Intimale Lidocaine Delay

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

Uses and Indications

This drug is indicated for the temporary prevention of premature ejaculation in adult males. It is intended for use in patients who experience this condition, providing a therapeutic option to enhance sexual performance and satisfaction.

Dosage and Administration

Healthcare professionals should instruct patients to apply 3 or more sprays of the product to the head and shaft of the penis prior to sexual activity, or as directed by a physician. The product should be massaged onto the penis until fully absorbed.

It is important to note that the maximum allowable dosage is 10 sprays. Patients are advised to use the minimum effective quantity to achieve the desired results.

Contraindications

Use is contraindicated in the following situations:

• Application on broken or inflamed skin is prohibited due to the potential for exacerbating the condition and causing further irritation.

• Use is not recommended if the partner is pregnant, as safety during pregnancy has not been established.

• Application to large areas of the body is contraindicated to minimize the risk of systemic absorption and potential adverse effects.

• Oral use is strictly prohibited, as it may lead to unintended complications and is not an approved route of administration.

Warnings and Precautions

Premature ejaculation may indicate an underlying condition that necessitates medical supervision. If the product does not provide relief when used as directed, it is imperative to discontinue use and consult a physician for further evaluation and management.

This product is intended for external use only. It is crucial to avoid contact with the eyes, as this may lead to irritation. In the event that either the user or their partner experiences a rash or irritation, such as burning or itching, use should be discontinued immediately, and a physician should be consulted.

General precautions must be observed to ensure safe use of the product. It should not be applied to broken or inflamed skin, nor should it be used if the partner is pregnant. Additionally, the product should not be applied to large areas of the body or used orally.

In case of accidental ingestion, it is essential to seek emergency medical assistance or contact a poison control center without delay.

Healthcare professionals should remain vigilant for any adverse reactions and advise patients accordingly.

Side Effects

Patients using this product may experience adverse reactions that necessitate careful consideration and monitoring. Serious adverse reactions include the potential for premature ejaculation, which may indicate an underlying condition requiring medical supervision. If the product does not provide relief when used as directed, patients are advised to discontinue use and consult a physician.

Common adverse reactions may include skin irritation, such as rashes, burning, or itching. Should either the patient or their partner develop such symptoms, it is recommended to discontinue use and seek medical advice.

This product is intended for external use only and should not be applied to broken or inflamed skin, on large areas of the body, or used orally. Additionally, contact with the eyes should be avoided. In the event that the product is swallowed, immediate medical attention or contact with a poison control center is necessary.

Patients should be aware of these warnings and adverse reactions to ensure safe and effective use of the product.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Intimale Lidocaine Delay (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be advised to keep this product out of reach of children. In the event that the product is swallowed, it is crucial to seek medical attention or contact a poison control center immediately.

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

Pregnant patients should not use this medication on broken or inflamed skin, on large areas of the body, or orally. The safety of this medication during pregnancy has not been established, and its use in these circumstances may pose risks to fetal outcomes. Healthcare professionals are advised to consider alternative treatments for pregnant patients or those who may become pregnant. Caution is recommended when prescribing this medication to women of childbearing potential.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or its effects on lactation. Additionally, there is no available data on the excretion of this medication in breast milk or its potential effects on breastfed infants. Healthcare professionals should consider the absence of information when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 event of an overdosage, immediate medical attention is essential. If the product is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a poison control center without delay.

Prompt intervention is critical to mitigate potential adverse effects associated with overdosage. It is important for healthcare providers to assess the situation thoroughly and initiate appropriate management procedures based on the severity of the symptoms presented.

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 that if the product is swallowed, it is imperative to seek medical attention or contact a poison control center immediately. This information is crucial for ensuring patient safety and prompt intervention in the event of accidental ingestion.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is recommended to store the product in a cool, dry place, ensuring that the temperature does not exceed 30°C (86°F). Care should be taken to keep the product out of direct sunlight to maintain its integrity and efficacy. Proper storage conditions are crucial for preserving the quality of the product throughout its shelf life.

Additional Clinical Information

Patients should apply 3 or more sprays of the product to the head and shaft of the penis prior to sexual activity, or as directed by their clinician. It is important to massage the product onto the penis until fully absorbed and not to exceed 10 sprays. Patients are advised to use the minimum effective quantity to achieve the desired effect.

Drug Information (PDF)

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

View product document (PDF)