Product Information: Fluconazole - (Diflucan
The Number 1 drug to treat yeast infections.
This famous anti-fungal
drug is the world's most commonly used drug to treat yeast infections,
which are far more common than many people believe.
Fluconazole is available under the trade name Loitin®.
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.
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.
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.
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
Before beginning and during the course of DIFLUCAN treatment, the hepatic
functions should be observed regularly (transaminase, etc.).
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.
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
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
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.
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.
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
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 (ml/min) Interval between
> 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:
- 20% dextrose
- Ringer's solution
- Hartmann's solution
- Potassium chloride in dextrose
- 4.2% sodium bicarbonate
- 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, Assistence, 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
The patient should inform his doctor or pharmacist
of any unpleasant side effects not described in this leaflet.
Be careful not to use this medicine following the expiry date on the box.
No special care is required for storage.
KEEP THIS AND ALL OTHER MEDICINE OUT OF
THE REACH OF CHILDREN