Neoprofen

Ibuprofen is both an over-the-counter and a prescription medication. The over-the-counter form is used both to treat minor aches and pains and also to reduce fever. The prescription form is used for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis, mild to moderate pain, and to treat primary dysmenorrhea. It may also be used to reduce fever in adults. This medication page refers to the prescription form of ibuprofen.

This medication comes in tablet and oral suspension forms. Ibuprofen may be given up to 6 times per day with food or milk to avoid stomach irritation.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Common side effects of ibuprofen include nausea, heartburn, diarrhea, stomach irritation, or headache. Ibuprofen can also cause dizziness. Do not drive or operate heavy machinery until you know how this medication will affect you.

Serious side effects have been reported with ibuprofen. See “Drug Precautions” section.

Common side effects of ibuprofen include:

• stomach effects:  nausea, heartburn, diarrhea, stomach irritation, bloating or flatulence, constipation
• others: headache, dizziness, ringing in the ears, swelling of arms or legs, rash

This is not a complete list of ibuprofen side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of ibuprofen, there are no specific foods that you must exclude from your diet when receiving ibuprofen.

Before taking ibuprofen, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have kidney problems
• have liver problems
• have heart problems
• have had a stomach bleed or ulcer (hole in the lining of the stomach) in the past
• have asthma
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Take ibuprofen exactly as prescribed. Ibuprofen may be taken several times per day, depending on reason for use.

Shake oral suspension ibuprofen before use. May take ibuprofen with food or milk to prevent stomach irritation.

Do not exceed 3.2 grams (3200 mg) per day.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of ibuprofen at the same time unless instructed by your doctor.

Dosing may vary according to type of and severity of condition.

Do not exceed 3.2 grams per day (3200 mg), as this is the recommended maximum dose.

If you take too much ibuprofen, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

10 mg/mL as a clear sterile preservative-free solution of the L-lysine salt of ibuprofen in a 2 mL single-use vial.

6.1 Clinical Trials Experience

The most frequently reported adverse events with NeoProfen were as shown in Table 1.

6.2 Renal Function

Compared to placebo, there was a small decrease in urinary output in the ibuprofen group on days 2-6 of life, with a compensatory increase in urine output on day 9. In other studies, adverse events classified as renal insufficiency including oliguria, elevated BUN, elevated creatinine, or renal failure were reported in ibuprofen treated infants.

6.3 Additional Adverse Events

The adverse events reported in the multicenter study and of unknown association include tachycardia, cardiac failure, abdominal distension, gastroesophageal reflux, gastritis, ileus, inguinal hernia, injection site reactions, cholestasis, various infections, feeding problems, convulsions, jaundice, hypotension, and various laboratory abnormalities including neutropenia, thrombocytopenia, and hyperglycemia.

6.4 Post-marketing Experience

The following adverse reactions have been identified from spontaneous post-marketing reports or published literature: gastrointestinal perforation, necrotizing enterocolitis, and pulmonary hypertension. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency, or establish a causal relationship to drug exposure.

The following signs and symptoms have occurred in individuals (not necessarily in premature infants) following an overdose of oral ibuprofen: breathing difficulties, coma, drowsiness, irregular heartbeat, kidney failure, low blood pressure, seizures, and vomiting. There are no specific measures to treat acute overdosage with NeoProfen. The patient should be followed for several days because gastrointestinal ulceration and hemorrhage may occur.

Ibuprofen is given as an infusion into a vein. A healthcare provider will give you this injection.

Drink plenty of liquids while you are receiving NeoProfen.

Because you will receive NeoProfen in a clinical setting, you are not likely to miss a dose.