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Why it's used

Fluconal 50 Tablet is used to treat the fungal infection of the vagina (also called, vaginal candidiasis). This medicine works by preventing the formation of an enzyme (ergosterol) which is necessary for the synthesis of the fungal cell wall. Fluconal 50 is also used to treat fungal infection of mouth, throat, and pharynx, to treat brain and spinal cord infection (cryptococcal meningitis) in AIDS patients, to prevent fungal infection in patients undergoing bone marrow transplantation who receive radiation therapy and chemotherapy, to treat urinary tract infection, to treat inflammation of membrane that covers abdominal organs (peritonitis), to treat pneumonia, to treat fungal infection of the blood (candidemia), to treat fungal infection of internal body organs such as liver, kidney, brain, and heart (disseminated candidiasis), and to treat fungal inflammation of penis head (candidal balanitis).
Azole Antifungal
Fluconal 50 belongs to a class of medicines called Azole Antifungal. Azole antifungals are a group of drugs that treat fungal infections of the skin and body, including athlete's foot, fungal nail infections, ringworm, and vaginal candidiasis. These medicines limit the growth of a wide range of fungi by damaging the fungal cell membrane.

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How to use

Read the medicine guide provided by your pharmacist, your doctor, or the medicine company. If you have any questions related to Fluconal 50, ask your doctor or pharmacist. Use Fluconal 50 Tablet as per the instructions provided by your doctor.
Fluconal 50 is used with or without food.

Typical Dosage

The typical dose of Fluconal 50 for adults is 100-400 mg once a day (not more than 600 mg per day). The usual dose for children is 3-12 mg/kg (1.4-5.4 mg/lb) of body weight. The maximum dose for adult patients of Fluconal 50 is 400 mg per day. This medicine is generally used for a period of 2-3 weeks for fungal infection of mouth, throat, and pharynx, 10-12 weeks for brain and spinal cord infection in AIDS patients, and 7 days for fungal infection in patients undergoing bone marrow transplantation. This medicine is not known to be addictive or habit-forming.
This medicine should be used on an as-needed basis. This medicine can be given for 10-12 weeks in the initial treatment of brain and spinal cord infection (cryptococcal meningitis).
If using the liquid form of this medicine, measure the dose using the provided measuring cup, spoon, or dropper. Before pouring the medicine into the measuring device, you should check the measurement markings carefully. Then, pour the dose amount into the device. After use, clean and store the measuring device in a safe place for your next use. You should not use a tablespoon or teaspoon as the dose measuring devices since it can result in an incorrect dose. If indicated on the product package, shake the medicine before use.
The injection form of the medicine may be used on the veins. Fluconal 50 injection is intended for use in the veins only. The intravenous infusion of Fluconal 50 is taken at the rate of approximately 200 mg/hour, which is given as a continuous infusion. Visually analyze for any impurity and discoloration of the solution prior to injecting into the veins.

Talk to Your Doctor

Discuss with your doctor if you develop new symptoms. Discuss with your doctor if infection returns after seven days, more than two infections occur within 6 months, and no improvement in symptoms of infection after seven days of treatment. If you have any kidney disease, There is no need for adjustment of single dose for vaginal candidiasis in patients with kidney dysfunction, and the patients who are on multiple doses of Fluconal 50, an initial dose of 50-400 mg is given. Further dosage adjustment depends upon the clinical condition.
Your doctor may prescribe a lower starting dose of this medicine to understand the impact on the body. Please follow your doctor's recommendations. Older patients may see an increase in the incidence of side-effects. As a result, a lower dose may be recommended for older patients.

Use in Children

If you are giving Fluconal 50 Tablet to a child, be sure to use a product that is for use in children. Use the child's weight or age to find the right dose from the product package or medicine label. You can also read the dosage section of this page to know the correct dose for your child. Else, consult with your doctor and follow their recommendation.

Lab Tests

Your doctor may request that specific lab tests be performed before you start using Fluconal 50 Tablet. Your doctor may ask you to undergo Antibiotic Susceptibility test. The test is done to select appropriate therapy at appropriate doses for fungal infection.
Medicines may be recommended for uses other than those listed in the medicine guide. You should not use Fluconal 50 Tablet for conditions or symptoms for which it was not prescribed. Do not give Fluconal 50 Tablet to other people, even if they have the same conditions or symptoms that you have. The use of this medicine without the advice of a doctor may cause harm.

Storage

Follow storage instructions on the product package if available. Store Fluconal 50 Tablet at 5°C-30°C (41°F-86°F), and away from moisture. Store this medicine away from children and pets.

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How to take Fluconal 50

The dose and frequency of using Fluconal 50 will depend on the following factors:
  • age of the patient
  • the weight of the patient
  • patient's health
  • the health of the patient's liver
  • medicines recommended by the doctor
  • any other medicines being used
  • response to the medicine

Fluconal 50 Dosage

Dosage for infection of the food pipe (esophageal candidiasis)

Adult
  • Recommended: 200 mg first day, followed by 100 mg once daily
  • Maximum: 400 mg/day for three weeks
Children
  • Recommended: 6 mg/kg (2.72 mg/lb) first day, followed by 3 mg/kg (1.36 mg/kg) of dose once daily
  • Maximum: 12 mg/kg/day (5.45 mg/lb/day) for a minimum of three weeks and for at least 2 weeks following the symptoms.

Dosage for fungal infection of mouth and throat

Adult
  • Recommended: 200 mg first day, followed by 100 mg dose once daily for not less than two weeks
Children (6 months to 13 years)
  • Recommended: 6 mg/kg (2.72 mg/lb) first day, followed by 3 mg/kg (1.36 mg/lb) dose once daily. Treatment should be given for not less than two weeks to decrease the likelihood of getting ill again

Dosage for fungal infection on skin or mucous membrane

Adult
  • Maximum: 400 mg daily
Children
  • Recommended: 6-12 mg/kg/day (2.72 - 5.45 mg/lb/day)

Dosage for urinary tract infections

Adult
  • Recommended: 50-200 mg of daily dose

Dosage for inflammation of the lining of the abdominal wall (peritonitis)

Adult
  • Recommended: 50-200 mg of daily dose

Dosage for infection of the brain and spinal cord

Adult
  • Recommended: 400 mg first day, followed by 200 mg of dose once daily for 10-12 weeks. Based on the medical judgment of the patient’s response to Fluconal 50 therapy, dose of 400 mg once daily may be used.
Children
  • Recommended: 12 mg/kg (5.45 mg/lb) first day, followed by 6 mg/kg (2.72 mg/lb) once daily for 10-12 weeks

Dosage for vaginal and vulval yeast infections

Adult
  • Recommended: 150 mg single oral dose

Dosage for patients undergoing bone marrow transplantation

Adult
  • Recommended: 400 mg once daily for 7 days. Patients who are expected to have severe decreased white blood cells (less than 500 neutrophils per cu mm) should start Fluconal 50 prophylaxis several days before the expected onset of decreased white blood cells (neutropenia), and continue the same for 7 days after the neutrophil sumup rises above 1000 cells/cu mm.

Dosage for suppression of relapse of meningitis

Adult
  • Recommended: 200 mg once daily
Children
  • Recommended: 6 mg/kg (2.72 mg/lb) once daily

Minimum Age

6 months

Maximum Age

65 years

Dosage calculation for children

To calculate the dosage for children please use the weight based dose calculator to calculate the appropriate dosage as per the weight of your child.

Forms

Tablet
Strength: 50, 100, 150 and 200 mg
Oral suspension
Strength: 350 mg or 1400 mg
Injection
Strength: 200 mg/100 mL, 400 mg/200 mL
Capsule
Strength: 150 mg

Special Instructions

Oral suspension
Shake oral suspension well before use. Store the reconstituted suspension between 41°F - 86°F (5°C - 30°C). Discard the unused portion after 2 weeks. It is necessary to protect it from freezing.
Capsule
One capsule should be swallowed completely. A capsule is not recommended for children (under 16 years) and elderly patients over 60 years.
Injection
The intravenous infusion of Fluconal 50 should be given at a maximum rate of approximately 200 mg/hour, as a continuous infusion. Do not use the solution if it is precipitated or cloudy or if the seal is not intact.

Missed Dose

A missed dose should be taken as early as you remember it. However, if the time for the next dose is almost there, then the missed dose should be skipped, and the regular dosing schedule should be continued.

Overdose

What to do if you overdose on Fluconal 50?
If you have taken more than the recommended dose of Fluconal 50 get medical advice immediately. If necessary, the toxic effect can be reduced by cleaning out the contents of the stomach (gastric lavage). Removal of Fluconal 50 may be increased by excessive urine formation (forced diuresis) and removing waste products from the blood (hemodialysis).
Symptoms of an overdose of Fluconal 50
If you use too much of this medicine, it could lead to dangerous levels of the medicine in your body. In such cases, symptoms of an overdose may include:
  • hallucination
  • suspiciousness and mistrust of others (paranoid behavior)
If you think you have overdosed on Fluconal 50 Tablet, call a poison control center immediately. You can look up the poison control center information from the Poison Center Finder at TabletWise.com.

Precautions while using Fluconal 50

Before you use Fluconal 50, tell your doctor of your medical and health history including the following:
  • existing irregular heartbeat (proarrhythmic disease)
  • kidney dysfunction
Before you use Fluconal 50 Tablet, tell your doctor if you are allergic to it or its ingredients. Your doctor may prescribe an alternative medicine and update your medical records to record this information. Tell your doctor if you are allergic to other azoles.
The use of this medicine may change transaminases and alkaline phosphatase. This medicine should be used with caution in patients with abnormal liver function. Careful monitoring of liver enzymes is required in such patients.

Use in Pregnancy

Consult with your doctor on the use of Fluconal 50 Tablet during pregnancy. Using high doses of Fluconal 50 in women during their first 3 months of pregnancy can cause birth defects among infants. The features seen in the infants were: flat head syndrome (brachycephaly), abnormal facies, abnormal skull development, splits in the roof of the mouth (cleft palate), bow-leggedness (femoral bowing), thin ribs and long bones, birth defect of shortened joint (arthrogryposis), and birth defect of structure of the heart (congenital heart disease).

Use while Breastfeeding

Fluconal 50 should be used while breastfeeding only when required. Cautions should be taken while breastfeeding as this medicine passes into breast milk.

Impact on Fertility

Consult with your doctor on the use of Fluconal 50 Tablet, if you are trying to conceive. The patient should be informed about the harmful effects on the unborn baby.

Seizures

Fluconal 50 Tablet can make you feel sleepy. Be careful while driving, using machinery, or doing any other activity that needs you to be alert. The consumption of alcohol with Fluconal 50 Tablet can make you feel more sleepy. Fluconal 50 Tablet may cause seizures in some people. Discuss with your doctor if you perform activities where a loss of consciousness may cause you or others harm.

Side-effects in Children

Fluconal 50 Tablet may cause an increased risk of side-effects in younger patients. Children using this medicine may see an increased risk of vomiting, abdominal pain, nausea, diarrhea, increased levels of transaminases, and increased levels of alkaline phosphatase.

Side-effects in Older Patients

Fluconal 50 Tablet may increase side-effects in older patients. Elderly patients may see an increased risk of the reduced functioning of the kidney.

Fluconal 50 Side-effects

The following side-effects may commonly occur when using Fluconal 50 Tablet. If any of these side-effects worsen or last for a long time, you should consult with your doctor:
The following side-effects may commonly occur in older patients on the use of Fluconal 50 Tablet. Discuss with your doctor if any of these side-effects last for a long time or are severe:
The following side-effects may commonly occur in children when using Fluconal 50 Tablet. Discuss with your doctor if any of these side-effects last for a long time or are severe:
Rarely, the use of Fluconal 50 Tablet may cause the following side-effects:
The following severe side-effects may also occur when using Fluconal 50 Tablet:
  • hematopoietic and lymphatic disorders
    Symptoms: decreased white blood cells (leukopenia), abnormally low amount of white blood cell (neutropenia), deficiency of granulocytes in the blood, low level of thrombocytes decreased amount of red blood cells (anemia)
  • central nervous system
    Symptoms: seizures
  • heart disorder such as heart rhythm disorder (QT prolongation and torsade de pointes) (sudden heart death)
    Fluconal 50 should be taken with caution by patients with structural heart disease, electrolyte abnormalities or proarrhythmic conditions.
  • liver disorders (possibly fatal)
    Symptoms: inflammation of the liver (hepatitis), reduced bile flow from the liver (cholestasis) severe liver failure
    Patients should be monitored for the development of more severe liver injury. Fluconal 50 should be discontinued if clinical signs and symptoms are constant with liver disease.
  • Symptoms: high cholesterol (hypercholesterolemia), high level of triglycerides in the blood (hypertriglyceridemia) low potassium level
  • gastrointestinal disorder
    Symptoms: reduced bile flow from the liver (cholestasis), liver damage, dry mouth, vomiting indigestion
  • nervous system disorder
    Symptoms: drowsiness
  • skin and appendages disorders
    Symptoms: severe drug-related disorder (acute generalized exanthematous-pustulosis), severe skin disorder (Stevens-Johnson syndrome), severe skin reaction redness and peeling of the skin (dermatitis exfoliative)
Your doctor has prescribed this Fluconal 50 because they have judged that the benefits outweigh the risks posed by side-effects. Many people using this medicine do not have serious side-effects. This is not a complete list of possible side-effects for Fluconal 50.
If you experience side-effects or notice other side-effects not listed above, contact your doctor for medical advice. You may also report side-effects to your local food and drug administration authority. You can look up the drug authority contact information from the Drug Authority Finder at TabletWise.com.

Warnings

Intolerance to Sugars

Patients with a family history of galactose intolerance and defect in glucose-galactose absorption are at an increased risk. Such patients should not be advised to take Fluconal 50 capsules containing lactose.

Heart Problems

Patients with low potassium level and heart failure are at an increased risk when using this medicine. Such patients are at risk of life-threatening heart disorders causing rhythm problems of the heart. Fluconal 50 should be taken with caution in patients of heart rhythm disorders.

Kidney Dysfunction

Patients with a disturbance in the functioning of the kidney are at an increased risk. Fluconal 50 should be given with caution to patients who have kidney problems.

Use of Halofantrine

Patients taking Fluconal 50 with halofantrine are at an increased risk. Such patients may experience prolonged and irregular heartbeat. Fluconal 50 and halofantrine should not be used together.

Use of Terfenadine

Patients taking Fluconal 50 with terfenadine are at an increased risk. Such patients may experience abnormal heart rhythm disorder (QT prolongation). The use of Fluconal 50 at a dose lower than 400 mg per day with terfenadine should be monitored carefully.

Use of Cytochrome P450 Enzymes

Patients taking Fluconal 50 with other compounds metabolized by CYP2C9 and CYP3A4 enzymes are at an increased risk. Patients should be carefully monitored and caution should be exercised when using these combinations.

Liver Injury

Patients with abnormal liver function are at an increased risk when using this medicine. These patients may have a fatal liver damage. Monitoring should be required for the development of more severe liver injuries. This medicine should be discontinued if the signs and symptoms consistently develop with the use of Fluconal 50.

Severe Allergic Reaction (Anaphylaxis)

The patients with anaphylaxis are at an increased risk when using this medicine. This medicine should be discontinued if the patient experiences a severe allergic reaction.

Skin Disorder

Patients with serious disorders such as AIDS and cancer are at an increased risk. These patients may develop serious skin rashes when using this medicine. Closely monitor the patients who develop rashes and the medicine should be discontinued in case of symptoms further progress.

Women in their first Trimester of Pregnancy

The use of this medicine in a high dose in women who are in their first trimester are at an increased risk of having birth defects in their baby. The children from these women may have short head (brachycephaly), abnormal facies, abnormal skull development, splits in the upper lip and the roof of the mouth (cleft palate), bent leg bone (femoral bowing), thin ribs and long bones, curving of joints (arthrogryposis), and heart disease related to birth. The pregnant women should be informed of the potential hazard to the child.

Abnormal Functioning of Kidney Glands

Patients on treatment with Fluconal 50 may experience adrenal insufficiency.

Interactions with Fluconal 50

When two or more medicines are taken together, it can change how the medicines work and increase the risk of side-effects. In medical terms, this is called as a Drug Interaction.
This page does not contain all the possible interactions of Fluconal 50 Tablet. Share a list of all medicines that you use with your doctor and pharmacist. Do not start, stop, or change the dose of any medicines without the approval of your doctor.

Oral Hypoglycemics

Fluconal 50 Tablet may interact with oral hypoglycemics (tolbutamide, glyburide, and glipizide), which are used to lower the blood glucose levels. This medicine decreases the metabolism of oral hypoglycemic medicines and increases their level in the blood. When Fluconal 50 is used with these medicines, carefully monitoring of blood glucose levels is required. The dose of these medicines should also be adjusted in such patients.

Anticoagulants

There may be an interaction of Fluconal 50 with anticoagulants, which are used to prevent blood clot formation. When Fluconal 50 is used with anticoagulants such as coumarin and warfarin, it can cause bleeding problems such as skin injury that results in a discoloration of the skin (bruising), bleeding from nasal cavity (epistaxis), stomach and intestinal bleeding, presence of blood in urine (hematuria), and black tarry stools (melena). These bleeding problems have been reported in along with increasing the blood clotting time in such patients. In such patients, time taken by blood to clot (prothrombin time) should be monitored carefully.

Anticonvulsants

Fluconal 50 Tablet interacts with phenytoin, which is used to treat epilepsy. When Fluconal 50 is used with this medicine, it increases the level of phenytoin in the blood. Such patients should be monitored carefully for elevated phenytoin levels.

Antihistamines

Special instructions need to be followed while taking this medicine along with antihistamines (terfenadine and astemizole), which are used to relieve allergy symptoms. The patients using these medicines may develop abnormal and prolonged heartbeat. Also, when the combination of these drugs is used at higher doses involving Fluconal 50 400mg or 800 mg, Fluconal 50 significantly increases the blood levels of terfenadine. Similarly, use of Fluconal 50 with astemizole has resulted in decreased clearance of astemizole. Use of Fluconal 50 and astemizole is not recommended and use of Fluconal 50 with terbinafine at doses lower than 400 mg/day should be monitored carefully.

Gastroprokinetic Agent

Your doctor's guidelines may need to be followed while taking this medicine along with cisapride, which is used to increase gastric motility. When Fluconal 50 is used with cisapride, there has been a significant increase in cisapride blood levels and abnormal heartbeat (prolongation of QTc interval). Use of both the medicines together is not recommended.

Antifungal Drugs

Fluconal 50 Tablet may interact with voriconazole, which is used to treat fungal infections. Monitoring of side-effects and damage related to voriconazole is recommended, particularly when voriconazole is started within 24 hour of the last dose of Fluconal 50. Using both the medicines together should be avoided.

Antipsychotic Agent

There may be an interaction of Fluconal 50 with pimozide, which is used to treat mental disorders. When Fluconal 50 is used with this medicine, it increases the level of pimozide in the blood that may result in an abnormal and prolonged heartbeat. Avoid taking both the medicines together.

Opioids Analgesics

Fluconal 50 Tablet interacts with opioid analgesics (fentanyl and alfentanil), which are used to relieve pain. When Fluconal 50 is used with these medicines, it may lead to failure of the lungs to exchange carbon dioxide and oxygen. Due to the possibility of fatal outcomes, avoid using these medicines together. Patients should be monitored closely for the risk of respiratory-depression. Dosage adjustment of alfentanil and fentanyl may be necessary.

Antimalarial Drugs

Special instructions need to be followed while taking this medicine along with antimalarial drugs (halofantrine and quinidine), which are used to treat malaria. When Fluconal 50 is used in combination with halofantrine, it has resulted in increased blood levels of halofantrine due to an inhibitory effect on enzyme CYP3A4. It also increases the risk of heart rhythm disorder (prolonged QT interval, torsades de pointes). These medicines should not be taken together.
Your doctor's guidelines may need to be followed while taking this medicine along with Erythromycin. When Fluconal 50 is used with erythromycin, it may increase the risk of abnormal and prolonged heartbeat that may cause heart muscles damage. Avoid using these medicines together.

Oral Contraceptives

Fluconal 50 Tablet may interact with oral contraceptives, which are used to prevent pregnancy. When Fluconal 50 is used with these medicines, it affects the efficacy of oral contraceptives.

Antiviral Drugs

There may be an interaction of Fluconal 50 with saquinavir and zidovudine, which are used in the treatment of viral infections. Fluconal 50 increases the exposure of drug to the body, maximun level of drug in the blood, and decreases clearance of saquinavir due to prevention of breakdown of saquinavir in liver. Use of Fluconal 50 may increase the duration of action of zidovudine. Dose adjustment is required in such cases.
Fluconal 50 Tablet interacts with sirolimus, which is used in organ transplantation to prevent rejection. Fluconal 50 increases the amount of sirolimus in the blood. The dose of this medicine should be adjusted when using in combination with Fluconal 50.

Antihypertensives

Special instructions need to be followed while taking this medicine along with losartan, which is used to treat high blood pressure. Fluconal 50 decreases the metabolism of this medicine. When using these medicines together, it is required to monitor blood pressure continuously.

Expired Medication

Taking a single dose of expired Fluconal 50 is unlikely to cause a side-effect. However, please discuss with your doctor or pharmacist, if you feel unwell or sick. An expired medicine may become ineffective in treating your prescribed conditions. To be on the safe side, it is important not to use an expired drug. You are much safer by always keeping a fresh supply of unexpired medicines.

Safe Disposal of Medication

  • If there are disposal instructions on the package, please follow the instructions.
  • If there are medicine take-back programs in your country, you should contact the respective authority to arrange for the disposal of the medicine. For example, in the USA, the Drug Enforcement Administration regularly hosts National Prescription Drug Take-Back events.
  • If there are no take-back programs, mix the medicine with dirt and place them in a sealed plastic bag. Throw the plastic bag in your household trash. Separately, remove all personal information including the prescription label from the medicine packaging and then dispose off the container.
  • If specifically indicated on the medicine package that it needs to be flushed down the toilet when no longer needed, perform the required step.

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