Terazol 3, Terazol 7

DRUG DESCRIPTION

TERAZOL®7 (terconazole) Vaginal Cream 0.4% is a white to off-white, water washable cream for intravaginal administration containing 0.4% of the antifungal agent terconazole, cis-1-[p-[[2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-4-isopropylpiperazine, compounded in a cream base consisting of butylated hydroxyanisole, cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, propylene glycol, stearyl alcohol, and purified water.

TERAZOL®3 (terconazole) Vaginal Cream 0.8% is a white to off-white, water washable cream for intravaginal administration containing 0.8% of the antifungal agent terconazole, cis-1-[p-[[2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-4-isopropylpiperazine, compounded in a cream base consisting of butylated hydroxyanisole, cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, propylene glycol, stearyl alcohol, and purified water.

TERAZOL®3 (terconazole) Vaginal Suppositories are white to off-white suppositories for intravaginal administration containing 80 mg of the antifungal agent terconazole, cis-1-[p-[[2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-4-isopropylpiperazine, in triglycerides derived from coconut and/or palm kernel oil (a base of hydrogenated vegetable oils) and butylated hydroxyanisole.

The structural formula of terconazole is as follows:

TERAZOL® (terconazole)    Structural Formula Illustration

Terconazole, a triazole derivative, is a white to almost white powder with a molecular weight of 532.47. It is insoluble in water; sparingly soluble in ethanol; and soluble in butanol.

What are the possible side effects of terconazole vaginal (Terazol 3, Terazol 7)?

If you experience an allergic reaction (swelling of the lips, face, or tongue; shortness of breath; or hives), stop using terconazole vaginal and seek emergency medical attention.

Other, less serious side effects may be more likely to occur including vaginal burning or itching, irritation of the skin, and an increased need to urinate. Talk to your doctor if these side effects persist or seem excessive.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual...

Read All Potential Side Effects and See Pictures of Terazol 3, Terazol 7 »

What are the precautions when taking terconazole (Terazol 3, Terazol 7)?

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other azole antifungal agents (such as clotrimazole, fluconazole); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, immune system problems (such as HIV-AIDs), frequent vaginal yeast infections (more than 4 per year).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Ask your doctor whether you can have sexual intercourse while using...

Read All Potential Precautions of Terazol 3, Terazol 7 »


Terazol 3, Terazol 7 Consumer (continued)

SIDE EFFECTS: Headache, increased vaginal/urethral burning/itching/pain, or menstrual cramps may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

The following may be side effects. However, they may also be symptoms of a different or more serious condition (bacterial vaginosis or Pelvic Inflammatory Disease-PID) that may require different treatment. Tell your doctor immediately if any of these unlikely but serious effects occur: flu-like symptoms (including fever/chills), foul-smelling discharge from the vagina, stomach/abdominal pain.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other azole antifungal agents (such as clotrimazole, fluconazole); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, immune system problems (such as HIV-AIDs), frequent vaginal yeast infections (more than 4 per year).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Ask your doctor whether you can have sexual intercourse while using this product. The suppository (but not the cream form) may damage rubber products (such as latex condoms, diaphragms, cervical caps) and lead to failure. This can result in pregnancy. Therefore, do not use these products during treatment with the suppository form and for 3 days after treatment is over. Consult your doctor about other forms of barrier protection/birth control (such as polyurethane condoms) during this time or use the cream form of this product.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Pregnant women should use extra care when using the vaginal applicator. Follow your doctor's instructions closely on how to insert the medication using the applicator. The Canadian manufacturer does not recommend using this product during the first 3 months of pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk and the effect on a nursing infant is unknown. Discuss the risks and benefits with your doctor before breast-feeding.


Terazol 3, Terazol 7 Patient Information Including Side Effects

Brand Names: Terazol 3, Terazol 7

Generic Name: terconazole vaginal (Pronunciation: ter CAW na zole)

  • What is terconazole vaginal (Terazol 3, Terazol 7)?
  • What are the possible side effects of terconazole vaginal (Terazol 3, Terazol 7)?
  • What is the most important information I should know about terconazole vaginal (Terazol 3, Terazol 7)?
  • What should I discuss with my healthcare provider before using terconazole vaginal (Terazol 3, Terazol 7)?
  • How should I use terconazole vaginal (Terazol 3, Terazol 7)?
  • What happens if I miss a dose (Terazol 3, Terazol 7)?
  • What happens if I overdose (Terazol 3, Terazol 7)?
  • What should I avoid while using terconazole vaginal (Terazol 3, Terazol 7)?
  • What other drugs will affect terconazole vaginal (Terazol 3, Terazol 7)?
  • Where can I get more information?

What is terconazole vaginal (Terazol 3, Terazol 7)?

Terconazole is an antifungal medication. It prevents fungus from growing.

Terconazole vaginal is used to treat vaginal candida (yeast) infections.

Terconazole vaginal may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of terconazole vaginal (Terazol 3, Terazol 7)?

If you experience an allergic reaction (swelling of the lips, face, or tongue; shortness of breath; or hives), stop using terconazole vaginal and seek emergency medical attention.

Other, less serious side effects may be more likely to occur including vaginal burning or itching, irritation of the skin, and an increased need to urinate. Talk to your doctor if these side effects persist or seem excessive.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about terconazole vaginal (Terazol 3, Terazol 7)?

Use this medication for the full amount of time prescribed by your doctor or as recommended in the package, even if you begin to feel better. Your symptoms may improve before the infection is completely healed.

Avoid wearing tight-fitting, synthetic clothing (e.g., panty hose) that does not allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.

Avoid getting this medication in the eyes, nose, or mouth.

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