Sumamed (azithromycin) powder for oral suspension 100 mg/5 ml. 400 mg. 20 ml. vial

Description

Sumamed (azithromycin) powder for oral suspension 100 mg/5 ml. 400 mg. 20 ml. vial

Composition

active substance: azithromycin;

1 dose (5 ml) of suspension contains azithromycin 100 mg in the form of azithromycin dihydrate;

Excipients: sucrose, sodium phosphate, hydroxypropylcellulose, xanthan gum, colloidal anhydrous silica,

flavoring agent (s) and / or dye:

banana flavor, cherry flavor, vanilla flavor or titanium dioxide (E 171), strawberry flavor.

Dosage form

Powder for oral suspension.

Main physical and chemical properties: white or yellowish-white powder with a characteristic odor of cherry and banana or strawberry.

The reconstituted suspension is a homogeneous suspension of yellowish-white color with a characteristic odor of cherry and banana or strawberry.

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 oral suspension 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 oral suspension, is used once a day at least 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.

Dose measurement

The package has a syringe and a double-sided dosing spoon or a one-sided measuring spoon for dosing:

• one-sided spoon: filled to the top spoon contains 5 ml;
• double-sided spoon: a large spoon filled to the brim contains 5 ml, a smaller one – 2.5 ml;
• the syringe contains 5 ml.

Use a spoon or syringe on your doctor’s advice.

For infections of the ENT organs and respiratory tract, skin and soft tissues (except for chronic migratory erythema), the daily dose of azithromycin is 10 mg / kg body weight, which corresponds to 0.5 ml / kg body weight of the finished suspension. The duration of treatment is 3 days.

Depending on the child’s body weight, the following dosage regimen of Sumamed oral suspension is recommended:

Preparation and use of Sumamed oral suspension

Distilled or boiled and cooled water must be added to the vial containing the powder.

1. Push the vial cap down and turn it counterclockwise.

2. Using a dosing syringe, measure 12 ml of water from a clean container and add to the powder vial.

3. Shake the contents of the vial thoroughly to obtain a homogeneous suspension. After dissolving the powder, the vial will contain an additional 5 ml of suspension (to compensate for possible losses of the suspension during use),      25 ml of Sumamed suspension will be obtained.

4. Immerse the syringe in the suspension and, pulling the plunger up, dial the required amount of suspension.

5. If there are air bubbles in the syringe, return the product to the vial and repeat procedure 3.

6. Place the baby as for feeding.

7. Put the tip of the syringe into the child’s mouth and slowly squeeze the contents.

8. Give the child the opportunity to gradually swallow the entire amount.

9. After taking the drug, give the child to drink some tea or juice to wash away and swallow the remnants of the             suspension in the mouth.

10. Disassemble the used syringe, rinse under running water, dry and store in a dry and clean place with the drug.

11. After the child has taken the last dose of the drug, the syringe and vial should be disposed of.

With migratory erythema, the duration of treatment is 5 days. On day 1, 20 mg / kg of azithromycin body weight should be taken, corresponding to 1 ml / kg of reconstituted suspension. From 2 to 5 days to take 10 mg / kg body weight, corresponding to 0.5 ml / kg of the finished 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).