Apo-Clindamycin: Uses, Side Effects and Dosage

What is APO-CLINDAMYCIN used for?

• To treat serious infections caused by germs (bacteria).
• To help prevent serious infections during and after surgery.

How does APO-CLINDAMYCIN work?

APO-CLINDAMYCIN prevents the growth of germs causing your infection.

What are the ingredients in APO-CLINDAMYCIN?

Medicinal ingredients: Clindamycin hydrochloride

Non-medicinal ingredients:

Stearic acid and talc.

Capsule shell: 150 mg and 300 mg: FD&C Blue #1, gelatin and titanium dioxide.

150 mg only: D&C Red #28, D&C Red #33, FD&C Red #40 and FD&C Yellow #5.

The edible ink on the capsule shell contains: ammonium hydroxide 28%, propylene glycol, shellac glaze-45% (20% esterified), simethicone and titanium dioxide.

APO-CLINDAMYCIN comes in the following dosage forms:

Capsules: 150 mg and 300 mg

Do not use APO-CLINDAMYCIN if:

• You are allergic (hypersensitive) to

  • Clindamycin
  • Lincomycin
  • Other ingredients in the product (see list of non-medicinal ingredients)

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

• have a history of intestinal disorders such as colitis (inflammation of the colon), or inflammatory bowel disease.
• have diarrhea or usually get diarrhea when you take antibiotics or have ever suffered from problems with your stomach or intestines (e.g. bowel disease, colitis).
• suffer from problems with your kidneys or liver.
• have glucose-6-phosphate dehydrogenase (G-6-PD) deficiency and taking primaquine. You need to have routine blood tests while taking APO-CLINDAMYCIN with primaquine to monitor for potential blood cell changes.
• are pregnant or planning to become pregnant. Clindamycin passes to the human fetus.
• are breastfeeding or planning to breastfeed.

Other warnings you should know about:

Long term use of APO-CLINDAMYCIN

If you have to take APO-CLINDAMYCIN for a long time, your doctor may arrange regular liver, kidney and blood tests. Do not miss these check-ups with your doctor. Long term use can also make you more likely to get other infections that do not respond to APO-CLINDAMYCIN treatment.

Taking APO-CLINDAMYCIN with primaquine

Patients with G-6-PD deficiency taking the combination of clindamycin and primaquine should have routine blood examinations during therapy with primaquine to monitor for potential blood cell changes.

Breastfeeding

If you are breastfeeding or planning to breastfeed while taking APO-CLINDAMYCIN, talk to your doctor. APO-CLINDAMYCIN will pass through your breast milk to your baby. Your doctor will decide if you should take this medicine while breastfeeding. If your doctor has told you that you can take APO-CLINDAMYCIN while breastfeeding, monitor your baby for possible side effects such as: diarrhea, mouth infection (thrush: white lesions in your baby’s mouth), diaper rash or blood in their stool. If your baby shows any signs, talk to your doctor and to your baby’s doctor.

REMEMBER: This medication is for YOU. Never give it to others. It may harm them even if their symptoms are the same as yours.

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

The following may interact with APO-CLINDAMYCIN:

• Erythromycin (an antibiotic)
• Rifampin (an antibiotic)
• Muscle relaxants used for operations
• Aminoglycosides (a class of antibiotics)
• Primaquine (antimalarial)
• St. John’s Wort (Hypericum perforatum)

Tell your doctor if you are taking or being administered any other topical or oral medication, including erythromycin or neuromuscular blocking agents.

How to take APO-CLINDAMYCIN:

Take your medicine (or give the medicine to your child) as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

The capsules should be taken with a full glass of water and no less than 30 minutes before lying down to avoid throat irritation. The capsules can be taken with or without food.

Usual dose:

Treatment of infection:

Adult dose:

150 mg to 450 mg by mouth every 6 hours depending on the severity of infection.

Child dose (over 1 month of age and able to swallow capsules):

2 mg to 5 mg per kg every 6 hours depending on the severity of the infection.

Keep taking this medicine for the full time of treatment, even if you (or your child) begin to feel better after a few days.

Prevention of infection (patients undergoing surgery):

Adult dose:

300 mg by mouth at 1 hour before procedure; then 150 mg at 6 hours after the first dose.

Child dose (over 1 month of age and able to swallow capsules):

10 mg per kg by mouth at 1 hour before procedure; then 5 mg / kg at 6 hours after the first dose.

If you stop taking APO-CLINDAMYCIN

If you stop taking the medicine too soon your infection may come back again or get worse.

Do not stop taking APO-CLINDAMYCIN unless your doctor tells you to.

If you have any further questions on how to take this product, ask your doctor or pharmacist.

Overdose:

Missed Dose:

If you missed a dose of this medication, take it as soon as you remember. This will help to keep a constant amount of medication in your blood. But, if it is almost time for your next dose, skip the missed dose and continue with your next scheduled dose. Do not take two doses at the same time.

What are possible side effects from using APO-CLINDAMYCIN?

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

APO-CLINDAMYCIN can cause side effects such as:

• skin reddening, rash, itching, hives
• feeling sick, vomiting, diarrhea, stomach pain
• sore throat, throat sores
• low red blood cells (anemia) with symptoms such as bruising, bleeding
• low white blood cells (neutropenia) which can lead to more infections
• vaginal infection or vaginitis (inflamed vagina)

Contact your doctor immediately if the following happens:

• You have a severe allergic reaction with symptoms such as:

  • sudden wheeziness
  • difficulty in breathing
  • swelling of eyelids, face or lips
  • rash or itching (especially affecting the whole body)
• Blistering and peeling of large areas of skin
• Fever
• Cough
• Feeling unwell
• Swelling of the gums, tongue or lips

• You have liver problems with symptoms such as:

  • yellowing of the skin and whites of the eyes (jaundice).

• You have Clostridioides difficile colitis (bowel inflammation) with symptoms such as:

  • severe, persistent watery or bloody diarrhea (watery or bloody) with or without

    • abdominal pain
    • nausea
    • fever
    • vomiting

This may happen months after the last dose of medication. If this occurs, stop taking the medication and contact your doctor right away.

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

Reporting Side Effects

Storage:

Keep in a safe place out of the reach and sight of children.

Store at controlled room temperature (15°C to 30°C), away from heat and direct light.

Do not store in the fridge or freezer.

Do not store in the bathroom as moisture and heat can cause damage.

If you want more information about APO-CLINDAMYCIN:

• 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: February 20, 2025