Fluconazole (DiflucanŽ)
Chemical
Fluconazole
Lactose, cornstarch, precipitate silica, magnesium stearate,
sodium laurel sulphate capsules also contain: gelatin, indigotin, and titanium
dioxide
Each 100-phial for intravenous injection- Sodium chloride,
sterile water.
Classification
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Antimycotic drug
Diflucan Is Recommended For
The treatment of acute and recurrent vaginal candidosis, cases of dermatomycosis
such as tinea pedis (athlete's foot), tinea cruris (dhobie itch) tinea corporis
and tinea versicolor, and skin candidosis.
It is also recommended for the treatment of candidosis of the
oropharnynx (parasitic stomatitis), even in the case of patients with immunity
problems caused by malignant mycotic pathologies or by acquired immune
deficiency syndrome (AIDS) or atrophic oral candidosis.
Fluconazole is recommended in the treatment of serious mycotic
infections arising from Candida albicans and Cryptococcus neoformans, including
those which reveal problems in the immune system arising from malignant
pathologies, acquired immune deficiency syndrome or mycoses caused by
antineoplastic chemotherapy. This medicine can also be used in the treatment of
cryptococcic meningitis, in anti-relapse maintenance treatment and in the
treatment of skin and pulmonary cryptococcosis. This treatment of candida
infections includes oesophagitis, peritonitis, pulmonary and genito-urinary
infections as well as extended candidemia and candidosis.
It is also recommended for the prevention of those fungal
infections, which respond to DIFLUCAN (fluconazole), in patients with neoplastic
affections and who are undergoing cytotoxic chemotherapy. In the treatment of
skin or mucous infections, this product should be limited only to those cases
which are particularly extended or serious and which have not been cured by
traditional local treatment.
Contraindications
Fluconazole) should not be used by patients with hypersensitivity to any of the
ingredients contained in this product or to triazolic compounds.
It should also not be used by patients with either acute and
chronic hepatic problems or renal insufficiency.
Pregnant Women And Nursing Mothers
This product should not be administered during pregnancy. Before taking it, any
woman in the childbearing age should ensure by means of the proper test that she
is not expecting a baby. Moreover, during treatment she should take the
necessary contraceptives to avoid conception-taking place. Similarly, this
product should not be taken by nursing mothers.
Children
Since the information available concerning the use of DIFLUCAN by children under
the age of 16 is limited, this product is not recommended for these patients.
Special Precaution
Before beginning and during the course of DIFLUCAN treatment, the hepatic
functions should be observed regularly (transaminase, etc.).
Interactions
The interaction of DIFLUCAN (fluconazole) has been studied with warfarin
(extension of prothrombin time), with tolbutamide and sulphonylurea drugs
(prolongation of serum half-life), with hydrochlorothiazide (40% increase in the
plasmatic concentrations of DIFLUCAN), with fenitoin (increased haematic
levels), Rifampicin* (25% decrease of AUC and 20% decrease in the half-life of
DIFLUCAN), with theophylline (18% lowering in plasmatic clearance). If these
products must be taken together with DIFLUCAN, it will be sufficient to monitor
the haematic levels with the respective medicines and adapt the dosages to
therapeutic needs.
It should be specially noted that in the simultaneous use of
DIFLUCAN (fluconazole) and tolbutamide, both sugar levels and the dosage of
medicine for hypoglycemia should be controlled.
Patients who have had kidney transplants and are undergoing
simultaneous treatment of DIFLUCAN and cyclosporin A are advised to monitor the
plasmatic concentration of cyclosporin.
No clinically significant interactions have been seen with
DIFLUCAN, cimetidine or antacids.
There are no known negative effects due to the simultaneous
use of DIFLUCAN and oral contraceptives.
Special Warning
Very rare cases have been seen of patients who have died as a result of their
serious base pathologies, have also been treated with multiple doses of DIFLUCAN,
and whose autopsy reports have revealed hepatic necrosis. These patients had
simultaneously taken numerous other pharmaceutical products, some of which were
known for their hepatotoxic effects and/or were patients whose base illnesses
could have caused hepatic alterations. Even though no causal relation has been
established between these events and DIFLUCAN, patients who experience a
significant increase in hepatic enzymes should seriously consider whether it is
worthwhile to continue DIFLUCAN treatment. For DIFLUCAN's effect on Children,
see CONTRAINDICATIONS.
Driving And Operating Machinery
Tests have shown that DIFLUCAN does not affect the patient's capacity for
driving or operating machinery.
Dosage
The daily dosage of DIFLUCAN must be based on the nature and degree of the
mycotic infection.
The majority of cases of vaginal candidosis respond to a
single dose. Treatment for infections requiring multiple doses should be
continued until clinical parameters and laboratory tests show that the active
infection has been cured. An insufficient period of treatment may lead to a
relapse of the active infection.
Patients suffering from AIDS and cryptococcic meningitis or
from recurrent candidosis of the oropharnynx require maintenance treatment to
avoid a relapse.
Adults
For vaginal candidosis, 150 mg in a single dose on a single day.
For dermatomycosis, the usual dosage is 50-100 mg per day in
one single dose for a period of 14-28 days.
Tinea pedis (athlete's foot) may require treatment for up to
42 days. For candidosis of the oropharnynx, even in patients with immunity
problems, the usual dosage is 50 mg once daily for 7-14 days. If necessary, this
treatment may be prolonged for a longer period, especially in the case of
serious immunodepressive problems. For atrophic oral candidosis in denture
wearers, the normal dosage is 50 mg daily for 14 days. During this time an
antiseptic treatment of the oral cavity and dentures should be carried out.
For serious, potentially life-threatening pathologies,
including cryptococcic meningitis and extended candidosis, the usual dosage is
400 mg, to be taken in a single dose on one day. Following this, the dosage
should be 200 mg, once daily. Depending on the patient's reaction, these
successive doses can also be maintained at 400 mg/daily. In general, the
duration of this treatment for cryptococcic meningitis is 6-8 weeks. Duration of
treatment for extended candidosis depends on the clinical reaction of the
patient.
To prevent a relapse of cryptococcic meningitis in AIDS
patients, 200 mg of DIFLUCAN can be administered daily on an indefinite basis,
once the patient has finished the first cycle of treatment and the culture
examination has proved negative.
For other local candida infections, such as oesophagitis,
infections of the urinary apparatus, etc., the usual effective dosage is 50 mg
daily for 14-30 days.
This dosage may be increased to 100 mg daily in cases, which
are especially difficult to treat.
For preventive treatment in high-risk patients who may develop
mycotic infections as a consequence of neutropenia caused by cytotoxic
chemotherapy or radiotherapy, the dosage is 50 mg per day.
Elderly Patients
If there is no evidence of renal insufficiency, the patient is to follow the
normal recommended dosage. For patients with renal insufficiency (creatine
clearance < 40 ml/min), the dosage should be regulated as follows.
Patients With Renal Insufficiency
DIFLUCAN is eliminated in large part with urine. No measures should be taken if
a single dosage is applied (vaginal candidosis). However, when treatment for
patients with renal problems consists of two doses, the normal dose can be
administered on the first and second day of therapy. After this, the interval
between one dose and the next is modified based on the creatine clearance:
Creatine clearance (ml/min) Interval between doses (hours)
> 40 24 (normal dose) 21 - 40 48 (or half-dose) 10-20 72 (or 1/3 dose)
Dialysis patients 1 administration following each session of dialysis
Directions For Use
DIFLUCAN can be taken either by mouth or by intravenous injection (introducing
not more than 10 ml/minute), with the choice of the administration route
depending on the clinical conditions of the patient. In changing from
intravenous injection to taking the pharmaceutical product by mouth and vice
versa, it is not necessary to modify the daily dosage. DIFLUCAN is formulated in
a solution of 9% sodium chloride; every 200 mg.
Because DIFLUCAN is available diluted in saline solution, the
percentage of liquid administered is well tolerated by patients who require
sodium and liquid restrictions. DIFLUCAN by intravenous injection is compatible
with the administration of the following liquids: a) 20% dextrose b) Ringer's
solution c) Hartmann's solution d) Potassium chloride in dextrose e) 4.2% sodium
bicarbonate f) Aminofusina g) Solution for peritoneal dialysis
DIFLUCAN can be administered using a pre-established
intravenous route with one of the aforementioned solutions. Although specific
incompatibilities have not been observed, mixing other pharmaceutical products
before administering this medicine is not recommended.
In Case Of Overdose (Symptoms, Assistance, And Antidotes)
Should overdose take place, a symptomatic treatment will be necessary with
adequate support therapy and possible gastric lavage. DIFLUCAN is largely
excreted by means of urine; forced diuresis probably increases the percentage of
the elimination.
A 3-hour haemodialysis session lowers plasmatic levels by
approximately 50%.
Unpleasant Side Effects
DIFLUCAN (fluconazole) is generally well tolerated. The most common unpleasant
side effects caused by this product are related with the gastrointestinal
apparatus, including nausea, abdominal pain, diarrhea, flatulence, vomiting.
In addition to gastrointestinal symptoms, the side effect most
frequently seen is skin rash; also possible are headaches, lack of appetite and
dizziness. Alterations involving the hepatic enzymes are also occasionally seen.
In some patients, particularly those suffering serious
illnesses such as AIDS or cancer, alternations in the liver, kidney and blood
functions have been observed during treatment with DIFLUCAN and similar
products. The clinical significance and relation with the treatment, however,
have not been established. A small number of patients suffering from AIDS have
shown this type of reaction when taking DIFLUCAN together with other agents
known for causing exfoliate skin rashes. Should it be seen that DIFLUCAN is the
cause of skin rash, treatment with this pharmaceutical product should be
interrupted.
In patients with systematic fungal infections causing rash,
careful monitoring should be carried out and treatment with DIFLUCAN should be
interrupted if blistered lesions or multiform erythema develop. In rare cases,
such as other azoles, it is possible to verify anaphylactic phenomena.
The patient should inform his doctor or pharmacist of any
unpleasant side effects not described in this leaflet.
Expiry Date
Be careful not to use this medicine following the expiry date on the box.
Storage
No special care is required for storage.
KEEP THIS AND ALL OTHER MEDICINE OUT OF THE REACH OF CHILDREN
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