Clindamycin Injection, USP (Mylan Pharmaceuticals): Uses, Side Effects and Dosage

What CLINDAMYCIN INJECTION, USP is used for:

CLINDAMYCIN INJECTION, USP is used for the treatment of serious bacterial infections.

How does CLINDAMYCIN INJECTION, USP work?

CLINDAMYCIN INJECTION, USP reduces the production of key protein in germs. This prevents growth in germs and reduces the infection.

What are the ingredients in CLINDAMYCIN INJECTION, USP:

Medicinal ingredients: Clindamycin phosphate.

Non-medicinal ingredients: Each mL of undiluted CLINDAMYCIN INJECTION, USP contains benzyl alcohol 9.45 mg, disodium edetate 0.5 mg, sodium hydroxide (for pH adjustment), dilute hydrochloric acid (for pH adjustment), nitrogen and sterilised water for injection

CLINDAMYCIN INJECTION, USP comes in the following dosage forms:

CLINDAMYCIN INJECTION, USP is a clear, colourless solution. It is supplied in glass vials containing 2 ml, 4 ml or 6 ml of undiluted sterile solution containing 150 mg/mL clindamycin (as clindamycin phosphate).

Do not use CLINDAMYCIN INJECTION, USP 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 CLINDAMYCIN INJECTION, USP. Talk about any health conditions or problems you may have, including if you:

• have had intestinal disorders such as:

  • colitis (inflammation of the colon)
  • inflammatory bowel disease.
• have diarrhea or get diarrhea when you take antibiotics.
• suffer from problems with your stomach or intestines (e.g. bowel disease, colitis).
• suffer from problems with your kidneys or liver

• are pregnant or planning to become pregnant.

• are breastfeeding or planning to breastfeed.
• you are taking primaquine for an enzyme deficiency called glucose-6-phosphate dehydrogense (G-6-PD). You need to have routine blood tests, to monitor for potential blood cell changes.

Other warnings you should know about:

CLINDAMYCIN INJECTION, USP contains benzyl alcohol which may be harmful to newborns and children up to 3 years old.

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 CLINDAMYCIN INJECTION, USP:

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

How to take CLINDAMYCIN INJECTION, USP:

The health care professional will administer CLINDAMYCIN INJECTION, USP and will:

• Decide whether the medicine should be:

  • injected into a vein or
  • injected into a muscle

• Ensure that:

  • the medicine will be diluted before it is administered into a vein.
  • medicine will not be diluted if administered into a muscle
  • the medicine will be given for the full treatment period

  • the medicine will be inspected to determine there is:

    • no discolouration
    • no leaks
    • no solid particles floating in solution
    • no haziness in the solution

Usual dose:

Your doctor will determine the dose and for how long you should receive it.

Long term use of CLINDAMYCIN INJECTION, USP:

• If you have to use 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 clindamycin treatment.

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 CLINDAMYCIN

INJECTION, USP?

These are not all the possible side effects you may feel when taking CLINDAMYCIN INJECTION, USP. If you experience any side effects not listed here, contact your healthcare professional. Please also see Warnings and Precautions.

CLINDAMYCIN INJECTION, USP can cause side effects such as:

• skin reddening, rash, itching, hives
• throat ulcers, sore throat
• feeling sick, being sick
• stomach pain and diarrhea
• injection site irritation
• thrombophlebitis (inflammation of the vein due to blood clot)
• low red blood cells (anemia) with symptoms such as bruising, bleeding
• low white blood cells (neutropenia) which can lead to 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 Clostridium 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 and contact your doctor right away.

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 health care professional.

Reporting Side Effects

Storage:

• Keep out of the reach and sight of children.
• This medicine should be stored at controlled room temperature between 15 and 30°C.
• This medicine should not be refrigerated or frozen

If you want more information about CLINDAMYCIN INJECTION, USP:

• 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; or by calling 1-800-575-1379
• This document can be found at: www.mylan.ca.

Etobicoke, Ontario M8Z 2S6

Last Revised on: August 16, 2016.

Mylan Pharmaceuticals ULC Etobicoke, ON, M8Z 2S6 1-800-575-1379 www.mylan.ca