Ibuprofen Lysine

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Overview

What is Ibuprofen Lysine?

Ibuprofen Lysine Injection 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 Ibuprofen Lysine Injection 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:

Ibuprofen Lysine Injection is designated chemically as α-methyl-4-(2-methyl propyl) benzeneacetic acid lysine salt. Its molecular weight is 352.48. Its empirical formula is CHNO. It occurs as a white crystalline solid which is soluble in water and slightly soluble in ethanol.

What does Ibuprofen Lysine look like?

What are the available doses of Ibuprofen Lysine?

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

What should I talk to my health care provider before I take Ibuprofen Lysine?

Sorry No records found

How should I use Ibuprofen Lysine?

Ibuprofen Lysine Injection 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.

A course of therapy is three doses of Ibuprofen Lysine Injection administered intravenously (administration via an umbilical arterial line has not been evaluated). An initial dose of 10 mg per kilogram is followed by two doses of 5 mg per kilogram each, after 24 and 48 hours. All doses should be based on birth weight. If anuria or marked oliguria (urinary output <0.6 mL/kg/hr) is evident at the scheduled time of the second or third dose of Ibuprofen Lysine Injection, no additional dosage should be given until laboratory studies indicate that renal function has returned to normal. If the ductus arteriosus closes or is significantly reduced in size after completion of the first course of Ibuprofen Lysine Injection, no further doses are necessary. If during continued medical management the ductus arteriosus fails to close or reopens, then a second course of Ibuprofen Lysine Injection, alternative pharmacological therapy, or surgery may be necessary.

What interacts with Ibuprofen Lysine?

Sorry No Records found

What are the warnings of Ibuprofen Lysine?

Sorry No Records found

What are the precautions of Ibuprofen Lysine?

Sorry No Records found

What are the side effects of Ibuprofen Lysine?

Sorry No records found

What should I look out for while using Ibuprofen Lysine?

Ibuprofen Lysine Injection is contraindicated in:

What might happen if I take too much Ibuprofen Lysine?

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 Ibuprofen Lysine Injection. The patient should be followed for several days because gastrointestinal ulceration and hemorrhage may occur.

How should I store and handle Ibuprofen Lysine?

Protect from light. Epinephrine is light sensitive and should be stored in the case provided to protect it from light. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature). Do not refrigerate. Before using, check to make sure the solution in the syringe is clear and colorless. Replace the product if the solution is discolored (pinkish or brown color), cloudy, or contains particles. Used SYMJEPI should be given to a healthcare provider or emergency room personnel for proper disposal. Expired or discolored SYMJEPI should be returned to a healthcare provider or pharmacy for proper disposal.How SuppliedIbuprofen Lysine Injection is dispensed in clear glass single-use vials, each containing 2 mL of sterile solution (NDC 39822-1030-1). The solution is not buffered and contains no preservatives. Each milliliter contains 17.1 mg/mL (±)-ibuprofen L-lysine [equivalent to 10 mg/mL (±)-ibuprofen] dissolved in Water for Injection, USP. Ibuprofen Lysine Injection is supplied in a carton containing 3 single-use vials (NDC 39822-1030-2).Storage and HandlingStore at 20 – 25°C (68 – 77°F); excursions permitted 15 – 30°C (59 – 86°F) [see USP Controlled Room Temperature]. Protect from light. Store vials in carton until contents have been used.How SuppliedIbuprofen Lysine Injection is dispensed in clear glass single-use vials, each containing 2 mL of sterile solution (NDC 39822-1030-1). The solution is not buffered and contains no preservatives. Each milliliter contains 17.1 mg/mL (±)-ibuprofen L-lysine [equivalent to 10 mg/mL (±)-ibuprofen] dissolved in Water for Injection, USP. Ibuprofen Lysine Injection is supplied in a carton containing 3 single-use vials (NDC 39822-1030-2).Storage and HandlingStore at 20 – 25°C (68 – 77°F); excursions permitted 15 – 30°C (59 – 86°F) [see USP Controlled Room Temperature]. Protect from light. Store vials in carton until contents have been used.How SuppliedIbuprofen Lysine Injection is dispensed in clear glass single-use vials, each containing 2 mL of sterile solution (NDC 39822-1030-1). The solution is not buffered and contains no preservatives. Each milliliter contains 17.1 mg/mL (±)-ibuprofen L-lysine [equivalent to 10 mg/mL (±)-ibuprofen] dissolved in Water for Injection, USP. Ibuprofen Lysine Injection is supplied in a carton containing 3 single-use vials (NDC 39822-1030-2).Storage and HandlingStore at 20 – 25°C (68 – 77°F); excursions permitted 15 – 30°C (59 – 86°F) [see USP Controlled Room Temperature]. Protect from light. Store vials in carton until contents have been used.How SuppliedIbuprofen Lysine Injection is dispensed in clear glass single-use vials, each containing 2 mL of sterile solution (NDC 39822-1030-1). The solution is not buffered and contains no preservatives. Each milliliter contains 17.1 mg/mL (±)-ibuprofen L-lysine [equivalent to 10 mg/mL (±)-ibuprofen] dissolved in Water for Injection, USP. Ibuprofen Lysine Injection is supplied in a carton containing 3 single-use vials (NDC 39822-1030-2).Storage and HandlingStore at 20 – 25°C (68 – 77°F); excursions permitted 15 – 30°C (59 – 86°F) [see USP Controlled Room Temperature]. Protect from light. Store vials in carton until contents have been used.

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Clinical Information

Chemical Structure

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Clinical Pharmacology

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.

Non-Clinical Toxicology

Ibuprofen Lysine Injection is contraindicated in:

Certain drugs tend to produce hyperglycemia and may lead to loss of blood glucose control. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel-blocking drugs, and isoniazid. When such drugs are administered to a patient receiving acarbose, the patient should be closely observed for loss of blood glucose control. When such drugs are withdrawn from patients receiving acarbose in combination with sulfonylureas or insulin, patients should be observed closely for any evidence of hypoglycemia.

Patients Receiving Sulfonylureas or Insulin: Sulfonylurea agents or insulin may cause hypoglycemia. Acarbose given in combination with a sulfonylurea or insulin may cause a further lowering of blood glucose and may increase the potential for hypoglycemia. If hypoglycemia occurs, appropriate adjustments in the dosage of these agents should be made. Very rarely, individual cases of hypoglycemic shock have been reported in patients receiving acarbose therapy in combination with sulfonylureas and/or insulin.

Intestinal adsorbents (for example, charcoal) and digestive enzyme preparations containing carbohydrate-splitting enzymes (for example, amylase, pancreatin) may reduce the effect of acarbose and should not be taken concomitantly.

Acarbose has been shown to change the bioavailability of digoxin when they are coadministered, which may require digoxin dose adjustment (see ).

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.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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