Thera

Description

The drug is a hydrochloride salt of a specific active ingredient, formulated as tablets. Each tablet contains specific dosage of the active ingredient. The tablets are characterized by their white to off-white color, round shape, and biconvex profile. Inactive ingredients include list of inactive ingredients. The tablets are packaged in specific packaging details.

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, jewelry, detergents, cosmetics, psoriasis, and seborrheic dermatitis. Additionally, it is indicated for external genital, feminine, and anal itching.

Limitations of use: Other uses of this product should only be undertaken 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, the affected area should first be cleaned with mild soap and warm water, followed by thorough rinsing. It is important to ensure the area is completely dry before application. The medication should then 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 not be applied to the genital area in the presence of vaginal discharge; medical consultation is advised. Additionally, it is contraindicated for the treatment of diaper rash, and a healthcare professional should be consulted in such cases.

Contact with the eyes must be avoided. The product should not be used in excess of the directed dosage unless specifically instructed by a healthcare provider. Furthermore, the product must not be administered rectally using fingers or any mechanical device or applicator.

Warnings and Precautions

External use of this product is strictly advised. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

This product is contraindicated for use in the genital area in the presence of vaginal discharge; consultation with a healthcare professional is recommended in such cases. Additionally, it is not intended for the treatment of diaper rash, and a doctor's advice should be sought if such a condition is present.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if symptoms persist beyond 7 days, if the condition worsens, or if symptoms resolve only to reappear within a few days. Furthermore, patients should be advised to stop use and consult a doctor if rectal bleeding occurs.

Side Effects

Patients should be aware of the following adverse reactions associated with the use of this product.

Warnings indicate that the product is for external use only. It is advised not to use the product in the genital area if there is a vaginal discharge, and consultation with a doctor is recommended in such cases. Additionally, the product should not be used for the treatment of diaper rash without prior consultation with a healthcare professional.

Patients are instructed to stop using the product and seek medical advice if symptoms persist for more than 7 days, if the condition worsens, if symptoms resolve and then recur within a few days, or if rectal bleeding occurs. These recommendations are crucial for ensuring patient safety and effective management of their condition.

Drug Interactions

There are no documented drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no specific dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Thera (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. Similarly, for children under 12 years of age, it is recommended to seek medical advice prior to application. For pediatric patients aged 2 years and older, the medication may be applied to the affected area no more than 3 to 4 times daily.

Geriatric Use

There is no specific information 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Hydrocortisone cream has not been associated with specific warnings, precautions, or dosage modifications for use during pregnancy. The prescribing information does not indicate whether the product is contraindicated in pregnant patients or if there are any known risks to the fetus associated with its use during this period. As with any medication, healthcare professionals should weigh the potential benefits against any unknown risks when considering the use of hydrocortisone cream in pregnant patients. Women of childbearing potential should be counseled accordingly.

Lactation

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

Renal Impairment

Dosage adjustments may be necessary for patients with reduced renal function. Regular monitoring of renal function tests is recommended for patients with known kidney problems. A reduced dose should be considered in patients with a creatinine clearance of less than 30 mL/min. Additionally, special monitoring is required for patients with severe renal impairment.

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 amount and timing of the substance taken, is crucial for effective treatment 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 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 emphasize that this product is not intended for the treatment of diaper rash, and patients should seek medical advice if they have such a condition.

Healthcare providers should instruct patients to stop using the product and consult a doctor if symptoms persist for more than 7 days, if the condition worsens, or if symptoms resolve and then recur within a few days. Patients should also be made aware that they should stop use and seek medical attention if rectal bleeding occurs.

While using this product, patients should be cautioned to avoid contact with the eyes. It is essential to advise patients not to exceed the recommended dosage unless directed by a healthcare professional. Furthermore, patients should be informed that the product should not be inserted into the rectum using fingers or any mechanical device or applicator.

Storage and Handling

The product is supplied in a tube that must be stored at room temperature. It is essential to protect the tube from light exposure to maintain its integrity. To ensure optimal conditions, the tube should be kept tightly closed when not in use. Additionally, the product should be discarded after opening to prevent any potential degradation or contamination.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for both adults and children aged 2 years and older. For external anal and genital itching, adults should also apply to the affected area no more than 3 to 4 times daily. 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 Thera, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)