Sumamed forte, powder for oral suspension, banana, 200mg/5ml 16.74g/15ml

Composition

5 ml of the finished suspension contains azithromycin dihydrate 200 mg;

auxiliary components:

sucrose,

trisodium phosphate anhydrous,

hydroxypropylcellulose,

xanthan gum,

cherry flavor J7549,

banana flavor 78701-31,

vanilla flavor D-125038,

colloidal silicon dioxide.

Pharmacological action

Sumamed forte is an antibiotic of the macrolide group-azalide. It has a wide spectrum of antimicrobial action. Binds to the 50S subunit of the ribosome, inhibits protein biosynthesis of microorganisms. In high concentrations, it has a bactericidal effect.

Azithromycin is active against gram-positive aerobic bacteria:  Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus viridans, streptococci of groups C, F and G, Staphylococcus aureus, Staphylococcus epidermidis; some gram-positive anaerobic bacteria:  Clostridium perfringens.

Azithromycin is active against gram-negative aerobic bacteria:  Haemophilus influenzae, Haemophilus parainfluenzae, Haemophilus ducreyi, Moraxella catarrhalis, Bordetella pertussis, Bordetella parapertussis, Neisseria gonorrhoeae, Neisseria meningitidis, Helicobacter pylori, Gardnerella vaginalis, Campylobacter jejuni.

Azithromycin is also active against intracellular and other microorganisms: Mycobacterium avium complex, Legionella pneumophila, Chlamydia trachomatis, Chlamydia pneumoniae, Mycoplasma pneumoniae, Ureaplasma urealyticum, Listeria monocitogenes, Borrelia burgdorferi, Treponema pallidum.

Gram-positive bacteria resistant to erythromycin are resistant to the drug.

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:

– infections of the upper respiratory tract and ear (bacterial pharyngitis, tonsillitis, sinusitis, otitis media);– infections of the lower respiratory tract (bacterial bronchitis, interstitial and alveolar pneumonia, exacerbation of chronic bronchitis); infections of skin and soft tissues (chronic erythema migrans, the initial stage, Lyme disease, erysipelas, impetigo, secondary dermatoses); infection, sexually transmitted infections (urethritis, cervicitis);– diseases of the stomach and duodenum, associated with Helicobacter pylori.

Use during pregnancy and lactation

During pregnancy, the drug should only be administered if the expected benefit to the mother exceeds the potential risk to the fetus.

If it is necessary to introduce Sumamed to women during lactation, it is necessary to decide whether to stop breastfeeding.

Contraindications

-severe liver and kidney dysfunction;

– hypersensitivity to macrolide antibiotics;

With caution:  during pregnancy and lactation, with impaired liver and kidney function, patients with disorders or predisposition to arrhythmias and prolongation of the QT interval.

Side effects

They are rare (in 1% of cases or less).

From the digestive system:  melena, cholestatic jaundice, nausea, vomiting, diarrhea, constipation, decreased appetite, gastritis, reversible moderate increase in liver enzyme activity.

From the urinary system:  jade.

From the side of the reproductive system:  vaginal candidiasis.

From the cardiovascular system:  palpitations, chest pains.

From the central nervous system and peripheral nervous system:  dizziness, headache, vertigo, drowsiness, increased fatigue; in children-headache (in the treatment of otitis media), hyperkinesia, anxiety, neurosis, sleep disorders.

Allergic reactions:  skin rashes, angioedema, urticaria, conjunctivitis.

Dermatological reactions:  photosensitivity, itching.

From the side of laboratory parameters:  in some cases – neutrophilia, eosinophilia (altered indicators return to normal 2-3 weeks after discontinuation of treatment).

Interaction

Antacids (containing aluminum, magnesium), ethanol and food intake significantly reduce the absorption of azithromycin (capsules and suspension), so the drug should be taken at least 1 hour before or 2 hours after taking these drugs and eating.

Azithromycin, unlike other macrolide antibiotics, does not bind to cytochrome P450 isoenzymes. To date, no interactions with theophylline, terfenadine, carbamazepine, triazolam, or digoxin have been observed.

Macrolides when taken concomitantly with cycloserine, indirect anticoagulants, methylprednisolone, felodipine and drugs undergoing microsomal oxidation (cyclosporine, hexobarbital, ergot alkaloids, valproic acid, disopyramide, bromocriptine, phenytoin, oral hypoglycemic agents), slow down the elimination, increase the concentration and toxicity of these drugs, while when used in combination with cycloserine, indirect anticoagulants, methylprednisolone, felodipine and drugs undergoing microsomal oxidation (cyclosporine, hexobarbital, ergot alkaloids, valproic acid, disopyramide, bromocriptine, phenytoin, oral hypoglycemic agents). No such interaction of azalides has been observed to date.

If co-use with warfarin is necessary, careful monitoring of prothrombin time is recommended. When macrolides are taken simultaneously with ergotamine and dihydroergotamine, their toxic effect may manifest (vascular spasm, dysesthesia).

Lincosamines reduce, and tetracycline and chloramphenicol increase the effectiveness of azithromycin Pharmacologically, azithromycin is incompatible with heparin.

How to take, course of use and dosage

The drug is prescribed orally 1 time/day. Capsules and suspensions should be taken at least 1 hour before or 2 hours after a meal. The bioavailability of the drug in tablet form does not depend on food intake.

Children 6 months and older are recommended to use the drug in the form of an oral suspension or 125 MG tablets for infections of the upper and lower respiratory tract, skin and soft tissues (with the exception of chronic erythema migrans) for adults, the drug is prescribed at a dose of 500 mg 1 time/day for 3 days, the course dose is 1.5 g.

Children are prescribed at the rate of 10 mg / kg of body weight 1 time / day for 3 days, the course dose is 30 mg/kg.

For chronic erythema migrans:

for adults, the drug is prescribed 1 time/day for 5 days: 1 day – 1 g (2 tablets. 500 mg), then from 2 to 5 days at the 500 mg dose of 3 g. Children administered on day 1 at a dose of 20 mg/kg of body weight and then from 2 to 5 days – a daily dose of 10 mg/kg of body weight, dose of 60 mg/kg.

In diseases of the stomach and duodenum associated with Helicobacter pylori,1 g (2 tablets of 500 mg) is prescribed per day for 3 days in combination with an antisecretory agent and other medications.

For sexually transmitted

infections, for the treatment of uncomplicated urethritis/cervicitis, a dose of 1 g is prescribed once;

for the treatment of complicated long-term urethritis / cervicitis caused by Chlamydia trachomatis,1 g is prescribed 3 times with an interval of 7 days (1,7,14 days), the course dose is 3 g.

Rules for the preparation

of SUMAMED FORTE suspension (200 mg / 5 ml-20 ml): 8 ml of water is added to a vial containing 800 mg of azithromycin using a metered-dose syringe.

SUMAMED FORTE (200 mg / 5 ml-30 ml): 14.5 ml of water is added to a vial containing 1400 mg of azithromycin using a metered-dose syringe.

The shelf life of the prepared suspension is 5 days.

Before use, the contents of the vial are thoroughly shaken until a homogeneous suspension is obtained.

Immediately after taking the suspension, the child is given a few sips of tea to wash off and swallow the suspension remaining in the oral cavity.

After use, the dosage syringe is disassembled, washed with running water, dried and stored in a dry place.

Overdose

Symptoms: nausea, vomiting, diarrhea, temporary hearing loss.

Treatment:  symptomatic.

Special instructions

If you miss taking one dose of the drug, the missed dose should be taken as early as possible, and the subsequent ones should be taken at intervals of 24 hours.

The patient should be warned about the need to inform the doctor about the occurrence of any side effect.

Form of production

Powder for the preparation of a suspension for oral use

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

2 years

Active ingredient

Azithromycin

Conditions of release from pharmacies

By prescription

Dosage form

suspension for oral use

Purpose

Adults as prescribed by a doctor, Children as prescribed by a doctor, Pregnant women as prescribed by a doctor

Indications

Pneumonia, Otitis Media, Skin Infections, Pharyngitis, Sinusitis, Bronchitis, Infectious Diseases, Urethritis, Respiratory Tract Infections, Sore Throat, Tonsillitis