Zidonil tablets

Zidonil

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

The active ingredient of Zidonil 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

Zidonil 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 Zidonil include: Abdominal or stomach pain; heartburn; fainting; vomiting of blood; lower back or side pain; irregular or slow heart rate; fast heartbeat; red skin lesions, often with a purple center.

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Cautions

Hypersensitivity to other azoles

Use caution in proarrhythmic conditions and renal impairment

Use extreme caution or avoid in congenital long-QT patients and patients with conditions that increase QT-prolongation risk

Zidonil inhibits CYP2C9, CYP2C19, and CYP3A4 isoenzymes; coadministration with drugs that are substrates if these isoenzymes may be contraindicated or warrant dosage modifications

Capsules contain lactose and should not be given to patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption

Powder for oral suspension contains sucrose and should not be used in patients with hereditary fructose, glucose/galactose malabsorption or sucrase-isomaltase deficiency

Syrup contains glycerol; may cause headache, stomach upset, and diarrhea

Hepatotoxicity reported with use; use with caution in patients with hepatic impairment

Rare exfoliative skin disorders reported; monitor closely if rash develops and discontinue if it progresses

When driving vehicles or operating machines, it should be taken into account that dizziness or seizures may occasionally occur

Candida krusei is inherently resistant

Convenience and efficacy of single dose oral tablet of Zidonil regimen for the treatment of vaginal yeast infections should be weighed against acceptability of higher incidence of drug related adverse events with Zidonil (26%) versus intravaginal agents (16%)

If drug is used during pregnancy or if patient becomes pregnant while taking the drug, patient should be informed of potential hazard to fetus; effective contraceptive measures should be considered in women of child-bearing potential who are being treated with 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

What are the side effects of Diflucan (Zidonil)?

Common side effects of Zidonil include

Other important side effects include

Possible serious side effects include

  • seizures,
  • reduced number of white blood cells,
  • reduced number of blood platelets, and
  • toxic epidermal necrolysis.

Rarely, serious allergic reactions, including angioedema (swelling of tissues), may also occur. Liver dysfunction (jaundice, hepatitis) and abnormal heart beats have been associated with Zidonil. Stevens-Johnson syndrome has also been reported.

An open-label, comparative study of the efficacy and safety of DIFLUCAN (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 Zidonil.

Clinical cure at the end of treatment was reported for 86% of Zidonil-treated patients compared to 46% of nystatin treated patients. Mycologically, 76% of Zidonil 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 DIFLUCAN and 16% for subjects receiving nystatin. At 4 weeks after the end of treatment, the percentages of patients with clinical relapse were 22% for DIFLUCAN and 23% for nystatin.

Warnings for people with certain health conditions

For people with kidney disease: If you have kidney disease or a history of kidney disease, your kidneys may not be able to remove this drug from your body like they should. This may increase the levels of Zidonil in your body and cause more side effects. This drug may also make existing kidney disease worse.

People with liver problems: Zidonil can cause liver problems. If you already have liver problems, talk to your healthcare provider before taking this drug.

People with high blood sugar levels: The oral suspension form of this drug contains sucrose, a kind of sugar. You shouldn’t use this form of the drug if you have a condition that increases your blood sugar level. Talk to your doctor before using this drug if you have high blood sugar levels or a condition, such as diabetes, which can cause high blood sugar levels.

People with abnormal heart rhythms: Using Zidonil can affect your heart rhythm. If you already have an abnormal heart rhythm, taking Zidonil may lead to dangerous heart rhythm problems.

People with certain conditions that lower immunity: If you have certain conditions that lower your immunity, such as cancer, human immunodeficiency virus infection (HIV), or acquired immunodeficiency syndrome (AIDS) you’re more likely to get a rash from Zidonil. Your doctor will monitor you for a rash and peeling skin.

What are some things I need to know or do while I take Zidonil Tablets?

  • Tell all of your health care providers that you take this medicine (Zidonil tablets). This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine (Zidonil tablets) affects you.
  • Do not use longer than you have been told. A second infection may happen.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Talk with your doctor before you drink alcohol.
  • This medicine may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking this medicine (Zidonil tablets) with your other drugs.
  • Very bad skin problems like rashes have happened with this medicine (Zidonil tablets). Sometimes, this has been deadly in people with other bad health problems. Talk with the doctor.
  • Very bad liver problems have rarely happened with this medicine (Zidonil tablets). Sometimes, this has been deadly in people with other bad health problems. Talk with the doctor.
  • A severe and sometimes deadly reaction has happened. Most of the time, this reaction has signs like fever, rash, or swollen glands with problems in body organs like the liver, kidney, blood, heart, muscles and joints, or lungs. If you have questions, talk with the doctor.
  • If you are 65 or older, use this medicine (Zidonil tablets) with care. You could have more side effects.
  • If you are able to get pregnant, talk with your doctor. You may need to use birth control to prevent pregnancy while taking this medicine (Zidonil tablets) and for some time after your last dose.
  • This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this medicine (Zidonil tablets), call your doctor right away.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

The effects of Zidonil on the pharmacokinetics of the sulfonylurea oral hypoglycemic agents tolbutamide, glipizide, and glyburide were evaluated in three placebo-controlled studies in normal volunteers. All subjects received the sulfonylurea alone as a single dose and again as a single dose following the administration of DIFLUCAN 100 mg daily for 7 days. In these three studies, 22/46 (47.8%) of DIFLUCAN-treated patients and 9/22 (40.1%) of placebo-treated patients experienced symptoms consistent with hypoglycemia. (See PRECAUTIONS.)

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 Zidonil than unexposed pregnancies (4.43% vs. 4.25%; hazard ratio, 1.48); Zidonil 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

Dermatologic

Exfoliative skin disorders during treatment with DIFLUCAN 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 DIFLUCAN should be monitored closely and the drug discontinued if lesions progress. Zidonil should be discontinued in patients treated for superficial fungal infection who develop a rash that may be attributed to Zidonil.

What do I need to tell my doctor BEFORE I take Zidonil Tablets?

  • If you have an allergy to Zidonil or any other part of this medicine (Zidonil tablets).
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you are taking any of these drugs: Astemizole, cisapride, erythromycin, olaparib, pimozide, quinidine, terfenadine, or voriconazole.
  • If you are pregnant or may be pregnant. You will need to talk with your doctor about if this medicine (Zidonil tablets) is right for you.

This is not a list of all drugs or health problems that interact with this medicine (Zidonil tablets).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine (Zidonil tablets) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What other drugs will affect Zidonil?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Zidonil can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Many drugs can affect Zidonil, and some drugs should not be used at the same time. Tell your doctor about all your current medicines and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

Coadministration of Zidonil (400 mg on Day 1 and 200 mg once daily for 6 days ) and tofacitinib (30 mg single dose on Day 5) in healthy subjects resulted in increased mean tofacitinib AUC and Cmax values of approximately 79% (90% CI: 64% to 96%) and 27% (90% CI: 12% to 44%), respectively, compared to administration of tofacitinib alone. (See PRECAUTIONS.)

Tacrolimus

Zidonil may increase the serum concentrations of orally administered tacrolimus up to 5 times due to inhibition of tacrolimus metabolism through CYP3A4 in the intestines. No significant pharmacokinetic changes have been observed when tacrolimus is given intravenously. Increased tacrolimus levels have been associated with nephrotoxicity. Dosage of orally administered tacrolimus should be decreased depending on tacrolimus concentration. (See CLINICAL PHARMACOLOGY: Drug Interaction Studies.)


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