Patient Medication Information: uses, side effects, how to take - Ketek
ABOUT THIS MEDICATION
What the medication is used for:
The following bacterial infections can be treated by KETEK:
Mild to moderate pneumonia (patients of
18 years old and over)
What it does
KETEK is used to kill the bacteria or “germs” which cause infections. You may begin to feel better quickly; however, in order to make sure that all the bacteria are killed, you should complete the full course of medication. KETEK, like other antibiotics, does not kill viruses.
When it should not be used:
Do not take KETEK if you have a muscular
disease known as myasthenia gravis. Worsening of myasthenia gravis symptoms including life-threatening breathing problems have happened in patients with myasthenia gravis after taking KETEK in some cases leading to death.
You have had an allergic reaction to
telithromycin and/or any components of KETEK tablets (see What the nonmedicinal ingredients are), or to any macrolide antibiotic, such as erythromycin, azithromycin (Zithromax), or clarithromycin (Biaxin).
You are using any of the following drugs:
astemizole, cisapride, ergot alkaloids (i.e. dihydroergotamine, ergotamine), pimozide (also called Orap), terfenadine. (Astemizole, terfenadine and cisapride are no longer marketed in Canada.)
You have a history of liver problems (e.g.
hepatitis and/or jaundice (yellow colour to the skin and/or eyes)) associated with taking KETEK
or any macrolide antibiotic.
What the medicinal ingredient is:
KETEK contains telithromycin and it belongs to a new family of antibiotics called ketolides.
What the nonmedicinal ingredients are:
Reduced size tablet (New formulation without lactose and corn starch)
Coloring agents (red iron oxide, yellow iron oxide), croscarmellose sodium, hydroxypropyl
methylcellulose, magnesium stearate,
microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide.
What dosage forms it comes in:
Reduced size tablets: 400 mg
WARNINGS AND PRECAUTIONS
KETEK may cause fainting (especially if you are already experiencing severe nausea, vomiting, and/or light-headedness), confusion, hallucination and visual problems such as blurred vision, trouble focussing and double vision. If these symptoms occur, avoid driving, operating machinery, or engaging in hazardous activities. Do not take your next dose until you call your doctor or go to a clinic.
BEFORE using KETEK, tell your doctor if any of the following applies to you and discuss with your doctor if:
- You have ever had a severe allergic reaction to any of the group of antibiotics known as “macrolides” such as erythromycin, azithromycin (Zithromax), or clarithromycin (Biaxin).
- You have a rare heart condition that results in the lengthening of the heartbeat on an ECG test (congenital QTc interval prolongation) or you are related by blood to someone who has this condition.
- You have fainted or had an irregular heart beat after taking any medication.
- You have low blood potassium (hypokalemia) or low blood magnesium (hypomagnesemia).
- You have heart, kidney, liver or other disease.
- You have ever had jaundice (yellowing of the skin and eyes, dark urine) while taking KETEK.
You are using any other prescription or
nonprescription medications.
You are pregnant, planning to become pregnant or nursing your baby.
IMPORTANT: PLEASE READ
MEDICATION INTERACTIONS
It is important to let your doctor and your pharmacist know about all the medicines you are taking including those obtained without a prescription.
In addition to the medications listed above under “When it should not be used”, drugs that may interact with KETEK include:
- Alprazolam
Antiarrythmic drugs (a drug for the treatment of
irregular heartbeats, such as procainamide quinidine, amiodaron, sotalol)
Anticoagulants (a drug that reduces clot
formation in the blood) such as warfarin (Coumadin)
- Carbamazepine
Cholesterol-lowering medications: simvastatin
(Zocor), lovastatin (Mevacor), atorvastatin (Lipitor), pravastatin (Pravachol) and rosuvastatin (Crestor)
- Digoxin
Metoprolol for heart failure (Betaloc or
Lopressor)
- Midazolam
- Phenobarbital
- Phenytoin
- Rifampin
- St. John’s Wort
- Triazolam
Do not take other medicines with KETEK without first checking with your doctor. Your doctor will tell you if you can take other medicines with KETEK.
PROPER USE OF THIS MEDICATION
Usual dose:
The usual dose in patients with pneumonia and age 18 years and older is:
Two 400 mg tablets, taken together as one dose
(that is 800 mg), once a day, for 7 to 10 days.
KETEK may be taken with or without food. However, it is best if you take it at the same time each day. Your doctor may suggest that you take this medication at bedtime, to avoid potential side effects such as visual disturbances or fainting.
KETEK has a bitter taste, therefore, do not chew or crush the tablets but swallow each one whole with a glass of water.
The length of treatment is 7 to 10 days. You may begin to feel better quickly; however, in order to make sure that all bacteria are killed, you should complete the full course of medication. If your symptoms do not improve within a few days, or if they become worse, check with your doctor.
If you have a severe kidney disease you should talk to your doctor because the dose you need may be different.
If you are not sure how many tablets to take, or how often to take them, or for how long, consult your doctor or pharmacist. Do not increase the dose of KETEK unless your doctor tells you to do so.
Do not share KETEK with other people, even if they have the same symptoms that you have. It may harm them.
Overdose:
In case of overdosage, contact your doctor, regional poison control centre or nearest hospital immediately. If possible, take your tablets or the box with you to show the doctor.
Missed Dose:
If a dose of this medication is missed, it should be taken as soon as possible. This will help to keep a constant amount of medication in the blood. However, if it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule. Do not take more than one dose of KETEK in a 24-hour period.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
The most common side effect that may occur with KETEK is diarrhea, which is usually mild and goes away on its own.
KETEK may cause unwanted effects such as visual disturbances, including blurred vision, trouble focusing and double vision, which may affect your daily activities. Problems with vision were usually mild to moderate and occurred at any dose, mostly after the first or second dose. These reversible problems may last for a few hours, may recur at any time, and usually disappear at the end of treatment. If you experience these visual symptoms consideration should be given to not driving a vehicle or operating machinery. If visual problems do affect your daily activities you should tell your doctor and consider taking KETEK at bedtime.
If you experience fainting and vision problems do not take your next dose of KETEK until you call your doctor or go to a clinic.
If you develop vaginitis (a vaginal infection associated with local itching, burning and white discharge) you may wish to consult your health professional.
Other side effects, which may occur with KETEK are nausea, vomiting, headaches, stomach pain, flatulence (excess wind), dizziness, disturbances of taste or smell, confusion, hallucination, pain in a joint or muscular pain. Side effects usually disappear after the end of treatment.
If you have other side effects not mentioned in this section or have concerns about side effects be sure to tell your health professional.
If you feel worse or have taken all the tablets and do not feel better tell your doctor as soon as possible.
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
Severe liver damage, in some cases leading to a liver transplant or death has happened in patients treated with KETEK Severe liver damage has happened during treatment, even after a few doses, or right after treatment with KETEK has ended. You should stop treatment with KETEK and contact your doctor immediately if signs and symptoms of liver disease develop such as loss of appetite, nausea, fatigue, jaundice (yellow colour to the skin and/or eyes), dark urine, light-coloured stools, generalised itching or abdominal pain. Do not take your next dose of KETEK until you call your doctor or go to a clinic.
If you think you are having an allergic reaction or if you have a skin reaction such as itching, swelling or red spots and blisters, stop taking KETEK and call your doctor or go to a clinic.
If you experience fainting, irregular heartbeat or vision problems do not take your next dose of KETEK until you call your doctor or go to a clinic.
If you have severe diarrhea (prolonged or bloody), call your doctor. If you still have tablets left, do not take any more unless your doctor tells you so.
| 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 | ||||
| Severe liver damage, with symptoms such as nausea, fatigue, loss of appetite, jaundice (yellowing of the skin and eyes), abdominal pain. | √ | ||||
Allergic reaction with symptoms such as swelling of the mouth, throat, hands, difficulty in breathing or swallowing, itching, rash, red spots and blisters. | √ | ||||
| Vision problems | √ | ||||
| Irregular heartbeat or fainting spells | √ | ||||
| Signs of muscle weakness, pain, breathing difficulties (shortness of breath) which may be signs of a serious condition such as myasthenia gravis (see “When it should not be used” section) | √ | ||||
| Severe diarrhea | √ | ||||
This is not a complete list of side effects. If you have any unexpected effects while taking this drug, contact your doctor or pharmacist.
HOW TO STORE IT
Keep your tablets in a safe place where children cannot reach them.
KETEK should be stored at room temperature (15 to 30°C) in a tightly closed container away from heat and direct light. Do not use the tablets in this package after the expiry date shown on the container label.
If your doctor decides to stop the treatment, do not keep any leftover medicine unless your doctor tells you to. Please discard all unused KETEK tablets.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada through the Canada Vigilance Program collects information on serious and unexpected side effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Canada Vigilance:
By toll-free telephone: 866-234-2345 By toll-free fax: 866-678-6789
Online: www.healthcanada.gc.ca/medeffect By email: CanadaVigilance@hc-sc.gc.ca
By regular mail:
Canada Vigilance National Office
Marketed Health Products Safety and Effectiveness Information Division
Marketed Health Products Directorate Health Products and Food Branch
Health Canada
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Before contacting Canada Vigilance, you should contact your physician or pharmacist. 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 at: http://www.sanofi-aventis.ca or by contacting the sponsor, sanofi-aventis Canada Inc. at:
sanofi-aventis Canada Inc.
2150 St. Elzear Blvd. West
Laval, Quebec
H7L 4A8
Telephone: 1-800-265-7927