Ibuprofen Ca

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

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 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 prior to administration.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to any other pain reliever or fever reducer, due to the potential for severe hypersensitivity reactions. Additionally, the product should not be administered immediately before or after heart surgery, as it may pose risks to cardiovascular stability during this critical period.

Warnings and Precautions

Ibuprofen is associated with several significant warnings and precautions that healthcare professionals should consider when prescribing or advising patients on its use.

Allergy Alert Ibuprofen may induce 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 emergency medical assistance.

Stomach Bleeding Warning As a nonsteroidal anti-inflammatory drug (NSAID), ibuprofen carries a risk of severe stomach bleeding. This risk is heightened in patients who meet any of the following criteria:

• Are aged 60 years or older

• Have a history of stomach ulcers or bleeding disorders

• Are concurrently using anticoagulants or steroid medications

• Are taking other NSAIDs, whether prescription or over-the-counter (e.g., aspirin, naproxen)

• Consume three or more alcoholic beverages daily while using ibuprofen

• Exceed the recommended dosage or duration of use

Heart Attack and Stroke Warning The use of NSAIDs, excluding aspirin, is associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced in patients who use ibuprofen in excess of the recommended dosage or for prolonged periods.

General Precautions Healthcare providers should advise patients to consult a physician prior to using ibuprofen if any of the following conditions apply:

• The patient has a history of stomach bleeding or related issues

• The patient has experienced serious side effects from pain relievers or fever reducers

• The patient has a history of gastrointestinal problems, such as heartburn

• The patient has pre-existing conditions, including high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke

• The patient is taking diuretics

Additionally, patients should be counseled to seek advice from a doctor or pharmacist if they are:

• Under medical supervision for any serious health condition

• Using aspirin for the prevention of heart attack or stroke, as ibuprofen may diminish the cardioprotective effects of aspirin

• Taking any other medications

Emergency Medical Help In the event of an allergic reaction, patients must stop using ibuprofen and seek immediate medical attention.

When to Stop Taking Ibuprofen and Contact a Doctor Patients should discontinue ibuprofen and consult a healthcare provider if they experience any of the following symptoms indicative of stomach bleeding:

• Feeling faint

• Vomiting blood

• Passing bloody or black stools

• Persistent stomach pain

Additionally, patients should seek medical advice if they exhibit symptoms suggestive of heart problems or stroke, including:

• Chest pain

• Difficulty breathing

• Weakness on one side of the body

• Slurred speech

• Swelling in the legs

Patients should also stop taking ibuprofen if their 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 is associated with an increased risk of severe stomach bleeding, particularly 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 use other NSAIDs concurrently. Patients should be vigilant for signs of stomach bleeding, which may manifest as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Additionally, ibuprofen carries warnings regarding cardiovascular risks. The use of NSAIDs, excluding aspirin, has been linked to 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.

Patients are advised to discontinue use and consult a healthcare professional if they experience any symptoms indicative of stomach bleeding or cardiovascular issues, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling. Furthermore, if pain persists beyond 10 days or fever worsens or lasts more than three days, medical advice should be sought. Redness or swelling in the affected area or the emergence of any new symptoms also warrants consultation.

Before initiating treatment with ibuprofen, patients should seek medical advice if they have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. It is also important for patients to inform their healthcare provider if they are taking diuretics or if they are under care for any serious condition. Special caution is advised for those taking aspirin for cardiovascular protection, as ibuprofen may diminish the effectiveness of aspirin in this context.

Drug Interactions

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

Antiplatelet Agents Ibuprofen may diminish the cardioprotective effects of aspirin when used for the prevention of heart attack or stroke. It is advisable for patients to consult their healthcare provider regarding the concurrent use of these medications.

Anticoagulants and Corticosteroids The concomitant use of ibuprofen with anticoagulants or steroid medications increases the risk of gastrointestinal bleeding. Patients should be monitored closely for signs of bleeding and may require dosage adjustments or alternative therapies.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) The risk of gastrointestinal bleeding is further elevated when ibuprofen is taken alongside other NSAIDs, whether prescription or over-the-counter, such as aspirin or naproxen. It is recommended that patients avoid the use of multiple NSAIDs simultaneously to mitigate this risk.

Diuretics Patients on diuretics should seek medical advice before initiating ibuprofen therapy, as there may be implications for fluid balance and renal function. Monitoring of renal parameters may be necessary in these patients.

Packaging & NDC

Below are the non-prescription pack sizes of Ibuprofen Ca (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, a dose of 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, may have an increased risk of severe stomach bleeding when using this medication. It is essential for healthcare providers to exercise caution when prescribing to this population, as the likelihood of adverse gastrointestinal events may be heightened.

Before initiating treatment, it is advisable for healthcare providers to assess the medical history of geriatric patients. Specifically, patients with 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 precautionary measure is critical to ensure the safety and efficacy of the treatment in elderly individuals, who may have multiple comorbidities that could influence their response to the medication.

Ongoing monitoring and appropriate dose adjustments may be necessary to mitigate risks and enhance therapeutic outcomes in this vulnerable population.

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 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 at 20 weeks of gestation or later 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 status to ensure safety and efficacy.

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 patients with compromised liver function to discuss their medical history, including any conditions such as high blood pressure, heart disease, kidney disease, asthma, or previous strokes, with their healthcare provider to ensure safe and effective use of the medication. Monitoring of liver function may be warranted in these patients to assess any potential impact on drug metabolism and overall safety.

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 Overdose Patients experiencing an ibuprofen overdose may present with a range of symptoms, including nausea, vomiting, stomach pain, drowsiness, headache, and confusion. These symptoms can vary in severity depending on the amount ingested and the individual’s health status.

In more severe cases, an overdose can lead to critical complications such as kidney failure, liver damage, and gastrointestinal bleeding. These conditions require immediate medical intervention and can have serious long-term consequences if not addressed promptly.

Recommended Actions If an ibuprofen overdose is suspected, it is imperative to seek immediate medical attention. Healthcare providers should advise patients or caregivers to contact a poison control center for further guidance. Timely intervention is crucial in managing the effects of an overdose and mitigating potential harm.

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 reported voluntarily or through surveillance programs. These include allergic reactions such as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, severe stomach bleeding has been noted, particularly in individuals over 60 years of age, those with a history of stomach ulcers or bleeding problems, and those concurrently using anticoagulants or other nonsteroidal anti-inflammatory drugs (NSAIDs). Furthermore, there is an increased risk of heart attack, heart failure, and stroke associated with NSAID use, especially when utilized in higher doses or for extended durations.

Patient Counseling

Patients should be advised to keep this medication out of reach of children. In the event of an overdose, they should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

It is important 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, they should avoid using it right before or after heart surgery.

Patients should be instructed to stop using the medication 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 stomach pain that does not improve. They should also seek medical advice if they notice 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.

Healthcare providers should counsel patients to discontinue use and 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 advised to take the medication with food or milk if they experience stomach upset. It is also essential to recommend that they consult a doctor before use if the warning regarding stomach bleeding applies to them, or if they have experienced problems or serious side effects from taking pain relievers or fever reducers in the past.

Furthermore, patients should be encouraged to seek medical advice before using this medication if they have a history of stomach problems, such as heartburn, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. They should also consult a doctor before use if they are taking a diuretic.

Lastly, patients should be advised to speak with a doctor or pharmacist before using this medication if they are under a doctor’s care for any serious condition, if they are taking aspirin for heart attack or stroke (as ibuprofen may reduce the effectiveness of aspirin), or if they are taking any other medications.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20-25ºC (68-77ºF) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept in a suitable container that protects it from environmental factors. Special handling requirements should be observed to prevent any compromise to the product's quality.

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 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 Ca, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)