Mycelvan is prescribed to treat fungal infections in adults. It is commonly prescribed for fungal nail infections and is sometimes prescribed for fungal skin infections. It works by killing the fungus causing the infection.
Carcinogenesis, Mutagenesis, Impairment of Fertility
In a 28-month oral carcinogenicity study in rats, an increase in the incidence of liver tumors was observed in males at the highest dose tested, 69 mg/kg/day (2 times the MRHD based on AUC comparisons of the parent Mycelvan); however, even though dose-limiting toxicity was not achieved at the highest tested dose, higher doses were not tested.
The results of a variety of in vitro (mutations in E. coli and S. typhimurium , DNA repair in rat hepatocytes, mutagenicity in Chinese hamster fibroblasts, chromosome aberration, and sister chromat >in vivo (chromosome aberration in Chinese hamsters, micronucleus test in mice) genotoxicity tests gave no evidence of a mutagenic or clastogenic potential.
Oral reproduction studies in rats at doses up to 300 mg/kg/day (12 times the MRHD based on BSA comparisons) did not reveal any specific effects on fertility or other reproductive parameters. Intravaginal application of Mycelvan hydrochloride at 150 mg/day in pregnant rabbits did not increase the incidence of abortions or premature deliveries nor affect fetal parameters.
What is Mycelvan (LamISIL)?
Mycelvan is an antifungal medication that fights infections caused by fungus.
Mycelvan tablets are used to treat infections caused by fungus that affect the fingernails or toenails.
Mycelvan oral granules are used to treat a fungal infection of scalp hair follicles in children who are at least 4 years old.
Mycelvan may also be used for purposes not listed in this medication guide.
Side effects of Mycelvan
Mycelvan appears to be a relatively safe drug. Side effects, usually minor, arise occasionally. Serious side effects occur rarely. Routine blood test monitoring is not considered necessary .
Adverse reactions to Mycelvan may include:
Patient Counseling Information
Advise the patient to read the FDA-Approved Medication Guide.
Patients taking Mycelvan tablets should receive the following information and instructions:
- Advise patients to immediately report to their physician or get emergency help if they experience any of the following symptoms: hives, mouth sores, blistering and peeling of skin, swelling of face, lips, tongue, or throat, difficulty swallowing or breathing. Mycelvan tablets treatment should be discontinued.
- Advise patients to immediately report to their physician any symptoms of persistent nausea, anorexia, fatigue, vomiting, right upper abdominal pain, jaundice, dark urine, or pale stools. Mycelvan tablets treatment should be discontinued.
- Advise patients to report to their physician any signs of taste disturbance, smell disturbance and/or depressive symptoms, fever, skin eruption, lymph node enlargement, erythema, scaling, loss of pigment, and unusual photosensitivity that can result in a rash. Mycelvan tablets treatment should be discontinued.
- Advise patients to minimize exposure to natural and artificial sunlight (tanning beds or UVA/B treatment) while using Mycelvan tablets.
- Advise patients that if they forget to take Mycelvan tablets, to take their tablets as soon as they remember, unless it is less than 4 hours before the next dose is due.
- Advise patients to call their physician if they take too many Mycelvan tablets.
- Advise patients to call their physician if they become pregnant during treatment with Mycelvan tablets.
Medication Gu >www.northstarrxllc.com/products or call 1-800-206-7821. Manufactured for: Northstar Rx LLC Memphis, TN 38141.
Manufactured by: Aurobindo Pharma Limited Hyderabad-500 090, India.
What Is Mycelvan and How Does It Work?
Mycelvan is an antifungal antibiotic used to treat infections caused by fungus that affect the fingernails or toenails (onychomycosis). Oral granules are used to treat a fungal infection of scalp hair follicles in children who are at least 4 years old.
Mycelvan is available under the following different brand names: Lamisil.
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The most frequently reported adverse events observed in the 3 U.S./Canadian placebo-controlled trials are listed in the Table 1. The adverse events reported encompass gastrointestinal symptoms (including diarrhea, dyspepsia, and abdominal pain), liver test abnormalities, rashes, urticaria, pruritus, and taste disturbances. Changes in the ocular lens and retina have been reported following the use of Mycelvan tablets in controlled trials. The clinical significance of these changes is unknown. In general, the adverse events were mild, transient, and did not lead to discontinuation from study participation. Table 1. Most frequently reported adverse events observed in the 3 U.S./Canadian placebo-controlled trials
Before taking Mycelvan,
- tell your doctor and pharmacist if you are allergic to Mycelvan, any other medications, or any of the ingredients in Mycelvan granules or tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: amiodarone (Cordarone, Nexterone, Pacerone); beta blockers such as atenolol (Tenormin), labetalol (Trandate), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Hemangeol, Inderal LA, Innopran XL); caffeine (in Excedrin, Fioricet, Fiorinal, others); cimetidine (Tagamet); cyclosporine (Gengraf, Neoral, Sandimmune); dextromethorphan (Delsym, in Mucinex DM, Promethazine DM, others); flecainide; fluconazole (Diflucan); ketoconazole (Nizoral); monoamine oxidase type B (MAO-B) inhibitors such as rasagiline (Azilect), and selegiline (Eldepryl, Emsam, Zelapar); propafenone (Rythmol); rifampin (Rifadin, Rimactane, in Rifamate, Rifater); selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), paroxetine (Paxil), and sertraline (Zoloft); tricyclic antidepressants (TCAs) such as amitriptyline, amoxapine, clomipramine (Anafranil), desipramine (Norpramin), doxepin (Silenor), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have or have ever had liver disease. Your doctor will probably tell you not to take Mycelvan.
- tell your doctor if you have or have ever had human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), a weakened immune system, lupus (condition in which the immune system attacks many tissues and organs including the skin, joints, blood, and kidneys), or kidney disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking Mycelvan, call your doctor. Do not breastfeed while taking Mycelvan.
- plan to avoid unnecessary or prolonged exposure to sunlight and artificial sunlight (tanning beds or UVA/B treatment) and wear protective clothing, sunglasses, and sunscreen. Mycelvan may make your skin sensitive to sunlight.