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Terconazole: Drug information

Terconazole: Drug information
(For additional information see "Terconazole: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: Canada
  • TARO-Terconazole
Pharmacologic Category
  • Antifungal Agent, Azole Derivative;
  • Antifungal Agent, Vaginal
Dosing: Adult
Candidiasis, vulvovaginal

Candidiasis, vulvovaginal:

Note: A longer duration of up to 14 days may be necessary in patients with complicated infection (ie, recurrent or severe infection, infection with non-albicans Candida, or infection in an immunocompromised host) (Ref). Not effective against Candida glabrata (Ref).

Cream 0.4%: Intravaginal: Insert 1 applicatorful (~5 g) once daily (at bedtime) for 7 days (Ref).

Cream 0.8%: Intravaginal: Insert 1 applicatorful (~5 g) once daily (at bedtime) for 3 days (Ref).

Suppository 80 mg: Intravaginal: Insert 1 suppository once daily (at bedtime) for 3 days (Ref).

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%: Central nervous system: Headache

1% to 10%:

Central nervous system: Chills, pain

Gastrointestinal: Abdominal pain

Genitourinary: Dysmenorrhea, vaginal discomfort (burning, irritation, or itching)

Miscellaneous: Fever

<1%, postmarketing, and/or case reports: Anaphylaxis, asthenia, bronchospasm, burning sensation of the penis, dizziness, facial edema, flu-like symptoms (including nausea, vomiting, myalgia, arthralgia, malaise), hypersensitivity, skin rash, toxic epidermal necrolysis, urticaria

Contraindications

Hypersensitivity to terconazole or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Dermatologic toxicity: If toxic epidermal necrolysis (TEN) occurs, discontinue therapy; implement supportive care/monitoring. Do not reinstitute therapy.

• Hypersensitivity/anaphylaxis: If anaphylaxis occurs, discontinue therapy; implement supportive care/monitoring. Do not reinstitute therapy.

• Idiosyncratic reactions: If fever, chills, or flu-like symptoms occur, discontinue therapy. Do not reinstitute therapy.

• Irritation: If irritation or sensitization occurs, discontinue use. Do not reinstitute therapy.

Dosage form specific issues:

• Vaginal suppository: The base in the suppository formulation may weaken latex or rubber (condoms or diaphragms); concurrent use is not recommended.

Other warnings/precautions:

• Lack of response: Microbiological studies (KOH smear and/or cultures) should be repeated in patients not responding to terconazole in order to confirm the diagnosis and rule out other pathogens.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Cream, Vaginal:

Generic: 0.4% (45 g); 0.8% (20 g)

Suppository, Vaginal:

Generic: 80 mg (1 ea, 3 ea)

Generic Equivalent Available: US

Yes

Pricing: US

Cream (Terconazole Vaginal)

0.4% (per gram): $0.96 - $0.99

0.8% (per gram): $2.05 - $2.45

Suppository (Terconazole Vaginal)

80 mg (per each): $32.63 - $47.17

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Cream, Vaginal:

Generic: 0.4% (45 g)

Administration: Adult

Intravaginal:

Vaginal cream: Use applicator provided by manufacturer. Insertion should be as far as possible into the vagina without causing discomfort. Wash applicator after each use; allow to dry thoroughly before putting back together.

Vaginal suppository: Remove foil package prior to use. Insertion should be as far as possible into the vagina without causing discomfort. If the provided applicator is used for insertion, wash and dry thoroughly prior to additional use.

Use: Labeled Indications

Candidiasis, vulvovaginal: For the local treatment of vulvovaginal candidiasis (moniliasis). As terconazole is effective only for vulvovaginitis caused by the genus Candida, the diagnosis should be confirmed by KOH smears or cultures.

Medication Safety Issues
Sound-alike/look-alike issues:

Terconazole may be confused with tioconazole

International issues:

Terazol [US, Canada] may be confused with Theradol brand name for tramadol [Netherlands]

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Progesterone: Antifungal Agents (Vaginal) may diminish the therapeutic effect of Progesterone. Risk X: Avoid combination

Reproductive Considerations

This product may weaken latex condoms and diaphragms (CDC [Workowski 2021]).

Pregnancy Considerations

The rate and extent of absorption are similar in pregnant and nonpregnant patients with vulvovaginal candidiasis.

The manufacturer recommends that use should be avoided during the first trimester of pregnancy (due to systemic absorption) and that use may be considered in the second or third trimesters if the benefits outweigh risks to the fetus; however, topical azole therapies with 7-day regimens are recommended in pregnant patients with vulvovaginal candidiasis (CDC [Workowski 2021]). Shorter courses of topical azoles are less effective (Hirsch 1989; Young 2001).

Breastfeeding Considerations

It is not known if terconazole is excreted in breast milk.

Due to the potential for adverse reactions in the breastfed infant, the manufacturer recommends a decision be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the importance of the treatment to the mother.

Mechanism of Action

Terconazole is a triazole ketal antifungal agent; involves inhibition of fungal cytochrome P450. Specifically, terconazole inhibits cytochrome P450-dependent 14-alpha-demethylase which results in accumulation of membrane disturbing 14-alpha-demethylsterols and ergosterol depletion.

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Suppository: ~70% remains in vaginal area; ~10% is absorbed systemically

Protein binding: 94.9%

Time to peak, serum: ~5 to 10 hours

Half-life elimination: 6.4 to 8.5 hours

Excretion: Suppository: Urine (3% to 10%); feces (2% to 6%)

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Sex: Following terconazole administration, absorption varies in hysterectomized subjects (5% to 8% absorption) vs nonhysterectomized subjects (12% to 16% absorption). Other than this, overall absorption is similar in all women.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (BE) Belgium: Gyno terazol;
  • (BR) Brazil: Ginconazol | Gyno Fungix | Gyno-fungistat | Tecomax | Terconan | Terconazol;
  • (CH) Switzerland: Gyno terazol | Gyno terazol p;
  • (CO) Colombia: Fungistat;
  • (CZ) Czech Republic: Gyno terazol;
  • (DE) Germany: Tercospor;
  • (DO) Dominican Republic: Fungistat;
  • (EG) Egypt: Gynoconazol | Gynoconazole | Gynomonix | Tercomagictam | Viatrazo;
  • (FI) Finland: Terazol;
  • (IN) India: Gyno terazol;
  • (LT) Lithuania: Gyno terazol;
  • (LU) Luxembourg: Gyno terazol;
  • (LV) Latvia: Gyno terazol;
  • (MX) Mexico: Fungistat;
  • (NL) Netherlands: Gyno terazol;
  • (PR) Puerto Rico: Terazol 3 | Terazol 7 | Zazole;
  • (SE) Sweden: Terazol;
  • (SG) Singapore: Fungistat;
  • (TW) Taiwan: Terconer;
  • (VE) Venezuela, Bolivarian Republic of: Fungistat;
  • (ZA) South Africa: Terazol
  1. Hirsch HA. Clinical evaluation of terconazole. European experience. J Reprod Med. 1989;34(suppl 8):593-596. [PubMed 2677364]
  2. Pappas PG, Kauffman CA, Andes DR, et al. Clinical practice guidelines for the management of candidiasis: 2016 update by the Infectious Disease Society of America. Clin Infect Dis. 2016;62(4):409-417. [PubMed 26810419]
  3. Terazol (terconazole) [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals Inc; May 2018.
  4. Terconazole cream (terconazole) [prescribing information]. Hawthorne, NY: Taro Pharmaceuticals USA, Inc; January 2019.
  5. Terconazole suppositories (terconazole) [prescribing information]. Allegan, MI: Perrigo; December 2018.
  6. US Department of Health and Human Services (HHS) Panel on Opportunistic Infections in Adults and Adolescents with HIV. Guidelines for the prevention and treatment of opportunistic infections in adults and adolescents with HIV: recommendations from the Centers for Disease Control and Prevention, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America. https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/adult-adolescent-oi/guidelines-adult-adolescent-oi.pdf. Accessed May 5, 2020.
  7. Workowski KA, Bachmann LH, Chan PA, et al. Sexually transmitted infections treatment guidelines, 2021. MMWR Recomm Rep. 2021;70(4):1-187. doi:10.15585/mmwr.rr7004a1 [PubMed 34292926]
  8. Young GL, Jewell D. Topical treatment for vaginal candidiasis (thrush) in pregnancy. Cochrane Database Syst Rev. 2001;(4):CD000225. doi:10.1002/14651858.CD000225 [PubMed 11687074]
Topic 9978 Version 211.0

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