Sandbox drug2

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Sandbox drug2
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];

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Black Box Warning

ConditionName:
See full prescribing information for complete Boxed Warning.
Cigarette Smoking and Serious Cardiovascular Risks:

Cigarette smoking increases the risk of serious cardiovascular events from hormonal contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, hormonal contraceptives, including ORTHO EVRA, should not be used by women who are over 35 years of age and smoke. ConditionName: ConditionName:

Cigarette smoking increases the risk of serious cardiovascular events from hormonal contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, hormonal contraceptives, including ORTHO EVRA, should not be used by women who are over 35 years of age and smoke.

Risk of Venous Thromboembolism

The risk of venous thromboembolism (VTE) among women aged 15–44 who used the ORTHO EVRA patch compared to women who used several different oral contraceptives was assessed in five U.S. epidemiologic studies using electronic healthcare claims data. The relative risk estimates ranged from 1.2 to 2.2; one of the studies found a statistically significant increased relative risk of VTE for current users of ORTHO EVRA [see WARNINGS AND PRECAUTIONS (5.1)].

Pharmacokinetic (PK) Profile of Ethinyl Estradiol (EE)

The PK profile for the ORTHO EVRA patch is different from the PK profile for oral contraceptives in that it has a higher steady state concentrations and a lower peak concentration. Area under the time-concentration curve (AUC) and average concentration at steady state (Css) for EE are approximately 60% higher in women using ORTHO EVRA compared with women using an oral contraceptive containing 35 mcg of EE. In contrast, the peak concentration (Cmax) for EE is approximately 25% lower in women using ORTHO EVRA. It is not known whether there are changes in the risk of serious adverse events based on the differences in PK profiles of EE in women using ORTHO EVRA compared with women using oral contraceptives containing 30–35 mcg of EE. Increased estrogen exposure may increase the risk of adverse events, including VTE [see WARNINGS AND PRECAUTIONS (5.2) and CLINICAL PHARMACOLOGY (12.3)].

Overview

Sandbox drug2 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 .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Condition1
  • Dosing Information
  • Dosage
Condition2
  • Dosing Information
  • Dosage
Condition3
  • Dosing Information
  • Dosage
Condition4
  • Dosing Information
  • Dosage

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Sandbox drug2 in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Sandbox drug2 in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding FDA-Labeled Use of Sandbox drug2 in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Sandbox drug2 in pediatric patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Sandbox drug2 in pediatric patients.

Contraindications

  • Condition1

Warnings

ConditionName:
See full prescribing information for complete Boxed Warning.
Cigarette Smoking and Serious Cardiovascular Risks:

Cigarette smoking increases the risk of serious cardiovascular events from hormonal contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, hormonal contraceptives, including ORTHO EVRA, should not be used by women who are over 35 years of age and smoke. ConditionName: ConditionName:

Cigarette smoking increases the risk of serious cardiovascular events from hormonal contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, hormonal contraceptives, including ORTHO EVRA, should not be used by women who are over 35 years of age and smoke.

Risk of Venous Thromboembolism

The risk of venous thromboembolism (VTE) among women aged 15–44 who used the ORTHO EVRA patch compared to women who used several different oral contraceptives was assessed in five U.S. epidemiologic studies using electronic healthcare claims data. The relative risk estimates ranged from 1.2 to 2.2; one of the studies found a statistically significant increased relative risk of VTE for current users of ORTHO EVRA [see WARNINGS AND PRECAUTIONS (5.1)].

Pharmacokinetic (PK) Profile of Ethinyl Estradiol (EE)

The PK profile for the ORTHO EVRA patch is different from the PK profile for oral contraceptives in that it has a higher steady state concentrations and a lower peak concentration. Area under the time-concentration curve (AUC) and average concentration at steady state (Css) for EE are approximately 60% higher in women using ORTHO EVRA compared with women using an oral contraceptive containing 35 mcg of EE. In contrast, the peak concentration (Cmax) for EE is approximately 25% lower in women using ORTHO EVRA. It is not known whether there are changes in the risk of serious adverse events based on the differences in PK profiles of EE in women using ORTHO EVRA compared with women using oral contraceptives containing 30–35 mcg of EE. Increased estrogen exposure may increase the risk of adverse events, including VTE [see WARNINGS AND PRECAUTIONS (5.2) and CLINICAL PHARMACOLOGY (12.3)].
  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Sandbox drug2 in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Sandbox drug2 in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Sandbox drug2 in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Sandbox drug2 during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Sandbox drug2 with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Sandbox drug2 with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Sandbox drug2 with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Sandbox drug2 with respect to specific gender populations.

Race

There is no FDA guidance on the use of Sandbox drug2 with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Sandbox drug2 in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Sandbox drug2 in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Sandbox drug2 in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Sandbox drug2 in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Sandbox drug2 in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Sandbox drug2 in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Sandbox drug2 in the drug label.

Pharmacology

There is limited information regarding Sandbox drug2 Pharmacology in the drug label.

Mechanism of Action

Structure

File:Sandbox drug201.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Sandbox drug2 in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Sandbox drug2 in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Sandbox drug2 in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Sandbox drug2 in the drug label.

How Supplied

Storage

There is limited information regarding Sandbox drug2 Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Sandbox drug2 |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Sandbox drug2 |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Sandbox drug2 in the drug label.

Precautions with Alcohol

  • Alcohol-Sandbox drug2 interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

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

  1. ↑ Empty citation (help)
  2. ↑ "http://www.ismp.org". External link in |title= (help)

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