Cinazith/Cinazith-DS

Cinazith: Each tablet contains: Azithromycin Dihydrate USP Eq. to Anhydrous Azithromycin 500 mg.
Cinazith-DS: Each 5 mL (one teaspoonful) contains: Azithromycin dihydrate equivalent to Azithromycin 200 mg.

Pharmacology: Azithromycin, a semisynthetic antibiotic belonging to the macrolide sub-group of Azalides, is used to treat STDs due to Chlamydia and gonorrhea, community-acquired pneumonia, pelvic inflammatory disease, pediatric otitis media and pharyngitis, and Mycobacterium avium complex (MAC) in patients with advanced HIV disease. Similar in structure to erythromycin, Azithromycin reaches higher intercellular concentrations than erythromycin, increasing its efficacy and duration of action.
Mechanism of Action: Azithromycin binds to the 50S subunit of the 70S bacterial ribosomes, and therefore inhibits RNA-dependent protein synthesis in bacterial cells.
Pharmacokinetics: Azithromycin given orally is about 40% bioavailable. Absorption from capsules, but not tablets, is reduced by food.
Peak plasma concentrations are achieved 2 to 3 hours after a dose, but Azithromycin is extensively distributed to the tissues, and tissue concentrations subsequently remain much higher than those in the blood; in contrast to most other antibacterials, plasma concentrations are therefore of little value as a guide to efficacy. High concentrations are taken up into white blood cells. There is little diffusion into the CSF when the meninges are not inflamed. Small amount of Azithromycin are demethylated in the liver, and it is excreted in bile as unchanged drug and metabolites.
For prevention of Mycobacterium avium complex (MAC) disease.
Following oral administration in human, Azithromycin is widely distributed throughout the body; bioavailability is approximately 40%.
No significant decrease in bioavailability was observed when Azithromycin tablets were administered with a meal. The time taken to peak plasma levels is 2-3 hours. Plasma terminal elimination half-life closely reflects the tissue depletion half-life of 2 to 4 days.

Cinazith: Azithromycin is indicated for the treatment of Infection from respiratory tract pathogens (e.g., S. pyogenes, sp., pneumoniae, M. catarrhalis, C. trachomatis, Legionella, C. pneumoniae and M. avium infection); uncomplicated chlamydial urethritis, cervicitis or pharyngitis; alternative drug for multi-drug resistant Salmonella typhi infection outside the Central Nervous System (CNS).
Cinazith-DS: For the treatment of respiratory tract infections (including otitis media) in skin and soft tissue infections, and in uncomplicated genital infections. It may also be used for the prophylaxis, and as component of regimens in the treatment of Mycobacterium avium complex (MAX) infections.

Cinazith: Adults and adolescents: 1 gram taken once as a single dose.
For gonococcal infections: Adults and adolescents: 2 grams taken once as a single dose.
For Otitis media and pneumonia: Children 6 months to 12 years of age: 10 milligrams (mg) per kilogram (kg) (4.5 mg per pound) of body weight once a day on the first day, then 5 mg per kg (2.2 mg per pound) of body weight once a day on days two to five.
For strep throat: Children 2 to 12 years of age: 12 mg per kg (5.4 mg per pound) of body weight once a day for five days.
Children up to 2 years of age: Use and dose must be determined by doctor.
Adults and adolescents 16 years of age and older: 1200 mg once a week.
Children up to 16 years of age: use and dose must be determined by the doctor.
For sinusitis: Adults and adolescents: 500 mg a day for 3 days.
Children up to 16 years of age: Use and dose must determined by the doctor.
About 6% of an oral dose (representing about 20% of the amount in the systemic circulation) is excreted in the urine. The terminal elimination half-life is about 68 hours.
For bronchitis, strep throat, pneumonia, and skin infections: Adults and adolescents 16 years of age and older: 500 milligrams (mg) on the first day, then 250 mg once a day on days two to five.
Children up to 16 years of age and older: 1000 mg taken once as a single dose.
Children up to 16 years of age: Use and dose must be determined by the doctor.
For chlamydia infections: Adults and adolescents 16 years of age and older: 1000 mg taken once as s single dose.
Children up to 16 years of age: Use and dose must be determined by the doctor.
Or as prescribed by the physician.
Cinazith-DS: Children under 16 years: The usual dose for children is 10 mg/kg body weight orally, once a day for 3 days. Alternatively after 10 mg/kg body weight oral loading dose on the first day, therapy can be continued at a dose of 5 mg/kg body weight on subsequent four days.
Infants under 6 months: Not recommended. Or as prescribed by the physician.

Azithromycin tablet is contraindicated in patients with known hypersensitivity to Azithromycin or any macrolides or ketolides antibiotics.

Azithromycin should not be used in patients with hepatic impairment.
Use in Children: This medicine has been tested in a limited number of children up to the age 16. In effective doses, the medicine has not been shown to cause different side effects or problems than it does in adults.
Use in Elderly: This medicine has been tested in a limited number of elderly patients and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy: Azithromycin has not been studied in pregnant women. However, Azithromycin has not been shown to cause birth defects or other problems in animal studies.
Breast-feeding: It is not known whether Azithromycin passes into breast milk, although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Abdominal or stomach cramps or pain (severe); abdominal tenderness; diarrhea (watery and severe, which may be bloody); difficulty in breathing; fever, joint pain; skin rash; swelling of face, mouth, neck, hands and feet.
Diarrhea (mild); nausea; stomach pain or discomfort, dizziness; headache.
Azithromycin is well tolerated with a low incidence of adverse effects in children. The most frequent adverse effects are gastrointestinal and are dose related. They include nausea, vomiting, abdominal pain and diarrhoea. Occasionally reversible elevations in liver transaminases have been seen. Allergic reactions like skin rash may occur.

Nelfinavir: side effects of Azithromycin, such as liver enzyme abnormalities and hearing impairment, is warranted.
Azithromycin did not affect the prothrombin time response to a single dose of Warfarin. However, prudent medical practice dictates careful monitoring of prothrombin time in all patients treated with Azithromycin and Warfarin concomitantly. Concurrent use of macrolides and Warfarin in clinical practice has been associated with increased anticoagulant effects. Drug interaction studies were performed with Azithromycin and other drugs likely to be coadministered.
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 (intravenous and oral), triazolam, trimethoprim/sulfamethoxazole or zidovudine. Co-administration with efavirenz or fluconazole had a modest effect on the pharmacokinetics of Azithromycin. No dosage adjustment of either drug is recommended when Azithromycin is co-administered with any of the above agents. Interactions with the drugs listed as follows have not been reported in clinical trials with Azithromycin; however, no specific drug interaction studies have been performed to evaluate potential drug-drug interaction. Nonetheless, they have been observed with macrolides products. Until further data are developed regarding drug interactions when Azithromycin and these drugs are used concomitantly, careful monitoring of patients is advised: Digoxin: elevated digoxin concentrations.
Ergotamine or dihydroergotamine: acute ergot toxicity characterized by severe peripheral vasospasm and dysesthesia.
Theophylline: There is no evidence of any pharmacokinetic interaction when azithromycin and theophylline are co-administered to healthy volunteers Terfenadine. No clinically significant pharmacokinetic interactions observed.
Ergot: The theoretical possibility of ergotism contraindicates the concurrent use of azithromycin with ergot derivatives.
Cyclosporine: Caution should be exercised before concurrent administration of azithromycin and Cyclosporine levels should be monitored and the dose should be adjusted accordingly.
Digoxin: Some of the macrolide antibiotics have been reported to impair the metabolism of digoxin. In patients receiving concomitant Azithromycin and digoxin the possibility of raised digoxin levels should be borne in mind. However, no interactions have been reported so far.
Antacids: Azithromycin and antacids should not be taken simultaneously. Antacids reduce peak serum concentrations by up to 30%, although overall bioavailability is unaffected.
Cimetidine: No alterations of Azithromycin pharmacokinetics were seen.

Store at temperatures not exceeding 30°C.

Macrolides

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

Rx