Ibuprofen

Description

EQUALINE® is a nonsteroidal anti-inflammatory drug (NSAID) containing ibuprofen as its active ingredient. Each tablet is formulated to deliver 200 mg of ibuprofen, serving as a pain reliever and fever reducer. The product is available in a dosage form of coated tablets, with a total of 100 tablets per package. The National Drug Code (NDC) for this product is 41163-116-03. EQUALINE® is comparable to Motrin® IB in terms of its active ingredient.

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

The medication should be administered orally. For adults and children aged 12 years and older, the recommended dosage is 1 tablet every 4 to 6 hours as needed while symptoms persist. If the initial dose of 1 tablet does not adequately relieve pain or fever, a dose of 2 tablets may be taken. However, the total daily dosage must 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 recommendations. It is important to use the smallest effective dose to manage symptoms and to adhere strictly to the prescribed dosage guidelines.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer, due to the risk of severe hypersensitivity reactions. Additionally, the product should not be used immediately before or after heart surgery, as it may interfere with postoperative recovery and increase the risk of complications.

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 is associated with a risk of severe stomach bleeding. The likelihood of experiencing such adverse effects is heightened in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are concurrently using anticoagulants or steroid medications, 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.

The use of NSAIDs, excluding aspirin, is linked to an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk escalates with the use of higher doses or prolonged treatment beyond the recommended guidelines.

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

Patients should be instructed to discontinue use and consult a physician if they experience any of the following symptoms indicative of stomach bleeding: feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, symptoms suggestive of heart problems or stroke warrant immediate medical evaluation and include chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling. 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 may experience a range of adverse reactions associated with the use of this product, which contains an NSAID. Serious adverse reactions include severe allergic reactions, which may manifest as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters, particularly in individuals with a known allergy to aspirin.

The use of this NSAID is also associated with an increased risk of severe stomach bleeding, especially 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, or exceed the recommended dosage or duration of use. Signs of stomach bleeding that warrant immediate medical attention include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Additionally, there is a warning regarding the increased risk of heart attack, heart failure, and stroke associated with NSAID use, excluding aspirin. This risk is heightened when the medication is used in excess of the recommended dosage or for prolonged periods. Patients should seek medical advice if they experience symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling.

Common adverse reactions may include worsening pain lasting more than 10 days, fever persisting beyond three days, or the presence of redness or swelling in the affected area. Patients are advised to consult a healthcare professional if any new symptoms arise.

Before using this product, patients should consult a doctor if they have a history of serious side effects from pain relievers or fever reducers, if the stomach bleeding warning applies to them, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. It is also recommended to seek medical advice if taking aspirin for heart attack or stroke, as ibuprofen may diminish the cardioprotective effects of aspirin.

Drug Interactions

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

Interactions with Antiplatelet Agents: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 to avoid the simultaneous use of ibuprofen and aspirin for these indications to ensure optimal therapeutic outcomes.

Interactions with Anticoagulants and Corticosteroids:The concomitant use of ibuprofen with anticoagulants or steroid medications increases the risk of gastrointestinal bleeding. Clinicians should monitor patients closely for signs of bleeding and consider dosage adjustments or alternative therapies when prescribing ibuprofen in patients receiving these medications.

Cardiovascular Risks:The use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, is associated with an elevated risk of cardiovascular events such as heart attack, heart failure, and stroke. This risk is particularly pronounced when ibuprofen is used in higher doses or for extended periods. It is recommended that healthcare providers assess the necessity of ibuprofen therapy and consider the lowest effective dose for the shortest duration possible to mitigate these risks.

Packaging & NDC

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

Geriatric Use

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

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. It is particularly important to avoid the use of ibuprofen after 20 weeks of pregnancy unless specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery. Healthcare providers should carefully consider the potential risks and benefits when prescribing this medication to pregnant patients.

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 healthcare provider, 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 this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering its use in lactating individuals.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of kidney disease. It is essential to assess the patient's overall health status, including any comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, asthma, or a history of stroke, as these factors may influence the management of their renal function and the appropriateness of treatment. Monitoring and potential dosing adjustments may be necessary based on the patient's renal function and associated health conditions.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have a history of liver cirrhosis. It is essential for these patients to discuss their liver function status, as compromised liver function may influence the safety and efficacy of the treatment. Monitoring of liver function may be warranted in this population to ensure appropriate management and to mitigate potential risks associated with the use of the medication.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations, as timely medical support can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care, symptomatic treatment, and specific antidotes if applicable. Healthcare providers should remain vigilant and prepared to implement appropriate interventions based on the clinical presentation of the patient.

Nonclinical Toxicology

It is especially important not to use ibuprofen during the last three months of pregnancy unless definitely directed to do so 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 specific details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the medication. Reports include gastrointestinal bleeding, renal impairment, and elevations in liver enzymes. Additionally, cases of anaphylaxis and serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been documented.

Cardiovascular events, including heart attack and stroke, have been observed in patients using nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen. Furthermore, elevated blood pressure and heart failure have been noted in postmarketing surveillance. Instances of hypersensitivity reactions, including asthma exacerbations and allergic reactions, have also been reported in patients taking ibuprofen.

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, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Patients should be informed to take the medication with food or milk if they experience any stomach upset. They should be cautioned to stop use and consult a doctor if they notice any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve.

Additionally, patients should be advised to discontinue use and seek medical attention if they experience symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or swelling in the legs. They should also be instructed to consult a doctor if their pain worsens or persists for 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.

Patients should be encouraged to ask a doctor before use if they have experienced problems or serious side effects from pain relievers or fever reducers in the past. It is also important for patients to consult a doctor if the warning regarding stomach bleeding applies to them, or if they have a history of stomach issues such as heartburn.

Furthermore, patients should be advised to seek medical advice before using the medication if they have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. They should also consult a doctor if they are taking a diuretic or if they are under a doctor's care for any serious condition. Lastly, patients should be reminded to speak with a doctor or pharmacist before using the medication if they are taking aspirin for heart attack or stroke, as ibuprofen may reduce the effectiveness of aspirin.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature of 20-25°C (68-77°F). Care must be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F). Proper storage conditions are essential to maintain the integrity and efficacy of the product.

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.

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)