KALETRA- lopinavir and ritonavir tablet, film coated

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

REMEDYREPACK INC.

INN (Isem Internazzjonali):

LOPINAVIR

Kompożizzjoni:

LOPINAVIR 200 mg

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

KALETRA 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 KALETRA. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to KALETRA [see Microbiology ( 12.4)] . - KALETRA 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. - KALETRA 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)] . Alpha 1- Adr

Sommarju tal-prodott:

Tablets: 200 mg lopinavir/ 50 mg ritonavir Yellow film-coated ovaloid tablets debossed with the “a” logo and the code KA NDC: 70518-0091-00 NDC: 70519-0091-01 NDC: 70518-0091-02 PACKAGING: 28 in 1 BLISTER PACK PACKAGING: 16 in 1 BLISTER PACK PACKAGING: 30 in 1 BLISTER PACK Store KALETRA tablets at 20°- 25°C (68°- 77°F); excursions permitted to 15°- 30°C (59°- 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. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

L-istatus ta 'awtorizzazzjoni:

New Drug Application

Fuljett ta 'informazzjoni

REMEDYREPACK INC.
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This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Revised: October 2020
Repackaged By / Distributed By: RemedyRepack Inc.
625 Kolter Drive, Indiana, PA 15701
[phone]
MEDICATION GUIDE
KALETRA ® (kuh-LEE-tra)
(lopinavir and ritonavir)
tablets
KALETRA ® (kuh-LEE-tra)
(lopinavir and ritonavir)
oral solution
What is the most important information I should know about KALETRA?
KALETRA may cause serious side effects, including:
•
Interactions with other medicines. It is important to know the
medicines that should not be taken with
KALETRA. For more information, see "Who should not take KALETRA?”
•
Side Effects in babies taking KALETRA oral solution. KALETRA 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). KALETRA 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
KALETRA. 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 KALETRA. Your
healthcare provider should do blood tests before and during your
treatment with KALETRA 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 KALETRA.
Tell your healthcare provider right away if you have any signs and
symptoms of liver problems
including:
•
loss of appetite
•
ye

Karatteristiċi tal-prodott

KALETRA- LOPINAVIR AND RITONAVIR TABLET, FILM COATED
REMEDYREPACK INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
KALETRA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR KALETRA.
KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FOR ORAL USE
KALETRA (LOPINAVIR AND RITONAVIR) ORAL SOLUTION
INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
Contraindications ( 4)
12/2019
INDICATIONS AND USAGE
KALETRA 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)
KALETRA 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.
KALETRA can be given as once daily or twice daily regimen. See Full
Prescribing Information for details.
KALETRA 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):
KALETRA 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 KALETRA may be needed when co-administering with
efavirenz, nevirapine, or
nelfinavir. ( 2.3, 2.4, 7.3)
KALETRA oral solution should not b