Zolen tablets

Zolen

  • Active Ingredient: Fluconazole
  • 200 mg, 150 mg, 50 mg
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What is Zolen?

The active ingredient of Zolen brand is fluconazole. Fluconazole is an antifungal medicine. Fluconazole USP is a white crystalline solid which is slightly soluble in water and saline. Fluconazole tablets USP contain 50, 100, 150, or 200 mg of Fluconazole USP and the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, FD&C Red No. 40 aluminum lake dye, magnesium stearate, microcrystalline cellulose and povidone.

Used for

Zolen is used to treat diseases such as: Blastomycosis, Bone Marrow Transplantation, Candida Urinary Tract Infection, Candidemia, Chronic Mucocutaneous Candidiasis, Coccidioidomycosis, Coccidioidomycosis, Meningitis, Cryptococcal Meningitis, Immunocompetent Host, Cryptococcal Meningitis, Immunosuppressed Host, Cryptococcosis, Esophageal Candidiasis, Fungal Infection Prophylaxis, Fungal Infection, Internal and Disseminated, Fungal Peritonitis, Fungal Pneumonia, Histoplasmosis, Onychomycosis, Fingernail, Onychomycosis, Toenail, Oral Thrush, Sporotrichosis, Systemic Candidiasis, Tinea Corporis, Tinea Cruris, Tinea Versicolor, Vaginal Yeast Infection.

Side Effect

Possible side effects of Zolen include: difficulty with swallowing; hives, itching, or skin rash; sore throat; hoarseness; diarrhea; Acid or sour stomach.

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Generic Name: Zolen Tablets (floo KON a zole)Brand Name: Diflucan

Medically reviewed by Drugs.com. Last updated on Jul 27, 2019.

Zolen Dosage

Zolen is available in pill, liquid, and cream form.

You should always take the exact amount each day that your doctor prescribed, and be sure to finish the entire amount of the medication -- even if you no longer experience symptoms -- unless your doctor has instructed otherwise.

To treat fungus in the mouth, known as thrush, your doctor may have you take 200 milligrams (mg) the first day and then 100 mg per day for at least two weeks.

People with fungal infections of the esophagus may take 200 mg on the first day and then 100 mg per day for at least three weeks.

After the fungus goes away, you should continue taking Zolen for at least two weeks. Depending on how well the medication works for you, your doctor may increase your daily dose up to 400 mg per day.

To treat yeast infections of the vagina, only a one-time dose of 150 mg by mouth is needed.

To help try to avoid or prevent fungal infections while treating bone marrow transplant patients, the usual dose is 400 mg per day.

People with a type of meningitis (commonly seen in those with AIDS) are typically prescribed 400 mg or more of Zolen for the first day and then 200 mg per day.

Depending on how your body responds to the medication, your doctor may have you take doses as high as 800 mg per day.

Your doctor may also have you continue taking Zolen until the test results on your brain fluid (cerebral spinal fluid) come back negative.

Zolen dosing is usually based on the weight of the child, so ask your healthcare provider for more information.

Side effects of Zolen

Zolen is generally well tolerated. Occasional side effects include:

  • Nausea and vomiting.
  • Diarrhoea and flatulence.
  • Headache.
  • Abnormal liver function tests (10%); severe hepatitis has been reported very rarely.
  • Allergic skin rash including urticaria , exfoliative dermatitis .
  • Endocrine effects including enlarged breasts (in males), alopecia and impotence.

Zolen should not normally be taken in pregnancy. Use during breast-feeding is not generally recommended, because the drug is found in breast milk.

What Is Zolen and How Does It Work?

Zolen is used to treat vaginal yeast infections. It works by stopping the growth of common types of vaginal yeast (fungus). This medication belongs to a class of drugs called azole antifungals.

Zolen is available under the following different brand names: Diflucan.

Dosages of Zolen:

Adult and Pediatric Dosage Forms and Strengths

Dosage Considerations – Should be Given as Follows:

Adult: 200 mg orally on Day 1, THEN 100 mg once/day

Pediatric: 6 mg/kg orally on Day 1, THEN 3 mg/kg once/day; not to exceed 600 mg/day

  • Treatment should be administered for at least 2 weeks to decrease likelihood of relapse

Adult: 200 mg orally on Day 1, THEN 100 mg once/day; doses up to 400 mg/day may be used based on patient's response

Pediatric: 6 mg/kg orally on Day 1, THEN 3 mg/kg once/day

Doses up to 12 mg/kg/day may be used, based on patient's response

  • Treat for a minimum of 3 weeks and for at least 2 weeks following resolution of symptoms

Adult

  • 400 mg orally on Day 1, THEN 200 mg orally once/day
  • Dosage of up to 400 mg once/day may be used based on patient's response
  • Suppression of relapse in patients with AIDS: 200 mg orally once/day

  • 12 mg/kg orally/intravenously (IV) on Day 1, THEN 6 mg/kg once/day
  • Dose of 12 mg/kg once daily may be used, based on patient's response
  • Suppression in children with AIDS: 6 mg/kg once daily

  • Recommended duration of therapy is 10-12 weeks after cerebrospinal fluid becomes culture negative

Prophylaxis of Candidiasis with BMT

Prevention of candidiasis incidence in patients undergoing bone marrow transplant

400 mg orally once/day

  • Patients who are anticipated to have severe granulocytopenia should start prophylaxis several days before anticipated onset of neutropenia and continue for 7 days after neutrophil count rises greater than 1000 cells per mm³

Uncomplicated: 150 mg orally as a single dose

Complicated: 150 mg orally every 72 hours for 3 doses

Recurrent: 150 mg orally once/day for 10-14 days followed by 150 mg once weekly for 6 months

50-200 mg orally once/day

Systemic Candida Infections, Pediatric

6-12 mg/kg/day orally/intravenously (IV); not to exceed 600 mg/day

26-29 weeks' gestation: 6-12 mg/kg intravenously (IV)/orally

Maintenance: 3-6 mg/kg IV/orally once/day

Maintenance dose interval

  • 26-29 weeks' gestation: every 72 hours; administer every 24 hours after 2 weeks of life

Hepatic impairment: Not studied

  • Percent of recommended dose:
  • -CrCl greater than 50 mL/min: 100% of dose
  • -CrCl up to 50 mL/min: 50% dose
  • -Regular dialysis: 100% dose after each dialysis; on non-dialysis days, reduce dose according to creatinine clearance

Single maternal PO dose of 150 mg for vaginal candidiasis

  • Results of a Danish study concludes there is a possible increased risk of miscarriage; women who are pregnant or actively trying to get pregnant should ask their physician about alternative treatments
  • Spontaneous abortion between 7 and 22 weeks' gestation occurred significantly more often in women exposed to oral Zolen than unexposed pregnancies (4.43% vs. 4.25%; hazard ratio, 1.48); Zolen was also compared with intravaginal azole antifungals to account for confounding by candidiasis, again, the oral drug was associated with significantly increased risk for spontaneous abortion - JAMA. 2016;315(1):58-67
  • CDC guidelines recommend only using topical antifungal products to treat pregnant women with vulvovaginal yeast infections, including for longer periods than usual if these infections persist or recur

Zidovudine

Zolen increases the Cmax and AUC of zidovudine by 84% and 74%, respectively, due to an approximately 45% decrease in oral zidovudine clearance. The half-life of zidovudine was likewise prolonged by approximately 128% following combination therapy with Zolen. Patients receiving this combination should be monitored for the development of zidovudine-related adverse reactions. Dosage reduction of zidovudine may be considered.

Physicians should be aware that interaction studies with medications other than those listed in the CLINICAL PHARMACOLOGY section have not been conducted, but such interactions may occur.

Administration of a single oral 200 mg dose of DIFLUCAN after 15 days of rifampin administered as 600 mg daily in eight healthy male volunteers resulted in a significant decrease in Zolen AUC and a significant increase in apparent oral clearance of Zolen. There was a mean ± SD reduction in Zolen AUC of 23% ± 9% (range: –13 to –42%). Apparent oral clearance of Zolen increased 32% ± 17% (range: 16 to 72%). Zolen half-life decreased from 33.4 ± 4.4 hours to 26.8 ± 3.9 hours. (See PRECAUTIONS.)

Warnings for other groups

Pregnant women: Research in humans has shown adverse effects to the fetus when the mother takes this drug in doses of 150 mg or higher. In lower doses, research in animals has shown adverse effects. There haven’t been enough studies done to be certain how lower doses of the drug might affect the human fetus.

This drug should only be used during pregnancy in serious cases where it’s needed to treat a dangerous infection in the mother. And it should only be used if the potential risk to the fetus is acceptable given the drug’s potential benefit.

Talk to your doctor if you’re pregnant or planning to become pregnant. Ask your doctor to tell you about the specific harm that may be done to the fetus.

If you become pregnant while taking this drug, call your doctor right away.

Women who are breastfeeding: Zolen passes into breast milk and may cause side effects in a child who is breastfed. Talk to your doctor if you breastfeed your child. You may need to decide whether to stop breastfeeding or stop taking this drug.

For seniors: The kidneys of older adults may not work as well as they used to. This can cause your body to process drugs more slowly. As a result, more of a drug stays in your body for a longer time. This raises your risk of side effects.

For children: This medication shouldn’t be used in people younger than 6 months.

Dose regime for oral Zolen

For vulvovaginal candidiasis, a single oral dose of Zolen 150 mg is usually effective. It can be repeated.

For dermatophyte (tinea) infections and pityriasis versicolor, either 50 mg daily or 150 mg once weekly is taken for two to six weeks.

Once-weekly Zolen is often used off-label to treat toenail fungal infections (onychomycosis).

Larger doses (up to 400 mg daily) are required for systemic infections.

Zolen is not normally used in children but doses of 5 mg/kg/day have been safely prescribed for a serious infection .

Non-Steroidal Anti-Inflammatory Drugs

The Cmax and AUC of flurbiprofen were increased by 23% and 81%, respectively, when coadministered with Zolen compared to administration of flurbiprofen alone. Similarly, the Cmax and AUC of the pharmacologically active isomer were increased by 15% and 82%, respectively, when Zolen was coadministered with racemic ibuprofen (400 mg) compared to administration of racemic ibuprofen alone.

Although not specifically studied, Zolen has the potential to increase the systemic exposure of other non-steroidal anti-inflammatory drugs (NSAIDs) that are metabolized by CYP2C9 (e.g., naproxen, lornoxicam, meloxicam, diclofenac). Frequent monitoring for adverse events and toxicity related to NSAIDs is recommended. Adjustment of dosage of NSAIDs may be needed.

What is Diflucan (Zolen)? How does it work (mechanism of action)?

Diflucan (Zolen) is an anti-fungal medication related to clotrimazole (Lotrimin), ketoconazole (Nizoral), itraconazole (Sporanox), and miconazole (Micatin, Monistat). Zolen prevents growth of fungi by preventing production of the membranes that surround fungal cells.


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