efinaconazole

REMS

Topical treatment of onychomycosis of the toenail.

Contraindicated in:

None noted.

Use Cautiously in:

OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding;
Pedi: Children <6 yr (safety and effectiveness not established);
Geri: Older adults may be more sensitive to drug effects.

Local: application site dermatitis, application site pain, application site vesicles, ingrown toenail

Drug-drug:

None reported.

(Generic available)

Topical solution: 10%

(Adults and Children ≥6 yr): Apply to affected toenails once daily for 48 wk.

Jublia

Inhibits synthesis of ergosterol, a component of fungal cell membranes.

Therapeutic effects:

Resolution of toenail fungus.

Spectrum:

Active against Tricyhophyton rubrum and Trychophyton mentagrophytes.

Therapeutic Classification: antifungals

Pharmacologic Classification: triazoles

Absorption: Minimal systemic absorption follows application to toenails.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-Life: 29.9 hr.

ROUTE	ONSET	PEAK	DURATION
Topical‡	unknown	unknown	unknown

‡Prolonged treatment is necessary due to need for treatment throughout growth of new toenails.

Instruct patient to apply efinaconazole as directed for full course of therapy, even if feeling better. Emphasize the importance of topical use only, not for oral, ophthalmic or intravaginal use. Advise patient to wait at least 10 min after showering, bathing, or washing before applying. Efinaconazole is flammable; avoid use near heat or open flame.
Advise patient to report increased skin irritation (redness, itching, swelling) to health care professional.
Caution patient to avoid pedicures, nail polish, and cosmetic nail procedures during therapy.
Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
Advise female patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

eff-in-a-KON-a-zole

NDC Code

0187- Bausch Health US LLC
- 0187-5400- JUBLIA
  - 0187-5400-02- 1 BOTTLE, WITH APPLICATOR in 1 CARTON (0187-5400-02) / 2 mL in 1 BOTTLE, WITH APPLICATOR

0187- Bausch Health US LLC
- 0187-5400- JUBLIA
  - 0187-5400-04- 1 BOTTLE, WITH APPLICATOR in 1 CARTON (0187-5400-04) / 4 mL in 1 BOTTLE, WITH APPLICATOR

0187- Bausch Health US LLC
- 0187-5400- JUBLIA
  - 0187-5400-08- 1 BOTTLE, WITH APPLICATOR in 1 CARTON (0187-5400-08) / 8 mL in 1 BOTTLE, WITH APPLICATOR

46016- Procos S.p.A.
- 46016-1642-
  - 46016-1642-0- 50 kg in 1 CONTAINER (46016-1642-0)

46438- Dipharma Francis Srl
- 46438-0644-
  - 46438-0644-0- 25 kg in 1 DRUM (46438-0644-0)

51265- KAKEN Pharmaceutical Co., LTD
- 51265-541-
  - 51265-541-04- 4 BOX in 1 BOX (51265-541-04) / 145 BOTTLE, WITH APPLICATOR in 1 BOX / 4 mL in 1 BOTTLE, WITH APPLICATOR

51265- KAKEN Pharmaceutical Co., LTD
- 51265-541-
  51265-541-08- 4 BOX in 1 BOX (51265-541-08) / 145 BOTTLE, WITH APPLICATOR in 1 BOX / 8 mL in 1 BOTTLE, WITH APPLICATOR

51557- HAMARI PFST, Ltd.
- 51557-001-
  51557-001-05- 5 kg in 1 BAG (51557-001-05)

51557- HAMARI PFST, Ltd.
- 51557-001-
  51557-001-20- 20 kg in 1 DRUM (51557-001-20)

51686- VIRUPAKSHA ORGANICS LIMITED
- 51686-0012-
  51686-0012-0- 25 kg in 1 DRUM (51686-0012-0)

58175- Wavelength Enterprises LTD
- 58175-0606-
  58175-0606-0- 1 BAG in 1 DRUM (58175-0606-0) / 50 kg in 1 BAG

65015- Mylan Laboratories Limited
- 65015-896-
  65015-896-61- 25 kg in 1 DRUM (65015-896-61)

66039- Glenmark Life Sciences Limited
- 66039-930-
  66039-930-04- 50 kg in 1 DRUM (66039-930-04)

66064- Harman Finochem Limited
- 66064-1024-
  66064-1024-1- 10 kg in 1 DRUM (66064-1024-1)

68259- Sumitomo Chemical Company, Limited
- 68259-1314-
  68259-1314-1- 30 kg in 1 BAG (68259-1314-1)

68259- Sumitomo Chemical Company, Limited
- 68259-1314-
  68259-1314-2- 30 kg in 1 DRUM (68259-1314-2)

70600- Maithri Drugs Private Limited
- 70600-001-
  70600-001-01- 50 kg in 1 DRUM (70600-001-01)

76397- Zhejiang Ausun Pharmaceutical Co., Ltd.
- 76397-006-
  76397-006-07- 20 g in 1 BAG (76397-006-07)

76397- Zhejiang Ausun Pharmaceutical Co., Ltd.
- 76397-006-
  76397-006-08- 100 g in 1 BAG (76397-006-08)

76397- Zhejiang Ausun Pharmaceutical Co., Ltd.
- 76397-017-
  76397-017-02- 25 kg in 1 DRUM (76397-017-02)

76397- Zhejiang Ausun Pharmaceutical Co., Ltd.
- 76397-017-
  76397-017-04- 5 kg in 1 DRUM (76397-017-04)

76397- Zhejiang Ausun Pharmaceutical Co., Ltd.
- 76397-017-
  76397-017-05- 10 kg in 1 DRUM (76397-017-05)

76397- Zhejiang Ausun Pharmaceutical Co., Ltd.
- 76397-018-
  76397-018-02- 25 kg in 1 DRUM (76397-018-02)

76397- Zhejiang Ausun Pharmaceutical Co., Ltd.
- 76397-018-
  76397-018-04- 5 kg in 1 DRUM (76397-018-04)

76397- Zhejiang Ausun Pharmaceutical Co., Ltd.
- 76397-018-
  76397-018-05- 10 kg in 1 DRUM (76397-018-05)

84206- Matrix Pharmacorp Private Limited
- 84206-0036-
  84206-0036-1- 25 kg in 1 DRUM (84206-0036-1)

84678- Kaneka Corporation
- 84678-001-
  84678-001-01- 3 BAG in 1 DRUM (84678-001-01) / 10 kg in 1 BAG

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Indications ⬇

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Pronunciation ⬆ ⬇

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