NV-ZET 250mg Tablet

Description

NV-ZET 250mg Tablet

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1. Pharmacokinetics

Absorption: Rapidly absorbed orally; peak plasma levels occur within 2–3 hours.

Distribution: Widely distributed in body tissues, especially lungs, tonsils, and macrophages; plasma protein binding ~50%.

Metabolism: Partially metabolized in the liver.

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

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

Special Populations: Adjust dose in severe hepatic impairment; no adjustment usually needed for mild to 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 many 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 the 50S subunit of bacterial ribosomes, inhibiting protein synthesis and preventing bacterial replication.

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

 

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4. Specification

Form: Film-coated tablet

Strength: 250mg

Appearance: Round or oval tablet, usually 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 dose: 500mg on day 1, followed by 250mg once daily for 4 more days

Children <12 years: Dose calculated based on body weight (10mg/kg on day 1, then 5mg/kg once daily for 4 days)

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

 

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7. Precautions

Avoid in patients with known hypersensitivity to azithromycin or other macrolides.

Use cautiously in patients with liver disease or cardiac conditions (risk of QT prolongation).

Monitor for signs of superinfection with prolonged use.

 

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8. Warnings

Risk of Clostridium difficile-associated diarrhea with prolonged therapy.

Monitor for severe diarrhea, rash, jaundice, or palpitations.

Use with caution in patients taking 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; take antacids 2 hours before or after azithromycin.

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

Avoid concurrent use with other drugs that prolong QT interval.

 

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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 the full course of therapy even if symptoms improve.

Suitable for adults and children (dose-adjusted).

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