What happens if I overdose Fungoral?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately. Fungoral shampoo may be harmful if swallowed.
Proper storage of Fungoral shampoo:
Store Fungoral shampoo at room temperature, below 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Fungoral shampoo out of the reach of children and away from pets.
Overdose of Fungoral in details
Treatment: There has been no experience of overdosage with Fungoral cream.
To Avoid Aspiration: Gastric lavage or induced emesis should not be performed. It has been reported that Fungoral cannot be removed by hemodialysis.
Specific Treatment: Use general supportive measures and appropriate routine overdose management.
Supportive Care: Patients in whom intentional overdose is confirmed or suspected should be referred for psychiatric consultation.
What should I avoid while taking Fungoral?
Avoid taking antacids or stomach acid reducers (Tagamet, Pepcid, Axid, Zantac, and others) for at least 2 hours after you have taken your dose of Fungoral. These medications can make it harder for the Fungoral tablet to dissolve in your stomach.
Avoid drinking alcohol. It may cause unpleasant side effects while you are taking Fungoral.
Fungoral warnings
Fungoral® 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 Fungoral. 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 Fungoral® Tablets 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 Fungoral® 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, Fungoral 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 Fungoral (rechallenge). If it is decided to restart oral Fungoral, monitor the patient frequently to detect any recurring liver injury from the drug.
QT Prolongation and Drug Interactions Leading to QT Prolongation
Fungoral can prolong the QT interval. Co-administration of the following drugs with Fungoral is contraindicated: dofetilide, quinidine, pimozide, and cisapride. Fungoral 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
Fungoral® 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 - 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
Fungoral 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 Fungoral have not been established in these settings and the use of Fungoral 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 Fungoral tablets (1200 mg/day). It is not possible to ascertain from the information available whether death was related to Fungoral therapy or adrenal insufficiency in these patients with serious underlying disease.
Hypersensitivity
Anaphylaxis has been reported after the first dose. Several cases of hypersensitivity reactions including urticaria have also been reported.
Enhanced Sedation
Co-administration of Fungoral® 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 Fungoral® Tablets with oral triazolam, oral midazolam, or alprazolam is contraindicated.
Myopathy
Co-administration of CYP3A4 metabolized HMG-CoA reductase inhibitors such as simvastatin, and lovastatin is contraindicated with Fungoral® Tablets.
What should I discuss with my healthcare provider before taking Fungoral?
You should not use Fungoral if you are allergic to Fungoral, or if you have liver disease.
Some medicines can interact with Fungoral and should not be used at the same time. Certain drug interactions can cause life-threatening irregular heartbeats. Your doctor may need to change your treatment plan if you use any of the following drugs:
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alprazolam, midazolam, or triazolam;
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cisapride or pimozide;
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dihydroergotamine or ergotamine;
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disopyramide, dofetilide, dronedarone, eplerenone, nisoldipine, quinidine, or ranolazine;
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lovastatin or simvastatin; or
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methadone.
To make sure Fungoral is safe for you, tell your doctor if you have:
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any history of liver problems;
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problems with your adrenal gland;
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personal or family history of long QT syndrome; or
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if you also use certain antibiotics, heart rhythm medication, migraine headache medicine, anti-malaria medication, or medicine to treat depression or mental illness.
It is not known whether Fungoral will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.
Fungoral can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.
Do not give this medicine to a child without medical advice.
Fungoral precautions
Severe hypersensitivity reactions, including anaphylaxis, have been reported during post-marketing use of Fungoral Shampoo, 2%. If a reaction suggesting sensitivity or chemical irritation should occur, use of the medication should be discontinued.
Information for Patients
Patients should be advised of the following:
- Fungoral Shampoo, 2% may be irritating to mucous membranes of the eyes and contact with this area should be avoided.
- The following have been reported with the use of Fungoral Shampoo, 2%: hair discoloration and abnormal hair texture, removal of the curl from permanently waved hair, itching, skin burning sensation and contact dermatitis, hypersensitivity, angioedema, alopecia, rash, urticaria, skin irritation, dry skin, and application site reactions.
- Patients who develop allergic reactions, such as generalized rash, skin reactions, severe swelling, angioedema, or shortness of breath should discontinue Fungoral Shampoo, 2% and contact their physician immediately.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies to assess the carcinogenic potential of Fungoral Shampoo, 2% have not been conducted. A long-term feeding study of Fungoral in Swiss Albino mice and in Wistar rats showed no evidence of oncogenic activity. The dominant lethal mutation test in male and female mice revealed that single oral doses of Fungoral as high as 80 mg/kg were not genotoxic. The Ames Salmonella microsomal activator assay was also negative.
Pregnancy
Teratogenic EffectsPregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Fungoral should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In humans, Fungoral is not detected in plasma after chronic shampooing on the scalp.
Fungoral has been shown to be teratogenic (syndactylia and oligodactylia) in the rat when given orally in the diet at 80 mg/kg/day (a dose 10 times the maximum recommended human oral dose). However, these effects may be related to maternal toxicity, which was seen at this and higher dose levels.
Nursing Mothers
There are no adequate and well-controlled studies in nursing women. Fungoral is not detected in plasma after chronic shampooing on the scalp. Caution should be exercised when Fungoral Shampoo, 2%, is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in children have not been established.
What happens if I miss a dose of Fungoral?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.
References
- DailyMed. "KETOCONAZOLE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DrugBank. "ketoconazole". http://www.drugbank.ca/drugs/DB01026 (accessed September 17, 2018).
- MeSH. "14-alpha Demethylase Inhibitors". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
