Ibuprofen

Description

XL-DOL is a pharmaceutical formulation containing ibuprofen as the active ingredient, with a dosage strength of 200 mg. Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) utilized for its analgesic and anti-inflammatory properties. The product is designed for oral administration and is presented in a suitable dosage form for effective delivery.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, toothache, backache, menstrual cramps, the common cold, muscular aches, and minor pain of arthritis. 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 12 years and older are advised to take 1 softgel every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 softgel, a dosage of 2 softgels may be administered. It is imperative that the total daily dosage does not exceed 6 softgels 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 before administration.

Contraindications

Use is contraindicated in individuals with a history of allergic reactions to any other pain reliever or fever reducer.

Administration is also contraindicated immediately before or after heart surgery due to potential complications.

Additionally, the use of ibuprofen during the last trimester of pregnancy is contraindicated unless specifically directed by a healthcare professional, as it may pose risks to the unborn child or lead to complications during delivery.

Warnings and Precautions

Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic response may include hives, facial swelling, asthma (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.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of such an event is heightened in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are concurrently using blood-thinning medications (anticoagulants) or steroids, are taking other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic beverages daily while using this product, or exceed the recommended dosage or duration of use.

NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. The risk is amplified when the medication is used in excess of the recommended dosage or for an extended period.

In cases of overdose, immediate medical attention is required. Healthcare professionals should advise patients to contact a Poison Control Center (1-800-222-1222) without delay.

Patients should be instructed to discontinue use and consult a physician if they experience any signs of stomach bleeding, which may manifest as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation. Patients should also seek medical advice if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, if redness or swelling occurs in the affected area, or if any new symptoms arise.

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, which can be categorized by seriousness and frequency.

Severe allergic reactions have been reported, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters.

The use of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), carries a warning for the potential risk of severe stomach bleeding. This risk is heightened in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, consume three or more alcoholic drinks daily while using the product, or take other NSAIDs (including aspirin, ibuprofen, or naproxen). Patients are advised to discontinue use and consult a healthcare provider if they experience signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain.

Additionally, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced in patients who exceed the recommended dosage or duration of use. Patients should seek medical attention if they exhibit symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling.

Patients are also cautioned against using ibuprofen if they have a history of allergic reactions to other pain relievers or fever reducers, or if they are scheduled for heart surgery. It is recommended that individuals consult a healthcare provider prior to use if they have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma, or if they are taking diuretics. Furthermore, patients under a physician's care for serious conditions or those taking aspirin for cardiovascular protection should seek advice, as ibuprofen may diminish the effectiveness of aspirin.

Common adverse reactions may include worsening pain lasting more than 10 days, fever persisting beyond 3 days, redness or swelling in the affected area, or the emergence of any new symptoms.

Drug Interactions

Ibuprofen may interact with several classes of medications, leading to significant clinical effects that warrant careful consideration.

Pharmacodynamic Interactions

Ibuprofen has the potential to diminish the cardioprotective effects of aspirin when both medications are used concurrently for the prevention of heart attack or stroke. It is advisable for healthcare providers to assess the necessity of ibuprofen in patients who are on low-dose aspirin therapy for cardiovascular protection.

Additionally, the concomitant use of ibuprofen with anticoagulants or steroid medications may elevate the risk of gastrointestinal bleeding. This risk is further compounded when ibuprofen is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen. Clinicians should monitor patients closely for signs of gastrointestinal complications and consider alternative pain management strategies when appropriate.

Recommendations for Monitoring and Dosage Adjustments

Healthcare professionals should exercise caution when prescribing ibuprofen to patients who are also taking anticoagulants or steroids. Regular monitoring for gastrointestinal symptoms is recommended, and dosage adjustments may be necessary based on the patient's overall risk profile and concurrent medication use.

Packaging & NDC

Below are the non-prescription pack sizes of Ibuprofen (ibuprofen 200 mg). 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. For adolescents aged 12 years and older, the recommended dosage is 1 softgel every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 softgel, a maximum of 2 softgels may be administered. It is important not to exceed 6 softgels in a 24-hour period unless directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, may have an increased risk of severe stomach bleeding. Healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the potential for heightened adverse effects.

It is advisable to closely monitor elderly patients for any signs of gastrointestinal bleeding and to evaluate the necessity of dosage adjustments based on individual patient factors. Careful assessment of the risk-benefit profile is essential in this population to ensure safe and effective use of the medication.

Pregnancy

Pregnant patients are advised to consult a healthcare professional before using this medication. It is particularly important to avoid the use of ibuprofen during the last trimester of pregnancy unless explicitly directed by a physician. The use of ibuprofen in this period may pose risks to the developing fetus and could lead to complications during delivery. Therefore, careful consideration and professional guidance are essential for women of childbearing potential when contemplating the use of this medication during pregnancy.

Lactation

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

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the severity of renal impairment.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have conditions such as liver cirrhosis. It is essential for patients with compromised liver function to receive appropriate medical guidance to assess the potential risks and benefits associated with the use of this medication. Monitoring of liver function may be necessary to ensure safety and efficacy in this population.

Overdosage

Overdosage of ibuprofen can result in significant health risks. Healthcare professionals should be aware of the potential symptoms and management strategies associated with such incidents.

Symptoms of Overdosage Patients experiencing an ibuprofen overdose may present with a range of symptoms, including nausea, vomiting, stomach pain, drowsiness, headache, and confusion. In more severe cases, the consequences can escalate to critical conditions such as kidney failure, liver damage, or gastrointestinal bleeding.

Recommended Actions In the event of a suspected overdose, it is imperative to seek emergency medical attention immediately. Prompt intervention is crucial to mitigate the risks associated with ibuprofen overdosage and to initiate appropriate management procedures.

Nonclinical Toxicology

It is especially important not to use ibuprofen during the last three months of pregnancy unless specifically directed by a healthcare professional, as it may lead to complications for the unborn child or during delivery.

Nonsteroidal anti-inflammatory drugs (NSAIDs), with the exception of aspirin, have been associated with an increased risk of serious cardiovascular events, including heart attack, heart failure, and stroke, which can be fatal. The likelihood of these adverse effects is heightened with prolonged use or exceeding the recommended dosage.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, cases of stomach bleeding have been noted, particularly in patients with certain risk factors. There is also an increased risk of heart attack, heart failure, and stroke associated with the use of NSAIDs, especially when used at higher doses or for extended durations beyond those recommended.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical help or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. Patients should be informed not to use this medication if they have ever experienced an allergic reaction to any other pain reliever or fever reducer. It is crucial to instruct patients to avoid using this product right before or after heart surgery.

Providers should encourage patients to consult a doctor before use if they have a history of stomach bleeding or if they have experienced problems or serious side effects from taking pain relievers or fever reducers. Additionally, patients with a history of stomach issues, such as heartburn, high blood pressure, heart disease, liver cirrhosis, or kidney disease should also seek medical advice prior to use. Those with asthma or who are taking a diuretic should be advised to consult a healthcare professional before using this medication.

Patients should be reminded to discuss their current medications with a doctor or pharmacist, especially if they are taking aspirin for heart attack or stroke, as ibuprofen may diminish the effectiveness of aspirin. It is also important for patients to inform their healthcare provider if they are under care for any serious condition or if they are taking any other drugs.

When using this product, patients should be advised to take it with food or milk if they experience stomach upset. They should be instructed to stop use and consult a doctor if they notice any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Patients should also be informed to seek medical attention if they experience symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling. They should be advised to stop use and consult a doctor if their pain worsens or lasts more than 10 days, if their fever worsens or lasts more than 3 days, if there is redness or swelling in the painful area, or if any new symptoms arise.

For patients who are pregnant or breastfeeding, it is essential to recommend consulting a healthcare professional before use. Special caution should be emphasized regarding the use of ibuprofen during the last three months of pregnancy, as it may pose risks to the unborn child or lead to complications during delivery.

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 a temperature range of 20°C to 25°C (68°F to 77°F) and protected from light to prevent degradation. Additionally, it is essential to keep the product out of reach of children. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The route of administration for the medication is oral. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly crucial to avoid ibuprofen during the last trimester of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)