Azithromycin Tablets IP 250mg/ 500mg

Product

Adult dose

Pediatric dose

Adjustment in Renal / Hepatic Impaired patients

Azitec

IV. 500MG OD for 3 days, Oral:250mg-500mg OD

16 yrs. Of age & older-refer adult dosage

No

Product name

Composition

Indication/s

Strengths

Packing

Azitec

Azithromycin

Oral: ABECB, Sinusitis, CAP, Genital ulcer Diseases (Chancroid)in men, pharyngitis/ Tonsilitis, SSTI, Uretheritis & Cervicitis, Injection: CAP,PID

250mg

1 x 6 tabs

500mg

1 x3 tabs

500mg

1 Vial

Product name

Storage

Stability after reconstitution

Prep of solution

Diluent

Azitec (Azithromycin 250mg/ 500mg Tab & 500mg vial)

1) Azitec tablets should be stored between 15º to 30º 2) Store dry powder below 30ºC at controlled room temperature

When diluted according to the instructions (1.0mg/ml to 2.0 mg/ml). AZITEC (azithromycin for injectio) is stable for 24hrs. Below temp. (30ºC) or for 7 days if stored under refrigeration (5ºC)

1. Prepare the intial solution by adding 4.8ml of sterile water for inj. To the 500mg vial. Each ml of of reconstituted solution contains 100mg azithromycin.

2. Dilute this solution further prior to administration as instructed below:

To provide azithromycin over a conc. Range of 1.0-2.0mg/ml, transfer 5ml of the 100mg/ml azithromycin solution into the appropriate amount of any of the diluents listed.

Sterile water for Injection, Normal saline (0.9% sodium chloride). 1/2 Normal saline (0.45% NaCl). 5% Dextrose in water, Lactated Rnger's Solution.

Dilute 500mg vial as per the table below

Final infusion solution Concentration (mg/ml)

Amount of Diluent (mL)

1.0 mg/ml

500 ml

2.0 mg/ml

250 ml

It is recommended that a 50mg dose of AZITEC, diluted as above be infused over a period of not less than 60 minutes. Azitec should not be given as a bolus or as an intramuscular injection