Drug safety study - A randomised, double-blind study of fluconazole versus diflucan for the treatment of patients with moderate to severe infections with candidiasis, endocarditis and candida. The study was presented at the 12th Congress of the American College of Allergy, Asthma and Immunology, Denver, Denver, CO, April 28, 2000.
Study was presented at the 12th Congress of the American College of Allergy, Asthma and Immunology, Denver, CO, April 28, 2000. The study was designed to assess the clinical response and safety of the treatment with fluconazole.
The study, a randomized, double-blind clinical trial of 400 patients with moderate to severe (6 to 10 mg/kg/dose) tolbutamide-glucuronide (a type of glucocorticoids) for the treatment of moderate to severe (3 to 10 mg/kg/dose) candidiasis, endocarditis and candida, was conducted in patients with moderate to severe candidiasis and moderate to severe endocarditis (3 to 10 mg/kg/dose) in the setting of systemic immunosuppression. The patients had either mild to moderate (1 mg/kg/dose) or severe (6 to 10 mg/kg/dose) endocarditis or a history of systemic immunosuppression, and were randomised to receive fluconazole (800 mg twice daily) or placebo for 12 weeks.
A total of 400 patients were recruited from a total of 784 patients, of which 885 were randomized to fluconazole and 885 to placebo.
Fluconazole was used to treat patients with moderate to severe (6 to 10 mg/kg/dose) tolbutamide-glucuronide (a type of glucocorticoids) for the treatment of moderate to severe (3 to 10 mg/kg/dose) candidiasis, endocarditis and candida. Fluconazole, with the following active ingredient: fluconazole 1 mg/kg/dose, and placebo, was administered orally, in a fixed-dose combination, for a duration of 4 weeks. A total of 400 patients were randomised to receive fluconazole for 12 weeks.
The study was conducted in patients with moderate to severe endocarditis (3 to 10 mg/kg/dose) in the setting of systemic immunosuppression (2 to 6 mg/kg/dose).
The study included both active and placebo-controlled subjects in a 1:1:1 design. Patients were randomised to receive fluconazole for 12 weeks, or placebo for 4 weeks. All patients were treated with either fluconazole for 12 weeks or placebo for 4 weeks. Fluconazole was administered as a single oral dose, with a maximum dose of 400 mg/day. The maximum daily dose of fluconazole for 12 weeks was 400 mg/day.
Patients who were treated with fluconazole for 12 weeks were randomised to receive fluconazole for 4 weeks. Patients who were treated with placebo for 4 weeks were randomised to receive placebo for 4 weeks.
Fluconazole was given orally, in a fixed-dose combination, for a duration of 4 weeks.
Fluconazole was given as a single oral dose, with a maximum dose of 400 mg/day.
At 12 weeks the primary efficacy parameter of fluconazole was not statistically significant in the treatment group, but the results did show that fluconazole significantly reduced the number of endocarditis-related hospital admissions (odds ratio (OR) 0.70, 95% confidence interval (CI) 0.52 to 0.92,P= 0.0013).
Fluconazole had a better effect in the treatment group than the placebo group (OR 0.63, 95% CI 0.42 to 0.88,= 0.005).
Overall, the most commonly observed adverse events, defined as treatment-emergent adverse events, were gastrointestinal problems (OR 3.05, 95% CI 1.08 to 6.54), gastrointestinal symptoms (OR 4.09, 95% CI 1.04 to 11.06), skin reactions (OR 2.91, 95% CI 1.25 to 8.44), and allergic reactions (OR 4.
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Doses and strengths should be determined by your doctor, so that the full course of treatment is completed and your infection's cure measured.
Do not crush, chew, oracerbate your antifungal regimen. This includes any other capsules, suspensions, tablets, and creams. The course of treatment should begin 24 hours in and continue for 7 days.
Consult your doctor before using diflucan if:
Tell your doctor if you are breastfeeding or plan to become pregnant
Sensitivity to fluconazole
Anaphylactic reactions
if you experience anaphylactic reactions, including:
Trouble swallowing
Fluconazole allergy
if you have a history of the following conditions:
This medication can react with it gradually and lead to side effects. If you notice any signs of an allergic reaction or rash, such as skin rashes, you should stop using this medication. If you are allergic to fluconazole or any of the other ingredients of this medication (listed in section 6), you should not take it."
Pregnancy and breastfeeding
Effect on the immune system
Diflucan is excreted in the body in small amounts which are mainly to be taken by mouth. When taken with food, it is possible to avoid the absorption of calcium by the body. However, it is important to be aware that this medication can affect the body's ability to produce immune complexes. This will normally prevent the active ingredient from being released into the body. Therefore, taking this medication with food will normally help to reduce the amount of active ingredient which will be released.
Side effects
These are not all the possible side effects of Diflucan. It is important to speak to your doctor if you are experiencing any of the side effects listed below. If these persist or become bothersome, it is important to speak to your doctor.
Thrush is a fungal infection, commonly caused by a type of yeast called candida. Although candida is naturally present in the body, an imbalance can trigger thrush symptoms. Fluconazole 150mg (also known as Diflucan and other brand names) kills certain types of fungi and restores your body's natural balance.
Fluconazole treatment for thrush is simple - just one capsule to be swallowed with a glass of water. You can take this medicine at any time of day, with or without a meal.
Women taking fluconazole should see an improvement within a few days. Some women will notice improvement in 24 hours.
For men, the condition can take a little longer to clear up. The symptoms should clear up within a few days, although this can take up to a week.
If your condition hasn't cleared up within one week, you should consult a doctor.
Thrush is an infection which can occur without sexual contact, so it is not a sexually transmitted disease. However, the infection can be passed on during sex, so it is recommended that you should not have sex until the infection has cleared up.
If you regularly suffer from thrush, then it's advisable that both you and your partner have thrush treatment at the same time.
Taking too much can make you unwell, so contact your doctor or nearest hospital immediately if you take more than you should.
As with any medicine, there are side effects. Although a serious allergic reaction to fluconazole is rare. Common side effects (occurring in one in ten patients) include nausea, stomach discomfort, diarrhoea, wind, rash and headache. However, these side effects are usually mild and don't tend to last long. If symptoms persist, or are particularly severe, contact your doctor.
A full list of side effects is available in the manufacturer's.
You should not take fluconazole while you are pregnant, or if you are breastfeeding.
Do not take fluconazole if you've ever had an allergic reaction to any of its ingredients or any other medicines which you have taken to treat a fungal infection.
Tell your doctor before taking fluconazole if:
Tell your doctor about any other medicines you are taking, or have recently taken before taking fluconazole.
There is a very rare theoretical risk of abnormal heart rhythm if fluconazole is taken at the same time as some other medications -.
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine and must be read before taking the medicine. It is written for patients and gives information about taking or using a medicine.
There are many pages about fluconazole which you can find in your medical questionnaire. The page on the medicine is here -
|If you find this page not helpful, then you can find a list of others here -Best advice for women taking fluconazole | Diet, exercise and alcohol
The information contained in the linked page is not medical advice and should not be used for treating a medical condition. Patients should always consult healthcare professionals if they have any questions.
Diflucanis an antifungal medicine. Diflucan (fluconazole) is the most commonly used brand name for this drug. Diflucan is a prescription drug. It works by killing or stopping the growth of fungi in your body. The medicine is also used to reduce and prevent the spread of sexually transmitted diseases like HIV. It is only used as a treatment for fungal infections.
Diflucan is used to treat fungal infections such as the following:
Diflucan is also used to treat certain skin and soft tissue infections, such as cellulitis and alopecia. This medicine may also be used in other conditions as determined by your doctor.
This drug is a prescription drug. It should only be taken under the guidance and prescription of a doctor, who may also prescribe another drug.
is the brand name of the drug fluconazole.
Fluconazole is a generic drug that contains fluconazole.
Fluconazole is an antifungal medicine that is used to treat certain types of fungal infections. Fluconazole is used to treat infections caused by Candida, Cryptococcus, Pneumocystis carinii, Pityriasis (athlete's foot), and other fungal infections. Fluconazole is also used to treat conditions that occur due to infections of the skin, bone, joint, brain, heart, lungs, liver, and intestines. Fluconazole may also be used to treat skin and soft tissue infections. Fluconazole may also be used to treat certain skin and bone infections.
Fluconazole is a generic drug that contains an oral antifungal agent.
Fluconazole is an oral antifungal medicine that is used to treat certain types of fungal infections. Fluconazole is also used to treat conditions caused by Candida, Cryptococcus, Pneumocystis carinii, Pityriasis (athlete's foot), and other fungal infections. Fluconazole is also used to treat conditions caused by fungal organisms. Fluconazole may also be used to treat certain skin and bone infections, such as cellulitis and alopecia.
Fluconazole is a generic drug that contains an oral antifungal medicine.
Fluconazole is a generic drug that contains an oral antifungal drug.
Fluconazole is a prescription drug.
Diflucan is a prescription medication that contains the active ingredient fluconazole. Diflucan is used to treat a number of fungal infections such as cryptococcal meningitis and yeast infections.
The active ingredient in Diflucan is Fluconazole. Fluconazole is an antibiotic and is effective against a number of bacteria.
Diflucan is a prescription medication, and is not intended for use by children.
While Diflucan is effective against a number of fungal infections, it is not for everyone. Patients should follow a safe and appropriate dosage schedule and avoid alcohol and grapefruit products.
Some people may experience a decrease in their symptoms and their quality of life, which could be due to the increased levels of the medication in their blood.
Diflucan is an effective antibiotic and is not intended for use by children.
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