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Apo-Cephalex: Uses, Side Effects and Dosage

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Prescription (Rx)
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500 mg, 250 mg
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Source: Health Canada – Drug Product Database (DPD) and product monographs · About this document

Patient Medication Information: uses, side effects, how to take - Apo-Cephalex

What is APO-CEPHALEX used for?

  • APO-CEPHALEX is used to treat certain bacterial infections in the:

    • respiratory tract;
    • ear (otitis media);
    • genitals and urinary tract;
    • bones and joints;
    • skin and soft tissue.
  • Antibacterial drugs like APO-CEPHALEX treat only bacterial infections. They do not treat viral infections, such as the common cold.

How does APO-CEPHALEX work?

APO-CEPHALEX is an antibiotic that:

  • Stops the growth of bacteria
  • Kills bacteria

What are the ingredients in APO-CEPHALEX?

Medicinal ingredients: Cephalexin

Non-medicinal ingredients: Colloidal silicon dioxide, FD&C yellow #6, hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, stearic acid, and titanium dioxide.

APO-CEPHALEX comes in the following dosage forms:

250 mg Tablets: Supplied in bottles of 100 and 1000 Tablets.

500 mg Tablets: Supplied in bottles of 100 and 500 Tablets.

Do not use APO-CEPHALEX if:

  • you are allergic to cephalexin, cephalosporin antibiotics or to any of the other ingredients in

    APO-CEPHALEX

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APO-CEPHALEX. Talk about any health conditions or problems you may have, including if you:

  • you are allergic to or react badly to penicillins or other antibiotics.
  • you have intestinal or bowl problems.
  • you have kidney problems.

  • you are pregnant or plan to be pregnant.

  • you are breast-feeding or plan to breast-feed.

Other warnings that you should know about:

  • Using antibiotics like APO-CEPHALEX may cause with Clostridium difficile-associated disease

    (CDAD). See “Serious side effects and what to do about them”, below.

  • APO-CEPHALEX may interfere with some blood and urine test results. Talk to your doctor if you are given a blood or urine test while taking APO-CEPHALEX.

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

How to take APO-CEPHALEX:

  • Take APO-CEPHALEX orally on an empty stomach.

  • Although you may feel better early in treatment, APO-CEPHALEX should be used exactly as directed.
  • Misuse or overuse of APO-CEPHALEX could lead to the growth of bacteria that will not be killed by APO-CEPHALEX (resistance). This means that APO-CEPHALEX may not work for you in the future.
  • Do not share your medicine.

Usual dose:

Adult:

The adult dosage ranges from 1 to 4 g daily in divided doses. The usual adult dose is 1 g/day in divided doses every 6 hours.

Children:

The recommended daily dosage for children is 25 to 50 mg/kg/day in divided doses every 6 hours.

Overdose:

Symptoms of oral overdose may include:

  • nausea
  • vomiting
  • abdominal pain
  • diarrhea
  • bloody urine

What are possible side effects from using APO-CEPHALEX?

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

You may experience diarrhea, nausea, vomiting, loose stools, abdominal pain, diaper rash, inflammation of the vagina or discharge, dizziness, fatigue, headache, agitation, confusion, hallucinations or symptoms that you do not understand. You should tell your health professional for of any of these symptoms as soon as possible.

Vertigo (loss of balance or unsteadiness), tinnitus (ringing in the ears), hearing loss and behavioural

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

changes in young children have been reported.

APO-CEPHALEX may also cause effects such as yellowing of the whites of the eyes or skin (jaundice) or the inflammation of the liver (hepatitis).

Serious side effects and what to do about them

Symptom / effect

Talk to your healthcare

professional

Stop taking drug and get immediate medical help
Only if severeIn all cases
RARE

Symptoms of a severe bowel condition (Clostridium difficile colitis):

  • persistent diarrhea
  • bloody or watery diarrhea

  • abdominal or stomach

    pain/cramping

  • blood/mucus in stool
√

Severe skin reactions:

  • 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)

  • widespread rash with

    blisters and skin peeling on much of the body

    surface particularly

    around the mouth, nose, eyes and genitals.

√

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.

Storage:

Tablets:

Store at room temperature (15°C to 30°C) in a tightly closed container. Dispense in a light-resistant container, as prolonged exposure to light may cause fading of the coating.

If you want more information about APO-CEPHALEX:

  • 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/dpd- bdpp/index-eng.jsp). Find the Patient Medication Information on the manufacturer’s website http://www.apotex.ca/products, or by calling 1-800-667-4708.

Last revised: September 16, 2020.

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.

About this document

Source: Health Canada – Drug Product Database (DPD) and product monographs · DIN (Drug Identification Number): 00768715

Revision date stated in the text: September 16, 2020

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Apo-Cephalex

Rx or OTC
Prescription (Rx)?
DIN 00768715, 00768723
Schedule(s) PRESCRIPTION
Active ingredient(s) Cephalexin (cephalexin monohydrate)
Dosage form(s) Tablet
Route(s) of administration Oral
Drug class (WHO ATC)
  1. J Antiinfectives for systemic use
    1. J01 Antibacterials for systemic use
      1. J01D Other beta-lactam antibacterials
        1. J01DB First-generation cephalosporins
          1. J01DB01 Cefalexin
Company APOTEX INC
Current status Marketed
Current status date December 31, 1988
Strengths and forms
DIN Strength Dosage form(s) Current status
00768715 500 MG Tablet Marketed December 31, 1988
00768723 250 MG Tablet Marketed December 31, 1988

Source: Health Canada – Drug Product Database (DPD) and product monographs, data as of November 1, 2026. Data from the Health Canada Drug Product Database, as published there. Not a substitute for the advice of a doctor or pharmacist.