|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).
|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
|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.
| 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.
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
| 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.
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:
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.
Usage in Pregnancy: Pregnancy Category C:
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.
The safety and efficacy of the prophylactic use of clotrimazole troches in children have not been established.
DOSAGE FORMS AND STRENGTHS:
| 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.
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)
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
| 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.
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
| 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.
Drug UPDATES: CRESEMBA ®- isavuconazonium sulfate capsule and Injectable form.
Initial U.S. Approval: 2015
Mechanism of Action
INDICATIONS AND USAGE:
1.2 Invasive Mucormycosis
HOW SUPPLIED/STORAGE AND HANDLING
Store in original container to protect from moisture.
Capsules are packaged in aluminum blister packs, seven (7) capsules per sheet with desiccant. (NDC 0469-0520-14)
Individually packaged vials are available for intravenous administration. (NDC 0469-0420-99)
Storage and Handling
Store CRESEMBA for injection unreconstituted vials at 2° to 8°C (36° to 46°F) in a refrigerator. CRESEMBA is a single-dose vial of unpreserved sterile lyophile. Following reconstitution of the lyophile with water for injection USP, the reconstituted solution should be used immediately, or stored below 25°C for a maximum of 1 hour prior to preparation of the patient infusion solution. The prepared infusion solution should be kept for not more than 6 hours at room temperature [20°C to 25°C (68°F to 77°F)] or 24 hours at 2° to 8°C (36° to 46°F) prior to use. CRESEMBA for injection vials are for single-dose use only.
| DOSAGE AND ADMINISTRATION
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
Treatment of Aspergillosis
Treatment in Life Threatening Situations
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
Use in Patients with Renal Impairment
Use in Patients with Hepatic Impairment
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.
Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature]
| 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
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
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
| INDICATIONS AND USAGE:
Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.
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.
WARNINGS AND PRECAUTIONS:
Carcinogenesis, Mutagenesis, Impairment of Fertility
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.
DOSAGE FORMS AND STRENGTHS:
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.
|Drug Updates: Noxafil ® (posaconazole) injection 18 mg/mL
Noxafil ® (posaconazole) delayed-release tablets 100 mg
Noxafil ® (posaconazole) oral suspension 40 mg/mL
Initial U.S. Approval: 2006 (oral suspension)
Dosing: Click (+) next to Dosage and Administration section (drug info link)
Initial U.S. Approval: 2013
INDICATIONS AND USAGE: Noxafil is an azole antifungal agent 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 HSCT recipients with GVHD or those with hematologic malignancies with prolonged neutropenia from chemotherapy. (1.1)
Oral suspension- treatment of oropharyngeal candidiasis (OPC), including OPC refractory (rOPC) to itraconazole and/or fluconazole.
HOW SUPPLIED: Noxafil injection: 300 mg per 16.7 mL (18 mg per mL)
INDICATIONS AND USAGE
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
WARNINGS AND PRECAUTIONS
DOSAGE AND ADMINISTRATION
*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.
DOSAGE FORMS AND STRENGTHS
| DOSAGE AND ADMINISTRATION
Superficial mycoses (tinea corporus, cruris, pedis, capitis; cutaneous candidiasis): 250 mg orally once daily.
Systemic mycosis: 250-500mg orally once daily.
SEE PACKAGE INSERT FOR EXTENSIVE WARNINGS/PRECAUTIONS
|DOSAGE AND ADMINISTRATION
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
(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 ≥ 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 ≥ 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.
Dosage adjustment in patients unable to tolerate treatment:
Renal Dosing: Oral: no adjustments necessary.
Supplied: Tablet: 50 mg, 200 mg. Oral suspension: 200 mg/5 mL (70 mL). 200 mg (Inj - powder for reconstitution).
|Apply cream once or twice daily. [cream 1%]|
|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]|
|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]|
|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%]|
|Tinea: apply once or twice daily. Supplied: [cream 1%]|
|Apply twice a day. Supplied: [1% cream /powder/ gel /solution]|
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Please review the latest applicable package insert for additional information and possible updates. A local search option of this data can be found here.
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