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Azitral Drug Information [ Shreya Life Sciences; Instituto Sanitas ]

Table of content

Azitral category:

Active ingredients:

Azithromycin

Azitral companies and manufacturers:

General Information

Azitral forms, composition and dosages:

Capsule; Oral; Azithromycin 250 mg
Capsule; Oral; Azithromycin 500 mg

Indications, usages and classification codes:

J01FA10 - Azithromycin

There is an additional general information about this medication active ingredient azithromycin:

Pharmacological action

Azithromycin is an macrolide antibiotic of azalides group. This medication inhibits RNA-dependent protein synthesis of sensitive microorganisms.
It active against gram-positive bacteria: Staphylococcus aureus, Streptococcus spp. (including Streptococcus pneumoniae, Streptococcus pyogenes group A); gram-negative bacteria: Haemophilus influenzae, Haemophilus parainfluenzae, Haemophilus ducreyi, Moraxella catarrhalis, Escherichia coli, Bordetella pertussis, Bordetella parapertussis, Borrelia burgdorferi, Neisseria gonorrhoeae, Campylobacter spp., Legionella pneumophila; anaerobic bacteria: Bacteroides fragilis.

Pharmacokinetics

This drug rapidly absorbed from the gastrointestinal tract. Ingestion reduces the absorption of azithromycin. C_max in plasma is reached after 2-3 hours. This medicine rapidly distributed in tissues and biological fluids. 35% of the azithromycin is metabolized in the liver by demethylation. More than 59% is excreted in the bile in unchanged form, about 4.5% in the urine in unchanged form.

Why is Azitral prescribed?

Infectious-inflammatory diseases caused by microorganisms susceptible to azithromycin, including bronchitis, pneumonia, infections of skin and soft tissue, otitis media, sinusitis, pharyngitis, tonsillitis, gonorrheal and non gonorrheal urethritis and / or cervicitis, Lyme disease (borreliosis).

Dosage and administration

Dosage is setted individually according to nosology, disease severity and sensitivity of the pathogen. Dosage for adults for oral administration is 0.25-1 g 1 time/day; for children - 5-10 mg/kg 1 time/day. The duration of administration is 2-5 days.

Azitral side effects

Digestive system: nausea, vomiting, flatulence, diarrhea, abdominal pain, transient elevation of liver enzymes, rarely - cholestatic jaundice.
Allergic reactions: rarely - a skin rash, angioedema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Dermatological reactions: rarely - photosensitization.
CNS: dizziness, headache, rarely - drowsiness, weakness.
Hematopoietic system: rarely - leukopenia, neutropenia, thrombocytopenia.
Cardiovascular system: rarely - chest pain.
Urogenital system: vaginitis, rarely - candidiasis, nephritis, increased residual nitrogen urea.
Other: rarely - hyperglycemia, arthralgia.

Contraindications

Hypersensitivity to azithromycin and other macrolide antibiotics.

Using during pregnancy and breastfeeding

Azithromycin crosses the placental barrier. Use in pregnancy only in cases where the intended benefits to the mother outweighs the potential risk to the fetus.
If necessary to use azithromycin in the lactation period should solve the issue of termination of breastfeeding.

Special instructions

This drug not recommended for use in patients with compromised liver function.
Azithromycin uses with careful with impaired renal function.
This medication should be taken at least 1 hour before or 2 hours after eating or taking of antacids.

Azitral drug interactions

Simultaneous administration of azithromycin with these drugs and medications may has followed effects:

ergot alkaloids: can not been exclude the risk of ergotism;

warfarin: there was described amplification effect of warfarin;

digoxin or digitoxin: may be significantly increase the concentration of cardiac glycosides in plasma and risk of glycoside intoxication;

disopyramide: described a case of ventricular fibrillation;

lovastatin: there was describes some cases of rhabdomyolysis;

rifabutin increases risk of neutropenia and leukopenia;

cyclosporine: disturbed metabolism of cyclosporine which increases the risk of adverse and toxic reactions caused by cyclosporine

PLEASE, BE CAREFUL!

Be sure to consult your doctor before taking any medication!

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