NV-ZET 500mg Tablet

Description

NV-ZET 500mg Tablet

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1. Pharmacokinetics

Absorption: Rapidly absorbed from the gastrointestinal tract; peak plasma levels in 2–3 hours.

Distribution: Widely distributed in tissues (lungs, tonsils, macrophages); plasma protein binding ~50%.

Metabolism: Partially metabolized in the liver.

Excretion: Mainly via bile; small amounts excreted in urine.

Half-life: ~68 hours, allowing convenient once-daily dosing.

Special Populations: Dose adjustment may be required in severe hepatic impairment; usually not needed in mild/moderate renal impairment.

 

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2. Pharmacodynamics

Class: Macrolide antibiotic

Action: Bacteriostatic; inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit.

Effect: Effective against Gram-positive, Gram-negative, and atypical bacteria causing respiratory, skin, and soft tissue infections.

 

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3. Mechanism of Action

Azithromycin binds to bacterial 50S ribosomal subunit, blocking protein synthesis and preventing bacterial replication.

Concentrates in tissues and phagocytes, achieving high intracellular activity against pathogens.

 

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4. Specification

Form: Film-coated tablet

Strength: 500mg

Appearance: Round or oval tablet, typically pink or red

Route: Oral

 

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5. Clinical Indications

Respiratory tract infections: pneumonia, bronchitis, sinusitis, pharyngitis, tonsillitis

Skin and soft tissue infections

Otitis media

Genital infections (e.g., Chlamydia)

Mycoplasma infections

 

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6. Dosage and Administration

Adults and children ≥12 years:

Typical regimen: 500mg once daily for 3–5 days (depending on infection type)

Children <12 years: Dose based on body weight (10–12mg/kg once daily, duration as prescribed)

Administration: Take orally with or without food; swallow whole with water.

 

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7. Precautions

Avoid in patients with hypersensitivity to azithromycin or other macrolides.

Caution in patients with liver disease or prolonged QT interval.

Monitor for signs of superinfection with prolonged therapy.

 

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8. Warnings

Risk of Clostridium difficile-associated diarrhea.

Report severe diarrhea, rash, jaundice, or palpitations immediately.

Avoid combining with drugs that prolong QT interval.

 

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9. Side Effects

Common:

Nausea, vomiting, diarrhea

Abdominal pain

Headache

Serious (rare):

Liver dysfunction

Allergic reactions (rash, urticaria, anaphylaxis)

Cardiac arrhythmias

Severe diarrhea due to C. difficile

 

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10. Drug Interactions

Antacids may reduce absorption; separate by 2 hours.

May increase levels of warfarin, digoxin, or certain statins.

Avoid concurrent use with QT-prolonging drugs.

 

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11. Storage and Stability

Store below 25°C

Protect from moisture and light

Keep out of reach of children

Shelf-life: 2–3 years

 

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12. Additional Notes

Complete full course even if symptoms improve.

Suitable for adults and children (dose-adjusted).

Patient Advice: Report severe diarrhea, rash, yellowing of eyes/skin, or palpitations immediately.