Consumer Information for: AURO-CEFUROXIME

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

AURO-CEFUROXIME is an antibiotic medicine. It is similar to other antibiotic medicines called cephalosporins. Your doctor has prescribed AUROCEFUROXIME because you have an infection.

Your doctor should test the type of bacteria causing your infection and monitor whether the bacteria are sensitive to AURO-CEFUROXIME during your treatment.

Antibacterial drugs like AURO-CEFUROXIME treat only bacterial infections. They do not treat viral infections such as the common cold. Although you may feel better early in treatment, AURO-CEFUROXIME should be used exactly as directed. Misuse or overuse of AURO-CEFUROXIME could lead to the growth of bacteria that will not be killed by AUROCEFUROXIME (resistance). This means that AUROCEFUROXIME may not work for you in the future. Do not share your medicine.

What it does

AURO-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 AURO-CEFUROXIME if you are allergic to cefuroxime or to, cephalosporin antibiotics or to any of the other ingredients in AURO-CEFUROXIME (see What the important nonmedicinal ingredients are).

What the medicinal ingredient is

Cefuroxime (as Cefuroxime axetil).

What the non-medicinal ingredients are

Non-medicinal ingredients: Microcrystalline Cellulose, Croscarmellose sodium, Sodium Lauryl Sulphate, Silica colloidal anhydrous and Hydrogenated vegetable oil.

Coating Ingredients:
Hypromellose (Methocel E5 LV Premium), Titanium dioxide and Macrogol 400 (Polyglycol 400).

What dosage form it comes in

AURO-CEFUROXIME is available in two strengths which contain 250 mg and 500 mg cefuroxime (as cefuroxime axetil).

The 250 mg tablets are White to off-white, film-coated, capsule shaped tablets with ‘A33’ debossed on one side and plain on the other side. The 500 mg tablets are White to off-white, film-coated, capsule shaped tablets with ‘A34’ debossed on one side and plain on the other side. Available in blister of 6 x 10’s count & bottle pack of 60 tablets.

Warnings and precautions

BEFORE you use AURO-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 AURO-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 AURO-CEFUROXIME include:

  • Medicines used to reduce the amount of acid in your stomach (e.g. antacids used to treat heartburn) can affect how AURO-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 AURO-CEFUROXIME.
  • AURO-CEFUROXIME may reduce how well the contraceptive pill works. If you are taking the contraceptive pill while you are being treated with AURO-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 - 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 FINISHED, EVEN IF YOU BEGIN TO FEEL BETTER.

YOU SHOULD NOT INCREASE OR DECREASE THE PRESCRIBED DOSE UNLESS ADVISED BY YOUR DOCTOR.

Take AURO-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. AURO-CEFUROXIME has a bitter taste, therefore, do not chew or crush the tablets but swallow each one whole with a drink of water.

AURO-CEFUROXIME tablets are not recommended for infants and children less than 12 years of age.

Overdose

If you think you have taken too much AUROCEFUROXIME contact your healthcare 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, 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 p

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 AURO-CEFUROXIME and contact your doctor immediately.

Other side effects include seizure and kidney problems. AURO-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 AURO-CEFUROXIME, as it may affect your result

On rare occasions, medicines like AUROCEFUROXIME 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 cefuroxime axetil 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, AURO-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 this severe skin reaction occurs, stop taking AURO-CEFUROXIME and contact your doctor immediately.

Very rarely, AURO-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.

Serious side effects and what to do about them
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)     ✔
Unknown
Severe Cutaneous Adverse Reactions (SCAR) (severe skin reactions that may also affect other organs):
  • Skin peeling, scaling, or blistering (with or without pus) which may also affect your eyes, mouth, nose or genitals, itching, severe rash, bumps under the skin, skin pain, skin color changes (redness, yellowing, purplish).
  • Swelling and redness of eyes or face
  • Flu-like feeling, fever, chills, body aches, swollen glands, cough
  • Shortness of breath, chest pain, or discomfort
     ✔

This is not a complete list of side effects. For any unexpected effects while taking AUROCEFUROXIME, contact your doctor or pharmacist.

How to store

Store between 15°C and 30°C.

Keep your tablets in a safe place where children cannot reach or see them.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

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 AUROCEFUROXIME:

This leaflet was prepared by:
Auro Pharma Inc.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada.

Date of Preparation: January 8, 2021

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