Drug Name

Motrin (Ibuprofen)

Generic Name

Ibuprofen Tablets (Prescription Strength) (EYE-bue-PROE-fen)

Manufacturer / Distributor

McNEIL PEDIATRICS

Dosage Form

Tablets

Route Of Administration

ORAL

Alternatives

Pain
Tramadol, Naprosyn (Naproxen), Oxycodone, Morphine, Percocet, Vicodin
Rheumatoid Arthritis
Naprosyn (Naproxen), Celebrex (Celecoxib), Diclofenac, Etodolac, Aspirin
Osteoarthritis
Naprosyn (Naproxen), Celebrex (Celecoxib), Diclofenac, Etodolac, Aspirin
Headache
Naprosyn (Naproxen), Aleve (Naproxen), Advil, Fioricet
Gout -- Acute
Naprosyn (Naproxen), Colchicine, Indocin (Indomethacin), Advil
Period Pain
Naprosyn (Naproxen), Diclofenac, Voltaren (Diclofenac), Celebrex (Celecoxib), Advil
Fever
Naprosyn (Naproxen), Ultracet (Acetaminophen/Tramadol), Aspirin, Tylenol, Advil
Cystic Fibrosis
Advil, Gentamicin, Tobramycin, Pancrelipase, Ku-Zyme
Patent Ductus Arteriosus
Indocin (Indomethacin), Advil, Midol IB, Nuprin

Drug Uses

Motrin is a nonsteroidal anti-inflammatory drug available in both prescription and nonprescription forms. Prescription Motrin is used in adults for relief of the symptoms of rheumatoid arthritis and osteoarthritis, treatment of menstrual pain, and relief of mild to moderate pain. In children aged 6 months and older it can be given to reduce fever and relieve mild to moderate pain. It is also used to relieve the symptoms of juvenile arthritis.

Drug class

Nonsteroidal anti-inflammatory drugs (also called NSAIDs) are used to relieve some symptoms caused by arthritis (rheumatism), such as inflammation, swelling, stiffness, and joint pain. However, this medicine does not cure arthritis and will help you only as long as you continue to take it.
Some of these medicines are also used to relieve other kinds of pain or to treat other painful conditions, such as:

• gout attacks;
• bursitis;
• tendinitis;
• sprains, strains, or other injuries; or
• menstrual cramps.

Contains

The active ingredient in Motrin is ibuprofen, which is a member of the propionic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). 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 77C. It is practically insoluble in water (<0.1 mg/mL), but readily soluble in organic solvents such as ethanol and acetone. Ibuprofen has a pKa of 4.43±0.03 and an n-octanol/water partition coefficient of 11.7 at pH 7.4.

Chemical formula

The chemical name for ibuprofen is (±)-2-(p-isobutylphenyl) propionic acid. The molecular weight of ibuprofen is 206.28. Its molecular formula is C13H1802 and it has the following structural formula:

Mechanism of Action

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that possesses anti-inflammatory, analgesic and antipyretic activity. Its mode of action, like that of other NSAIDs, is not completely understood, but may be related to prostaglandin synthetase inhibition. After absorption of the racemic ibuprofen, the [-]R-enantiomer undergoes interconversion to the [+]S-form. The biological activities of ibuprofen are associated with the [+]S-enantiomer.

How Taken

Take this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended.
Do not take more of this medication than is recommended. An overdose of motrin can cause damage to your stomach or intestines. The maximum amount of motrin for adults is 800 milligrams per dose or 3200 mg per day (4 maximum doses). Use only the smallest amount of motrin needed to get relief from your pain, swelling, or fever.
Take motrin with food or milk to lessen stomach upset.
Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
The motrin chewable tablet must be chewed before you swallow it.
If you take motrin for a long period of time, your doctor may want to check you on a regular basis to make sure this medication is not causing harmful effects. Do not miss any scheduled visits to your doctor.

Dosage and Administration

ADULTS
Rheumatoid Arthritis and Osteoarthritis
The usual dosage is 1,200 to 3,200 milligrams per day divided into 3 or 4 doses. Your doctor will tailor the dose to your individual needs. Symptoms should be reduced within 2 weeks. Daily dosage should not be greater than 3,200 milligrams.
Mild to Moderate Pain
The usual dose is 400 milligrams every 4 to 6 hours as necessary.
Menstrual Pain
The usual dose is 400 milligrams every 4 hours as necessary. Begin treatment when symptoms first appear.

CHILDREN 6 MONTHS TO 12 YEARS OF AGE
Fever reduction
The recommended dose is 5 milligrams per 2.2 pounds of body weight if temperature is less than 102.5F or 10 milligrams per 2.2 pounds of body weight if temperature is 102.5F or greater. The fever should go down for 6 to 8 hours. Do not give the child more than 40 milligrams per 2.2 pounds of body weight in one day.
Mild to Moderate Pain
The usual dose is 10 milligrams per 2.2 pounds of body weight every 6 to 8 hours. Do not give the child more than 4 such doses per day.
Juvenile Arthritis
The usual dose is 30 to 40 milligrams daily per 2.2 pounds of body weight, divided into 3 or 4 doses. Some children may need only 20 milligrams daily per 2.2 pounds.

Missed Dose

Since ibuprofen is sometimes taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose.
Do not take extra medicine to make up the missed dose.

Overdose

Seek emergency medical attention if you think you have used too much of this medicine. Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org/findyour.htm ), or emergency room immediately.
Symptoms of an Motrin overdose may include:

• nausea,
• vomiting,
• stomach pain,
• drowsiness,
• black or bloody stools,
• coughing up blood,
• shallow breathing,
• fainting, or coma.

Storage

Store Motrin at room temperature, between 68 and 77 degrees F (20 and 25 degrees C).
Store away from heat, moisture, and light. Do not store in the bathroom.
Keep Motrin out of the reach of children and away from pets.

What is the most important information I should know about Motrin (Ibuprofen)?

This medicine can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use Motrin. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).
Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.
This medicine can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking Motrin. Older adults may have an even greater risk of these serious gastrointestinal side effects.
Call your doctor at once if you have symptoms of bleeding in your stomach or intestines. This includes black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.
Do not take more of this medication than is recommended.
An overdose of Motrin can cause damage to your stomach or intestines. The maximum amount of Motrin for adults is 800 milligrams per dose or 3200 mg per day (4 maximum doses). Use only the smallest amount of Motrin needed to get relief from your pain, swelling, or fever. Avoid taking Motrin if you are taking aspirin to prevent stroke or heart attack. Motrin can make aspirin less effective in protecting your heart and blood vessels. If you must use both medications, take the Motrin at least 8 hours before or 30 minutes after you take the aspirin (non-enteric coated form). Do not drink alcohol while taking Motrin. Alcohol can increase your risk of stomach bleeding caused by Motrin.

What should I discuss with my doctor before taking Motrin (Ibuprofen)?

Taking an NSAID can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use an NSAID. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).
NSAIDs can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking an NSAID. Older adults may have an even greater risk of these serious gastrointestinal side effects.
Do not use this medication if you are allergic to Motrin, aspirin or other NSAIDs.
Before taking Motrin, tell your doctor if you are allergic to any drugs, or if you have:

• a history of heart attack, stroke, or blood clot;
• heart disease, congestive heart failure, high blood pressure;
• a history of stomach ulcers or bleeding;
• asthma;
• polyps in your nose; or
• liver or kidney disease,
• systemic lupus erythematosus (SLE);
• a bleeding or blood clotting disorder; or
• if you smoke.

If you have any of these conditions, you may not be able to use Motrin, or you may need a dosage adjustment or special tests during treatment.
If you are taking aspirin to prevent heart attack or stroke, avoid also taking Motrin. Motrin may make aspirin less effective in protecting your heart and blood vessels. If you must use both medications, take the Motrin at least 8 hours before or 30 minutes after you take the aspirin (non-enteric coated form). FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby during early pregnancy. Tell your doctor if you are pregnant or plan to become pregnant during treatment. However, taking Motrin during the last 3 months of pregnancy may result in birth defects. Do not take Motrin during pregnancy unless your doctor has told you to. It is not known whether Motrin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medicine to a child without the advice of a doctor.

Absorption

In vivo studies indicate that ibuprofen is well absorbed orally from the suspension formulation, with peak plasma levels usually occurring within 1 to 2 hours.

Distribution

Motrin, like most drugs of its class, is highly protein bound (>99% bound at 20 ?g/mL). Protein binding is saturable and at concentrations >20 ?g/mL binding is non-linear. Based on oral dosing data there is an age- or fever- related change in volume of distribution for ibuprofen. Febrile children <11 years old have a volume of approximately 0.2 L/kg while adults have a volume of approximately 0.12 L/kg. The clinical significance of these findings is unknown.

Metabolism

Following oral administration, the majority of the dose was recovered in the urine within 24 hours as the hydroxy-(25%) and carboxypropyl-(37%) phenylpropionic acid metabolites. The percentages of free and conjugated ibuprofen found in the urine were approximately 1% and 14%, respectively. The remainder of the drug was found in the stool as both metabolites and unabsorbed drug.

Excretion

Motrin is rapidly metabolized and eliminated in the urine. The excretion of Motrin is virtually complete 24 hours after the last dose. It has a biphasic plasma elimination time curve with a half-life of approximately 2.0 hours. There is no difference in the observed terminal elimination rate or half-life between children and adults, however, there is an age-or fever-related change in total clearance. This suggests that the observed change in clearance is due to changes in the volume of distribution of Motrin.

Possible side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking Motrin and seek medical attention or call your doctor at once if you have any of these serious side effects:

• chest pain, weakness, shortness of breath, slurred speech, problems with vision or
• balance;
• black, bloody, or tarry stools;
• coughing up blood or vomit that looks like coffee grounds;
• swelling or rapid weight gain;
• urinating less than usual or not at all;
• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
• bruising, severe tingling, numbness, pain, muscle weakness; or
• fever, headache, neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions).

Keep taking Motrin and talk to your doctor if you have any of these less serious side effects:

• upset stomach, mild heartburn, diarrhea, constipation;
• bloating, gas;
• dizziness, headache, nervousness;
• skin itching or rash;
• blurred vision; or
• ringing in your ears.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Motrin (Ibuprofen)?

Before taking Motrin, tell your doctor if you are taking any of the following drugs:

• aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as diclofenac (Voltaren), etodolac (Lodine), flurbiprofen (Ansaid), indomethacin (Indocin), ketoprofen (Orudis), ketorolac (Toradol), mefenamic acid (Ponstel), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others;
• an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), or trandolapril (Mavik);
• lithium (Eskalith, Lithobid);
• diuretics (water pills) such as furosemide (Lasix);
• methotrexate (Rheumatrex, Trexall);
• steroids (prednisone and others); or
• a blood thinner such as warfarin (Coumadin).

If you are using any of these drugs, you may not be able to use Motrin or you may need dosage adjustments or special tests during treatment.
There may be other drugs not listed that can affect Motrin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

What should I avoid while taking Motrin (Ibuprofen)?

Avoid taking Motrin if you are taking aspirin to prevent stroke or heart attack. Motrin can make aspirin less effective in protecting your heart and blood vessels. If you must use both medications, take the Motrin at least 8 hours before or 30 minutes after you take the aspirin (non-enteric coated form). Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Many medicines available over the counter contain aspirin or other medicines similar to Motrin (such as ketoprofen or naproxen). If you take certain products together you may accidentally take too much of this type of medication. Read the label of any other medicine you are using to see if it contains aspirin, ibuprofen, ketoprofen, or naproxen. Do not drink alcohol while taking Motrin. Alcohol can increase the risk of stomach bleeding caused by Motrin. Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Motrin can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

Contraindications

Motrin Suspension is contraindicated in patients with known hypersensitivity to ibuprofen.
Motrin 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.
Motrin Suspension is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.

Warnings

CARDIOVASCULAR EFFECTS

Cardiovascular Thrombotic Events
Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. All NSAIDs, both COX-2 selective and nonselective, may have a similar risk. Patients with known CV disease or risk factors for CV disease may be at greater risk. To minimize the potential risk for an adverse CV event in patients treated with an NSAID, the lowest effective dose should be used for the shortest duration possible. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. Patients should be informed about the signs and/or symptoms of serious CV events and the steps to take if they occur.
There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID does increase the risk of serious GI events (see GI WARNINGS).
Two large, controlled, clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10-14 days following CABG surgery found an increased incidence of myocardial infarction and stroke (see CONTRAINDICATIONS).
Hypertension
NSAIDs, including Motrin Suspension, can lead to onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAIDs, including Motrin Suspension, should be used with caution in patients with hypertension. Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy.
Congestive Heart Failure and Edema
Fluid retention and edema have been observed in some patients taking NSAIDs. Motrin Suspension should be used with caution in patients with fluid retention or heart failure.

Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation

NSAIDs, including Motrin 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 prior history of peptic ulcer disease and/or gastrointestinal bleeding 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.

Renal Effects

Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of a nonsteroidal anti-inflammatory drug may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.

Advanced Renal Disease

No information is available from controlled clinical studies regarding the use of Motrin Suspension in patients with advanced renal disease. Therefore, treatment with Motrin Suspension is not recommended in these patients with advanced renal disease. If Motrin Suspension therapy must be initiated, close monitoring of the patient's renal function is advisable.

Anaphylactoid Reactions

As with other NSAIDs, anaphylactoid reactions may occur in patients without known prior exposure to Motrin Suspension. Motrin Suspension should not be given to patients with the aspirin triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs. Emergency help should be sought in cases where an anaphylactoid reaction occurs.

Skin Reactions

NSAIDs, including Motrin Suspension, can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. These serious events may occur without warning. Patients should be informed about the signs and symptoms of serious skin manifestations and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

Pregnancy

In late pregnancy, as with other NSAIDs, Motrin should be avoided because it may cause premature closure of the ductus arteriosus.

Precautions

General

Motrin 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 Motrin in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions.

Hepatic Effects

Borderline elevations of one or more liver tests may occur in up to 15% of patients taking NSAIDs including Motrin. 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 Motrin. If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, etc.), Motrin should be discontinued.

Hematological Effects

Anemia is sometimes seen in patients receiving NSAIDs, including Motrin. 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 Motrin, 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 daily (osteoarthritis), and in 22.8% of 189 patients taking 2400 mg of 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 Motrin who may be adversely affected by alterations in platelet function, such as those with coagulation disorders or patients receiving anticoagulants, should be carefully monitored.

Preexisting Asthma

Patients with asthma may have aspirin-sensitive asthma. The use of aspirin in patients with aspirin-sensitive asthma has been associated with severe bronchospasm, which can be fatal. Since cross reactivity, including bronchospasm, between aspirin and other nonsteroidal anti-inflammatory drugs has been reported in such aspirin-sensitive patients, Motrin should not be administered to patients with this form of aspirin sensitivity and should be used with caution in patients with preexisting asthma.

Aseptic Meningitis

Aseptic meningitis, with fever and coma, has been observed on rare occasions in patients on ibuprofen therapy. Although it is probably more likely to occur in p