Fluconazole 2mg/ml Solution for Injection, Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, Fluconazole Dosage

ge & Rx Info | Fluconazole Uses, Side Effects – Antifungal/ Antibacterial, Fluconazole 2mg/ml Solution for Injection: Indications, Side Effects, Warnings, Fluconazole - Drug Information - Taj Pharma, Fluconazole dose Taj pharmaceuticals Fluconazole interactions, Taj Pharmaceutical Fluconazole contraindications, Fluconazole price, Fluconazole , Taj Pharma Fluconazole 2mg/ml Solution for Injection, - Taj Pharma . Stay connected to all updated on Fluconazole Taj Pharmaceuticals Taj pharmaceuticals Hyderabad. Patient Information Leaflets, PIL.

FLUCONAZOLE SOLUTION 1. What Fluconazole Soultion for 2. Before you are given Fluconazole
Infusion is and what it is used for Soultion for Infusion
FOR INFUSION Fluconazole Soultion for Infusion is for Do not use Fluconazole Infusion
treating and preventing fungal infections. • if you are allergic to fluconazole or other
2MG/ML Fluconazole Soultion for Infusion (called similar medicines such as ketoconazole and
Fluconazole Infusion throughout the rest of itraconazole or to any of the other ingredients
Package leaflet: Information for the patient
this leaflet) belongs to a group of antifungal of Fluconazole Infusion (see section 6)
Fluconazole 2mg/ml Soultion for Infusion.
medicines called imidazoles. It works by • if you are taking other drugs known to affect
stopping the growth of the fungus. It is used your heart and be metabolised in the same
Read all of this leaflet carefully before you
for the treatment/ prevention of the following way as fluconazole, such as cisapride,
start taking this medicine because it
types of fungal infection: astemizole, pimozide, erythromycin and
contains important information for you.
quinidine.
- Keep this leaflet. You may need to read it Adults
again. • Treatment of: Warnings and precautions
- If you have any further questions, ask your - candida fungal infections affecting the whole Talk to your doctor, pharmacist or nurse
doctor or pharmacist. body before using Fluconazole Infusion
- This medicine has been prescribed for you - a fungal infection in the brain called • if you are currently, or have previously had
only. Do not pass it on to others. It may harm cryptococcal meningitis problems with your liver
them, even if their signs of illness are the same - severe candida fungal infections affecting • if you have AIDS or have an infection that
as yours. mucous membranes (mouth, throat, affects your whole body
- If any of the side effects gets serious, or if oesophagus, bronchuses and lungs) where oral • if you have heart disease
you notice any side effects not listed in this treatment is not possible. • if you receive warfarin or any other drug
leaflet, please tell your doctor. • Prevention of: which prolongs blood coagulation
- candida fungal infections in patients with • if you have kidney disease
What is in this leaflet reduced amounts of white blood cells • if you have a yeast infection called
(neutropenia) following bone marrow cryptococcosis
1. What Fluconazole Soultion for Infusion is transplants. • if you have a fungal infection after travelling
and what it is used for outside of Europe
2. Before you are given Fluconazole Soultion Children and adolescents • if you develop signs of ‘adrenal insufficiency’
for Infusion • Treatment of: where the adrenal glands do not produce
3. How you will be given Fluconazole Soultion - candida fungal infections affecting the whole adequate amounts of certain steroid
for Infusion body hormones such as cortisol (chronic, or long
4. Possible side effects - severe candida fungal infections affecting lasting fatigue, muscle weakness, loss of
5. How Fluconazole Soultion for Infusion is mucous membranes (mouth, throat, appetite, weight loss, abdominal pain).
stored oesophagus, bronchuses and lungs) where oral
6. Contents of the pack and other information treatment is not possible. Other medicines and Fluconazole Infusion
Tell your doctor or pharmacist if you are
taking, have recently taken or might take any
Fluconazole 2mg/ml Solution for Injection, Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, Fluconazole Dosage & Rx Info | Fluconazole Uses, Side Effects – Antifungal/ Antibacterial, Fluconazole 2mg/ml Solution for Injection: Indications, Side Effects, Warnings, Fluconazole - Drug Information - Taj Pharma, Fluconazole dose Taj pharmaceuticals Fluconazole interactions, Taj Pharmaceutical Fluconazole contraindications, Fluconazole price, Fluconazole , Taj Pharma Fluconazole 2mg/ml Solution for Injection, - Taj Pharma . Stay connected to all updated on Fluconazole Taj Pharmaceuticals Taj pharmaceuticals Hyderabad. Patient Information Leaflets, PIL.

other medicines, including medicines obtained • Non-Steroidal Anti-inflammatory Drugs Pregnancy, breast-feeding and fertility
without a prescription. If Fluconazole Infusion (NSAIDs) (used to treat pain and Pregnancy
and certain other medications are taken at the inflammation) • Before starting treatment you must inform
same time, the effect of treatment may be • Oral Contraceptives your doctor if you are pregnant or intend to
affected. This applies for example to the • Phenytoin (for epilepsy) become pregnant. The doctor will then decide
following: • Pimozide (for mental disorders) whether you should take Fluconazole Infusion.
• Alfentanil (synthetic opioid analgesic drug – • Prednisone (used in inflammation and organ Women of child-bearing potential should use
used against pain) transplants) reliable contraception during long-term
• Amitriptyline (for depression) • Quinidine (for heart disorders) treatment with Fluconazole Infusion.
• Amphotericin B (for fungal infections) • Rifabutin and Rifampicin (for tuberculosis
• Astemizole (antihistamine) and other infections) Breast-feeding
• Azithromycin (for bacterial infections) • Saquinavir (used to treat HIV infections) • Fluconazole enters breast milk so women are
• Benzodiazepines such as midazolam or • Sulphonylureas such as chlorpropamide, advised not to breast-feed their babies while
triazolam (certain sleeping pills) glibenclamide, glipizide and tolbutamide on Fluconazole Infusion.
• Calcium channel antagonists: nifedipine, (used for diabetes)
isradipine, nicardipine, amlodipine, felodipine • Tacrolimus and sirolimus (used in organ Fertility
(used in the control of heart rhythm and blood transplantation) • There is no data regarding the effects of
pressure) • Terfenadine (used to treat hay fever and Fluconazole on the human fertility.
• Carbamazepine (for epilepsy) allergies)
Driving and using machines
• Celecoxib (for inflammation) • Theophylline (for respiratory problems)
• Occasionally dizziness or fits can occur in
• Ciclosporin (used in organ transplantation) • Trimetrexate (used in pneumonia)
people taking fluconazole so care should be
• Cisapride (used to treat heart burn and • Vinca Alkaloids (used in cancer treatment)
taken when driving or operating machinery
reduce the amount of acid in the stomach) • Vitamin A
(see section 4 of this leaflet for more
• Cyclophospamide (used in cancer • Voriconazole (for serious fungal infections)
information on possible side effects).
treatment) • Warfarin and other coumarin type
• Didanosine (treatment used in AIDS) medicines (certain blood-thining agents) Fluconazole Infusion contains Sodium
• Erythromycin (for bacterial infections) • Xanthine bases, other antiepileptic drugs chloride
• Everolimus (used after organ transplants and isoniazid • Fluconazole Infusion contains sodium
and in the treatment of cancer) • Zidovudine (treatment used in AIDS) chloride (salt). The infusion contains 3.5mg of
• Fentanyl (a strong painkiller) • Ketoconazole (used to treat infections sodium per ml of infusion (a total of 88mg
• Halofantrin (for malaria) caused by a fungus or yeast) sodium in a 25ml bottle, 177mg sodium in a
• HMG-CoA-reductase-inhibitors: • Amiodarone (used for treating uneven 50ml bottle, 354mg sodium in a 100ml bottle
atorvastatin, simvastatin, fluvastatin (agents heartbeats ‘arrhythmias’). and 709mg sodium in a 200ml bottle). If you
that reduce blood lipids) are on a low sodium (salt) diet tell your doctor,
• Hydrochlorothiazide (a diuretic) Fluconazole Infusion with food, drink and
pharmacist or nurse before they give you
• Losartan (for high blood pressure) alcohol
Fluconazole Infusion.
• Methadone (opioid analgesic drug – used • Fluconazole Infusion can be used with or
against pain) without food.
Fluconazole 2mg/ml Solution for Injection, Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, Fluconazole Dosage & Rx Info | Fluconazole Uses, Side Effects – Antifungal/ Antibacterial, Fluconazole 2mg/ml Solution for Injection: Indications, Side Effects, Warnings, Fluconazole - Drug Information - Taj Pharma, Fluconazole dose Taj pharmaceuticals Fluconazole interactions, Taj Pharmaceutical Fluconazole contraindications, Fluconazole price, Fluconazole , Taj Pharma Fluconazole 2mg/ml Solution for Injection, - Taj Pharma . Stay connected to all updated on Fluconazole Taj Pharmaceuticals Taj pharmaceuticals Hyderabad. Patient Information Leaflets, PIL.

3. How you will be given Fluconazole first day then 100-200mg once daily for 7- • Your doctor will decide what dose is
Soultion for Infusion 21 days right for you.
A doctor or nurse will administer the infusion - For oesophageal candidiasis the
via a drip (slow injection into a vein). recommended dose is 200-400mg on the Children (4 weeks of age to 11 years old)
Treatment will normally continue until the first day, then 100-200mg once daily for • Treatment of cryptococcal meningitis :
infection has gone. 14-30 days - The recommended dose is 6 – 12mg/kg
- For Candiduria the recommended dose is per day.
Adults • Prevention of cryptococcal meningitis in
• Candida infections affecting the whole 200-400mg for 7-21 days
- For chronic atrophic candidiasis the children who are at risk of getting an
body: infection:
- The recommended dose is 800mg on the recommended dose is 50mg once daily for
14 days - The recommended dose is 3-12 mg/kg
first day, then 400mg once daily until you per day.
are told to stop. - For chronic mucocutaneous candidiasis
the recommended dose is 50-100mg once • Treatment of mucosal candidiasis:
• Cryptococcal meningitis: - The recommended dose is 3mg/kg per
- The recommended dose is 400mg on the daily for up to 28 days.
• Prevention of oropharyngeal candidiasis day. 6mg/kg may be given on day 1.
first day, then 200-400mg once daily
- The maximum daily dose is 400mg daily and oesophageal candidiasis for patients
Children (under 4 weeks of age)
- Depending on how you respond, your at risk of getting an infection:
• In the first two weeks of life babies can
treatment can last for 6 – 8 weeks - The recommended dose is 100-200mg
be given the same dose as children but the
- In life-threatening infections the daily once daily, or 200mg 3 times per week
dose must be given every 72 hours
dose can be increased to 800mg. until you are told to stop.
• In weeks three and four of life babies can
• Prevention of cryptococcal meningitis: - • Prevention of candida infections in
be given the same dose as children but the
The recommended dose is 200mg once patients following bone marrow
dose must be given every 48 hours.
daily, until you are told to stop by your transplants:
doctor. - The recommended dose is 400mg per Patients with kidney problems
• Coccidioidomycosis: day. • Your doctor will adjust the dose based
- The recommended dose is 200-400mg on your kidney function.
Elderly
on the first day, then 200-400mg once • If your kidneys are working normally you
daily If you use more Fluconazole Infusion
will be given the recommended adult than you should
- Depending on how you respond, your dose.
treatment can last for 11-24 months. - It is unlikely that you will be given too
• Candida infections affecting mucous much infusion. However, in the unlikely
Adolescents (from 12 to 17 years old)
membranes: event that this does occur you will be
• The recommended dose is between 3
- For oryphangeal candidiasis the monitored carefully by medical staff
and 12mg/kg of body weight per day
recommended dose is 200-400mg on the - In most patients overdosing may result
Fluconazole 2mg/ml Solution for Injection, Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, Fluconazole Dosage & Rx Info | Fluconazole Uses, Side Effects – Antifungal/ Antibacterial, Fluconazole 2mg/ml Solution for Injection: Indications, Side Effects, Warnings, Fluconazole - Drug Information - Taj Pharma, Fluconazole dose Taj pharmaceuticals Fluconazole interactions, Taj Pharmaceutical Fluconazole contraindications, Fluconazole price, Fluconazole , Taj Pharma Fluconazole 2mg/ml Solution for Injection, - Taj Pharma . Stay connected to all updated on Fluconazole Taj Pharmaceuticals Taj pharmaceuticals Hyderabad. Patient Information Leaflets, PIL.

in gastrointestinal complaints and skin hives and difficulties breathing • Paraesthesia, vertigo
reactions like itching and rash • Severe skin reaction which causes the outer • Pain in muscles
- If you are worried you have been given layer of skin to detach (Toxic epidermal • Feeling weak and tired
too much or have any questions about the necrolysis) • Fever
• Severe rashes that may involve blistering • Decreased appetite
dose talk to your doctor or nurse.
and peeling of the skin (Stevens-Johnson • Fixed Drug eruption (Type of allergic
If you forget to use Fluconazole Infusion syndrome) reaction with patches of redness, swelling of
• Lesions or ulcers in the throat, mouth and skin and blisters to a medicine usually
- It is unlikely that you will miss a dose as
skin due to changes in white blood cells recurring in same site).
your doctor or nurse will monitor when to • Liver problems and toxicity, including liver
give you each dose failure and hepatitis. Other side effects Rare (may affect up to 1 in 1,000 people)
- If you think you have missed a dose • Increased levels of fats in the blood
speak to your doctor or nurse. Common (may affect up to 1 in 10 people) (cholesterol and triglycerides)
If you have any further questions on the • Headache • Decreased levels of potassium leading to
use of this product, ask your doctor, nurse • Rash weakness and an irregular or fast heart beat
or pharmacist. • Feeling sick (nausea) • Tremor
• Being sick (vomiting) • Hair loss (alopecia)
4. Possible Side Effects • Stomach ache or pain • Itching, reddening or scaling of the skin
Like all medicines, this medicine can cause • Diarrhoea • Patches of red, blistering skin
side effects, although not everybody gets • Increase in the blood of substances produced
by the liver called liver enzymes. Very rare (may affect up to 1 in 10,000
them.
people)
Serious side effects Uncommon (may affect up to 1 in 100 • Severe rash, blistering or scaling decay of the
If you notice any of the following symptoms of people) skin.
a serious allergic reaction, you should inform • Decreases in certain blood cells (white blood
cells and platelets) Not known (frequency cannot be estimated
the doctor or nurse immediately and the
• Changes in taste, dry mouth from the available data)
infusion should be stopped:
• Constipation • Fluconazole Infusion may affect your adrenal
Uncommon (may affect up to 1 in 100 • Dizziness glands and the levels of steroid hormones
people) • Indigestion produced. The signs of adrenal problems
• Fits (convulsions) • Wind (flatulence) include:
• Yellowing of the skin and eyes (jaundice) and • Itching or rash, wheals, swelling or blistering - tiredness
liver abnormalities. (hives) - muscle weakness
• Increased sweating - loss of appetite
Frequency Rare (may affect up to 1 in 1,000 • Loss of appetite or increased appetite - weight loss
people) • Changes to some body chemicals and liver - abdominal pain.
• Anaphylaxis (allergic reaction): Swollen face, and kidney enzymes
lips, tongue or throat, difficulty swallowing, • Abnormal sleep Additional side effects more common in
children
Fluconazole 2mg/ml Solution for Injection, Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, Fluconazole Dosage & Rx Info | Fluconazole Uses, Side Effects – Antifungal/ Antibacterial, Fluconazole 2mg/ml Solution for Injection: Indications, Side Effects, Warnings, Fluconazole - Drug Information - Taj Pharma, Fluconazole dose Taj pharmaceuticals Fluconazole interactions, Taj Pharmaceutical Fluconazole contraindications, Fluconazole price, Fluconazole , Taj Pharma Fluconazole 2mg/ml Solution for Injection, - Taj Pharma . Stay connected to all updated on Fluconazole Taj Pharmaceuticals Taj pharmaceuticals Hyderabad. Patient Information Leaflets, PIL.

• Irritability What Fluconazole Soultion for Infusion infusion. The product can be infused at a
• Anaemia (low blood iron levels causing contains maximum rate of 10ml/minute. In children the
tiredness and fatigue). - The active substance is fluconazole. Each ml rate of intravenous infusion should not exceed
Fluconazole Infusion may cause a reduction in of infusion contains 2mg fluconazole. 5ml/minute. For premature infants the
the number of white blood cells and your Each 25ml bottle of Fluconazole Infusion infusion time should be no less than 15
resistance to infection may be decreased. If contains 50mg of fluconazole. minutes. In patients requiring sodium or fluid
you experience an infection with symptoms Each 50ml bottle of Fluconazole Infusion restriction, the rate of administration should
such as fever and serious deterioration of your contains 100mg of fluconazole. be taken into consideration as Fluconazole
general condition, or fever with local infection Each 100ml bottle of Fluconazole Infusion Infusion consists of a salt solution. In such
symptoms such as sore throat/pharynx/mouth contains 200mg of fluconazole. cases the infusion should be given over a
or urinary problems you should see your Each 200ml bottle of Fluconazole Infusion longer period.
doctor immediately. A blood test will be taken contains 400mg of fluconazole.
to check possible reduction of white blood - The other ingredients are: sodium chloride, 2. Handling Instructions
cells (agranulocytosis). It is important to water for injections, hydrochloric acid for pH For single use only. Any unused product or
inform your doctor about your medicine. adjustment and sodium hydroxide for pH waste material should be disposed of in
adjustment. accordance with local requirements.
Reporting of side effects The product should be inspected visually for
If you get any side effects, talk to your doctor What Fluconazole Soultion for Infusion particles and discolouration prior to
or pharmacist. This includes any possible side looks like and contents of the pack administration. Only clear and colourless
effects not listed in this leaflet. By reporting Fluconazole Infusion is a clear sterile and solutions should be used.
side effects you can help provide more colourless solution for infusion. The infusion is
information on the safety of this medicine. Fluconazole 2mg/ml Solution for Infusion is
supplied in a glass bottle closed with a rubber
compatible with the following infusion
stopper and a flip-off aluminium cap.
5. How Fluconazole Soultion for Infusion fluids:
Fluconazole Infusion is available in a bottle
is stored a. Glucose 20%
containing 25ml, 50ml, 100ml or 200ml of
You will not be asked to store the medicine. It b. Ringer’s solution
solution for infusion.
will be brought to you ready to be c. Hartmann’s solution
Not all pack sizes may be marketed.
administered, which should be done straight d. Potassium chloride in glucose
away. The following information is intended e. Sodium carbonate 4.2%
Do not use this medicine after the expiry date f. 0.9% sodium chloride (isotonic saline)
for medical or healthcare professionals
stated on the carton or bottle. The expiry date Compatibility has been shown for short
only: duration (10 minutes).
refers to the last day of that month.
Do not refrigerate or freeze. Dilution of Fluconazole 2mg/ml Solution for
1. Administration
Keep this medicine out of the sight and reach Infusion is not required prior to administration.
For intravenous use as infusion.
of children. If necessary, Fluconazole and the solutions
Fluconazole is dissolved in an isotonic saline
mentioned above should be administered
solution, with an electrolyte content of
6. Contents of the pack and other through separate infusion containers. The two
150mmol Na+ and 150mmol CI- per 1000ml,
information reservoirs should be connected using a "Y"
and may be administered directly as an
Fluconazole 2mg/ml Solution for Injection, Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, Fluconazole Dosage & Rx Info | Fluconazole Uses, Side Effects – Antifungal/ Antibacterial, Fluconazole 2mg/ml Solution for Injection: Indications, Side Effects, Warnings, Fluconazole - Drug Information - Taj Pharma, Fluconazole dose Taj pharmaceuticals Fluconazole interactions, Taj Pharmaceutical Fluconazole contraindications, Fluconazole price, Fluconazole , Taj Pharma Fluconazole 2mg/ml Solution for Injection, - Taj Pharma . Stay connected to all updated on Fluconazole Taj Pharmaceuticals Taj pharmaceuticals Hyderabad. Patient Information Leaflets, PIL.

connection. The two solutions are then mixed

in a single line and the administration is
performed. The above method is
recommended in order to avoid effects such as
the “layering effect” if the two solutions were
mixed in one infusion container for the total
period of the administration.

3. Storage information
Do not use after the expiry date stated on the
carton or bottle. The expiry date refers to the
last day of that month. Do not refrigerate or
freeze.

After first opening

From the microbiological point of view, unless
the method of opening precludes the risk of
microbial contamination, the product should
be used immediately.
If not used immediately, in-use storage times
and conditions are the responsibility of the
user.

Manufactured in India by:

TAJ PHARMACEUTICALS LTD.
Mumbai, India
At: 615, GIDC, Kerala, Bavla, Dist. Ahmedabad
438225, Gujarat, INDIA

This leaflet was last revised in July 2019