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FEATURED PRODUCTS : ESOMEPRAZOLE FOR INJECTION 40 MG

ESOSAN

Esomeprazole for Injection 40 mg (Lyophilised Injection)

DESCRIPTION:

Esomeprazole is the S-isomer of omeprazole and reduces gastric acid secretion through a specific targeted mechanism of action. It is a specific inhibitor of the acid pump in the parietal cell. Both the R- and S-isomer of omeprazole have similar pharmacodynamic activity.

MECHANISM OF ACTION:

Esomeprazole is a weak base and is concentrated and converted to the active form in the highly acidic environment of the secretory canaliculi of the parietal cell, where it inhibits the enzyme H+K+-ATPase C the acid pump and inhibits both basal and stimulated acid secretion.

INDICATIONS:

Short-term (4-8 weeks) treatment of erosive esophagitis; maintaining symptom resolution and healing of erosive esophagitis; treatment of symptomatic gastroesophageal reflux disease; as part of a multidrug regimen for Helicobacter pylori eradication in patients with duodenal ulcer disease (active or history of within the past 5 years); prevention of gastric ulcers associated with continuous NSAID therapy.

DOSAGE AND ADMINISTRATION:

The recommended adult dose of Esomeprazole I.V is either 20 or 40 mg given once daily by intravenous injection (no less than 3 minutes) or intravenous infusion (10 to 30 minutes). Esomeprazole I.V. should not be administered concomitantly with any other medications through the same intravenous site and or tubing. The intravenous line should always be flushed with either 0.9% Sodium Chloride Injection, USP, Lactated Ringer Injection, USP or 5% Dextrose Injection, USP both prior to and after administration of Esomeprazole I.V. for Injection.

Recommended Esomeprazole Dosage Schedule:

IndicationDoseFrequency
Gastroesophageal 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 Gastroesophageal Reflux Disease20 mgOnce Daily for 4 Weeks***
Pediatric GERD
12 to 17 Year Olds
Short-term Treatment of GERD20 mg or 40 mgOnce Daily for up to 8 Weeks
1 to 11 Year Olds+
Short-term Treatment of Symptomatic GERD10 mgOnce Daily for up to 8 Weeks
Healing of Erosive Esophagitis
weight < 20 kg10 mgOnce Daily for 8 Weeks
weight ≥ 20 kg10 mg or 20 mgOnce Daily for 8 Weeks
Risk Reduction of NSAID-Associated Gastric Ulcer20 mg or 40 mgOnce Daily for up to 6 months **
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
Triple Therapy:
Esomerazole For Injection
40 mgOnce Daily for 10 Days
Amoxicillin1000 mgTwice Daily for 10 Days
Clarithromycin500 mgTwice Daily for 10 Days
Pathological Hypersecretory Conditions Including Zollinger - Ellison Syndrome40 mgtTwice Daily


General Information:
  • Do not use Esomeprazole if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • If you also take an imidazole antifungal (eg, ketoconazole), take it at least 2 hours before using Esomeprazole.
  • Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
  • Esomeprazole should only be used for a short time (up to 10 days), until you are able to take medicine by mouth. Discuss any questions or concerns with your doctor.
  • Continue to use Esomeprazole even if you feel well. Do not miss any doses.
  • If you miss a dose of Esomeprazole, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
DIRECTION FOR RECONSTITUTION:

A solution for intravenous infusion is prepared by first reconstituting the contents of one vial with 5 mL of 0.9% Sodium Chloride Injection, USP, Lactated Ringer's Dextrose Injection, USP and further diluting the resulting solution to a final volume of 50 mL. The solution (admixture) should be administered as an intravenous infusion over a period of 10 to 30 minutes.

The admixture should be stored at room temperature up to 30(86) and should be administered within the designated time period as listed in the Table below. No refrigeration is required.

DiluentAdminister within:
0.9% Sodium Chloride Injection, USP12 hours
Lactated Ringer's Injection, USP12 hours
5% Dextrose Injection, USP6 hours


Adverse Effects:
  • Common Side effects: Constipation; diarrhea; dry mouth; gas; headache; nausea; pain, swelling, or redness at the injection site; stomach pain.
  • Severe Side effects: Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); chest pain; fast heartbeat; fever, chills, or sore throat; red, swollen, blistered, or peeling skin; unusual bruising or bleeding; unusual tiredness. Seek medical attention right away if any of these SEVERE side effects occur
Contraindications: Esomeprazole for Injection is contra indicated in patients with known hypersensitivity to the formulation.

Presentation: Esomeprazole for Injection (40mg) Lyophilised, is available as 10 ml Vial.


Important: The drug information on this Web page is meant to be educational. It is not a substitute for medical advice. Please see your health care professional for more information about your specific medical condition and the use of the above mentioned drug.
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