Menstrual Pain Synergy

Description

MENSTRUAL PAIN Synergy is an observation media specifically designed for the assessment of menstrual pain. The effective time for this media is recorded as April 1, 2016. It is presented in the form of an image file, with the media type classified as JPEG. The reference value associated with this media is denoted as Menstrual Pain-15ml.jpg.

Uses and Indications

This drug is indicated for topical application to the clean skin around the lower abdomen. It is recommended to apply 10 to 20 drops of the product and rub it into the skin. The application should occur twice daily for optimal results. Additionally, this drug may be used as a preventative measure by applying it prior to the onset of menstruation.

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

Dosage and Administration

The recommended dosage for adults is a maximum of 4 ml per day.

Administration should be performed according to the prescribed route, ensuring that the preparation is handled in a sterile manner to maintain product integrity. It is essential to adhere to the specified dosing limit to avoid potential adverse effects.

Healthcare professionals should monitor patients for efficacy and tolerability, adjusting the dosage as necessary within the established maximum limit.

Contraindications

Use of this product is contraindicated for external use only. Patients should discontinue use and consult a healthcare professional if a rash occurs. Additionally, this product must be kept out of reach of children to prevent accidental ingestion or misuse.

Warnings and Precautions

For external use only. It is imperative that healthcare professionals advise patients to refrain from using this product on any internal areas or mucous membranes.

In the event of a rash or any adverse skin reaction, patients should be instructed to discontinue use immediately and consult a healthcare provider for further evaluation and management.

Additionally, this product should be stored out of reach of children to prevent accidental ingestion or misuse. Proper patient education regarding these precautions is essential to ensure safe and effective use.

Side Effects

Patients should be aware that the product is intended for external use only. In the event of a rash occurring, it is advised to discontinue use and consult a healthcare professional. Additionally, the product should be kept out of reach of children to ensure safety.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Menstrual Pain Synergy (menstrual pain). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. There are no specific age ranges, dosage differences, or study outcomes provided for pediatric use in the available data. Caution is advised when administering this medication to ensure safety in the pediatric population.

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

There is no specific information regarding the use of this drug during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the absence of established safety data and the importance of discussing any plans for pregnancy with their healthcare provider.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. The effects on breastfed infants have not been established.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to 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 outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution and consider the overall clinical context when prescribing this medication to patients with hepatic impairment.

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 toxicology experts for guidance on specific management protocols and interventions tailored to the substance involved.

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 that the product is intended for external use only. Patients should be instructed to discontinue use and consult their healthcare provider if a rash occurs. Additionally, it is important to emphasize the necessity of keeping the product out of reach of children to prevent accidental ingestion or misuse.

Storage and Handling

This product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to protect the product from excessive heat and direct sunlight to maintain its integrity and efficacy. Proper storage conditions should be observed to ensure optimal performance.

Additional Clinical Information

The product is administered topically, with patients instructed to apply 10 to 20 drops evenly to clean skin around the lower abdomen. This application should occur twice daily, and it may also be used preventatively by applying before menstruation. 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 Menstrual Pain Synergy, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)