Omez 10 (capsule)
Omez 20 (capsule)
Omez 40 (capsule)
SCHEDULING STATUS:
Proprietary name
(And dosage form):
Omez 10 (capsule)
Omez 20 (capsule)
Omez 40 (capsule)
COMPOSITION:
Omez 10: Each capsule contains 10 mg of omeprazole
Omez 20: Each capsule contains 20 mg omeprazole
Omez 40: Each capsule contains 40 mg of omeprazole
Pharmacological classification
11.4.3 A drug, on the gastric-intestinal tract other
Pharmacological action
Omeprazole is an inhibitor of the Proton pump (H +, K +-ATPase). It inhibits both the basal and stimulated gastric acid secretion by parietal cells, whether by acetylcholine, gastrin and histamine-induced. Please pay attention to the side effects of omeprazole
Omeprazole does not affect of acetylcholine, histamine, or stomach receptors.
Pharmacokinetics
Oral omeprazole is good, but absorbed in varying degrees. The absorption of omeprazole takes place in the small intestine and typically within three minutes before six hours completed. The bioavailability is dependent on dose and gastric pH and can reach 70% with repeated administration. Food does not affect the bioavailability of omeprazole.
Omeprazole is bound more than 95% of plasma proteins. Will have clearance from the circuit by metabolism in the liver with a plasma half-life of 30 to 90 minutes.
Mainly, hepatic metabolism via the cytochrome P450 (CYP) Isoenzyme (CYP2C19). The inactive metabolites are excreted mainly via the urine (80%), while the remaining 20% of the ingested dose are their droppings. The average elimination half-life in the Terminal phase of the plasma concentration time curve is about 40 minutes. There is no change in plasma half-life during treatment. Time curve (AUC), and not on the actual plasma concentration at any given time – the inhibition of acid secretion is used the area under the plasma concentration.
INDICATIONS
Omeprazole is indicated:
Adults
• Treatment of duodenal ulcer, including measures to prevent a relapse of peptic ulcer and reflux esophagitis.
• Long-term management of reflux esophagitis and Zollinger-Ellison syndrome.
• For the symptomatic treatment of heartburn in patients with gastroesophageal reflux disease (GERD) and the short term relief of functional dyspepsia.
• Helicobacter pylori-positive duodenal ulcers as part of a program to eradicate with suitable antibiotics.
• Treatment of non-steroidal anti-inflammatory drugs (NSAID) numerous stomach and / or duodenal ulcers / erosions.
• Reducing the risk of stomach and / or duodenal ulcers / erosion and reduce the risk of relapse after previously healed stomach and / or to develop peptic ulcers / erosions in patients with NSAID.
Children
In the short term (up to 3 months) treatment of severe ulcerative reflux esophagitis resistant to previous medical treatment.
CONTRA-INDICATIONS
Hypersensitivity to any of the ingredients
Safety in pregnancy and lactation has not been established
WARNINGS about side effects of omeprazole
Symptomatic response to omeprazole therapy does not preclude the presence of gastric ulcers or malignancy or a malignant disease of the esophagus. The administration of omeprazole in this situation may delay the diagnosis (see special precautions).
A dose reduction can patients with impaired liver function (see dosage and application).
There are only very limited experience with the use of omeprazole IN CHILDREN.
THE LONG TERM SAFETY OF omeprazole in patients with kidney AND / OR liver failure was not proven.
This medicine can cause sleepiness and HAVING difficulty concentrating THAT EXACERBATED by the simultaneous intake of alcohol or other Central depressant CAN RESULT. Patients should be advised, especially at the beginning of therapy AGAINST taking charge of vehicles and machinery or performing potentially hazardous activities WHERE can result in loss of concentration to accidents.
Observe interactions and side effects of omeprazole
Omeprazole is via the hepatic cytochrome P450 enzyme system, which metabolizes the metabolism of other drugs that may affect metabolized, if at the same time given by these enzymes. The Elimination of diazepam, warfarin and phenytoin can extend when omeprazole is administered at the same time.
The audit recommended the INR and serum levels of phenytoin and dosage reductions may be necessary if omeprazole is at the same time. There is a possible interaction of omeprazole with digoxin and a 10% increase in the bioavailability of Digoxin can be expected.
It may interact with other drugs that also will be metabolized by the cytochrome P450 enzyme system.
Pregnancy and lactation
Safety in pregnancy and lactation has not been established (see contra-indications).
DOSAGE and instructions for use
Omeprazole will be recommended, given in the morning and unzerkaut with a half glass of liquid. The capsules should be not chewed or crushed.
Recommended dosages FOR ADULTS
Duodenal ulcer
20 mg once a day for two to four weeks.
In some duodenal ulcer patients, which can be once a day effective refractory to other treatment regimens, 40 mg.
Prevention of recurrence in patients with ulcers duodenal
10 mg once daily.
If necessary, the dose to 20 can increase-40 mg once a day.
The above recommended doses include Helicobacter pylori-positive duodenal ulcers as part of the programme to eradicate with suitable antibiotics.
Peptic ulcer and reflux esophagitis
20 mg once a day for four to eight weeks.
In some stomach ulcer and reflux esophagitis patients, which can be once a day effective refractory to other treatment regimens, 40 mg.
For the long-term treatment of patients with reflux esophagitis, the recommended dose is 20 mg once a day. If necessary, the dose to 20 can increase-40 mg once a day.
In patients with severe or symptomatic reflux esophagitis treatment can continue once a day with omeprazole at a dose of 20 mg.
NSAID-associated gastric-duodenal lesions with or without a long term therapy with NSAIDS
20 mg once a day.
The healing period of 4 weeks occurs in most patients. For patients not fully cure be cured after the first course can usually while another 4 weeks of treatment.
Prevention of NSAID-associated gastric-duodenal lesions and dyspeptic symptoms
20 mg once a day. Side effects of omeprazole are to be taken seriously.
Symptomatic gastro reflux disease
20 mg daily.
The patients can adequately on 10 mg daily, therefore individual dose adjustment should be taken into account.
If the control of symptoms not every day has been reached after 2 weeks treatment with 20 mg recommended further investigation.
Zollinger-Ellison Syndrome
60 mg once a day.
The dosage should be individually adjusted and the treatment continues as long as it is clinically indicated. At doses of 80 mg a day should the dose divided and administered twice a day.
There are only very limited experience with the use of omeprazole for children (see warnings).
Severe colitis reflux esophagitis in children 1 year and older
Recommended dosage:
Weight: Dosage:
10-20 kg: 10 mg once daily. If necessary on 20 mg once daily
> 20 kg: 20 mg once a day. If required increase to 40 mg once daily
Old
Dose reduction is necessary in elderly patients.
The long-term safety of omeprazole in patients with renal and hepatic dysfunction has not been studied (see warnings).
Patients with impaired renal function
Not when impaired renal function dose reduction needed.
Impaired liver function
Bioavailability and half-life in plasma of omeprazole are increased in patients with impaired liver function, is therefore a daily dose of 10-20 mg usually sufficient.
SIDE EFFECTS AND SPECIAL PRECAUTIONS
Side effects
Blood and lymphatic system
Rare: Leukopenia, thrombocytopenia, agranulocytosis, Pancytopenia
Endocrine diseases
Rare: Gynecomastia
Metabolic and nutritional disorders
Rare: Hyponatremia
Psychiatric disorders
Rare: Reversible confusion, restlessness, aggression, depression and hallucinations (particularly in critically ill patients)
Diseases of the nervous system
Common: headache (hard enough to the weaning some patients cause)
Occasionally: Dizziness, drowsiness, insomnia, parasthaesias
Eye diseases
Rare: blurred vision
Vascular disease
Rare: Peripheral edema
Respiratory, thoracic and Mediastinal disorders
Rare: Bronchospasm
Diseases of the gastrointestinal tract
Frequent: Diarrhea (hard enough to a discontinuation of therapy in some patients require), constipation, abdominal pain or colic, nausea, vomiting, flatulence
Rare: dry mouth, stomatitis, esophageal candidiasis, taste disorders
Liver and gall diseases
Uncommon: Increased liver enzyme values
Rare: Hepatitis with or without jaundice, hepatic encephalopathy
Skin and subcutaneous tissue
Occasional: skin rash, urticaria, pruritus
Rare: sensitivity to light, bullous eruption, Toxic Epidermal Necrolysis, Stevens-Johnson Syndrome, alopecia, erythema multiforme
Musculoskeletal, connective tissue and bone disorders
Rare: Asthenia, joint pain, muscle pain
Kidneys and urinary tract
Rare: interstitial nephritis
Others
Uncommon: Discomfort
Rare: hypersensitivity (E.g., fever, angioedema, bronchospasm, interstitial nephritis) and anaphylactic shock
Special precautions
Effects associated with acid inhibition:
During a long-term treatment, gastric glands cyst in increased frequency reported. These physiological changes result from pronounced inhibition of secretion of stomach acid. Reduced stomach acid stomach acid increases count of bacteria normally in the gastro-intestinal tract. The treatment with omeprazole can lead to an increased risk of gastric-intestinal infections such as salmonella and Campylobacter.
In the presence of symptoms such as significant unintended weight loss, repeated vomiting, dysphagia, hematemesis or melena, and if stomach ulcer is suspected or exists, malignancy should be excluded because symptoms and diagnostic delay treatment with omeprazole can alleviate.
Known symptoms of overdosage and particulars of its treatment
Blurred vision, confusion, sweating, hot flashes, headaches, malaise, nausea and tachycardia of omeprazole overdose have been reported. There is no specific antidote for overdose with omeprazole.
The treatment is symptomatic and supportive.
Due to high protein binding omeprazole is not easily dialysierbar. Advice should are recommended for doctor / medical patients, in which an overdose is confirmed or suspected.
IDENTIFICATION
Omez 10: Off-white to pale yellow elliptical, spherical enteric pellets in a hard gelatin capsule with opaque Lavender CAP and opaque yellow coloured body filled. “Omeprazole 10 mg ‘ engraved printed in black ink on the CAP and”R157″with black ink on the body.
Omez 20: Body grey off-white to pale yellow elliptical, spherical enteric pellets in a hard gelatin capsule with opaque Lavender CAP and opaque iron filled. “Omeprazole 20 mg ‘ engraved printed in black ink on the CAP and”R158″with black ink on the body.
Omez 40: Off-white to pale yellow elliptical, spherical enteric pellets in a hard gelatin capsule with opaque yellow CAP and opaque Lavender colored body filled. “Omeprazole 40 mg ‘ engraved printed in black ink on the CAP and”R159″with black ink on the body.
PRESENTATION
Omez 10: Blister packs of 30 capsules
Omez 20: Blister packs of 30 capsules
White plastic bottles with 30 capsules
Omez 40: Blister packaging with 14 capsules
STORAGE
Not more than 25 ° C. Before light and moisture.
Keep the blister in the carton until ready to use.
Do not store the containers tightly closed.
Not ACCESSIBLE BY CHILDREN because of the side effects of omeprazole.