Produced by Meivo international for pharmaceutical industries.
- Trade name: Klemazice.
- Generic Name: Esomeprazole.
- Composition: Each delayed release enteric coated pellet in hard gelatin capsule contains 45 mg Esomeprazole magnesium trihydrate Equivalent to 40 mg Esomeprazole.
- Pharmaceutical form: Oral delayed release enteric coated pellets in hard gelatin capsules.
- Pharmacological action: Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/K+-ATPase in the gastric parietal cell. By acting specifically on the proton pump. Esomeprazole blocks the final step in acid production. thus reducing gastric acidity.
- Treatment of gastroesophageal reflux disease (GERD).
- Treatment of Erosive Esophagitis, maintaining the healing of erosive esophagitis and symptomatic treatment.
- Risk reduction of NSAID-associated gastric ulcer .
- Esomeprazole in combination with amoxicillin and clarithromycin is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease.
- Pathological hypersecretory condibons including zollinger-ellison syndrome.
DOSAGE AND ADMINISTRATION
KLEMAZICE is supplied as delayed-release capsules for oral administration; should be taken at least one hour before meals. The dose is as follows:
- Treatment of gastroesophageal disease: Erosive oesophagitis: once daily capsule for 4 to 8 weeks, for those patients who have not healed after 4 to 8 weeks of treatment, an additional 4 to 8 week course is considered.
- Maintenance of healed erosive esophagitis: once daily capsule.
- Symptomatic treatment of gastroesophageal reflux disease: once daily capsule for 4 weeks.
- Risk reduction of NSAID-associated gastric ulcer: once daily capsule.
- As a part of triple therapy for H.pylori eradication: once daily capsule for 10 days .
- Hypersecretory conditions: one capsule twice daily.
- Geriatric patients: No dosage adjustment is necessary.
- Renal Insufficiency: No dosage adjustment is necessary.
- Hepatic Insufficiency: No dosage adjustment is necessary in patients with mild to moderate liver impairment, for patients with severe liver impairment a dose of 20 mg should not be exceeded.
KLEMAZICE is contraindicated in patients with known hypersensitivity to any component of the drug.
Body as a Whole: Enlarged abdomen, allergic reaction, asthenia. back pain, chest pain, substemal chest pain, facial edema, peripheral edema, hot flushes, fatigue, fever, flu-like disorder, generalized edema, leg edema, pain, malaise.
Cardiovascular: Flushing, hypertension, tachycardia.
Gastrointestinal: Diarrhoea, headache. nausea, 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, vomiting, ulcerative stomatitis.
Hearing: Earache, tinnitus.
Hematologic: Anemia, hypochromic anemia, cervical lymphadenopathy epistaxis, leukocytosis, leucopenia, thrombocytopenia.
Hepatic: bilirubinemia, abnormal hepatic function, SGOT increased, SGPT increased.
Metabolic/Nutritional: Glycosuna, hyperuricemia, hyponatremia, increased alkaline phosphatase, thirst, vitamin 612 deficiency, weight increase and weight decrease.
Musculoskeletal: Arthralgia, aggravated arthritis, arthropathy, cramps. hernia, fibromyalgia syndrome.
Nervous System/Psychiatric: anorexia, apathy, increased appetite, confusion, depression aggravated, dizziness, hypertonia, nervousness, insomnia, hypoesthesia,,migraine, migraine aggravated, somnolence, sleep disorder, tremors, vertigo, paresthesia, visual field defect.
Reproductive: Dysmenorrhea, menstrual disorder, vaginitis.
Respiratory: asthma aggravated, coughing.,dyspnea, pharyngitis,larynx edema, rhinitis, sinusitis.
Skin and Appendages: Acne, angioedema, dermatitis, pruritus, pruritus ani, rash, rash erythematous, maculo-papular rash, skin inflammation, increased sweating, 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, abnormal vision.
Post marketing reports: Musculoskeletal: bone fracture.
- Effects on absorption: Esomeprazole inhibits gastric acid secretion. Therefore, esomeprazole may interfere with absorption of drugs where gastric pH is an important determinant of bioavailability (ketoconazole, iron salts. digoxin).
- Co administration of atazanavir with proton pump inhibitors is expected to substantially decrease atazanavir plasma concentrations and thereby reduce its therapeutic.
- Concomitant warfarin and Esomeprazole therapy Increases INR, prothrombin time and may lead to abnormal bleeding. Patients treated with proton pump inhibitors and warfarin concomitantly may need to be monitored for increases in INR and prothrombin time.
Pregnancy and lactation
Pregnancy Category B: There are no adequate and well controlled studies of Esomeprazole use in pregnancy or during lactation, and so this drug is contraindicated during pregnancy or during lactation.
The safety and effectiveness of Esomeprazole for the treatment patients < 1 year of age are not established.
Precautions and warnings
Prescription proton pump inhibitor (PPI) drugs may cause low serum magnesium levels (hypomagnesemia) if taken for prolonged periods of time (in most cases, longer than one year), magnesium supplementation alone did not improve low serum magnesium levels and the PPI had to be discontinued. Low serum magnesium levels can result in serious adverse events including muscle spasm (tetany), irregular heartbeat (arrhythmias), and convulsions (seizures), however, patients do not always have these symptoms. Treatment of hypomagnesemia generally requires magnesium supplements. Treatment in patients taking a PPI and who have hypomagnesemia may also require stopping the PPI.
Several published observational studies suggest that proton pump inhibitor(PPI) therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. The risk of fracture was increased in patients who received high dose, defined as muitiple daily doses, and long term PPI therapy( a year or longer).
Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Patients at risk for osteoporosis-related fracture should be managed according to the established treatment guidelines.
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