Budpak Anti-Itch

Description

Hydrocortisone is a synthetic corticosteroid with the chemical name pregn-4-ene-3,20-dione, 11,17-dihydroxy-. Its molecular formula is C21H30O5, and it has a molecular weight of 362.46. The compound appears as a white to practically white, odorless, crystalline powder. Hydrocortisone exhibits solubility in alcohol, chloroform, and ether, is slightly soluble in water, and is practically insoluble in hexane. The formulation includes inactive ingredients such as butylated hydroxytoluene, cetyl alcohol, glycerin, mineral oil, polysorbate 60, propylene glycol, purified water, and stearyl alcohol.

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritations and rashes due to various conditions, including eczema, seborrheic dermatitis, psoriasis, insect bites, and contact with poison ivy, oak, or sumac. It is also effective for itching caused by soaps, detergents, cosmetics, jewelry, and external genital, feminine, and anal areas.

Limitations of use include that any other applications or the use of this product for more than 7 days should be undertaken only under the advice and supervision of a healthcare professional.

Dosage and Administration

For the treatment of itching associated with skin irritation, inflammation, and rashes, the recommended dosage for adults and children aged 2 years and older is to apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a physician prior to use.

In cases of external anal and genital itching in adults, it is recommended to first clean the affected area with mild soap and water, ensuring thorough rinsing. The area should then be gently dried by patting or blotting with toilet tissue or a soft cloth before application. The medication should be applied to the affected area no more than 3 to 4 times daily. For children under 12 years of age, consultation with a physician is also recommended prior to use.

Contraindications

Use of this product is contraindicated in the following situations:

• Application in the genital area is contraindicated in patients with vaginal discharge; consultation with a healthcare professional is advised.

• The product should not be used for the treatment of diaper rash; a healthcare professional should be consulted for appropriate management.

Additionally, if rectal bleeding occurs, the use of this product should be discontinued, and a doctor should be consulted.

Warnings and Precautions

For external use only. It is imperative to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

General precautions must be observed when using this product. It is contraindicated for use in the genital area if there is a vaginal discharge; consultation with a healthcare professional is advised in such cases. Additionally, this product should not be utilized for the treatment of diaper rash unless directed by a physician.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if any of the following occur: the condition worsens, symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Patients should refrain from using any other hydrocortisone products unless they have consulted a doctor. Rectal bleeding is another critical sign that necessitates immediate medical consultation.

In case of ingestion, it is crucial to obtain emergency medical help or contact a Poison Control Center promptly.

Side Effects

For external use only. Patients should discontinue use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, patients should not begin the use of any other hydrocortisone product without first consulting a doctor. Rectal bleeding is another serious condition that warrants immediate medical attention.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Budpak Anti-Itch (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area for itching associated with skin irritation, inflammation, and rashes, not exceeding 3 to 4 times daily. For children under 2 years, it is advised to consult a doctor prior to use.

In cases of external anal and genital itching, it is recommended that children under 12 years of age also consult a doctor before application.

Geriatric Use

There is no specific information regarding the use of Budpak Anti-Itch (hydrocortisone cream) in geriatric patients. The prescribing information does not provide any recommended age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients.

Healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering the absence of specific data on this population. Monitoring for efficacy and potential adverse effects is advisable, as individual responses to treatment may vary.

Pregnancy

There is no specific information available regarding the use of Budpak Anti-Itch (hydrocortisone cream) during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution when considering the use of this medication in pregnant women, as the potential risks and benefits have not been established. It is advisable to weigh the necessity of treatment against any unknown risks to fetal outcomes. Women of childbearing potential should be informed of the lack of data and encouraged to discuss any concerns with their healthcare provider.

Lactation

There are no specific warnings or recommendations regarding the use of this product by nursing mothers. Additionally, there are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants during the use of this product in lactation.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

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 from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as indicated based on the clinical scenario and the substance involved. Consultation with a poison control center or a medical toxicologist may also be beneficial in managing the situation effectively.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for guiding treatment decisions and ensuring patient safety.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of swallowing the product, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use the product in the genital area if they have a vaginal discharge and to consult a doctor in such cases. Additionally, it is important to clarify that this product is not intended for the treatment of diaper rash, and patients should seek medical advice if they have questions regarding its use for this condition.

Patients should be instructed to stop using the product and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. They should also be advised not to begin the use of any other hydrocortisone product without first consulting a doctor.

Instruct patients to stop using the product and seek medical attention if they experience rectal bleeding. While using this product, patients should be cautioned to avoid contact with their eyes and to adhere strictly to the directed dosage. They should not exceed the recommended amount unless specifically directed by a healthcare professional. Furthermore, patients should be advised against inserting the product directly into the rectum using fingers or any mechanical device or applicator.

Storage and Handling

The product is supplied in a tube, with specific Lot Number and Expiration Date indicated on the crimp of the tube. It should be stored at room temperature to maintain its efficacy. It is essential to keep the product out of reach of children to prevent accidental ingestion. In the event of swallowing the product, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Additional Clinical Information

The route of administration for the medication is topical. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Budpak Anti-Itch, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)