Ibuprofen 100mg/5ml Oral Susp Berry

Manufacturer PADAGIS 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
Nonsteroidal Anti-inflammatory Drug (NSAID), Analgesic, Antipyretic
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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 medicine that helps reduce fever, relieve pain (like headaches, toothaches, muscle aches), and lessen swelling and inflammation. It's commonly used for children to treat fever and minor aches and pains.
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How to Use This Medicine

Taking Your Medication Correctly

To ensure you get the most benefit from your medication, follow these steps:

Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
You can take your medication with or without food. If it causes stomach upset, take it with food.
Swallow your medication with a full glass of water.
If you are taking a liquid form of this medication, shake the bottle well before use and measure your dose carefully using the measuring device provided. If no device is included, ask your pharmacist for one.

Storing and Disposing of Your Medication

To keep your medication safe and effective:

Store it at room temperature in a dry place, away from the bathroom.
Protect it from heat.
Keep all medications in a safe place, out of the 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. Check with your pharmacist for guidance on the best way to dispose of your medication. You may also be able to participate in a drug take-back program in your area.

What to Do If You Miss a Dose

If you take your medication regularly and miss a dose:

Take the missed dose as soon as you remember.
If it is 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 your medication as needed, do not take it more often than directed by your doctor.
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Lifestyle & Tips

  • Always use the dosing syringe or cup provided with the medication to measure the correct dose. Do not use household spoons.
  • Shake the oral suspension well before each use.
  • Give with food or milk to help prevent stomach upset.
  • Ensure adequate hydration, especially when treating fever in children.
  • Do not give more than the recommended dose or more often than directed.
  • Avoid giving other NSAIDs (like naproxen or aspirin) at the same time unless directed by a doctor.
  • Store at room temperature, away from light and moisture.

Dosing & Administration

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Adult Dosing

Standard Dose: 200-400 mg every 4-6 hours as needed (Note: 100mg/5ml suspension is less common for adult standard dosing, typically higher strength tablets are used).
Dose Range: 200 - 800 mg

Condition-Specific Dosing:

Max OTC Dose: 1200 mg/day
Max Prescription Dose: 3200 mg/day
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Pediatric Dosing

Neonatal: Not established (contraindicated in infants <6 months without physician supervision)
Infant: For infants 6 months to 2 years (12-23 lbs or 5.5-10.9 kg): 5 mg/kg/dose for temperature <102.5°F (39.2°C) or mild pain; 10 mg/kg/dose for temperature â‰Ĩ102.5°F (39.2°C) or moderate-severe pain. Doses every 6-8 hours as needed. Max 4 doses/day.
Child: For children 2-12 years: 5-10 mg/kg/dose every 6-8 hours as needed for fever or pain. Max 40 mg/kg/day.
Adolescent: For adolescents 12-18 years: 200-400 mg every 4-6 hours as needed. Max 1200 mg/day (OTC) or 3200 mg/day (prescription).
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment, monitor renal function.
Moderate: Use with caution, consider lower doses and monitor renal function closely. Avoid if possible.
Severe: Contraindicated or avoid use due to risk of acute renal failure.
Dialysis: Not significantly removed by hemodialysis; avoid use due to risk of renal impairment.

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 exacerbating hepatic dysfunction.

Pharmacology

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Mechanism of Action

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that exerts its therapeutic effects primarily through the inhibition of cyclooxygenase (COX) enzymes, specifically COX-1 and COX-2. This inhibition leads to a reduction in the synthesis of prostaglandins, which are mediators of inflammation, pain, and fever. By reducing prostaglandin levels, ibuprofen produces analgesic, anti-inflammatory, and antipyretic effects.
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Pharmacokinetics

Absorption:

Bioavailability: 80-100%
Tmax: 1-2 hours (oral suspension may be slightly faster)
FoodEffect: Food delays the rate of absorption (Tmax) but does not significantly affect the extent of absorption (AUC).

Distribution:

Vd: 0.1-0.2 L/kg
ProteinBinding: >99% (primarily to albumin)
CnssPenetration: Limited

Elimination:

HalfLife: 1.8-2.5 hours
Clearance: Not readily available as a single rate, but primarily hepatic metabolism followed by renal excretion.
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

Safety & Warnings

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BLACK BOX WARNING

Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. Ibuprofen is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. NSAIDs 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 or seek immediate 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, significant weight gain, or swelling in the arms or legs.
Cardiovascular Concerns: Chest pain or pressure, rapid heartbeat, or weakness on one side of the body.
Neurological Symptoms: Difficulty speaking or thinking, balance changes, drooping on one side of the face, or blurred vision.
General Concerns: Extreme fatigue or weakness, ringing in the ears, severe back pain, or changes in vision.
Severe Skin Reactions: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), or other serious reactions, which may be life-threatening. Seek immediate medical help if you experience red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, eyes, genitals, or skin; fever; chills; body aches; shortness of breath; or swollen glands.

Other Possible Side Effects

Most medications can cause side effects, but many people experience none or only mild symptoms. If you encounter any of the following side effects or any other concerns, contact your doctor or seek medical attention:

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

This is not an exhaustive list of potential 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 or discomfort
  • Black, tarry stools or blood in vomit (signs of stomach bleeding)
  • Unusual bruising or bleeding that doesn't stop
  • Swelling of the face, hands, ankles, or feet
  • Difficulty breathing or shortness of breath
  • Severe skin rash, blistering, or peeling
  • Yellowing of the skin or eyes (jaundice)
  • Dark urine or pale stools
  • Unusual tiredness or weakness
  • Signs of an allergic reaction (hives, rash, swelling of face/throat, severe dizziness)
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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 and situations 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.
Presence of gastrointestinal (GI) bleeding or kidney problems.
Heart failure (weak heart) or a recent heart attack.
Current use of other NSAIDs, salicylate drugs like aspirin, or pemetrexed.
Difficulty conceiving or undergoing fertility evaluation.
Pregnancy, planned pregnancy, or pregnancy during treatment. 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 issues with your doctor and pharmacist. Verify that it is safe to take this medication with your existing treatments and health conditions. 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.

There is a risk of developing high blood pressure while taking this medication. Your doctor will likely advise you to have your blood pressure checked regularly. Additionally, discuss your alcohol consumption with your doctor before drinking. If you smoke, talk to your doctor about the potential risks. Individuals with asthma should also consult their doctor, as they may be more sensitive to this medication.

Adhere to the prescribed dosage and do not exceed the recommended amount, as this may increase the risk of severe side effects. Do not take this medication for longer than your doctor has instructed.

Be cautious, as this medication may affect your blood's ability to clot, making you more prone to bleeding. To minimize the risk of injury, use a soft toothbrush and an electric razor.

The use of this medication may increase the risk of heart failure, particularly in individuals who already have a history of heart failure. This may lead to a higher risk of heart attack, hospitalization, and death. Discuss these risks with your doctor. Furthermore, individuals who have recently experienced a heart attack may be at a higher risk of heart attack and heart-related death while taking this medication. Your doctor can provide more information on this potential risk.

There is a rare but serious risk of developing aseptic meningitis, a brain condition, while taking 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.

Liver problems, including potentially life-threatening conditions, have been associated with this medication. If you notice signs of liver problems, such as dark urine, fatigue, decreased appetite, stomach pain, pale stools, vomiting, or yellowing of the skin and 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 this medication may affect ovulation, potentially impacting fertility. However, this effect is typically reversible when the medication is discontinued. Discuss any concerns with your doctor.

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

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Abdominal pain
  • Drowsiness
  • Dizziness
  • Headache
  • Nystagmus (involuntary eye movement)
  • Tinnitus (ringing in ears)
  • Rarely: metabolic acidosis, coma, acute renal failure, apnea, seizures

What to Do:

If an overdose is suspected, seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. 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 (regular use, high dose, due to interference with antiplatelet effect)
  • Coronary Artery Bypass Graft (CABG) surgery (peri-operative pain)
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Major Interactions

  • Anticoagulants (e.g., Warfarin, Dabigatran, Rivaroxaban) - increased risk of bleeding
  • Antiplatelet agents (e.g., Clopidogrel, Ticagrelor) - increased risk of bleeding
  • Corticosteroids (e.g., Prednisone) - increased risk of GI ulceration/bleeding
  • SSRIs/SNRIs (e.g., Fluoxetine, Sertraline) - increased risk of GI 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) - reduced antihypertensive effect, increased risk of renal impairment
  • Angiotensin Receptor Blockers (ARBs) (e.g., Valsartan) - reduced antihypertensive effect, increased risk of renal impairment
  • Cyclosporine - increased risk of nephrotoxicity
  • Tacrolimus - increased risk of nephrotoxicity
  • Digoxin - increased digoxin levels
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Moderate Interactions

  • Sulfonylureas (e.g., Glipizide) - enhanced hypoglycemic effect
  • Phenytoin - increased phenytoin levels
  • Cholestyramine - reduced ibuprofen absorption (administer ibuprofen 1 hour before or 4-6 hours after cholestyramine)
  • Alcohol - increased risk of GI irritation/bleeding
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Minor Interactions

  • Ginkgo Biloba - theoretical increased bleeding risk

Monitoring

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Baseline Monitoring

Renal function (Serum Creatinine, BUN)

Rationale: To assess baseline kidney function, especially important before initiating NSAIDs due to potential for renal impairment.

Timing: Before initiation, particularly in patients with pre-existing renal impairment, dehydration, or concomitant nephrotoxic drugs.

Liver function tests (ALT, AST)

Rationale: To assess baseline liver function, as ibuprofen is metabolized hepatically and can rarely cause liver injury.

Timing: Before initiation, especially in patients with pre-existing hepatic impairment.

Complete Blood Count (CBC)

Rationale: To assess baseline hemoglobin, hematocrit, and platelet count, especially if long-term use is anticipated, due to risk of GI bleeding or rare hematologic effects.

Timing: Before initiation for long-term therapy.

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Routine Monitoring

Renal function (Serum Creatinine, BUN)

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

Target: Within normal limits or stable from baseline

Action Threshold: Significant increase in creatinine or BUN; consider dose reduction or discontinuation.

Blood Pressure

Frequency: Periodically (especially in hypertensive patients)

Target: Within target range for patient

Action Threshold: Significant increase in blood pressure; consider alternative analgesic or antihypertensive adjustment.

Signs/Symptoms of GI bleeding (e.g., black/tarry stools, severe abdominal pain)

Frequency: Continuously (patient education)

Target: Absence of symptoms

Action Threshold: Presence of symptoms; discontinue ibuprofen and seek immediate medical attention.

Fluid retention/Edema

Frequency: Continuously (patient education)

Target: Absence of symptoms

Action Threshold: Development of significant edema or weight gain; consider discontinuation.

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Symptom Monitoring

  • Abdominal pain
  • Indigestion (dyspepsia)
  • Nausea
  • Vomiting
  • Black, tarry stools (melena)
  • Vomiting blood or coffee-ground like material (hematemesis)
  • Unusual bruising or bleeding
  • Swelling of ankles, feet, or hands (edema)
  • Unexplained weight gain
  • Shortness of breath or chest pain
  • Skin rash or blistering
  • Yellowing of skin or eyes (jaundice)
  • Dark urine
  • Unusual fatigue or weakness
  • Flu-like symptoms (fever, body aches, chills)

Special Patient Groups

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Pregnancy

Use of NSAIDs, including ibuprofen, should be avoided in the third trimester of pregnancy due to the risk of premature closure of the fetal ductus arteriosus and fetal renal dysfunction. Use in the first and second trimesters should be with caution and only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Limited data, but potential for increased risk of miscarriage and congenital malformations (e.g., cardiac septal defects, gastroschisis) cannot be excluded. Use with caution.
Second Trimester: Generally considered safer than the first or third trimester, but still use with caution and only if clearly needed. Prolonged use may still pose risks.
Third Trimester: Contraindicated due to significant risks to the fetus (premature closure of ductus arteriosus, persistent pulmonary hypertension, renal dysfunction leading to oligohydramnios) and to the mother (prolonged labor, increased bleeding).
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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
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Pediatric Use

Ibuprofen 100mg/5ml oral suspension is specifically formulated and commonly used for pediatric patients (6 months and older) for fever and pain relief. Dosing is weight-based. Contraindicated in infants younger than 6 months without specific medical advice. Close monitoring for adverse effects, especially GI and renal, is important.

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Geriatric Use

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

Clinical Information

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Clinical Pearls

  • Always use the provided measuring device (syringe or cup) for accurate dosing, especially in children.
  • Administer with food or milk to minimize gastrointestinal upset.
  • Educate parents/caregivers on weight-based dosing for children and the maximum daily dose.
  • Remind patients that ibuprofen is an NSAID and carries risks of GI bleeding and cardiovascular events, even at OTC doses.
  • Advise against concomitant use with other NSAIDs (including aspirin for pain/fever) to avoid additive toxicity.
  • Ensure adequate hydration, particularly in febrile children, to reduce the risk of renal complications.
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Alternative Therapies

  • Acetaminophen (Paracetamol) - for fever and pain relief (different mechanism, no anti-inflammatory effect)
  • Naproxen - another NSAID (longer half-life, less frequent dosing)
  • Celecoxib - selective COX-2 inhibitor (prescription, lower GI risk but similar cardiovascular risk)
  • Topical analgesics (e.g., lidocaine patches, capsaicin cream) - for localized pain
  • Non-pharmacological interventions (e.g., rest, ice, heat, massage, hydration)
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Cost & Coverage

Generic Available: Yes
Insurance Coverage: Tier 1 (Preferred Generic) or OTC (often not covered by prescription plans unless prescribed)
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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. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to 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 details about the medication taken, the amount, and the time it happened.