in your upper abdomen due to stomach acid.
• NSAID-associated Ulceration: Ulcers that develop as a side effect of taking non-steroidal anti-inflammatory drugs (NSAIDs).
• Prophylaxis of Acid Aspiration: It’s used before general anesthesia to prevent stomach acid from entering the lungs.

Dosage Guidelines

Omez FF (Omeprazole) can be taken orally (by mouth) or, in some cases, administered intravenously (into a vein) in clinical settings.

Oral Dosing for Adults:

• Peptic Ulcer:
  • Typically 20 mg daily, or 40 mg daily for severe cases.
  • Treatment usually lasts 4 weeks for duodenal ulcers and 8 weeks for gastric ulcers.
  • For long-term prevention (maintenance), the dose is usually 10-20 mg daily.
  • All doses should be taken once in the morning.
• NSAID-associated Ulceration: 20 mg once in the morning.
• Gastro-oesophageal Reflux Disease (GERD):
  • 20 mg daily for 4 weeks; can be extended for another 4-8 weeks if necessary.
  • For severe or unresponsive oesophagitis (refractory oesophagitis): 40 mg daily.
  • Maintenance after healing: 20 mg daily for oesophagitis; 10 mg daily for acid reflux.
  • All doses should be taken once in the morning.
• Zollinger-Ellison Syndrome:
  • Initial dose is 60 mg once in the morning, adjusted based on your response.
  • The typical daily dose range is 20-120 mg.
  • If your daily dose is more than 80 mg, it should be given in two divided doses.
• Prophylaxis of Acid Aspiration (before general anesthesia): 40 mg given in the evening and another 40 mg 2-6 hours pre-op.
• Acid-related Dyspepsia: 10 or 20 mg once in the morning for 2-4 weeks.
• Erosive Oesophagitis:
  • 20 mg daily for 4-8 weeks.
  • Maintenance to prevent recurrence: 20 mg daily for up to 12 months.
  • All doses should be taken once in the morning.
• H. pylori Infection (always combined with antibiotics):
  • Triple Therapy (for 7 or 10 days):
    • 20 mg twice daily (bid) OR 40 mg once daily.
    • Combined with: Amoxicillin (500 mg) and Metronidazole (400 mg) (both taken three times daily, tid), OR Clarithromycin (250 mg) and Metronidazole (400 mg or Tinidazole 500 mg) (both taken twice daily, bid), OR Amoxicillin (1 g) and Clarithromycin (500 mg) (both taken twice daily, bid).
  • Dual Therapy (for 2 weeks):
    • 20 mg twice daily (bid) OR 40 mg once daily.
    • Combined with: Amoxicillin (750 mg to 1 g) twice daily (bid), OR Clarithromycin (500 mg) three times daily (tid).

Intravenous (IV) Dosing for Adults:

• Gastro-oesophageal Reflux Disease; Gastric and Duodenal Ulcers; NSAID-associated Ulceration: 40 mg once daily, typically infused over 20-30 minutes or given as a slow injection over 5 minutes. This method is used until oral medication can be resumed.
• Zollinger-Ellison Syndrome: Initial dose is 60 mg daily, adjusted based on your body’s response. If the total daily dose is greater than 60 mg, it should be given in two divided doses.

Dosing for Children (Oral):

• GERD:
  • Under 1 year: Safety and effectiveness haven’t been established.
  • 1 year and older:
    • 5-10 kg: 5 mg once daily.
    • 10-20 kg: 10 mg once daily.
    • Over 20 kg: 20 mg once daily.
• Erosive Oesophagitis (treatment and maintenance):
  • Under 1 month: Safety and effectiveness haven’t been established.
  • 1 month to under 1 year:
    • 3 to less than 5 kg: 2.5 mg once daily.
    • 5 to less than 10 kg: 5 mg once daily.
    • Over 10 kg: 10 mg once daily.
    • May be treated for up to 6 weeks.
  • 1-16 years:
    • 5 to less than 10 kg: 5 mg once daily.
    • 10 to less than 20 kg: 10 mg once daily.
    • Over 20 kg: 20 mg once daily.
    • May be treated for 4-8 weeks.

Dosing Adjustments for Specific Conditions:

• Elderly: No dosage adjustment is usually needed.
• Hepatic Impairment (liver problems): A lower dose of 10-20 mg daily is typically recommended.
• Renal Impairment (kidney problems): No dosage adjustment is typically needed.

How to Take Omez FF Capsule (Administration)

The way you take Omez FF depends on its specific formulation:

• 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 & its entire contents sprinkled in a spoonful of applesauce. Swallow the drug/food mixture without chewing immediately after preparation. The drug/food mixture should not be stored for future use.
• Powder for Oral Suspension (if applicable):
  • Should be taken on an empty stomach, at least 1 hour before a meal.
• MUPS (Multiple Unit Pellet System) Tablets (if applicable):
  • May be taken with or without food.
• Standard Capsules (if applicable):
  • Should be taken with food. Take immediately before a meal.

Important Warnings and Precautions

• Do not use Omez FF if you have a known hypersensitivity (severe allergic reaction) to omeprazole or any of its ingredients.
• Your doctor should rule out serious conditions like stomach cancer (gastric malignancy) before you start treatment, as some symptoms can be similar.
• Pregnancy and Lactation: Omeprazole distributes into human breast milk; use caution if you are pregnant, planning to become pregnant, or breastfeeding. Always consult your doctor.
• Children: Safety and effectiveness are not established for children under 1 year for GERD, and under 1 month for erosive oesophagitis.
• Monitoring: Your doctor might monitor your magnesium concentrations prior to initiation and periodically thereafter, especially with long-term use or if you are taking diuretics.

Potential Drug Interactions

Omez FF can interact with other medications, potentially affecting their efficacy or increasing side effects. It’s crucial to inform your doctor about all medications you’re taking, including over-the-counter drugs, supplements, and herbal remedies.

Key interactions include:

• Diuretics: Increased risk of low magnesium levels (hypomagnesaemia).
• Warfarin: May increase INR and prothrombin time, potentially raising bleeding risk.
• Digoxin: Increased risk of digoxin-induced cardiotoxic effects.
• Certain Benzodiazepines (e.g., diazepam), Clarithromycin, Methotrexate: May increase their plasma concentrations.
• Itraconazole, Ketoconazole, Posaconazole, Dasatinib, Iron Salts: Decreased absorption of these medications.
• Diazepam, Cilostazol, Phenytoin, Ciclosporin: May prolong their elimination from your body.
• Clopidogrel: May reduce the antiplatelet effect of clopidogrel.
• Potentially Fatal: May decrease plasma concentrations and pharmacological effects of certain HIV medications (e.g., rilpivirine, nelfinavir, atazanavir).

Possible Side Effects

While generally well-tolerated, Omeprazole can cause side effects. Common ones (occurring in 1-10% of users) 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 but serious side effects (frequency not defined) can include:

• Fracture of bone, osteoporosis-related
• Hepatotoxicity (rare liver damage)
• Agranulocytosis (severe decrease in white blood cells)
• Anorexia (loss of appetite)
• Gastric polyps
• Hip fracture
• Alopecia (hair loss)
• Atrophic gastritis (inflammation of stomach lining)
• Interstitial nephritis (rare kidney inflammation)
• Pancreatitis (rare inflammation of the pancreas)
• Rhabdomyolysis (muscle breakdown)
• Taste perversion (altered taste)
• Abnormal dreams
• Toxic epidermal necrolysis (rare severe skin reaction)

Potentially Fatal Side Effect:

• Anaphylaxis: A severe, life-threatening allergic reaction. Seek immediate medical attention if you experience symptoms like sudden swelling, difficulty breathing, or severe rash.

Important Note: This information about Omez FF Capsule is for general knowledge only and should not replace professional medical advice. Always consult a qualified healthcare professional for any health concerns, diagnosis, or treatment decisions.