When to Test Blood Again After Taking Terbinafine
What is Lamisil and how is information technology used?
Lamisil is a prescription medicine used to treat symptoms of fungus (Onychomycosis) of the toenail or fingernail. Lamisil may be used alone or with other medications.
Lamisil belongs to a form of drugs chosen Antifungals, Systemic.
Information technology is not known if Lamisil is rubber and effective in children.
What are the possible side effects of Lamisil?
Lamisil may cause serious side effects including:
- changes in your sense of sense of taste or smell,
- depressed mood,
- sleep problems,
- lack of involvement in daily activity,
- feeling anxious or restless,
- pale skin,
- piece of cake bruising,
- unusual bleeding (nose, mouth, vagina or rectum),
- royal or ruby-red pinpoint spots under your pare
- ,
- swelling,
- rapid weight gain,
- little or no urinating,
- claret in your urine or stools,
- weight loss due to taste changes or loss of ambition,
- nausea,
- upper stomach hurting,
- airsickness,
- tiredness,
- dark urine,
- clay-colored stools,
- yellowing of the skin or eyes (jaundice),
- skin sores, and
- butterfly-shaped skin rash on your cheeks or nose that worsens in sunlight
Get medical assistance right away, if yous have whatsoever of the symptoms listed in a higher place.
The most common side effects of Lamisil include:
- diarrhea,
- nausea,
- gas,
- stomach pain or upset,
- rash,
- headache, and
- abnormal liver office tests
Tell your dr. if yous have whatever side upshot that bothers you or that does not go abroad.
These are not all the possible side furnishings of Lamisil. For more information, ask your doctor or chemist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at ane-800-FDA-1088.
DESCRIPTION
Lamisil Tablets contain the synthetic allylamine antifungal compound terbinafine hydrochloride. Chemically, terbinafine hydrochloride is (E)-N-(half dozen,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:
Terbinafine hydrochloride is a white to off-white fine crystalline pulverisation. It is freely soluble in methanol and methylene chloride, soluble in ethanol, and slightly soluble in water.
Each tablet contains:
Active Ingredients: terbinafine 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.
DOSAGE AND Assistants
Fingernail onychomycosis: One 250 mg tablet in one case daily for 6 weeks.
Toenail onychomycosis: One 250 mg tablet once daily for 12 weeks.
The optimal clinical effect is seen some months after mycological cure and cessation of treatment. Thisis related to the period required for outgrowth of healthy nail.
HOW SUPPLIED
Dosage Forms And Strengths
Tablet, 250 mg white to yellow-tinged white round, bi-convex, askew tablets imprinted with "LAMISIL" in round form on one side and code "250" on the other side.
Storage And Handling
Lamisil Tablets are supplied as white to yellow-tinged white circular, bi-convex, beveled tablets containing 250 mg of terbinafine imprinted with "LAMISIL" in round form on one side and code "250" on the other.
Bottles of 100 tablets NDC 0078-0179-05
Bottles of 30 tablets NDC 0078-0179-15
Store Lamisil Tablets below 25°C (77°F); in a tight container. Protect from calorie-free.
Distributed by: Novartis Pharmaceuticals Corporation, Eastward Hanover, New Jersey 07936. Revised: Feb 2015
SIDE Furnishings
Clinical Trials Feel
Considering clinical trials are conducted under widely varying weather condition, adverse reaction rates in the clinical trials of a drug cannot be direct compared to rates in the clinical trials of some other drug and may not reflect the rates observed in practice.
The most frequently reported adverse events observed in the 3 Usa/Canadian placebo-controlled trials are listed in the table below. The agin events reported cover gastrointestinal symptoms (including diarrhea, dyspepsia, and abdominal hurting), liver test abnormalities, rashes, urticaria, pruritus, and taste disturbances. Changes in the ocular lens and retina have been reported following the use of Lamisil Tablets in controlled trials. The clinical significance of these changes is unknown. In general, the agin events were mild, transient, and did non lead to discontinuation from study participation.
Adverse Event | Discontinuation | |||
Lamisil Tablets (%) n=465 | Placebo (%) due north=137 | Lamisil Tablets (%) n=465 | Placebo (%) n=137 | |
Headache | 12.9 | 9.five | 0.2 | 0.0 |
Gastrointestinal Symptoms: | ||||
Diarrhea | v.half dozen | two.nine | 0.six | 0.0 |
Dyspepsia | 4.3 | 2.nine | 0.4 | 0.0 |
Abdominal Pain | 2.four | 1.5 | 0.iv | 0.0 |
Nausea | ii.half-dozen | ii.nine | 0.ii | 0.0 |
Flatulence | 2.ii | 2.2 | 0.0 | 0.0 |
Dermatological Symptoms: | ||||
Rash | v.half-dozen | ii.2 | 0.9 | 0.7 |
Pruritus | 2.8 | i.v | 0.2 | 0.0 |
Urticaria | ane.one | 0.0 | 0.0 | 0.0 |
Liver Enzyme Abnormalities* | iii.iii | ane.4 | 0.2 | 0.0 |
Gustation Disturbance | 2.viii | 0.vii | 0.two | 0.0 |
Visual Disturbance | i.i | ane.5 | 0.9 | 0.0 |
*Liver enzyme abnormalities ≥ 2x the upper limit of normal range. |
Postmarketing Experience
The following agin events accept been identified during postapproval use of Lamisil Tablets. Because these events are reported voluntarily from a population of uncertain size, information technology is not always possible to reliably estimate their frequency or constitute a causal human relationship to drug exposure.
Blood and lymphatic organization disorders: Pancytopenia, agranulocytosis, severe neutropenia, thrombocytopenia, anemia [see WARNINGS AND PRECAUTIONS]
Allowed system disorders: Serious hypersensitivity reactions e.g., angioedema and allergic reactions (including anaphylaxis), precipitation and exacerbation of cutaneous and systemic lupus erythematosus [run into WARNINGS AND PRECAUTIONS], serum sickness-like reaction
Psychiatric disorders: Anxiety and depressive symptoms independent of taste disturbance have been reported with employ of Lamisil Tablets. In some cases, depressive symptoms accept been reported to subside with discontinuance of therapy and to recur with reinstitution of therapy [see WARNINGS AND PRECAUTIONS].
Nervous organisation disorders: Cases of taste disturbance, including gustatory modality loss, have been reported with the use of Lamisil Tablets. It tin be severe enough to effect in decreased food intake, weight loss, feet, and depressive symptoms. Cases of smell disturbance, including olfactory property loss, have been reported with the use of Lamisil Tablets [see WARNINGS AND PRECAUTIONS]. Cases of paresthesia and hypoesthesia have been reported with the utilize of Lamisil Tablets.
Eye disorders: Visual field defects, reduced visual acuity
Ear and labyrinth disorders: Hearing harm, vertigo, tinnitus
Vascular disorders: Vasculitis
Gastrointestinal disorders: Pancreatitis, vomiting
Hepatobiliary disorders: Cases of liver failure some leading to liver transplant or death [run across WARNINGS AND PRECAUTIONS], idiosyncratic and symptomatic hepatic injury. Cases of hepatitis, cholestasis, and increased hepatic enzymes [see WARNINGS AND PRECAUTIONS] have been seen with the use of Lamisil Tablets.
Peel and subcutaneous tissue disorders: Serious peel reactions [e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, bullous dermatitis, and drug reaction with eosinophilia and systemic symptoms (Clothes) syndrome] [see WARNINGS AND PRECAUTIONS], astute generalized exanthematous pustulosis, psoriasiform eruptions or exacerbation of psoriasis, photosensitivity reactions, hair loss
Musculoskeletal and connective tissue disorders: Rhabdomyolysis, arthralgia, myalgia
General disorders and administration site weather: Malaise, fatigue, influenza-like illness, pyrexia
Investigations: Altered prothrombin time (prolongation and reduction) in patients concomitantly treated with warfarin and increased blood creatine phosphokinase have been reported
DRUG INTERACTIONS
Drug-Drug Interactions
In vivo studies take shown that terbinafine is an inhibitor of the CYP450 2D6 isozyme. Drugs predominantly metabolized by the CYP450 2D6 isozyme include the following drug classes: tricyclic antidepressants, selective serotonin reuptake inhibitors, beta-blockers, antiarrhythmics course 1C (e.g., flecainide and propafenone) and monoamine oxidase inhibitors Type B. Coadministration of Lamisil Tablets should be done with careful monitoring and may require a reduction in dose of the 2D6- metabolized drug. In a study to assess the effects of terbinafine on desipramine in salubrious volunteers characterized as normal metabolizers, the administration of terbinafine resulted in a two-fold increase in Cmax and a v-fold increase in area under the curve (AUC). In this report, these effects were shown to persist at the concluding observation at four weeks after discontinuation of Lamisil Tablets. In studies in healthy subjects characterized as all-encompassing metabolizers of dextromethorphan (antitussive drug and CYP2D6 probe substrate), terbinafine increases the dextromethorphan/dextrorphan metabolite ratio in urine by 16- to 97-fold on average. Thus, terbinafine may convert extensive CYP2D6 metabolizers to poor metabolizer status.
In vitro studies with human liver microsomes showed that terbinafine does not inhibit the metabolism of tolbutamide, ethinylestradiol, ethoxycoumarin, cyclosporine, cisapride and fluvastatin. In vivo drug-drug interaction studies conducted in healthy volunteer subjects showed that terbinafine does non affect the clearance of antipyrine or digoxin. Terbinafine decreases the clearance of caffeine by 19%. Terbinafine increases the clearance of cyclosporine by 15%.
The influence of terbinafine on the pharmacokinetics of fluconazole, cotrimoxazole (trimethoprim and sulfamethoxazole), zidovudine or theophylline was not considered to be clinically meaning.
Coadministration of a single dose of fluconazole (100 mg) with a unmarried dose of terbinafine resulted in a 52% and 69% increase in terbinafine Cmax and AUC, respectively. Fluconazole is an inhibitor of CYP2C9 and CYP3A enzymes. Based on this finding, it is likely that other inhibitors of both CYP2C9 and CYP3A4 (e.g., ketoconazole, amiodarone) may also atomic number 82 to a substantial increase in the systemic exposure (Cmax and AUC) of terbinafine when concomitantly administered.
There have been spontaneous reports of increase or decrease in prothrombin times in patients concomitantly taking oral terbinafine and warfarin, however, a causal relationship between Lamisil Tablets and these changes has not been established.
Terbinafine clearance is increased 100% by rifampin, a CYP450 enzyme inducer, and decreased 33% by cimetidine, a CYP450 enzyme inhibitor. Terbinafine clearance is unaffected by cyclosporine. There is no information available from adequate drug-drug interaction studies with the post-obit classes of drugs: oral contraceptives, hormone replacement therapies, hypoglycemics, phenytoins, thiazide diuretics, and calcium channel blockers.
Food Interactions
An evaluation of the effect of food on Lamisil Tablets was conducted. An increase of less than xx% of the AUC of terbinafine was observed when Lamisil Tablets were administered with nutrient. Lamisil Tablets tin exist taken with or without food.
WARNINGS
Included every bit function of the PRECAUTIONS section.
PRECAUTIONS
Hepatotoxicity
Cases of liver failure, some leading to liver transplant or decease, take 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 utilize 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 affliction. Handling with Lamisil Tablets should exist discontinued if biochemical or clinical show of liver injury develops.
Lamisil Tablets are not recommended for patients with chronic or active liver disease. Before prescribing Lamisil Tablets, liver role tests should be performed since hepatotoxicity may occur in patients with and without pre-existing liver affliction. Periodic monitoring of liver function tests is recommended. Lamisil should be immediately discontinued in case of height of liver role 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, night urine, or pale stools. Patients with these symptoms should discontinue taking oral terbinafine, and the patient’s liver function should exist immediately evaluated.
Gustation Disturbance Including Loss of Taste
Gustatory modality disturbance, including taste loss, has been reported with the use of Lamisil Tablets. It can be astringent enough to upshot in decreased food intake, weight loss, anxiety, and depressive symptoms. Taste disturbance may resolve within several weeks after discontinuation of treatment, but may be prolonged (greater than i year), or may exist permanent. If symptoms of a sense of taste disturbance occur, Lamisil Tablets should be discontinued.
Smell Disturbance Including Loss Of Smell
Olfactory property disturbance, including loss of smell, has been reported with the use of Lamisil Tablets. Aroma disturbance may resolve later discontinuation of treatment, but may exist prolonged (greater than ane year), or may be permanent. If symptoms of a scent disturbance occur, Lamisil Tablets should be discontinued.
Depressive Symptoms
Depressive symptoms have occurred during postmarketing utilise of Lamisil Tablets. Prescribers should be alarm to the evolution of depressive symptoms, and patients should be instructed to report depressive symptoms to their physician.
Hematologic Furnishings
Transient decreases in absolute lymphocyte counts (ALCs) have been observed in controlled clinical trials. In placebo-controlled trials, viii/465 subjects receiving Lamisil Tablets (ane.seven%) and three/137 subjects receiving placebo (two.2%) had decreases in ALC to below 1000/mm³ on two or more than occasions. In patients with known or suspected immunodeficiency, physicians should consider monitoring complete blood counts if handling continues for more than half dozen weeks. Cases of astringent neutropenia take been reported. These were reversible upon discontinuation of Lamisil Tablets, with or without supportive therapy. If clinical signs and symptoms suggestive of secondary infection occur, a complete claret count should be obtained. If the neutrophil count is ≤ yard cells/mm³, Lamisil Tablets should be discontinued and supportive management started.
Serious Skin/Hypersensitivity Reactions
There accept been postmarketing reports of serious skin/hypersensitivity reactions [eastward.g., Stevens-Johnson Syndrome, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, bullous dermatitis, and drug reaction with eosinophilia and systemic symptoms (Dress) syndrome]. Manifestations of DRESS syndrome may include cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, and one or more organ complications such as hepatitis, pneumonitis, nephritis, myocarditis, and pericarditis. If progressive skin rash or signs/symptoms of the higher up drug reactions occur, treatment with Lamisil Tablets should be discontinued.
Lupus Erythematosus
During postmarketing experience, precipitation and exacerbation of cutaneous and systemic lupus erythematosus have been reported in patients taking Lamisil Tablets. Lamisil Tablets should exist discontinued in patients with clinical signs and symptoms suggestive of lupus erythematosus.
Laboratory Monitoring
Measurement of serum transaminases (ALT and AST) is brash for all patients before taking Lamisil Tablets.
Patient Counseling Information
See FDA-Approved Patient Labeling (PATIENT Information)
Patients taking Lamisil Tablets should receive the following information and instructions:
- Advise patients to immediately report to their md or become emergency assist if they experience any of the following symptoms: hives, mouth sores, blistering and peeling of skin, swelling of face, lips, tongue, or pharynx, difficulty swallowing or breathing. Lamisil Tablets treatment should be discontinued.
- Advise patients to immediately report to their md any symptoms of persistent nausea, anorexia, fatigue, vomiting, right upper abdominal hurting, jaundice, dark urine, or pale stools. Lamisil Tablets treatment should be discontinued.
- Advise patients to study to their physician any signs of gustatory modality disturbance, odor disturbance and/or depressive symptoms, fever, skin eruption, lymph node enlargement, erythema, scaling, loss of paint, and unusual photosensitivity that can issue in a rash. Lamisil Tablets treatment should exist discontinued.
- Advise patients to minimize exposure to natural and artificial sunlight (tanning beds or UVA/B handling) while using Lamisil Tablets.
- Advise patients that if they forget to take Lamisil Tablets, to take their tablets equally before long equally they remember, unless it is less than iv hours before the next dose is due. Advise patients to call their medico if they take also many Lamisil Tablets.
Nonclinical Toxicology
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 (2x the MRHD based on AUC comparisons of the parent terbinafine); however, even though dose-limiting toxicity was not achieved at the highest tested dose, college doses were not tested.
The results of a multifariousness of in vitro (mutations in East. coli and S. typhimurium, DNA repair in rat hepatocytes, mutagenicity in Chinese hamster fibroblasts, chromosome aberration, and sis chromatid exchanges in Chinese hamster lung cells), and in vivo (chromosome aberration in Chinese hamsters, micronucleus examination in mice) genotoxicity tests gave no prove of a mutagenic or clastogenic potential.
Oral reproduction studies in rats at doses upwards to 300 mg/kg/day (approximately 12x the MRHD based on BSA comparisons) did not reveal whatsoever specific effects on fertility or other reproductive parameters. Intravaginal application of terbinafine hydrochloride at 150 mg/twenty-four hours in pregnant rabbits did not increase the incidence of abortions or premature deliveries nor affect fetal parameters.
Use In Specific Populations
Pregnancy
Pregnancy Category B
There are no adequate and well-controlled studies in significant women. Because animal reproduction studies are not always predictive of homo response, and because handling of onychomycosis can be postponed until afterwards pregnancy is completed, it is recommended that Lamisil Tablets not exist initiated during pregnancy.
Oral reproduction studies have been performed in rabbits and rats at doses up to 300 mg/kg/day [12x to 23x the maximum recommended man dose (MRHD), in rabbits and rats, respectively, based on trunk surface area (BSA) comparisons] and have revealed no evidence of impaired fertility or impairment to the fetus due to terbinafine.
Nursing Mothers
After oral assistants, terbinafine is present in chest milk of nursing mothers. The ratio of terbinafine in milk to plasma is seven:i. Handling with Lamisil Tablets is not recommended in women who are nursing.
Pediatric Use
The safe and efficacy of Lamisil Tablets have not been established in pediatric patients with onychomycosis.
Geriatric Use
Clinical studies of Lamisil Tablets did not include sufficient numbers of subjects aged 65 years and over to determine whether they reply differently from younger subjects. Other reported clinical experience has non identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Renal Impairment
In patients with renal impairment (creatinine clearance less than or equal to 50 mL/min) the utilize of Lamisil Tablets has not been adequately studied.
Overdosage & Contraindications
OVERDOSE
Clinical experience regarding overdose with oral terbinafine is express. Doses up to v grams (20 times the therapeutic daily dose) take been taken without inducing serious adverse reactions. The symptoms of overdose included nausea, vomiting, abdominal pain, dizziness, rash, frequent urination, and headache.
CONTRAINDICATIONS
Lamisil Tablets are contraindicated in individuals with a history of allergic reaction to oral terbinafine considering of the risk of anaphylaxis.
CLINICAL PHARMACOLOGY
Machinery Of Action
Terbinafine is an allylamine antifungal [run across Microbiology].
Pharmacodynamics
The pharmacodynamics of Lamisil Tablets is unknown.
Pharmacokinetics
Following oral administration, terbinafine is well captivated ( > 70%) and the bioavailability of Lamisil Tablets as a result of first-pass metabolism is approximately 40%. Elevation plasma concentrations of one μg/mL appear within two hours after a single 250 mg dose; the AUC is approximately 4.56 μg&bu;ll;h/mL. An increment in the AUC of terbinafine of less than twenty% is observed when Lamisil Tablets are administered with nutrient.
In plasma, terbinafine is > 99% bound to plasma proteins and there are no specific bounden sites. At steady-state, in comparison to a unmarried dose, the acme concentration of terbinafine is 25% higher and plasma AUC increases past a gene of 2.5; the increase in plasma AUC is consistent with an effective half-life of ~36 hours. Terbinafine is distributed to the sebum and skin. A terminal half-life of 200-400 hours may represent the slow elimination of terbinafine from tissues such as skin and adipose. Prior to excretion, terbinafine is extensively metabolized by at least 7 CYP isoenzymes with major contributions from CYP2C9, CYP1A2, CYP3A4, CYP2C8, and CYP2C19. No metabolites have been identified that have antifungal activity similar to terbinafine. Approximately 70% of the administered dose is eliminated in the urine.
In patients with renal impairment (creatinine clearance ≤ 50 mL/min) or hepatic cirrhosis, the clearance of terbinafine is decreased by approximately 50% compared to normal volunteers. No consequence of gender on the blood levels of terbinafine was detected in clinical trials. No clinically relevant age-dependent changes in steady-country plasma concentrations of terbinafine have been reported.
Microbiology
Terbinafine, an allylamine antifungal, inhibits biosynthesis of ergosterol, an essential component of fungal prison cell membrane, via inhibition of squalene epoxidase enzyme. This results in fungal cell death primarily due to the increased membrane permeability mediated by the aggregating of high concentrations of squalene simply not due to ergosterol deficiency. Depending on the concentration of the drug and the fungal species test in vitro, terbinafine hydrochloride may exist fungicidal. However, the clinical significance of in vitro data is unknown.
Terbinafine has been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections:
Trichophyton mentagrophytes
Trichophyton rubrum
The following in vitro data are available, but their clinical significance is unknown. In vitro, terbinafine exhibits satisfactory MIC'southward against nigh strains of the following microorganisms; however, the rubber and efficacy of terbinafine in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled clinical trials:
Candida albicans
Epidermophyton floccosum
Scopulariopsis brevicaulis
Brute Toxicology And/Or Pharmacology
A wide range of in vivo studies in mice, rats, dogs, and monkeys, and in vitro studies using rat, monkey, and homo hepatocytes propose that peroxisome proliferation in the liver is a rat-specific finding. However, other effects, including increased liver weights and APTT, occurred in dogs and monkeys at doses giving Css trough levels of the parent terbinafine 2-3x those seen in humans at the MRHD. Higher doses were not tested.
Clinical Studies
The efficacy of Lamisil Tablets in the treatment of onychomycosis is illustrated by the response of subjects with toenail and/or fingernail infections who participated in 3 United states of america/Canadian placebo-controlled clinical trials.
Results of the first toenail trial, as assessed at week 48 (12 weeks of treatment with 36 weeks follow-upward after completion of therapy), demonstrated mycological cure, defined as simultaneous occurrence of negative KOH plus negative civilisation, in 70% of subjects. Fifty-nine per centum (59%) of subjects experienced effective treatment (mycological cure plus 0% nail interest or > 5mm of new unaffected nail growth); 38% of subjects demonstrated mycological cure plus clinical cure (0% boom involvement).
In a second toenail trial of dermatophytic onychomycosis, in which nondermatophytes were also cultured, like efficacy against the dermatophytes was demonstrated. The pathogenic role of the nondermatophytes cultured in the presence of dermatophytic onychomycosis has not been established. The clinical significance of this association is unknown.
Results of the fingernail trial, every bit assessed at week 24 (6 weeks of treatment with eighteen weeks follow-upwards later on completion of therapy), demonstrated mycological cure in 79% of subjects, constructive treatment in 75% of the subjects, and mycological cure plus clinical cure in 59% of the subjects.
The mean fourth dimension to overall success was approximately 10 months for the first toenail trial and iv months for the fingernail trial. In the first toenail trial, for subjects evaluated at least 6 months after achieving clinical cure and at least 1 twelvemonth after completing therapy with Lamisil Tablets, the clinical relapse charge per unit was approximately fifteen%.
PATIENT Information
Lamisil
(Lam-i-sil)
(terbinafine hydrochloride) Tablets
What are Lamisil Tablets ?
Lamisil Tablets is a prescription antifungal medicine used to treat fungal infections of the fingernails and toenails (onychomycosis).
Your doctor should exercise tests to check you lot for fungal infection of your nails before you start Lamisil Tablets.
It is not known if Lamisil Tablets are condom and effective in children for the treatment of onychomycosis.
Who should not have Lamisil Tablets ?
Do not take Lamisil Tablets if you lot are allergic to terbinafine hydrochloride when taken by mouth.
What should I tell my doctor before taking Lamisil Tablets ?
Before you lot take Lamisil Tablets , tell your doctor if y'all:
- have or had liver bug
- have a weakened allowed organisation (immunocompromised)
- have lupus (an autoimmune affliction)
- have any other medical conditions
- are meaning or program to go pregnant. It is not known if Lamisil Tablets will impairment your unborn baby. You should not start taking Lamisil Tablets during pregnancy without talking with your medico.
- are breastfeeding or plan to breastfeed. Lamisil can pass into your breast milk and may impairment your infant. Talk to your physician about the best manner to feed your baby if y'all take Lamisil Tablets.
Tell your doctor nearly all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Lamisil Tablets may affect the way other medicines work and other medicines may bear upon how Lamisil Tablets work. Especially tell your doctor if yous take:
- a medicine for depression
- a medicine for high claret force per unit area
- a medicine for heart issues
- desipramine (Norpramin)
- caffeine
- cyclosporine (Gengraf, Neoral, Sandimmune)
- fluconazole (Diflucan)
- rifampin (Rifater, Rifamate, Rimactane, Rifadine)
- cimetidine (Tagamet)
If you are not sure if your medicine is i listed above, ask your md or pharmacist.
Know the medicines y'all take. Proceed a list of them to show your doctor and pharmacist when you get a new medicine.
How should I have Lamisil Tablets ?
- Accept Lamisil Tablets exactly as your doctor tells y'all to take information technology.
- Lamisil comes every bit a tablet that you take past mouth.
- Lamisil Tablets are normally taken:
- 1 time each day for vi weeks to treat fungal infections of your fingernail, or
- 1 fourth dimension each day for 12 weeks to treat fungal infections of your toenail
- Lamisil Tablets can exist taken with or without food.
- If you lot miss a dose of Lamisil Tablets, take it as soon as you lot recollect. If it is less than 4 hours before your side by side dose, skip the missed dose. Just take the side by side dose at your regular fourth dimension.
If you take too many Lamisil Tablets phone call your md. You may have the following symptoms:
- nausea
- vomiting
- stomach (abdomen) pain
- dizziness
- rash
- frequent urination
- headache
What should I avoid while taking Lamisil Tablets ?
- Avoid sunlight. Lamisil Tablets can make your skin sensitive to the sun and the light from sunlamps and tanning beds. Yous tin get a severe sunburn. Apply sunscreen and wear a lid and wearing apparel that cover your skin if you have to be in sunlight. Talk to your dr. if you lot go sunburn.
What are the possible side effects of Lamisil Tablets ?
Lamisil Tablets may crusade serious side furnishings, including:
- liver problems that can lead to the need for liver trans plant, or death. Tell your doc right away if you become any of these symptoms of a liver problem:
- nausea
- upper right stomach-area (abdomen) pain
- poor appetite
- yellowing of your peel or eyes (jaundice)
- tiredness
- night (tea-colored) urine
- airsickness
- stake or light colored stools
Your dr. should do a blood test to cheque you for liver problems earlier y'all accept Lamisil Tablets.
- change in sense of taste or los s of taste may happen with Lamisil Tablets and tin be severe. This may better within several weeks after you stop taking Lamisil Tablets, just may last for a long time or may become permanent. Tell your doctor if you have:
- alter in gustation or loss of gustation
- poor ambition
- unwanted weight loss
- anxiousness
- change in mood or depressive symptoms
- change in odour or loss of smell may happen with Lamisil Tablets. This may amend after y'all stop taking Lamisil Tablets, but may concluding for a long time or may become permanent.
- depressive symptoms. Tell your physician right abroad if you have whatever of these signs or symptoms:
- feel sad or worthless
- change in sleep design
- loss of energy or interest in daily activities
- restlessness
- mood changes
- depression white blood cell count. People taking Lamisil Tablets may accept a decrease in white blood cells, especially neutrophils. Yous may have a higher hazard of getting an infection when your white blood prison cell count is low.
- serious skin or allergic reactions. Tell your medico right away or get emergency help if y'all get whatever of these symptoms:
- skin rash, hives, sores in your mouth, or your skin blisters and peels
- swelling of your face, eyes, lips, tongue or throat, trouble swallowing or breathing
- drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome – peel rash, fever, swollen lymph glands, involvement of internal organs
- new or worsening lupus (an autoimmune disease). Stop taking Lamisil Tablets and tell your doctor if you lot become whatsoever of the following:
- progressive skin rash that is scaly, red, shows scarring, or loss of paint
- unusual sensitivity to the sunday that can pb to a rash
The nigh common side effects of Lamisil Tablets include:
- headache
- diarrhea
- rash
- upset stomach
- abnormal liver role tests
- itching
- change in taste
- nausea
- stomach-expanse (belly) pain
- gas
Tell your doctor if you take whatever side result that bothers you or that does not go away.
These are non all of the possible side effects of Lamisil Tablets. For information, inquire your md or pharmacist.
Call your doctor for medical communication nearly side effects. You may report side effects to FDA at ane-800-FDA-1088.
How should I store Lamisil Tablets ?
- Shop Lamisil Tablets below 77°F (25°C)
- Keep Lamisil Tablets in a tightly airtight container and go along out of the lite.
Keep Lamisil Tablets and all medicines out of the reach of children.
Full general information virtually the safe and effective use of Lamisil Tablets .
Medicines are sometimes prescribed for purposes other than those listed in Patient Information. Do not apply Lamisil Tablets for a condition for which it was not prescribed. Practice not give Lamisil Tablets to other people, even if they accept the aforementioned symptoms that you have. Information technology may harm them.
You can inquire your pharmacist or md for information near Lamisil Tablets that is written for health professionals.
What are the ingredients in Lamisil Tablets ?
Active ingredient: terbinafine hydrochloride
Inactive ingredients: colloidal silicon dioxide, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate
This Patient Information has been approved by the U.Southward. Food and Drug Assistants.
From
Written report Problems to the Nutrient and Drug Assistants
Yous are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Source: https://www.rxlist.com/lamisil-drug.htm
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