Motrin 400mg Tablets

Manufacturer PFIZER Active Ingredient Ibuprofen Tablets(eye byoo PROE fen) Pronunciation eye-byoo-PROE-fen
WARNING: This drug may raise the risk of heart and blood vessel problems like heart attack and stroke. These effects can be deadly. The risk may be greater if you have heart disease or risks for heart disease. However, it can also be raised even if you do not have heart disease or risks for heart disease. The risk can happen within the first weeks of using this drug and may be greater with higher doses or long-term use. Do not use this drug right before or after bypass heart surgery.This drug may raise the chance of severe and sometimes deadly stomach or bowel problems like ulcers or bleeding. The risk is greater in older people, and in people who have had stomach or bowel ulcers or bleeding before. These problems may occur without warning signs. @ COMMON USES: It is used to ease pain, swelling, and fever.It is used to ease painful period (menstrual) cycles.It is used to treat arthritis.It may be given to you for other reasons. Talk with the doctor.
đŸˇī¸
Drug Class
Nonsteroidal Anti-inflammatory Drug (NSAID), Analgesic, Antipyretic
đŸ§Ŧ
Pharmacologic Class
Cyclooxygenase (COX) Inhibitor
🤰
Pregnancy Category
C (1st and 2nd trimester), D (3rd trimester)
✅
FDA Approved
Jan 1970
âš–ī¸
DEA Schedule
Not Controlled

Overview

â„šī¸

What is this medicine?

Ibuprofen is a common medicine used to relieve pain, reduce fever, and lessen inflammation (swelling and redness). It belongs to a group of medicines called NSAIDs. It works by blocking certain natural substances in your body that cause pain and inflammation.
📋

How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food. If it causes stomach upset, take it with food to help minimize this side effect. Always take the medication with a full glass of water.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry location, avoiding the bathroom. Protect it from heat and keep it out of reach of children and pets. When you no longer need this medication or it has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so. If you have questions about the best way to dispose of your medication, consult your pharmacist. You may also want to check if there are any drug take-back programs available in your area.

Missing a Dose

If you take this medication on a regular schedule and miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and continue with your regular schedule. Do not take two doses at the same time or take extra doses. If you take this medication as needed, do not take it more frequently than directed by your doctor.
💡

Lifestyle & Tips

  • Take with food or milk to reduce stomach upset.
  • Drink plenty of fluids to help protect your kidneys.
  • Avoid or limit alcohol consumption while taking ibuprofen, as it can increase the risk of stomach bleeding.
  • Do not take more than the recommended dose or for longer than directed without consulting a doctor.
  • Inform your doctor or dentist that you are taking ibuprofen before any surgery or dental procedures.
💊

Available Forms & Alternatives

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: 400 mg orally every 4 to 6 hours as needed
Dose Range: 200 - 800 mg

Condition-Specific Dosing:

mildToModeratePain: 400 mg orally every 4-6 hours as needed
dysmenorrhea: 400 mg orally every 4-6 hours as needed
rheumatoidArthritisOsteoarthritis: 400-800 mg orally 3-4 times daily (max 3200 mg/day for prescription, 1200 mg/day for OTC)
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established (400mg tablet not suitable)
Infant: Not established (400mg tablet not suitable, dosing is weight-based for suspension)
Child: Not established (400mg tablet not suitable, dosing is weight-based for suspension/chewable tablets)
Adolescent: For adolescents weighing >40 kg: 400 mg orally every 4-6 hours as needed (max 1200 mg/day for OTC uses)
âš•ī¸

Dose Adjustments

Renal Impairment:

Mild: Use with caution; monitor renal function.
Moderate: Avoid or use with extreme caution at lowest effective dose; monitor renal function closely.
Severe: Contraindicated due to risk of worsening renal function.
Dialysis: Not significantly removed by hemodialysis; avoid use due to risk of adverse effects.

Hepatic Impairment:

Mild: Use with caution; monitor liver function.
Moderate: Use with caution at lowest effective dose; monitor liver function closely.
Severe: Avoid use due to risk of worsening hepatic function and increased systemic exposure.

Pharmacology

đŸ”Ŧ

Mechanism of Action

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that exerts its analgesic, anti-inflammatory, and antipyretic effects primarily through the reversible inhibition of cyclooxygenase (COX-1 and COX-2) enzymes. This inhibition leads to a reduction in the synthesis of prostaglandins, which are mediators of inflammation, pain, and fever.
📊

Pharmacokinetics

Absorption:

Bioavailability: 80-100%
Tmax: 1-2 hours (fasted state)
FoodEffect: Food may decrease the rate but not the extent of absorption, delaying Tmax.

Distribution:

Vd: 0.1-0.2 L/kg
ProteinBinding: >99% (primarily to albumin)
CnssPenetration: Limited (low concentrations in CSF, but sufficient for central antipyretic effect)

Elimination:

HalfLife: 1.8-2.5 hours
Clearance: Not available (highly variable)
ExcretionRoute: Renal (approximately 60-90% as metabolites and their conjugates), Fecal (approximately 10% as metabolites)
Unchanged: <1% (in urine)
âąī¸

Pharmacodynamics

OnsetOfAction: 30-60 minutes (analgesia/antipyresis)
PeakEffect: 1-2 hours (analgesia/antipyresis), 1-2 weeks (anti-inflammatory)
DurationOfAction: 4-6 hours

Safety & Warnings

âš ī¸

BLACK BOX WARNING

CARDIOVASCULAR THROMBOTIC EVENTS: NSAIDs, including ibuprofen, 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 is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. GASTROINTESTINAL RISK: NSAIDs, including ibuprofen, 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.
âš ī¸

Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:

Allergic Reaction: Rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Bleeding: Vomiting or coughing up blood, coffee ground-like vomit, blood in the urine, black, red, or tarry stools, bleeding gums, abnormal vaginal bleeding, unexplained bruises or bruises that enlarge, or uncontrollable bleeding.
Kidney Problems: Inability to urinate, changes in urine output, blood in the urine, or sudden significant weight gain.
High Potassium Levels: Abnormal heartbeat, confusion, weakness, lightheadedness, dizziness, feeling faint, numbness or tingling, or shortness of breath.
High Blood Pressure: Severe headache, dizziness, fainting, or changes in vision.
Respiratory Issues: Shortness of breath, sudden significant weight gain, or swelling in the arms or legs.
Cardiovascular Issues: Chest pain or pressure, rapid heartbeat, or weakness on one side of the body.
Neurological Issues: Difficulty speaking or thinking, balance changes, drooping on one side of the face, or blurred vision.
Extreme Fatigue: Feeling extremely tired or weak.
Other Symptoms: Ringing in the ears, severe back pain, or changes in vision.

Severe Skin Reactions: This medication can cause life-threatening skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other severe reactions. These reactions can affect internal organs and be fatal. Seek immediate medical attention if you experience:
Red, swollen, blistered, or peeling skin
Red or irritated eyes
Sores in the mouth, throat, nose, eyes, genitals, or skin
Fever
Chills
Body aches
Shortness of breath
Swollen glands

Other Side Effects

Most people experience no side effects or only mild side effects while taking this medication. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor:

Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Heartburn
Gas
Dizziness

Reporting Side Effects

If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
🚨

Seek Immediate Medical Attention If You Experience:

  • Severe stomach pain, black or tarry stools, vomit that looks like coffee grounds (signs of stomach bleeding)
  • Swelling of the face, lips, tongue, or throat; difficulty breathing; severe rash (signs of allergic reaction)
  • Chest pain, shortness of breath, weakness on one side of the body, slurred speech (signs of heart attack or stroke)
  • Unusual weight gain or swelling (fluid retention)
  • Decreased urination, unusual tiredness (kidney problems)
  • Yellowing of skin or eyes, dark urine (liver problems)
  • Unusual bruising or bleeding
📋

Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
Allergies to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen.
A history of asthma triggered by salicylate medications, such as aspirin, or NSAIDs.
Certain health conditions, including:
+ Gastrointestinal (GI) bleeding
+ Kidney problems
+ Heart failure (a weak heart)
+ Recent heart attack
Concurrent use of other NSAIDs, salicylate drugs like aspirin, or pemetrexed.
Fertility issues or ongoing fertility evaluation, as this medication may affect fertility.
* Pregnancy, planned pregnancy, or suspected pregnancy. This medication can harm an unborn baby if taken after 20 weeks of gestation. If you are between 20 and 30 weeks pregnant, only take this medication under your doctor's guidance. Do not take this medication if you are more than 30 weeks pregnant.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. Verify that it is safe to take this medication with your existing treatments and health status. Never start, stop, or adjust the dosage of any medication without consulting your doctor.
âš ī¸

Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are on long-term treatment with this drug, your doctor may recommend regular blood tests to monitor your condition.

There is a risk of developing high blood pressure with this type of medication. Your doctor will advise you on how often to have your blood pressure checked. Additionally, consult your doctor before consuming alcohol, as it may interact with this medication.

If you smoke, discuss this with your doctor, as it may affect your treatment. Individuals with asthma should also consult their doctor, as they may be more sensitive to this medication.

To minimize the risk of severe side effects, do not exceed the prescribed dosage, and do not take this medication for longer than recommended by your doctor. Be cautious and avoid injuries, as this medication may increase your risk of bleeding. Use a soft toothbrush and an electric razor to reduce the risk of bleeding.

The use of this medication may increase the risk of heart failure, particularly in individuals who already have heart failure. This may lead to a higher risk of heart attack, hospitalization for heart failure, and death. Discuss this with your doctor to understand the potential risks.

In people who have recently experienced a heart attack, the use of this medication may increase the risk of another heart attack and heart-related death. Additionally, individuals taking this medication after a first heart attack may have a higher risk of death within the following year compared to those not taking this medication. Consult your doctor to discuss these potential risks.

This medication may also increase the risk of a severe brain problem called aseptic meningitis. Seek medical attention immediately if you experience symptoms such as headache, fever, chills, severe nausea or vomiting, stiff neck, rash, sensitivity to light, drowsiness, or confusion.

In rare cases, this medication may cause liver problems, which can be life-threatening. Monitor for signs of liver problems, including dark urine, fatigue, decreased appetite, nausea or stomach pain, pale stools, vomiting, or yellowing of the skin or eyes. If you experience any of these symptoms, contact your doctor promptly.

If you are 60 years or older, use this medication with caution, as you may be more susceptible to side effects. Women of childbearing age should be aware that this medication may affect ovulation, which can impact fertility. However, this effect is reversible, and ovulation typically returns to normal after stopping the medication. Discuss this with your doctor if you are planning to become pregnant.

If you are breastfeeding, consult your doctor to discuss the potential risks to your baby.
🆘

Overdose Information

Overdose Symptoms:

  • Severe stomach pain
  • Nausea, vomiting
  • Drowsiness, dizziness
  • Headache
  • Ringing in the ears (tinnitus)
  • Blurred vision
  • Nystagmus (involuntary eye movement)
  • Rarely: metabolic acidosis, renal failure, coma, seizures

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222.

Drug Interactions

đŸšĢ

Contraindicated Interactions

  • Aspirin (high-dose, regular use, due to interference with antiplatelet effect)
  • Other NSAIDs (increased risk of GI and renal adverse effects)
  • Coronary Artery Bypass Graft (CABG) surgery (peri-operative pain)
🔴

Major Interactions

  • Anticoagulants (e.g., Warfarin, Heparin): Increased risk of bleeding.
  • Antiplatelet agents (e.g., Clopidogrel): Increased risk of bleeding.
  • Corticosteroids: Increased risk of GI ulceration and bleeding.
  • Lithium: Increased lithium levels and toxicity.
  • Methotrexate: Increased methotrexate levels and toxicity.
  • Diuretics (e.g., Furosemide, Hydrochlorothiazide): Reduced diuretic and antihypertensive effects, increased risk of renal impairment.
  • ACE Inhibitors (e.g., Lisinopril) / Angiotensin Receptor Blockers (ARBs) (e.g., Valsartan): Reduced antihypertensive effect, increased risk of renal impairment and hyperkalemia.
  • Cyclosporine: Increased risk of nephrotoxicity.
  • Tacrolimus: Increased risk of nephrotoxicity.
🟡

Moderate Interactions

  • SSRIs/SNRIs: Increased risk of GI bleeding.
  • Digoxin: May increase digoxin levels.
  • Beta-blockers: Reduced antihypertensive effect.
  • Phenytoin: May increase phenytoin levels.
  • Sulfonylureas: May enhance hypoglycemic effect.
  • Aminoglycosides: May increase aminoglycoside levels (especially in neonates).
đŸŸĸ

Minor Interactions

  • Alcohol: Increased risk of GI irritation/bleeding.
  • Ginkgo Biloba: Theoretical increased bleeding risk.

Monitoring

đŸ”Ŧ

Baseline Monitoring

Renal function (BUN, Creatinine)

Rationale: To establish baseline kidney function, especially important for patients with pre-existing renal impairment or those at risk (elderly, dehydrated, concomitant nephrotoxic drugs).

Timing: Before initiating long-term therapy or in at-risk patients.

Liver function tests (ALT, AST)

Rationale: To establish baseline liver function, especially for patients with pre-existing hepatic impairment or those on long-term therapy.

Timing: Before initiating long-term therapy or in at-risk patients.

Blood pressure

Rationale: NSAIDs can cause new onset hypertension or worsen pre-existing hypertension.

Timing: Before initiating therapy.

📊

Routine Monitoring

Renal function (BUN, Creatinine)

Frequency: Periodically (e.g., every 6-12 months for chronic use, more frequently in high-risk patients or with dose changes)

Target: Within normal limits or stable from baseline

Action Threshold: Significant increase in creatinine (>20% from baseline), signs of acute kidney injury.

Liver function tests (ALT, AST)

Frequency: Periodically (e.g., every 6-12 months for chronic use, if symptoms of liver injury develop)

Target: Within normal limits or stable from baseline

Action Threshold: Significant elevation (e.g., >3x ULN), signs of liver injury.

Blood pressure

Frequency: Regularly (e.g., at each visit for chronic use)

Target: Individualized, within target range for patient

Action Threshold: Sustained elevation, new onset hypertension.

Complete Blood Count (CBC) with differential

Frequency: Periodically (e.g., annually for chronic use, if signs of anemia or bleeding)

Target: Within normal limits

Action Threshold: Significant drop in hemoglobin/hematocrit, signs of GI bleeding.

Occult blood in stool

Frequency: Annually for chronic use, or if GI symptoms present

Target: Negative

Action Threshold: Positive test, signs of GI bleeding.

đŸ‘ī¸

Symptom Monitoring

  • Signs of gastrointestinal bleeding (black, tarry stools; coffee-ground vomit; severe abdominal pain)
  • Signs of renal dysfunction (decreased urine output, swelling in ankles/feet, unusual fatigue)
  • Signs of cardiovascular events (chest pain, shortness of breath, weakness on one side of body, slurred speech)
  • Signs of liver injury (yellowing of skin/eyes, dark urine, persistent nausea/vomiting, unusual fatigue)
  • Signs of allergic reaction (rash, itching, hives, swelling of face/lips/tongue/throat, difficulty breathing)
  • Unusual bruising or bleeding

Special Patient Groups

🤰

Pregnancy

Avoid use in the third trimester due to risk of premature closure of the fetal ductus arteriosus and persistent pulmonary hypertension of the newborn. Use in the first and second trimesters should be avoided unless the potential benefit outweighs the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Possible increased risk of miscarriage and congenital malformations (e.g., cardiac septal defects, gastroschisis), though data are conflicting.
Second Trimester: Generally considered lower risk than 1st or 3rd trimester, but still use with caution and only if clearly needed.
Third Trimester: Contraindicated due to risk of premature closure of the fetal ductus arteriosus, persistent pulmonary hypertension of the newborn, and potential for renal dysfunction in the fetus leading to oligohydramnios.
🤱

Lactation

Considered compatible with breastfeeding when used at usual analgesic doses for short periods. Low levels are excreted into breast milk.

Infant Risk: Low risk of adverse effects in breastfed infants. Monitor for potential effects like rash or GI upset, though rare.
đŸ‘ļ

Pediatric Use

Ibuprofen 400mg tablets are generally not recommended for children under 12 years of age due to dosing considerations (weight-based dosing is preferred for younger children) and potential for overdose. Pediatric formulations (suspensions, chewable tablets) are available for appropriate dosing in younger children.

👴

Geriatric Use

Elderly patients are at increased risk for serious adverse reactions to NSAIDs, including gastrointestinal bleeding, ulceration, perforation, renal impairment, and cardiovascular events. Use the lowest effective dose for the shortest duration possible. Monitor renal function and for signs of GI bleeding closely.

Clinical Information

💎

Clinical Pearls

  • Always advise patients to take ibuprofen with food, milk, or a full glass of water to minimize GI upset.
  • Educate patients on the signs of GI bleeding (black, tarry stools; coffee-ground vomit) and to seek immediate medical attention if they occur.
  • Remind patients that ibuprofen can interact with many common medications, including blood thinners, blood pressure medications, and other pain relievers. Advise them to inform their healthcare provider of all medications they are taking.
  • For chronic use, emphasize the importance of regular monitoring of blood pressure, renal function, and liver function.
  • Counsel patients on the maximum daily dose for OTC use (1200 mg/day) and prescription use (3200 mg/day) to prevent overdose.
  • NSAIDs like ibuprofen should be avoided in patients with severe heart failure or advanced kidney disease.
🔄

Alternative Therapies

  • Acetaminophen (Tylenol) - for pain and fever, no anti-inflammatory effect, different side effect profile.
  • Naproxen (Aleve) - another NSAID with longer half-life, allowing less frequent dosing.
  • Aspirin - another NSAID, but with distinct antiplatelet effects at low doses.
  • Celecoxib (Celebrex) - COX-2 selective NSAID, potentially lower GI risk but similar cardiovascular risk.
  • Opioid analgesics (for severe pain, with higher risk of dependence and side effects).
  • Topical analgesics (e.g., diclofenac gel, capsaicin cream) - for localized pain.
💰

Cost & Coverage

Average Cost: $5 - $20 per 30 tablets (400mg generic)
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic) or Tier 2 (Brand)
📚

General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, we encourage you to discuss them with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.