Название документа

Drug "Sumamed ^®" is applied at the infections caused by the microorganisms sensitive to azithromycin:

ENT organs (bacterial pharyngitis / tonsillitis, sinusitis, average otitis);
respiratory infection (bacterial bronchitis, community-acquired pneumonia);
an infection of leather and soft tissues: the migrating erythema (initial stage of a disease of Lyme), an ugly face, impetigo, secondary pyodermatoses;
an infection, sexually transmitted: the uncomplicated genital infections caused by Chlamydia trachomatis.

Structure

1 tablet contains 500 mg of azithromycin (active ingredient) in the form of dihydrate azithromycin.

Excipients: sodium saccharin dihydrate, cellulose microcrystalline, krospovidon (type A), povidone, sodium lauryl sulfate, silicon dioxide colloidal waterless, magnesium stearate, aspartame (E 951), fragrance orange.

Contraindication

Hypersensitivity to azithromycin, erythromycin, to any makrolidny or ketolidny antibiotic and also to any other component of medicine.

Route of administration

is Applied inside in 1 hour prior to or in 2 hours after meal. In case of the admission of reception of 1 dose of medicine it is necessary to accept the passed dose as soon as possible, and the subsequent - with an interval of 24 hours.

Tablet that is dispersed, is previously dissolved in not less than 50 ml of water. Before application carefully to stir the received suspension.

Adults and children are more senior than 12 years with body weight ≥ 45 kg.

In infections of ENT organs, airways, skin and soft tissues (except the chronic migrating erythema) the general dose of azithromycin makes 1500 mg (500 mg of 1 times a day). Duration of treatment is 3 days.

At the migrating erythema the general dose of azithromycin makes 3 g which should be accepted according to the following scheme: 1000 mg in the first day, then - on 500 mg of 1 times a day from the 2nd to the 5th day.

In infections, sexually transmitted , the recommended dose of azithromycin makes 1000 mg once.

Children of 3-12 years with body weight <45 kg.

In infections of ENT organs, airways, skin and soft tissues (except the chronic migrating erythema) azithromycin is applied at the rate of 10 mg/kg of body weight of 1 times a day within 3 days (the general dose of azithromycin makes 30 mg/kg).

Calculation of a dose for children with body weight <45 kg.

Body weight	an azithromycin Dose in mg
18-30 kg	250 mg
31-44 kg	375 mg
not less than 45 kg	Dose recommended for adults

to Children up to 3 years recommends to apply "Sumamed ^®", powder to oral suspension (100 mg / 5 ml), or "Sumamed ^® forte", powder for oral suspension (200 mg / 5 ml). In pharyngitis/tonsillitis, caused Streptococcus pyogenes , medicine "Sumamed ^®" apply in a dose 20 mg/kg/days within 3 days (course dose of 60 mg/kg). The maximum daily dose makes 500 mg/days

At the migrating erythema apply azithromycin at the rate of 20 mg/kg of 1 times a day in the first day then - 10 mg/kg of 1 times a day from the 2nd to the 5th day.

To convenience of application of a course dose of 60 mg/kg to children recommends to apply "Sumamed ^®", powder to oral suspension (100 mg / 5 ml), or "Sumamed ^® forte", powder for oral suspension (200 mg / 5 ml).

Feature of application

Pregnant women

Are not present adequate data on use of azithromycin to pregnant women. In researches of reproductive toxicity at animals of a teratogenic adverse effect of azithromycin on a fruit it is noted, however medicine got through a placenta. Safety of use of azithromycin during pregnancy is not confirmed. Therefore azithromycin is appointed during pregnancy, only if the advantage exceeds risk.

It was reported, that azithromycin gets into breast milk, but corresponding and properly controlled clinical trials which would give the chance to characterize pharmacokinetics of excretion of azithromycin in breast milk, was not carried out.

Research of fertility was conducted on rats; the indicator of pregnancy decreased after administration of azithromycin. The relevance of these data on the person is unknown.

Drivers

Proof that azithromycin can worsen ability to steer motor transport or other mechanisms are absent, but it is necessary to consider a possibility of development of side reactions, such as dizziness, drowsiness, disorder of vision.

Overdose

Experience of clinical use of azithromycin demonstrates to what side effects which develop at reception of higher than is recommended, medicine doses, are similar to those that are observed at application of usual therapeutic doses. They can include diarrhea, nausea, vomiting, a reverse hearing loss. In case of overdose if necessary intake of activated carbon and performing the general symptomatic and supporting treatment is recommended.

Side reactions

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In the following table the side reactions defined by clinical trials and in the period of post-marketing observation at application of all dosage forms of azithromycin. Side reactions are given on the systems of bodies and frequency. The undesirable reactions registered in the period of post-marketing observation are italicized. Frequency is determined as follows: very often (≥ 1/10); often (≥ 1/100 to <1/10); infrequently (≥ 1/1000 to <1/100); seldom (≥ 1/10000 to <1/1000), it is very rare (<1/10000); it is unknown (it is impossible to determine by the available data). Within each group on the frequency of manifestations the undesirable phenomena are noted as reduction of their weight.

Undesirable reactions which are possibly connected with azithromycin on the basis of the data obtained during clinical trials and during post-marketing observation.

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Class of systems and bodies	Undesirable reaction	Frequency
Infection and an invasion	Candidiasis, oral candidiasis, vaginal infections, pneumonia, a fungal infection, a bacterial infection, pharyngitis, a gastroenteritis, breath dysfunction, rhinitis	infrequently
Infection and an invasion	Pseudomembranous colitis
from blood and lymphatic system	Leukopenia, a neutropenia, an eosinophilia	infrequently
from blood and lymphatic system	Thrombocytopenia, hemolytic anemia	is unknown
from the immune system	Quincke's disease, reaction of hypersensitivity	infrequently
from the immune system	Anaphylactic reaction
from a metabolism	Anorexia	infrequently
from mentality	Nervousness, insomnia	infrequently
	Agitation	is rare
	Aggression, concern, a delirium, hallucinations
from nervous system	Headache	is frequent
	Dizziness, drowsiness, a dysgeusia, paresthesias	infrequently
	Faint, spasms, a hypesthesia, psychomotor superactivity, an anosmia, an ageusia, a parosmiya, a myasthenia gravis
from organs of sight	Disorder of vision	infrequently
from organs of hearing	Disorder from organs of hearing, vertigo	infrequently
from organs of hearing	Hearing disorder, including deafness and/or a ring in ears
from heart	Palpitation	infrequently
from heart	Trembling fibrillation of ventricles (torsade de pointes), arrhythmia, including ventricular tachycardia,	does not know lengthening of a QT interval on the ECG
from vessels	Inflows	infrequently
from vessels	Arterial hypotension	is unknown
from a respiratory system	Dispnoe, nasal bleeding	infrequently
from a digestive tract	Diarrhea
	Vomiting, an abdominal pain, nausea	it is frequent
	Constipation, a meteorism, dyspepsia, gastritis, a dysphagy, dryness in a mouth, an eructation, ulcers in an oral cavity, saliva hypersecretion	infrequently
	Pancreatitis, discoloration of language
from a gepatobiliarny system	Abnormal liver function, cholestatic jaundice	it is rare
from a gepatobiliarny system	Liver failure (which seldom led to a lethal outcome), fulminantny hepatitis, necrotic hepatitis	is unknown
from skin and hypodermic cellulose	infrequently
	Photosensitivity, sharp generalized exanthematous pustulyoz	is rare
	Stephens-Johnson's Syndrome, a toxic epidermal necrolysis, a polymorphic erythema, reaction to medicine with an eosinophilia and system symptoms	is unknown
from a musculoskeletal system	Osteoarthritis, myalgia, a dorsodynia, neck pain	infrequently
from a musculoskeletal system	Arthralgia	is unknown
from an urinary system	Dysuria, kidney pain	infrequently
from an urinary system	Acute renal failure, interstitial nephrite	is unknown
from a reproductive system and mammary glands	Uterine bleeding, testicular violations	infrequently
General violations and local reactions	Hypostasis, an adynamy, an indisposition, fatigue, a face edema, a stethalgia, a hyperthermia, pain, peripheral hypostasis	infrequently
Laboratory indicators	Lowered quantity of lymphocytes, the increased quantity of eosinophils, reduced level of bicarbonate of blood, increase in level of basophiles, increase in level of monocytes, increase in level of neutrophils	is frequent
Laboratory indicators	Raised the AsAT level, raised the AlAT level, raised bilirubin level in blood, raised urea level in blood, raised creatinine level in blood, changes of indicators of potassium in blood, increase in level of alkaline phosphatase, increase in level of chloride, increase in level of glucose, increase in level of platelets, decrease in level of a hematocrit, increase in level of bicarbonate, a sodium level deviation	infrequently
Defeat and poisoning	Complication after the procedure	infrequently

Information on side effects which, perhaps, are connected with prevention and treatment Mycobacterium Avium Complex , is based on data of clinical trials and observations during the post-marketing period. These undesirable reactions differ on type or on frequency from about what it was reported at application of high-speed dosage forms and dosage forms of long action.

Undesirable reactions which are perhaps connected with prevention and treatment of Mycobacterium Avium Complex.

Rash, an itch

Class of systems and bodies	Undesirable reaction	Frequency
from a metabolism	Anorexia	it is frequent
from nervous system	Dizziness, a headache, paresthesias, a dysgeusia	is frequent
from nervous system	Hypesthesia	infrequently
from organs of sight	Disorder of vision	is frequent
from organs of hearing	Deafness	is frequent
from organs of hearing	Hearing disorder, a ring in ears	infrequently
from heart	Palpitation	infrequently
from a digestive tract	Diarrhea, an abdominal pain, nausea, a meteorism, gastrointestinal discomfort, a frequent liquid chair	is very frequent
from digestive system	Hepatitis	infrequently
from skin and hypodermic cellulose	is frequent
from skin and hypodermic cellulose	Stephens-Johnson's Syndrome, photosensitivity	infrequently
from a musculoskeletal system	Arthralgia	is frequent
General violations and local reactions	Increased fatigue	is frequent
General violations and local reactions	Asthenia, an indisposition	infrequently

Storage conditions

Drug does not demand special storage conditions. To store out of children's reach.

Expiration date - 2 years.

Characteristics
Active ingredients	Azithromycin
Amount of active ingredient	500 mg
Applicant	Teva
Code of automatic telephone exchange	J01FA10 Azithromycin
Interaction with food	To
Light sensitivity	Not sensitive
Market status	The branded generic
Origin	Chemical
Prescription status	According to the prescription
Primary packing	blister
Producer	D.O.O. PLIVA HRVATSKA.
Quantity in packing	6 tablets
Release form	tablets for internal use dispersed
Route of administration	Oral
Sign	Import
Storage temperature	from 5 °C to 25 °C
Trade name	Sumamed