Indications:
- Treatment of Gastro esophageal reflux disease (GERD)
Healing of erosive esophagitis
Eso-protocol is indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis. For those patients who have not healed after 4 to 8 weeks of treatment, an additional 4 to 8 weeks course of Eso-protocol may be considered.
Maintenance of Healing of erosive esophagitis
Eso-protocol is indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months.
Symptomatic Gastro esophageal reflux disease
Eso-protocol is indicated for short-term (4 to 6 weeks 0 of heartburn and other symptoms associated with GERD in adults and children 1 year or older.
- Risk reduction of NSAID- Associated Gastric Ulcer
Eso-protocol indicated for the reduction in the occurrence of gastric ulcers associated with continuous NSAID therapy in patients at risk for developing gastric ulcers. Patients are considered to be at risk due to their age (≥60) and / or documented history of gastric ulcers. Controlled studies do not extend beyond 6 months.
- H. pylori Eradication to reduce the risk of duodenal ulcer recurrence
Triple therapy (Eso-protocol plus amoxicillin and clarithromycin): Esomeprazole, in combination with amoxicillin and clarithromycin, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate.H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. In case of patients that their therapy fails, susceptibility testing should be done, if resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted.
- Pathological hypersecretory conditions including Zollinger-Ellison Syndrome
Eso-protocol is indicated for the long-term treatment of pathological hypersecretory conditions, including: Zollinger-Ellison Syndrome.
Patients requiring continued NSAID therapy (Healing of gastric ulcers associated with NSAID therapy - Pnts at risk)revention of gastric and duodenal ulcers associated with NSAID therapy in patie.

Dosage:
Adults and adolescents from the age of 12 years
Gastro esophageal reflux (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 Gastro esophageal 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. 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 ulcer, subsequent symptom control using an on demand regimen is not recommended.
Adults
In combination with an appropriate antibacterial therapeutic regimen for the eradication Helicobacter pylori and healing of Helicobacter pylori associated ulcer and prevention of relapse of peptic ulcer in patients with Helicobacter pylori associated ulcers. 20 mg Eso-protocol with 1 gm amoxicillin and 500 mg clarithromycin, all 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.
- Treatment of Zollinger Ellison Syndrome
The recommended initial dosage is Eso-protocol 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 to 160 mg esomeprazole daily. With dose above 80 mg daily, the dose should be divided and given twice daily.
Children below the age of 12 years
Eso- protocol 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 Esomeprazole
should not be exceeded.
Elderly
Dose adjustment is not required in the elderly.

Side effect:
Body as a whole: abdomen enlarged, allergic reaction, ansthenia, back pain, chest pain, substernal chest pain, facial oedema, peripheral oedema, hot flushes, fatigue, fever, flu-like disorder, generalized oedema, leg oedema, malaise, pain, rigors.
Cardiovascular: flushing, hypertension, tachycardia.
Endocrine: goiter.
Gastrointestinal: bowel irregularity, constipation aggravated, dyspepsia, dysphagia, dysplasia G.I., epigastric pain, eructation, esophageal disorder, frequent stool, gastroenteritis, G.I. haemorrhage, G.I. symptoms not otherwise specified, hiccup, melena, mouth disorder, pharynx disorder, rectal disorder, serum gastrin increased, tongue disorder, tongue oedema, uncreative stomatitis, vomiting.
Hearing: earache, tinnitus.
Hematologic: anaemia, anaemia hyperchromic, cervical lymphadenopathy, epistaxis, leukocytosis, leucopoenia, thrombocytopenia.
Hepatic: Bilirubinemia, Hepatic function abnormal, SGOT increased, SGPT increased. Metabolic/Nutritional: Glycosyuria, Hyperuricemia, Hyponatremia, Increased alkaline phosphatase, Thirst, Vitamin B12 deficiency, Weight increase, Weight decrease.
Musculoskeletal: arthritis aggravated, arthropathy, cramps, fibromyalgia syndrome, hernia, polymyalgia rheumatic.
Nervous system/Pyschiatric: anorexia, apathy, appetite increased, confusion, depression aggravated, dizziness, hypertonia, nervousness, hypoesthesia, impotence, insomnia, migraine, migraine aggravated, paresthesia, sleep disorder, somnolence, tremor, vertigo, visual field effect.
Reproductive: dysmenorrhoeal, menstrual disorder, vaginitis.
Respiratory: asthma aggravated, coughing dyspnea, larynx oedema, pharyngitis, rhinitis, sinusitis.
Skin and appendages: acne, angioedema, dermatitis, pruritus ani, rash, rash erythematous, rash maculapapular, skin inflammation, sweating increased.
Metabolic/Nutritional: Glycosyuria, Hyperuricemia, Hyponatremia, Increased alkaline phosphatase, Thirst, Vitamin B12 deficiency, Weight increase, Weight decrease.
Musculoskeletal: arthritis aggravated, arthropathy, cramps, fibromyalgia syndrome, hernia, polymyalgia rheumatic.
Nervous system/Pyschiatric: anorexia, apathy, appetite increased, confusion, depression aggravated, dizziness, hypertonia, nervousness, hypoesthesia, impotence, insomnia, migraine, migraine aggravated, paresthesia, sleep disorder, somnolence, tremor, vertigo, visual field effect.
Reproductive: dysmenorrhoeal, menstrual disorder, vaginitis.
Respiratory: asthma aggravated, coughing dyspnea, larynx oedema, pharyngitis, rhinitis, sinusitis.
Skin and appendages: acne, angioedema, dermatitis, pruritus ani, rash, rash erythematous, rash maculapapular, skin inflammation, sweating increased.
Urticaria; Special sense: 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.
The following potentially clinically significant laboratory change in clinical trials, irrespective of relationship to Nexium, were reported in ≤ 1% of patients: increased ceratinine, uric acid, total bilirubin, alkaline phosphatase, ALT. AST, hemoglobin, white blood cell count, platelets, serum gastrin, potassium, sodium, thyroxin and thyroid stimulating hormone. Decreases were seen in hemoglobin, white blood cell count, platelets, potassium, sodium and thyroxin. Endoscopic finding that were reported as adverse reactions include: duodenitis, esophagitis, esophageal stricture, esophageal ulceration, esophageal varices, gastric ulcer, gastritis, hernia, benign polyps or nodules, Barrett’s esophagus, and mucosal discoloration. The incidence of treatment-related adverse reactions during 6-month maintenance treatment was similar to placebo. There were no differences in type of related adverse reaction seen during maintenance treatment up to 12 months compared to short-term treatment. Two placebo-controlled studies were conducted in 710 patients for the treatment of symptomatic gastroesophageal reflux disease. The most common adverse reaction that were reported as possibly or probably related to Nexium were diarrhea (4.3%), headache (3.8%), and abdominal pain (3.8%).
Drug interaction:
Effects of esomeprazole on the pharmacokinetics of other drugs
Medicinal products with PH dependent absorption:
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.Co-administration of omeprazole (40mg once daily) with atazanvir 300mg / ritonavir 100mg to healthy volunteers resulted in a substantial reduction in atazanvir exposure (approximately 75% decrease in AUC, Cmax and Cmin).Increasing the atazanvir dose to 400 mg did not compensate the impact of omeprazole on atazanvir exposure. PPIs including esomeprazole should not be co-administrated with atazanvir.
Drugs metabolized by CYP2C19:
Omeprazole acts as an inhibitor of CYP2C19. Omeprazole, given in doses of 40mg daily for one week to 20 healthy subjects in cross-over study, increased Cmax and AUC of cilostazol by 18% and 26% respectively. Cmax and AUC of one of its active metabolites, 3, 4-dihydrocilostazol, which has 4-7 times the activity of cilostazol, were increased by 29% and 69% respectively. Co-administration of Cilostazol with esomeprazole is expected to increase concentrations of Cilostazol and it is above mentioned active metabolite. Therefore a dose reduction of cilostazol from 100 mg b.i.d. to 50 mg b.i.d. should be considered. Esomeprazole inhibits CYP2C19, the major esomeprazole metabolizing enzyme. Thus, when esomeprazole is combined with drugs metabolized by CYP2C19, such as diazepam, citalopram, imipramine, clomipramine, phenytoin etc, the plasma concentrations of these drugs may be increased and dose reduction could be needed. This should be considered especially when prescribing esomeprazole for in demand therapy. Concomitant administration of 30 mg esomeprazole resulted in 45% decrease in clearance of the CYP2C19 substrate diazepam. Concomitant administration of 40mg esomeprazole resulted in 13% increase in through plasma level of phenytoin in epileptic patients. It is recommended to monitor the plasma concentrations of phenytoin when treatment with esomeprazole is introduced or withdrawn. Omperazole (40 mg once daily) increased voriconazole (a CYP2C19 substrate) Cmax and AUC by 15% and 41% respectively. Concomitant administration of 40mg esomeprazole to Warfarin-treated patients in clinical trial showed that coagulation times were within the accepted range. However, post-marketing, a few isolated cases of elevated INR of clinical significance have been reported during concomitant treatment. Monitoring is recommended when initiating and ending concomitant esomeprazole treatment during treatment with warfarin or other coumarine derivatives. In healthy volunteers, concomitant administration of 40 mg esomeprazole resulted in 32% increase in area under the plasma concentration time curve (AUC) and a 31% prolongation of elimination half-life (T1/2) time but no significant increase in peak plasma levels of cisapride. The slightly prolonged QTc interval observed after administration of cisapride alone, was not further prolonged when cisapride was given in combination with esomeprazole. 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.
Effects of other drugs on the pharmacokinetics of esomeprazole
Esomeprazole is metabolized by CYP2C19 and CYP3A4. Concomitant administration of esomeprazole and CYP3A4 inhibitor or Clarithromycin (500 mg b.i.d.) resulted in a doubling of the exposure (AUC) to esomeprazole. Dose adjustment of esomeprazole is not required.
Pregnancy and Lactation
For esomeprazole, clinical data on exposed pregnancies are insufficient. With the racemic mixture Omperazole data on a larger number of exposed pregnancies from epidemiological studies indicate no malformative nor foetotoxic effects. Animal studies with esomeprazole do not indicate direct or indirect harmful effects with respect to embryonal / fetal development. Animal studies with the racemic mixture do not indicate direct or indirect harmful effects with respect to pregnancy, parturition or postnatal development. Caution should be exercised when prescribing to pregnant woman. It is not known whether esomeprazole is excreted in human breast milk. No studies in lactating woman have should not be used during breast-feeding.
Effect on ability to drive and use machines
No effects have been observed.
Undesirable effects
Body as a whole: abdomen enlarged, allergic reaction, ansthenia, back pain, chest pain, substernal chest pain, facial oedema, peripheral oedema, hot flushes, fatigue, fever, flu-like disorder, generalized oedema, leg oedema, malaise, pain, rigors.
Cardiovascular: flushing, hypertension, tachycardia.
Endocrine: goiter.
Gastrointestinal: bowel irregularity, constipation aggravated, dyspepsia, dysphagia, dysplasia G.I., epigastric pain, eructation, esophageal disorder, frequent stool, gastroenteritis, G.I. haemorrhage, G.I. symptoms not otherwise specified, hiccup, melena, mouth disorder, pharynx disorder, rectal disorder, serum gastrin increased, tongue disorder, tongue oedema, uncreative stomatitis, vomiting.
Hearing: earache, tinnitus.
Hematologic: anaemia, anaemia hyperchromic, cervical lymphadenopathy, epistaxis, leukocytosis, leucopoenia, thrombocytopenia.
Hepatic: Bilirubinemia, Hepatic function abnormal, SGOT increased, SGPT increased.
Metabolic/Nutritional: Glycosyuria, Hyperuricemia, Hyponatremia, Increased alkaline phosphatase, Thirst, Vitamin B12 deficiency, Weight increase, Weight decrease.
Musculoskeletal: arthritis aggravated, arthropathy, cramps, fibromyalgia syndrome, hernia, polymyalgia rheumatic.
Nervous system/Pyschiatric: anorexia, apathy, appetite increased, confusion, depression aggravated, dizziness, hypertonia, nervousness, hypoesthesia, impotence, insomnia, migraine, migraine aggravated, paresthesia, sleep disorder, somnolence, tremor, vertigo, visual field effect.
Reproductive: dysmenorrhoeal, menstrual disorder, vaginitis.
Respiratory: asthma aggravated, coughing dyspnea, larynx oedema, pharyngitis, rhinitis, sinusitis.
Skin and appendages: acne, angioedema, dermatitis, pruritus ani, rash, rash erythematous, rash maculapapular, skin inflammation, sweating increased.
Urticaria; Special sense: 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.
The following potentially clinically significant laboratory change in clinical trials, irrespective of relationship to Nexium, were reported in ≤ 1% of patients: increased ceratinine, uric acid, total bilirubin, alkaline phosphatase, ALT. AST, hemoglobin, white blood cell count, platelets, serum gastrin, potassium, sodium, thyroxin and thyroid stimulating hormone. Decreases were seen in hemoglobin, white blood cell count, platelets, potassium, sodium and thyroxin. Endoscopic finding that were reported as adverse reactions include: duodenitis, esophagitis, esophageal stricture, esophageal ulceration, esophageal varices, gastric ulcer, gastritis, hernia, benign polyps or nodules, Barrett’s esophagus, and mucosal discoloration. The incidence of treatment-related adverse reactions during 6-month maintenance treatment was similar to placebo. There were no differences in type of related adverse reaction seen during maintenance treatment up to 12 months compared to short-term treatment. Two placebo-controlled studies were conducted in 710 patients for the treatment of symptomatic gastroesophageal reflux disease. The most common adverse reaction that were reported as possibly or probably related to Nexium were diarrhea (4.3%), headache (3.8%), and abdominal pain (3.8%).
Packages:
Eso-protocol 20 mg hard gelatin capsule
Carton box contains 1, 2, 3 (AL/PVC) strips each of 10 hard Gelatin capsules
with inner leaflet.
Eso-protocol 40 mg hard gelatin capsule
Carton box contains 1, 2, 3 (AL/PVC) strips each of 10 hard Gelatin capsules
with inner leaflet.

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