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MEXIDOL® (Emoxipine) 125 mg, 50 coated tablets
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Description
The instruction for medical use
of Mesakol Torgovoye medicine a name
Mesakol
Mezhdunarodnoye the unlicensed
name Mesalazin Lekarstvennaya
the Tablet form, coated 400 mg
Structure
One tablet contains
active agent of a mesalazin of 400 mg,
excipients: hydrophosphate calcium a dihydrate, starch corn, cellulose microcrystalline, a gipromelloza of 2208 (Metotsel of K4M), K-90 povidone, talc purified of silicon dioxide colloidal anhydrous, sodium of starch glikolit (Type A), isopropyl alcohol,
structure of a cover: methacrylic acid a kopolimer type C (Eudragit of L-100-55), methacrylic acid a kopolimer type B (Eudragit of S-100), the dibutyl phthalate, talc purified the titan dioxide (E 171), ferrous oxide red (E 172), polyethyleneglycol 6000, isopropyl alcohol, acetone, water purified.
The description
of the Tablet of henna-red color, round, biconvex, covered with a kishechnorastvorimy cover.
Pharmacotherapeutic group
Intestinal anti-inflammatory drugs. Aminosalicylic acid and similar drugs.
The code of automatic telephone exchange A07EC02
the Pharmacological
Pharmacokinetics Later properties of intake of Mesakol during a passage on intestines mesalazin is released from tablets gradually, and about 28% – in an ileal gut, the rest of a tablet is completely released in terminal department of a small intestine and in a large intestine. This process is not influenced by changes rn the Wednesdays caused by intake of food or other drugs. Due to rather low extent of absorption of a mesalazin and its fast transformation into N-acetyl-5-aminosalicylic acid (N-atsetil-5-ASK) already in a mucous membrane of intestines, concentration of a mesalazin in blood plasma remains rather small. Linking with proteins of blood plasma of a mesalazin makes 43%, a metabolite (N-atsetil-5-ASK) of 75-83%.
Time of achievement of the maximum concentration (Tmax) of a mesalazin and its metabolite (N-atsetil-5-ASK) is 4-12 hours. Elimination half-life (T1/2) of a mesalazin and metabolite (N-atsetil-5-ASK) makes about 12 hours, but can fluctuate within 2-15 hours, depending on the accepted dose, the clearance-300 of ml/min. Mesalazin is removed by kidneys, mainly in an acetylized form.
The pharmacodynamics
Mesakol inhibits activity of a neutrophylic lipoxygenase and synthesis of metabolites of arachidonic acid (prostaglandins and leukotrienes) which are inflammation mediators. Slows down migration, degranulation, phagocytosis of neutrophils and also secretion of immunoglobulins lymphocytes. Mesakol has antioxidant properties due to ability to contact free oxygen radicals and to destroy them.
Indications
– the nonspecific ulcer colitis (NUC) (prevention and treatment of aggravations)
– Crohn’s disease (prevention and treatment of aggravations)
the Route of administration and doses
the Adult: for treatment of easy and medium-weight forms of the nonspecific ulcer colitis (NUC) and Crohn’s disease appoint inside 400 mg 3 times a day, the maximum single dose makes 800 mg. At severe forms the daily dose can be increased to maximum – 3-4 g. Recommend to use drug in high doses no more than 8-12 weeks.
For prevention of a recurrence drug appoint 1.2 g/days in a dose.
To children 6 years (prevention and treatment) are more senior: at acute process, depending on weight of a clinical picture, apply 30-50 mg/kg/days, divide a daily dose into three receptions. For maintenance of steady remission of 15-30 mg/kg/days, the daily dose is divided into 2 receptions. Children with body weight more than 40 kg can appoint a dose, as for the adult.
Duration and the scheme of treatment are determined by the attending physician.
A pill should be taken to food, without chewing.
Side effects
Often
– dryness in a mouth, stomatitis, loss of appetite, nausea, vomiting, an abdominal pain, a meteorism, diarrhea, heartburn, increase in activity of liver enzymes in blood, hepatitis, acute pancreatitis
– a headache, dizziness, an indisposition, sleep disorders, paresthesias, a tremor, sonitus, a depression
– fever
– a bronchospasm
– a pericarditis, myocarditis
– interstitial nephrite, a nephrotic syndrome, a renal failure
Seldom
– urticaria, a skin itching, an erythema
– a hair loss
– tachycardia, an arterial hypertension or hypotonia, pains behind a breast
– an asthma
– myalgias, arthralgias
Isolated cases
– a proteinuria, a hamaturia, a crystalluria, an oliguria, an anury
– anemia, a leukopenia, an agranulocytosis, thrombocytopenia, a prothrombinopenia
– reduction of products of plaintive liquid
of the Contraindication
– hypersensitivity to salicylates or other component of drug
– blood diseases (anemia, leukoses)
– hemorrhagic diathesis
– a peptic ulcer of a stomach or duodenum in an aggravation phase
– deficit glyukozo-6-fosfatdegidrogenazy
– a heavy chronic liver failure
– heavy chronic kidney disease
– pregnancy and the period of a lactation
– children’s age up to 6 years
Medicinal interactions
Mesakol causes strengthening of effect of anticoagulants, strengthening of hypoglycemic action of derivatives of sulphonylurea, increases toxicity of a methotrexate, reduces tuberculostatic effect of rifampicin and uricosuric action of a probenetsid, weakens activity of furosemide, Spironolactonum, streptocides. Slows down cyanocobalamine absorption.
Special instructions
Reasonablly regular performing the general blood test (before the beginning, in time and also after treatment) and urine, control of secretory function of kidneys.
In case of the admission of administration of drug the passed dose should be accepted at any time or together with the following dose. At suspicion on development of a syndrome of acute intolerance of a mesalazin it is necessary to cancel administration of drug.
Features of influence of medicine 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 potentially dangerous mechanisms.
Overdose
it is not revealed.
Form of release and packing
of the Tablet, coated 400 mg.
On 10 tablets place in planimetric bezjyacheykovy packing from aluminum foil. On 5 planimetric bezjyacheykovy packs together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.
To Store storage conditions in the dry, protected from light place, at a temperature not over 25C.
To store out of children’s reach!
4 years
not to use a period of storage after an expiration date.
Prescription status
According to the prescription
Sun Pharmaceutical Industries Ltd Producer.
Legal address:
Acme Plaza, Andheri – Kurla Road,
Andheri (E), Mumbai 400,059, India
the Address of location of production:
Survey #214, Govt. Ind. Area, Phase II,
Silvassa 396,230, U.T of D & NH, India.
The name and the country of the owner of the registration certificate
of Sun Pharmaceutical Industries Ltd., India
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods):
050004, Almaty, Tulebayev St., 38, 5 floor
Ph. (727) 250-92-35, fax (727) 250-33-64
sunreports@intelsoft.kz, sunalmaty@intelsoft.kz
Additional information
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