What Dalacin Vaginal Cream is used for and how to use it
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Dalacin Vaginal Cream - Consumer Medicine Information

Manufacture: Pfizer Inc.
Country: Canada
Condition: Bacterial Infection, Bacterial Vaginitis
Class: Anti-infectives, Antibiotics/antineoplastics, Lincomycin derivatives, Vaginal anti-infectives
Form: Cream
Ingredients: сlindamycin phosphate, sorbitan monostearate, polysorbate 60, propylene glycol, stearic acid, cetostearyl alcohol, cetyl palmitate, mineral oil, benzyl alcohol, purified water

Clindamycin Phosphate Vaginal Cream

About This Medication

What the Medication is Used For

DALACIN VAGINAL CREAM is an antibiotic used to kill bacteria responsible for your vaginal infection. Symptoms of this infection may include a milky discharge and fishy odour from the vagina.

What It Does

DALACIN VAGINAL CREAM works by killing or preventing growth of the bacteria responsible for your vaginal infection.

When It Should not be Used

Do not use DALACIN VAGINAL CREAM if:

  • You have a history of hypersensitivity (allergies) to preparations including clindamycin or lincomycin or any components of the cream (see what the non-medicinal ingredients are).
  • You have a history of inflammatory bowel diseases (including regional enteritis and ulcerative colitis), or a history of antibiotic-associated colitis (inflamed bowel).

What the Medicinal Ingredient Is

Clindamycin phosphate

What the Nonmedicinal Ingredients Are

Sorbitan monostearate, polysorbate 60, propylene glycol, stearic acid, cetostearyl alcohol, cetyl palmitate, mineral oil, benzyl alcohol and purified water.

What Dosage Form It Comes In

DALACIN VAGINAL CREAM (clindamycin phosphate vaginal cream), 20 mg clindamycin per gram, is available as a semi-solid white cream in 40g collapsible laminate tubes with 7 disposable applicators for intravaginal use. Each full applicator (one dose), contains 100 mg of clindamycin (as clindamycin phosphate) in 5 grams of cream.

Warnings and Precautions

BEFORE you use DALACIN VAGINAL CREAM talk to your doctor or pharmacist if:

  • you are pregnant, or planning to become pregnant
  • you are breast-feeding or plan to breast-feed while using DALACIN VAGINAL CREAM as a small amount of Dalacin is absorbed into the body with vaginal application

While using DALACIN VAGINAL CREAM:

  • Do not use condoms or vaginal contraceptive diaphragms for 3 days after you use this medicine. The mineral oil in this medicine can weaken latex or rubber products. This might make condoms and diaphragms less effective and you will not be fully protected.
  • Do not engage in vaginal intercourse or use other vaginal products (such as tampons or douches) during treatment with this medicine.
  • Do not start using this medicine if you have your period (menstruating). Wait until your period is finished before using this medicine.
  • Do not use this medicine if you are pregnant or breast feeding unless your doctor has told you to.
  • Avoid contact with the eyes. In case of accidental contact, rinse thoroughly with tap water.

Interactions With This Medication

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

Proper Use of This Medication

Usual Adult Dose

Apply 1 applicator of cream intravaginally each night before you go to bed for 7 nights. Complete the entire 7 day treatment to help ensure treatment success.

There are 7 plastic applicators in the package. The applicator consists of both a plunger and a barrel. The tube of cream contains enough medicine to last for 7 days.

Use the plastic applicator to permit proper placement of the cream in the vagina.

Note: This cream is inserted into the vagina in much the same way as a tampon.

Follow These Steps to Load the Applicator

  1. Remove the cap from the tube of cream.
  2. Screw the open end of the applicator on the threaded end of the tube.
  3. Gently squeeze the other end of the tube. This will push the cream into the barrel of the applicator. As the cream enters the barrel, the plunger will be forced outward. The applicator is full when the plunger stops.
  4. Unscrew the applicator from the tube when the barrel is full.
  5. Replace the cap on the tube of cream. Roll the tube from the bottom.

Follow These Steps to Insert the Vaginal Cream

  1. Stand, squat or lie on your back in a comfortable position.
  2. Insert the loaded applicator gently into the vagina as far as it will comfortably go.
  3. Hold the barrel of the applicator steady. Slowly press the plunger until it stops. This will deposit the cream in the vagina.
  4. Remove the applicator and throw out. Remember to use a new applicator each and every time you insert this cream.

REMEMBER: This medication is for YOU. Never give it to others. It may harm them even if their symptoms are the same as yours.

Overdose

In case of drug overdose, particularly accidental oral ingestion, contact a health care professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

If you miss a dose one day, take the next dose the following day. Do not take extra doses.

Side Effects and What to Do About Them

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 DALACIN VAGINAL CREAM and contact your doctor immediately.

Other side effects that may occur and do not normally require medical attention unless they become bothersome, include:

  • itching, hives, redness and gastrointestinal symptoms such as indigestion and gas.

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

How to Store It

Keep out of reach of children.

Store at room temperature (15℃ to 30℃), away from heat and direct light.

Protect from freezing. Do not store in the fridge or freezer.

Do not store in the bathroom as moisture and heat can cause damage.

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 distributor Paladin Labs Inc. at 1-888-867-7426 (Medical Information).