What is NeoProfen used for?
NeoProfen is used to treat patent ductus arteriosus (PDA).
NeoProfen is a clear sterile preservative-free solution of the L-lysine salt of (±)-ibuprofen which is the active ingredient. (±)-Ibuprofen is a nonsteroidal anti-inflammatory agent (NSAID). L-lysine is used to create a water-soluble drug product salt suitable for intravenous administration. Each mL of NeoProfen contains 17.1 mg of ibuprofen lysine (equivalent to 10 mg of (±)-ibuprofen) in Water for Injection, USP. The pH is adjusted to 7.0 with sodium hydroxide or hydrochloric acid.
The structural formula is:
NeoProfen is designated chemically as α-methyl-4-(2-methyl propyl) benzeneacetic acid lysine salt. Its molecular weight is 352.48. Its empirical formula is C 19H 32N 2O 4. It occurs as a white crystalline solid which is soluble in water and slightly soluble in ethanol.
Mechanism of Action
The mechanism of action through which ibuprofen causes closure of a patent ductus arteriosus (PDA) in neonates is not known. In adults, ibuprofen is an inhibitor of prostaglandin synthesis.
Before taking NeoProfen, tell your doctor:
- If your child is allergic to NeoProfen; any part of this medicine; or any other drugs, foods, or substances. Tell the doctor about the allergy and what signs your child had.
- If your child has an allergy to aspirin or NSAIDs.
- If your child has ever had asthma caused by a salicylate drug like aspirin or a drug like this one like NSAIDs.
- If your child has any health problems that NeoProfen must not be taken with like an untreated infection, certain bleeding problems, and certain types of heart or kidney disease. There are many health problems that your child must not take NeoProfen with.
- If your child has low platelet levels.
- If your child has active bleeding.
- If your child has bowel problems.
This is not a list of all drugs or health problems that interact with this medicine.
Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take NeoProfen with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
What are some things I need to know or do while I take NeoProfen?
- Tell all of your child’s health care providers that your child is taking NeoProfen. This includes your child’s doctors, nurses, pharmacists, and dentists.
- Your child may bleed more easily. Talk with the doctor.
How is NeoProfen best taken?
Give NeoProfen as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
- It is given as an infusion into a vein over a period of time.
What do I do if I miss a dose?
- Call your child’s doctor to find out what to do.
What are the side effects of NeoProfen that I need to call my doctor about immediately?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of bleeding like throwing up or coughing up blood; vomit that looks like coffee grounds; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a cause or that get bigger; or bleeding you cannot stop.
- Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
- Signs of bowel problems like black, tarry, or bloody stools; fever; mucus in the stools; throwing up blood or throw up that looks like coffee grounds; or very bad stomach pain, constipation, or diarrhea.
- Signs of low blood sugar like dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating.
- Signs of electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, seizures, not hungry, or very bad upset stomach or throwing up.
- Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
- Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss.
- Feeling very tired or weak.
- Shortness of breath.
- Long stops between breaths.
- Fever or chills.
- This medicine may irritate the vein. If the drug leaks from the vein, it may also cause irritation around that area. Tell your child’s nurse if your child has any redness, burning, pain, swelling, or leaking of fluid where the drug is going into your child’s body.
What are some other side effects of NeoProfen?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
- Irritation where the shot is given.
These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.
If overdose is suspected:
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
How do I store and/or throw out NeoProfen?
- If you need to store NeoProfen at home, talk with your child’s doctor, nurse, or pharmacist about how to store it.
- NDC 55292-122-523 x 2 mL Single Use Vials
NeoProfen ® (ibuprofen lysine) injection
- (10mg/mL)Sterile Solution for IV Use Only
RECORDATI RARE DISEASES GROUP
Each mL contains:
Ibuprofen 10 mg (as ibuprofen lysine) in Water for Injection, USP.
Dilute to an appropriate volume with dextrose or saline. Please refer to the Package Insert for full prescribing information.
Store at 20-25ºC (68-77ºF); excursions permitted 15-30ºC (59-86ºF). Store vials in carton until use.
Manufactured by: Alcami Carolinas Corporation
Charleston, SC 29405, U.S.A.
For: Recordati Rare Diseases Inc.
Lebanon, NJ 08833, U.S.A.
® Trademark of Recordati Rare Diseases Inc.