Rozith Suspension 15ml

Azithromycin is a macrolide antibiotic that remains stable in acidic gastric conditions, allowing effective oral administration without the need for acid protection. It is rapidly absorbed from the gastrointestinal tract, with absorption enhanced when taken on an empty stomach. Peak plasma concentrations are generally achieved within 2.1 to 3.2 hours after oral dosing.

The drug is actively transported by phagocytic cells to sites of infection, where it is released during the inflammatory response. Because of its high lipid solubility and ion-trapping characteristics, tissue concentrations may exceed plasma concentrations by more than 50-fold, resulting in prolonged antibacterial activity.

Azithromycin has a long elimination half-life of approximately 68 hours, allowing convenient once-daily dosing and shorter treatment durations while maintaining therapeutic concentrations in infected tissues. Elimination occurs mainly through biliary excretion as an unchanged drug, with approximately 6% of the administered dose excreted unchanged in urine over one week.

Mechanism of Action

Azithromycin inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit of susceptible bacteria. This action prevents bacterial growth without affecting nucleic acid synthesis.

Antibacterial Spectrum

Azithromycin demonstrates activity against a broad range of susceptible microorganisms, including:

Gram-positive bacteria

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

Anaerobic organisms

• Peptostreptococcus species
• Prevotella bivia

Beta-lactamase production does not significantly reduce the antibacterial activity of azithromycin.

Dosage & Administration

Oral Dosage

Adults

• 500 mg once daily for 3 days, or
• 500 mg on Day 1, followed by 250 mg once daily on Days 2–5

For uncomplicated Chlamydia trachomatis infections

• 1 g as a single oral dose, or
• 500 mg on Day 1, followed by 250 mg once daily for the next 2 days, according to the physician's recommendation.

Children (Above 6 Months)

• 10 mg/kg once daily for 3 days

Weight-based suspension dosing:

• 15–25 kg: 200 mg (1 teaspoonful) daily for 3 days
• 26–35 kg: 300 mg (1½ teaspoonfuls) daily for 3 days
• 36–45 kg: 400 mg (2 teaspoonfuls) daily for 3 days

Typhoid Fever

• 500 mg (2½ teaspoonfuls) once daily for 7–10 days

Intravenous Infusion (Adults Only)

Community-Acquired Pneumonia

• 500 mg IV once daily for at least 2 days, followed by 500 mg orally once daily to complete a 7–10 day treatment course.

Pelvic Inflammatory Disease

• 500 mg IV once daily for 1–2 days, followed by 250 mg orally once daily to complete a 7-day course.
• If anaerobic organisms are suspected, appropriate anaerobic antimicrobial therapy should be added.

Pediatric Use

• The safety and efficacy of intravenous azithromycin have not been established in children and adolescents younger than 16 years.

* রেজিস্টার্ড চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন।

Administration

Preparation of Suspension

1. Shake the bottle thoroughly to loosen the dry powder.
2. Add previously boiled and cooled water up to the marked level on the bottle.
3. Shake vigorously until a smooth, uniform suspension is obtained.

For optimal absorption, Rozith should preferably be taken 1 hour before or 2 hours after meals.

* রেজিস্টার্ড চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন।

Drug Interactions

• Antacids: Take azithromycin at least 1 hour before or 2 hours after antacid preparations.
• Carbamazepine: No clinically significant interaction has been observed.
• Cyclosporine: Use with caution; monitor cyclosporine concentrations and adjust dosage if necessary.
• Digoxin: May increase digoxin levels; monitoring is recommended.
• Ergot derivatives: Concomitant use is contraindicated because of the potential risk of ergotism.
• Methylprednisolone: No significant pharmacokinetic interaction has been reported.
• Theophylline: Although significant interaction is unlikely, monitoring of theophylline levels is advisable.
• Warfarin: Routine monitoring of prothrombin time (PT/INR) is recommended during concomitant use.
• Terfenadine: No clinically relevant effect on pharmacokinetics or QT interval has been demonstrated.

Contraindications

Rozith should not be used in patients with:

• Known hypersensitivity to azithromycin, erythromycin, or other macrolide antibiotics
• Concurrent use of ergot alkaloids
• Significant hepatic impairment or active liver disease

Side Effects

Rozith is generally well tolerated, and most adverse reactions are mild to moderate.

Common adverse effects include:

• Nausea
• Vomiting
• Diarrhoea
• Loose stools
• Abdominal pain or cramps
• Flatulence

Less common reactions include:

• Skin rash
• Photosensitivity
• Elevated liver enzymes
• Mild transient neutropenia

Rare but serious adverse effects:

• Severe hypersensitivity reactions, including anaphylaxis and angioedema
• Cholestatic jaundice
• Reversible hearing impairment, mainly with prolonged high-dose therapy

Pregnancy & Lactation

Pregnancy Category: B

Animal studies have not demonstrated fetal harm; however, adequate controlled studies in pregnant women are lacking. Rozith should be used during pregnancy only when the expected benefit outweighs the potential risk.

It is unknown whether azithromycin is excreted in human breast milk. Therefore, caution should be exercised when administering Rozith to breastfeeding mothers.

Precautions & Warnings

• Serious allergic reactions, including anaphylaxis and angioedema, have been reported.
• Use cautiously in patients with severe hepatic or renal impairment.
• Prolonged or repeated use may result in overgrowth of non-susceptible organisms.
• Discontinue treatment immediately if severe hypersensitivity or significant liver dysfunction develops.

Use in Special Populations

Renal Impairment

No dosage adjustment is required for patients with mild renal impairment (creatinine clearance >40 mL/min). Use cautiously in patients with severe renal dysfunction.

Hepatic Impairment

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

Driving and Operating Machinery

Azithromycin is not expected to impair the ability to drive or operate machinery. However, patients experiencing dizziness should avoid such activities.

Overdose

Symptoms of overdose may include:

• Severe nausea and vomiting
• Diarrhoea
• Temporary hearing impairment

Management consists of symptomatic and supportive treatment, including gastric lavage where appropriate.

Therapeutic Class

Macrolide Antibiotic

Storage Conditions

Store below room temperature in a cool, dry place, protected from heat, moisture, and direct light. Keep out of the reach of children.