Product Name

Esante
20 & 40mg Capsules
Composition
Each Capsule Contains: Esomeprazole 20, 40mg


Pack
14's


INDICATION & USAGE
Esomeprazole is indicated for treatment of conditions where a reduction of gastric acid secretion is required such as: reflux esophagitis, maintenance treatment of patients with reflux esophagitis, symptomatic gastroesophageal reflux disease (i.e. heartburn and regurgitation), and H. pylori eradication.
Esomeprazole, in combination with clarithromycin and amoxicillin, is indicated for the treatment of patients with duodenal ulcer disease associated with Helicobacter pylori infection to eradicate the H. pylori and heal ulcers.

DOSAGE AND ADMINISTRATION

The capsule should be swallowed whole with sufficient water. The pellets must not be chewed or crushed.
Treatment of conditions where a reduction of gastric acid secretion is required are;
Reflux Esophagitis

The recommended adult dose in patients with reflux esophagitis is 40 mg Esomeprazole once daily for 4 to 8 weeks in order to optimize the healing rate and symptom resolution. Healing occurs in the majority of patients within 4 weeks. Sustained freedom from symptoms is achieved rapidly for most patients. An additional 4 weeks of treatment is recommended for patients in whom esophagitis has not healed or who have persistent symptoms.


Maintenance of Healing of Erosive Esophagitis
For the long-term treatment of patients whose reflux esophagitis has been healed with acid suppression therapy, the recommended adult dose is 20 mg Esomeprazole once daily. Controlled studies do not extend beyond 6 months.

Symptomatic Gastroesophageal Reflux Disease

In patients with heartburn and/or acid regurgitation, without esophagitis, the recommended adult dose is 20 mg Esomeprazole once daily for 2 to 4 weeks.
Helicobacter pylori Eradication
In patients with H. pylori-associated active duodenal ulcer the recommended dose is Esomeprazole 20 mg, amoxicillin 1000 mg and clarithromycin 500 mg, all twice daily for seven days.
In patients with a history of duodenal ulcer
The recommended dose is Esomeprazole 20 mg, amoxicillin 1000 mg and clarithromycin 500 mg, all twice daily for seven days. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.

CONTRAINDICATIONS
Hypersensitivity to esomeprazole, substituted benzimidazoles or any of the components of this medication.

WARNINGS & PRECAUTIONS
Use in Pregnancy
The safety of Esomeprazole in pregnancy has not been established. Esomeprazole capsules should not be administered to pregnant women unless the expected benefits outweigh the potential risks.
Nursing Mothers
It has not been investigated whether or not esomeprazole is excreted in human breast milk. No studies in lactating women have been performed. Therefore, Esomeprazole capsules should not be given to nursing mothers unless its use is considered essential.
Patients with Hepatic Insufficiency
Dose adjustment is not required in patients with mild to moderate liver impairment.
Patients with Renal Insufficiency
Esomeprazole is extensively protein-bound and is, therefore, not expected to be readily dialyzable. Dose adjustment is not required in patients with impaired renal function.

DRUG INTERACTIONS
Esomeprazole is metabolized by the cytochrome P-450 system (CYP), mainly in the liver, through CYP 2C19 and CYP 3A4. There are no clinically significant interactions between Esomeprazole and diazepam, phenytoin, warfarin, quinidine or cisapride.

OVERDOSAGE
No information is available on the effects of higher doses in man, and specific recommendations for treatment cannot be given. Esomeprazole is extensively protein-bound and is therefore not readily dialyzable. Treatment should be symptomatic and general supportive measures should be utilized.

STORAGE
Store at room temperature. Protect from heat, light and moisture. Keep all medicines out of the reach of children.

PRESENTATION
Esante 20mg capsules… Blister of 2x7’s
Esante 40mg capsules… Blister of 2x7’s

 
 
 
 
 
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