IBUPROFEN LYSINE solution

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Prasco Laboratories

INN (Jina la Kimataifa):

IBUPROFEN LYSINE

Tungo:

IBUPROFEN 10 mg in 1 mL

Njia ya uendeshaji:

INTRAVENOUS

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

Ibuprofen Lysine 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 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.

Bidhaa muhtasari:

How Supplied Ibuprofen Lysine Injection is dispensed in treated1 clear glass single-use vials, each containing 2 mL of sterile solution (NDC 66993-490-84). 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 is supplied in a carton (NDC 66993-490-36) containing 3 single-use vials. Storage and Handling Store 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.

Idhini hali ya:

New Drug Application Authorized Generic

Tabia za bidhaa

IBUPROFEN LYSINE- IBUPROFEN LYSINE SOLUTION
PRASCO LABORATORIES
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
IBUPROFEN LYSINE SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR IBUPROFEN
LYSINE.
IBUPROFEN LYSINE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1974
RECENT MAJOR CHANGES
Warnings and Precautions (5.6)
10/2023
INDICATIONS AND USAGE
Ibuprofen Lysine 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 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 has not been assessed for neurodevelopmental outcome
and growth (5.1)
Ibuprofen Lysine may alter the usual signs