Sumamed (azithromycin) coated tablets 125 mg. №6

Description

Sumamed (azithromycin) coated tablets 125 mg. №6

Composition

active substance: azithromycin;

1 tablet contains azithromycin 125 mg in the form of dihydrate;

Excipients: calcium phosphate disubstituted anhydrous, hydroxypropylmethylcellulose, corn starch, modified starch, microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate, indigotine (E 132), titanium dioxide (E 171) and poly (E 171), poly.

Dosage form

Film-coated tablets.

Main physical and chemical properties: film-coated tablets, light blue, round, biconvex, marked PLIVA on one side and 125 on the other.

Pharmacotherapeutic group

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

Indications

Sumamed coated 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 tablets 125, should be used as a single daily dose 1 hour before or 2 hours after a meal. Swallow the tablets without chewing. 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 tablets 125, should be used in children weighing> 45 kg. For this group of children (weighing> 45 kg) it is recommended to prescribe an adult dose. For the treatment of children weighing 45 kg, it is recommended to prescribe Sumamed in more convenient dosage forms, such as oral suspension.

For ENT and respiratory, skin and soft tissue infections (except chronic migratory erythema), the total dose of azithromycin is 30 mg / kg body weight (10 mg / kg body weight once daily). The duration of treatment is 3 days.

In migratory erythema, the total dose of azithromycin is 60 mg / kg body weight: on the 1st day you should take 20 mg / kg body weight, then 10 mg / kg body weight once a day from the 2nd to the 5th day. The duration of treatment is 5 days.

Azithromycin has been shown to be effective in the treatment of streptococcal pharyngitis in children as a single dose of 10 mg / kg or 20 mg / kg for 3 days. A comparison of these two doses in clinical trials showed similar clinical efficacy, although bacterial eradication was more significant at a daily dose of 20 mg / kg. However, penicillin is usually the drug of choice for the prevention of pharyngitis caused by Streptococcus pyogenes and rheumatoid arthritis.

Children

Sumamed tablets 125, should be used in children weighing> 45 kg. For the treatment of children weighing 45 kg, it is recommended to prescribe Sumamed® in more convenient dosage forms, such as oral suspension.

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).