Indications
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চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন'
Pharmacology
Anaerobic microorganisms:
Peptostreptococcus species, Prevotella bivia
Dosage
Oral-
Adult: 500 mg once daily orally
for 3 days or 500 mg once on day 1, then 250 mg once on days 2-5 for 4 days.
For sexually transmitted diseases caused by Chlamydia trachomatis in adults,
the dose is 1 gm given as a single dose or 500 mg once on day 1, followed by
250 mg once daily for next 2 days may also be given.
Children:
10 mg/kg body weight once daily
for 3 days for child over 6 months
200 mg (1 teaspoonful) for 3 days
if body weight is 15-25 kg
300 mg (1½ teaspoonfuls) for 3
days if body weight is 26-35 kg; 400 mg (2 teaspoonfuls) for 3 days if body
weight is 36-45 kg.
In typhoid fever, 500 mg (2½
teaspoonfuls) once daily for 7-10 days is given.
Azithromycin Injection (For IV Infusion
only): The recommended dose of Azithromycin for injection for the treatment of
adult patients with community-acquired pneumonia due to the indicated organisms
is:
500 mg as a single daily dose by
the intravenous route for at least two days. Intravenous therapy should be
followed by Azithromycin by the oral route at a single, daily dose of 500 mg,
administered as two 250-mg tablets to complete a 7 to 10-day course of therapy.
The timing of the switch to oral therapy should be done at the discretion of
the physician and in accordance with clinical response.
The recommended dose of
Azithromycin for the treatment of adult patients with pelvic inflammatory
disease due to the indicated organisms is: 500 mg as a single daily dose by the
intravenous route for one or two days. Intravenous therapy should be followed
by Azithromycin by the oral route at a single, daily dose of 250 mg to complete
a 7-day course of therapy. The timing of the switch to oral therapy should be
done at the discretion of the physician and in accordance with clinical
response. If anaerobic microorganisms are suspected of contributing to the
infection, an antimicrobial agent with anaerobic activity should be
administered in combination with Azithromycin.
Safety and effectiveness of azithromycin
for injection in children or adolescents under 16 years have not been
established.
* রেজিস্টার্ড
চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন'
Administration
Reconstitution procedure of
suspension-
* রেজিস্টার্ড
চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন'
Interaction
Antacid: In patients receiving
azithromycin and antacids, azithromycin should be taken at least 1 hour before
or 2 hours after the antacid. Carbamazepine: In a pharmacokinetic interaction
study in healthy volunteers, no significant effect was observed on the plasma
levels of carbamazepine or its active metabolite.
Cyclosporin: Some of the related
macrolide antibiotics interfere with the metabolism of cyclosporin. In the
absence of conclusive data from pharmacokinetic studies or clinical data
investigating potential interactions between azithromycin and cyclosporine,
caution should be exercised before co-administration of these two drugs. If
coadministrations is necessary, cyclosporin levels should be monitored and the
dose adjusted accordingly.
Digoxin: Some of the macrolide
antibiotics have been reported to impair the metabolism of digoxin (in the gut)
in some patients. Therefore, in patients receiving concomitant azithromycin and
digoxin the possibility of raised digoxin levels should be borne in mind and
digoxin levels monitored.
Ergot derivatives: Because of the
theoretical possibility of ergotism, azithromycin and ergot derivatives should
not be co-administered.
Methylprednisolone: In a
pharmacokinetic interaction study in healthy volunteers, azithromycin had no
significant effect on the pharmacokinetics of methylprednisolone.
Theophylline: There is no
evidence of any pharmacokinetic interaction when azithromycin and theophylline
are co-administered to healthy volunteers. In general, however, theophylline
levels should be monitored.
Warfarin: In a pharmacodynamic
interaction study, azithromycin did not alter the anticoagulant effect of a
single 15 mg dose of warfarin administered to healthy volunteers. Zimax and
warfarin may be co-administered, but monitoring of the prothrombin time should
be continued as routinely performed.
Terfenadine: Zimax did not affect
the pharmacokinetics of terfenadine administered at the recommended dose of 60
mg every 12 hours. Addition of azithromycin did not result in any significant
changes in cardiac repolarisation (QTc interval) measured during the steady
state dosing of terfenadine.
Contraindications
Side Effects
Zimax is well tolerated with a
low incidence of side-effects. Most side-effects observed were mild to moderate
in severity. The majority of side-effects were gastrointestinal in origin with
nauseas, abdominal discomfort (pain/cramps), vomiting, flatulence, diarrhoea
and loose stools being occasionally observed. Allergic reactions such as rash
or photosensitivity have occurred and there have also been rare reports of
serious hypersensitivity reactions. Reversible elevations in liver
transaminases have been seen with a frequency similar to the comparative
macrolides and penicillins used in clinical trials. Rarely, cases of
cholestatic jaundice have been observed. Transient mild reductions in neutrofil
counts have occasionally been observed in clinical trials, although a causal
relationship to azithromycin has not been established. Hearing impairment: In
investigational studies where higher doses were used for prolonged periods of
time, reversible hearing impairment was seen in some patients.
Pregnancy & Lactation
Pregnancy Category of
Azithromycin Dihydrate is B. Animal reproduction studies have demonstrated that
Azithromycin has no evidence of harm to the fetus. There are no adequate and
well controlled studies in pregnant women. Since animal reproduction studies
are not always predictive of human response, Azithromycin should be used during
pregnancy only if adequate alternatives are not available. It is not known
whether Azithromycin is secreted in breast milk. So, caution should be
exercised when Azithromycin is administered to nursing women.
Precautions & Warnings
As with erythromycin and other
macrolides, rare serious allergic reactions, including angioneurotic oedema and
anaphylaxis, has been reported. Some of these reactions with azithromycin have
resulted in recurrent symptoms and required a long period of observation and
treatment.
Use in Special Populations
Use in renal impairment: No dose
adjustment is needed in patients with mild renal impairment (creatinine
clearance >40 ml/min), but there are no data regarding azithromycin in
patients with more severe renal impairment, thus caution should be exercised in
using azithromycin in these patients.
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.
Effects on ability to drive and
use machines: There is no evidence to suggest that azithromycin may have an
effect on a patient’s ability to drive or operate machinery.
Overdose Effects
Storage Conditions
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