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sulconazole nitrate

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Overview

What is Exelderm?

EXELDERM (sulconazole nitrate, USP) SOLUTION, 1.0% is a broad-spectrum antifungal agent intended for topical application. Sulconazole nitrate, USP, the active ingredient in EXELDERM SOLUTION, is an imidazole derivative with antifungal and antiyeast activity. Its chemical name is (±)-1-[2,4-Dichloro-β-[( -chlorobenzyl)thio]phenethyl] imidazole mononitrate and it has the following chemical structure:

Sulconazole nitrate, USP is a white to off-white crystalline powder with a molecular weight of 460.77. It is freely soluble in pyridine; slightly soluble in ethanol, acetone, and chloroform; and very slightly soluble in water. It has a melting point of about 130°C.

EXELDERM SOLUTION contains sulconazole nitrate, USP 10 mg/mL in a solution of propylene glycol, poloxamer 407, polysorbate 20, butylated hydroxyanisole, and purified water, with sodium hydroxide and, if necessary, nitric acid added to adjust the pH.



What does Exelderm look like?



What are the available doses of Exelderm?

Sorry No records found.

What should I talk to my health care provider before I take Exelderm?

Sorry No records found

How should I use Exelderm?

EXELDERM (sulconazole nitrate, USP) SOLUTION, 1.0% is a broad-spectrum antifungal agent indicated for the treatment of tinea cruris and tinea corporis caused by , , , and ; and for the treatment of tinea versicolor. Effectiveness has not been proven in tinea pedis (athlete’s foot).

Symptomatic relief usually occurs within a few days after starting EXELDERM SOLUTION and clinical improvement usually occurs within one week.

A small amount of the solution should be gently massaged into the affected and surrounding skin areas once or twice daily.

Symptomatic relief usually occurs within a few days after starting EXELDERM (sulconazole nitrate, USP) SOLUTION, 1.0%, and clinical improvement usually occurs within one week. To reduce the possibility of recurrence, tinea cruris, tinea corporis, and tinea versicolor should be treated for 3 weeks.

If significant clinical improvement is not seen after 4 weeks of treatment, an alternate diagnosis should be considered.


What interacts with Exelderm?

EXELDERM (sulconazole nitrate, USP) SOLUTION, 1.0% is contraindicated in patients who have a history of hypersensitivity to any of the ingredients.



What are the warnings of Exelderm?

Sorry No Records found


What are the precautions of Exelderm?

General

EXELDERM (sulconazole nitrate, USP) SOLUTION, 1.0% is for external use only. Avoid contact with the eyes. If irritation develops, the solution should be discontinued and appropriate therapy instituted.

Information for Patients

Patients should be told to use EXELDERM SOLUTION as directed by the physician, to use it externally only, and to avoid contact with the eyes.

Carcinogenesis, Mutagenesis and Impairment of Fertility

Long-term animal studies to determine carcinogenic potential have not been performed. studies have shown no mutagenic activity.

Pregnancy

Sulconazole nitrate has been shown to be embryotoxic in rats when given in doses 125 times the human dose (in mg/kg). The drug at this dose given orally to rats also resulted in prolonged gestation and dystocia. Several females died during the perinatal period, most likely due to labor complications. Sulconazole nitrate was not teratogenic in rats or rabbits at oral doses of 50 mg/kg/day.

There are no adequate and well-controlled studies in pregnant women. Sulconazole nitrate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when sulconazole nitrate is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in children have not been established.

Geriatric Use

Clinical studies of EXELDERM SOLUTION, 1.0%, did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently than younger patients. Other reported clinical experience has not identified differences in responses between elderly and younger patients.


What are the side effects of Exelderm?

There were no systemic effects and only infrequent cutaneous adverse reactions in 370 patients treated with sulconazole nitrate solution in controlled clinical trials. Approximately 1% of these patients reported itching and 1% burning or stinging. These complaints did not usually interfere with treatment.


What should I look out for while using Exelderm?

EXELDERM (sulconazole nitrate, USP) SOLUTION, 1.0% is contraindicated in patients who have a history of hypersensitivity to any of the ingredients.


What might happen if I take too much Exelderm?

Sorry No Records found


How should I store and handle Exelderm?

Store at 20° to 25°C (68° to 77°F).[See USP Controlled Room Temperature]Dispense in a tight container as defined in the USP.Store at 20° to 25°C (68° to 77°F).[See USP Controlled Room Temperature]Dispense in a tight container as defined in the USP.Store at 20° to 25°C (68° to 77°F).[See USP Controlled Room Temperature]Dispense in a tight container as defined in the USP.EXELDERM (sulconazole nitrate, USP) SOLUTION, 1.0% is a clear, slightly viscous, colorless to slightly yellow liquid with a slight characteristic odor. It is supplied as follows:30 mL        Plastic Bottle         NDC 10631-100-302 x 30 mL       Plastic Bottle         NDC 10631-100-04Avoid excessive heat, above 40°C (104°F), and protect from light.To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or .Manufactured by:DPT Laboratories Inc.San Antonio, TX 78215Distributed by:Sun Pharmaceutical Industries, Inc.Cranbury, NJ 08512EXELDERM (sulconazole nitrate, USP) SOLUTION, 1.0% is a clear, slightly viscous, colorless to slightly yellow liquid with a slight characteristic odor. It is supplied as follows:30 mL        Plastic Bottle         NDC 10631-100-302 x 30 mL       Plastic Bottle         NDC 10631-100-04Avoid excessive heat, above 40°C (104°F), and protect from light.To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or .Manufactured by:DPT Laboratories Inc.San Antonio, TX 78215Distributed by:Sun Pharmaceutical Industries, Inc.Cranbury, NJ 08512EXELDERM (sulconazole nitrate, USP) SOLUTION, 1.0% is a clear, slightly viscous, colorless to slightly yellow liquid with a slight characteristic odor. It is supplied as follows:30 mL        Plastic Bottle         NDC 10631-100-302 x 30 mL       Plastic Bottle         NDC 10631-100-04Avoid excessive heat, above 40°C (104°F), and protect from light.To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or .Manufactured by:DPT Laboratories Inc.San Antonio, TX 78215Distributed by:Sun Pharmaceutical Industries, Inc.Cranbury, NJ 08512EXELDERM (sulconazole nitrate, USP) SOLUTION, 1.0% is a clear, slightly viscous, colorless to slightly yellow liquid with a slight characteristic odor. It is supplied as follows:30 mL        Plastic Bottle         NDC 10631-100-302 x 30 mL       Plastic Bottle         NDC 10631-100-04Avoid excessive heat, above 40°C (104°F), and protect from light.To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or .Manufactured by:DPT Laboratories Inc.San Antonio, TX 78215Distributed by:Sun Pharmaceutical Industries, Inc.Cranbury, NJ 08512EXELDERM (sulconazole nitrate, USP) SOLUTION, 1.0% is a clear, slightly viscous, colorless to slightly yellow liquid with a slight characteristic odor. It is supplied as follows:30 mL        Plastic Bottle         NDC 10631-100-302 x 30 mL       Plastic Bottle         NDC 10631-100-04Avoid excessive heat, above 40°C (104°F), and protect from light.To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or .Manufactured by:DPT Laboratories Inc.San Antonio, TX 78215Distributed by:Sun Pharmaceutical Industries, Inc.Cranbury, NJ 08512EXELDERM (sulconazole nitrate, USP) SOLUTION, 1.0% is a clear, slightly viscous, colorless to slightly yellow liquid with a slight characteristic odor. It is supplied as follows:30 mL        Plastic Bottle         NDC 10631-100-302 x 30 mL       Plastic Bottle         NDC 10631-100-04Avoid excessive heat, above 40°C (104°F), and protect from light.To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or .Manufactured by:DPT Laboratories Inc.San Antonio, TX 78215Distributed by:Sun Pharmaceutical Industries, Inc.Cranbury, NJ 08512EXELDERM (sulconazole nitrate, USP) SOLUTION, 1.0% is a clear, slightly viscous, colorless to slightly yellow liquid with a slight characteristic odor. It is supplied as follows:30 mL        Plastic Bottle         NDC 10631-100-302 x 30 mL       Plastic Bottle         NDC 10631-100-04Avoid excessive heat, above 40°C (104°F), and protect from light.To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or .Manufactured by:DPT Laboratories Inc.San Antonio, TX 78215Distributed by:Sun Pharmaceutical Industries, Inc.Cranbury, NJ 08512EXELDERM (sulconazole nitrate, USP) SOLUTION, 1.0% is a clear, slightly viscous, colorless to slightly yellow liquid with a slight characteristic odor. It is supplied as follows:30 mL        Plastic Bottle         NDC 10631-100-302 x 30 mL       Plastic Bottle         NDC 10631-100-04Avoid excessive heat, above 40°C (104°F), and protect from light.To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or .Manufactured by:DPT Laboratories Inc.San Antonio, TX 78215Distributed by:Sun Pharmaceutical Industries, Inc.Cranbury, NJ 08512EXELDERM (sulconazole nitrate, USP) SOLUTION, 1.0% is a clear, slightly viscous, colorless to slightly yellow liquid with a slight characteristic odor. It is supplied as follows:30 mL        Plastic Bottle         NDC 10631-100-302 x 30 mL       Plastic Bottle         NDC 10631-100-04Avoid excessive heat, above 40°C (104°F), and protect from light.To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or .Manufactured by:DPT Laboratories Inc.San Antonio, TX 78215Distributed by:Sun Pharmaceutical Industries, Inc.Cranbury, NJ 08512EXELDERM (sulconazole nitrate, USP) SOLUTION, 1.0% is a clear, slightly viscous, colorless to slightly yellow liquid with a slight characteristic odor. It is supplied as follows:30 mL        Plastic Bottle         NDC 10631-100-302 x 30 mL       Plastic Bottle         NDC 10631-100-04Avoid excessive heat, above 40°C (104°F), and protect from light.To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or .Manufactured by:DPT Laboratories Inc.San Antonio, TX 78215Distributed by:Sun Pharmaceutical Industries, Inc.Cranbury, NJ 08512EXELDERM (sulconazole nitrate, USP) SOLUTION, 1.0% is a clear, slightly viscous, colorless to slightly yellow liquid with a slight characteristic odor. It is supplied as follows:30 mL        Plastic Bottle         NDC 10631-100-302 x 30 mL       Plastic Bottle         NDC 10631-100-04Avoid excessive heat, above 40°C (104°F), and protect from light.To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or .Manufactured by:DPT Laboratories Inc.San Antonio, TX 78215Distributed by:Sun Pharmaceutical Industries, Inc.Cranbury, NJ 08512


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Sulconazole nitrate is an imidazole derivative that inhibits the growth of the common pathogenic dermatophytes including , , , and . It also inhibits the organism responsible for tinea versicolor, , and certain gram positive bacteria.

A maximization test with sulconazole nitrate solution showed no evidence of irritation or contact sensitization.

Non-Clinical Toxicology
EXELDERM (sulconazole nitrate, USP) SOLUTION, 1.0% is contraindicated in patients who have a history of hypersensitivity to any of the ingredients.

There is evidence that the anticonvulsant action of phenytoin is antagonized by folic acid. A patient whose epilepsy is completely controlled by phenytoin may require increased doses to prevent convulsions if folic acid is given.

Folate deficiency may result from increased loss of folate, as in renal dialysis and/or interference with metabolism (e.g., folic acid antagonists such as methotrexate); the administration of anticonvulsants, such as diphenylhydantoin, primidone, and barbiturates; alcohol consumption and, especially, alcoholic cirrhosis; and the administration of pyrimethamine and nitrofurantoin.

False low serum and red cell folate levels may occur if the patient has been taking antibiotics, such as tetracycline, which suppress the growth of

EXELDERM (sulconazole nitrate, USP) SOLUTION, 1.0% is for external use only. Avoid contact with the eyes. If irritation develops, the solution should be discontinued and appropriate therapy instituted.

There were no systemic effects and only infrequent cutaneous adverse reactions in 370 patients treated with sulconazole nitrate solution in controlled clinical trials. Approximately 1% of these patients reported itching and 1% burning or stinging. These complaints did not usually interfere with treatment.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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