Lactigo

Description

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

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints.

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

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is performed with clean hands and that the affected area is clean and dry prior to administration.

For children under 2 years of age, it is advised to consult a healthcare professional before use to determine the appropriate course of action.

Contraindications

Use is contraindicated in children due to the risk of 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. It is imperative to avoid contact with the eyes and mucous membranes to prevent irritation or adverse reactions. In the event that symptoms worsen, or if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days, the use of this product should be discontinued immediately, and a healthcare professional should be consulted.

This product should not be applied to wounds or damaged skin, as this may exacerbate irritation or lead to complications. Additionally, it is important to avoid tight bandaging of the area where the product is applied, as this may hinder proper healing and increase the risk of adverse effects.

In cases of accidental ingestion, it is crucial to seek medical assistance or contact a Poison Control Center without delay to ensure appropriate management and care.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions. This product is intended for external use only and should not come into contact with the eyes or mucous membranes. In the event that symptoms worsen, or if they persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients are advised to discontinue use and consult a healthcare professional.

Additionally, the product should not be applied to wounds or damaged skin, and it is important to avoid tight bandaging of the area where the product is applied. These precautions are essential to minimize the risk of adverse reactions and ensure the safety and efficacy of the treatment.

Drug Interactions

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

Packaging & NDC

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

Pediatric Use

Pediatric patients under 2 years of age should consult a doctor prior to use. For children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to keep this product out of reach of children to prevent accidental ingestion.

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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

Pregnancy

There is no information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or any special precautions that should be taken. Healthcare professionals are advised to consider the lack of data when prescribing this medication to pregnant patients and to weigh the potential risks and benefits. Women of childbearing potential should be counseled accordingly.

Lactation

There is no specific information available regarding the use of LactiGo (menthol gel) in nursing mothers or its effects on lactation. Consequently, healthcare professionals should exercise caution when recommending this product to lactating mothers. The potential for excretion in breast milk and its effects on breastfed infants remain undetermined. It is advisable for lactating mothers to consult with their healthcare provider before using this product.

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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide valuable assistance in the management of overdosage cases.

Continued vigilance and adherence to dosing recommendations are crucial to minimize the risk of overdosage and ensure patient safety.

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 the potential risks associated with ingestion by children.

In the event that the medication is swallowed, healthcare providers should instruct patients to seek medical help or contact a Poison Control Center immediately. This prompt action is crucial to ensure the safety and well-being of the patient.

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 a temperature range of 15°C to 30°C (59°F to 86°F) to maintain its efficacy and stability. Proper container requirements should be adhered to, ensuring that the product is kept in a suitable environment. Special handling needs must be observed to prevent any compromise to the product's integrity during storage and transportation.

Additional Clinical Information

Patients aged 2 years and older are advised 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 recommended to consult a doctor prior to use. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)