Azithromycin intravenous
Other products: Azithromycin
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Dosing in kidney impairment
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Preparation and administration
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Preparation of the Solution for Intravenous Administration The infusate concentration and rate of infusion for ZITHROMAX for injection should be either 1 mg/mL over 3 hr or 2 mg/mL over 1 hr. ZITHROMAX for injection should not be given as a bolus or as an intramuscular injection. ZITHROMAX for injection should be followed by ZITHROMAX by the oral route as required. [see Dosage and Administration and ] .
Reconstitution Prepare the initial solution of ZITHROMAX for injection by adding 4.8 mL of Sterile Water for Injection to the 500 mg vial, and shaking the vial until all of the drug is dissolved. Since ZITHROMAX for injection is supplied under vacuum, it is recommended that a standard 5 mL (non-automated) syringe be used to ensure that the exact amount of 4.8 mL of Sterile Water is dispensed.
Each mL of reconstituted solution contains 100 mg azithromycin. Reconstituted solution is stable for 24 hr when stored below 30°C (86°F). Parenteral drug products should be inspected visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, the drug solution should be discarded.
Dilute this solution further prior to administration as instructed below. Dilution To provide azithromycin over a concentration range of 1–2 mg/mL, transfer 5 mL of the 100 mg/mL azithromycin solution into the appropriate amount of any of the diluents listed below: Normal Saline (0.9% sodium chloride) 1/2 Normal Saline (0.45% sodium chloride) 5% Dextrose in Water Lactated Ringer's Solution 5% Dextrose in 1/2 Normal Saline (0.45% sodium chloride) with 20 mEq KCl 5% Dextrose in Lactated Ringer's Solution 5% Dextrose in 1/3 Normal Saline (0.3% sodium chloride) 5% Dextrose in 1/2 Normal Saline (0.45% sodium chloride) Normosol ® -M in 5% Dextrose Normosol ® -R in 5% Dextrose [See table below.] Other intravenous substances, additives, or medications should not be added to ZITHROMAX for injection, or infused simultaneously through the same intravenous line.
Storage When diluted according to the instructions (1 mg/mL to 2 mg/mL), ZITHROMAX for injection is stable for 24 hr at or below room temperature 30°C (86°F), or for 7 days if stored under refrigeration 5°C (41°F).
| Final Infusion Solution Concentration (mg/mL) | Amount of Diluent (mL) |
|---|---|
| 1 mg/mL | 500 mL |
| 2 mg/mL | 250 mL |
Drug interactions
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- Azithromycin intravenous
Label text (4 paragraphs)
7 DRUG INTERACTIONS • Nelfinavir: Close monitoring for known adverse reactions of azithromycin, such as liver enzyme abnormalities and hearing impairment, is warranted. ( 7.1 ) • Warfarin: Use with azithromycin may increase coagulation times; monitor prothrombin time. ( 7.2 )
7.1 Nelfinavir Co-administration of nelfinavir at steady-state with a single oral dose of azithromycin resulted in increased azithromycin serum concentrations. Although a dose adjustment of azithromycin is not recommended when administered in combination with nelfinavir, close monitoring for known adverse reactions of azithromycin, such as liver enzyme abnormalities and hearing impairment, is warranted. [see Adverse Reactions (6) ]
7.2 Warfarin Spontaneous postmarketing reports suggest that concomitant administration of azithromycin may potentiate the effects of oral anticoagulants such as warfarin, although the prothrombin time was not affected in the dedicated drug interaction study with azithromycin and warfarin. Prothrombin times should be carefully monitored while patients are receiving azithromycin and oral anticoagulants concomitantly.
7.3 Potential Drug-Drug Interaction with Macrolides Interactions with digoxin, colchicine or phenytoin have not been reported in clinical trials with azithromycin. No specific drug interaction studies have been performed to evaluate potential drug-drug interaction. However, drug interactions have been observed with other macrolide products. Until further data are developed regarding drug interactions when digoxin, colchicine or phenytoin are used with azithromycin careful monitoring of patients is advised.
Contraindications
4 CONTRAINDICATIONS • Patients with known hypersensitivity to azithromycin, erythromycin, any macrolide, or ketolide antibacterial drug. ( 4.1 ) • Patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin. ( 4.2 )
4.1 Hypersensitivity ZITHROMAX is contraindicated in patients with known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide drugs.
4.2 Hepatic Dysfunction ZITHROMAX is contraindicated in patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin.
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
ALikelihood score A: Well known but rare cause of clinically apparent liver injury.
Azithromycin is a semisynthetic macrolide antibiotic which is commonly used for a wide variety of mild-to-moderate bacterial infections. Azithromycin has been linked to rare instances of acute liver injury that can be severe and even fatal.
ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Available data from published literature and postmarketing experience over several decades with azithromycin use in pregnant women have not identified any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data ). Developmental toxicity studies with azithromycin in rats, mice, and rabbits showed no drug-induced fetal malformations at doses up to 4, 2, and 2 times, respectively, an adult human daily dose of 500 mg based on body surface area.
Decreased viability and delayed development were observed in the offspring of pregnant rats administered azithromycin from day 6 of pregnancy through weaning at a dose equivalent to 4 times an adult human daily dose of 500 mg based on body surface area (see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Data Human Data Available data from published observational studies, case series, and case reports over several decades do not suggest an increased risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes with azithromycin use in pregnant women. Limitations of these data include the lack of randomization and inability to control for confounders such as underlying maternal disease and maternal use of concomitant medications. Animal Data Reproductive and developmental toxicology studies have not been conducted using IV administration of azithromycin to animals.
Azithromycin administered during the period of organogenesis did not cause fetal malformations in rats and mice at oral doses up to 200 mg/kg/day (moderately maternally toxic). Based on body surface area, this dose is approximately 4 (rats) and 2 (mice) times an adult human daily dose of 500 mg. In rabbits administered azithromycin at oral doses of 10, 20, and 40 mg/kg/day during organogenesis, reduced maternal body weight and food consumption were observed in all groups; no evidence of fetotoxicity or teratogenicity was observed at these doses, the highest of which is estimated to be 2 times an adult human daily dose of 500 mg based on body surface area.
In a pre- and postnatal development study, azithromycin was administered orally to pregnant rats from day 6 of pregnancy until weaning at doses of 50 or 200 mg/kg/day. Maternal…
Breastfeeding (LactMed)
Because of the low levels of azithromycin in breastmilk and use in infants in higher doses, it would not be expected to cause adverse effects in breastfed infants. Monitor the infant for possible effects on the gastrointestinal flora, such as vomiting, diarrhea, candidiasis (thrush, diaper rash). Maternal use of an eye drop that contains azithromycin presents negligible risk for the nursing infant. To substantially diminish the amount of drug that reaches the breastmilk after using eye drops, place pressure over the tear duct by the corner of the eye for 1 minute or more, then remove the excess solution with an absorbent tissue.
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