Consists of clobetasol, ofloxacin, ornidazole, terbinafine
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Clobion-OT Dosage |
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Consists of clobetasol, ofloxacin, ornidazole, terbinafine
Note: For proper dispensing of foam, hold the can upside down and depress the actuator.
Clobetasol (Clobion-OT) (clobetasol 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 (Clobion-OT) (clobetasol 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 (Clobion-OT) (clobetasol 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 (Clobion-OT) (clobetasol 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 (Clobion-OT) (clobetasol propionate) Foam should not be used with occlusive dressings.
Instructions for applying Clobetasol (Clobion-OT) (clobetasol propionate) Foam
Apply Clobetasol (Clobion-OT) (clobetasol propionate) Foam twice a day, once in the morning and once at night. Apply only enough to cover the affected areas. Clobetasol (Clobion-OT) (clobetasol propionate) Foam should not be applied to the groin, armpits, or other skin fold areas.
To use Clobetasol (Clobion-OT) (clobetasol propionate) Foam:
Before applying Clobetasol (Clobion-OT) (clobetasol 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 (Clobion-OT) (clobetasol 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 (Clobion-OT) (clobetasol 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 (Clobion-OT) (clobetasol 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 (Clobion-OT) (clobetasol propionate) Foam. Throw away any of the unused medicine that you squirted out of the can.
Clobetasol (Clobion-OT) (clobetasol 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 (Clobion-OT) (clobetasol propionate).com. VersaFoam-HF is a trademark, and the V logo, the interlocking C design, Clobetasol (Clobion-OT) (clobetasol propionate) and Connetics are registered trademarks, of Connetics Corporation. January 2006. FDA revision date: 7/11/2006
It is not likely that other drugs you take orally or inject will have an effect on topically applied clobetasol topical. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
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.
The usual dose of Ofloxacin (Clobion-OT)® (ofloxacin 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.
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.
The excretion of ofloxacin 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 per day should therefore not be exceeded.
Ofloxacin (Clobion-OT)® (ofloxacin 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 (Clobion-OT) (ofloxacin) ” and the appropriate strength. Ofloxacin (Clobion-OT)® (ofloxacin) 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 (Clobion-OT)® (ofloxacin) 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
Tell your doctor about all medicines you use, and those you start or stop using during your treatment with ofloxacin, especially:
theophylline;
a diuretic or "water pill";
heart rhythm medication--amiodarone, disopyramide, dofetilide, dronedarone, procainamide, quinidine, sotalol, and others;
medicine to treat depression or mental illness--amitriptylline, clomipramine, clozapine, desipramine, duloxetine, iloperidone, imipramine, nortriptyline, ziprasidone, and others; or
NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.
This list is not complete. Other drugs may interact with ofloxacin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Drugs Known to Prolong QT Interval: Ofloxacin, 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 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 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 should be discontinued.
Ofloxacin 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 and cimetidine has not been reported.
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): The concomitant administration of a NSAID with a quinolone, including ofloxacin, 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 has not been reported.
Theophylline: Steady-state theophylline levels may increase when ofloxacin and theophylline are administered concurrently. As with other quinolones, concomitant administration of ofloxacin 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 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 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, 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.
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.
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.
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.
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.
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.
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.
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.
Digitalis toxicity may be aggravated by the initial release of norepinephrine caused by Ornidazole (Clobion-OT) Tosylate Injection.
The pressor effects of catecholamines such as dopamine or norepinephrine are enhanced by Ornidazole (Clobion-OT) 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 (Clobion-OT) Tosylate, these drugs are often administered concurrently without any evidence of interactions resulting in adverse effects or diminished efficacy.
Applies to the following strength(s): 250 mg; 125 mg; 187.5 mg
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Tablets: 250 mg orally once a day for 6 weeks
Comments:
-Optimal clinical effect observed some months after mycological cure and end of therapy; related to time required for outgrowth of healthy nail.
Approved
Indication: Treatment of onychomycosis of the fingernail due to dermatophytes (tinea unguium)
Tablets: 250 mg orally once a day for 12 weeks
Comments:
-Optimal clinical effect observed some months after mycological cure and end of therapy; related to time required for outgrowth of healthy nail.
Approved
Indication: Treatment of onychomycosis of the toenail due to dermatophytes (tinea unguium)
Oral granules: 250 mg orally once a day for 6 weeks
Comments:
-Some evidence suggests that a longer duration of therapy (e.g., 6 to 8 weeks) or higher dosage may be necessary when tinea capitis is caused by Microsporum canis.
(Not approved by FDA)
Tablets: 250 mg orally once a day for 2 to 4 weeks
(Not approved by FDA)
Tablets: 250 mg orally once a day for 2 to 4 weeks
(Not approved by FDA)
Tablets: 250 mg orally once a day for 2 to 4 weeks
(Not approved by FDA)
Tablets: 250 mg orally once a day for 2 to 6 weeks
Oral granules
:
4 years or older:
Less than 25 kg: 125 mg orally once a day
25 to 35 kg: 187.5 mg orally once a day
Greater than 35 kg: 250 mg orally once a day
Duration of therapy: 6 weeks
Comments:
-Some evidence suggests that a longer duration of therapy (e.g., 6 to 8 weeks) or higher dosage may be necessary when tinea capitis is caused by Microsporum canis.
CrCl 50 mL/min or less: Data not available
Chronic or active liver disease: Not recommended.
Consult WARNINGS section for dosing related precautions.
Data not available
Administration advice:
-Oral granules: Take with food. Sprinkle the contents of each packet on a spoonful of pudding or other soft, nonacidic food (e.g., mashed potatoes) and swallow the entire spoonful without chewing; do not use applesauce or fruit-based foods.
General:
-Before starting therapy with Terbinafine (Clobion-OT) tablets, appropriate nail specimens for laboratory testing (potassium hydroxide preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis of onychomycosis.
-Clinical resolution may not be observed until several weeks after mycological cure.
Monitoring:
-Hematologic: Complete blood counts in patients with immunodeficiency (known or suspected) using Terbinafine (Clobion-OT) for more than 6 weeks or if clinical signs/symptoms suggestive of secondary infection develop
-Hepatic: Serum transaminases (ALT and AST) in all patients before starting therapy
-Psychiatric: Depressive symptoms
Patient advice:
-Minimize exposure to natural and artificial sunlight (tanning beds or UVA/B treatment) during therapy.
Before taking Terbinafine (Clobion-OT), tell your doctor if you are taking any of the following medicines:
This list is not complete and other drugs may interact with Terbinafine (Clobion-OT). Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
In vivo studies have shown that Terbinafine (Clobion-OT) 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 (Clobion-OT) 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 (Clobion-OT) on desipramine in healthy volunteers characterized as normal metabolizers, the administration of Terbinafine (Clobion-OT) 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 (Clobion-OT) Tablets. In studies in healthy subjects characterized as extensive metabolizers of dextromethorphan (antitussive drug and CYP2D6 probe substrate), Terbinafine (Clobion-OT) increases the dextromethorphan/dextrorphan metabolite ratio in urine by 16- to 97-fold on average. Thus, Terbinafine (Clobion-OT) may convert extensive CYP2D6 metabolizers to poor metabolizer status.
In vitro studies with human liver microsomes showed that Terbinafine (Clobion-OT) 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 (Clobion-OT) does not affect the clearance of antipyrine or digoxin. Terbinafine (Clobion-OT) decreases the clearance of caffeine by 19%. Terbinafine (Clobion-OT) increases the clearance of cyclosporine by 15%.
The influence of Terbinafine (Clobion-OT) 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 (Clobion-OT) resulted in a 52% and 69% increase in Terbinafine (Clobion-OT) 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 (Clobion-OT) when concomitantly administered.
There have been spontaneous reports of increase or decrease in prothrombin times in patients concomitantly taking oral Terbinafine (Clobion-OT) and warfarin, however, a causal relationship between Terbinafine (Clobion-OT) Tablets and these changes has not been established.
Terbinafine (Clobion-OT) clearance is increased 100% by rifampin, a CYP450 enzyme inducer, and decreased 33% by cimetidine, a CYP450 enzyme inhibitor. Terbinafine (Clobion-OT) 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.
An evaluation of the effect of food on Terbinafine (Clobion-OT) Tablets was conducted. An increase of less than 20% of the AUC of Terbinafine (Clobion-OT) was observed when Terbinafine (Clobion-OT) Tablets were administered with food. Terbinafine (Clobion-OT) Tablets can be taken with or without food.
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Information checked by Dr. Sachin Kumar, MD Pharmacology
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