Fluconazole (Fluconazole)

Trade Name : Fluconazole

Teva Pharmaceuticals USA, Inc.

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 Teva Pharmaceuticals USA, Inc.. 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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Rx only

Fluconazole, USP, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration.
Fluconazole, USP is designated chemically as 2,4-Difluoro-1u2032,1u2032-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol and has the following structural formula:
CHFNO M.W. 306.27
Fluconazole, USP is a white crystalline solid which is slightly soluble in water and saline.
Fluconazole Tablets USP, for oral administration, contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole, USP and have the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C red #40 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and talc.

No data

Fluconazole Tablets are indicated for the treatment of:
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.
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.

Cryptococcal Meningitis
In a multicenter study comparing fluconazole (200 mg/day) to amphotericin B (0.3 mg/kg/day) for treatment of cryptococcal meningitis in patients with AIDS, a multivariate analysis revealed three pretreatment factors that predicted death during the course of therapy: abnormal mental status, cerebrospinal fluid cryptococcal antigen titer greater than 1:1024, and cerebrospinal fluid white blood cell count of less than 20 cells/mm. Mortality among high risk patients was 33% and 40% for amphotericin B and fluconazole patients, respectively (p = 0.58), with overall deaths 14% (9 of 63 subjects) and 18% (24 of 131 subjects) for the 2 arms of the study (p = 0.48). Optimal doses and regimens for patients with acute cryptococcal meningitis and at high risk for treatment failure remain to be determined. (Saag, N Engl J Med 1992; 326:83-9.)
Vaginal Candidiasis
Two adequate and well-controlled studies were conducted in the U.S. using the 150 mg tablet. In both, the results of the fluconazole regimen were comparable to the control regimen (clotrimazole or miconazole intravaginally for 7 days) both clinically and statistically at the one month post-treatment evaluation.
The therapeutic cure rate, defined as a complete resolution of signs and symptoms of vaginal candidiasis (clinical cure), along with a negative KOH examination and negative culture for (microbiologic eradication), was 55% in both the fluconazole group and the vaginal products group.
Approximately three-fourths of the enrolled patients had acute vaginitis (< 4 episodes/12 months) and achieved 80% clinical cure, 67% mycologic eradication, and 59% therapeutic cure when treated with a 150 mg fluconazole tablet administered orally. These rates were comparable to control products. The remaining one-fourth of enrolled patients had recurrent vaginitis (u2265 4 episodes/12 months) and achieved 57% clinical cure, 47% mycologic eradication, and 40% therapeutic cure. The numbers are too small to make meaningful clinical or statistical comparisons with vaginal products in the treatment of patients with recurrent vaginitis.
Substantially more gastrointestinal events were reported in the fluconazole group compared to the vaginal product group. Most of the events were mild to moderate. Because fluconazole was given as a single dose, no discontinuations occurred.
Oropharyngeal Candidiasis
An open-label, comparative study of the efficacy and safety of fluconazole (2 to 3 mg/kg/day) and oral nystatin (400,000 I.U. 4 times daily) in immunocompromised children with oropharyngeal candidiasis was conducted. Clinical and mycological response rates were higher in the children treated with fluconazole.
Clinical cure at the end of treatment was reported for 86% of fluconazole-treated patients compared to 46% of nystatin-treated patients. Mycologically, 76% of fluconazole-treated patients had the infecting organism eradicated compared to 11% for nystatin-treated patients.
The proportion of patients with clinical relapse 2 weeks after the end of treatment was 14% for subjects receiving fluconazole and 16% for subjects receiving nystatin. At 4 weeks after the end of treatment, the percentages of patients with clinical relapse were 22% for fluconazole and 23% for nystatin.

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 (see and ).

No data

No data

Fluconazole is generally well tolerated.
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 available as pink, modified oval-shaped, unscored tablets, debossed u201c5410u201d on one side and u201cIvax hourglass logou201d u201c50u201d on the other side and packaged in bottles of 30 (NDC 0172-5410-46) tablets.
Fluconazole Tablets USP, 100 mg are available as pink, modified oval-shaped, unscored tablets, debossed u201c5411u201d on one side and u201cIvax hourglass logou201d u201c100u201d on the other side and packaged in bottles of 30 (NDC 0172-5411-46) and 100 (NDC 0172-5411-60) tablets.
Fluconazole Tablets USP, 150 mg are available as pink, modified oval-shaped, unscored tablets, debossed u201c5412u201d on one side and u201cIvax hourglass logou201d u201c150u201d on the other side and packaged in a carton of 12 (NDC 0172-5412-11) unit-of-use cards of 1 tablet.
Fluconazole Tablets USP, 200 mg are available as pink, modified oval-shaped, unscored tablets, debossed u201c5413u201d on one side and u201cIvax hourglass logou201d u201c200u201d on the other side and packaged in bottles of 30 (NDC 0172-5413-46) and 100 (NDC 0172-5413-60) tablets.
Store at 20u02da to 25u02daC (68u02da to 77u02daF) [See USP Controlled Room Temperature].
Dispense in a tight container as defined in the USP, with a child resistant closure (as required).
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.
Manufactured In India By:
Cipla Ltd.
Kurkumbh, India
Manufactured For:
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454
Rev. L 3/2019

Fluconazole Tablets
This leaflet contains important information about fluconazole (floo-KON-a-zole). It is not meant to take the place of your doctor's instructions. Read this information carefully before you take fluconazole. Ask your doctor or pharmacist if you do not understand any of this information or if you want to know more about fluconazole.
What Is Fluconazole?
Fluconazole is a tablet you swallow to treat vaginal yeast infections caused by a yeast called Fluconazole helps stop too much yeast from growing in the vagina so the yeast infection goes away.
Fluconazole is different from other treatments for vaginal yeast infections because it is a tablet taken by mouth. Fluconazole is also used for other conditions. However, this leaflet is only about using fluconazole for vaginal yeast infections. For information about using fluconazole for other reasons, ask your doctor or pharmacist. See the section of this leaflet for information about vaginal yeast infections.
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.
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.
If you get a vaginal yeast infection, you may have any of the following symptoms:
What To Tell Your Doctor Before You Start Fluconazole?
Do not take fluconazole 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?
To avoid a possible serious reaction, do NOT take fluconazole if you are taking erythromycin, astemizole, pimozide, quinidine, and cisapride (Propulsid) since they can cause changes in heartbeat in some people if taken with fluconazole.
How Should I Take Fluconazole?
Take fluconazole by mouth with or without food. You can take fluconazole at any time of the day.
Fluconazole 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?
Some medicines can affect how well fluconazole works. Check with your doctor before starting any new medicines within seven days of taking fluconazole.
What Are the Possible Side Effects of Fluconazole?
Like all medicines, fluconazole may cause some side effects that are usually mild to moderate.
The most common side effects of fluconazole are:
Allergic reactions to fluconazole 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 Symptoms (DRESS)).
Fluconazole 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.
Fluconazole 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.
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.
How to Store Fluconazole
Keep fluconazole and all medicines out of the reach of children.
General Advice About Prescription Medicines
Medicines are sometimes prescribed for conditions that are mentioned in patient information leaflets. Do not use fluconazole for a condition for which it was not prescribed. Do not give fluconazole to other people, even if they have the same symptoms you have. It may harm them.
This leaflet summarizes the most important information about fluconazole. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about fluconazole that is written for health professionals. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.
Manufactured In India By:
Cipla Ltd.
Kurkumbh, India
Manufactured For:
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454
Rev. H 3/2019

NDCn- 5410
Fluconazoleu00a0n- Tablets USPn- 50 mg
Rx only
30 TABLETS
TEVA

NDCn- 5411
Fluconazolen- Tablets USPn- 100 mg
Rx only
30 TABLETS
TEVA

NDCn- 5412
Fluconazoleu00a0n- Tablets USPn- 150 mg
Each tablet contains:fluconazole, USP 150 mg
PHARMACIST: PLEASE DISPENSE WITH PATIENT INFORMATION LEAFLET PROVIDED SEPARATELY.
Rx only
12 Cards x 1 Unit-Dose Tablet
TEVA

No data

NDCn- 5413
Fluconazolen- Tablets USPn- 200 mg
Rx only
30 TABLETS
TEVA

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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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