Description
Ibuprofen lysine is used to treat patent ductus arteriosus (PDA) in premature babies (babies born too early) weighing between 500 to 1500 grams (g), who are born not more than 32 weeks of pregnancy when usual medical management is not effective. PDA is a heart disease where a blood vessel, the ductus arteriosus, fails to close normally after birth. This blood vessel is only used before birth, and is no longer needed after the baby is born. Ibuprofen lysine works by causing the PDA to constrict, and this closes the blood vessel.
This medicine is to be given only by or under the supervision of your doctor.
This product is available in the following dosage forms:
- Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies performed to date have not demonstrated pediatrics-specific problems that would limit the usefulness of ibuprofen lysine injection in premature babies.
Geriatric
No information is available on the relationship of age to the effects of ibuprofen lysine injection in geriatric patients.
Breastfeeding
Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Ketorolac
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abciximab
- Aceclofenac
- Acemetacin
- Acenocoumarol
- Amiloride
- Amineptine
- Amitriptyline
- Amitriptylinoxide
- Amoxapine
- Amtolmetin Guacil
- Anagrelide
- Apixaban
- Ardeparin
- Argatroban
- Asciminib
- Aspirin
- Balsalazide
- Bemetizide
- Bemiparin
- Bendroflumethiazide
- Benzthiazide
- Betrixaban
- Bismuth Subsalicylate
- Bivalirudin
- Bromfenac
- Budesonide
- Bufexamac
- Bumetanide
- Cangrelor
- Carbamazepine
- Celecoxib
- Certoparin
- Chlorothiazide
- Chlorthalidone
- Choline Magnesium Trisalicylate
- Choline Salicylate
- Cilostazol
- Citalopram
- Clomipramine
- Clonixin
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Acebutolol
- Amikacin
- Atenolol
- Azilsartan
- Azilsartan Medoxomil
- Benazepril
- Betaxolol
- Bisoprolol
- Candesartan
- Captopril
- Carteolol
- Carvedilol
- Celiprolol
- Enalapril
- Enalaprilat
- Eprosartan
- Esmolol
- Fosinopril
- Irbesartan
- Labetalol
- Levobunolol
- Lisinopril
- Losartan
- Mavacamten
- Metipranolol
- Metoprolol
- Moexipril
- Nadolol
- Nebivolol
- Olmesartan
- Oxprenolol
- Penbutolol
- Perindopril
- Pindolol
- Propranolol
- Quinapril
- Ramipril
- Sotalol
- Spirapril
- Telmisartan
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Ethanol
- Tobacco
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Bleeding problems, active (eg, intracranial hemorrhage, stomach or bowel bleeding) or
- Blood clotting problems or
- Congenital heart disease or
- Infection, untreated or
- Kidney disease, severe or
- Stomach or bowel problems (eg, necrotizing enterocolitis) or
- Thrombocytopenia (low platelets in the blood)—Should not be used in patients with these conditions.
- Hyperbilirubinemia (high bilirubin in the blood)—May cause this condition to get worse.
Proper Use
A nurse or other trained health professional will give your child this medicine in a hospital. It is given through a needle placed into one of your child's veins. This medicine must be given slowly, so the IV tube will need to stay in place for at least 15 minutes.
Precautions
It is very important that your doctor check your child's progress closely while you are receiving this medicine to make sure that it is working properly. Blood tests may be needed to check for unwanted effects.
This medicine may increase your child's risk for infection. Check with your doctor right away if your child has fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
This medicine may cause serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, and acute generalized exanthematous pustulosis (AGEP). Check with your doctor right away if your child has blistering, peeling, or loosening of the skin, chills, cough, cracks in the skin, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, scaly skin, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
More common
- Agitation
- anxiety
- bladder pain
- bloody or cloudy urine
- blurred vision
- chills
- cold sweats
- coma
- confusion
- cough
- darkening of the skin
- decreased urine output
- depression
- diarrhea
- difficult, burning, or painful urination
- dizziness
- fainting
- fast heartbeat
- fever
- frequent urge to urinate
- headache
- hostility
- increased hunger
- irritability
- lethargy
- lightheadedness
- loss of appetite
- lower back or side pain
- mood or mental changes
- muscle cramps in the hands, arms, feet, legs, or face
- muscle twitching
- nausea
- nervousness
- numbness and tingling around the mouth, fingertips, or feet
- pale skin
- rapid weight gain
- restlessness
- seizures
- severe stomach pain
- shakiness
- slurred speech
- sneezing
- sore throat
- stomach cramps
- stupor
- swelling of the face, ankles, or hands
- tremor
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting
Incidence not known
- Blistering, peeling, or loosening of the skin
- bloody, black, or tarry stools
- chest pain
- diarrhea
- heartburn
- indigestion
- itching
- joint or muscle pain
- red irritated eyes
- red skin lesions, often with a purple center
- sores, ulcers, or white spots on the lips or in the mouth
- stomach cramping or burning
- swollen glands
- vomiting of material that looks like coffee grounds, severe an continuing
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-20069199
