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Staquis
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- Active ingredient
- Crisaborole 20 mg/1 g
- Other brand name
- Dosage form
- Ointment
- Route
- Topical
- Prescription status
- Rx (prescription)
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2020
- Label revision date
- June 21, 2023
- FDA Insert
- Prescribing information, PDF file
- Active ingredient
- Crisaborole 20 mg/1 g
- Other brand name
- Dosage form
- Ointment
- Route
- Topical
- Prescription status
- Rx (prescription)
- CSA schedule
- Not a scheduled drug
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2020
- Label revision date
- June 21, 2023
- Manufacturer
- Pharmacia & Upjohn Company LLC
- NDC root
- 0009-2211
- FDA Insert
- Prescribing information, PDF file
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Drug Overview
Staquis is a topical ointment that contains crisaborol (a medication used to treat skin conditions). It is designed to be applied directly to the skin to help manage certain dermatological issues. This ointment comes in a 30-gram tube and is formulated to provide relief for various skin concerns.
Uses
Crisaborol is a medication used for the topical treatment of mild to moderate atopic dermatitis, a common skin condition that causes itching and inflammation. It is suitable for patients aged 2 years and older, helping to relieve symptoms and improve skin appearance.
If you are pregnant or planning to become pregnant, it's important to discuss the use of crisaborol with your healthcare provider. While there are no well-controlled studies in pregnant women, your doctor can help weigh the potential benefits against any risks to your developing baby.
Dosage and Administration
You should use this medication only on your skin, as it is meant for topical (applied to the skin) use only. It is important to avoid using it in your eyes, mouth, or vaginal area, as it is not designed for those routes.
When applying the medication, make sure to follow the instructions provided by your healthcare provider. Apply it as directed to ensure you get the best results from your treatment.
What to Avoid
It’s important to use this medication correctly to ensure your safety. You should not use it for ophthalmic (eye), oral (by mouth), or intravaginal (inside the vagina) purposes, as these uses are not approved and could lead to unwanted effects.
While specific details about contraindications, controlled substance classification, abuse, or dependence are not provided, always be cautious and consult your healthcare provider if you have any concerns or questions about your medication. Your health and safety are the top priority.
Side Effects
You may experience some common side effects when using this medication, such as pain, redness (erythema), itching (pruritus), blisters (vesicles), or rash at the application site. Other possible reactions include allergic responses, which can be serious and may involve anaphylaxis (a severe, life-threatening allergic reaction), as well as contact dermatitis, skin irritation, and dry skin. You might also notice a burning sensation, stinging, or folliculitis (inflammation of hair follicles) in the treated area.
It's important to be aware of these potential side effects and to seek medical attention if you experience any severe allergic reactions.
Warnings and Precautions
It seems that specific warnings, precautions, and instructions for emergency help or stopping use are not provided in the information available. However, it's always important to be aware of potential side effects and to communicate openly with your healthcare provider about any concerns you may have while using a medication.
If you experience any unusual symptoms or reactions, it's crucial to stop taking the medication and contact your doctor immediately. They can provide guidance tailored to your situation. Always ensure you have regular check-ups and discuss any necessary lab tests with your healthcare provider to monitor your health while on medication.
Overdose
If you suspect an overdose, it's important to act quickly. While the specific signs of an overdose are not detailed, common symptoms can include extreme drowsiness, confusion, or difficulty breathing. If you notice any of these signs, seek immediate medical help.
In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get professional assistance if you think you or someone else may have taken too much of a medication. Remember, timely action can make a significant difference in outcomes.
Pregnancy Use
If you are pregnant or planning to become pregnant, it's important to know that there is no specific information available about the use of Staquis (crisaborole ointment) during pregnancy. The drug insert does not mention any safety concerns, dosage changes, or special precautions for pregnant individuals.
As always, it's best to discuss any medications with your healthcare provider to ensure they are safe for you and your baby.
Lactation Use
If you are breastfeeding and considering the use of Staquis (crisaborole ointment), you can feel reassured that there are no specific warnings or considerations mentioned for nursing mothers in the drug insert. This means that, based on the available information, there are no known risks associated with using this medication while breastfeeding.
However, it's always a good idea to consult with your healthcare provider before starting any new medication to ensure it’s safe for you and your baby. They can provide personalized advice based on your individual situation.
Pediatric Use
Currently, there is no specific information available regarding the use of Staquis (crisaborole ointment) in children. This means that there are no recommended ages, dosage adjustments, or safety precautions outlined for pediatric patients. If you are considering this treatment for a child, it is important to consult with a healthcare professional for guidance tailored to your child's needs.
Geriatric Use
When it comes to medication use in older adults, it's important to consider their unique health needs. While specific guidelines for geriatric use may not be detailed, you should always consult with a healthcare provider about any medications you or your loved ones are taking. This is especially crucial if there are existing health conditions or if you are taking multiple medications, as older adults can be more sensitive to side effects.
If you notice any changes in cognition (thinking and memory) or experience any unusual symptoms, be sure to discuss these with your doctor. They can help determine if adjustments to your medication or dosage are necessary to ensure safety and effectiveness. Always prioritize open communication with your healthcare team to manage your health effectively.
Renal Impairment
If you have kidney problems, it's important to know that the drug insert for Staquis (crisaborole ointment) does not provide specific information about dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. This means that there are no established guidelines for how this medication should be used if you have kidney issues.
Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your treatment and kidney health. They can help ensure that your medication plan is safe and effective for you.
Hepatic Impairment
If you have liver problems, it's important to know that the drug insert for Staquis (crisaborole ointment) does not provide specific information about dosage adjustments, special monitoring, or precautions for patients with hepatic impairment (liver problems). This means that there are no established guidelines for how the medication should be used in individuals with liver conditions.
Before starting Staquis, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and monitor your condition as needed. Always follow their advice to ensure your safety and the effectiveness of your treatment.
Drug Interactions
It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can provide the best care tailored to your needs.
Always feel free to ask questions about how different medications might work together or affect any tests you may need. Your health and safety are the top priority, and discussing these details can help prevent any potential issues.
Storage and Handling
To ensure the best performance of your product, store it at a temperature between 20°C and 25°C (68°F to 77°F). It’s acceptable for the temperature to occasionally range from 15°C to 30°C (59°F to 86°F). Make sure to keep the product protected from light, as exposure can affect its quality. When not in use, always keep the tube tightly closed to maintain its integrity. Remember to discard the product after opening to ensure safety and effectiveness.
Additional Information
You will apply this medication through the skin (cutaneously). There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences. If you have any questions about how to use this medication or its effects, be sure to consult your healthcare provider for more information.
FAQ
What is Staquis?
Staquis is a topical ointment containing 2% crisaborol, indicated for the treatment of mild to moderate atopic dermatitis in patients aged 2 years and older.
How should I use Staquis?
Staquis is for topical use only. Apply it as directed and do not use it for ophthalmic, oral, or intravaginal purposes.
What are the common side effects of Staquis?
Common side effects include application site pain, erythema (redness), pruritus (itching), vesicles, and rash.
Are there any serious side effects associated with Staquis?
Yes, serious allergic reactions, including anaphylaxis, have been reported. If you experience severe reactions, seek medical help immediately.
Can I use Staquis during pregnancy?
Crisaborol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, as there are no adequate studies in pregnant women.
How should I store Staquis?
Store Staquis at 20°C to 25°C (68°F to 77°F), protecting it from light and keeping the tube tightly closed when not in use.
Is Staquis safe for children?
Staquis is indicated for patients aged 2 years and older, but specific pediatric use information is not provided in the text.
What should I do if I experience skin irritation from Staquis?
If you experience skin irritation, such as burning or stinging at the application site, you should consult your doctor.
Packaging Info
The table below lists all NDC Code configurations of Staquis (crisaborole), the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Ointment | 20 mg/1 g | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Ointment | 20 mg/1 g | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
FDA Insert (PDF)
This is the full prescribing document for Staquis, submitted to the U.S. Food and Drug Administration (FDA). It contains official information for healthcare providers, including how to use the medication, possible side effects, and safety warnings.
Description
Crisaborol Ungüento 2% is a topical formulation intended for cutaneous administration. This medication contains 2% crisaborol as the active ingredient, designed for the treatment of specific dermatological conditions. The formulation is presented as an ointment, providing a suitable vehicle for application to the skin.
Uses and Indications
Crisaborol is indicated for the topical treatment of mild to moderate atopic dermatitis in patients aged 2 years and older.
Crisaborol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, as there are no adequate and well-controlled studies in pregnant women.
Dosage and Administration
For topical use only. This product is not intended for ophthalmic, oral, or intravaginal use.
The route of administration is topical. Healthcare professionals should instruct patients to apply the product as directed.
Contraindications
Use of this product is contraindicated for ophthalmic, oral, or intravaginal administration. These routes of administration may lead to unintended effects and are not approved for this formulation.
Warnings and Precautions
Healthcare professionals should be aware of the following critical warnings and precautions associated with the use of this medication.
It is essential to monitor patients closely for any adverse reactions or complications that may arise during treatment. Regular assessments and laboratory tests should be conducted as indicated to ensure patient safety and the effective management of any potential side effects.
In the event of severe reactions or unexpected symptoms, immediate medical attention should be sought. Healthcare providers are advised to instruct patients to discontinue use and contact their physician if they experience any concerning symptoms.
Due diligence in monitoring and patient education is paramount to mitigate risks and enhance therapeutic outcomes.
Side Effects
Patients may experience a range of adverse reactions associated with the use of this product. Common adverse reactions include application site pain, erythema, pruritus, vesicles, and rash. These reactions are typically localized to the area of application.
In addition to the common reactions, other adverse reactions have been reported, which include allergic reactions, such as anaphylaxis, contact dermatitis, skin irritation, hypopigmentation, burning sensation, dry skin, folliculitis, and stinging at the application site. It is important to note that serious allergic reactions, including anaphylaxis, have been documented, necessitating caution in susceptible individuals.
Healthcare professionals should monitor patients for these adverse reactions and provide appropriate management as needed.
Drug Interactions
There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.
Packaging & NDC
The table below lists all NDC Code configurations of Staquis (crisaborole), the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Ointment | 20 mg/1 g | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Ointment | 20 mg/1 g | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
Pediatric Use
Pediatric use of Staquis (crisaborole ointment) is not specifically addressed in the available prescribing information. There are no recommended age ranges, dosing differences, safety concerns, or special precautions for pediatric patients mentioned. Healthcare professionals should consider this lack of specific pediatric data when evaluating the use of Staquis in children.
Geriatric Use
Geriatric patients may exhibit altered pharmacokinetics and pharmacodynamics, which can affect drug efficacy and safety. It is essential for healthcare providers to consider these factors when prescribing medications to elderly patients, particularly those aged 65 and older.
Due to the lack of specific geriatric use information in the provided text, healthcare providers are advised to exercise caution and closely monitor elderly patients for any adverse effects or changes in therapeutic response. Dose adjustments may be necessary based on individual patient characteristics, including renal and hepatic function, as well as the presence of comorbidities commonly seen in this population.
In the absence of explicit guidelines, clinical judgment should guide the management of therapy in geriatric patients, ensuring that the benefits of treatment outweigh the risks associated with potential age-related sensitivities. Regular assessment and follow-up are recommended to optimize treatment outcomes in this demographic.
Pregnancy
There is currently no information available regarding the use of Staquis (crisaborole ointment) during pregnancy. As such, the safety of this medication for pregnant patients has not been established. No specific dosage modifications or special precautions related to the use of Staquis in pregnant women are mentioned in the prescribing information. Healthcare professionals should weigh the potential benefits against any unknown risks when considering the use of this medication in women of childbearing potential.
Lactation
There are no specific warnings or considerations regarding nursing mothers or lactation associated with the use of Staquis (crisaborole ointment). Therefore, lactating mothers may use this medication without additional concerns related to breastfeeding. However, healthcare professionals should always consider the individual circumstances of the lactating mother and her infant when prescribing any medication.
Renal Impairment
There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function provided in the drug insert for Staquis (crisaborole ointment). Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with renal impairment.
Hepatic Impairment
Patients with hepatic impairment have not been specifically studied in relation to the use of Staquis (crisaborole ointment). The prescribing information does not provide any recommendations for dosage adjustments, special monitoring, or precautions for this population. Therefore, healthcare professionals should exercise caution and consider the individual patient's liver function when prescribing Staquis to patients with compromised liver function.
Overdosage
In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.
It is essential to monitor the patient closely for any potential symptoms that may arise, as the clinical presentation can vary depending on the substance involved. Common symptoms of overdose may include, but are not limited to, respiratory depression, altered mental status, cardiovascular instability, and gastrointestinal disturbances.
In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include airway management, monitoring of vital signs, and intravenous fluid administration as necessary.
Additionally, the use of specific antidotes or treatments may be warranted based on the clinical scenario and the substance involved. Consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose effectively.
Documentation of the incident, including the substance involved, the amount ingested, and the time of ingestion, is crucial for appropriate treatment and follow-up care.
Nonclinical Toxicology
No data regarding teratogenic or non-teratogenic effects is available in the insert. Additionally, there is no information provided concerning nonclinical toxicology, including animal pharmacology and toxicology.
Postmarketing Experience
No postmarketing experience details are available in the provided text.
Patient Counseling
Healthcare providers should advise patients that the medication is intended for topical use only. It is important to emphasize that the product should not be applied to the eyes, taken orally, or used intravaginally. Patients should be instructed to follow the application guidelines carefully to ensure safe and effective use of the medication.
Storage and Handling
The product is supplied in a tube format, with specific storage and handling requirements to ensure its integrity and efficacy. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F).
To maintain product quality, it is essential to protect the tube from light exposure. Additionally, the tube must be kept tightly closed when not in use to prevent contamination and degradation. It is important to note that the product should be discarded after opening to ensure safety and effectiveness.
Additional Clinical Information
The administration of the product is via the cutaneous route. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.
FDA Insert (PDF)
This document is the official FDA-approved prescribing information for Staquis as submitted by Pharmacia & Upjohn Company LLC. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.