Generic equivalent of Azithromycin Dihydrate
4 SKUs available · Available to order · NABP accredited · DSCSA compliant
Azithromycin dihydrate is the generic equivalent of the brand-name drug Azithromycin Dihydrate. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Azithromycin dihydrate through Premier Pharma with same-day fulfillment on in-stock SKUs.
1 INDICATIONS AND USAGE Azithromycin is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2) ] Azithromycin is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: Acute bacterial exacerbations of chronic bronchitis in adults ( 1.1 ) Acute bacterial sinusitis in adults ( 1.1 ) Uncomplicated skin and skin structure infections in a…
12.1 Mechanism of Action Azithromycin is a macrolide antibacterial drug . [see Microbiology (12.4) ]
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Azithromycin is a macrolide antibacterial drug . [see Microbiology (12.4) ] 12.2 Pharmacodynamics Based on animal models of infection, the antibacterial activity of azithromycin appears to correlate with the ratio of area under the concentration-time curve to minimum inhibitory concentration (AUC/MIC) for certain pathogens ( S. pneumoniae and S. aureus ). The principal pharmacokinetic/pharmacodynamic parameter best associated with clinical and microbiological cure has not been elucidated in clinical trials with azithromycin. Cardiac Electrophysiology QTc interval prolongation was studied in a randomized, placebo-controlled parallel trial in 1…
4 CONTRAINDICATIONS Patients with known hypersensitivity to azithromycin, erythromycin, any macrolide, or ketolide drug. ( 4.1 ) Patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin. ( 4.2 ) 4.1 Hypersensitivity Azithromycin is contraindicated in patients with known hypersensitivity to azithromycin, erythromycin, any macrolide, or ketolide drug. 4.2 Hepatic Dysfunction Azithromycin is contraindicated in patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin.
6 ADVERSE REACTIONS Most common adverse reactions are diarrhea (5% to 14%), nausea (3% to 18%), abdominal pain (3% to 7%), or vomiting (2% to 7%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact TAGI Pharma, Inc. at 1-855-225-8244 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the c…
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…
2 DOSAGE AND ADMINISTRATION Adult Patients ( 2.1 ) Infection Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity) Pharyngitis/tonsillitis (second-line therapy) Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5 Acute bacterial exacerbations of chronic bronchitis (mild to moderate) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5 or 500 mg once daily for 3 days Acut…
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). General Patient Counseling Azithromycin tablets can be taken with or without food. Patients should also be cautioned not to take aluminum- and magnesium-containing antacids and azithromycin simultaneously. The patient should be directed to discontinue azithromycin immediately and contact a physician if any signs of an allergic reaction occur. Direct parents or caregivers to contact their physician if vomiting and irritability with feeding occurs in the infant. Patients should b…
Source: FDA. For professional use only. Not a substitute for prescribing information.
| Name | Status |
|---|---|
| AZITHROMYCIN 500MG 30 TAB | 2-Day |
| AZITHROMYCIN 500MG TAB 30 | 2-Day |
| AZITHROMYCIN DIHYDRATE 500MG 1X3 TAB | 2-Day |
| AZITHROMYCIN TABS | 2-Day |
Premier Pharma stocks 4 Azithromycin dihydrate SKUs — 0 currently in stock — available to licensed pharmacies, clinics, doctor's offices, and veterinary practices. Azithromycin dihydrate is the generic equivalent of Azithromycin Dihydrate. Create a free account to see live wholesale pricing and place orders with same-day fulfillment for in-stock items.
Premier Pharma carries Azithromycin dihydrate in 500 mg/1 and TABLET, FILM COATED.
Azithromycin dihydrate carries an FDA Orange Book TE code of AB. Therapeutically equivalent — meets FDA bioequivalence requirements; may be substituted for the reference listed drug. Always verify substitution with the current Orange Book before dispensing.
12.1 Mechanism of Action Azithromycin is a macrolide antibacterial drug . [see Microbiology (12.4) ]
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