Ibuprofen Oral Susp 40mg/ml Drops
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.
Drug Class
Nonsteroidal Anti-inflammatory Drug (NSAID), Analgesic, Antipyretic
Pharmacologic Class
Cyclooxygenase (COX) inhibitor
Pregnancy Category
Category C (1st and 2nd trimesters), Category D (3rd trimester)
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ibuprofen is a medicine that helps reduce fever and relieve mild to moderate pain, such as headaches, toothaches, muscle aches, and pain from colds or flu. It works by reducing substances in the body that cause pain and inflammation.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food. If it causes stomach upset, take it with food to help minimize this side effect. Always take it with a full glass of water. Before using, shake the medication well. If you're taking the liquid form, measure your dose carefully using the measuring device that comes with the medication. If one isn't provided, ask your pharmacist for a suitable device to ensure accurate measurement.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom to prevent moisture exposure. Protect it from heat sources. Keep all medications in a safe location, out of the 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 by your pharmacist. Instead, check with your pharmacist for the best disposal method or inquire about drug take-back programs in your area.
Missing a Dose
If you take this medication on a regular schedule and miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take two doses at the same time or extra doses. If you take this medication as needed, follow your doctor's instructions and do not take it more frequently than recommended.
To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food. If it causes stomach upset, take it with food to help minimize this side effect. Always take it with a full glass of water. Before using, shake the medication well. If you're taking the liquid form, measure your dose carefully using the measuring device that comes with the medication. If one isn't provided, ask your pharmacist for a suitable device to ensure accurate measurement.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom to prevent moisture exposure. Protect it from heat sources. Keep all medications in a safe location, out of the 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 by your pharmacist. Instead, check with your pharmacist for the best disposal method or inquire about drug take-back programs in your area.
Missing a Dose
If you take this medication on a regular schedule and miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take two doses at the same time or extra doses. If you take this medication as needed, follow your doctor's instructions and do not take it more frequently than recommended.
Lifestyle & Tips
- Always use the dosing syringe or dropper provided with the medication to ensure accurate dosing, especially for children.
- Give with food or milk to help prevent stomach upset.
- Do not give more often than directed (typically every 6-8 hours) and do not exceed the maximum daily dose.
- Ensure the child stays hydrated, especially when they have a fever.
- Store at room temperature, away from light and moisture, and out of reach of children.
Available Forms & Alternatives
Available Strengths:
- Ibuprofen Oral Susp 40mg/ml Drops
- Ibuprofen 100mg/5ml Oral Susp
- Ibuprofen 100mg/5ml Oral Susp
- Ibuprofen 200mg Tablets
- Ibuprofen 800mg Tablets
- Ibuprofen 600mg Tablets
- Ibuprofen 400mg Tablets
- Ibuprofen 100mg/5ml Oral Susp Berry
- Ibuprofen 200mg Capsules
- Ibuprofen 50mg/1.25ml Drops
- Ibuprofen Lysine 10mg/ml Inj, 2ml
Dosing & Administration
Adult Dosing
Standard Dose:
Not typically used for adult dosing; this is a pediatric formulation. Adult oral ibuprofen typically 200-400 mg every 4-6 hours.
Pediatric Dosing
Neonatal:
Not established; generally not recommended for infants under 6 months without physician consultation.
Infant:
For fever/pain (6 months to 2 years): 5-10 mg/kg/dose every 6-8 hours as needed. Max 40 mg/kg/day. Use calibrated dropper.
Child:
For fever/pain (2-12 years): 5-10 mg/kg/dose every 6-8 hours as needed. Max 40 mg/kg/day. Use calibrated dropper.
Adolescent:
For fever/pain (12-18 years): 200-400 mg every 4-6 hours as needed. Max 1.2 g/day (or 40 mg/kg/day, whichever is less). This formulation (40mg/ml) may be impractical for higher adolescent doses.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment, 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 significantly removed by hemodialysis. Avoid use in end-stage renal disease.
Hepatic Impairment:
Mild:
No specific adjustment, but monitor liver function.
Moderate:
Use with caution; consider dose reduction. Avoid if possible.
Severe:
Avoid use due to risk of accumulation and worsening hepatic function.
Pharmacology
Mechanism of Action
Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that exerts its therapeutic effects by inhibiting the 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.
Pharmacokinetics
Absorption:
Bioavailability:
80-100%
Tmax:
1-2 hours (oral suspension may be slightly faster)
FoodEffect:
Food may delay the rate of absorption (Tmax) but does not significantly affect the extent of absorption (AUC).
Distribution:
Vd:
0.1-0.2 L/kg
ProteinBinding:
>90% (primarily to albumin)
CnssPenetration:
Limited
Elimination:
HalfLife:
2-4 hours
Clearance:
Not readily available as a single value, but primarily hepatic metabolism followed by renal excretion.
ExcretionRoute:
Renal (primarily as inactive metabolites)
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
30-60 minutes
PeakEffect:
1-2 hours
DurationOfAction:
4-6 hours
Safety & Warnings
BLACK BOX WARNING
CARDIOVASCULAR THROMBOTIC EVENTS: NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, 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 for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. GASTROINTESTINAL RISK: 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.
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, redness, swelling, blistering, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or speaking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Bleeding: Vomiting or coughing up blood, coffee ground-like vomit, blood in the urine, black, red, or tarry stools, bleeding gums, abnormal vaginal bleeding, unexplained bruises or bruises that enlarge, or uncontrollable bleeding.
Kidney Problems: Inability to urinate, changes in urine output, blood in the urine, or sudden weight gain.
High Potassium Levels: Abnormal heartbeat, confusion, weakness, lightheadedness, dizziness, fainting, numbness or tingling, or shortness of breath.
High Blood Pressure: Severe headache, dizziness, fainting, or changes in vision.
Respiratory Issues: Shortness of breath, sudden 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.
Extreme Fatigue: Feeling very tired or weak.
Other Symptoms: Ringing in the ears, severe back pain, or changes in vision.
Severe Skin Reactions: This medication can cause life-threatening skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other severe reactions. These reactions can affect internal organs and be fatal. Seek immediate medical attention if you experience:
Red, swollen, blistered, or peeling skin
Red or irritated eyes
Sores in the mouth, throat, nose, eyes, genitals, or skin
Fever, chills, body aches, shortness of breath, or swollen glands
Other Side Effects
Most people do not experience severe side effects, and many have only minor or no side effects at all. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor:
Constipation, diarrhea, stomach pain, upset stomach, or vomiting
Heartburn
Gas
Dizziness
Reporting Side Effects
If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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, redness, swelling, blistering, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or speaking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Bleeding: Vomiting or coughing up blood, coffee ground-like vomit, blood in the urine, black, red, or tarry stools, bleeding gums, abnormal vaginal bleeding, unexplained bruises or bruises that enlarge, or uncontrollable bleeding.
Kidney Problems: Inability to urinate, changes in urine output, blood in the urine, or sudden weight gain.
High Potassium Levels: Abnormal heartbeat, confusion, weakness, lightheadedness, dizziness, fainting, numbness or tingling, or shortness of breath.
High Blood Pressure: Severe headache, dizziness, fainting, or changes in vision.
Respiratory Issues: Shortness of breath, sudden 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.
Extreme Fatigue: Feeling very tired or weak.
Other Symptoms: Ringing in the ears, severe back pain, or changes in vision.
Severe Skin Reactions: This medication can cause life-threatening skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other severe reactions. These reactions can affect internal organs and be fatal. Seek immediate medical attention if you experience:
Red, swollen, blistered, or peeling skin
Red or irritated eyes
Sores in the mouth, throat, nose, eyes, genitals, or skin
Fever, chills, body aches, shortness of breath, or swollen glands
Other Side Effects
Most people do not experience severe side effects, and many have only minor or no side effects at all. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor:
Constipation, diarrhea, stomach pain, upset stomach, or vomiting
Heartburn
Gas
Dizziness
Reporting Side Effects
If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of stomach bleeding: black, tarry stools; vomiting blood or material that looks like coffee grounds; severe stomach pain.
- Signs of allergic reaction: rash, hives, itching, swelling of the face, lips, tongue, or throat; difficulty breathing.
- Signs of kidney problems: decreased urination, swelling in the feet or ankles, unusual tiredness.
- Signs of liver problems: yellowing of the skin or eyes (jaundice), dark urine, unusual tiredness, nausea, vomiting, loss of appetite, pain in the upper right part of the stomach.
- Unusual bruising or bleeding.
- Chest pain, weakness on one side of the body, sudden vision changes, slurred speech (signs of heart attack or stroke).
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 (weak heart)
+ Recent heart attack
Concurrent use of other NSAIDs, salicylate drugs like aspirin, or pemetrexed.
Fertility issues or ongoing fertility evaluation, as this medication may affect fertility.
* Pregnancy, planned pregnancy, or suspected pregnancy. This medication 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 to ensure safe use. Never start, stop, or adjust the dosage of any medication without consulting 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 (weak heart)
+ Recent heart attack
Concurrent use of other NSAIDs, salicylate drugs like aspirin, or pemetrexed.
Fertility issues or ongoing fertility evaluation, as this medication may affect fertility.
* Pregnancy, planned pregnancy, or suspected pregnancy. This medication 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 to ensure safe use. Never start, stop, or adjust the dosage of any medication without consulting your doctor.
Precautions & Cautions
Important Information About Your Medication
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 medication long-term, your doctor may recommend regular blood tests to monitor your condition. Be sure to discuss any concerns or questions you have with your doctor.
Blood Pressure Monitoring
Drugs like this one can cause high blood pressure. Follow your doctor's instructions for checking your blood pressure regularly.
Interactions with Other Substances
Before consuming alcohol, talk to your doctor about any potential risks. If you smoke, discuss this with your doctor, as it may affect your treatment. Additionally, if you have asthma, consult with your doctor, as you may be more sensitive to this medication.
Safe Use of Your Medication
Do not exceed the dosage prescribed by your doctor, as taking more than recommended can increase your risk of severe side effects. Also, do not take this medication for longer than your doctor has advised.
Bleeding Risks
This medication may affect your blood's ability to clot, making you more prone to bleeding. Be cautious and avoid injuries. To minimize risks, use a soft toothbrush and an electric razor.
Heart Health
The use of drugs 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.
If you have recently had a heart attack, be aware that drugs like this one can increase your risk of another heart attack and heart-related death. In fact, 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 it. Talk to your doctor about these risks.
Rare but Serious Side Effects
This medication may increase your risk of developing a severe brain condition called aseptic meningitis. Seek medical attention immediately if you experience symptoms such as headache, fever, chills, severe nausea or vomiting, stiff neck, rash, sensitivity to light, drowsiness, or confusion.
In rare cases, liver problems can occur with the use of drugs like this one, and in some instances, these problems can be fatal. If you notice any signs of liver problems, such as dark urine, fatigue, loss of appetite, stomach pain or nausea, pale stools, vomiting, or yellowing of the skin or eyes, contact your doctor right away.
Special Considerations
If you are 60 years or older, use this medication with caution, as you may be more susceptible to side effects.
Fertility and Pregnancy
NSAIDs like this medication may affect ovulation, which can impact fertility. However, this effect is typically reversible when the medication is stopped. Discuss any concerns with your doctor.
Breastfeeding
If you are breastfeeding, consult with your doctor to discuss any potential risks to your baby.
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 medication long-term, your doctor may recommend regular blood tests to monitor your condition. Be sure to discuss any concerns or questions you have with your doctor.
Blood Pressure Monitoring
Drugs like this one can cause high blood pressure. Follow your doctor's instructions for checking your blood pressure regularly.
Interactions with Other Substances
Before consuming alcohol, talk to your doctor about any potential risks. If you smoke, discuss this with your doctor, as it may affect your treatment. Additionally, if you have asthma, consult with your doctor, as you may be more sensitive to this medication.
Safe Use of Your Medication
Do not exceed the dosage prescribed by your doctor, as taking more than recommended can increase your risk of severe side effects. Also, do not take this medication for longer than your doctor has advised.
Bleeding Risks
This medication may affect your blood's ability to clot, making you more prone to bleeding. Be cautious and avoid injuries. To minimize risks, use a soft toothbrush and an electric razor.
Heart Health
The use of drugs 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.
If you have recently had a heart attack, be aware that drugs like this one can increase your risk of another heart attack and heart-related death. In fact, 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 it. Talk to your doctor about these risks.
Rare but Serious Side Effects
This medication may increase your risk of developing a severe brain condition called aseptic meningitis. Seek medical attention immediately if you experience symptoms such as headache, fever, chills, severe nausea or vomiting, stiff neck, rash, sensitivity to light, drowsiness, or confusion.
In rare cases, liver problems can occur with the use of drugs like this one, and in some instances, these problems can be fatal. If you notice any signs of liver problems, such as dark urine, fatigue, loss of appetite, stomach pain or nausea, pale stools, vomiting, or yellowing of the skin or eyes, contact your doctor right away.
Special Considerations
If you are 60 years or older, use this medication with caution, as you may be more susceptible to side effects.
Fertility and Pregnancy
NSAIDs like this medication may affect ovulation, which can impact fertility. However, this effect is typically reversible when the medication is stopped. Discuss any concerns with your doctor.
Breastfeeding
If you are breastfeeding, consult with your doctor to discuss any potential risks to your baby.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Abdominal pain
- Drowsiness
- Dizziness
- Headache
- Nystagmus (involuntary eye movements)
- Tinnitus (ringing in ears)
- Metabolic acidosis
- Hypotension
- Bradycardia
- Apnea
- Coma
- Acute renal failure (in severe cases)
What to Do:
If an overdose is suspected, call a poison control center immediately (1-800-222-1222 in the US) or seek emergency medical attention. Treatment is supportive and may include gastric decontamination (e.g., activated charcoal if within 1-2 hours of ingestion), correction of fluid and electrolyte imbalances, and monitoring of vital signs and renal function.
Drug Interactions
Contraindicated Interactions
- Aspirin (in patients with aspirin-sensitive asthma, urticaria, or other allergic-type reactions)
- Peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery
Major Interactions
- Anticoagulants (e.g., warfarin, dabigatran): Increased risk of bleeding.
- Other NSAIDs (including aspirin for antiplatelet effect) and salicylates: Increased risk of GI adverse effects and bleeding.
- Corticosteroids: Increased risk of GI ulceration and bleeding.
- Methotrexate: Increased methotrexate levels and toxicity.
- Lithium: Increased lithium levels and toxicity.
- Diuretics (e.g., furosemide, thiazides): Reduced diuretic and antihypertensive effects, increased risk of renal impairment.
- ACE inhibitors/ARBs: Reduced antihypertensive effect, increased risk of renal impairment.
- Cyclosporine, Tacrolimus: Increased risk of nephrotoxicity.
- SSRIs/SNRIs: Increased risk of GI bleeding.
Moderate Interactions
- Digoxin: May increase digoxin levels.
- Sulfonylureas: May enhance hypoglycemic effect.
- Phenytoin: May increase phenytoin levels.
- Beta-blockers: Reduced antihypertensive effect.
- Cholestyramine: May delay or decrease ibuprofen absorption.
Minor Interactions
- Ginkgo biloba, Garlic, Ginger, Dong quai: Potential increased bleeding risk (theoretical).
Monitoring
Baseline Monitoring
Renal function (BUN, serum creatinine)
Rationale: To establish baseline and identify pre-existing renal impairment, especially before chronic use.
Timing: Before initiating therapy, particularly for long-term use or in patients with risk factors for renal dysfunction.
Liver function tests (ALT, AST)
Rationale: To establish baseline and identify pre-existing hepatic impairment, especially before chronic use.
Timing: Before initiating therapy, particularly for long-term use or in patients with risk factors for hepatic dysfunction.
Complete Blood Count (CBC)
Rationale: To establish baseline and monitor for potential hematologic adverse effects (e.g., anemia from GI bleeding) with chronic use.
Timing: Before initiating therapy for long-term use.
Routine Monitoring
Renal function (BUN, serum creatinine)
Frequency: Periodically (e.g., every 6-12 months) for chronic use, or more frequently in patients with risk factors or on concomitant nephrotoxic drugs.
Target: Within normal limits for age.
Action Threshold: Significant increase in creatinine or BUN; consider dose adjustment or discontinuation.
Liver function tests (ALT, AST)
Frequency: Periodically for chronic use (e.g., every 6-12 months).
Target: Within normal limits.
Action Threshold: Significant elevation (e.g., >3x ULN); consider discontinuation.
Blood pressure
Frequency: Periodically, especially in patients with hypertension or at risk for cardiovascular events.
Target: Within target range for age/condition.
Action Threshold: Significant increase; consider alternative therapy or antihypertensive adjustment.
Signs/symptoms of GI bleeding
Frequency: Continuously, patient/caregiver education.
Target: Absence of symptoms.
Action Threshold: Black, tarry stools; coffee-ground emesis; severe abdominal pain; seek immediate medical attention.
Symptom Monitoring
- Signs of gastrointestinal bleeding (black, tarry stools; vomiting blood; severe abdominal pain)
- Signs of allergic reaction (rash, hives, itching, swelling of face/lips/tongue/throat, difficulty breathing)
- Signs of fluid retention/edema (swelling in ankles, feet, hands)
- Changes in urination (decreased urine output)
- Unusual weight gain
- Persistent or worsening pain/fever despite medication
- Yellowing of skin or eyes (jaundice)
- Unusual bruising or bleeding
Special Patient Groups
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 persistent pulmonary hypertension of the newborn. Use in the first and second trimesters should only be if the potential benefit justifies the potential risk to the fetus.
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.
Third Trimester:
Category D. Contraindicated due to risk of premature closure of the fetal ductus arteriosus, persistent pulmonary hypertension, and potential for renal dysfunction in the fetus leading to oligohydramnios.
Lactation
Ibuprofen is considered compatible with breastfeeding. It is excreted into breast milk in very small amounts, and adverse effects on breastfed infants are not expected.
Infant Risk:
L1 (Safest) - Minimal risk to the infant.
Pediatric Use
Dosing is weight-based and must be precise. Not recommended for infants under 6 months of age without consulting a healthcare professional. Caregivers must be educated on proper measurement using the provided calibrated dropper/syringe. Risk of Reye's syndrome is associated with aspirin, not ibuprofen, but this distinction is important for parents.
Geriatric Use
Elderly patients are at increased risk for serious adverse reactions, particularly gastrointestinal bleeding and renal impairment. Use the lowest effective dose for the shortest possible duration. Monitor renal function and for signs of GI bleeding more closely.
Clinical Information
Clinical Pearls
- Always emphasize weight-based dosing for pediatric patients and the importance of using the provided calibrated measuring device (dropper/syringe) to prevent dosing errors.
- Advise caregivers to administer ibuprofen with food or milk to minimize gastrointestinal upset.
- Educate parents on the difference between ibuprofen and acetaminophen (Tylenol) and that they can be alternated for fever control, but not given simultaneously unless directed by a healthcare professional.
- Counsel on the signs of serious adverse effects, especially GI bleeding and allergic reactions, and when to seek immediate medical attention.
- Remind patients/caregivers that ibuprofen is for symptomatic relief and does not treat the underlying cause of fever or pain. If symptoms persist or worsen, medical evaluation is necessary.
Alternative Therapies
- Acetaminophen (Tylenol): Another common analgesic and antipyretic, often preferred for very young infants or those with GI/renal issues.
- Naproxen (for older children/adolescents): Longer-acting NSAID, typically dosed every 8-12 hours.
- Non-pharmacological interventions: Cool compresses for fever, rest, hydration.
Cost & Coverage
Average Cost:
Varies widely per 120-480 ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 1 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication. Some medications may come with additional patient information leaflets, so it is a good idea to consult with your pharmacist for more details. If you have any questions or concerns about your medication, do not hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for clarification and support. 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 critical information, including the name of the medication taken, the amount, and the time it was taken, to facilitate prompt and appropriate treatment.