Excinol Arthritis (acetaminophen)

Description

Excinol Arthritis contains acetaminophen as its active ingredient, with a dosage strength of 650 mg per unit. Acetaminophen is a widely used analgesic and antipyretic agent. The formulation is designed for the management of pain and fever associated with arthritis.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including arthritis, headache, muscular aches, toothache, backache, and menstrual cramps. Additionally, it is indicated for the temporary reduction of fever and for alleviating discomfort associated with the common cold.

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

Dosage and Administration

Patients are advised to take 2 caplets every 8 hours with a full glass of water. It is important to swallow the caplets whole; they should not be crushed, chewed, split, or dissolved to ensure proper release and absorption of the medication.

The maximum recommended dosage is 6 caplets within a 24-hour period. Patients should not exceed this limit to avoid potential adverse effects. Additionally, the use of this medication should not extend beyond 10 days unless directed by a healthcare professional.

For individuals under 18 years of age, it is recommended to consult a doctor prior to use to ensure safety and appropriateness of treatment.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or non-prescription, due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• History of allergic reaction to acetaminophen or any of the inactive ingredients in this product, as this may lead to severe hypersensitivity reactions.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that the risk of liver injury increases significantly if they exceed 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic beverages daily while taking this product.

It is crucial to exercise caution in specific patient populations. Patients with liver disease should be advised to consult a healthcare provider prior to use. Additionally, individuals taking the anticoagulant warfarin should seek guidance from a doctor or pharmacist before using this product, as potential interactions may occur.

Patients should be instructed to discontinue use and contact their healthcare provider if any of the following occur: pain worsens or persists for more than 10 days, fever intensifies or lasts longer than 3 days, new symptoms develop, or if there is any redness or swelling. These symptoms may indicate a serious underlying condition that requires further evaluation.

No specific instructions for obtaining emergency medical help are provided; however, healthcare professionals should remain vigilant for signs of severe adverse reactions and advise patients accordingly.

Side Effects

Patients using this product should be aware of the potential for serious adverse reactions, particularly related to liver health. The product contains acetaminophen, and severe liver damage may occur if patients exceed 4,000 mg of acetaminophen in a 24-hour period, use it in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if pain worsens or persists for more than 10 days, if fever intensifies or lasts longer than 3 days, if new symptoms develop, or if there is any redness or swelling. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Additionally, patients with a history of liver disease should seek medical advice before using this product. It is also recommended that individuals taking the blood-thinning medication warfarin consult their doctor or pharmacist prior to use to avoid potential interactions.

Drug Interactions

Patients taking warfarin, a blood-thinning medication, should consult their healthcare provider or pharmacist prior to initiating treatment with this drug. This interaction is significant due to the potential for altered anticoagulant effects, which may necessitate dosage adjustments or increased monitoring of coagulation parameters to ensure patient safety.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 18 years of age should consult a healthcare professional before use. It is essential to evaluate the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

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. It is advisable to monitor these patients closely for any 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 on 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

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this population to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if patients exceed the following limits:

• More than 4,000 mg of acetaminophen in a 24-hour period.

• Concurrent use with other medications that contain acetaminophen.

• Consumption of three or more alcoholic drinks daily while using this product.

Due to the potential for increased risk of liver toxicity, patients with compromised liver function should be advised to adhere strictly to the recommended dosage and to avoid the aforementioned risk factors. Regular assessment of liver function may be warranted in these patients to ensure safety and efficacy of treatment.

Overdosage

In cases of overdosage, significant health risks are associated with the consumption of acetaminophen.

Risk of Severe Liver Damage Healthcare professionals should be aware that severe liver damage may occur if an individual ingests more than 4,000 mg of acetaminophen within a 24-hour period. This risk is compounded when acetaminophen is taken concurrently with other medications that also contain acetaminophen, as this can lead to cumulative dosing that exceeds safe limits.

Additionally, the risk of severe liver damage is heightened in individuals who consume three or more alcoholic beverages daily while using acetaminophen. The interaction between alcohol and acetaminophen can exacerbate hepatotoxicity, leading to potentially life-threatening conditions.

Recommended Actions In the event of suspected overdosage, immediate medical evaluation is essential. Healthcare providers should assess the patient's clinical status and consider the need for supportive care and potential interventions, such as the administration of N-acetylcysteine, which is an antidote for acetaminophen toxicity. Monitoring liver function tests and providing symptomatic treatment may also be necessary based on the severity of the symptoms presented.

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 to keep this medication out of reach of children to prevent accidental ingestion. Patients should be informed not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or non-prescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult with a doctor or pharmacist.

It is crucial to inform patients that they should not use this medication if they have a history of allergic reactions to acetaminophen or any of the inactive ingredients present in the product. Patients should be instructed to discontinue use and seek medical advice if their pain worsens or persists for more than 10 days, or if their fever worsens or lasts longer than 3 days. Additionally, patients should be advised to stop using the medication and consult a doctor if they experience new symptoms, or if they notice any redness or swelling, as these may indicate a serious condition.

Healthcare providers should also recommend that patients consult with a doctor before using this medication if they have liver disease. Furthermore, patients taking the blood-thinning medication warfarin should be advised to speak with their doctor or pharmacist prior to using this product to ensure safety and avoid potential interactions.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which can be referenced for identification. It is essential to store the product at a temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy.

Healthcare professionals should ensure that the neck wrap is intact before use; the product must not be utilized if the neck wrap is broken or missing. For traceability, the lot number and expiration date can be found on the end panel of the packaging. Proper handling and storage conditions are crucial to ensure the product remains safe and effective for patient use.

Additional Clinical Information

Patients should take the medication orally, with a recommended dosage of 2 caplets every 8 hours, ensuring they swallow the caplets whole without crushing, chewing, splitting, or dissolving them. It is important not to exceed 6 caplets within a 24-hour period and to limit use to no more than 10 days unless directed by a healthcare professional.

Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. Additionally, patients with liver disease or those taking the blood-thinning medication warfarin should seek medical advice before starting treatment.

Drug Information (PDF)

This file contains official product information for Excinol Arthritis (acetaminophen), including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)