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Trizivir Drug Description
TRIZIVIR®
(abacavir sulfate, lamivudine, and zidovudine) Tablets


WARNINGS
TRIZIVIR contains 3 nucleoside analogues (abacavir sulfate, lamivudine,
and zidovudine) and is intended only for patients whose regimen would otherwise
include these 3 components.
Hypersensitivity Reactions: Serious and sometimes fatal hypersensitivity
reactions have been associated with abacavir sulfate, a component of TRIZIVIR.
Hypersensitivity to abacavir is a multi-organ clinical syndrome usually characterized
by a sign or symptom in 2 or more of the following groups: (1) fever, (2) rash,
(3) gastrointestinal (including nausea, vomiting, diarrhea, or abdominal pain),
(4) constitutional (including generalized malaise, fatigue, or achiness), and
(5) respiratory (including dyspnea, cough, or pharyngitis). Discontinue TRIZIVIR
as soon as a hypersensitivity reaction is suspected.
Patients who carry the HLA-B*5701 allele are at high risk for experiencing
a hypersensitvity reaction to abacavir. Prior to initiating therapy with abacavir,
screening for the HLA-B*5701 allele is recommended; this approach has been found
to decrease the risk of hypersensitivity reaction. Screening is also recommended
prior to reinitiation of abacavir in patients of unknown HLA-B*5701 status who
have previously tolerated abacavir. HLA-B*5701-negative patients may develop
a suspected hypersensitivity reaction to abacavir; however, this occurs significantly
less frequently than in HLA-B*5701-positive patients.
Regardless of HLA-B*5701 status, permanently discontinue TRIZIVIR if hypersensitivity
cannot be ruled out, even when other diagnoses are possible.
Following a hypersensitivity reaction to abacavir, NEVER restart TRIZIVIR
or any other abacavir-containing product because more severe symptoms can occur
within hours and may include life-threatening hypotension and death.
Reintroduction of TRIZIVIR or any other abacavir-containing product, even
in patients who have no identified history or unrecognized symptoms of hypersensitivity
to abacavir therapy, can result in serious or fatal hypersensitivity reactions.
Such reactions can occur within hours (see WARNINGS
and PRECAUTIONS: Information for Patients). Hematologic Toxicity: Zidovudine has been associated with hematologic toxicity
including neutropenia and severe anemia, particularly in patients with advanced
Human Immunodeficiency Virus (HIV-1) disease (see WARNINGS).
Prolonged use of zidovudine has been associated with symptomatic myopathy. Lactic Acidosis and Severe Hepatomegaly: Lactic acidosis and severe hepatomegaly
with steatosis, including fatal cases, have been reported with the use of
nucleoside analogues alone or in combination, including abacavir, lamivudine,
zidovudine, and other antiretrovirals (see WARNINGS). 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 HIV-1 and have discontinued lamivudine, which is one component of
TRIZIVIR. Hepatic function should be monitored closely with both clinical
and laboratory follow-up for at least several months in patients who discontinue
TRIZIVIR and are co-infected with HIV-1 and HBV. If appropriate, initiation
of anti-hepatitis B therapy may be warranted (see WARNINGS).

DRUG DESCRIPTION



What are the possible side effects of abacavir-lamivudine-zidovudine (Trizivir) (Trizivir)?

Stop using this medication and call your doctor at once if you have any of these signs of an allergic reaction to abacavir:

Group 1 - fever;
Group 2 - rash;
Group 3 - nausea, vomiting, diarrhea, stomach pain;
Group 4 - general tiredness, body aches;
Group 5 - shortness of breath, cough, sore throat.

Once you have had an allergic reaction to abacavir, you must never use it again. If you stop taking Trizivir...
Read All Potential Side Effects for Trizivir »




TRIZIVIR: TRIZIVIR Tablets contain the following 3 synthetic nucleoside
analogues: abacavir sulfate (ZIAGEN®), lamivudine (also known as EPIVIR®
or 3TC), and zidovudine (also known as RETROVIR®, azidothymidine, or ZDV)
with inhibitory activity against HIV-1.
TRIZIVIR Tablets are for oral administration. Each film-coated tablet contains the active ingredients 300 mg of abacavir as abacavir sulfate, 150 mg of lamivudine, and 300 mg of zidovudine, and the inactive ingredients magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The tablets are coated with a film (OPADRY® green 03B11434) that is made of FD&C Blue No. 2, hypromellose, polyethylene glycol, titanium dioxide, and yellow iron oxide.
Abacavir Sulfate: The chemical name of abacavir sulfate is (1S,cis)-4-[2-amino-6-(cyclopropylamino)-9H-purin-9-yl]-2-cyclopentene-1-methanol
sulfate (salt) (2:1). Abacavir sulfate is the enantiomer with 1S, 4R absolute
configuration on the cyclopentene ring. It has a molecular formula of (C14H18N6O)2•H2SO4
and a molecular weight of 670.76 daltons. It has the following structural formula:








Abacavir sulfate is a white to off-white solid with a solubility of approximately 77 mg/mL in distilled water at 25°C.
In vivo, abacavir sulfate dissociates to its free base, abacavir. In
this insert, all dosages for ZIAGEN (abacavir sulfate) are expressed in terms
of abacavir.
Lamivudine: The chemical name of lamivudine is (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one.
Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine
has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine.
It has a molecular formula of C8H11N3O3S
and a molecular weight of 229.3 daltons. It has the following structural formula:








Lamivudine is a white to off-white crystalline solid with a solubility of approximately 70 mg/mL in water at 20°C.
Zidovudine: The chemical name of zidovudine is 3′-azido-3′-deoxythymidine.
It has a molecular formula of C10H13N5O4
and a molecular weight of 267.24 daltons. It has the following structural formula:








Zidovudine is a white to beige, crystalline solid with a solubility of 20.1
mg/mL in water at 25°C.
Last reviewed on RxList: 4/13/2009




Trizivir Drug Description
TRIZIVIR®
(abacavir sulfate, lamivudine, and zidovudine) Tablets


WARNINGS
TRIZIVIR contains 3 nucleoside analogues (abacavir sulfate, lamivudine,
and zidovudine) and is intended only for patients whose regimen would otherwise
include these 3 components.
Hypersensitivity Reactions: Serious and sometimes fatal hypersensitivity
reactions have been associated with abacavir sulfate, a component of TRIZIVIR.
Hypersensitivity to abacavir is a multi-organ clinical syndrome usually characterized
by a sign or symptom in 2 or more of the following groups: (1) fever, (2) rash,
(3) gastrointestinal (including nausea, vomiting, diarrhea, or abdominal pain),
(4) constitutional (including generalized malaise, fatigue, or achiness), and
(5) respiratory (including dyspnea, cough, or pharyngitis). Discontinue TRIZIVIR
as soon as a hypersensitivity reaction is suspected.
Patients who carry the HLA-B*5701 allele are at high risk for experiencing
a hypersensitvity reaction to abacavir. Prior to initiating therapy with abacavir,
screening for the HLA-B*5701 allele is recommended; this approach has been found
to decrease the risk of hypersensitivity reaction. Screening is also recommended
prior to reinitiation of abacavir in patients of unknown HLA-B*5701 status who
have previously tolerated abacavir. HLA-B*5701-negative patients may develop
a suspected hypersensitivity reaction to abacavir; however, this occurs significantly
less frequently than in HLA-B*5701-positive patients.
Regardless of HLA-B*5701 status, permanently discontinue TRIZIVIR if hypersensitivity
cannot be ruled out, even when other diagnoses are possible.
Following a hypersensitivity reaction to abacavir, NEVER restart TRIZIVIR
or any other abacavir-containing product because more severe symptoms can occur
within hours and may include life-threatening hypotension and death.
Reintroduction of TRIZIVIR or any other abacavir-containing product, even
in patients who have no identified history or unrecognized symptoms of hypersensitivity
to abacavir therapy, can result in serious or fatal hypersensitivity reactions.
Such reactions can occur within hours (see WARNINGS
and PRECAUTIONS: Information for Patients). Hematologic Toxicity: Zidovudine has been associated with hematologic toxicity
including neutropenia and severe anemia, particularly in patients with advanced
Human Immunodeficiency Virus (HIV-1) disease (see WARNINGS).
Prolonged use of zidovudine has been associated with symptomatic myopathy. Lactic Acidosis and Severe Hepatomegaly: Lactic acidosis and severe hepatomegaly
with steatosis, including fatal cases, have been reported with the use of
nucleoside analogues alone or in combination, including abacavir, lamivudine,
zidovudine, and other antiretrovirals (see WARNINGS). 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 HIV-1 and have discontinued lamivudine, which is one component of
TRIZIVIR. Hepatic function should be monitored closely with both clinical
and laboratory follow-up for at least several months in patients who discontinue
TRIZIVIR and are co-infected with HIV-1 and HBV. If appropriate, initiation
of anti-hepatitis B therapy may be warranted (see WARNINGS).

DRUG DESCRIPTION



What are the possible side effects of abacavir-lamivudine-zidovudine (Trizivir) (Trizivir)?

Stop using this medication and call your doctor at once if you have any of these signs of an allergic reaction to abacavir:

Group 1 - fever;
Group 2 - rash;
Group 3 - nausea, vomiting, diarrhea, stomach pain;
Group 4 - general tiredness, body aches;
Group 5 - shortness of breath, cough, sore throat.

Once you have had an allergic reaction to abacavir, you must never use it again. If you stop taking Trizivir...
Read All Potential Side Effects for Trizivir »




TRIZIVIR: TRIZIVIR Tablets contain the following 3 synthetic nucleoside
analogues: abacavir sulfate (ZIAGEN®), lamivudine (also known as EPIVIR®
or 3TC), and zidovudine (also known as RETROVIR®, azidothymidine, or ZDV)
with inhibitory activity against HIV-1.
TRIZIVIR Tablets are for oral administration. Each film-coated tablet contains the active ingredients 300 mg of abacavir as abacavir sulfate, 150 mg of lamivudine, and 300 mg of zidovudine, and the inactive ingredients magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The tablets are coated with a film (OPADRY® green 03B11434) that is made of FD&C Blue No. 2, hypromellose, polyethylene glycol, titanium dioxide, and yellow iron oxide.
Abacavir Sulfate: The chemical name of abacavir sulfate is (1S,cis)-4-[2-amino-6-(cyclopropylamino)-9H-purin-9-yl]-2-cyclopentene-1-methanol
sulfate (salt) (2:1). Abacavir sulfate is the enantiomer with 1S, 4R absolute
configuration on the cyclopentene ring. It has a molecular formula of (C14H18N6O)2•H2SO4
and a molecular weight of 670.76 daltons. It has the following structural formula:








Abacavir sulfate is a white to off-white solid with a solubility of approximately 77 mg/mL in distilled water at 25°C.
In vivo, abacavir sulfate dissociates to its free base, abacavir. In
this insert, all dosages for ZIAGEN (abacavir sulfate) are expressed in terms
of abacavir.
Lamivudine: The chemical name of lamivudine is (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one.
Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine
has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine.
It has a molecular formula of C8H11N3O3S
and a molecular weight of 229.3 daltons. It has the following structural formula:








Lamivudine is a white to off-white crystalline solid with a solubility of approximately 70 mg/mL in water at 20°C.
Zidovudine: The chemical name of zidovudine is 3′-azido-3′-deoxythymidine.
It has a molecular formula of C10H13N5O4
and a molecular weight of 267.24 daltons. It has the following structural formula:








Zidovudine is a white to beige, crystalline solid with a solubility of 20.1
mg/mL in water at 25°C.
Last reviewed on RxList: 4/13/2009




Trizivir Drug Description
TRIZIVIR®
(abacavir sulfate, lamivudine, and zidovudine) Tablets


WARNINGS
TRIZIVIR contains 3 nucleoside analogues (abacavir sulfate, lamivudine,
and zidovudine) and is intended only for patients whose regimen would otherwise
include these 3 components.
Hypersensitivity Reactions: Serious and sometimes fatal hypersensitivity
reactions have been associated with abacavir sulfate, a component of TRIZIVIR.
Hypersensitivity to abacavir is a multi-organ clinical syndrome usually characterized
by a sign or symptom in 2 or more of the following groups: (1) fever, (2) rash,
(3) gastrointestinal (including nausea, vomiting, diarrhea, or abdominal pain),
(4) constitutional (including generalized malaise, fatigue, or achiness), and
(5) respiratory (including dyspnea, cough, or pharyngitis). Discontinue TRIZIVIR
as soon as a hypersensitivity reaction is suspected.
Patients who carry the HLA-B*5701 allele are at high risk for experiencing
a hypersensitvity reaction to abacavir. Prior to initiating therapy with abacavir,
screening for the HLA-B*5701 allele is recommended; this approach has been found
to decrease the risk of hypersensitivity reaction. Screening is also recommended
prior to reinitiation of abacavir in patients of unknown HLA-B*5701 status who
have previously tolerated abacavir. HLA-B*5701-negative patients may develop
a suspected hypersensitivity reaction to abacavir; however, this occurs significantly
less frequently than in HLA-B*5701-positive patients.
Regardless of HLA-B*5701 status, permanently discontinue TRIZIVIR if hypersensitivity
cannot be ruled out, even when other diagnoses are possible.
Following a hypersensitivity reaction to abacavir, NEVER restart TRIZIVIR
or any other abacavir-containing product because more severe symptoms can occur
within hours and may include life-threatening hypotension and death.
Reintroduction of TRIZIVIR or any other abacavir-containing product, even
in patients who have no identified history or unrecognized symptoms of hypersensitivity
to abacavir therapy, can result in serious or fatal hypersensitivity reactions.
Such reactions can occur within hours (see WARNINGS
and PRECAUTIONS: Information for Patients). Hematologic Toxicity: Zidovudine has been associated with hematologic toxicity
including neutropenia and severe anemia, particularly in patients with advanced
Human Immunodeficiency Virus (HIV-1) disease (see WARNINGS).
Prolonged use of zidovudine has been associated with symptomatic myopathy. Lactic Acidosis and Severe Hepatomegaly: Lactic acidosis and severe hepatomegaly
with steatosis, including fatal cases, have been reported with the use of
nucleoside analogues alone or in combination, including abacavir, lamivudine,
zidovudine, and other antiretrovirals (see WARNINGS). 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 HIV-1 and have discontinued lamivudine, which is one component of
TRIZIVIR. Hepatic function should be monitored closely with both clinical
and laboratory follow-up for at least several months in patients who discontinue
TRIZIVIR and are co-infected with HIV-1 and HBV. If appropriate, initiation
of anti-hepatitis B therapy may be warranted (see WARNINGS).

DRUG DESCRIPTION



What are the possible side effects of abacavir-lamivudine-zidovudine (Trizivir) (Trizivir)?

Stop using this medication and call your doctor at once if you have any of these signs of an allergic reaction to abacavir:

Group 1 - fever;
Group 2 - rash;
Group 3 - nausea, vomiting, diarrhea, stomach pain;
Group 4 - general tiredness, body aches;
Group 5 - shortness of breath, cough, sore throat.

Once you have had an allergic reaction to abacavir, you must never use it again. If you stop taking Trizivir...
Read All Potential Side Effects for Trizivir »




TRIZIVIR: TRIZIVIR Tablets contain the following 3 synthetic nucleoside
analogues: abacavir sulfate (ZIAGEN®), lamivudine (also known as EPIVIR®
or 3TC), and zidovudine (also known as RETROVIR®, azidothymidine, or ZDV)
with inhibitory activity against HIV-1.
TRIZIVIR Tablets are for oral administration. Each film-coated tablet contains the active ingredients 300 mg of abacavir as abacavir sulfate, 150 mg of lamivudine, and 300 mg of zidovudine, and the inactive ingredients magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The tablets are coated with a film (OPADRY® green 03B11434) that is made of FD&C Blue No. 2, hypromellose, polyethylene glycol, titanium dioxide, and yellow iron oxide.
Abacavir Sulfate: The chemical name of abacavir sulfate is (1S,cis)-4-[2-amino-6-(cyclopropylamino)-9H-purin-9-yl]-2-cyclopentene-1-methanol
sulfate (salt) (2:1). Abacavir sulfate is the enantiomer with 1S, 4R absolute
configuration on the cyclopentene ring. It has a molecular formula of (C14H18N6O)2•H2SO4
and a molecular weight of 670.76 daltons. It has the following structural formula:








Abacavir sulfate is a white to off-white solid with a solubility of approximately 77 mg/mL in distilled water at 25°C.
In vivo, abacavir sulfate dissociates to its free base, abacavir. In
this insert, all dosages for ZIAGEN (abacavir sulfate) are expressed in terms
of abacavir.
Lamivudine: The chemical name of lamivudine is (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one.
Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine
has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine.
It has a molecular formula of C8H11N3O3S
and a molecular weight of 229.3 daltons. It has the following structural formula:








Lamivudine is a white to off-white crystalline solid with a solubility of approximately 70 mg/mL in water at 20°C.
Zidovudine: The chemical name of zidovudine is 3′-azido-3′-deoxythymidine.
It has a molecular formula of C10H13N5O4
and a molecular weight of 267.24 daltons. It has the following structural formula:








Zidovudine is a white to beige, crystalline solid with a solubility of 20.1
mg/mL in water at 25°C.
Last reviewed on RxList: 4/13/2009




Trizivir Drug Description
TRIZIVIR®
(abacavir sulfate, lamivudine, and zidovudine) Tablets


WARNINGS
TRIZIVIR contains 3 nucleoside analogues (abacavir sulfate, lamivudine,
and zidovudine) and is intended only for patients whose regimen would otherwise
include these 3 components.
Hypersensitivity Reactions: Serious and sometimes fatal hypersensitivity
reactions have been associated with abacavir sulfate, a component of TRIZIVIR.
Hypersensitivity to abacavir is a multi-organ clinical syndrome usually characterized
by a sign or symptom in 2 or more of the following groups: (1) fever, (2) rash,
(3) gastrointestinal (including nausea, vomiting, diarrhea, or abdominal pain),
(4) constitutional (including generalized malaise, fatigue, or achiness), and
(5) respiratory (including dyspnea, cough, or pharyngitis). Discontinue TRIZIVIR
as soon as a hypersensitivity reaction is suspected.
Patients who carry the HLA-B*5701 allele are at high risk for experiencing
a hypersensitvity reaction to abacavir. Prior to initiating therapy with abacavir,
screening for the HLA-B*5701 allele is recommended; this approach has been found
to decrease the risk of hypersensitivity reaction. Screening is also recommended
prior to reinitiation of abacavir in patients of unknown HLA-B*5701 status who
have previously tolerated abacavir. HLA-B*5701-negative patients may develop
a suspected hypersensitivity reaction to abacavir; however, this occurs significantly
less frequently than in HLA-B*5701-positive patients.
Regardless of HLA-B*5701 status, permanently discontinue TRIZIVIR if hypersensitivity
cannot be ruled out, even when other diagnoses are possible.
Following a hypersensitivity reaction to abacavir, NEVER restart TRIZIVIR
or any other abacavir-containing product because more severe symptoms can occur
within hours and may include life-threatening hypotension and death.
Reintroduction of TRIZIVIR or any other abacavir-containing product, even
in patients who have no identified history or unrecognized symptoms of hypersensitivity
to abacavir therapy, can result in serious or fatal hypersensitivity reactions.
Such reactions can occur within hours (see WARNINGS
and PRECAUTIONS: Information for Patients). Hematologic Toxicity: Zidovudine has been associated with hematologic toxicity
including neutropenia and severe anemia, particularly in patients with advanced
Human Immunodeficiency Virus (HIV-1) disease (see WARNINGS).
Prolonged use of zidovudine has been associated with symptomatic myopathy. Lactic Acidosis and Severe Hepatomegaly: Lactic acidosis and severe hepatomegaly
with steatosis, including fatal cases, have been reported with the use of
nucleoside analogues alone or in combination, including abacavir, lamivudine,
zidovudine, and other antiretrovirals (see WARNINGS). 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 HIV-1 and have discontinued lamivudine, which is one component of
TRIZIVIR. Hepatic function should be monitored closely with both clinical
and laboratory follow-up for at least several months in patients who discontinue
TRIZIVIR and are co-infected with HIV-1 and HBV. If appropriate, initiation
of anti-hepatitis B therapy may be warranted (see WARNINGS).

DRUG DESCRIPTION



What are the possible side effects of abacavir-lamivudine-zidovudine (Trizivir) (Trizivir)?

Stop using this medication and call your doctor at once if you have any of these signs of an allergic reaction to abacavir:

Group 1 - fever;
Group 2 - rash;
Group 3 - nausea, vomiting, diarrhea, stomach pain;
Group 4 - general tiredness, body aches;
Group 5 - shortness of breath, cough, sore throat.

Once you have had an allergic reaction to abacavir, you must never use it again. If you stop taking Trizivir...
Read All Potential Side Effects for Trizivir »




TRIZIVIR: TRIZIVIR Tablets contain the following 3 synthetic nucleoside
analogues: abacavir sulfate (ZIAGEN®), lamivudine (also known as EPIVIR®
or 3TC), and zidovudine (also known as RETROVIR®, azidothymidine, or ZDV)
with inhibitory activity against HIV-1.
TRIZIVIR Tablets are for oral administration. Each film-coated tablet contains the active ingredients 300 mg of abacavir as abacavir sulfate, 150 mg of lamivudine, and 300 mg of zidovudine, and the inactive ingredients magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The tablets are coated with a film (OPADRY® green 03B11434) that is made of FD&C Blue No. 2, hypromellose, polyethylene glycol, titanium dioxide, and yellow iron oxide.
Abacavir Sulfate: The chemical name of abacavir sulfate is (1S,cis)-4-[2-amino-6-(cyclopropylamino)-9H-purin-9-yl]-2-cyclopentene-1-methanol
sulfate (salt) (2:1). Abacavir sulfate is the enantiomer with 1S, 4R absolute
configuration on the cyclopentene ring. It has a molecular formula of (C14H18N6O)2•H2SO4
and a molecular weight of 670.76 daltons. It has the following structural formula:








Abacavir sulfate is a white to off-white solid with a solubility of approximately 77 mg/mL in distilled water at 25°C.
In vivo, abacavir sulfate dissociates to its free base, abacavir. In
this insert, all dosages for ZIAGEN (abacavir sulfate) are expressed in terms
of abacavir.
Lamivudine: The chemical name of lamivudine is (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one.
Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine
has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine.
It has a molecular formula of C8H11N3O3S
and a molecular weight of 229.3 daltons. It has the following structural formula:








Lamivudine is a white to off-white crystalline solid with a solubility of approximately 70 mg/mL in water at 20°C.
Zidovudine: The chemical name of zidovudine is 3′-azido-3′-deoxythymidine.
It has a molecular formula of C10H13N5O4
and a molecular weight of 267.24 daltons. It has the following structural formula:








Zidovudine is a white to beige, crystalline solid with a solubility of 20.1
mg/mL in water at 25°C.
Last reviewed on RxList: 4/13/2009




Trizivir Drug Description
TRIZIVIR®
(abacavir sulfate, lamivudine, and zidovudine) Tablets


WARNINGS
TRIZIVIR contains 3 nucleoside analogues (abacavir sulfate, lamivudine,
and zidovudine) and is intended only for patients whose regimen would otherwise
include these 3 components.
Hypersensitivity Reactions: Serious and sometimes fatal hypersensitivity
reactions have been associated with abacavir sulfate, a component of TRIZIVIR.
Hypersensitivity to abacavir is a multi-organ clinical syndrome usually characterized
by a sign or symptom in 2 or more of the following groups: (1) fever, (2) rash,
(3) gastrointestinal (including nausea, vomiting, diarrhea, or abdominal pain),
(4) constitutional (including generalized malaise, fatigue, or achiness), and
(5) respiratory (including dyspnea, cough, or pharyngitis). Discontinue TRIZIVIR
as soon as a hypersensitivity reaction is suspected.
Patients who carry the HLA-B*5701 allele are at high risk for experiencing
a hypersensitvity reaction to abacavir. Prior to initiating therapy with abacavir,
screening for the HLA-B*5701 allele is recommended; this approach has been found
to decrease the risk of hypersensitivity reaction. Screening is also recommended
prior to reinitiation of abacavir in patients of unknown HLA-B*5701 status who
have previously tolerated abacavir. HLA-B*5701-negative patients may develop
a suspected hypersensitivity reaction to abacavir; however, this occurs significantly
less frequently than in HLA-B*5701-positive patients.
Regardless of HLA-B*5701 status, permanently discontinue TRIZIVIR if hypersensitivity
cannot be ruled out, even when other diagnoses are possible.
Following a hypersensitivity reaction to abacavir, NEVER restart TRIZIVIR
or any other abacavir-containing product because more severe symptoms can occur
within hours and may include life-threatening hypotension and death.
Reintroduction of TRIZIVIR or any other abacavir-containing product, even
in patients who have no identified history or unrecognized symptoms of hypersensitivity
to abacavir therapy, can result in serious or fatal hypersensitivity reactions.
Such reactions can occur within hours (see WARNINGS
and PRECAUTIONS: Information for Patients). Hematologic Toxicity: Zidovudine has been associated with hematologic toxicity
including neutropenia and severe anemia, particularly in patients with advanced
Human Immunodeficiency Virus (HIV-1) disease (see WARNINGS).
Prolonged use of zidovudine has been associated with symptomatic myopathy. Lactic Acidosis and Severe Hepatomegaly: Lactic acidosis and severe hepatomegaly
with steatosis, including fatal cases, have been reported with the use of
nucleoside analogues alone or in combination, including abacavir, lamivudine,
zidovudine, and other antiretrovirals (see WARNINGS). 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 HIV-1 and have discontinued lamivudine, which is one component of
TRIZIVIR. Hepatic function should be monitored closely with both clinical
and laboratory follow-up for at least several months in patients who discontinue
TRIZIVIR and are co-infected with HIV-1 and HBV. If appropriate, initiation
of anti-hepatitis B therapy may be warranted (see WARNINGS).

DRUG DESCRIPTION



What are the possible side effects of abacavir-lamivudine-zidovudine (Trizivir) (Trizivir)?

Stop using this medication and call your doctor at once if you have any of these signs of an allergic reaction to abacavir:

Group 1 - fever;
Group 2 - rash;
Group 3 - nausea, vomiting, diarrhea, stomach pain;
Group 4 - general tiredness, body aches;
Group 5 - shortness of breath, cough, sore throat.

Once you have had an allergic reaction to abacavir, you must never use it again. If you stop taking Trizivir...
Read All Potential Side Effects for Trizivir »




TRIZIVIR: TRIZIVIR Tablets contain the following 3 synthetic nucleoside
analogues: abacavir sulfate (ZIAGEN®), lamivudine (also known as EPIVIR®
or 3TC), and zidovudine (also known as RETROVIR®, azidothymidine, or ZDV)
with inhibitory activity against HIV-1.
TRIZIVIR Tablets are for oral administration. Each film-coated tablet contains the active ingredients 300 mg of abacavir as abacavir sulfate, 150 mg of lamivudine, and 300 mg of zidovudine, and the inactive ingredients magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The tablets are coated with a film (OPADRY® green 03B11434) that is made of FD&C Blue No. 2, hypromellose, polyethylene glycol, titanium dioxide, and yellow iron oxide.
Abacavir Sulfate: The chemical name of abacavir sulfate is (1S,cis)-4-[2-amino-6-(cyclopropylamino)-9H-purin-9-yl]-2-cyclopentene-1-methanol
sulfate (salt) (2:1). Abacavir sulfate is the enantiomer with 1S, 4R absolute
configuration on the cyclopentene ring. It has a molecular formula of (C14H18N6O)2•H2SO4
and a molecular weight of 670.76 daltons. It has the following structural formula:








Abacavir sulfate is a white to off-white solid with a solubility of approximately 77 mg/mL in distilled water at 25°C.
In vivo, abacavir sulfate dissociates to its free base, abacavir. In
this insert, all dosages for ZIAGEN (abacavir sulfate) are expressed in terms
of abacavir.
Lamivudine: The chemical name of lamivudine is (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one.
Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine
has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine.
It has a molecular formula of C8H11N3O3S
and a molecular weight of 229.3 daltons. It has the following structural formula:








Lamivudine is a white to off-white crystalline solid with a solubility of approximately 70 mg/mL in water at 20°C.
Zidovudine: The chemical name of zidovudine is 3′-azido-3′-deoxythymidine.
It has a molecular formula of C10H13N5O4
and a molecular weight of 267.24 daltons. It has the following structural formula:








Zidovudine is a white to beige, crystalline solid with a solubility of 20.1
mg/mL in water at 25°C.
Last reviewed on RxList: 4/13/2009





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trizivir.com. This domain name has been registered by Safenames. Please visit our website at www.safenames.net Domain Registered By Safenames Ltd.


Trizivir is a fixed dose combination of three reverse transcriptase inhibitors patented by GlaxoSmithKline: abacavir ("ABC") lamivudine ("3TC") zidovudine ("AZT") Trizivir - Wikipedia, the free encyclopedia


Trizivir is used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Includes Trizivir side effects, interactions and indications. Trizivir Information from Drugs.com


TRIZIVIR® (abacavir sulfate, lamivudine, and zidovudine) Tablets abacavir sulfate, lamivudine, and zidovudine abacavir sulfate, lamivudine, and zidovudine


Learn about the prescription medication Trizivir (Abacavir Sulfate, Lamivudine, and Zidovudine), drug uses, dosage, side effects, drug interactions, warnings, reviews and patient ... Trizivir (Abacavir Sulfate, Lamivudine, and Zidovudine) Drug ...


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