Trichophyton mentagrophytes and trichophyton rubrum

Trichophyton mentagrophytes and trichophyton rubrum
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

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Black Box Warning

ConditionName: See full prescribing information for complete Boxed Warning. * This product is intended for use by physicians who are experienced in the administration of allergenic extracts or for use under the guidance of an allergy specialist. Skin tests should be performed after the patient's physical well being and allergic history have been evaluated. Patients should be instructed to recognize adverse reaction symptoms and cautioned to contact the physician if symptoms occur. As with all allergenic extracts, severe systemic reactions may occur, and in certain individuals these reactions may cause death. Patients should be observed for at least 20 minutes after skin tests have been completed. Emergency measures as well as personnel trained in their use should be immediately available in the event of a life threatening reaction. This product should never be injected intravenously.

Overview

Trichophyton mentagrophytes and trichophyton rubrum is a {{{drugClass}}} that is FDA approved for the treatment of {{{indication}}}. There is a Black Box Warning for this drug as shown here. Common adverse reactions include {{{adverseReactions}}}.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• Intradermal skin tests with Trichophyton extract are indicated for use in persons who are suspected of having Type I hypersensitivity (i.e. allergy) to the fungus.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Trichophyton mentagrophytes and trichophyton rubrum in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Trichophyton mentagrophytes and trichophyton rubrum in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Trichophyton mentagrophytes and trichophyton rubrum in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Trichophyton mentagrophytes and trichophyton rubrum in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Trichophyton mentagrophytes and trichophyton rubrum in pediatric patients.

Contraindications

• Conditions under which the administration of allergenic extract may be contraindicated, depending upon individual circumstances, include: EXTREME SENSITIVITY TO AN ALLERGEN - Determined from the allergic history, or from previous anaphylaxis following skin testing or subcutaneous injection; MYOCARDIAL INFARCTION - Patients who have experienced a recent myocardial infarction may be less able to tolerate the life-threatening effects of a serious adverse reaction. ASTHMA - Patients with highly unstable asthma are at greater risk of fatal reactions from skin tests than are patients without asthma, especially during seasonal exacerbations of the disease. Also, the combination of unstable asthma and treatment with B-adrenergic blockers appears to increase this risk5. Allergenic extract should be temporarily withheld from patients if any of the following conditions exist: 1) severe symptoms of hay fever and/or asthma; 2) infection or flu accompanied by fever; and 3) exposure to excessive amounts of clinically relevant allergen(s) prior to skin testing.

Warnings

ConditionName: See full prescribing information for complete Boxed Warning. * This product is intended for use by physicians who are experienced in the administration of allergenic extracts or for use under the guidance of an allergy specialist. Skin tests should be performed after the patient's physical well being and allergic history have been evaluated. Patients should be instructed to recognize adverse reaction symptoms and cautioned to contact the physician if symptoms occur. As with all allergenic extracts, severe systemic reactions may occur, and in certain individuals these reactions may cause death. Patients should be observed for at least 20 minutes after skin tests have been completed. Emergency measures as well as personnel trained in their use should be immediately available in the event of a life threatening reaction. This product should never be injected intravenously.

• Physicians who use allergenic extracts should have a knowledge and practical understanding of allergy skin testing as described in the published literature6,7,8.

Allergenic extracts are manufactured to assure high potency and therefore have the ability to cause serious local and systemic reactions, including death in highly sensitive patients5. Patients should be informed of the risks of skin testing and instructed in the recognition of symptoms of an adverse allergic reaction.

• Excessively large local reactions or systemic reactions are more likely to occur if the patient is skin tested shortly after exposure to allergens to which he or she is sensitive.

Adverse Reactions

Clinical Trials Experience

• LOCAL REACTIONS Large, persistent local reactions or minor exacerbations of the patient's allergic symptoms may be treated by local cold applications and/or the use of oral anti-histamines.

• SYSTEMIC REACTIONS Allergenic extracts are highly potent and in highly sensitive individuals can cause systemic symptoms, including anaphylaxis. It cannot be overemphasized that anaphylactic shock is always a possibility under certain unpredictable combinations of circumstances. Other possible systemic reaction symptoms may include fainting, pallor, bradycardia, hypotension, angioedema, cough, wheezing, conjunctivitis, rhinitis and urticaria. Therefore, it is imperative that physicians administering skin tests understand and be prepared to treat severe allergic reactions.

• If a systemic or anaphylactic reaction occurs during or following skin testing, the patient should be treated with 1:1000 epinephrine hydrochloride. The recommended dose: infants to 2 years of age 0.05 to 0.1 mL, children 2 to 6 years, 0.15 mL, children 6 to 12 years, 0.2 mL, adults 0.3 - 0.5 mL. If necessary, treatment may be repeated up to three times every 10 - 15 minutes.

• After administration of epinephrine, profound shock or vasomotor collapse should be treated with intravenous fluids and possibly vasoactive drugs. Oxygen should be given by mask. Intravenous antihistamine, aminophylline, inhaled bronchodilators or adrenal corticosteroids may be used if necessary after adequate epinephrine and circulatory support have been given. Emergency resuscitation measures and personnel trained in their use should be available immediately. The physician should be prepared in advance for all contingencies. Promptness in beginning emergency treatment is of utmost importance14.

• Serious adverse reactions should be reported to MedWatch: The FDA Safety Information and Adverse Event Reporting Program, Office Of The Center Director, Center for Drug Evaluation and Research, 5515 Security Lane, Suite 5100, Rockville, MD 20852, Telephone (800) 332-1088.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Trichophyton mentagrophytes and trichophyton rubrum in the drug label.

Drug Interactions

There is limited information regarding Trichophyton mentagrophytes and trichophyton rubrum Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Trichophyton mentagrophytes and trichophyton rubrum in women who are pregnant.
Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Trichophyton mentagrophytes and trichophyton rubrum in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Trichophyton mentagrophytes and trichophyton rubrum during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Trichophyton mentagrophytes and trichophyton rubrum with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Trichophyton mentagrophytes and trichophyton rubrum with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Trichophyton mentagrophytes and trichophyton rubrum with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Trichophyton mentagrophytes and trichophyton rubrum with respect to specific gender populations.

Race

There is no FDA guidance on the use of Trichophyton mentagrophytes and trichophyton rubrum with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Trichophyton mentagrophytes and trichophyton rubrum in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Trichophyton mentagrophytes and trichophyton rubrum in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Trichophyton mentagrophytes and trichophyton rubrum in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Trichophyton mentagrophytes and trichophyton rubrum in patients who are immunocompromised.

Administration and Monitoring

Administration

• Intravenous

Monitoring

There is limited information regarding Monitoring of Trichophyton mentagrophytes and trichophyton rubrum in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Trichophyton mentagrophytes and trichophyton rubrum in the drug label.

Overdosage

• The signs and symptoms of overdosage are the same as those listed under adverse reactions.
• The treatment of a systemic allergic reaction resulting from skin tests should include the following:

• The patient should be placed in the recumbent position to maintain blood flow to the head.
• Aqueous epinephrine 1:1,000 should be administered subcutaneously.
• Reassurance should be provided.

• The above steps should be performed nearly simultaneously and as soon as possible after the reaction begins. Persistent wheezing may necessitate treatment with intravenous aminophylline and inhaled bronchodilators. For profound shock and hypotension, intravenous fluids, vasopressors and oxygen also may be needed.

• Maintenance of an open airway is critical if upper airway obstruction is present. Corticosteroids may provide benefit if symptoms are prolonged or recurrent.

There is limited information regarding Chronic Overdose of Trichophyton mentagrophytes and trichophyton rubrum in the drug label.

Pharmacology

There is limited information regarding Trichophyton mentagrophytes and trichophyton rubrum Pharmacology in the drug label.

Mechanism of Action

Structure

There is limited information regarding Trichophyton mentagrophytes and trichophyton rubrum Structure in the drug label.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Trichophyton mentagrophytes and trichophyton rubrum in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Trichophyton mentagrophytes and trichophyton rubrum in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Trichophyton mentagrophytes and trichophyton rubrum in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Trichophyton mentagrophytes and trichophyton rubrum in the drug label.

How Supplied

Storage

There is limited information regarding Trichophyton mentagrophytes and trichophyton rubrum Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Trichophyton mentagrophytes and trichophyton rubrum in the drug label.

Precautions with Alcohol

• Alcohol-Trichophyton mentagrophytes and trichophyton rubrum interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• TRICHOPHYTON FOR INTRADERMAL SKIN TESTING ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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