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Overview
What is Clotrimazole and Betamethasone Dipropionate?
Clotrimazole and betamethasone dipropionate cream USP, 1%/0.05% (base), contains combinations of clotrimazole USP, an azole antifungal, and betamethasone dipropionate USP, a corticosteroid, for topical use.
Chemically, clotrimazole USP is 1-[(2-Chlorophenyl)diphenylmethyl]-1H-imidazole, with the empirical formula C
H
ClN
, a molecular weight of 344.84, and the following structural formula:
Clotrimazole USP is a white to pale yellow, crystalline powder, odorless, practically insoluble in water, freely soluble in methanol, in acetone, in chloroform, and in alcohol.
Betamethasone dipropionate USP has the chemical name 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C
H
FO
, a molecular weight of 504.59, and the following structural formula:
Betamethasone dipropionate USP is a white to almost white crystalline powder, practically insoluble in water, freely soluble in acetone and in methylene chloride, sparingly soluble in alcohol.
Each gram of clotrimazole and betamethasone dipropionate cream USP, 1%/0.05% (base) contains 10 mg of clotrimazole USP and 0.643 mg of betamethasone dipropionate USP (equivalent to 0.5 mg of betamethasone), in a white to off-white, hydrophilic cream consisting of benzyl alcohol, cetyl alcohol plus stearyl alcohol, ceteareth-30, mineral oil, monobasic sodium phosphate monohydrate, phosphoric acid, propylene glycol, sodium hydroxide, white petrolatum and purified water.
What does Clotrimazole and Betamethasone Dipropionate look like?
What are the available doses of Clotrimazole and Betamethasone Dipropionate?
Cream, 1%/0.05% (
)
Each gram of clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) contains 10 mg of clotrimazole and 0.643 mg betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) (
)
What should I talk to my health care provider before I take Clotrimazole and Betamethasone Dipropionate?
How should I use Clotrimazole and Betamethasone Dipropionate?
Clotrimazole and betamethasone dipropionate cream USP is a combination of an azole antifungal and corticosteroid and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to
and
in patients 17 years and older.
Treatment of tinea corporis or tinea cruris:
Treatment of tinea pedis:
Clotrimazole and betamethasone dipropionate cream is for topical use only. It is not for oral, ophthalmic, or intravaginal use.
What interacts with Clotrimazole and Betamethasone Dipropionate?
Sorry No Records found
What are the warnings of Clotrimazole and Betamethasone Dipropionate?
Sorry No Records found
What are the precautions of Clotrimazole and Betamethasone Dipropionate?
Sorry No Records found
What are the side effects of Clotrimazole and Betamethasone Dipropionate?
Sorry No records found
What should I look out for while using Clotrimazole and Betamethasone Dipropionate?
None.
What might happen if I take too much Clotrimazole and Betamethasone Dipropionate?
Sorry No Records found
How should I store and handle Clotrimazole and Betamethasone Dipropionate?
Unopened vials of gemcitabine for injection, USP are stable until the expiration date indicated on the package when stored at controlled room temperature 20° to 25°C (68° to 77°F) and that allows for excursions between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature] [].Clotrimazole and betamethasone dipropionate cream USP, 1%/0.05% (base) is supplied as:NDC 68071-4401-5 BOX OF 15gStore at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Rx onlyClotrimazole and betamethasone dipropionate cream USP, 1%/0.05% (base) is supplied as:NDC 68071-4401-5 BOX OF 15gStore at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Rx onlyClotrimazole and betamethasone dipropionate cream USP, 1%/0.05% (base) is supplied as:NDC 68071-4401-5 BOX OF 15gStore at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Rx onlyClotrimazole and betamethasone dipropionate cream USP, 1%/0.05% (base) is supplied as:NDC 68071-4401-5 BOX OF 15gStore at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Rx only
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Clinical Information
Chemical Structure
No Image found
Clinical Pharmacology
Clotrimazole is an azole antifungal
Betamethasone dipropionate is a corticosteroid. Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action for the treatment of tinea pedis, tinea cruris and tinea corporis is unknown.
Non-Clinical Toxicology
None.
Inhibitors of CYP2D6
The concomitant use of tramadol and CYP2D6 inhibitors, such as quinidine, fluoxetine, paroxetine and bupropion, may result in an increase in the plasma concentration of tramadol and a decrease in the plasma concentration of M1, particularly when an inhibitor is added after a stable dose of tramadol is achieved. Since M1 is a more potent µ-opioid agonist, decreased M1 exposure could result in decreased therapeutic effects, and may result in signs and symptoms of opioid withdrawal in patients who had developed physical dependence to tramadol. Increased tramadol exposure can result in increased or prolonged therapeutic effects and increased risk for serious adverse events including seizures and serotonin syndrome.
After stopping a CYP2D6 inhibitor, as the effects of the inhibitor decline, the tramadol plasma concentration will decrease and the M1 plasma concentration will increase which could increase or prolong therapeutic effects but also increase adverse reactions related to opioid toxicity, and may cause potentially fatal respiratory depression (see
)
If concomitant use of a CYP2D6 inhibitor is necessary, follow patients closely for adverse reactions including opioid withdrawal, seizures, and serotonin syndrome.
If a CYP2D6 inhibitor is discontinued, consider lowering tramadol dosage until stable drug effects are achieved. Follow patients closely for adverse events including respiratory depression and sedation.
Use With Quinidine
Quinidine is a selective inhibitor of CYP2D6, so that concomitant administration of quinidine and tramadol results in increased concentrations of tramadol and reduced
concentrations of M1. The clinical consequences of these findings are unknown.
Inhibitors of CYP3A4
The concomitant use of tramadol and CYP3A4 inhibitors, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. ketoconazole), protease inhibitors (e.g., ritonavir), can increase the plasma concentration of tramadol, and may result in a greater amount of metabolism via CYP2D6 and greater levels of M1. Follow patients closely for increased risk of serious adverse events including seizures and serotonin syndrome, and adverse reactions related to opioid toxicity including potentially fatal respiratory depression, particularly when a CYP3A4 inhibitor is added after a stable dose of tramadol is achieved.
After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the tramadol plasma concentration will decrease (see
), resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to tramadol.
If concomitant use is necessary, consider dosage reduction of tramadol until stable drug effects are achieved. Follow patients closely for seizures and serotonin syndrome, and signs of respiratory depression and sedation at frequent intervals. If a CYP3A4 inhibitor is discontinued, consider increasing the tramadol dosage until stable drug effects are achieved and follow patients for signs and symptoms of opioid withdrawal.
CYP3A4 Inducers
The concomitant use of tramadol and CYP3A4 inducers, such as rifampin, carbamazepine and phenytoin, can decrease the plasma concentration of tramadol resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to tramadol (see
).
After stopping a CYP3A4 inducer, as the effects of the inducer decline, the tramadol plasma concentration will increase, which could increase or prolong both the therapeutic effects and adverse reactions, and may cause seizures and serotonin syndrome, and potentially fatal respiratory depression.
Use With Carbamazepine
Patients taking carbamazepine, a CYP3A4 inducer, may have a significantly reduced analgesic effect of tramadol. Because carbamazepine increases tramadol metabolism and because of the seizure risk associated with tramadol, concomitant administration of tramadol and carbamazepine is not recommended.
Benzodiazepines and Other Central Nervous System (CNS) Depressants
Due to additive pharmacologic effects, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, increases the risk of respiratory depression, profound sedation, coma, and death. Examples of other CNS depressants include other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, and some illicit drugs.
Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit the treatment to the minimum effective dosages and durations. Follow patients closely for signs of respiratory depression and sedation (see
).
Serotonergic Drugs
The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. Examples of these drugs include, selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that effect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone), monoamine oxidase (MAO) inhibitors (used to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).
If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue tramadol immediately if serotonin syndrome is suspected.
Monoamine Oxidase Inhibitors (MAOIs)
Do not use tramadol in patients taking MAOIs or within 14 days of stopping such treatment.
MAOI interactions with opioids may manifest as serotonin syndrome (see
) or opioid toxicity (e.g., respiratory depression, coma) (see
). Examples of these drugs include, phenelzine, tranylcypromine, linezolid.
Digoxin
Post-marketing surveillance has revealed rare reports of digoxin toxicity. Follow patients for signs of digoxin toxicity and adjust dosage of digoxin as needed.
Warfarin
Post-marketing surveillance of tramadol has revealed rare reports of alteration of warfarin effect, including elevation of prothrombin times. Monitor the prothrombin time of patients on warfarin for signs of an interaction and adjust the dosage of warfarin as needed.
Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics
Mixed agonist/antagonist and partial agonist opioid analgesics may reduce the analgesic effect of tramadol and/or precipitate withdrawal symptoms. Examples of these drugs include butorphanol, nalbuphine, pentazocine and buprenorphine. Avoid concomitant use of these drugs.
Muscle Relaxants
Tramadol may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression. Monitor patients for signs of respiratory depression that may be greater than otherwise expected and decrease the dosage of tramadol and/or the muscle relaxant as necessary.
Diuretics
Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone. Monitor patients for signs of diminished diuresis and/or effects on blood pressure and increase the dosage of the diuretic as needed.
Anticholinergic Drugs
The concomitant use of anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus. Monitor patients for signs of urinary retention or reduced gastric motility when tramadol is used concomitantly with anticholinergic drugs.
Clotrimazole and betamethasone dipropionate cream can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. Cushing’s syndrome and hyperglycemia may also occur due to the systemic effect of corticosteroids while on treatment. Factors that predispose a patient to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressing, altered skin barrier, liver failure, and young age.
Because of the potential for systemic corticosteroid effects, patients may need to be periodically evaluated for HPA axis suppression. This may be done by using the adrenocorticotropic hormone (ACTH) stimulation test.
In a small trial, clotrimazole and betamethasone dipropionate cream was applied using large dosages, 7 g daily for 14 days (BID) to the crural area of normal adult subjects. Three of the 8 normal subjects on whom clotrimazole and betamethasone dipropionate cream was applied exhibited low morning plasma cortisol levels during treatment. One of these subjects had an abnormal cosyntropin test. The effect on morning plasma cortisol was transient and subjects recovered 1 week after discontinuing dosing. In addition, 2 separate trials in pediatric subjects demonstrated adrenal suppression as determined by cosyntropin testing
If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid.
Pediatric patients may be more susceptible to systemic toxicity due to their larger skin-surface-to-body mass ratios
