Azi-Once Suspension

Azithromycin

200mg/5ml

Jamjoom Pharmaceuticals Company Ltd.

Pack size	15ml Glass Bottle (Powder) + 1 Plastic Ampoule (9ml Water) + 1 Plastic Syringe (10ml)
Dispensing mode	POM
Source	SAUDI ARABIA
Agent	Unicare for Medical Trading
Retail Price	12.00 AED

Available as:

200mg/5ml - Suspension 200mg/5ml - Suspension 250mg - Capsules (Hard gelatin)

Indications

Azi-Once Suspension 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.

Adverse 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.

Mechanism 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

Azi-Once 200mg/5ml Suspension manufactured by Jamjoom Pharmaceuticals Company Ltd.. Its generic name is Azithromycin. Azi-Once is availble in United Arab Emirates. Farmaco UAE drug index information on Azi-Once Suspension is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.

Some other brands of Azithromycin :

Tablets / Film-coated

Z-Mycin ^250mg

Medpharma Pharma. & Chem. Ind's (L.L.C)

Tablets / Film-coated

Z-Mycin ^500mg

Medpharma Pharma. & Chem. Ind's (L.L.C)

Capsules (Hard Gelatin)

Zithrova ^250mg

Oman Pharmaceutical Products

Capsules (Hard Gelatin)