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Terazol 7 Vaginal Cream 0.4%: Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx) Current status: Cancelled Post Market
Strength:
4 mg
Active ingredient:
ATC code:
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Source: Health Canada – Drug Product Database (DPD) and product monographs · About this document

Patient Medication Information: uses, side effects, how to take - Terazol 7 Vaginal Cream 0.4%

ABOUT THIS MEDICATION

What the medication is used for:

TERAZOL® 7 Vaginal Cream is used for the local treatment of yeast infections caused by an organism called candidiasis (moniliasis).

What it does:

TERAZOL® 7 is a synthetic antifungal agent which is active against various strains of Candida albicans by interfering with the fungal cell membrane to stop growth of the fungus and help stop the infection.

When it should not be used:

You should not take TERAZOL® 7 if you are allergic to terconazole, or to any of the non-medicinal ingredients in the product (see What the nonmedicinal ingredients are).

What the medicinal ingredient is:

Terconazole

What the nonmedicinal ingredients are:

TERAZOL® 7 Vaginal Cream contains butylated hydroxyanisole, cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, propylene glycol, purified water and stearyl alcohol.

What dosage forms it comes in:

TERAZOL® 7: 0.4% w/w Vaginal Cream

WARNINGS AND PRECAUTIONS

BEFORE you use TERAZOL® 7 talk to your doctor or pharmacist if:

  • you are pregnant, or think you may be; this medication should not be used in the first trimester of pregnancy;

  • you are breastfeeding or planning to breastfeed;
  • you are a diabetic.

For topical use on the vulva and inside the vagina only. TERAZOL® 7 is not for ophthalmic or oral use.

Stop TERAZOL® 7 use and contact your doctor immediately if irritation, fever, chills or flu-like symptoms occur.

INTERACTIONS WITH THIS MEDICATION

TERAZOL® 7 is not affected by oral contraceptive usage.

PROPER USE OF THIS MEDICATION

Usual Adult Dose:

TERAZOL® 7 Vaginal Cream:

One applicatorful (5 g) of TERAZOL® 7 Vaginal Cream is administered intravaginally once daily at bedtime for seven consecutive days. In addition, a thin layer of TERAZOL® 7 Vaginal Cream is applied for seven consecutive days directly to the vulva and massaged in gently.

Directions for using the ORTHO® vaginal cream applicator

Filling the applicator: Remove cap from tube. Reverse cap to puncture seal. Screw applicator to tube. Squeeze tube until applicator plunger is fully extended, then remove applicator from tube.

Hold the filled applicator by the cylinder and gently insert it into the vagina as far as it will go comfortably.

Press plunger and deposit the cream. While keeping plunger depressed, remove the applicator from the vagina.

Care of applicator:

  • After each use, clean the applicator: hold the cylinder of the applicator with one hand and remove the plunger with the other hand by pulling in the opposite direction. Wash with soap and warm water. To reassemble, gently push the plunger back into the cylinder as far as it will go.

Complete the prescribed course of treatment to reduce the chance of re-infection.

Avoid tight-fitting undergarments, pants, pantyhose, etc.

Overdose:

In the event of oral ingestion of vaginal cream, your doctor will provide supportive and symptomatic measures. If the cream is accidentally applied to the eyes, wash with clean water or saline and seek medical attention if symptoms persist.

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

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Along with its intended action, any medication may cause unwanted effects. Some of the side effects that have been reported include:

  • headache
  • burning
  • pain
  • itching
  • irritation
  • allergic reaction, sometimes severe
  • rash
  • fever
  • chills.

Be alert to the following serious side effects which are possible for those using TERAZOL® 7.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
Symptom / effectTalk with your doctor or pharmacistStop taking drug and call your doctor or pharmacist
Only if severeIn all cases
Very Rare

Severe allergic reaction with symptoms such as

swollen face, lips, mouth,

tongue or throat; difficulty

swallowing or breathing;

✓
life-threatening rash with blisters and peeling skin✓

This is not a complete list of side effects. For any unexpected effects while taking TERAZOL® 7, contact your doctor or pharmacist.

HOW TO STORE IT

TERAZOL® 7 Vaginal Cream should be stored at room temperature (15-30°C).

Keep out of the reach and sight of children.

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:

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  • 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 0701E

      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.janssen.ca

or by contacting the sponsor, Janssen Inc., at:

1-800-567-3331 or 1-800-387-8781.

Janssen Inc.

Toronto, Ontario M3C 1L9

Last revised: August 13, 2014

About this document

Source: Health Canada – Drug Product Database (DPD) and product monographs · DIN (Drug Identification Number): 00894729

Revision date stated in the text: August 13, 2014

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Terazol 7 Vaginal Cream 0.4%

Rx or OTC
Prescription (Rx)?
DIN 00894729
Schedule(s) PRESCRIPTION
Active ingredient(s) Terconazole 4 MG
Dosage form(s) Cream
Route(s) of administration Vaginal
Drug class (WHO ATC)
  1. G Genito urinary system and sex hormones
    1. G01 Gynecological antiinfectives and antiseptics
      1. G01A Antiinfectives and antiseptics, excl. combinations with corticosteroids
        1. G01AG Triazole derivatives, gynecological antiinfectives and antiseptics
          1. G01AG02 Terconazole
Company JANSSEN INC
Current status Cancelled Post Market
Current status date November 30, 2016

Source: Health Canada – Drug Product Database (DPD) and product monographs, data as of November 1, 2026. Data from the Health Canada Drug Product Database, as published there. Not a substitute for the advice of a doctor or pharmacist.