Ibuprofen Information
Ibuprofen (Ibuprofen)
Ibuprofen (Ibuprofen)
Ibuprofen (Ibuprofen) Description
The active ingredient in Ibuprofen (Ibuprofen) suspension is Ibuprofen (Ibuprofen) , which is a member of the propionic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Ibuprofen (Ibuprofen) is a racemic mixture of [+]S- and [-]R-enantiomers. It is a white to off-white crystalline powder, with a melting point of 74° to 77°C. It is practically insoluble in water (
Ibuprofen (Ibuprofen) suspension is a sweetened, orange colored, berry flavored suspension containing 100 mg of Ibuprofen (Ibuprofen) in 5 mL (20 mg/mL). Inactive ingredients include: anhydrous citric acid, artificial berry flavor, butylparaben, , D&C red #33, FD&C yellow #6, glycerin, high fructose corn syrup, hypromellose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, xanthan gum.
Ibuprofen (Ibuprofen) Clinical Pharmacology
In vivo
Table 1
Controlled clinical trials comparing doses of 5 and 10 mg/kg Ibuprofen (Ibuprofen) suspension and 10-15 mg/kg of acetaminophen elixir have been conducted in children 6 months to 12 years of age with fever primarily due to viral illnesses. In these studies there were no differences between treatments in fever reduction for the first hour and maximum fever reduction occurred between 2 and 4 hours. Response after 1 hour was dependent on both the level of temperature elevation as well as the treatment. In children with baseline temperatures at or below 102.5°F both Ibuprofen (Ibuprofen) doses and acetaminophen were equally effective in their maximum effect. In children with temperatures above 102.5°F, the Ibuprofen (Ibuprofen) 10 mg/kg dose was more effective. By 6 hours, children treated with Ibuprofen (Ibuprofen) 5mg/kg tended to have recurrence of fever, whereas children treated with Ibuprofen (Ibuprofen) 10 mg/kg still had significant fever reduction at 8 hours. In control groups treated with 10 mg/kg acetaminophen, fever reduction resembled that seen in children treated with 5 mg/kg of Ibuprofen (Ibuprofen) , with the exception that temperature elevation tended to return 1-2 hours earlier.
In patients with primary dysmenorrhea, Ibuprofen (Ibuprofen) has been shown to reduce elevated levels of prostaglandin activity in the menstrual fluid and to reduce testing and active intrauterine pressure, as well as the frequency of uterine contractions. The probable mechanism of action is to inhibit prostaglandin synthesis rather than simply to provide analgesia.
Ibuprofen (Ibuprofen) Indications And Usage
Carefully consider the potential benefits and risks of Ibuprofen (Ibuprofen) suspension and other treatment options before deciding to use Ibuprofen (Ibuprofen) suspension. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see ).
Since there have been no controlled trials to demonstrate whether there is any beneficial effect or harmful interaction with the use of Ibuprofen (Ibuprofen) in conjunction with aspirin, the combination cannot be recommended. (See ).
Ibuprofen (Ibuprofen) Contraindications
Ibuprofen (Ibuprofen) suspension is contraindicated in patients with known hypersensitivity to Ibuprofen (Ibuprofen) .
Ibuprofen (Ibuprofen) suspension should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDS have been reported in such patients (see and ).
Ibuprofen (Ibuprofen) suspension is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see ).
Ibuprofen (Ibuprofen) Warnings
NSAIDs, including Ibuprofen (Ibuprofen) suspension, can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients, who develop a serious upper GI adverse event on NSAID therapy, is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occur in approximately 1% of patients treated for 3-6 months, and in about 2-4% of patients treated for one year. These trends continue with longer duration of use, increasing the likelihood of developing a serious GI event at some time during the course of therapy. However, even short-term therapy is not without risk.
NSAIDs should be prescribed with extreme caution in those with a prior history of ulcer disease or gastrointestinal bleeding. Patients with a who use NSAIDs have a greater than 10-fold risk for developing a GI bleed compared to patients with neither of these risk factors. Other factors that increase the risk for GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status. Most spontaneous reports of fatal GI events are in elderly or debilitated patients and therefore, special care should be taken in treating this population.
To minimize the potential risk for an adverse GI event in patients treated with an NSAID, the lowest effective dose should be used for the shortest possible duration. Patients and physicians should remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. This should include discontinuation of the NSAID until a serious GI adverse event is ruled out. For high risk patients, alternate therapies that do not involve NSAIDs should be considered.
Ibuprofen (Ibuprofen) Precautions
Ibuprofen (Ibuprofen) suspension cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids.
The pharmacological activity of Ibuprofen (Ibuprofen) suspension in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions.
Borderline elevations of one or more liver tests may occur in up to 15% of patients taking NSAIDs including Ibuprofen (Ibuprofen) suspension. These laboratory abnormalities may progress, may remain unchanged, or may be transient with continuing therapy. Notable elevations of ALT or AST (approximately three or more times the upper limit of normal) have been reported in approximately 1% of patients in clinical trials with NSAIDs. In addition, rare cases of severe hepatic reactions, including jaundice and fatal fulminant hepatitis, liver necrosis and hepatic failure, some of them with fatal outcomes have been reported.
A patient with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver test has occurred, should be evaluated for evidence of the development of a more severe hepatic reaction while on therapy with Ibuprofen (Ibuprofen) suspension. If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, etc.), Ibuprofen (Ibuprofen) suspension should be discontinued.
Anemia is sometimes seen in patients receiving NSAIDs, including Ibuprofen (Ibuprofen) suspension. This may be due to fluid retention, occult or gross GI blood loss, or an incompletely described effect upon erythropoiesis. Patients on long-term treatment with NSAIDs, including Ibuprofen (Ibuprofen) suspension, should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia.
In two postmarketing clinical studies the incidence of a decreased hemoglobin level was greater than previously reported. Decrease in hemoglobin of 1 gram or more was observed in 17.1% of 193 patients on 1600 mg Ibuprofen (Ibuprofen) daily (osteoarthritis), and in 22.8% of 189 patients taking 2400 mg of Ibuprofen (Ibuprofen) daily (rheumatoid arthritis). Positive stool occult blood tests and elevated serum creatinine levels were also observed in these studies.
NSAIDs inhibit platelet aggregation and have been shown to prolong bleeding time in some patients. Unlike aspirin, their effect on platelet function is quantitatively less, of shorter duration, and reversible. Patients receiving Ibuprofen (Ibuprofen) suspension who may be adversely affected by alterations in platelet function, such as those with coagulation disorders or patients receiving anticoagulants, should be carefully monitored.
Patients should be informed of the following information before initiating therapy with an NSAID and periodically during the course of ongoing therapy. Patients should also be encouraged to read the NSAID Medication Guide that accompanies each prescription dispensed.
Ibuprofen (Ibuprofen) Adverse Reactions
In patients taking Ibuprofen (Ibuprofen) or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1-10% of patients are: Abnormal renal function, anemia, dizziness, edema, elevated liver enzymes, fluid retention, gastrointestinal experiences (including abdominal pain, bloating, constipation, diarrhea, dyspepsia, epigastric pain, flatulence, heartburn, nausea, vomiting), headaches, increased bleeding time, nervousness, pruritus, rashes (including maculopapular) and tinnitus.
Additional adverse experiences reported occasionally include:
Other adverse reactions, which occur rarely are:
Ibuprofen (Ibuprofen) Overdosage
The toxicity of Ibuprofen (Ibuprofen) overdose is dependent upon the amount of drug ingested and the time elapsed since ingestion, though individual response may vary, which makes it necessary to evaluate each case individually. Although uncommon, serious toxicity and death have been reported in the medical literature with Ibuprofen (Ibuprofen) overdosage. The most frequently reported symptoms of Ibuprofen (Ibuprofen) overdose include abdominal pain, nausea, vomiting, lethargy and drowsiness. Other central nervous system symptoms include headache, tinnitus, CNS depression and seizures. Metabolic acidosis, coma, acute renal failure and apnea (primarily in very young children) may rarely occur. Cardiovascular toxicity, including hypotension, bradycardia, tachycardia and atrial fibrillation, also have been reported.
The treatment of acute Ibuprofen (Ibuprofen) overdose is primarily supportive. Management of hypotension, acidosis and gastrointestinal bleeding may be necessary. In cases of acute overdose, the stomach should be emptied through ipecac-induced emesis or lavage. Emesis is most effective if initiated within 30 minutes of ingestion. Orally administered activated charcoal may help in reducing the absorption and reabsorption of Ibuprofen (Ibuprofen) .
In children, the estimated amount of Ibuprofen (Ibuprofen) ingested per body weight may be helpful to predict the potential for development of toxicity although each case must be evaluated. Ingestion of less than 100 mg/kg is unlikely to produce toxicity. Children ingesting 100 to 200 mg/kg may be managed with induced emesis and a minimal observation time of four hours. Children ingesting 200 to 400 mg/kg of Ibuprofen (Ibuprofen) should have immediate gastric emptying and at least four hours observation in a health care facility. Children ingesting greater than 400 mg/kg require immediate medical referral, careful observation and appropriate supportive therapy. Ipecac-induced emesis is not recommended in overdoses greater than 400 mg/kg because of the risk for convulsions and the potential for aspiration of gastric contents.
In adult patients the history of the dose reportedly ingested does not appear to be predictive of toxicity. The need for referral and follow-up must be judged by the circumstances at the time of the overdose ingestion. Symptomatic adults should be carefully evaluated, observed and supported.
Ibuprofen (Ibuprofen) Dosage And Administration
Carefully consider the potential benefits and risks of Ibuprofen (Ibuprofen) suspension and other treatment options before deciding to use Ibuprofen (Ibuprofen) suspension. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see ).
After observing the response to initial therapy with Ibuprofen (Ibuprofen) suspension, the dose and frequency should be adjusted to suit an individual patient's needs.
Ibuprofen (Ibuprofen) How Supplied
Ibuprofen (Ibuprofen) Suspension, 100 mg/5 mL is available as follows:Orange-colored, berry-flavored suspensionBottle of 120 mL (NDC 45802--26)Bottle of 473 mL (NDC 45802--43)
Shake well before using. Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].
Ibuprofen (Ibuprofen)
Ibuprofen (Ibuprofen) Medication Guide For Non-steroidal Anti-inflammatory Drugs (nsalds)
NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:
These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines.
Ibuprofen (Ibuprofen) Principal Display Panel - Fl Oz Carton
Ibuprofen (Ibuprofen) Oral Suspension USP
100 mg/5 mL
Dosage Cup Included
Rx Only
Ibuprofen (Ibuprofen) Principal Display Panel - Fl Oz Label
Ibuprofen (Ibuprofen) Oral Suspension USP
100 mg/5 mL
Rx Only
Ibuprofen (Ibuprofen) Principal Display Panel - One Pint Label
Ibuprofen (Ibuprofen) Oral Suspension USP
100 mg/5 mL
DO NOT USE IF PRINTED NECKBAND IS BROKEN OR MISSING.
SHAKE WELL.
Store at 20º-25ºC (68º-77ºF) [see USP Controlled Room Temperature].
SEE PACKAGE INSERT FOR COMPLETE PRODUCT DETAILS.
Contains FD&C yellow #6.
ATTENTION PHARMACIST:
1. A central NSAID Medication Guide has been made available to you. As required by law, provide a Medication Guide with
each prescription and refill dispensed.
2. Dispense in a tight container as defined in the USP.
Rx Only
