Kofal

Description

Kofal MP PDP is a pharmaceutical formulation designed for specific therapeutic applications. The product's precise chemical composition and structural characteristics are integral to its efficacy. It is presented in a dosage form suitable for administration, ensuring optimal delivery of its active components. The formulation exhibits a defined appearance, consistent with industry standards for quality and safety. Further details regarding its molecular weight and chemical formula are essential for understanding its pharmacological properties and potential interactions.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with conditions such as simple backache, arthritis, strains, bruises, and sprains.

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

Dosage and Administration

For adults and children aged 12 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 dry before application.

For children under 12 years of age, the product should not be used without consulting a healthcare professional.

Contraindications

Use of this product is contraindicated in the following situations:

Application on wounds or irritated skin is prohibited due to the potential for exacerbating irritation or delaying healing. Additionally, tight bandaging is not recommended, as it may lead to compromised circulation and increased risk of adverse effects.

Warnings and Precautions

For external use only; contact with the eyes should be strictly avoided. Application on wounds or irritated skin is contraindicated. It is essential to refrain from tightly bandaging the area where the product is applied.

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

This product must be kept out of reach of children. In cases of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

Side Effects

Patients should be aware that the product is for external use only and should avoid contact with the eyes. It is contraindicated to apply the product on wounds or irritated skin, and it should not be bandaged tightly.

In the event that the condition worsens, or if symptoms persist for more than 7 days or clear up and then recur within a few days, patients are advised to stop use and consult a healthcare professional immediately.

For pregnant or breastfeeding individuals, it is recommended to seek advice from a healthcare professional prior to use.

Additionally, the product should be kept out of reach of children. In cases of accidental ingestion, medical assistance should be sought immediately, or contact with a Poison Control Center is advised.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not use this medication without consulting a doctor. For adolescents and adults aged 12 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

Geriatric Use

There is no specific information regarding the use of Kofal Max Power Menthol ointment in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as the absence of data necessitates careful consideration of individual patient factors and potential risks. Monitoring for efficacy and adverse effects is recommended in this population, given the lack of established guidelines for geriatric use.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is currently no available data regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

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 medication. Consequently, there are no 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, it is imperative to seek immediate medical assistance. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center without delay if the substance has been ingested.

Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment of the patient's condition is essential. Prompt recognition of symptoms can facilitate timely intervention and management.

Management of overdosage should be guided by the severity of symptoms and the specific substance involved. Healthcare providers are encouraged to follow established protocols for the treatment of overdosage, which may include supportive care and symptomatic treatment as necessary.

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.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event that the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be instructed not to apply the medication on wounds or irritated skin, as this may exacerbate the condition. Additionally, they should be cautioned against bandaging the area tightly, as this could lead to further complications.

It is important for healthcare providers to inform patients to stop using the medication and consult a doctor immediately if their condition worsens. Patients should also be advised to discontinue use and seek medical advice if symptoms persist for more than 7 days or if symptoms clear up and then recur within a few days.

Storage and Handling

The product is supplied in a container with a clear seal over the jar. It is essential to inspect the seal prior to use; do not use the product if the seal is broken, torn, or missing.

For optimal storage, the product should be maintained at a temperature range of 59° to 86°F (15° to 30°C). Proper adherence to these storage conditions is crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)