Esomep 20mg

Tablet
Esomeprazole
ACI Pharmaceuticals

Other Strength:

Alternative:
- Opton 20mg
- MAXIMA 20mg
- Maxima MUPS 20mg
- Nexum 20mg
- Sergel 20mg
- Progut 20mg
- Esopra 20mg
- Emep 20mg
- Esoz 20mg
- Esoben 20mg
- Esoben MUPS 20mg
- Esonix 20mg
- Nexum MUPS 20mg
- Maxpro 20mg
- Maxpro MUPS 20mg



Esomep
Description
Esomep®is a preparation of Esomeprazolewhich is the S-isomer of Omeprazole, a proton pump inhibitor, weak base in nature and is concentrated and converted to the active form in the highly acidic environment of the intracellular canaliculi within the parietal cell, where it inhibits the enzyme H+/K+-ATPase, the acid pump. This effect on the final step of the gastric acid formation process is dose-dependent and provides for highly effective inhibition of both basaland stimulated acid secretion, irrespective of the stimulus.

Indications
Esomep®is indicated for:
Treatmentof gastroesophageal reflux disease (GERD)-Healing of erosive esophagitis -Maintenance of healing of erosive esophagitis-Symptomatictreatment ofgastroesophageal reflux disease (GERD)
Risk reduction of NSAID-associated gastric ulcer-Healing of gastric ulcers associated with NSAID therapy-Prevention of gastric and duodenal ulcers associated with NSAID
H. pylorieradication to reduce the risk of duodenal ulcer recurrence-Healing of H. pyloriassociated duodenal ulcer-Prevention of relapse of pepticulcers in patient with H.pyloriassociated Pathologicalhypersecretory conditions including Zollinger-Ellison Syndrome

Dosage and administration
Esomep®tabletandcapsule

The recommended adult dosages outlinedin the tablebelow. Esomep®tabletandcapsuleshould be taken one hour before meal.
IndicationDoseFrequencyGastroesophageal reflux disease (GERD)-Healing of erosive esophagitis20 mg or 40 mgOnce daily for 4 to 8 weeks*-Maintenance of healing of erosive esophagitis20 mgOnce daily**-Symptomatic treatment of gastroesophageal reflux disease (GERD)20 mgOnce daily for 4 weeks***Risk reduction of NSAID-associated gastric ulcer20 mg or 40mgOnce daily for up to 6 months**H. pylorieradication to reduce the risk of duodenal ulcer recurrence(triple therapy)-Esomep®40 mgOnce daily for 10 days-Amoxicillin1000 mg Twice daily for 10 days-Clarithromycin500 mg Twice daily for 10 daysPathological hypersecretory conditions including Zollinger-Ellison Syndrome40 mg Twice dailyPediatric GERDDoseFrequency-12 to 17 year olds (Short term treatment of GRED)20 mg or 40 mg Once daily for up to 8weeks-1 to 11 year olds+(weight ≥ 20 kg) (Healing of Erosive Esophagitis)10 mg or 20 mg Once daily for up to 8 weeks
The majority of patients are healed within 4 to 8 weeks. For patients who do not heal after 4-8 weeks, an additional 4-8 weeks of treatment may be considered.** Controlled studies did not extend beyond six months.***If symptoms do not resolve completely after 4 weeks, an additional 4 weeks of treatment may be considered. + Doses over 1 mg/kg/day have not been studied.
Esomep®IV injection for GERD patients with Erosive Esophagitis (EE)AdultDoseAdministration timeOver 18 years20 mg or 40 mg IV injection: > 3 minutes IV infusion: 10-30 minutesPediatric patients (1 years to 17 years)DoseAdministration time-Body weight less than 55 kg10 mgIV infusion over 10-30 minutes-Body weight 55 kg or greater20 mgIV infusion over 10-30 minutesPediatric patients (1 month to less than 1 year of age)0.5 mg/kgIV infusion over 10-30 minutes

Direction for use of intravenous injection
Solution for injection should beprepared by adding 5ml0.9%w/wSodium ChlorideBPinto the vial containing thepowder. The reconstituted solution for injection is clear and colorless to very slightly yellow. The reconstituted solution should be given as an intravenous injection over a period of at least 3 minutes. Half of the IV injection should be used when 20mg isto be administrated. Use only freshly prepared solution. The reconstituted solution should be stored at room temperature (below 30°C)and should be administered within 12 hours after reconstitution. No refrigeration is required

Esomep®IV injection for GERD patients with Erosive Esophagitis (EE)AdultDoseAdministration timeOver 18 years20 mg or 40 mg IV injection: > 3 minutes IV infusion: 10-30 minutesPediatric patients (1 years to 17 years)DoseAdministration time-Body weight less than 55 kg10 mgIV infusion over 10-30 minutes-Body weight 55 kg or greater20 mgIV infusion over 10-30 minutesPediatric patients (1 month to less than 1 year of age)0.5 mg/kgIV infusion over 10-30 minutesDirection for use of intravenousinjectionSolution for injection should beprepared by adding 5ml0.9%w/wSodium ChlorideBPinto the vial containing thepowder. The reconstituted solution for injection is clear and colorless to very slightly yellow. The reconstituted solution should be given as an intravenous injection over a period of at least 3 minutes. Half of the IV injection should be used when 20mg isto be administrated. Use only freshly prepared solution. The reconstituted solution should be stored at room temperature (below 30°C)and should be administered within 12 hours after reconstitution. No refrigeration is required.Patientswith impaired hepatic function: No dosage adjustment is necessary in patients with mild to moderate liver impairment. For
patients with severe liver impairment a dose of 20 mg of Esomep® should not be exceeded.
Patients with renal impairment: No dose adjustment is necessary in patients with impaired renal function.

Use in pregnancy & lactation
Pregnancy category B. Animal studies have revealed no teratogenic effects. No sufficient clinical data is available on exposed pregnancies for Esomeprazole. So, caution should be exercised when prescribing to pregnant women.It is not known whether Esomeprazole is excreted in human breast milk. Therefore Esomeprazole should not be used during breast-feeding.

Precautions
Symptomatic response to therapy with Esomeprazoledoes not preclude the presence of gastric malignancy. When gastric ulcer is suspected or present, malignancy should be excluded, as treatment with Esomeprazole may alleviate symptoms and delay diagnosis.When prescribing Esomeprazolefor eradication of H.pyloripossible drug interactions for all components in the triple therapy should be considered.

Side effects
The most commonly reported side effects were nausea, vomiting, abdominal pain, flatulence, diarrhoea, constipationand headache. Less frequent side-effects include dry mouth, peripheral edema, dizziness, sleep disturbances, fatigue, paraesthesia, arthralgia, myalgia, rash,and pruritus. Other side-effects reported rarely or very rarely include taste disturbance, stomatitis, hepatitis, jaundice, hypersensitivity reactions (including anaphylaxis, bronchospasm), fever, depression, hallucinations, confusion, gynaecomastia, interstitial nephritis, hyponatraemia, blood disorders (including leucopenia, leucocytosis, pancytopenia, thrombocytopenia), visual disturbances, sweating, photosensitivity, alopecia, Stevens-Johnson syndrome, and toxic epidermal necrolysis.

Contraindications
Esomeprazole is contraindicated in patients with known hypersensitivity to any component of the formulation or to substituted benzimidazoles.

Overdosage
There is very limited experience to date with deliberate overdose. The symptoms described in connection with 280mg were gastrointestinal symptomsand weakness. Single doses of 80 mg Esomeprazolewere uneventful. No specific antidote is known. Esomeprazole is extensively plasma protein bound and is therefore not readily dialyzable. As in any case of overdose, treatment should be symptomatic and general supportive measures should be utilized.

Drug interactions
Esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g., ketoconazole, ironsalts and digoxin). Coadministration of atazanavir with Esomeprazole is expected to substantially decrease atazanavir plasmaconcentrations and thereby reduce its therapeuticeffect. Esomeprazole inhibits CYP2C19, the major Esomeprazolemetabolising enzyme. Thus, when Esomeprazoleis combined with drugs metabolised by CYP2C19, such as diazepam, citalopram, imipramine, clomipramine, phenytoin etc., the plasma concentrations of these drugs may be increased and a dose reduction could be needed.

Pharmaceutical PrecautionsEsomep®capsule and tablet: Store in a cool &dry place. Protect from light.Esomep® IVinjection: Store in a cool (below 30°C)& dry place. Protect from light.

Presentation
Esomep®20mgtablet: Each enteric coated tablet contains Esomeprazole 20mg as Magnesium Trihydrate USP.Esomep®40mgtablet: Each enteric coatedtablet contains Esomeprazole 40mg as Magnesium Trihydrate USP.Esomep®20 mg capsule: Each capsule contains Esomeprazole 20 mg as Magnesium Trihydrate USPin enteric coated pellets.Esomep®40 mg capsule: Each capsule contains Esomeprazole 40 mg as Magnesium Trihydrate USPin enteric coated pellets.Esomep® 40mg lyophilized powder for injection:Each vial contains Esomeprazole 40mgas Sodium INN.

Package quantities
Esomep®20mg tablet: Cartons of 50tabletsin blister.Esomep®40mg tablet: Cartons of 30 tablets in blister.Esomep®20 mg capsule: Cartons of 50 capsules in blister.Esomep®40mg capsule: Cartons of 40 capsules in blister.Esomep®40mgIV Injection: Cartoncontaining1 vial of 40mg lyophilized Esomeprazole, 1 ampoule of 5ml Salinor® (0.9% w/vSodium Chloride BP)as diluent.

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