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Systemic and Topical Antifungals

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BACKGROUND

The systemic antifungals as a class have extensive warnings and precautions that should be reviewed before prescribing/dispensing. Many of these agents also have major black box warnings. This section contains only basic dosing information.  Please refer to the specific package insert for additional information or possible updates.
Topicals Link to UPDATED IV Section
Amphoterecin-B Ampho B lipid (Albecet ®):
anidulafungin - Eraxis ™ caspofungin - Cancidas ®
Clotrimazole (Mycelex ®): fluconazole (Diflucan ®)
flucytosine (Ancobon ®): Griseofulvin:
Itraconazole (Sporanox ®): ketoconazole (Nizoral ®):
Micafungin - Mycamine ®: nystatin (Mycostatin ®)
Posaconazole - Noxafil® terbinafine (Lamisil ®): 
voriconazole (Vfend ®): Infectious Disease -ALL Agents (INDEX)

Amphoterecin-B: top of page

DOSAGE AND ADMINISTRATION
Test dose: (optional): 1 mg/20-50 ml D5W over 10-30 minutes. Monitor temp, pulse, RR and BP q30min x 4 hours. Do not give premeds with test dose. 

Maintenance dose: Initially give 0.25-0.3 mg/kg/day. Increase as tolerated by an equivalent amount once daily. Usual daily dose: 0.5-1 mg/kg/day or up to 1.5 mg/kg every other day. For life-threatening infection may give full dose the first day (usually 0.6-0.7 mg/kg IBW on Day # 1). 

Premedication: Prevention of fever/chills: Tylenol 650mg PO/PR + Benadryl 25-50mg PO/IVP 60min prior to maintenance infusion. May also add: Hydrocortisone 25-50mg IV/IM +/- Demerol 50mg IV.

Renal dosing: <10/ q24-36h. During therapy if the BUN increases above 40 mg/dl or the serum creatinine exceeds 2.5-3 mg/dl, Hold Ampho B until renal function improves, then restart at a reduced dose or change to every other day dosing until Serum creatinine/BUN improve. 


Bladder irrigation: Add 30-50mg Ampho B to 1000ml (or less) sterile H2O administered intermittently or continuously for 2 to 14 days. (Note: use of D5W for Bladder irrigations is not recommended because of the possibility of enhancing microbial and fungal growth in the bladder).

Ampho B lipid (Albecet ®): top of page

DOSAGE AND ADMINISTRATION

Premedication: For patients who experience infusion-related immediate reactions, premedicate with the following drugs 30-60 minutes prior to drug administration: A nonsteroidal anti-inflammatory agent +/- diphenhydramine or acetaminophen with diphenhydramine or hydrocortisone 50-100 mg. If the patient experiences rigors during the infusion, meperidine may be administered.

Usual dosage: I.V.: 2.5 to 5 mg/kg/day as a single infusion

anidulafungin - Eraxis ™: top of page

MOA: Anidulafungin is a semi-synthetic echinocandin with antifungal activity. Anidulafungin inhibits glucan synthase, an enzyme present in fungal, but not mammalian cells. This results in inhibition of the formation of 1,3-β-D-glucan, an essential component of the fungal cell wall.  Indications: use in the treatment of the following fungal infections: Candidemia and other forms of Candida infections (intra-abdominal abscess, and peritonitis). ERAXIS has not been studied in endocarditis, osteomyelitis, and meningitis due to Candida, and has not been studied in sufficient numbers of neutropenic patients to determine efficacy in this group.

Dosage
The recommended dose is a single 200 mg loading dose of ERAXIS on Day 1, followed by 100 mg daily dose thereafter. Duration of treatment should be based on the patient’s clinical response. In general, antifungal therapy should continue for at least 14 days after the last positive culture. Esophageal candidiasis: The recommended dose is a single 100 mg loading dose of ERAXIS on Day 1, followed by 50 mg daily dose thereafter. Patients should be treated for a minimum of 14 days and for at least 7 days following resolution of symptoms. 

Preparation: must be reconstituted with the companion diluent (20% (w/w) Dehydrated Alcohol in Water for Injection) and subsequently diluted with only D5W or 0.9% NS.  Aseptically reconstitute each 50 mg vial with 15 mL of the companion diluent to provide a conc of 3.33 mg/mL. The reconstituted solution must be further diluted and administered within 24 hours. 
Dilution and Infusion:
  The rate of infusion should not exceed 1.1 mg/minute. 



Supplied:  50mg vial (powder for reconstitution) + 15 ml diluent.
Storage/stability:  Reconstituted vials & final solution: 24 hours at room temp.  Do not Freeze.

caspofungin - Cancidas ®: top of page

DOSING: ADULTS — Note: Duration of caspofungin treatment should be determined by patient status and clinical response. Empiric therapy should be given until neutropenia resolves. In patients with positive cultures, treatment should continue until 14 days after last positive culture. In neutropenic patients, treatment should be given at least 7 days after both signs and symptoms of infection and neutropenia resolve.

Empiric therapy: Initial dose: 70 mg on day 1; subsequent dosing: 50 mg/day; may increase up to 70 mg/day if tolerated, but clinical response is inadequate.

Invasive Aspergillus, candidiasis: I.V.: Initial dose: 70 mg on day 1; subsequent dosing: 50 mg/day

Esophageal candidiasis: I.V.: 50 mg/day; Note: The majority of patients studied for this indication also had oropharyngeal involvement.

Dosage adjustment with concomitant use of an enzyme inducer: Patients receiving rifampin: 70 mg caspofungin daily.
Patients receiving carbamazepine, dexamethasone, efavirenz, nevirapine, or phenytoin (and possibly other enzyme inducers) may require an increased daily dose of caspofungin (70 mg/day).

MOA: Inhibits synthesis of B(1,3)-D-glucan, an essential component of the cell wall of susceptible fungi. Highest activity in regions of active cell growth. Mammalian cells do not require B(1,3)-D-glucan, limiting potential toxicity.

USE — Treatment of invasive Aspergillus infections in patients who are refractory or intolerant of other therapy; treatment of candidemia and other Candida infections (intra-abdominal abscesses, esophageal, peritonitis, pleural space); empirical treatment for presumed fungal infections in febrile neutropenic patient

Clotrimazole (Mycelex ®): top of page

INDICATIONS AND USAGE:
Mycelex® Troches are indicated for the local treatment of oropharyngeal candidiasis.The diagnosis should be confirmed by a KOH smear and/or culture prior to treatment.

Mycelex® Troches are also indicated prophylactically to reduce the incidence of oropharyngeal candidiasis in patients immunocompromised by conditions that include chemotherapy, radiotherapy, or steroid therapy utilized in the treatment of leukemia, solid tumors, or renal transplantation. There are no data from adequate and well-controlled trials to establish the safety and efficacy of this product for prophylactic use in patients immunocompromised by etiologies other than those listed in the previous sentence.

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DOSAGE AND ADMINISTRATION:
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Mycelex® Troches are administered only as a lozenge that must be slowly dissolved in the mouth. The recommended dose is one troche five times a day for fourteen consecutive days. Only limited data are available on the safety and effectiveness of the clotrimazole troche after prolonged administration; therefore, therapy should be limited to short term use, if possible.

For prophylaxis to reduce the incidence of oropharyngeal candidiasis in patients immunocompromised by conditions that include chemotherapy, radiotherapy, or steroid therapy utilized in the treatment of leukemia, solid tumors, or renal transplantation, the recommended dose is one troche three times daily for the duration of chemotherapy or until steroids are reduced to maintenance levels.

WARNINGS AND PRECAUTIONS:
WARNING
Mycelex® Troches are not indicated for the treatment of systemic mycoses including systemic candidiasis.

PRECAUTIONS
Abnormal liver function tests have been reported in patients treated with clotrimazole troches; elevated SGOT levels were reported in about 15% of patients in the clinical trials. In most cases the elevations were minimal and it was often impossible to distinguish effects of clotrimazole from those of other therapy and the underlying disease (malignancy in most cases). Periodic assessment of hepatic function is advisable particularly in patients with pre-existing hepatic impairment.

Since patients must be instructed to allow each troche to dissolve slowly in the mouth in order to achieve maximum effect of the medication, they must be of such an age and physical and/or mental condition to comprehend such instructions.

Carcinogenesis:
An 18 month dosing study with clotrimazole in rats has not revealed any carcinogenic effect.

Usage in Pregnancy: Pregnancy Category C:
Clotrimazole has been shown to be embryotoxic in rats and mice when given in doses 100 times the adult human dose (in mg/kg), possibly secondary to maternal toxicity. The drug was not teratogenic in mice, rabbits, and rats when given in doses up to 200, 180, and 100 times the human dose.

Clotrimazole given orally to mice from nine weeks before mating through weaning at a dose 120 times the human dose was associated with impairment of mating, decreased number of viable young, and decreased survival to weaning. No effects were observed at 60 times the human dose. When the drug was given to rats during a similar time period at 50 times the human dose, there was a slight decrease in the number of pups per litter and decreased pup viability.

There are no adequate and well controlled studies in pregnant women. Clotrimazole troches should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

PEDIATRIC USE
Safety and effectiveness of clotrimazole in children below the age of 3 years have not been established; therefore, its use in such patients is not recommended.

The safety and efficacy of the prophylactic use of clotrimazole troches in children have not been established.

GERIATRIC USE
Clinical studies of clotrimazole did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

DOSAGE FORMS AND STRENGTHS:
Mycelex® Troches, white discoid, uncoated tablets are supplied in bottles of 70 and 140. Mycelex® Troches are also available for institutional use in foil packages of 70 tablets. Each tablet will be identified with the following: Mycelex 10. Strength: 10mg


SOURCE:
Package insert data:

fluconazole (Diflucan ®): top of page

Candidiasis: Candidemia, primary therapy, non-neutropenic: 400-800 mg/day for 14 days after last positive blood culture and resolution of signs/symptoms.  Alternate therapy: 800 mg/day with amphotericin B for 4-7 days followed by 800 mg/day for 14 days after last positive blood culture and resolution of signs/symptoms.  Candidemia, secondary, neutropenic: 6-12 mg/kg/day for 14 days after last positive blood culture and resolution of signs/symptoms.  Chronic, disseminated: 6 mg/kg/day for 3-6 months.
Oropharyngeal (long-term suppression): 200 mg/day; chronic therapy is recommended in immunocompromised patients with history of oropharyngeal candidiasis (OPC).  Osteomyelitis: 6 mg/kg/day for 6-12 months.  Esophageal: 200 mg on day 1, then 100-200 mg/day for 2-3 weeks after clinical improvement.   Prophylaxis in bone marrow transplant: 400 mg/day; begin 3 days before onset of neutropenia and continue for 7 days after neutrophils >1000 cells/mm3.  Urinary: 200 mg/day for 1-2 weeks.

Coccidiomycosis: 400 mg/day; doses of 800-1000 mg/day have been used for meningeal disease; usual duration of therapy ranges from 3-6 months for primary uncomplicated infections and up to 1 year for pulmonary (chronic and diffuse) infection.   Endocarditis, prosthetic valve, early: 6-12 mg/kg/day for 6 weeks after valve replacement.
Endophthalmitis: 6-12 mg/kg/day or 400-800 mg/day for 6-12 weeks after surgical intervention. Note:C. krusei and C. galbrata infection acquired exogenously should be treated with voriconazole.

Meningitis, cryptococcal: 400-800 mg/day for 10-12 weeks or with flucytosine 100-150 mg/day for 6 weeks; maintenance: 200-400 mg/day.  Pneumonia, cryptococcal (mild-to-moderate): 200-400 mg/day for 6-12 months (life-long in HIV-positive patients)

Vaginal candidiasis: 150 mg x 1. 
Systemic candidiasis: 400 mg orally or IV once daily.   Esophageal candidiasis: 100-200 mg orally once daily (up to 400mg/day).  
Cryptococcal meningitis: 400mg orally x 1, followed by 200mg  once a day x 10-12 weeks  (Suppression: 50-200mg orally once daily). 
Onychomycosis: 200-300mg once a week or 100-200mg orally every other day  (further studies needed).  
Coccidioides immitis. Therapy with oral fluconazole is currently preferred. The dosage used in reported clinical trials was 400 mg/day. Some physicians begin therapy with 800 or 1000 mg/day of fluconazole. Alternative: (meningitis) 800mg qd for life. 

Renal Dosing: Loading dose:  [CRCL >50] No changes.  [CRCL <50]: Multiple dose regimens only: Give 50% of usual dose q24h. Some sources recommend for CRCL <20: 50% of usual dose q48h.   Hemo: Give usual dose after each hemodialysis session.

MECHANISM OF ACTION — Interferes with cytochrome P450 activity, decreasing ergosterol synthesis (principal sterol in fungal cell membrane) and inhibiting cell membrane formation.

PHARMACODYNAMICS / KINETICS:  Distribution: Widely throughout body with good penetration into CSF, eye, peritoneal fluid, sputum, skin, and urine
  Relative diffusion blood into CSF: Adequate with or without inflammation (exceeds usual MICs).  CSF:blood level ratio: Normal meninges: 70% to 80%; Inflamed meninges: >70% to 80%.

 

flucytosine (Ancobon ®): top of page

Dosing (Adults): Usual: 12.5 to 37.5 mg/kg q6h.   

Endocarditis:  25 to 37.5 mg/kg  orally every 6 hours (with amphotericin B) for at least 6 weeks after valve replacement.

Meningoencephalitis, cryptococcal
Induction:  25 mg/kg/dose orally (with amphotericin B) every 6 hours for 2 weeks; if clinical improvement, may discontinue both amphotericin and flucytosine and follow with an extended course of fluconazole (400 mg/day); alternatively, may continue flucytosine for 6-10 weeks (with amphotericin B) without conversion to fluconazole treatment.

Renal Dosing:  
[CRCL >40] No change.  
[20-40]: 12.5-37.5 mg/kg q12h.  
[10-20]: 12.5-37.5 mg/kg q24h. 
[<10]: 12.5-37.5 mg/kg q24-48h. 

Hemo: Give usual dose (12.5 – 37.5mg/kg) after each dialysis. Some sources recommend giving 25-50 mg/kg after each dialysis. Administration guidelines: Administer around-the-clock to promote less variation in peak and trough serum levels. To avoid nausea and vomiting, administer a few capsules at a time over 15 minutes until full dose is taken.

Supplied: Capsule: Ancobon®: 250 mg, 500 mg

Griseofulvin: top of page

DOSAGE AND ADMINISTRATION

Microsize: Adults: 500mg orally once daily will give a satisfactory response in most patients with tinea corporis, tinea cruris, and tinea capitis. For those fungus infections more difficult to eradicate such as tinea pedis and tinea unguium, a daily dose of 1.0 g is recommended. 
 [Supplied: Grifulvin V: 250 mg or 500 mg of griseofulvin microsize tablets.]


Ultramicrosize:  Adults:  375 mg (as a single dose or in divided doses) will give a satisfactory response in most patients with tinea corporis, tinea crurirs, and tinea capitis. For those fungal infections more difficult to eradicate, such as tinea pedis and tinea unguium, a divided dose of 750 mg is recommended.  
[Supplied:  Gris-PEG® (griseofulvin ultramicrosize)  125, 250mg tabs]

Itraconazole (Sporanox ®): top of page

DOSAGE AND ADMINISTRATION

CAPSULE:
Itraconazole capsules should be taken with a full meal to ensure maximal absorption.
Itraconazole capsules are a different preparation than itraconazole oral solution and should not be used interchangeably.

Treatment of Blastomycosis and Histoplasmosis
The recommended dose is 200 mg once daily (two capsules). If there is no obvious improvement or there is evidence of progressive fungal disease, the dose should be increased in 100 mg increments to a maximum of 400 mg daily. Doses above 200 mg/day should be given in two divided doses.

Treatment of Aspergillosis
A daily dose of 200 mg to 400 mg is recommended.

Treatment in Life Threatening Situations
In life threatening situations, a loading dose should be used.

Although clinical studies did not provide for a loading dose, it is recommended, based on pharmacokinetic data, that a loading dose of 200 mg (two capsules) 3 times daily (600 mg/day) be given for the first 3 days of treatment.

Treatment should be continued for a minimum of 3 months and until clinical parameters and laboratory tests indicate that the active fungal infection has subsided. An inadequate period of treatment may lead to recurrence of active infection.

Itraconazole capsules and itraconazole oral solution should not be used interchangeably. Only the oral solution has been demonstrated effective for oral and/or esophageal candidiasis.

Treatment of Onychomycosis
Toenails with or without Fingernail Involvement
The recommended dose is 200 mg (two capsules) once daily for 12 consecutive weeks.

Fingernails Only
The recommended dosing regimen is two treatment courses, each consisting of 200 mg (two capsules) b.i.d. (400 mg/day) for 1 week. The courses are separated by a 3-week period without itraconazole capsules.

Use in Patients with Renal Impairment
Limited data are available on the use of oral itraconazole in patients with renal impairment. Caution should be exercised when this drug is administered in this patient population. (See package insert CLINICAL PHARMACOLOGY: Special Populations and PRECAUTIONS for further information.)

Use in Patients with Hepatic Impairment
Limited data are available on the use of oral itraconazole in patients with hepatic impairment. Caution should be exercised when this drug is administered in this patient population.

TABLET:
INDICATIONS AND USAGE
ONMEL is indicated for the treatment of onychomycosis of the toenail due to Trichophyton rubrum or T. mentagrophytes in non-immunocompromised patients. Prior to initiating treatment, appropriate nail specimens for laboratory testing (KOH preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis of onychomycosis.
DOSE:
ONMEL should be taken with a full meal at the same time each day. The recommended dose is 200 mg (one tablet) once daily for 12 consecutive weeks.

SOLUTION:
Treatment of Oropharyngeal and Esophageal Candidiasis
The solution should be vigorously swished in the mouth (10 mL at a time) for several seconds and swallowed.

The recommended dosage of SPORANOX® (itraconazole) Oral Solution for oropharyngeal candidiasis is 200 mg (20 mL) daily for 1 to 2 weeks. Clinical signs and symptoms of oropharyngeal candidiasis generally resolve within several days.

For patients with oropharyngeal candidiasis unresponsive/refractory to treatment with fluconazole tablets, the recommended dose is 100 mg (10 mL) b.i.d. For patients responding to therapy, clinical response will be seen in 2 to 4 weeks. Patients may be expected to relapse shortly after discontinuing therapy. Limited data on the safety of long-term use (>6 months) of SPORANOX® Oral Solution are available at this time.

The recommended dosage of SPORANOX® Oral Solution for esophageal candidiasis is 100 mg (10 mL) daily for a minimum treatment of three weeks. Treatment should continue for 2 weeks following resolution of symptoms. Doses up to 200 mg (20 mL) per day may be used based on medical judgment of the patient's response to therapy.

SPORANOX® Oral Solution and SPORANOX® Capsules should not be used interchangeably. Patients should be instructed to take SPORANOX® Oral Solution without food, if possible. Only SPORANOX® Oral Solution has been demonstrated effective for oral and/or esophageal candidiasis.

HOW SUPPLIED

CAPSULE:
Itraconazole Capsules are available containing 100 mg of itraconazole, USP as white to off-white beads filled in a hard gelatin capsule with a dark blue opaque cap and caramel opaque body printed with MYLAN over 5100 in white ink on both cap and the body. They are available as follows:

NDC 0378-5100-93
bottles of 30 capsules

TABLET:
ONMEL is available containing 200 mg of itraconazole, as a white to slightly grey, oblong, biconvex tablet engraved with "BARRIER" on one side and "It 200" on the other side. Each carton (NDC 0259-1420-28) contains two blister cards of 14 tablets each (NDC 0259-1420-14).

SOLUTION:
SPORANOX® (itraconazole) Oral Solution is available in 150 mL amber glass bottles (NDC 50458-295-15) containing 10 mg of itraconazole per mL.

Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature]
Protect from light and moisture.

ketoconazole (Nizoral ®): top of page

INDICATIONS AND USAGE
Ketoconazole tablets USP, 200 mg should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweigh the potential risks.

Ketoconazole tablets USP, 200 mg are indicated for the treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. Ketoconazole tablets USP, 200 mg should not be used for fungal meningitis because it penetrates poorly into the cerebrospinal fluid.

DOSAGE AND ADMINISTRATION
There should be laboratory as well as clinical documentation of infection prior to starting ketoconazole therapy. The usual duration of therapy for systemic infection is 6 months. Treatment should be continued until active fungal infection has subsided.

Adults
The recommended starting dose of ketoconazole tablets is a single daily administration of 200 mg (one tablet). If clinical responsiveness is insufficient within the expected time, the dose of ketoconazole tablets may be increased to 400 mg (two tablets) once daily.

Children
In small numbers of children over 2 years of age, a single daily dose of 3.3 to 6.6 mg/kg has been used. Ketoconazole tablets have not been studied in children under 2 years of age.

Micafungin - Mycamine ®: top of page

MOA: Concentration-dependent inhibition of 1,3-beta-D-glucan synthase resulting in reduced formation of 1,3-beta-D-glucan, an essential polysaccharide comprising 30% to 60% of Candida cell walls (absent in mammalian cells); decreased glucan content leads to osmotic instability and cellular lysis

Dosing (Adults): 
Do not mix or co-infuse Mycamine with other medications. Mycamine has been shown to precipitate when mixed directly with a number of other commonly used medications.

Mycamine Dosage
Indication

Recommended Reconstituted Dose Once Daily

 Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses*  100 mg
Treatment of Esophageal Candidiasis† 150 mg
Prophylaxis of Candida Infections in HSCT Recipients‡ 50 mg
*In patients treated successfully for candidemia and other Candida infections, the mean duration of treatment was 15 days (range 10-47 days).

† In patients treated successfully for esophageal candidiasis, the mean duration of treatment was 15 days (range 10-30 days).

‡ In hematopoietic stem cell transplant (HSCT) recipients who experienced success of prophylactic therapy, the mean duration of prophylaxis was 19 days (range 6-51 days).

A loading dose is not required. Typically, 85% of the steady-state concentration is achieved after three daily Mycamine doses.

No dosing adjustments are required based on race, gender, or in patients with severe renal dysfunction or mild-to-moderate hepatic insufficiency. The effect of severe hepatic impairment on micafungin pharmacokinetics has not been studied.

No dose adjustment for Mycamine is required with concomitant use of mycophenolate mofetil, cyclosporine, tacrolimus, prednisolone, sirolimus, nifedipine, fluconazole, voriconazole, itraconazole, amphotericin B, ritonavir, or rifampin. 

Supplied:  Injection - 50 mg and 100 mg single-use vials

nystatin (Mycostatin ®) top of page

INDICATIONS AND USAGE:
Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.

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DOSAGE AND ADMINISTRATION:
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Infants: 2 mL (approximately ½ teaspoon) (200,000 units) four times daily. Place one-half of dose, 1 mL (approximately ¼ teaspoon), in each side of mouth and avoid feeding for 5 to 10 minutes.

NOTE: Limited clinical studies in premature and low birth weight infants indicate that 1 mL four times daily is effective.

Children and Adults: 4-6 mL (approximately 1 teaspoon) (400,000 to 600,000 units) four times daily (one-half of dose in each side of mouth). The preparation should be retained in the mouth as long as possible before swallowing.

Continue treatment for at least 48 hours, after perioral symptoms have disappeared and cultures demonstrate eradication of Candida albicans.

CONTRAINDICATIONS:
The preparation is contraindicated in patients with a history of hypersensitivity to any of its components.

WARNINGS AND PRECAUTIONS:
PRECAUTIONS

General
This medication is not to be used for the treatment of systemic mycoses. Discontinue treatment if sensitization or irritation is reported during use.

Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term animal studies have been performed to evaluate carcinogenic potential. There also have been no studies to determine mutagenicity or whether this medication affects fertility in males or females.

Pregnancy
Teratogenic Effects

Category C: Animal reproduction studies have not been conducted with nystatin oral suspension. It is also not known whether nystatin oral suspension can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Nystatin oral suspension should be given to a pregnant woman only if clearly needed.

Nursing Mothers
It is not known whether nystatin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when nystatin is administered to a nursing woman.

Pediatric Use
See DOSAGE AND ADMINISTRATION.

DOSAGE FORMS AND STRENGTHS:
Nystatin Oral Suspension, USP is available as a yellow, cherry-flavored, pleasant-tasting, ready-to-use suspension containing 100,000 USP Nystatin Units per mL in 60 mL bottles (supplied with a calibrated dropper), 8 oz (237 mL) bottles (supplied with dose cup) and one pint (473 mL) bottles.

SHAKE WELL BEFORE USING.

Store at controlled room temperature 59°-86°F (15°-30°C). Avoid freezing.

Dispense in a tight, light-resistant container as defined in the USP.

SOURCE:
Package insert data:

Posaconazole - Noxafil®: top of page

INDICATIONS AND USAGE
Prophylaxis of Invasive Aspergillus and Candida Infections
Noxafil® injection, delayed-release tablets, and oral suspension are indicated for prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy.

Noxafil injection is indicated in patients 18 years of age and older.

Noxafil delayed-release tablets and oral suspension are indicated in patients 13 years of age and older.

Treatment of Oropharyngeal Candidiasis Including Oropharyngeal Candidiasis Refractory to Itraconazole and/or Fluconazole
Noxafil oral suspension is indicated for the treatment of oropharyngeal candidiasis, including oropharyngeal candidiasis refractory to itraconazole and/or fluconazole.

WARNINGS AND PRECAUTIONS
  • Calcineurin Inhibitor Toxicity: Noxafil increases concentrations of cyclosporine or tacrolimus; reduce dose of cyclosporine and tacrolimus and monitor concentrations frequently.
  • Arrhythmias and QTc Prolongation: Noxafil has been shown to prolong the QTc interval and cause cases of TdP. Administer with caution to patients with potentially proarrhythmic conditions. Do not administer with drugs known to prolong QTc interval and metabolized through CYP3A4. Correct K+, Mg++, and Ca++ before starting Noxafil.
  • Hepatic Toxicity: Elevations in LFTs may occur. Discontinuation should be considered in patients who develop abnormal LFTs or monitor LFTs during treatment.
  • Noxafil injection should be avoided in patients with moderate or severe renal impairment (creatinine clearance <50 mL/min), unless an assessment of the benefit/risk to the patient justifies the use of Noxafil injection.
  • Midazolam: Noxafil can prolong hypnotic/sedative effects. Monitor patients and benzodiazepine receptor antagonists should be available.

DOSAGE AND ADMINISTRATION
Indication Dose and Duration of Therapy
Prophylaxis of invasive Aspergillus and Candida infections Injection*:
Loading dose: 300 mg Noxafil injection intravenously twice a day on the first day.
Maintenance dose: 300 mg Noxafil injection intravenously once a day thereafter. Duration of therapy is based on recovery from neutropenia or immunosuppression. 
Delayed-Release Tablets†:
Loading dose: 300 mg (three 100 mg delayed-release tablets) twice a day on the first day.
Maintenance dose: 300 mg (three 100 mg delayed-release tablets) once a day, starting on the second day. Duration of therapy is based on recovery from neutropenia or immunosuppression. 

Oral Suspension: 200 mg (5 mL) three times a day. Duration of therapy is based on recovery from neutropenia or immunosuppression. 
Oropharyngeal Candidiasis (OPC) Oral Suspension
Loading dose: 100 mg (2.5 mL) twice a day on the first day.
Maintenance dose: 100 mg (2.5 mL) once a day for 13 days. 
OPC Refractory (rOPC) to Itraconazole and/or Fluconazole Oral Suspension‡: 400 mg (10 mL) twice a day. Duration of therapy is based on the severity of the patient's underlying disease and clinical response.

*Noxafil injection must be administered through an in-line filter. Administer by intravenous infusion over approximately 90 minutes via a central venous line. Never give Noxafil injection as an intravenous bolus injection.
†Noxafil delayed-release tablets should be taken with food.
‡Noxafil oral suspension should be taken with a full meal.

DOSAGE FORMS AND STRENGTHS
Noxafil injection: 300 mg per 16.7 mL (18 mg per mL)
Noxafil delayed-release tablet 100 mg
Noxafil oral suspension 40 mg per mL

terbinafine (Lamisil ®):  top of page

DOSAGE AND ADMINISTRATION
Superficial mycoses (tinea corporus, cruris, pedis, capitis; cutaneous candidiasis): 250 mg orally once daily. 

Onychomycosis:
(fingernails) 250mg orally once daily x 6 weeks or pulse dosing: 500mg orally once daily for 1st week of month x 2 months.
(Toenails): 250mg orally once daily x 12 weeks  or  pulse dosing: 500mg once daily for 1st week of month x 4 months. 

Systemic mycosis: 250-500mg orally once daily.
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SEE PACKAGE INSERT FOR EXTENSIVE WARNINGS/PRECAUTIONS
  • Liver failure, sometimes leading to liver transplant or death, has occurred with the use of oral terbinafine. Obtain pretreatment serum transaminases.  Discontinue Lamisil Tablets if liver injury develops.
  • Taste disturbance, including taste loss, has been reported with the use of Lamisil Tablets. Taste disturbance can be severe, may be prolonged, or may be permanent. Discontinue Lamisil Tablets if taste disturbance occurs.
  • Smell disturbance, including loss of smell, has been reported with the use of Lamisil Tablets. Smell disturbance may be prolonged, or may be permanent. Discontinue Lamisil Tablets if smell disturbance occurs.
  • Depressive symptoms have been reported with terbinafine use. Prescribers should be alert to the development of depressive symptoms.
  • Severe neutropenia has been reported. If the neutrophil count is <1000 cells/mm3, Lamisil Tablets should be discontinued.
  • Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, bullous dermatitis, and drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome have been reported with oral terbinafine use. If signs or symptoms of drug reaction occur, treatment with Lamisil Tablets should be discontinued.

voriconazole (Vfend ®): top of page

DOSAGE AND ADMINISTRATION
Dosing (Adults): 
Invasive aspergillosis and other serious fungal infections
-  6 mg/kg IV q12h x 2 doses, then 4 mg/kg q12h.   
Candidemia and other deep tissue Candida infections: Initial: Loading dose 6 mg/kg IV every 12 hours for 2 doses; followed by maintenance dose of 3-4 mg/kg every 12 hours.

Review package insert
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(Oral): Conversion to oral dosing:  
Patients <40 kg: 100 mg every 12 hours; increase to 150 mg every 12 hours in patients who fail to respond adequately. 
Patients geq 40 kg: 200 mg every 12 hours; increase to 300 mg every 12 hours in patients who fail to respond adequately. 
Esophageal candidiasis: Oral:  Patients <40 kg: 100 mg every 12 hours.  
Patients geq 40 kg: 200 mg every 12 hours.  
Note: Treatment should continue for a minimum of 14 days, and for at least 7 days following resolution of symptoms.
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Dosage adjustment in patients unable to tolerate treatment: 
IV: Dose may be reduced to 3 mg/kg every 12 hours.  
Oral: Dose may be reduced in 50 mg increments to a minimum dosage of 200 mg every 12 hours in patients weighing geq 40 kg (100 mg every 12 hours in patients <40 kg). 

Renal Dosing: Oral: no adjustments necessary. 
[CRCL <50 ml/min]: IV voriconazole should be avoided, unless the benefit justifies the risk. Accumulation of the intravenous vehicle may occur.

Supplied: Tablet: 50 mg, 200 mg. Oral suspension: 200 mg/5 mL (70 mL). 200 mg (Inj - powder for reconstitution). 

Topical Antifungals: top of page


>Updated section
butenafine 
(Mentax ®)
Apply cream once or twice daily. [cream 1%]
ciclopirox 
(Loprox ®): 
Apply cream or lotion twice daily  [cream/lotion 1%]
clotrimazole (Lotrimin ®): Apply twice daily.   Supplied:  [1% cream /solution /lotion]
econazole (Spectazole ®):  Tinea: apply once daily. Candida: apply twice daily.   Supplied:[1% cream]
ketoconazole
(Nizoril ®) 
Tinea/candida: apply once a day  Supplied: [2% cream]. Seborrheic dermatitis: apply shampoo/cream  once or twice daily. Dandruff: shampoo 2 times per week.
Miconazole: Tinea/candida: apply twice a day.  Supplied:  [2% cream/powder/spray]
naftifine 
(Naftin ®): 
Tinea: apply once daily (cream) or  twice a day- (gel)
nystatin: candidiasis: apply 2 to 3 times daily.   Supplied: [cream / powder/ ointment]
oxiconazole (Oxistat ®):  Tinea: apply once or twice daily.   Supplied: [cream/lotion 1%]
terbinafine 
(Lamisil ®):
Tinea: apply once or twice daily.   Supplied: [cream 1%]
tolnaftate 
(Tinactin ®):
 Apply twice a day.  Supplied:  [1% cream /powder/ gel /solution]

Disclaimer top of page

Listed dosages are for - Adult patients ONLY. PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER. GlobalRPH does not directly or indirectly practice medicine or provide medical services and therefore assumes no liability whatsoever of any kind for the information and data accessed through the Service or for any diagnosis or treatment made in reliance thereon.

David F. McAuley, Pharm.D., R.Ph.  GlobalRPh Inc.
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