Details for: APO-CEPHALEX
Company: APOTEX INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 00768723 | APO-CEPHALEX | CEPHALEXIN (CEPHALEXIN MONOHYDRATE) | 250 MG | TABLET | ORAL |
| 00768715 | APO-CEPHALEX | CEPHALEXIN (CEPHALEXIN MONOHYDRATE) | 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-CEPHALEX is used to treat certain bacterial infections in the:
- respiratory tract;
- ear (otitis media);
- genitals and urinarytract;
- 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 commoncold.
What it does
APO-CEPHALEX is an antibiotic that:
- Stops the growth of bacteria
- Kills bacteria
When it should not be used
- you are allergic to cephalexin, cephalosporin antibiotics or to any of the other ingredients in APO-CEPHALEX
What the medicinal ingredient is
Cephalexin
What the non-medicinal ingredients are
Colloidal silicon dioxide, FD&C yellow #6, hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, stearic acid, and titanium dioxide.
What dosage form it comes in
250 mg Tablets: Supplied in bottles of 100 and 1000 Tablets.
500 mg Tablets: Supplied in bottles of 100 and 500 Tablets.
Warnings and precautions
- you are allergic to or react badly to penicillins or other antibiotics.
- you have intestinal or bowl problems.
- you have kidneyproblems.
- you are pregnant or plan to bepregnant.
- you are breast-feeding or plan tobreast-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 takingAPO-CEPHALEX.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication
Proper use of this medication
- 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
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.
Symptoms of oral overdose may include:
- nausea
- vomiting
- abdominal pain
- diarrhea
- bloody urine
Side effects and what to do about them
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 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).
| 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 | |||
Symptoms of a severe bowel
condition (Clostridium difficile
colitis):
|
✔ | ||
Severe skin reactions:
|
✔ | ||
Severe Cutaneous Adverse
Reactions (SCAR) (severe skin
reactions that may also affect other
organs):
|
✔ | ||
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
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.
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
- 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: September 16, 2020.