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Quick Overview

 Our aim is to reach out to the globe within shortest possible time frame. 

To promote this objective, not only we distribute and market our Gastroenterology  range of products globally through our distribution channels but we also undertake ‘contract manufacturing’& ‘formulation development ’of our wide range of generic products such as Esaktive 2o which contains Esomeprazole Magnesium Trihydrate USP Equivalent to Esomeprazole 20mg.




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Each enteric-coated tablet contains:

Esomeprazole Magnesium Trihydrate USP

Equivalent to Esomeprazole 20mg

Excipients q.s.

Colour: Red Iron Oxide NF, Allura Red and

Titanium Dioxide BP


Chemical Name: (S)-5-methoxy-2-[(4-methoxy-3,5-

dimethylpyridin-2-yl) methylsulfinyl]-3H-benzoimidazole

Category: Proton Pump Inhibitor

Description :

Light Pink color caplet shaped Biconvex Enteric coated Tablet plain on both Side.


Pharmacodynamic actions:

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. It 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 - the acid pump and inhibits both basal and stimulated acid secretion.

Pharmacokinetic actions:

Absorption: Absorption of Esomeprazole is rapid, with peak plasma levels occurring approximately 1-2 hours after dose. The absolute bioavailability is 64% after a single dose of 40 mg and increases to 89% after repeated once-daily administration. For 20 mg Esomeprazole the corresponding values are 50% and 68%, respectively. Food intake both delays and decreases the absorption of Esomeprazole although this has no significant influence on the effect of Esomeprazole on intragastric acidity.

Distribution: The apparent volume of distribution at steady state in healthy subjects is approximately 0.22 L/kg body weight. Esomeprazole is 97% plasma protein bound. Total plasma clearance is about 17 L/h after a single dose and about 9 L/h after repeated administration.

The plasma elimination half-life is about 1.3 hours after repeated once-daily dosing.

Metabolism: Esomeprazole is completely metabolised by the cytochrome P450 system (CYP). The major part of the metabolism of Esomeprazole is dependent on the polymorphic CYP2C19, responsible for the formation of the hydroxy- and desmethyl metabolites of Esomeprazole. The remaining part is dependent on another specific isoform, CYP3A4, responsible for the formation of Esomeprazole sulphone, the main metabolite in plasma.

Elimination: Almost 80% of an oral dose of Esomeprazole is excreted as metabolites in the urine, the remainder in the faeces. Less than 1% of the parent drug is found in urine.


Gastro-Oesophageal Reflux Disease (GORD)

• Treatment of erosive reflux oesophagitis

• Long-term management of patients with healed oesophagitis to prevent relapse

• Symptomatic treatment of gastro-oesophageal reflux disease (GORD) In combination with an appropriate antibacterial therapeutic regimen for the eradication of Helicobacter pylori and

• Healing of Helicobacter pylori associated duodenal ulcer and

• Prevention of relapse of peptic ulcers in patients with Helicobacter pylori associated ulcers.

Patients requiring continued NSAID therapy

• Healing of gastric ulcers associated with NSAID therapy.

• Prevention of gastric and duodenal ulcers associated with NSAID therapy, in patients at risk. Prolonged treatment after IV induced prevention of rebleeding of peptic ulcers. Treatment of Zollinger Ellison Syndrome


Adults and adolescents from the age of 12 years. Gastro- Oesophageal Reflux Disease (GORD)

An additional 4 weeks treatment is recommended for patients in whom oesophagitis has not healed or who have persistent symptoms.

• Long-term management of patients with healedoesophagitis to prevent relapse

20 mg once daily.

• Symptomatic treatment of gastro-oesophageal reflux disease (GORD) 20 mg once daily in patients without oesophagitis. If symptom control has not been achieved after four weeks, the patient should be further investigated. Once symptoms have resolved, subsequent symptom control can be achieved using 20 mg once daily. In adults, an on demand regimen taking 20 mg once daily, when needed,

can be used. In NSAID treated patients at risk of developing gastric and duodenal ulcers, subsequent symptom control using an on demand regimen is not recommended. 


In combination with an appropriate antibacterial therapeutic regimen for the eradication of Helicobacter pylori

• Healing of Helicobacter pylori associated duodenal ulcer and prevention of relapse of peptic ulcers in

patients with Helicobacter pylori associated ulcers. 20 mg Eskative with 1 g amoxicillin and 500 mg

clarithromycin, all twice daily for 7 days. Patients requiring continued NSAID therapy - Healing of

gastric ulcers associated with NSAID therapy:

• The usual dose is 20 mg once daily. The treatment duration is 4-8 weeks. Prevention of gastric and duodenal ulcers associated with

NSAID therapy in patients at risk:

• 20 mg once daily.

Prolonged treatment after IV induced prevention of rebleeding of peptic ulcers.


The dosage should then be individually adjusted and treatment continues as long as clinically indicated. Based on the clinical data available, the majority of patients can be controlled on doses between 80 and 160 mg

Esomeprazole daily. With doses above 80 mg daily, the dose should be divided and given twice-daily.

Children below the age of 12 years

Eskative should not be used in children younger than 12 years since no data is available.

Impaired renal function Dose adjustment is not required in patients with impaired

renal function. Due to limited experience in patients with severe renal insufficiency, such patients should be treated with caution.

Impaired hepatic function

Dose adjustment is not required in patients with mild to moderate liver impairment. For patients with severe liver impairment, a maximum dose of 20 mg Eskative should not be exceeded.


Dose adjustment is not required in the elderly.


Known hypersensitivity to Esomeprazole, substituted benzimidazoles or any other constituents of the



In the presence of any alarm symptom (e.g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melaena) and when gastric ulcer is suspected or present, malignancy should be excluded, as treatment with Esemoprasole may alleviate symptoms and delay diagnosis.Patients on long-term treatment (particularly those treated for more than a year) should be

kept under regular surveillance. Patients on on-demand treatment should be instructed to contact their physician if their symptoms change in character. When prescribing Esomeprazole for on-demand therapy, the implications for interactions with other pharmaceuticals, due to fluctuating plasma concentrations of Esomeprazole should be considered. Treatment with proton pump inhibitors may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter.

Drug Interactions

Esomeprazole should not be used concomitantly with nelfinavir. When prescribing Esomeprazole for eradication of Helicobacter pylori possible drug interactions for all components in the triple therapy should be considered. Clarithromycin is a potent inhibitor of CYP3A4 and hence contraindications and interactions for Clarithromycin should be considered when the triple therapy is used in patients concurrently taking other drugs metabolised via CYP3A4 such as cisapride. Co-administration of Esomeprazole with atazanavir is not recommended. If the combination of atazanavir with a

proton pump inhibitor is judged unavoidable, close clinical monitoring is recommended in combination with an increase in the dose of atazanavir to 400 mg with 100 mg of ritonavir; Esomeprazole 20 mg should not be exceeded. The decreased intragastric acidity during treatment with Esomeprazole, might increase or decrease the absorption of drugs if the mechanism of absorption is influenced by gastric acidity. In common with the use of other inhibitors of acid secretion or antacids, the absorption of ketoconazole and itraconazole can decrease during treatment with Esomeprazole. Esomeprazole inhibits CYP2C19, the major Esomeprazole metabolizing enzyme. Thus, when Esomeprazole is 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.

Monitoring is recommended when initiating and ending concomitant Esomeprazole treatment during treatment with warfarin or other coumarine derivatives. Esomeprazole has been shown to have no clinically relevant effects on the pharmacokinetics of amoxicillin or quinidine.

Studies evaluating concomitant administration of Esomeprazole and either naproxen or rofecoxib did not identify any clinically relevant pharmacokinetic interactions during short-term studies.

Pregnancy & Lactation

Clinical data on exposed pregnancies are insufficient. Caution should be exercised when prescribing to

pregnant women. It is not known whether Esomeprazole is excreted in human breast milk and study data being unavailable, Esomeprazole should not be used during lactation.

Effects on ability to drive and use machines

No effects have been observed.


The adverse reactions are classified according to f r e q u e n c y ( c o m m o n > 1 / 1 0 0 , < 1 / 1 0 ;

uncommon>1/1000, <1/100; rare>1/10000,<1/1000; very rare <1/10000).

Common: Headache, Abdominal pain, constipation, diarrhoea, flatulence, nausea/vomiting.

Un-Common: Peripheral oedema, Insomnia, Dizziness, paraesthesia, somnolence, Ver tigo, Dry mouth,

Increased liver enzymes, Dermatitis, pruritus, rash, urticaria. Rare: Leukopenia, thrombocytopenia, Hypersensitivity reactions e.g. fever, angioedema and anaphylactic reaction/shock, Hyponatraemia, Agitation, confusion, depression, Taste disturbance, Blurred vision, stomatitis, gastrointestinal candidiasis, Hepatitis with or without jaundice, Alopecia, photosensitivity, Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), Arthralgia, myalgia, Malaise, increased


Very Rare: Agranulocytosis, pancytopenia, Aggression, hallucinations, Hepatic failure, encephalopathy in patients with pre-existing liver disease, Muscular weakness, Interstitial nephritis, Gynaecomastia.


There is very limited experience to date with deliberate overdose. The symptoms described in connection with 280mg were gastrointestinal symptoms and weakness.

Single doses of 80 mg esomeprazole were 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.

Packing: Blister of 10 Tablets

Storage: Store in a cool and dry place below 30 C.

Protect from light.

Keep out of reach of Children.

Tablets should not be split, chewed or crushed before administration.

Shelf Life: 24 Months from the date of manufacturing.