MOVELOXIN 400mg250ml solution for infusion

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

MOXIFLOXACIN

Available from:

EUCOGEN SDN BHD

INN (International Name):

MOXIFLOXACIN

Units in package:

20 x 250 ml

Manufactured by:

HK inno. N Corporation

Summary of Product characteristics

pharmacist prior to continuing treatment if symptoms of neuropathy
such as pain, burning, tingling, numbness, or weakness develop in
order to
prevent the development of potentially irreversible condition (see
section Undesirable Effects).
PSYCHIATRIC REACTIONS
Psychiatric reactions may occur even after the first administration of
fluoroquinolones, including moxifloxacin. In very rare cases
depression or
psychotic reactions have progressed to suicidal thoughts and
self-injurious behavior such as suicide attempts (see “
_Undesirable effects_
”). In the
event that the patient develops these reactions, MOVELOXIN should be
discontinued and appropriate measures instituted. Caution is
recommended if MOVELOXIN is to be used in psychotic patients or in
patients with a history of psychiatric disease.
GENITAL TRACT INFECTIONS
Because of the widespread and rising prevalence of
fluoroquinolone-resistant
_Neisseria gonorrhoeae_
infections, monotherapy with moxifloxa-
cin should be avoided in patients with pelvic inflammatory disease,
unless fluoroquinolone-resistant
_N. gonorrhoeae_
can be excluded. If
fluoroquinolone-resistant
_N. gonorrhoeae_
can not be excluded, the addition of an appropriate antibiotic which
is regularly active against
_N. _
_gonorrhoeae_
(e.g., a cephalosporin) to empirical moxifloxacin therapy, should be
considered.
DYSGLYCEMIA
As with all fluoroquinolones, disturbances in blood glucose, including
both hypoglycemia and hyperglycemia have been reported with
MOVELOXIN. In MOVELOXIN-treated patients, dysglycemia occurred
predominantly in elderly diabetic patients receiving concomitant
treatment with an oral hypoglycemic agent (e.g. sulfonylurea) or with
insulin. In diabetic patients, careful monitoring of blood glucose is
recommended (see “
_Undesirable effects_
”).
INFORMATION ABOUT EXCIPIENTS
In patients for whom sodium intake is of medical concern (patients
with congestive heart failure, renal failure, nephrotic syndrome,
etc.) the
additional sodium load of the solution for infusion should be tak