Dermikem OC Uses

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What is the dose of your medication?

Consists of Clobetasol, Ofloxacin, Ornidazole, Terbinafine

What is Clobetasol (Dermikem OC)?

Clobetasol (Dermikem OC) topical is used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions. The solution are used for scalp problems, the foam is used for mild to moderate plaque psoriasis, the cream, lotion, and spray are used for moderate to severe plaque psoriasis, and the foam and shampoo are used for moderate to severe scalp psoriasis. Clobetasol (Dermikem OC) is a corticosteroid (cortisone-like medicine or steroid).

Clobetasol (Dermikem OC) is available only with your doctor's prescription.

Clobetasol (Dermikem OC) 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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Indication

Clobetasol (Dermikem OC) Propionate Spray, 0.05% is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older. The total dosage should not exceed 50 g (59 mL or 2 fl. oz.) per week. Do not use more than 26 sprays per application or 52 sprays per day. Treatment should be limited to 4 consecutive weeks. Patients should be instructed to use Clobetasol (Dermikem OC) Propionate Spray, 0.05% for the minimum amount of time necessary to achieve the desired results. Use in patients under 18 years of age is not recommended because safety has not been established and because numerically high rates of HPA axis suppression were seen with other Clobetasol (Dermikem OC) propionate topical formulations.

Limitations of Use

Clobetasol (Dermikem OC) Propionate Spray, 0.05% should not be used on the face, axillae, or groin. Clobetasol (Dermikem OC) Propionate Spray, 0.05% should not be used if there is atrophy at the treatment site. Clobetasol (Dermikem OC) Propionate Spray, 0.05% should not be used in the treatment of rosacea or perioral dermatitis.

How should I use Clobetasol (Dermikem OC)?

Use Clobetasol (Dermikem OC) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Wash your hands before using Clobetasol (Dermikem OC). If your fingers are warm, rinse them in cold water and dry before you apply Clobetasol (Dermikem OC).
  • Use the smallest amount of medicine necessary to cover the affected area.
  • Shake well before each use.
  • Turn the can upside down and squirt a small amount of foam (up to the size of a golf ball) into the cap of the can, onto a clean saucer, or onto another cool, clean surface. You may also squirt it directly onto the affected area. Do not squirt the medicine directly into the hand because it will start to melt immediately upon touching warm skin.
  • Gently rub the medicine into the affected area until it disappears.
  • Throw away any unused medicine that has been squirted out of the can.
  • Wash your hands immediately after using Clobetasol (Dermikem OC), unless your hands are a part of the treated area.
  • Do not use Clobetasol (Dermikem OC) on your face, groin, or underarms unless your doctor tells you otherwise.
  • Do not use Clobetasol (Dermikem OC) over large areas of the body without first checking with your doctor.
  • Do not bandage or wrap the affected area unless directed to do so by your doctor.
  • If you miss a dose of Clobetasol (Dermikem OC), apply it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Clobetasol (Dermikem OC).

Uses of Clobetasol (Dermikem OC) 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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Clobetasol (Dermikem OC) is used to treat itching, redness, dryness, swelling, and discomfort of various scalp and skin conditions, including immune-mediated skin disease with red scaly patches (psoriasis).

Clobetasol (Dermikem OC) description

Clobetasol (Dermikem OC) is a post-ganglionic parasympathetic inhibitor. It decreases gastric acid and pepsin secretion and suppresses spontaneous contractions of the colon. Clobetasol (Dermikem OC) diminishes gastric acid and pepsin secretion. Clobetasol (Dermikem OC) also suppresses spontaneous contractions of the colon. Pharmacologically, it is a post-ganglionic parasympathetic inhibitor. It has not been shown to be effective in contributing to the healing of peptic ulcer, decreasing the rate of recurrence, or preventing complications.

Clobetasol (Dermikem OC) dosage

Note: For proper dispensing of foam, hold the can upside down and depress the actuator.

Clobetasol (Dermikem OC) (Clobetasol (Dermikem OC) propionate) Foam should be applied to the affected area twice daily, once in the morning and once at night. Invert the can and dispense a small amount of Clobetasol (Dermikem OC) (Clobetasol (Dermikem OC) propionate) Foam (up to a maximum of a golf-ball-size dollop or one and a half capfuls) into the cap of the can, onto a saucer or other cool surface, or to the lesion, taking care to avoid contact with the eyes. Dispensing directly onto hands is not recommended (unless the hands are the affected area), as the foam will begin to melt immediately upon contact with warm skin. When applying Clobetasol (Dermikem OC) (Clobetasol (Dermikem OC) propionate) Foam to a hair-bearing area, move the hair away from the affected area so that the foam can be applied to each affected area. Pick up small amounts with fingertips and gently massage into affected area until the foam disappears. Repeat until entire affected area is treated.

Apply the smallest amount possible that sufficiently covers the affected area(s). No more than one and a half capfuls of foam should be used at each application. Do not apply to face or intertriginous areas.

Clobetasol (Dermikem OC) (Clobetasol (Dermikem OC) propionate) Foam is a super-high-potency topical corticosteroid; therefore, treatment should be limited to 2 consecutive weeks and amounts greater than 50 g/week should not be used. Use in pediatric patients under 12 years of age is not recommended. Unless directed by a physician, Clobetasol (Dermikem OC) (Clobetasol (Dermikem OC) propionate) Foam should not be used with occlusive dressings.

Instructions for applying Clobetasol (Dermikem OC) (Clobetasol (Dermikem OC) propionate) Foam

Apply Clobetasol (Dermikem OC) (Clobetasol (Dermikem OC) propionate) Foam twice a day, once in the morning and once at night. Apply only enough to cover the affected areas. Clobetasol (Dermikem OC) (Clobetasol (Dermikem OC) propionate) Foam should not be applied to the groin, armpits, or other skin fold areas.

To use Clobetasol (Dermikem OC) (Clobetasol (Dermikem OC) propionate) Foam:

Before applying Clobetasol (Dermikem OC) (Clobetasol (Dermikem OC) propionate) Foam for the first time, break the tiny plastic piece at the base of the can's rim by gently pushing back (away from the piece) on the nozzle.

Turn the can upside down.

Push the button to squirt a small amount of Clobetasol (Dermikem OC) (Clobetasol (Dermikem OC) propionate) Foam into the cap of the can, onto a saucer or other cool surface, or your affected skin area. This amount should be no more than 1 ½ capfuls, about the size of a golf ball.

Do not squirt Clobetasol (Dermikem OC) (Clobetasol (Dermikem OC) propionate) Foam directly onto your hands (unless your hands are the affected areas), because the foam will begin to melt right away on contact with your warm skin. If your fingers are warm, rinse them in cold water first. (Be sure to dry them thoroughly before handling the foam.)

If the can seems warm or the foam seems runny, run the can under cold water.

Using your fingertips, gently massage Clobetasol (Dermikem OC) (Clobetasol (Dermikem OC) propionate) Foam into the affected areas until the foam disappears.

If you are treating areas with hair such as the scalp, move any hair away so that the foam can be applied directly to the affected areas.

Repeat the process until the affected areas are treated.

Keep the foam away from your eyes, as it will sting and may cause eye problems if there is frequent contact with your eyes. If the foam gets in your eyes, rinse them well with cold water right away. If the stinging continues, contact your doctor right away.

Wash your hands after applying Clobetasol (Dermikem OC) (Clobetasol (Dermikem OC) propionate) Foam. Throw away any of the unused medicine that you squirted out of the can.

How supplied

Clobetasol (Dermikem OC) (Clobetasol (Dermikem OC) propionate) Foam is supplied in 100 g (NDC 63032-031-00) and 50 g (NDC 63032- 031-50) aluminum cans.

Store at controlled room temperature 68-77°F (20-25°C).

WARNING

FLAMMABLE. AVOID FIRE, FLAME OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION. Keep out of reach of children. Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120°F (49°C).

Manufactured for : Connetics Corporation, Palo Alto, CA 94304, USA. For additional information: 1-888-500-DERM or visit, www.Clobetasol (Dermikem OC) (Clobetasol (Dermikem OC) propionate).com. VersaFoam-HF is a trademark, and the V logo, the interlocking C design, Clobetasol (Dermikem OC) (Clobetasol (Dermikem OC) propionate) and Connetics are registered trademarks, of Connetics Corporation. January 2006. FDA revision date: 7/11/2006

Clobetasol (Dermikem OC) interactions

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What other drugs will affect Clobetasol (Dermikem OC)?

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ACE inhibitors

May result in severely elevated serum potassium levels.

Alcohol, barbiturates, narcotics

Orthostatic hypotension may be potentiated.

Angiotensin II receptor antagonists (eg, candesartan, losartan, telmisartan)

Risk of hyperkalemia, especially in patients with renal impairment or type 2 diabetes, may be increased.

Corticosteroids

Increased risk of electrolyte depletion, particularly hypokalemia.

Digitalis glycosides

May decrease digoxin clearance, resulting in increased serum digoxin levels and toxicity; may attenuate inotropic action of digoxin.

Diuretics

Risk of dilutional hyponatremia may be increased.

Mitotane

May decrease therapeutic response to mitotane.

Salicylates

May result in decreased diuretic effect.

Lithium

Lithium clearance may be reduced, increasing the risk of toxicity.

Nondepolarizing muscle relaxants (eg, tubocurarine)

Increased responsiveness to muscle relaxant effect may occur.

NSAIDs (eg, indomethacin)

Risk of severe hyperkalemia may be increased.

Potassium preparations

May severely increase serum potassium levels, possibly resulting in cardiac arrhythmias or cardiac arrest. Do not take with potassium preparations.

Pressor amines (eg, norepinephrine)

Vascular responsiveness to norepinephrine may be decreased. Use with caution in patients receiving regional or general anesthesia.

Clobetasol (Dermikem OC) side effects

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What are the possible side effects of Clobetasol (Dermikem OC)?

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In a controlled pharmacokinetic study, 5 of 13 subjects experienced reversible suppression of the adrenals at any time during the 14 days of Clobetasol (Dermikem OC) (Clobetasol (Dermikem OC) propionate) Foam therapy to at least 20% of the body surface area. Of the 13 subjects studied, 1 of 9 with psoriasis were suppressed after 14 days and all 4 of the subjects with atopic dermatitis had abnormal cortisol levels indicative of adrenal suppression at some time after starting therapy with Clobetasol (Dermikem OC) (Clobetasol (Dermikem OC) propionate) Foam.

Table 3: Subjects with reversible HPA axis suppression at any time during treatment

Dermatosis Clobetasol (Dermikem OC) Foam
Psoriasis 1 of 9
Atopic Dermatitis* 4 of 4
*Clobetasol (Dermikem OC) Foam is not indicated for non-scalp atopic dermatitis, as the safety and efficacy of Clobetasol (Dermikem OC) Foam in non-scalp atopic dermatitis has not been established. Use in children under 12 years of age is not recommended.

Systemic absorption of topical corticosteroids has produced reversible adrenal suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.

In a controlled clinical trial (188 subjects) with Clobetasol (Dermikem OC) (Clobetasol (Dermikem OC) propionate) Foam in subjects with psoriasis of the scalp, there were no localized scalp adverse reactions reported in the Clobetasol (Dermikem OC) (Clobetasol (Dermikem OC) propionate) Foam treated subjects. In two controlled clinical trials (360 subjects) with Clobetasol (Dermikem OC) (Clobetasol (Dermikem OC) propionate) Foam in subjects with psoriasis of non-scalp regions, localized adverse events that occurred in the Clobetasol (Dermikem OC) (Clobetasol (Dermikem OC) propionate) Foam treated subjects included application site burning (10%), application site dryness ( < 1%), and other application site reactions (4%).

In larger controlled trials with other Clobetasol (Dermikem OC) propionate formulations, the most frequently reported local adverse reactions have included burning, stinging, irritation, pruritus, erythema, folliculitis, cracking and fissuring of the skin, numbness of the fingers, skin atrophy, and telangiectasia (all less than 2%).

The following additional local adverse reactions have been reported with topical corticosteroids, but they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids such as Clobetasol (Dermikem OC) (Clobetasol (Dermikem OC) propionate) Foam. These reactions are listed in an approximate decreasing order of occurrence: dryness, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, striae, and miliaria.

Clobetasol (Dermikem OC) contraindications

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What is the most important information I should know about Clobetasol (Dermikem OC)?

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.

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.

Do not use this medication on a child without medical advice. Children are more likely to absorb large amounts of a topical steroid through the skin. Steroid absorption in children may cause unwanted side effects, or a delay in growth with long-term use. Talk with your doctor if you think your child is not growing at a normal rate while using this medication over a long treatment period.

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.

What is Ofloxacin (Dermikem OC)?

Ofloxacin (Dermikem OC) is an antibiotic that treats infections caused by bacteria.

Ofloxacin (Dermikem OC) otic (for the ear) is used to treat infections of the ear canal in adults and children who are at least 6 months old. Ofloxacin (Dermikem OC) otic is used in adults and children at least 1 year old to treat an inner ear infection (also called otitis media).

Ofloxacin (Dermikem OC) otic may be used on a long-term basis to treat an infection that causes a hole in the ear drum (ruptured ear drum) in adults and children who are at least 12 years old.

Ofloxacin (Dermikem OC) may also be used for purposes not listed in this medication guide.

Ofloxacin (Dermikem OC) 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.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ofloxacin (Dermikem OC) tablets and other antibacterial drugs, Ofloxacin (Dermikem OC) tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Ofloxacin (Dermikem OC) tablets are indicated for the treatment of adults with mild to moderate infections (unless otherwise indicated) caused by susceptible strains of the designated microorganisms in the infections listed below. Please see DOSAGE AND ADMINISTRATION for specific recommendations.

Acute Bacterial Exacerbations of Chronic Bronchitis (ABECB) due to Haemophilus influenzae or Streptococcus pneumoniae.

Because fluoroquinolones, including Ofloxacin (Dermikem OC), have been associated with serious adverse reactions, and for some patients ABECB is self-limiting, reserve Ofloxacin (Dermikem OC) for treatment of ABECB in patients who have no alternative treatment options.

Community-Acquired Pneumonia due to Haemophilus influenzae or Streptococcus pneumoniae.

Uncomplicated Skin and Skin Structure Infections due to methicillin-susceptible Staphylococcus aureus, Streptococcus pyogenes, or Proteus mirabilis.

Acute, Uncomplicated Urethral and Cervical Gonorrhea due to Neisseria gonorrhoeae.

Nongonococcal Urethritis and Cervicitis due to Chlamydia trachomatis.

Mixed Infections of the Urethra and Cervix due to Chlamydia trachomatis and Neisseria gonorrhoeae.

Acute Pelvic Inflammatory Disease (including severe infection) due to Chlamydia trachomatis and/or Neisseria gonorrhoeae.

NOTE: If anaerobic microorganisms are suspected of contributing to the infection, appropriate therapy for anaerobic pathogens should be administered.

Uncomplicated Cystitis due to Citrobacter diversus, Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosa.

Because fluoroquinolones, including Ofloxacin (Dermikem OC), have been associated with serious adverse reactions, and for some patients uncomplicated cystitis is self-limiting, reserve Ofloxacin (Dermikem OC) for treatment of uncomplicated cystitis in patients who have no alternative treatment options.

Complicated Urinary Tract Infections due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Citrobacter diversus,* or Pseudomonas aeruginosa.*

Prostatitis due to Escherichia coli.

* = Although treatment of infections due to this organism in this organ system demonstrated a clinically significant outcome, efficacy was studied in fewer than 10 patients.

Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to Ofloxacin (Dermikem OC), USP. Therapy with Ofloxacin (Dermikem OC), USP may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued.

As with other drugs in this class, some strains of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with Ofloxacin (Dermikem OC), USP. Culture and susceptibility testing performed periodically during therapy will provide information not only on the therapeutic effect of the antimicrobial agent but also on the possible emergence of bacterial resistance.

How should I use Ofloxacin (Dermikem OC)?

Use Ofloxacin (Dermikem OC) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Ofloxacin (Dermikem OC) is only for the ear. Do not get it in your eyes, nose, or mouth.
  • Before using, hold the ear drop container in your hand for 1 or 2 minutes to avoid dizziness that may result from putting cold drops into the ear. Lie down or tilt your head so that the affected ear faces up. For adults, gently pull the earlobe up and back to straighten the ear canal. For children, gently pull the earlobe down and back to straighten the ear canal. Drop the medicine into the ear canal. Keep the ear facing up for 5 minutes so the medicine can run to the bottom of the ear canal. A clean cotton plug may be gently inserted into the ear canal to prevent medicine from leaking out.
  • To prevent germs from contaminating the medicine, do not touch the applicator to any surface, including the ear. Keep the container tightly closed.
  • If you are using Ofloxacin (Dermikem OC) for a middle ear infection, pump the flap over the ear 4 times after instilling the medicine in order to help it reach the middle ear.
  • Ofloxacin (Dermikem OC) works best if used at the same time each day.
  • To clear up your infection completely, use Ofloxacin (Dermikem OC) for the full course of treatment. Keep using it even if you feel better in a few days.
  • If you miss a dose of Ofloxacin (Dermikem OC), use 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 use 2 doses at once.

Ask your health care provider any questions you may have about how to use Ofloxacin (Dermikem OC).

Uses of Ofloxacin (Dermikem OC) 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.

Use: Labeled Indications

Treatment of acute exacerbations of chronic bronchitis, community-acquired pneumonia, skin and skin structure infections (uncomplicated), urethral and cervical gonorrhea (acute, uncomplicated), urethritis and cervicitis (nongonococcal) due to Chlamydia trachomatis infection, mixed infections of the urethra and cervix, pelvic inflammatory disease (acute), cystitis (uncomplicated), urinary tract infections (complicated), prostatitis

Note: As of April 2007, the CDC no longer recommends the use of fluoroquinolones for the treatment of gonococcal disease.

Off Label Uses

Epididymitis

Based on the Centers for Disease Control and Prevention (CDC) sexually transmitted diseases treatment guidelines and the Canadian Guidelines on Sexually Transmitted Infections, Ofloxacin (Dermikem OC) is an effective and recommended treatment option for acute epididymitis likely caused by enteric organisms (as monotherapy). The CDC guidelines also recommend Ofloxacin (Dermikem OC) in combination with ceftriaxone for acute epididymitis likely caused by sexually transmitted chlamydia and gonorrhea and enteric organisms in men who practice insertive anal sex.

Leprosy (multibacillary)

Data from a limited number of patients in an open-label, parallel assessment study suggest that Ofloxacin (Dermikem OC), in combination with rifampin and minocycline (ROM), may be beneficial for the treatment of multibacillary leprosy. Additional trials may be necessary to further define the role of multiple and single dose Ofloxacin (Dermikem OC) regimens in paucibacillary leprosy. The World Health Organization Expert Committee on Leprosy and the National Hansen's Disease Program currently do not recommend Ofloxacin (Dermikem OC) for the treatment of paucibacillary leprosy.

Spontaneous bacterial peritonitis (treatment)

According to national and international guidelines regarding treatment of spontaneous bacterial peritonitis (SBP), Ofloxacin (Dermikem OC) may be considered as an alternative therapy to IV third-generation cephalosporins in patients with uncomplicated SBP who are not infected with a suspected quinolone-resistant organism. If fluoroquinolone-resistant, gram-negative bacteria are suspected as the causative organisms, when fluoroquinolones have been used for prophylaxis, or when patients are located in areas where incidence of quinolone-resistant bacterial infections are high, cefotaxime is the treatment of choice.

Traveler's diarrhea

Based on the Infectious Diseases Society of America Guidelines for the Practice of Travel Medicine and the American College of Gastroenterology (ACG) Guideline for the Diagnosis, Treatment, and Prevention of Acute Diarrheal Infections in Adults, Ofloxacin (Dermikem OC) is an effective and recommended fluoroquinolone for antibiotic treatment of traveler's diarrhea.

Ofloxacin (Dermikem OC) description

Ofloxacin (Dermikem OC) Solution also contains benzalkonium chloride as inactive ingredient.

Ofloxacin (Dermikem OC) is (±)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido [1,2,3,-de][1,4]benzoxazine-6-carboxylic acid.

Ofloxacin (Dermikem OC) has a molecular formula of C18H20FN3O4, molecular weight of 361.37 and melting point of 260°-270°C (decomposition). Ofloxacin (Dermikem OC) occurs as pale yellowish-white to light yellowish-white crystals or crystalline powder, is odorless and has a bitter taste. It is freely soluble in glacial acetic acid, sparingly soluble in chloroform, slightly soluble in water, methanol, ethanol and acetone and very slightly soluble in ethyl acetate. It is slowly colorized by light and has no specific rotation.

Partition Coefficient: Chloroform: 0.1 mol/L phosphate buffer (pH 7.4):4.95. N-Octanol: 0.1 mol/L phosphate buffer (pH 7):0.33.

pH: 6-7. Osmotic pressure ratio (to physiological saline) 1-1.2.

Ofloxacin (Dermikem OC) dosage

The usual dose of Ofloxacin (Dermikem OC)® (Ofloxacin (Dermikem OC) tablets) Tablets is 200 mg to 400 mg orally every 12 h as described in the following dosing chart. These recommendations apply to patients with normal renal function (i.e., creatinine clearance > 50 mL/min). For patients with altered renal function (i.e., creatinine clearance < 50 mL/min), see the Patients with Impaired Renal Function Subsection.

Infection† Unit Dose Frequency Duration Daily Dose
Acute Bacterial Exacerbation of Chronic Bronchitis 400 mg q12h 10 days 800 mg
Comm. Acquired Pneumonia 400 mg q12h 10 days 800 mg
Uncomplicated Skin and Skin Structure Infections 400 mg q12h 10 days 800 mg
Acute, Uncomplicated Urethral and Cervical Gonorrhea 400 mg single dose 1 day 400 mg
Nongonococcal Cervicitis/Urethritis due to C. trachomatis 300 mg q12h 7 days 600 mg
Mixed Infection of the urethra and cervix due to C. trachomatis and N. gonorrhoeae 300 mg q12h 7 days 600 mg
Acute Pelvic Inflammatory Disease 400 mg q12h 10-14 days 800 mg
Uncomplicated Cystitis due to E. coli or K. pneumoniae 200 mg q12h 3 days 400 mg
Uncomplicated Cystitis due to other approved pathogens 200 mg q12h 7 days 400 mg
Complicated UTI's 200 mg q12h 10 days 400 mg
Prostatitis due to E.Coli 300 mg q12h 6 weeks 600 mg
† DUE TO THE DESIGNATED PATHOGENS

Antacids containing calcium, magnesium, or aluminum; sucralfate; divalent or trivalent cations such as iron; or multivitamins containing zinc; or Videx® (didanosine) should not be taken within the two-hour period before or within the two-hour period after taking Ofloxacin (Dermikem OC).

Patients with Impaired Renal Function: Dosage should be adjusted for patients with a creatinine clearance < 50 mL/min. After a normal initial dose, dosage should be adjusted as follows:

Creatinine Clearance Maintenance Dose Frequency
20-50 mL/min the usual recommended unit dose q24h
< 20 mL/min ½ the usual recommended unit dose q24h

When only the serum creatinine is known, the following formula may be used to estimate creatinine clearance.

Men: Creatinine Clearance (mL/min) = (140 – age) x (actual body wt in kg)
72 x (serum creatinine)

Women: 0.85 x the value calculated for men

The serum creatinine should represent a steady-state of renal function.

Patients with Cirrhosis:

The excretion of Ofloxacin (Dermikem OC) may be reduced in patients with severe liver function disorders (e.g., cirrhosis with or without ascites). A maximum dose of 400 mg of Ofloxacin (Dermikem OC) per day should therefore not be exceeded.

How supplied

Ofloxacin (Dermikem OC)® (Ofloxacin (Dermikem OC) tablets) Tablets are supplied as 200 mg light yellow, 300 mg white, and 400 mg pale gold oval, straight-edged, coated tablets. Each tablet is distinguished by an imprint of “Ofloxacin (Dermikem OC) (Ofloxacin (Dermikem OC)) ” and the appropriate strength. Ofloxacin (Dermikem OC)® (Ofloxacin (Dermikem OC)) Tablets are packaged in bottles in the following configurations:

200 mg tablets - bottles of 50 (NDC 0062 - 1540-02)

300 mg tablets - bottles of 50 (NDC 0062 - 1541-02)

400 mg tablets - bottles of 100 (NDC 0062 - 1542-01)

Ofloxacin (Dermikem OC)® (Ofloxacin (Dermikem OC)) Tablets should be stored in well-closed containers. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).

Keep out of the reach of children.

Ortho-McNeil, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. Raritan, NJ USA 08869. Issued January 2011

Ofloxacin (Dermikem OC) interactions

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What other drugs will affect Ofloxacin (Dermikem OC)?

Drugs Known to Prolong QT Interval: Ofloxacin (Dermikem OC), like other fluoroquinolones, should be used with caution in patients receiving drugs known to prolong the QT interval (eg, class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics).

Prolongation of bleeding time has been reported during concomitant administration of Ofloxacin (Dermikem OC) and anticoagulants.

There may be a further lowering of the cerebral seizure threshold when quinolones are given concurrently with other drugs which lower the seizure threshold eg, theophylline. However, Ofloxacin (Dermikem OC) is not thought to cause a pharmacokinetic interaction with theophylline, unlike some other fluoroquinolones.

Further lowering of the cerebral seizure threshold may also occur with certain nonsteroidal anti-inflammatory drugs.

In case of convulsive seizures, treatment with Ofloxacin (Dermikem OC) should be discontinued.

Ofloxacin (Dermikem OC) may cause a slight increase in serum concentrations of glibenclamide administered concurrently; patients treated with this combination should be closely monitored.

Vitamin K Antagonists: Coagulation tests should be monitored in patients treated with vitamin K antagonists because of a possible increase in the effect of coumarin derivatives.

Cimetidine: Cimetidine has demonstrated interference with the elimination of some quinolones. This interference has resulted in significant increases in t½ and AUC of some quinolones. The potential for interaction between Ofloxacin (Dermikem OC) and cimetidine has not been reported.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): The concomitant administration of a NSAID with a quinolone, including Ofloxacin (Dermikem OC), may increasethe risk of CNS stimulation and convulsive seizures.

Probenecid: The concomitant use of probenecid with certain other quinolones has been reported to affect renal tubular secretion. The effect of probenecid on the elimination of Ofloxacin (Dermikem OC) has not been reported.

Theophylline: Steady-state theophylline levels may increase when Ofloxacin (Dermikem OC) and theophylline are administered concurrently. As with other quinolones, concomitant administration of Ofloxacin (Dermikem OC) may prolong the t½ of theophylline, elevate serum theophylline levels and increase the risk of theophylline-related adverse reactions.

Theophylline levels should be closely monitored and theophylline dosage adjustments made, if appropriate, when Ofloxacin (Dermikem OC) is co-administered. Adverse reactions (including seizures) may occur with or without an elevation in the serum theophylline level.

Warfarin: Some quinolones have been reported to enhance the effects of the oral anticoagulant warfarin or its derivatives. Therefore, if a quinolone antimicrobial is administered concomitantly with warfarin or its derivatives, the prothrombin time or other suitable coagulation test should be closely monitored.

Antidiabetic Agents (eg, Insulin, Glyburide/Glibenclamide): Since disturbances of blood glucose, including hyperglycemia and hypoglycemia, have been reported in patients treated concurrently with quinolones and an antidiabetic agent, careful monitoring of blood glucose is recommended when these agents are used concomitantly.

Cyclosporine: Elevated serum levels of cyclosporine have been reported with concomitant use of cyclosporine with some other quinolones. The potential for interaction between Ofloxacin (Dermikem OC) and cyclosporine has not been reported.

Drugs Metabolized by Cytochrome P450 (CYP450) Enzymes: Most quinolone antimicrobial drugs inhibit CYP450 enzyme activity. This may result in a prolonged t½ for some drugs that are also metabolized by this system (eg, cyclosporine, theophylline/methylxanthines, warfarin) when co-administered with quinolones. The extent of this inhibition varies among different quinolones.

Interactions with Laboratory Tests: Some quinolones, including Ofloxacin (Dermikem OC), may produce false-positive urine screening results for opiates using commercially available immunoassay kits. Confirmation of positive opiate screens by more specific methods may be necessary.

Ofloxacin (Dermikem OC) side effects

See also:
What are the possible side effects of Ofloxacin (Dermikem OC)?

Subjects with Otitis Externa

In the phase III clinical trials performed in support of once-daily dosing, 799 subjects with otitis externa and intact tympanic membranes were treated with Ofloxacin (Dermikem OC) otic solution. The studies, which served as the basis for approval, were 020 (pediatric, adolescents and adults), 016 (adolescents and adults) and 017 (pediatric). The following treatment-related adverse events occurred in two or more of the subjects.

An unexpected increased incidence of application site reaction was seen in studies 016/017 and was similar for both Ofloxacin (Dermikem OC) and the active control drug (neomycin-polymyxin B sulfate-hydrocortisone). This finding is believed to be the result of specific questioning of the subjects regarding the incidence of application site reactions.

In once daily dosing studies, there were also single reports of nausea, seborrhea, transient loss of hearing, tinnitus, otitis externa, otitis media, tremor, hypertension and fungal infection.

In twice daily dosing studies, the following treatment-related adverse events were each reported in a single subject: dermatitis, eczema, erythematous rash, follicular rash, hypoaesthesia, tinnitus, dyspepsia, hot flushes, flushing and otorrhagia.

Subjects with Acute Otitis Media with Tympanostomy Tubes (AOM TT) and Subjects with Chronic Suppurative Otitis Media (CSOM) with Perforated Tympanic Membranes

In phase III clinical trials which formed the basis for approval, the following treatment-related adverse events occurred in 1% or more of the 656 subjects with non-intact tympanic membranes in AOM TT or CSOM treated twice-daily with Ofloxacin (Dermikem OC) otic solution:

Other treatment-related adverse reactions reported in subjects with non-intact tympanic membranes included: diarrhea (0.6%), nausea (0.3%), vomiting (0.3%), dry mouth (0.5%), headache (0.3%), vertigo (0.5%), otorrhagia (0.6%), tinnitus (0.3%), fever (0.3%). The following treatment-related adverse events were each reported in a single subject: application site reaction, otitis externa, urticaria, abdominal pain, dysaesthesia, hyperkinesia, halitosis, inflammation, pain, insomnia, coughing, pharyngitis, rhinitis, sinusitis, and tachycardia.

Post-marketing Adverse Events

Cases of uncommon transient neurospsychiatric disturbances have been included in spontaneous post-marketing reports. A causal relationship with Ofloxacin (Dermikem OC) otic solution 0.3% is unknown.

Ofloxacin (Dermikem OC) contraindications

See also:
What is the most important information I should know about Ofloxacin (Dermikem OC)?

You should not use this medication if you have a history of myasthenia gravis, or if you are allergic to Ofloxacin (Dermikem OC) or similar antibiotics such as ciprofloxacin (Cipro), gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), and others.

Before taking Ofloxacin (Dermikem OC), tell your doctor if you have kidney or liver disease, joint problems, myasthenia gravis, seizures or epilepsy, diabetes, low levels of potassium in your blood (hypokalemia), or a personal or family history of Long QT syndrome.

Avoid taking antacids, vitamin or mineral supplements, sucralfate (Carafate), or didanosine (Videx) powder or chewable tablets within 2 hours before or after you take Ofloxacin (Dermikem OC). These other medicines can make Ofloxacin (Dermikem OC) much less effective when taken at the same time.

Ofloxacin (Dermikem OC) may cause swelling or tearing of a tendon (the fiber that connects bones to muscles in the body), especially in the Achilles' tendon of the heel. These effects may be more likely to occur if you are over 60, if you take steroid medication, or if you have had a kidney, heart, or lung transplant. Stop taking Ofloxacin (Dermikem OC) and call your doctor at once if you have sudden pain, swelling, tenderness, stiffness, or movement problems in any of your joints. Rest the joint until you receive medical care or instructions.

Do not share this medication with another person (especially a child), even if they have the same symptoms you have.

Ornidazole (Dermikem OC) 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.

Oral

Amoebiasis

Adult: 0.5 g bid for 5-10 days.

Child: 25 mg/kg as a single daily dose for 5-10 days.

Renal impairment: Haemodialysis patients: Give a supplemental dose (50% of the usual dose) before dialysis.

Hepatic impairment: Severe: Double the interval between doses.

Oral

Amoebic dysentery

Adult: 1.5 g as a single daily dose for 3 days. Alternatively for patients >60 kg: 1 g bid for 3 days.

Child: 40 mg/kg daily.

Renal impairment: Haemodialysis patients: Give a supplemental dose (50% of the usual dose) before dialysis.

Hepatic impairment: Severe: Double the interval between doses.

Oral

Giardiasis

Adult: 1-1.5 g as a single daily dose for 1-2 days.

Child: 30-40 mg/kg daily.

Renal impairment: Haemodialysis patients: Give a supplemental dose (50% of the usual dose) before dialysis.

Hepatic impairment: Severe: Double the interval between doses.

Oral

Trichomoniasis

Adult: 1.5 g as a single daily dose or 0.5 g bid for 5 days. Treat sexual partners concomitantly.

Child: 25 mg/kg as a single dose.

Renal impairment: Haemodialysis patients: Give a supplemental dose (50% of the usual dose) before dialysis.

Hepatic impairment: Severe: Double the interval between doses.

Intravenous

Severe amoebic dysentery; Amoebic liver abscess

Adult: Initially, 0.5-1 g infusion followed by 0.5 g every 12 hrs for 3-6 days.

Child: 20-30 mg/kg body wt daily.

Renal impairment: Haemodialysis patients: Give a supplemental dose (50% of the usual dose) before dialysis.

Hepatic impairment: Severe: Double the interval between doses.

Reconstitution: Dilute to a concentration of ≤5 mg/ml.

Intravenous

Anaerobic bacterial infections

Adult: Initially, 0.5-1 g followed by 1 g daily as a single dose or in 2 divided doses for 5-10 days. Doses to be given via infusion. Substitute with 500 mg every 12 hr orally as soon as possible.

Child: 10 mg/kg every 12 hr for 5-10 days.

Renal impairment: Haemodialysis patients: Give a supplemental dose (50% of the usual dose) before dialysis.

Hepatic impairment: Severe: Double the interval between doses.

Reconstitution: Dilute to a concentration of ≤5 mg/ml.

Intravenous

Prophylaxis of postoperative anaerobic bacterial infections

Adult: 1 g by IV about 30 minutes before surgery.

Renal impairment: Haemodialysis patients: Give a supplemental dose (50% of the usual dose) before dialysis.

Hepatic impairment: Severe: Double the interval between doses.

Reconstitution: Dilute to a concentration of ≤5 mg/ml.

Uses of Ornidazole (Dermikem OC) 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.

Ornidazole (Dermikem OC) is used in the treatment of infections of vagina, urinary tract, intestine and other parts of the body caused by anaerobic bacteria (bacteria that do not use oxygen) or protozoa (amoeba or single-celled parasites). It is also used to prevent these infections during surgical procedures.

Ornidazole (Dermikem OC) description

Ornidazole (Dermikem OC) blocks the release of noradrenaline from the peripheral sympathetic nervous system, and is used in emergency medicine, cardiology, and other specialties for the acute management of ventricular tachycardia and ventricular fibrillation. The primary mode of action for bretylium is thought to be inhibition of voltage-gated K(+) channels. Recent evidence has shown that bretylium may also inhibit the Na,K-ATPase by binding to the extracellular K-site.

Ornidazole (Dermikem OC) dosage

Oral

Amoebiasis

Adult: 0.5 g bid for 5-10 days.

Child: 25 mg/kg as a single daily dose for 5-10 days.

Renal impairment: Haemodialysis patients: Give a supplemental dose (50% of the usual dose) before dialysis.

Hepatic impairment: Severe: Double the interval between doses.

Oral

Amoebic dysentery

Adult: 1.5 g as a single daily dose for 3 days. Alternatively for patients >60 kg: 1 g bid for 3 days.

Child: 40 mg/kg daily.

Renal impairment: Haemodialysis patients: Give a supplemental dose (50% of the usual dose) before dialysis.

Hepatic impairment: Severe: Double the interval between doses.

Oral

Giardiasis

Adult: 1-1.5 g as a single daily dose for 1-2 days.

Child: 30-40 mg/kg daily.

Renal impairment: Haemodialysis patients: Give a supplemental dose (50% of the usual dose) before dialysis.

Hepatic impairment: Severe: Double the interval between doses.

Oral

Trichomoniasis

Adult: 1.5 g as a single daily dose or 0.5 g bid for 5 days. Treat sexual partners concomitantly.

Child: 25 mg/kg as a single dose.

Renal impairment: Haemodialysis patients: Give a supplemental dose (50% of the usual dose) before dialysis.

Hepatic impairment: Severe: Double the interval between doses.

Intravenous

Severe amoebic dysentery; Amoebic liver abscess

Adult: Initially, 0.5-1 g infusion followed by 0.5 g every 12 hrs for 3-6 days.

Child: 20-30 mg/kg body wt daily.

Renal impairment: Haemodialysis patients: Give a supplemental dose (50% of the usual dose) before dialysis.

Hepatic impairment: Severe: Double the interval between doses.

Reconstitution: Dilute to a concentration of ≤5 mg/ml.

Intravenous

Anaerobic bacterial infections

Adult: Initially, 0.5-1 g followed by 1 g daily as a single dose or in 2 divided doses for 5-10 days. Doses to be given via infusion. Substitute with 500 mg every 12 hr orally as soon as possible.

Child: 10 mg/kg every 12 hr for 5-10 days.

Renal impairment: Haemodialysis patients: Give a supplemental dose (50% of the usual dose) before dialysis.

Hepatic impairment: Severe: Double the interval between doses.

Reconstitution: Dilute to a concentration of ≤5 mg/ml.

Intravenous

Prophylaxis of postoperative anaerobic bacterial infections

Adult: 1 g by IV about 30 minutes before surgery.

Renal impairment: Haemodialysis patients: Give a supplemental dose (50% of the usual dose) before dialysis.

Hepatic impairment: Severe: Double the interval between doses.

Reconstitution: Dilute to a concentration of ≤5 mg/ml.

Ornidazole (Dermikem OC) interactions

Digitalis toxicity may be aggravated by the initial release of norepinephrine caused by Ornidazole (Dermikem OC) Tosylate Injection.

The pressor effects of catecholamines such as dopamine or norepinephrine are enhanced by Ornidazole (Dermikem OC) Tosylate. When catecholamines are administered, dilute solutions should be used and blood pressure should be monitored closely.

Although there is little published information on concomitant administration of lidocaine and Ornidazole (Dermikem OC) Tosylate, these drugs are often administered concurrently without any evidence of interactions resulting in adverse effects or diminished efficacy.

Ornidazole (Dermikem OC) side effects

Somnolence, headache, nausea, vomiting, dizziness, tremor, rigidity, poor coordination, seizures, tiredness, vertigo, temporary loss of consciousness and signs of sensory or mixed peripheral neuropathy, taste disturbances, abnormal LFTs, skin reactions.

Ornidazole (Dermikem OC) contraindications

Hypersensitivity to Ornidazole (Dermikem OC) or to other nitroimidazole derivatives.

What is Terbinafine (Dermikem OC)?

Terbinafine (Dermikem OC) is used to treat infections caused by a fungus. It works by killing the fungus or preventing its growth.

Terbinafine (Dermikem OC) 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 (Dermikem OC) is available both over-the-counter (OTC) and with your doctor's prescription.

Terbinafine (Dermikem OC) 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.

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 (Dermikem OC) 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 (Dermikem OC) tablets may also be indicated in the treatment of tineal skin infections (Tinea corporis, Tinea cruris and Tinea pedis).

Note:

Oral Terbinafine (Dermikem OC) is not effective in Pityriasis versicolor.

How should I use Terbinafine (Dermikem OC)?

Use Terbinafine (Dermikem OC) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Terbinafine (Dermikem OC). Talk to your pharmacist if you have questions about this information.
  • Take Terbinafine (Dermikem OC) 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 (Dermikem OC) 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 (Dermikem OC), 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 (Dermikem OC).

Uses of Terbinafine (Dermikem OC) 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.

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 (Dermikem OC) is an antifungal that works by preventing the growth of fungus.

How to use Terbinafine (Dermikem OC) (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 (Dermikem OC) description

Each gram of gel and cream contains Terbinafine (Dermikem OC) base 10 mg and Terbinafine (Dermikem OC) hydrochloride 10 mg, respectively.

Terbinafine (Dermikem OC) 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 (Dermikem OC) 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.

Terbinafine (Dermikem OC) dosage

Terbinafine (Dermikem OC) Dosage

Generic name: Terbinafine (Dermikem OC) HYDROCHLORIDE 250mg

Dosage form: tablet

See also:

  • Terbinafine (Dermikem OC)

    Oral Granules oral granules

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 (Dermikem OC) 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 (Dermikem OC) (Terbinafine (Dermikem OC))

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Consumer resources

  • Terbinafine (Dermikem OC)
  • Terbinafine (Dermikem OC)

    Oral Granules

  • Terbinafine (Dermikem OC) (Advanced Reading)
  • Other brands: Terbinex

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Other formulations

  • Terbinafine (Dermikem OC) AT
  • Terbinafine (Dermikem OC) AT Cream for Jock Itch
  • Terbinafine (Dermikem OC) AT Cream
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Related treatment guides

  • Onychomycosis, Toenail
  • Cutaneous Candidiasis
  • Onychomycosis, Fingernail
  • Tinea Capitis
  • Tinea Corporis
  • More (2) »

Terbinafine (Dermikem OC) interactions

See also:
What other drugs will affect Terbinafine (Dermikem OC)?

Drug-Drug Interactions

In vivo studies have shown that Terbinafine (Dermikem OC) 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 (Dermikem OC) 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 (Dermikem OC) on desipramine in healthy volunteers characterized as normal metabolizers, the administration of Terbinafine (Dermikem OC) 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 (Dermikem OC) Tablets. In studies in healthy subjects characterized as extensive metabolizers of dextromethorphan (antitussive drug and CYP2D6 probe substrate), Terbinafine (Dermikem OC) increases the dextromethorphan/dextrorphan metabolite ratio in urine by 16- to 97-fold on average. Thus, Terbinafine (Dermikem OC) may convert extensive CYP2D6 metabolizers to poor metabolizer status.

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

The influence of Terbinafine (Dermikem OC) 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 (Dermikem OC) resulted in a 52% and 69% increase in Terbinafine (Dermikem OC) 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 (Dermikem OC) when concomitantly administered.

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

Terbinafine (Dermikem OC) clearance is increased 100% by rifampin, a CYP450 enzyme inducer, and decreased 33% by cimetidine, a CYP450 enzyme inhibitor. Terbinafine (Dermikem OC) 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 (Dermikem OC) Tablets was conducted. An increase of less than 20% of the AUC of Terbinafine (Dermikem OC) was observed when Terbinafine (Dermikem OC) Tablets were administered with food. Terbinafine (Dermikem OC) Tablets can be taken with or without food.

Terbinafine (Dermikem OC) side effects

See also:
What are the possible side effects of Terbinafine (Dermikem OC)?

Clinical Trials Experience

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 (Dermikem OC) 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 (Dermikem OC) Tablets (%)

n=465

Placebo (%)

n=137

Terbinafine (Dermikem OC) 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 (Dermikem OC) 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 (Dermikem OC) 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 (Dermikem OC) 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 (Dermikem OC) Tablets. Cases of paresthesia and hypoesthesia have been reported with the use of Terbinafine (Dermikem OC) 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, idiosyncratic and symptomatic hepatic injury. Cases of hepatitis, cholestasis, and increased hepatic enzymes have been seen with the use of Terbinafine (Dermikem OC) 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

Terbinafine (Dermikem OC) contraindications

See also:
What is the most important information I should know about Terbinafine (Dermikem OC)?

Before using Terbinafine (Dermikem OC), 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 (Dermikem OC) will not treat a viral infection such as the common cold or flu.

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

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 (Dermikem OC).



Active ingredient matches for Dermikem OC:

Clobetasol/Ofloxacin/Ornidazole/Terbinafine


List of Dermikem OC substitutes (brand and generic names)

Sort by popularity
Unit description / dosage (Manufacturer)Price, USD
AFDERM-MX cream 15g (Anglo French)$ 0.79
CLOBION-OT cream 15g (Bionics)
CLOBRIQ-OT cream 15g (Aprique)
Funzi MX 1% w/w Powder (Corona Remedies Pvt Ltd)$ 1.34
FUNZI-MX POWDER 1 box / 75 GM powder each (Corona (Xmex))$ 1.11
FUNZI-MX cream 15g (Corona (Xmex))$ 0.86
OBIOTIC OINTMENT oint 15g (BRD)$ 0.86
ONICE-CT cream 15g (Shinto Biotec)$ 1.03
PANDERM + POWDER 1 box / 100 GM powder each (Macleods Pharmaceuticals Pvt Ltd)$ 1.36
Terbofin-OC Cream (Torque Pharmaceuticals Pvt Ltd)$ 1.14
TERBONIK-OC cream 15g (Jainik)

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. PubChem. "clobetasol". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Dermikem OC are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Dermikem OC. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

User reports

3 consumers reported useful

Was the Dermikem OC drug useful in terms of decreasing the symptom or the disease?
According to the reports released by ndrugs.com website users, the below mentioned percentages of users say the drug is useful / not useful to them in decreasing their symptoms/disease. The usefulness of the drug depends on many factors, like severity of the disease, perception of symptom, or disease by the patient, brand name used [matters only to a certain extent], other associated conditions of the patient. If the drug is not effective or useful in your case, you need to meet the doctor to get re-evaluated about your symptoms/disease, and he will prescribe an alternative drug.
Users%
Not useful2
66.7%
Useful1
33.3%


Consumer reported price estimates

No survey data has been collected yet


1 consumer reported time for results

To what extent do I have to use Dermikem OC before I begin to see changes in my health conditions?
As part of the reports released by ndrugs.com website users, it takes 1 day and a few days before you notice an improvement in your health conditions.
Please note, it doesn't mean you will start to notice such health improvement in the same time frame as other users. There are many factors to consider, and we implore you to visit your doctor to know how long before you can see improvements in your health while taking Dermikem OC. To get the time effectiveness of using Dermikem OC drug by other patients, please click here.
Users%
1 day1
100.0%


8 consumers reported age

Users%
16-294
50.0%
30-452
25.0%
6-151
12.5%
< 11
12.5%


Consumer reviews


There are no reviews yet. Be the first to write one!


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Information checked by Dr. Sachin Kumar, MD Pharmacology

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