NEXIUM Infusion
Esomeprazole Sodium Injection
40mg
ASTRAZENECA AB
| Pack size | 10 Vials (Dry) |
|---|---|
| Dispensing mode | POM |
| Source | SWEDEN |
| Agent | Modern Pharmaceutical Co. |
| Retail Price | 372.00 AED |
Indications
NEXIUM Infusion is used for:
Heartburn, Acid Related Dyspepsia, Peptic ulcer disease, Zollinger-Ellison syndrome, Gastroesophageal reflux disease (GERD), Helicobacter pylori infection, Erosive Esophagitis, Gouty arthritis.
Adult Dose
Intravenous
Gastro-oesophageal reflux disease
Adult: 20 or 40 mg by inj over at least 3 min or infusion over 10-30 min once daily for <10 days. Convert to oral therapy as soon as possible.
NSAID-associated ulceration
Adult: 20 mg/day by inj over at least 3 min or infusion over 10-30 min. Convert to oral therapy as soon as possible.
Gastric and duodenal ulcers
Adult: 80 mg infusion over 30 min followed by continuous infusion of 8 mg/hr over 72 hr, then convert to oral therapy given as 40 mg once daily for 4 wk.
Elderly: No dosage adjustment needed.
Hepatic impairment: Severe (Child-Pugh class C): <20 mg/day.
Child Dose
Short-term Treatment of GERD
IV
Short-term treatment of GERD with erosive esophagitis when oral therapy is not possible or appropriate
<1 month: Safety and efficacy not established
1 month to 1 year: 0.5 mg/kg IV qDay
>1 year (<55 kg): 10 mg IV qDay
>1 year (?55 kg): 20 mg IV qDay
Renal Dose
Renal impairment: No dosage adjustment needed.
Administration
Reconstitution:
Each single-use vial contains 20 or 40 mg of esomeprazole.
For IV inj: Reconstitute each vial w/ 5 mL of normal saline and consume w/in 12 hr.
For IV infusion: Reconstitute each vial w/ 5 mL of normal saline, lactated Ringer's inj or dextrose 5% inj, then further dilute the resultant solution to a final volume of 50 mL.
IV Administration
IV injection
Injection: Over no less than 3 min
Intermittent IV infusion
Infuse over 10-30 min regardless of amount
Flush IV line with NS, LR, or D5W prior to and after administration
Do not administer with any other drugs
Continuous IV infusion
Administer initial 80 mg IV dose over 30 min, THEN follow with
Continuous IV infusion of 8 mg/hr for total treatment duration of 72 hr
Contra Indications
Esomeprazole is contraindicated in patients with known hypersensitivity to any component of the formulation or to substituted Benzimidazoles.
Precautions
Paediatric; pregnancy, lactation. Malignancy and hepatic impairment. Increased risk of developing certain infections such as community-acquired pneumonia. For patients with severe liver impairment, a dose of 20 mg should not be exceeded.
Lactation: Unknown whether esomeprazole is distributed into breast milk; discontinue drug or do not nurse
Pregnancy-Lactation
Pregnancy
There are no adequate and well-controlled studies in pregnant women; esomeprazole is the S-isomer of omeprazole; available epidemiologic data fail to demonstrate an increased risk of major congenital malformations or other adverse pregnancy outcomes with first trimester omeprazole use; reproduction studies in rats and rabbits resulted in dose-dependent embryo-lethality at omeprazole doses that were approximately 3.4 to 34 times an oral human dose of 40 mg (based on a body surface area for a 60 kg person)
Lactation
Esomeprazole is the S-isomer of omeprazole and limited data suggest that omeprazole may be present in human milk; there are no clinical data on effects of esomeprazole on breastfed infant or on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from treatment or from underlying maternal condition
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.
Adverse Effects
Side effects of Esomeprazole Sodium Injection :
>10%
Headache (2-11%)
1-10%
Flatulence (10%), Indigestion (6%), Nausea (6%), Abdominal pain (1-6%), Diarrhea (2-4%), Xerostomia (3-4%), Dizziness (2-3%), Constipation (2-3%), Somnolence (1-2%), Pruritus (1%)
<1%
Blood and lymphatic system disorders: Agranulocytosis, pancytopenia
Blurred vision,
GI disorders: Pancreatitis, stomatitis, microscopic colitis
Hepatobiliary disorders: Hepatic failure, hepatitis with or without jaundice
Anaphylactic reaction/shock
GI candidiasis
Hypomagnesemia
Musculoskeletal disorders: Muscular weakness, myalgia, bone fracture
Nervous system disorders: Hepatic encephalopathy, taste disturbance
Psychiatric disorders: Aggression, agitation, depression, hallucination
Interstitial nephritis
Gynecomastia
Bronchospasm
Skin and subcutaneous tissue disorders: Alopecia, erythema multiforme, hyperhidrosis, photosensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis (sometimes fatal fatal)
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.
Note
NEXIUM 40mg Infusion manufactured by ASTRAZENECA AB. Its generic name is Esomeprazole Sodium Injection. NEXIUM is availble in United Arab Emirates.
Farmaco UAE drug index information on NEXIUM Infusion is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.