ABACAVIR AND LAMIVUDINE tablet, film coated

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

ABACAVIR SULFATE (UNII: J220T4J9Q2) (ABACAVIR - UNII:WR2TIP26VS), LAMIVUDINE (UNII: 2T8Q726O95) (LAMIVUDINE - UNII:2T8Q726O95)

Διαθέσιμο από:

AvKARE

INN (Διεθνής Όνομα):

ABACAVIR SULFATE

Σύνθεση:

ABACAVIR 600 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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:Abacavir and lamivudine tablets are contraindicated in patients: - who have the HLA-B*5701 allele [see Warnings and Precautions ( 5.1)]. 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 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)]. with moderate

Περίληψη προϊόντος:

Abacavir and lamivudine tablets USP, 600 mg/300 mg are available as follows: Each tablet contains 600 mg of abacavir as abacavir sulfate, USP and 300 mg of lamivudine, USP and is a yellow, film-coated, convex,capsule-shaped tablet debossed “5382” on one side of the tablet and "TV" on the other side, in bottles of 30 (NDC 42291-115-30). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Φύλλο οδηγιών χρήσης

AvKARE
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MEDICATION GUIDE
Abacavir (a-BAK-a-vir) and Lamivudine (la-MIV-ue-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:
1.
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 variation.
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.
Symptoms(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 times.
If you stop abacavir and lamivudine tablets because of an allergic
reaction, never take abacavir and
lamivudine tablets or any other abacavir-containing medicine (TRIUMEQ
®, TRIZIVIR ® or ZIAGEN ®)
again.
1.
If you have an allergic reaction, dispose of any unused abacavir and
lamivudine tablets. Ask your
pharmacist how to properly dispose of medicines.
2.
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.
3.
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 them
again. Taking abacavir and lamivudine tablets again can cause a
s

Αρχείο Π.Χ.Π.

ABACAVIR AND LAMIVUDINE- ABACAVIR AND LAMIVUDINE TABLET, FILM COATED
AVKARE
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HIGHLIGHTS OF PRESCRIBING INFORMATION
ABACAVIR AND LAMIVUDINE TABLETS USP
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, LACTIC ACIDOSIS AND SEVERE
HEPATOMEGALY WITH STEATOSIS, AND EXACERBATIONS OF HEPATITIS B
. _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
HYPERSENSITIVITY REACTIONS
1. SERIOUS AND SOMETIMES FATAL HYPERSENSITIVITY REACTIONS HAVE
OCCURRED WITH ABACAVIR-
CONTAINING PRODUCTS. ( 5.1)
2. HYPERSENSITIVITY TO ABACAVIR IS A MULTI-ORGAN CLINICAL SYNDROME. (
5.1)
3. PATIENTS WHO CARRY THE HLA-B*5701 ALLELE ARE AT A HIGHER RISK OF
EXPERIENCING A
HYPERSENSITIVITY REACTION TO ABACAVIR. ( 5.1)
4. ABACAVIR AND LAMIVUDINE TABLETS ARE CONTRAINDICATED IN PATIENTS
WITH A PRIOR
HYPERSENSITIVITY REACTION TO ABACAVIR AND IN HLA-B*5701-POSITIVE
PATIENTS. ( 4)
5. DISCONTINUE ABACAVIR AND LAMIVUDINE TABLETS AS SOON AS A
HYPERSENSITIVITY REACTION IS
SUSPECTED. REGARDLESS OF HLA-B*5701 STATUS, PERMANENTLY DISCONTINUE
ABACAVIR AND
LAMIVUDINE TABLETS IF HYPERSENSITIVITY CANNOT BE RULED OUT, EVEN WHEN
OTHER
DIAGNOSES ARE POSSIBLE. ( 5.1)
6. FOLLOWING A HYPERSENSITIVITY REACTION TO ABACAVIR AND LAMIVUDINE
TABLETS, NEVER
RESTART ABACAVIR AND LAMIVUDINE TABLETS OR ANY OTHER
ABACAVIR-CONTAINING PRODUCT. (
5.1)
LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS
1. LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING
FATAL CASES, HAVE
BEEN REPORTED WITH THE USE OF NUCLEOSIDE ANALOGUES. ( 5.2)
EXACERBATIONS OF HEPATITIS B
1. 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 TABLET