Naftin

Generic Name: Naftifine Hydrochloride
Class: Allylamines
ATC Class: D01AE22
VA Class: DE102
Chemical Name: (E)-N-Methyl-N-(3-phenyl-2-propenyl)-1-naphthalenemethanamine hydrochloride
Molecular Formula: C₂₁H₂₁N•HCl
CAS Number: 65473-14-5

Introduction

Antifungal; synthetic allylamine structurally and pharmacologically related to terbinafine.^{1 3 4 5 9 11 13 14 16 21 22 23 25 29 31 35 36 37 38 41 42 43 48 63 64 65 66 67 68 69}

Uses for Naftin

Dermatophytoses

Treatment of tinea corporis (body ringworm)^{1 22 39 46 48 49 50 51 54 55 63} and tinea cruris (jock itch)^{1 22 23 39 45 48 49 50 51 54 55 63} caused by Epidermophyton floccosum,^{1 39 45 47 49 50 51 53 63} Microsporum canis†,^{49 50 55} Trichophyton mentagrophytes,^{1 39 47 49 50 51 53 55 63} T. rubrum,¹ T. tonsurans,^a T. verrucosum†,^{50 51 53} or T. violaceum†.⁵⁰

Treatment of tinea pedis (athlete's foot)^{1 15 28 47 48 49 51 54 55 63} or tinea manuum†^{51 54 55} caused by Epidermophyton floccosum,^{1 39 45 47 49 50 51 53 63} Microsporum canis†,^{49 50 55} Trichophyton mentagrophytes,^{1 39 47 49 50 51 53 55 63} T. rubrum,¹ T. tonsurans,^a T. verrucosum†,^{50 51 53} or T. violaceum†.⁵⁰

Topical antifungals usually effective for treatment of uncomplicated tinea corporis and tinea cruris.^{69 70 71 72 73} An oral antifungal may be necessary when tinea corporis or tinea cruris is extensive, dermatophyte folliculitis is present, the infection is chronic or does not respond to topical therapy, or the patient is immunocompromised because of coexisting disease or concomitant therapy.^{69 70 71 72 73}

Topical antifungals usually effective for treatment of uncomplicated tinea pedis.^{69 70 71 72 73} An oral antifungal may be necessary for the treatment of hyperkeratotic areas on the palms and soles,^{70 73} for chronic moccasin-type (dry-type) tinea pedis,^{69 70 72} and for tinea unguium (fingernail or toenail dermatophyte infections, onychomycosis).^{69 70 71 72}

Gel has been used in the treatment of tinea unguium (onychomycosis)†.⁵⁷

Cutaneous Candidiasis†

Treatment of cutaneous candidiasis† caused by Candida albicans.^{47 50 51 53 54 55 56 62} Less active than imidazole derivatives.^{36 37 56}

Naftin Dosage and Administration

Administration

Topical Administration

Apply topically to the skin as a cream or gel.^{1 63}

Do not apply to the eye, nose, mouth, or other mucous membranes.^{1 63}

Do not use with occlusive dressings or wrappings, unless otherwise directed by clinician.^{1 63}

Apply a sufficient amount of topical cream or gel; rub gently into the affected area and surrounding skin.^{1 22 33 39 46 47 49 50 51 53 54 60 63}

Wash hands after applying.^{1 63}

Dosage

Available as naftifine hydrochloride; dosage expressed in terms of naftifine.^a

Adults

Dermatophytoses

Tinea Corporis or Tinea Cruris

Topical

Cream: Apply once daily for 2–4 weeks.^{1 15 22 25 33 39 45 46 49 53 54 60}

Gel: Apply twice daily (morning and evening) for 2–4 weeks.^{22 25 39 45 46 49 a}

Clinical improvement usually occurs within the first week of treatment.^{22 25 39 45} If clinical improvement does not occur after 4 weeks of treatment, reevaluate diagnosis.^{1 63} Severe infections may require prolonged treatment.^{50 60 61}

Tinea Pedis

Topical

Cream: Apply once daily for 4–6 weeks.^{1 15 22 15 25 33 39 45 46 47 49 53 54 60}

Gel: Apply twice daily (morning and evening) for 4–6 weeks.^{15 22 25 39 45 46 47 49 a}

Clinical improvement usually occurs within the first week of treatment.^{22 25 39 45} If clinical improvement does not occur after 4 weeks of treatment, reevaluate diagnosis.^{1 63} Severe infections may require prolonged treatment.^{50 60 61}

Special Populations

No special population dosage recommendations at this time.^a

Cautions for Naftin

Contraindications

• 
  

  Known hypersensitivity to naftifine or any ingredient in the formulation. ^{1 63}

  
  

Warnings/Precautions

Warnings

Administration Precautions

For external use only.^{1 63} Use only for topical application to the skin; not for ophthalmic use.^{1 63}

Avoid contact with eyes, nose, mouth, and other mucous membranes.^{1 63}

Sensitivity Reactions

Contact dermatitis has been reported occasionally.^{20 39 49 54 56}

If irritation or sensitivity occurs, discontinue drug and initiate appropriate therapy.^{1 63}

General Precautions

Selection and Use of Antifungals

Prior to use, confirm diagnosis by direct microscopic examination of scrapings from infected tissue mounted in potassium hydroxide (KOH) or by culture.^{1 63}

Specific Populations

Pregnancy

Category B.^a

Lactation

Not known whether distributed into milk following topical application.^{1 63} Use with caution.^{1 63}

Pediatric Use

Safety and efficacy not established.^a

Common Adverse Effects

Burning, stinging.^{1 22 32 39 46 47 50 51 55 63}

Interactions for Naftin

No formal drug interaction studies to date.

Naftin Pharmacokinetics

Absorption

Bioavailability

Following topical application, approximately 3–6% absorbed.^{1 43 63}

Distribution

Extent

Not known whether naftifine crosses the placenta.⁶⁰

Distributed into milk in rats; not known whether distributed into human milk.^{1 43 60 63}

Elimination

Metabolism

Metabolized by oxidation and by N-dealkylation.¹⁸

Elimination Route

Systemically absorbed drug excreted in urine (40–60%) as unchanged drug and metabolites and in feces.^{1 18 43 63}

Half-life

2–3 days.^{1 60 63}

Stability

Storage

Topical

Cream

<30°C;¹ cream is stable for 24 months after the date of manufacture.⁶⁰

Gel

Room temperature.⁶³

Actions and SpectrumActions

• 
  

  Allylamine antifungal.^{1 3 4 5 9 11 13 14 16 21 22 23 25 29 31 35 36 37 38 41 42 43 48 63}

  
  


• 
  

  Usually fungicidal against susceptible dermatocytes.^{1 9 14 41 42} Usually fungistatic against Candida; may be fungicidal at high concentrations.^{1 3 9 14 41 42}

  
  


• 
  

  Exact mechanism unknown; ^{1 3 11 16 41 43} appears to interfere with sterol biosynthesis by inhibiting the enzyme squalene monooxygenase (squalene 2,3-epoxidase).^{1 11 13 14 16 21 41 43} The resulting accumulation of squalene (the usual substrate of the enzyme) in the cells and decreased amounts of sterols, especially ergosterol,^{1 3 10 11 16 41} may contribute to the antifungal effects.⁴¹

  
  


• 
  

  Spectrum of antifungal activity includes many fungi, including dermatophytes and yeasts.^{1 2 3 4 5 8 9 12 22 23 31 37 42} Also may have in vitro activity against some gram-positive and -negative bacteria,^{58 60 61} and Leishmania.²⁷

  
  


• 
  

  Candida: Active in vitro against Candida albicans,^{1 3 4 12 36} C. krusei,⁴ C. parapsilosis,^{4 12 31 41} and C. tropicalis;¹² however, less active than imidazole derivatives against Candida.^{36 37 56}

  
  


• 
  

  Dermatophytes and other fungi: Active in vitro against Aspergillus flavus,¹² A. fumigatus,¹² Blastomyces dermatitidis,¹² Cryptococcus neoformans,¹² Epidermophyton floccosum,^{1 4 8 12 38 42} Histoplasma capsulatum,¹² Microsporum audouinii,¹ M. canis,^{1 8 38 42} M. gypseum,^{1 8} Petriellidium boydii,¹² Sporothrix schenckii,^{4 12} Trichophyton mentagrophytes,^{1 2 8 38 41 42} T. rubrum,^{1 8 38 42} T. tonsurans,^{1 38} T. verrucosum,⁴² and T. violaceum.^{8 38}

  
  


• 
  

  Also has anti-inflammatory activity when applied topically.^{51 52}

  
  


• 
  

  No reports to date of resistance in organisms originally susceptible to naftifine.^{60 61}

  
  

Advice to Patients

• 
  

  Importance of completing full course of treatment, even if symptoms improve.¹

  
  


• 
  

  Importance of contacting clinician if improvement does not occur within 4 weeks.^{1 63}

  
  


• 
  

  Importance of notifying clinician if condition worsens or treated area shows signs of increased irritation.^a

  
  


• 
  

  Importance of applying to affected areas as directed and avoiding contact with eyes, nose, mouth, or other mucous membranes.^{1 63}

  
  


• 
  

  Advise patients to wash their hands after touching the affected areas.^a

  
  


• 
  

  Importance of not using occlusive dressings, unless otherwise directed by clinician.^{1 63}

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.^a

  
  


• 
  

  Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.^a

  
  


• 
  

  Importance of informing patients of other important precautionary information. (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Naftifine Hydrochloride

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Topical	Cream	1%	Naftin (with benzyl alcohol)	Merz
	Gel	1%	Naftin (with alcohol 52% v/v)	Merz

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Naftin 1% Cream (MERZ PHARMACEUTICAL): 30/$109.99 or 90/$285.96

Naftin 1% Cream (MERZ PHARMACEUTICAL): 60/$190 or 180/$559.94

Naftin 1% Cream (MERZ PHARMACEUTICAL): 90/$239.98 or 270/$676

Naftin 1% Gel (MERZ PHARMACEUTICAL): 40/$155.99 or 120/$435.96

Naftin 1% Gel (MERZ PHARMACEUTICAL): 90/$269.99 or 270/$769.94

Naftin 1% Gel (MERZ PHARMACEUTICAL): 60/$216 or 180/$589.99

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions January 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Allergan. Naftin (naftifine hydrochloride) 1% cream prescribing information (dated 1996). In: Physicians’ desk reference. 53rd ed. Montvale, NJ: Medical Economics Company Inc; 1999:501-2.

2. Meingassner JG, Sleytr U, Petranyi G. Morphological changes induced by naftifine, a new antifungal agent, in Trichophyton mentagrophytes. J Invest Dermatol. 1981; 77:444-51. [IDIS 141591] [PubMed 7310168]

3. Ryder NS, Seidl G, Troke PF. Effect of the antimycotic drug naftifine on growth of and sterol biosynthesis in Candida albicans. Antimicrob Agents Chemother. 1984; 25:483-7. [IDIS 184282] [PubMed 6375557]

4. Georgopoulos A, Petranyi G, Mieth H et al. In vitro activity of naftifine, a new antifungal agent. Antimicrob Agents Chemother. 1981; 19:386-9. [IDIS 134653] [PubMed 7247366]

5. Kerridge D. Mode of action of clinically important antifungal drugs. Adv Microbiol Physiol. 1986; 27:1-64.

6. Dittmar W, Jovic N. Laboratory techniques alternative to in vivo experiments for studying the liberation, penetration and fungicidal action of topical antimycotic agents in the skin, including ciclopiroxolamine. Mykosen. 1987; 30:326-42. [PubMed 3657856]

7. Gehse M, Kuster S, Gloor M. On the effective dimension of inhibition of ciclopiroxolamine and naftifine in the horny layer with regard to the galenic preparation. Mykosen. 1987; 30:322-5. [PubMed 3657855]

8. Regli P, Ferrari H, Buffard Y et al. In vitro activity of naftifine, a new antifungal agent, against dermatophytes. Path Biol. 1985; 33:614-7.

9. Petranyi G, Georgopoulos A, Mieth H. In vivo antimycotic activity of naftifine. Antimicrob Agents Chemother. 1981; 19:390-2. [PubMed 7247367]

10. Georgopapadakou NH, Dix BA, Smith SA et al. Effect of antifungal agents on lipid biosynthesis and membrane integrity in Candida albicans. Antimicrob Agents Chemother. 1987; 31:46-51. [PubMed 3551826]

11. Ryder NS. Specific inhibition of fungal sterol biosynthesis by SF 86-327, a new allylamine antimycotic agent. Antimicrob Agents Chemother. 1985; 27:252-6. [PubMed 4039119]

12. Shadomy S, Espinel-Ingroff A, Gebhart RJ. In- vitro studies with SF 86-327, a new orally active allylamine derivative. Sabouraudia. 1985; 23:125-32. [PubMed 2990057]

13. Petranyi G, Ryder NS, Stutz A. Allylamine derivatives: new class of synthetic antifungal agents inhibiting fungal squalene epoxidase. Science. 1984; 224:1239-41. [PubMed 6547247]

14. Ryder NS. Effect of allylamine antimycotic agents on fungal sterol biosynthesis measured by sterol side-chain methylation. J Gen Microbiol. 1985; 131:1595-1602. [PubMed 3900280]

15. Bojanovsky VA, Haas P. Antimycotic effect of naftifine in tinea pedis: comparative double-blind study with bifonazole. Fortschr Med. 1985; 103:677-9. [PubMed 3897005]

16. Ryder NS, Dupong MC. Inhibition of squalene epoxidase by allylamine antimycotic compounds. Biochem J. 1985; 230:765-70. [PubMed 3877503]

17. Grimus RC, Schuster I. The role of the lymphatic transport in the enteral absorption of naftifine by the rat. Xenobiotica. 1984; 14:287-94. [PubMed 6464498]

18. Schatz F, Haberl H, Battig F et al. Major routes of naftifine biotransformation in laboratory animals and man. Arzneimittelforschung. 1986; 36:248-55. [PubMed 3964331]

19. Schatz F, Haberl H. Analytical methods for the determination of naftifine and its metabolites in human plasma and urine. Arzneimittelforschung. 1986; 36:1850-3. [PubMed 3566849]

20. Hoting VE, Kuchmeister B, Hausen BM. Allergic contact dermatitis from naftifine. Dermatosen. 1987; 35:124-7.

21. Hay RJ. Recent advances in the management of fungal infections. Quart J Med. 1987; 244:631-9.

22. Millikan LE, Galen WK, Gewirtzman GB et al. Naftifine cream 1% versus econazole cream 1% in the treatment of tinea cruris and tinea corporis. J Am Acad Dermatol. 1988; 18:52-6. [PubMed 3279083]

23. Ganzinger U, Stutz A, Petranyi G et al. Allylamines: topical and oral treatment of dermatomycoses with a new class of antifungal agents. Acta Derm Venerol (Stockh). 1986; 121:155-60.

24. Hira SK, Abraham MS, Mwinga A et al. Naftifine solution (1%) in the treatment of pityriasis versicolor in Zambia. Mykosen. 1986; 29:378-81. [PubMed 3531847]

25. Zaun H, Liszpinski P. Multicentric double-blind contralateral comparision of naftifine- and clotrimazole-cream in patients with dermatophytosis or Candidosis. Z Hautkr. 1984; 59:1209-17. [PubMed 6388169]

26. Bechter R, Schmid B, Mayer FK. Teratogenic potential of antimycotic drugs evaluated in the whole- embryo culture system. Food Chem Toxicol. 1986; 24:641-2.

27. Berman JD, Gallalee JV. In vitro antileishmanial activity of inhibitors of steroid biosynthesis and combinations of antileishmanial agents. J Parasitol. 1987; 73:671-3. [PubMed 3037057]

28. Klaschka F, Gartmann H, Weidinger G. Antimycotic naftifine: placebo-controlled comparison in tinea pedum. Z Hautkr. 1984; 59:1218-25. [PubMed 6388170]

29. Bechter R, Schmid BP. Teratogenicity in vitro: a comparative study of four antimycotic drugs using the whole-embryo culture system. Toxicol in Vitro. 1987; 1:11-5. [PubMed 20702373]

30. Schuster I. The interaction of representative members from two classes of antimycotics—the azoles and the allylamines—with cytochromes P-450 in steroidogenic tissues and liver. Xenobiotica. 1985; 15:529-46. [PubMed 4036174]

31. Meingassner JG, Sleytr UB. The effects of naftifine on the ultrastructure of Candida parapsilosis: a freeze fracture study. Sabouraudia. 1982; 20:199-207. [PubMed 7135143]

32. Hantschke D, Reichenberger M. Double blind, randomized in vivo investigations comparing the antifungals clotrimazole, tolnaftate and naftifine. Mykosen. 1980; 23:657-68. [PubMed 7012610]

33. Meinicke K, Striegel C, Weidinger G. Treatment of dermatomycoses with naftifine: therapeutic efficacy after once-a-day and twice-a-day application. Mykosen. 1984; 27:608-14. [PubMed 6395017]

34. Nolting S, Weidinger G. Naftifine in severe dermatomycosis: econazole-controlled therapeutic comparison. Mykosen. 1983; 28:69-76.

35. Stutz A, Georgopoulos A, Granitzer W et al. Synthesis and structure-activity relationships of naftifine-related allylamine antimycotics. J Med Chem. 1986; 29:112-25. [PubMed 3510297]

36. Schaude M, Ackerbauer H, Mieth H. Inhibitory effect of antifungal agents on germ tube formation in Candida albicans. Mykosen. 1987; 30:281-7. [PubMed 3306370]

37. Cauwenbergh G. New and prospective developments in antifungal drugs. Acta Derm Venereol (Stockh). 1986; 121:147-53.

38. Faruqi AH, Khan KA, Qazi AA et al. In vitro antifungal activity of naftifine: (SN 105-843 GEL) against dermatophytes. J Pakistan Med Assoc. 1981; 31:279-82.

39. Lee CT, Giam YC, Tan T. The use of naftifine (Exoderil) cream in the treatment of dermatophytosis. Singapore Med J. 1987; 28:429-31. [PubMed 3324355]

40. Stuttgen G. Biopharmaceutical aspects of topically applied antifungal treatment. Mykosen. 1987; 30(Suppl 1):7-14.

41. Ivessa E, Daum G, Paltauf F. Mechanism of action of naftifine. Mykosen. 1987; 30(Suppl 1):15-21.

42. Petranyi G. Preclinical evaluation of Exoderil (naftifine). Part I. Results of experimental studies of the antifungal activity profile. Mykosen. 1987; 30(Suppl 1):22-7.

43. Czok R. Preclinical evaluation of Exoderil (naftifine). Part II. Mechanism of action, absorption, metabolism and excretion. Mykosen. 1987; 30(Suppl 1):28-31. [PubMed 3550458]

44. Obenaus H, Schon H. Preclinical evaluation of Exoderil (naftifine). Part III. Summary of results of toxicological studies. Mykosen. 1987; 30(Suppl 1):32-7.

45. Gip L, Brundin G. A double-blind, two group multicentre study, comparing naftifine 1% cream with placebo cream in the treatment of tinea cruris. Mykosen. 1987; 30:(Suppl 1)38-41.

46. Zaun H, Luszpinski P. Antifungal treatment of hospital inpatients: left versus right study to compare naftifine and clotrimazole. Mykosen. 1987; 30(Suppl 1):42-8.

47. Haas PJ, Tronnier H, Weidinger G. Naftifine in tinea pedis: double-blind comparison with clotrimazole. Mykosen. 1987; 30(Suppl 1):50-6.

48. Maibach HI. Naftifine: dermatotoxicology and clinical efficacy. Mykosen. 1987; 30(suppl 1):57-62. [PubMed 3553928]

49. Kagawa S. Comparative clinical trial of naftifine and clotrimazole in tinea pedum, tinea cruris and tinea corporis. Mykosen. 1987; 30(Suppl 1):63-9.

50. Nolting S, Weidinger G. Naftifine in severe dermatomycoses: econazole-controlled therapeutic comparison. Mykosen. 1987; 30(Suppl 1):70-7.

51. Tronnier H. Inflammatory dermatomycoses: comparative study of naftifine and a combination of a corticosteroid and an imidazole derivative. Mykosen. 1987; 30(Suppl 1):78-87.

52. Jung EG. The anti-inflammatory efficacy of naftifine as evaluated from the erythema response to ultraviolet light. Mykosen. 1987; 30(Suppl 1):88-91.

53. Polemann G. Antifungal efficacy of naftifine applied once-daily. Mykosen. 1987; 30(Suppl 1):92-7.

54. Meinicke K, Striegel C, Weidinger G. Treatment of dermatomycoses with naftifine: therapeutic efficacy on application once daily and twice daily. Mykosen. 1987; 30(Suppl 1):98-103.

55. Effendy I, Friederich HC. Double-blind, randomized comparative study of naftifine solution (once daily) and clotrimazole solution (twice daily) in the treatment of dermatomycoses. Mykosen. 1987; 30(Suppl 1):104-11.

56. Paetzold OH, Engst R, Kneist W et al. Yeast infections of the skin: comparative double-blind therapeutic trial with naftifine and clotrimazole. Mykosen. 1987; 30(Suppl 1):112-8.

57. Klaschka F. Treatment of onychomycosis with naftifine gel. Mykosen. 1987; 30(Suppl 1):119-23.

58. Nolting S. Investigation of the antibacterial effect of the antifungal agent naftifine: left versus right clinical comparative study between naftifine and gentamycin in pyoderma. Mykosen. 1987; 30(Suppl 1):124-8.

59. Anon. Topical neomycin. Med Lett Drugs Ther. 1973; 15:101-2. [PubMed 4765413]

60. Houser E (Herbert Laboratories, Irvine, CA): Personal communication; 1988 Dec.

61. Reviewers’ comments (personal observations); 1988 Dec.

62. Zaias N, Astorga E, Cordero CN et al. Naftifine cream in the treatment of cutaneous candidiasis. Cutis. 1988; 42:238-40. [PubMed 3048914]

63. Allergan. Naftin (naftifine hydrochloride) 1% gel prescribing information (dated 1996). In: Physicians’ desk reference. 53rd ed. Montvale, NJ: Medical Economics Company Inc; 1999:502.

64. Greer DL, Jolly HW Jr. Treatment of tinea cruris with topical terbinafine. J Am Acad Dermatol. 1990; 23:800-4. [PubMed 2229527]

65. Shear NH, Villars VV, Marsolais C. Terbinafine: an oral and topical antifungal agent. Clin Dermatol. 1992; 9:487-95.

66. Lyman CA, Walsh TJ. Systemically administered antifungal agents: a review of their clinical pharmacology and therapeutic applications. Drugs. 1992; 44:9-35. [PubMed 1379913]

67. Anon. Topical terbinafine for tinea infections. Med Lett Drugs Ther. 1993; 35:76-8. [PubMed 8341207]

68. Smith EB. Topical antifungal drugs in the treatment of tinea pedis, tinea cruris, and tinea corporis. J Am Acad Dermatol. 1993; 28(5 Part 1):S24-8. [PubMed 8496408]

69. Gupta AK, Einarson TR, Summerbell RC et al. An overview of topical antifungal therapy in dermatomycoses: a North American perspective. Drugs. 1998; 55:645-74. [PubMed 9585862]

70. Piérard GE, Arrese JE, Piérard-Franchimont C. Treatment and prophylaxis of tinea infections. Drugs. 1996; 52:209-24. [PubMed 8841739]

71. Lesher JL. Recent developments in antifungal therapy. Dermatol Clin. 1996; 14:163-9. [PubMed 8821170]

72. Hay RJ. Dermatophytosis and other superficial mycoses. In: Mandel GL, Douglas RG Jr, Bennett JE, eds. Principles and practices of infectious disease. 4th ed. New York: Churchill Livingston; 1995: 2375-86.

73. Drake LA, Dincehart SM, Farmer ER et al. Guidelines of care for superficial mycotic infections of the skin: tinea corporis, tinea cruris, tinea faciei, tinea manuum, and tinea pedis. J Am Acad Dermatol. 1996; 34:282-6. [IDIS 363962] [PubMed 8642094]

74. Reviewers’ comments (personal observations) on Sulconazole 84:04.08.

a. Merz Pharmaceuticals. Naftin (naftifine hydrochloride 1%) gel and cream prescribing information. Greensboro, NC; 2007 May.

More Naftin resources

• Naftin Side Effects (in more detail)
• Naftin Use in Pregnancy & Breastfeeding
• Naftin Support Group
• 0 Reviews for Naftin - Add your own review/rating

• Naftin Prescribing Information (FDA)


• Naftin Concise Consumer Information (Cerner Multum)


• Naftin Topical Advanced Consumer (Micromedex) - Includes Dosage Information


• Naftin Cream MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Naftin with other medications

• Tinea Corporis
• Tinea Cruris
• Tinea Pedis

Lamisil Once

1. Name Of The Medicinal Product

Lamisil^® Once^TM 1% cutaneous solution

2. Qualitative And Quantitative Composition

Each gram contains 10 mg terbinafine (as hydrochloride).

For excipients, see section 6.1.

3. Pharmaceutical Form

Cutaneous solution.

Clear to slightly opaque viscous solution.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment for tinea pedis (athlete's foot).

4.2 Posology And Method Of Administration

Adults 18 years of age and over: single administration.

Lamisil Once should be applied once on both feet, even if lesions are visible on one foot only. This ensures elimination of the fungi (dermatophytes) that might be found in areas of the foot where no lesions are visible.

Patients should wash and dry both feet and hands before applying the product. They should treat one foot, then the other.

Starting between the toes, patients should apply a thin layer evenly between and all around the toes, as well as cover the sole and sides of the foot for up to 1.5 cm. The product should be applied in the same way to the other foot, even if the skin looks healthy. The product should be left to dry to a film for 1-2 minutes. Patients should then wash their hands. Lamisil Once should not be massaged into skin.

For the best results, the treated area should not be washed for 24 hours after application. It is therefore recommended to apply Lamisil Once after a shower or bath and wait until the same time the following day before washing the feet again.

Patients should use the quantity they need to cover both feet as instructed above. Any unused medication is to be discarded.

Relief of clinical symptoms usually occurs within a few days. If there are no signs of improvement after one week, patients should see a doctor. There are no data on repeated treatment with Lamisil Once. Therefore a second treatment cannot be recommended within a particular episode of athlete's foot.

Children:

Lamisil Once has not been studied in the paediatric population. Its use is therefore not recommended in patients below 18 years of age.

The elderly:

There is no evidence to suggest that elderly patients require different dosages or experience side effects different from those in younger patients.

4.3 Contraindications

Hypersensitivity to terbinafine or any of the excipients (see 6.1. List of excipients).

4.4 Special Warnings And Precautions For Use

Lamisil Once is not recommended to treat hyperkeratotic chronic plantar tinea pedis (moccasin type).

Lamisil Once is for external use only. It should not be used on the face; it may be irritating to the eyes. In case of accidental contact with the eyes, rinse eyes thoroughly with running water. Do not swallow.

In the unlikely event of allergic reaction, the film should be removed with an organic solvent such as denatured alcohol and the feet washed with warm soapy water.

Contains alcohol; keep away from naked flames

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No drug interactions are known with use of topical Lamisil formulations.

4.6 Pregnancy And Lactation

Animal studies did not reveal any teratogenic or embryofoetotoxic potential of terbinafine. No cases of malformations in humans have been reported with terbinafine to date. However, since clinical experience in pregnant women is very limited, Lamisil Once should be used only if clearly indicated during pregnancy.

Terbinafine is excreted in breast milk, and therefore mothers should not receive Lamisil Once whilst breast-feeding.

4.7 Effects On Ability To Drive And Use Machines

Cutaneous application of Lamisil Once does not affect the ability to drive and use machines.

4.8 Undesirable Effects

Undesirable effects include mild and transient reactions at the site of application. In very rare instances, allergic reactions may occur.

Skin and subcutaneous tissue disorders:

Very rare (<1/10,000, including isolated reports): allergic reactions such as rash, pruritus, dermatitis bullous and urticaria.

General disorders and administration site conditions

Uncommon (>1/1,000, <1/100): application site reactions such as skin dryness, skin irritation or burning sensation.

4.9 Overdose

Overdose is very unlikely to happen since the product is for single dose, cutaneous use, and the tube only contains the necessary quantity for one application. Accidental ingestion of one 4 g tube of product which contains 40 mg terbinafine is much lower than one 250 mg Lamisil tablet (oral unit dose). Should several tubes be ingested however, adverse effects similar to those observed with an overdose of Lamisil tablets (e.g. headache, nausea, epigastric pain and dizziness) are to be expected.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Antifungal for topical use (ATC code D01 A E15)

Terbinafine is an allylamine which has a broad spectrum of antifungal activity in fungal infections of the skin caused by dermatophytes such as Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum. At low concentrations terbinafine is fungicidal against dermatophytes and moulds. The activity against yeasts is fungicidal (e.g. Pityrosporum orbiculare or Malassezia furfur) or fungistatic, depending on the species.

Terbinafine interferes specifically with fungal sterol biosynthesis at an early step. This leads to a deficiency in ergosterol and to an intracellular accumulation of squalene, resulting in fungal cell death. Terbinafine acts by inhibition of squalene epoxidase in the fungal cell membrane. The enzyme squalene epoxidase is not linked to the cytochrome P450 system. Terbinafine does not influence the metabolism of hormones or other drugs.

Studies in patients have shown that a single dose application of Lamisil Once 1 % cutaneous solution on both feet demonstrated efficacy in patients with tinea pedis (athlete's foot) presenting lesions between the toes, and extending to adjacent skin areas of the sides and soles of the feet. The rate of relapse/reinfection at 3 months after treatment was low: 1 person out of 8 (12.5%).

5.2 Pharmacokinetic Properties

Once applied to the skin, Lamisil Once 1 % cutaneous solution forms a film on the skin. Terbinafine in the film stays on the skin for up to 72 hours. The film quickly delivers terbinafine to the stratum corneum: at 60 minutes after application, 16 to 18% of the applied dose will be present in the stratum corneum. Delivery progressively continues and terbinafine persists in the stratum corneum for up to 13 days, at levels which are in excess of the in vitro Minimum Inhibitory Concentration for terbinafine against dermatophytes.

Systemic bioavailability is very low. An application of Lamisil Once 1 % cutaneous solution on the back, on an area of 3 times the area of both feet, resulted in exposure to terbinafine of less than 0.5% of the exposure following oral administration of a 250 mg tablet.

5.3 Preclinical Safety Data

In long-term studies (up to 1 year) in rats and dogs no marked toxic effects were seen in either species up to oral doses of about 100 mg/kg a day. At high oral doses, the liver and possibly also the kidneys were identified as potential target organs.

In a two-year oral carcinogenicity study in mice, no neoplastic or other abnormal findings attributable to treatment were made up to doses of 130 (males) and 156 (females) mg/kg a day. In a two-year oral carcinogenicity study in rats at the highest dose level, 69 mg/kg a day, an increased incidence of liver tumours was observed in males. The changes, which may be associated with peroxisome proliferation, have been shown to be species-specific since they were not seen in the carcinogenicity study in mice or in other studies in mice, dogs or monkeys.

During the studies of high dose oral terbinafine in monkeys, refractile irregularities were observed in the retina at the higher doses (non-toxic effect level was 50 mg/kg). These irregularities were associated with the presence of a terbinafine metabolite in ocular tissue and disappeared after drug discontinuation. They were no associated histological changes.

A standard battery of in vitro and in vivo genotoxicity tests revealed no evidence of a mutagenic or clastogenic potential for the drug.

No adverse effects on fertility or other reproduction parameters were observed in studies in rats or rabbits.

Repeated dermal administration of Lamisil Once 1 % cutaneous solution in rats and minipigs produces plasma terbinafine levels which are at least 50-100 times lower than the no-adverse-effect-levels established in terbinafine animal toxicity studies, so use of the product is not expected to produce any systemic adverse effect. Lamisil Once 1 % cutaneous solution was well tolerated in a variety of tolerability studies and did not cause sensitisation.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Acrylates/octylacrylamide copolymer;

hydroxypropylcellulose;

medium chain triglycerides;

ethanol.

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Store in the original package. There is no special temperature precaution for storage.

6.5 Nature And Contents Of Container

4 g aluminium laminated tube (polyethylene-aluminium-polyethylene) with a polyethylene screw cap.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Novartis Consumer Health, Horsham, RH12 5AB, UK

8. Marketing Authorisation Number(S)

PL 00030/0213

9. Date Of First Authorisation/Renewal Of The Authorisation

4 November 2005

10. Date Of Revision Of The Text

23 November 2005

Legal category: GSL

Fluorinse

Generic Name: fluoride topical (FLOR ide TOP i kal)

Brand Names: ACT Fluoride Rinse, ACT Kids Fluoride Rinse, ACT Restoring Mouthwash Cinnamon, ACT Restoring Mouthwash Mint, ACT Restoring Mouthwash Spearmint, ACT Restoring Mouthwash Vanilla Mint, Control Rx, Denta 5000 Plus, Dentagel, Ethedent, Fluoridex, Fluoridex Daily Defense, Fluoridex Daily Defense Enhanced Whitening, Fluorigard, Fluorinse, Gel-Kam, Gel-Kam Dental Therapy Pak, Gel-Kam Dentinbloc, Gel-Kam Sensitivity Therapy, NaFrinse Daily/Acidulated, NaFrinse Daily/Neutral, Nafrinse Solution, NaFrinse Weekly, Neutracare Gel, Neutragard, Neutragard Advanced, Neutral Sodium Fluoride Rinse, Omnii Gel, Omnii Gel Just For Kids, Oral B Anti-Cavity, Perfect Choice, Perio Med, Phos-Flur, Prevident, Prevident 500 Plus Boost, PreviDent 5000 Booster, Prevident 5000 Dry Mouth, Prevident 5000 Plus, Prevident 5000 Sensitive, Prevident Dental Rinse, SF, SF 5000 Plus, Stop, Thera-Flur-N

What is Fluorinse (fluoride topical)?

Fluoride is a substance that strengthens tooth enamel. This helps to prevent dental cavities.

Fluoride topical is used as a medication to prevent tooth decay in patients that have a low level of fluoride topical in their drinking water. Fluoride topical is also used to prevent tooth decay in patients who undergo radiation of the head and/or neck, which may cause dryness of the mouth and an increased incidence of tooth decay.

Fluoride may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Fluorinse (fluoride topical)?

Fluoride topical should not be used if the level of fluoride in the drinking water is greater than 0.7 parts per million (ppm).

Before using fluoride topical, tell your dentist and doctor if you are on a low salt or a salt free diet. You may not be able to use fluoride topical, or you may need special tests while you are using it.

Do not eat, drink, or rinse your mouth for 30 minutes after using a fluoride topical. Do not swallow fluoride topical. Spit it out after use. Do not allow a child to swallow fluoride topical or serious overdose symptoms could result.

Overdose symptoms may result if you swallow large amounts of fluoride while using it.

What should I discuss with my healthcare provider before using Fluorinse (fluoride topical)?

Fluoride topical should not be used if the level of fluoride in the drinking water is greater than 0.7 parts per million (ppm).

Before using fluoride topical, tell your dentist and doctor if you are on a low salt or a salt free diet. You may not be able to use fluoride topical, or you may need special tests while you are using it.

If you have gum disease, some forms of fluoride topical may be irritating to your gums. Talk to your dentist or doctor if you have bothersome mouth irritation while using fluoride topical.

Talk to your doctor and dentist before using fluoride topical if you are pregnant. Talk to your doctor and dentist before using fluoride topical if you are breast-feeding. The use of fluoride is particularly important in children to protect against tooth decay. The American Dental Association's Council on Dental Therapeutics recommends the use of fluoride by children up to 13 years of age. The American Academy of Pediatrics recommends fluoride supplementation in children until the age of 16 years old. Do not allow a child to swallow fluoride topical or serious overdose symptoms could result.

How should I use Fluorinse (fluoride topical)?

Use this medication exactly as directed on the label, or as it was prescribed by your dentist or doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Fluoride topical should be used immediately after brushing or flossing your teeth. For best results, use the medication just before bedtime, unless your doctor tells you otherwise.

Swish this medication in your mouth without swallowing. Then spit it out.

Do not eat, drink, or rinse your mouth for 30 minutes after using fluoride topical. Store fluoride topical at room temperature away from moisture and heat.

What happens if I miss a dose?

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include nausea, vomiting, stomach pain, diarrhea, drooling, numbness or tingling, loss of feeling anywhere in your body, muscle stiffness, or seizure (convulsions).

Overdose symptoms may result if you swallow large amounts of fluoride while using it.

What should I avoid while using Fluorinse (fluoride topical)?

Do not swallow fluoride topical. Spit it out after use.

Fluorinse (fluoride topical) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor if you have any of the following side effects:

• 
  

  discolored teeth;

  
  


• 
  

  weakened tooth enamel; or

  
  


• 
  

  any changes in the appearance of your teeth.

  
  

Less serious side effects may include:

• 
  

  stomach upset;

  
  


• 
  

  headache; or

  
  


• 
  

  weakness.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Fluorinse (fluoride topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied fluoride. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Fluorinse resources

• Fluorinse Side Effects (in more detail)
• Fluorinse Use in Pregnancy & Breastfeeding
• Fluorinse Support Group
• 0 Reviews for Fluorinse - Add your own review/rating

• APF Gel Advanced Consumer (Micromedex) - Includes Dosage Information


• EtheDent Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Gel-Kam Rinse MedFacts Consumer Leaflet (Wolters Kluwer)


• Phos-Flur Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• PreviDent 5000 Sensitive MedFacts Consumer Leaflet (Wolters Kluwer)


• Prevident 5000 Booster Prescribing Information (FDA)


• Prevident 5000 Dry Mouth Prescribing Information (FDA)


• Prevident 5000 Enamel Protect Prescribing Information (FDA)


• Prevident 5000 Sensitive Prescribing Information (FDA)

Compare Fluorinse with other medications

• Prevention of Dental Caries

Where can I get more information?

• Your pharmacist can provide more information about fluoride topical.

See also: Fluorinse side effects (in more detail)

Cleocin

Pronunciation: KLIN-da-MYE-sin
Generic Name: Clindamycin
Brand Name: Cleocin

Infrequently, there are severe, rarely fatal, intestinal problems that can occur after use of Cleocin. Consult your doctor right away if you develop persistent diarrhea, stomach pain, or blood or mucus in your stool. These symptoms may occur weeks after stopping use of Cleocin. Do not use antidiarrhea products or narcotic pain medicines if you have these symptoms. These products may make the symptoms worse. Your doctor will monitor you closely while you are using Cleocin.

Cleocin is used for:

Treating serious infections caused by certain bacteria. It is not used to treat meningitis.

Cleocin is a lincomycin antibiotic. Cleocin kills sensitive bacteria by stopping the production of essential proteins needed by the bacteria to survive.

Do NOT use Cleocin if:

• you are allergic to any ingredient in Cleocin or to lincomycin


• you have certain intestinal problems (eg, antibiotic-associated colitis, Crohn disease, ulcerative colitis) or meningitis

Contact your doctor or health care provider right away if any of these apply to you.

Before using Cleocin:

Some medical conditions may interact with Cleocin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have diarrhea, or a history of liver problems or stomach or bowel problems (eg, colitis)


• if you are allergic to tartrazine

Some MEDICINES MAY INTERACT with Cleocin. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Nondepolarizing muscle relaxants (eg, vecuronium) or succinylcholine because the risk of their side effects may be increased by Cleocin


• Erythromycin because it may decrease Cleocin's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Cleocin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Cleocin:

Use Cleocin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Cleocin by mouth with or without food.


• Take Cleocin with a full glass of water (8 oz/240 mL).


• Cleocin works best if it is taken at the same time each day.


• To clear up your infection completely, take Cleocin for the full course of treatment. Keep taking it even if you feel better in a few days.


• If you miss a dose of Cleocin, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Cleocin.

Important safety information:

• Cleocin only works against bacteria; it does not treat viral infections (eg, the common cold).


• Be sure to use Cleocin for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.


• Long-term or repeated use of Cleocin may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.


• This product may contain tartrazine dye (FD&C Yellow No. 5). This may cause an allergic reaction in some patients. If you have ever had an allergic reaction to tartrazine, ask your pharmacist if your product has tartrazine in it.


• Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.


• Lab tests, including liver function, kidney function, and complete blood cell counts, may be performed while you use Cleocin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Cleocin with caution in the ELDERLY; they may be more sensitive to its effects, especially diarrhea.


• Use Cleocin with extreme caution in CHILDREN younger than 10 years old who have diarrhea or an infection of the stomach or bowel.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Cleocin while you are pregnant. Cleocin is found in breast milk. If you are or will be breast-feeding while you use Cleocin, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Cleocin:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Mild diarrhea; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or tarry stools; decreased urination; joint pain or swelling; red, swollen, blistered, or peeling skin; severe or persistent diarrhea; severe stomach cramps or pain; unusual vaginal discharge, itching, or odor; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Cleocin side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Cleocin:

Store Cleocin at room temperature, between 68 to 77 degrees F (20 to 25 degrees C) in a tightly-closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Cleocin out of the reach of children and away from pets.

General information:

• If you have any questions about Cleocin, please talk with your doctor, pharmacist, or other health care provider.


• Cleocin is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Cleocin. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Cleocin resources

• Cleocin Side Effects (in more detail)
• Cleocin Dosage
• Cleocin Use in Pregnancy & Breastfeeding
• Drug Images
• Cleocin Drug Interactions
• Cleocin Support Group
• 7 Reviews for Cleocin - Add your own review/rating

Compare Cleocin with other medications

• Aspiration Pneumonia
• Babesiosis
• Bacteremia
• Bacterial Endocarditis Prevention
• Bacterial Infection
• Bacterial Vaginitis
• Bone infection
• Deep Neck Infection
• Diverticulitis
• Intraabdominal Infection
• Joint Infection
• Malaria
• Pelvic Inflammatory Disease
• Peritonitis
• Pneumocystis Pneumonia
• Pneumonia
• Prevention of Perinatal Group B Streptococcal Disease
• Sinusitis
• Skin Infection
• Surgical Prophylaxis
• Toxoplasmosis
• Toxoplasmosis, Prophylaxis

Alpha-E

Generic Name: vitamin e (Oral route)

VYE-ta-min E

Commonly used brand name(s)

In the U.S.

• Alpha-E


• Aqua Gem-E


• Aquasol E


• D-Alpha Gems


• E-400


• E-600


• E-Gems


• Formula E 400


• Gamma E-Gems


• Gamma E Plus


• Key-E


• Natural Vitamin Blend E-400IU


• Nutr-E-Sol

Available Dosage Forms:

• Liquid


• Solution


• Tablet


• Capsule, Liquid Filled


• Tablet, Chewable


• Powder for Solution


• Capsule

Therapeutic Class: Nutritive Agent

Pharmacologic Class: Vitamin E (class)

Uses For Alpha-E

Vitamins are compounds that you must have for growth and health. They are needed in only small amounts and are available in the foods that you eat. Vitamin E prevents a chemical reaction called oxidation, which can sometimes result in harmful effects in your body. It is also important for the proper function of nerves and muscles.

Some conditions may increase your need for vitamin E. These include:

• Intestine disease


• Liver disease


• Pancreas disease


• Surgical removal of stomach

Increased need for vitamin E should be determined by your health care professional.

Infants who are receiving a formula that is not fortified with vitamin E may be likely to have a vitamin E deficiency. Also, diets high in polyunsaturated fatty acids may increase your need for vitamin E.

Claims that vitamin E is effective for treatment of cancer and for prevention or treatment of acne, aging, loss of hair, bee stings, liver spots on the hands, bursitis, diaper rash, frostbite, stomach ulcer, heart attacks, labor pains, certain blood diseases, miscarriage, muscular dystrophy, poor posture, sexual impotence, sterility, infertility, menopause, sunburn, and lung damage from air pollution have not been proven. Although vitamin E is being used to prevent certain types of cancer, there is not enough information to show that this is effective.

Lack of vitamin E is extremely rare, except in people who have a disease in which it is not absorbed into the body.

Vitamin E is available without a prescription.

Importance of Diet

For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.

Vitamin E is found in various foods including vegetable oils (corn, cottonseed, soybean, safflower), wheat germ, whole-grain cereals, and green leafy vegetables. Cooking and storage may destroy some of the vitamin E in foods.

Vitamin supplements alone will not take the place of a good diet and will not provide energy. Your body also needs other substances found in food such as protein, minerals, carbohydrates, and fat. Vitamins themselves often cannot work without the presence of other foods. For example, small amounts of fat are needed so that vitamin E can be absorbed into the body.

The daily amount of vitamin E needed is defined in several different ways.

• For U.S.—


• Recommended Dietary Allowances (RDAs) are the amount of vitamins and minerals needed to provide for adequate nutrition in most healthy persons. RDAs for a given nutrient may vary depending on a person's age, sex, and physical condition (e.g., pregnancy).


• Daily Values (DVs) are used on food and dietary supplement labels to indicate the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous designation of United States Recommended Daily Allowances (USRDAs).

• For Canada—


• Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed to provide adequate nutrition and lessen the risk of chronic disease.

Vitamin E is available in various forms, including d- or dl-alpha tocopheryl acetate, d- or dl-alpha tocopherol, and d- or dl-alpha tocopheryl acid succinate. In the past, the RDA for vitamin E have been expressed in Units. This term has been replaced by alpha tocopherol equivalents (alpha-TE) or milligrams (mg) of d-alpha tocopherol. One Unit is equivalent to 1 mg of dl-alpha tocopherol acetate or 0.6 mg d-alpha tocopherol. Most products available in stores continue to be labeled in Units.

Normal daily recommended intakes in milligrams (mg) of alpha tocopherol equivalents (mg alpha-TE) and Units for vitamin E are generally defined as follows:

Persons	U.S.		Canada
	mg alpha-TE	Units	mg alpha-TE	Units
Infants and children Birth to 3 years of age	3–6	5–10	3–4	5–6.7
4 to 6 years of age	7	11.7	5	8.3
7 to 10 years of age	7	11.7	6–8	10–13
Adolescent and adult males	10	16.7	6–10	10–16.7
Adolescent and adult females	8	13	5–7	8.3–11.7
Pregnant females	10	16.7	8–9	13–15
Breast-feeding females	11–12	18–20	9–10	15–16.7

Before Using Alpha-E

If you are taking this dietary supplement without a prescription, carefully read and follow any precautions on the label. For this supplement, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Problems in children have not been reported with intake of normal daily recommended amounts. You should check with your health care professional if you are giving your baby an unfortified formula. In that case, the baby must get the vitamins needed some other way. Some studies have shown that premature infants may have low levels of vitamin E. Your health care professional may recommend a vitamin E supplement.

Geriatric

Problems in older adults have not been reported with intake of normal daily recommended amounts.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	A	Adequate studies in pregnant women have not shown an increased risk of fetal abnormalities.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this dietary supplement, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this dietary supplement with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Dicumarol

Using this dietary supplement with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this dietary supplement. Make sure you tell your doctor if you have any other medical problems, especially:

• Bleeding problems—Vitamin E, when taken in doses greater than 800 Units a day for long periods of time, may make this condition worse

Proper Use of vitamin e

This section provides information on the proper use of a number of products that contain vitamin e. It may not be specific to Alpha-E. Please read with care.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral solution dosage form:
  
  • To prevent the following deficiencies in infants:
    
    • Infants receiving a formula high in polyunsaturated fatty acids—15 to 25 Units per day or 7 Units per 32 ounces of formula.
    
    
    • Infants with certain colon problems—15 to 25 Units per kilogram (kg) (6.8 to 11 Units per pound) of body weight per day. The water-soluble form of vitamin E must be used.
    
    
    • Infants of normal birthweight—5 Units per 32 ounces of formula.
    
    
  
  


• For oral dosage forms (capsules, tablets, oral solution):
  
  • To prevent deficiency for individuals (other than infants), the amount taken by mouth is based on normal daily recommended intakes:
    
    • For the U.S.
    
    
    • Adult and teenage males—10 milligrams (mg) of alpha tocopherol equivalents (mg alpha-TE) or 16.7 Units per day.
    
    
    • Adult and teenage females—8 mg alpha-TE or 13 Units per day.
    
    
    • Pregnant females—10 mg alpha-TE or 16.7 Units per day.
    
    
    • Breast-feeding females—11 to 12 mg alpha-TE or 18 to 20 Units per day.
    
    
    • Children 4 to 10 years of age—7 mg alpha-TE or 11.7 Units per day.
    
    
    • Children birth to 3 years of age—3 to 6 mg alpha-TE or 5 to 10 Units per day.
    
    
    • For Canada
    
    
    • Adult and teenage males—6 to 10 mg alpha-TE or 10 to 16.7 Units per day.
    
    
    • Adult and teenage females—5 to 7 mg alpha-TE or 8.3 to 11.7 Units per day.
    
    
    • Pregnant females—8 to 9 mg alpha-TE or 13 to 15 Units per day.
    
    
    • Breast-feeding females—9 to 10 mg alpha-TE or 15 to 16.7 Units per day.
    
    
    • Children 7 to 10 years of age—6 to 8 mg alpha-TE or 10 to 13 Units per day.
    
    
    • Children 4 to 6 years of age—5 mg alpha-TE or 8.3 Units per day.
    
    
    • Children birth to 3 years of age—3 to 4 mg alpha-TE or 5 to 6.7 Units per day.
    
    
  
  
  • To treat deficiency:
    
    • Adults, teenagers, and children—Treatment dose is determined by prescriber for each individual based on the severity of deficiency.
    
    
  
  

For individuals taking the oral liquid form of this dietary supplement:

• This preparation should be taken by mouth even though it comes in a dropper bottle.


• This dietary supplement may be dropped directly into the mouth or mixed with cereal, fruit juice, or other food.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the dietary supplement in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Alpha-E Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

With doses greater than 400 Units a day and long-term use

• Blurred vision


• diarrhea


• dizziness


• headache


• nausea or stomach cramps


• unusual tiredness or weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Alpha-E side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

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More Alpha-E resources

• Alpha-E Side Effects (in more detail)
• Alpha-E Use in Pregnancy & Breastfeeding
• Alpha-E Drug Interactions
• Alpha-E Support Group
• 0 Reviews for Alpha-E - Add your own review/rating

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Gelnique topical

Generic Name: oxybutynin (topical) (OX i BUE ti nin)

Brand Names: Gelnique

What is oxybutynin topical?

Oxybutynin reduces muscle spasms of the bladder and urinary tract.

Oxybutynin topical (for the skin) is used to treat symptoms of overactive bladder, such as frequent or urgent urination and incontinence (urine leakage).

Oxybutynin topical may also be used for purposes not listed in this medication guide.

What is the most important information I should know about oxybutynin topical?

Do not use this medication if you are allergic to oxybutynin, or if you have uncontrolled narrow-angle glaucoma, a blockage in your digestive tract, if you have decreased urination, or if you are unable to urinate.

Before using oxybutynin topical, tell your doctor if you have urination problems, glaucoma, liver or kidney disease, myasthenia gravis, severe constipation, ulcerative colitis or other intestinal disorder, gastroesophageal reflux disease (GERD), or slow digestion.

Do not bathe, shower, swim, use a hot tub, or exercise vigorously for at least 1 hour after applying this medication.

It is best to cover treated skin areas with clothing after the gel has dried completely. This will help prevent getting this medicine on your other skin or on other people.

Oxybutynin gel is flammable. Avoid using near open flame, and do not smoke until the gel has completely dried on your skin. Oxybutynin can cause blurred vision, drowsiness, or dizziness. Be careful if you drive or do anything that requires you to be alert and able to see clearly. Drinking alcohol can increase certain side effects of oxybutynin topical.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Drink plenty of fluids to keep yourself hydrated while you are using oxybutynin topical.

What should I discuss with my healthcare provider before using oxybutynin topical?

Do not use this medication if you are allergic to oxybutynin, or if you have:

• 
  

  untreated or uncontrolled narrow-angle glaucoma;

  
  


• 
  

  a blockage in your digestive tract (stomach or intestines); or

  
  


• 
  

  if you have decreased urination or are unable to urinate.

  
  

To make sure you can safely use oxybutynin topical, tell your doctor if you have any of these other conditions:

• 
  

  bladder obstruction or other urination problems;

  
  


• 
  

  glaucoma;

  
  


• 
  

  liver disease;

  
  


• 
  

  kidney disease;

  
  


• 
  

  myasthenia gravis (a nerve-muscle disorder);

  
  


• 
  

  severe constipation;

  
  


• 
  

  an intestinal disorder such as ulcerative colitis; or

  
  


• 
  

  a stomach disorder such as gastroesophageal reflux disease (GERD) or slow digestion.

  
  

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether oxybutynin topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use oxybutynin topical?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Wash your hands with soap and water before and after applying this medication. Also wash the skin area to be treated. Use a mild soap or cleanser.

Each packet of oxybutynin gel is for one use only. Throw away the empty packet in a place where children and pets cannot get to it.

Tear open the sealed packet and empty the entire contents into your hand. You may also empty the packet directly onto the treatment area. Oxybutynin topical can be applied to the skin on your stomach, upper arm, shoulder, or thigh.

Apply the gel to a different place on any of these skin areas each time you use it. Do not apply the gel to the same skin two days in a row.

Do not bathe, shower, swim, use a hot tub, or exercise vigorously for at least 1 hour after applying this medication.

It is best to cover treated skin areas with clothing after the gel has dried completely. This will help prevent getting this medicine on your other skin or on other people. If someone else does come into contact with a treated skin area, they should wash the contact area right away with soap and water.

Oxybutynin gel is flammable. Avoid using near open flame, and do not smoke until the gel has completely dried on your skin. Keep oxybutynin gel in its sealed packet until you are ready to use it. Store the packets at room temperature away from heat and moisture.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include feeling restless or excited, warmth or tingly feeling, fever, thirst, hot and dry skin, uneven heart rate, vomiting, and urinating less than usual or not at all.

What should I avoid while using oxybutynin topical?

Avoid applying lotions, powders, or oils to the skin you plan to treat with oxybutynin topical. These other skin products can make it harder for your skin to absorb oxybutynin, and it may not work as well. You may apply oxybutynin gel to skin that has been treated with sunscreen.

Avoid getting this medication in your eyes, nose, or mouth. If this does happen, rinse with water. Do not apply the gel to recently shaved skin, open wounds, or irritated or broken skin. Oxybutynin can cause blurred vision, drowsiness, or dizziness. Be careful if you drive or do anything that requires you to be alert and able to see clearly. Drinking alcohol can increase certain side effects of oxybutynin topical.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Drink plenty of fluids to keep yourself hydrated while you are using oxybutynin topical.

Oxybutynin topical side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using oxybutynin topical and call your doctor at once if you have a serious side effect such as:

• 
  

  fever with hot, dry skin;

  
  


• 
  

  uneven heart rate;

  
  


• 
  

  pain, burning, or other difficulty when urinating; or

  
  


• 
  

  severe itching, redness, pain, rash, or other irritation where the medication was applied.

  
  

Less serious side effects may include:

• 
  

  mild skin irritation where the gel was applied;

  
  


• 
  

  cold symptoms such as stuffy nose, sneezing, sore throat;

  
  


• 
  

  dizziness, drowsiness, tired feeling;

  
  


• 
  

  headache;

  
  


• 
  

  blurred vision;

  
  


• 
  

  dry mouth;

  
  


• 
  

  constipation; or

  
  


• 
  

  nausea, vomiting, stomach cramps, diarrhea.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect oxybutynin topical?

Tell your doctor about all other medications you use, especially:

• 
  

  atropine (Atreza, Sal-Tropine), belladonna (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);

  
  


• 
  

  bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);

  
  


• 
  

  glycopyrrolate (Robinul);

  
  


• 
  

  mepenzolate (Cantil);

  
  


• 
  

  other forms of oxybutynin (Ditropan, Oxytrol);

  
  


• 
  

  other bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), tolterodine (Detrol), or solifenacin (Vesicare); or

  
  


• 
  

  irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), or propantheline (Pro-Banthine).

  
  

This list is not complete and other drugs may interact with oxybutynin topical. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Gelnique resources

• Gelnique Side Effects (in more detail)
• Gelnique Dosage
• Gelnique Use in Pregnancy & Breastfeeding
• Gelnique Drug Interactions
• Gelnique Support Group
• 1 Review for Gelnique - Add your own review/rating

Compare Gelnique with other medications

• Dysuria
• Overactive Bladder
• Urinary Incontinence

Where can I get more information?

• Your pharmacist can provide more information about oxybutynin topical.

See also: Gelnique side effects (in more detail)