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medicalmeds.eu Medicines Antibiotic. Hemomitsin

Hemomitsin

Препарат Хемомицин. Stada Arzneimittel ("ШТАДА Арцнаймиттель") Германия



General characteristics. Structure:

Gelatinous solid capsules, light blue color, size No. 0; contents of capsules - powder of white color. 1 капс. azithromycin (in the form of a dihydrate) 250 mg Excipients: lactose anhydrous, starch corn, sodium lauryl sulfate, magnesium stearate. Structure of a cover: titanium E171 dioxide, dye patent blue VE131, gelatin. 6 - blisters (1) - packs cardboard. Tablets, film coated caesious color, round, biconvex. 1 таб. azithromycin (in the form of a dihydrate) 500 mg Excipients: cellulose microcrystallic and cellulose microcrystallic silicate, sodium carboxymethylstarch (type A), povidone, magnesium stearate, talc, silicon dioxide colloid. Structure of a cover: titanium dioxide, talc, коповидон, ethyl cellulose, macrogoal 6000, indigo carmine (indigotin) E132, dye varnish of green 8%: indigo carmine (indigotin) E132, quinolinic yellow E104. 3 - blisters (1) - packs cardboard. Powder for preparation of suspension for intake of white or almost white color, with a fruit smell; the prepared suspension of almost white color with a fruit smell. 5 ml ready сусп. azithromycin (in the form of a dihydrate) 100 mg Excipients: xanthane gum, sodium saccharinate, calcium carbonate, silicon dioxide colloid, sodium phosphate anhydrous, sorbitol, fragrance cherry, fragrances apple and strawberry. 11:43 g - bottles of dark glass (1) complete with a measured spoon - packs cardboard. Powder for preparation of suspension for intake of white or almost white color, with a fruit smell; ready suspension of almost white color with a fruit smell. 5 ml ready сусп. azithromycin (in the form of a dihydrate) 200 mg Excipients: xanthane gum, sodium saccharinate, calcium carbonate, silicon dioxide colloid, sodium phosphate dodecahydrate, sorbitol, fragrance cherry, fragrances apple and strawberry. 10 g - bottles of dark glass (1) complete with a measured spoon - packs cardboard.




Pharmacological properties:

Antibiotic of a broad spectrum of activity. Azithromycin is the representative of subgroup of makrolidny antibiotics - azaleads. In high concentration has bactericidal effect. Hemomitsin is active concerning aerobic gram-positive bacteria: Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus spp. groups C, F and G, Streptococcus viridans, Staphylococcus aureus; aerobic gram-negative bacteria: Haemophilus influenzae, Moraxella catarrhalis, Bordetella pertussis, Bordetella parapertussis, Legionella pneumophila, Haemophilus ducreyi, Helicobacter pylori, Campylobacter jejuni, Neisseria gonorrhoeae and Gardnerella vaginalis; anaerobic bacteria: Bacteroides bivius, Clostridium perfringens, Peptostreptococcus spp. Drug is active concerning intracellular microorganisms: Chlamydia trachomatis, Mycoplasma pneumoniae, Ureaplasma urealyticum, Borrelia burgdorferi, and also concerning Treponema pallidum. To drug gram-positive bacteria, resistant are steady against erythromycin. Absorption. Azithromycin is quickly absorbed from a GIT that is caused by its stability in acid medium and lipophilicity. After intake of Hemomitsin in a dose of 500 mg of Cmax of azithromycin in a blood plasma it is reached in 2.5-2.96 h and makes 0.4 mg/l. Bioavailability makes 37%. Distribution. Azithromycin well gets into respiratory tracts, bodies and fabrics of an urogenital path, into a prostate, into skin and soft tissues. High concentration in fabrics (is 10-50 times higher, than in a blood plasma) and long T1/2 are caused by low linkng of azithromycin with proteins of a blood plasma, and also its ability to get into eukaryotic cells and to concentrate in the environment with a low rn, a surrounding lysosome. It, in turn, defines the big seeming Vd (31.1 l/kg) and high plasma clearance. Ability of azithromycin to collect preferential in lysosomes is especially important for elimination of intracellular activators. It is proved that phagocytes deliver azithromycin to places of localization of an infection where it is released in the course of phagocytosis. Concentration of azithromycin in the centers of an infection it is reliable above, than in healthy fabrics (on average for 24-34%) and correlates with degree of inflammatory hypostasis. Despite high concentration in phagocytes, azithromycin has no significant effect on their function. Azithromycin remains in bactericidal concentration in the inflammation center within 5-7 days after reception of the last dose that allowed to develop short (3-day and 5-day) courses of treatment. Removal. Removal of azithromycin from a blood plasma takes place in 2 stages: T1/2 makes 14-20 h in the range from 8 to 24 h after administration of drug and 41 h – in the range from 24 to 72 h that allows to use drug of 1 times/days.


Indications to use:

The infectious and inflammatory diseases caused by microorganisms, sensitive to drug: — infections of upper parts of respiratory tracts and ENT organs (quinsy, sinusitis, tonsillitis, average otitis); — scarlet fever; — infections of lower parts of respiratory tracts (bacterial and atypical pneumonia, bronchitis); — infections of an urogenital path (uncomplicated urethritis and/or cervicitis); — infections of skin and soft tissues (the ugly face, impetigo for the second time infected a dermatosis); — a disease Laima (borreliosis) for treatment of an initial stage (erythema migrans); — the diseases of a stomach and a duodenum associated with Helicobacter pylori (as a part of a combination therapy) (for tablets).


Route of administration and doses:

Children (drug is allowed for use since 6 months depending on a dosage. See the instruction):
 
Way of preparation of suspension for intake:
gradually add the water (distilled to a bottle or prokipyachenny and cooled) to a tag, carefully shake up bottle contents before receiving homogeneous suspension. If the level of homogeneous suspension is located below a tag on the label of a bottle, repeatedly add water to a tag and shake up. The prepared suspension is stable at the room temperature within 5 days.
Drug is accepted in 1 times/days. In 1 hour prior to or in 2 hours after food.
At infections of upper and lower respiratory tracts, skin and soft tissues (except for the chronic migrating erythema) the amount of drug undertakes at the rate of 10 mg on 1 kg of weight of the child, 1 times a day, during 3kh days (a course dose of 30 mg/kg). Depending on the body weight of the child the following mode of dosing is recommended:
Body weight of the patient
 
Daily dosage (if you bought suspension of 100 mg / 5 to ml)
 
Daily dosage (if you bought suspension of 200 mg / 5 to ml)
 
10 – 14 kg
 
100 mg (5 ml) – 1 spoon a day – 3 days
 
100 mg (2,5 ml) – ½ spoons a day – 3 days
 
15 – 25 kg
 
200 mg (10 ml) – 2 spoons a day – 3 days
 
200 mg (5 ml) – 1 spoon a day – 3 days
 
26 – 35 kg
 
300 mg (15 ml) – 3 spoons a day – 3 days
 
300 mg (7,5 ml) – 1 ½ spoons a day – 3 days
 
36 – 45 kg
 
400 mg (20 ml) – 4 spoons a day – 3 days
 
400 mg (10 ml) – 2 spoons a day – 3 days
 
More than 45 kg
 
Appoint doses for adults: 1 tablet 500 of mg a day – 3 days
 
Appoint doses for adults: 1 tablet 500 of mg a day – 3 days
 
 
Directly after suspension reception the child should allow to drink several drinks of liquid (water, tea) to wash away and swallow the suspension which remained in an oral cavity.
 
In that case if the dose of drug was passed, it needs to be accepted, whenever possible, at once, and then to accept the subsequent doses at an interval of the 24th hour.
 

Adults and children are more senior than 12 years:

Drug is accepted in 1 times/days. In 1 hour prior to or in 2 hours after food.
At infections of upper and lower parts of respiratory tracts – 500 mg a day within 3 days (a course dose – 1,5 mg)
At infections of skin and soft tissues – 1 g a day in the first day for 1 reception, further on 500 mg a day daily from 2 to 5 day (a course dose of 3 g)
At acute infections of an urogenital path and urinogenital bodies (an uncomplicated urethritis or a cervicitis) – once 1 g.
At a disease Laima (borreliosis) for treatment of an initial stage (erythema migrans) – 1 g a day in the first day ha one reception and on 500 mg a day daily from 2 to 5 day (a course dose of 3 g)
At the peptic ulcer of a stomach and a 12-perstny gut associated with Helicobacter pylori – 1 g a day within 3 days as a part of the combined antikhelikobakterny therapy.

Features of use:

It is not necessary to accept drug during meal. Observance of an interval not less than 2 h between Hemomitsin's reception and antiacid drugs is recommended. After cancellation of treatment at some patients hypersensitivity reactions can remain that demands specific therapy and medical control.


Side effects:

From the alimentary system: diarrhea (5%), nausea (3%), abdominal pains (3%); 1% and less - dyspepsia, vomiting, a meteorism, a melena, cholestatic jaundice, increase in activity of liver enzymes, at children is locks, anorexia, gastritis, taste change, candidiasis of a mucous membrane of an oral cavity. From cardiovascular system: heartbeat, thorax pain (1% and less). From TsNS: dizziness, headache, вертиго, drowsiness; children have a headache (at therapy of average otitis), a hyperkinesia, uneasiness, neurosis, a sleep disorder (1% and less). From a reproductive system: vaginal candidiasis. From an urinary system: nephrite (1% and less). Allergic reactions: rash, Quincke's edema; children have a conjunctivitis, an itch, urticaria. Other: increased fatigue, photosensitization.


Interaction with other medicines:

At simultaneous use of Hemomitsin and antacids (aluminum - and magniysoderzhashchy) azithromycin absorption is slowed down. Ethanol and food slow down and reduce azithromycin absorption. At joint purpose of warfarin and azithromycin (in usual doses) change of a prothrombin time is not revealed, however considering that at interaction of macroleads and warfarin strengthening of anticoagulating effect is possible, careful control of a prothrombin time is necessary for patients. The combined use of azithromycin and digoxin increases concentration of the last. At simultaneous use of azithromycin with ergotamine and dihydroergotamine strengthening of toxic action of the last (a vasospasm, a dizesteziya) is noted. Joint purpose of a triazolam and azithromycin reduces clearance and strengthens pharmacological action of a triazolam. Azithromycin slows down removal and increases concentration in plasma and toxicity of Cycloserinum, indirect anticoagulants, Methylprednisolonum, felodipin, and also the medicines which are exposed to a microsomal oxidation (carbamazepine, терфенадин, cyclosporine, hexobarbital, ergot alkaloids, valproic acid, Disopyramidum, Bromocriptinum, Phenytoinum, peroral hypoglycemic means, theophylline and other ksantinovy derivatives) - at the expense of inhibition azithromycin of a microsomal oxidation in hepatocytes. Linkozamina weaken efficiency of azithromycin, and tetracycline and chloramphenicol - strengthen. Pharmaceutical interaction Pharmaceutical azithromycin is incompatible with heparin.


Contraindications:

liver failure; — renal failure; — children's age up to 12 years (for capsules and tablets); — children's age up to 12 months (for suspension of 200 mg / 5 ml); — children's age up to 6 months (for suspension of 100 mg / 5 ml); — hypersensitivity to antibiotics of group of macroleads. With care it is necessary to appoint drug at pregnancy, at arrhythmia (ventricular arrhythmias and lengthening of an interval of QT are possible), to children with the expressed abnormal liver functions or kidneys.


Overdose:

Symptoms: nausea, temporary hearing loss, vomiting, diarrhea. Treatment: gastric lavage, performing symptomatic therapy.


Storage conditions:

List B. It is necessary to store drug in the unavailable to children, protected from light place, at a temperature from 15 ° to 25 °C. A period of validity - 2 years.


Issue conditions:

According to the recipe


Packaging:

Tablets, film coated 500 mg. In the blister 3 tablets, 1 blister in a cardboard pack; Capsules of 250 mg. In the blister of 6 capsules, 1 blister in a cardboard pack; Powder for preparation of suspension for intake of 100 mg / 5 мл*. In a bottle from dark glass. The measured spoon on 5 ml, with risky on 2,5 ml is enclosed in packaging. * That the dosage of 100 mg / 5 ml means: it means that in each 5 ml (1 whole spoon) of ready suspension 100 mg of active ingredient of an antibiotic contain. At preparation of medicine for the use in a bottle 20 ml (4 spoons) of suspension turn out. Thus, if your child weighs from 10 to 14 kg, then on a course of treatment to you there will be enough one bottle of Hemomitsin, 100 mg / 5 ml. Powder for preparation of suspension for intake of 200 mg / 5 мл*. In a bottle from dark glass. The measured spoon on 5 ml, with risky on 2,5 ml is enclosed in packaging. * That the dosage of 200 mg / 5 ml means: it means that in each 5 ml (1 whole spoon) of ready suspension 200 mg of active ingredient of an antibiotic contain. At preparation of medicine for the use in a bottle 20 ml (4 spoons) of suspension turn out. Thus, if your child weighs from 15 to 25 kg, then on a course of treatment to you there will be enough one bottle of Hemomitsin, 200 mg / 5 ml.



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