Pronunciation:

eye-byoo-PROE-fen LYE-seen

Brand Names:

• Neoprofen

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Analgesic

Pharmacologic—

Ibuprofen

Chemical—

Ibuprofen

Uses of This Medicine:

Ibuprofen lysine is used to treat patent ductus arteriosus (PDA) in premature infants (babies born too early) who weigh between 1.1 and 3.3 pounds. PDA is a heart problem 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 available only with your doctor's prescription .

Before Using This Medicine:

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.

Children—

Appropriate studies performed to date have not demonstrated pediatrics-specific problems that would limit the usefulness of ibuprofen lysine in premature babies .

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast-feeding—

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

Other medicines—

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

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or 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:

• Active bleeding (brain or intestine) or
• Blood clotting problem (thrombocytopenia) or
• Congenital heart disease or
• Infection, untreated or
• Kidney problem or
• Necrotizing enterocolitis, known or suspected (an inflamed intestine)—This medicine should not be used in babies with these conditions .

• Hyperbilirubinemia (high bilirubin in the blood)—May cause this condition to get worse .

Precautions While Using This Medicine:

Ibuprofen lysine may change how the body reacts during an infection. Tell your baby's doctor if you notice any fever, chills, or other unusual behavior in your baby while this medicine is being used .

This medicine may affect the action of platelets, which are necessary for clotting the blood. This may increase the chance of bleeding for your baby. Call your baby's doctor right away if you notice any unusual bleeding or bruising, any dark-colored urine or stools, or other signs of bleeding in your baby .

Side Effects of This Medicine:

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 immediately if any of the following side effects occur:

More common

Abdominal cramps

abdominal pain or swelling

anxiety

black, tarry stools

bladder pain

blood in eyes

bloody or cloudy urine

blue lips, fingernails, or skin

bruising or purple areas on skin

bumps on skin

burning, itching, redness, or stinging of skin

chills

cold sweats

coma

cool, pale skin

cough

coughing up blood

darkening of skin

decreased alertness

decreased frequency or amount of urine

diarrhea

difficulty in breathing

fast heartbeat

fever

high blood pressure

increased blood pressure

increased hunger

increased thirst

indigestion

irregular, fast or slow, or shallow breathing

irregular heartbeats

irritability

joint pain or swelling

loss of appetite

muscle cramps in hands, arms, feet, legs, or face

muscle twitching

nausea or vomiting

nervousness

nosebleeds

passing of gas

rapid, shallow breathing

rash on skin

restlessness

seizures

shakiness

shortness of breath

sneezing

stomach pain, fullness, or discomfort

swelling of face, fingers, feet or lower legs

tremor

troubled breathing with exertion

unusual bleeding or bruising

unusual tiredness or weakness

Incidence not known

Bleeding, blistering, coldness, discoloration of skin, hives, infection, inflammation, itching, lumps, pain, rash, redness, scarring, soreness, swelling, tenderness, ulceration, or warmth at injection site

bleeding gums

blood in stools

chest pain or discomfort

clay-colored stools

dark urine

dilated neck veins

dry mouth

extreme fatigue

fast, pounding, or irregular heartbeat or pulse

flushed, dry skin

fruit-like breath odor

pinpoint red spots on skin

severe constipation

severe vomiting

stomach upset

sweating

swelling of abdominal or stomach area

tenderness in stomach area

ulcers, sores, or white spots in mouth

unexplained weight loss

unpleasant breath odor

vomiting of blood

weight gain

wheezing

yellow eyes or skin

Symptoms of overdose

Agitation

change in consciousness

drowsiness

lethargy

loss of consciousness

rapid weight gain

stupor

swelling of face, ankles, or hands

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.