Dalacin T - Consumer Medicine Information
|Condition:||Aspiration Pneumonia, Acne Vulgaris (Acne), 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|
|Ingredients:||clindamycin phosphate, isopropyl alcohol (500 mg) (50.0% w/v), propylene glycol (50 mg) (5.0% w/v)|
About This Medication
What the Medication is Used For
DALACIN T is used for the treatment of pimples (Acne Vulgaris).
What it Does
DALACIN T provides clindamycin, which is an antibacterial. Clindamycin works by preventing growth of bacteria associated with acne.
When It Should not be Used
Do Not use DALACIN T if:
- You have a history of hypersensitivity (allergies) to preparations including clindamycin or lincomycin or to any ingredient in the formulation or component of the container (see What the non-medicinal ingredients are).
- You have a history of inflammatory bowel disease (including regional enteritis and ulcerative colitis, or a history of antibiotic-associated colitis (inflamed bowel).
What the Medicinal Ingredient Is
What the Important Nonmedicinal Ingredients Are
isopropyl alcohol (500 mg) (50.0% w/v), propylene glycol (50 mg) (5.0% w/v).
What Dosage Forms it Comes In
Each ml of DALACIN T solution contains 10 mg of clindamycin (as clindamycin phosphate). DALACIN T is a clear colourless solution available in 30 and 60 mL bottles. A separate applicator and cap for placement into the bottle is provided.
Warning and Precautions
DALACIN T is for external use only. Not for oral, intravaginal or ophthalmic use. Avoid contact with eyes, mouth, lips, other mucous membranes, or areas of broken skin.
BEFORE you use DALACIN T talk to your doctor or pharmacist if:
Safety and effectiveness in pediatric patients under the age of 12 have not been established.
- you are pregnant, or planning to become pregnant. Safety for use in pregnancy has not been established.
- you are breast-feeding or plan to breast-feed while using DALACIN T as the active substance in this medicine may be passed into breast milk. Your doctor will decide if DALACIN T is suitable for you.
DALACIN T solution is flammable. Do not smoke or be near a flame during and immediately after the application of DALACIN T.
Interactions with Medication
Tell your doctor about all your medicines, including vitamin supplements, herbal remedies or homeopathic remedies, including those you have bought yourself. Some medicines can affect the way this medicine works. These include:
- Aminoglycosides (gentamycin)
- Muscle relaxants (neuromuscular blocking agent) used in surgery
Using another topical product that contains alcohol such as cleansers, medicated soaps or cosmetics in the same area as DALACIN T may lead to additional skin dryness or irritation.
Proper Use of This Medication
Apply a thin film of DALACIN T to the skin affected by acne twice daily.
Before applying this medicine
Wash the area to be treated thoroughly but gently with warm water and bland soap. Unless skin is oily, washing 2 or 3 times a day with non-medicinal cleanser is enough.
Rinse well and pat dry.
Wait 30 minutes after shaving, before applying the medicine because the alcohol in it may irritate freshly shaven skin.
To use the applicator:
- Remove cap from bottle and discard.
- Firmly press applicator into bottle.
- Seal firmly by tightening domed-cap.
The pharmacist may have assembled the bottle for you, in which case the applicator top will already be attached to the bottle.
To apply DALACIN T
Apply the medicine directly to the skin using the applicator top. The bottle should be tilted and pressed firmly against the skin using a dabbing rather than a rolling motion. Reducing the pressure will decrease the flow.
A thin film of the medicine is to be applied to the whole area affected by acne, not just to the pimples themselves. To avoid getting medication into the eyes, nose, or mouth, the medicine should be spread away from these areas when applied.
If the medicine does get in the eyes, they must be washed out immediately but carefully, using large amounts of cool tap water. If the eyes still burn or are painful, get medical help immediately.
After applying this medicine do not wash your face for at least two hours.
You should wash your hands after applying this medicine.
Your condition may get better after 8 weeks if you respond well to the treatment. If you need more than 12 weeks treatment, talk to your doctor.
Watch for signs of increased dryness or irritation if you use the medicine with other topical products.
REMEMBER: This medication is for YOU. Never give it to others. It may harm them even if their symptoms are the same as yours.
If you should forget to apply your medicine on your skin at the usual time, apply it when you remember, unless it is almost time for your next application, in which case wait and apply at the next application time. The dose should not be doubled to make up for a missed dose.
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.
Absorption of isopropyl alcohol into the body should be considered a possibility if there has been accidental ingestion.
Side Effects and What to Do About Them
DALACIN T may cause side effects. These include the following:
- Dry or scaly skin
- Peeling of skin
- Stinging or burning feeling
- Eye pain
- Itching, hives, redness and gastrointestinal symptoms such as indigestion and gas.
Contact your doctor immediately if you develop any of the following side effects:
- Skin rash, itching, redness or other signs or irritation not present before using this medicine.
If you experience symptoms such as severe diarrhea (bloody or watery) with or without fever, abdominal pain, or tenderness, you may have Clostridium difficile colitis (bowel inflammation). If this occurs, stop taking DALACIN T and contact your healthcare professional immediately.
Serious Side Effects, How Often They Happen and What to Do About Them
|Symptom / effect||Stop taking|
drug and get
Skin reactions: itching,
peeling, dry, sunburn
Nausea, abdominal pain
This is not a complete list of side effects. For any unexpected effects while taking DALACIN T, contact your doctor or pharmacist.
How to Store It
Keep all medications out of the reach and sight of children.
Store at room temperature 15°C to 30°C.
Store away from heat and direct light. Do not freeze.
Store the bottle in an upright fashion.
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
Postal Locator 0701D
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.
This document plus the full product monograph, prepared for
health professionals can be found at:
or by contacting the sponsor, Pfizer Canada Inc., at: