Ormax (azithromycin) powder 30 ml. suspension 200 mg/5 ml.

Description

Ormax composition
active substance: azithromycin;
5 ml of suspension contain 200 mg of azithromycin (in the form of dihydrate);
Excipients: sodium benzoate (E 211), sucrose or sucrose with colloidal anhydrous silica, sodium phosphate, hydroxypropylcellulose, xanthan gum, colloidal anhydrous silica, fruit flavor “apricot”. Does not contain dyes.

Dosage form
Powder for oral suspension.

Pharmacological properties
Azithromycin is a representative of a new generation of macrolide antibiotics, belonging to the subgroup of azalides. The antibacterial effect of the drug is due to blocking the biosynthesis of proteins of sensitive microorganisms by binding to 50S subunits of ribosomes and inhibition of peptide translocation. Sensitive to the drug: Streptococcus pneumoniae (penicillin-sensitive), Streptococcus pyogenes, Staphylococcus aureus (methicillin-sensitive), H.influenzae, H.parainfluenzae, M.catarrhalis, Pasteurella multocila, Pneumophyllum, Clostridium, Clostridium, Clostridium ., Porphyromonas spp., Chlamydia trachomatis, Chlamydia pneumoniae, Mycoplasma pneumoniae. Types of microorganisms for which acquired resistance can be problematic: Streptococcus pneumoniae with intermediate sensitivity to penicillin and penicillin-resistant. Complete cross-resistance exists in Streptococcus pneumoniae, beta-hemolytic streptococcus group A, Enterococcus faecalis, bacterioids Bacteroides fragilis, Staphylococcus MRSA and MRSE (methicillin-resistant staphylococcus is very common in .
The prevalence of acquired resistance for selected species may vary depending on the area and time, so local information on resistance is required, especially in the treatment of severe infections. If necessary, you can seek qualified advice if the local prevalence of resistance is such that the effectiveness of the drug for the treatment of at least some types of infections is questionable.

Indication
Infections caused by microorganisms sensitive to azithromycin:

• ENT infections (bacterial pharyngitis / tonsillitis, sinusitis, otitis media);
• respiratory tract infections (bacterial bronchitis, community-acquired pneumonia);
• skin and soft tissue infections: migrating erythema (early stage of Lyme disease), erysipelas, impetigo, secondary pyodermatosis.

Contraindication
Hypersensitivity to azithromycin, erythromycin or to any macrolide or ketolide antibiotic, or to any other component of the drug. Due to the theoretical possibility of ergotism, azithromycin should not be prescribed concomitantly with ergot derivatives.

Children
Ormax in the form of a suspension of 100 mg / 5 ml should be used in children weighing 5 to 15 kg. Children weighing more than 15 kg use Ormax in the form of a suspension of 200 mg / 5 ml.

Use during pregnancy or breastfeeding
Azithromycin crosses the placenta, but no evidence of fetal toxicity in animal studies of original azithromycin has been obtained. However, there are no adequate and well-controlled studies in pregnant women. Because studies on the reproductive function of animals do not always correspond to the effect in humans, azithromycin should be prescribed during pregnancy only for vital indications. Azithromycin is excreted in human milk, but there are no appropriate and controlled studies of excretion pharmacokinetics. Azithromycin should be used during breast-feeding only if the expected benefit to the mother outweighs the potential risk to the baby.

Method of application and dosage
To prepare the suspension, invert the powder container so that the powder separates from the bottom, then add 15 ml of boiled water at room temperature using a dosing syringe. After adding water, close the vial and shake thoroughly to form a homogeneous suspension. After that in a special frame of a label it is necessary to put date of preparation of suspension. Store the finished suspension in the refrigerator. The suspension should be well shaken before each use. Take the suspension orally once a day for 1 hour before or 2 hours after eating. Immediately after applying the suspension, the child should be given a few sips of liquid to wash away and swallow the remnants of the suspension in the mouth.
If you miss a drug, it should be taken as soon as possible, and the next dose should be taken after 24 hours.
For infections of the ENT organs and respiratory tract, skin and soft tissues (except for chronic migratory erythema), Ormax should be administered at a dose of 10 mg / kg body weight once a day for 3 days.
Depending on the child’s body weight, the following dosing regimen is recommended:

• 5 kg – 2.5 ml (50 mg);
• 6 kg – 3 ml (60 mg);
• 7 kg – 3.5 ml (70 mg);
• 8 kg – 4 ml (80 mg);
• 9 kg – 4.5 ml (90 mg);
• 10-14 kg – 5 ml (100 mg).

With migratory erythema (Lyme disease) Ormax prescribed once a day for 5 days at a dose of 20 mg / kg body weight on the 1st day, then 10 mg / kg body weight from the 2nd to the 5th day (total duration treatment is 5 days).

Overdose
Symptoms. At overdose of azithromycin the expressed nausea, vomiting, diarrhea, abdominal pain, reversible hearing loss are observed.
Treatment. Reception of activated charcoal and carrying out the general symptomatic and supporting medical actions.

Side effects:

• Infections and invasions: candidiasis, vaginal infections, pneumonia, fungal infection, bacterial infection, pharyngitis, gastroenteritis, respiratory disorders, rhinitis, oral candidiasis;
• From the blood and lymphatic system: leukopenia, neutropenia, eosinophilia;
• From the nervous system: headache, dizziness, drowsiness, dysgeusia, paresthesia;
• From the digestive tract: diarrhea, vomiting, abdominal pain, nausea, constipation, flatulence, dyspepsia, gastritis, dysphagia, bloating, dry mouth, belching, mouth ulcers, hypersecretion of saliva;
• From the hepatobiliary system: liver dysfunction, cholestatic jaundice;
• From the skin and subcutaneous tissue: rash, itching, urticaria, dermatitis, dry skin, hyperhidrosis;
• From the musculoskeletal system: osteoarthritis, myalgia, back pain, neck pain;
• From the urinary system: dysuria, kidney pain;
• From the reproductive system and mammary glands: uterine bleeding, testicular disorders;
• General disorders and local reactions: edema, asthenia, malaise, fatigue, facial edema, chest pain, hyperthermia, pain, peripheral edema;
• Laboratory parameters: decreased number of lymphocytes, increased number of eosinophils, decreased blood bicarbonate, increased basophil levels, increased monocytes, increased neutrophil count.

Expiration date
2 years. The shelf life of the finished suspension is not more than 5 days.
Do not use the drug after the expiration date indicated on the package.

Storage conditions
Store at a temperature not exceeding 25 ºC. Keep out of reach of children. Store the finished suspension for no more than 5 days at a temperature of 2 ºC to 8 ºC.