ter-KON-a-zole

Therapeutic Classification: antifungals (vaginal)

• Treatment of vulvovaginal candidiasis.

• Affects the permeability of the fungal cell wall, allowing leakage of cellular contents. Not active against bacteria.

• Inhibited growth and death of susceptible Candida, with decrease in accompanying symptoms of vulvovaginitis (vaginal burning, itching, discharge).

Absorption: 5–16% is systemically absorbed following intravaginal administration.

Distribution: Unknown. Action is primarily local.

Metabolism/Excretion: Negligible with local application.

Half-life: 6.4–8.5 hr.

(plasma concentrations)

Contraindicated in:

• Hypersensitivity to active ingredients, additives, or preservatives
• OB: Do not use during first trimester.

Use Cautiously in:

• OB: May be used during 2nd and 3rd trimesters if potential benefit outweighs possible risks to fetus
• Lactation: Safety not established.

CNS: headache.

Derm: TOXIC EPIDERMAL NECROLYSIS.

GI: abdominal pain.

GU: dysmenorrhea, irritation, itching, vulvovaginal burning.

Misc: ANAPHYLAXIS, fever.

Drug-Drug:

• Not known.

• Vag (Adults): Vaginal cream — 1 applicatorful (5 g) of 0.4% cream at bedtime for 7 days or 1 applicatorful (5 g) of 0.8% cream at bedtime for 3 days. Vaginal suppositories — 1 suppository (80 mg) at bedtime for 3 days.

(Generic available)

• Vaginal cream: 0.4%; 0.8%;
• Vaginal suppositories: 80 mg;

• Inspect involved areas of skin and mucous membranes before and frequently during therapy. Increased skin irritation may indicate sensitization and warrant discontinuation of medication.

• Consult health care professional for proper cleansing technique before applying medication.
• Vag: Applicators are supplied for vaginal administration.

• Instruct patient to apply medication as directed for full course of therapy, even if feeling better. Therapy should be continued during menstrual period.
  • Advise patient to avoid using tampons or douches while using this product.
  • Instruct patient on proper use of vaginal applicator. Medication should be inserted high into the vagina at bedtime. Instruct patient to remain recumbent for at least 30 min after insertion. Advise use of sanitary napkins to prevent staining of clothing or bedding.
  • Advise patient to report to health care professional increased skin irritation or lack of response to therapy. A second course may be necessary if symptoms persist.
  • Advise patient to thoroughly clean the applicator after each use.
  • Advise patient to notify health care professional if signs and symptoms of anaphylaxis (hives, shortness of breath, facial swelling) or rash occurs.
  • Advise patient to consult health care professional regarding intercourse during therapy. Vaginal medication may cause minor skin irritation in sexual partner. Advise patient that this medication may weaken latex or rubber contraceptive products. Another method of contraception should be used during treatment. Advise patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

• Decrease in skin irritation and vaginal discomfort. Therapeutic response is usually seen after 1 wk. Diagnosis should be reconfirmed with smears or cultures before a second course of therapy to rule out other pathogens associated with vulvovaginitis. Recurrent vaginal infections may be a sign of systemic illness.

Terazol-3, Terazol-7

• Risk for infection (Indications).
• Risk for impaired skin integrity (Indications).

NDC Code^*

• 0168- E. Fougera and Co. a division of Fougera Pharmaceuticals Inc.
  • 0168-0346- Terconazole
    • 0168-0346-46- 45 g in 1 TUBE, WITH APPLICATOR (0168-0346-46)

• 0713- G and W Laboratories, Inc.
  • 0713-0552- Terconazole
    • 0713-0552-73- 3 BLISTER PACK in 1 CARTON (0713-0552-73) > 1 SUPPOSITORY in 1 BLISTER PACK

• 45802- Perrigo New York Inc
  • 45802-717- Terconazole
    • 45802-717-08- 3 BLISTER PACK in 1 CARTON (45802-717-08) > 1 SUPPOSITORY in 1 BLISTER PACK (45802-717-00)

• 50090- A-S Medication Solutions
  • 50090-0917- Terconazole
    • 50090-0917-0- 1 TUBE, WITH APPLICATOR in 1 CARTON (50090-0917-0) > 45 g in 1 TUBE, WITH APPLICATOR

• 50090- A-S Medication Solutions
  • 50090-1196- Terconazole
    • 50090-1196-0- 1 TUBE, WITH APPLICATOR in 1 CARTON (50090-1196-0) > 20 g in 1 TUBE, WITH APPLICATOR

• 50090- A-S Medication Solutions
  • 50090-2341- TERCONAZOLE
    • 50090-2341-0- 1 TUBE, WITH APPLICATOR in 1 CARTON (50090-2341-0) > 45 g in 1 TUBE, WITH APPLICATOR

• 51672- Taro Pharmaceuticals U.S.A., Inc.
  • 51672-1302- Terconazole
    • 51672-1302-0- 1 TUBE, WITH APPLICATOR in 1 CARTON (51672-1302-0) > 20 g in 1 TUBE, WITH APPLICATOR

• 51672- Taro Pharmaceuticals U.S.A., Inc.
  • 51672-1304- Terconazole
    • 51672-1304-6- 1 TUBE, WITH APPLICATOR in 1 CARTON (51672-1304-6) > 45 g in 1 TUBE, WITH APPLICATOR

• 51672- Taro Pharmaceuticals U.S.A., Inc.
  • 51672-1330- Terconazole
    • 51672-1330-3- 1 DOSE PACK in 1 CARTON (51672-1330-3) > 3 SUPPOSITORY in 1 DOSE PACK

• 53002- RPK Pharmaceuticals, Inc.
  • 53002-7240- Terconazole
    • 53002-7240-1- 1 TUBE, WITH APPLICATOR in 1 CARTON (53002-7240-1) > 20 g in 1 TUBE, WITH APPLICATOR

• 53002- RPK Pharmaceuticals, Inc.
  • 53002-8130- Terconazole
    • 53002-8130-1- 1 TUBE, WITH APPLICATOR in 1 CARTON (53002-8130-1) > 45 g in 1 TUBE, WITH APPLICATOR

• 68071- NuCare Pharmaceuticals,Inc.
  • 68071-1626- Terconazole
    • 68071-1626-2- 20 g in 1 BOX (68071-1626-2)

• 70518- REMEDYREPACK INC.
  • 70518-1185- Terconazole
    • 70518-1185-0- 1 TUBE, WITH APPLICATOR in 1 CARTON (70518-1185-0) > 20 g in 1 TUBE, WITH APPLICATOR