Fluconazole (Fluconazole)

Trade Name : Fluconazole

Dr. Reddy's Laboratories Limited

TABLET

Strength 50 mg/1

FLUCONAZOLE Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Fluconazole (Fluconazole) which is also known as Fluconazole and Manufactured by Dr. Reddy's Laboratories Limited. It is available in strength of 50 mg/1 per ml. Read more

Fluconazole (Fluconazole) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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No data

Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration.
Fluconazole is designated chemically as 2,4-difluoro-u03b1,u03b1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with a molecular formula of CHFNO and molecular weight 306.3. The structural formula is:
Fluconazole USP is a white or almost white crystalline powder, which is freely soluble in methanol, soluble in alcohol and in acetone, sparingly soluble in isopropyl alcohol and in chloroform. Slightly soluble in water, very slightly soluble in toluene.
Fluconazole tablets USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole USP and the following inactive ingredients: dibasic calcium phosphate anhydrous, ferric oxide (iron oxide, red), magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, and starch.
Fluconazole tablets meets USP Test 2.

No data

Fluconazole tablets are indicated for the treatment of:u00a0
1. Vaginal candidiasis (vaginal yeast infections due to )
2. Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia.n
Arrayn- Array
Prophylaxis: Fluconazole tablets are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy.u00a0
Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. 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.

No data

Fluconazole is contraindicated in patients who have shown hypersensitivity to fluconazole or to any of its excipients. There is no information regarding cross-hypersensitivity between fluconazole and other azole antifungal agents. Caution should be used in prescribing fluconazole to patients with hypersensitivity to other azoles. Coadministration of terfenadine is contraindicated in patients receiving fluconazole at multiple doses of 400 mg/day or higher based upon results of a multiple dose interaction study. Coadministration of other drugs known to prolong the QT interval and which are metabolized via the enzyme CYP3A4 such as cisapride, astemizole, erythromycin, pimozide, and quinidine are contraindicated in patients receiving fluconazole.u00a0(See and .)

Arrayn- (1) Hepatic injury: n- Fluconazole should be administered with caution to patients with liver dysfunction. n- 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 the patient has been observed. Fluconazole hepatotoxicity has usually, but not always, been reversible on discontinuation of therapy. Patients who develop abnormal liver function tests during fluconazole therapy n
(2) Anaphylaxis: In rare cases, anaphylaxis has been reported.
(3) Dermatologic: Exfoliative skin disorders during treatment with fluconazole have been reported. Fatal outcomes have been reported in patients with serious underlying diseases. Patients with deep seated fungal infections who develop rashes during treatment with fluconazole should be monitored closely and the drug discontinued if lesions progress. Fluconazole should be discontinued in patients treated for superficial fungal infection who develop a rash that may be attributed to fluconazole.u00a0
(4) Potential for fetal harm There are no adequate and well-controlled clinical trials of fluconazole in pregnant women. Case reports describe a pattern of distinct congenital anomalies in infants exposed in utero to high dose maternal fluconazole (400 to 800 mg/day) during most or all of the first trimester. These reported anomalies are similar to those seen in animal studies. If fluconazole is used during pregnancy or if the patient becomes pregnant while taking the drug, the patient should be informed of the potential hazard to the fetus. Effective contraceptive measures should be considered in women of child-bearing potential who are being treated with fluconazole 400 to 800 mg/day and should continue throughout the treatment period and for approximately 1 week (5 to 6 half-lives) after the final dose. Epidemiological studies suggest a potential risk of spontaneous abortion and congenital abnormalities in infants whose mothers were treated with 150 mg of fluconazole as a single or repeated dose in the first trimester, but these epidemiological studies have limitations and these findings have not been confirmed in controlled clinical trials (See .)

No data

Fluconazole is generally well tolerated.u00a0u00a0
In some patients, particularly those with serious underlying diseases such as AIDS and cancer, changes in renal and hematological function test results and hepatic abnormalities have been observed during treatment with fluconazole and comparative agents, but the clinical significance and relationship to treatment is uncertain.

There have been reports of overdose with fluconazole accompanied by hallucination and paranoid behavior.
In the event of overdose, symptomatic treatment (with supportive measures and gastric lavage if clinically indicated) should be instituted.
Fluconazole is largely excreted in urine. A 3-hour hemodialysis session decreases plasma levels by approximately 50%.
In mice and rats receiving very high doses of fluconazole, clinical effects in both species included decreased motility and respiration, ptosis, lacrimation, salivation, urinary incontinence, loss of righting reflex, and cyanosis; death was sometimes preceded by clonic convulsions.

No data

Fluconazole tablets USP, 50 mg are peach colored, oval, flat, bevelled edged, uncoated tablets debossed u2018Ru2019 on one side and u201c143u2019 on other side and are supplied in bottles of 30, 100, 500 and unit dose package of 100 (10 x 10).u00a0
Bottles of 30 NDC 55111-143-30
Bottles of 100 NDC 55111-143-01
Bottles of 500 NDC 55111-143-05
Unit Dose Package of 100 (10 x 10) NDC 55111-143-78u00a0
Fluconazole tablets USP, 100 mg are peach colored, oval, flat, bevelled edged, uncoated tablets debossed u2018Ru2019 on one side and u201c144u2019 on other side and are supplied in bottles of 30, 100, 500 and unit dose package of 100 (10 x 10).u00a0
Bottles of 30 NDC 55111-144-30
Bottles of 100 NDC 55111-144-01
Bottles of 500 NDC 55111-144-05
Unit Dose Package of 100 (10 x 10) NDC 55111-144-78u00a0
Fluconazole tablets USP, 150 mg are peach colored, oval, flat, bevelled edged, uncoated tablets debossed u2018Ru2019 on one side and u201c145u2019 on other side and are supplied in unit dose package of 12 (12 x 1).u00a0
Unit Dose Package of 12 (12 x 1) NDC 55111-145-12u00a0
Fluconazole tablets USP, 200 mg are peach colored, oval, flat, bevelled edged, uncoated tablets debossed u2018Ru2019 on one side and u201c146u2019 on other side and are supplied in bottles of 30, 100, 500 and unit dose package of 100 (10 x 10).u00a0
Bottles of 30 NDC 55111-146-30
Bottles of 100 NDC 55111-146-01
Bottles of 500 NDC 5511-146-05
Unit Dose Package of 100 (10 x 10) NDC 55111-146-78n n
Storage:
Maaloxu00aeis a registered trademark of Novartis Consumer Health, Inc.
XELJANZu00aeis a registered trademark of Pfizer Inc.

PATIENT INFORMATION
Fluconazole Tablet USP, 150 mg
(floo kon' a zole)
This leaflet contains important information about fluconazole tablet. It is not meant to take the place of your doctor's instructions. Read this information carefully before you take fluconazole tablet. Ask your doctor or pharmacist if you do not understand any of this information or if you want to know more about fluconazole tablet. u00a0
What Is Fluconazole Tablet?
Fluconazole is a tablet you swallow to treat vaginal yeast infections caused by a yeast called . Fluconazole tablet helps stop too much yeast from growing in the vagina so the yeast infection goes away. u00a0
Fluconazole tablet is different from other treatments for vaginal yeast infections because it is a tablet taken by mouth. Fluconazole tablet is also used for other conditions. However, this leaflet is only about using fluconazole tablet for vaginal yeast infections. For information about using fluconazole tablet for other reasons, ask your doctor or pharmacist. See the section of this leaflet for information about vaginal yeast infections. u00a0
What Is a Vaginal Yeast Infection?
It is normal for a certain amount of yeast to be found in the vagina. Sometimes too much yeast starts to grow in the vagina and this can cause a yeast infection. Vaginal yeast infections are common. About three out of every four adult women will have at least one vaginal yeast infection during their life. u00a0
Some medicines and medical conditions can increase your chance of getting a yeast infection. If you are pregnant, have diabetes, use birth control pills, or take antibiotics you may get yeast infections more often than other women. Personal hygiene and certain types of clothing may increase your chances of getting a yeast infection. Ask your doctor for tips on what you can do to help prevent vaginal yeast infections. u00a0
If you get a vaginal yeast infection, you may have any of the following symptoms:
What To Tell Your Doctor Before You Start Fluconazole Tablet?
Do not take fluconazole tablet if you take certain medicines. They can cause serious problems. Therefore, tell your doctor about all the medicines you take including:
Since there are many brand names for these medicines, check with your doctor or pharmacist if you have any questions.
Who Should Not Take Fluconazole Tablet?
To avoid a possible serious reaction, do NOT take fluconazole tablet if you are taking erythromycin, astemizole, pimozide, quinidine, and cisapride (Propulsid) since it can cause changes in heartbeat in some people if taken with fluconazole tablet.
How Should I Take Fluconazole Tablet
Take fluconazole tablet by mouth with or without food. You can take fluconazole tablet at any time of the day. u00a0
Fluconazole tablet keeps working for several days to treat the infection. Generally the symptoms start to go away after 24 hours. However, it may take several days for your symptoms to go away completely. If there is no change in your symptoms after a few days, call your doctor.
Just swallow 1 fluconazole tablet to treat your vaginal yeast infection.
What Should I Avoid while Taking Fluconazole Tablet?
Some medicines can affect how well fluconazole tablet works. Check with your doctor before starting any new medicines within seven days of taking fluconazole tablet. u00a0
What Are the Possible Side Effects of Fluconazole Tablet?
Like all medicines, fluconazole tablet may cause some side effects that are usually mild to moderate. u00a0
The most common side effects of fluconazole tablet are:
Allergic reactions to fluconazole tablet are rare, but they can be very serious if not treated right away by a doctor. If you cannot reach your doctor, go to the nearest hospital emergency room. Signs of an allergic reaction can include shortness of breath; coughing; wheezing; fever; chills; throbbing of the heart or ears; swelling of the eyelids, face, mouth, neck, or any other part of the body; or skin rash, hives, blisters or skin peeling. u00a0
Tell your doctor or pharmacist if you experience 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) as they may be signs of a hypersensitivity reaction (Drug Reaction or rash with Eosinophilia and Systemic Symptons (DRESS)).
Fluconazole tablet has been linked to rare cases of serious liver damage, including deaths, mostly in patients with serious medical problems. Call your doctor if your skin or eyes become yellow, your urine turns a darker color, your stools (bowel movements) are light-colored, or if you vomit or feel like vomiting or if you have severe skin itching.
In patients with serious conditions such as AIDS or cancer, rare cases of severe rashes with skin peeling have been reported. Tell your doctor right away if you get a rash while taking fluconazole tablet. u00a0
Fluconazole tablet may cause other less common side effects besides those listed here. If you develop any side effects that concern you, call your doctor. For a list of all side effects, ask your doctor or pharmacist. u00a0
Cases of reversible adrenal insufficiency have been reported with fluconazole. Tell your doctor is you experience chronic, or long lasting fatigue, muscle weakness, loss of appetite, weight loss or abdominal pain.
What to Do For an Overdose
In case of an accidental overdose, call your doctor right away or go to the nearest emergency room. u00a0
How to Store Fluconazole Tablet
Keep fluconazole tablet and all medicines out of the reach of children. u00a0
General Advice about Prescription Medicines
Medicines are sometimes prescribed for conditions that are mentioned in patient information leaflets. Do not use fluconazole tablet for a condition for which it was not prescribed. Do not give fluconazole tablet to other people, even if they have the same symptoms you have. It may harm them. u00a0
This leaflet summarizes the most important information about fluconazole tablet. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about fluconazole tablet that is written for health professionals. u00a0
Rx Only
Manufactured by:
Dr. Reddyu2019s Laboratories Limited
Bachupally u2013 500 090 INDIAu00a0u00a0
Revised: 1020
For Patient Information Sheet, please visit:www.drreddys.com/pi/fluconazole150mgtabs.pdf

Unvarnished Area consists of: 2D Barcode, Lot Number, Expiry Date and Serial number.
Fluconazole Tablets USP, 50 mg - Container Labeling

Fluconazole Tablets USP, 100 mg - Container Labeling

Fluconazole Tablets USP, 200 mg - Container Labeling

Fluconazole Tablets USP, 50 mg - Carton Labeling

Fluconazole Tablets USP, 100 mg - Carton Labeling

Fluconazole Tablets USP, 150 mg - Blister Card Labeling

Fluconazole Tablets USP, 150 mg - Carton Labeling

Fluconazole Tablets USP, 200 mg - Carton Labeling

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Fluconazole (Fluconazole)

Trade Name : Fluconazole

TABLET

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Fluconazole (Fluconazole)

Trade Name : Fluconazole

TABLET

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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