Ibuprofen

Description

The product is a nonsteroidal anti-inflammatory drug (NSAID) with the chemical name Ibuprofen. Its molecular formula is C13H18O2, and it has a molecular weight of 206.28 g/mol. The structural formula is represented as follows:

CH3
  |
CH3-CH-COOH
  |
C6H4

Ibuprofen appears as a white to off-white crystalline powder. It is characterized by its practical insolubility in water, solubility in alcohol, and slight solubility in chloroform. The formulation includes several inactive ingredients: corn starch, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and iron oxide.

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

Patients should adhere strictly to the recommended dosage and not exceed the directed amount. The smallest effective dose should be utilized to manage symptoms effectively.

For adults and children aged 12 years and older, the recommended dosage is 1 capsule every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 capsule, a maximum of 2 capsules may be administered. However, it is imperative not to exceed 6 capsules within a 24-hour period unless specifically directed by a healthcare professional.

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

Contraindications

Use is contraindicated in patients with a history of allergic reactions to any other 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 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, are using 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.

Additionally, NSAIDs, excluding aspirin, are associated with an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is heightened when the medication is used in excess of the recommended dosage or for prolonged periods.

Healthcare professionals should advise patients to consult a physician prior to use if any of the following conditions apply: a history of stomach bleeding, adverse reactions to pain relievers or fever reducers, previous stomach issues such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, a history of stroke, or if they are currently taking a diuretic. Furthermore, patients should seek guidance from a doctor or pharmacist if they are under medical care for any serious condition, are using aspirin for cardiovascular protection, or are taking any other medications.

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

Patients should discontinue use and contact their healthcare provider if they experience any signs of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. They should also seek medical advice if they exhibit symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling. Additionally, if pain worsens or persists beyond 10 days, fever intensifies or lasts more than 3 days, redness or swelling occurs in the affected area, or any new symptoms arise, patients should consult their physician.

Side Effects

Patients using ibuprofen should be aware of potential adverse reactions, which can range from serious to common.

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, or blisters. Additionally, the use of ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a risk of severe stomach bleeding. This risk is heightened in patients aged 60 or older, those with a history of stomach ulcers or bleeding problems, individuals taking anticoagulants or steroid medications, and those consuming three or more alcoholic drinks daily while using this product. The likelihood of stomach bleeding also increases with prolonged use or exceeding the recommended dosage.

Furthermore, NSAIDs, excluding aspirin, are associated with an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk escalates with the use of higher doses or extended duration beyond what is directed.

Patients are advised to discontinue use and consult a healthcare professional if they experience any signs indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Symptoms suggestive of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical attention. Other reasons to seek medical advice include worsening pain lasting more than 10 days, a fever that persists or worsens beyond three days, the presence of redness or swelling in the painful area, or the emergence of any new symptoms.

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 monitor patients closely for any signs of reduced efficacy of aspirin in such scenarios. Consideration should be given to the timing of administration, as taking ibuprofen at least 30 minutes after or 8 hours before aspirin may help mitigate this interaction.

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 capsule every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 capsule, 2 capsules may be administered. It is important not to exceed 6 capsules in 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. Therefore, it is essential for healthcare providers to exercise caution when prescribing this medication to geriatric patients.

Before initiating treatment, it is advisable for healthcare providers to assess the patient's medical history thoroughly. Geriatric patients with pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should consult with their healthcare provider prior to use. This precaution is critical to ensure the safety and efficacy of the treatment in this population.

Monitoring for adverse effects, particularly gastrointestinal complications, is recommended in elderly patients due to their heightened vulnerability. Adjustments to dosage may be necessary based on individual patient assessments and clinical judgment.

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 gestation 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 evaluate the potential benefits and risks when considering the use of this medication in pregnant patients.

Lactation

Lactating mothers are advised to consult a healthcare professional before using this medication while breastfeeding. It is particularly important to avoid the use of ibuprofen at 20 weeks of gestation or later unless specifically 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 this medication in breast milk or its effects on breastfed infants. Therefore, healthcare providers should weigh the potential benefits against the risks when considering this medication for lactating mothers.

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 clinical response.

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 tests may be warranted to ensure appropriate management and to mitigate potential risks associated with the use of this medication in individuals with hepatic impairment.

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 are advised to call the Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial in mitigating potential adverse effects associated with overdose. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms as they arise.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and to address any complications that may develop during the course of treatment.

Nonclinical Toxicology

It is especially important not to use ibuprofen at 20 weeks or later in 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 details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the text.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the medication. Reports include gastrointestinal bleeding, renal impairment, and cardiovascular events. Serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have also been documented. Additionally, cases of liver enzyme elevations and liver failure have been reported. Anaphylactic reactions, including angioedema and bronchospasm, have been noted in the postmarketing data. Furthermore, there are reports of hypertension and heart failure associated with the use of ibuprofen.

Patient Counseling

Patients should be advised to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

Patients must be informed not to use this medication if they have a history of allergic reactions to any other pain reliever or fever reducer. Additionally, it should not be used immediately before or after heart surgery.

Healthcare providers should instruct patients to discontinue use and consult a doctor if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Patients should also be advised to stop use and seek medical attention if they exhibit 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.

Patients should be counseled to monitor their pain and fever. If pain worsens or persists for more than 10 days, or if fever intensifies or lasts longer than 3 days, they should contact their healthcare provider. Any redness or swelling in the painful area or the appearance of new symptoms should also prompt a consultation with a doctor.

When using this product, patients should take it with food or milk if they experience stomach upset. It is important for patients to consult a doctor before use if they have a history of stomach bleeding or if they have experienced serious side effects from pain relievers or fever reducers.

Patients with a history of stomach problems, such as heartburn, or those with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should also seek medical advice before using this medication. Furthermore, patients taking diuretics or any other medications should consult their healthcare provider or pharmacist prior to use.

Finally, patients should be informed that if they are under a doctor's care for any serious condition or are taking aspirin for heart attack or stroke, they should discuss this with their healthcare provider, as ibuprofen may reduce the effectiveness of aspirin.

Storage and Handling

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

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly critical to avoid ibuprofen after 20 weeks 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)