Ibuprofen Lysine 10mg/ml Inj, 2ml

Ibuprofen lysine is a non-steroidal anti-inflammatory drug (NSAID) that inhibits prostaglandin synthesis. It is believed to act by inhibiting cyclooxygenase (COX-1 and COX-2), an enzyme that catalyzes the formation of prostaglandin precursors from arachidonic acid. Prostaglandins are known to maintain the patency of the ductus arteriosus. Inhibition of prostaglandin synthesis leads to constriction and closure of the ductus arteriosus.

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 your child exhibits any of the following symptoms, contact their 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, coffee ground-like vomit, 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.
Bowel Problems: Black, tarry, or bloody stools, fever, mucus in the stools, vomiting blood or coffee ground-like vomit, severe stomach pain, constipation, or diarrhea.
Low Blood Sugar: Dizziness, headache, drowsiness, weakness, shaking, rapid heartbeat, confusion, hunger, or sweating.
Electrolyte Imbalance: Mood changes, confusion, muscle pain, cramps, or spasms, weakness, shakiness, balance disturbances, abnormal heartbeat, seizures, loss of appetite, or severe nausea and vomiting.
Urinary Tract Infection (UTI): Blood in the urine, burning or pain while urinating, frequent or urgent need to urinate, fever, lower abdominal pain, or pelvic pain.
Adrenal Gland Problems: Severe nausea and vomiting, extreme dizziness or fainting, muscle weakness, fatigue, mood changes, decreased appetite, or weight loss.
Other Severe Symptoms: Extreme fatigue or weakness, shortness of breath, prolonged pauses between breaths, fever, or chills.

Severe Skin Reactions: This medication may cause rare but potentially deadly skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other severe reactions. If your child exhibits any of the following symptoms, seek immediate medical attention: 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.

Vein Irritation: This medication may cause vein irritation, and if it leaks from the vein, it can cause surrounding tissue irritation. Inform your child's nurse if they experience redness, burning, pain, swelling, or fluid leakage at the injection site.

Other Side Effects: Like all medications, this drug may cause side effects. Although many people do not experience side effects or only have mild ones, contact your child's doctor or seek medical help if any of the following symptoms bother your child or persist:

Irritation at the injection site

This is not an exhaustive list of potential side effects. If you have concerns about side effects, consult your child's doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Giving This Medication to Your Child: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

If your child is allergic to this medication, any of its components, or other substances, including foods and drugs. Describe the allergic reaction and its symptoms.
If your child has an allergy to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen.
If your child has a history of asthma triggered by salicylate medications, such as aspirin, or NSAIDs.
If your child has any underlying medical conditions that may interact with this medication, including:
+ Untreated infections
+ Certain bleeding disorders
+ Specific types of heart disease
+ Certain types of kidney disease
If your child has low platelet counts.
If your child is experiencing active bleeding.
* If your child has bowel problems.

Please note that this is not an exhaustive list of all potential interactions. It is crucial to discuss all of your child's medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with the doctor and pharmacist to ensure safe use. Do not initiate, stop, or modify the dosage of any medication without consulting your doctor first.

It is essential to inform all of your child's healthcare providers, including doctors, nurses, pharmacists, and dentists, that your child is taking this medication. Your child may experience an increased risk of bleeding due to this drug, so it is crucial to discuss this potential side effect with their doctor to understand the associated risks and necessary precautions.

• Other NSAIDs (increased risk of adverse effects)
• Diuretics (e.g., furosemide, thiazides - reduced diuretic effect, increased risk of nephrotoxicity)
• Corticosteroids (increased risk of gastrointestinal bleeding)

• Aminoglycosides (e.g., gentamicin, amikacin - increased risk of nephrotoxicity due to reduced renal clearance of aminoglycosides)
• Warfarin (increased risk of bleeding due to antiplatelet effect and displacement from protein binding)
• Methotrexate (increased methotrexate levels and toxicity due to reduced renal clearance)
• Lithium (increased lithium levels and toxicity due to reduced renal clearance)

• ACE inhibitors/ARBs (reduced antihypertensive effect, increased risk of renal impairment)
• Beta-blockers (reduced antihypertensive effect)
• SSRIs/SNRIs (increased risk of bleeding)
• Cyclosporine (increased risk of nephrotoxicity)

• Antacids (may reduce absorption, but not clinically significant for IV form)

• Decreased urine output (oliguria, anuria)
• Signs of bleeding (e.g., blood in stool, urine, emesis; petechiae, purpura, bruising)
• Abdominal distension
• Feeding intolerance
• Vomiting
• Lethargy
• Signs of infection (fever, increased respiratory distress, apnea, bradycardia)
• Signs of fluid retention (edema, weight gain)

Not applicable. This medication is used in premature neonates, not pregnant individuals.

Not applicable. This medication is used in premature neonates, not lactating individuals.

This medication is specifically indicated for use in premature neonates (infants weighing 500 to 1500 g, no more than 32 weeks gestational age) for the closure of clinically significant patent ductus arteriosus (PDA). Dosing and monitoring are tailored to this population due to immature organ function and unique physiological considerations.

Not applicable. This medication is not indicated for geriatric use.

• Ibuprofen Lysine is a first-line pharmacologic treatment for PDA in premature infants, offering an alternative to indomethacin with potentially fewer adverse effects (e.g., less vasoconstriction, less reduction in cerebral blood flow).
• Careful monitoring of renal function (urine output, serum creatinine) is paramount due to the risk of NSAID-induced renal impairment in vulnerable neonates.
• Contraindications include active bleeding (especially intracranial hemorrhage or GI bleeding), severe renal impairment, thrombocytopenia, and confirmed or suspected necrotizing enterocolitis (NEC).
• Echocardiographic assessment is essential before, during, and after treatment to confirm PDA diagnosis, monitor closure, and guide further management.
• Fluid restriction may be necessary during treatment to manage potential fluid retention.
• While generally well-tolerated, potential adverse effects include renal dysfunction, gastrointestinal bleeding, platelet dysfunction, and hyperbilirubinemia.

• Indomethacin (another NSAID used for PDA closure)
• Surgical ligation of the patent ductus arteriosus (for cases unresponsive to pharmacologic therapy or with contraindications)

If your child's symptoms or health issues persist or worsen, it is essential to contact their doctor promptly. To ensure safety, never share your child's medication with others, and do not administer someone else's medication to your child.

All medications should be stored in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed otherwise, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the correct disposal method, consult your pharmacist for guidance. Many communities offer drug take-back programs, which can be a safe and environmentally friendly way to dispose of unwanted medications.

Some medications may come with an additional patient information leaflet. If you have any questions or concerns about this medication, it is crucial to discuss them with your child's doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it occurred, as this will aid in providing appropriate care.