Terbinafine Biogaran 1% is used to treat infections caused by a fungus. It works by killing the fungus or preventing its growth.
Terbinafine Biogaran 1% is applied to the skin to treat:
ringworm of the body (tinea corporis);
ringworm of the foot (interdigital and plantar tinea pedis; athlete's foot);
ringworm of the groin (tinea cruris; jock itch);
tinea versicolor (sometimes called “sun fungus”); and
yeast infections of the skin (cutaneous candidiasis).
Terbinafine Biogaran 1% is available both over-the-counter (OTC) and with your doctor's prescription.
Terbinafine Biogaran 1% indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Treatment of fungal infections of the skin and nails caused by dermatophytes eg, Trichophyton (eg, T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), M. canis and E. floccosum.
Oral Terbinafine Biogaran 1% is indicated in the treatment of onychomycosis (fungal infection of the nail) caused by dermatophyte fungi. Where oral therapy is considered appropriate owing to the site, severity or extent of the infection, Terbinafine Biogaran 1% tablets may also be indicated in the treatment of tineal skin infections (Tinea corporis, Tinea cruris and Tinea pedis).
Note:
Oral Terbinafine Biogaran 1% is not effective in Pityriasis versicolor.
How should I use Terbinafine Biogaran 1%?
Use Terbinafine Biogaran 1% granules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
An extra patient leaflet is available with Terbinafine Biogaran 1% granules. Talk to your pharmacist if you have questions about this information.
Take Terbinafine Biogaran 1% granules by mouth with food.
Hold the packet with the cut line on top and shake it gently to settle the contents. Open the packet by tearing along the cut line (or using scissors to cut across the line).
Sprinkle all of the medicine from the packet over a spoonful of soft, nonacidic food (eg, pudding, mashed potatoes). Do not use applesauce or a fruit-based food.
Mix the medicine with the food and swallow the mixture right away. Do not crush or chew the medicine before swallowing. Do not store the mixture for future use.
If 2 packets are needed for your dose, you may mix the contents of 2 packets with 1 spoonful of food. You may also mix each packet separately on its own spoonful of food.
To clear up your infection completely, take Terbinafine Biogaran 1% granules for the full course of treatment (usually 6 weeks). Keep taking it even if you feel better in a few days.
If you miss a dose of Terbinafine Biogaran 1% granules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Terbinafine Biogaran 1% granules.
Uses of Terbinafine Biogaran 1% in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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This medication is used to treat a variety of fungal skin infections such as ringworm, athlete's foot, and jock itch. This medication is also used to treat a skin condition known as pityriasis (tinea versicolor), a fungal infection that causes a lightening or darkening of the skin of the neck, chest, arms, or legs. Terbinafine Biogaran 1% is an antifungal that works by preventing the growth of fungus.
How to use Terbinafine Biogaran 1% (Aerosol) topical
Use this medication on the skin only. Clean and thoroughly dry the area to be treated. Apply enough medication to wet the skin on and around the affected area, usually once or twice daily as directed on the product package. If you are uncertain about any of the information, consult your doctor or pharmacist. If your doctor has prescribed this medication to you, then use as directed. Wash your hands after using unless the area being treated includes the hands. Do not wrap, cover, or bandage the area unless directed to do so by your doctor.
Do not use the medication in the eyes, nose, or mouth, or inside the vagina. If you do get the medication in those areas, flush with plenty of water.
Do not use this medication on the scalp or nails unless otherwise directed by your doctor.
Do not use the spray form of this medication on the face.
The dosage and length of treatment depends on the type of infection being treated.
Do not apply more often or use longer than directed. This may increase the risk of side effects.
Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time(s) each day.
Continue to use this medication as directed until the full treatment period is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection.
Your condition may continue to improve after stopping the medication as directed. Inform your doctor if your condition worsens or does not improve after 1 week of treatment.
Terbinafine Biogaran 1% description
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Each gram of gel and cream contains Terbinafine base 10 mg and Terbinafine Biogaran 1% hydrochloride 10 mg, respectively.
Terbinafine Biogaran 1% derm topical gel also contains the following excipients: Purified water, ethanol 96%, isopropyl myristate, polysorbate 20, carbomer, sorbitan laurate, benzyl alcohol, sodium hydroxide and butylhydroxytoluene (E321).
Terbinafine Biogaran 1% cream also contains the following excipients: Purified water, sodium hydroxide, benzyl and stearyl alcohol, sorbitan stearate, cetyl palmitate and alcohol, polysorbate 60 and isopropyl myristate.
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Assessment Prior to Initiation
​Before administering Terbinafine Biogaran 1% Tablets, evaluate patients for evidence of chronic or active liver disease.
Dosage
Fingernail onychomycosis: One 250 mg tablet once 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. This is related to the period required for outgrowth of healthy nail.
More about Terbinafine Biogaran 1% (Terbinafine Biogaran 1%)
In vivo studies have shown that Terbinafine Biogaran 1% 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 Terbinafine Biogaran 1% 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 Biogaran 1% on desipramine in healthy volunteers characterized as normal metabolizers, the administration of Terbinafine Biogaran 1% 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 Terbinafine Biogaran 1% Tablets. In studies in healthy subjects characterized as extensive metabolizers of dextromethorphan (antitussive drug and CYP2D6 probe substrate), Terbinafine Biogaran 1% increases the dextromethorphan/dextrorphan metabolite ratio in urine by 16- to 97-fold on average. Thus, Terbinafine Biogaran 1% may convert extensive CYP2D6 metabolizers to poor metabolizer status.
In vitro studies with human liver microsomes showed that Terbinafine Biogaran 1% 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 Biogaran 1% does not affect the clearance of antipyrine or digoxin. Terbinafine Biogaran 1% decreases the clearance of caffeine by 19%. Terbinafine Biogaran 1% increases the clearance of cyclosporine by 15%.
The influence of Terbinafine Biogaran 1% 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 Terbinafine Biogaran 1% resulted in a 52% and 69% increase in Terbinafine Biogaran 1% 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 Terbinafine Biogaran 1% when concomitantly administered.
There have been spontaneous reports of increase or decrease in prothrombin times in patients concomitantly taking oral Terbinafine Biogaran 1% and warfarin, however, a causal relationship between Terbinafine Biogaran 1% Tablets and these changes has not been established.
Terbinafine Biogaran 1% clearance is increased 100% by rifampin, a CYP450 enzyme inducer, and decreased 33% by cimetidine, a CYP450 enzyme inhibitor. Terbinafine Biogaran 1% 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.
Food Interactions
An evaluation of the effect of food on Terbinafine Biogaran 1% Tablets was conducted. An increase of less than 20% of the AUC of Terbinafine Biogaran 1% was observed when Terbinafine Biogaran 1% Tablets were administered with food. Terbinafine Biogaran 1% Tablets can be taken with or without food.
Because clinical trials are conducted under widely varying conditions, 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 most frequently reported adverse events observed in the 3 US/Canadian placebo-controlled trials are listed in the table below. The adverse events reported encompass gastrointestinal symptoms (including diarrhea, dyspepsia, and abdominal pain), liver test abnormalities, rashes, urticaria, pruritus, and taste disturbances. Changes in the ocular lens and retina have been reported following the use of Terbinafine Biogaran 1% Tablets in controlled trials. The clinical significance of these changes is unknown. In general, the adverse events were mild, transient, and did not lead to discontinuation from study participation.
Adverse Event
Discontinuation
Terbinafine Biogaran 1% Tablets (%)
n=465
Placebo (%)
n=137
Terbinafine Biogaran 1% Tablets (%)
n=465
Placebo (%)
n=137
Headache
12.9
9.5
0.2
0.0
Gastrointestinal Symptoms:
Diarrhea
5.6
2.9
0.6
0.0
Dyspepsia
4.3
2.9
0.4
0.0
Abdominal Pain
2.4
1.5
0.4
0.0
Nausea
2.6
2.9
0.2
0.0
Flatulence
2.2
2.2
0.0
0.0
Dermatological Symptoms:
Rash
5.6
2.2
0.9
0.7
Pruritus
2.8
1.5
0.2
0.0
Urticaria
1.1
0.0
0.0
0.0
Liver Enzyme Abnormalities*
3.3
1.4
0.2
0.0
Taste Disturbance
2.8
0.7
0.2
0.0
Visual Disturbance
1.1
1.5
0.9
0.0
*Liver enzyme abnormalities ≥ 2x the upper limit of normal range.
Postmarketing Experience
The following adverse events have been identified during postapproval use of Terbinafine Biogaran 1% 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
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 Terbinafine Biogaran 1% Tablets. In some cases, depressive symptoms have been reported to subside with discontinuance of therapy and to recur with reinstitution of therapy.
Nervous system disorders: Cases of taste disturbance, including taste loss, have been reported with the use of Terbinafine Biogaran 1% 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 Terbinafine Biogaran 1% Tablets. Cases of paresthesia and hypoesthesia have been reported with the use of Terbinafine Biogaran 1% Tablets.
Eye disorders: Visual field defects, reduced visual acuity
Ear and labyrinth disorders: Hearing impairment, vertigo, tinnitus
Hepatobiliary disorders: Cases of liver failure some leading to liver transplant or death, idiosyncratic and symptomatic hepatic injury. Cases of hepatitis, cholestasis, and increased hepatic enzymes have been seen with the use of Terbinafine Biogaran 1% Tablets.
Skin and subcutaneous tissue disorders: Serious skin 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], 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
Before using Terbinafine Biogaran 1%, tell your doctor if you have liver or kidney disease, or an autoimmune disorder such as lupus or psoriasis.
Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Terbinafine Biogaran 1% will not treat a viral infection such as the common cold or flu.
Some people taking Terbinafine Biogaran 1% have developed severe liver damage leading to liver transplant or death. It is not clear whether Terbinafine Biogaran 1% actually caused the liver damage in these patients. In most cases, the patient had a serious medical condition before taking Terbinafine Biogaran 1%.
Call your doctor at once if you have symptoms of liver damage, such as nausea, upper stomach pain, itching, loss of appetite, 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.
To be sure this medicine is not causing harmful effects, your blood may need to be tested often. Your liver function may also need to be tested. Visit your doctor regularly.
It may take several months for your nails to return to their normal appearance after your treatment with Terbinafine Biogaran 1%.
Active ingredient matches for Terbinafine Biogaran 1%:
DailyMed. "TERBINAFINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
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