COMPOSITION
Fluzamed contains:
Fluconazole - 150 mg.
THERAPEUTIC INDICATIONS
- cryptococcosis, including cryptococcal
meningitis and other localizations of the infection (Lungs, skin, etc.), for
patients with normal immune respond, and patients with various forms of
immunodepression (including AIDS, and organs transplantation); the medicine
can be used as means of supporting therapy for preventive maintenance of
cryptococcal infections for patients with AIDS;
- systemic candidiasis, including candidemia,
disseminated candidiasis and other forms of invasive candidal infections (abdominal
infections, endocarditis, eye, respiratory and urinary tracts infections).
The treatment can be made for patients with cancer, patients in intensive
therapy, patients having cytostatic or immunosuppressive therapies, and also
in case of other factors contributing to development of candidiasis;
- candidiasis of mucous membranes, including
oral cavities and gullet cavities, noninvasive bronchopulmonary candidiases,
candiduria, candidiases of skin and mucous membranes, and also atrophic
candidiasis of oral cavity because of dental artificial limbs (treatment can
be made for patients with normal or lowered immunity function); preventive
maintenance of relapse oropharyngeal candidiasis for patients with AIDS;
- genital candidiasis: vaginal candidiasis (acute
and chronic recurrent).
Preventive administration with the purpose of
reduction of frequency of vaginal candidiasis (3 and more episodes a year);
candidal balanitis;
- Preventive maintenance of fungoid infections
for patients with cancer, predisposed to such infections as a result of
cytostatic chemotherapy or radio therapy;
- Skin mycosises, including feet mycosises,
inguinal region; branny lichen; onychomycosis; skin candidiasis;
- deep endemic mycosises, including
coccidioidomycosis, paracoccidioidomycosis, sporotrichosis and
histoplasmosis at patients with normal immunity.
CONTRAINDICATIONS
Hypersensitivity to any drug component or
structurally close azole compounds, period of lactation, children age (up 6
months).
WARNINGS
Patients with hepatic and/or renal impairment
should use Fluzamed with cautious, the treatment is possible under a
doctor’s prescription only.
Fluzamed is not recommended for patients
suffering from chronic alcoholism.
The initiation of therapy may be before the
results of inoculation and other laboratory tests are ready, but the
antiinfectious therapy should be adjusted when the results are obtained.
In case of skin rush definitely associated
with Fluzamed withdraw the application of the medicine and consult a doctor.
In case of rush in patients with invasive/systemic
fungal infection the close medical observation and withdrawal is required.
Effects on ability to drive and operate with
mechanisms
The medicine does not cause the changes of
psychophysical patient’s state and does not disturb the ability for driving
and operating with mechanisms.
ADVERSE REACTIONS
Fluzamed, as a rule, it is well tolerated.
More often reported adverse reactions:
From GIT: nausea, pain in a stomach, diarrhea,
meteorism.
From CNS: headache;
Dermatological reactions: skin rash.
In some patients, especially with such
diseases as AIDS or cancer, the changes of blood parameters, infringement of
liver and kidney function during treatment with the medicine have been
observed, however clinical value and interrelation of these undesirable
reactions with Fluzamed reception are not established.
Rare: Exfoliative skin diseases, spasmes,
leukocytopenia, thrombocytopenia and alopecia, however in these cases
relationship of cause and effect has not been established.
Very seldom: anaphylactic reactions.
DOSAGE AND ADMINISTRATION
The daily doze of Fluzamed depends on nature
and severity of fungoid infection.
The treatment of other forms of disease
demands repeated administration of the medicine till clinically and
laboratory confirmed disappearance of active stage of fungoid infection.
Patients with AIDS and cryptococcal meningitis
or recurrent oropharyngeal candidiasis usually require supporting therapy
with the purpose of relapses prevention.
For adults: in cryptococcal meningitis and
cryptococcal infections of other localizations in the first day usually 400
mg, and then 200-400 mg once a day. The treatment duration of cryptococcal
infections depends on clinical efficiency confirmed by mycological research;
in case of cryptococcal meningitis the treatment is carried out for at least
6-8 weeks
For preventive maintenance of cryptococcal
meningitis relapse in patients with AIDS, after end of a full term of
primary treatment, Fluzamed is prescribed in a doze of 200 mg/day during the
long period of time.
For candidemia, disseminated candidiasis and
other invasive candidal infections the doze usually is 400 mg in the first
day, and then - 200 mg. In case of insufficient clinical efficiency the doze
of the medicine can be increased up to 400 mg/day. The duration of therapy
depends on clinical efficiency.
For preventive maintenance of oropharyngeal
candidiasis relapses in patients with AIDS after end of full term of primary
therapy Fluzamed can be prescribed as 150 mg once a week.
For vaginal candidiasis Fluzamed is taken
orally in a single doze of 150 mg. For decrease of frequency of vaginal
candidiasis relapses the medicine can be used in a doze of 150 mg once a
month. The duration of therapy is determined individually; it varies from 4
till 12 months. For some patient more frequent administration can be
required.
For balanitis, caused by Candida, Fluzamed is
prescribed in a single oral doze of 150 mg.
For preventive maintenance of a candidiasis it
is recommended 50-400 mg of Fluzamed once a day depending on risk of
development of fungoid infection.
In case of presence of high risk of
generalized infection, for example for patients with expected expressed or
persistent neutropenia, the recommended doze is 400 mg once/day. Fluzamed is
prescribed several days prior to expected occurrence of neutropenia; after
increase of number of neutrophils more than 1000 in mm3 the
treatment should be continued for 7 days more.
For skin mycosises, including foot mycosises,
skin of inguinal region and skin candidiases, the recommended doze is 150 mg
once a week. Duration of therapy in usual cases is 2-4 weeks, however, for
feet mycosises, can be required longer therapy (to 6 weeks).
For onychomycosis the recommended doze is 150
mg once a week. Treatment should be continued till replacement of the
infected nail (growth of not infected nail). For repeated nails growth on
hand and feet fingers is normally required 3-6 months and 6-12 months
accordingly. However growth rate can vary over a wide range at different
people, and can also depend on age. After successful treatment of persistent
chronic infections sometimes change of the form of nails is observed.
For deep endemic mycosises can be required the
administration of a medicine in a doze of 200-400 mg/day for 2 years.
Duration of therapy is determined individually; it makes 11-24 months for
coccidioidomycosis, 2-17 months for paracoccidioidomycosis, 1-16 months for
sporotrichosis and 3-17 months for histoplasmosis.
Elderly patients: For patients with normal
renal function Fluzamed is prescribed in usual dose for adult patients.
Patients with renal impairment:
Fluzamed is eliminated basically with urine in
unchanged form. In case of a single administration it is not required to
change of a doze. In case of repeated medicine prescription to patients with
impaired kidney function it is necessary to give a loading dose from 50 mg
up to 400 mg. If CC is more than 50 ml/min, the usual medicine doze (100 %
of recommended doze) is applied. At CC from 11 to 50 ml/min the doze in 50 %
of recommended is applied. To the patients who are on dialysis on a regular
basis, one doze of medicine is applied after each session of a hemodialysis.
Fluzamed can be introduced inside or
intravenously drop-by-drop with a speed no more than 10 ml/min; the choice
of way of introduction depends on a clinical status of the patient. When
transferring the patient from i/v introductions to oral medicine intake or
on the contrary changes of daily doze is not required.
OVERDOSAGE
Symptoms: hallucinations, paranoid behavior.
Therapy: gastric lavage, symptomatic therapy
in clinical conditions (a patient should be immediately got in a hospital).
DRUG INTERACTIONS
The co-administration of Fluzamed with
warfarin and other cumarin anticoagulants enhances the therapeutic effect of
the latter.
The concomitant administration of Fluzamed and
oral hypoglycemising drugs (chlorpropanide, glibenclamid, gliside,
tolbutamide) may result in hypoglycemia (the dosage adjustment of
hypoglycemic agents is required).
The co-administration of Fluzamed with
hydrochlorthiazide and other diuretics may cause the increase in fluconazole
plasma concentration.
The co-administration of Fluzamed with
phenytoine may result in increase of phenytoine plasma concentration.
Therefore if concomitant administration of these medicines is necessary, it
is necessary to control phenytoine concentration with doze correction with
the purpose of maintenance of medicine level within the limits of a
therapeutic interval.
In case of the co-administration of Fluzamed
with rifampicin consult a doctor as the dose of Fluzamed should be increased.
The co-administration of Fluzamed with
teophyline increases the half-life of the latter and the risk of the toxic
effects (the dosage adjustment of teophyline is required teophyline).
The co-administration of Fluzamed with
zidovudine increases the plasma concentration of the latter and the risk of
the adverse effects of zidovudine.
The therapeutic effect of fluconazole does not
change by reception with food, and also at concomitant administration with
cimetidine, antacids, or after total irradiation during bone marrow
transplantation.
PREGNACY AND LACTATION
The drug should be prescribed during
pregnancy only if treatment efficacy justifies potential risk for fetus.
The breast-feeding should be ceased during
treatment as Fluzamed is found in breast milk in the same concentration as
in plasma.
DOSAGE FORM
One hard gelatin capsule 150 mg is in a
blister.
1 blister is in a carton box with the leaflet.
SALES TERMS
Sold under prescription.
