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ERTACZO

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Overview

What is ERTACZO?

ERTACZO (sertaconazole nitrate) Cream, 2%, contains the imidazole antifungal, sertaconazole nitrate. Sertaconazole nitrate contains one asymmetric carbon atom and exists as a racemic mixture of equal amounts of R and S enantiomers.

Sertaconazole nitrate is designated chemically as (±)-1-[2,4-dichloro-β-[(7-chlorobenzo-[]thien-3-yl)methoxy]phenethyl]imidazole nitrate. It has a molecular weight of 500.8. The molecular formula is CHClNOS • HNO, and the structural formula is as follows:

Sertaconazole nitrate is a white or almost white powder. It is practically insoluble in water, soluble in methanol, sparingly soluble in alcohol and in methylene chloride. Each gram of ERTACZO Cream, 2%, contains 17.5 mg of sertaconazole (as sertaconazole nitrate, 20 mg) in a white cream base of ethylene glycol and polyethylene glycol palmitostearate, glyceryl isostearate, light mineral oil, methylparaben, polyoxyethylened saturated glycerides and glycolized saturated glycerides, sorbic acid and purified water.



What does ERTACZO look like?



What are the available doses of ERTACZO?

Sorry No records found.

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

Sorry No records found

How should I use ERTACZO?

ERTACZO (sertaconazole nitrate) Cream, 2%, is indicated for the topical treatment of interdigital tinea pedis in immunocompetent patients 12 years of age and older, caused by: (see Section).

In the treatment of interdigital tinea pedis, ERTACZO Cream, 2%, should be applied twice daily for 4 weeks. Sufficient ERTACZO Cream, 2%, should be applied to cover both the affected areas between the toes and the immediately surrounding healthy skin of patients with interdigital tinea pedis. If a patient shows no clinical improvement 2 weeks after the treatment period, the diagnosis should be reviewed.


What interacts with ERTACZO?

ERTACZO Cream, 2%, is contraindicated in patients who have a known or suspected sensitivity to sertaconazole nitrate or any of its components or to other imidazoles.



What are the warnings of ERTACZO?

Extract should be temporarily withheld or dosage reduced in case of any of the following conditions: 1) flu or other infection with fever; 2) exposure to excessive amounts of allergen prior to injection; 3) rhinitis and/or asthma exhibiting severe symptoms; 4) adverse reaction to previous injection until cause of reaction has been evaluated by physician supervising patient’s immunotherapy program.


What are the precautions of ERTACZO?

General:

Diagnosis of the disease should be confirmed either by direct microscopic examination of infected superficial epidermal tissue in a solution of potassium hydroxide or by culture on an appropriate medium.

Physicians should exercise caution when prescribing ERTACZO Cream, 2%, to patients known to be sensitive to imidazole antifungals, since cross-reactivity may occur.













              Information for Patients:

              Drug/Laboratory Test Interactions:

              Carcinogenesis, Mutagenesis, Impairment of Fertility:

              in vivo

              Pregnancy: Teratogenic Effects. Pregnancy Category C:

              There are no adequate and well-controlled studies that have been conducted on topically applied ERTACZO Cream, 2%, in pregnant women. Because animal reproduction studies are not always predictive of human response, ERTACZO Cream, 2%, should be used during pregnancy only if clearly needed.

              Nursing Mothers:

              Pediatric Use:

              Geriatric Use:


              What are the side effects of ERTACZO?

              Sorry No records found


              What should I look out for while using ERTACZO?

              ERTACZO Cream, 2%, is contraindicated in patients who have a known or suspected sensitivity to sertaconazole nitrate or any of its components or to other imidazoles.

              ERTACZO Cream, 2%, is not indicated for ophthalmic, oral or intravaginal use.


              What might happen if I take too much ERTACZO?

              Overdosage with ERTACZO Cream, 2%, has not been reported to date. ERTACZO Cream, 2%, is intended for topical dermatologic use only. It is not for oral, ophthalmic, or intravaginal use.


              How should I store and handle ERTACZO?

              Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP] .ERTACZO Cream, 2%, is supplied in tubes in the following size:Store at 25°C (77°F); excursions permitted to 15º-30°C (59º-86°F) [see USP Controlled Room Temperature].Rx only.Patent No. 5,135,943Distributed By: OrthoNeutrogenaDIVISION OF ORTHO-McNEIL PHARMACEUTICAL, INC.Los Angeles, CA 90045Repackaged By: Rebel DistributorsThousand Oaks, CA 91320Rev November 2005 128354ERTACZO Cream, 2%, is supplied in tubes in the following size:Store at 25°C (77°F); excursions permitted to 15º-30°C (59º-86°F) [see USP Controlled Room Temperature].Rx only.Patent No. 5,135,943Distributed By: OrthoNeutrogenaDIVISION OF ORTHO-McNEIL PHARMACEUTICAL, INC.Los Angeles, CA 90045Repackaged By: Rebel DistributorsThousand Oaks, CA 91320Rev November 2005 128354ERTACZO Cream, 2%, is supplied in tubes in the following size:Store at 25°C (77°F); excursions permitted to 15º-30°C (59º-86°F) [see USP Controlled Room Temperature].Rx only.Patent No. 5,135,943Distributed By: OrthoNeutrogenaDIVISION OF ORTHO-McNEIL PHARMACEUTICAL, INC.Los Angeles, CA 90045Repackaged By: Rebel DistributorsThousand Oaks, CA 91320Rev November 2005 128354ERTACZO Cream, 2%, is supplied in tubes in the following size:Store at 25°C (77°F); excursions permitted to 15º-30°C (59º-86°F) [see USP Controlled Room Temperature].Rx only.Patent No. 5,135,943Distributed By: OrthoNeutrogenaDIVISION OF ORTHO-McNEIL PHARMACEUTICAL, INC.Los Angeles, CA 90045Repackaged By: Rebel DistributorsThousand Oaks, CA 91320Rev November 2005 128354ERTACZO Cream, 2%, is supplied in tubes in the following size:Store at 25°C (77°F); excursions permitted to 15º-30°C (59º-86°F) [see USP Controlled Room Temperature].Rx only.Patent No. 5,135,943Distributed By: OrthoNeutrogenaDIVISION OF ORTHO-McNEIL PHARMACEUTICAL, INC.Los Angeles, CA 90045Repackaged By: Rebel DistributorsThousand Oaks, CA 91320Rev November 2005 128354ERTACZO Cream, 2%, is supplied in tubes in the following size:Store at 25°C (77°F); excursions permitted to 15º-30°C (59º-86°F) [see USP Controlled Room Temperature].Rx only.Patent No. 5,135,943Distributed By: OrthoNeutrogenaDIVISION OF ORTHO-McNEIL PHARMACEUTICAL, INC.Los Angeles, CA 90045Repackaged By: Rebel DistributorsThousand Oaks, CA 91320Rev November 2005 128354ERTACZO Cream, 2%, is supplied in tubes in the following size:Store at 25°C (77°F); excursions permitted to 15º-30°C (59º-86°F) [see USP Controlled Room Temperature].Rx only.Patent No. 5,135,943Distributed By: OrthoNeutrogenaDIVISION OF ORTHO-McNEIL PHARMACEUTICAL, INC.Los Angeles, CA 90045Repackaged By: Rebel DistributorsThousand Oaks, CA 91320Rev November 2005 128354


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              Clinical Information

              Chemical Structure

              No Image found
              Clinical Pharmacology

              Pharmacokinetics:

              2

              2

              ®

              2

              Non-Clinical Toxicology
              ERTACZO Cream, 2%, is contraindicated in patients who have a known or suspected sensitivity to sertaconazole nitrate or any of its components or to other imidazoles.

              ERTACZO Cream, 2%, is not indicated for ophthalmic, oral or intravaginal use.

              In vitro

              Gabapentin is not appreciably metabolized nor does it interfere with the metabolism of commonly coadministered antiepileptic drugs.

              The drug interaction data described in this section were obtained from studies involving healthy adults and adult patients with epilepsy.

              General:

              Diagnosis of the disease should be confirmed either by direct microscopic examination of infected superficial epidermal tissue in a solution of potassium hydroxide or by culture on an appropriate medium.

              Physicians should exercise caution when prescribing ERTACZO Cream, 2%, to patients known to be sensitive to imidazole antifungals, since cross-reactivity may occur.

              In clinical trials, cutaneous adverse events occurred in 7 of 297 (2%) patients (2 of them severe) receiving ERTACZO Cream, 2%, and in 7 of 291 (2%) patients (2 of them severe) receiving vehicle. These reported cutaneous adverse events included contact dermatitis, dry skin, burning skin, application site reaction and skin tenderness.

              In a dermal sensitization study, 8 of 202 evaluable patients tested with ERTACZO Cream, 2%, and 4 of 202 evaluable patients tested with vehicle, exhibited a slight erythematous reaction in the challenge phase. There was no evidence of cumulative irritation or contact sensitization in a repeated insult patch test involving 202 healthy volunteers. In non-US post-marketing surveillance for ERTACZO Cream, 2%, the following cutaneous adverse events were reported: contact dermatitis, erythema, pruritus, vesiculation, desquamation, and hyperpigmentation.

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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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              Tips

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              Interactions

              Interactions

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