What Dalacin C Phosphate is used for and how to use it
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Dalacin C Phosphate - Consumer Medicine Information

Manufacture: Pfizer Inc.
Country: Canada
Condition: Bacterial Infection
Class: Antibiotics/antineoplastics, Lincomycin derivatives
Form: Liquid solution, Intramuscular (IM), Intravenous (IV)
Ingredients: clindamycin phosphate, benzyl alcohol 9 mg, disodium edentate 0.5 mg, sodium hydroxide (for pH adjustment), dilute hydrochloric acid (for pH adjustment), sterilized water for injection

DALACIN* C PHOSPHATE

Clindamycin Injection USP

Sterile Solution

About This Medication

What the Medication is Used For

DALACIN C PHOSPHATE is used for the treatment of serious bacterial infections.

What It Does

DALACIN C PHOSPHATE provides clindamycin which interferes with protein synthesis in bacteria, thereby preventing growth of the bacteria causing your infection.

When It Should not be Used

Do not use DALACIN C PHOSPHATE if:

  • • You are hypersensitive (allergic) to clindamycin, another antibiotic called lincomycin or to any of the other ingredients in this medicine or component of the container (see What the non-medicinal ingredients are).

What the Medicinal Ingredient Is

Clindamycin phosphate

What the Important Non-medicinal Ingredients Are

Each mL of undiluted DALACIN C PHOSPHATE contains benzyl alcohol 9 mg, disodium edentate 0.5 mg, sodium hydroxide (for pH adjustment), dilute hydrochloric acid (for pH adjustment) and sterilized water for injection.

What Dosage Forms It Comes In

DALACIN C PHOSPHATE is a clear, colourless solution. It is supplied in 2 mL, 4 mL and 6 mL vials of undiluted sterile solution.

Warnings and Precautions

Before you are given this medicine make sure that your doctor knows 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 if you 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. Clindamycin passes to the human fetus.
  • are breastfeeding or planning to breastfeed. Clindamycin is passed to the infant through human breast milk. Because of the potential for serious adverse reactions in nursing infants, clindamycin should not be administered to nursing mothers.
  • have glucose-6-phosphate dehydrogense (G-6-PD) deficiency and are taking primaquine. You need to have routine blood tests while taking DALACIN C PHOSPHATE with primaquine, to monitor for potential blood cell changes.

DALACIN C PHOSPHATE contains benzyl alcohol which may cause serious side effects in neonates and children up to 3 years old.

Interactions With This Medication

Some medicines can affect the way DALACIN C PHOSPHATE works, or DALACIN C PHOSPHATE itself can reduce the effectiveness of other medicines taken at the same time. These include:

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

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

DALACIN C PHOSPHATE will be given to you (or your child) by a health care professional for the full time of treatment, even if you (or your child) begin to feel better after a few days.

The dose of DALACIN C PHOSPHATE and whether the medicine will be given to you as an injection into the muscle (intra-muscular) or into the vein (intravenous infusion) depend on the severity of your infection.

The product must be diluted before being given as an intravenous infusion.

The product can be given as an intramuscular injection without being diluted.

This product should be visually inspected for haziness, particulate matter, discolouration and leakage prior to administration.

When prescribing you DALACIN C PHOSPHATE, your doctor will determine the dose and rate of administration.

Long term use of DALACIN C PHOSPHATE: If you have to take 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 clindamycin treatment.

Overdose

In case of drug overdose, contact your doctor, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

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.

Side Effects and What to Do About Them

DALACIN C PHOSPATE may cause side effects. These include the following:

  • reddening of the skin, skin 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)
  • reduced numbers of blood cells which may cause bruising or bleeding or weaken the immune system
  • vaginal infection or vaginitis (inflammation of the vagina)

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.
  • liver problem, yellowing of the skin and whites of the eyes (jaundice).
  • severe or persistent diarrhea (watery or bloody) with or without abdominal pain, nausea, fever or vomiting. These may be symptoms of Clostridium difficile –associated disease (bowel inflammation). This may happen months after the last dose of medication.

Serious Side Effects and What to Do About Them

Symptom / effectTalk to your healthcare professionalStop taking drug and get immediate medical help
Only if severeIn all cases
VERY COMMON
Liver problem


COMMON
Diarrhea
Rash


RARE
Nausea, abdominal pain
Vomiting
Skin reactions : itching







Injection site irritation, pain

This is not a complete list of side effects. For any unexpected effects while taking DALACIN C PHOSPHATE, contact your doctor or pharmacist.

How to Store It

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

Reporting Suspected Side Effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to: Canada Vigilance Program
      Health Canada
      Postal Locator 0701D
      Ottawa, Ontario
      K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More Information

This document plus the full product monograph, prepared for health professionals can be found at:

http://www.pfizer.ca

or by contacting the sponsor, Pfizer Canada Inc., at: 1-800-463-6001.