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

Manufacture: Pfizer Inc.
Country: Canada
Condition: Aspiration Pneumonia, Babesiosis, Bacteremia, Bacterial Endocarditis Prevention (Bacterial Endocarditis Prophylaxis), Bacterial Infection, Bacterial Vaginitis, Bone infection (Osteomyelitis), Deep Neck Infection, Diverticulitis, Intraabdominal Infection, Joint Infection, Lemierre's Syndrome, Malaria, Pelvic Inflammatory Disease, Peritonitis, Pneumocystis Pneumonia, Pneumonia, Prevention of Perinatal Group B Streptococcal Disease, Sinusitis, Skin or Soft Tissue Infection, Surgical Prophylaxis, Toxoplasmosis, Prophylaxis, Toxoplasmosis
Class: Lincomycin derivatives
Form: Syrup
Ingredients: clindamycin palmitate hydrochloride, artificial cherry flavour, ethyl paraben, pluronic F68, polymethylsiloxane, sucrose

DALACIN* C FLAVOURED GRANULES

(Clindamycin Palmitate Hydrochloride for Oral Solution USP) 75 mg/5 mL clindamycin

About This Medication

What the Medication is Used For

DALACIN C FLAVOURED GRANULES is used for:

  • the treatment of serious bacterial infections, and
  • the prevention of serious bacterial infections in some patients undergoing surgery

What It Does

DALACIN C FLAVOURED GRANULES provides clindamycin which works by preventing growth of the bacteria responsible for your infection.

When it Should not be Used

Do not use DALACIN C FLAVOURED GRANULES if:

You have a history of hypersensitivity (allergies) to preparations including clindamycin or lincomycin or any of the other ingredients in the formulation or component of the container (See what the nonmedicinal ingredients are).

What the Medicinal Ingredient Is

Clindamycin palmitate hydrochloride.

What the Important Nonmedicinal Ingredients Are

Artificial cherry flavour, ethyl paraben, pluronic F68, polymethylsiloxane, sucrose (when reconstituted with 75 mL of water, each 5 mL contains approximately 1837 mg of sucrose). Energy: 25.1 kj (6 kcal)/5mL. Sodium: trace. Gluten-free.

What Dosage Forms It Comes In

Oral Solution 100 ml size: 75 mg clindamycin / 5 mL when reconstituted.

Warnings and Precautions

BEFORE you use DALACIN C FLAVOURED GRANULES talk to your doctor or pharmacist if:

  • you have a history of intestinal disorders such as colitis (inflammation of the colon), or inflammatory bowel disease
  • you 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).
  • you suffer from problems with your kidneys or liver.
  • you have glucose-6-phosphate dehydrogense (G-6-PD) deficiency.
  • you are pregnant or planning to become pregnant. Clindamycin passes to the human fetus.
  • you 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 taken by nursing mothers.

The oral solution contains sucrose, so it is important to have an accurate oral hygiene. Brush your teeth twice daily with toothpaste.

Interactions With This Medication

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

  • Erythromycin (an antibiotic).
  • Muscle relaxants used for operations.
  • Aminoglycosides (a class of antibiotics)
  • Primaquine (antimalarial)
  • St-John’s wort

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

The effect of the treatment can be influenced if this medicinal product is taken with other medicinal products. Please tell your doctor or pharmacist if you are taking any other medicines.

Proper Use of This Medication

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.

Treatment of Infection

Child dose (over 1 month of age)

The daily dose is based on the body weight and the severity of the infection.

The daily dose is to be given to the child in divided doses every 8 hours or 6 hours.

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)

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

The medication can be taken with or without food.

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

Like all medicines, DALACIN C FLAVOURED GRANULES can cause side effects. These include:

  • reddening of the skin, skin rash, itching, hives
  • throat ulcers, sore throat, feeling sick, being sick, stomach pain and diarrhea
  • 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 (or your child) 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, sever 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







How to Store It

Keep DALACIN C FLAVOURED GRANULES out of the reach and sight of children.

Before reconstitution, store at controlled room temperature (20-25°C).

Do not refrigerate the reconstituted solution, since under conditions of low temperature, the solution may thicken and is difficult to pour.

The reconstituted solution is stable at room temperature for 14 days.

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.