Azocan 50mg capsules

United Kingdom - English - eMC (Electronic Medicines Compendium)

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Active ingredient:
Fluconazole
Available from:
FDC International Ltd
ATC code:
J02AC01
INN (International Name):
Fluconazole
Dosage:
50mg
Pharmaceutical form:
Capsule
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 05020100; GTIN: 5050135001231
Authorization number:
; PL 15872/0013

Adolescents from 12 to 17 years old

Follow the dose prescribed by your doctor (either adults or children posology).

Children to 11 years old

The maximum dose for children is 400 mg daily.

The dose will be based on the child's weight in kilograms.

Use in children 0 to 4 weeks of age

Use in children of 3 to 4 weeks of age:

The same dose as above but given once every 2 days. The maximum dose is 12 mg per kg of body weight every 48 hours.

Use in children less than 2 weeks old:

The same dose as above but given once every 3 days. The maximum dose is 12 mg per kg of body weight every 72 hours.

Elderly

The usual adult dose should be given unless you have kidney problems.

Patients with kidney problems

Your doctor may modify your dose, depending on your kidney function.

If you take more Azocan than you should

Taking too many capsules at once may make you unwell. Contact your doctor or your nearest hospital casualty department at once.

The symptoms of a possible overdose may include hearing, seeing, feeling and thinking things that are not real (hallucination and

paranoid behaviour). Symptomatic treatment (with supportive measures and gastric lavage if necessary) may be adequate.

If you forget to take Azocan

Do not take a double dose to make up for a forgotten dose. If you forgot to take a dose, take it as soon as you remember. If it is almost

time for your next dose, do not take the dose that you missed.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE-EFFECTS

Like all medicines Azocan may sometimes cause side-effects, although not everybody gets them.

A few people develop allergic reactions although serious allergic reactions are rare. If you get any side effects, talk to your doctor

or pharmacist. This includes any possible side effects not listed in this leaflet. If you get any of the following symptoms, tell your

doctor immediately.

sudden wheeziness, difficulty breathing or tightness in the chest

swelling of the eyelids, face or lips

itching all over the body, reddening of the skin or itchy red spots

hypersensitivity reaction with skin rash, fever, swollen glands, increase in a type of white blood cell (eosinophilia) and

inflammation of internal organs (liver, lungs, heart, kidneys and large intestine) (Drug Reaction or rash with Eosinophilia and

Systemic Symptoms (DRESS).

severe skin reactions such as a rash that causes blistering (this can affect the mouth and tongue)

Azocan may affect your liver. The signs of liver problems include:

tiredness

loss of appetite

vomiting

yellowing of your skin or the whites of your eyes (jaundice)

If any of these happen, stop taking Azocan and tell your doctor immediately.

Other side effects:

Additionally, if any of the following side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your

doctor or pharmacist.

Common side effects (may affect up to 1 in 10 people) are:

headache

stomach discomfort, diarrhoea, feeling sick, vomiting

increases in blood tests of liver function

rash

Uncommon side effects (may affect up to 1 in 100 people) are:

reduction in red blood cells which can make skin pale and cause weakness or breathlessness

decreased appetite

inability to sleep, feeling drowsy

fit, dizziness, sensation of spinning, tingling, pricking or numbness, changes in sense of taste

constipation, difficult digestion, wind, dry mouth

muscle pain

liver damage and yellowing of the skin and eyes (jaundice)

wheals, blistering (hives), itching, increased sweating

tiredness, general feeling of being unwell, fever

Rare side effects (may affect up to 1 in 1,000 people) are:

lower than normal white blood cells that help defend against infections and blood cells that help to stop bleeding

red or purple discoloration of the skin which may be caused by low platelet count, other blood cell changes

blood chemistry changes (high blood levels of cholesterol, fats)

low blood potassium

shaking

abnormal electrocardiogram (ECG), change in heart rate or rhythm

liver failure

allergic reactions (sometimes severe), including widespread blistering rash and skin peeling, severe skin reactions, swelling of

the lips or face

hair loss

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Yellow Card Scheme at

www.mhra.gov.uk/yellowcard or search for MHRA Yellow

Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this

medicine.

5. HOW TO STORE AZOCAN

Keep out of the sight and reach of children.

Do not store above 25 C.

Do not use your medicine after the expiry date shown on the carton after EXP. The expiry date refers to the last day of the month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no

longer required. These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What AZOCAN contains

Azocan 50mg Capsules contain 50mg fluconazole as the active ingredient.

Azocan 200mg Capsules contain 200mg fluconazole as the active ingredient.

The capsules also contain lactose, pregelatinised maize starch, sodium laurilsulfate, colloidal anhydrous silica, magnesium

stearate and purified talc. The capsule shells also contain gelatin, sodium laurilsulfate, water and the colours brilliant blue (E133),

titanium dioxide (E171) and erythrosine (E127).

What AZOCAN looks like and contents of pack

The 50mg capsules are blue and white and the 200mg capsules are violet and white.

Both the 50mg and 200mg capsules are supplied in packs containing 7 capsules.

2000010462

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or nurse.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the

same as yours.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this

leaflet. See section 4.

What is in this leaflet

1. What AZOCAN is and what it is used for

2. What you need to know before you take AZOCAN

3. How to take AZOCAN

4. Possible side effects

5. How to store AZOCAN

6. Contents of the pack and other information

1. WHAT AZOCAN IS AND WHAT IT IS USED FOR

Fluconazole, the active ingredient, belongs to a group of medicines called anti-fungal agents and it is used to treat infections caused

by fungi and may also be used to stop you from getting a candidal infection. The most common cause of fungal infections is yeast

called Candida.

Adults

You might be given this medicine by your doctor to treat the following types of fungal infections:

Cryptococcal meningitis – a fungal infection in the brain

Coccidioidomycosis – a disease of the bronchopulmonary system

Infections caused by Candida and found in the blood stream, body organs (e.g. heart, lungs) or urinary tract

Mucosal thrush - infection affecting the lining of the mouth, throat and denture sore mouth

Genital thrush – infection of the vagina or penis

Skin infections - e.g. athlete's foot, ringworm, jock itch, nail infection

You might also be given Azocan to:

stop cryptococcal meningitis from coming back

stop mucosal thrush from coming back

reduce recurrence of vaginal thrush

stop you from getting an infection caused by Candida (if your immune system is weak and not working properly)

Children and adolescents (0 to 17 years old)

You might be given this medicine by your doctor to treat the following types of fungal infections:

Mucosal thrush - infection affecting the lining of the mouth, throat

Infections caused by Candida and found in the blood stream, body organs (e.g. heart, lungs) or urinary tract

Cryptococcal meningitis – a fungal infection in the brain

You might also be given Azocan to:

stop you from getting an infection caused by Candida (if your immune system is weak and not working properly).

stop cryptococcal meningitis from coming back

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AZOCAN

Do not take Azocan if:

You have ever had an allergic reaction to fluconazole, to other medicines you have taken to treat fungal infections or to any of the

other ingredients of this medicine (listed in section 6). The symptoms may include itching, reddening of the skin or difficulty in

breathing.

You are taking terfenadine or astemizole (antihistamine medicines for allergies), cisapride (used for stomach upsets), pimozide

(used for treating mental illness), quinidine (used for treating heart arrhythmia), erythromycin (an antibiotic for treating

infections).

Warnings and precautions

Talk to your doctor or pharmacist before taking Azocan

if you have any disease or illness affecting your liver or kidneys

if you suffer from heart disease, including heart rhythm problems

if you have abnormal levels of potassium, calcium or magnesium in your blood

if you develop severe skin reactions (itching, reddening of the skin or difficulty in breathing)

if you develop signs of 'adrenal insufficiency' where the adrenal glands do not produce adequate amounts of certain steroid

hormones such as cortisol (chronic, or long lasting fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain)

Other medicines and Azocan

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Tell your doctor immediately if you are taking astemizole, terfenadine (an antihistamine for treating allergies) or cisapride (used for

stomach upsets) or pimozide (used for treating mental illness) or quinidine (used for treating heart arrhythmia) or erythromycin (an

antibiotic for treating infections) as these should not be taken with Azocan (see section: “Do not take Azocan if you”).

There are some medicines that may interact with Azocan. Make sure your doctor knows if you are taking any of the following

medicines:

nifedipine, isradipine, amlodipine, felodipine and losartan (for hypertension-high blood pressure)

rifampicin, rifabutine (antibiotics for infections)

medicines that thin the blood to prevent blood clots (Warfarin or similar medicines)

benzodiazepines (midazolam, triazolam or similar medicines) used to help you sleep or for anxiety

olaparib (used for treating ovarian cancer)

chlorpropamide, glibenclamide, glipizide or tolbutamide (used to control diabetes)

phenytoin, carbamazepine (used for treating fits)

ciclosporin, everolimus, sirolimus or tacrolimus (to prevent transplant rejection)

theophylline (used to control asthma)

tofacitinib (used for treating rheumatoid arthritis)

zidovudine, also known as AZT, or saquinavir (used in HIV-infected patients)

prednisone (steroid)

oral contraceptives

alfentanil, fentanyl (used as anaesthesia)

celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (Non-Steroidal Anti-Inflammatory Drugs

(NSAID))

amitriptyline and nortriptyline (used as anti-depressant)

amphotericin B, voriconazole (anti-fungal)

cyclophosphamide and vinca alkaloids (vincristine, vinblastine or similar medicines) used for treating cancer

halofantrine (used for treating malaria)

statins (atorvastatin, simvastatin and fluvastatin or similar medicines) used for reducing high cholesterol levels

vitamin A (nutritional supplement)

methadone (used for pain)

ivacaftor (used for treating cystic fibrosis)

amiodarone (used for treating uneven heartbeats 'arrhythmias')

hydrochlorothiazide (a diuretic)

Azocan with food and drink

You may take the capsule with or without a meal.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant, are planning to have a baby, ask your doctor or pharmacist for

advice before taking this medicine.

You should not take Azocan while you are pregnant unless your doctor has told you to.

You can continue breast-feeding after taking a single dose of Azocan up to 150 mg.

You should not breast-feed if you are taking a repeated dose of Azocan.

Driving and using machines

When driving vehicles or using machines, it should be taken into account that occasionally dizziness or fits may occur.

Azocan contains lactose (milk sugar) and sodium (salt)

This medicine contains a small amount of lactose (milk sugar). If your doctor has told you that you have an intolerance to some

sugars, such as lactose, please contact your doctor before taking this medicine.

Azocan capsules contain less than 1 mmol sodium (23 mg) per capsule, that is to say essentially 'sodium-free’

3. HOW TO TAKE AZOCAN

Always take Azocan exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Swallow the capsule whole with a glass of water. It is best to take your capsules at the same time each day.

The recommended doses of this medicine for treatment of the different infections are below:

AZOCAN 50 MG CAPSULES

AZOCAN 200 MG CAPSULES

(Fluconazole)

Condition

To treat cryptococcal meningitis

To stop cryptococcal meningitis from coming back

To treat coccidioidomycosis

To treat internal fungal infections caused

by Candida

To treat mucosal infections affecting the lining of

mouth, throat and denture sore mouth

To treat mucosal thrush – dose depends on

where the infection is located

50 mg to 400 mg once daily for 7 to 30 days until

you are told to stop

200 mg to 400 mg on the first day then 100 mg to

200 mg until you are told to stop

800 mg on the first day then 400 mg once daily

until you are told to stop

400 mg on the first day then 200 mg to 400 mg

once daily for 6 to 8 weeks or longer if needed.

Sometimes doses are increased up to 800 mg

200 mg to 400 mg once daily from 11 months for

up to 24 months or longer if needed. Sometimes

doses are increased up to 800 mg

Dose

200 mg once daily until you are told to stop

To stop mucosal infections affecting the lining of

mouth, throat from coming back

To treat genital thrush

To reduce recurrence of vaginal thrush

150 mg as a single dose

100 mg to 200 mg once daily, or 200 mg 3 times a

week, while you are at risk of getting an infection

150 mg every third day for a total of 3 doses

(day 1, 4 and 7) and then once a week for

6 months while you are at risk of getting an infection

To treat fungal skin and nail infections

To stop you from getting an infection caused

by Candida (if your immune system is weak and

not working properly)

Depending on the site of the infection 50 mg once

daily, 150 mg once weekly, 300 to 400 mg once

weekly for 1 to 4 weeks (Athlete's foot may be up

to 6 weeks, for nail infection treatment until

infected nail is replaced)

200 mg to 400 mg once daily while you are at risk

of getting an infection

Adults

Marketing Authorisation Holder and Manufacturer

FDC International Ltd, Unit 6, Fulcrum 1, Solent Way, Whiteley, Fareham,

Hampshire, PO15 7FE

Hard to see or read the leaflet? Call+ 44(0) 1489 565222 for help.

This leaflet was last revised in February 2020.

Condition

Mucosal thrush and throat infections caused by

Candida – dose and duration depends on the

severity of the infection and on where the

infection is located

Cryptococcal meningitis or internal fungal

infections caused by Candida

To stop cryptococcal meningitis from

coming back

To stop children from getting an infection

caused by Candida (if their immune system

is not working properly)

3 mg per kg of body weight (6 mg per kg of body

weight might be given on the first day)

6 mg to 12 mg per kg of body weight

6 mg per kg of body weight once daily

3 mg to 12 mg per kg of body weight once daily

Package leaflet: Information for the user

PANTONE Reflex Blue C

Colour :

Version 08

Pantone BLACK C

SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT

Azocan 50mg Capsules

Fluconazole 50mg Capsules

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each capsule contains fluconazole

50mg.

Excipient(s) of known effects: each hard capsule also contains 25 mg

lactose.

For the full list of excipients, see section 6.1

3

PHARMACEUTICAL FORM

Hard capsule

A hard gelatin size “4” capsule with a blue cap and white body containing a

white free flowing powder.

4

CLINICAL PARTICULARS

4.1. Therapeutic indications

Fluconazole is indicated for the treatment of the following fungal infections

(see section 5.1):

Fluconazole is indicated in adults for the treatment of:

Coccidioidomycosis (see section 4.4).

Invasive candidiasis.

Vaginal candidiasis, acute or recurrent; when local therapy is not

appropriate.

Candidal balanitis when local therapy is not appropriate.

Mucosal candidiasis including oropharyngeal, oesophageal

candidiasis, candiduria and chronic mucocutaneous candidiasis.

Chronic oral atrophic candidiasis (denture sore mouth) if dental

hygiene or tropical treatment are insufficient.

Dermatomycosis including tinea pedis, tinea corporis, tinea cruris,

tinea versicolor and dermal candida infections when systemic therapy

is indicated.

Cryptococcal meningitis (see section 4.4).

Tinea unguinium (onychomycosis) when other agents are not

considered appropriate.

Fluconazole is indicated in adults for the prophylaxis of:

Relapse of cryptococcal meningitis in patients with high risk of

recurrence.

Relapse of oropharyngeal or oesophageal candidiasis in patients

infected with HIV who are at high risk of experiencing relapse.

To reduce the incidence of recurrent vaginal candidiasis (4 or more

episodes a year).

Prophylaxis of candidal infections in patients with prolonged

neutropenia (such as patients with haematological malignancies

receiving chemotherapy or patients receiving Hematopoietic Stem

Cell Transplantation (see section 5.1)).

Fluconazole is indicated in term newborn infants, infants, toddlers,

children, and adolescents aged from 0 to 17 years old:

Fluconazole is used for the treatment of mucosal candidiasis

(oropharyngeal, oesophageal), invasive candidiasis, cryptococcal

meningitis and the prophylaxis of candidal infections in

immunocompromised patients. Fluconazole can be used as

maintenance therapy to prevent relapse of cryptococcal meningitis in

children with high risk of reoccurrence (see section 4.4).

Therapy may be instituted before the results of the cultures and other

laboratory studies are known; however, once these results become

available, anti-infective therapy should be adjusted accordingly.

Consideration should be given to official guidance on the appropriate

use of antifungals.

4.2. Posology and method of administration

Posology

The daily dose of fluconazole should be based on the nature and severity of

the fungal infection. Therapy for those types of infections requiring multiple

dose treatment should be continued until clinical parameters or laboratory

tests indicate that active fungal infection has subsided. An inadequate period

of treatment may lead to recurrence of active infection.

Adults

Indications

Posology

Duration of

treatment

Cryptococcosis

- Treatment of

cryptococcal

meningitis.

Loading dose:

400 mg on Day

Usually at least 6

to 8 weeks.

Subsequent

dose: 200 mg to

400 mg once

daily

In life

threatening

infections the

daily dose can be

increased to 800

- Maintenance

therapy to

prevent relapse

of cryptococcal

meningitis in

patients with

high risk of

recurrence.

200 mg once

daily

Indefinitely at a

daily dose of 200

Coccidioidomycosis

200 mg to 400

mg once daily

11 months up to

24 months or

longer

depending on

the patient. 800

mg daily may

be considered

for some

infections and

especially for

meningeal

disease

Invasive

candidiasis

Loading dose:

800 mg on Day

Subsequent

dose: 400 mg

once daily

In general, the

recommended

duration of

therapy for

candidemia is

for 2 weeks

after first

negative blood

culture result

and resolution

of signs and

symptoms

attributable to

candidemia.

Treatment of

mucosal

candidiasis

- Oropharyngeal

candidiasis

Loading dose:

200 mg to 400

mg on Day 1

Subsequent

dose: 100 mg

to 200 mg once

daily

7 to 21 days

(until

oropharyngeal

candidiasis is in

remission).

Longer periods

may be used in

patients with

severely

compromised

immune function

- Oesophageal

candidiasis

Loading dose:

200 mg to 400

mg on Day 1

Subsequent

dose: 100 mg to

200 mg once

daily

14 to 30 days

(until

oesophageal

candidiasis is in

remission).

Longer periods

may be used in

patients with

severely

compromised

immune function

- Candiduria

200 mg to 400

mg once daily

7 to 21 days.

Longer periods

may be used in

patients with

severely

compromised

immune

function.

- Chronic atrophic

candidiasis

50 mg once

daily

14 days

- Chronic

mucocutaneous

candidiasis

50 mg to 100

mg once daily

Up to 28 days.

Longer periods

depending on

both the

severity of

infection or

underlying

immune

compromisation

and infection

- Oropharyngeal

candidiasis

100 mg to 200

mg once daily

or 200 mg 3

times per week

An indefinite

period for

patients with

chronic

immune

suppression

Prevention of

relapse of mucosal

candidiasis in

patients infected

with HIV who are

at high risk of

experiencing

relapse

- Oesophageal

candidiasis

100 mg to 200

mg once daily

or 200 mg 3

times per week

An indefinite

period for

patients with

chronic

immune

suppression

- Acute vaginal

candidiasis

- Candidal

balanitis

150 mg

Single dose

Genital candidiasis

- Treatment and

prophylaxis of

recurrent vaginal

candidiasis (4 or

more episodes a

year).

150 mg every

third day for a

total of 3 doses

(day 1, 4, and

7) followed by

150 mg once

weekly

maintenance

dose

Maintenance

dose: 6 months.

- tinea pedis,

- tinea corporis,

- tinea cruris,

candida infections

150 mg once

weekly or 50

mg once daily

2 to 4

weeks, tinea

pedis may

require

treatment for up

to 6 weeks

300 mg to 400

mg once

weekly

1 to 3 weeks

- tinea versicolor

50 mg once

daily

2 to 4 weeks

Dermatomycosis

- tinea unguium

(onychomycosis)

150 mg once

weekly

Treatment

should be

continued until

infected nail is

replaced

(uninfected nail

grows in).

Regrowth of

fingernails and

toenails

normally

requires 3 to 6

months and 6 to

12 months,

respectively.

However,

growth rates

may vary

widely in

individuals, and

by age. After

successful

treatment of

long-term

chronic

infections, nails

occasionally

remain

disfigured.

Prophylaxis of

candidal infections

in patients with

prolonged

neutropenia

200 mg to 400

mg once daily

Treatment

should start

several days

before the

anticipated

onset of

neutropenia and

continue for 7

days after

recovery from

neutropenia

after the

neutrophil

count rises

above 1000

cells per mm

Special population

Elderly

Dosage

should

adjusted

based

renal

function

(see

“Renal

impairment”).

Renal impairment

Fluconazole is predominantly excreted in the urine as unchanged active

substance. No adjustments in single dose therapy are required. In patients

(including paediatric population) with impaired renal function who will

receive multiple doses of fluconazole, an initial dose of 50 mg to 400 mg

should be given, based on the recommended daily dose for the indication.

After the initial loading dose, the daily dose (acoording to indication)

should be based on the following table:

Creatinine clearance (ml/min)

Percent of recommended dose

> 50

100%

50 (no dialysis)

Regular dialysis

100% after each dialysis

Patients on haemodialysis should receive 100% of the recommended dose

after each haemodialysis; on non-dialysis days, patients should receive a

reduced dose according to their creatinine clearance.

Hepatic impairment

Limited data are available in patients with hepatic impairment, therefore

fluconazole should be administered with caution to patients with liver

dysfunction (see sections 4.4 and 4.8).

Paediatric population

A maximum dosage of 400mg daily should not be exceeded in paediatric

population.

As with similar infections in adults, the duration of treatment is based on the

clinical and mycological response. Fluconazole is administered as a single

daily dose.

For paediatric patients with impaired renal function, see dosing in “Renal

impairment”. The pharmacokinetics of fluconazole has not been studied in

paediatric population with renal insufficiency (for “Term newborn infants”

who often exhibit primarily renal immaturity please see below).

Infants, toddlers and children (from 28 days to 11 years old):

Indication

Posology

Recommendations

- Mucosal candidiasis

Initial dose: 6 mg/kg

Subsequent

dose: 3 mg/kg once

daily

Initial dose may be

used on the first day

to achieve steady

state levels more

rapidly

- Invasive candidiasis

- Cryptococcal meningitis

Dose: 6 to 12 mg/kg

once daily

Depending on the

severity of the

disease

- Maintenance therapy to

prevent relapse

cryptococcal meningitis in

children with high risk of

recurrence

Dose: 6 mg/kg once

daily

Depending on the

severity of the

disease

- Prophylaxis of Candida in

Immunocompromised

patients

Dose: 3 to 12 mg/kg

once daily

Depending on the

extent and duration

of the induced

neutropenia (see

Adults posology)

Adolescents (from 12 to 17 years old):

Depending on the weight and pubertal development, the prescriber would need to

assess which posology (adults or children) is the most appropriate. Clinical data

indicate that children have a higher fluconazole clearance than observed for adults.

A dose of 100, 200 and 400 mg in adults corresponds to a 3, 6 and 12 mg/kg dose

in children to obtain a comparable systemic exposure.

Safety and efficacy for genital candidiasis indication in paediatric population has

not been established. Current available safety data for other paediatric indications

are described in section 4.8. If treatment for genital candidiasis is imperative in

adolescents (from 12 to 17 years old), the posology should be the same as adults

posology.

Term newborn infants (0 to 27 days):

Neonates excrete fluconazole slowly. There are few pharmacokinetic data

to support this posology in term newborn infants (see section 5.2).

Age group

Posology

Recommendations

Term newborn infants

(0 to 14 days)

The same mg/kg dose

as for infants, toddlers

and children should be

given every 72 hours

A maximum dose

of 12 mg/kg every

72 hours should

not be exceeded

Term newborn infants

(from 15 to 27

days)

The same mg/kg dose

as for infants, toddlers

and children should be

given

every 48 hours

A maximum dose

of 12 mg/kg every

48 hours should

not be exceeded

Method of administration

Fluconazole may be administered either orally or by intravenous infusion, the

route being dependent on the clinical state of the patient. On transferring from the

intravenous to the oral route, or vice versa, there is no need to change the daily

dose.

The physician should prescribe the most appropriate pharmaceutical form and

strength according to age, weight and dose. The capsule formulation is not adapted

for use in infants and small children. Oral liquid formulations of fluconazole are

available that are more suitable in this population.

The capsules should be swallowed whole and independent of food intake.

4.3. Contraindications

Fluconazole should not be used in patients with known hypersensitivity

to fluconazole, to related azole compounds or to any of the excipients

listed in section 6.1.

Co-administration of terfenadine is contraindicated in patients receiving

fluconazole at multiple doses of 400 mg per day or higher based upon

results of a multiple dose interaction study. Coadministration of other

medicinal products known to prolong the QT interval and which are

metabolised via the cytochrome P450 (CYP) 3A4 such as cisapride,

astemizole, pimozide, quinidine, and erythromycin are contraindicated in

patients receiving fluconazole (see sections 4.4 and 4.5).

4.4. Special warnings and precautions for use

Hepatobiliary system

Fluconazole should be administered with caution to patients with liver

dysfunction.

Fluconazole has been associated with rare cases of serious hepatic toxicity

including fatalities, primarily in patients with serious underlying medical

conditions. In cases of fluconazole-associated hepatotoxicity, no obvious

relationship to total daily dose, duration of therapy, sex or age of patient has

been observed. Fluconazole hepatotoxicity has usually been reversible on

discontinuation of therapy.

Patients

develop

abnormal

liver

function

tests

during

fluconazole

therapy must be monitored closely for the development of more serious

hepatic injury.

The patient should be informed of suggestive symptoms of serious hepatic

effect

(important

asthenia,

anorexia,

persistent

nausea,

vomiting

jaundice). Treatment of fluconazole should be immediately discontinued

and the patient should consult a physician.

Dermatological reactions

Patients

have

rarely developed

exfoliative

cutaneous

reactions,

such

Stevens-Johnson syndrome and toxic epidermal necrolysis, during treatment

with fluconazole. AIDS patients are more prone to the development of severe

cutaneous reactions to many drugs. If a rash develops in a patient treated for

a superficial fungal infection which is considered attributable to fluconazole,

further therapy with this agent should be discontinued. If patients with

invasive/systemic fungal infections develop rashes, they should be monitored

closely

fluconazole

discontinued

bullous

lesions

erythema

multiforme develop.

Terfenadine

The coadministration of fluconazole at doses lower than 400 mg per day

with terfenadine should be carefully monitored (see sections 4.3 and 4.5).

Hypersensitivity

In rare cases anaphylaxis has been reported (see section 4.3).

Cardiovascular system

Some azoles, including fluconazole, have been associated with prolongation

interval

electrocardiogram.

Fluconazole

causes

prolongation via the inhibition of Rectifier Potassium Channel current (I

prolongation

caused

other

medicinal

products

(such

amiodarone) may be amplified via the inhibition of cytochrome P450 (CYP)

3A4. During post-marketing surveillance, there have been very rare cases of

QT prolongation and torsade de pointes in patients taking fluconazole. These

reports included seriously ill patients with multiple confounding risk factors,

such as structural heart disease, electrolyte abnormalities and concomitant

medications that may have been contributory. Patients with hypokalaemia

and advanced cardiac failure are at an increased risk for the occurrence of

life threatening ventricular arrhythmias and torsades de pointes

Fluconazole should be administered with caution to patients with these

potentially proarryhthmic conditions. Coadministration of other medicinal

products known to prolong the QT interval and which are metabolised via

the cytochrome P450 (CYP) 3A4 are contraindicated (see sections 4.3 and

4.5).

Renal System

Fluconazole should be use with caution in patients with renal dysfunction (

see section 4.2).

Adrenal insufficiency

Ketoconazole is known to cause adrenal insufficiency, and this could also

although rarely seen be, applicable to fluconazole.

Adrenal insufficiency relating to concomitant treatment with Prednisone is

described in section 4.5. The effect of fluconazole on other medicinal

products.

Tinea capitis

Fluconazole has been studied for treatment of tinea capitis in children. It was

shown not to be superior to griseofulvin and the overall success rate was less

than 20%. Therefore, Diflucan should not be used for tinea capitis.

Cryptococcosis

The evidence for efficacy of fluconazole in the treatment of cryptococcosis

of other sites (e.g. pulmonary and cutaneous cryptococcosis) is limited,

which prevents dosing recommendations.

Deep endemic mycoses

The evidence for efficacy of fluconazole in the treatment of other forms of

endemic

mycoses

such

paracoccidioidomycosis,

lymphocutaneous

sporotrichosis and histoplasmosis is limited, which prevents specific dosing

recommendations.

Halofantrine

Halofantrine has been shown to prolong QTc interval at the recommended

therapeutic dose and is a substrate of CYP3A4. The concomitant use of

fluconazole and halofantrine is therefore not recommended (see section 4.5).

Cytochrome P450

Fluconazole is a moderate CYP2C9 and CYP3A4 inhibitor. Fluconazole is

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