Afassco 1% Hydrocortisone

Description

Afassco® is a cream formulation containing 1% hydrocortisone as the active ingredient. It is indicated as a 1% anti-itch analgesic for the temporary relief of minor skin irritations. Each unit contains 1 gram (1/32 oz) of the product, and it is packaged with 25 units per box. Afassco® is manufactured for Afassco, Inc. in Minden, NV 89423, and is produced in China.

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to various conditions, including eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, and psoriasis scrapes. Additionally, it is indicated for the relief of external genital, feminine, and anal itching.

Other uses of this product should only be undertaken under the advice and supervision of a healthcare professional.

Dosage and Administration

For adults and children aged 2 years and older, the product should be applied to the affected area no more than 3 to 4 times daily. Prior to application, adults are advised to cleanse the area with mild soap and warm water, ensuring thorough rinsing. Alternatively, the area may be cleansed by patting or blotting with an appropriate cleansing pad. After cleansing, the area should be gently dried by patting or blotting with toilet tissue or a soft cloth before applying the product.

For children under 2 years of age, the product is not recommended, and consultation with a doctor is advised. Additionally, for children under 12 years of age experiencing external itching, it is recommended to consult a doctor prior to use.

Contraindications

Use of this product is contraindicated in patients who are concurrently using any other Hydrocortisone product without prior consultation with a healthcare professional.

Additionally, contact with the eyes should be avoided to prevent irritation or injury. The product should not be administered rectally using fingers, mechanical devices, or applicators, as this may lead to adverse effects.

Warnings and Precautions

For external use only. It is imperative that healthcare professionals advise patients against the concurrent use of this product with any other hydrocortisone formulation unless a consultation with a physician has occurred.

In cases where the product is ingested, immediate action is required; patients should contact a Poison Control center without delay.

Healthcare providers should instruct patients to discontinue use and seek medical advice under the following circumstances: if there is a vaginal discharge associated with external feminine itching, if the recommended daily dosage is exceeded, if any bleeding occurs, or if the condition worsens. Additionally, if symptoms persist beyond 7 days or if there is a recurrence of symptoms after a temporary improvement, patients should be advised to consult their doctor.

It is also essential to remind patients to seek medical guidance prior to using this product if they are currently utilizing any other hydrocortisone products.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is important to consult a doctor prior to use if there is any vaginal discharge associated with external feminine itching.

In clinical practice, patients are advised not to exceed the recommended daily dosage for external itching. Should any bleeding occur, or if the condition worsens or symptoms persist for more than 7 days, patients should seek medical advice. Additionally, if symptoms clear up and then recur within a few days, consultation with a healthcare professional is recommended.

Patients currently using any other hydrocortisone product should also ask a doctor before using this product to avoid potential interactions or compounded effects.

Drug Interactions

The concurrent use of hydrocortisone with other hydrocortisone products is not recommended without prior consultation with a healthcare professional. This precaution is essential to avoid potential additive effects and to ensure safe and effective use of hydrocortisone therapy.

Patients are advised to seek medical advice before initiating treatment with hydrocortisone if they are currently using any other hydrocortisone-containing products. This will help in assessing the appropriateness of combined therapy and in determining any necessary dosage adjustments or monitoring requirements.

Packaging & NDC

Below are the non-prescription pack sizes of Afassco 1% Hydrocortisone (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 years and older may use the medication, applying it to the affected area no more than 3 to 4 times daily. For children under 2 years of age, the use of this medication is not recommended, and a healthcare professional should be consulted. Additionally, for children under 12 years of age experiencing external itching, it is advised to consult a doctor prior to use.

It is important to keep the medication out of reach of children. In the event of accidental ingestion, immediate contact with a Poison Control center is necessary.

Geriatric Use

Elderly patients should consult a healthcare provider prior to use, particularly for those under 65 years of age, as no specific geriatric use information or dosage adjustments have been provided in the prescribing information.

While there are no explicit recommendations for dosage modifications in geriatric patients, it is advisable for healthcare providers to exercise caution and closely monitor this population for any potential adverse effects. Additionally, for external itching, it is recommended that elderly patients consult a doctor if they are considering use for children under 12 years of age.

Overall, careful consideration and professional guidance are essential when administering this medication to elderly patients, given the lack of specific data regarding its use in this demographic.

Pregnancy

The safety of hydrocortisone during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use. There may be potential risks to the fetus; therefore, hydrocortisone should only be used if clearly needed and if the benefits outweigh the risks.

Dosage adjustments may be necessary during pregnancy, and it is essential for healthcare providers to offer guidance on appropriate dosing. Special precautions should be taken, and hydrocortisone should be used with caution and under medical supervision during pregnancy to ensure the safety of both the mother and the developing fetus.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

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.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.

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 limits the assessment of potential risks associated with the compound in these areas.

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 and to contact a Poison Control center immediately if swallowed. Patients should be informed not to use this product in conjunction with any other hydrocortisone product unless they have consulted a doctor.

When using this product, patients should be cautioned to avoid contact with the eyes and to refrain from inserting the product into the rectum using fingers or any mechanical device or applicator.

Patients should be encouraged to consult a doctor before use if they have a vaginal discharge, particularly for external feminine itching. They should also be advised not to exceed the recommended daily dosage for external itching and to seek medical advice if bleeding occurs. If the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients should be instructed to contact their healthcare provider. Additionally, patients should be reminded to ask a doctor before use if they are currently using any other hydrocortisone product.

Storage and Handling

The product is supplied in tamper-evident packaging. It is essential to inspect the packaging prior to use; do not utilize any packets that are torn, cut, or opened.

For optimal storage, the product should be maintained at a controlled room temperature between 15° to 30° C (59° to 86° F). It is important to avoid exposure to excessive heat and humidity to ensure the integrity of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Afassco 1% Hydrocortisone, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)