A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Combivir Indications, Dosage, Storage, Stability - Lamivudine and zidovudine
Combivir Indications, Dosage, Storage, Stability - Lamivudine and zidovudine
INDICATIONS AND USAGE
COMBIVIR in combination with other antiretroviral agents is
indicated for the treatment of HIV infection.
Description of Clinical Studies
COMBIVIR: There have been no clinical trials
conducted with COMBIVIR. See CLINICAL PHARMACOLOGY
for information about bioequivalence. One COMBIVIR Tablet given twice daily
is an alternative regimen to EPIVIR Tablets 150 mg twice daily plus RETROVIR
600 mg per day in divided doses.
Lamivudine Plus Zidovudine: The NUCB3007 (CAESAR)
stud y was conducted using EPIVIR 150-mg Tablets (150 mg twice daily) and RETROVIR
100- mg Capsules (2 x 100 mg 3 times daily). CAESAR was a multicenter, double-blind,
placebo-controlled study comparing continued current therapy [zidovudine alone
(62% of patients) or zidovudine with didanosine or zalcitabine (38% of patients)]
to the addition of EPIVIR or EPIVIR plus an investigational non-nucleoside reverse
transcriptase inhibitor, randomized 1:2:1. A total of 1,816 HIV- infected adults
with 25 to 250 (median 122) CD4 cells/mm3 at baseline were enrolled:
median age was 36 years, 87% were male, 84% were nucleoside-experienced, and
16% were therapy-naive. The median duration on study was 12 months. Results
are summarized in Table 3.
|
Table 3. Number of Patients (%) With At Least 1 HIV Disease-Progression
Event or Death
|
| |
|
|
EPIVIR plus a
|
| |
|
EPIVIR plus
|
NNRTI* plus
|
| |
Current Therapy
|
Current Therapy
|
Current Therapy
|
|
Endpoint
|
(n = 460)
|
(n = 896)
|
(n = 460)
|
|
HIV progression or death
|
90 (19.6%)
|
86 (9.6%)
|
41 (8.9%)
|
|
Death
|
27 (5.9%)
|
23 (2.6%)
|
14 (3.0%)
|
|
*An investigational non-nucleoside reverse transcriptase
inhibitor not approved in the United States.
|
DOSAGE AND ADMINISTRATION
The recommended oral dose of COMBIVIR for adults and adolescents
(at least 12 years of age) is 1 tablet (containing 150 mg of lamivudine and
300 mg of zidovudine) twice daily.
Dose Adjustment: Because it is a fixed-dose combination,
COMBIVIR should not be prescribed for patients requiring dosage adjustment such
as those with reduced renal function (creatinine clearance <50 mL/min) or
those experiencing dose- limiting adverse events.
A reduction in the daily dose of zidovudine may be necessary
in patients with mild to moderate impaired hepatic function or liver cirrhosis.
Because COMBIVIR is a fixed-dose combination that cannot be adjusted for this
patient population, COMBIVIR is not recommended for patients with impaired hepatic
function.
HOW SUPPLIED
COMBIVIR Tablets, containing 150 mg lamivudine and 300
mg zidovudine, are white, film-coated, modified-capsule-shaped tablets engraved
with "GXFC3" on one side. They are available as follows:
60 Tablets/Bottle (NDC 0173-0595-00)
Store between 2° and 30°C (36° and 86°F).
Unit Dose Pack of 120 (NDC 0173-0595-02)
Store between 2° and 30°C (36° and 86°F).
GlaxoSmithKline Research Triangle Park, NC
27709, Lamivudine is manufactured under agreement from Shire Pharmaceuticals
Group plc Basingstoke, UK Ó 2004,
GlaxoSmithKline. All rights reserved. Updated Aug 02, 2004
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