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Combivir
Overview
What is Combivir?
COMBIVIR:
COMBIVIR Tablets are for oral administration. Each film-coated tablet
contains 150 mg of lamivudine, 300 mg of zidovudine, and the inactive
ingredients colloidal silicon dioxide, hypromellose, magnesium stearate,
microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch
glycolate, and titanium dioxide.
Lamivudine:
Lamivudine is a white to off-white crystalline solid with a solubility of
approximately 70 mg/mL in water at 20°C.
Zidovudine:
What does Combivir look like?
What are the available doses of Combivir?
Sorry No records found.
What should I talk to my health care provider before I take Combivir?
Pregnancy Category C.
Fetal Risk Summary:
Antiretroviral Pregnancy Registry:
Clinical Considerations:
[see Clinical Studies (14.2)]
Pharmacokinetics of lamivudine and zidovudine in pregnant women are similar
to the pharmacokinetics in nonpregnant women. No dose adjustments are needed
during pregnancy.
In a clinical trial, adverse events among HIV-1-infected women were not
different among untreated women and women treated with zidovudine. It is not
known whether risks of adverse events associated with lamivudine are altered in
pregnant women compared with other HIV-1-infected patients (see Human data
below).
Data:
Human Data:
Lamivudine:
Zidovudine:
[see Clinical Studies
(14.2)]
Zidovudine pharmacokinetics were studied in a Phase 1 study of 8 women during
the last trimester of pregnancy. As pregnancy progressed, there was no evidence
of drug accumulation. The pharmacokinetics of zidovudine were similar to that of
nonpregnant adults. Consistent with passive transmission of the drug across the
placenta, zidovudine concentrations in neonatal plasma at birth were essentially
equal to those in maternal plasma at delivery.
Animal Data:
Lamivudine:
[see Nonclinical Toxicology
(13.2)].
Zidovudine:
[see
Nonclinical Toxicology
(13.2)]
The Centers for Disease Control and Prevention recommend that
HIV-1-infected mothers in the United States not breastfeed their infants to
avoid risking postnatal transmission of HIV-1 infection. Because of both the
potential for HIV-1 transmission and serious adverse reactions in nursing
infants, mothers should be instructed not to breastfeed if they are receiving
COMBIVIR.
Although no studies of COMBIVIR excretion in breast milk have been performed,
lactation studies performed with lamivudine and zidovudine show that both drugs
are excreted in human breast milk. Samples of breast milk obtained from
20 mothers receiving lamivudine monotherapy (300 mg twice daily) or combination
therapy (150 mg lamivudine twice daily and 300 mg zidovudine twice daily) had
measurable concentrations of lamivudine. In another study, after administration
of a single dose of 200 mg zidovudine to 13 HIV-1-infected women, the mean
concentration of zidovudine was similar in human milk and serum.
COMBIVIR should not be administered to pediatric patients
weighing less than 30 kg, because it is a fixed-dose combination that cannot be
adjusted for this patient population.
Clinical studies of COMBIVIR did not include sufficient numbers
of subjects aged 65 and over to determine whether they respond differently from
younger subjects. In general, dose selection for an elderly patient should be
cautious, reflecting the greater frequency of decreased hepatic, renal, or
cardiac function, and of concomitant disease or other drug therapy. COMBIVIR is
not recommended for patients with impaired renal function (i.e., creatinine
clearance less than 50 mL/min) because it is a fixed-dose combination that
cannot be adjusted.
Reduction of the dosages of lamivudine and zidovudine is
recommended for patients with impaired renal function. Patients with creatinine
clearance less than 50 mL/min should not receive COMBIVIR because it is a
fixed-dose combination that cannot be adjusted
A reduction in the daily dose of zidovudine may be necessary in
patients with mild to moderate impaired hepatic function or liver cirrhosis.
COMBIVIR is not recommended for patients with impaired hepatic function because
it is a fixed-dose combination that cannot be adjusted
How should I use Combivir?
COMBIVIR, a combination of two nucleoside analogues, is indicated
in combination with other antiretrovirals for the treatment of HIV-1 infection.
The recommended oral dose of COMBIVIR in HIV-1-infected adults
and adolescents weighing greater than or equal to 30 kg is 1 tablet (containing
150 mg of lamivudine and 300 mg of zidovudine) twice daily.
The
recommended oral dosage of scored COMBIVIR Tablets for pediatric patients who
weigh greater than or equal to 30 kg and for whom a solid oral dosage form is
appropriate is 1 tablet administered twice daily.
Before
prescribing COMBIVIR Tablets, children should be assessed for the ability to
swallow tablets. If a child is unable to reliably swallow a COMBIVIR tablet, the
liquid oral formulations should be prescribed: EPIVIR
(lamivudine) Oral Solution and RETROVIR (zidovudine)
Syrup.
Because COMBIVIR is a fixed-dose combination tablet, it should
not be prescribed for pediatric patients weighing less than 30 kg or patients
requiring dosage adjustment, such as those with reduced renal function
(creatinine clearance less than 50 mL/min), patients with hepatic impairment, or
patients experiencing dose-limiting adverse reactions. Liquid and solid oral
formulations of the individual components of COMBIVIR are available for these
populations.
COMBIVIR Tablets are white, scored, film-coated, modified
capsule-shaped tablets, debossed on both tablet faces, such that when broken in
half, the full “GX FC3” code is present on both halves of the tablet (“GX” on
one face and “FC3” on the opposite face of the tablet).
What interacts with Combivir?
Sorry No Records found
What are the warnings of Combivir?
Sorry No Records found
What are the precautions of Combivir?
Sorry No Records found
What are the side effects of Combivir?
Sorry No records found
What should I look out for while using Combivir?
COMBIVIR Tablets are contraindicated in patients with previously
demonstrated clinically significant hypersensitivity (e.g., anaphylaxis,
Stevens-Johnson syndrome) to any of the components of the product.
Zidovudine, one of the 2 active ingredients in
COMBIVIR, has been associated with hematologic toxicity
including neutropenia and anemia, particularly in patients with advanced HIV-1
disease .
Prolonged use of zidovudine has been associated with
symptomatic myopathy .
Lactic acidosis and hepatomegaly with steatosis, including
fatal cases, have been reported with the use of nucleoside analogues alone or in
combination, including lamivudine, zidovudine, and other antiretrovirals.
Suspend treatment if clinical or laboratory findings suggestive of lactic
acidosis or pronounced hepatotoxicity occur .
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 COMBIVIR. Hepatic function
should be monitored closely with both clinical and laboratory follow-up for at
least several months in patients who discontinue COMBIVIR and are co-infected
with HIV-1 and HBV. If appropriate, initiation of anti-hepatitis B therapy may
be warranted .
What might happen if I take too much Combivir?
COMBIVIR:
Lamivudine:
Zidovudine:
O
D
How should I store and handle Combivir?
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.A Schedule CIII Narcotic.Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.A Schedule CIII Narcotic.Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.A Schedule CIII Narcotic.COMBIVIR Tablets, containing 150 mg lamivudine and 300 mg zidovudine, are white, scored, film-coated, modified-capsule-shaped tablets, debossed on both tablet faces, such that when broken in half, the full “GXFC3” code is present on both halves of the tablet (“GX” on one face and “FC3” on the opposite face of the tablet). They are available as follows:60 Tablets/Bottle (NDC 0173-0595-00).Unit Dose Pack of 120 (NDC 0173-0595-02).Store between 2° and 30°C (36° and 86°F).COMBIVIR Tablets, containing 150 mg lamivudine and 300 mg zidovudine, are white, scored, film-coated, modified-capsule-shaped tablets, debossed on both tablet faces, such that when broken in half, the full “GXFC3” code is present on both halves of the tablet (“GX” on one face and “FC3” on the opposite face of the tablet). They are available as follows:60 Tablets/Bottle (NDC 0173-0595-00).Unit Dose Pack of 120 (NDC 0173-0595-02).Store between 2° and 30°C (36° and 86°F).COMBIVIR Tablets, containing 150 mg lamivudine and 300 mg zidovudine, are white, scored, film-coated, modified-capsule-shaped tablets, debossed on both tablet faces, such that when broken in half, the full “GXFC3” code is present on both halves of the tablet (“GX” on one face and “FC3” on the opposite face of the tablet). They are available as follows:60 Tablets/Bottle (NDC 0173-0595-00).Unit Dose Pack of 120 (NDC 0173-0595-02).Store between 2° and 30°C (36° and 86°F).COMBIVIR Tablets, containing 150 mg lamivudine and 300 mg zidovudine, are white, scored, film-coated, modified-capsule-shaped tablets, debossed on both tablet faces, such that when broken in half, the full “GXFC3” code is present on both halves of the tablet (“GX” on one face and “FC3” on the opposite face of the tablet). They are available as follows:60 Tablets/Bottle (NDC 0173-0595-00).Unit Dose Pack of 120 (NDC 0173-0595-02).Store between 2° and 30°C (36° and 86°F).
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
COMBIVIR is an antiviral agent .
Pharmacokinetics in Adults:
COMBIVIR:
Lamivudine:
Zidovudine:
Effect of Food on Absorption of COMBIVIR:
Special Populations:
Pregnancy:
See Use in Specific
Populations (8.1)
COMBIVIR:
Zidovudine:
Nursing Mothers:
See Use in
Specific Populations (8.3)
Pediatric Patients:
Geriatric Patients:
Gender:
Race:
Lamivudine:
Zidovudine:
Drug Interactions:
See Drug
Interactions (7.0).
No drug interaction studies have been conducted using COMBIVIR Tablets.
Lamivudine Plus Zidovudine:
Ribavirin:
[see Warnings and Precautions (5.5)]
Mechanism of Action:
Lamivudine:
Zidovudine:
Antiviral Activity:
Lamivudine Plus Zidovudine:
Lamivudine:
Zidovudine:
Resistance:
Lamivudine Plus
Zidovudine Administered As Separate Formulations:
HIV-1 strains resistant to both lamivudine and zidovudine have been isolated
from patients after prolonged lamivudine/zidovudine therapy. Dual resistance
required the presence of multiple amino acid substitutions, the most essential
of which may be G333E. The incidence of dual resistance and the duration of
combination therapy required before dual resistance occurs are unknown.
Lamivudine:
Zidovudine:
Cross-Resistance:
Lamivudine Plus Zidovudine:
Lamivudine:
Zidovudine:
Non-Clinical Toxicology
COMBIVIR Tablets are contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., anaphylaxis, Stevens-Johnson syndrome) to any of the components of the product.Zidovudine, one of the 2 active ingredients in COMBIVIR, has been associated with hematologic toxicity including neutropenia and anemia, particularly in patients with advanced HIV-1 disease .
Prolonged use of zidovudine has been associated with symptomatic myopathy .
Lactic acidosis and hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including lamivudine, zidovudine, and other antiretrovirals. Suspend treatment if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur .
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 COMBIVIR. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue COMBIVIR and are co-infected with HIV-1 and HBV. If appropriate, initiation of anti-hepatitis B therapy may be warranted .
Zidovudine, a component of COMBIVIR, has been associated with hematologic toxicity including neutropenia and anemia, particularly in patients with advanced HIV-1 disease. COMBIVIR should be used with caution in patients who have bone marrow compromise evidenced by granulocyte count less than 1,000 cells/mm or hemoglobin less than 9.5 g/dL .
Frequent blood counts are strongly recommended in patients with advanced HIV-1 disease who are treated with COMBIVIR. Periodic blood counts are recommended for other HIV-1-infected patients. If anemia or neutropenia develops, dosage interruption may be needed.
Myopathy and myositis, with pathological changes similar to that produced by HIV-1 disease, have been associated with prolonged use of zidovudine, and therefore may occur with therapy with COMBIVIR.
Lactic acidosis and hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including lamivudine, zidovudine, and other antiretrovirals. A majority of these cases have been in women. Obesity and prolonged nucleoside exposure may be risk factors. Particular caution should be exercised when administering COMBIVIR to any patient with known risk factors for liver disease; however, cases have also been reported in patients with no known risk factors. Treatment with COMBIVIR should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations).
Posttreatment Exacerbations of Hepatitis:
Important Differences Among Lamivudine-Containing Products:
Emergence of Lamivudine-Resistant HBV:
COMBIVIR is a fixed-dose combination of lamivudine and zidovudine. COMBIVIR should not be administered concomitantly with other lamivudine- or zidovudine-containing products including EPIVIR (lamivudine) Tablets and Oral Solution, EPIVIR-HBV Tablets and Oral Solution, RETROVIR (zidovudine) Tablets, Capsules, Syrup, and IV Infusion, EPZICOM (abacavir sulfate and lamivudine) Tablets, or TRIZIVIR (abacavir sulfate, lamivudine, and zidovudine) Tablets; or emtricitabine-containing products, including ATRIPLA (efavirenz, emtricitabine, and tenofovir), EMTRIVA (emtricitabine), or TRUVADA (emtricitabine and tenofovir).
In vitro studies have shown ribavirin can reduce the phosphorylation of pyrimidine nucleoside analogues such as lamivudine and zidovudine. Although no evidence of a pharmacokinetic or pharmacodynamic interaction (e.g., loss of HIV-1/HCV virologic suppression) was seen when ribavirin was coadministered with lamivudine or zidovudine in HIV-1/HCV co-infected patients , hepatic decompensation (some fatal) has occurred in HIV-1/HCV co-infected patients receiving combination antiretroviral therapy for HIV-1 and interferon alfa with or without ribavirinPatients receiving interferon alfa with or without ribavirin and COMBIVIR should be closely monitored for treatment-associated toxicities, especially hepatic decompensation, neutropenia, and anemia. Discontinuation of COMBIVIR should be considered as medically appropriate. Dose reduction or discontinuation of interferon alfa, ribavirin, or both should also be considered if worsening clinical toxicities are observed, including hepatic decompensation (e.g., Childs Pugh greater than 6) (see the complete prescribing information for interferon and ribavirin).
Exacerbation of anemia has been reported in HIV-1/HCV co-infected patients receiving ribavirin and zidovudine. Co-administration of ribavirin and zidovudine is not advised.
COMBIVIR should be used with caution in patients with a history of pancreatitis or other significant risk factors for the development of pancreatitis. Treatment with COMBIVIR should be stopped immediately if clinical signs, symptoms, or laboratory abnormalities suggestive of pancreatitis occur
Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including COMBIVIR. During the initial phase of combination antiretroviral treatment, patients whose immune systems respond may develop an inflammatory response to indolent or residual opportunistic infections (such as infection, cytomegalovirus, pneumonia [PCP], or tuberculosis), which may necessitate further evaluation and treatment.
Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and “cushingoid appearance” have been observed in patients receiving antiretroviral therapy. The mechanism and long-term consequences of these events are currently unknown. A causal relationship has not been established.
The following adverse reactions are discussed in greater detail in other sections of the labeling:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In addition to adverse reactions reported from clinical trials, the following reactions have been identified during post-approval use of EPIVIR, RETROVIR, and/or COMBIVIR. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to EPIVIR, RETROVIR, and/or COMBIVIR.
Body as a Whole:
[see Warnings and Precautions (5.9)]
Cardiovascular:
Endocrine and Metabolic:
Gastrointestinal:
General:
Hemic and Lymphatic:
Hepatic and Pancreatic:
[see Boxed Warning, Warnings and Precautions (5.3), (5.4), (5.7)]
Hypersensitivity:
Musculoskeletal:
Nervous:
Respiratory:
Skin:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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