Gastritis and Ulcer / Gastrointestinal tract and Liver

Omez 1’s 40 mg lyophilized powder for injection

Brands: Dr. Reddys (India)

$15.10

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Omez 1's 40 mg lyophilized powder for injection quantity

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bc871683463e

Brands:: Dr. Reddys (India)

Description

The instruction for medical use

of OMEZ medicine

the Trade name
Omez

Mezhdunarodnoye the unlicensed

name Omeprazolum Dosage Form Powder

the Structure lyophilized for preparation of solution for injections of 40 mg
One bottle contains
active agents: omeprazolum of sodium of BP equivalent to omeprazolum of 40 mg (buffer)
excipients: sodium a carbonate anhydrous, water for injections.

The description
From white till light yellow color the lyophilized flat cake, or powder in the form of units, or the loose dried-up powder

Pharmacotherapeutic group
Antiulcerous drugs and drugs for treatment of a gastroegzofagealny reflux. Inhibitors of the protonew pump.
The ATC A02BC01 code

the Pharmacological

Pharmacokinetics Volume properties of distribution of omeprazolum at healthy people and at patients with impaired renal function identical. The volume of distribution of omeprazolum is reduced at elderly people and at patients from the liver broken by function. Linking with proteins of blood plasma – about 95%. Elimination half-life after intravenous administration of omeprazolum – about 40 minutes. Omeprazolum is completely metabolized in a system P450 cytochrome, mainly in a liver. There is no metabolite influencing gastric secretion. Nearly 80% of an intravenous dose of omeprazolum are brought out of an organism by urine in the form of metabolites and a small amount – a stake.
The pharmacodynamics
Omez is the anti-secretory drug known as inhibitor of a proton pomp, belongs to the benzimidazolny derivatives inhibiting H+K+ enzyme ATP-ase (proton pomp) in covering cells of a stomach.
After intravenous administration Omez, anti-secretory effect the maximum effect occurs within an hour, – within 2 hours. The single intravenous dose of an omez of 40 mg affects intragastralny acidity as well as repeatedly entered oral dose of an omez of 20 mg within 24 hours. The anti-secretory effect is much more long, than it was possible to expect, considering very short half-life period. It is connected with long blocking of the proton pump in covering cells.

Indications
– a peptic ulcer of a stomach and duodenum, in t. h associated with Helicobacter pylori
– a gastroesophageal reflux disease of the I-IV stage
– the erosive cankers of a stomach and duodenum connected with intake of nesteroydny anti-inflammatory drugs
– Zollinger-Ellison’s syndrome
– treatment and prevention of stressful ulcers and also their complications (bleeding, perforation, a penetration).

The route of administration and doses
At impossibility of performing oral therapy to patients with ulcer of stomach and duodenum or a reflux esophagitis is recommended to appoint intravenous administration of Omez in a dose of 40 mg once a day. Initial intravenous administration of Omez in a dose of 60 mg a day is recommended to patients with Zolingera-Ellison’s syndrome. Doses are selected individually, introduction of higher dose sometimes is required. If the size of a daily dose exceeds 60 mg, then the dose has to be divided into two introductions. Infusion solution of the drug Omez is entered intravenously by drop infusion within 20-30 minutes. It is recommended to enter infusion solution at once after its preparation.
Intravenous administration
At intravenous administration the lyophilized powder Omez of 40 mg is parted in 10 ml of sterile water for injections. The received concentration Omez – 4 mg/ml. Omez 40 mg need to be entered intravenously slowly (within 5 minutes).
Intravenous drop administration
to Part 1 bottle of Omez for intravenous drop administration in 10 ml of sterile water for injections, to add Contents of a bottle to 90 ml 0.9% of solution of sodium of chloride, or to 5% to dextrose solution.

Side effects
– thorax pains, tachycardia, bradycardia, heartbeat, hypertensia, peripheral hypostases
– lack of appetite, a meteorism, irritation of intestines, esophageal candidiasis, an atrophy mucous language, dry language
– moderate tranzitorny increase in level of transaminases, pancreatitis,
– a hyponatremia, a hypoglycemia, increase in body weight
– spasms, muscle weakness, joint pains, the lower extremity pains
– a depression, aggression, hallucinations, insomnia, confusion of consciousness, nervousness, a tremor, apathy, drowsiness, feeling of alarm, dizziness, paresthesias, disturbance of sensitivity on a face
– nasal bleeding, a sore throat
– hemorrhagic rash and/or petechias, inflammation of integuments, urtikariya, angiootek, an itching of integuments, an alopecia, dryness of integuments, a hyperhidrosis
– sonitus, a food faddism
– interstitial nephrite, infections of urinary tract, microscopically a pyuria, frequent urination, increase in creatinine, a proteinuria, a hamaturia, a glucosuria, pain in testicles, a gynecomastia
in rare instances – a pancytopenia, a granulocytosis, thrombocytopenia, a neutropenia, anemia, a leukocytosis and hemolytic anemia
is in rare instances possible development of the hepatocellular, cholestatic or mixed hepatitis, necrosis of a liver, hepatitis in a stage of a decompensation and encephalopathy
Is very rare
– a scalded skin syndrome, a syndrome Stephens-Johnson and a multiformny erythema

of the Contraindication
– hypersensitivity to any of drug components
– pregnancy and the period of a lactation
– children’s and teenage age up to 18 years

the Medicinal interactions
of the Possibility of interaction of an omez with other medicines are limited. Omez is metabolized in a liver through a system P450 cytochrome therefore at simultaneous use of drugs which are metabolized in a liver also with the participation of this system Omez can reduce removal of these drugs. Omez slows down removal of diazepam, Phenytoinum and anticoagulants, such as warfarin (control of blood test, a prothrombin time is necessary, to adjust an omeprazolum dosage).

Omez, raising gastric pH, can reduce bioavailability of some drugs. At simultaneous use of omeprazolum the absorption of an itrakonazol can decrease, a ketokonazola and co-administration of a klaritromitsin of concentration of a kloritromitsin and omeprazolum in serum increase.
Omez does not influence the CYP isoforms as it was shown in reduced metabolic interaction with CYP1A2 substrates (caffeine, acetphenetidiene, theophylline), CYP2C9 (S-warfarin, piroxicam, diclofenac and Naproxenum), CYP2D6 (metoprolol, propranolol), CYP2E1 (ethanol) and CYP3A (cyclosporine, lidocaine, quinidine, oestradiol, erythromycin, budenozid).

Special instructions
Before the beginning and after the end of treatment the endoscopic control for an exception of a malignant new growth as treatment by Omez can disguise symptomatology is obligatory and delay the correct diagnostics. At long-term treatment by Omez there can be atrophic gastritises.
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.

Overdose
Symptoms: confusion of consciousness, drowsiness, disorders of vision, tachycardia, nausea, the increased sweating, a headache and dryness in a mouth.
Treatment: gastric lavage, intake of activated carbon, symptomatic therapy.

A form of release and packing
of 10 ml the bottle of USP Tip-I of dark glass closed by brombutilovy traffic jams, which is pressed out by aluminum caps and sealed
by flip off cover. On bottles self-adhesive paste labels.
On 1 bottle together with the instruction for use in the state and Russian languages put in a pack from cardboard.

To Store storage conditions in the dry, protected from light place, at a temperature not over 25 of 0C.
To store in the places inaccessible for children!

2 years
After an expiration date not to apply a period of storage.

Prescription status
According to the prescription

Dr. of Reddi’s Laboratoris Limited Producer
of G 17/1 M.I.D.C. The industrial
Area of Tarapur, Boysar, the area 401506, 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 Ltd in the Republic of Kazakhstan:
050057 Almaty, Dzhandosov St., 21
a post office box 7,
ph. 8 (727) 3941688
fax: 8 (727) 3941294

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