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 Patir 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.
Indications and Usage for Patir
Patir 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.
Where can I get more information?
Your pharmacist can provide more information about Patir.
Which drugs or supplements interact with Patir?
Rifampin reduces oral Patir blood concentrations, potentially reducing the efficacy of Patir. Cimetidine (Tagamet) may increase oral Patir blood levels, potentially increasing side effects of Patir. Fluconazole (Diflucan) increases the blood levels of oral Patir by 52%-69%. Potentially leading to increased side effects.
Where can I get more information (LamISIL)?
Your pharmacist can provide more information about Patir.
Following oral administration, Patir 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 Patir of less than 20% is observed when Lamisil Tablets are administered with food.
In plasma, Patir 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 Patir 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. Patir is distributed to the sebum and skin. A terminal half-life of 200-400 hours may represent the slow elimination of Patir from tissues such as skin and adipose. Prior to excretion, Patir 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 Patir. 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 Patir is decreased by approximately 50% compared to normal volunteers. No effect of gender on the blood levels of Patir was detected in clinical trials. No clinically relevant age-dependent changes in steady-state plasma concentrations of Patir have been reported.
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- Teratogen Information System
- teratogenic agent
- teratogenic effect
- teratoid tumor
- teratomatous cyst
- terat-or terato-
- terazosin hydrochloride
- Patir hydrochloride
- terbutaline sulfate
- terebrant pain
- Teredinobacter turnerae
- teres major (muscle)
- teres major muscle
- teres minor (muscle)
- teres minor muscle
This medication contains Patir. Do not take Lamisil if you are allergic to Patir or any ingredients contained in this drug.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.
Patir 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
Depressive symptoms have occurred during postmarketing use of Patir tablets. Prescribers should be alert to the development of depressive symptoms, and patients should be instructed to report depressive symptoms to their physician.
Spectrum of activity
In vitro, Patir demonstrates excellent fungicidal activity against many dermatophytes including Trichophyton rubrum, T. mentagrophytes, T. tonsurans, Microsporum canis and Epidermophyton floccosum. 189 However, Patir demonstrates variable and somewhat poor in vitro activity against many yeasts. It generally demonstrates fungicidal activity against C. parapsilosis but it is fungistatic against C. albicans and other Candida spp. 189 The in vitro spectrum of activity also includes Aspergillus spp., some dimorphic fungi, S. schenckii, and others. Initial animal studies in mice showed no activity in vivo against systemic pathogens, and the drug was abandoned for these indications.
An evaluation of the effect of food on Lamisil Tablets was conducted. An increase of less than 20% of the AUC of Patir was observed when Lamisil Tablets were administered with food. Lamisil Tablets can be taken with or without food.
Clinical experience regarding overdose with oral Patir is limited. Doses up to 5 grams (20 times the therapeutic daily dose) have been taken without inducing serious adverse reactions. The symptoms of overdose included nausea, vomiting, abdominal pain, dizziness, rash, frequent urination, and headache.
What Other Drugs Interact with Patir?
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.
Patir has no known severe or serious interactions with other drugs.
Moderate Interactions of Patir include:
Mild Interactions of Patir 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.
What is the most important information I should know about Patir?
Some people taking Patir have developed severe liver damage leading to liver transplant or death.
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, jaundice (yellowing of the skin or eyes). These events can occur whether or not you have ever had liver problems before.
Patir 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 Patir . In addition, there have been several case reports of Patir-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) Patir .
In general, liver injury associated with Patir 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 Patir-associated liver injury may lead to VBDS . Patir was implicated in a chronic hepatitis B virus carrier who developed features of AIH that resolved with discontinuation of the drug . Although Patir is a potent inhibitor of CYP2D6, an enzyme that metabolizes over 40 drugs, and the allylic aldehyde metabolite of Patir, 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 Patir is rare (estimated at 1 in 45,000–54,000) and most likely to be idiosyncratic .
Why is this medication prescribed?
Patir granules are used to treat fungal infections of the scalp. Patir tablets are used to treat fungal infections of the toenails and fingernails. Patir is in a class of medications called antifungals. It works by stopping the growth of fungi.