Ibuprofen lysine (Intravenous route)
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:
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.
Appropriate studies performed to date have not demonstrated pediatrics-specific problems that would limit the usefulness of ibuprofen lysine in premature babies .
|1st Trimester||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
|2nd Trimester||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
|3rd Trimester||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.|
Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.
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.
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.
- Beta Glucan
- Dabigatran Etexilate
- Pentosan Polysulfate Sodium
- Protein C
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.
- Azilsartan Medoxomil
- Candesartan Cilexetil
- Enalapril Maleate
- Ethacrynic Acid
- Olmesartan Medoxomil
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:
- More common
- Abdominal cramps
- abdominal pain or swelling
- 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
- cold sweats
- cool, pale skin
- coughing up blood
- darkening of skin
- decreased alertness
- decreased frequency or amount of urine
- difficulty in breathing
- fast heartbeat
- high blood pressure
- increased blood pressure
- increased hunger
- increased thirst
- irregular, fast or slow, or shallow breathing
- irregular heartbeats
- joint pain or swelling
- loss of appetite
- muscle cramps in hands, arms, feet, legs, or face
- muscle twitching
- nausea or vomiting
- passing of gas
- rapid, shallow breathing
- rash on skin
- shortness of breath
- stomach pain, fullness, or discomfort
- swelling of face, fingers, feet or lower legs
- 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
- 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
- yellow eyes or skin
- Symptoms of overdose
- change in consciousness
- loss of consciousness
- rapid weight gain
- swelling of face, ankles, or hands
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:
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.
Last Updated: 11/4/2014