Apozyth 200 mg/5 ml (Powder for Suspension)
Medicine Details
| Category | Details |
|---|---|
| Generic | Azithromycin dihydrate |
| Company | Apollo pharmaceutical ltd |
| Also available as |
Title and Category
Apozyth 200 mg/5 ml Suspension
Indications
- Lower respiratory tract infections including bronchitis and pneumonia
- Upper respiratory tract infections including sinusitis and pharyngitis/tonsillitis
- Otitis media
- Skin and soft tissue infections
- Sexually transmitted diseases in men and women - non-gonococcal urethritis and cervicitis due to Chlamydia trachomatis
Mode of Action
Azithromycin is acid-stable and can be taken orally with no need of protection from gastric acids. It is readily absorbed and has high concentration in phagocytes. It acts by binding to the 50S ribosomal subunit of susceptible microorganisms, interfering with microbial protein synthesis.
Pharmacokinetics
- Absorption: Greater on an empty stomach, time to peak concentration in adults is 2.1 to 3.2 hours for oral dosage forms
- Distribution: High concentration in phagocytes, released during active phagocytosis, over 50 times higher than in plasma in tissues due to ion trapping and high lipid solubility
- Elimination: Prolonged terminal half-life, biliary excretion of azithromycin, approximately 6% of the administered dose appears as unchanged drug in urine
Dosage
- Oral - Adult:
- 500 mg once daily orally for 3 days
- 500 mg once on day 1, then 250 mg once on days 2-5 for 4 days
- Oral - Children:
- 10 mg/kg body weight once daily for 3 days for child over 6 months
- 200 mg (1 teaspoonful) for 3 days if body weight is 15-25 kg
- 300 mg (1½ teaspoonfuls) for 3 days if body weight is 26-35 kg
- 400 mg (2 teaspoonfuls) for 3 days if body weight is 36-45 kg
- IV Infusion: 500 mg as a single daily dose by the intravenous route for at least two days
Administration
Reconstitution procedure of suspension - Shake well, add boiled and cooled water, shake until powder is completely mixed with water. Azithromycin should be taken at least 1 hour before or 2 hours after meal.
Interactions
- Antacid
- Carbamazepine
- Cyclosporin
- Digoxin
- Ergot derivatives
- Methylprednisolone
- Theophylline
- Warfarin
- Terfenadine
Contraindications
- Hypersensitivity to Azithromycin or any other macrolide antibiotic
- Co-administration of ergot derivatives and Azithromycin
- Patients with hepatic diseases
Side Effects
Gastrointestinal side-effects, allergic reactions, reversible elevations in liver transaminases, rare cases of cholestatic jaundice, transient mild reductions in neutrofil counts, reversible hearing impairment
Pregnancy & Lactation
- Pregnancy Category: B
- Notes: No adequate and well controlled studies in pregnant women, caution advised during pregnancy, caution advised for nursing women
Precautions & Warnings
Rare serious allergic reactions reported, caution advised
Use in Special Populations
- Renal Impairment: No dose adjustment needed in patients with mild renal impairment, caution advised in more severe renal impairment
- Hepatic Impairment: Not to be used in patients with hepatic disease
- Ability to Drive and Use Machines: No evidence to suggest impact on patient’s ability to drive or operate machinery
Overdose Effects
No data on overdosage with Apozyth
Storage Conditions
Keep in a dry place away from light and heat, keep out of the reach of children