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Terbinafine (topical): Drug information

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

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • FT Athletes Foot (Terbinafine) [OTC];
  • LamISIL AT Athletes Foot [OTC];
  • LamISIL AT Jock Itch [OTC] [DSC];
  • LamISIL AT [OTC] [DSC]
Brand Names: Canada
  • LamISIL
Pharmacologic Category
  • Antifungal Agent, Topical
Dosing: Adult
Cutaneous candidiasis

Cutaneous candidiasis (off-label use): Topical: Cream 1%: Apply to affected area once or twice daily for 1 to 2 weeks (Ref).

Tinea infection

Tinea infection:

Tinea corporis/tinea cruris (OTC labeling): Topical:

Cream 1%, solution (spray) 1% [Canadian product]: Apply to affected and surrounding area(s) once daily until clinical resolution, typically 1 week (Ref).

Tinea pedis (OTC labeling)/tinea manuum (off-label use): Topical:

Cream 1%, solution (spray) 1% [Canadian product]: Apply to affected and surrounding area(s) once or twice daily (cream) or once daily (spray) until 1 week after clinical resolution, typically for 2 weeks total (Ref).

Tinea versicolor (pityriasis versicolor) (off-label use): Topical:

Cream 1%, solution (spray) 1% [Canadian product]: Apply to affected area(s) and immediate surrounding skin twice daily for 1 to 2 weeks (Ref).

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Liver Impairment: Adult

The liver dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Matt Harris, PharmD, MHS, BCTXP, FAST, FCCP; Jeong Park, PharmD, MS, BCPS, FCCP, FAST; Arun Jesudian, MD, Sasan Sakiani, MD.

Note: Systemic absorption from topical administration is minimal (<5%).

Child-Turcotte-Pugh class A to C: Topical: No dosage adjustment necessary (Ref).

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Terbinafine (topical): Pediatric drug information")

Dosage guidance:

Dosage form information: Some dosage forms may not be available in the United States.

Tinea corporis

Tinea corporis (ringworm): Children and Adolescents: Limited data available in ages <12 years: Cream, solution (spray [Canadian product]): 1%: Topical: Apply to affected and surrounding area(s) once daily until clinical resolution, typically 1 to 2 weeks (Ref).

Tinea cruris

Tinea cruris (jock itch): Children and Adolescents: Limited data available in ages <12 years: Cream, solution (spray [Canadian product]): 1%: Topical: Apply to affected and surrounding area(s) once daily until clinical resolution, typically 1 to 2 weeks (Ref).

Tinea pedis

Tinea pedis (athlete's foot): Children and Adolescents: Limited data available in ages <12 years: Cream, solution (spray [Canadian product]): 1%: Topical: Apply to affected and surrounding area(s) once or twice daily until clinical resolution, typically 1 to 4 weeks (Ref).

Tinea versicolor

Tinea versicolor (pityriasis versicolor): Limited data available: Children ≥12 years and Adolescents: Topical: Cream, Solution (spray [Canadian product]): Apply to affected area(s) twice daily for 1 week; duration may be longer (eg, 2 to 4 weeks) depending on clinical response (Ref).

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Liver Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions

There are no adverse reactions listed in the manufacturer's labeling.

Contraindications

There are no contraindications listed within the US manufacturer's labeling.

Canadian labeling: Hypersensitivity to terbinafine or any component of the formulation

Warnings/Precautions

Concerns related to adverse events:

• Local irritation: If irritation/sensitivity develops, discontinue therapy and institute appropriate alternative therapy.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer's labeling.

Other warnings/precautions:

• Appropriate use: For topical use only. Not intended for ophthalmologic, oral, or vaginal administration. Do not use on nails or scalp.

Warnings: Additional Pediatric Considerations

Some dosage forms may contain propylene glycol; in neonates large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures and respiratory depression; use caution (AAP 1997; Shehab 2009).

Dosage Forms: US

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

Cream, External, as hydrochloride:

FT Athletes Foot (Terbinafine): 1% (30 g) [contains benzyl alcohol, cetyl alcohol]

LamISIL AT: 1% (12 g [DSC], 30 g [DSC], 42 g [DSC]) [contains benzyl alcohol, cetyl alcohol]

LamISIL AT Athletes Foot: 1% (30 g) [contains benzyl alcohol, cetyl alcohol]

LamISIL AT Jock Itch: 1% (12 g [DSC]) [contains benzyl alcohol, cetyl alcohol]

Generic: 1% (15 g, 30 g)

Generic Equivalent Available: US

Yes

Pricing: US

Cream (LamISIL AT Athletes Foot External)

1% (per gram): $0.49

Cream (Terbinafine HCl External)

1% (per gram): $0.54

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:

LamISIL: 1% (15 g, 30 g) [contains benzyl alcohol, cetyl alcohol]

Solution, External, as hydrochloride:

LamISIL: 1% (30 mL) [contains alcohol, usp, propylene glycol]

Administration: Adult

Topical:

Cream: Wash affected area with soap and water prior to use and dry completely; wash hands after use.

Solution (spray) 1% [Canadian product]: Cleanse and dry affected area prior to application. Spray sufficiently to wet the treatment area and to cover affected skin and surrounding area.

Administration: Pediatric

Topical: Cream, solution (spray [Canadian product]): For external use only; avoid contact with eyes or mouth. Do not use on nails, scalp, or for vaginal yeast infections. Apply to clean, dry affected and surrounding area(s) (eg, ~1 to 2 cm beyond lesions) in sufficient quantity to cover (Ref). Wash hands after use.

Solution (spray [Canadian product]): Cleanse and dry affected area prior to application. Spray sufficiently to wet the treatment area and to cover affected skin and surrounding area.

Use: Labeled Indications

Dermatologic fungal infections: Treatment of tinea pedis (athlete's foot), tinea cruris (jock itch), and tinea corporis (ringworm).

Use: Off-Label: Adult

Cutaneous candidiasis; Tinea manuum; Tinea versicolor (pityriasis versicolor)

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

LamISIL may be confused with LaMICtal

Terbinafine may be confused with terbutaline

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

Systemic absorption is limited following topical application. If antifungal treatment cannot be delayed until after pregnancy, topical therapy when appropriate may be considered (Kaul 2017).

Breastfeeding Considerations

Following oral administration, terbinafine is present in breast milk (refer to the Terbinafine [Systemic] monograph for additional information).

Systemic absorption is limited following topical application. Breastfeeding mothers should not apply topical formulations to the breast and infants should avoid contact with treated skin.

Mechanism of Action

Synthetic allylamine derivative that inhibits squalene epoxidase, a key enzyme in sterol biosynthesis in fungi. This results in a deficiency in ergosterol within the fungal cell membrane and results in fungal cell death.

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Limited (<5%)

Distribution: Distributed to sebum and skin predominantly

Half-life elimination: 14 to 35 hours

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

  • (AE) United Arab Emirates: Glenisil | Lamifen | Lamisil | Medisil | Negafen | Terfina;
  • (AR) Argentina: Antimicotico lauria | Fungueal | Lamisil | Maditez | Micoklon | Piecidex | Piecidex nf | Piecidex sec rapid | Repliderm | Silk medic | Sinamida Terbinafina | Tacna | Terbinafina richet | Terekol | Terfin;
  • (AT) Austria: Amykal | Lamisil | Mayfung Terbinafin | Terbiderm | Terbinafin Ratiopharm;
  • (AU) Australia: Apohealth terbinafine anti fungal | Chemists' Own Tamsil | Lamisil | Priceline pharmacy terbinafine hydrochloride | Solveasy tinea | Terbinafine | Tinasil;
  • (BD) Bangladesh: Anpar | Binafin | Derbicil | Derfin | Elvina | Infud | Lamisil | Mycofin | Mycofree | Skinabin | Telfin | Terbex | Terbifin | Terbikill | Terbimax | Terbin | Terbisol | Termider | Xfin;
  • (BE) Belgium: Lamisil | Terbinafine EG | Terbinafine Mylan;
  • (BF) Burkina Faso: Tallis | Terbinol | Terfin;
  • (BG) Bulgaria: Fungiter | Fungofin | Lamisil | Mycofin | Myconafine | Ternafin;
  • (BR) Brazil: Binafin | Cloridrato de terbinafina | Dakinzol | Finex | Funtyl | Lakesia pro | Lamisil | Lamisilate | Lorentil | Micosil | Micoter;
  • (CH) Switzerland: Fung x | Helvepedin | Lamisil | Lamisil Pedisan | Terbinafin Helvepharm | Terbinafin Mepha | Terbinafin zentiva | Tineafin;
  • (CI) Côte d'Ivoire: Lamisil | Teguma | Terfin;
  • (CL) Chile: Dermoxyl | Dicil | Elater | Finex | Lamisil | Micoset | Mucivil | Terbicil | Terbicrem | Terbimic | Terbinafina | Terfex;
  • (CN) China: Bi fu te | Ding ke | Lamisil | Lan mei shu | Mujonal | Shun feng kang ning;
  • (CO) Colombia: Bellex | Dermatidina | Enisol | Farbicil | Filut | Fincosix | Fungifeet | Fungofin | Fungyclean | Funide | Hongoderm | Hongofin | K Micot | Lamicol | Lamisil | Lamiterb | Silk medic | Telmisar | Terbifeet | Terbifin | Terbinafina | Terbinafina genfar | Termisil;
  • (CZ) Czech Republic: Lamisil | Terbisil;
  • (DE) Germany: Fungizid Extra | Lamisil | Terbiderm | Terbinafin 1 a pharma | Terbinafin abz | Terbinafin CT | Terbinafin HCL acis | Terbinafin sandoz | Terbinafinhyd Stada | Terbinafinhydro AL | Terbisil;
  • (DK) Denmark: Finigen;
  • (DO) Dominican Republic: Farbicil | Fungoter | Lamisil | Micostop | Mycelvan | Secalia t | Terbix | Terekol;
  • (EC) Ecuador: Beralfina | Clorhidrato de terbinafina | Dermicina | Dermoxil | Dermoxyl | Dicil | Donter | Finex | Funcor | Funide | Lamisil | Medigener feet | Micostop | Micozone | Nodorex | Omax | Pulvaterb | Silka medic | Solutot | Terbifin | Terbifung | Terbilazar | Terbinafina | Terbinafina clorhidrato | Terbinafina genamerica | Terbinox | Terbisil | Terbitinea | Terbix | Terfex | Terfin | Terfinamed | Tevir | Vardenil;
  • (EE) Estonia: Lamisil | Terbinafin Ratiopharm | Terbisil | Terbital;
  • (EG) Egypt: Benafin | Fungiban | Fungisafe | Fungistate | Lamifen | Lamisil | Mycopedis | Terbecomasil | Terbifungin | Terbin | Unitopfin;
  • (ES) Spain: Fongeal | Lamicosil | Lamisil | Scholmed | Terbinafina Combix | Terbinafina SSL;
  • (ET) Ethiopia: Lamisil | Terbinafine;
  • (FI) Finland: Fungis | Fungorin | Lamisil | Lamisil consumer | Terbinafin Ratiopharm | Terbistada;
  • (FR) France: Lamisil | Lamisilate | Terbinafine Actavis | Terbinafine Arrow | Terbinafine biogaran | Terbinafine EG | Terbinafine Mylan | Terbinafine Pierre Fabre;
  • (GB) United Kingdom: Boots athlete's foot | Clearfeet athletes foot | Cuplex Athlete's Foot | Lamisil | Lamisil at | Lamisil gsl | Terbinafine;
  • (GR) Greece: Anaplas | Chemiderm | Counter fungus | Demsil | Ealk | Lamisil | Romiver | Teranfis | Terbigram | Terbin | Terbinafine | Terbinafine/anfarm | Terbiprol | Terbiskin | Termisil | Thateron;
  • (HK) Hong Kong: Advance antifungal | Hc terbinafine | Interbi | Lamisil | Lisim | Muzona | Namisil | Orlasil | Otosil | Probisil | Rosilen | Terbifin | Terbinafin | Terbinsil | Terfine | Ternabin;
  • (HR) Croatia: Atere | Lamisil;
  • (HU) Hungary: Lamisil | Terbinafin wagner | Terbisil;
  • (ID) Indonesia: Interbi | Lamisil | Termisil;
  • (IE) Ireland: Fungasil | Lamisil | Lamisil at | Lanafine;
  • (IL) Israel: Lamisil;
  • (IN) India: Abzorb t | Acbro | Af-ter | Daskil | Dermafine | Elifin | Exifine | Finbinta | Finlin | Fintrix | Fungotek | Gris odt | Hifen | Ifin | Lamifin | Lamisil | Mycofem | Octerb | Phyte | Sebifin | Tebif | Tebina | Tef | Teraderm | Terbest | Terbicip | Terbicrat | Terbiderm | Terbiforce | Terbikem | Terbin | Terbinator | Terbinext | Terbinyl | Terbit | Terbitotal | Terbized | Terbo | Terbocet | Terbofin | Terbol | Terbosil | Terfast | Terfaze | Terfung | Tergosil | Terisoft | Tersig | Terzide | Tetmosol plus | Tfine | Tinabine | Tinafin | Tinafix | Topcos | Trfy | Turfine | Tyza dp | Wafine | Zimig | Zoterb;
  • (IT) Italy: Daskil | Lamisil | Terbinafina EG;
  • (JO) Jordan: Lamifen | Lamisil | Solveasy tinea | Terfinil | Tinasil;
  • (JP) Japan: Kelger | Lamisil | Lamisil at | Ramitect | Spastop t | Tebeana | Tebinaceil | Terbinafine | Terbinafine HCL | Terbinafine Hcl Fuji | Terbinafine hydrochloride f | Terbinafine hydrochloride iwaki | Terbinafine hydrochloride nichiiko | Terbinafine hydrochloride towa | Terfinabine | Termisil | Viras;
  • (KE) Kenya: Binter | Dermafin | Fungifin | Fungiter | Lamifen | Lamisil | Mycofin | Oncosil | Terbex | Terbifin | Terbifre | Terbin | Terbinol | Terbisil | Terbized | Termider;
  • (KR) Korea, Republic of: Anyzon | Bacxil | Balmood | Balmud | Baregen | Barfin | Bargio | Bensnazole | Binafin | Br terbin | Curasil | Denasil | Dernasil | Foot fine | Fulcare plus | Hanival | Hanshin terapin | Iksu temuzol | Infoot | J terbin | Jw terbinafine | Labijin | Labizin | Lamilex | Lamipin | Lamisil | Laniten | Lapiderm | Lavina | Lespo | Limecin | Lonasil | Losinol | Maltice | Micasil | Micosil | Moojo pin | Mudis | Mujonal | Murazol | Murazol derm | Muzolasil | Muzome | Muzomen | Muzona | Muzonal | Nabisil | Namigin | Namijin | Namisol | Namuzole | Nanisil | Nanisill | Narbi | Narvi | Natocil | Nelson Terbinafine Hcl | Newpang | Nobaron | Nomusol | Ok | Otenol | Ronacildom | Ronasil | Rosil | Rosile | Sang a terbinafine | Sendasil | Sentoes | Serina | Tanasil | Telami | Temisil | Tenaban | Tenafine | Tenapine | Tenasil | Tenazol | Terbellmi | Terbin | Terbina | Terbinafine | Terbincool | Terbine | Terbinew | Terbinex | Terbizol | Tercen | Terfin | Termina | Termisil | Ternabin | Ternabine | Ternapin | Ternazole | Terzol | Tinasil | Tinisil | Trico | Virnosil;
  • (KW) Kuwait: Lamisil | Negafen | Solveasy tinea;
  • (LB) Lebanon: Fungur | Lamifen | Laminox | Lamisil | Terafan;
  • (LT) Lithuania: Lamisil | Terbinafin bijon | Terbinafin Ratiopharm | Terbinafine Actavis | Terbisil | Terbital;
  • (LU) Luxembourg: Fungizid Extra | Lamisil;
  • (LV) Latvia: Lamisil | Terbinafin actavis | Terbinafin Ratiopharm | Terbisil | Terbital;
  • (MA) Morocco: Dermafine | Lamisil | Lifongid | Onifine | Teguma | Terix;
  • (MX) Mexico: Binafex | Derman f uno | Erbitrax | Finmilex | Fyterdin | Hudiclor | Lamisil | Lamisil at | Losil c | Losil s | Mycelvan | Nafich | Polcrim | Rixoba | Silka medic | Terbinafina | Terbinafina gi pha | Terbinafina gi ser | Unasal | Xilatril | Zinfhon | Zonconax;
  • (MY) Malaysia: Binafin | Binafine | Binter | Creobic Gold | Dermafin | Finab | Freederm | Fungotek | Itch guard plus | Lamisil | Nafine | Otenol | Tefin | Terbicip | Terbin | Ternafin;
  • (NG) Nigeria: Lamisil | Tabasil | Tydisilxtra | Vpl terbinafine;
  • (NL) Netherlands: Lamisil | Terbinafine HCl A | Terbinafine HCl CF | Terbinafine Mdq;
  • (NO) Norway: Lamisil | Terbinafin | Terbinafin hexal | Terbinafinhydroklorid norfri;
  • (NZ) New Zealand: Ethics athlete's foot cream | Ethics dermafex | Lamisil | Solveasy tinea | Terbinafine;
  • (PE) Peru: Betamiderm | Dermoxyl | Finex | Funide | Hongofin | Hongokil | Hongonicol | Isana | Lafi til 7 | Lamidizol | Lamisil | Micofinal | Micomisil | Micosolin | Micostop | Micoterat | Micoterbin | Silka medic | Terbicel | Terbifun | Terbilab | Terbimass | Terbinafina | Terbisil | Terbispor | Terfex | Terfitil | Term;
  • (PH) Philippines: Amizil | Dermifene | Lamifen | Lamisil | Terbinafine HCL;
  • (PK) Pakistan: Ademac | Benasil | Bina | Binalfine | Binaz | Bluwin | Caweda | Cutis | Daskil | Exinofin | Fesmogen | Funasole | Fungi rid | Hybinaf | Karisil | Lamisil | Monofin | Mycoderm | Mycostin | Novaterafine | Qtec | Retipro | Terbiderm | Terbilet | Terbimax | Terbin | Terbisan | Terbisil | Terbitec | Terbix | Terbizor | Termi | Ternafine | Tersil | Tinea;
  • (PL) Poland: Lamifortan active | Lamisilatt | Myconafine | Tenasil | Terbiderm | Terbilum | Terbinafina ziaja | Terbistad | Tersilat | Undofen max;
  • (PR) Puerto Rico: Lamisil | Lamisil At Cures Jock Itch | Lamisil jock itch | Lamisil odor guard | Terbinafine | Terbinafine HCL;
  • (PT) Portugal: Fungur | Lamisil | Silbiter | Terbinafina aristo | Termycol;
  • (PY) Paraguay: Finex | Fungosel | Lamisil | Limpex | Mircol | Piecidex | Terbimax | Terfin;
  • (QA) Qatar: Lamifen | Laminox | Lamisil | Lamisil AT | Lamisil Dermgel | Medisil | Negafen | Terfina | Turbosil;
  • (RO) Romania: Fungisil mk | Taficen | Terbisil;
  • (RU) Russian Federation: Atifin | Binafin | Bramizil | Eco terbin | Exifine | Exiter | Fungoterbine | Lamifungin | Lamisil | Lamitel | Miconorm | Tebikur | Terbifin | Terbinafine | Terbinafine canon | Terbinox | Terbisil | Terbix | Terbized | Termicon | Ungusan;
  • (SA) Saudi Arabia: Lamifen | Lamisil | Negafen | Riatebifine | Terfina;
  • (SE) Sweden: Funginix | Lamisil | Terbinafin abece | Terbinafin actavis | Terbinafin apofri | Terbinafin Ratiopharm | Terbisil;
  • (SG) Singapore: Dermafin | Lamisil | Lisim;
  • (SI) Slovenia: Atifan | Lamisil;
  • (SK) Slovakia: Lamisil | Terbinafin actavis | Terbisil | Terbistad;
  • (SR) Suriname: Terbinafine hcl sam | Terbinafine Mylan | Terbisil;
  • (TH) Thailand: Eu 2000 | Lamisil;
  • (TN) Tunisia: Lamisil | Onycal | Tallis | Terbisil | Tercyd | Tinasil;
  • (TR) Turkey: Corbinal | Laminox | Lamisil | Mikonafin | Mycocur | Tekfin | Terbin | Terbisil | Terbonile | Terminus;
  • (TW) Taiwan: A.M.S | Anti-fungus | B fine | Balmood | Binafine | Chi fungus | Chinasu | Defungals | Ethersu | Foot relief | Fultrix | Fungi-x | Fungitech | Jye Mei | Kangmeishu | Lafin | Lamifine | Lamisil | Lemarso | Lisim | Lomafine | Lomi | Misymia | Nafin | Perlafin | Shin shin terbinafine | Shu mei fen | Terbanin | Terbifin | Terbifungi | Terbimed | Terbin | Terbina | Terbinafine | Terbisil | Terfine | Terfung | Terlamine | Terneat | Yuga;
  • (UA) Ukraine: Binafin | Exifine | Fungotec | Fungotek | Fungoterbine | Lamicon dermgel | Lamiderm | Lamifen | Lamisil | Micozil | Mycofin | Myconorm | Terbinorm | Terbinox | Terbisil | Terfin;
  • (UG) Uganda: Binafin | Fungisafe | Lamifen | Lamisil | Niofine | Terbicon | Terbiderm | Terbinol;
  • (UY) Uruguay: Lamisil | Terbimax | Terbinafina | Terfenam | Terfin | Terfiren;
  • (VE) Venezuela, Bolivarian Republic of: Farbicil | Funtopic | Lamisil | Losil c | Nafina | Perten | Terbicrym | Terbinafina | Terfex;
  • (VN) Viet Nam: Bunpil | Fitneal | Philtenafin | Tri genol;
  • (ZA) South Africa: Almatil | Lamisil | Terbane | Terbaspor | Terbicil;
  • (ZM) Zambia: Terbact | Terbane | Terbicip | Terbofin;
  • (ZW) Zimbabwe: Lamisil | Terbifin
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