KETOCONAZOLE 200 mg Tablet, 10-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Cortisol Synthesis Inhibitor class.
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🏭 Manufacturer & labeler
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🩺 Clinical
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Supplement & herbal interactions
Some supplements/herbs that may interact with Ketoconazole — tap one for details:
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII NPU9M2E6L8
Methylcellulose is a plant-derived thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and a viscosity builder in liquid formulations.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
4 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.9407 | $9.41 / 10 tablets |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Ketoconazole 200 mg 35573-0433-02 | Burel | 100 tablets | $0.648 | AB | Availability likely | — |
| Ketoconazole 200 mg 64380-0827-06 | Strides | 100 tablets | $0.648 | AB | Availability likely | — |
| Ketoconazole 200 mg 69292-0224-01 | Amici | 100 tablets | $0.648 | AB | Availability likely | — |
| Ketoconazole 200 mg 50090-6142-01 | A-S | 7 tablets | — | AB | FDA listed | — |
| Ketoconazole 200 mg 51672-4026-00 | Sun | 100 tablets | — | AB | FDA listed | — |
| Ketoconazole 200 mg 60429-0020-01 | Golden | 100 tablets | — | AB | FDA listed | — |
| Ketoconazole 200 mg 70685-0001-01 | Esjay | 30 tablets | — | AB | Discontinued | — |
| Ketoconazole 200 mg 71335-0439-01 | Bryant | 10 tablets | — | AB | FDA listed | — |
| Ketoconazole 200 mgthis 71335-1849-01 | Bryant | 10 tablets | — | AB | FDA listed | — |
| Ketoconazole 200 mg 72189-0180-07 | Direct | 7 tablets | — | AB | FDA listed | — |
| Ketoconazole 200 mg 72189-0428-07 | Direct_Rx | 7 tablets | — | AB | FDA listed | — |
| Ketoconazole 200 mg 72789-0052-30 | PD-Rx | 30 tablets | — | AB | FDA listed | — |
| Ketoconazole 200 mg 87564-0051-10 | Amerisyn | 100 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 71335-1849-01 You're viewing this | 10 TABLET in 1 BOTTLE (71335-1849-1) | 2021-12-21 | Active |
| 71335-1849-02 | 30 TABLET in 1 BOTTLE (71335-1849-2) | 2021-12-21 | Active |
| 71335-1849-03 | 40 TABLET in 1 BOTTLE (71335-1849-3) | 2021-12-21 | Active |
| 71335-1849-04 | 60 TABLET in 1 BOTTLE (71335-1849-4) | 2021-12-21 | Active |
| 71335-1849-05 | 8 TABLET in 1 BOTTLE (71335-1849-5) | 2021-12-21 | Active |
| 71335-1849-06 | 7 TABLET in 1 BOTTLE (71335-1849-6) | 2021-12-21 | Active |
| 71335-1849-07 | 14 TABLET in 1 BOTTLE (71335-1849-7) | 2021-12-21 | Active |
| 71335-1849-08 | 90 TABLET in 1 BOTTLE (71335-1849-8) | 2021-12-21 | Active |
You're viewing one of 8 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 71335-1849-01?
What is the difference between NDC 71335-1849-01 and NDC 71335-1849-06?
What NDC number is used to bill for this package of KETOCONAZOLE 200 mg Tablet?
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING Because ketoconazole tablets have been associated with serious adverse reactions (see WARNINGS section), ketoconazole tablets are not indicated for treatment of onychomycosis, cutaneous dermatophyte infections, or Candida infections. Ketoconazole tablets should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweigh the potential risks. Hepatotoxicity Serious hepatotoxicity, including cases with a fatal outcome or requiring liver transplantation has occurred with the use of oral ketoconazole.
Some patients had no obvious risk factors for liver disease. Patients receiving this drug should be informed by the physician of the risk and should be closely monitored. See WARNINGS section.
QT Prolongation and Drug Interactions Leading to QT Prolongation Co-administration of the following drugs with ketoconazole is contraindicated: dofetilide, quinidine, pimozide, cisapride, methadone, disopyramide, dronedarone, ranolazine. Ketoconazole can cause elevated plasma concentrations of these drugs and may prolong QT intervals, sometimes resulting in life-threatening ventricular dysrhythmias such as torsades de pointes. See CONTRAINDICATIONS , WARNINGS , and PRECAUTIONS: DRUG INTERACTIONS sections.
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Ketoconazole tablets are not indicated for treatment of onychomycosis, cutaneous dermatophyte infections, or Candida infections. Ketoconazole tablets should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweigh the potential risks. Ketoconazole tablets are indicated for the treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis.
Ketoconazole tablets should not be used for fungal meningitis because it penetrates poorly into the cerebrospinal fluid.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION There should be laboratory as well as clinical documentation of infection prior to starting ketoconazole therapy. The usual duration of therapy for systemic infection is 6 months. Treatment should be continued until active fungal infection has subsided.
Adults The recommended starting dose of ketoconazole tablets is a single daily administration of 200 mg (one tablet). If clinical responsiveness is insufficient within the expected time, the dose of ketoconazole tablets may be increased to 400 mg (two tablets) once daily. Children In small numbers of children over 2 years of age, a single daily dose of 3.3 to 6.6 mg/kg has been used.
Ketoconazole tablets have not been studied in children under 2 years of age.
⛔ Contraindications ▾
CONTRAINDICATIONS Drug Interactions Coadministration of a number of CYP3A4 substrates such as dofetilide, quinidine cisapride and pimozide is contraindicated with ketoconazole tablets. Coadministration with ketoconazole can cause elevated plasma concentrations of these drugs and may increase or prolong both therapeutic and adverse effects to such an extent that a potentially serious adverse reaction may occur. For example, increased plasma concentrations of some of these drugs can lead to QT prolongation and sometimes resulting in life-threatening ventricular tachyarrhythmias including occurrences of torsades de pointes, a potentially fatal arrhythmia.
(See PRECAUTIONS: DRUG INTERACTIONS .) Additionally, the following other drugs are contraindicated with ketoconazole tablets: methadone, disopyramide, dronedarone, ergot alkaloids such as dihydroergotamine, ergometrine, ergotamine, methylergometrine, irinotecan, lurasidone, oral midazolam, alprazolam, triazolam, felodipine, nisoldipine, ranolazine, tolvaptan, eplerenone, lovastatin, simvastatin and colchicine. (See PRECAUTIONS: DRUG INTERACTIONS .) Enhanced Sedation Coadministration of ketoconazole tablets with oral midazolam, oral triazolam or alprazolam has resulted in elevated plasma concentrations of these drugs.
This may potentiate and prolong hypnotic and sedative effects, especially with repeated dosing or chronic administration of these agents. Concomitant administration of ketoconazole tablets with oral triazolam, oral midazolam or alprazolam is contraindicated. (See PRECAUTIONS: DRUG INTERACTIONS .) Myopathy Coadministration of CYP3A4 metabolized HMG-CoA reductase inhibitors such as simvastatin, and lovastatin is contraindicated with ketoconazole tablets.
(See PRECAUTIONS: DRUG INTERACTIONS .) Ergotism Concomitant administration of ergot alkaloids such as dihydroergotamine and ergotamine with ketoconazole tablets is contraindicated. (See PRECAUTIONS: DRUG INTERACTIONS .) Liver Disease The use of ketoconazole tablets is contraindicated in patients with acute or chronic liver disease. Hypersensitivity Ketoconazole tablets USP, 200 mg is contraindicated in patients who have shown hypersensitivity to the drug.
⚠️ Warnings ▾
WARNINGS Because of the serious adverse reactions that have been reported in association with ketoconazole, including fatal hepatotoxicity, ketoconazole tablets are not indicated for treatment of onychomycosis, cutaneous dermatophyte infections, or Candida infections. Ketoconazole tablets should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweigh the potential risks. Hepatotoxicity Serious hepatotoxicity, including cases with a fatal outcome or requiring liver transplantation, has occurred with the use of oral ketoconazole.
Some patients had no obvious risk factors for liver disease. Serious hepatotoxicity was reported both by patients receiving high doses for short treatment durations and by patients receiving low doses for long durations. The hepatic injury has usually, but not always, been reversible upon discontinuation of ketoconazole treatment.
Cases of hepatitis have been reported in children. At baseline, obtain laboratory tests (such as SGGT, alkaline phosphatase, ALT, AST, total bilirubin (TBL), Prothrombin Time (PT), International Normalization Ratio (INR), and testing for viral hepatitides). Patients should be advised against alcohol consumption while on treatment.
If possible, use of other potentially hepatotoxic drugs should be avoided in patients receiving ketoconazole tablets. Prompt recognition of liver injury is essential. During the course of treatment, serum ALT should be monitored weekly for the duration of treatment.
If ALT values increase to a level above the upper limit of normal or 30 percent above baseline, or if the patient develops symptoms, ketoconazole treatment should be interrupted and a full set of liver tests should be obtained. Liver tests should be repeated to ensure normalization of values. Hepatotoxicity has been reported with restarting oral ketoconazole (rechallenge).
If it is decided to restart oral ketoconazole, monitor the patient frequently to detect any recurring liver injury from the drug. QT Prolongation and Drug Interactions Leading to QT Prolongation Ketoconazole can prolong the QT interval. Co-administration of the following drugs with ketoconazole is contraindicated: dofetilide, quinidine, pimozide, cisapride, methadone, disopyramide, dronedarone, ranolazine.
Ketoconazole can cause elevated plasma concentrations of these drugs which may prolong the QT interval, sometimes resulting in life-threatening ventricular dysrhythmias such as torsades de pointes. Adrenal Insufficiency Ketoconazole tablets decrease adrenal corticosteroid secretion at doses of 400 mg and higher. This effect is not shared with other azoles.
The recommended dose of 200 mg to 400 mg daily should not be exceeded. Adrenal function should be monitored in patients with adrenal insufficiency or with borderline adrenal function and in patients under prolonged periods of stress (major surgery, intensive care, etc.). Adverse Reactions Associated with Unapproved Uses Ketoconazole has been used in high doses for the treatment of advanced prostate cancer and for Cushing's syndrome when other treatment options have failed.
The safety and effectiveness of ketoconazole have not been established in these settings and the use of ketoconazole for these indications is not approved by FDA. In a clinical trial involving 350 patients with metastatic prostatic cancer, eleven deaths were reported within two weeks of starting treatment with high doses of ketoconazole tablets (1200 mg/day). It is not possible to ascertain from the information available whether death was related to ketoconazole therapy or adrenal insufficiency in these patients with serious underlying disease.
Hepatoxicity, including fatal cases and cases requiring liver transplantation, have been reported in patients who received ketoconazole for treatment of onychomycosis, cutaneous dermatophyte infections, or Candida infections. Hypersensitivity Anaphylaxis has been reported after…
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following adverse reactions were reported in clinical trials: Immune System Disorders: anaphylactoid reaction Endocrine Disorders: gynecomastia Metabolism and Nutrition Disorders: alcohol intolerance, anorexia, hyperlipidemia, increased appetite Psychiatric Disorders: insomnia, nervousness Nervous System Disorders: headache, dizziness, paresthesia, somnolence Eye Disorders: photophobia Vascular Disorders: orthostatic hypotension Respiratory, Thoracic and Mediastinal Disorders: epistaxis Gastrointestinal Disorders: vomiting, diarrhea, nausea, constipation, abdominal pain, abdominal pain upper, dry mouth, dysgeusia, dyspepsia, flatulence, tongue discoloration Hepatobiliary Disorders: hepatitis, jaundice, hepatic function abnormal Skin and Subcutaneous Tissues Disorders: erythema multiforme, rash, dermatitis, erythema, urticaria, pruritus, alopecia, xeroderma Musculoskeletal and Connective Tissue Disorders: myalgia Reproductive System and Breast Disorders: menstrual disorder General Disorders and Administration Site Conditions: asthenia, fatigue, hot flush, malaise, edema peripheral, pyrexia, chills Investigations: platelet count decreased.
Post-Marketing Experience The following adverse reactions have been identified during postapproval use of ketoconazole tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions were reported during post-marketing experience: Blood and Lymphatic System Disorders: thrombocytopenia Immune System Disorders: allergic conditions including anaphylactic shock, anaphylactic reaction, angioneurotic edema Endocrine Disorders: adrenocortical insufficiency Nervous System Disorders: reversible intracranial pressure increased (e.g. papilloedema, fontanelle bulging in infants) Hepatobiliary Disorders: serious hepatotoxicity including hepatitis cholestatic, biopsy-confirmed hepatic necrosis, cirrhosis, hepatic failure including cases resulting in transplantation or death Skin and Subcutaneous Tissue Disorders: acute generalized exanthematous pustulosis, photosensitivity Musculoskeletal and Connective Tissue Disorders: arthralgia Reproductive System and Breast Disorders: erectile dysfunction; with doses higher than the recommended therapeutic dose of 200 or 400mg daily, azoospermia.
🔄 Drug Interactions ▾
Drug Interactions Coadministration of a number of CYP3A4 substrates such as dofetilide, quinidine cisapride and pimozide is contraindicated with ketoconazole tablets. Coadministration with ketoconazole can cause elevated plasma concentrations of these drugs and may increase or prolong both therapeutic and adverse effects to such an extent that a potentially serious adverse reaction may occur. For example, increased plasma concentrations of some of these drugs can lead to QT prolongation and sometimes resulting in life-threatening ventricular tachyarrhythmias including occurrences of torsades de pointes, a potentially fatal arrhythmia.
(See PRECAUTIONS: DRUG INTERACTIONS .) Additionally, the following other drugs are contraindicated with ketoconazole tablets: methadone, disopyramide, dronedarone, ergot alkaloids such as dihydroergotamine, ergometrine, ergotamine, methylergometrine, irinotecan, lurasidone, oral midazolam, alprazolam, triazolam, felodipine, nisoldipine, ranolazine, tolvaptan, eplerenone, lovastatin, simvastatin and colchicine. (See PRECAUTIONS: DRUG INTERACTIONS .) Enhanced Sedation Coadministration of ketoconazole tablets with oral midazolam, oral triazolam or alprazolam has resulted in elevated plasma concentrations of these drugs.
This may potentiate and prolong hypnotic and sedative effects, especially with repeated dosing or chronic administration of these agents. Concomitant administration of ketoconazole tablets with oral triazolam, oral midazolam or alprazolam is contraindicated. (See PRECAUTIONS: DRUG INTERACTIONS .) Myopathy Coadministration of CYP3A4 metabolized HMG-CoA reductase inhibitors such as simvastatin, and lovastatin is contraindicated with ketoconazole tablets.
(See PRECAUTIONS: DRUG INTERACTIONS .) Ergotism Concomitant administration of ergot alkaloids such as dihydroergotamine and ergotamine with ketoconazole tablets is contraindicated. (See PRECAUTIONS: DRUG INTERACTIONS .) Liver Disease The use of ketoconazole tablets is contraindicated in patients with acute or chronic liver disease. Hypersensitivity Ketoconazole tablets USP, 200 mg is contraindicated in patients who have shown hypersensitivity to the drug.
🆘 Overdosage ▾
OVERDOSAGE In the event of acute accidental overdose, treatment consists of supportive and symptomatic measures. Within the first hour after ingestion, activated charcoal may be administered.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Pharmacokinetics Absorption Ketoconazole is a weak dibasic agent and thus requires acidity for dissolution and absorption. Mean peak plasma concentrations of approximately 3.5 mcg/mL are reached within 1 to 2 hours, following oral administration of a single 200 mg dose taken with a meal. Oral bioavailability is maximal when the tablets are taken with a meal.
Absorption of ketoconazole tablets is reduced in subjects with reduced gastric acidity, such as subjects taking medications known as acid neutralizing medicines (e.g. aluminum hydroxide) and gastric acid secretion suppressors (e.g. H2-receptor antagonists, proton pump inhibitors) or subjects with achlorhydria caused by certain diseases. (See Section PRECAUTIONS: DRUG INTERACTIONS .) Absorption of ketoconazole under fasted conditions in these subjects is increased when ketoconazole tablets are administered with an acidic beverage (such as non-diet cola).
After pretreatment with omeprazole, a proton pump inhibitor, the bioavailability of a single 200 mg dose of ketoconazole under fasted conditions was decreased to 17% of the bioavailability of ketoconazole administered alone. When ketoconazole was administered with non-diet cola after pretreatment with omeprazole, the bioavailability was 65% of that after administration of ketoconazole alone. Distribution In vitro, the plasma protein binding is about 99% mainly to the albumin fraction.
Ketoconazole is widely distributed into tissues; however, only a negligible proportion reaches the cerebrospinal fluid. Metabolism Following absorption from the gastrointestinal tract, ketoconazole tablets are converted into several inactive metabolites. In vitro studies have shown that CYP3A4 is the major enzyme involved in the metabolism of ketoconazole.
The major identified metabolic pathways are oxidation and degradation of the imidazole and piperazine rings, by hepatic microsomal enzymes. In addition, oxidative O-dealkylation and aromatic hydroxylation does occur. Ketoconazole has not been demonstrated to induce its own metabolism.
Elimination Elimination from plasma is biphasic with a half-life of 2 hours during the first 10 hours and 8 hours thereafter. Approximately 13% of the dose is excreted in the urine, of which 2 to 4% is unchanged drug. The major route of excretion is through the bile into the intestinal tract with about 57% being excreted in the feces.
Special Populations Patients with Hepatic or Renal Impairment In patients with hepatic or renal impairment, the overall pharmacokinetics of ketoconazole was not significantly different when compared with healthy subjects. Pediatric Patients Limited pharmacokinetic data are available on the use of ketoconazole tablets in the pediatric population. Measurable ketoconazole plasma concentrations have been observed in pre-term infants (single or daily doses of 3 to 10 mg/kg) and in pediatric patients 5 months of age and older (daily doses of 3 to 13 mg/kg) when the drug was administered as a suspension, tablet or crushed tablet.
Limited data suggest that absorption may be greater when the drug is administered as a suspension compared to a crushed tablet. Conditions that raise gastric pH may lower or prevent absorption (See Section PRECAUTIONS: DRUG INTERACTIONS ). Maximum plasma concentrations occurred 1 to 2 hours after dosing and were in the same general range as those seen in adults who received a 200 to 400 mg dose.
Electrocardiogram Pre-clinical electrophysiological studies have shown that ketoconazole inhibits the rapidly activating component of the cardiac delayed rectifier potassium current, prolongs the action potential duration, and may prolong the QT c interval. Data from some clinical PK/PD studies and drug interaction studies suggest that oral dosing with ketoconazole at 200 mg twice daily for 3 to 7 days can result in an increase of the QT c interval: a mean maximum increase of about 6 to 12 msec was seen at ketoconazole peak plasma concentrations abo…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Ketoconazole tablets USP, 200 mg are white to off-white, round, flat faced bevel edge, scored tablets, debossed "A" over "35" on one side and plain with bisect on the other side. NDC: 71335-1849-1: 10 Tablets in a BOTTLE NDC: 71335-1849-2: 30 Tablets in a BOTTLE NDC: 71335-1849-3: 40 Tablets in a BOTTLE NDC: 71335-1849-4: 60 Tablets in a BOTTLE NDC: 71335-1849-5: 8 Tablets in a BOTTLE NDC: 71335-1849-6: 7 Tablets in a BOTTLE NDC: 71335-1849-7: 14 Tablets in a BOTTLE NDC: 71335-1849-8: 90 Tablets in a BOTTLE Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP. Keep out of reach of children. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc.
Burbank, CA 91504
📋 Description ▾
DESCRIPTION Ketoconazole tablets USP is a synthetic broad-spectrum antifungal agent available in scored white tablets, each containing 200 mg ketoconazole base for oral administration. Inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and methylcellulose. Ketoconazole is cis-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl] methoxyl]phenyl] piperazine and has the following structural formula: Ketoconazole is a white to slightly beige, odorless powder, soluble in acids, with a molecular weight of 531.44g/mol.
FDA approved dissolution test specifications differ from USP.
💬 Medication Guide ▾
MEDICATION GUIDE Ketoconazole (KEE-toe-KON-a-zole) Tablets USP, 200 mg What is the most important information I should know about ketoconazole tablets USP? Ketoconazole tablets is not the only medicine available to treat fungal infections and should only be used when other medicines are not right for you. Talk to your healthcare provider to find out if ketoconazole tablets are right for you.
Ketoconazole tablets USP can cause serious side effects, including: liver problems (hepatotoxicity). Some people who were treated with ketoconazole the active ingredient in ketoconazole tablets, had serious liver problems that led to death or the need for a liver transplant. Call your healthcare provider right away if you have any of the following symptoms: loss of appetite or start losing weight (anorexia) nausea or vomiting feel tired stomach pain or tenderness dark urine or light colored stools yellowing of your skin or the whites of your eyes fever or rash changes in the electrical activity of your heart called QT prolongation.
QT prolongation can cause irregular heart beats that can be life threatening. This can happen when ketoconazole tablets are taken with certain medicines, such as dofetilide, quinidine, pimozide, cisapride, methadone, disopyramide, dronedarone, and ranolazine. Talk to your healthcare provider about other medicines you are taking before you start taking ketoconazole tablets.
Tell your healthcare provider right away if you feel faint, lightheaded, dizzy, or feel your heart beating irregularly or fast. These may be symptoms related to QT prolongation. What are ketoconazole tablets USP?
Ketoconazole tablets are prescription medicine used to treat serious fungal infections including: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. Ketoconazole tablets are not for people with fungal nail infections. Ketoconazole tablets have not been approved for the treatment of advanced prostate cancer or Cushing's syndrome.
The safety and efficacy have not been established. Ketoconazole tablets should only be used in children if prescribed by the healthcare provider who has determined that the benefits outweigh the risks. Who should not take ketoconazole tablets USP?
Do not take ketoconazole tablets if you: have liver problems take simvastatin, and lovastatin. Ketoconazole tablets when taken with these medicines may cause muscle problems. take eplerenone, dihydroergotamine, ergotamine, ergometrine (ergonovine), methylergometrine (methylergonovine) or nisoldipine. take triazolam, midazolam, or alprazolam. Taking ketoconazole tablets with these medicines may make you very drowsy and make your drowsiness last longer. are allergic to ketoconazole or any of the ingredients in ketoconazole tablets.
See the end of this Medication Guide for a complete list of ingredients in ketoconazole tablets. Before you take ketoconazole tablets USP, tell your healthcare provider if you: have had an abnormal heart rhythm tracing (ECG) or anyone in your family have or have had a heart problem called "congenital long QT syndrome". have adrenal insufficiency. are pregnant or plan to become pregnant. It is not known if ketoconazole tablets will harm your unborn baby. are breastfeeding or plan to breastfeed.
Ketoconazole tablets can pass into your breast milk. You and your healthcare provider should decide if you will take ketoconazole tablets or breastfeed. You should NOT do both.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using ketoconazole tablets with certain other medicines may affect each other. Using ketoconazole tablets with other medicines can cause serious side effects.
How should I take ketoconazole tablets USP? Take ketoconazole tablets 1 time each day. Do not stop taking ketoconazole tablets without first talking to your healthcare provider.
What should I avoid while taking ketoconazole tablet…