ABACAVIR AND LAMIVUDINE tablet, film coated
Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
Gebrauchsinformation
(PIL)
02-09-2023
Fachinformation
(SPC)
02-09-2023
Wirkstoff:
ABACAVIR SULFATE (UNII: J220T4J9Q2) (ABACAVIR - UNII:WR2TIP26VS), LAMIVUDINE (UNII: 2T8Q726O95) (LAMIVUDINE - UNII:2T8Q726O95)
Verfügbar ab:
Laurus Labs Limited
Verabreichungsweg:
ORAL
Verschreibungstyp:
PRESCRIPTION DRUG
Anwendungsgebiete:
Abacavir and lamivudine tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Abacavir and lamivudine tablets are contraindicated in patients: - who have the HLA-B*5701 allele [see Warnings and Precautions (5.1)] . - with prior hypersensitivity reaction to abacavir [see Warnings and Precautions (5.1)] or lamivudine. - with moderate or severe hepatic impairment [see Use in Specific Populations (8.7)] . Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to abacavir and lamivudine during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Available data from the APR show no difference in the overall risk of birth defects for abacavir or lamivudine compared with the background rate for birth defects of 2.7% in the Metropolitan Atlanta
Produktbesonderheiten:
Abacavir and lamivudine tablets, USP contain 600 mg of abacavir as abacavir sulfate USP and 300 mg of lamivudine USP. The tablets are orange colored, capsule-shaped, biconvex film coated tablets, debossed with “LT” on one side and plain on other side. They are packaged as follows: Bottles of 30 tablets NDC 42385-962-30 Bottles of 90 tablets NDC 42385-962-90 Bottles of 180 tablets NDC 42385-962-18 Store 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.]
Berechtigungsstatus:
Abbreviated New Drug Application
Gebrauchsinformation
Laurus Labs Limited
----------
MEDICATION GUIDE
Abacavir and Lamivudine
(a-BAK-a-veer, and la-MI-vyoo-deen)
Tablets, USP
What is the most important information I should know about abacavir
and lamivudine tablets?
Abacavir
and
lamivudine
tablets
can
cause
serious
side
effects,
including:
•
Serious allergic reactions (hypersensitivity reaction) that can cause
death have happened with
abacavir and lamivudine tablets and other abacavir-containing
products. Your risk of this allergic
reaction is much higher if you have a gene variation called
HLA-B*5701. Your healthcare
provider can determine with a blood test if you have this gene
version.
If you get a symptom from 2 or more of the following groups while
taking abacavir and lamivudine
tablets, call your healthcare provider right away to find out if you
should stop taking abacavir and
lamivudine
tablets.
Symptom(s)
Group
1 Fever
Group
2 Rash
Group
3 Nausea,
vomiting,
diarrhea,
abdominal
(stomach
area)
pain
Group
4 Generally
ill
feeling,
extreme
tiredness,
or
achiness
Group
5 Shortness
of
breath,
cough,
sore
throat
A list of these symptoms is on the Warning Card your pharmacist gives
you. Carry this Warning Card
with
you
at
all
time.
If you stop abacavir and lamivudine tablets because of an allergic
reaction, never take abacavir and
lamivudine tablets (abacavir and lamivudine) or any other
abacavir-containing medicine (TRIUMEQ,
TRIZIVIR,
or
ZIAGEN)
again.
•
If you have an allergic reaction, dispose of any unused abacavir and
lamivudine tablets. Ask your
pharmacist how to properly dispose of medicines.
•
If you take abacavir and lamivudine tablets or any other
abacavir-containing medicine again after
you have had an allergic reaction, within hours you may get
life-threatening symptoms that may
include very low blood pressure ordeath.
•
If you stop abacavir and lamivudine tablets for any other reason, even
for a few days, and you are
not allergic to abacavir and lamivudine tablets, talk with your
healthcare provider before taking it
again. Taking abacavir and lam
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Fachinformation
ABACAVIR AND LAMIVUDINE - ABACAVIR AND LAMIVUDINE TABLET, FILM COATED
LAURUS LABS LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ABACAVIR AND
LAMIVUDINE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR ABACAVIR
AND LAMIVUDINE TABLETS.
ABACAVIR AND LAMIVUDINE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2004
WARNING: HYPERSENSITIVITY REACTIONS AND EXACERBATIONS OF HEPATITIS B
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
_ _HYPERSENSITIVITY REACTIONS
● SERIOUS AND SOMETIMES FATAL HYPERSENSITIVITY REACTIONS HAVE
OCCURRED WITH ABACAVIR-
CONTAINING PRODUCTS. (5.1)
● HYPERSENSITIVITY TO ABACAVIR IS A MULTI-ORGAN CLINICAL SYNDROME.
(5.1)
● PATIENTS WHO CARRY THE HLA-B*5701 ALLELE ARE AT A HIGHER RISK OF
EXPERIENCING A
HYPERSENSITIVITY REACTION TO ABACAVIR. (5.1)
● ABACAVIR AND LAMIVUDINE IS CONTRAINDICATED IN PATIENTS WITH A
PRIOR HYPERSENSITIVITY
REACTION TO ABACAVIR AND IN HLA-B*5701-POSITIVE PATIENTS. (4)
● DISCONTINUE ABACAVIR AND LAMIVUDINE AS SOON AS A HYPERSENSITIVITY
REACTION IS
SUSPECTED. REGARDLESS OF HLA-B*5701 STATUS, PERMANENTLY DISCONTINUE
ABACAVIR AND
LAMIVUDINE IF HYPERSENSITIVITY CANNOT BE RULED OUT, EVEN WHEN OTHER
DIAGNOSES ARE
POSSIBLE. (5.1)
● FOLLOWING A HYPERSENSITIVITY REACTION TO ABACAVIR AND LAMIVUDINE,
NEVER RESTART
ABACAVIR AND LAMIVUDINE OR ANY OTHER ABACAVIR-CONTAINING PRODUCT.
(5.1)
EXACERBATIONS OF HEPATITIS B
● SEVERE ACUTE EXACERBATIONS OF HEPATITIS B HAVE BEEN REPORTED IN
PATIENTS WHO ARE
CO-INFECTED WITH HEPATITIS B VIRUS (HBV) AND HUMAN IMMUNODEFICIENCY
VIRUS (HIV-1) AND
HAVE DISCONTINUED LAMIVUDINE, A COMPONENT OF ABACAVIR AND LAMIVUDINE.
MONITOR
HEPATIC FUNCTION CLOSELY IN THESE PATIENTS AND, IF APPROPRIATE,
INITIATE ANTI-HEPATITIS B
TREATMENT. (5.2)
RECENT MAJOR CHANGES
Dosage and Administration, Not Recommended Due to
Lack of Dosage Adjustment (2.4) 12/2021
INDICATIONS AND USAGE
Abacavir and lamivudine tablets, are combination of abacavir and
lamivudine,
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