An evaluation of the effect of food on Terbinafina tablets was conducted. An increase of less than 20% of the AUC of Terbinafina was observed when Terbinafina tablets were administered with food. Terbinafina tablets can be taken with or without food.
Smell Disturbance Including Loss of Smell
Smell disturbance, including loss of smell, has been reported with the use of Terbinafina tablets. Smell disturbance may resolve after discontinuation of treatment, but may be prolonged (greater than 1 year), or may be permanent. If symptoms of a smell disturbance occur, Terbinafina tablets should be discontinued.
What other drugs will affect Terbinafina?
Other drugs may interact with Terbinafina, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
What Are Side Effects Associated with Using Terbinafina?
Common side effects of Terbinafina include:
Serious side effects of Terbinafina include:
- Persistent nausea
- Loss of appetite
- Right upper abdominal pain
- Yellowing skin and eyes (jaundice)
- Dark urine
- Pale stools
- Smell disturbance
Postmarketing side effects of Terbinafina reported include:
- Idiosyncratic and symptomatic hepatic injury; more rarely, cases of liver failure, some leading to death or liver transplant
- Skin and subcutaneoustissue disorders (e.g., Stevens-Johnson Syndrome and toxic epidermal necrolysis), drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome
- Severe allergic reaction (anaphylaxis), skin swelling (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, joint pain, muscle pain, muscle wasting (rhabdomyolysis), reduced visual acuity, visual field defect, hair loss, serum sickness-like reaction, vasculitis, pancreatitis, influenza-like illness, pyrexia, increased bloodcreatine phosphokinase, photosensitivity reactions
- Hearing impairment, spinning sensation (vertigo)
- Thrombotic microangiopathy (TMA), including thrombotic thrombocytopenic purpura and hemolytic uremic syndrome
This is not a complete list of side effects and other serious side effects may occur. Call your doctor for information and medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Terbinafina side effects
Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).
Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, flu-like symptoms, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes. This reaction may occur several weeks after you began using Terbinafina.
Some people taking Terbinafina have developed severe liver damage leading to liver transplant or death. It is not clear whether Terbinafina actually caused the liver damage in these patients. In most cases, the patient had a serious medical condition before taking Terbinafina.
Call your doctor at once if you have symptoms of liver damage, such as nausea, upper stomach pain, vomiting, loss of appetite, tiredness, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes). These events can occur whether or not you have ever had liver problems before.
Also call your doctor if you have:
changes in your sense of taste or smell;
depressed mood, sleep problems, lack of interest in daily activity, feeling anxious or restless;
pale skin, easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
swelling, rapid weight gain, little or no urinating;
blood in your urine or stools;
weight loss due to taste changes or loss of appetite; or
skin sores, butterfly-shaped skin rash on your cheeks and nose (worsens in sunlight).
Common side effects may include:
diarrhea, nausea, gas, stomach pain or upset;
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Terbinafina has occasionally been thought to have caused or exacerbated cutaneous lupus erythematosus. Several further cases have been reported.
A 59-year-old man with a history of cutaneous lupus erythematosus, which had been in complete remission for 5 years, took oral Terbinafina for onychomycosis and after 1 month developed cutaneous lupus erythematosus, with typical papulosquamous lesions and a raised titer of antinuclear antibodies (6 A ) . Terbinafina was withdrawn and systemic and topical steroids were given; the eruption resolved over several weeks.
A 50-year-old woman had a severe cutaneous flare-up of pre-existing systemic lupus erythematosus 7 weeks after starting treatment with Terbinafina (7 A ) .
A 25-year-old woman with stable systemic lupus erythematosus, who was taking corticosteroids and chloroquine 200 mg/day, was given Terbinafina for onychomycosis and 7 days later developed cheilitis and bilateral conjunctivitis followed by epidermolysis involving 10% of the skin (8 A ) . There was massive hematuria and proteinuria, and a renal biopsy showed lupus glomerulonephritis. Antihistone antibodies were strongly positive. She was given systemic corticosteroids, chloroquine, and cyclophosphamide and recovered.
A 39-year-old women with systemic lupus erythematosus took Terbinafina 250 mg/day for onychomycosis and after 7 days developed a widespread severe erythematous eruption (9 A ) . Clinical, histological, and immunofluorescent investigations confirmed the diagnosis of co-existing subacute cutaneous and systemic lupus erythematosus. Terbinafina was withdrawn.
Three patients with sicca syndrome, lung carcinoma, and Kikuchi disease were given Terbinafina for suspected dermatophytic infections; each developed subacute cutaneous lupus erythematosus within 7 weeks (10 Ar ) .
Terbinafina 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.
What is Terbinafina, and how does it work (mechanism of action)?
Terbinafina is an antifungal agent that is taken by mouth or applied to the skin. Terbinafina acts by interfering with the ability of fungi to make chemicals called sterols that are an important part of the membrane that surrounds fungal cells and holds them together. This weakens the cell membrane. Oral Terbinafina is more effective for treating fungal nail infections than griseofulvin (Fulvicin; Gris-Peg) and itraconazole (Sporanox), two other antifungal agents used for treating fungal nail infections. Topical Terbinafina was approved by the FDA in 1993. Terbinafina oral tablets were approved in 1996.
Cases of liver failure, some leading to liver transplant or death, have occurred with the use of Lamisil Tablets in individuals with and without preexisting liver disease.
In the majority of liver cases reported in association with use of Lamisil Tablets, the patients had serious underlying systemic conditions. The severity of hepatic events and/or their outcome may be worse in patients with active or chronic liver disease. Treatment with Lamisil Tablets should be discontinued if biochemical or clinical evidence of liver injury develops.
Lamisil Tablets are not recommended for patients with chronic or active liver disease. Before prescribing Lamisil Tablets, liver function tests should be performed since hepatotoxicity may occur in patients with and without pre-existing liver disease. Periodic monitoring of liver function tests is recommended. Lamisil should be immediately discontinued in case of elevation of liver function tests. Patients prescribed Lamisil Tablets should be warned to report immediately to their physician any symptoms of persistent nausea, anorexia, fatigue, vomiting, right upper abdominal pain or jaundice, dark urine, or pale stools. Patients with these symptoms should discontinue taking oral Terbinafina, and the patientâ€™s liver function should be immediately evaluated.
There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, and because treatment of onychomycosis can be postponed until after pregnancy is completed, it is recommended that Lamisil Tablets not be initiated during pregnancy.
Oral reproduction studies have been performed in rabbits and rats at doses up to 300 mg/kg/day and have revealed no evidence of impaired fertility or harm to the fetus due to Terbinafina.
What is Terbinafina?
Terbinafina is an allylamine medicine used to treat fungal infections. It is especially effective against dermatophytes (tinea infections).
The original brand is Lamisil®. In New Zealand (2016) it is available as 250 mg tablets (Dr Reddy's Terbinafina, fully funded by PHARMAC) and Terbinafina-DRLA. The tablets require a doctor's prescription. Topical options include creams, gel , solution and spray from various manufacturers, and are available at a pharmacy without a prescription.
How does Terbinafina control fungal infections?
Terbinafina inhibits a fungal enzyme , squalene epoxidase, and stops the cells making ergosterol, the main component of the cell wall.
Patient Counseling Information
Advise the patient to read the FDA-Approved Medication Guide.
Patients taking Terbinafina 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. Terbinafina 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. Terbinafina 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. Terbinafina tablets treatment should be discontinued.
- Advise patients to minimize exposure to natural and artificial sunlight (tanning beds or UVA/B treatment) while using Terbinafina tablets.
- Advise patients that if they forget to take Terbinafina 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 Terbinafina tablets.
- Advise patients to call their physician if they become pregnant during treatment with Terbinafina 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.
Terbinafina tablets are contraindicated for patients with chronic or active liver disease . Cases of liver failure, some leading to liver transplant or death, have occurred with the use of Terbinafina tablets in individuals with and without preexisting liver disease. The severity of hepatic events and/or their outcome may be worse in patients with active or chronic liver disease.