Ibuprofen 200mg Capsules

Manufacturer RUGBY LABORATORIES Active Ingredient Ibuprofen Capsules(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 (first and second trimesters); Category D (third 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 lessen inflammation (swelling and redness). It belongs to a group of drugs called NSAIDs. It works by blocking certain natural substances in your body that cause pain and inflammation.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. 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 and swallow the tablet whole - do not chew, break, or crush it.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, away from the bathroom. Protect it from heat and keep it out of reach of children and pets. When you no longer need your 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 disposing of your medication, consult your pharmacist. You may also want to check if there are any drug take-back programs in your area.

What to Do If You Miss 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 return to 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 often than your doctor advises.
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Lifestyle & Tips

  • Take with food or milk to reduce stomach upset.
  • Drink a full glass of water with each dose.
  • Do not lie down for at least 10 minutes after taking.
  • Avoid alcohol while taking ibuprofen, as it can increase the risk of stomach bleeding.
  • Do not take more than directed or for longer than 10 days for pain or 3 days for fever without consulting a doctor.

Dosing & Administration

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Adult Dosing

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

Condition-Specific Dosing:

Pain/Fever (OTC): 200-400 mg every 4-6 hours; maximum 1200 mg/day (OTC), 3200 mg/day (Rx)
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Pediatric Dosing

Neonatal: Not established
Infant: Dosing is weight-based (e.g., 5-10 mg/kg/dose every 6-8 hours for fever/pain); 200mg capsules are not typically used for infants.
Child: Dosing is weight-based (e.g., 5-10 mg/kg/dose every 6-8 hours for fever/pain, max 40 mg/kg/day); 200mg capsules may be appropriate for older children (e.g., >12 years or >40 kg) at adult doses.
Adolescent: 200-400 mg every 4-6 hours as needed; maximum 1200 mg/day (OTC), 3200 mg/day (Rx)
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Dose Adjustments

Renal Impairment:

Mild: Use with caution; monitor renal function.
Moderate: Use with caution; consider lower doses and monitor renal function closely. Avoid if possible.
Severe: Contraindicated due to risk of worsening renal function.
Dialysis: Not dialyzable; avoid use in patients on dialysis due to risk of fluid retention and hyperkalemia.

Hepatic Impairment:

Mild: Use with caution; monitor liver function.
Moderate: Use with caution; consider lower doses and monitor liver function closely.
Severe: Avoid use due to risk of accumulation and worsening hepatic function.

Pharmacology

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Mechanism of Action

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

Absorption:

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

Distribution:

Vd: 0.11-0.21 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
ExcretionRoute: Renal (approximately 60-90% as metabolites and their conjugates, 1% as unchanged drug)
Unchanged: Approximately 1%
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Pharmacodynamics

OnsetOfAction: 30-60 minutes (analgesic/antipyretic)
PeakEffect: 1-2 hours (analgesic/antipyretic)
DurationOfAction: 4-6 hours (analgesic/antipyretic)

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 Immediately

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 or seek medical attention right away:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of bleeding, including:
+ 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
+ Uncontrollable bleeding
Signs of kidney problems, such as:
+ Inability to urinate
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of high potassium levels, including:
+ Abnormal heartbeat
+ Confusion
+ Weakness, lightheadedness, or dizziness
+ Feeling faint or numbness/tingling
+ Shortness of breath
Signs of high blood pressure, such as:
+ Severe headache or dizziness
+ Fainting or changes in vision
Shortness of breath, sudden weight gain, or swelling in the arms or legs
Chest pain or pressure, or a rapid heartbeat
Weakness on one side of the body, difficulty speaking or thinking, balance changes, drooping on one side of the face, or blurred vision
Extreme fatigue or weakness
Ringing in the ears
Severe back pain
Changes in vision

Severe Skin Reactions

This medication can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions. These conditions can be life-threatening and may affect internal organs. Seek medical help immediately 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, or body aches
Shortness of breath or swollen glands

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. However, if you notice any of the following side effects or any other symptoms that bother you or persist, contact your doctor:

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

This is not an exhaustive list of possible side effects. If you have questions or concerns 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/tarry stools, or vomit that looks like coffee grounds (signs of stomach bleeding)
  • Chest pain, shortness of breath, sudden weakness on one side of the body, or slurred speech (signs of heart attack or stroke)
  • Swelling of the face, lips, tongue, or throat; difficulty breathing; severe rash or hives (signs of allergic reaction)
  • Unusual weight gain or swelling (fluid retention)
  • Decreased urination or dark urine (kidney problems)
  • Yellowing of the skin or eyes (jaundice, liver problems)
  • Persistent headache or vision changes
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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 drugs, such as aspirin, or NSAIDs.
Certain health conditions, including:
+ Gastrointestinal (GI) bleeding
+ Kidney problems
+ Heart failure (weak heart)
+ Recent heart attack
Current 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 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.

You should also have your blood pressure checked regularly, as medications like this one can cause high blood pressure. Your doctor will advise you on how often to have your blood pressure checked.

Before consuming alcohol, discuss the potential risks with your doctor. If you smoke, talk to your doctor about the potential interactions with this medication. Additionally, if you have asthma, consult with your doctor, as you may be more sensitive to this drug.

To minimize the risk of severe side effects, do not exceed the dosage prescribed by your doctor. Taking more than the recommended dose can increase your risk of adverse reactions. Furthermore, do not take this medication for longer than your doctor has instructed.

As this medication can affect your blood's ability to clot, you may be more prone to bleeding. To reduce the risk of injury, be careful and use a soft toothbrush and an electric razor.

The use of medications like this one can increase the risk of heart failure. If you already have heart failure, your risk of heart attack, hospitalization for heart failure, and death may be higher. Discuss these risks with your doctor.

In people who have recently experienced a heart attack, the use of medications like this one can increase the risk of another heart attack and heart-related death. Additionally, research has shown that people taking this type of medication after a first heart attack were more likely to die within the following year compared to those not taking this medication. It is crucial to discuss these risks with your doctor.

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

In rare cases, medications like this one can cause liver problems, which can be life-threatening. If you notice any 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, contact your doctor right away.

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 NSAIDs like this medication can affect ovulation, which may impact fertility. However, this effect is typically reversible when the medication is stopped. Discuss any concerns with your doctor.

If you are breastfeeding, inform your doctor, as they will need to assess the potential risks to your baby.
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Overdose Information

Overdose Symptoms:

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

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment may involve activated charcoal if ingested recently, supportive care, and management of symptoms.

Drug Interactions

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Contraindicated Interactions

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

  • Anticoagulants (e.g., Warfarin, Heparin, DOACs): Increased risk of bleeding.
  • Antiplatelet agents (e.g., Clopidogrel): Increased risk of bleeding.
  • Corticosteroids: Increased risk of GI ulceration and 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 and hyperkalemia.
  • Lithium: Increased lithium levels and toxicity.
  • Methotrexate: Increased methotrexate levels and toxicity.
  • Cyclosporine: Increased risk of nephrotoxicity.
  • Digoxin: Increased digoxin levels.
  • SSRIs/SNRIs: Increased risk of GI bleeding.
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Moderate Interactions

  • Beta-blockers: Reduced antihypertensive effect.
  • Phenytoin: Increased phenytoin levels.
  • Sulfonylureas: Potentiation of hypoglycemic effect.
  • Tacrolimus: Increased risk of nephrotoxicity.
  • 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

Not typically required for short-term OTC use.

Rationale: Ibuprofen 200mg is an OTC product for acute, short-term use.

Timing: N/A

Renal function (BUN, Creatinine)

Rationale: To assess baseline kidney function, especially in patients with pre-existing renal impairment or risk factors.

Timing: Prior to initiation for chronic or high-dose therapy, or in at-risk patients.

Blood pressure

Rationale: NSAIDs can cause fluid retention and elevate blood pressure.

Timing: Prior to initiation for chronic or high-dose therapy, or in at-risk patients.

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Routine Monitoring

Not typically required for short-term OTC use.

Frequency: N/A

Target: N/A

Action Threshold: N/A

Renal function (BUN, Creatinine)

Frequency: Periodically (e.g., every 6-12 months or as clinically indicated) for chronic or high-dose therapy.

Target: Within normal limits; monitor trends.

Action Threshold: Significant increase in creatinine (>20-30% from baseline) or development of acute kidney injury.

Blood pressure

Frequency: Periodically for chronic or high-dose therapy.

Target: Individualized, typically <130/80 mmHg.

Action Threshold: Sustained elevation above target range.

Complete Blood Count (CBC)

Frequency: Periodically for chronic or high-dose therapy (e.g., annually).

Target: Within normal limits.

Action Threshold: Significant decrease in hemoglobin/hematocrit (suggesting GI bleeding) or platelet count.

Liver function tests (ALT, AST)

Frequency: Periodically for chronic or high-dose therapy (e.g., annually).

Target: Within normal limits.

Action Threshold: Significant elevation (>3x upper limit of normal).

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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 the body, slurred speech)
  • Signs of allergic reaction (rash, itching, swelling of face/throat, severe dizziness, trouble breathing)
  • Unexplained weight gain or swelling (fluid retention)
  • Persistent headache or vision changes
  • Yellowing of skin or eyes (jaundice)

Special Patient Groups

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Pregnancy

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

Trimester-Specific Risks:

First Trimester: Possible increased risk of miscarriage and congenital malformations (e.g., cardiac defects, gastroschisis), though data are conflicting.
Second Trimester: Generally considered safer than the first or third 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, oligohydramnios, and renal dysfunction in the fetus.
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Lactation

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

Infant Risk: Low risk (L1)
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Pediatric Use

Dosing is weight-based for children. 200mg capsules are generally not suitable for very young children due to fixed dose and potential for choking. Liquid formulations or chewable tablets are preferred for younger children. Avoid in children with chickenpox or flu-like symptoms due to theoretical risk of Reye's syndrome (though primarily associated with aspirin).

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Geriatric Use

Increased risk of adverse effects, particularly gastrointestinal bleeding, renal impairment, and cardiovascular events. Use the lowest effective dose for the shortest duration possible. Monitor renal function and blood pressure closely.

Clinical Information

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Clinical Pearls

  • Ibuprofen is a common OTC NSAID effective for mild to moderate pain, fever, and inflammation.
  • Always advise patients to take with food or milk to minimize GI upset.
  • Counsel patients on the black box warnings for cardiovascular and GI risks, especially for chronic use or in at-risk populations.
  • Emphasize the importance of not exceeding the maximum daily dose and avoiding concomitant use with other NSAIDs.
  • Remind patients that ibuprofen should be avoided in the third trimester of pregnancy.
  • For patients with hypertension, heart failure, or renal impairment, ibuprofen can worsen these conditions; consider alternative analgesics.
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Alternative Therapies

  • Acetaminophen (Tylenol) - for pain and fever, no anti-inflammatory effect, different side effect profile.
  • Naproxen (Aleve) - another NSAID with longer duration of action.
  • Aspirin - NSAID, but with specific antiplatelet uses and different side effect profile.
  • Other NSAIDs (e.g., diclofenac, celecoxib - Rx only)
  • Topical analgesics (e.g., diclofenac gel, capsaicin cream) for localized pain.
  • Non-pharmacological therapies (e.g., RICE - Rest, Ice, Compression, Elevation; physical therapy).
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Cost & Coverage

Average Cost: $5 - $20 per 100 tablets (OTC)
Generic Available: Yes
Insurance Coverage: OTC (Over-the-Counter) - generally not covered by insurance unless prescribed or part of a specific FSA/HSA plan.
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not hesitate to discuss them with your doctor, nurse, 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.