Aprofen

Description

The product is identified as "product." It is associated with the media type "image/jpeg," and a reference image for the product is available as "mm1_aprophen.jpg."

Uses and Indications

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

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

Dosage and Administration

Adults and children aged 12 years and older are advised to take 1 tablet every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 tablet, a dosage of 2 tablets may be administered. It is imperative that the total daily dosage does not exceed 6 tablets within a 24-hour period, unless otherwise directed by a healthcare professional.

For children under 12 years of age, it is recommended to consult a doctor prior to administration.

Contraindications

Use of this product is contraindicated in the following situations:

• The product should be kept out of reach of children to prevent accidental ingestion.

• In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center (1-800-222-1222) without delay.

Warnings and Precautions

Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of such reactions can include hives, facial swelling, wheezing, shock, skin reddening, rash, and blisters. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance without delay.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of experiencing this adverse effect is heightened in certain populations, including individuals aged 60 years or older, those with a history of stomach ulcers or bleeding disorders, and patients concurrently using anticoagulants or steroid medications. Additionally, the risk increases for individuals taking other NSAIDs, whether prescription or over-the-counter, such as aspirin, ibuprofen, or naproxen. Consumption of three or more alcoholic beverages daily while using this product may further elevate the risk of stomach bleeding. It is crucial for patients to adhere strictly to the recommended dosage and duration of use to minimize these risks.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. Serious adverse reactions include severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions may manifest as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters.

Additionally, there is a significant risk of severe stomach bleeding, which may be exacerbated in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, or are concurrently using blood-thinning medications (anticoagulants) or steroid drugs. The risk is also heightened for those taking other nonsteroidal anti-inflammatory drugs (NSAIDs), including prescription or over-the-counter options such as aspirin, ibuprofen, or naproxen. Furthermore, patients who consume three or more alcoholic drinks daily while using this product, or who exceed the recommended dosage or duration of use, may also face an increased risk of stomach bleeding.

It is essential for patients to be aware of these potential adverse reactions and to consult healthcare professionals if they experience any concerning symptoms.

Drug Interactions

Taking ibuprofen concurrently with anticoagulant medications may elevate the risk of severe gastrointestinal bleeding. It is advisable to monitor patients closely for signs of bleeding and consider dosage adjustments as necessary.

Additionally, the concomitant use of ibuprofen with other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen, may also increase the risk of severe stomach bleeding. Healthcare providers should exercise caution and evaluate the need for alternative pain management strategies in patients requiring multiple NSAIDs.

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

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, may have an increased risk of stomach bleeding. Healthcare providers should exercise caution when prescribing medications that may exacerbate this risk in this population. It is essential to monitor these patients closely for any signs of gastrointestinal bleeding and to consider appropriate dose adjustments or alternative therapies as necessary to ensure their safety.

Pregnancy

The use of ibuprofen during pregnancy is contraindicated, particularly in the third trimester. Administration of ibuprofen may pose risks to the fetus, including potential cardiovascular effects. Pregnant patients are advised to avoid the use of ibuprofen unless specifically directed by a healthcare professional.

In cases where ibuprofen is deemed necessary, dosage adjustments may be required; therefore, it is essential for healthcare providers to evaluate the risks and benefits and provide appropriate guidance. Women of childbearing potential should be counseled on these risks and the importance of consulting a healthcare provider before using ibuprofen during pregnancy.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or its effects on lactation. Additionally, there is no available data on the excretion of this medication in breast milk or its potential effects on breastfed infants. Healthcare professionals should consider the absence of information when advising lactating mothers about the use of this medication.

Renal Impairment

There is no specific information available 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 these patients to ensure safety and efficacy.

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 available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with overdosage.

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 question.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as anaphylaxis, angioedema, and urticaria. Gastrointestinal events have been noted, including bleeding, ulceration, and perforation. Renal toxicity has been observed, encompassing acute renal failure and interstitial nephritis. Hepatic toxicity has also been reported, characterized by elevated liver enzymes and hepatitis. Additionally, cardiovascular events, including myocardial infarction and stroke, have been documented. Skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been identified as well.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of safety in the home environment, particularly for households with young children.

In the event of an overdose, healthcare providers should instruct patients to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Patients should be made aware of the potential seriousness of an overdose and the importance of prompt action.

Storage and Handling

The product is supplied in a configuration that ensures optimal handling and storage. 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 to maintain its integrity. Additionally, the product must be kept out of reach of children to ensure safety. Once opened, the product should be discarded to prevent any potential degradation or contamination.

Additional Clinical Information

For adults and children aged 12 years and older, the recommended dosage is 1 tablet every 4 to 6 hours as needed for symptom relief. If pain or fever does not adequately respond to 1 tablet, a maximum of 2 tablets may be taken. However, the total daily dosage should not exceed 6 tablets within a 24-hour period unless otherwise directed by a healthcare professional. For children under 12 years of age, it is advised to consult a doctor for appropriate dosing guidance.

Drug Information (PDF)

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

View product document (PDF)