Sumamed 500 mg, 3 film-coated tablets

Composition and release form

Sumamed® Capsules – 1 capsule:

• active ingredients: azithromycin (in the form of dihydrate) - 250 mg;
• excipients: MCC; sodium lauryl sulfate; magnesium stearate.

There are 6 pcs in a blister; 1 blister in a box.

Film-coated tablets - 1 tablet:

• active ingredients: azithromycin (in the form of dihydrate) - 125 mg - 500 mg;
• core: anhydrous calcium phosphate, hypromellose, corn starch, pregelatinized starch, MCC, sodium lauryl sulfate, magnesium stearate;
• shell: hypromellose, dye similar to Indigotine (E132), polysorbate 80, titanium dioxide (E171), talc.

In a blister there are 3 (500 mg) or 6 (125 mg) pieces; 1 blister in a box.

Powder for the preparation of a suspension for oral administration (prepared suspension) - 5 ml:

• active ingredients: azithromycin (in the form of dihydrate) - 100 mg;
• excipients: sucrose, sodium carbonate anhydrous, sodium benzoate, tragacanth, titanium dioxide, glycine, colloidal silicon dioxide, strawberry, apple and mint flavors.

In 50 ml dark glass bottles - 17 g of powder (complete with dosing spoon, dosing syringe); 1 bottle in a box.

Lyophilisate for preparing solution for infusion - 1 vial:

• active ingredients: azithromycin (in the form of dihydrate) - 500 mg;
• excipients: citric acid, sodium hydroxide.

In bottles; There are 5 bottles in a cardboard pack.

Sumamed® forte Powder for the preparation of suspension for oral administration (prepared suspension) - 5 ml:

• active ingredients: azithromycin (in the form of dihydrate) - 200 mg;
• excipients: sucrose, trisodium phosphate anhydrous, hydroxypropylcellulose; xanthan gum, cherry flavor J7549, banana flavor 78701-31, vanillin flavor D-125Q38, colloidal silicon dioxide.

In bottles of 20, 35 or 42.5 ml (complete with dosing spoon or dosing syringe); 1 bottle in a box.

Side effects

From the hematopoietic system: rarely - thrombocytopenia, neutropenia, eosinophilia.

From the central nervous system and peripheral nervous system: sometimes - dizziness/vertigo, headache, drowsiness, convulsions; rarely - paresthesia, asthenia, insomnia, hyperactivity, aggressiveness, anxiety, nervousness.

From the digestive system: often - nausea, vomiting, diarrhea, abdominal pain and cramps; sometimes - diarrhea, flatulence, digestive disorders, anorexia; rarely - constipation, discoloration of the tongue, pseudomembranous colitis, cholestatic jaundice, hepatitis, changes in laboratory parameters of liver function; very rarely - liver dysfunction and liver necrosis (possibly fatal).

Allergic reactions: sometimes - itching, skin rashes; rarely - angioedema, urticaria, photosensitivity, anaphylactic reaction, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.

Contraindications for use

• severe dysfunction of the liver and kidneys;
• lactation period;
• simultaneous use with ergotamine and dihydroergotamine;
• hypersensitivity to azithromycin and other components of the drug;
• increased sensitivity to macrolide antibiotics;
• children under 12 years of age and body weight less than 45 kg (for capsules and tablets 500 mg);
• children under 3 years of age (for tablets 125 mg).

Sumamed should be prescribed with caution in cases of moderate impairment of liver and kidney function, in patients with disorders or predisposition to arrhythmias and prolongation of the QT interval.

Dosage

Sumamed is prescribed orally 1 time, at least 1 hour before or 2 hours after meals. Sumamed is taken without chewing.

For adults and children over 12 years of age weighing more than 45 kg, sumamed is prescribed in the form of tablets and capsules.

For children aged 6 months and older, sumamed should be prescribed in the form of an oral suspension; for children aged 3 years and older, sumamed can also be prescribed in the form of 125 mg tablets.

Sumamed in the form of tablets 125 mg is dosed taking into account the child’s body weight, as presented in the table.

For infections of the ENT organs, upper and lower respiratory tract, skin and soft tissues in adults and children over 12 years of age weighing more than 45 kg, sumamed is prescribed at a dose of 500 mg once a day for 3 days, the course dose is 1.5 g.

For children aged 6 months and older, sumamed is prescribed at the rate of 10 mg/kg body weight 1 time/for 3 days, the course dose of sumamed is 30 mg/kg.

Description of the dosage form

Sumamed® Capsules: hard, gelatinous, opaque, size No. 1. The body color is blue, the lid is blue. Capsule contents: white to light yellow powder.

Film-coated tablets: blue, round (125 mg) or oblong (500 mg) in shape with biconvex surfaces and the designation “PLIVA” on one side and “125” or “500” on the other. The fractured appearance is white to almost white.

Powder for oral suspension 100 mg/5 ml: white or light yellow granular powder.

Lyophilisate for the preparation of solution for infusion: lyophilized powder or compacted white mass.

Sumamed® forte Powder for the preparation of a suspension for oral administration: granular, white or light yellow in color with a characteristic odor of banana and cherry. After dissolution in water - a homogeneous suspension of white or light yellow color with a characteristic odor of banana and cherry.