Dermikem OC Actions

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Consists of Clobetasol, Ofloxacin, Ornidazole, Terbinafine

Actions of Clobetasol (Dermikem OC) in details

The action of the drug on the human body is called Pharmacodynamics in Medical terminology. To produce its effect and to change the pathological process that is happening the body and to reduce the symptom or cure the disease, the medicine has to function in a specific way. The changes it does to the body at cellular level gives the desired result of treating a disease. Drugs act by stimulating or inhibiting a receptor or an enzyme or a protein most of the times. Medications are produced in such a way that the ingredients target the specific site and bring about chemical changes in the body that can stop or reverse the chemical reaction which is causing the disease.
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The precise mechanism of the antiinflammatory activity of topical steroids in the treatment of steroid-responsive dermatoses, in general, is uncertain. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2. Initially, however, Clobetasol (Dermikem OC), like other corticosteroids, bind to the glucocorticoid receptor, which complexes, enteres the cell nucleus and modifies genetic transcription (transrepression/transactivation).

How should I take Clobetasol (Dermikem OC)?

It is very important that you use Clobetasol (Dermikem OC) only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.

Clobetasol (Dermikem OC) is for use on the skin only. Do not get it in your eyes, nose, mouth, or vagina. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

To help clear up your skin or scalp problem completely, it is very important that you keep using Clobetasol (Dermikem OC) for the full time of treatment. Do not miss any doses.

Clobetasol (Dermikem OC) should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present. Clobetasol (Dermikem OC) should not be used to treat certain kinds of skin infections or conditions, such as severe burns.

Do not use Clobetasol (Dermikem OC) on the face, groin, or underarms, or have skin thinning unless directed to do so by your doctor.

To use the cream, foam, gel, lotion, ointment, or spray:

To use the foam, scalp solution, or shampoo:

Clobetasol (Dermikem OC) comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

Dosing

The dose of Clobetasol (Dermikem OC) will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of Clobetasol (Dermikem OC). If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Missed Dose

If you miss a dose of Clobetasol (Dermikem OC), apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the foam can at room temperature, away from heat and direct light. Do not keep Clobetasol (Dermikem OC) inside a car where it could be exposed to extreme heat. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Store the Temovate® E cream at room temperature, away from heat, moisture, and direct light. Do not refrigerate. Keep from freezing.

Clobetasol (Dermikem OC) administration

Administration of drug is important to know because the drug absorption and action varies depending on the route and time of administration of the drug. A medicine is prescribed before meals or after meals or along with meals. The specific timing of the drug intake about food is to increase its absorption and thus its efficacy. Few work well when taken in empty stomach and few medications need to be taken 1 or 2 hrs after the meal. A drug can be in the form of a tablet, a capsule which is the oral route of administration and the same can be in IV form which is used in specific cases. Other forms of drug administration can be a suppository in anal route or an inhalation route.
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Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts or for longer than recommended.

Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body.

Wash your hands before and after using Clobetasol (Dermikem OC) topical, unless you are using the medication to treat the skin on your hands.

Apply a small amount to the affected area and rub it gently into the skin. Do not use this medication over a large area of skin.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with Clobetasol (Dermikem OC) topical can increase the amount of medicine your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions.

Contact your doctor if your condition does not improve within 2 weeks of using this medicine, or if you develop signs of a bacterial, fungal, or viral skin infection. It is important to use Clobetasol (Dermikem OC) topical regularly to get the most benefit.

If you use this medication long-term, your blood will need to be tested often. Visit your doctor regularly.

Store at room temperature away from moisture and heat. Keep from freezing.

Clobetasol (Dermikem OC) pharmacology

Pharmacokinetics of a drug can be defined as what body does to the drug after it is taken. The therapeutic result of the medicine depends upon the Pharmacokinetics of the drug. It deals with the time taken for the drug to be absorbed, metabolized, the process and chemical reactions involved in metabolism and about the excretion of the drug. All these factors are essential to deciding on the efficacy of the drug. Based on these pharmacokinetic principles, the ingredients, the Pharmaceutical company decides dose and route of administration. The concentration of the drug at the site of action which is proportional to therapeutic result inside the body depends on various pharmacokinetic reactions that occur in the body.
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Like other topical corticosteroids, Clobetasol (Dermikem OC) foam has anti-inflammatory, antipruritic, and vasoconstrictive properties. The precise mechanism of the anti-inflammatory activity of topical steroids in the treatment of steroid-responsive dermatoses, in general, is uncertain. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A.

Pharmacokinetics

Topical corticosteroids can be absorbed from intact healthy skin. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Occlusion, inflammation and/or other disease processes in the skin may also increase percutaneous absorption.

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Due to the fact that circulating levels are well below the level of detection, the use of pharmacodynamic endpoints for assessing the systemic exposure of topical corticosteroids is necessary. They are metabolized, primarily in the liver, and are then excreted by the kidneys. In addition, some corticosteroids and their metabolites are also excreted in the bile.

Clinical Studies

A well-controlled clinical study evaluated 188 subjects with moderate to severe scalp psoriasis. Subjects were treated twice daily for 2 weeks with one of four treatments: Clobetasol (Dermikem OC) Foam, Vehicle foam, a commercially available Clobetasol (Dermikem OC) solution (Temovate® Scalp Application), or Vehicle solution. The efficacy of Clobetasol (Dermikem OC) (Clobetasol (Dermikem OC)) Foam in treating scalp psoriasis at the end of the 2 weeks' treatment was superior to that of Vehicle (foam and solution), and was comparable to that of Temovate Scalp Application. See Table 1 below.

Table 1: Efficacy results from a controlled clinical trial in scalp psoriasis

Clobetasol (Dermikem OC) Foam

n (%)

Vehicle Foam

n (%)

Total number of subjects 62 31
Subjects with Treatment Success* 39 (63) 1 (3)
Subjects with Parameter Clear at End point (Scalp Psoriasis)
Scaling-Clear at End point 42 (68) 3 (10)
Erythema-Clear at End point 27 (44) 2 (6)
Plaque Thickness-Clear at End point 41 (66) 3 (10)
*Defined as a composite of an Investigator's Global Assessment of “completely clear” or “almost clear,” a plaque thickness score of 0, an erythema score of 0 or 1, and a scaling score of 0 or 1 at Endpoint, scored on a severity scale of 0-4.

Another well-controlled clinical study evaluated 279 subjects with mild to moderate plaque-type psoriasis (mean Body Surface Area at baseline was 6.7% with a range from 1% to 20%) of non-scalp regions. Subjects were treated twice daily for 2 weeks with Clobetasol (Dermikem OC) (Clobetasol (Dermikem OC)) Foam or Vehicle foam. The face and intertriginous areas were excluded from treatment. The efficacy of Clobetasol (Dermikem OC) (Clobetasol (Dermikem OC)) Foam in treating non-scalp psoriasis at the end of 2 weeks' treatment was superior to that of Vehicle foam. See Table 2 below.

Table 2: Efficacy results from a controlled clinical trial in non-scalp psoriasis Plaque Thickness - Clear at Endpoint 41 (66) 3 (10)

Clobetasol (Dermikem OC) Foam

n (%)

Vehicle Foam

n (%)

Total number of subjects 139 140
Subjects with Treatment Success* 39 (28) 4 (3)
Physician's Static Global Assessment-Clear or 94 (68) 30 (21)
Almost Clear at Endpoint
Scaling-Clear or Almost Clear at Endpoint 101 (73) 42 (30)
Erythema-Clear or Almost Clear at Endpoint 88 (63) 35 (25)
Plaque Thickness-Clear at Endpoint 44 (32) 5 (4)
*Defined as a composite of a Physician's Static Global Assessment score of 0 or 1, scaling score of 0 or 1, an erythema score of 0 or 1 and a plaque thickness score of 0, based on a severity scale of 0-5 at Endpoint.

Actions of Ofloxacin (Dermikem OC) in details

The action of the drug on the human body is called Pharmacodynamics in Medical terminology. To produce its effect and to change the pathological process that is happening the body and to reduce the symptom or cure the disease, the medicine has to function in a specific way. The changes it does to the body at cellular level gives the desired result of treating a disease. Drugs act by stimulating or inhibiting a receptor or an enzyme or a protein most of the times. Medications are produced in such a way that the ingredients target the specific site and bring about chemical changes in the body that can stop or reverse the chemical reaction which is causing the disease.
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Pharmacokinetics: Drug concentrations in serum (in subjects with tympanostomy tubes and perforated tympanic membranes), in otorrhea and in mucosa of the middle ear (in subjects with perforated tympanic membranes) were determined following otic administration of Ofloxacin (Dermikem OC) solution. In two single-dose studies, mean Ofloxacin (Dermikem OC) serum concentrations were low in adult patients with tympanostomy tubes, with and without otorrhea, after otic administration of 0.3% solution [4.1 ng/mL (n=3) and 5.4 ng/mL (n=5), respectively]. In adults with perforated tympanic membranes, the maximum serum drug level of Ofloxacin (Dermikem OC) detected was 10 ng/mL after administration of a 0.3% solution. Ofloxacin (Dermikem OC) was detectable in the middle ear mucosa of some adult subjects with perforated tympanic membranes (11 out of 15 subjects). The variability of Ofloxacin (Dermikem OC) concentration in the middle ear mucosa was high. The concentrations ranged from 1.2-602 mcg/g after otic administration of a 0.3% solution. Ofloxacin (Dermikem OC) was present in high concentrations in otorrhea (389-2850 mcg/g, n=13) 30 min after otic administration of a 0.3% solution in subjects with chronic suppurative otitis media and perforated tympanic membranes. However, the measurement of Ofloxacin (Dermikem OC) in the otorrhea does not necessarily reflect the exposure of the middle ear to Ofloxacin (Dermikem OC).

Microbiology: Ofloxacin (Dermikem OC) has in vitro activity against a wide range of gram-negative and gram-positive microorganisms. Ofloxacin (Dermikem OC) exerts its antibacterial activity by inhibiting DNA gyrase, a bacterial topoisomerase. DNA gyrase is an essential enzyme which controls DNA topology and assists in DNA replication, repair, deactivation and transcription. Cross-resistance has been observed between Ofloxacin (Dermikem OC) and other fluoroquinolones. There is generally no cross-resistance between Ofloxacin (Dermikem OC) and other classes of antibacterial agents eg, β-lactams or aminoglycosides.

Ofloxacin (Dermikem OC) has been shown to be active against most strains of the following microorganisms, both in vitro and clinically in otic infections :

Gram-Positive Aerobes: Staphylococcus aureus and Streptococcus pneumoniae.

Gram-Negative Aerobes: Haemophilus influenzae, Proteus mirabilis, Moraxella catarrhalis and Pseudomonas aeruginosa.

How should I take Ofloxacin (Dermikem OC)?

Take Ofloxacin (Dermikem OC) only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Ofloxacin (Dermikem OC) comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

You may take Ofloxacin (Dermikem OC) with or without food.

Drink plenty of fluids while you are being treated with Ofloxacin (Dermikem OC). Drinking extra water will help to prevent some unwanted effects of Ofloxacin (Dermikem OC).

If you are also using antacids containing aluminum or magnesium (such as Maalox®, Mylanta®), multivitamins (with calcium, iron, or zinc), didanosine (Videx®), or sucralfate (Carafate®), take these medicines at least 2 hours before or 2 hours after you take Ofloxacin (Dermikem OC). These medicines may keep Ofloxacin (Dermikem OC) from working properly.

Keep using Ofloxacin (Dermikem OC) for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.

Dosing

The dose of Ofloxacin (Dermikem OC) will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of Ofloxacin (Dermikem OC). If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Missed Dose

If you miss a dose of Ofloxacin (Dermikem OC), take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Ofloxacin (Dermikem OC) administration

Administration of drug is important to know because the drug absorption and action varies depending on the route and time of administration of the drug. A medicine is prescribed before meals or after meals or along with meals. The specific timing of the drug intake about food is to increase its absorption and thus its efficacy. Few work well when taken in empty stomach and few medications need to be taken 1 or 2 hrs after the meal. A drug can be in the form of a tablet, a capsule which is the oral route of administration and the same can be in IV form which is used in specific cases. Other forms of drug administration can be a suppository in anal route or an inhalation route.

Use Ofloxacin (Dermikem OC) otic exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Do not use this medication in the eyes or take it by mouth. Ofloxacin (Dermikem OC) otic is intended for use in the ears only.

In general, Ofloxacin (Dermikem OC) otic should be used as follows:

Ofloxacin (Dermikem OC) ear drops are usually used twice a day, about 12 hours apart. Follow your doctor's instructions.

Use all of the medication that has been prescribed. Symptoms may begin to improve before the condition is completely treated. If you do not use all of the medication prescribed, the condition could return or worsen.

It is important to use Ofloxacin (Dermikem OC) otic regularly to get the most benefit.

Notify your doctor if the condition does not improve or appears to worsen.

Avoid getting water inside of the affected ear(s) during treatment with Ofloxacin (Dermikem OC). Care should be used while bathing, and swimming may not be recommended. Talk to your healthcare provider.

Store Ofloxacin (Dermikem OC) otic at room temperature, away from moisture, heat, and direct light. Keep the bottle properly capped.

Ofloxacin (Dermikem OC) pharmacology

Pharmacokinetics of a drug can be defined as what body does to the drug after it is taken. The therapeutic result of the medicine depends upon the Pharmacokinetics of the drug. It deals with the time taken for the drug to be absorbed, metabolized, the process and chemical reactions involved in metabolism and about the excretion of the drug. All these factors are essential to deciding on the efficacy of the drug. Based on these pharmacokinetic principles, the ingredients, the Pharmaceutical company decides dose and route of administration. The concentration of the drug at the site of action which is proportional to therapeutic result inside the body depends on various pharmacokinetic reactions that occur in the body.

Pharmacokinetics:

Serum, urine and tear concentrations of Ofloxacin (Dermikem OC) were measured in 30 healthy women at various time points during a ten-day course of treatment with Ofloxacin (Dermikem OC) Ophthalmic Solution. The mean serum Ofloxacin (Dermikem OC) concentration ranged from 0.4 ng/mL to 1.9 ng/mL. Maximum Ofloxacin (Dermikem OC) concentration increased from 1.1 ng/mL on day one to 1.9 ng/mL on day 11 after QID dosing for 10 1/2 days. Maximum serum Ofloxacin (Dermikem OC) concentrations after ten days of topical ophthalmic dosing were more than 1000 times lower than those reported after standard oral doses of Ofloxacin (Dermikem OC).

Tear Ofloxacin (Dermikem OC) concentrations ranged from 5.7 to 31 mcg/g during the 40 minute period following the last dose on day 11. Mean tear concentration measured four hours after topical ophthalmic dosing was 9.2 mcg/g.

Corneal tissue concentrations of 4.4 mcg/mL were observed four hours after beginning topical ocular application of two drops of Ofloxacin (Dermikem OC) Ophthalmic Solution every 30 minutes. Ofloxacin (Dermikem OC) was excreted in the urine primarily unmodified.

Microbiology:

Ofloxacin (Dermikem OC) has in vitro activity against a broad range of gram-positive and gram-negative aerobic and anaerobic bacteria. Ofloxacin (Dermikem OC) is bactericidal at concentrations equal to or slightly greater than inhibitory concentrations. Ofloxacin (Dermikem OC) is thought to exert a bactericidal effect on susceptible bacterial cells by inhibiting DNA gyrase, an essential bacterial enzyme which is a critical catalyst in the duplication, transcription, and repair of bacterial DNA.

Cross-resistance has been observed between Ofloxacin (Dermikem OC) and other fluoroquinolones. There is generally no cross-resistance between Ofloxacin (Dermikem OC) and other classes of antibacterial agents such as beta-lactams or aminoglycosides.

Ofloxacin (Dermikem OC) has been shown to be active against most strains of the following organisms both in vitro and clinically, in conjunctival and/or corneal ulcer infections as described in the section.

*Efficasy for this organism was studied in fewer than 10 infection

The safety and effectiveness of Ofloxacin (Dermikem OC) Ophthalmic Solution in treating ophthalmologic infections due to the following organisms have not been established in adequate and well-controlled clinical trials. Ofloxacin (Dermikem OC) Ophthalmic Solution has been shown to be active in vitro against most strains of these organisms but the clinical significance in ophthalmologic infections is unknown.

Clinical Studies:

Conjunctivitis: In a randomized, double-masked, multicenter clinical trial, Ofloxacin (Dermikem OC) Ophthalmic Solution was superior to its vehicle after 2 days of treatment in patients with conjunctivitis and positive conjunctival cultures. Clinical outcomes for the trial demonstrated a clinical improvement rate of 86% (54/63) for the Ofloxacin (Dermikem OC) treated group versus 72% (48/67) for the placebo treated group after 2 days of therapy. Microbiological outcomes for the same clinical trial demonstrated an eradication rate for causative pathogens of 65% (41/63) for the Ofloxacin (Dermikem OC) treated group versus 25% (17/67) for the vehicle treated group after 2 days of therapy. Please note that microbiologic eradication does not always correlate with clinical outcome in anti-infective trials.

Corneal Ulcers: In a randomized, double-masked, multi-center clinical trial of 140 subjects with positive cultures, Ofloxacin (Dermikem OC) Ophthalmic Solution treated subjects had an overall clinical success rate (complete reepithelialization and no progression of the infiltrate for two consecutive visits) of 82% (61/74) compared to 80% (53/66) for the fortified antibiotic group, consisting of 1.5% tobramycin and 10% cefazolin solutions. The median time to clinical success was 11 days for the Ofloxacin (Dermikem OC) treated group and 10 days for the fortified treatment group.

Actions of Ornidazole (Dermikem OC) in details

The action of the drug on the human body is called Pharmacodynamics in Medical terminology. To produce its effect and to change the pathological process that is happening the body and to reduce the symptom or cure the disease, the medicine has to function in a specific way. The changes it does to the body at cellular level gives the desired result of treating a disease. Drugs act by stimulating or inhibiting a receptor or an enzyme or a protein most of the times. Medications are produced in such a way that the ingredients target the specific site and bring about chemical changes in the body that can stop or reverse the chemical reaction which is causing the disease.

Pharmacology: Ornidazole (Dermikem OC) contains a 5-nitro group which gets reduced inside the nucleus of microbes impairing DNA function.

Microbiology: Ornidazole (Dermikem OC) is active against protozoal infections due to Trichomonas vaginalis, Gardnerella vaginalis, Giardia lamblia and Entamoeba histolytica and anaerobic infections due to Bacteroides, Clostridium and Fusobacterium (MIC <4 mcg/mL).

Pharmacokinetics: After an oral dose of 500 mg, the maximum concentration achieved in plasma is 8.3 mcg/mL. The drug has a plasma half-life of 12-14 hrs. Distribution is extensive with 15% of plasma protein-binding. Ornidazole (Dermikem OC) is extensively metabolised in the liver (95%) to glucuronide and sulfa-conjugates. It is excreted by the kidney and biliary route.

Ornidazole (Dermikem OC) administration

Administration of drug is important to know because the drug absorption and action varies depending on the route and time of administration of the drug. A medicine is prescribed before meals or after meals or along with meals. The specific timing of the drug intake about food is to increase its absorption and thus its efficacy. Few work well when taken in empty stomach and few medications need to be taken 1 or 2 hrs after the meal. A drug can be in the form of a tablet, a capsule which is the oral route of administration and the same can be in IV form which is used in specific cases. Other forms of drug administration can be a suppository in anal route or an inhalation route.

Should be taken with food.

Ornidazole (Dermikem OC) pharmacology

Pharmacokinetics of a drug can be defined as what body does to the drug after it is taken. The therapeutic result of the medicine depends upon the Pharmacokinetics of the drug. It deals with the time taken for the drug to be absorbed, metabolized, the process and chemical reactions involved in metabolism and about the excretion of the drug. All these factors are essential to deciding on the efficacy of the drug. Based on these pharmacokinetic principles, the ingredients, the Pharmaceutical company decides dose and route of administration. The concentration of the drug at the site of action which is proportional to therapeutic result inside the body depends on various pharmacokinetic reactions that occur in the body.

Ornidazole (Dermikem OC) inhibits norepinephrine release by depressing adrenergic nerve terminal excitability. The mechanisms of the antifibrillatory and antiarrhythmic actions of bretylium are not established. In efforts to define these mechanisms, the following electrophysiologic actions of bretylium have been demonstrated in animal experiments: increase in ventricular fibrillation threshold, increase in action potential duration and effective refractory period without changes in heart rate, little effect on the rate of rise or amplitude of the cardiac action potential (Phase 0) or in resting membrane potential (Phase 4) in normal myocardium, decrease in the disparity in action potential duration between normal and infarcted regions, and increase in impulse formation and spontaneous firing rate of pacemaker tissue as well as increase ventricular conduction velocity.

Actions of Terbinafine (Dermikem OC) in details

The action of the drug on the human body is called Pharmacodynamics in Medical terminology. To produce its effect and to change the pathological process that is happening the body and to reduce the symptom or cure the disease, the medicine has to function in a specific way. The changes it does to the body at cellular level gives the desired result of treating a disease. Drugs act by stimulating or inhibiting a receptor or an enzyme or a protein most of the times. Medications are produced in such a way that the ingredients target the specific site and bring about chemical changes in the body that can stop or reverse the chemical reaction which is causing the disease.

Pharmacology: Mechanism of Action: Terbinafine is an allylamine which has a broad spectrum of antifungal activity. At low concentrations, terbinafine is fungicidal against dermatophytes, molds and certain dimorphic fungi. The activity against yeasts is fungicidal or fungistatic, depending on the species.

Terbinafine interferes specifically with fungal sterol biosynthesis. This leads to a deficiency in ergosterol and to an intracellular accumulation of squalene, resulting in fungal cell death. The enzyme squalene epoxidase is not linked to the cytochrome P-450 system, hence terbinafine does not influence the metabolism of hormones or other drugs. When given orally, the drug concentrates rapidly in skin, hair and nails at levels associated with fungicidal activity.

Pharmacokinetics: Absorption: A single oral dose of terbinafine 250 mg results in peak plasma concentrations of 0.97 mcg/mL within 2 hrs after administration. The absorption t½ is 0.8 hrs and the distribution t½ is 4.6 hrs. The bioavailability of terbinafine is moderately increased by a fat-rich meal, but not sufficiently to require dosing adjustments.

Distribution: Terbinafine binds strongly to plasma proteins (99%). It rapidly diffuses through the dermis and concentrates in the lipophilic stratum corneum. Terbinafine is also secreted in sebum, thus achieving high concentrations in hair follicles, hair and in sebum-rich skin. There is also evidence that terbinafine is distributed into the nail plate within the first few weeks of commencing therapy, resulting in a rapid onset of action.

Metabolism: Terbinafine is metabolized rapidly and extensively by at least 7 CYP isoenzymes with major contributions from CYP2C9, CYP1A2, CYP3A4, CYP2C8 and CYP2C19. As a result of first-pass metabolism, the bioavailability of terbinafine is approximately 40%. No metabolites have been identified that have antifungal activity similar to terbinafine.

Elimination: Approximately 70% of the administered dose is eliminated in the urine. The terminal t½ is 17 hrs. There is no evidence of accumulation. No age-dependent changes in pharmacokinetics have been observed but the elimination rate may be reduced in patients with renal or hepatic impairment, resulting in higher blood levels of terbinafine or the clearance of terbinafine is decreased by approximately 50% compared to normal volunteers.

How should I take Terbinafine (Dermikem OC)?

Apply enough Terbinafine (Dermikem OC) to cover the affected and surrounding skin areas and rub in gently.

Apply enough terbinafine solution to wet and cover the affected and surrounding skin areas. Allow it to dry.

Keep terbinafine away from the eyes, nose, mouth, and other mucous membranes. The solution may be especially irritating to the eyes.

Terbinafine spray solution contains alcohol and should not be applied to the face.

Do not apply an occlusive dressing (airtight covering, such as a tight bandage or plastic kitchen wrap) over terbinafine unless you have been directed to do so by your doctor.

Dosing

The dose of terbinafine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of terbinafine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

To help clear up your infection completely, it is very important that you keep using terbinafine for the full time of treatment, even if your symptoms begin to clear up after a few days. Since fungus infections may be very slow to clear up, you may have to continue using terbinafine every day for several weeks or more. If you stop using terbinafine too soon, your symptoms may return. Do not miss any doses.

Missed Dose

If you miss a dose of terbinafine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Terbinafine (Dermikem OC) administration

Administration of drug is important to know because the drug absorption and action varies depending on the route and time of administration of the drug. A medicine is prescribed before meals or after meals or along with meals. The specific timing of the drug intake about food is to increase its absorption and thus its efficacy. Few work well when taken in empty stomach and few medications need to be taken 1 or 2 hrs after the meal. A drug can be in the form of a tablet, a capsule which is the oral route of administration and the same can be in IV form which is used in specific cases. Other forms of drug administration can be a suppository in anal route or an inhalation route.

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Take the terbinafine tablet with a full glass (8 ounces) of water.

Terbinafine granules should be sprinkled into a spoonful of pudding or mashed potatoes (do not mix with applesauce, fruit juice, or other acidic foods). Swallow this mixture right away without chewing. Do not save the mixture for later use.

The terbinafine granule mixture should be taken with a meal.

Terbinafine is usually taken for 6 to 12 weeks.

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 will not treat a viral infection such as the common cold or flu.

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.

Store at room temperature away from moisture, heat, and light.

Keep the terbinafine oral granules in their sealed packet until you are ready to use.

Terbinafine (Dermikem OC) pharmacology

Pharmacokinetics of a drug can be defined as what body does to the drug after it is taken. The therapeutic result of the medicine depends upon the Pharmacokinetics of the drug. It deals with the time taken for the drug to be absorbed, metabolized, the process and chemical reactions involved in metabolism and about the excretion of the drug. All these factors are essential to deciding on the efficacy of the drug. Based on these pharmacokinetic principles, the ingredients, the Pharmaceutical company decides dose and route of administration. The concentration of the drug at the site of action which is proportional to therapeutic result inside the body depends on various pharmacokinetic reactions that occur in the body.

Mechanism of Action

Terbinafine is an allylamine antifungal.

Pharmacodynamics

The pharmacodynamics of Terbinafine (Dermikem OC) Tablets is unknown.

Pharmacokinetics

Following oral administration, terbinafine is well absorbed (>70%) and the bioavailability of Terbinafine (Dermikem OC) 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.h/mL. An increase in the AUC of terbinafine of less than 20% is observed when Terbinafine (Dermikem OC) Tablets are administered with food.

In plasma, terbinafine 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 terbinafine 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. Terbinafine is distributed to the sebum and skin. A terminal half-life of 200-400 hours may represent the slow elimination of terbinafine from tissues such as skin and adipose. Prior to excretion, terbinafine 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 terbinafine. 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 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-state plasma concentrations of terbinafine have been reported.

Microbiology

Terbinafine, an allylamine antifungal, inhibits biosynthesis of ergosterol, an essential component of fungal cell membrane, via inhibition of squalene epoxidase enzyme. This results in fungal cell death primarily due to the increased membrane permeability mediated by the accumulation of high concentrations of squalene but not due to ergosterol deficiency. Depending on the concentration of the drug and the fungal species test in vitro, terbinafine hydrochloride may be fungicidal. However, the clinical significance of in vitro data is unknown.

Terbinafine 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, terbinafine exhibits satisfactory MIC’s against most strains of the following microorganisms; however, the safety and efficacy of terbinafine 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



References

  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).
  2. DailyMed. "OFLOXACIN: 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).
  3. NCIt. "Terbinafine: NCI Thesaurus (NCIt) provides reference terminology for many systems. It covers vocabulary for clinical care, translational and basic research, and public information and administrative activities.". https://ncit.nci.nih.gov/ncitbrowser... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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