Ibuprofen 100mg/5ml Oral Susp

Manufacturer PERRIGO Active Ingredient Ibuprofen Suspension(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
Non-steroidal 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 medicine used to reduce fever and relieve mild to moderate pain, such as headaches, muscle aches, toothaches, and menstrual cramps. It also helps reduce inflammation (swelling and redness) caused by conditions like arthritis.
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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. Take your medication as directed, with or without food. If you experience stomach upset, take it with food to help minimize discomfort. Always take your medication with a full glass of water. Before using, shake the container well. When taking a liquid dose, measure it carefully using the device that comes with the medication. If no device is provided, ask your pharmacist for a suitable measuring tool.

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. Dispose of unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so. If you have questions about disposal, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.

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 or milk to reduce stomach upset.
  • Drink plenty of fluids to help prevent kidney problems.
  • 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 recommended without consulting a doctor.
  • For children, use the dosing syringe or cup provided to ensure accurate dosing based on weight/age.

Dosing & Administration

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Adult Dosing

Standard Dose: Not typically used in adults for 100mg/5ml concentration. Adult dosing for pain/fever is typically 200-400mg every 4-6 hours.
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Pediatric Dosing

Neonatal: Not established (generally not recommended for infants < 6 months without medical supervision)
Infant: 5-10 mg/kg/dose every 6-8 hours for fever/pain (max 4 doses/day). For infants 6 months to 2 years, consult weight-based dosing charts.
Child: 5-10 mg/kg/dose every 6-8 hours for fever/pain (max 4 doses/day). Max 40 mg/kg/day. For children 2-12 years, consult weight-based dosing charts.
Adolescent: 5-10 mg/kg/dose every 6-8 hours for fever/pain (max 4 doses/day). Max 40 mg/kg/day or 1200 mg/day, whichever is less. For adolescents >12 years, adult dosing may apply (200-400mg every 4-6 hours).
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed, but monitor renal function.
Moderate: Use with caution; consider dose reduction or increased dosing interval. 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 adverse effects.

Hepatic Impairment:

Mild: No specific adjustment needed, but monitor liver function.
Moderate: Use with caution; consider dose reduction. Monitor liver function closely.
Severe: Avoid use due to risk of worsening hepatic function and accumulation.

Pharmacology

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Mechanism of Action

Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID) that exerts its therapeutic effects primarily by inhibiting the cyclooxygenase (COX) enzymes, COX-1 and COX-2. This inhibition leads to a reduction in the synthesis of prostaglandins, which are mediators of inflammation, pain, and fever. Inhibition of COX-1 contributes to gastrointestinal and platelet-related side effects, while inhibition of COX-2 is primarily responsible for the anti-inflammatory, analgesic, and antipyretic effects.
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Pharmacokinetics

Absorption:

Bioavailability: 80-100%
Tmax: 1-2 hours (oral suspension may be slightly faster)
FoodEffect: Food may decrease the rate of absorption (delay Tmax) but generally does not affect the extent of absorption (AUC). Taking with food can reduce GI upset.

Distribution:

Vd: 0.1-0.2 L/kg
ProteinBinding: 90-99% (primarily to albumin)
CnssPenetration: Limited (low concentrations, 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, 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: 4-8 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 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: 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.
Signs of 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.
Signs of kidney problems: inability to urinate, changes in urine output, blood in the urine, or sudden significant weight gain.
Signs of high potassium levels: irregular heartbeat, confusion, weakness, lightheadedness, dizziness, feeling faint, numbness or tingling, or shortness of breath.
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision.
Shortness of breath, significant weight gain, or swelling in the arms or legs.
Chest pain or pressure, or rapid heartbeat.
Weakness on one side of the body, difficulty speaking or thinking, balance problems, 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 reactions can affect other organs and be life-threatening. 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
Body aches
Shortness of breath
Swollen glands

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor ones. If you are bothered by any of the following side effects or if they persist, contact your doctor:

Constipation
Diarrhea
Stomach pain
Upset stomach
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 or tarry stools, or vomit that looks like coffee grounds (signs of stomach bleeding)
  • Swelling of the face, lips, tongue, or throat; difficulty breathing; severe rash or hives (signs of allergic reaction)
  • Decreased urination, swelling in the legs or feet, unusual tiredness (signs of kidney problems)
  • Chest pain, sudden weakness on one side of the body, sudden slurred speech (signs of heart attack or stroke)
  • Yellowing of the skin or eyes (jaundice), dark urine, unusual tiredness (signs of liver problems)
  • Unexplained weight gain or swelling
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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 weakened 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 can harm an unborn baby if taken after 20 weeks of pregnancy. 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.

It is crucial to follow your doctor's instructions regarding the dosage and duration of treatment. Taking more than the prescribed amount or using this medication for longer than recommended can increase your risk of severe side effects.

As this medication may affect your blood's ability to clot, you may be more prone to bleeding. To minimize this risk, be careful to avoid injuries, use a soft toothbrush, and consider using an electric razor.

The use of medications like this one can increase the risk of heart failure, heart attack, and death, particularly in people who have already experienced heart failure. If you have a history of heart failure, discuss the potential risks with your doctor. Furthermore, if you have recently had a heart attack, be aware that this medication may increase your risk of another heart attack or heart-related death.

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

In rare cases, medications like this one can cause liver problems, which can be life-threatening. If you notice signs of liver problems, such as dark urine, fatigue, loss of appetite, stomach pain, pale stools, vomiting, or yellowing of the skin or eyes, seek medical attention 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 NSAIDs like this medication may affect ovulation, potentially impacting fertility. However, this effect is reversible when the medication is stopped. Discuss any concerns with your doctor.

If you are breastfeeding, consult with your doctor to discuss 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 movement)
  • Rarely: kidney failure, liver damage, coma, seizures

What to Do:

If an overdose is suspected, call your local poison control center (1-800-222-1222) or seek emergency medical attention immediately. Do not induce vomiting unless instructed by a healthcare professional.

Drug Interactions

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Contraindicated Interactions

  • Other NSAIDs (increased risk of GI adverse events)
  • Aspirin (high-dose, for anti-inflammatory effect - may reduce cardioprotective effect of low-dose aspirin)
  • Ketorolac
  • Celecoxib (if used with other NSAIDs)
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Major Interactions

  • Anticoagulants (e.g., Warfarin, Heparin, DOACs - increased risk of bleeding)
  • Antiplatelet agents (e.g., Clopidogrel, Ticagrelor - increased risk of bleeding)
  • Corticosteroids (increased risk of GI ulceration/bleeding)
  • Diuretics (e.g., Furosemide, Hydrochlorothiazide - reduced diuretic and antihypertensive effect, increased risk of renal impairment)
  • ACE inhibitors (e.g., Lisinopril, Enalapril - reduced antihypertensive effect, increased risk of renal impairment)
  • Angiotensin Receptor Blockers (ARBs) (e.g., Valsartan, Losartan - reduced antihypertensive effect, increased risk of renal impairment)
  • Lithium (increased lithium levels and toxicity)
  • Methotrexate (increased methotrexate levels and toxicity)
  • Cyclosporine (increased risk of nephrotoxicity)
  • Tacrolimus (increased risk of nephrotoxicity)
  • SSRIs/SNRIs (increased risk of GI bleeding)
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Moderate Interactions

  • Beta-blockers (reduced antihypertensive effect)
  • Digoxin (may increase digoxin levels)
  • Phenytoin (may increase phenytoin levels)
  • Sulfonylureas (may enhance hypoglycemic effect)
  • Quinolone antibiotics (increased risk of seizures)
  • Aminoglycosides (may increase aminoglycoside levels)
  • Pemetrexed (increased risk of myelosuppression, renal, and GI toxicity)
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Minor Interactions

  • Alcohol (increased risk of GI irritation/bleeding)
  • Ginkgo biloba (theoretical increased bleeding risk)

Monitoring

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Baseline Monitoring

Renal function (BUN, Creatinine)

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

Timing: Prior to initiation, especially for long-term therapy or high-risk patients.

Liver function tests (ALT, AST)

Rationale: To establish baseline liver function, especially in patients with pre-existing hepatic impairment.

Timing: Prior to initiation, especially for long-term therapy or high-risk patients.

Blood pressure

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

Timing: Prior to initiation.

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Routine Monitoring

Renal function (BUN, Creatinine)

Frequency: Periodically, especially with long-term use (>1 month) or in high-risk patients (e.g., every 3-6 months).

Target: Within normal limits or stable from baseline.

Action Threshold: Significant increase from baseline, or signs of acute kidney injury.

Liver function tests (ALT, AST)

Frequency: Periodically, especially with long-term use (>1 month).

Target: Within normal limits or stable from baseline.

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

Blood pressure

Frequency: Regularly, especially in hypertensive patients.

Target: Individualized target.

Action Threshold: Sustained elevation above target.

Complete Blood Count (CBC)

Frequency: Periodically with long-term use (>1 month) due to risk of anemia from GI bleeding or rare hematologic effects.

Target: Within normal limits.

Action Threshold: Significant drop in hemoglobin/hematocrit, or abnormal platelet/WBC counts.

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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 allergic reaction (rash, itching, hives, swelling of face/lips/tongue, difficulty breathing)
  • Signs of cardiovascular events (chest pain, shortness of breath, weakness on one side of the body, slurred speech)
  • Unexplained weight gain or edema
  • Persistent headache or vision changes

Special Patient Groups

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Pregnancy

Avoid use in the third trimester 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 only be if the potential benefit justifies the potential risk to the fetus, and at the lowest effective dose for the shortest duration possible.

Trimester-Specific Risks:

First Trimester: Category C. Potential increased risk of miscarriage and congenital malformations (e.g., cardiac septal defects, gastroschisis) in some studies, though data are conflicting.
Second Trimester: Category C. Generally considered safer than third trimester, but still use with caution and only if clearly needed. Risk of oligohydramnios (low amniotic fluid) and fetal renal dysfunction.
Third Trimester: Category D. Contraindicated due to significant risks including premature closure of the fetal ductus arteriosus, persistent pulmonary hypertension of the newborn, fetal renal dysfunction leading to oligohydramnios, and inhibition of labor.
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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

Ibuprofen oral suspension is specifically formulated for pediatric use. Dosing must be carefully calculated based on the child's weight or age to avoid overdose. Not recommended for infants under 6 months of age without consulting a healthcare professional. Use with caution in dehydrated children due to increased risk of renal adverse effects.

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Geriatric Use

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

Clinical Information

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Clinical Pearls

  • Always use the provided dosing device (syringe or cup) for accurate measurement of oral suspension, especially in children.
  • Advise patients to take ibuprofen with food or milk to minimize gastrointestinal upset.
  • Educate patients about the signs and symptoms of GI bleeding and renal dysfunction, and when to seek immediate medical attention.
  • Remind patients that ibuprofen is an NSAID and should not be taken with other NSAIDs (including other OTC products like naproxen or aspirin for pain) to avoid additive toxicity.
  • For fever, if the child is not drinking fluids well or has signs of dehydration, consider acetaminophen as an alternative or consult a physician before administering ibuprofen.
  • Counsel patients on the black box warnings regarding cardiovascular and gastrointestinal risks, especially for long-term use or in high-risk individuals.
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Alternative Therapies

  • Acetaminophen (Tylenol, Paracetamol) - for pain and fever, generally safer for GI and renal systems, especially in children and high-risk patients.
  • Naproxen (Aleve) - another NSAID, longer half-life, less frequent dosing.
  • Aspirin (low-dose for antiplatelet effect, high-dose for pain/inflammation - generally avoided in children due to Reye's Syndrome risk).
  • Topical analgesics (e.g., lidocaine patches, diclofenac gel) for localized pain.
  • Non-pharmacological interventions (e.g., rest, ice/heat, hydration).
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Cost & Coverage

Generic Available: Yes
Insurance Coverage: Tier 1 (Generic)
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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 check with your pharmacist. If you have any questions or concerns about this medication, consult 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.