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Eflornithine (topical): Pediatric drug information

Eflornithine (topical): Pediatric drug information
(For additional information see "Eflornithine (topical): Drug information" and see "Eflornithine (topical): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Vaniqa [DSC]
Brand Names: Canada
  • Vaniqa
Therapeutic Category
  • Antiprotozoal;
  • Topical Skin Product
Dosing: Pediatric
Reduction of unwanted facial hair

Reduction of unwanted facial hair: Topical: Cream: Female Children ≥12 years and Adolescents: Apply thin layer of cream to affected areas of face and adjacent chin twice daily, at least 8 hours apart.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in manufacturer's labeling; however, dosage adjustment unlikely necessary due to limited systemic absorption.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in manufacturer's labeling; however, dosage adjustment unlikely necessary due to limited systemic absorption.

Dosing: Adult

(For additional information see "Eflornithine (topical): Drug information")

Facial hair reduction

Facial hair reduction (females): Topical: Apply thin layer to affected areas of face and areas under the chin twice daily, at least 8 hours apart.

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.

Adverse Reactions

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

>10%: Dermatologic: Pseudofolliculitis barbae (16%)

1% to 10%:

Dermatologic: Burning sensation of skin (4%), erythema of skin (1%), skin rash (3%), stinging of the skin (8%)

Gastrointestinal: Dyspepsia (3%)

Nervous system: Tingling of skin (4%)

<1%:

Dermatologic: Cheilitis, contact dermatitis, dermal hemorrhage, folliculitis, rosacea

Hypersensitivity: Swelling of lips

Infection: Herpes simplex infection

Nervous system: Numbness

Contraindications

Hypersensitivity to eflornithine or any component of the formulation.

Warnings/Precautions

Dosage form specific issues:

• Appropriate use: For topical use by females only; discontinue if hypersensitivity occurs.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Cream, External, as hydrochloride:

Vaniqa: 13.9% (45 g [DSC]) [contains cetearyl alcohol, methylparaben, propylparaben]

Generic Equivalent Available: US

No

Pricing: US

Cream (Vaniqa External)

13.9% (per gram): $4.43

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, External, as hydrochloride:

Vaniqa: 13.9% (30 g) [contains cetearyl alcohol, methylparaben, polyethylene glycol 100 stearate, propylparaben]

Administration: Pediatric

Topical: For external use only. Rub in thoroughly. Hair removal techniques must still be continued; wait at least 5 minutes after removing hair to apply cream. Do not wash affected area for at least 4 hours following application. Makeup and sunscreen may be used over treated area(s) after cream has dried.

Administration: Adult

Topical: For external use only. Apply a thin layer to the affected areas of the face and chin; rub in thoroughly. Hair removal techniques must still be continued; wait at least 5 minutes after removing hair to apply cream. Do not wash affected area for at least 4 hours following application. Makeup and sunscreen may be used over treated area(s) after cream has dried.

Storage/Stability

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59 °F to 86°F); do not freeze.

Use

Reduction of unwanted hair from face and adjacent areas under the chin (Cream: FDA approved in females ≥12 years and adults).

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

Vaniqa may be confused with Viagra

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

Information related to the use of eflornithine for facial hair reduction during pregnancy is limited.

Monitoring Parameters

Hypersensitivity.

Mechanism of Action

Eflornithine inhibits the enzyme ornithine decarboxylase which inhibits cell division and synthetic functions and thereby affects the rate of hair growth.

Pharmacokinetics (Adult Data Unless Noted)

Onset of action: Decreased hair growth: 4 to 8 weeks.

Duration of action: Decreased hair growth: Continues until ~8 weeks after discontinuing treatment.

Absorption: <1%.

Half-life elimination: 8 hours.

Excretion: Primarily urine (as unchanged drug).

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

  • (AR) Argentina: Vaniqa;
  • (AT) Austria: Vaniqa;
  • (BD) Bangladesh: Elorim | Vaniflo | Wonica;
  • (BE) Belgium: Vaniqa;
  • (CH) Switzerland: Vaniqa;
  • (DE) Germany: Vaniqa;
  • (EE) Estonia: Vaniqa;
  • (EG) Egypt: Eflotism | Flornith | Malsa;
  • (ES) Spain: Vaniqa;
  • (FI) Finland: Vaniqa;
  • (FR) France: Eflornithine Dci | Ornidyl | Vaniqa;
  • (GB) United Kingdom: Vaniqa;
  • (GR) Greece: Vaniqa;
  • (IE) Ireland: Vaniqa;
  • (IL) Israel: Vaniqa;
  • (IN) India: Eflok | Eflora | Eflosheen | Efnithin | Elyn | Follinil;
  • (IT) Italy: Vaniqa;
  • (JO) Jordan: Florexa;
  • (LB) Lebanon: Florexa;
  • (LT) Lithuania: Vaniqa;
  • (LV) Latvia: Vaniqa;
  • (NL) Netherlands: Vaniqa;
  • (NO) Norway: Vaniqa;
  • (NZ) New Zealand: Vaniqa;
  • (PE) Peru: Cycladin;
  • (PK) Pakistan: Bio eflorin | Candinil | Depilus | Efloderm | Eflonet | Epila | Harex | Hirso | Hirsunil | Protolimit | Santhine | Trichonil | Vanifall | Vanika;
  • (PL) Poland: Vaniqa;
  • (PR) Puerto Rico: Vaniqa;
  • (PT) Portugal: Ornidyl | Vaniqa;
  • (SE) Sweden: Vaniqa;
  • (TR) Turkey: Eflorin
  1. Priotto G, Kasparian S, Mutombo W, et al. Nifurtimox-eflornithine combination therapy for second-stage African Trypanosoma brucei gambiense trypanosomiasis: a multicentre, randomized, phase III, non-inferiority trial. Lancet. 2009;374(9683):56-64. doi: 10.1016/S0140-6736(09)61117-X. [PubMed 19559476]
  2. Vaniqa (eflornithine) [prescribing information]. Madison, NJ: Allergan USA Inc; January 2018.
Topic 143707 Version 6.0

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