Assured

Description

The drug is a hydrochloride salt of a specific chemical compound, formulated as tablets. Each tablet contains specific active ingredient as the active ingredient. The tablets are characterized by their white to off-white color, round shape, and biconvex design, with a score on one side for ease of splitting. Inactive ingredients include list of inactive ingredients.

Uses and Indications

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

Other uses of this product should be undertaken only under the advice and supervision of a healthcare professional. There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For the relief of skin irritation, inflammation, and rashes, the recommended dosage for adults and children aged 2 years and older is to apply the product 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, it is recommended that, when practical, the affected area be cleaned with mild soap and warm water, followed by thorough rinsing. The area should then be gently dried by patting or blotting with toilet tissue or a soft cloth before application. The product 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 recommended before use.

Contraindications

Use of this product is contraindicated in the following situations:

• The product should be kept out of reach of children to prevent accidental ingestion.

• In the event of accidental swallowing, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

Warnings and Precautions

For external use only. This product is not intended for use in the genital area if there is a vaginal discharge; consultation with a healthcare professional is advised in such cases. It is also contraindicated for the treatment of diaper rash, and a doctor should be consulted before use in this context.

When utilizing this product, it is imperative to avoid contact with the eyes. Users should adhere strictly to the recommended dosage and should not exceed the directed amount unless specifically instructed to do so by a healthcare provider. Additionally, the product should not be administered directly into the rectum using fingers, mechanical devices, or applicators.

Patients should discontinue use and seek medical advice if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms improve and then recur within a few days, or if rectal bleeding is observed. It is important to refrain from initiating any other hydrocortisone product without prior consultation with a healthcare professional.

Side Effects

Patients using this product should be aware that it is intended for external use only and should not be applied to the genital area in the presence of vaginal discharge. Consultation with a healthcare professional is advised for the treatment of diaper rash.

During the use of this product, patients are cautioned to avoid contact with the eyes and to adhere strictly to the recommended dosage. It is important not to exceed the directed use unless specifically instructed by a healthcare provider. Additionally, patients should refrain from inserting the product directly into the rectum using fingers or any mechanical device or applicator.

Patients are advised to discontinue use and seek medical attention if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Immediate medical consultation is also necessary if rectal bleeding occurs.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been noted in the available data. Therefore, routine monitoring or dosage adjustments related to drug or laboratory test interactions are not required.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 2 years of age should consult a healthcare professional before use. For children under 12 years of age, it is also recommended to seek medical advice prior to application.

For adults and children aged 2 years and older, the product may be applied to the affected area no more than 3 to 4 times daily.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

The use of hydrocortisone cream during pregnancy does not carry specific warnings or precautions as per the available prescribing information. There are no indicated dosage modifications or contraindications for pregnant patients. However, as with any medication, healthcare professionals should consider the potential benefits and risks when prescribing hydrocortisone cream to women of childbearing potential. It is advisable to monitor for any adverse effects in both the mother and fetus during treatment.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on a nursing infant are not well studied; therefore, caution is advised.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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 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 initiate supportive care, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management and treatment options.

Documentation of the incident, including the amount and timing of the substance taken, 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 use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and minimizing potential risks associated with accidental exposure.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, maintaining a range of 68° to 77° F (20° to 25° C). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

For patients aged 2 years and older, the medication should be applied 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 doctor prior to use. In cases of external anal and genital itching, adults may also apply the medication to the affected area up to 3 to 4 times daily, while for children under 12 years, a doctor's consultation is recommended.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)