Consumer Information for: AURO-CEFIXIME

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

Antibacterial drugs like AURO-CEFIXIME treat only bacterial infections. They do not treat viral infections such as the common cold.

AURO-CEFIXIME is used to treat infections caused by bacteria. These include infections of the:

  • Upper respiratory tract
  • Middle ear
  • Sinuses that surround the nasal cavity
  • Lower respiratory tract
  • Urinary tract.

It is also used to treat uncomplicated gonorrhea.

What it does

AURO-CEFIXIME is an antibiotic. It is used to treat certain types of bacterial infections. AURO-CEFIXIME is from a class of antibiotics called cephalosporins. It kills bacteria by interfering with their cell wall.

When it should not be used

  • You are allergic to the cephalosporin or any of the ingredients in AURO-CEFIXIME or to any part of the container.
  • You are allergic to penicillin.

Safety and effectiveness in infants aged less than six months have not been established.

What the medicinal ingredient is

Cefixime

What the non-medicinal ingredients are

Silica Colloidal Anhydrous, Strawberry Guarana Flavor, Sucrose and Xanthan Gum.

What dosage form it comes in

Powder for Oral Suspension, 100 mg / 5 mL when reconstituted. Once reconstituted as directed, the suspension contains 100 mg / 5 mL cefixime.

Warnings and precautions

  • have or have had gastrointestinal disease (diseases of the stomach or gut)
  • have had a condition called hemolytic anemia (loss of red blood cells) after taking an antibiotic
  • have kidney problems
  • have had an allergic reaction in the past, including to a medicine
  • have an inherited condition that causes sugar intolerance, called glucose-galactose malabsorption or sucrase-isomaltase insufficiency
  • are pregnant or planning to become pregnant
  • are breastfeeding or planning to breastfeed

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Interactions with this medication
  • carbamazepine, a medicine used to treat seizures
  • medicines used to thin your blood and prevent clots such as warfarin
  • acetylsalicylic acid (aspirin), used to treat fever and pain

Proper use of this medication
  • Take AURO-CEFIXIME oral suspension by mouth.
  • Take it exactly how your healthcare professional has told you to.
  • Take AURO-CEFIXIME for the full number of days that your healthcare professional has told you to.
  • Although you may feel better early in treatment, AURO-CEFIXIME should be used exactly as directed.
  • Misuse or overuse of AURO-CEFIXIME could lead to the growth of bacteria that will not be killed by AUROCEFIXIME (resistance). This is means that AURO-CEFIXIME may not work for you in the future.
  • Do not share your medicine.

The healthcare professional will usually provide you the reconstituted suspension. If product was not previously reconstituted by the healthcare professional and provided in powder form, reconstitute as follows for 50 mL of suspension (provides 100 mg / 5 mL when reconstituted):

  • Tap the bottle several times to loosen powder contents
  • Add a total volume of 33.5 mL of water. The total volume of water (33.5 mL) should be split into TWO SEPARATE PORTIONS when added to the powder.
  • Mix well after each addition

Usual Dose

  • Your healthcare professional will decide how much AURO-CEFIXIME your child should take and for how long they should take it.
  • The dose they are given will depend on your child’s weight, their age and on the infection they have.
  • AURO-CEFIXIME can be taken by children who are 6 months or older.

Overdose

If you think you have taken too much AURO-CEFIXIME, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

  • If you miss a dose of AURO-CEFIXIME by a few hours, take it as soon as you remember.
  • However, if it is nearly time for the next dose, skip the missed dose.
  • Do not take a double dose to make up for a forgotten dose.
Side effects and what to do about them

These are not all the possible side effects you may feel when taking AURO-CEFIXIME. If you experience any side effects not listed here, contact your healthcare professional.

Side effects may include:

  • diarrhea
  • nausea
  • vomiting
  • upset stomach
  • gas
  • headache
  • dizziness

AURO-CEFIXIME can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.

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
Seizures     ✔
Kidney problems, including kidney failure: abdominal or back pain, changes in your urine, confusion, fatigue, irregular heartbeat, nausea, shortness of breath, swelling, weakness.     ✔
Severe allergic reaction: difficulty breathing, hives, itching, skin rash, swelling of your tongue or throat, weakness. ✔    
Severe skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforma: blistering, hives, itching, blistering, inflamed, peeling, red and dying skin and severe rash ✔    
Clostridium difficile colitis (inflamed bowel), fever, severe diarrhea (bloody or watery) and stomach pain or tenderness.     ✔
Blood problems such as: decreased blood platelets (thrombocytopenia) leads to increased bleeding , decreased red blood cells (hemolytic anemia) leads to fatigue, shortness of breath and decreased white blood cells (neutropenia, leucopenia, agranulocytosis) leads to increased infection   ✔  
Liver problems: abdominal pain, dark urine, fatigue, loss of appetite, nausea, vomiting, yellowing of the skin or eyes (jaundice).   ✔  
Breathing problems including asthma: difficulty breathing, shortness of breath, wheezing.   ✔  
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
     ✔

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

How to store

Store the Dry powder at room temperature (15-30°C).
Store suspension at room temperature (15°C-25°C) or refrigerate for up to 14 days, then discard unused portion after 14 days.
Keep out of reach and sight of children.

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

  • Talk to your healthcare professional
  • Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://health-products.canada.ca/dpdbdpp/index-eng.jsp); the manufacturer’s website http:// www.auropharma.ca, or by calling 1-855-648-6681.

This leaflet was prepared by

Auro Pharma Inc.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada

Date of Revision: November 5, 2020.

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