Azimex 500 Tablet

✔️ Side Effects

Azimex is generally well tolerated, with most adverse reactions being mild and self-limiting.

Common

• Nausea
• Vomiting
• Abdominal pain or cramping
• Diarrhea
• Loose stools
• Flatulence

Less Common

• Skin rash
• Photosensitivity
• Mild elevation of liver enzymes
• Temporary reduction in neutrophil count

Rare

• Cholestatic jaundice
• Severe hypersensitivity reactions
• Reversible hearing impairment, particularly with prolonged high-dose therapy

✔️ Mechanism of Action

Azithromycin inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit, preventing bacterial growth and replication without affecting nucleic acid synthesis.

It demonstrates activity against numerous susceptible microorganisms, including:

Gram-positive bacteria

• Staphylococcus aureus
• Streptococcus pneumoniae
• Streptococcus pyogenes
• Streptococcus agalactiae
• Group C, F and G streptococci
• Viridans streptococci

Gram-negative bacteria

• Haemophilus influenzae
• Haemophilus ducreyi
• Moraxella catarrhalis
• Neisseria gonorrhoeae
• Bordetella pertussis
• Legionella pneumophila

Other susceptible organisms

• Chlamydia trachomatis
• Chlamydia pneumoniae
• Mycoplasma pneumoniae
• Peptostreptococcus species
• Prevotella bivia

Azithromycin remains active against many organisms regardless of beta-lactamase production.

✔️ Dosage & Administration

Oral Administration

Adults

• Respiratory, skin, and soft tissue infections:
  • 500 mg once daily for 3 days, or
  • 500 mg on Day 1 followed by 250 mg once daily on Days 2–5.
• Chlamydial urethritis or cervicitis:
  • 1 g as a single dose, or
  • 500 mg on Day 1 followed by 250 mg daily for the next 2 days.

Children (Over 6 Months)

• 10 mg/kg once daily for 3 days.

Weight-based dosing:

• 15–25 kg: 200 mg daily for 3 days
• 26–35 kg: 300 mg daily for 3 days
• 36–45 kg: 400 mg daily for 3 days

Typhoid Fever

• 500 mg once daily for 7–10 days.

Renal Impairment

No dosage adjustment is generally required for patients with mild renal dysfunction (creatinine clearance >40 mL/min). Exercise caution in patients with severe renal impairment due to limited clinical data.

Hepatic Impairment

Since azithromycin is primarily eliminated through the liver, it should be avoided in patients with significant hepatic disease.

Driving and Operating Machinery

There is no evidence that Azimex adversely affects the ability to drive or operate machinery.

✔️ Pregnancy & Lactation

Pregnancy

Azithromycin is classified as Pregnancy Category B. Animal studies have not demonstrated fetal harm; however, adequate studies in pregnant women are limited. The medicine should be used during pregnancy only when the expected benefits outweigh potential risks.

Breastfeeding

It is unknown whether azithromycin is excreted in human breast milk. Therefore, caution should be exercised when prescribing Azimex to nursing mothers.

✔️ Precautions & Warnings

Serious allergic reactions, including anaphylaxis and angioedema, have rarely been reported with azithromycin. Some reactions may recur despite initial treatment and require prolonged monitoring and supportive care.

Patients should seek immediate medical attention if symptoms such as facial swelling, difficulty breathing, or widespread skin rash occur.

✔️ Storage:

• Store in a cool, dry place.
• Protect from excessive heat, moisture, and direct light.
• Keep out of the reach of children.