Apo-Terbinafine tablets are contraindicated for patients with chronic or active liver disease. Before prescribing Apo-Terbinafine tablets, perform liver function tests because hepatotoxicity may occur in patients with and without preexisting liver disease. Cases of liver failure, some leading to liver transplant or death, have occurred with the use of Apo-Terbinafine tablets in individuals with and without preexisting liver disease.
In the majority of liver cases reported in association with use of Apo-Terbinafine 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. Periodic monitoring of liver function tests is recommended. Discontinue Apo-Terbinafine tablets if biochemical or clinical evidence of liver injury develops.
Warn patients prescribed Apo-Terbinafine tablets and/or their caregivers to report immediately to their healthcare providers any symptoms or signs of persistent nausea, anorexia, fatigue, vomiting, right upper abdominal pain or jaundice, dark urine, or pale stools. Advise patients with these symptoms to discontinue taking oral Apo-Terbinafine, and immediately evaluate the patient’s liver function.
Apo-Terbinafine (Lamisil, Lamisil AT) is an antifungal medication prescribed for the treatment of fungal nails, jock itch, and athlete's foot. Side effects, drug interactions, warnings and precautions, and pregnancy safety information should be reviewed prior to using this medication.
Patient Counseling Information
Advise the patient to read the FDA-Approved Medication Guide.
Patients taking Apo-Terbinafine 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. Apo-Terbinafine 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. Apo-Terbinafine 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. Apo-Terbinafine tablets treatment should be discontinued.
- Advise patients to minimize exposure to natural and artificial sunlight (tanning beds or UVA/B treatment) while using Apo-Terbinafine tablets.
- Advise patients that if they forget to take Apo-Terbinafine 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 Apo-Terbinafine tablets.
- Advise patients to call their physician if they become pregnant during treatment with Apo-Terbinafine 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 the most important information I should know about Apo-Terbinafine (LamISIL)?
Some people taking Apo-Terbinafine have developed severe liver damage leading to liver transplant or death.
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, jaundice (yellowing of the skin or eyes). These events can occur whether or not you have ever had liver problems before.
Before taking Apo-Terbinafine
Some medicines are not suitable for people with certain conditions, and sometimes a medicine can only be used if extra care is taken. For these reasons, before you start taking Apo-Terbinafine it is important that your doctor knows:
- If you are pregnant or breastfeeding.
- If you have a problem with the way your liver works, or if you have a problem with the way your k >