Hongofin tablets

Hongofin

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

The active ingredient of Hongofin 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

Hongofin 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 Hongofin include: difficulty with swallowing; skin rash or itching; loss of voice; nausea; red, irritated eyes; belching; vomiting.

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What Are Side Effects Associated with Using Hongofin?

Common side effects of Hongofin include:

Serious side effects of Hongofin include:

  • Persistent nausea
  • Loss of appetite
  • Fatigue
  • Vomiting
  • Right upper abdominal pain
  • Yellowing skin and eyes (jaundice)
  • Dark urine
  • Pale stools
  • Smell disturbance

Postmarketing side effects of Hongofin reported include:

  • Idiosyncratic and symptomatic hepatic injury; more rarely, cases of liver failure, some leading to death or liver transplant
  • Skin and subcutaneoustissue disorders (e.g., Stevens-Johnson Syndrome and toxic epidermal necrolysis), drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome
  • Severe allergic reaction (anaphylaxis), skin swelling (angioedema)
  • Severe neutropenia, thrombocytopenia, agranulocytosis, pancytopenia, anemia
  • Psoriasiform eruptions or exacerbation of psoriasis, acute generalized exanthematous pustulosis, precipitation and exacerbation of cutaneous and systemic lupus erythematosus
  • Taste and smell disturbances
  • Malaise, fatigue, vomiting, joint pain, muscle pain, muscle wasting (rhabdomyolysis), reduced visual acuity, visual field defect, hair loss, serum sickness-like reaction, vasculitis, pancreatitis, influenza-like illness, pyrexia, increased bloodcreatine phosphokinase, photosensitivity reactions
  • Hearing impairment, spinning sensation (vertigo)
  • Thrombotic microangiopathy (TMA), including thrombotic thrombocytopenic purpura and hemolytic uremic syndrome

This is not a complete list of side effects and other serious side effects may occur. Call your doctor for information and medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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 Hongofin.

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

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.

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 disease.

In the majority of liver cases reported in association with use 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 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 function 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, dark urine, or pale stools. Patients with these symptoms should discontinue taking oral Hongofin, and the patient’s liver function should be immediately evaluated.

Hongofin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • diarrhea
  • indigestion
  • itching
  • headache
  • feeling sad, worthless, restless, or other changes in mood
  • loss of energy or interest in daily activities
  • changes in how you sleep

Taste Disturbance Including Loss of Taste

Taste disturbance, including taste loss, has been reported with the use of Hongofin tablets. It can be severe enough to result 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 1 year), or may be permanent. If symptoms of a taste disturbance occur, Hongofin tablets should be discontinued.

Serious Skin/Hypersensitivity Reactions

There have been postmarketing reports of serious skin/hypersensitivity reactions . 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 above drug reactions occur, treatment with Hongofin tablets should be discontinued.

Pregnancy

Available data from postmarketing cases on the use of Hongofin tablets in pregnant women are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

In animal reproduction studies, Hongofin d >(see data) .

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown; however, in the U.S. general population, the estimated background risk of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies.

In embryo-fetal development studies in rats and rabbits, pregnant animals received orally (by gavage) doses of Hongofin up to 300 mg/kg/day, during the period of organogenesis. There were no maternal or embryo-fetal effects in either species up to the maximum dose tested. The 300 mg/kg/day dose level in rats and rabbits corresponds to 23 and 12 times the MRHD , respectively.

In a rat peri- and postnatal development study, Hongofin doses of up to 300 mg/kg/day (12 times the MRHD based on BSA comparisons) given by oral gavage during late pregnancy and lactation (Day 15 of gestation to day 20 post-partum) had no adverse effects on parturition and lactation.

Drug-Drug Interactions

In vivo studies have shown that Hongofin 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.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 Hongofin on desipramine in healthy volunteers characterized as normal metabolizers, the administration of Hongofin resulted in a 2-fold increase in Cmax and a 5-fold increase in area under the curve (AUC). In this study, these effects were shown to persist at the last 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), Hongofin increases the dextromethorphan/dextrorphan metabolite ratio in urine by 16- to 97-fold on average. Thus, Hongofin may convert extensive CYP2D6 metabolizers to poor metabolizer status.

In vitro studies with human liver microsomes showed that Hongofin 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 Hongofin does not affect the clearance of antipyrine or digoxin. Hongofin decreases the clearance of caffeine by 19%. Hongofin increases the clearance of cyclosporine by 15%.

The influence of Hongofin on the pharmacokinetics of fluconazole, cotrimoxazole (trimethoprim and sulfamethoxazole), zidovudine or theophylline was not considered to be clinically significant.

Coadministration of a single dose of fluconazole (100 mg) with a single dose of Hongofin resulted in a 52% and 69% increase in Hongofin 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 lead to a substantial increase in the systemic exposure (Cmax and AUC) of Hongofin when concomitantly administered.

There have been spontaneous reports of increase or decrease in prothrombin times in patients concomitantly taking oral Hongofin and warfarin, however, a causal relationship between Lamisil Tablets and these changes has not been established.

Hongofin clearance is increased 100% by rifampin, a CYP450 enzyme inducer, and decreased 33% by cimetidine, a CYP450 enzyme inhibitor. Hongofin clearance is unaffected by cyclosporine. There is no information available 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.

Hongofin Hydrochlor > Imprint: T Strength: 250 mg Color: White Shape: Round Availability: Prescription only Drug Class: Miscellaneous antifungals Pregnancy Category: B - No proven risk in humans CSA Schedule: Not a controlled drug Labeler / Supplier: Sandoz Pharmaceuticals Inc. National Drug Code (NDC): 00781-5417

Hongofin

Hongofin is an orally and topically active agent used in the treatment of onychomycosis. Clinically significant cholestatic liver injury was reported in two patients in a postmarketing surveillance study of 25,884 patients treated with Hongofin . In addition, there have been several case reports of Hongofin-associated hepatotoxicity . In a meta-analysis of the safety of oral antifungal treatments for superficial dermatophytosis and onychomycosis in immunocompetent patients, the risk of liver injury requiring termination of treatment was 0.34% for continuous (250 mg/day) and 0.56% for intermittent (500 mg/day for 1 week every month) Hongofin .

In general, liver injury associated with Hongofin exhibits a mixed cholestatic-hepatocellular pattern, although a predominant and prolonged cholestatic injury has been described. The latency period between the start of medication and development of liver injury is reported to be approximately 4–6 weeks . ALF requiring liver transplantation has been reported . In two patients, reduced numbers of interlobular bile ducts were found on liver biopsy, suggesting that Hongofin-associated liver injury may lead to VBDS . Hongofin was implicated in a chronic hepatitis B virus carrier who developed features of AIH that resolved with discontinuation of the drug . Although Hongofin is a potent inhibitor of CYP2D6, an enzyme that metabolizes over 40 drugs, and the allylic aldehyde metabolite of Hongofin, 7,7-dimethylhept-2-ene-4-ynal (or TBF-A), has been proposed to play a role in the pathogenesis of its hepatotoxicity , liver injury associated with Hongofin is rare (estimated at 1 in 45,000–54,000) and most likely to be idiosyncratic .

Assessment Prior to Initiation

Before administering Hongofin tablets, evaluate patients for ev >.

INDICATIONS

Lamisil (Hongofin hydrochloride) 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.

Renal Impairment

In patients with renal impairment (creatinine clearance less than or equal to 50 mL/min), the use of Hongofin tablets has not been adequately studied.


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