IBUPROFEN LYSINE solution

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

IBUPROFEN LYSINE (UNII: N01ORX9D6S) (IBUPROFEN - UNII:WK2XYI10QM)

Fáanlegur frá:

XGen Pharmaceuticals DJB, Inc.

INN (Alþjóðlegt nafn):

IBUPROFEN LYSINE

Samsetning:

IBUPROFEN 10 mg in 1 mL

Stjórnsýsluleið:

INTRAVENOUS

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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. Ibuprofen Lysine Injection is contraindicated in: - Preterm infants with proven or suspected infection that is untreated; - Preterm infants with congenital heart disease in whom patency of the PDA is necessary for satisfactory pulmonary or systemic blood flow (e.g., pulmonary atresia, severe tetralogy of Fallot, severe coarctation of the aorta); - Preterm infants who are bleeding, especially those with active intracranial hemorrhage or gastrointestinal bleeding; - Preterm infants with thrombocytopenia; - Preterm infants with coagulation defects; - Preterm infants with or who are suspected of having necrotizing enterocolitis; - Preterm infants with significant impairment of renal function. Safety and effectiveness have only been established in premature infants.

Vörulýsing:

How Supplied Ibuprofen Lysine Injection is dispensed in clear plastic 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 Handling Store at 20 to 25°C (68 to 77°F); excursions permitted 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Protect from light. Store vials in carton until contents have been used.

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

IBUPROFEN LYSINE- IBUPROFEN LYSINE SOLUTION
XGEN PHARMACEUTICALS DJB, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
IBUPROFEN LYSINE
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
IBUPROFEN LYSINE
INJECTION.
IBUPROFEN LYSINE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2006
RECENT MAJOR CHANGES
Warnings and Precautions ( 5.6)
10/2023
INDICATIONS AND USAGE
Ibuprofen Lysine Injection is a nonsteroidal anti-inflammatory drug
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 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. (1)
DOSAGE AND ADMINISTRATION
A course of therapy is three doses administered I.V. (2.1)
An initial dose of 10 mg/kg (based on birth weight) is followed by two
doses of 5 mg/kg each, after 24
and 48 hours (2.1)
Do not administer if anuria or marked oliguria (<0.6 mL/kg/hr) is
evident at the scheduled time of the
second or third dose (2.1)
DOSAGE FORMS AND STRENGTHS
20 mg/2 mL (10 mg/mL) as a clear sterile preservative-free solution of
the L-lysine salt of ibuprofen in a
2 mL single-use vial (3)
CONTRAINDICATIONS
Ibuprofen Lysine Injection is contraindicated in preterm infants:
With proven or suspected infection that is untreated (4)
With congenital heart disease in whom patency of the PDA is necessary
for satisfactory pulmonary or
systemic blood flow (4)
With impaired renal function (4)
With thrombocytopenia, coagulation defects or who are bleeding (4)
With or who are suspected of having necrotizing enterocolitis (4)
WARNINGS AND PRECAUTIONS
Ibuprofen Lysine Injection has not been assessed for
neurodevelopmental outcom