Indications
Azexia Tablet is used for:
Bacterial infections, bacterial endocarditis, typhoid fever, community-acquired pneumonia, uncomplicated gonorrhea, streptococcal pharyngitis/tonsillitis, COPD, acute bacterial sinusitis, acute otitis media, uncomplicated UTI, Uncomplicated gonorrhea, PID, non-gonococcal urethritis, chancroid, acute salmonellosis, cervicitis, babesiosis, chlamydial infections, pelvic inflammatory disease, PID, traveler's diarrhea,
Adult Dose
Oral
Skin and soft tissue infections, Respiratory tract infections
Adult: As tab, cap, or immediate release suspension: 500 mg daily for 3 days. Alternatively, 500 mg as single dose on day 1 followed by 250 mg daily on days 2-5.
Community-acquired pneumonia
Adult: As tab, cap, or immediate release suspension: 500 mg on day 1, followed by 250 mg once daily on days 2-5. As extended release suspension: 2 g as a single dose.
Chancroid, Uncomplicated genital infections due to Chlamydia trachomatis
Adult: 1 g as a single dose.
Uncomplicated gonorrhoea
Adult: 1 g or 2 g as a single dose, in combination with ceftriaxone.
Prophylaxisof disseminated Mycobacterium avium complex (MAC) infections
Adult: 1.2 g once weekly.
Acute bacterial sinusitis
Adult: As tab, cap or immediate release suspension: 500 mg once daily for 3 days. As extended release suspension: 2 g as a single dose.
Intravenous
Community-acquired pneumonia
Adult: 500 mg as a single daily dose for at least 2 days, given at a rate of 1 mg/mL over 3 hours or 2 mg/mL over 1 hour, followed by oral dose of 500 mg daily to complete 7-10 days.
Pelvic inflammatory disease
Adult: 500 mg daily as a single dose for 1 or 2 days, given at a rate of 1 mg/mL over 3 hours or 2 mg/mL over 1 hour, followed by oral dose of 250 mg daily to complete 7 days.
Hepatic impairment: No dosage adjustment needed.
Child Dose
Child: PO: q24h
>6 months
Otitis: 10 mg/kg/day for 1 day, then 5 mg/kg for 4 days; or 10 mg/kg/day for 3 days; or 30 mg/kg once.
Tonsillitis, Pharyngitis: 12 mg/kg/day for 5 days.
Sinusitis: 10 mg/kg/day for 3 days.
CABP: 10 mg/kg for 1 day, then 5 mg/kg/day for 4 days or 60 mg/kg once of ER susp
MAC/PCP prophylaxis: 5 mg/kg/day
Skin and soft tissue infections, Respiratory tract infections: 10 mg/kg daily for 3 days or 10 mg/kg on day 1, followed by 5 mg/kg/day on days 2-5.
IV: 10 mg/kg q24h
>6 mth 10 mg/kg;
15-25 kg: 200 mg;
26-35 kg: 300 mg;
36-45 kg: 400 mg.
All doses to be taken once daily for 3 days.
Renal Dose
Renal impairment: No dosage adjustment needed.
Administration
Oral Administration
Tablet: Take tablets without regard to food; however, food may enhance tolerability
Oral suspension
Conventional oral suspension (100 mg/5 mL, 200 mg/5 mL) may be stored for 10 days after reconstitution and taken without regard to food
Conventional 1 g package must be taken immediately after reconstitution
Extended-release oral suspension must be taken on empty stomach within 12 hours of reconstitution; given only in single dose; not interchangeable with immediate release formulation
IV Preparation
Dilute 500-mg vial in 4.8 mL of SWI (100 mg/mL)
Dilute further in NS to 1 mg/mL (500 mL) or 2 mg/mL (250 mL)
IV Administration
1 mg/mL solution: Infuse over 3 hours
2 mg/mL solution: Infuse over 1 hour
Contra Indications
Known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotic. Coadministration w/ pimozide. History of cholestatic jaundice/hepatic dysfunction associated w/ prior use of azithromycin.
Precautions
May increase the risk of Torsades de pointes and fatal heart arrhythmias in patients w/ prolonged QT interval, low K or Mg blood levels, slow heart rate and medication treating abnormal heart rhythms. Impaired hepatic and renal function. Pregnancy and lactation. Monitoring Parameters Liver function tests, CBC w/ differential.
Lactation: Unknown whether drug is excreted into breast milk; use with caution
Pregnancy-Lactation
Pregnancy
Available data from published literature and postmarketing experience over several decades with azithromycin use in pregnant women have not identified drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data); data do not suggest embryofetal risk (Developmental and Reproductive Toxicology Database [DART]; https://toxnet.nlm.nih.gov/newtoxnet/dart.htm)
Animal data
Developmental toxicity studies with azithromycin in rats, mice, and rabbits showed no drug-induced fetal malformations at doses up to 4, 2, and 2 times, respectively, an adult human daily dose of 500 mg based on body surface area; decreased viability and delayed development were observed in offspring of pregnant rats administered azithromycin from day 6 of pregnancy through weaning at a dose equivalent to 4 times an adult human daily dose of 500 mg based on body surface area
Lactation
Drug is present in human milk; non-serious adverse reactions reported in breastfed infants after maternal administration of therapy; there are no available data on effects on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and potential adverse effects on breastfed infant from drug or underlying maternal condition; advise women to monitor breastfed infant for diarrhea, vomiting, or rash.
Interactions
Increases serum concentrations of digoxin, ciclosporin, terfenadine, hexobarbital and phenytoin. Decreased rate of absorption w/ antacids containing aluminium and magnesium. Increased risk of ergot toxicity.
Potentially Fatal: Increased risk of cardiotoxicity w/ pimozide.
Side Effects
Side effects of Azithromycin :
>10%
High single dose therapy
Diarrhea (52.8%), Nausea (32.6%), Abdominal pain (27%), Loose stool (19.1%)
1-10%
Cramping (2-10%), Vaginitis (2-10%), Dyspepsia (9% with single high dose therapy), Flatulence (9% with single high dose therapy), Vomiting (6.7% with single high dose therapy), Malaise (1.1%)
<1%
Agitation, Allergic reaction, Anemia, Anorexia, Candidiasis, Chest pain, Conjunctivitis, Constipation, Dermatitis (fungal), Dizziness, Eczema, Edema, Enteritis, Facial edema, Fatigue, Gastritis, Headache, Hyperkinesia, Hypotension, Increased cough, Insomnia, Leukopenia, Malaise, Melena, Mucositis, Nervousness, Oral candidiasis, Pain, Palpitations, Pharyngitis, Pleural effusion, Pruritus, Pseudomembranous colitis, Rash, Rhinitis, Seizures, Somnolence, Urticaria, Vertigo
Potentially Fatal: Angioedema and cholestatic jaundice.
Mode of Action
Azithromycin is a semisynthetic azalide antibiotic. It blocks transpeptidation by binding to 50s ribosomal subunit of susceptible organisms and disrupting RNA-dependent protein synthesis at the chain elongation step.
Note
Azexia 500mg Tablet generic name is Azithromycin. Azexia 500mg Tablet is manufactured by Pharmasia Ltd.Azexia is availble in all over Bangladesh.
Mes BD drug index information on Azexia Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.