Monistat Complete Care Instant Itch Relief

Description

MONISTAT Care® Itch Relief Cream contains hydrocortisone at a concentration of 1%. The product is formulated for topical application and is provided in a net weight of 1 ounce (28 grams).

Uses and Indications

This drug is indicated for the temporary relief of external genital itching. Other uses of this product should be undertaken only under the advice and supervision of a physician.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults, the recommended application frequency is to apply the medication to the affected area no more than 3 to 4 times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under 12 years of age, it is advised to consult a physician prior to use. This ensures that the appropriate dosage and administration guidelines are followed based on the child's specific health needs.

Contraindications

Use of this product is contraindicated in patients who exceed the recommended dosage. Additionally, patients should not initiate the use of any other hydrocortisone product without consulting a healthcare professional.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to consult a physician prior to use if they are experiencing any vaginal discharge, as this may indicate an underlying condition that requires medical evaluation.

When utilizing this product, it is imperative to avoid contact with the eyes. Patients should be instructed to adhere strictly to the recommended dosage and not exceed the directed amount. Additionally, patients should refrain from initiating the use of any other hydrocortisone products without prior consultation with a healthcare provider.

Patients must be informed to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay.

Side Effects

Patients using this product should be aware that it is for external use only. It is important to consult a healthcare professional before use if there is a vaginal discharge present.

During the use of this product, patients are advised to avoid contact with the eyes and to adhere strictly to the directed usage. Additionally, patients should not initiate the use of any other hydrocortisone product without prior consultation with a healthcare provider.

Patients should discontinue use and seek medical advice if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

This product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay.

Drug Interactions

The use of hydrocortisone should be strictly in accordance with the prescribed dosage. Patients are advised not to exceed the directed amount. Additionally, it is recommended that individuals consult a healthcare professional before initiating any other hydrocortisone products to avoid potential interactions.

There are no specific drug or laboratory test interactions identified for hydrocortisone. However, it remains essential for healthcare providers to monitor patients for any unforeseen effects when hydrocortisone is used in conjunction with other medications or during laboratory testing.

Packaging & NDC

Below are the non-prescription pack sizes of Monistat Complete Care Instant Itch Relief (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. The safety and efficacy of this medication in this age group have not been established, and specific dosing recommendations are not provided for children in this category. Caution is advised when considering treatment for pediatric patients.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

There is no specific information available regarding the use of MONISTAT COMPLETE CARE INSTANT ITCH RELIEF (hydrocortisone cream) during pregnancy. As such, safety concerns, dosage modifications, or special precautions for pregnant patients have not been established in the provided drug insert. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes. It is recommended that pregnant patients consult their healthcare provider before using this product.

Lactation

There is no specific information regarding nursing mothers or lactation considerations provided in the drug insert for Monistat Complete Care Instant Itch Relief (hydrocortisone cream). Therefore, the effects on breastfed infants and the excretion of the drug in breast milk are not established. Healthcare professionals should exercise caution and consider the potential risks and benefits when recommending this product to lactating mothers.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help without delay. Contacting a Poison Control Center at 1-800-222-1222 is recommended for further guidance and support.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Healthcare providers should be prepared to assess the patient's condition and implement appropriate management strategies based on the severity of symptoms and the specific substance involved.

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 provided text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Patients should be informed to discontinue use and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Additionally, they should be advised to stop using the product and seek medical advice if symptoms improve and then recur within a few days.

It is important to instruct patients to avoid contact with the eyes while using this product. They should also be cautioned not to exceed the recommended dosage. Furthermore, patients should be advised against starting any other hydrocortisone product without first consulting a healthcare provider.

Lastly, patients should be encouraged to ask a doctor before using this product if they have a vaginal discharge, ensuring that they receive appropriate guidance based on their specific health needs.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a temperature range of 20°-25°C (68°-77°F). Care must be taken to protect the product from freezing and excessive heat to ensure its integrity and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Monistat Complete Care Instant Itch Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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