Azithromycin description, usages, side effects, indications, overdosage, supplying and lots more!

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Azithromycin

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

AZITHROMYCIN DESCRIPTION


Azithromycin





CLINICAL PHARMACOLOGY


PHARMACOKINETICS

Pharmacokinetics






***




Absorption





Distribution




*
*








Metabolism


Elimination



Special Populations

Renal insufficiency


Hepatic insufficiency


Gender


Geriatric patients


Pediatric patients
In two clinical studies, azithromycin for oral suspension was dosed at 10 mg/kg on day 1, followed by 5 mg/kg on days 2 through 5 to two groups of pediatric patients (aged 1 to 5 years and 5 to 15 years, respectively). The mean pharmacokinetic parameters on day 5 were Cmax = 0.216 mcg/mL, Tmax = 1.9 hours, and AUC0-24 = 1.822 mcghr/mL for the 1- to 5-year-old group and were Cmax = 0.383 mcg/mL, Tmax = 2.4 hours, and AUC0-24 = 3.109 mcghr/mL for the 5- to 15-year-old group.
Two clinical studies were conducted in 68 pediatric patients aged 3 to 16 years to determine the pharmacokinetics and safety of azithromycin for oral suspension. Azithromycin was administered following a low-fat breakfast.
The first study consisted of 35 pediatric patients treated with 20 mg/kg/day (maximum daily dose 500 mg) for 3 days of whom 34 patients were evaluated for pharmacokinetics.
In the second study, 33 pediatric patients received doses of 12 mg/kg/day (maximum daily dose 500 mg) for 5 days of whom 31 patients were evaluated for pharmacokinetics.
In both studies, azithromycin concentrations were determined over a 24 hour period following the last daily dose. Patients weighing above 25.0 kg in the 3 day study or 41.7 kg in the 5 day study received the maximum adult daily dose of 500 mg. Eleven patients (weighing 25.0 kg or less) in the first study and 17 patients (weighing 41.7 kg or less) in the second study received a total dose of 60 mg/kg. The following table shows pharmacokinetic data in the subset of pediatric patients who received a total dose of 60 mg/kg.

Pharmacokinetic3 Day Regimen (205 Day Regimen (12Parameter [mean (SD)]mg/kg x 3 days)mg/kg x 5 days)n1117Cmax (mcg/mL)1.1 (0.4)0.5 (0.4)Tmax (hr)2.7 (1.9)2.2 (0.8)AUC0-24 (mcghr/mL)7.9 (2.9)3.9 (1.9)The similarity of the overall exposure (AUC0-between the 3 day and 5 day regimens in pediatric patients is unknown.
Single dose pharmacokinetics in pediatric patients given doses of 30 mg/kg have not been studied (see DOSAGE AND ADMINISTRATION).

Drug-Drug Interactions
Drug interaction studies were performed with azithromycin and other drugs likely to be coadministered. The effects of coadministration of azithromycin on the pharmacokinetics of other drugs are shown in Table 1 and the effect of other drugs on the pharmacokinetics of azithromycin are shown in Table 2.
Coadministration of azithromycin at therapeutic doses had a modest effect on the pharmacokinetics of the drugs listed in Table 1. No dosage adjustment of drugs listed in Table 1 is recommended when coadministered with azithromycin.
Coadministration of azithromycin with efavirenz or fluconazole had a modest effect on the pharmacokinetics of azithromycin. Nelfinavir significantly increased the Cmax and AUC of azithromycin. No dosage adjustment of azithromycin is recommended when administered with drugs listed in Table 2 (see PRECAUTIONS, Drug Interactions).

Table 1. Drug Interactions: Pharmacokinetic Parameters for Coadministered Drugs in the Presence of Azithromycin
Coad-Dose ofDose ofnRatio (with/without azithromycin)ministe-Coadminis-Azithromycinof Coadministered Drugredtered DrugPharmacokinetic ParatmetersDrugMean CmaxMean AUCAtorva-10 mg/day500 mg/day12 0.83 (0.631.01 (0.81statinx 8 daysPO on daysto 1.08)to 1.25)6 to 8Carba-200 mg/day500 mg/day70.97 (0.88 to0.96 (0.88 tomazepinex 2 days,PO for days1.06)1.06)then 200 mg16 to 18BID x 18 daysCetiriz-20 mg/day500 mg PO141.03 (0.93 to1.02 (0.92 toinex 11 dayson day 7, then1.14)1.13)250 mg/dayon days 8to11Didan-200 mg PO1,200 mg/day61.44 (0.85 to1.14 (0.83 toosineBID x 21PO on days2.43)1.57)days8 to 21Efavir-400 mg/day600 mg PO 141.04*0.95*enzx 7 dayson day 7Flucon-200 mg PO1,200 mg PO18 1.04 (0.981.01 (0.97azolesingle dosesingle doseto 1.11)to 1.05)Indina-800 mg TID1,200 mg PO18 0.96 (0.860.90 (0.81virx 5 dayson day 5to 1.08)to 1.00)Midaz-15 mg PO500 mg/day12 1.27 (0.891.26 (1.01olamon day 3PO x 3 daysto 1.81)to 1.56)Nelfin-750 mg TID1,200 mg PO14 0.90 (0.810.85 (0.78avirx 11 dayson day 9to 1.01)to 0.93)Rifabu-300 mg/day500 mg PO6See footnoteNAtinx 10 dayson day 1,belowthen 250mg/day ondays 2 to 10Silden-100 mg on500 mg/day12 1.16 (0.860.92 (0.75afildays 1 and 4PO x 3 daysto 1.57)to 1.12)Theop-4 mg/kg IV500 mg PO10 1.19 (1.021.02 (0.86hyllineon days 1,on day 7, 250to 1.40)to 1.22)11, 25mg/day on8 to 11Theop-300 mg PO500 mg PO81.09 (0.92 to1.08 (0.89 tohyllineBID x 15on day 6, then1.29)1.31)days250 mg/dayon days 7to10Triazo-0.125 mg500 mg PO12 1.06*1.02*lamon day 2on day 1, then250 mg/dayon day 2Trime-160 mg/8001,200 mg PO12 0.85 (0.75 to0.87 (0.80 tothoprim/mg/day POon day 70.97)/0.900.95)/0.96Sulfam-x 7 days(0.78 to 1.03)(0.88 to 1.03)ethoxazoleZidovu-500 mg/day600 mg/day51.12 (0.42 to0.94 (0.52 todinePO x 21daysPO x 14 days3.02)1.70)Zidovu-500 mg/day1,200 mg/day41.31 (0.43 to1.30 (0.69 todinePO x 21daysPO x 14 days3.97)2.43)*- 90% Confidence interval not reported

NANot Available

Mean rifabutin concentrations one-half day after the last dose of rifabutin were 60 ng/mL when coadministered with azithromycin and 71 ng/mL when coadministered with placebo.

Coa-Dose ofDose ofnRatio (with/without coadministeredadminCoadmiAzithromycindrug of Azithromycin PharmacokineticisterednisteredDrugDrug1.00Mean CmaxMean AUCEfavi-400600 mg PO14 1.22 (1.040.92*renzmg/dayon day 7to 1.42)x 7 daysFluc-200 mg1,200 mg PO18 0.82 (0.661.07 (0.94onaz-POsingle doseto 1.02)to 1.22)olesingledoseNelfi-750 mg1,200 mg PO14 2.36 (1.772.12 (1.80navirTID xon day 9to 3.15)to 2.50)11 daysRifa-300500 mg PO on6See footnoteNAbutinmg/dayday 1, then 250belowx 10daysmg/day on days2 to 10*- 90% Confidence interval not reported

NANot Available
Mean azithromycin concentrations one day after the last dose were 53 ng/mL when coadministered with 300 mg daily rifabutin and 49 ng/mL when coadministered with placebo.

MICROBIOLOGY

Microbiology








































Pathogen***











INDICATIONS & USAGE

INDICATIONS AND USAGE


Adults



















Pediatric Patients













AZITHROMYCIN CONTRAINDICATIONS

CONTRAINDICATIONS


WARNINGS

Hypersensitivity



Hepatotoxicity


Treatment of Pneumonia


Clostridium Difficile-Associated Diarrhea




PRECAUTIONS

General





INFORMATION FOR PATIENTS

Information for Patients






DRUG INTERACTIONS









LABORATORY TESTS

Laboratory Test Interactions


CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

Carcinogenesis, Mutagenesis, Impairment of Fertility


PREGNANCY


Teratogenic Effects

Pregnancy category B


NURSING MOTHERS

Nursing Mothers


PEDIATRIC USE

Pediatric Use







GERIATRIC USE

Geriatric Use





AZITHROMYCIN ADVERSE REACTIONS

ADVERSE REACTIONS


Clinical

Adults

Multiple-dose regimens









Single 1 gram dose regimen



Single 2 gram dose regimen


Pediatric Patients

Single and multiple-dose regimens


Acute otitis media




Community-acquired pneumonia




Pharyngitis/tonsillitis














Postmarketing Experience













Laboratory Abnormalities

Adults




Pediatric Patients

One, three and five day regimens



DOSAGE & ADMINISTRATION

DOSAGE AND ADMINISTRATION


Adults

**



Renal Insufficiency


Hepatic Insufficiency



Pediatric Patients


Acute Otitis Media


Acute Bacterial Sinusitis


Community-Acquired Pneumonia



OTITIS MEDIA AND COMMUNITY-ACQUIREDPNEUMONIA: (5 Day Regimen)*Dosing Calculated on 10 mg/kg/day Day 1and 5 mg/kg/dayDays 2 to 5.Weight100 mg/ 5mL200 mg/ 5mLTotal mLTotal mgper Treat-per Treat-mentmentCourseCourseKgLbs.Day 1DaysDay 1Days2 to 52 to 5*


OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS:(3 Day Regimen)*Dosing Calculated on 10 mg/kg/dayWeight100 mg/200 mg/Total mL perTotal mg per5 mL5 mLTreatmentTreatmentCourseCourseKgLbs.Day 1 toDay 1 to33*


OTITIS MEDIA: (1 Day Regimen)Dosing Calculated on 30 mg/kg as a single doseWeight200 mg/Total mL perTotal mg per5 mLTreatmentTreatmentCourseCourseKgLbs.Day 1*



Pharyngitis/Tonsillitis



PHARYNGITIS/TONSILLITIS: (5 Day Regimen)Dosing Calculated on 12 mg/kg/day for 5 days.Weight200 mg/Total mL perTotal mg per5 mLTreatmentTreatmentCourseCourseKgLbs.Day 1 to5


HOW SUPPLIED

HOW SUPPLIED





CLINICAL STUDIES

CLINICAL STUDIES


Pediatric Patients


Acute Otitis Media

Safety and efficacy using azithromycin 30 mg/kg given over 5 days

Protocol 1



Protocol 2





Protocol 3





Safety and efficacy using azithromycin 30 mg/kg given over 3 days

Protocol 4




Safety and efficacy using azithromycin 30 mg/kg given as a single dose

Protocol 5




Protocol 6





Pharyngitis/Tonsillitis





Adult Patients












ANIMAL PHARMACOLOGY & OR TOXICOLOGY

ANIMAL TOXICOLOGY


REFERENCES












INACTIVE INGREDIENT

INACTIVE INGREDIENTS:
BUTYLATED HYDROXYTOLUENE

ANHYDROUS DIBASIC CALCIUM PHOSPHATE
SILICON DIOXIDE
FD&C RED NO. 40
ALUMINUM OXIDE
FD&C YELLOW NO. 6
HYPROMELLOSE 2910 (15 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
TRIACETIN

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Azithromycin



Azithromycin



Azithromycin

Azithromycin TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-685(NDC:0093-7169)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
AZITHROMYCIN azithromycin 500 mg

Inactive Ingredients

Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
SILICON DIOXIDE
FD&C RED NO. 40
FD&C YELLOW NO. 6
ALUMINUM OXIDE
HYPROMELLOSE 2910 (15 MPA.S)
lactose monohydrate
MAGNESIUM STEARATE
STARCH, CORN
SODIUM LAURYL SULFATE
talc
titanium dioxide
triacetin

Product Characteristics

Color Size Imprint Code Shape
pink 18 mm 93;7169 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-685-14 2 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065193 2011-04-12


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