Ibuprofen

Description

Ibuprofen Caplets are nonsteroidal anti-inflammatory drugs (NSAIDs) indicated for the relief of pain and reduction of fever. These caplets are manufactured by Granules India Limited, located in Madhapur, Hyderabad, India, and are distributed by Western Family Foods, Inc., with a mailing address of PO Box 4057, Portland, OR 97208, USA.

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 caplet every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 caplet, a dosage of 2 caplets may be administered. It is imperative that the total daily dosage does not exceed 6 caplets 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 for appropriate dosing guidance.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to any pain reliever or fever reducer. Additionally, the product should not be administered immediately before or after heart surgery due to potential complications associated with surgical recovery.

Warnings and Precautions

Ibuprofen may cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions can 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 experiencing this adverse effect is increased in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are taking anticoagulants or steroid medications, consume three or more alcoholic beverages daily while using this product, or exceed the recommended dosage or duration of use.

Healthcare professionals should advise patients to consult a physician prior to using ibuprofen if they have experienced problems or serious side effects from pain relievers or fever reducers, if the stomach bleeding warning is applicable, or if they have a history of gastrointestinal issues such as heartburn. Additionally, patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma should seek medical advice before use. It is also recommended that patients inform their healthcare provider if they are taking a diuretic, if they are using aspirin for cardiovascular protection, or if they are under treatment for any serious medical condition.

In the event of an overdose, immediate medical attention should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Patients should be instructed to discontinue use and contact their healthcare provider if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, if pain worsens or lasts longer than 10 days, if fever intensifies or persists beyond three days, if redness or swelling occurs in the affected area, or if any new symptoms arise, medical consultation is advised.

Side Effects

Patients may experience a range of adverse reactions associated with the use of ibuprofen, which is classified as a nonsteroidal anti-inflammatory drug (NSAID).

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.

Additionally, ibuprofen carries a warning for the potential risk of severe stomach bleeding. The likelihood of this serious adverse reaction is increased in patients who are aged 60 years or older, have a history of stomach ulcers or bleeding problems, are taking blood-thinning medications (anticoagulants) or steroids, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily while using the product, or exceed the recommended dosage or duration of use.

Patients are advised to discontinue use and consult a healthcare professional if they experience any signs indicative of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. Additional symptoms warranting medical consultation include worsening pain lasting more than 10 days, fever persisting for more than 3 days, redness or swelling in the painful area, or the emergence of any new symptoms.

Before using ibuprofen, patients should seek medical advice if they have a history of serious side effects from pain relievers or fever reducers, if the stomach bleeding warning is applicable, or if they have a history of stomach problems such as heartburn. Those with high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma should also consult a healthcare provider prior to use.

Furthermore, patients taking aspirin for the prevention of heart attack or stroke should be aware that ibuprofen may diminish the cardioprotective effects of aspirin. It is also recommended that individuals under a doctor's care for any serious condition or those taking other medications consult with a healthcare professional or pharmacist before using ibuprofen.

Drug Interactions

Ibuprofen has the potential to diminish the cardioprotective effects of aspirin when both medications are administered concurrently for the prevention of heart attack or stroke. It is advisable to consider alternative analgesics that do not interfere with aspirin's efficacy in these clinical scenarios. Monitoring for any signs of reduced effectiveness of aspirin therapy is recommended when ibuprofen is used in patients requiring aspirin for cardiovascular protection.

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 aged 12 years and older, the recommended dosage is 1 caplet every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 caplet, 2 caplets may be administered. It is important not to exceed 6 caplets in a 24-hour period unless directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk of severe stomach bleeding. It is recommended that these patients take the medication with food or milk to mitigate potential stomach upset. Additionally, the risk of heart attack or stroke may be heightened in geriatric patients who exceed the recommended dosage or duration of use.

For elderly patients, it is crucial not to exceed 6 caplets in a 24-hour period unless directed by a healthcare provider. Furthermore, it is advisable for these patients to consult a physician prior to use if the stomach bleeding warning is applicable, as this consideration is especially pertinent for older adults. Careful monitoring and adherence to dosage guidelines are essential to ensure the safety of geriatric patients using this medication.

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication, particularly if they are in the later stages of pregnancy or breastfeeding. It is especially important to avoid the use of ibuprofen during the last trimester unless specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery. Healthcare providers should weigh the potential benefits against the risks when considering the use of this medication in pregnant patients.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. It is particularly important to avoid the use of ibuprofen during the last three months of pregnancy unless explicitly directed by a physician, 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, healthcare providers should carefully consider the potential risks and benefits when recommending this medication to lactating mothers.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is recommended that the smallest effective dose be utilized in this population to minimize potential risks associated with reduced kidney function. Regular monitoring of renal function may be necessary to ensure safety and efficacy in patients with compromised renal clearance.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the medication. It is essential to assess liver function prior to initiating treatment. In patients with liver cirrhosis, dosage adjustments may be necessary, and close monitoring of liver function is recommended throughout the treatment course.

Patients with significant hepatic impairment should be evaluated for potential contraindications, particularly if they also have comorbid conditions such as high blood pressure, heart disease, or kidney disease. Regular monitoring of liver enzymes and other relevant laboratory values is advised to ensure patient safety and therapeutic efficacy.

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 help 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 and symptomatic treatment, tailored to the specific symptoms presented. Healthcare providers should remain vigilant and prepared to implement appropriate interventions based on the clinical scenario.

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. 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 current information.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the medication. These include gastrointestinal bleeding, renal impairment, and hypersensitivity reactions, which encompass anaphylaxis and various skin reactions. Additionally, reports have documented serious cardiovascular events, such as myocardial infarction and stroke.

Liver enzyme elevations and instances of liver failure have also been noted in postmarketing data. Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported. Furthermore, there have been occurrences of asthma exacerbation in patients with a prior history of asthma. Other reported events include dizziness, headache, and tinnitus.

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. It is crucial to inform patients that they should not use this medication if they have ever experienced an allergic reaction to any other pain reliever or fever reducer. Additionally, patients should be cautioned against using this product right before or after heart surgery.

Patients must be instructed to stop using the medication and consult a doctor if they experience any signs of stomach bleeding, which include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. They should also be advised to seek medical attention if pain worsens or lasts more than 10 days, if fever worsens or lasts more than 3 days, if redness or swelling occurs in the painful area, or if any new symptoms appear.

When using this product, patients should be encouraged to take it with food or milk if they experience stomach upset. It is important to communicate that the risk of heart attack or stroke may increase if the medication is used in excess of the directed dosage or for a longer duration than recommended.

Healthcare providers should recommend that patients consult a doctor before use if they have a history of problems or serious side effects from pain relievers or fever reducers, or if the stomach bleeding warning applies to them. Patients with a history of stomach problems, such as heartburn, high blood pressure, heart disease, liver cirrhosis, or kidney disease should also be advised to seek medical advice prior to use. Furthermore, patients with asthma or those taking a diuretic should consult a doctor before using this medication.

Patients should be informed to ask a doctor or pharmacist before use if they are taking aspirin for heart attack or stroke, as ibuprofen may diminish the benefits of aspirin. Lastly, it is advisable for patients to consult a doctor or pharmacist if they are under a doctor's care for any serious condition or if they are taking any other medications.

Storage and Handling

The product is supplied in a carton that must be retained for proper storage. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F). It is imperative that the product is not used if the imprinted foil under the cap is broken or missing, as this may indicate compromised integrity.

Additional Clinical Information

No further data are available.

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)