NV-ZET 200mg/5ml Oral Suspension

Description

NV-ZET 200mg/5ml Oral Suspension

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1. Pharmacokinetics

Absorption: Rapidly absorbed after oral administration. Peak plasma concentrations occur within 2–3 hours.

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

Metabolism: Partially metabolized in the liver.

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

Half-life: Approximately 68 hours (allows 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

 

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3. Mechanism of Action

Inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit, preventing bacterial growth and replication.

Concentrates in tissues and phagocytes, allowing high intracellular activity against infections.

 

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4. Specification

Form: Oral suspension

Strength: 200mg/5ml

Volume: 15ml

Appearance: Pink to red viscous suspension

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: 500mg on day 1, followed by 250mg once daily for 4 days

Children <12 years: 10mg/kg on day 1, followed by 5mg/kg once daily for 4 days (or as prescribed)

Administration: Shake well before use; measure with a proper measuring spoon or syringe

 

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7. Precautions

Use cautiously in patients with liver disease

Avoid in known hypersensitivity to macrolides

May cause QT prolongation; caution in patients with cardiac conditions

 

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8. Warnings

Superinfections with prolonged use

May cause Clostridium difficile-associated diarrhea

Monitor for severe diarrhea, rash, or jaundice

 

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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

 

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10. Drug Interactions

May interact with antacids (separate by 2 hours)

Increases levels of drugs like warfarin, digoxin, and some 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 light and moisture

Keep out of reach of children

Shelf-life: 2 years

Shake well before use

 

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12. Additional Notes

Suitable for children and adults for short-course therapy

Complete the full course even if symptoms improve

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