Abacavir, Lamivudine, and Zidovudine (Systemic)
VA CLASSIFICATION
Primary: AM840
Commonly used brand name(s): Trizivir.
Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).
Category:
Antiviral (systemic) —
Indications
General considerations
Human immunodeficiency virus (HIV-1) isolates with reduced susceptibility to abacavir, lamivudine, or zidovudine have been recovered in vitro, as well as from some patients treated with this combination and with lamivudine and zidovudine combination.{01} After 16 to 48 weeks of therapy with abacavir, lamivudine, and zidovudine combination, genetic analysis of HIV-1 isolates from 21 previously antiretroviral therapy–naive patients with confirmed virologic failure revealed that 16 of the 21 isolates had developed an abacavir/lamivudine-associated mutation, either alone or in combination with abacavir- or zidovudine-associated mutations.{01} Available phenotypic data revealed that in vitro susceptibility to lamivudine had decreased 25- to 86-fold in 7 of 10 isolates.{01} In addition, in vitro susceptibility to abacavir had decreased 7- to 10-fold in 2 of the 7 isolates.{01}
In vitro, cross-resistance has been observed with other nucleoside reverse transcriptase inhibitors; recombinant laboratory strains of HIV-1 (HXB2) containing multiple reverse transcriptase mutations conferring abacavir resistance exhibited cross-resistance to lamivudine, didanosine, and zalcitabine{01}.
Cross-resistance among certain reverse transcriptase inhibitors has been recognized.{01} However, cross-resistance between lamivudine and zidovudine has not been reported.{01}
Accepted
Human immunodeficiency virus type 1 (HIV-1) infection (treatment) —Abacavir, lamivudine, and zidovudine combination is indicated for concurrent use with other nucleoside analogs or alone for the treatment of HIV-1 infection{01}{02}.
—There are limited data on the use of abacavir, lamivudine, and zidovudine combination in patients who have baseline viral load concentrations > 100,000 copies per mL.{01}
Pharmacology/Pharmacokinetics
Physicochemical characteristics:
Molecular weight—
Abacavir: 670.76 daltons{01}
Lamivudine: 229.3 daltons{01}
Zidovudine: 267.24 daltons{01}
Mechanism of action/Effect:
Abacavir, lamivudine, and zidovudine are synthetic nucleoside analogs. Intracellularly, abacavir, lamivudine, and zidovudine are phosphorylated to their respective active metabolites, carbovir triphosphate, lamivudine triphosphate, and zidovudine triphosphate. HIV reverse transcriptase utilizes these nucleotide analogs when transcribing viral RNA to DNA. Incorporation of carbovir triphosphate, lamivudine triphosphate, and zidovudine triphosphate into the growing chain of viral DNA results in termination of reverse transcriptase and thus inhibition of HIV reverse transcription.{01}{02}
Carbovir triphosphate, which is the active metabolite of abacavir, competes for the natural substrate, deoxyguanoside-5'-triphosphate (dGTP), and incorporates itself into viral DNA and therefore inhibits the HIV-1 reverse transcriptase activity. Lamivudine triphosphate is a weak inhibitor of mammalian DNA polymerases alpha and beta, and of mitochondrial DNA polymerase gamma. Zidovudine triphosphate is a weak inhibitor of mammalian DNA polymerase alpha and mitochondrial DNA polymerase gamma; it also has been reported to be incorporated into the DNA of cells in culture.{01}
Absorption:
Abacavir—Rapidly absorbed; oral bioavailability is 86 ± 25% (mean ± SD){01}.
Lamivudine—Rapidly absorbed; oral bioavailability is 86 ± 16% (mean ± SD){01}.
Zidovudine—Rapidly absorbed; oral bioavailability is 64 ± 10% (mean ± SD){01}.
Distribution:
Abacavir—Vol D is approximately 0.86 ± 0.15 L per kg{01}.
Lamivudine—Vol D is approximately 1.3 ± 0.4 L per kg{01}.
Zidovudine—Vol D is approximately 1.6 ± 0.6 L per kg{01}.
Protein binding:
Abacavir—Moderate (approximately 50%){01}.
Lamivudine—Low to moderate (< 36%){01}.
Zidovudine—Low to moderate (< 38%){01}.
Biotransformation:
Abacavir—Hepatic, by alcohol dehydrogenase (to the 5´-carboxylic acid metabolite) and glucuronyl transferase (to the 5´-glucuronide metabolite).{01}
Lamivudine—In humans, the only known metabolite is the trans-sulfoxide metabolite, which accounts for approximately 5% of an oral dose after 12 hours{01}.
Zidovudine— Hepatic;{02} the major metabolites are 3'-azido-3'-deoxy-5'-O-beta- D-glucopyranuronosylthymidine (GZDV) and 3'-amino-3'-deoxythymidine (AMT){01}.
Half-life:
Elimination:
Abacavir: 1.45 ± 0.32 hours{01}.
Lamivudine: 5 to 7 hours{01}.
Zidovudine: 0.5 to 3 hours{01}.
Elimination:
Abacavir—Primarily hepatic via metabolism{01}{02}.
Lamivudine—Renal; approximately 70% of an intravenous dose is recovered unchanged in the urine{01}.
Zidovudine—Primarily hepatic; following oral administration, unchanged zidovudine and GZDV account for 14% and 74% of the dose, respectively, recovered in the urine{01}.
Precautions to Consider
Carcinogenicity/Tumorigenicity
Abacavir
Carcinogenicity studies in mice and rats are ongoing with abacavir.{01}
Lamivudine
Long-term carcinogenicity studies in mice and rats showed no evidence of carcinogenic potential at exposures of up to 10 and 58 times, respectively, those observed in humans at the recommended therapeutic dose.{01}
Zidovudine
In mice given 120 mg per kg of body weight (mg/kg) per day for 90 days then 40 mg/kg per day thereafter, seven vaginal neoplasms (five nonmetastasizing squamous cell carcinomas, one squamous cell papilloma, and one squamous polyp) occurred after 19 months of treatment. In mice given 60 mg/kg per day for 90 days then 30 mg/kg per day thereafter, one vaginal squamous cell papilloma occurred after 19 months of treatment. No vaginal tumors were found in mice given 30 mg/kg per day for 90 days then 20 mg/kg per day thereafter. No other medication-related tumors were observed in any of the male or female mice. At doses that produced tumors in mice, the estimated exposure of zidovudine (as measured by the area under the plasma concentration–time curve [AUC]) was approximately three times the estimated human exposure at the recommended therapeutic dose of 100 mg every 4 hours.{01}
In rats given 600 mg/kg per day for 90 days, then 450 mg/kg per day until day 279, then 300 mg/kg per day thereafter, two nonmetastasizing vaginal squamous cell carcinomas occurred after 20 months of treatment; no vaginal tumors were found in rats given 80 or 220 mg/kg per day. No other medication-related tumors were observed in any of the male or female rats. At doses that produced tumors in rats, the estimated exposure of zidovudine (as measured by the AUC) was approximately 24 times the estimated human exposure at the recommended therapeutic dose.{01}
Two transplacental carcinogenicity studies were conducted in mice. In the first study, pregnant mice were administered zidovudine at doses of 20 or 40 mg/kg per day from gestation day 10 through parturition and lactation with dosing continuing in offspring for 24 months postnatally. After 24 months, an increase in the incidence of vaginal tumors was noted in the offspring of mice receiving 40 mg/kg per day with no increase in the incidence of any other tumors in male or female offspring. In the second study, pregnant mice were administered zidovudine at maximum tolerated doses of 12.5 or 25 mg per day (approximately 1000 or 450 mg/kg of nonpregnant or term body weight, respectively) from days 12 through 18 of gestation. There was an increase in the number of tumors in the liver, lung, and female reproductive tracts in the offspring of mice receiving the higher dose of zidovudine.{01}
Mutagenicity
Abacavir:
Abacavir was found to induce chromosomal aberrations both in the presence and absence of metabolic activation in an in vitro cytogenicity study in human lymphocytes. It was mutagenic in the absence of metabolic activation, although it was not mutagenic in the presence of metabolic activation in an L5178Y/TK± mouse lymphoma assay. Abacavir was clastogenic in males and not clastogenic in females in an in vivo mouse bone marrow micronucleus assay at systemic exposures approximately nine times higher than that in humans at the therapeutic dose. Abacavir was not found to be mutagenic in bacterial mutagenicity assays in either the presence or the absence of metabolic activation.{01}
Lamivudine:
Lamivudine was mutagenic in the L5178Y/TK+/- mouse lymphoma assay and clastogenic in a cytogenetic assay using cultured human lymphocytes. Lamivudine was not mutagenic in a microbial mutagenicity screen, an in vitro cell transformation assay, the rat micronucleus test, a rat bone marrow cytogenetic assay, or the unscheduled DNA synthesis test in rat liver.{01}
Zidovudine:
Zidovudine was mutagenic in the L5178Y/TK+/- mouse lymphoma assay, an in vitro cell transformation assay, and mouse and rat micronucleus tests after repeated doses, and clastogenic in a cytogenetic assay using cultured human lymphocytes. Zidovudine was not mutagenic in rats given a single dose in a cytogenetic study.{01}
Pregnancy/Reproduction
Fertility—
Abacavir
No adverse effects on the mating performance or fertility of male and female rats were observed with abacavir at doses of up to 500 mg per kg of body weight (mg/kg) per day (producing exposures approximately eightfold higher than that in humans at the therapeutic dose based on body surface area comparisons).{01}
Lamivudine
At doses of up to 130 times the usual adult human dose (on a body surface area basis), lamivudine administered to male and female rats showed no evidence of impairing fertility and had no effect on the survival, growth, or development of offspring to weaning.{01}
Zidovudine
At doses of up to seven times the usual adult human dose (on a body surface area basis), zidovudine administered to male and female rats had no effects on fertility.{01}
Pregnancy—
Adequate and well-controlled studies of abacavir, lamivudine, and zidovudine combination have not been done in humans. However, both abacavir and lamivudine have been shown to cross the placenta.{01}
Abacavir
Studies in rats revealed that abacavir crosses the placenta. At doses of 1000 mg/kg per day (35 times the human exposure, based on area under the curve [AUC]) during organogenesis, developmental toxicity (depressed fetal body weight and reduced crown-rump length) and increased incidences of fetal anasarca and skeletal malformations were found. In a fertility study, doses of 500 mg/kg per day were associated with evidence of toxicity to the developing embryos and fetuses (increased resorptions and decreased fetal body weights). Studies in female rats at doses of 500 mg/kg per day (beginning at embryo implantation and ending at weaning) showed an increased incidence of stillbirths and lower body weights throughout life. Studies in rabbits at doses of up to 700 mg/kg (8.5 times the human exposure at the recommended dose, based on AUC) found no evidence of drug-related developmental toxicity or increases in fetal malformations.{01}
Lamivudine
Studies in rats and rabbits revealed no evidence of teratogenicity at doses of 130 and 60 times, respectively, the usual adult human dose (on a body surface area basis). Early embryo lethality was observed in rabbits at doses similar to those produced by the usual adult human dose and higher; embryo lethality was not observed in rats administered doses of up to 130 times the usual adult human dose. Lamivudine crosses the placenta in rats and rabbits.{01}
Zidovudine
Studies in rats and rabbits revealed no evidence of teratogenicity at doses of up to 500 mg/kg per day. Zidovudine was embryotoxic or fetotoxic in rats given 150 or 450 mg/kg per day and in rabbits given 500 mg/kg per day. In rats, 3000 mg/kg per day (resulting in peak plasma concentrations of 350 times the peak human plasma concentration) caused marked maternal toxicity and an increase in the incidence of fetal malformations.{01}
FDA Pregnancy Category C.{01}
Note: An Antiretroviral Pregnancy Registry has been established to monitor the outcomes of pregnant women exposed to antiretroviral agents. Physicians are encouraged by the manufacturer to register patients by calling (800) 258-4263.{01}
Breast-feeding
Zidovudine is distributed into human breast milk; abacavir is distributed into the breast milk of rats and it is not known whether lamivudine is distributed into breast milk.The Centers for Disease Control and Prevention recommend that HIV-infected mothers do not breast-feed their infants to avoid potential postnatal transmission of HIV.{01}
Pediatrics
Abacavir, lamivudine, and zidovudine combination should not be administered to patients weighing less than 40 kg because the fixed-dose combination product cannot be adjusted {01}.
Geriatrics
Appropriate studies on the relationship of age to the effects of abacavir, lamivudine, and zidovudine combination have not been performed in the geriatric population. Dose selection should be done with caution. Elderly patients are more likely to have age related problems such as decreased hepatic, renal or cardiac function, and concomitant diseases or other drug therapy.{01}
Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):
Note: No drug interaction studies have been conducted using abacavir, lamivudine and zidovudine combination{01}.
Combinations containing any of the following medications, depending on the amount present, may also interact with this medication. The drug interactions described are based on studies conducted using the individual medications.{01}
» Abacavir or
» Lamivudine or
» Zidovudine (abacavir, lamivudine, and zidovudine combination is a fixed-dose product; concurrent use of abacavir, lamivudine, or zidovudine with the combination product is not recommended{01})
Atovaquone{01}or
Ethanol{01}
Fluconazole{01} or
Nelfinavir{01} or
Probenecid{01} or
Ritonavir{01} or
Trimethoprim and sulfamethoxazole combination{01} or
Valproic acid{01} (concurrent use of abacavir with ethanol causes a decrease in elimination of abacavir causing an increase in overall exposure{01})
(concurrent use of lamivudine with nelfinavir or trimethoprim and sulfamethoxazole combination increases the area under the plasma concentration–time curve [AUC] of lamivudine; no dosing modifications are necessary{01})
(concurrent use of zidovudine with atovaquone, fluconazole, probenecid, or valproic acid increases the AUC of zidovudine{01}; concurrent use with nelfinavir or ritonavir decreases the AUC of zidovudine{01}; no dosing modifications are necessary{01})
» Bone marrow depressants, other{01} (see Appendix II) or
» Ganciclovir{01} or
» Interferons, alpha{01} (concurrent use of bone marrow depressing agents with zidovudine may increase the hematologic toxicity of zidovudine{01}; caution should be used when bone marrow depressants are administered concurrently with zidovudine-containing regimens{02})
» Doxorubicin{01} or
» Ribavirin{01} or
» Stavudine{01} (concurrent use is not recommended because in vitro studies have demonstrated antagonistic relationships between zidovudine and these medications{01})
Methadone{01} (concurrent use with abacavir may increase the clearance of methadone;{01} no dosing modification is necessary in the majority of patients;{01} however, a small number of patients may require an increase in methadone dosage;{01} concurrent use with zidovudine may increase the AUC of zidovudine;{01} however, no dosing modification is necessary{01})
Laboratory value alterations
The following have been selected on the basis of their potential clinical significance (possible effect in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):
With physiology/laboratory test values
» Alanine aminotransferase (ALT [SGPT]){01} and
Amylase{01} and
Aspartate aminotransferase (AST [SGOT]){01} and
Creatine kinase{01} and
Gamma glutamyl transferase (GGT){01} ( values may be increased{01} )
Bilirubin{01} and
Glucose, blood{01} and
Triglycerides{01} ( concentrations may be increased{01})
» Hemoglobin{01} (concentration may be decreased{01} )
» Neutrophils{01} and
Platelets{01} (counts may be decreased{01})
Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).
Except under special circumstances, this medication should not be used when the following medical problems exist:
» Hypersensitivity to abacavir, lamivudine, or zidovudine{01}
» Renal function impairment (reduction of the dosage of abacavir, lamivudine, and zidovudine combination is recommended for patients with renal function impairment{01}; therefore, patients with creatinine clearance £ 50 mL per minute should not receive abacavir, lamivudine, and zidovudine combination as it is a fixed-dose tablet{01})
Risk-benefit should be considered when the following medical problems exist
» Bone marrow depression (abacavir, lamivudine, and zidovudine combination should be used with caution in patients with bone marrow compromise evidenced by granulocyte count < 1000 cells per cubic millimeter or hemoglobin < 9.5 grams per deciliter{01})
» Hepatic function impairment or
» Hepatitis B virus and human immunodeficiency virus (HIV) co-infection{02} (caution should be used when administering abacavir, lamivudine, and zidovudine combination to patients with known risk factors for hepatic dysfunction; abacavir, lamivudine, and zidovudine combination therapy should be discontinued in patients who develop clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity{01})
(some patients with HIV infection who have chronic liver disease due to hepatitis B virus infection experienced clinical or laboratory evidence of recurrent hepatitis upon discontinuation of lamivudine; consequences may be more severe in patients with decompensated hepatic disease{01})
Patient monitoring
The following may be especially important in patient monitoring (other tests may be warranted in some patients, depending on condition; » = major clinical significance):
» Complete blood counts (CBCs){01} (frequent blood counts are strongly recommended in patients with advanced HIV disease who are treated with zidovudine-containing regimens{02}; periodic blood counts are recommended in HIV-infected patients and patients with asymptomatic or early HIV disease{01})
Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:
Those indicating need for medical attention
Incidence more frequent
Neutropenia {01}(chills; fever; sore throat)
Incidence less frequent
Anemia {01}(pale skin; unusual tiredness or weakness)
hepatotoxicity, including lactic acidosis {01}(abdominal pain, severe; fever; nausea; skin rash; unusual tiredness or weakness; vomiting; yellow eyes or skin )—more frequent in women{01}
hypersensitivity reaction (abdominal pain; cough; diarrhea; fever; headache; nausea; numbness or tingling of face, feet, or hands; pain in joints; pain in muscles; shortness of breath; skin rash; sore throat; swelling of feet or lower legs; unusual feeling of discomfort or illness; unusual tiredness or weakness; vomiting)—incidence approximately 5%; associated with abacavir{01}
myopathy or myositis {01}(muscle tenderness and weakness )—associated with prolonged use of zidovudine{01}
Note: Possible risk factors for hepatotoxicity include obesity and prolonged nucleoside exposure, as well as other risk factors for liver disease; although cases have occurred in the absence of any known risk factors.{01} Therapy should be discontinued in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity.{01}
Therapy with abacavir-containing regimens{02} should be discontinued as soon as possible if a hypersensitivity reaction is suspected.{01} The diagnosis of hypersensitivity reaction should be carefully considered for patients presenting with acute onset respiratory disease symptoms, even if alternative respiratory diagnoses (pneumonia, bronchitis, pharyngitis, or flu-like illness) are possible.{01} Therapy should be permanently discontinued if hypersensitivity cannot be ruled out, even when other diagnoses are possible and should not be reintroduced because more severe symptoms, possibly including life-threatening hypotension and death, may occur within hours.{01} Severe or fatal hypersensitivity reactions also can occur within hours after reintroduction in patients who have no identified history or unrecognized symptoms of hypersensitivity to the medication.{01} Following discontinuation of abacavir-containing regimens{02} for reasons other than hypersensitivity reactions, therapy may be reinstated with continued monitoring and readily available access to medical care should a hypersensitivity reaction occur.{01}
Symptoms of the hypersensitivity reaction usually occur within the first 6 weeks of treatment, although they may occur at any time and indicate multi-organ/body involvement.{01} The reaction may be severe, progressing to an anaphylactic-like reaction,{02} hepatic failure, renal failure, hypotension, and death.{01} Symptoms worsen with continued therapy but frequently resolve on withdrawal of abacavir.{01} The hypersensitivity reaction–associated skin rash is usually maculopapular or urticarial, but the appearance varies and hypersensitivity reactions have occurred without skin rash.{01} Other physical findings with the hypersensitivity reaction include lymphadenopathy and mucous membrane lesions.{01} Laboratory value alterations may include elevated hepatic function test, creatine kinase, or creatinine values, and lymphopenia.{01}
A warning card that provides information about recognition of abacavir hypersensitivity reactions should be dispensed to the patient with each new prescription and refill.{01}
An Abacavir Hypersensitivity Registry has been established to facilitate the reporting of hypersensitivity reactions and to collect information about each case.{01} Physicians are encouraged by the manufacturer to register patients by calling (800) 270-0425.{01}
Incidence rare
Pancreatitis {01}( abdominal pain, severe; fever; nausea; vomiting)
thrombocytopenia {01}(black, tarry stools; blood in urine or stools; pinpoint red spots on skin; unusual bleeding or bruising )
Those indicating need for medical attention only if they continue or are bothersome
Incidence more frequent
Abdominal cramps or pain {01}
anorexia (loss of appetite ){01}
arthralgia {01}(pain in joints)
cough {01}
diarrhea {01}
fever and/or chills {01}
headache {01}
insomnia and other sleep disorders (sleeplessness; trouble sleeping ){01}
malaise and/or fatigue (general feeling of discomfort or illness; unusual tiredness or weakness ){01}
musculoskeletal pain {01}
myalgia {01}( pain in muscles)
nausea {01}
vomiting {01}
Overdose
For more information on the management of overdose or unintentional ingestion, contact a poison control center (see Poison Control Center Listing).
Clinical effects of overdose
For lamivudine, one case of an adult ingesting 6 grams has been reported. There were no clinical signs or symptoms noted, and hematologic tests remained normal.{01}
For zidovudine, acute overdoses in children and adults ingesting up to 50 grams have been reported. Nausea and vomiting were consistently noted among these cases. Other reported occurrences included confusion, dizziness, drowsiness, headache, and lethargy. Hematologic changes were transient, and all patients recovered.{01}
Treatment of overdose
To enhance elimination—It is not known whether abacavir or lamivudine can be removed by hemodialysis or peritoneal dialysis. Hemodialysis and peritoneal dialysis have a negligible effect on the removal of zidovudine. However, either process may be used to enhance the removal of the primary metabolite of zidovudine (GZDV).{01}
Supportive care—Patients in whom intentional overdose is confirmed or suspected should be referred for psychiatric consultation.
Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Abacavir, Lamivudine, and Zidovudine (Systemic).
In providing consultation, consider emphasizing the following selected information (» = major clinical significance):
Before using this medication
» Conditions affecting use, especially:
Hypersensitivity to abacavir, lamivudine, or zidovudine
Pregnancy—Abacavir caused birth defects and slowed growth in animals given doses equivalent to 8.5 to 35 times the human exposure; risk-benefit should be considered
Zidovudine crosses the placenta; it caused birth defects in animals given doses equivalent to 350 times the human exposure
Breast-feeding—Zidovudine is distributed into breast milk; it is recommended that HIV-infected mothers do not breast-feed their infants to avoid potential postnatal transmission of HIV
Use in children— Because this is a fixed-dose combination and the dosage cannot be adjusted, use is not recommended in patients weighing less than 40 kg (88 lbs)
Other medications, especially abacavir, alpha interferons, doxorubicin, ganciclovir, lamivudine, other bone marrow depressants, ribavirin, stavudine, or zidovudine
Other medical problems, especially bone marrow depression, hepatic function impairment, hepatitis B virus and HIV co-infection, or renal function impairment
Proper use of this medication
» Importance of not taking more medication than prescribed; importance of not discontinuing medication without checking with physician
» Importance of not missing doses and of taking at evenly spaced times
Not sharing medication with others
» Proper dosing
Taking as soon as possible; not taking if almost time for next dose; not doubling doses
Proper storage
Precautions while using this medication
» Regular visits to physician for blood tests
» Checking with physician immediately if signs or symptoms of a hypersensitivity reaction (cough, dyspnea, fever, skin rash, fatigue, gastrointestinal symptoms, or pharyngitis) occur
Carrying warning card for recognition of hypersensitivity reaction
Side/adverse effects
Signs of potential side effects, especially neutropenia; anemia; hepatotoxicity, including lactic acidosis; hypersensitivity reaction; myopathy or myositis; pancreatitis; and thrombocytopenia
General Dosing Information
A Medication Guide and Warning Card that provide information about the recognition of hypersensitivity reactions should be dispensed with each new prescription and refill.{01}
This product contains three nucleoside analogs and is intended only for patients whose regimen would otherwise include these three components.{01}
Oral Dosage Forms
ABACAVIR SULFATE, LAMIVUDINE, AND ZIDOVUDINE TABLETS
Usual adult and adolescent dose
Human immunodeficiency virus (HIV-1) infection
Adults and adolescents 40 kg of body weight and over: Oral, 300 mg of abacavir, 150 mg of lamivudine, and 300 mg of zidovudine two times a day.{01}
Adults and adolescents up to 40 kg of body weight: Use is not recommended.{01}
Usual pediatric dose
Human immunodeficiency virus (HIV-1) infection
Children up to 40 kg of body weight: Use is not recommended.{01}
Children 40 kg of body weight and over: See Usual adult and adolescent dose.
Usual geriatric dose
Dose selection for elderly patients should be cautious due to the greater frequency of geriatric-specific problems.{01}
Strength(s) usually available
U.S.—
300 mg of abacavir , 150 mg of lamivudine, and 300 mg of zidovudine (Rx) [Trizivir (magnesium stearate) (microcrystalline cellulose) (sodium starch glycolate){01}]
Packaging and storage:
Store at 25 °C (77 °F), excursions permitted to 15°C to 30°C (59° to 86°F).{01}
Developed: 06/28/2001
Revised: 10/22/2001
References
- Product Information: Trizivir®, abacavir sulfate, lamivudine, and zidovudine. GlaxoSmithKline, Research Triangle Park, North Carolina. (PI revised 4/2001) reviewed 7/2001.
- Manufacturer comment, 09/17/01.
