Apo-Cefaclor: Uses, Side Effects and Dosage

What is APO-CEFACLOR used for?

APO-CEFACLOR is used to treat infections that are caused by certain bacteria. Antibacterial drugs like APO-CEFACLOR treat only bacterial infections. They do not treat viral infections such as the common cold.

How does APO-CEFACLOR work?

APO-CEFACLOR works to:

• Stop growth of bacteria.
• Kill the bacteria.
• Reduce the infection in your body.

What are the ingredients in APO-CEFACLOR?

Capsules: In addition to the active ingredient cefaclor, each capsule contains the non-medicinal ingredients croscarmellose sodium, colloidal silicon dioxide and stearic acid. The capsule shell contains the non-medicinal ingredients D&C red #28, FD&C blue #1, FD&C yellow #6, gelatin, iron oxide black (500 mg only), iron oxide red (500 mg only), iron oxide yellow (500 mg only), silicon dioxide, sodium lauryl sulfate, titanium dioxide.

The edible black ink on the capsule shell contains the non-medicinal ingredients ammonium hydroxide, D&C yellow #10, FD&C blue #1, FD&C blue #2and FD&C red #40, iron oxide black, propylene glycol and shellac.

Powder for Oral Suspension: In addition to the active ingredient cefaclor, the powder for oral suspension contains the non-medicinal ingredients artificial strawberry flavouring, carboxymethylcellulose, citric acid, colloidal silicon dioxide, sucrose, FD&C red #40, maltodextrin, polydimethylsiloxane, silica, sodium lauryl sulfate, and xanthan gum.

APO-CEFACLOR comes in the following dosage forms:

APO-CEFACLOR Capsules: 250 and 500 mg

APO-CEFACLOR Oral Suspension: 125 mg/5 mL, 250 mg/5 mL and 375 mg/5 mL

Do not use APO-CEFACLOR if:

You have an allergy to:

• Cefaclor any other cephalosporins or any of the non-medicinal ingredients in this medication.

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

Tell your doctor if you have or have had any of the following medical conditions:

• allergic reaction to any antibiotics like penicillin medicines.
• kidney problems.
• stomach or bowel problems .

• pregnant or plan to become pregnant.

• are breast feeding or place to breastfeed.

The following may interact with APO-CEFACLOR:

• Other Antibiotics
• Probenecid
• Oral anticoagulants (warfarin)

These medicines may be affected by cefaclor, or may affect how well it works. You may need to take different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you.

APO-CEFACLOR may affect certain blood or urine tests. Tell your doctor that you are taking APO-CEFACLOR if you are given a blood or urine test.

How to take APO-CEFACLOR:

• Although you may feel better early in treatment, APO-CEFACLOR should be used exactly as directed.

• Misuse or overuse of APO-CEFACLOR could lead to the growth of bacteria that will not be killed by

  APO-CEFACLOR (resistance). This means that APO-CEFACLOR may not ·work for you in the future.

• Do not share your medicine.

Usual Adult Dose:

• Take 250 mg 2 – 3 times daily or as directed by your doctor. The maximum daily dose is 2000 miligrams per day.

Usual Children’s Dose:

Your doctor will decide how much APO-CEFACLOR to give your child. This will be based on your child’s weight.

Missed Dose:

• If you forget to take APO-CEFACLOR, take the dose as soon as you remember.
• If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Overdose:

If you think you have taken too much APO-CEFACLOR, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

What are possible side effects from using APO-CEFACLOR?

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

APO-CEFACLOR may cause serious side effects. Stop APO-CEFACLOR and call your doctor if you have:

•

• urticaria and morbilliform eruptions
• Breathing problems
• Fever or chills
• Sore throat
• Stomach pain or cramps
• Swollen joints

Serious side effects and what to do about them

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.

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/health-canada/services/drugs-health-products/medeffect-canada/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.

Storage:

Store capsules and powder for oral suspension at room temperature 15°C to 30°C.

Suspension: After reconstitution, oral suspensions must be refrigerated and used within 14 days. Shake well before using. Keep tightly closed.

Keep out of reach and sight of children.

If you want more information about APO-CEFACLOR:

• 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://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website http://www.apotex.ca/products, or by calling 1-800-667-4708.

Last Revised: November 21, 2018.