Therapeutic Group: Antibiotics
Makzit® 500 tablet: Each
film-coated tablet contains Azithromycin Dihydrate USP equivalent to
Azithromycin 500 mg.
Makzit® 15 ml PFS: When reconstituted, each 5 ml suspension contains Azithromycin Dihydrate USP equivalent to Azithromycin 200 mg.
Makzit® 30 ml PFS: When reconstituted, each 5 ml suspension contains Azithromycin Dihydrate USP equivalent to Azithromycin 200 mg.
Makzit® contains Azithromycin
USP. It is an azalide antibiotic. Azithromycin acts by binding to the 50s
ribosomal subunit of susceptible organisms, thus interfering with microbial
protein synthesis.
Azithromycin is well tolerated
with a low incidence of side effects. Most frequently reported side effects are
related to Gastrointestinal system with diarrhoea, nausea, abdominal pain,
flatulence, melena. Allergic reactions such as rash, edema, urticaria have
occured and there have also been rare reports of serious hypersensitivity reactions. Transient
mild reductions in neutrophil counts have occasionally been observed in
clinical trials, although a causal relationship to Azithromycin has not been
established.
Liver is the principle route of
elimination of Azithromycin, caution should be exercised when Azithromycin is
administered to patients with impaired hepatic function. If any allergic
reaction occurs, the drug should be discontinued and appropriate therapy should
be instituted.
Azithromycin absorption was
reduced in presence of food & antacid. So, Azithromycin should be
administered 1 hour before or 2 hour after taking food & antacid. Careful
monitoring of patients is advised if Azithromycin is concurrently used with digoxin
& ergot derivatives, as there is possibility of increased concentration of
digoxin and theoretical possibility of ergotism. There have been no
pharmacokinetic drug interactions between Azithromycin and warfarin,
theophylline, carbamazepine, methylprednisolone and cimetidine.
Most adverse events experienced
in higher then recommended doses were similar in type and may be more frequent
than those seen at normal doses. The incidence of tinnitus and ototoxicity is
more frequent in overdosage than at normal doses. In the event of overdosage,
general symptomatic and supportive measures are indicated as required.
Store in a cool and dry place
below 30º C. Protect from light and moisture.
Makzit® 500 Tablet: Each box containing 3X4’s tablet in Alu-Alu blister strips.
Makzit® 15 ml PFS: When reconstituted bottle contains 15 ml suspension.
Makzit® 30 ml PFS: When reconstituted bottle contains 30 ml suspension.