What it's for (Indications)
- Ibuprofen is used for relief from mild, moderate, and severe pain, reduction of fever, and anti-inflammatory effects.
- Specific indications include pleuritis, serous membrane inflammation, ovaritis (ovary infection), appendicitis (appendix infection), pericarditis (infection of the membrane surrounding the heart), peritonitis, polyarthritis, arthritis, pleurodynia (especially of the right side and mostly in women), stiches of the heart, various forms of pneumonia (e.
- g.
- , along with exudation and noisy expectoration, after perspiration, pleuropneumonia), pleurisy with effusion, catarrh of the chest, pain in the 9th and 10th rib, intercostal rheumatism, suffocation, and sharp pain aggravated by changes in breathing, pressure, and temperature.
Dosage Information
| Type | Guideline |
|---|---|
| Standard | The lowest effective dosage for the shortest duration consistent with individual patient treatment goals should be used. Administration may be continued after the disappearance of symptoms, but long-term use requires doctor's approval. For Oral Administration (local context): Take with or without meals, as soon as pain is experienced. A common local dosage mentioned is 10-15 drops mixed in water, 4-6 times daily. Always consult a doctor for specific guidance on oral dosage. For Intravenous Administration (FDA - CALDOLOR): - **Adult Pain**: 400 mg to 800 mg intravenously over 30 minutes every 6 hours as necessary. - **Adult Fever**: 400 mg intravenously over 30 minutes, followed by 400 mg every 4 to 6 hours or 100-200 mg every 4 hours as necessary. - **Pediatric (Pain and Fever)**: - **Ages 12 to 17 years**: 400 mg intravenously over 10 minutes every 4 to 6 hours as necessary. - **Aged 6 months to less than 12 years**: 10 mg/kg intravenously over 10 minutes, up to a maximum single dose of 400 mg, every 4 to 6 hours as necessary. - **Aged 3 months to less than 6 months**: 10 mg/kg intravenously over 10 minutes, up to a maximum single dose of 100 mg. - **Preparation**: CALDOLOR Injection vials must be diluted before administration; CALDOLOR Injection bags are ready to use. |
Safety & Warnings
Common Side Effects
- Common side effects include nausea, flatulence, vomiting, headache, hemorrhage, dizziness, nervousness, running nose, diarrhea, and drowsiness.
- Serious adverse reactions can include stomach upset and bleeding (gastrointestinal bleeding, ulceration, perforation), skin rash (serious skin reactions), thrombocytopenia (low platelet count), aseptic meningitis (rarely), cardiovascular thrombotic events (myocardial infarction and stroke), hepatotoxicity, hypertension, heart failure and edema, renal toxicity and hyperkalemia, and anaphylactic reactions.
- In pediatric patients, infusion site pain, vomiting, nausea, anemia, and headache are among the common adverse reactions.
Serious Warnings
- Black Box Warning: WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS. Non-steroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Ibuprofen (Caldolor) is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. NSAIDs also cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.
- Risk of serious cardiovascular thrombotic events (including myocardial infarction and stroke) which can be fatal, potentially occurring early in treatment and increasing with duration of use.
- Increased risk of serious gastrointestinal bleeding, ulceration, and perforation, which can be fatal.
- Other serious risks include hepatotoxicity, hypertension, heart failure and edema, renal toxicity and hyperkalemia, anaphylactic reactions, and serious skin reactions.
- Hematologic toxicity, such as thrombocytopenia, may occur.
- Monitoring: Individuals taking ibuprofen are advised to monitor renal and gastrointestinal functions.
- An ECG should be carried out before administration to exclude pulmonary hypertension and ductal-dependent congenital heart disease.
- Lung pressure must be monitored in cases of hypoxemia.
- Pregnancy and Lactation: Insufficient data is available regarding the effects in pregnant and lactating females.
- Ibuprofen should not be used by pregnant or lactating women unless absolutely necessary and under medical guidance.
- Pregnancy risk cannot be ruled out.
- Alcohol: Avoid consuming alcohol while taking this medicine.
- General Use: Exercise caution in cases of infections.
- Do not exceed the recommended daily dose.
- Do not use for longer than prescribed or long-term without a doctor's approval.
- Not for children younger than 6 months of age unless specifically advised by a doctor.
- Inform your doctor about your complete medical history before using this medicine.
- Do not use after its expiry date, or if the quality seal is broken or missing.
- Do not alter your dosage without a doctor’s approval.
- If ibuprofen does not suit you, stop using it immediately.
- Overdose of certain products may not cause serious reactions, but any suspected overdose should prompt immediate medical consultation.
How it Works (Mechanism of Action)
Ibuprofen has analgesic, anti-inflammatory, and antipyretic properties. Its mechanism of action involves inhibition of cyclooxygenase (COX-1 and COX-2), which leads to a decrease in prostaglandin synthesis in peripheral tissues. Prostaglandins are mediators of inflammation and pain, and their reduction contributes to ibuprofen's therapeutic effects.