Motrin 800mg 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.
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Drug Class
Nonsteroidal Anti-inflammatory Drug (NSAID)
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Pharmacologic Class
Cyclooxygenase (COX) Inhibitor
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Pregnancy Category
Category C (1st/2nd trimester), Category D (3rd trimester)
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FDA Approved
May 1974
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Ibuprofen is a common medicine used to relieve pain, reduce fever, and decrease 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 inflammation and pain.
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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, but if it causes stomach upset, take it with food. Always take it with a full glass of water.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, avoiding the bathroom. Protect it from heat and keep it out of reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, check with your pharmacist for guidance on the best disposal method or look into local drug take-back programs.

Missing a Dose

If you take this medication regularly 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 resume your regular schedule. Do not take two doses at the same time or take extra doses. If you take this medication as needed, follow your doctor's instructions and do not take it more frequently than recommended.
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Lifestyle & Tips

  • Take with food, milk, or an antacid to reduce stomach upset.
  • Drink plenty of fluids to help protect your kidneys.
  • Avoid alcohol 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, as this can increase the risk of serious side effects.
  • Inform your doctor or dentist that you are taking ibuprofen before any surgery or dental procedures.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 400-800 mg orally every 6-8 hours as needed
Dose Range: 400 - 800 mg

Condition-Specific Dosing:

pain_fever: 400 mg orally every 4-6 hours as needed; max 1200 mg/day (OTC), 3200 mg/day (Rx)
rheumatoid_arthritis_osteoarthritis: 400-800 mg orally 3-4 times daily; max 3200 mg/day
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Pediatric Dosing

Neonatal: Not established (generally avoided)
Infant: Not established for routine use; consult physician for specific conditions (e.g., PDA closure)
Child: 5-10 mg/kg/dose orally every 6-8 hours for fever/pain; max 40 mg/kg/day
Adolescent: Same as adult dosing for pain/fever (e.g., 200-400 mg every 4-6 hours); for inflammatory conditions, may use adult Rx doses under supervision.
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Dose Adjustments

Renal Impairment:

Mild: Use with caution; monitor renal function.
Moderate: Avoid if possible; if necessary, use lowest effective dose for shortest duration; monitor renal function closely.
Severe: Contraindicated due to risk of worsening renal function.
Dialysis: Not dialyzable; avoid use.

Hepatic Impairment:

Mild: Use with caution; monitor liver function tests.
Moderate: Use with caution; consider dose reduction; monitor liver function tests closely.
Severe: Avoid use due to risk of worsening hepatic function.

Pharmacology

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Mechanism of Action

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that exerts its therapeutic effects by reversibly inhibiting cyclooxygenase (COX) enzymes, specifically COX-1 and COX-2. This inhibition leads to a reduction in the synthesis of prostaglandins, thromboxanes, and prostacyclins, which are mediators of inflammation, pain, and fever.
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Pharmacokinetics

Absorption:

Bioavailability: 80-100%
Tmax: 1-2 hours (oral)
FoodEffect: Food can delay Tmax but does not significantly affect the extent of absorption.

Distribution:

Vd: 0.15-0.2 L/kg
ProteinBinding: >99% (primarily albumin)
CnssPenetration: Limited

Elimination:

HalfLife: 1.8-2.5 hours
Clearance: Not available (highly variable)
ExcretionRoute: Renal (primarily as inactive metabolites)
Unchanged: <1%
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Pharmacodynamics

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

Safety & Warnings

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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.
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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, vomit that resembles coffee grounds, blood in the urine, black, red, or tarry stools, bleeding from the 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 or 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 problems, drooping on one side of the face, or blurred vision.
General Symptoms: Extreme fatigue or weakness, ringing in the ears, severe back pain, or changes in vision.

Severe Skin Reactions: This medication can cause rare but potentially life-threatening skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions. These reactions can also affect internal organs and may 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, or shortness of breath
Swollen glands

Other Side Effects

Most people taking this medication will not experience severe side effects, and some may not have any side effects at all. However, if you notice any of the following symptoms, contact your doctor or seek medical attention if they persist or bother you:

Constipation, diarrhea, stomach pain, upset stomach, or vomiting
Heartburn
Gas
Dizziness

This is not an exhaustive list of potential side effects. If you have concerns or questions about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe stomach pain, black or tarry stools, vomit that looks like coffee grounds (signs of stomach bleeding)
  • Chest pain, sudden weakness on one side of the body, slurred speech (signs of heart attack or stroke)
  • Swelling of the face, lips, tongue, or throat; difficulty breathing; severe skin rash (signs of allergic reaction)
  • Unusual weight gain or swelling in your arms or legs (signs of fluid retention or heart problems)
  • Yellowing of the skin or eyes, dark urine, unusual tiredness (signs of liver problems)
  • Little or no urination (signs of kidney problems)
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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
Current use of other NSAIDs, salicylate drugs like aspirin, or pemetrexed.
Fertility issues or ongoing fertility testing, as this medication may affect fertility.
* Pregnancy, planned pregnancy, or suspected pregnancy. This medication may 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.
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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 taking this drug for an extended period, your doctor may recommend regular blood tests to monitor your condition.

As this medication can cause high blood pressure, your doctor will likely advise you to have your blood pressure checked regularly. Additionally, it is crucial to discuss your alcohol consumption with your doctor before drinking. If you smoke, you should also talk to your doctor about the potential risks.

If you have asthma, you may be more sensitive to this medication, so it is vital to consult with your doctor. To minimize the risk of severe side effects, do not exceed the dosage prescribed by your doctor, and do not take this medication for longer than recommended.

You may experience increased bleeding tendencies while taking this medication. To reduce the risk of injury, be careful, use a soft toothbrush, and consider using an electric razor.

The use of this medication may increase the risk of heart failure, particularly in individuals with pre-existing heart failure. This can lead to a higher risk of heart attack, hospitalization for heart failure, and death. Your doctor will discuss the potential risks and benefits with you.

Furthermore, the risk of heart attack and heart-related death may be higher in people taking this medication after a recent heart attack. In fact, studies have shown that individuals taking this medication after a first heart attack were more likely to die within a year compared to those not taking this medication. Your doctor will help you understand the potential risks and benefits.

This medication may also increase the risk of a severe brain condition called aseptic meningitis. If you experience symptoms such as headache, fever, chills, severe nausea or vomiting, stiff neck, rash, sensitivity to light, drowsiness, or confusion, contact your doctor immediately.

In rare cases, this medication can cause liver problems, which can be life-threatening. If you notice signs of liver problems, such as dark urine, fatigue, decreased appetite, stomach pain or nausea, pale stools, vomiting, or yellowing of the skin or eyes, seek medical attention promptly.

If you are 60 years or older, you may be more susceptible to side effects from this medication, so it is essential to use it with caution. Women of childbearing age should be aware that this medication may affect ovulation, which can impact fertility. However, this effect is typically reversible when the medication is stopped. Your doctor will discuss the potential risks and benefits with you.

Finally, if you are breastfeeding, you should consult with your doctor to discuss any potential risks to your baby.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Abdominal pain
  • Lethargy
  • Drowsiness
  • Headache
  • Tinnitus (ringing in ears)
  • Nystagmus (involuntary eye movements)
  • Metabolic acidosis
  • Renal failure
  • Coma (in severe cases)
  • Seizures

What to Do:

In case of overdose, seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is supportive and symptomatic. Gastric decontamination (e.g., activated charcoal) may be considered if ingestion is recent and significant. Monitor vital signs, renal function, and acid-base balance.

Drug Interactions

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Contraindicated Interactions

  • Aspirin (high-dose, for anti-inflammatory effect)
  • Other NSAIDs (increased risk of GI and renal toxicity)
  • Ketorolac (increased risk of GI and renal toxicity)
  • Methotrexate (high-dose, increased methotrexate toxicity)
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Major Interactions

  • Anticoagulants (e.g., Warfarin, Dabigatran, Rivaroxaban): Increased risk of bleeding.
  • Antiplatelet agents (e.g., Clopidogrel, Aspirin low-dose): Increased risk of bleeding.
  • SSRIs/SNRIs: Increased risk of GI bleeding.
  • Diuretics (e.g., Furosemide, Hydrochlorothiazide): Reduced diuretic and antihypertensive effects, increased risk of renal impairment.
  • ACE Inhibitors/ARBs: Reduced antihypertensive effect, increased risk of renal impairment, hyperkalemia.
  • Cyclosporine/Tacrolimus: Increased risk of nephrotoxicity.
  • Lithium: Increased lithium levels and toxicity.
  • Digoxin: Increased digoxin levels.
  • Methotrexate (low-dose): Increased methotrexate toxicity.
  • Corticosteroids: Increased risk of GI ulceration and bleeding.
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Moderate Interactions

  • Sulfonylureas: Enhanced hypoglycemic effect.
  • Phenytoin: Increased phenytoin levels.
  • Beta-blockers: Reduced antihypertensive effect.
  • Cholestyramine: Reduced ibuprofen absorption (administer ibuprofen 1 hour before or 4-6 hours after cholestyramine).
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Minor Interactions

  • Alcohol: Increased risk of GI irritation/bleeding.

Monitoring

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Baseline Monitoring

Complete Blood Count (CBC)

Rationale: To establish baseline for potential hematologic adverse effects (e.g., anemia, thrombocytopenia) with long-term use.

Timing: Prior to initiation of long-term therapy.

Renal Function (Serum Creatinine, BUN)

Rationale: To assess baseline kidney function, as NSAIDs can cause renal impairment.

Timing: Prior to initiation, especially in patients with pre-existing renal impairment or risk factors.

Liver Function Tests (ALT, AST, Bilirubin)

Rationale: To assess baseline liver function, as NSAIDs can cause hepatic injury.

Timing: Prior to initiation, especially in patients with pre-existing hepatic impairment or risk factors.

Blood Pressure

Rationale: To establish baseline, as NSAIDs can cause new onset hypertension or worsen pre-existing hypertension.

Timing: Prior to initiation.

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Routine Monitoring

Renal Function (Serum Creatinine, BUN)

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

Target: Within normal limits or stable from baseline

Action Threshold: Significant increase in creatinine (>20% from baseline or above upper limit of normal); consider dose reduction or discontinuation.

Liver Function Tests (ALT, AST)

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

Target: Within normal limits or stable from baseline

Action Threshold: Significant elevation (e.g., >3x upper limit of normal); discontinue ibuprofen.

Blood Pressure

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

Target: Individualized, within target range for patient

Action Threshold: Sustained elevation; consider alternative antihypertensive therapy or discontinuation of ibuprofen.

Complete Blood Count (CBC)

Frequency: Periodically (e.g., annually for chronic use)

Target: Within normal limits

Action Threshold: Significant decrease in hemoglobin/hematocrit or platelet count; investigate cause and consider discontinuation.

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Symptom Monitoring

  • Signs of gastrointestinal bleeding (black, tarry stools; coffee-ground vomit; severe abdominal pain)
  • Signs of allergic reaction (rash, hives, swelling of face/throat, difficulty breathing)
  • Signs of fluid retention/heart failure (swelling in ankles/feet, sudden weight gain, shortness of breath)
  • Signs of liver injury (yellowing of skin/eyes, dark urine, persistent nausea/vomiting, unusual fatigue)
  • Signs of kidney problems (decreased urine output, unusual swelling, fatigue)
  • Chest pain, shortness of breath, weakness on one side of the body, slurred speech (signs of cardiovascular events)

Special Patient Groups

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Pregnancy

Ibuprofen is generally not recommended during pregnancy, especially in the third trimester due to risks to the fetus. Use in the first and second trimesters should be with caution and only if the potential benefit justifies the potential risk.

Trimester-Specific Risks:

First Trimester: Limited data, but potential increased risk of miscarriage and congenital malformations (e.g., cardiac defects, gastroschisis) cannot be excluded.
Second Trimester: Potential for oligohydramnios (low amniotic fluid) and fetal renal dysfunction with prolonged use.
Third Trimester: Contraindicated due to risk of premature closure of the fetal ductus arteriosus, persistent pulmonary hypertension of the newborn, and renal dysfunction in the fetus leading to oligohydramnios.
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Lactation

Ibuprofen is considered compatible with breastfeeding. It is excreted into breast milk in very small amounts, and adverse effects on breastfed infants are unlikely.

Infant Risk: Low risk (L3 - Moderately safe)
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Pediatric Use

Dosing is weight-based for fever and pain. Not recommended for infants under 6 months of age without physician consultation. Increased risk of Reye's syndrome if used for viral infections (though less than aspirin).

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Geriatric Use

Elderly patients are at increased risk for serious adverse effects, particularly gastrointestinal bleeding, renal impairment, and cardiovascular events. Use the lowest effective dose for the shortest duration possible. Monitor renal function, blood pressure, and signs of GI bleeding closely.

Clinical Information

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Clinical Pearls

  • Always advise patients to take ibuprofen with food, milk, or an antacid to minimize gastrointestinal upset and irritation.
  • Remind patients about the potential for serious cardiovascular and gastrointestinal side effects, especially with long-term or high-dose use.
  • Educate patients to avoid concomitant use of other NSAIDs (prescription or OTC) to prevent additive toxicity.
  • Stress the importance of adequate hydration, especially in patients at risk for renal impairment.
  • Be aware of 'hidden' NSAIDs in combination cold/flu medications.
  • For patients on low-dose aspirin for cardioprotection, ibuprofen may interfere with aspirin's antiplatelet effect. If co-administration is necessary, advise taking ibuprofen at least 30 minutes after or 8 hours before immediate-release aspirin.
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Alternative Therapies

  • Acetaminophen (Tylenol) for pain and fever (no anti-inflammatory effect, different side effect profile)
  • Other NSAIDs (e.g., Naproxen, Diclofenac, Celecoxib) for pain, fever, and inflammation
  • Opioid analgesics (for severe pain, with higher risk of side effects and dependence)
  • Topical analgesics (e.g., topical NSAIDs, capsaicin, lidocaine patches)
  • Non-pharmacological therapies (e.g., RICE therapy for injuries, physical therapy, acupuncture, massage)
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (800mg)
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic) or Tier 2 (Preferred Brand)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. 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 about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate 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 reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.