Zithrocare 200/Zithrocare 500

Azithromycin dihydrate.

Azithromycin (Zithrocare 200/Zithrocare 500) contains the active ingredient azithromycin (as dihydrate); an azalide, a subclass of macrolide antibiotic.
Azithromycin (Zithrocare 200/Zithrocare 500) is used to treat different types of infections caused by gram positive and gram negative organisms.
Zithrocare 200: Each 5 mL contains: Azithromycin (as dihydrate) 200 mg, Excipients q.s.
Zithrocare 500: Each film-coated tablet contains: Azithromycin (as dihydrate USP) 500 mg.
Excipients/Inactive Ingredients: Colour: Titanium dioxide BP.

Pharmacology: Pharmacodynamics: Azithromycin is a 15-membered ring azalide antibiotic. Azithromycin interferes with ribosome function in susceptible bacteria by inhibiting the translocation of peptides, achieved through specific competitive binding to its target site on the 50S ribosomal subunit.
Pharmacokinetics: After oral administration, azithromycin rapidly absorbed and widely distributed throughout the body. It is extensively distributed to the tissues and peak plasma concentrations are achieved in 2 to 3 hours after oral administration. The average half-life of azithromycin is 68 hours. The serum protein binding of azithromycin is variable, ranging from 12% to 50%, depending on concentration. Azithromycin is excreted in bile as unchanged drug and metabolites. Approximately 6% of an oral dose is excreted in the urine.

Zithrocare 200: For the treatment of patients with mild to moderate infection caused by susceptible strains of the designated microorganisms in specific condition listed as follows: Sexually Transmitted Diseases: Non-gonococcal urethritis and cervicitis due to Chlamydia trachomatis.
Prophylaxis Of disseminated Mycobacterium avium complex (MAC) disease: taken alone or in combination with rifabutin at its approved dose is indicated for the prevention of disseminated MAC disease in persons with advanced HIV infection.
Treatment of Disseminated MAC Disease: Taken in combination with ethambutol is indicated for the treatment of disseminated MAC infection in persons with advanced HIV infection.
Zithrocare 500: It is used in the treatment of respiratory-tract infections (including otitis media), in skin and soft-tissue infections, and in uncomplicated genitals infections. It is also used for the prophylaxis of Mycobacterium avium complex (MAC) infections.

Azithromycin suspension/tablets are for oral administration and should be administered as a single daily dose. The period of dosing with regard to infection is given as follows. Azithromycin suspension/tablets can be taken with or without food.
In adults: For the treatment of sexually transmitted diseases: For the treatment of non-gonococcal urethritis and cervicitis caused by Chlamydia trachomatis in sexually transmitted diseases, the dose is 1 g/1000 mg as a single oral dose.
For prophylaxis against Mycobacterium avium intracellulare complex (MAC) infections: in patients infected with the human immunodeficiency virus (HIV), the dose is 1.2 g/1200 mg once per week.
In children: The maximum recommended total dose for any treatment is 1.5 g/1500 mg for children.
In general, the total dose in children is 30 mg/Kg. Treatment for pediatric streptococcal pharyngitis should be dosed at a different regimen.
The total dose of 30 mg/Kg should be given as a single daily dose of 10 mg/Kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/Kg on day 1, then 5 mg/Kg on day 2-5.
In the elderly: In patients with renal impairment: No dose adjustment is necessary in patients with mild to moderate renal impairment (GFR 10-80 mL/min). Caution should be exercised when azithromycin is administered to patients with severe renal impairment (GFR <10 mL/min).
In patients with hepatic impairment: The same dosage as in patients with normal hepatic function may be used in patients with mild to moderate hepatic impairment.
Or as directed by the Physician.
Zithrocare 500: In adults: For the treatment of lower respiratory tract infection: the recommended dose of azithromycin is 500 mg once daily for three days or as an alternative 500 mg on day 1 followed by 250 mg once daily on days 2 to 5.
For the treatment of upper respiratory tract infection: the recommended dose of azithromycin is 500 mg once daily for three days.
For the treatment of Community Acquired Pneumonia (CAP): the recommended dose of azithromycin is 500 mg once daily for three days or as an alternative 500 mg twice on day 1 followed by 500 mg once daily for 4 days.
For the treatment of skin infections: the recommended dose of azithromycin is 500 mg as single dose on day 1 followed by 250 mg once daily for 4 days.
In children: As an alternative to the previously mentioned dosing, treatment for children with acute otitis media can be given as a single dose of 30 mg/Kg.
For pediatric streptococcal pharyngitis, azithromycin given as a single dose of 10 mg/Kg or 20 mg/Kg for 3 days has been shown to be effective, however a daily dose of 500 mg must not be exceeded.
Azithromycin tablets should only be administered to children weighing more than 45 kg.

Do not exceed the recommended doses. In case of overdosage consult the physician immediately.

Hypersensitivity to azithromycin or any of the macrolide antibiotics. Co-administration with ergot derivatives.

Zithrocare 200: QT interval prolongation may lead to Torsade de Pointes (TdP) and cardiac arrhythmia.
Serious allergic reactions including angioedema, anaphylaxis and dermatologic reactions including Steven-johnson syndrome and toxic epidermal necrolysis have been reported rarely.
Hepatotoxicity.
Clostridium difficile associated diarrhea (CDAD).
Exacerbation of Myasthenia gravis.
Use in sexually transmitted infection.
Development of drug resistant bacteria.
Zithrocare 500: Severe hypersensitivity reactions occur rarely but may be prolonged. Transient reduction in neutrophil count has been seen in patients receiving azithromycin.

Azithromycin should only be used during pregnancy if it is clearly indicated. Caution should be taken when administered to a pregnant woman.
It is not known whether azithromycin is excreted in human milk. Caution should be taken when administered to a nursing woman.

Zithrocare 200: Serious: angioedema and cholestatic jaundice, nausea, vomiting, diarrhea or abdominal pain.
Multiple-dose regimen: diarrhea/loose stools, nausea, abdominal pain.
Cardiovascular: Palpitations and chest pain.
Gastrointestinal: Dyspepsia, flatulence, vomiting, melena and cholestatic jaundice.
Genitourinary: Monilia, vaginitis and nephritis.
Nervous system: Dizziness, headache, vertigo and somnolence.
General: Fatigue.
Allergic: Rash, photosensitivity and angioedema.
Post marketing experience: Allergic: Arthralgia, edema, urticaria and angioedema.
Cardiovascular: Arrythmias, including ventricular tachycardia and hypotension. There have been reports of QT prolongation and Torsade de Pointes.
Gastrointestinal: Anorexia, constipation, dyspepsia, flatulence, vomiting, diarrhea, pseudomembranous colitis, pancreatitis, oral candidiasis, pyloric stenosis and tongue discoloration.
General: Asthenia, paresthesia, fatigue, malaise and anaphylaxis.
Genitourinary: Interstitial nephritis, acute renal failure and vaginitis.
Hematopoietic: Thrombocytopenia.
Liver/Biliary: Abnormal liver function, hepatitis, cholestatic jaundice, hepatic necrosis and hepatic failure.
Nervous system: Convulsions, dizziness/vertigo, headache, somnolence, hyperactivity, nervousness, agitation and syncope.
Psychiatric: Aggressive reaction and anxiety.
Skin/Appendages: Pruritus and serious skin reaction including erythema multiforme, Stevens-johnson syndrome, and toxic epidermal necrolysis.
Special Senses: Hearing disturbances including hearing loss, deafness and/or tinnitus and reports of taste/smell perversion and/or loss.
Zithrocare 500: Gastrointestinal disturbances are the most frequent adverse effect but those are usually mild. Headache may occur and taste disturbances have been reported rarely.

Zithrocare 200: Nelfinavir: Co-administration of nelfinavir at steady-state with a single oral dose of azithromycin resulted in increased azithromycin serum concentration. Although dose adjustment of azithromycin is not recommended then administered in combination with nelfinavir, close monitoring for known adverse reactions of azithromycin, such as liver enzyme abnormalities and hearing impairment, is warranted.
Warfarin: Spontaneous post-marketing reports suggests 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 time should be carefully monitored while patients are receiving azithromycin and oral anticoagulants concomitantly.
Zithrocare 500: Caution is advised while using azithromycin in conjunction with drugs like carbamazepine, corticosteroids, cyclosporine, digoxin, ergot alkaloids, theophylline and warfarin.
Azithromycin should be taken at least one hour before or two hours after administration of food and antacid preparations.

Store at temperatures not exceeding 30°C. Protect from light.

Macrolides

J01FA10 - azithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.

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