LOPINAVIR AND RITONAVIR tablet, film coated

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Laurus Labs Limited

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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)] . - 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 ritonavir is contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening reactions [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)] .          

ملخص المنتج:

Lopinavir and Ritonavir Tablets, USP are available in the following strengths and package sizes: Lopinavir and Ritonavir Tablets USP, 100 mg/25 mg : Yellow colored, film coated oval shaped biconvex tablets debossed with “LA59” on one side and plain on other side. Bottles of 60                                                   NDC 42385-933-60 Lopinavir and Ritonavir Tablets USP, 200 mg/50 mg : Yellow colored, film coated oval shaped biconvex tablets debossed with “LA58” on one side and plain on other side. Bottles of 120                                                 NDC 42385-934-12 Recommended Storage: Store lopinavir and ritonavir tablets, USP at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP controlled room temperature]. Dispense in original container or USP equivalent tight container. For patient use: exposure of this product to high humidity outside the original container or USP equivalent tight container for longer than 2 weeks is not recommended.

الوضع إذن:

Abbreviated New Drug Application

نشرة المعلومات

Laurus Labs Limited
----------
MEDICATION GUIDE
Lopinavir and Ritonavir
(loe-PIN-a-veer and ri-TOE-na-vir)
Tablets, 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
◦
pale
colored
stools
◦
yellow
skin
and
whites
of
eyes
(jaundice)
◦
itchy
ski

خصائص المنتج

LOPINAVIR AND RITONAVIR - LOPINAVIR AND RITONAVIR TABLET, FILM COATED
LAURUS LABS LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LOPINAVIR AND
RITONAVIR TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR LOPINAVIR
AND RITONAVIR TABLETS.
LOPINAVIR AND RITONAVIR TABLETS, FOR ORAL USE
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
Tablets: May be taken with or without food, swallowed whole and not
chewed, broken, or crushed. (2.1)
Oral solution: must be taken with food. (2.1)
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 administered to
neonates before a postmenstrual
age (first day of the mother’s last menstrual peri