LOPINAVIR-RITONAVIR solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LOPINAVIR (UNII: 2494G1JF75) (LOPINAVIR - UNII:2494G1JF75), RITONAVIR (UNII: O3J8G9O825) (RITONAVIR - UNII:O3J8G9O825)

Available from:

Lannett Company, Inc.

INN (International Name):

LOPINAVIR

Composition:

LOPINAVIR 80 mg in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lopinavir and ritonavir is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 14 days and older. Limitations of Use: - Genotypic or phenotypic testing and/or treatment history should guide the use of lopinavir and ritonavir. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to lopinavir and ritonavir [see Microbiology ( 12.4 )] . Genotypic or phenotypic testing and/or treatment history should guide the use of lopinavir and ritonavir. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to lopinavir and ritonavir [see Microbiology ( 12.4 )] . - Lopinavir and ritonavir is contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, urticaria, angioedema) to any of its ingredients, including ritonavir. Lopinavir and riton

Product summary:

Lopinavir and Ritonavir Oral Solution USP is a colorless to yellow colored liquid supplied in amber-colored multiple-dose bottles containing 400 mg lopinavir and 100 mg ritonavir per 5 mL (80 mg lopinavir and 20 mg ritonavir per mL) packaged with a marked syringe and bottle adapter in the following size: 160 mL bottle …………………………………(NDC 0527-1947-48) Recommended Storage: Store lopinavir and ritonavir oral solution at 2°-8°C (36°-46°F) until dispensed. Avoid exposure to excessive heat. For patient use: refrigerated lopinavir and ritonavir oral solution remains stable until the expiration date printed on the label. If stored at room temperature up to 25°C (77°F), oral solution should be used within 2 months.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Lannett Company, Inc.
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MEDICATION GUIDE
Lopinavir and Ritonavir
(loe pin' a vir) (ri ton' na vir)
Oral Solution USP
What is the most important information I should know about lopinavir
and ritonavir?
Lopinavir and ritonavir may cause serious side effects, including:
•
Interactions with other medicines. It is important to know the
medicines that should not be taken with
lopinavir and ritonavir. For more information, see "Who should not
take lopinavir and ritonavir?”
•
Side Effects in babies taking lopinavir and ritonavir oral solution.
Lopinavir and ritonavir oral solution
contains alcohol (ethanol) and propylene glycol. Call your healthcare
provider right away if your baby
appears too sleepy or their breathing changes.
•
Inflammation of your pancreas (pancreatitis). Lopinavir and ritonavir
can cause pancreatitis which may be
serious and may lead to death. People who have high levels of a
certain fat (triglycerides) have a risk for
developing pancreatitis. If you have advanced HIV-1 disease, you may
have an increased risk of high
triglyceride levels in your blood, and pancreatitis. If you have a
history of pancreatitis, you may have an
increased risk of it coming back again during treatment with lopinavir
and ritonavir. Tell your healthcare
provider if you have any signs or symptoms of pancreatitis including:
° nausea
° vomiting
° stomach-area (abdominal) pain
•
Liver problems. Liver problems, including death, can happen in people
who take lopinavir and ritonavir.
Your healthcare provider should do blood tests before and during your
treatment with lopinavir and ritonavir
to check your liver function. If you have Hepatitis B or Hepatitis C,
or other liver problems, you may have an
increased risk for developing new or worsening of liver problems
during treatment with lopinavir and
ritonavir. Tell your healthcare provider right away if you have any
signs and symptoms of liver problems
including:
° loss of appetite
° yellow skin and whites of eyes (jaundice)
° dark-colored urine
° pale color

Summary of Product characteristics

LOPINAVIR-RITONAVIR- LOPINAVIR-RITONAVIR SOLUTION
LANNETT COMPANY, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LOPINAVIR AND
RITONAVIR ORAL SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
LOPINAVIR AND RITONAVIR ORAL SOLUTION.
LOPINAVIR AND RITONAVIR ORAL SOLUTION
INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
Contraindications (4) 12/2019
INDICATIONS AND USAGE
Lopinavir and ritonavir is an HIV-1 protease inhibitor indicated in
combination with other antiretroviral
agents for the treatment of HIV-1 infection in adults and pediatric
patients (14 days and older). (1)
DOSAGE AND ADMINISTRATION
Oral solution: must be taken with food. (2.1)
Lopinavir and ritonavir oral solution is not recommended for use with
polyurethane feeding tubes due to
potential incompatibility. Feeding tubes composed of silicone or
polyvinyl chloride (PVC) can be used. (2.2)
Adults (2.3):
Total recommended daily dosage is 800/200 mg given once or twice
daily.
Lopinavir and ritonavir can be given as once daily or twice daily
regimen. See Full Prescribing
Information for details.
Lopinavir and ritonavir once daily dosing regimen is not recommended
in:
Adult patients with three or more of the following lopinavir
resistance-associated substitutions:
L10F/I/R/V, K20M/N/R, L24I, L33F, M36I, I47V, G48V, I54L/T/V,
V82A/C/F/S/T, and I84V. (12.4)
In combination with carbamazepine, phenobarbital, or phenytoin. (7.3)
In combination with efavirenz, nevirapine, or nelfinavir. (12.3)
In pregnant women. (2.5, 8.1, 12.3)
Pediatric Patients (14 days and older) (2.4):
Lopinavir and ritonavir once daily dosing regimen is not recommended
in pediatric patients.
Twice daily dose is based on body weight or body surface area.
Concomitant Therapy in Adults and Pediatric Patients:
Dose adjustments of lopinavir and ritonavir may be needed when
co-administering with efavirenz,
nevirapine, or nelfinavir. (2.3, 2.4, 7.3)
Lopinavir and ritonavir oral solution should not be adm