Ibuprofen lysine (Intravenous)

Ibuprofen lysine is used to treat patent ductus arteriosus (PDA) in premature babies (babies born too early) who weigh between 500 to 1500 grams (g) and are born no more than 32 weeks into pregnancy when usual medical management is not effective. PDA is a heart condition where a blood vessel, the ductus arteriosus, does not close normally after birth. This blood vessel is only needed before birth and is not required after the baby is born. Ibuprofen lysine works by causing the PDA to constrict, which closes the blood vessel.

This medicine should only be given by or under the supervision of your doctor.

It is very important that your doctor closely monitors your child's progress while they are receiving this medicine to ensure it is working properly. Blood tests may be necessary to check for unwanted effects.

This medicine may increase your child's risk for infection. Contact your doctor right away if your child has a 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). Contact your doctor immediately 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.

In deciding to use a drug, the risks of using the medicine must be weighed against the beneficial it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this drug or any other drugs. Also inform 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 issues that would limit the usefulness of ibuprofen lysine injection in premature babies.

Geriatric

No guidance is available on the relationship of age to the effects of ibuprofen lysine injection in geriatric patients.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain drugs should not be used together at all, in other cases two different medications may be used together even if an interaction might occur. In these cases, your physician may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially essential 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 drug with any of the following medicines is not advised. Your doctor may decide not to treat you with this medicine or change some of the other medications you take.

• Ketorolac

Using this medication with any of the following medications is usually not advised, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how frequently you use one or both of the medicines.

• Abciximab
• Aceclofenac
• Acemetacin
• Acenocoumarol
• Amiloride
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Amtolmetin Guacil
• Anagrelide
• Apixaban
• Ardeparin
• Argatroban
• Aspirin
• Balsalazide
• Bemetizide
• Bemiparin
• Bendroflumethiazide
• Benzthiazide
• Betamethasone
• Betrixaban
• Bismuth Subsalicylate
• Bivalirudin
• Bromfenac
• Budesonide
• Bufexamac
• Bumetanide
• Cangrelor
• Celecoxib
• Certoparin
• Chlorothiazide
• Chlorthalidone
• Choline Magnesium Trisalicylate
• Choline Salicylate
• Cilostazol
• Citalopram
• Clomipramine
• Clonixin
• Clopamide
• Clopidogrel
• Cortisone
• Cyclopenthiazide
• Cyclosporine
• Cyclothiazide
• Dabigatran Etexilate
• Dalteparin
• Danaparoid
• Deflazacort
• Desipramine
• Desirudin
• Desmopressin
• Desvenlafaxine
• Dexamethasone
• Dexibuprofen
• Dexketoprofen
• Diazoxide
• Dibenzepin
• Diclofenac
• Diflunisal
• Digoxin
• Dipyridamole
• Dipyrone
• Dothiepin
• Doxepin
• Droxicam
• Duloxetine
• Edoxaban
• Emtricitabine
• Enoxaparin
• Eplerenone
• Epoprostenol
• Eptifibatide
• Escitalopram
• Ethacrynic Acid
• Etodolac
• Etofenamate
• Etoricoxib
• Etozolin
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Feverfew
• Floctafenine
• Fluconazole
• Flufenamic Acid
• Fluocortolone
• Fluoxetine
• Flurbiprofen
• Fluvoxamine
• Fondaparinux
• Furosemide
• Ginkgo
• Gossypol
• Heparin
• Hydrochlorothiazide
• Hydrocortisone
• Hydroflumethiazide
• Iloprost
• Imipramine
• Indapamide
• Indomethacin
• Inotersen
• Ketoprofen
• Lepirudin
• Levomilnacipran
• Lithium
• Lofepramine
• Lornoxicam
• Loxoprofen
• Lumacaftor
• Lumiracoxib
• Mavacamten
• Meadowsweet
• Meclofenamate
• Mefenamic Acid
• Melitracen
• Meloxicam
• Melphalan
• Mesalamine
• Methotrexate
• Methyclothiazide
• Methylprednisolone
• Metolazone
• Milnacipran
• Morniflumate
• Nabumetone
• Nadroparin
• Naproxen
• Nefazodone
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Nortriptyline
• Olsalazine Sodium
• Opipramol
• Oxaprozin
• Oxyphenbutazone
• Paramethasone
• Parecoxib
• Parnaparin
• Paroxetine
• Pemetrexed
• Pentosan Polysulfate Sodium
• Pentoxifylline
• Phenindione
• Phenprocoumon
• Phenylbutazone
• Piketoprofen
• Piretanide
• Piroxicam
• Polythiazide
• Potassium Citrate
• Pranoprofen
• Prasugrel
• Prednisolone
• Prednisone
• Proglumetacin
• Propyphenazone
• Proquazone
• Protein C
• Protriptyline
• Quinethazone
• Reviparin
• Rivaroxaban
• Rofecoxib
• Salicylic Acid
• Salsalate
• Selexipag
• Sertraline
• Sibutramine
• Sodium Salicylate
• Spironolactone
• Sulfasalazine
• Sulfinpyrazone
• Sulindac
• Sulodexide
• Tacrolimus
• Tenofovir Alafenamide
• Tenofovir Disoproxil Fumarate
• Tenoxicam
• Tianeptine
• Tiaprofenic Acid
• Ticagrelor
• Ticlopidine
• Tinzaparin
• Tirofiban
• Tocilizumab
• Tolfenamic Acid
• Tolmetin
• Torsemide
• Trazodone
• Treprostinil
• Triamterene
• Trichlormethiazide
• Trimipramine
• Valdecoxib
• Venlafaxine
• Vilazodone
• Vorapaxar
• Vortioxetine
• Warfarin
• Xipamide

Using this medication 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 medications are prescribed together, your doctor may change the dose or how often you use one or both of the medications.

• Acebutolol
• Amikacin
• Atenolol
• Azilsartan
• Azilsartan Medoxomil
• Benazepril
• Betaxolol
• Bisoprolol
• Candesartan
• Captopril
• Carteolol
• Carvedilol
• Celiprolol
• Enalapril
• Enalaprilat
• Eprosartan
• Esmolol
• Fosinopril
• Irbesartan
• Labetalol
• Levobunolol
• Lisinopril
• Losartan
• Metipranolol
• Metoprolol
• Moexipril
• Nadolol
• Nebivolol
• Olmesartan
• Oxprenolol
• Penbutolol
• Perindopril
• Pindolol
• Propranolol
• Quinapril
• Ramipril
• Sotalol
• Spirapril
• Telmisartan
• Timolol
• Trandolapril
• Valsartan

Interactions with Food/Tobacco/Alcohol

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 drugs may as well 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 medication with any of the following is usually not advised, 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 Issues

The presence of other medical issues may affect the use of this medicine. Make sure you tell your clinician if you have any other medical problems, especially:

• Bleeding problems, active (eg, intracranial hemorrhage, stomach or bowel bleeding) or
• Blood clotting issues or
• Congenital heart disease or
• Infection, untreated or
• Kidney disease, serious 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.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do happen, 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 and 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.

In the U.S.

• Neoprofen

Available Dosage Forms:

• Solution

Therapeutic Class: Analgesic

Pharmacologic Class: Ibuprofen

Chemical Class: Ibuprofen

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.

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