Patient Medication Information: uses, side effects, how to take - Mylan-Voriconazole
ABOUT THIS MEDICATION
What Mylan-Voriconazole is used for:
Mylan-Voriconazole is prescribed by your doctor to treat certain fungal infections, specifically Aspergillus or Candida infections.
What Mylan-Voriconazole does:
Mylan-Voriconazole works by killing or interfering with the growth of fungi which helps stop the infection.
When it should not be used:
- If you are allergic to voriconazole or any of the other ingredients of Mylan-Voriconazole (see below, under “What are the nonmedicinal ingredients”).
- If you are taking other medication that must not be taken with Mylan-Voriconazole (see listing under “Interactions with this medication”).
What is the medicinal ingredient of Mylan-Voriconazole and what dosage forms does it come in:
Voriconazole tablets, 50 mg and 200 mg
What are the nonmedicinal ingredients:
croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, povidone, pregelatinized starch, titanium dioxide and triacetin.
Mylan-Voriconazole has been prescribed for you. Do not allow anyone else to take it. This product should only be taken under the supervision of a doctor.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
|
For more information, see warnings below and “Side Effects and what to do about them” |
Take special care with Mylan-Voriconazole:
Before being treated with Mylan-Voriconazole, tell your doctor if:
- you have any of the following conditions: history of heart disease, or an irregular heart beat.
- you have had any drug allergies including allergic reactions to other azoles.
- you are suffering from, or have ever suffered from liver disease.
- you are suffering from, or have ever suffered from kidney disease.
- you are already being treated with certain medication (See ”Interactions with this medication” )
- you think you have galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, please check with your doctor before starting to take Mylan-Voriconazole tablets since they contain lactose monohydrate.
you are pregnant: Mylan-Voriconazole must not be taken during pregnancy, unless indicated by your doctor. Effective contraception must be used in women of child-bearing potential. Contact your doctor immediately if you become pregnant while taking Mylan-Voriconazole.
- you are breast-feeding: Mylan-Voriconazole must not be taken during breast feeding. Ask your doctor or pharmacist for advice before taking any medicine while breast feeding.
While being treated with Mylan-Voriconazole:
- tell your doctor immediately if you develop a severe skin rash or blisters.
- strong sunlight should be avoided while being treated with Mylan-Voriconazole. Tell your doctor if you develop an increased sensitivity of skin to the sun.
- your doctor may wish to monitor the function of your liver and kidney by doing blood tests.
INTERACTIONS WITH THIS MEDICATION
Taking other medicines with Mylan-Voriconazole:
It is very important that you inform your doctor or pharmacist if you are taking or have taken any other medicines, even those that are obtained without a prescription. Some medicines affect the way Mylan-Voriconazole works and dosage adjustments or monitoring may be necessary, such as for the following:
- Cyclosporine (a medicine used in transplant patients)
- Tacrolimus (a medicine used in transplant patients)
- Tricyclic antidepressants
- Antiarrhythmics (drugs that stabilize heart function such as procainamide, amiodarone, quinidine, sotalol)
- Antipsychotic drugs
- HIV protease inhibitors
- Macrolide antibiotics
- Methadone
- Oral contraceptives
- Short-acting opiates (e.g. alfentanil, sufentanil)
- Long-acting opiates (e.g. oxycodone, fentanyl)
- Some oral anticoagulants (e.g. warfarin, coumarin)
- Fluconazole (used for fungal infections)
- Everolimus (used for treating advanced kidney cancer and in transplant patients)
- Benzodiazepines (e.g. midazolam, triazolam, alprazolam)
- Calcium channel blockers (heart medications)
- Sulfonylureas (e.g. glyburide, glipizide)
Tell your doctor if you are taking non-steroidal anti- inflammatories (NSAIDS) (used for treating pain and inflammation) including ibuprofen and diclofenac, as the NSAID dose may have to be adjusted.
The following list of medicines must not be taken during your course of Mylan-Voriconazole treatment:
- Terfenadine+ (a medicine for allergy)
- Astemizole+ (a medicine for allergy)
- Cisapride+ (a medicine for stomach problems)
- Pimozide (a medicine for treating mental illness)
- Quinidine (a medicine for irregular heart beat)
- Rifampin (a medicine for treating tuberculosis)
- Carbamazepine (a medicine used to treat seizures)
- Long acting barbiturates (medicines for severe insomnia and seizures) such as phenobarbital
- Sirolimus (used in transplant patients)
- Rifabutin (a medicine for fungal infections)
- Ergot Alkaloids: ergotamine and dihydroergotamine (a medicine for migraines)
- Ritonavir (doses of 400 mg twice daily or higher) and efavirenz (doses of 400 mg once daily or higher) (medicines for the treatment of HIV)
- St John’s Wort (Hypericum perforatum)
+ Not marketed in Canada
PROPER USE OF THIS MEDICATION
Usual Adult dose:
Your doctor will determine your dose depending on your weight and the type of infection (or suspected infection) you have.
Always take Mylan-Voriconazole exactly as directed by your doctor. You should check with your doctor or pharmacist if you are unsure. Never change the dose yourself.
Your doctor will prescribe a higher dose of Mylan-Voriconazole on your first day of treatment to more quickly obtain an effective blood level of the antibiotic in your body.
| Infection | First 24 hours (2 doses 12 hours apart) | After the first 24 hours | |||||
| 40 kg or more | Less than 40 kg | 40 kg or more | Less than 40 kg | ||||
| Aspergillus | 400 mg | 200 mg | 200 mg twice a day | 100 mg twice a day | |||
| Candida | 400 mg | ||||||
It has been shown that taking all doses at the appropriate times may greatly increase the effectiveness of your medicine.
Mylan-Voriconazole tablets must be taken at least one hour before or two hours after a meal. Swallow the tablet whole with some water.
If you have liver disease, your doctor may prescribe a lower dose of Mylan-Voriconazole.
Your doctor may order periodic blood tests to monitor your liver function during Mylan-Voriconazole treatment.
Continue taking Mylan-Voriconazole until your doctor tells you to stop. Do not stop treatment early because your infection may not be cured. Patients with a weakened immune system or those with difficult infections may require long term treatment to prevent the infection from returning.
Overdose:
| If you think you have taken too much Mylan-Voriconazole, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. |
Take your bottle of Mylan-Voriconazole tablets with you.
Missed Dose:
If you miss taking a dose of Mylan-Voriconazole, just take the next dose when it is due. Do not take a double dose to make up for the forgotten dose.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medicines, Mylan-Voriconazole can have side effects. If any side effects occur, most are likely to be minor and temporary. However, some may be serious and need medical attention.
The most commonly reported side effects are visual disturbances (blurring of vision, reduced vision, colour vision change and increased sensitivity to light), fever, rash, nausea, vomiting, diarrhea, headache, swelling of the extremities and stomach pains.
Other reported side effects include: changes in heart rate or rhythm, changes in blood pressure, blood cell changes, blood chemistry changes, dizziness, itchiness, weakness, back pain, chest pain, flu-like symptoms, facial swelling, hallucinations and other nervous symptoms, tingling, cough, breathing difficulty, hair loss, pain and irritation of the eyes, joint pain.
The following side effects have also been reported with the use of Mylan-Voriconazole: peripheral neuropathy (nerve damage) with symptoms such as a burning pain, tingling, numbness, sensitivity to touch and weakness, and hyponatremia (low levels of sodium in the blood) with symptoms such as nausea, vomiting, confusion, weakness, fatigue, cramps, decreased consciousness and seizures.
Check with your doctor immediately if chills, fever, flushing, sweating, muscle aches or pains, or other fIu-like symptoms occur, especially if they occur shortly before, or together with a skin rash. Also, contact your doctor in case of a fast heartbeat, chest tightness or faintness. Very rarely, these effects may be the first signs of a serious reaction to this medication.
Contact your doctor if you suffer persistent abdominal pain and tenderness or vomiting as this may be a sign of a serious condition (pancreatitis).
If you develop bone pain during treatment, contact your doctor.
Driving and using machines
Mylan-Voriconazole may cause changes to vision, including blurring and/or photophobia (sensitivity to light). The majority of visual symptoms appeared to spontaneously resolve within 60 minutes. While being treated with Mylan-Voriconazole you must avoid potentially hazardous tasks, such as driving or operating machinery if you perceive any change in vision. You should not drive at night while taking Mylan-Voriconazole.
If any of these side effects persist or are troublesome, please tell your doctor.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and seek immediate emergency medical attention | ||||
| Only if severe | In all cases | |||||
| Uncommon | Heart Failure | √ | ||||
| Irregular heartbeat | √ | |||||
| Visual disturbances | √ | |||||
| Severe skin reactions | √ | |||||
| Liver problems (yellowing of the eyes or skin, itching, feeling more tired than usual or like you have the flu, stomach pains or nausea and vomiting) | √ | |||||
This is not a complete list of side effects. If you notice any unexpected side effects while using Mylan-Voriconazole, please contact your doctor or pharmacist.
HOW TO STORE IT
- Keep Mylan-Voriconazole out of the reach and sight of children.
- Store Mylan-Voriconazole Tablets at room temperature (15°C to 30°C).
- Do not use after the expiry date stated on the label.
REPORTING SUSPECTED SIDE EFFECTS
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information. 3 ways to report:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
MORE INFORMATION
This document can be found at: www.mylan.ca.
The full product monograph prepared for health professionals can be obtained by contacting the sponsor, Mylan Pharmaceuticals ULC, at: 1-800-575-1379
Revised on: May 3, 2016
Mylan Pharmaceuticals ULC Etobicoke, ON M8Z 2S6 1-800-575-1379 www.mylan.ca