Funide cream

Funide

  • Active Ingredient: Terbinafine
  • 250 mg
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What is Funide?

The active ingredient of Funide brand is terbinafine. Terbinafine is an antifungal medication that fights infections caused by fungus. Terbinafine hydrochloride USP 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 Ingredient: Terbinafine hydrochloride USP (equivalent to 250 mg of Terbinafine) Inactive Ingredients: Microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, hypromellose, and magnesium stearate.

Used for

Funide is used to treat diseases such as: Cutaneous Candidiasis, Onychomycosis, Fingernail, Onychomycosis, Toenail, Tinea Capitis, Tinea Corporis, Tinea Cruris, Tinea Pedis.

Side Effect

Possible side effects of Funide include: red, scaling, or crusted skin; tightness in the chest; Acid or sour stomach; vomiting; Black, tarry stools; unusual tiredness or weakness.

How to Buy Funide tablets online?

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Pharmacokinetics

Following oral administration, Funide is well absorbed ( > 70%) and the bioavailability of Lamisil Tablets as a result of first-pass metabolism is approximately 40%. Peak 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 increase in the AUC of Funide of less than 20% is observed when Lamisil Tablets are administered with food.

In plasma, Funide is > 99% bound to plasma proteins and there are no specific binding sites. At steady-state, in comparison to a single dose, the peak concentration of Funide is 25% higher and plasma AUC increases by a factor of 2.5; the increase in plasma AUC is consistent with an effective half-life of

36 hours. Funide is distributed to the sebum and skin. A terminal half-life of 200-400 hours may represent the slow elimination of Funide from tissues such as skin and adipose. Prior to excretion, Funide 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 Funide. 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 Funide is decreased by approximately 50% compared to normal volunteers. No effect of gender on the blood levels of Funide was detected in clinical trials. No clinically relevant age-dependent changes in steady-state plasma concentrations of Funide have been reported.

Clinical Studies

The efficacy of Funide tablets in the treatment of onychomycosis is illustrated by the response of subjects with toenail and/or fingernail infections who participated in 3 U.S./Canadian placebo-controlled clinical trials.

Results of the first toenail trial, as assessed at week 48 (12 weeks of treatment with 36 weeks follow-up after completion of therapy), demonstrated mycological cure, defined as simultaneous occurrence of negative KOH plus negative culture, in 70% of subjects. Fifty-nine percent (59%) of subjects experienced effective treatment (mycological cure plus 0% nail involvement or greater than 5mm of new unaffected nail growth); 38% of subjects demonstrated mycological cure plus clinical cure (0% nail involvement).

In a second toenail trial of dermatophytic onychomycosis, in which nondermatophytes were also 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, as assessed at week 24 (6 weeks of treatment with 18 weeks follow-up after 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 after achieving clinical cure and at least 1 year after completing therapy with Funide tablets, the clinical relapse rate was approximately 15%.

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 Funide.

Some people taking Funide have developed severe liver damage leading to liver transplant or death. It is not clear whether Funide actually caused the liver damage in these patients. In most cases, the patient had a serious medical condition before taking Funide.

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;
  • rash;
  • headache;
  • 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.

What Is Funide and How Does It Work?

Funide is an antifungal antibiotic used to treat infections caused by fungus that affect the fingernails or toenails (onychomycosis). Oral granules are used to treat a fungal infection of scalp hair follicles in children who are at least 4 years old.

Funide is available under the following different brand names: Lamisil.

Funide 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 Funide.

Some people taking Funide have developed severe liver damage leading to liver transplant or death. It is not clear whether Funide actually caused the liver damage in these patients. In most cases, the patient had a serious medical condition before taking Funide.

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.

Animal Toxicology and/or Pharmacology

A w >in vivo studies in mice, rats, dogs, and monkeys, and in vitro studies using rat, monkey, and human hepatocytes suggest 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 C ss trough levels of the parent Funide 2 to 3 times those seen in humans at the MRHD. In a 52-week oral toxicology study conducted in juvenile maturing dogs, increased heart and liver weights were noted in males and signs of CNS disturbance including 3 cases of single episodes of seizures were noted in females at the highest dose tested, 100 mg/kg/day . No treatment related findings were noted at 30 mg/kg/day in this study.

Postmarketing Experience

The following adverse events have been identified during post-approval use of Funide tablets. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Blood and lymphatic system disorders: Pancytopenia, agranulocytosis, severe neutropenia, thrombocytopenia, anemia, thrombotic microangiopathy (TMA), including thrombotic thrombocytopenic purpura and hemolytic uremic syndrome Immune system disorders: Serious hypersensitivity reactions e.g., angioedema and allergic reactions (including anaphylaxis), precipitation and exacerbation of cutaneous and systemic lupus erythematosus , serum sickness-like reaction

Psychiatric disorders: Anxiety and depressive symptoms independent of taste disturbance have been reported with use of Funide tablets. In some cases, depressive symptoms have been reported to subs >. Nervous system disorders: Cases of taste disturbance, including taste loss, have been reported with the use of Funide tablets. It can be severe enough to result in decreased food intake, weight loss, anxiety, and depressive symptoms. Cases of smell disturbance, including smell loss, have been reported with the use of Funide tablets . Cases of paresthesia and hypoesthesia have been reported with the use of Funide 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 , > have been seen with the use of Funide tablets. Skin and subcutaneous tissue disorders: Serious skin reactions , 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 administration site conditions: 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

What Other Drugs Interact with Funide?

If your doctor has directed you to use this medication for your condition, your doctor or pharmacist may already be aware of any possible drug interactions or side effects and may be monitoring you for them. Do not start, stop, or change the dosage of this medicine or any medicine before getting further information from your doctor, healthcare provider or pharmacist first.

Funide has no known severe or serious interactions with other drugs.

Moderate Interactions of Funide include:

Mild Interactions of Funide include:

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Which drugs or supplements interact with Funide?

Rifampin reduces oral Funide blood concentrations, potentially reducing the efficacy of Funide. Cimetidine (Tagamet) may increase oral Funide blood levels, potentially increasing side effects of Funide. Fluconazole (Diflucan) increases the blood levels of oral Funide by 52%-69%. Potentially leading to increased side effects.

How to use Funide Hcl

Read the Medication Guide provided by your pharmacist before you start taking Funide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food, usually once a day or as directed by your doctor. Dosage and length of treatment is based on your medical condition and response to treatment.

It may take several months after you finish treatment to see the full benefit of this drug. It takes time for your new healthy nails to grow out and replace the infected nails.

Continue to take this medication until the full prescribed amount is finished. Stopping the medication too early may allow the fungus to continue to grow, which may result in a return of the infection.

Tell your doctor if your condition persists or worsens.

Microbiology

Funide, an allylamine antifungal, inhibits biosynthesis of ergosterol, an essential component of fungal cell membrane, via inhibition of squalene epox >in vitro , Funide hydrochlor >in vitro data is unknown.

Funide 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 , Funide exhibits satisfactory MIC’s against most strains of the following microorganisms; however, the safety and efficacy of Funide 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 Susceptibility Testing

For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC.

Generic Name: Funide (ter BIN na feen)Brand Name: LamISIL

Medically reviewed by Drugs.com on Nov 11, 2019 – Written by Cerner Multum

Nursing Mothers

After oral administration, Funide is present in breast milk of nursing mothers. The ratio of Funide in milk to plasma is 7:1. Treatment with Lamisil Tablets is not recommended in women who are nursing.

What other drugs will affect Funide (LamISIL)?

Other drugs may interact with Funide, 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.


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