the Trade name
the International unlicensed
name Omeprazolum Dosage Form
of the Capsule kishechnorastvorimy, 20 mg
One capsule contains
active agent – omeprazolum of 20.00 mg
excipients: sugar micropellets *, sodium glikolit starch type A (Explotab), sodium lauryl sulfate, povidone (PVP K30), a gipromelloza phthalate 50 (HP 50), sucrose, a hydroksipropilmetiltsellyuloza (mivatst) 603 (gipromelloza), Mannitolum, a diacetylized monoglyceride, talc
structure of a cover of the capsule:
capsule body: copper complexes of chlorophyllins (E 141), titan dioxide (E 171), gelatin,
capsule lid: ferrous oxide yellow (E 172), the titan dioxide (E 171), gelatin
Solid gelatin capsules of No. in size 2 with the opaque body of yellow color and an opaque lid of dark green color are made of sucrose and starch corn the Description. Contents of capsules – white or whitish spherical micropellets, flavourless
Antiulcerous drugs and drugs for treatment of a gastroesophageal reflux Inhibitors of the proton
pump ATX A02BC01 Code Pharmacological Pharmacokinetics At Properties intake omeprazolum are quickly soaked up from digestive tract. Gets into covering cells of a mucous membrane of a stomach. 90-95% of omeprazolum contact proteins of blood plasma. It Biotransformirutsya in a liver. Elimination half-life makes 0.5 – 1 hour. At patients with chronic diseases of a liver the elimination half-life increases till 3 o’clock. About 72-80% are removed by kidneys, 20% are removed with a stake.
of Omegast® is inhibitor H +-To +-ATP-ases. Brakes activity of N +-To +-ATP-ases in covering cells of a stomach, thereby blocks a final stage of secretion of hydrochloric acid that leads to decrease in level of basal and stimulated secretion. After single dose of drug inside therapeutic action develops within the first hour, reaches a maximum in 2 h and continues during 24 h. After the reception termination the secretory activity is completely restored in 3-5 days. In combination therapy for N.’s eradikation of pylori the simultaneous use of Omegasta® and antibiotics allows to stop quickly disease symptoms, to reach high extent of healing of the damaged mucous, permanent long remission and to reduce a likelihood of developing bleeding from digestive tract.
– a peptic ulcer of a stomach and duodenum
– a gastroesophageal reflux disease (GERD), a reflux esophagitis
– Zollinger’s syndrome – Ellisona
– the digestive tract erosive cankers connected with intake of non-steroidal anti-inflammatory drugs (NPVS)
– as a part of combination therapy for Helicobacter pylori eradikation
the Route of administration and doses
by the Adult.
Drug is recommended to be used before food, without damaging the capsule, to wash down with a small amount of liquid.
In a peptic ulcer of a stomach – on 20-40 mg of 1 times a day within 4-8 weeks.
In a peptic ulcer of a duodenum of Omegast® about 20 mg of 1 times a day within 2-4 weeks are appointed. In resistant cases the increase in a dose to 40 mg is possible.
In a gastroesophageal reflux disease (GERD), a reflux esophagitis – on 20 mg daily 1 time a day within 4-8 weeks.
At Zollingera-Ellison’s syndrome of Omegast® about 60 mg of 1 times a day are appointed. If necessary the dose is raised to 80-120 mg, dividing into 2 receptions. Duration of a course is defined individually (before surgery).
In the digestive tract erosive cankers caused by intake of NPVS non-steroidal anti-inflammatory drugs – on 20 mg of 1 times a day within 4-8 weeks.
For Helicobacter pylori eradikation – 2 times a day (strictly in 12 hours, in the morning and in the evening) within 7 – 14 days in a combination with antimicrobic therapy are appointed Omegast® on 20 mg (depending on the applied scheme of treatment).
– urticaria, an itching, a Quincke’s disease
– fatigue, the general weakness
– increase in body weight, a hypoglycemia, a hyponatremia
– a purpura, petechias, xeroderma, a hair loss
– tachycardia, bradycardia, hypertensia, a vasculitis, peripheral hypostases
– nausea, vomiting, irritation of a large intestine, an atrophy mucous language, dryness in a mouth
– myalgia, muscle and bones pain, muscular spasms, muscle weakness
– sonitus, a food faddism, moderate disturbances of visual and hearing
– aggression, a depression, drowsiness, hallucinations, block, sleep disorders, nervousness, alarm, a tremor, dizziness, paresthesia
– a proteinuria, a hamaturia, a glucosuria, increase in creatinine of serum
– a gynecomastia, pain in testicles
– moderate increase in laboratory indicators of function of a liver
is Very rare
– anaphylactic reactions
– a pancytopenia, an agranulocytosis, anemia, including hemolytic anemia, a neutropenia, thrombocytopenia, a leukocytosis
– Stephens-Johnson’s syndrome
– a liver failure
– interstitial nephrite
of the Contraindication
– hypersensitivity to drug components
– children’s and teenage age up to 12 years
– pregnancy and the period of a lactation
– hereditary intolerance of fructose or malabsorption of glucose galactose
At simultaneous use with the drug Omegast® the decrease in absorption of a ketokonazol, ampicillin, iron preparations and and lengthening of the period of removal of warfarin, diazepam, Phenytoinum and other medicines which mabolizirutsya in a liver with the participation of enzymes of a system of P450 2C19 cytochrome is possible.
Omeprazolum strengthens action of a defenin, slows down discharge of benzodiazepine tranquilizers (Sibazonum).
At prolonged use of omeprazolum and a klaritromitsin, there is an increase in their concentration in blood plasma.
At simultaneous use with antacids the medicinal interaction is not noted.
before therapy it is necessary to exclude malignant new growths of digestive tract as treatment of Omegastom® can disguise symptomatology. Against the background of Omegast® the distortion of results of laboratory indicators of a liver and indicators of gastrin in plasma is possible.
Use in pediatrics
the Efficiency and safety of treatment of children is adequately not confirmed.
Pregnancy and the period of a lactation
is not recommended to be applied to pregnant women and nursing mothers as adequate researches were not conducted.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Considering side effects from nervous system (moderate disturbances of visual and hearing, aggression, a depression, drowsiness, fatigue, weakness, hallucinations, block, sleep disorders, nervousness, alarm, a tremor, dizziness, paresthesia), it is necessary to be careful at the control of transport or other types of activity demanding the increased speed of psychomotor reactions and concentration of attention.
Signs of overdose were noted after administration of drug in a dose from 320 mg to 900 mg (i.e. in doses, at 16-45 times exceeding therapeutic).
Symptoms: disorders of vision, confusion of consciousness, sweating strengthening, drowsiness, dryness in a mouth, a headache, nausea, tachycardia, arrhythmia.
Treatment: carry out symptomatic therapy. Carrying out a hemodialysis is not rather effective in connection with high extent of linking of omeprazolum with proteins of blood plasma.
The form of release and packing
On 7 or 10 capsules place in blister strip packaging from a formatura of aluminum and printing aluminum foil.
On 1, 3, 5 (for 10 capsules) or 2 (for 7 capsules) planimetric packings together with the instruction for medical use in the state and Russian languages place in a pack cardboard with the hologram of firm – producer.
To Store storage conditions at a temperature not above 25 °C in the dry, protected from light place.
To store out of children’s reach!
not to apply a period of storage after the expiration date specified on packing.
According to the prescription
JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika Producer
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