Azimed of a tablet

General characteristics. Structure:

Acting veshchestvo:azithromycin;

1 tablet contains dihydrate azithromycin, in terms of azithromycin, 500 mg;

auxiliary veshchestva:kaltion hydrophosphate anhydrous; gipromeloz (gidroksipropilmetiltsellyuloz); starch corn; sodium krakhmalglikolit (type A); cellulose microcrystallic; to sodium lauryl sulfate; magnesium stearate; mix for a covering of "Opadry II BLUE" 33G30700 (polyethyleneglycol (macrogoal); lactose, monohydrate; titanium dioxide (Е 171); gipromeloz (gidroksipropilmetiltsellyuloz); triacetin, indigo carmine (Е 132)).

Description. Tablets, film coated.

Pharmacological properties:

Pharmacodynamics. Azithromycin is the representative of group of makrolidny antibiotics – azaleads which have a wide range of antimicrobic action. It suppresses biosynthesis of proteins of microorganisms, contacting ribosome 50S-subunit. It is active concerning a number of gram-positive bacteria: Streptococcus pneumoniae, S. pyogenes, S. agalacticae, streptococci of the C, F groups, and G, Staphylococcus aureus and S. epidermidis. Does not affect the gram-positive bacteria steady against effect of erythromycin. It is effective rather gram-negative microorganisms: Haemophilus influenzae, H. parainfluenzae and H. ducrei, Moraxella catarrhalis, Bordetella pertussis and B. parapertussis, Neisseria gonorrhoeae and N. meningitidis, Brucella melitensis, Helicobacter pylori, Gardnerella vaginalis. Affects sensitive anaerobic microbes: Clostridium spp., Peptostreptococcus spp. and Peptococcus spp. Besides, it is effective rather intracellular and other microorganisms, including Legionella pneumophila, Chlamydia trachomatis and C. pneumoniae, Mycoplasma pneumoniae, Ureaplasma urealyticum, Listeria monocitogenes, Treponema pallidum, Borrelia burgdorferi.

Pharmacokinetics. At intake drug is well soaked up and quickly distributed on all organism, and in fabrics very high concentration of an antibiotic are reached. Has a long elimination half-life and it is slowly allocated from fabrics.

The specified properties define a drug route of administration: once a day for 3 days. It is removed, generally with bile in not changed look, a small part is removed by kidneys 

Pharmaceutical characteristics.

The main physical and chemical svoystva:tabletka, film coated, light blue color, an oval form, with a biconvex surface, from a risky on the one hand tablet. On cross section the kernel of white color is visible.

Incompatibility. Pharmaceutical it is incompatible with heparin.

Indications to use:

The infections caused by the microorganisms sensitive to azithromycin:
Infections of ENT organs (bacterial pharyngitis / tonsillitis, sinusitis, average otitis).
Respiratory infections (bacterial bronchitis, not hospital pneumonia).
Infections of skin and soft tissues: the chronic migrating erythema (an initial stage of a disease of Lyme), an ugly face, impetigo, secondary pyodermatoses.
Infections, sexually transmitted: uncomplicated urethritis / cervicitis.
The infections of a stomach and duodenum caused by Helicobacter pylori as a part of complex therapy.

Route of administration and doses:

Азимед® it is necessary to apply for an hour to or in two hours after food as the concomitant use breaks azithromycin absorption.

Drug is accepted once a day. Swallow of tablets, without chewing.

Adult and детямс body weight bolee45 kg.

At infections of ENT organs, respiratory tracts, skin and soft tissues (except the chronic migrating erythema): 500 mg (1 tablet disposable) in days within 3 days.

At chronic migrating eriteme:vzrosly – 1 time a day for 5 days, the 1st day – 1 g (2 tablets on 500 mg), then – on 500 mg (1 tablet) from the 2nd to the 5th day.

At infections, sexually transmitted (an uncomplicated urethritis / cervicitis):1 g disposable (2 tablets on 500 mg).

At a peptic ulcer of a stomach and duodenal kishki:1 (2 tablets on 500 mg) in days for 3 days as a part of complex therapy on doctor's orders.

In case of the admission of reception of 1 dose of drug it is necessary to accept the passed dose as soon as possible, and the following – bucketed at 24 o'clock.

Детямс with a body weight less than 45 kg use azithromycin drugs in other dosage form.

Patients with the broken function pochek:bolny with a slight or moderately severe renal failure it is not necessary to korrigirovat a dose. There is no experience of use of drug at heavy renal failures.

Patients with the broken function to a pecheni:poskolk azithromycin is metabolized in a liver and removed with bile, drug should not be used to patients with a serious illness of a liver.

At people of elderly vozrastant need to change a dosage.

Features of use:

Allergic reactions.

In isolated cases it was reported about ability of azithromycin to cause serious side reactions (seldom – lethal), such as Quincke's disease and anaphylaxis. Some of these reactions were followed by recurrent symptoms and demanded longer observation and treatment. After the end of treatment of reaction of hypersensitivity at some patients can remain that demands specific therapy under observation of the doctor.

The extended cordial repolarization and interval of QT which increased risk of development of cardiac arrhythmia and trembling/ventricular fibrillation were observed at treatment by other makrolidny antibiotics. The similar effect of azithromycin cannot be excluded completely at patients with the increased risk of the extended cordial repolarization. It is necessary to appoint with care drug to patients with the inborn or acquired prolongation of an interval of QT, with disturbances of electrolytic balance, especially in the presence of a hypopotassemia and a hypomagnesiemia.

Streptococcal infections.

Penicillin is drug of the first row at treatment of the pharyngitis/tonsillitis caused by Streptococcus pyogenes and also at prevention of acute rheumatic polyarthritis. Azithromycin is generally effective in treatment of a streptococcal infection of a stomatopharynx, but there are no data which would confirm its efficiency in prevention of acute rheumatic polyarthritis.

Superinfections.

As well as at treatment possibility of superinfection (for example, mycoses) exists other antibacterial drugs.

Renal failure.

Patients with insignificant dysfunction of kidneys (clearance of creatinine> of 40 ml/min.) have no need to change a dose.

Liver failure.

As azithromycin is metabolized in a liver and removed with bile, drug should not be used to patients with serious diseases of a liver.

Drug contains lactose that should be considered to patients with insufficiency of lactase, a galactosemia or a syndrome of disturbance of absorption of a glucose/galactose.

During treatment by drug it is necessary to abstain from the use of alcoholic drinks.

Ability to influence speed of response at control of motor transport or work with other mechanisms.

Does not influence.

Side effects:

From system of a krovi:trombotsitopeniye, tranzitorny weak neutropenia.

From the central nervous system: dizziness / вертиго, headache, drowsiness, syncope, spasms, food faddism, disturbance of sense of smell, paresthesia, adynamy, sleeplessness.

Mental расстройства:редко – aggression, concern, a hyperactivity, uneasiness, nervousness.

From body a hearing slukha:ukhudsheniye, deafness, a ring in ears (the majority of these problems are reversible).

From cardiovascular system: a heart consciousness, the arrhythmia connected with ventricular tachycardia; seldom – lengthening of a QT interval, trembling/ventricular fibrillation, arterial hypotension, thorax pain.

From a digestive trakta:toshnot, vomiting, diarrhea, pains/spasms in a stomach, liquid excrements, anorexia, dyspepsia, a lock, language discoloration, pancreatitis, a loss of appetite, gastritis, a meteorism; in isolated cases – pseudomembranous colitis.

From gepatobiliarny system: seldom – hepatitis, reversible moderate increase in activity of hepatic transaminases, cholestatic jaundice; in isolated cases – necrotic hepatitis, liver dysfunction (in isolated cases leads to a lethal outcome).

From skin: itch, rash, Quincke's disease, small tortoiseshell, photosensitivity, poliformny erythema, Stephens-Johnson's syndrome, toxic epidermal necrolysis.

From musculoskeletal apparata:artralgiya.

From an urinary system: intersticial nephrite, acute renal failure.

From reproductive system: vaginitis.

Others: an anaphylaxis, including hypostases (in isolated cases leads to a lethal outcome), candidiasis.

Interaction with other medicines:

It is necessary to appoint carefully azithromycin to patients together with other drugs which can extend QT interval.

Antacids. When studying influence of simultaneous use of antacids on azithromycin pharmacokinetics changes in bioavailability generally are not observed though plasma peak concentration of azithromycin decrease. Azithromycin needs to be accepted for an hour to or in 2 hours after reception of an antacid.

Carbamazepine. Azithromycin does not show considerable influence on plasma levels of carbamazepine or on its active metabolites.

Cyclosporine. Some of related makrolidny antibiotics influence cyclosporine metabolism. As pharmacokinetic and clinical researches of possible interaction at a concomitant use of azithromycin and cyclosporine were not conducted, it is necessary to weigh carefully a therapeutic situation before purpose of a concomitant use of these drugs. If the combined treatment is considered justified, it is necessary to carry out careful monitoring of levels of cyclosporine and to respectively regulate a dosage.

Coumarinic anticoagulants. It was reported about the raised tendency to bleedings in communication by simultaneous use of azithromycin and warfarin or cumarine-like peroral anticoagulants. It is necessary to pay attention to the frequency of monitoring of a prothrombin time.

Digoxin. At some patients certain makrolidny antibiotics influence metabolism of digoxin in intestines. Respectively, in case of simultaneous use of azithromycin and digoxin it is necessary to remember a possibility of increase in concentration of digoxin and to carry out monitoring of levels of digoxin.

Methylprednisolonum. Azitromitsinne considerably influences Methylprednisolonum pharmacokinetics.

Terfenadin. It was not reported about interaction between azithromycin and terfenadiny. As well as in a case with other makrolidny antibiotics, it is necessary to appoint azithromycin with care in a combination with terfenadiny.

Theophylline. Azithromycin does not influence theophylline pharmacokinetics at a concomitant use of azithromycin and theophylline. The combined use of theophylline and other makrolidny antibiotics can lead to increase in level of theophylline in blood serum.

Zidovudin.1000 mg single doses and 1200 mg or 600 mg reusable doses of azithromycin do not influence plasma pharmacokinetics and allocation with urine of a zidovudine or its glyukuronidny metabolites. However reception of azithromycin increases concentration of a fosforilirovanny zidovudine, clinically active metabolite in mononukleara in peripheric circulation. The clinical importance of these data is not clear, but can be useful to patients.

Didanozin. Use of azithromycin in a daily dose of 1200 mg does not influence pharmacokinetics of a didanozin at their concomitant use.

Rifabutin. Simultaneous use of azithromycin and a rifabutin does not influence plasma concentration of these drugs. At a concomitant use of azithromycin and rifampicin development of a neutropenia is possible. Though the neutropenia, most likely, is connected using a rifabutin, the causal relationship with azithromycin is not established with a concomitant use.

Contraindications:

Hypersensitivity to active ingredient, to any other component of drug or to other makrolidny antibiotics.
Because of a theoretical possibility of an ergotism it is not necessary to appoint azithromycin along with ergot derivatives.
This dosage form is not intended for treatment of children with body weight to 45 kg.

Use during pregnancy or feeding by a breast.

In reproduction researches on animals of an adverse effect of azithromycin on a fruit it is noted. Drug gets through a placenta. Because of the insufficient number of clinical data are not recommended to appoint drug the pregnant women and mothers nursing (except for cases, when necessary according to vital indications). It is necessary to resolve an issue concerning the termination of feeding during administration of drug.

Children.

Drug is appointed to children with body weight by more than 45 kg.

Children with body weight to 45 kg are recommended to appoint azithromycin in other dosage forms.

Overdose:

Typical symptoms of overdose: a reversible hearing disorder (a temporary hearing loss), the expressed nausea, vomiting, diarrhea. In case of overdose it is necessary to accept absorbent carbon and to carry out the symptomatic therapy directed to support of vital signs of an organism.

Storage conditions:

Period of validity 2 years. Not to apply after the termination of the period of validity specified on packaging. To store in original packaging at a temperature not above 25 °C. To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

Tablets, film coated, on 500 mg No. 3 or No. 10 in the blister, 1 blister in a pack.