Makromitsin 3 Mill. 10s IU coated tablets
- $28.60
The instruction for medical use
of medicine
MAKROMITSIN of 3.0 million ME
the Trade name
Makromitsin of 3.0 million ME
the International unlicensed
name Spheromycinum Dosage Form
of the Tablet, coated, 3.0 million ME
Structure
One tablet contains
active agent - Spheromycinum of 705.88 mg that is equivalent to 3,000,000 ME,
excipients: microcrystalline cellulose, silicon colloidal anhydrous, sodium of starch glikollit (type A), talc cleaned, magnesium stearate,
structure of a cover: the talc purified, diethyl phthalate, a hydroksipropilmetiltsellyuloza of E-5, propylene glycol, the titan dioxide.
The description
of the Tablet, coated white or cream color of round shape, biconvex, on the one hand smooth, with another - dividing risk.
Pharmacotherapeutic group
Antibacterial drugs for system use. Macroleads.
The code of automatic telephone exchange J01FA02
the Pharmacological
Pharmacokinetics Makromitsin properties is soaked up not completely. The bioavailability after intake is 33-39% (within 10-69%). Speed of absorption of Spheromycinum is lower, than at erythromycin, at the expense of higher molecular lot and high extent of ionization in acidic environment of a stomach. Reception together with food reduces bioavailability approximately by 50% and delays achievement of the maximum concentration. Time of approach of Cmax after intake 1.5-3 hours.
Makromitsin well gets into bodies and body tissues. Communication with proteins – 10%. Concentrations in fabrics remain high after concentration in plasma decreases. The peak of concentration in saliva by 1.3-4.8 times exceeds concentration in plasma. Makromitsin gets through a placenta and is allocated in breast milk. High concentrations of Makromitsin are found in a liver. Makromitsin does not get through a blood-brain barrier. Big also varies distribution volume within 383-660 l. Makromitsin gets and collects in phagocytes in which concentrations are rather high. These properties explain Makromitsin's effects on intracellular bacteria. Metabolism happens in a liver to formation of active metabolites.
Elimination half-life about 8 hours. More than 80% of the entered dose are removed with bile. Through kidneys 4-14% of the entered dose are removed.
The pharmacodynamics
Makromitsin works bacteriostatic, breaking intracellular synthesis a squirrel. Usually sensitive microorganisms: minimum overwhelming concentration (MOC) of Rhodococcus equi, Branhamella catarrhalis, Bordetella pertussis, Helicobacter pylo-ri, Campylobacter jejuni, Legionella spp., Corynebacterium diphtheriae, Moraxella spp., Mycoplasma pneumoniae, Coxiella spp., Chlamydia spp., Treponema pallidum, Borrelia burgdorferi, Leptospira spp., Propionibacterium acnes, Actinomyces spp., Eubacterium spp., Porphyromonas spp., Mobiluncus spp., Bacteroides spp., Peptostreptococcus spp., Prevotella spp. Moderately sensitive microorganisms: the antibiotic is moderately active, positive takes can be noted at concentration of an antibiotic in the inflammation center above, than MPK: Neisseria gonorrhoeae, Ureaplasma urealyticum, Clostridium perfringens. Steady microorganisms (MPK> of 4 mg/l): at least 50% of strains are steady - Methicillinum - resistant staphylococcus, Enterobacter spp., Pseudomonas spp., Acinetobacter spp., Nocardia spp., Fusobacterium spp., Haemophilus spp., Mycoplasma hominis.
Indications
the Infectious and inflammatory diseases caused by microorganisms, sensitive to drug,
- sinusitis, tonsillitis
- sharp community-acquired pneumonia, including atypical pneumonia, exacerbation of chronic bronchitis
- periodontitis
- an ugly face, the secondary infected dermatosis, abscess
- osteomyelitis, arthritis
- prostatitis, an urethritis
- diseases sexually transmitted (including. genital clamidiosis)
- toxoplasmosis at pregnant women
- prevention of a sharp articulate syndrome in rheumatism at persons with allergic reaction to penicillin
the Route of administration and doses
Makromitsin's Dosage can be manifested both in milligrams (mg), and in the international units (IU). 1 mg of Spheromycinum corresponds to about 3000 ME.
For adults and teenagers:
Inside, to food, 1-2 g (3.0-6.0 million ME) twice a day, or 0.5-1.0 g (1.5-3.0 million ME) three times a day. At a heavy course of an infection it is possible to increase a dose to 2.0-2.5 g (6.0 million ME – 7.5 million ME) two times a day.
Duration of treatment is 7-10 days
For children (at the body weight of 20 kg and more): the dose is calculated, proceeding from 150-300 thousand ME on body weight kg a day, divided into 2 or 3 receptions. The maximum daily dose at children makes 300 thousand ME on body weight kg a day. Tablets with a dosage of 3 million ME at children are not applied.
Side effects
- nausea, vomiting, diarrhea
very seldom
- pseudomembranous colitis, an ulcer esophagitis and acute colitis
- changes of functional trials of a liver and development of cholestatic hepatitis - passing paresthesias - lengthening of an interval of QT on the ECG - skin rash, a small tortoiseshell, an itching
seldom or never
- a Quincke's disease, an acute anaphylaxis
of the Contraindication
- hypersensitivity to Spheromycinum and other components of drug
- deficiency of enzyme glyukozo-6-fosfatdegidrogenazy
- children's age up to 6 years
- the lactation period
Medicinal interactions
Unlike erythromycin, a comparison macrolead is possible, Makromitsin does not contact hepatic R-450 cytochrome isoenzymes and does not interact with cyclosporine or theophylline.
Levodopa and karbidopa: simultaneous use with Makromitsin can lead to increase in elimination half-life of these drugs owing to suppression of their absorption, and in a consequence, to change of a vermicular movement of intestines.
With care it is necessary to use drug with alkaloids of an ergot and oral contraceptives
Special instructions
At patients with abnormal liver functions during use of drug it is necessary to control indicators of function of a liver. With care to appoint antibiotics, including Makromitsin, to patients with allergy symptoms. In need of a repeated course of treatment it is necessary to take a possibility of superinfection, flora, caused growth insensitive to this drug, into account.
In case of superinfection to stop administration of drug and to take the appropriate measures.
With care appoint Makromitsin at obstruction of bile ducts or at hepatic insufficiency. Makromitsin's level in cerebrospinal fluid is much lower, than in blood plasma, and is too small for implementation of therapeutic effect. Therefore Makromitsin do not apply to treatment of patients with meningitis. With renal failures in connection with small renal excretion of Makromitsin of change of a dose it is not required to patients.
Pregnancy and the period of a lactation
Makromitsin is used at pregnant women for reduction of risk of transplacental transfer of toxoplasmosis. Makromitsin has no teratogenic effect.
There Is no feature of influence of medicine on ability to drive the car and to work with potentially dangerous mechanisms messages about Makromitsin's influence on ability of the patient to driving by the car and to control of moving mechanisms.
Overdose
Symptoms: discomfort in a stomach, nausea or diarrhea.
Treatment is symptomatic. Specific antidote does not exist.
A form of release and packing
On 10 tablets in blister strip packaging from a film of polyvinylchloride and aluminum foil.
On 1 blister strip packaging together with the instruction for medical use in the state and Russian languages place in a cardboard box.
To Store storage conditions in the dry, protected from light place at a temperature not above 30 ºC
to Store out of children's reach!
3 years
not to apply a period of storage after an expiration date.
Prescription status
According to the prescription
of Proizvoditel Makleods Pharmasyyutikalz Limited
304, Atlanta to the Arcade, Marol Chech Road, Anderi (East), Mumbai –
400059 INDIA
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products:
Representative office of Makleods Pharmasyyutikalz Limited
050004, Almaty, Zhibek Zholy St., 65 and, office 314.
313 Phone number / fax: (3272) 73 53 60
The scientific secretary
To develop
of medicine
MAKROMITSIN of 3.0 million ME
the Trade name
Makromitsin of 3.0 million ME
the International unlicensed
name Spheromycinum Dosage Form
of the Tablet, coated, 3.0 million ME
Structure
One tablet contains
active agent - Spheromycinum of 705.88 mg that is equivalent to 3,000,000 ME,
excipients: microcrystalline cellulose, silicon colloidal anhydrous, sodium of starch glikollit (type A), talc cleaned, magnesium stearate,
structure of a cover: the talc purified, diethyl phthalate, a hydroksipropilmetiltsellyuloza of E-5, propylene glycol, the titan dioxide.
The description
of the Tablet, coated white or cream color of round shape, biconvex, on the one hand smooth, with another - dividing risk.
Pharmacotherapeutic group
Antibacterial drugs for system use. Macroleads.
The code of automatic telephone exchange J01FA02
the Pharmacological
Pharmacokinetics Makromitsin properties is soaked up not completely. The bioavailability after intake is 33-39% (within 10-69%). Speed of absorption of Spheromycinum is lower, than at erythromycin, at the expense of higher molecular lot and high extent of ionization in acidic environment of a stomach. Reception together with food reduces bioavailability approximately by 50% and delays achievement of the maximum concentration. Time of approach of Cmax after intake 1.5-3 hours.
Makromitsin well gets into bodies and body tissues. Communication with proteins – 10%. Concentrations in fabrics remain high after concentration in plasma decreases. The peak of concentration in saliva by 1.3-4.8 times exceeds concentration in plasma. Makromitsin gets through a placenta and is allocated in breast milk. High concentrations of Makromitsin are found in a liver. Makromitsin does not get through a blood-brain barrier. Big also varies distribution volume within 383-660 l. Makromitsin gets and collects in phagocytes in which concentrations are rather high. These properties explain Makromitsin's effects on intracellular bacteria. Metabolism happens in a liver to formation of active metabolites.
Elimination half-life about 8 hours. More than 80% of the entered dose are removed with bile. Through kidneys 4-14% of the entered dose are removed.
The pharmacodynamics
Makromitsin works bacteriostatic, breaking intracellular synthesis a squirrel. Usually sensitive microorganisms: minimum overwhelming concentration (MOC) of Rhodococcus equi, Branhamella catarrhalis, Bordetella pertussis, Helicobacter pylo-ri, Campylobacter jejuni, Legionella spp., Corynebacterium diphtheriae, Moraxella spp., Mycoplasma pneumoniae, Coxiella spp., Chlamydia spp., Treponema pallidum, Borrelia burgdorferi, Leptospira spp., Propionibacterium acnes, Actinomyces spp., Eubacterium spp., Porphyromonas spp., Mobiluncus spp., Bacteroides spp., Peptostreptococcus spp., Prevotella spp. Moderately sensitive microorganisms: the antibiotic is moderately active, positive takes can be noted at concentration of an antibiotic in the inflammation center above, than MPK: Neisseria gonorrhoeae, Ureaplasma urealyticum, Clostridium perfringens. Steady microorganisms (MPK> of 4 mg/l): at least 50% of strains are steady - Methicillinum - resistant staphylococcus, Enterobacter spp., Pseudomonas spp., Acinetobacter spp., Nocardia spp., Fusobacterium spp., Haemophilus spp., Mycoplasma hominis.
Indications
the Infectious and inflammatory diseases caused by microorganisms, sensitive to drug,
- sinusitis, tonsillitis
- sharp community-acquired pneumonia, including atypical pneumonia, exacerbation of chronic bronchitis
- periodontitis
- an ugly face, the secondary infected dermatosis, abscess
- osteomyelitis, arthritis
- prostatitis, an urethritis
- diseases sexually transmitted (including. genital clamidiosis)
- toxoplasmosis at pregnant women
- prevention of a sharp articulate syndrome in rheumatism at persons with allergic reaction to penicillin
the Route of administration and doses
Makromitsin's Dosage can be manifested both in milligrams (mg), and in the international units (IU). 1 mg of Spheromycinum corresponds to about 3000 ME.
For adults and teenagers:
Inside, to food, 1-2 g (3.0-6.0 million ME) twice a day, or 0.5-1.0 g (1.5-3.0 million ME) three times a day. At a heavy course of an infection it is possible to increase a dose to 2.0-2.5 g (6.0 million ME – 7.5 million ME) two times a day.
Duration of treatment is 7-10 days
For children (at the body weight of 20 kg and more): the dose is calculated, proceeding from 150-300 thousand ME on body weight kg a day, divided into 2 or 3 receptions. The maximum daily dose at children makes 300 thousand ME on body weight kg a day. Tablets with a dosage of 3 million ME at children are not applied.
Side effects
- nausea, vomiting, diarrhea
very seldom
- pseudomembranous colitis, an ulcer esophagitis and acute colitis
- changes of functional trials of a liver and development of cholestatic hepatitis - passing paresthesias - lengthening of an interval of QT on the ECG - skin rash, a small tortoiseshell, an itching
seldom or never
- a Quincke's disease, an acute anaphylaxis
of the Contraindication
- hypersensitivity to Spheromycinum and other components of drug
- deficiency of enzyme glyukozo-6-fosfatdegidrogenazy
- children's age up to 6 years
- the lactation period
Medicinal interactions
Unlike erythromycin, a comparison macrolead is possible, Makromitsin does not contact hepatic R-450 cytochrome isoenzymes and does not interact with cyclosporine or theophylline.
Levodopa and karbidopa: simultaneous use with Makromitsin can lead to increase in elimination half-life of these drugs owing to suppression of their absorption, and in a consequence, to change of a vermicular movement of intestines.
With care it is necessary to use drug with alkaloids of an ergot and oral contraceptives
Special instructions
At patients with abnormal liver functions during use of drug it is necessary to control indicators of function of a liver. With care to appoint antibiotics, including Makromitsin, to patients with allergy symptoms. In need of a repeated course of treatment it is necessary to take a possibility of superinfection, flora, caused growth insensitive to this drug, into account.
In case of superinfection to stop administration of drug and to take the appropriate measures.
With care appoint Makromitsin at obstruction of bile ducts or at hepatic insufficiency. Makromitsin's level in cerebrospinal fluid is much lower, than in blood plasma, and is too small for implementation of therapeutic effect. Therefore Makromitsin do not apply to treatment of patients with meningitis. With renal failures in connection with small renal excretion of Makromitsin of change of a dose it is not required to patients.
Pregnancy and the period of a lactation
Makromitsin is used at pregnant women for reduction of risk of transplacental transfer of toxoplasmosis. Makromitsin has no teratogenic effect.
There Is no feature of influence of medicine on ability to drive the car and to work with potentially dangerous mechanisms messages about Makromitsin's influence on ability of the patient to driving by the car and to control of moving mechanisms.
Overdose
Symptoms: discomfort in a stomach, nausea or diarrhea.
Treatment is symptomatic. Specific antidote does not exist.
A form of release and packing
On 10 tablets in blister strip packaging from a film of polyvinylchloride and aluminum foil.
On 1 blister strip packaging together with the instruction for medical use in the state and Russian languages place in a cardboard box.
To Store storage conditions in the dry, protected from light place at a temperature not above 30 ºC
to Store out of children's reach!
3 years
not to apply a period of storage after an expiration date.
Prescription status
According to the prescription
of Proizvoditel Makleods Pharmasyyutikalz Limited
304, Atlanta to the Arcade, Marol Chech Road, Anderi (East), Mumbai –
400059 INDIA
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products:
Representative office of Makleods Pharmasyyutikalz Limited
050004, Almaty, Zhibek Zholy St., 65 and, office 314.
313 Phone number / fax: (3272) 73 53 60
The scientific secretary
To develop
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