Klacid/Klacid MR Caution For Usage

Incompatibilities: Not applicable.
Klacid IV: Use only Sterile Water for Injection to prepare the initial solution, as other diluents may cause precipitation during reconstitution. Do not use diluents containing preservatives or inorganic salts. No drug or chemical agent should be added to a clarithromycin I.V. fluid admixture unless its effect on the chemical and physical stability of the solution has first been determined.
Special precautions for disposal and other handling: Klacid Pediatric Suspension: Preparation for use: An appropriate amount of water should be added to the granules in the bottle until the 30mL or 60mL mark indicated on the label, and shaken until all of the particles are suspended. Avoid vigorous and/or lengthy shaking. Add water again to the same 30mL or 60mL mark. Shake prior to each subsequent use to ensure resuspension. The concentration of clarithromycin in the reconstituted suspension is either 125mg/5ml or 250mg/5ml.
Administration: Several devices can be used to dose and administer Clarithromycin Pediatric Suspension.
Conservation: After reconstitution, store at room temperature (15° to 30°C) and use within 14 days. Do not refrigerate.
Klacid IV: Preparation for Use: The final solution for infusion is prepared as follows: 1. Prepare the initial solution of clarithromycin I.V. by adding 10 ml of Sterile Water for Injection to the 500 mg vial. Use only Sterile Water for Injection, as other diluents may cause precipitation during reconstitution. Do not use diluents containing preservatives or inorganic salts. Note: When the product is reconstituted as directed previously, the resulting solution contains an effective antimicrobial preservative; each ml contains 50 mg of clarithromycin I.V.
2. Chemical and physical in-use stability has been demonstrated for 48 hours at 5°C and for 24 hours at 25°C. From a microbiological point of view, the reconstituted product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
3. The reconstituted product (500 mg in 10 ml Water for Injection) should be added to a minimum of 250 ml of one of the following diluents before administration: 5% dextrose in Lactated Ringer's Solution, 5% dextrose, Lactated Ringer's, 5% dextrose in 0.3% sodium chloride, Normosol-M in 5% dextrose, Normosol-R in 5% dextrose, 5% dextrose in 0.45% sodium chloride, and 0.9% sodium chloride.
4. Chemical and physical in-use stability has been demonstrated for 48 hours at 5°C and for six hours at 25°C. From a microbiological point of view, the final diluted product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
No drug or chemical agent should be added to a clarithromycin I.V. fluid admixture unless its effect on the chemical and physical stability of the solution has first been determined.