Esomeprazole

BRANDS OF ESOMEPRAZOLE IN KENYA

Cidopraz® , Opera Pharma (K) Ltd
Esocip®, Lords Healthcare Ltd
Esofag® ,Micro Labs Limited
Esofast®, Innocia Lifesciences Pvt. Ltd.
Esoflux®, The ACME Laboratories Ltd
Esofred®, Fredun Pharmaceuticals Ltd.
Esomac® , Cipla Ltd
Esome®, Getz Pharma (Pvt) Limited
Esomep®, Advanced Chemical Industries Limited
Esomezol® , Inventia Healthcare Pvt. Ltd.
Esonium®,Galaxy Pharmaceutical Limited
Esonix® , Incepta Pharmaceuticals Ltd
Esop® ,Swiss Parenterals (Pvt.) Ltd
Esopra® , PSA International (Export Division Of PSA Chemicals And Pharmaceuticals Pvt Ltd)
Esomepram® , MOL Chem Limited
Esopraz® , Highchem Marketing Ltd
Esopride®, Stallion Laboratories Pvt. Ltd
Esoral® , Eskayef Bangladesh Ltd.
Esose®, Glenmark Pharmaceuticals Limited
Esoxium®, Signature Healthcare Ltd
Espra® , CCL Pharmaceuticals (Pvt.) Ltd.
Esta® , Mac Heal Laboratories Ltd.
Esostar® , Medistar Pharmaceuticals Ltd
Esotid® , Radiance Pharmaceuticals Ltd
Eszed® , Zawadi Healthcare Ltd
Exium®, Radiant Pharmaceuticals Limited
Ezo®, Ind-Swift Limited
Grasozole®, Gracure pharmaceuticals Ltd
Gastrotab®, Krishna Chemist Ltd
Izra®, Unichem Laboratories Ltd.
Nexium®,AstraZeneca
Nexpro®, Torrent Pharmaceuticals Ltd
Prezola® , Medisel Kenya Ltd
Protas®, Square Pharmaceuticals Ltd.
Rayzium®, Biodeal Laboratories Ltd
Sergel® , Healthcare Pharmaceuticals Ltd
Sompraz® , Sun Pharmaceutical Industries Limited
Stulcer®, Gufic Stridden Biopharma Private Ltd.
Yesom®, Hetero Labs Limited
Zomep®, Zawadi Healthcare Ltd


Esomeprazole in Kenya: Esomeprazole Chemical Structure
Esomeprazole Chemical Structure

 


INDICATIONS / DOSAGE & ADMINISTRATION

Esomeprazole is indicated for:

Adults

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

– Healing of Helicobacter pylori associated duodenal ulcer

– 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 i.v. induced prevention of rebleeding of peptic ulcers.

Treatment of Zollinger Ellison Syndrome

Adolescents from the age of 12 years

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 antibiotics in treatment of duodenal ulcer caused by Helicobacter pylori.

DOSAGE AND ADMINISTRATION

Adults

Gastro-oesophageal Reflux Disease (GORD)

Treatment of erosive reflux oesophagitis

40 mg once daily for 4 weeks.

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 healed oesophagitis 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 4 weeks, the patient should be further investigated. Once symptoms have resolved, subsequent symptom control can be achieved using 20 mg once daily. 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 Esomeprazole 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 recommended 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 i.v. induced prevention of rebleeding of peptic ulcers

40 mg once daily for 4 weeks after i.v. induced prevention of rebleeding of peptic ulcers.

Treatment of Zollinger Ellison Syndrome

The recommended initial dosage is Esomeprazole 40 mg twice daily. The dosage should then be individually adjusted and treatment continued 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.

Special populations

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, (see section 5.2).

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 Esomeprazole should not be exceeded, (see section 5.2).

Elderly

Dose adjustment is not required in the elderly.

Paediatric population

Adolescents from the age of 12 years

Gastroesophageal Reflux Disease (GERD)

Treatment of erosive reflux esophagitis

40 mg once daily for 4 weeks.

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

Long-term management of patients with healed esophagitis to prevent relapse

20 mg once daily.

Symptomatic treatment of gastroesophageal reflux disease (GERD)

20 mg once daily in patients without esophagitis. If symptom control has not been achieved after 4 weeks, the patient should be further investigated. Once symptoms have resolved, subsequent symptom control can be achieved using 20 mg once daily.

Treatment of duodenal ulcer caused by Helicobacter pylori

When selecting appropriate combination therapy, consideration should be given to official national, regional and local guidance regarding bacterial resistance, duration of treatment (most commonly 7 days but sometimes up to 14 days), and appropriate use of antibacterial agents. The treatment should be supervised by a specialist.

The posology recommendation is:

WeightPosology
30 – 40 kgCombination with two antibiotics: esomeprazole 20 mg, amoxicillin 750 mg and clarithromycin 7.5 mg/kg body weight are all administered together twice daily for one week.
> 40 kgCombination with two antibiotics: esomeprazole 20 mg, amoxicillin 1 g and clarithromycin 500 mg are all administered together twice daily for one week.

ESOMEPRAZOLE DRUG REACTIONS:

Co-administration of atazanavir with proton pump inhibitors is expected to substantially decrease atazanavir plasma concentrations and may result in a loss of therapeutic effect and the development of drug resistance.

Co-administration of saquinavir with proton pump inhibitors is expected to increase saquinavir concentrations, which may increase toxicity and require dose reduction.

Like with other drugs that decrease the intragastric acidity, the absorption of drugs such as ketoconazole, atazanavir, iron salts, erlotinib and mycophenolate mofetil (MMF) can decrease, while the absorption of drugs such as digoxin can increase during treatment with esomeprazole.

Esomeprazole may potentially interfere with CYP2C19, the major esomeprazole metabolizing enzyme.

Concomitant use of esomeprazole 40 mg results in reduced plasma concentrations of the active metabolite of clopidogrel and a reduction in platelet inhibition

Concomitant use of esomeprazole 40 mg results in reduced plasma concentrations of the active metabolite of clopidogrel and a reduction in platelet inhibition

Drugs known to induce CYP2C19 or CYP3A4 or both (such as rifampin) may lead to decreased esomeprazole serum levels.

Concomitant administration of esomeprazole and tacrolimus may increase the serum levels of tacrolimus.

Case reports, published population pharmacokinetic studies, and retrospective analyses suggest that concomitant administration of PPIs and methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite hydroxymethotrexate

ADVERSE DRUG REACTIONS:

Body as a Whole: abdomen enlarged, allergic reaction, asthenia, back pain, chest pain, substernal chest pain, facial edema, peripheral edema, hot flushes, fatigue, fever, flu-like disorder, generalized edema, leg edema, malaise, pain, rigors;
Cardiovascular: flushing, hypertension, tachycardia;
Endocrine: goiter;
Gastrointestinal: bowel irregularity, constipation aggravated, dyspepsia, dysphagia, dysplasia GI, epigastric pain, eructation, esophageal disorder, frequent stools, gastroenteritis, GI hemorrhage, GI symptoms not otherwise specified, hiccup, melena, mouth disorder, pharynx disorder, rectal disorder, serum gastrin increased, tongue disorder, tongue edema, ulcerative stomatitis, vomiting;
Hearing: earache, tinnitus;
Hematologic: anemia, anemia hypochromic, cervical lymphadenopathy, epistaxis, leukocytosis, leukopenia, thrombocytopenia;
Hepatic: bilirubinemia, hepatic function abnormal, SGOT increased, SGPT increased;
Metabolic/Nutritional: glycosuria, hyperuricemia, hyponatremia, increased alkaline phosphatase, thirst, vitamin B12 deficiency, weight increase, weight decrease;
Musculoskeletal: arthralgia, arthritis aggravated, arthropathy, cramps, fibromyalgia syndrome, hernia, polymyalgia rheumatica;
Nervous System/Psychiatric: anorexia, apathy, appetite increased, confusion, depression aggravated, dizziness, hypertonia, nervousness, hypoesthesia, impotence, insomnia, migraine, migraine aggravated, paresthesia, sleep disorder, somnolence, tremor, vertigo, visual field defect;
Reproductive: dysmenorrhea, menstrual disorder, vaginitis;
Respiratory: asthma aggravated, coughing, dyspnea, larynx edema, pharyngitis, rhinitis, sinusitis;
Skin and Appendages: acne, angioedema, dermatitis, pruritus, pruritus ani, rash, rash erythematous, rash maculo-papular, skin inflammation, sweating increased, urticaria;
Special Senses: otitis media, parosmia, taste loss, taste perversion;
Urogenital: abnormal urine, albuminuria, cystitis, dysuria, fungal infection, hematuria, micturition frequency, moniliasis, genital moniliasis, polyuria;
Visual: conjunctivitis, vision abnormal.

Reporting of suspected adverse reactions:

The PPB Department of Pharmacovigilance was set up with a vision to develop, implement and continuously upgrade an appropriate system for detecting, reporting, and monitoring adverse drug reactions (ADRs) and other relevant problems with medicines in Kenya. The department strives to ensure the safety and efficacy of pharmaceutical products in Kenya.
Reporting suspected adverse reactions after authorization of the medicinal product are important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals/ Patients are encouraged to report any suspected adverse reactions via Pharmacovigilance Yellow Form, pv@pharmacyboardkenya.org or clicking below button:


Esomeprazole in Kenya
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Esomeprazole in Kenya
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Clinical | Pharmacokinetic data


Pregnancy Category: C (Risk not ruled out)
Routes of Administration: By mouth, IV
Bioavailability: 50 to 90%
Protein Binding: Not Available
Metabolosim: Liver (CYP2C19, CYP3A4)
Onset of Action: N/A
Elimination Half life: 1–1.5 hours
Excretion: 80% Kidney | 20% Faecal

Legal Status | Dosage forms & Strengths


Prescription Category:
Prescription only Medicine (POM) , ℞-only
Narcotic Drugs and Psychotropic Substances (Control ) Act Schedule:
This drug is not a controlled substance under Narcotic Drugs and Psychotropic Substances (Control ) Act
Dosage Forms | Strengths:


Drug Indentifiers:

CAS Number
PubChem CID
DrugBank
ChemSpider
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KEGG
ChEBI
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ECHA InfoCard


Drug Images

References/ Citation:




What was the patient being treated for
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