terbinafine (Rx)

Brand and Other Names:Lamisil
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 250mg

packet, oral granules (discontinued)

  • 125mg
  • 187.5mg

Onychomycosis

Indicated for onychomycosis of the toenail or fingernail owing to dermatophytes (tinea unguium

250 mg (1 tablet) PO daily for 6 weeks (fingernail) or 12 weeks (toenail)

Dosage Modifications

Renal impairment: Use not recommended if CrCl <50 mL/min

Hepatic impairment: Use contraindicated in chronic or active liver disease

Tinea Pedis (Off-label)

250 mg/day PO in single dose or divided q12hr for 2-6 weeks

Tinea Corporis, Tinea Cruris (Off-label)

250 mg/day PO in single dose or divided q12hr for 2-4 weeks

Sporotrichosis, Lymphocutaneous and cutaneous (Off-label)

500 mg/day PO q12hr for 2-6 weeks; treat for additional 2-4 weeks after resolution of all lesions (resolution may take 3-6 months)

Dosage Forms & Strengths

tablet

  • 250mg

packet, oral granules (discontinued)

  • 125mg
  • 187.5mg

Tinea Capitis

≥4 years (<25 kg): 125 mg/day PO for 6 weeks

≥4 years (25-35 kg): 187.5 mg/day PO for 6 weeks

≥4 years (>35 kg): 250 mg/day PO for 6 weeks

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Interactions

Interaction Checker

and terbinafine

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    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Headache (13%)

            1-10%

            Rash (6%)

            Pruritus (3%)

            Nausea (3%)

            Diarrhea (6%)

            Dyspepsia (4%)

            Abdominal pain (2%)

            Taste disturbance (3%)

            Elevated liver function test results (3%)

            Visual disturbance (1%)

            Postmarketing Reports

            Idiosyncratic and symptomatic hepatic injury; more rarely, cases of liver failure, some leading to death or liver transplant

            Skin and subcutaneous tissue disorders (eg, Stevens-Johnson Syndrome and toxic epidermal necrolysis), drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome

            Anaphylaxis, angioedema

            Severe neutropenia, thrombocytopenia, agranulocytosis, pancytopenia, anemia

            Psoriasiform eruptions or exacerbation of psoriasis, acute generalized exanthematous pustulosis, precipitation and exacerbation of cutaneous and systemic lupus erythematosus

            Taste and smell disturbances

            Malaise, fatigue, vomiting, arthralgia, myalgia, rhabdomyolysis, reduced visual acuity, visual field defect, hair loss, serum sickness-like reaction, vasculitis, pancreatitis, influenzalike illness, pyrexia, increased blood creatine phosphokinase, photosensitivity reactions

            Hearing impairment, vertigo

            Thrombotic microangiopathy (TMA), including thrombotic thrombocytopenic purpura and hemolytic uremic syndrome

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            Warnings

            Contraindications

            Hypersensitivity

            Chronic or active liver disease

            Cautions

            Discontinue if the following develop: Liver disease, neutropenia (absolute neutrophil count <1000 mcL); skin rash; signs or symptoms of SLE

            Changes in ocular lens and retina reported; may require discontinuation of therapy

            Use caution in renal and liver impairment

            Periodic monitoring of liver function tests is recommended

            Ask patients and caregivers to report immediately to healthcare provider any symptoms or signs of persistent nausea, anorexia, fatigue, vomiting, right upper abdominal pain or jaundice, dark urine, or pale stools; if these symptoms occur discontinue taking oral terbinafine, and immediately evaluate patient’s liver function

            Serious skin/hypersensitivity reactions (eg, Stevens-Johnson Syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms [DRESS] syndrome); manifestations of DRESS syndrome may include cutaneous reaction (eg, rash, exfoliative dermatitis), eosinophilia, and 1 or more organ complications (eg, hepatitis, pneumonitis, nephritis, myocarditis, pericarditis)

            Due to potential toxicity, confirmation of onychomycosis or dermatomycosis recommended

            Smell disturbance reported; discontinue therapy if symptoms occur

            CYP2D6 inhibitor; may also convert CYP2D6 extensive metabolizers to poor metabolizer status

            Cases of thrombotic microangiopathy (TMA), including thrombotic thrombocytopenic purpura and hemolytic uremic syndrome, some fatal, reported with terbinafine; discontinue terbinafine if clinical symptoms and laboratory findings consistent with TMA occur; the findings of unexplained thrombocytopenia and anemia should prompt further evaluation and consideration of diagnosis of TMA

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            Pregnancy & Lactation

            Pregnancy

            Available data from postmarketing cases in pregnant women are insufficient to evaluate drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes

            Animal data

            • In animal reproduction studies, the drug did not cause malformations or any harm to fetus when administered to pregnant rabbits and rats during period of organogenesis at oral doses up to 12 and 23 times the maximum recommended human dose (MRHD) of 250 mg/day, respectively

            Because treatment of onychomycosis can be postponed until after pregnancy is completed, it is recommended that oral terbinafine not be initiated during pregnancy

            Lactation

            After oral administration, terbinafine is present in human milk; however, there are no data on effects on breastfed child or on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy; tablets and any potential adverse effects on breastfed child from therapy or from underlying maternal condition

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Inhibits squalene epoxidase, reducing cell membrane ergosterol synthesis, causing inhibition of fungal cell-wall synthesis and subsequently fungal cell death

            Absorption

            Absorption >70%

            Bioavailability: 40% (Adults); 36-64% (children)

            Peak plasma time: 1-2 hr

            Peak plasma concentration (250-mg dose): 1 mcg/mL

            Distribution

            Predominantly distributed to sebum and skin

            Protein bound: >99%

            Vd: 2000 L

            Metabolism

            Metabolized in liver by several CYP450 enzymes; first-pass effect (40%)

            Metabolites: Inactive

            Enzymes inhibited: CYP2D6

            Elimination

            Half-life: 36 hr (drug released very slowly from skin and adipose tissues)

            Excretion: Urine (~70%)

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.