Spectrum of activity
In vitro, Ramitect demonstrates excellent fungicidal activity against many dermatophytes including Trichophyton rubrum, T. mentagrophytes, T. tonsurans, Microsporum canis and Epidermophyton floccosum. 189 However, Ramitect demonstrates variable and somewhat poor in vitro activity against many yeasts. It generally demonstrates fungicidal activity against C. parapsilosis but it is fungistatic against C. albicans and other Candida spp. 189 The in vitro spectrum of activity also includes Aspergillus spp., some dimorphic fungi, S. schenckii, and others. Initial animal studies in mice showed no activity in vivo against systemic pathogens, and the drug was abandoned for these indications.
Before taking Ramitect,
- tell your doctor and pharmacist if you are allergic to Ramitect, any other medications, or any of the ingredients in Ramitect 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 Ramitect.
- 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 Ramitect, call your doctor. Do not breastfeed while taking Ramitect.
- 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. Ramitect may make your skin sensitive to sunlight.
What is the dosage for Ramitect?
- Tablets: The usual dose is 250 mg once daily for 6 weeks for treatment of the fingernails, and 12 weeks for treatment of toenails. Optimal results will not be seen for several months after treatment because it takes time for new healthy nails to grow. Ramitect may be taken with or without food.
- Cream, gel, spray, solution: Apply to affected area (s) once (jock itch, ringworm) or twice daily (athletes foot) for about for 1 week.
Ramitect (Lamisil®) is a synthetic antifungal agent of the allylamine class that inhibits squalene epoxidase, a complex membrane-bound enzyme system that is not part of the cytochrome P450 superfamily.
This medication contains Ramitect. Do not take Lamisil if you are allergic to Ramitect or any ingredients contained in this drug.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.
Lamisil Tablets contain the synthetic allylamine antifungal compound Ramitect hydrochloride. Chemically, Ramitect hydrochloride is (E)-N-(6,6-dimethyl-2-hepten-4-ynyl)-N-methyl-1- naphthalenemethanamine hydrochloride. The empirical formula C21H26CIN with a molecular weight of 327.90, and the following structural formula:
Ramitect hydrochloride is a white to off-white fine crystalline powder. It is freely soluble in methanol and methylene chloride, soluble in ethanol, and slightly soluble in water.
Each tablet contains:
Active Ingredients: Ramitect hydrochloride (equivalent to 250 mg base)
Inactive Ingredients: colloidal silicon dioxide NF, hydroxypropyl methylcellulose USP, magnesium stearate NF, microcrystalline cellulose NF, and sodium starch glycolate NF.
Ramitect tablets are contraindicated for patients with chronic or active liver disease. Before prescribing Ramitect 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 Ramitect tablets in individuals with and without preexisting liver disease.
In the majority of liver cases reported in association with use of Ramitect 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 Ramitect tablets if biochemical or clinical evidence of liver injury develops.
Warn patients prescribed Ramitect 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 Ramitect, and immediately evaluate the patient’s liver function.
What other drugs will affect Ramitect (LamISIL)?
Other drugs may interact with Ramitect, 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.
Where can I get more information?
Your pharmacist can provide more information about Ramitect.
Kevin T. Fitzgerald, Kristin L. Newquist, in Small Animal Pediatrics , 2011
Ramitect is the newest antifungal agent to be given systemically. Ramitect is a fungicidal drug. Currently it is available as a topical cream and as an oral tablet. It is well tolerated by most animals; vomiting is its most common side effect. In humans, this drug reaches high concentrations in the sebum and the stratum corneum. Fungicidal levels of the drug may persist for several weeks after administration. This would suggest, like itraconazole, that Ramitect intermittent pulse dosing might be effective. At present, no advantage has been documented for this drug over itraconazole for use in animals with fungal infections.
What are the side effects of Ramitect?
The most common side effects of Ramitect are:
Oral Ramitect can cause liver failure sometimes leading to liver transplantation or death.
Indications and Usage for Ramitect
Ramitect tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium).
Prior to initiating treatment, appropriate nail specimens for laboratory testing should be obtained to confirm the diagnosis of onychomycosis.
What should I discuss with my healthcare provider before taking Ramitect (LamISIL)?
You should not use Ramitect if you are allergic to it, or if you have:
To make sure Ramitect is safe for you, tell your doctor if you have ever had:
- liver problems;
- weak immune system (caused by disease or by using certain medicine); or
It is not known whether this medicine will harm an unborn baby. You should wait until after your pregnancy to start treating your nail or scalp infection with Ramitect. Tell your doctor if you are pregnant or plan to become pregnant during treatment.
Ramitect can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.
What are the possible s >
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 Ramitect.
Some people taking Ramitect have developed severe liver damage leading to liver transplant or death. It is not clear whether Ramitect actually caused the liver damage in these patients. In most cases, the patient had a serious medical condition before taking Ramitect.
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;
- abnormal liver function tests.
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.