Esomac-D 40 mg Capsule 10s

Side Effects of Esomac-D 40 mg Capsule 10s

Increased risk of Clostridium difficile-associated diarrhoea (CDAD) and osteoporosis-related fracture. Headache, rash, pruritus, dizziness, fatigue, cough, back or abdominal pain, arthralgia and myalgia, urticaria, dry mouth, photosensitivity, bullous eruption, fever, angioedema, bronchospasm, somnolence, aggression and vertigo, insomnia, reversible confusional states, depression, agitation, hallucination. Increased liver enzyme, hepatitis, jaundice, hepatic encephalopathy. Rarely, candidiasis, paraesthesia, alopecia, muscular weakness, angina, tachycardia, bradycardia, blurred vision, alopecia, stomatitis, increased sweating, taste disturbances, peripheral oedema, malaise, hyponatraemia, hypomagnesaemia, blood disorders (e.g. agranulocytosis, leucopenia and thrombocytopenia), gynaecomastia, impotence and interstitial nephritis. Potentially Fatal: Anaphylaxis, Stevens-Johnson syndrome and toxic epidermal necrolysis.

Drug Interactions

Increased risk of digoxin-induced cardiotoxic effects. Increased risk of hypomagnesaemia w/ diuretics. May increase INR and prothrombin time w/ warfarin. May increase serum concentration of tacrolimus, saquinavir, methotrexate. May interfere the elimination of drugs metabolised by CYP2C19 (e.g. diazepam). May decrease the bioavailability of ketoconazole, erlotinib and Fe salts. Potentially Fatal: May decrease serum concentration and pharmacological effects of rilpivirine, atazanavir and nelfinavir. May decrease the antiplatelet effects of clopidogrel.

Contraindications

Concomitant use w/ rilpivirine, atazanavir, nelfinavir and clopidogrel.

Mechanism of Action

Esomeprazole is a PPI that suppresses gastric acid secretion by inhibiting H+/K+ ATPase in the gastric parietal cell. It is the S-isomer of omeprazole. Onset: W/in 1 hr. Absorption: Rapidly absorbed (oral). Absorption is delayed and reduced w/ food. Bioavailability: Approx 90% on repeated doses. Timt to peak plasma concentration: 1-2 hr. Distribution: Volume of distribution: 16 L. Plasma protein binding: Approx 97%. Metabolism: Extensive hepatic metabolism, via CYP2C19 isoenzyme to form hydroxy and, desmethyl metabolites, and the remainder via CYP3A4 isoenzyme to form esomeprazole sulfone. Excretion: Mainly via urine (approx 80%), the remainder in the faeces. Plasma elimination half-life: Approx 1.3 hr.

Special Precautions

Gastric malignancy should be ruled out. Severe hepatic impairment. Pregnancy and lactation. Monitoring Parameters Monitor Mg levels prior to initiation and periodically during prolonged use.

How to Use

Take orally with food and water, as directed by your physician.

How to Store

Keep in a cool, dry place away from sunlight and moisture.

Safety Concerns

• Alcohol: Avoid during treatment.
• Breastfeeding: Not recommended.
• Pregnancy: Contraindicated.
• Liver/Kidney: Use with caution.

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