(ter KONE a zole)
Candidiasis: 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.
Hypersensitivity to terconazole or any component of the formulation
Documentation of allergenic cross-reactivity for imidazole antifungals is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.
Vulvovaginal candidiasis: Intravaginal:
Vaginal cream 0.4%: Insert 1 applicatorful intravaginally at bedtime for 7 consecutive days.
Vaginal cream 0.8%: Insert 1 applicatorful intravaginally at bedtime for 3 consecutive days.
Vaginal suppository: Insert 1 suppository intravaginally at bedtime for 3 consecutive days.
Refer to adult dosing.
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.
Store at 15 ‚ °C to 30 ‚ °C (59 ‚ °F to 86 ‚ °F).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Cream, Vaginal:
Terazol 7: 0.4% (45 g) [contains cetyl alcohol, polysorbate 80, propylene glycol]
Terazol 3: 0.8% (20 g) [contains cetyl alcohol, polysorbate 80, propylene glycol]
Zazole: 0.4% (45 g [DSC]); 0.8% (20 g)
Generic: 0.4% (45 g); 0.8% (20 g)
Suppository, Vaginal:
Terazol 3: 80 mg (3 ea [DSC])
Zazole: 80 mg (3 ea)
Generic: 80 mg (3 ea)
Progesterone: Antifungal Agents (Vaginal) may diminish the therapeutic effect of Progesterone. Avoid combination
>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% (Limited to important or life-threatening): Anaphylaxis, asthenia, bronchospasm, burning sensation of the penis, facial edema, flu-like symptoms (including nausea, vomiting, myalgia, arthralgia, malaise), hypersensitivity, skin rash, toxic epidermal necrolysis, urticaria
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.
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:
- Petrolatum-based: Petrolatum-based vaginal products may damage rubber or latex 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.
C
Adverse events have been observed in some animal reproduction studies. Although 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, guidelines state that 7-day topical azole vaginal products are the preferred treatment of vulvovaginal candidiasis in pregnant women (CDC [Workowski 2015]. This product may weaken latex condoms and diaphragms (CDC [Workowski 2015]).
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.
Suppository: ~70% remains in vaginal area; ~10% is absorbed systemically
Suppository: Urine (3% to 10%); feces (2% to 6%)
~5 to 10 hours
6.4 to 8.5 hours
94.9%
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Patient may experience headache or menstrual pain. Have patient report immediately to prescriber severe vaginal irritation or signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes) (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.