Azotrin Tablets 500 mg
Composition:

Active ingredient: Each tablet contains 524.1 mg of azithromycin dihydrate, equivalent to 500 mg of azithromycin.
Excipients: starch (pregelatinized), low-substituted hydrogenated phosphate dihydrate, sodium lauryl sulfate, croscarmellose sodium (ac-di-sol), lactose anhydrous (derived from cow’s milk), colloidal anhydrous silica (E551), magnesium stearate (E572), hydroxypropyl methylcellulose 2910 - hypromellose 5cp (E464), macrogol-polyethylene glycol 400 (E1521), and titanium dioxide (E171).

Indications:

Used for the treatment of infections caused by certain bacteria and other microorganisms, including:

• Chest, throat, or nose infections (such as bronchitis, pneumonia, and sinusitis)

• Pharyngitis and tonsillitis caused byStreptococcus pyogenesin patients allergic to penicillin

• Acute ear infections (acute otitis media)

• Skin and soft tissue infections (such as abscesses or boils)

• Sexually transmitted infections caused byChlamydia

• Soft tissue ulcers caused byHaemophilus ducreyiand sexually transmitted infections caused by non-multi-drug-resistantNeisseria gonorrhoeae, without accompanying infections.

Contraindications:

• Allergy to Azotrin or any other macrolide antibiotics such as erythromycin or clarithromycin, or to any ingredients of Azotrin

• Known allergic reactions like rash or hives

• Liver problems

• Use of ergot derivatives such as ergotamine (used for migraine treatment)

Precautions:

Use Azotrin with caution if the patient:

• Has kidney problems

• Has heart diseases

• Has infectious diseases in the community

• Suspected or diagnosed with septicemia

• Is hospitalized

• Is elderly or severely debilitated

• Has other serious health problems (immune deficiency, congenital asplenia, surgical asplenia, etc.)

• Has liver disease

• Should be monitored by a doctor for secondary infections, including fungal infections

• Experiences diarrhea

If any of these warnings apply, the patient should consult their doctor before use.

Interactions with Food and Drink:

Take Azotrin 1 hour before or 2 hours after meals.

Pregnancy:

Consult your doctor before using. Azotrin should only be used during pregnancy if clearly needed. If pregnancy occurs during treatment, contact your doctor immediately.

Lactation:

It is unknown if azithromycin passes into breast milk. Consult your doctor or pharmacist before use during breastfeeding.

Important Information about Some Ingredients:

This medicine contains lactose. Patients with certain sugar intolerances should consult their doctor before use.

Dosage and Administration:

• For sexually transmitted infections caused byChlamydia trachomatis,Haemophilus ducreyi, or susceptibleNeisseria gonorrhoeae: a single oral dose of 1000 mg.

• For other infections: 1500 mg total, given as 500 mg once daily for 3 consecutive days.

• For tonsillitis-pharyngitis caused byS. pyogenes: 500 mg on day 1, followed by 250 mg on days 2, 3, 4, and 5.

• Taken orally, with whole tablets swallowed.

Use in Different Age Groups:

• Children over 45 kg: adult doses apply.

• For tonsillitis-pharyngitis, maximum recommended dose is 1500 mg for any treatment.

• Children under 45 kg: use oral suspension forms.

• Not recommended for infants under 6 months due to lack of safety and efficacy data.

Use in Elderly:
Same doses as adults.

Use in Kidney Dysfunction:
No dose adjustment needed for mild to moderate kidney dysfunction. Use with caution in severe kidney impairment.

Use in Liver Dysfunction:
Patients with mild to moderate liver dysfunction may use standard doses. Not recommended for severe liver impairment.

Storage:

Store in original packaging, out of reach of children, at room temperature up to 25°C.