terconazole

REMS

Treatment of vulvovaginal candidiasis.

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.

(Generic available)

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

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.

Terazol-3, Terazol-7

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

Therapeutic effects:

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

Therapeutic Classification: antifungals (vaginal)

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)

ROUTE	ONSET	PEAK	DURATION
Intravag	unknown	6.6 hr	unknown

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.

NDC Code

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

0168- E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
- 0168-0347- Terconazole Vaginal Cream 0.8%
  - 0168-0347-20- 20 g in 1 TUBE, WITH APPLICATOR (0168-0347-20)

0713- Cosette Pharmaceuticals, Inc.
- 0713-0552- Terconazole
  - 0713-0552-73- 3 BLISTER PACK in 1 CARTON (0713-0552-73) / 1 SUPPOSITORY in 1 BLISTER PACK

22568- W. R. Grace & Co.-Conn.
- 22568-1125-
  - 22568-1125-1- 5 kg in 1 DRUM (22568-1125-1)

45802- Padagis Israel Pharmaceuticals Ltd
- 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
- 50090-6266- Terconazole
  - 50090-6266-0- 45 g in 1 TUBE, WITH APPLICATOR (50090-6266-0)

50090- A-S Medication Solutions
- 50090-6299- Terconazole Vaginal Cream 0.8%
  - 50090-6299-0- 20 g in 1 TUBE, WITH APPLICATOR (50090-6299-0)

51672- Sun Pharmaceutical Industries, 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- Sun Pharmaceutical Industries, 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- Sun Pharmaceutical Industries, Inc.
- 51672-1330- Terconazole
  - 51672-1330-3- 1 DOSE PACK in 1 CARTON (51672-1330-3) / 3 SUPPOSITORY in 1 DOSE PACK

59349- Derivados Quimicos
- 59349-0011-
  - 59349-0011-0- 25 kg in 1 DRUM (59349-0011-0)

63629- Bryant Ranch Prepack
- 63629-8837- Terconazole Vaginal Cream 0.8%
  - 63629-8837-1- 20 g in 1 TUBE, WITH APPLICATOR (63629-8837-1)

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

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Indications ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Availability ⬆ ⬇

Route/Dosage ⬆ ⬇

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Classifications ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Pronunciation ⬆ ⬇

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