Arthriten

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, including the minor pain associated with arthritis.

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

Adults are advised to take two (2) caplets every 6 hours while symptoms persist. The total dosage should not exceed 4 doses (8 caplets) within a 24-hour period, unless otherwise directed by a healthcare professional. Each dose should be accompanied by a full glass of water to ensure proper administration.

This medication is intended for use by normally healthy adults only. For individuals under 18 years of age, usage should be strictly in accordance with a physician's instructions.

Contraindications

Use of this product is contraindicated in the following situations:

• Patients with a history of allergic reactions to any pain reliever or fever reducer.

• Concurrent use with any other medication containing acetaminophen, whether prescription or non-prescription. If uncertain about the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

• Prolonged use for pain exceeding 10 days, unless specifically directed by a healthcare provider.

• Use for fever lasting more than 3 days, unless directed by a healthcare provider.

Warnings and Precautions

Children and teenagers who are experiencing or recovering from chickenpox or flu-like symptoms should not use this product due to the risk of Reye's Syndrome. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is imperative to consult a healthcare professional, as these symptoms may indicate the onset of this rare but serious illness.

Aspirin, a component of this product, has the potential to cause severe allergic reactions. Symptoms of such reactions may include hives, facial swelling, asthma (wheezing), and shock. Healthcare professionals should be vigilant for these signs and advise patients to seek immediate medical attention if they occur.

Acetaminophen, another ingredient in this formulation, may lead to severe skin reactions. Symptoms can manifest as skin reddening, blisters, or rash. Should any skin reactions develop, it is crucial to discontinue use and seek medical assistance promptly.

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 8 caplets within a 24-hour period, using other products that also contain acetaminophen, or consuming three or more alcoholic drinks daily while using this product. Healthcare providers should monitor patients for signs of liver damage and educate them on the importance of adhering to recommended dosages.

Additionally, the presence of a non-steroidal anti-inflammatory drug (NSAID) in this product raises concerns regarding stomach bleeding. The risk is heightened in individuals aged 60 or older, those with a history of stomach ulcers or bleeding problems, patients taking blood thinners or steroid medications, and those consuming three or more alcoholic drinks daily while using this product. It is also important to consider the concurrent use of other NSAIDs, whether prescription or over-the-counter, such as aspirin, ibuprofen, or naproxen. Healthcare professionals should advise patients to take this product only as directed and to be aware of the signs of stomach bleeding, which include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Patients should be instructed to stop use and consult a healthcare provider if they experience an allergic reaction, if symptoms do not improve, if pain or fever persists or worsens, if redness or swelling occurs, if they notice ringing in the ears or hearing loss, or if new symptoms arise.

In the event of an overdose, it is critical to seek emergency medical help or contact a poison control center immediately. Prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Side Effects

Patients using this product should be aware of several serious and common adverse reactions associated with its use.

Reye's Syndrome is a rare but serious illness that may occur in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. If patients experience changes in behavior accompanied by nausea and vomiting while using this product, they should consult a doctor immediately, as these may be early signs of Reye's Syndrome.

Allergic reactions to this product can be severe. Patients may experience symptoms such as hives, facial swelling, asthma (wheezing), or shock. Additionally, acetaminophen, one of the components of this product, may lead to severe skin reactions, including skin reddening, blisters, or rash. If any skin reactions occur, patients should discontinue use and seek medical assistance promptly.

The product contains acetaminophen, which poses a risk of severe liver damage if patients exceed the maximum daily dosage of 8 caplets within 24 hours, use it in conjunction with other acetaminophen-containing products, or consume three or more alcoholic drinks daily while using this product.

Furthermore, the non-steroidal anti-inflammatory drug (NSAID) component may increase the risk of severe stomach bleeding, particularly in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking blood thinners or steroid medications, or are using other NSAIDs (such as aspirin, ibuprofen, or naproxen). The risk is also heightened if patients consume three or more alcoholic drinks daily or take the medication for longer than directed.

Patients are advised to stop using the product and consult a doctor if they experience any signs of an allergic reaction, if symptoms do not improve, if pain or fever persists or worsens, if redness or swelling is present, if they notice ringing in the ears or hearing loss, or if new symptoms arise. Additionally, they should seek medical attention if they exhibit any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Drug Interactions

Taking this product concurrently with other medications containing acetaminophen, whether prescription or non-prescription, may elevate the risk of severe liver damage. It is advisable to monitor liver function closely in patients using this combination.

The concomitant use of this product with certain classes of drugs may increase the risk of severe gastrointestinal bleeding. This includes:

• Anticoagulants (blood thinners)

• Corticosteroids (steroid drugs)

• Other nonsteroidal anti-inflammatory drugs (NSAIDs), both prescription and non-prescription, such as aspirin, ibuprofen, and naproxen

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

Patients taking these combinations should be monitored for signs of gastrointestinal bleeding and may require dosage adjustments or additional protective measures, such as the use of gastroprotective agents.

No specific interactions with laboratory tests have been identified in the available data.

Packaging & NDC

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

Pediatric Use

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product due to the risk of Reye's Syndrome, a rare but serious illness. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is essential to consult a doctor, as these may be early signs of Reye's Syndrome.

For individuals under 18 years of age, the product should only be used as directed by a healthcare professional. It is crucial to keep this product out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or a poison control center should be contacted. Prompt medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of severe stomach bleeding. It is essential for healthcare providers to advise these patients to consult a physician prior to using this medication if they fall within this age group and are concerned about the stomach bleeding warning.

Additionally, geriatric patients with pre-existing conditions such as high blood pressure, heart disease, liver disease, liver cirrhosis, or kidney disease should also seek medical advice before initiating treatment. This precaution is crucial to ensure the safe use of the medication and to mitigate potential risks associated with these underlying health issues. Monitoring and appropriate dose adjustments may be necessary based on the individual health status of elderly patients.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The use of aspirin during the last trimester of pregnancy is particularly cautioned against, as it may lead to adverse effects on fetal outcomes or complications during delivery. Therefore, it is essential that pregnant patients only use aspirin in this period if explicitly directed by a healthcare provider.

Lactation

Lactating mothers are advised to consult a healthcare professional before using this medication. It is particularly important to avoid the use of aspirin during the last three months of pregnancy, as it may pose risks to the unborn child or lead to complications during delivery. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication while breastfeeding.

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 patient population.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if patients exceed the maximum daily dosage of 8 caplets within a 24-hour period. Additionally, patients should avoid the concurrent use of other products containing acetaminophen, as this can further increase the risk of liver damage.

Furthermore, patients with compromised liver function are advised to limit alcohol consumption to fewer than 3 alcoholic drinks per day while using this product. Monitoring of liver function may be warranted in patients with existing liver conditions, and any signs of liver injury should be promptly evaluated.

Overdosage

In cases of overdosage, it is critical to recognize the potential for severe liver damage associated with the use of this product.

Maximum Daily Dosage Healthcare professionals should advise patients that exceeding 8 caplets within a 24-hour period poses a significant risk of severe liver damage. This dosage represents the maximum daily limit for safe consumption of this product.

Concurrent Use with Acetaminophen The risk of severe liver damage is further heightened when this product is taken in conjunction with other medications containing acetaminophen. It is essential for healthcare providers to assess all medications a patient is using to prevent unintentional overdose.

Alcohol Consumption Patients should be cautioned against the consumption of 3 or more alcoholic drinks daily while using this product, as this can also lead to severe liver damage. Healthcare professionals should inquire about alcohol intake during patient assessments to mitigate this risk.

In the event of suspected overdosage, immediate medical attention is warranted. Monitoring liver function and providing supportive care are critical components of management.

Nonclinical Toxicology

It is especially important not to use aspirin during the last three months of pregnancy unless definitely directed by a doctor, as it may cause problems in the unborn child or complications during delivery. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the text.

Postmarketing Experience

Serious side effects have been reported voluntarily or identified through surveillance programs. Healthcare professionals and patients are encouraged to report any serious adverse events to the designated phone number provided under the "Questions?" section. This information contributes to ongoing safety monitoring and evaluation of the product.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial to seek medical help or contact a poison control center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use the medication if they have ever experienced an allergic reaction to any other pain reliever or fever reducer. Additionally, they should not use this medication in conjunction with any other drug containing acetaminophen, whether prescription or non-prescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist.

It is important to instruct patients not to use the medication for more than 10 days for pain or more than 3 days for fever unless directed by a doctor. Patients should be advised to stop use and consult a doctor if they experience any allergic reactions, if symptoms do not improve, or if pain or fever persists or worsens. They should also seek medical advice if they notice redness or swelling, experience ringing in the ears or hearing loss, or if new symptoms arise.

Patients should be made aware of the signs of stomach bleeding and instructed to stop use and seek medical attention if they experience any of the following: feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. It is advisable to ask a doctor before use if the patient has a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them.

Furthermore, patients should be encouraged to consult a doctor before using the medication if they have high blood pressure, heart disease, liver disease, liver cirrhosis, or kidney disease. They should also seek medical advice if they are taking a diuretic or any prescription drug for diabetes, gout, or arthritis, as well as if they are taking any other medications.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, specifically within the range of 20°C to 25°C (68°F to 77°F). It is essential to protect the product from light exposure to ensure its stability and effectiveness.

Healthcare professionals are advised to inspect the seal of the container prior to use. The product should not be utilized if the seal appears broken or if the contents do not match the product description. Additionally, any remaining product should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

The medication is administered orally, with the recommended dosage for adults being two caplets every six hours while symptoms persist, not to exceed four doses (eight caplets) in a 24-hour period, unless otherwise directed by a healthcare professional.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding, as the use of aspirin during the last trimester of pregnancy may pose risks to the unborn child or lead to complications during delivery. Additionally, it is crucial to keep the medication out of reach of children, and in the event of an overdose, patients should seek medical assistance or contact a poison control center immediately, as prompt attention is essential for both adults and children, even in the absence of symptoms.

Drug Information (PDF)

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

View product document (PDF)