Dosing and uses of Terazol, Terazol 3 (terconazole vaginal)
Adult dosage forms and strengths
vaginal cream
- 0.4%
- 0.8%
suppository
- 80mg
Candidal Vulvovaginitis
0.4% vaginal cream: 1 full applicator intravaginally qHS x7 days Or
0.8% cream: 1 full applicator intravaginally qHS x3 days
Suppository: Insert 1 suppository (80mg) intravaginally qHS x3 days
Pediatric dosage forms and strengths
Safety & efficacy not established
Terazol, Terazol 3 (terconazole vaginal) adverse (side) effects
>10%
Headache
1-10%
Abdominal pain
Chills
Fever
Dysmenorrhea
Vulvar/vaginal burning
Dysmenorrhea
<1% (limited to important or life-threatening)
Vulvar itching, soreness, edema, or discharge
Polyuria
Burning or itching of penis of sexual partner
Flu-like syndrome
Postmarketing Reports
General: Asthenia, Influenza-like illness consisting of multiple listed reactions including fever and chills, nausea, vomiting, myalgia, arthralgia, malaise
Immune: Hypersensitivity, anaphylaxis, face edema
Nervous: Dizziness
Respiratory: Bronchospasm
Skin: Rash, toxic epidermal necrolysis, rrticaria
Warnings
Contraindications
Hypersensitivity
Cautions
Discontinue if irritation or sensitization occurs
Perform/repeat microbiological studies (KOH smear and/or cultures) in patients not responding to terconazole to rule out other pathogens
Anaphylaxis and toxic epidermal necrolysis (TENs) reported; discontinued if anaphylaxis or TENs develops
Product is petroleum based, which may damage latex or rubber condoms or diaphragms (separate use by 3 days)
Pregnancy and lactation
Pregnancy category: C
Lactation: unknown
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Terazol, Terazol 3 (terconazole vaginal)
Mechanism of action
Unknown; may alter fungal cell membrane permeability
Pharmacokinetics
Absorption: Systemic absorption after vaginal administration may depend on presence of a uterus; 5-8% absorption in women who had a hysterectomy versus 12-16% in nonhysterectomy women
Excretion: Feces & urine
