Cetilar

Description

The product is identified by the SPL code 34089-3 and is presented as a clear, colorless to pale yellow liquid. The active ingredient is Cetylpyridinium Chloride. Inactive ingredients consist of Water, Glycerin, Sodium Chloride, Sodium Citrate, Citric Acid, Potassium Sorbate, and Flavor.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with 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 over 12 years of age, the recommended application is to the affected area not more than 3 to 4 times daily. Following each application, it is essential to wash hands thoroughly with soap and water to prevent unintentional contact with other areas of the body or surfaces.

For children 12 years of age or younger, it is advised to consult a healthcare professional prior to use to determine the appropriate course of action.

Contraindications

Use of this product is contraindicated in the following situations:

Tight bandaging should be avoided, as it may lead to compromised circulation. Additionally, application to wounds or damaged skin is contraindicated due to the potential for irritation or adverse reactions.

Warnings and Precautions

For external use only; contact with the eyes should be strictly avoided to prevent irritation or injury. It is imperative that the product is not applied to wounds or damaged skin, as this may exacerbate the condition or lead to adverse effects.

When using this product, it is essential to avoid tight bandaging, which could impede circulation and lead to complications. Healthcare professionals should advise patients to 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.

In the event of accidental ingestion, immediate medical assistance should be sought, or the individual should contact a Poison Control Center without delay to ensure appropriate management and care.

Side Effects

Patients using this product should be aware that it is for external use only and must avoid contact with the eyes. It is important to follow specific guidelines during use; patients should not bandage the area tightly and should refrain from applying the product to wounds or damaged skin.

In the event that the condition worsens or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients are advised to stop use and consult a healthcare professional. Additionally, pregnant or breastfeeding individuals should seek advice from a health professional prior to use.

This product should be kept out of reach of children. In cases where the product is swallowed, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

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 Cetilar (menthol 1.4%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients 12 years of age or younger should consult a healthcare professional prior to use. For adolescents and children over 12 years, the recommended application is to the affected area no more than 3 to 4 times daily.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

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 health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

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, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures should include supportive care and symptomatic treatment as necessary. Continuous evaluation of the patient's condition is recommended to address any complications that may arise.

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 seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important for patients to understand that they should discontinue use and consult a doctor if their condition worsens. Additionally, patients should be informed to stop using the product and seek medical advice if symptoms persist for more than 7 days or if symptoms resolve and then recur within a few days.

Providers should also emphasize that while using this product, patients should avoid bandaging the area tightly. Furthermore, patients must be cautioned against applying the product to wounds or damaged skin to prevent potential complications.

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 50-86 °F (10-30ºC). The storage area should be dry and free from exposure to light and localized heat sources to maintain product integrity. Special handling precautions should be observed to ensure optimal conditions are met during storage.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)