OMEZ Capsule

ក្រុមហ៊ុនផលិតឱសថ:

 

Dr. REDDY'S LABORATORIES LTD, India

ក្រុមហ៊ុនចែកចាយឱសថនៅប្រទេសកម្ពុជា:

 

DKSH

  • សារធាតុសកម្ម
  • ប្រសិទ្ធិភាពព្យាបាល និង កម្រិតប្រើប្រាស់
  • ហាមប្រើ
  • ផលរំខាន
  • អន្តរប្រតិកម្ម
  • ស្ត្រីមានផ្ទៃពោះ និង ស្ត្រីបំបៅដោះកូន
  • ការប្រុងប្រយ័ត្នជាពិសេស
  • សកម្មភាពឱសថ
  • បរិយាយប័ណ្ណឱសថ 
  • សារធាតុសកម្ម

  • ប្រសិទ្ធិភាពព្យាបាល និង កម្រិតប្រើប្រាស់

  • ហាមប្រើ

    - hypersensitivity to omeprazole, substituted benzimidazoles or to any of the excipients,

    - omeprazole like other PPIs must not be used concomitantly with nelfinavir.

  • ផលរំខាន

    Side effects

    The most common side effects (1-10% of patients) are headache, abdominal pain, constipation, diarrhoea, flatulence, nausea/vomiting.

    Blood and lymphatic system disorders

    Rare: leukopenia, thrombocytopenia

    Very rare: agranulocytosis, pancytopenia

    Immune system disorders

    Rare: hypersensitivity reactions e.g. fever, angioedema and anaphylactic reaction/shock

    Metabolism and nutrition disorders

    Rare: hyponatraemia

    Not known: hypomagnesaemia, severe hypomagnesaemia may result in hypocalcaemia. Hypomagnesaemia may also be associated with hypokalaemia.

    Psychiatric disorders

    Uncommon: insomnia

    Rare: agitation, confusion, depression

    Very rare: aggression, hallucination

    Nervous system disorders

    Common: headache

    Uncommon: dizziness, paraesthesia, somnolence

    Eye disorders

    Rare: blurred vision

    Ear and labyrinth disorders

    Uncommon: vertigo

    Respiratory, thoracic and mediastinal disorders

    Rare: bronchospasm

    Gastrointestinal disorders

    Common: abdominal pain, constipation, diarrhoea, flatulence, nausea, vomiting

    Rare: dry mouth, stomatitis, gastrointestinal candidiasis

    Not known: microscopic colitis

    Hepatobiliary disorders

    Uncommon: increased liver enzymes

    Rare: hepatitis with or without jaundice

    Very rare: hepatic failure, encephalopathy in patients with pre-existing liver disease

    Skin and subcutaneous tissue disorders

    Uncommon: dermatitis, pruritus, rash, urticaria

    Rare: alopecia, photosensitivity

    Very rare: erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN)

    Musculoskeletal and connective tissue disorders

    Uncommon: hip fracture, wrist fracture, spinal fracture

    Rare: arthralgia, myalgia

    Very rare: muscular weakness

    Renal and urinary disorders

    Rare: interstitial nephritis

    Reproductive system and breast disorders

    Very rare: gynaecomastia

    General disorders and administration site conditions

    Uncommon: malaise, peripheral oedema

    Rare: increased sweating

    Paediatric population: See package insert.

  • អន្តរប្រតិកម្ម

    Active substances with pH dependent absorption

    The decreased intragastric acidity during treatment with omeprazole might increase or decrease the absorption of active substances with a gastric pH dependent absorption.

    Nelfinavir, atazanavir, Digoxin, Clopidogrel, Posaconazole, erlotinib, ketoconazole, itraconazole

    Active substances metabolized by CYP2C19

    The metabolism of concomitant active substances also metabolized by CYP2C19 may be decreased and the systemic exposure to these substances increased.

    Cilostazol, phenytoin,

    Unknown mechanism

    Saquinavir, Methotrexate, Tacrolimus

    Inhibitors CYP2C19 and/or CYP34

    Active substances known to inhibit CYP2C19 or CYP3A4 may lead to increased omeprazole serum levels by decreasing omeprazole’s rate of metabolism.

    Clarithromycin, voriconazole

    Induces of CYP2C19 and/or 3A4

    Active substances known to induce CYP2C19 or CYP3A4 may lead to decreased omeprazole serum levels by increasing omeprazole’s rate of metabolism.

    Rifampicin, St John’s wort

  • ស្ត្រីមានផ្ទៃពោះ និង ស្ត្រីបំបៅដោះកូន

    Pregnancy

    Omeprazole can be used during pregnancy.

    Lactation

    Omeprazole is excreted in breast milk but is not likely to influence the child when therapeutic doses are used.

  • ការប្រុងប្រយ័ត្នជាពិសេស

    Precautions

    Gastric malignancy

    In the presence of any alarm symptom (e.g. significant unintentional weight loss recurrent vomiting, dysphagia, haematemesis or melena) and when gastric ulcer is suspected or present, malignancy should be excluded, as treatment may alleviate symptoms and delay diagnosis.

    Vitamin B12 absorption

    Omeprazole may reduce the absorption of Vitamin B12 due to hypo- or achlorhydria. This should be considered in patients with reduced body stores or risk factors for reduced vitamin B12 absorption on long-term therapy.

    Children with chronic illnesses

    Some children with chronic illnesses may require long-term treatment although it is not recommended.

    Risk of gastrointestinal infections

    Treatment with PPI may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter. PPI therapy may also be associated with an increased risk of Clostridium difficile-associated diarrhoea (CDAD). A diagnosis of CDAD should be considered for patients taking PPIs who develop diarrhoea that does not improve. Symptoms include watery stool, abdominal pain and fever, which may develop into more serious intestinal conditions. Factors that may predispose an individual to developing CDAD include advanced age, certain chronic medical conditions and taking broad spectrum antibiotics. Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.

    Risk of hip, wrist and spine fracture

    PPIs, especially if used in high doses and over long durations (>1year), may modestly increase the risk of hip, wrist and spine fracture, predominantly in the elderly or in presence of other recognized risk factors.

    Exceeding a treatment

    When exceeding a treatment period of 1 year, patients should be kept under regular surveillance.

    Hypomagnesaemia

    For patients expected to be on prolonged treatment or who take PPIs with digoxin or drugs that may cause hypomagnesaemia (e.g., diuretics), health care professionals should consider measuring magnesium levels before starting PPI treatment and periodically during treatment.

    Interference with laboratory tests

    Increased chromogranin A (CgA) levels may interfere with investigations for neuroendocrine tumours. To avoid this interference the omeprazole treatment should be temporarily stopped 5 days before CgA measurements.

    Sucrose, Lactose

    capsules contain sucrose and lactose.

  • សកម្មភាពឱសថ

    Omeprazole, a racemic mixture of two enantiomers reduces gastric acid secretion through a highly targeted mechanism of action. It is a specific inhibitor of the acid pump in the parietal cell. It is rapidly acting and provides control through reversible inhibition of gastric acid secretion with once daily dosing.

    Omeprazole is a weak base and is concentrated and converted to the active form in the highly acidic environment of the intracellular canaliculi within the parietal cell, where it inhibits the enzyme H+K+-ATPase- the acid pump. This effect on the final step of the gastric acid formation process is dose-dependent and provides for highly effective inhibition of both basal acid secretion and stimulated acid secretion, irrespective of stimulus.

*ព័ត៌មានឱសថត្រូវបានរៀបរៀងដោយ អ៊ីម៉ាតុគឹ មេឌីក (ខេមបូឌា) ដោយផ្អែកលើប្រភពព័ត៌មានខាងក្រោម។ សម្រាប់ព័ត៌មានលម្អិត សូមស្វែងរកនៅក្នុងក្រដាសព័ត៌មាននៃឱសថនីមួយៗ ឬ សាកសួរទៅកាន់ក្រុមហ៊ុនឱសថឬតំណាងចែកចាយនៃឱសថនីមួយៗ។

ប្រភពព័ត៌មាន៖

- ក្រដាសព័ត៌មាននៃឱសថសម្រាប់អ្នកជំនាញវេជ្ជសាស្ត្រដែលប្រើប្រាស់នៅប្រទេសជប៉ុន (Pharmaceutical and Medical Devices Agency, Pmda): https://www.pmda.go.jp

- ព័ត៌មានសង្ខេបនៃឱសថសម្រាប់អ្នកជំងឺដែលប្រើប្រាស់នៅប្រទេសជប៉ុន: http://www.rad-ar.or.jp