| Composition |
Each F.C. tablet contains:
Zithropenda 250 mg: Azithromycin dihydrate equivalent to 250 mg Azithromycin. |
| Mechanism of Action |
| Azithromycin binds to the 23S rRNA of the bacterial 50S ribosomal subunit. It blocks protein synthesis by inhibiting the transpeptidation/translocation step of protein synthesis and by inhibiting the assembly of the 50S ribosomal subunit. |
| INDICATIONS & USAGE |
• Azithromycin is indicated for the treatment of patients with mild to moderate infections (pneumonia) caused by susceptible strains of the designated microorganisms in the specific conditions listed below.
• Acute bacterial exacerbations of chronic obstructive pulmonary disease due to Haemophilusinfluenzae, Moraxella catarrhalisor Streptococcus pneumoniae.
• Acute bacterial sinusitis due to Haemophilusinfluenzae, Moraxella catarrhalisorStreptococcus pneumoniae.
• Community-acquired pneumonia due to Chlamydophilapneumoniae, Haemophilusinfluenzae, Mycoplasma pneumoniaeor Streptococcus pneumoniae.
• Pharyngitis/tonsillitis caused by Streptococcus pyogenes
• Uncomplicated skin infections due to Staphylococcus aureus, Streptococcus pyogenes, or Streptococcus agalactiae.
• Urethritis and cervicitis due to Chlamydia trachomatis or Neisseria gonorrhoeae.
• Genital ulcer disease in men due to Haemophilusducreyi(chancroid).
• Acute otitis media caused by Haemophilusinfluenzae, Moraxella catarrhalis or Streptococcus pneumoniae.
• Azithromycin is indicated for the treatment of MAC infection and prophylaxis against MAC Infection.
• Treatment of Disseminated Mycobacterium aviumcomplex (MAC) Disease
• Azithromycin, taken in combination with ethambutol, is indicated for the treatment of disseminated MAC infections.
• Prophylaxis of Disseminated Mycobacterium aviumcomplex (MAC) Disease Azithromycin, taken alone or in combination with rifabutin.
• Sexually Transmitted Diseases
• Urethritis and cervicitis due to Chlamydia trachomatis.
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| CONTRAINDICATIONS |
| Azithromycin is contraindicated in patients with known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotic. Azithromycin is contraindicated in patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin. |
| WARNINGS |
Hypersensitivity
Could be serious allergic reactions, these patients required prolonged periods of observation and symptomatic treatment.
Hepatotoxicity
Abnormal liver function, hepatitis, cholestatic jaundice, hepatic necrosis, and hepatic failure have been reported. Discontinue azithromycin immediately if signs and symptoms of hepatitis occur.
Clostridium difficileassociated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including ZITHROPENDA.
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| PRECAUTIONS |
General: Because azithromycin is principally eliminated via the liver, caution should be exercised when azithromycin is administered to patients with impaired hepatic function.
Prescribing ZITHROPENDA (azithromycin) in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Exacerbation of symptoms of myasthenia gravis and new onset of myasthenic syndrome have been reported in patients receiving azithromycin therapy.
QT Prolongation
Prolonged cardiac repolarization and QT interval, imparting a risk of developing cardiac
arrhythmia and torsades de pointes, have been seen in treatment with macrolides, including azithromycin. Cases of torsades de pointes have been spontaneously reported during postmarketing surveillance in patients receiving azithromycin. Providers should consider the risk of QT prolongation when weighing the risks and benefits of azithromycin for at-risk groups including:
- Patients with known prolongation of the QT interval, a history of torsades de pointes, congenital long QT syndrome, bradyarrhythmias or uncompensated heart failure.
- Patients on drugs known to prolong the QT interval.
- Patients with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinicallysignificant bradycardia, and in patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, aminodarone, sotalol) antiarrhythmic agents.
- Elderlypatients maybe more susceptible to drug-associated effects on the QT interval.
Treatment of pneumonia
In the treatment of pneumonia, azithromycin has only been shown to be safe and effectivein the treatment of community-acquired pneumonia due to Chlamydia pneumoniae,Haemophilusinfluenzae, Mycoplasma pneumoniae or Streptococcus pneumoniae in patientsappropriate for oral therapy. Azithromycin should not be used in patients with pneumoniawho are judged to be inappropriate for oral therapy because of moderate to severe illnessor risk factors such as any of the following: patients with cystic fibrosis, patients withnosocomially acquired infections, patients with known or suspected bacteremia, patientsrequiring hospitalization, elderly or debilitated patients, or patients with significantunderlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia).
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| ADVERSE REACTIONS |
In clinical trials, most of the reported side effects were mild to moderate in severity and were reversible upon discontinuation of the drug. Potentially serious side effects of angioedema and cholestatic jaundice were reported rarely.
Palpitations, chest pain Dyspepsia, flatulence, vomiting, cholestatic jaundice.Monilia, vaginitis and nephritis. Dizziness, headache, vertigo and somnolence. Fatigue. Rash, pruritus, photosensitivity and angioedema.
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| Drug Interactions |
When used in therapeutic doses, azithromycin had a modest effect on the pharmacokinetics of atorvastatin,carbamazepine, cetirizine, didanosine, efavirenz, fluconazole, indinavir, midazolam, rifabutin, sildenafil, theophylline, triazolam, trimethoprim/sulfamethoxazole or zidovudine. Co-administration with efavirenz, or fluconazole had a modest effect on the pharmacokinetics of azithromycin.
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| PREGNANCY & LACTATION |
Pregnancy Category B:
There are, however, no adequate and well-controlled studies in pregnant women. Azithromycin should be used during pregnancy only if clearly needed.
Nursing Mothers: It is not known whether azithromycin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when azithromycin is administered to a nursing woman.
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| DOSAGE & ADMINISTRATION |
Adults
Infection* Recommended Dose/Duration of Therapy
Community-acquired pneumonia
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
obstructive pulmonary disease
500 mg once daily for 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5
Acute bacterial sinusitis 500 mg once daily for 3 days
Genital ulcer disease (chancroid) One single 1 gram dose
Non-gonococcal urethritis and cervicitis One single 1 gram dose
Gonococcal urethritis and cervicitis One single 2 gram dose
Prevention of Disseminated MAC Infections
The recommended dose of azithromycin for the prevention of disseminated Mycobacteriumaviumcomplex (MAC) disease is: 1200 mg taken once weekly. This dose of azithromycin may be combined with the approved dosage regimen of rifabutin.
Treatment of Disseminated MAC Infections
Azithromycin should be taken at a daily dose of 600 mg, in combination with ethambutol at the recommended daily dose of 15 mg/kg.
Renal Insufficiency:
No dosage adjustment is recommended for subjects with renal impairment (GFR=80 mL/min).Caution should be exercised when azithromycin is administered to subjects with severe renal impairment.
Hepatic Insufficiency:
No dose adjustment recommendations can be made in patients with impaired
No dosage adjustment is recommended based on age or gender.
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| Overdose |
| The undesirable effects at doses in excess of those recommended were similar to thoseafter normal doses. The typical symptoms of an overdose with macrolide antibioticsinclude reversible loss of hearing, severe nausea, vomiting and diarrhoea. In cases of overdose, administration of medicinal charcoal and general symptomatic treatment as well as measures to support vital functions are indicated where necessary. |
| Packaging |
| Zithropenda 250: 6 F. C. tablets in a blister inside a cartoon box with a leaflet. |
| Storage |
| F.C. tablets:Store between 15⁰Cto 30⁰C. |
