Sumamed (azithromycin) dispersible tablets 500 mg. №6

Description

Sumamed (azithromycin) dispersible tablets 500 mg. №6

Composition

active substance: azithromycin;

1 tablet contains 125 mg, 250 mg, 500 mg or 1000 mg of azithromycin in the form of azithromycin dihydrate;

Excipients: saccharin sodium dihydrate, microcrystalline cellulose, crospovidone (type A), povidone, sodium lauryl sulfate, colloidal anhydrous silica, magnesium stearate, aspartame (E 951), 125 mg tablets – banana flavor, 500 mg tablets, 250 mg tablets , 1000 mg – orange flavoring.

Dosage form

Dispersible tablets.

Basic physical and chemical properties:

• tablets of 125 mg: round flat tablets of white or almost white color with a bevel and embossing “TEVA 125” on one side;
• tablets of 250 mg: round flat tablets of white or almost white color with a bevel, with a line on one side and embossed “TEVA 250” on the other;
• tablets of 500 mg: round flat tablets of white or almost white color with a bevel, with a line on one side and embossed “TEVA 500” on the other;
• tablets of 1000 mg: round flat tablets of white or almost white color with a facet, with two perpendicular lines on one side and embossed “TEVA 1000” on the other.

Pharmacotherapeutic group

Antibacterial agents for systemic use. Macrolides, lincosamides and streptogramins. Azithromycin.
ATX code J01F A10.

Pharmacological properties

Azithromycin is a macrolide antibiotic that belongs to the group of azalides. The molecule is formed by the introduction of a nitrogen atom into the lactone ring of erythromycin A. The mechanism of action of azithromycin is to inhibit bacterial protein synthesis by binding to the 50S subunit of ribosomes and inhibiting peptide translocation.

Indications

Sumamed dispersible tablets is an antibiotic with a wide range of antimicrobial action. By binding to the 50S-cytogenetic unit of the ribosome, the drug suppresses the production of proteins in the pathogenic microorganism. In high concentrations, it has a bactericidal effect (kills bacteria). Active against a number of Gr + bacteria:

• Streptococcus agalactiae;
• Streptococcus pneumoniae;
• Streptococcus pyogenes;
• Streptococcus viridans;
• Staphylococcus aureus;
• Clostridium perfringens;
• Staphylococcus epidermidis.

The drug has no effect on Gr-bacteria that are resistant to the antibiotic erythromycin.
Also, this drug is effective against gram-negative microorganisms:

• Haemophilus influenza;
• Moraxella catar-rhalis;
• Haemophilus parainfluenzae;
• Haemophilus ducreyi;
• Bordetella pertussis;
• Helicobacter pylori;
• Gardnerella vaginalis;
• Neisseria meningitides;
• Bordetella parapertussis;
• Neisseria gonorrhoeae;
• Brucella melitensis;
• Campylobacter jejuni.

In addition, the drug is effective against Mycobacterium avium complex, Chlamydia pneumoniae, Legionella pneumophila, Chlamydia trachomatis, Mycoplasma pneumoniae, Listeria monocitogenes, Ureaplasma urealyticum, Borrelia burgdorferi, Treponema pallidum.
Sumamed is prescribed for infections of the upper respiratory tract (tonsillitis, sinusitis, bacterial pharyngitis, otitis media), lower respiratory tract infections (interstitial, alveolar pneumonia, exacerbation of chronic bronchitis, bacterial bronchitis), skin, soft tissues (impetigo, erysipelas, secondary pyodermatosis, initial stage tick-borne borreliosis – erythema migrans), as well as sexually transmitted infections (cervicitis, urethritis), diseases of the stomach / duodenum associated with Helicobacter pylori.

Contraindications

You can not prescribe Sumamed for allergies to antibiotics of the macrolide group, severe liver / kidney dysfunction. This medicine is used with caution in liver / kidney diseases, heart disorders, predisposed to arrhythmias, ECG changes (lengthening of the Q – T interval).

Application during pregnancy and lactation

Perhaps the appointment of Sumamed in these periods for health reasons.

Method of administration and dosage

Sumamed dispersible tablets used internally, 1 hour before or 2 hours after a meal. If you miss 1 dose of the drug, the missed dose should be taken as early as possible, and the next – at intervals of 24 hours.

Sumamed dispersible tablets is pre-dissolved in at least 50 ml of water. Stir the resulting suspension thoroughly before use.

Adults and children over 12 years of age weighing ≥45 kg.

For infections of the ENT organs, respiratory tract, skin and soft tissues (except chronic migratory erythema), the total dose of azithromycin is 1500 mg (500 mg once daily). The duration of treatment is 3 days.

In migratory erythema, the total dose of azithromycin is 3 g, which should be taken according to the following scheme: 1000 mg on the first day, then – 500 mg once a day from the 2nd to the 5th day.

For sexually transmitted infections, the recommended dose of azithromycin is 1000 mg once.

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

For infections of the ENT organs, respiratory tract, skin and soft tissues (except for chronic migratory erythema), azithromycin is used at a rate of 10 mg / kg body weight once daily for 3 days (total dose of azithromycin is 30 mg / kg).

Dose calculation for children weighing <45 kg:

18-30 kg 250 mg;

31-44 kg 375 mg;

At least 45 kg dose recommended for adults.

Sumamed, powder for oral suspension (100 mg / 5 ml), or Sumamed® forte, powder for oral suspension (200 mg / 5 ml) is recommended for children under 3 years of age. For pharyngitis / tonsillitis caused by Streptococcus pyogenes, Sumamed is used at a dose of 20 mg / kg / day for 3 days (course dose 60 mg / kg). The maximum daily dose is 500 mg / day.

In migratory erythema azithromycin is used at a rate of 20 mg / kg 1 time per day on the first day, then – 10 mg / kg 1 time per day from the 2nd to the 5th day.

For the convenience of using a course dose of 60 mg / kg for children, it is recommended to use Sumamed, powder for oral suspension (100 mg / 5 ml), or Sumamed forte, powder for oral suspension (200 mg / 5 ml).

Children

Used for children over 3 years.

Overdose

Overdose symptoms: temporary hearing loss, diarrhea (loose stools), vomiting.
Overdose treatment: urgent gastric lavage, intake of sorbents (for example, activated carbon), symptomatic treatment.

Side effects:

• Disorders of the central nervous system: vertigo (dizziness), convulsions, cephalgia (headache), paresthesia (tingling sensation, crawling creeps, burning sensation on the skin), drowsiness, impotence, insomnia, increased physical activity, aggressiveness, nervousness, anxiety.
• Disorders of the circulatory, lymphatic systems: a decrease in the number of platelets (thrombocytopenia), neutrophilic leukocytes (neutropenia).
• Disorders of the organs of perception: reversible hearing impairment, deafness, tinnitus, impaired perception of taste, smell.
• Digestive tract disorders: stool disorders (constipation, diarrhea), nausea, abdominal pain / cramps, flatulence (bloating), anorexia (lack of appetite), discoloration of the tongue, inflammation of the colon (pseudomembranous colitis), cholestatic jaundice (due to impaired bile outflow) ), hepatitis (liver inflammation), abnormal liver function tests, liver failure, liver necrosis (breakdown), sometimes fatal.
• Disorders of the cardiovascular system: arrhythmia (arrhythmia, palpitations, ventricular (ventricular) tachycardia, widening of the Q-T interval on the ECG, bidirectional ventricular tachycardia).
• Allergic reactions: angioedema (rapid swelling of the face, lips, tongue with impaired breathing), itching, rashes, urticaria, photosensitivity (sensitivity to the sun), anaphylactic shock (fatal in rare cases), erythema multiforme, allergic contact dermatitis.
• Disorders of the genitourinary system: nephritis (inflammation of the kidneys), acute kidney failure.
• Movement disorders: arthralgia (joint pain).
• Others: candidiasis (fungal infection), vaginitis (inflammation of the vagina).