Patient Medication Information: uses, side effects, how to take - PMS-Voriconazole
ABOUT THIS MEDICATION
What pms-VORICONAZOLE is used for:
pms-VORICONAZOLE is prescribed by your doctor to treat certain fungal infections, specifically Aspergillus or Candida infections.
What pms-VORICONAZOLE does:
pms-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 pms-VORICONAZOLE (see below under "What are the nonmedicinal ingredients").
- If you are taking other medication that must not be taken with pms-VORICONAZOLE (see listing under "Interactions with this medication")
What is the medicinal ingredient of pms-VORICONAZOLE and what dosage forms does it come in:
- pms-VORICONAZOLE, 200 mg per vial
What are the non-medicinal ingredients:
Sulphobutylether-β-Cyclodextrin Sodium (SBECD)
pms-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
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| For more information, see warnings below and “Side Effects and what do to about them”. |
Take special care with pms-VORICONAZOLE:
Before being treated with pms-VORICONAZOLE tell your doctor if:
- you have any of the following conditions: history of heart disease, or an irregular heartbeat.
- 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 are pregnant: pms-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 pms-VORICONAZOLE.
- you are breast-feeding: pms-VORICONAZOLE must not be taken during breast feeding. Ask your doctor or pharmacist for advise before taking any medicine while breast feeding.
While being treated with pms-VORICONAZOLE:
- tell your doctor immediately if you develop a severe skin rash or blisters.
- strong sunlight should be avoided while being treated with pms-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 pms-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 pms-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 pms-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 twice 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 pms-VORICONAZOLE exactly as directed by your doctor. You should check with your doctor or pharmacist if you are unsure. Never change the dose yourself.
Therapy must be initiated with the specified loading dose regimen of voriconazole to achieve adequate plasma concentrations on Day 1.
During the first 24 hours, you will be administered 2 doses of 6 mg/kg (12 hours apart).
After the first 24 hours:
- If you have an Aspergillus infection, you will be administered 4 mg/kg, twice a day.
- If you have a Candida infection, you will be administered 3 mg/kg or 4 mg/kg, twice a day.
It has been shown that taking all doses at the appropriate times may greatly increase the effectiveness of your medicine.
If you have liver disease, your doctor may prescribe a lower dose of pms-VORICONAZOLE.
Your doctor may order periodic blood tests to monitor your liver function during pms-VORICONAZOLE treatment.
Continue taking pms-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:
| In case of a drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. |
Missed Dose:
If you miss taking a dose of pms-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, pms-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 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
pms-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 pms-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 pms-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 call your doctor or pharmacist | |||||
| 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 pms-VORICONAZOLE, please contact your doctor or pharmacist.
HOW TO STORE IT
- Keep pms-VORICONAZOLE out of the reach and sight of children.
- Store pms-VORICONAZOLE at room temperature (15°C to 30°C).
- Following reconstitution with Water for Injection, the reconstituted solution should be used immediately. If not used immediately, in-use storage times and conditions prior to use should not be longer than 24 hours at 2° to 8°C. It should be ensured that reconstitution has taken place in controlled and validated aseptic conditions.
- If further diluted, the solutions should be used immediately.
- Do not use after the expiry date stated on the label.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect. NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice. |
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals, can be obtained by contacting the sponsor, Pharmascience Inc. at, 1-888-550-6060.
Pharmascience Inc.
Montréal Canada
H4P 2T4
www.pharmascience.com