about Azithromycin class, uses, side effects contraindications

see trade names in the World

Azithromycin

Short Description

Azithromycin is a new antibiotic belonging to the group of antibiotics called macrolides. These drugs disrupt the production of proteins in bacteria but not in humans.?

Pregnancy category: B

Indications

To treat mild community-acquired pneumonia, otitis media, pharyngitis, tonsillitis, and uncomplicated skin and soft-tissue infections , ORAL SUSPENSION,
Adults.500 mg as a single dose on day 1, followed by 250 mg daily on days 2 through 5. Children age 6 months or over with acute otitis media or community-acquired pneumonia.10 mg/kg as a single dose (not to exceed 500 mg daily) on day 1, followed by 5 mg/kg (not to exceed 250 mg daily) daily on days 2 through 5. Or, for acute otitis media, 30 mg/kg of oral suspension as a single dose or 10 mg/kg daily for 3 days. Children age 12 or over with pharyngitis or tonsillitis.12 mg/kg (not to exceed 500 mg daily) as single dose daily for 5 days. To treat mild to moderate acute bacterial exacerbations of COPD , ORAL SUSPENSION,
Adults. 500 mg daily for 3 days. Or, 500 mg as single dose on day 1, followed by 250 mg azithromycin 118 daily on days 2 through 5. To treat community-acquired pneumonia , ORAL SUSPENSION,, I.V. INFUSION Adults and adolescents age 16 or over. 500 mg I.V. as a single dose daily for at least 2 days, followed by 500 mg P.O. as a single dose daily until patient completes 7 to 10 days of therapy. To treat community-acquired pneumonia caused by Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, or Streptococcus pneumoniae (ZMAX)
Adults. 2 g as a single dose on an empty stomach. To treat chancroid caused by Haemophilus ducreyi; gonococcal pharyngitis; urethritis, cervicitis, or other infections caused by Chlamydia trachomatis , ORAL SUSPENSION,
Adults. 1 g as a one-time dose. Children age 8 or over and children under age 8 weighing 45 kg (99 lb) or more (with infections caused by C. trachomatis). 1 g as a one-time dose. To treat urethritis or cervicitis caused by Neisseria gonorrhoeae , ORAL SUSPENSION,
Adults.2 g as a one-time dose. To prevent Mycobacterium avium complex in patients with advanced HIV infection , ORAL SUSPENSION,, I.V. INFUSION
Adults.1.2 g once weekly, as indicated. To treat pelvic inflammatory disease , ORAL SUSPENSION,, I.V. INFUSION
Adults.500 mg I.V. as a single dose daily for 1 to 2 days, followed by 250 mg P.O. as a single dose daily until patient completes 7 days of therapy. To treat acute bacterial sinusitis ORAL SUSPENSION,
Adults. 500 mg daily for 3 days. Children.10 mg/kg daily for 3 days. To treat acute bacterial sinusitis caused by H. influenzae, Moraxella catarrhalis, or S. pneumoniae

ORALL

(ZMAX)
Adults.2 g as a single dose on an empty stomach. Route Onset Peak Duration P.O. Varies Unknown Unknown

Mechanism of Action

Binds to a ribosomal subunit of susceptible bacteria, blocking peptide translocation and inhibiting RNA-dependent protein synthesis. Drug concentrates in phagocytes, macrophages, and fibroblasts, which release it slowly and may help move it to infection sites.

Incompatibilities

Don’t add I.V. substances, additives, or to azithromycin I.V. solution, and don’t infuse through the same I.V. line.

Contraindications

Hypersensitivity to azithromycin, erythromycin, ketolide antibiotics, or other macrolide antibiotics

Interactions

antacids that contain aluminum or magnesium: Possibly decreased peak blood azithromycin level, but extent of absorption is unchanged carbamazepine, cyclosporine, phenytoin, terfenadine ( metabolized by P-450 cytochrome system): Possibly increased blood levels of these digoxin: Possibly increased blood digoxin level dihydroergotamine, ergotamine: Possibly severe peripheral vasospasm and abnormal sensations (acute ergot toxicity) HMG-CoA reductase inhibitors: Increased risk of severe myopathy or rhabdomyolysis pimozide: Possibly sudden death oral anticoagulants: Possibly potentiated effects of oral anticiagulants
theophylline: Possibly increased blood theophylline level triazolam: Possibly decreased excretion and increased therapeutic effects of triazolam
warfarin: Possibly increased anticoagulation food: Dramatically increased absorption rate of azithromycin

Side Efect

CNS: Aggressiveness, agitation, anxiety, asthenia, dizziness, fatigue, headache, hyperactivity, malaise, nervousness, paresthesia, seizures, somnolence, syncope, vertigo
CV: Chest pain, edema, elevated serum CK level, hypotension, palpitations, prolonged QT interval, torsades de pointes, ventricular tachycardia
EENT: Hearing loss, mucocutaneous candidiasis, perversion or loss of taste or smell, tinnitus
ENDO: Hyperglycemia
GI: Abdominal pain, anorexia, cholestatic jaundice, constipation, diarrhea, dyspepsia, elevated liver function test results, flatulence, hepatic necrosis or failure, hepatitis, nausea, pancreatitis, pseudomembranous colitis, vomiting
GU: Acute renal failure, elevated BUN and serum creatinine levels, nephritis, vaginal candidiasis
HEME: Leukopenia, neutropenia, thrombocytopenia
MS: Arthralgia
SKIN: Erythema multiforme, photosensitivity, pruritus, rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria
Other: Allergic reaction, anaphylaxis, angioedema, elevated serum phosphorus level, hyperkalemia, infusion site reaction (such as pain and redness), new or worsening myasthenia syndrome, superinfection

Cautions

Obtain culture and sensitivity test results, if possible, before starting therapy.

Use azithromycin cautiously in patients with hepatic dysfunction (drug is metabolized in the liver) or renal dysfunction (effects are unknown in this group).

Give azithromycin capsules 1 hour before or 2 to 3 hours after food. Give tablets or suspension without regard to food.
WARNING Don’t give azithromycin by I.V. bolus or I.M. injection because it may cause erythema, pain, swelling, tenderness, or other reaction at the site. Infuse it over 60 minutes or longer, as prescribed (typically 1 mg/ml over 3 hours or 2 mg/ml over 1 hour.)

If hepatic function is impaired, monitor liver function studies because drug is eliminated mainly by the liver.

Assess patient for bacterial or fungal superinfection, which may occur with prolonged or repeated therapy. If it occurs, expect to give another antibiotic or antifungal.

Monitor bowel elimination; if needed, obtain stool culture to rule out pseudomembranous colitis. If it occurs, expect to stop azithromycin and give fluid, electrolytes, and antibiotics effective with Clostridium difficile.

PATIENT SAFTY

Tell patient to take azithromycin capsules 1 hour before or 2 to 3 hours after food. Instruct patient to take tablets or suspension without regard to food.
WARNING Urge patient to consult prescriber before taking OTC , including antacids. If they’re prescribed, tell patient to take azithromycin 1 hour before or 2 to 3 hours after taking antacids.

Tell patient to immediately report signs and symptoms of allergic reaction (such as rash, itching, hives, chest tightness, and trouble breathing).

Warn patient that abdominal pain and loose, watery stools may occur. If diarrhea persists or becomes severe, urge him to contact prescriber and replace fluids.

Because azithromycin may destroy normal flora, teach patient to watch for and immediately report signs of superinfection, such as white patches in the mouth.

Trade Name & Company Name

Trade name	Company name
ZOCIN 250MG CAPSULE	ADVANCED PHARMACEUTICAL INDUSTRIES
ZOCIN 200MG-5ML POW.?FOR ORAL SUSPENSION	ADVANCED PHARMACEUTICAL INDUSTRIES
AZOMYCIN 250MG CAP.	Gulf Pharmaceutical Industries (Julphar)
AZOMYCIN 200MG/5ML SUSP.	Gulf Pharmaceutical Industries (Julphar)
AZOMYNE 200MG/5ML POWDER FOR ORAL SUSP	HAYAT PHARMACEUTICAL INDUSTRIES
AZI-ONCE	JAMJOOM PHARMACEUTICALS COMPANY
AZIMAC	RIYADH PHARMA
AZOMAX 250MG CAPSULE	SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO
ZIMAX 250MG FC TABLETS	SPIMACO
ZIMAX 250MG CAP.	SPIMACO
ZIMAX 500MG FC TABLETS	SPIMACO
ZIMAX 200MG/5ML SUSP	SPIMACO
ZETRON 250 MG CAPSULE	TABUK PHARMACEUTICAL MANUFACTURING CO.
ZETRON 200MG/5ML POWDER FOR SUSP	TABUK PHARMACEUTICAL MANUFACTURING CO.
ZITHROMAX 200MG-5ML SUSP.AFTER RECONSTIT	Pfizer
ZITHROMAX SD 2GM POWDER FOR SUSPENSION	Pfizer
ZEROX 500MG FC TABLETS	Hikma
ZEROX 200MG-5ML POWDER FOR ORAL SUSP.	Hikma
ZITHROMAX 250MG CAPS	Pfizer
ZITHROMAX 500 MG POWDER FOR IV INFUSION	Pfizer

effect of Azithromycin in Pregnancy, Fetal Health and Breast feeding

Pregnancy

. Azithromycin has a short serum t/2 in term pregnant women. Prolonged t/2 and high tissue levels occur in myometrium, placenta, and adipose tissue. When combined with doxycycline, it reduces the risk of postcesarean endomyometritis. Interconceptional use of azithromycin plus metronidazole does not reduce the prevalence of preterm birth compared to placebo. Considering its efficacy against other STDs and convenient dosing regimen, azithromycin is probably the treatment of choice for Chlamydia. Single-dose azithromycin may be as effective as penicillin G for the treatment of early syphilis. Partner pharmacotherapy is cost-effective. Azithromycin has been used in combination with artesunate as malaria prophylaxis. It was ineffective treatment to reduce lower genital tract colonization with Ureaplasma urealyticum in women with preterm labor. 77 Azithromycin also improves pulmonary function in women with cystic fibrosis and in women who are chronically infected with Pseudomonas aeruginosa.

Fetal Health

There are no adequate reports or well-controlled studies in human fetuses. Less than 3% of maternally administered azithromycin crosses the placenta. Not surprisingly, there have been no adverse effects reported in humans. Rodent studies are reassuring, revealing no evidence of teratogenicity or IUGR despite the use of doses higher than those used clinically.

Breastfeeding

Azithromycin is excreted in breast milk in a dose-dependent fashion that would approximate 0.4mg/kg/d, a subclinical amount. No neonatal effects have been reported.

the follwing drugs will increse Azithromycin by inhepiting cyp450

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the follwing drugs will decrease Azithromycin by inhancing cyp450