Omez Insta 5's 5.9g powder for oral suspension

The instruction for medical use of OMEZ® INSTA medicine the Trade name of Omez® of Inst Mezhdunarodnoye the unlicensed name Omeprazolum Dosage Form Powder for preparation of suspension for intake contains Structure of One sachet bag: active agent – the omeprazolum (micronized) 20 mg, excipients: Natrii hydrocarbonas, ksilitol, sucrose, a sucralose, xanthane gum, peppermint fragrance the Description From white till almost white color powder with a characteristic smell of mint. Pharmacotherapeutic group Digestive tract and metabolism. Drugs for treatment of the diseases connected with disturbance of acidity. Antiulcerous drugs and drugs for treatment of a gastroesophageal reflux. Inhibitors of the protonew pump. Omeprazolum ATX A02BC01 Code the Pharmacological Pharmacokinetics Omeprazolum properties powder at intake is quickly absorbed from digestive tract. At reception of 20-40 mg of omeprazolum the bioavailability is about 40%. Meal does not affect bioavailability of drug. The peak of concentration of omeprazolum in blood plasma is reached within 0.5 - 3.5 hours. Communication with proteins of plasma - about 95%. Omeprazolum is metabolized in a liver. Metabolism is carried out through the system of P450 cytochrome (CYP2C19 isoform - S-Mephenytoinum a hydroxylase). The most part of drug is removed by kidneys in the form of metabolites. Elimination half-life makes 0.5-1 hour. Concentration of omeprazolum in plasma does not correlate with degree and duration of suppression of secretion of Acidum hydrochloricum (t½ - 0.5-1 hour, and the anti-secretory effect lasts up to 2-3 days). Pharmacodynamics Specific inhibitor of the proton pump: brakes activity of H+-K+-ATFazy in covering cells of a stomach, blocking a final stage of secretion of hydrochloric acid, thereby reduces a kislotoproduktion. Omeprazolum is pro-medicine and is activated in acidic environment of secretory tubules of covering cells of a stomach. Influence is dose-dependent and provides effective inhibition to both basal, and stimulated secretion of acid, irrespective of the nature of the stimulating factor. Elimination of heartburn after administration of drug happens within 30 min. The inhibition of 50% of the maximum secretion of hydrochloric acid proceeds 24 h. Single dose in day provides the fast and effective oppression of day and night gastric secretion reaching the maximum in 4 days of treatment and disappearing by the end of the 3-4th day after the end of reception. At patients with a peptic ulcer of a duodenum the reception of 20 mg of omeprazolum supports intragastric pH higher than 3 during 17 h. Indications - treatment of the heartburn caused by hyperoxemia of gastric juice (hyperacidity). The route of administration and doses For adults and children are more senior than 18 years. Inside, in 30 min. prior to food. To pour out contents of a bag in a cup, to add 1–2 tablespoons of water (do not use other liquids or foodstuff!), carefully to stir before receiving uniform suspension and at once to drink. As necessary it is possible to wash down with a small amount of water. Single dose of 20 mg of drug is sufficient for fast stopping of symptoms of heartburn. Elderly patients and in a renal failure have no need to adjust a dose. In a liver failure there can be sufficient a daily dose of 20 mg. Side effects - thorax pains, tachycardia or bradycardia, heartbeat, hypertensia, peripheral hypostases - lack of appetite, a food faddism, an atrophy mucous language, dry language, esophageal candidiasis, a meteorism, irritation of intestines - moderate tranzitorny increase in activity of transaminases, pancreatitis - a hyponatremia, a hypoglycemia, increase in body weight - spasms, muscle weakness, joint pains, the lower extremity pains - a depression, aggression, hallucinations, drowsiness or insomnia, confusion of consciousness, nervousness, a tremor, apathy, feeling of alarm, dizziness, paresthesias - disorders of vision, sonitus, nasal bleeding, a sore throat - hemorrhagic rash and/or petechias, inflammation, an itching, dryness of integuments, a hyperhidrosis, an alopecia - urticaria, an itching, a Quincke's disease - interstitial nephrite, infections of urinary tract, a proteinuria, a hamaturia, a glucosuria - pain in testicles, a gynecomastia Seldom - a neutropenia, a leukopenia, an agranulocytosis, a leukocytosis, thrombocytopenia, anemia, including hemolytic anemia, a pancytopenia - the hepatocellular, cholestatic or mixed hepatitis Very seldom - a Lyell's disease, Stephens-Johnson's syndrome, a multiformny erythema - risk of developing spinal fractures, necks of a hip, the Contraindication wrist - hypersensitivity to any of drug components - malignant new growths of digestive tract - pregnancy and the period of a lactation - children's and teenage age up to 18 years Medicinal interactions of the Possibility of interaction of OmezInst with other medicines are limited. OmezInsta is metabolized in a liver through a system P450 cytochrome therefore at simultaneous use with drugs which are metabolized in a liver also with the participation of this system OmezInsta can reduce their removal. OmezInsta slows down excretion of diazepam, Phenytoinum and anticoagulants, such as warfarin. At combined use with anticoagulants the control of blood test, a prothrombin vremeniye, correction of a dose of OmezInst is necessary. OmezInsta, lowering acidity of gastric juice, can reduce absorption of an itrakonazol, ketokonazol. Special instructions Before the beginning and after the end of treatment the endoscopic control for an exception of a malignant new growth as treatment of OmezInsta suspension can disguise symptomatology is obligatory and delay the correct diagnostics. At long-term treatment of OmezInsta suspension there can be atrophic gastritises. Reception along with food does not affect its efficiency. Use in pediatrics the Efficiency and safety of use of OmezInsta suspension for children up to 18 years is not studied. Use for patients from the liver broken by function Omez is metabolized in a liver and at patients from the liver broken by function the elimination half-life of drug is extended therefore the drug dosage at such patients has to be reduced. Features of influence on ability to run the vehicle or potentially dangerous mechanisms Considering side effects of drug it is necessary to be careful at control of transport or other types of activity demanding the increased speed of psychomotor reactions and concentration of attention. Overdose Symptoms: confusion of consciousness, drowsiness, a headache, disorders of vision, tachycardia, dryness in a mouth nausea, the increased sweating Treatment: gastric lavage, intake of activated carbon, symptomatic therapy. Form of release and packing Packing. On 5.9 g of drug place in a sachet packages from the laminated aluminum foil. On 5 (10, 20 or 30) sachets packages together with the instruction for medical use in the state and Russian languages put in a pack from cardboard Storage conditions to Store in the dry place protected from light at a temperature not above 25 °C. To store out of children's reach! 2 years not to apply a period of storage after an expiration date. Prescription status Without prescription the Dr. of Reddi's Laboratoris Limited Producer, India the Owner of the registration certificate the Dr. of Reddi's Laboratoris Limited, India the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products Representative office Dr. of Reddi's Laboratoris Limited in the Republic of Kazakhstan: 050057 Almaty, 22nd Line St., 45