or permanent has been reported in patients.
Discontinue treatment if hearing loss occurs (5.6)
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥ 1%) are nausea, rash, vomiting,edema, headache, diarrhea, fatigue, fever, pruritus, hypertension, abnormal
hepatic function, abdominal pain, dizziness, hypokalemia, anorexia, malaise,decreased libido, somnolence, albuminuria, impotence.
To report SUSPECTED ADVERSE REACTIONS, contact MaynePharma at 1-844-825-8500 or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.
DRUG INTERACTIONS
Itraconazole is mainly metabolized through CYP3A4. Other drugs that eithershare this metabolic pathway or modify CYP3A4 activity may influence thepharmacokinetics of itraconazole.
See 17 for PATIENT COUNSELING INFORMATION and FDAapproved
patient labeling.
Revised: 12/2018
-------------------------------------------------------------------
FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: CONGESTIVE HEART FAILURE
AND DRUG INTERACTIONS
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
4.1 Drug Interactions
4.2 Hypersensitivity
5 WARNINGS AND PRECAUTIONS
5.1 Congestive Heart Failure
5.2 Hepatotoxicity
5.3 Cardiac Dysrhythmias
5.4 Drug Interaction Potential
5.5 Peripheral Neuropathy
5.6 Hearing Loss
5.7 Hypersensitivity Reactions
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 Effect of TOLSURA on Other Drugs
7.2 Effect of Other Drugs on TOLSURA
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
10OVERDOSAGE
11DESCRIPTION
12CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics
12.4 Microbiology
13NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment
of Fertility
13.2 Animal Toxicology and/or Pharmacology
14CLINICAL STUDIES
14.1 Blastomycosis
14.2 Histoplasmosis
14.3 Histoplasmosis in HIV-infected Patients
14.4 Aspergillosis
16HOW SUPPLIED/STORAGE AND HANDLING
17PATIENT COUNSELING INFORMATION
*Sections or subsections omitted from the full prescribinginformation are not listed.
-------------------------------------------------------------------
FULL PRESCRIBING INFORMATION
WARNING: CONGESTIVE HEART FAILURE and DRUG
INTERACTIONS
• Congestive Heart Failure
TOLSURA can cause or exacerbate congestive heart failure (CHF). Whenitraconazole was administered intravenously to healthy human volunteers and dogs,
negative inotropic effects were seen. If signs or symptoms of congestive heart failureoccur or worsen during administration of TOLSURA, reassess the benefit and risk
of continuing treatment [see Warnings and Precautions (5.1) and Adverse Reactions(6.1)].
• Drug Interactions
o Co-administration of certain drugs that are metabolized by human CYP3A4enzymes are contraindicated with TOLSURA because plasma concentrations ofsuch drugs are increased, which may also increase or prolong both thepharmacologic effects and/or adverse reactions to these drugs [seeContraindications (4.1) and Drug Interactions (7.1)]
o Co-administration with colchicine, fesoterodine and solifen |