Terazol 3

Name: Terazol 3

Manufacturer

  • Altura Pharmaceuticals, Inc.

  • Cheshire Pharm. Systems

  • Compumed Pharmaceuticals, Inc.

  • DispenseXpress, Inc.

  • Janssen Pharmaceuticals, Inc.

  • Ortho-McNeil-Janssen Pharmaceutical

  • Pharma Pac (A Service Of H.J. Harkins Co., Inc.)

  • Quality Care Pharmaceuticals

What happens if I overdose?

An overdose of terconazole vaginal is unlikely to occur.

What are some things I need to know or do while I take Terazol 3?

  • Tell all of your health care providers that you take Terazol 3. This includes your doctors, nurses, pharmacists, and dentists.
  • If you have an allergy to any type of nuts or seeds, talk with your doctor. Some products have nuts in them.
  • Do not use this medicine if you have belly pain, fever, or bad-smelling vaginal discharge. Talk with your doctor.
  • Do not use Terazol 3 for itching caused by a health problem other than a vaginal yeast infection. Talk with the doctor.
  • If vaginal yeast infections happen often, talk with the doctor.
  • Protect clothing and fabrics from staining.
  • Do not use tampons.
  • Dry outside vaginal area all the way after showering, bathing, or swimming. Change out of wet bathing suits or damp workout clothes right away.
  • Do not use douches unless your doctor tells you to do so. Douching may disturb the vaginal balance.
  • Do not scratch the affected area. Scratching can cause more irritation and spread the infection.
  • Do not have vaginal sex while using this medicine.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Terazol 3 while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
  • Avoid contact between this medicine and latex products like condoms or diaphragms. This medicine may damage the latex and the products may not work as well.

How is this medicine (Terazol 3) best taken?

Use Terazol 3 as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Use as you have been told, even if your signs get better.
  • Do not take this medicine by mouth. For vaginal use only. Keep out of your mouth, nose, and eyes (may burn).
  • Wash your hands before use.
  • Use at bedtime for best results.
  • Wash your hands and applicator after use.

What do I do if I miss a dose?

  • Use a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not use 2 doses or extra doses.

For Healthcare Professionals

Applies to terconazole topical: vaginal cream, vaginal suppository

Nervous system

Very common (10% or more): Headache (up to 30.3%)
Postmarketing reports: Dizziness[Ref]

Headache was reported in 26%, 21%, and 30.3% of patients using the 0.4% vaginal cream, 0.8% vaginal cream, and vaginal suppositories, respectively. In clinical trials with the suppository, headache occurred in up to 20.7% of patients given placebo.[Ref]

Local

The suppository formulation was discontinued most often due to burning and pruritus.[Ref]

Frequency nor reported: Pain, rash

Vaginal suppositories:
-Very common (10% or more): Burning (15.2%)
-Common (1% to 10%): Pruritus[Ref]

Genitourinary

The cream formulations were discontinued most often due to vulvovaginal itching.[Ref]

Vaginal cream 0.4%:
-Frequency not reported: Vulvovaginal burning/itching/irritation

Vaginal cream 0.8%:
-Common (1% to 10%): Dysmenorrhea, genital burning and itching
-Frequency not reported: Vulvovaginal itching

Vaginal suppositories:
-Common (1% to 10%): Pain of the female genitalia[Ref]

Other

Frequency not reported: Influenza-like illness (consisting of fever, chills, nausea, dizziness)
Postmarketing reports: Asthenia, influenza-like illness (consisting of multiple reactions including fever, chills, nausea, vomiting, myalgia, arthralgia, malaise), face edema

Vaginal cream 0.4%
-Common (1% to 10%): Body pain, fever
-Uncommon (0.1% to 1%): Chills

Vaginal cream 0.8%
-Uncommon (0.1% to 1%): Fever

Vaginal suppositories
-Common (1% to 10%): Body pain, fever, chills[Ref]

Gastrointestinal

Vaginal cream 0.8%:
-Common (1% to 10%): Abdominal pain[Ref]

Hypersensitivity

Postmarketing reports: Hypersensitivity, anaphylaxis[Ref]

Dermatologic

Photosensitivity reactions were reported after repeated dermal application of 2% and 0.8% cream formulations under conditions of filtered artificial ultraviolet light. During US and foreign clinical trials, photosensitivity reactions were not reported in patients who were treated with the suppositories or vaginal cream (0.4% and 0.8%).[Ref]

Frequency not reported: Photosensitivity reactions
Postmarketing reports: Rash, toxic epidermal necrolysis, urticaria[Ref]

Respiratory

Frequency not reported: Dyspnea
Postmarketing reports: Bronchospasm[Ref]

At least 1 patient developed leukocytosis and dyspnea.[Ref]

Hematologic

At least 1 patient developed leukocytosis and dyspnea.[Ref]

Frequency not reported: Leukocytosis[Ref]

Some side effects of Terazol 3 may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Liver Dose Adjustments

Data not available

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