I Took Terbinafine Hcl 250 Mg and Did Not Finish the Dosage ; Can I Take It Again
What is Lamisil and how is it used?
Lamisil is a prescription medicine used to treat symptoms of fungus (Onychomycosis) of the toenail or fingernail. Lamisil may exist used lonely or with other medications.
Lamisil belongs to a grade of drugs called Antifungals, Systemic.
It is not known if Lamisil is prophylactic and effective in children.
What are the possible side effects of Lamisil?
Lamisil may crusade serious side effects including:
- changes in your gustation or smell,
- depressed mood,
- sleep problems,
- lack of interest in daily activeness,
- feeling broken-hearted or restless,
- stake pare,
- like shooting fish in a barrel bruising,
- unusual bleeding (nose, oral cavity, vagina or rectum),
- purple or red pinpoint spots under your pare
- ,
- swelling,
- rapid weight gain,
- little or no urinating,
- blood in your urine or stools,
- weight loss due to taste changes or loss of appetite,
- nausea,
- upper tummy pain,
- vomiting,
- tiredness,
- dark urine,
- clay-colored stools,
- yellowing of the pare or eyes (jaundice),
- skin sores, and
- butterfly-shaped pare rash on your cheeks or nose that worsens in sunlight
Become medical aid right away, if you take any of the symptoms listed above.
The most common side effects of Lamisil include:
- diarrhea,
- nausea,
- gas,
- stomach pain or upset,
- rash,
- headache, and
- aberrant liver function tests
Tell your doctor if you have any side outcome that bothers you lot or that does non go abroad.
These are not all the possible side effects of Lamisil. For more information, ask your doctor or pharmacist.
Telephone call your doctor for medical advice almost side effects. You may written report side furnishings to FDA at one-800-FDA-1088.
Clarification
Lamisil Tablets contain the constructed allylamine antifungal compound terbinafine hydrochloride. Chemically, terbinafine hydrochloride is (East)-N-(6,six-dimethyl-2-hepten-4-ynyl)-N-methyl-ane- naphthalenemethanamine hydrochloride. The empirical formula C21H26CIN with a molecular weight of 327.xc, and the following structural formula:
Terbinafine hydrochloride is a white to off-white fine crystalline pulverisation. Information technology 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 ADMINISTRATION
Fingernail onychomycosis: Ane 250 mg tablet once daily for 6 weeks.
Toenail onychomycosis: One 250 mg tablet once daily for 12 weeks.
The optimal clinical outcome is seen some months after mycological cure and cessation of treatment. Thisis related to the period required for outgrowth of healthy boom.
HOW SUPPLIED
Dosage Forms And Strengths
Tablet, 250 mg white to yellowish-tinged white circular, bi-convex, beveled tablets imprinted with "LAMISIL" in round form on i 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 circular 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-xv
Store Lamisil Tablets below 25°C (77°F); in a tight container. Protect from calorie-free.
Distributed by: Novartis Pharmaceuticals Corporation, E Hanover, New Bailiwick of jersey 07936. Revised: February 2015
SIDE EFFECTS
Clinical Trials Feel
Because clinical trials are conducted nether widely varying weather condition, 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 nigh frequently reported adverse events observed in the 3 United states/Canadian placebo-controlled trials are listed in the table below. The adverse events reported encompass gastrointestinal symptoms (including diarrhea, dyspepsia, and abdominal pain), liver examination abnormalities, rashes, urticaria, pruritus, and taste disturbances. Changes in the ocular lens and retina take been reported following the use of Lamisil Tablets in controlled trials. The clinical significance of these changes is unknown. In full general, the adverse events were balmy, transient, and did non lead to discontinuation from study participation.
Adverse Event | Discontinuation | |||
Lamisil Tablets (%) n=465 | Placebo (%) n=137 | Lamisil Tablets (%) due north=465 | Placebo (%) n=137 | |
Headache | 12.9 | 9.5 | 0.2 | 0.0 |
Gastrointestinal Symptoms: | ||||
Diarrhea | 5.6 | two.9 | 0.6 | 0.0 |
Dyspepsia | 4.3 | 2.9 | 0.4 | 0.0 |
Intestinal Pain | 2.4 | i.5 | 0.4 | 0.0 |
Nausea | two.6 | 2.9 | 0.2 | 0.0 |
Flatulence | two.2 | 2.two | 0.0 | 0.0 |
Dermatological Symptoms: | ||||
Rash | v.6 | 2.2 | 0.9 | 0.seven |
Pruritus | 2.8 | 1.5 | 0.2 | 0.0 |
Urticaria | ane.one | 0.0 | 0.0 | 0.0 |
Liver Enzyme Abnormalities* | three.3 | i.4 | 0.2 | 0.0 |
Sense of taste Disturbance | 2.8 | 0.7 | 0.2 | 0.0 |
Visual Disturbance | ane.one | ane.5 | 0.ix | 0.0 |
*Liver enzyme abnormalities ≥ 2x the upper limit of normal range. |
Postmarketing Experience
The post-obit adverse events have been identified during postapproval utilize of Lamisil Tablets. Because these events are reported voluntarily from a population of uncertain size, information technology is not ever possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Claret and lymphatic arrangement disorders: Pancytopenia, agranulocytosis, severe neutropenia, thrombocytopenia, anemia [see WARNINGS AND PRECAUTIONS]
Immune organisation 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 accept been reported with utilize of Lamisil Tablets. In some cases, depressive symptoms have been reported to subside with discontinuance of therapy and to recur with reinstitution of therapy [encounter WARNINGS AND PRECAUTIONS].
Nervous system disorders: Cases of taste disturbance, including taste loss, have been reported with the utilize of Lamisil Tablets. It can be severe plenty to issue in decreased nutrient intake, weight loss, anxiety, and depressive symptoms. Cases of smell disturbance, including smell loss, have been reported with the use of Lamisil Tablets [see WARNINGS AND PRECAUTIONS]. Cases of paresthesia and hypoesthesia take been reported with the use of Lamisil Tablets.
Eye disorders: Visual field defects, reduced visual acuity
Ear and labyrinth disorders: Hearing impairment, vertigo, tinnitus
Vascular disorders: Vasculitis
Gastrointestinal disorders: Pancreatitis, vomiting
Hepatobiliary disorders: Cases of liver failure some leading to liver transplant or death [see WARNINGS AND PRECAUTIONS], idiosyncratic and symptomatic hepatic injury. Cases of hepatitis, cholestasis, and increased hepatic enzymes [meet WARNINGS AND PRECAUTIONS] take been seen with the use of Lamisil Tablets.
Skin and subcutaneous tissue disorders: Serious peel reactions [due east.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, bullous dermatitis, and drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome] [see WARNINGS AND PRECAUTIONS], acute generalized exanthematous pustulosis, psoriasiform eruptions or exacerbation of psoriasis, photosensitivity reactions, hair loss
Musculoskeletal and connective tissue disorders: Rhabdomyolysis, arthralgia, myalgia
General disorders and assistants site weather: Malaise, fatigue, influenza-like illness, pyrexia
Investigations: Contradistinct prothrombin time (prolongation and reduction) in patients concomitantly treated with warfarin and increased blood creatine phosphokinase take been reported
DRUG INTERACTIONS
Drug-Drug Interactions
In vivo studies accept 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 class 1C (e.thou., flecainide and propafenone) and monoamine oxidase inhibitors Type B. Coadministration of Lamisil Tablets should be done with conscientious 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 healthy volunteers characterized every bit normal metabolizers, the administration of terbinafine resulted in a 2-fold increase in Cmax and a 5-fold increment in surface area nether the curve (AUC). In this study, these effects were shown to persist at the concluding observation at 4 weeks after discontinuation of Lamisil Tablets. In studies in healthy subjects characterized as extensive 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 non 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 past xv%.
The influence of terbinafine on the pharmacokinetics of fluconazole, cotrimoxazole (trimethoprim and sulfamethoxazole), zidovudine or theophylline was non considered to be clinically significant.
Coadministration of a unmarried dose of fluconazole (100 mg) with a single 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 (east.chiliad., ketoconazole, amiodarone) may also pb to a substantial increase in the systemic exposure (Cmax and AUC) of terbinafine when concomitantly administered.
There take 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% past cimetidine, a CYP450 enzyme inhibitor. Terbinafine clearance is unaffected past cyclosporine. At that place is no information bachelor from adequate drug-drug interaction studies with the following classes of drugs: oral contraceptives, hormone replacement therapies, hypoglycemics, phenytoins, thiazide diuretics, and calcium channel blockers.
Food Interactions
An evaluation of the effect of nutrient on Lamisil Tablets was conducted. An increase of less than 20% of the AUC of terbinafine was observed when Lamisil Tablets were administered with nutrient. Lamisil Tablets can be taken with or without food.
WARNINGS
Included as part of the PRECAUTIONS section.
PRECAUTIONS
Hepatotoxicity
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 illness.
In the bulk of liver cases reported in association with utilise of Lamisil Tablets, the patients had serious underlying systemic weather. 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 role tests. Patients prescribed Lamisil Tablets should be warned to written report immediately to their medico whatever symptoms of persistent nausea, anorexia, fatigue, vomiting, correct upper intestinal pain or jaundice, dark urine, or stake stools. Patients with these symptoms should discontinue taking oral terbinafine, and the patient’south liver function should be immediately evaluated.
Gustatory modality Disturbance Including Loss of Taste
Taste disturbance, including taste loss, has been reported with the apply of Lamisil Tablets. It can be astringent enough to result in decreased nutrient intake, weight loss, anxiety, and depressive symptoms. Sense of taste disturbance may resolve within several weeks later on discontinuation of treatment, but may be prolonged (greater than 1 year), or may exist permanent. If symptoms of a taste disturbance occur, Lamisil Tablets should be discontinued.
Smell Disturbance Including Loss Of Odour
Odour disturbance, including loss of odour, has been reported with the utilise of Lamisil Tablets. Odour disturbance may resolve afterwards discontinuation of treatment, just may exist prolonged (greater than one yr), or may be permanent. If symptoms of a odour disturbance occur, Lamisil Tablets should be discontinued.
Depressive Symptoms
Depressive symptoms accept occurred during postmarketing use of Lamisil Tablets. Prescribers should exist alarm to the evolution of depressive symptoms, and patients should be instructed to report depressive symptoms to their doctor.
Hematologic Effects
Transient decreases in accented lymphocyte counts (ALCs) have been observed in controlled clinical trials. In placebo-controlled trials, 8/465 subjects receiving Lamisil Tablets (1.7%) and three/137 subjects receiving placebo (2.ii%) had decreases in ALC to below yard/mm³ on 2 or more occasions. In patients with known or suspected immunodeficiency, physicians should consider monitoring complete claret counts if treatment continues for more than than half-dozen weeks. Cases of astringent neutropenia have 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 consummate blood count should be obtained. If the neutrophil count is ≤ one thousand cells/mm³, Lamisil Tablets should exist discontinued and supportive management started.
Serious Skin/Hypersensitivity Reactions
There have been postmarketing reports of serious peel/hypersensitivity reactions [e.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 than organ complications such as hepatitis, pneumonitis, nephritis, myocarditis, and pericarditis. If progressive skin rash or signs/symptoms of the in a higher place drug reactions occur, treatment with Lamisil Tablets should be discontinued.
Lupus Erythematosus
During postmarketing experience, precipitation and exacerbation of cutaneous and systemic lupus erythematosus accept been reported in patients taking Lamisil Tablets. Lamisil Tablets should be discontinued in patients with clinical signs and symptoms suggestive of lupus erythematosus.
Laboratory Monitoring
Measurement of serum transaminases (ALT and AST) is advised for all patients before taking Lamisil Tablets.
Patient Counseling Information
See FDA-Canonical Patient Labeling (PATIENT INFORMATION)
Patients taking Lamisil Tablets should receive the post-obit information and instructions:
- Suggest patients to immediately report to their dr. or get emergency assistance if they experience whatever of the following symptoms: hives, rima oris sores, blistering and peeling of pare, swelling of confront, lips, natural language, or pharynx, difficulty swallowing or breathing. Lamisil Tablets handling should be discontinued.
- Advise patients to immediately study to their physician whatsoever symptoms of persistent nausea, anorexia, fatigue, vomiting, right upper abdominal pain, jaundice, nighttime urine, or stake stools. Lamisil Tablets handling should exist discontinued.
- Advise patients to report to their doc whatsoever signs of taste disturbance, scent disturbance and/or depressive symptoms, fever, skin eruption, lymph node enlargement, erythema, scaling, loss of paint, and unusual photosensitivity that can result in a rash. Lamisil Tablets treatment should be discontinued.
- Propose patients to minimize exposure to natural and artificial sunlight (tanning beds or UVA/B treatment) while using Lamisil Tablets.
- Advise patients that if they forget to take Lamisil Tablets, to take their tablets as soon as they remember, unless it is less than iv hours earlier the side by side dose is due. Propose patients to phone call their physician if they take besides many Lamisil Tablets.
Nonclinical Toxicology
Carcinogenesis, Mutagenesis, Damage Of Fertility
In a 28-month oral carcinogenicity written report in rats, an increment 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); nevertheless, even though dose-limiting toxicity was non accomplished at the highest tested dose, college doses were non 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 abnormality, and sister chromatid exchanges in Chinese hamster lung cells), and in vivo (chromosome abnormality in Chinese hamsters, micronucleus exam in mice) genotoxicity tests gave no evidence of a mutagenic or clastogenic potential.
Oral reproduction studies in rats at doses upwardly to 300 mg/kg/day (approximately 12x the MRHD based on BSA comparisons) did not reveal any specific effects on fertility or other reproductive parameters. Intravaginal application of terbinafine hydrochloride at 150 mg/24-hour interval in significant rabbits did not increase the incidence of abortions or premature deliveries nor affect fetal parameters.
Employ In Specific Populations
Pregnancy
Pregnancy Category B
In that location are no acceptable and well-controlled studies in pregnant women. Because animal reproduction studies are not ever predictive of homo response, and because handling of onychomycosis can be postponed until after pregnancy is completed, information technology is recommended that Lamisil Tablets not exist initiated during pregnancy.
Oral reproduction studies take been performed in rabbits and rats at doses up to 300 mg/kg/day [12x to 23x the maximum recommended human dose (MRHD), in rabbits and rats, respectively, based on body surface surface area (BSA) comparisons] and have revealed no evidence of impaired fertility or harm to the fetus due to terbinafine.
Nursing Mothers
Afterwards oral administration, terbinafine is nowadays in breast milk of nursing mothers. The ratio of terbinafine in milk to plasma is 7:ane. Treatment with Lamisil Tablets is not recommended in women who are nursing.
Pediatric Apply
The safety and efficacy of Lamisil Tablets have not been established in pediatric patients with onychomycosis.
Geriatric Apply
Clinical studies of Lamisil Tablets did non include sufficient numbers of subjects aged 65 years and over to determine whether they answer differently from younger subjects. Other reported clinical experience has not identified differences in responses betwixt the elderly and younger patients. In general, dose selection for an elderly patient should exist cautious, unremarkably starting at the low finish 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 damage (creatinine clearance less than or equal to fifty mL/min) the utilize of Lamisil Tablets has non been fairly studied.
Overdosage & Contraindications
OVERDOSE
Clinical experience regarding overdose with oral terbinafine is limited. Doses up to 5 grams (xx times the therapeutic daily dose) have been taken without inducing serious adverse reactions. The symptoms of overdose included nausea, airsickness, abdominal pain, dizziness, rash, frequent urination, and headache.
CONTRAINDICATIONS
Lamisil Tablets are contraindicated in individuals with a history of allergic reaction to oral terbinafine because of the risk of anaphylaxis.
CLINICAL PHARMACOLOGY
Mechanism Of Action
Terbinafine is an allylamine antifungal [see 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 issue of first-laissez passer metabolism is approximately xl%. Elevation plasma concentrations of 1 μg/mL appear within 2 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% jump to plasma proteins and there are no specific binding sites. At steady-state, in comparing to a single dose, the superlative concentration of terbinafine is 25% higher and plasma AUC increases by a factor of 2.5; the increase in plasma AUC is consequent with an constructive one-half-life of ~36 hours. Terbinafine is distributed to the sebum and skin. A final half-life of 200-400 hours may represent the wearisome elimination of terbinafine from tissues such as skin and adipose. Prior to excretion, terbinafine is extensively metabolized past at least 7 CYP isoenzymes with major contributions from CYP2C9, CYP1A2, CYP3A4, CYP2C8, and CYP2C19. No metabolites have been identified that accept antifungal activity similar to terbinafine. Approximately lxx% 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 effect of gender on the blood levels of terbinafine was detected in clinical trials. No clinically relevant age-dependent changes in steady-land 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 past the aggregating of loftier concentrations of squalene merely 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 post-obit 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 almost strains of the post-obit microorganisms; yet, the safety and efficacy of terbinafine in treating clinical infections due to these microorganisms have non been established in adequate and well-controlled clinical trials:
Candida albicans
Epidermophyton floccosum
Scopulariopsis brevicaulis
Creature 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 non 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 three United states/Canadian placebo-controlled clinical trials.
Results of the first toenail trial, every bit assessed at week 48 (12 weeks of treatment with 36 weeks follow-up afterwards completion of therapy), demonstrated mycological cure, defined as simultaneous occurrence of negative KOH plus negative culture, in seventy% of subjects. Fifty-nine per centum (59%) of subjects experienced effective handling (mycological cure plus 0% boom involvement or > 5mm of new unaffected boom 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 besides cultured, similar 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 (half-dozen weeks of treatment with 18 weeks follow-up afterwards completion of therapy), demonstrated mycological cure in 79% of subjects, effective treatment in 75% of the subjects, and mycological cure plus clinical cure in 59% of the subjects.
The mean time to overall success was approximately 10 months for the first toenail trial and 4 months for the fingernail trial. In the first toenail trial, for subjects evaluated at least 6 months afterward achieving clinical cure and at to the lowest degree 1 year after completing therapy with Lamisil Tablets, the clinical relapse rate was approximately xv%.
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 y'all for fungal infection of your nails before you kickoff Lamisil Tablets.
It is not known if Lamisil Tablets are condom and effective in children for the treatment of onychomycosis.
Who should not take Lamisil Tablets ?
Do not take Lamisil Tablets if you are allergic to terbinafine hydrochloride when taken by oral cavity.
What should I tell my doctor before taking Lamisil Tablets ?
Before you have Lamisil Tablets , tell your doctor if you:
- take or had liver problems
- have a weakened immune system (immunocompromised)
- have lupus (an autoimmune disease)
- take any other medical conditions
- are pregnant or plan to become meaning. It is not known if Lamisil Tablets will harm your unborn babe. You should not first 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 doctor about the best manner to feed your infant if you lot take Lamisil Tablets.
Tell your dr. almost all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Lamisil Tablets may bear upon the way other medicines work and other medicines may affect how Lamisil Tablets work. Especially tell your doctor if you take:
- a medicine for depression
- a medicine for loftier blood pressure
- a medicine for heart bug
- 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 1 listed above, enquire your doctor or chemist.
Know the medicines you have. Keep a list of them to show your physician and pharmacist when you go a new medicine.
How should I have Lamisil Tablets ?
- Have Lamisil Tablets exactly as your doctor tells you to take information technology.
- Lamisil comes as a tablet that you take past mouth.
- Lamisil Tablets are usually taken:
- 1 time each day for 6 weeks to treat fungal infections of your fingernail, or
- i 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 miss a dose of Lamisil Tablets, take it equally soon equally you call up. If information technology is less than four hours before your next dose, skip the missed dose. But take the next dose at your regular time.
If you have too many Lamisil Tablets call your dr.. You may have the following symptoms:
- nausea
- vomiting
- stomach (abdomen) pain
- dizziness
- rash
- frequent urination
- headache
What should I avert while taking Lamisil Tablets ?
- Avoid sunlight. Lamisil Tablets tin can make your skin sensitive to the sun and the light from sunlamps and tanning beds. You can become a severe sunburn. Apply sunscreen and article of clothing a lid and apparel that cover your skin if you have to be in sunlight. Talk to your doctor if yous get sunburn.
What are the possible side effects of Lamisil Tablets ?
Lamisil Tablets may cause serious side effects, including:
- liver problems that can atomic number 82 to the demand for liver trans institute, or death. Tell your doctor right abroad if you become any of these symptoms of a liver problem:
- nausea
- upper right tummy-expanse (abdomen) pain
- poor appetite
- yellowing of your skin or eyes (jaundice)
- tiredness
- dark (tea-colored) urine
- vomiting
- pale or light colored stools
Your doctor should practice a blood examination to check y'all for liver problems before you take Lamisil Tablets.
- change in taste or los due south of taste may happen with Lamisil Tablets and can be severe. This may better within several weeks after you end taking Lamisil Tablets, but may terminal for a long fourth dimension or may get permanent. Tell your medico if yous accept:
- alter in gustation or loss of gustatory modality
- poor appetite
- unwanted weight loss
- anxiousness
- modify in mood or depressive symptoms
- change in smell or loss of smell may happen with Lamisil Tablets. This may improve after you lot stop taking Lamisil Tablets, only may last for a long fourth dimension or may go permanent.
- depressive symptoms. Tell your dr. right away if you have whatever of these signs or symptoms:
- feel sad or worthless
- alter in slumber blueprint
- loss of energy or interest in daily activities
- restlessness
- mood changes
- low white claret cell count. People taking Lamisil Tablets may accept a decrease in white blood cells, especially neutrophils. You may have a higher risk of getting an infection when your white blood cell count is low.
- serious skin or allergic reactions. Tell your doctor correct away or get emergency help if you lot go any of these symptoms:
- skin rash, hives, sores in your mouth, or your skin blisters and peels
- swelling of your face, eyes, lips, tongue or pharynx, trouble swallowing or animate
- 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 get any of the post-obit:
- progressive skin rash that is scaly, scarlet, shows scarring, or loss of paint
- unusual sensitivity to the sun that can lead to a rash
The nigh common side effects of Lamisil Tablets include:
- headache
- diarrhea
- rash
- upset stomach
- aberrant liver function tests
- itching
- change in gustatory modality
- nausea
- stomach-expanse (abdomen) pain
- gas
Tell your doctor if you have any side issue that bothers yous or that does not go away.
These are not all of the possible side effects of Lamisil Tablets. For information, inquire your doctor or chemist.
Phone call your medico for medical advice virtually side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Lamisil Tablets ?
- Store Lamisil Tablets below 77°F (25°C)
- Go on Lamisil Tablets in a tightly closed container and go along out of the light.
Keep Lamisil Tablets and all medicines out of the reach of children.
General information about the safe and effective use of Lamisil Tablets .
Medicines are sometimes prescribed for purposes other than those listed in Patient Information. Do not use Lamisil Tablets for a condition for which it was not prescribed. Do not give Lamisil Tablets to other people, even if they have the same symptoms that you lot have. It may harm them.
You can ask your pharmacist or doctor for information about 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.Due south. Nutrient and Drug Administration.
From
Study Issues to the Nutrient and Drug Administration
You are encouraged to study negative side furnishings 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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