Hyphoral 200mg (Ketoconazole)

Hyphoral general information

What is Hyphoral used for?

Hyphoral tablets 200mg are used to treat severe systemic fungal infections only in patients who cannot tolerate other treatments or where other treatments have failed and where the potential benefits are considered to outweigh the potential risks.  Hyphoral tablets 200mg are used for systemic fungal infections caused by inhalation of the spores of a soil fungus that can affect internal organs and cause influenza-like illness with fever, cough, headaches, skin rash, and myalgia (muscle pain), such as coccidioidomycosis caused by Coccidioides immitis, Blastomycosis, caused by Blastomyces dermatitidis and histoplasmosis caused by Histoplasma capsulatum.  Serious symptoms can develop including chronic lung infection and widespread infection reaching the bones, skin and urinogenital tract.  Hyphoral 200 is also used to treat chromomycosis, caused by penetration of the skin by a thorn or splinter and infection by several different fungal species that spread slowly through the skin.  Hyphoral tablets 200mg should not be used to treat fungal meningitis as the medication cannot penetrate into the nervous system. 

How does Hyphoral work?

Hyphoral tablets 200mg contain ketoconazole, a synthetic broad-spectrum antifungal agent that specifically kills the fungus by inhibiting the synthesis of ergosterol, an important component of fungal cell membrane that is not found in animal cells.  Ketoconazole in Hyphoral tablets 200mg weakens the fungal cell membrane, causing the cell contents to leak out which kills the fungus, preventing the infection from spreading and relieving symptoms caused by the fungal infection, including pain and inflammation.

What does Hyphoral contain?

Hyphoral tablets 200mg contain the active ingredient ketoconazole, a synthetic broad-spectrum antifungal used to treat severe systemic fungal infections.

Treating systemic fungal infection with Hyphoral

Hyphoral tablets 200mg contain ketoconazole, a synthetic broad-spectrum antifungal agent that is used to treat severe systemic fungal infections in patients who cannot tolerate other treatments or where other treatments have failed and where the potential benefits are considered to outweigh the potential risks.  These infections include coccidioidomycosis, histoplasmosis and blastomycosis, which are all caused by inhalation of spores produced by soil fungi.  Symptoms usually include influenza-like illness with fever, cough, headaches, skin rash, and myalgia (muscle pain), however, these infections can be difficult to treat and can affect internal organs causing serious symptoms including chronic lung infection and widespread infection reaching the bones, skin and urinogenital tract.  Ketoconazole in Hyphoral tablets 200mg inhibits the synthesis of ergosterol, an important component of fungal cell membrane that is not found in animal cells, which weakens the fungal cell membrane, causing the cell contents to leak out which kills the fungus, preventing the infection from spreading. 

What are the side effects of Hyphoral?

The most commonly reported side effects when taking Hyphoral include: upset stomach, stomach cramps, nausea and vomiting, diarrhoea or constipation, headache, rash, dizziness, tingling sensations, sensitivity to light, erectile dysfunction, swelling of the breast.

What are the risks of using of Hyphoral?

Ketoconazole in Hyphoral tablets 200mg can cause serious liver toxicity and can result in the need for liver transplant or be fatal.  Liver function should therefore be checked before and during treatment with Hyphoral tablets 200mg.  Symptoms of liver toxicity include: nausea, vomiting feel tired, stomach pain or tenderness, weight loss, or loss of appetite, dark urine or light coloured stools, yellowing of the skin or the whites of the eyes, fever or rash.  Ketoconazole in Hyphoral tablets 200mg can also cause QT prolongation due to changes in the electrical activity of the heart, which can cause irregular heart beat and can be life threatening

When should Hyphoral not be used?

You should not use Hyphoral tablets 200mg if you:

• are allergic to ketoconazole or any ingredients in Hyphoral
• are pregnant or are breastfeeding
• have liver disease or are recovering from hepatitis as there is a risk of serious liver damage
• have adrenal insufficiency
• 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
• drink alcohol, as this may make you feel sick or cause headache in combination with ketoconazole
• are taking medicines that interact with Hyphoral, including terfenadine, mizolastine or astemizole for allergy, halofantrine for treating malaria, cisapride for reflux, statins for cholesterol lowering (simvastatin, atrovastatin lovastatin) pimozide for mental disorders, calcium channel blockers (bepridil, epleronone, nisoldipine) for angina and high blood pressure, medicines containing ergot alkaloids such as ergotamine, antiarrhythmic drugs for irregular heat beats (quinidine, disopyramide and dofetilide), irinotecan for cancer chemotherapy

What medications interact with Hyphoral?

Several medications interact with Hyphoral tablets 200mg and should either not be taken while you are taking Hyphoral or only after discussion and instruction from your doctor:

• Drugs that cause muscle problems with Hyphoral: the cholesterol lowering statins simvastatin, atrovastatin and lovastatin.
• Drugs that prolong the QT interval with with Hyphoral: pimozide for mental disorders, cisapride for reflux, methadone, the antiarrhythmics disopyramide, dofetilide, dronedarone, and ranolazine, medicines containing ergot alkaloids such as ergotamine
• Drugs that affect Hyphoral: ritonavir for HIV, anticonvulsants like phenytoin and carbamazepine, anti-infectives like rifampicin, nevirapine, isoniazid and rifabutin
• Drugs that are affected by Hyphoral: triazolam, midazolam, or alprazolam, halofantrine for treating malaria, terfenadine, mizolastine or astemizole for allergy, calcium channel blockers (bepridil, epleronone, nisoldipine) for angina and high blood pressure, irinotecan for cancer chemotherapy

How should Hyphoral be taken?

You should take your Hyphoral tablets 200mg swallowed whole with a glass of water and with food once a day.  You should continue to take your Hyphoral tablets 200mg for 5-10 days or up to several months, depending on what you are being treated for and your doctor’s recommendations.  Always finish your course of tablets even if you feel better, if not, the infection may not clear up completely.  Do not take medicines that neutralise stomach acid within 2 hours of taking Hyphoral 200mg tablets, as sufficient stomach acid is required for ketoconazole to be absorbed and do not drink any alcohol while taking Hyphoral tablets 200mg.

How long should you take Hyphoral?

You should continue to take your Hyphoral tablets 200mg for 5-10 days or up to several months, depending on what you are being treated for and your doctor’s recommendations. 

Missed dose of Hyphoral

If you miss a dose of Hyphoral tablets 200mg take it as soon as you remember, unless it is time to take the next dose, then skip the missed dose.  Do not take a double dose.

How should Hyphoral be stored?

You should store your Hyphoral tablets 200mg below 25°C in a cool dry place.