Ibuprofen 50mg/1.25ml Drops

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

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 medical attention immediately:

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 short of breath
+ Numbness or tingling
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 affect internal 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, or body aches
Shortness of breath or swollen glands

Other Side Effects

Like all medications, this drug can cause side effects. While many people experience no side effects or only mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, 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 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.

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 medications like aspirin, or pemetrexed.
Fertility issues or ongoing fertility evaluation.
* Pregnancy, planned pregnancy, or potential 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 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.

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.

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

Be aware that this medication may increase your risk of bleeding easily. To reduce this risk, be cautious and avoid injury. Use a soft toothbrush and an electric razor to minimize the risk of bleeding.

The use of medications like this one may 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 this with your doctor. Additionally, people who have had a recent heart attack may have a higher risk of heart attack and heart-related death when taking this medication. In fact, studies have shown that individuals 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 this with your doctor.

There is also a risk of developing a severe brain problem called aseptic meningitis. If you experience symptoms such as headache, fever, chills, severe stomach upset, 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, decreased appetite, stomach pain, pale stools, vomiting, or yellowing of the skin and 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 may affect ovulation, which can impact fertility. However, this effect is typically reversible when the medication is stopped. Discuss this with your doctor.

If you are breastfeeding, consult your doctor to discuss any potential risks to your baby.

• Aspirin (high dose, due to increased GI risk)
• Ketorolac (due to additive NSAID effects and toxicity)
• Other NSAIDs (due to additive toxicity)

• Anticoagulants (e.g., Warfarin, Heparin): Increased risk of bleeding.
• Antiplatelet agents (e.g., Clopidogrel, Aspirin low dose): 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 (e.g., Lisinopril) / Angiotensin Receptor Blockers (ARBs) (e.g., Valsartan): 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.

• Beta-blockers: Reduced antihypertensive effect.
• Phenytoin: Increased phenytoin levels.
• Sulfonylureas: Enhanced hypoglycemic effect.
• Tacrolimus: Increased risk of nephrotoxicity.
• Alcohol: Increased risk of GI irritation and bleeding.

• Cholestyramine: May reduce ibuprofen absorption (separate administration).

• Signs of gastrointestinal bleeding (e.g., black, tarry stools; coffee-ground vomit; severe abdominal pain)
• Signs of renal dysfunction (e.g., decreased urine output, swelling in ankles/feet, unusual fatigue)
• Signs of cardiovascular events (e.g., chest pain, shortness of breath, weakness on one side of body)
• Signs of allergic reaction (e.g., rash, itching, hives, swelling of face/lips/tongue, difficulty breathing)
• Unexplained weight gain or edema
• Changes in vision or hearing (rare, but reported)
• Severe skin reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)

Avoid use in the third trimester 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, and at the lowest effective dose for the shortest duration possible.

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

Ibuprofen drops are specifically formulated for pediatric use. Dosing must be carefully calculated based on the child's weight and age, using the provided measuring device. Do not exceed recommended doses or duration. Contraindicated in infants under 6 months unless directed by a physician. Use with caution in dehydrated children due to increased risk of renal adverse effects.

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

• Always use the provided measuring device (syringe or dropper) for accurate dosing of pediatric drops. Household spoons are not accurate.
• Advise parents to give ibuprofen with food or milk to minimize GI upset.
• Educate parents on the importance of not exceeding the recommended dose or frequency, and to consult a doctor if fever or pain persists beyond 3-5 days.
• Remind patients that ibuprofen is an NSAID and carries risks of GI bleeding and cardiovascular events, even at OTC doses, especially with prolonged use or in susceptible individuals.
• Be aware of potential drug interactions, especially with anticoagulants, antiplatelets, diuretics, ACE inhibitors, and SSRIs.
• In patients with asthma, particularly aspirin-sensitive asthma, ibuprofen can precipitate bronchospasm; use with extreme caution or avoid.

• Acetaminophen (Tylenol, Paracetamol): Another common analgesic/antipyretic, often preferred in children due to different side effect profile (no GI or cardiovascular black box warnings).
• Naproxen (Aleve): Another NSAID with a longer half-life, typically dosed less frequently.
• Aspirin: Not recommended for fever or pain in children due to the risk of Reye's syndrome.
• Non-pharmacological interventions: Rest, hydration, cool compresses for fever, topical analgesics for localized pain.

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 overdose, including the medication taken, the amount, and the time it occurred.