Azithromycin Azitrix 500 mg Tablets

Composition:

Active ingredient: 500 mg of azithromycin.
Excipients: Dibasic anhydrous calcium phosphate, pregelatinized corn starch, sodium starch glycolate, magnesium stearate, polyethylene glycol, titanium dioxide, and hydroxypropyl methylcellulose.

Indications:

Treatment of infections caused by susceptible microorganisms, including:

• Lower respiratory tract infections (e.g., bronchitis, pneumonia)

• Skin and soft tissue infections

• Acute otitis media

• Upper respiratory tract infections (e.g., sinusitis, pharyngitis, tonsillitis)

• Uncomplicated sexually transmitted infections caused by non-multiresistantChlamydia trachomatisandNeisseria gonorrhoeaein men and women

Dosage and Administration:

This medication should always be taken exactly as prescribed by your doctor. In case of doubt, consult a physician or pharmacist.

• Adults:

ForChlamydia trachomatisor susceptibleNeisseria gonorrhoeaeinfections: 1000 mg as a single dose.

For all other indications: a total dose of 1500 mg, taken as 500 mg once daily for 3 days.

Elderly patients:

Children:

• No dose adjustment necessary.

• Except for streptococcal pharyngitis treatment, daily dose is 30 mg/kg, administered as 10 mg/kg once daily for 3 days.

• For acute otitis media: either a single 30 mg/kg dose, or 10 mg/kg once daily for 3 days.

• Tablets are intended for children weighing over 45 kg.

If the patient feels the medicine is “too strong” or “too weak,” they should consult their doctor or pharmacist.
Azithromycin Azitrix should be swallowed with water, with or without food.
It is taken once daily.
The duration of treatment is determined by the prescribing physician.
Treatment should not be discontinued without medical advice.

Side Effects:

• Gastrointestinal: Loss of appetite, nausea, vomiting, diarrhea, loose stools, dyspepsia, abdominal discomfort, constipation, bloating.

• Rare: Pseudomembranous colitis, temporary discoloration of the tongue.

• Hearing issues: Hearing loss, tinnitus, deafness (rare, associated with macrolides).

• Renal: Interstitial nephritis, acute renal failure.

• Hematologic: Thrombocytopenia, transient mild neutropenia.

• Hepatic: Hepatitis, cholestatic jaundice, rare cases of hepatic necrosis and failure.

• Musculoskeletal: Joint pain.

• CNS: Dizziness, seizures, headache, drowsiness, sensory disturbances, hyperactivity.

• Psychiatric: Aggression, nervousness, restlessness, agitation.

• Others: Vaginitis, allergic reactions (rash, itching, urticaria, photosensitivity, edema), rare serious skin reactions (e.g., erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis), palpitations, arrhythmia (including ventricular tachycardia), fatigue, anaphylaxis.

Contraindications:

• Known hypersensitivity to azithromycin or other macrolide antibiotics.

Drug Interactions:

• Avoid concurrent use with antacids. Antacids should be taken at least 2 hours before azithromycin.

• Cimetidine should be taken 2 hours before azithromycin.

• Concurrent use with digoxin may increase digoxin levels.

• Not recommended to take with ergot derivatives due to risk of ergotism.

• Co-administration with rifabutin has been associated with decreased neutrophil count.

• Inform your doctor about all current or recent medications.

Special Precautions:

• Limited data on use in patients with creatinine clearance <40 mL/min—use with caution.

• Use with caution in patients with liver impairment.

• Monitor for signs of secondary infection, especially fungal.

• Not recommended for children under 6 months of age.

• If a dose is missed, do not double the next dose.

Pregnancy and Breastfeeding:

• Not recommended during pregnancy and lactation.

• Consult your doctor before use.

Driving and Operating Machinery:

• No data on the effect on ability to drive or operate machinery.

  
  

Overdose:

• In case of overdose, supportive and symptomatic treatment is indicated.

  
  

Storage Conditions:

• Store in original packaging, out of reach of children, at temperatures not exceeding 30°C.