Neoprofen

Name: Neoprofen

Neoprofen Precautions

Serious side effects have been reported with ibuprofen including:

  • Heart attack or stroke: Tell your healthcare provider right away if you have some or all of the following symptoms of...
    • shortness of breath
    • chest pain
    • weakness
    • slurring of speech
  • Hypertension: new hypertension or worsening of preexisting hypertension
    • Have your blood pressure monitored by your doctor closely if taking ibuprofen, especially if you have a history of hypertension or are taking medications to treat hypertension
  • Congestive heart failure (CHF): Tell your doctor if you...
    • have or have had CHF diagnosed in the past
    • note signs of CHF, such as swelling in the arms or legs, shortness of breath, unexplained weight gain, or fatigue
  • Serious and sometimes fatal skin reaction: Tell your healthcare provider right away if you have some or all of the following symptoms of...
    • rash
    • blistering
    • itching
    • fever
  • Stomach bleeding, and/or ulceration: Tell your healthcare provider right away if you have some or all of the following symptoms of...
    • pain
    • blood in stools (black or tarry stools)
    • coughing up of blood
    • indigestion or general stomach discomfort
  • Liver toxicity: Tell your healthcare provider right away if you have some or all of the following...
    • flu-like symptoms
    • fatigue
    • nausea
    • yellow tinting of the skin or eyes
  • Kidney injury: Patients at greatest risk of this reaction include those with preexisting renal dysfunction, heart failure,liver injury, those taking diuretics or ACE inhibitors, and the elderly. Ibuprofen is not recommended in these patients with advanced renal disease.
  • Anaphylactoid reaction: Tell your healthcare provider right away if you have some or all of the following symptoms...
    • swelling of the face or throat
    • difficulty of breathing
  • Changes in vision: Tell your healthcare provider right away if you have some or all of the following symptoms...
    • blurred or decreased vision
    • changes in color vision
    • dark or gray spots in field of vision
  • Pregnancy: In late pregnancy, ibuprofen should be avoided since it may cause premature closure of the ductus arteriosus.

Do not take ibuprofen if the following has occurred:

  • an allergic reaction to ibuprofen
  • asthma, hives, or other allergic-type reactions after taking aspirin or other NSAIDs
  • coronary artery bypass graft (CABG) surgery; ibuprofen is not to be used for treating pain before or after this surgery

Ibuprofen can cause dizziness. Do not drive or operate heavy machinery until you know how Ibuprofen affects you.

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.
  • To gain the most benefit, do not miss giving your child doses.
  • Your child may bleed more easily. Talk with the doctor.

Indications and Usage for NeoProfen

NeoProfen is indicated to close a clinically significant patent ductus arteriosus (PDA) in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management (e.g., fluid restriction, diuretics, respiratory support, etc.) is ineffective. The clinical trial was conducted among infants with an asymptomatic PDA. However, the consequences beyond 8 weeks after treatment have not been evaluated; therefore, treatment should be reserved for infants with clear evidence of a clinically significant PDA.

Warnings and Precautions

5.1 General

There are no long-term evaluations of the infants treated with ibuprofen at durations greater than the 36 weeks post-conceptual age observation period. Ibuprofen’s effects on neurodevelopmental outcome and growth as well as disease processes associated with prematurity (such as retinopathy of prematurity and chronic lung disease) have not been assessed.

5.2 Infection

NeoProfen may alter the usual signs of infection. The physician must be continually on the alert and should use the drug with extra care in the presence of controlled infection and in infants at risk of infection.

5.3 Platelet Aggregation

NeoProfen, like other non-steroidal anti-inflammatory agents, can inhibit platelet aggregation. Preterm infants should be observed for signs of bleeding. Ibuprofen has been shown to prolong bleeding time (but within the normal range) in normal adult subjects. This effect may be exaggerated in patients with underlying hemostatic defects (see CONTRAINDICATIONS).

5.4 Bilirubin Displacement

Ibuprofen has been shown to displace bilirubin from albumin binding-sites; therefore, it should be used with caution in patients with elevated total bilirubin.

5.5 Administration

NeoProfen should be administered carefully to avoid extravascular injection or leakage, as solution may be irritating to tissue.

Principal display panel

NDC 55292-122-52

3 x 2 mL Single Use Vials

NeoProfen ®

(ibuprofen lysine) injection

10 mg/mL

Sterile Solution for IV Use Only

RECORDATI RARE DISEASES GROUP

Rx only

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: AAIPharma Services

Charleston, SC 29405, U.S.A.

For: Recordati Rare Diseases Inc.

Lebanon, NJ 08833, U.S.A.

® Trademark of Recordati Rare Diseases Inc.

PC-4478B

Lot:

Exp.:

NeoProfen 
ibuprofen lysine solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:55292-122
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN LYSINE (IBUPROFEN) IBUPROFEN 10 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
Packaging
# Item Code Package Description
1 NDC:55292-122-52 3 VIAL in 1 CARTON
1 2 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021903 04/13/2006
Labeler - RECORDATI RARE DISEASES, INC. (181699406)
Establishment
Name Address ID/FEI Operations
AAIPharma Services Corp. 832394733 manufacture(55292-122)
Revised: 04/2016   RECORDATI RARE DISEASES, INC.

What is ibuprofen?

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID). Ibuprofen works by reducing hormones that cause inflammation and pain in the body.

NeoProfen is used to reduce fever and treat pain.

Neoprofen is used in premature babies to treat a condition called patent ductus arteriosus (an abnormal blood vessel opening that normally closes shortly after birth).

Ibuprofen may also be used for purposes not listed in this medication guide.

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