Coralite Cold and Hot

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for use in specific patient populations as determined by clinical guidelines. The precise indications and usage have not been explicitly stated in the provided information.

Healthcare professionals are advised to consider the absence of information regarding teratogenic and nonteratogenic effects when prescribing this medication. Further clinical evaluation and consultation of relevant guidelines are recommended to ensure appropriate use in targeted patient populations.

Dosage and Administration

No dosage and administration information is available in the provided text.

Contraindications

Use is contraindicated in the following situations:

Application on wounds or damaged skin is prohibited due to the risk of exacerbating the injury or causing irritation. Concurrent use with a heating pad or other topical analgesics is not recommended, as this may increase the risk of adverse effects. The product should not be applied to children under 12 years of age with arthritis-like conditions, as safety and efficacy have not been established in this population.

Additionally, avoid contact with eyes or mucous membranes to prevent irritation. Tight bandaging is contraindicated, as it may lead to increased local irritation or systemic absorption. The product should not be used immediately after bathing or showering, as this may affect its efficacy and increase the risk of skin irritation.

Warnings and Precautions

For external use only. This product is not intended for internal use, and caution should be exercised to prevent accidental ingestion.

General precautions must be observed to ensure safety. It is imperative to keep this product out of the reach of children. In the event of accidental ingestion, immediate medical assistance should be sought by contacting a Poison Control Center at 1-800-222-1222.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: worsening of conditions, persistence of symptoms beyond 7 days, recurrence of symptoms after initial improvement within a few days, or the occurrence of excessive skin irritation. These actions are crucial to ensure patient safety and effective management of any adverse reactions.

Side Effects

Patients should be aware that the product is intended for external use only. In the event that conditions worsen or symptoms persist for more than 7 days, it is advised to stop use and consult a healthcare professional. Additionally, if symptoms clear up and then recur within a few days, or if excessive skin irritation occurs, patients should seek medical advice.

Before using the product, individuals with redness over the affected area should consult a doctor to ensure safe and appropriate use.

Drug Interactions

The concurrent use of this medication with heating pads or other topical analgesics is contraindicated. Co-administration may lead to an increased risk of adverse effects due to enhanced absorption and systemic exposure. It is advised to avoid using these products simultaneously to prevent potential complications. Monitoring for any signs of increased local irritation or systemic effects is recommended if there is a need to use these therapies in close temporal proximity.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age with arthritis-like conditions should not use this medication. For children in this age group, it is advised to consult a healthcare professional prior to use.

For adolescents aged 12 years and older, the medication should not be applied for more than 8 hours at a time and should be used on the affected area no more than three 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 potential adverse effects or changes in efficacy, 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

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 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 absence of specific information regarding overdosage in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdosage.

Recommended Actions In the event of an overdosage, it is essential for healthcare providers to assess the patient's clinical status and initiate appropriate supportive care. Monitoring of vital signs and symptomatic treatment should be implemented as necessary.

Potential Symptoms While specific symptoms of overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise, given the variability in individual responses to medication.

Management Procedures In the absence of specific antidotes or treatment protocols, standard overdosage management practices should be followed. This may include gastric decontamination, such as activated charcoal, if appropriate and within the timeframe of ingestion. Continuous monitoring and supportive care are critical until the patient stabilizes.

Healthcare professionals are encouraged to report any cases of overdosage to the relevant authorities to contribute to the ongoing assessment of the product's safety profile.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

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. Instruct patients that if the medication is swallowed, they should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be informed to use the medication only as directed and to avoid contact with eyes or mucous membranes to prevent irritation or injury. It is important to emphasize that patients should not bandage the area tightly, as this may lead to complications.

Additionally, healthcare providers should counsel patients to discontinue use of the medication at least one hour before taking a bath or shower, and to avoid using it immediately after bathing or showering to ensure optimal effectiveness and safety.

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 room temperature, maintaining a range of 20-25°C (68-77°F). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The product is administered topically, with specific guidelines for different age groups. Adults and children aged 12 years and older should not wear the patch for more than 8 hours and may apply it to the affected area no more than three times daily. For children under 12 years of age, consultation with a doctor is advised prior to use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is also important to keep the product out of reach of children; in the event of ingestion, immediate medical assistance should be sought or contact with a Poison Control Center (1-800-222-1222) is recommended.

Drug Information (PDF)

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

View product document (PDF)