Xitro

Xitro

azithromycin

Manufacturer:

Akums Drug

Distributor:

Aisec Farma

Marketer:

Ambica
Full Prescribing Info
Contents
Azithromycin.
Description
Each 5 mL contains: Azithromycin eq. to Anhydrous Azithromycin 200 mg.
Action
Pharmacology: Pharmacokinetics: Azithromycin given orally is about 40% bioavailable. 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 amounts of Azithromycin are demethylated in the liver, and it is excreted in bile as unchanged drug metabolites. 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.
Indications/Uses
Infections from respiratory pathogens (e.g. S. pyogenes, S. pneumoniae, M. catarrhalis, C. trachomatis, Legionella sp., Mycoplasma pneumoniae, S. aureus and H. influenzae) 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).
Dosage/Direction for Use
Children: Over 6 months of age for pneumonia or otitis media: 10 mg/kg on the first day, then 5 mg/kg daily for a further 4 days.
Acute otitis media: 30 mg/kg as single dose, or 10 mg/kg daily for 3 days.
Children: Over 2 years for pharyngitis or tonsillitis: 12 mg/kg once daily for 5 days.
Directions for Use: Use in children: 1 year and older: The total dose in children is 30 mg/kg which should be given as a single daily dose of 10 mg/kg for 3 days according to the following guidance: <15 kg: 10 mg/kg once daily on days 1-3.
15-25 kg: 200 mg (5 mL) once daily on days 1-3.
26-35 kg: 300 mg (7.5 mL) once daily on days 1-3.
36-45 kg: 400 mg ( 10 mL) once daily on days 1-3.
>45 kg: Dose as per adults with Azithromycin Capsules 250 mg.
Or as prescribed by the physician.
Shake well before each use.
Overdosage
There are no data on overdosage with Azithromycin. Typical symptoms of overdosage with macrolide antibiotics include hearing loss, severe nausea, vomiting and diarrhoea. Gastric lavage and general supportive measures are indicated.
Contraindications
Azithromycin is contraindicated in patients with a known hypersensitivity to Azithromycin, erythromycin or any of the macrolide antibiotics.
Because of the theoretical possibility of ergotism, Azithromycin and ergot derivatives should not be co-administered.
Use in hepatic impairment: As the liver is the principal route of excretion of Azithromycin, it should not be used in patients with hepatic disease.
Warnings
Rare serious allergic reactions, including angioedema and anaphylaxis (rarely fatal), have been reported. Some of these reactions with Azithromycin have resulted in recurrent symptoms and required a longer period of observation and treatment.
Pseudomembranous colitis has been reported and may range in severity from mild to life threatening. Therefore, it is important to consider this diagnosis in patients with diarrhoea subsequent to administration of Azithromycin.
Observation for signs of superinfection with non-susceptible organisms, including fungi, is recommended.
Use in renal impairment: There are no data regarding Azithromycin usage in patients with renal impairment, thus caution should be exercised when prescribing Azithromycin in these patients.
Use in children under 1 year of age: The safety and efficacy of Azithromycin in children less than 1 year have not been established.
Adverse Reactions
The majority of side-effects are gastrointestinal in origin with anorexia, nausea abdominal discomfort (pain/cramps), flatulence, vomiting and diarrhoea less frequently resulting in dehydration, dyspepsia, constipation and loose stools.
There have been reports of hearing. impairment, including hearing loss, deafness and or tinnitus in some patients receiving Azithromycin.
Interstitial nephritis and acute renal failure have been reported.
Cases of abnormal liver function including hepatitis and cholestatic jaundice have been reported.
Reductions in neutrophil counts have occasionally been observed.
There have been rare reports of taste disturbances.
Asthenia and paraesthesia have been reported although a causal relationship may not have been established.
The following adverse effects have occurred: Chest pain, melena, nephritis, vaginitis, headache, dizziness, convulsions, vertigo, somnolence and fatigue.
Palpitations and arrythmias including ventricular tachycardia have been reported although a causal relationship with Azithromycin has not been established.
Allergic reactions including arthralgia, oedema, urticaria, rash, photosensitivity, angioedema and anaphylaxis (less frequently fatal) have occurred. Less frequently, serious skin reactions including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis have occurred.
Drug Interactions
Ergot derivatives: Because of the theoretical possibility of ergotism, Azithromycin and ergot derivatives should not be co-administered.
Special administration advised with the following: Antacids: In patients receiving Azithromycin and antacids, Azithromycin should be taken at least 1 hour before or 2 hours after the antacid.
Cimetidine: A single dose of cimetidine administered 2 hours before Azithromycin had no effect on the pharmacokinetics of Azithromycin.
No interactions reported with the following: Carbamazepine: In a pharmacokinetic interaction study in healthy volunteers, no significant effect was observed on the plasma levels of carbamazepine or its active metabolite.
Methylprednisolone: In a pharmacokinetic interaction study in healthy volunteers, Azithromycin had no significant effect on the pharmacokinetics of methylprednisolone.
Storage
Store at temperatures not exceeding 30°C.
MIMS Class
ATC Classification
J01FA10 - azithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
Presentation/Packing
Oral susp 200 mg/5 mL x 15 mL.
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