Clindamycin Injection - Consumer Medicine Information
|Manufacture:||Fresenius Kabi USA, LLC|
|Condition:||Bacteremia, Bacterial Infection, Bacterial Vaginitis, Pneumonia, Sinusitis, Skin or Soft Tissue Infection, Toxoplasmosis, Prophylaxis, Toxoplasmosis|
|Class:||Antibiotics/antineoplastics, Lincomycin derivatives|
|Form:||Liquid solution, Intravenous (IV)|
|Ingredients:||Clindamycin phosphate, edetate disodium, benzyl alcohol, sodium hydroxide, hydrochloric acid.|
About This Medication
What the Medication is Used For
Clindamycin Injection is an antibiotic used to kill bacteria or prevent the growth of bacteria responsible for your infection.
What It Does
Clindamycin Injection interferes with protein synthesis in bacteria, thereby preventing growth and killing the bacteria causing your infection.
When It Should not be Used
Do not use Clindamycin Injection if:
- You are hypersensitive (allergic) to clindamycin, another antibiotic called lincomycin or to any of the other ingredients in this medicine (see What the non-medicinal ingredients are).
What the Medicinal Ingredient Is
What the Nonmedicinal Ingredients Are
benzyl alcohol, edetate disodium, and Water for Injection. When necessary, the pH is adjusted with sodium hydroxide and/or hydrochloric acid.
What Dosage Form It Comes In
Clindamycin Injection is a clear, colourless to light yellow solution. It is supplied in glass vials containing either 2mL, 4 mL, or 6 mL of solution.
Warnings and Precautions
Before you are given this medicine make sure that your doctor knows if you:
- have diarrhea or usually get diarrhea when you take antibiotics or if you suffer from problems with your stomach or intestines (e.g. bowel disease, colitis).
- you suffer from problems with your kidneys or liver.
- you are pregnant or planning to become pregnant. Intravenously administered clindamycin crosses to the fetus.
- you are breastfeeding or planning to breastfeed. Clindamycin is passed to the infant through human breast milk.
Clindamycin Injection contains benzyl alcohol and must not be given to premature babies or babies less than one month old. It may cause allergy and toxic reactions in infants and children up to 3 years old. C
Interactions With This Medication
Some medicines can affect the way Clindamycin Injection works, or Clindamycin Injection itself can reduce the effectiveness of other medicines taken at the same time. These include:
- erythromycin (an antibiotic)
- muscle relaxants used during operations.
Please tell your doctor if you are taking or have recently taken any other medicines including medicines obtained without a prescription.
Proper Use of This Medication
Your doctor will give you your medicine as an injection into your vein (intravenous) or your muscle (intramuscular). This product must be diluted before use.
When giving you Clindamycin Injection, your doctor will determine the dose and ensure that it is not administered too quickly.
In case of drug overdose, particularly accidental oral ingestion, contact your doctor, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Take this medicine each day, even when you feel well. This drug works best when there is a constant amount in your body. If the medicine is stopped too soon, your symptoms may return. Do not miss doses, or take extra doses.
Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Clindamycin Injection or other antibacterial drugs in the future.
Side Effects and What to do About
Tell your doctor immediately if you develop:
- signs of a severe allergic reaction 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 and swelling of the gums, tongue or lips
- yellowing of the skin and whites of the eyes (jaundice).
Other possible side effects may include:
- Effects on your nervous system: impaired sense of taste
- Effects on your skin: reddening of the skin, skin rash, itching (hives).
- Effects on your stomach and intestines: throat ulcers, sore throat, feeling sick, being sick, stomach pain and diarrhea.
- Effects on your blood and lymph system: Reduced numbers of blood cells which may cause bruising or bleeding or weaken the immune system.
- Effects on your liver and kidney: poor liver function, a yellowing of the skin and whites of the eyes.
- Effects on your heart: low blood pressure (feeling light headed, dizzy or faint), rarely heart attack (if given too fast).
- Effects on your reproductive system and breasts: inflammation of the vagina.
- Injection site reactions: swelling, redness, irritation, pain and boil (abscess) formation around site of injection.
Clindamycin Injection may cause side effects. If they occur, they are likely to be minor and temporary. However, some may be serious and need medical attention.
If you develop severe or persistent diarrhea (watery or bloody) with or without abdominal pain, nausea, fever or vomiting, you may have Clostridium difficile colitis (bowel inflammation). If this occurs, stop taking Clindamycin Injection and contact your doctor immediately.
Also check with your doctor as soon as possible if any of the following side effects occur:
Skin rash, itching, redness or other signs or irritation not present before using this medicine.
This is not a complete list of side effects. For any unexpected effects while taking Clindamycin Injection, contact your doctor or pharmacist.
How to Store It
- Keep out of the reach and sight of children.
- Store Clindamycin Injection at room temperature between 15 °C and 30 °C.
- This medicine should not be refrigerated or frozen.
Reporting Side Effects
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:
- Online at MedEffect (http://hc-sc.gc.ca/dhpmps/medeff/index-eng.php);
- By calling 1-866-234-2345 (toll-free);
- By completing a Consumer Side Effect Reporting
Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
- Mail to: Canada Vigilance Program
Health Canada, Postal Locator
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect (http://hcsc.gc.ca/dhp-mps/medeff/indexeng.php).
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.
This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Fresenius Kabi Canada Ltd., at: 1-877-821-7724.
This leaflet was prepared by:
Fresenius Kabi Canada Ltd.
45 Vogell Rd, Suite 200
Richmond Hill, ON L4B 3P6
Date of Preparation: April 22, 2015