Details for: APO-CEFUROXIME
Company: APOTEX INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02244393 | APO-CEFUROXIME | CEFUROXIME (CEFUROXIME AXETIL) | 250 MG | TABLET | ORAL |
| 02244394 | APO-CEFUROXIME | CEFUROXIME (CEFUROXIME AXETIL) | 500 MG | TABLET | ORAL |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
APO-CEFUROXIME is an antibiotic medicine. It is similar to other antibiotic medicines called cephalosporins. Your doctor has prescribed APOCEFUROXIME because you have an infection.
Your doctor should test the type of bacteria causing your infection and monitor whether the bacteria are sensitive to APO-CEFUROXIME during your treatment.
Antibacterial drugs like APO-CEFUROXIME treat only bacterial infections. They do not treat viral infections such as the common cold. Although you may feel better early in treatment, APOCEFUROXIME should be used exactly as directed. Misuse or overuse of APOCEFUROXIME could lead to the growth of bacteria that will not be killed by APOCEFUROXIME (resistance). This means that APO-CEFUROXIME may not work for you in the future. Do not share your medicine.
What it does
APO-CEFUROXIME is used to kill the bacteria or "germs" which cause infections. The infection can be cleared up if you take your medication in the proper way.
When it should not be used
Do not use APO-CEFUROXIME if you are allergic to cefuroxime or to cephalosporin antibiotics or to any of the other ingredients in APO-CEFUROXIME (see What the important nonmedicinal ingredients are).
What the medicinal ingredient is
Cefuroxime (as cefuroxime axetil)
What the non-medicinal ingredients are
n addition to cefuroxime axetil, APO-CEFUROXIME contains the following non-medicinal ingredients: colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol and titanium dioxide.
What dosage form it comes in
APO-CEFUROXIME is available as tablets for oral use in two strengths, which contain 250mg and 500mg of cefuroxime (as cefuroxime axetil), supplied in package of 100.
Warnings and precautions
BEFORE you use APO-CEFUROXIME talk to your doctor or pharmacist if:
- you are allergic to or react badly to penicillins or other antibiotics.
- you have kidney problems, as your doctor may reduce your dose.
- you are having a urine test for sugar. False positive reactions may occur if using methods dependent on copper reduction. For this reason enzyme-based tests should be used. Ask your healthcare provider about these tests.
- you are pregnant or planning to become pregnant
- you are breastfeeding or planning to breastfeed. Cefuroxime is excreted in human breast milk. Discuss breastfeeding with your doctor.
- you are taking other medicines. Tell your doctor or pharmacist about all the medicines you are taking, including non-prescription drugs and natural health products
As this medication may cause dizziness, do not drive or operate machinery if you are feeling dizzy.
Talk to your doctor if the following occurs while taking APO-CEFUROXIME:
- you develop hemolytic anemia (breakdown of red blood cells) with symptoms such as pale skin, weakness, tiredness, shortness of breath, yellowing of your skin and/or the whites of your eyes.
Interactions with this medication
Drugs that may interact with APO-CEFUROXIME include:
- Medicines used to reduce the amount of acid in your stomach (e.g. antacids used to treat heartburn) can affect how APO-CEFUROXIME works.
- Medicines that promote the production of urine (such as furosemide and ethacrynic acid) may increase the risk of kidney problems when taken while being treated with APO-CEFUROXIME.
- APO-CEFUROXIME may reduce how well the contraceptive pill works. If you are taking the contraceptive pill while you are being treated with APO-CEFUROXIME, you also need to use a barrier method of contraception (such as condoms). Ask your doctor for advice.
Proper use of this medication
Usual Dose
The usual length of treatment is 7 to 10 days, although your doctor may adjust the prescription to suit your treatment. During the course of treatment, all the tablets must be taken to make sure that all germs have been killed. CONTINUE TAKING THE TABLETS UNTIL THEY ARE FINISHED, EVEN IF YOU BEGIN TO FEEL BETTER.
YOU SHOULD NOT INCREASE OR DECREASE THE PRESCRIBED DOSE UNLESS ADVISED BY YOUR DOCTOR.
Take APO-CEFUROXIME Tablets with food. This will help to make the treatment more effective.
You must take the medicine as prescribed by your doctor. If you are not sure how many tablets to take, or how often to take them, consult your doctor or pharmacist.
The usual dose for adults is one 250 mg tablet twice a day. APO-CEFUROXIME has a bitter taste, therefore, do not chew or crush the tablets but swallow each one whole with a drink of water.
Overdose
If you think you have taken too much APOCEFUROXIME, contact your health care professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.
It is important to follow the dosage instructions on the label of your medicine. Taking more than this dose is unlikely to be dangerous unless a large quantity of tablets is taken all at once. In this case, contact your doctor or nearest hospital emergency department immediately.
Missed Dose
If you forget to take a dose, take another as soon as possible. Then continue with the normal dose. Do not double doses.
Side effects and what to do about them
If you experience wheeziness and tightness of chest, swelling of eyelids, face or lips, or develop skin lumps or hives, or a skin rash (red spots), tell your doctor immediately. Do not take any more medicine unless your doctor tells you to do so. Your doctor may decide to stop your treatment.
You may experience diarrhea, nausea, vomiting, loose stools, abdominal pain, headache, dizziness, diaper rash, drowsiness, inflammation of the vagina or symptoms that you do not understand. There is no need to stop taking your tablets, but you should tell your doctor of any of these symptoms as soon as possible.
If you experience symptoms such as severe diarrhea (bloody or watery) with or without fever, abdominal pain, or tenderness, you may have Clostridium difficile colitis (bowel inflammation). If this occurs, stop taking APO-CEFUROXIME and contact your doctor immediately.
Other side effects include seizure and kidney problems. APO-CEFUROXIME may also cause an increase in a type of white blood cell (eosinophilia), a decrease in the number of white blood cells (leukopenia), decrease in number of blood platelets (cells that help blood to clot) called thrombocytopenia or an increase in some substances (enzymes) produced by the liver. If you are taking a blood test, you should tell your doctor that you are taking APO-CEFUROXIME, as it may affect your result.
On rare occasions, medicines like APOCEFUROXIME can cause an overgrowth of yeast (Candida) in the body which can lead to fungal infections (such as thrush). This side effect is more likely if you take APO-CEFUROXIME for a long time. Tell your doctor as soon as possible if you think you have a fungal infection. Your doctor may need to stop your treatment.
Very rarely, APO-CEFUROXIME may cause severe skin reactions, such as skin rash, which may blister, and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) known as erythema multiforme. If these severe skin reaction occurs, stop taking APO-CEFUROXIME and contact your doctor immediately.
Very rarely, APO-CEFUROXIME may cause effects such as:
- a high temperature (fever)
- yellowing of the whites of the eyes or skin (jaundice)
- inflammation of the liver (hepatitis) with symptoms such as abdominal pain, vomiting, nausea and jaundice, and
- a faster breakdown of red blood cells leading to a form of anemia (hemolytic anemia) with symptoms such as fatigue, shortness of breath and looking pale
If these symptoms occur or persist, contact your
doctor.
If you feel worse or you have taken all the tablets
and do not feel better TELL YOUR DOCTOR AS
SOON AS POSSIBLE.
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Rare | |||
| Overgrowth of Yeast (Candida): fungal infections (such as thrush) | ✔ | ||
| Bowel Inflammation : severe diarrhea (bloody or watery) with or without fever, abdominal pain, or tenderness | ✔ | ||
| Very rare | |||
| Allergic Reactions: wheeziness and tightness of chest, swelling of eyelids, face or lips, or develop skin lumps or hives, or a skin rash (red spots) | ✔ | ||
| Unkno wn | |||
Severe
Cutaneous
Adverse
Reactions
(SCAR)
(severe skin
reactions that
may also
affect other
organs):
|
✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking APOCEFUROXIME, contact your doctor or pharmacist.
How to store
Store at room temperature 15º C - 30º C. Keep in tightly closed container.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffectcanada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
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
If you want more information about APOCEFUROXIME:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://healthproducts.canada.ca/dpd-bdpp/index-eng.jsp). Find the Consumer Information on the manufacturer’s website http://www.apotex.ca/products, or by calling 1- 800-667-4708.
This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9.
Last revised: November 12, 2020