It has a molecular formula of C 15H 14N 4O and a molecular weight of 266.30. MATERIALS AND METHODS. However, approximately 15% of these subjects with hepatic fibrosis had nevirapine trough concentrations above 9,000 mcg per mL (2-fold the usual mean trough). See the end of this Medication Guide for a complete list of ingredients in Lamivudine, Nevirapine, and Zidovudine Tablets. The background risk for major birth defects and miscarriage for the indicated population is unknown. Among human hepatic cytochrome P450s, nevirapine was capable in vitro of inhibiting the 10-hydroxylation of (R)-warfarin (CYP3A). Do not take Lamivudine, Nevirapine, and Zidovudine Tablets: Before taking Lamivudine, Nevirapine, and Zidovudine Tablets, tell your healthcare provider about all of your medical conditions, including if you: What is the most important information I should know about Lamivudine, Nevirapine, and Zidovudine Tablets?. feel cold, especially in your arms and legs. Absolute bioavailability in 12 healthy adults following single-dose administration was 93 9% (mean SD) for a 50 mg tablet and 91 8% for an oral solution. Lactation: Instruct women with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in the breast milk [see Use in Specific Populations (8.2)] . You should continue to see your healthcare provider and have your liver checked regularly during your treatment with Lamivudine, Nevirapine, and Zidovudine Tablets. Starting Lamivudine, Nevirapine, and Zidovudine Tablets: It is important that you only take 1 dose of Lamivudine, Nevirapine, and Zidovudine Tablets each day for the first 14 days. Do not stop Lamivudine, Nevirapine, and Zidovudine Tablets without first talking to your healthcare provider. When discontinuing an antiretroviral regimen containing nevirapine, the long half-life of nevirapine should be taken into account; if antiretrovirals with shorter half-lives than nevirapine are stopped concurrently, low plasma concentrations of nevirapine alone may persist for a week or longer and virus resistance may subsequently develop [ see Microbiology (12.4)]. Table 7 Drug Interactions: Changes in Pharmacokinetic Parameters for Co-administered Drug in the Presence of Nevirapine (All interaction studies were conducted in HIV-1 positive subjects), = C min below detectable level of the assay, = Increase, = Decrease, = No Effect. NDC 42571-166-60 These events are often associated with rash. Autoinduction of CYP3A and CYP2B6 mediated metabolism leads to an approximately 1.5- to 2-fold increase in the apparent oral clearance of nevirapine as treatment continues from a single dose to two-to-four weeks of dosing with 200-400 mg per day. Other laboratory abnormalities (bilirubin, anemia, neutropenia, thrombocytopenia) were observed with similar frequencies in clinical trials comparing nevirapine and control regimens (see Table 4). Do not breastfeed during treatment with Lamivudine, Nevirapine, and Zidovudine Tablets. Graham Head, 66, who kidnapped and tried to rape two women, was caught after one victim remembered three digits of his car registration. GZDV area under the curve (AUC) is about 3-fold greater than the zidovudine AUC. MYOPATHY: Prolonged use of zidovudine has been associated with symptomatic myopathy [see Warnings and Precautions (5.4)] . Any patient experiencing a rash should have their liver enzymes (AST, ALT) evaluated immediately. Lamivudine, Nevirapine, and Zidovudine Tablets are for oral administration. Nevirapine had no antiviral activity in cell culture against group O HIV-1 isolates (n=3) or HIV-2 isolates (n=3) replicating in cord blood mononuclear cells. The 14-day lead-in period with nevirapine daily dosing has been observed to decrease the incidence of rash and must be followed [ see Warnings and Precautions (5.2)]. Genotypic analysis of isolates from antiretroviral-nave subjects experiencing virologic failure (n=71) receiving nevirapine once daily (n=25) or twice daily (n=46) in combination with lamivudine and stavudine (trial 2NN) for 48 weeks showed that isolates from 8/25 and 23/46 subjects, respectively, contained one or more of the following NNRTI resistance-associated substitutions: Y181C, K101E, G190A/S, K103N, V106A/M, V108I, Y188C/L, A98G, F227L, and M230L. If anemia or neutropenia develops, dosage interruption may be needed. Rash occurs most frequently within the first 6 weeks of therapy. During the initial phase of combination antiretroviral treatment, patients whose immune system responds may develop an inflammatory response to indolent or residual opportunistic infections (such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia, or tuberculosis), which may necessitate further evaluation and treatment. Concomitant use of St. John's wort ( Hypericum perforatum) or St. John's wort-containing products and nevirapine, a component of Lamivudine, Nevirapine, and Zidovudine Tablets, is not recommended. Nevirapine, a component of Lamivudine, Nevirapine, and Zidovudine Tablets, must not be used as a single agent to treat HIV-1 or added on as a sole agent to a failing regimen. MONITORING FOR HEPATOTOXICITY AND SKIN REACTIONS: Patients must be monitored intensively during the first 18 weeks of therapy with Lamivudine, Nevirapine, and Zidovudine Tablets to detect potentially life-threatening hepatotoxicity or skin reactions. Lamivudine, Nevirapine, and Zidovudine Tablets is not recommended for patients with impaired hepatic function because it is a fixed-dose combination that cannot be adjusted. What is the most important information I should know about Lamivudine, Nevirapine, and Zidovudine Tablets? Excipient information presented when available (limited, particularly for generics); consult specific product labeling. Discontinue Lamivudine, Nevirapine, and Zidovudine Tablets if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur, EXACERBATIONS OF HEPATIS 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 lamivudine, nevirapine, and zidovudine. Therefore, carefully monitor patients with either hepatic fibrosis or cirrhosis for evidence of drug-induced toxicity. Zidovudine: Zidovudine pharmacokinetics have been studied in a Phase 1 trial of 8 women during the last trimester of pregnancy. Liver enzyme test abnormalities (AST, ALT) were observed more frequently in subjects receiving nevirapine than in controls (Table 4). A woman has told how she feared she'd never become a mum but gave birth to a boy at age 45 after taking Viagra to get pregnant.. Carin Rockind, 48, welcomed a "miracle" baby after trying to have a . As a result, when giving these drugs concomitantly, plasma warfarin levels may change with the potential for increases in coagulation time. The prevalence of birth defects in live births was 3.1% (95% CI: 2.6% to 3.6%) following first trimester exposure to lamivudine-containing regimens and 2.8% (95% CI: 2.5% to 3.3%) following second/third trimester exposure to lamivudine-containing regimens. You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby. Table 3 Percentage of Subjects with Moderate or Severe Drug-Related Events in Adult Placebo-Controlled Trials. No other drug-related tumors were observed in either sex of either species. Tell your healthcare provider about all the medicines you take. Zidovudine has been shown to cross the placenta and concentrations in neonatal plasma at birth were essentially equal to those in maternal plasma at delivery [see Clinical Pharmacology (12.3)]. HIV 1 strains resistant to both lamivudine and zidovudine have been isolated from subjects after prolonged lamivudine/zidovudine therapy. Clinical Trial Experience in Adult Patients: The most serious adverse reactions associated with nevirapine are hepatitis, hepatic failure, Stevens-Johnson syndrome, toxic epidermal necrolysis, and hypersensitivity reactions. Weight-band dosing (see table below; dose is approximately 3TC 5 mg/kg per day twice daily or 3TC 10 mg/kg once daily) The scored tablet is the preferred formulation for pediatric patients weighing 14 kg who can swallow a tablet. In a retrospective review, women with CD4 + cell counts greater than 250 cells per mm 3 had a 12-fold higher risk of symptomatic hepatic adverse events compared to women with CD4 + cell counts less than 250 cells per mm 3 (11% versus 1%). Zidovudine: A study in pregnant rats (at 50, 150, or 450 mg per kg per day starting 26 days prior to mating through gestation to postnatal Day 21) showed increased fetal resorptions at doses that produced systemic exposures (AUC) approximately 33 times higher than exposure at the recommended daily human dose (300 mg twice daily). People who have abnormal liver test results before starting Lamivudine, Nevirapine, and Zidovudine Tablets and people with hepatitis B or C also have a greater risk of getting liver problems. It is unclear if pregnancy augments the risk observed in non-pregnant women [see Warnings and Precautions (5.1)]. If you stop taking Lamivudine, Nevirapine, and Zidovudine Tablets, your healthcare provider will need to check your health often and do blood test regularly for several months to check your liver. Patients developing signs or symptoms of severe skin reactions or hypersensitivity reactions (including, but not limited to, severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial edema, and/or hepatitis, eosinophilia, granulocytopenia, lymphadenopathy, and renal dysfunction) must permanently discontinue Lamivudine, Nevirapine, and Zidovudine Tablets and seek medical evaluation immediately. The median duration on study was 12 months. CAESAR was a multi-center, double-blind, placebo-controlled trial comparing continued current therapy (zidovudine alone [62% of patients] or zidovudine with didanosine or zalcitabine [38% of patients]) to the addition of lamivudine or lamivudine plus an investigational non-nucleoside reverse transcriptase inhibitor, randomized 1:2:1. This fat loss, which is most evident in the face, limbs, and buttocks, may be only partially reversible and improvement may take months to years after switching to a non-zidovudine-containing regimen. In some cases, hepatic injury progresses despite discontinuation of treatment. Coadministration of ribavirin and Lamivudine, Nevirapine, and Zidovudine Tablets is not advised. Because Lamivudine, Nevirapine, and Zidovudine Tablets is a fixed-dose combination and cannot be adjusted, it is not recommended for: Liquid and solid oral formulations of the individual components of Lamivudine, Nevirapine, and Zidovudine Tablets are available for these populations. See, have a history of pancreatitis (Inflammation of your pancreas). In animal reproduction studies, no evidence of adverse developmental outcomes were observed following oral administration of nevirapine during organogenesis in the rat and rabbit, at systemic exposures (AUC) to nevirapine approximately equal (rats) and 50% higher (rabbits) than the exposure in humans at the recommended 400 mg daily dose [see Data]. Nevirapine: In the multinational 2NN trial, a population pharmacokinetic substudy of 1077 subjects was performed that included 391 females. EXACERBATIONS OF HEPATIS 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 lamivudine, nevirapine, and zidovudine. Medically reviewed by Drugs.com. Similarly, ZDV-resistant isolates were susceptible to nevirapine in cell culture . However, no embryotoxicity was observed after oral administration of zidovudine to pregnant rats during organogenesis at doses that produced systemic exposure (AUC) approximately 117 times higher than exposures at the recommended clinical dose. Pregnant Women:Lamivudine: Lamivudine pharmacokinetics were studied in 36 pregnant women during 2 clinical trials conducted in South Africa. have or have had hepatitis (inflammation of your liver) or problems with your liver. The doses in mice were reduced to 20, 30, and 40 mg per kg per day after day 90 because of treatment-related anemia, whereas in rats only the high dose was reduced to 450 mg per kg per day on day 91 and then to 300 mg per kg per day on day 279. Genotypic analyses of the isolates selected in cell culture and recovered from zidovudine-treated subjects showed thymidine analogue mutation (TAM) substitutions HIV-1 RT (M41L, D67N, K70R, L210W, T215Y or F, QK219E/R/H/Q/N) that confer zidovudine resistance. It is important for you to keep all of your healthcare provider appointments. Genotypic analysis of isolates selected in cell culture and recovered from lamivudine-treated subjects showed that the resistance was due to a specific amino acid substitution in the HIV-1 reverse transcriptase at codon 184 changing the methionine to either valine or isoleucine (M184V/I). Lamivudine, Nevirapine, and Zidovudine Tablets contain 150 mg of lamivudine, 200 mg of nevirapine, and 300 mg of zidovudine. Drug Interactions: Advise patients that other medications may interact with Lamivudine, Nevirapine, and Zidovudine Tablets and certain medications, including ganciclovir, interferon alfa, and ribavirin, may exacerbate the toxicity of zidovudine, a component of Lamivudine, Nevirapine, and Zidovudine Tablets [see Drug Interactions (7)] . In controlled clinical trials (Trials 1037, 1038, 1046, and 1090), Grade 1 and 2 rashes were reported in 13% of subjects receiving nevirapine compared to 6% receiving placebo during the first 6 weeks of therapy. Symptoms of severe skin or hypersensitivity reactions include rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial edema, and/or hepatitis. Lamivudine, Nevirapine, and Zidovudine Tablets should be used with caution in patients who have bone marrow compromise evidenced by granulocyte count less than 1,000 cells per mm 3 or hemoglobin less than 9.5 grams per dL [see Adverse Reactions (6.1)] . Nevirapine is principally metabolized by the liver via the cytochrome P450 isoenzymes, 3A and 2B6. See full prescribing information for EPIVIR (lamivudine) and RETROVIR (zidovudine). MONITORING FOR HEPATOTOXICITY AND SKIN REACTIONS:Patients must be monitored intensively during the first 18 weeks of therapy with Lamivudine, Nevirapine, and Zidovudine Tablets to detect potentially life-threatening hepatotoxicity or skin reactions. This may help delay the development of serious health problems usually related to AIDS or HIV infection. Because of the design of the drug interaction trials (addition of 28 days of nevirapine therapy to existing HIV-1 therapy), the effect of the concomitant drug on plasma nevirapine steady-state concentrations was estimated by comparison to historical controls. Pharmacokinetic Parametersa for Lamivudine and Zidovudine in Adults. Other antiretroviral agents were given at approved doses. In humans, the only known metabolite is the trans-sulfoxide metabolite (approximately 5% of an oral dose after 12 hours). All 4 subjects experienced the rash early in the course of therapy (less than 4 weeks) and resolved upon nevirapine discontinuation. The children were stratified by age (2 to <6, 6 to <12, or 12 to 36 months) and randomly assigned in equal numbers to either nevirapine or ritonavir-boosted lopinavir, combined with zidovudine and . Some events, particularly those with rash and other symptoms, have progressed to hepatic failure with transaminase elevation, with or without hyperbilirubinemia, hepatic encephalopathy, prolonged partial thromboplastin time, or eosinophilia. Effect of Coadministered Drugs on Lamivudine and Zidovudine AUC a. Stavudine, lamivudine and nevirapine combination therapy for treatment of HIV infection and AIDS in adults. When possible, avoid use of sorbitol-containing medicines with lamivudine-containing medicines [see Clinical Pharmacology (12.3)] . 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., Child-Pugh greater than 6) (see full prescribing information for interferon and ribavirin). Lamivudine Plus Zidovudine Administered As Separate Formulations: In 4 randomized, controlled trials of lamivudine 300 mg per day plus zidovudine 600 mg per day, the following selected adverse reactions and laboratory abnormalities were observed (see Tables 1 and 2). Do not co-administer nevirapine with atazanavir because nevirapine substantially decreases atazanavir exposure and there is a potential risk for nevirapine-associated toxicity due to increased nevirapine exposures. Transaminase levels should be checked immediately for all patients who develop a rash in the first 18 weeks of treatment. Talk to your healthcare provider if you have any questions. Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg right away and must contact your health care provider immediately. Nevirapine: Long -term carcinogenicity studies in mice and rats were carried out with nevirapine. Steady-state trough nevirapine concentrations of 4.5 1.9 mcg per mL (17 7 micromolar), (n=242) were attained at 400 mg per day. Reduction of the dosage of lamivudine and zidovudine is recommended for patients with impaired renal function. At two years into the trail, 16% of subjects on nevirapine had experienced class C CDC events as compared to 21% of subjects on the control arm. Geriatric Patients:The pharmacokinetics of lamivudine, nevirapine, and zidovudine have not been studied in subjects over 65 years of age. How should I store Lamivudine, Nevirapine, and Zidovudine Tablets? Common side effects include headache, feeling tired, nausea, diarrhea, and fever. Nevirapine: In reproductive toxicology studies, evidence of impaired fertility was seen in female rats at doses providing systemic exposure, based on AUC, approximately equivalent to that provided with the recommended clinical dose of nevirapine. if you have any of the following symptoms of liver problems with or without a skin rash: if you get a rash with any of the following symptoms: If your healthcare provider tells you to stop treatment with, because you have had any of the severe liver or skin symptoms listed above, you should never take. Subjects were treated with nevirapine prior to trial entry, 7 mg/kg or 4 mg/kg QD x 2 weeks; BID x 1 week. Lamivudine, Nevirapine, and Zidovudine Tablets are contraindicated: Severe, life-threatening, and in some cases fatal hepatotoxicity, including fulminant and cholestatic hepatitis, hepatic necrosis and hepatic failure, have been reported in patients treated with nevirapine, a component of lamivudine, nevirapine, and zidovudine. You can ask your healthcare provider or pharmacist for a list of medicines that interact with Lamivudine, Nevirapine, and Zidovudine Tablets. Ribavirin: In vitro data indicate ribavirin reduces phosphorylation of lamivudine, stavudine, and zidovudine. Lamivudine: Long-term carcinogenicity studies with lamivudine in mice and rats showed no evidence of carcinogenic potential at exposures up to 10 times (mice) and 58 times (rats) the human exposures at the recommended dose of 300 mg. Zidovudine: Zidovudine was administered orally at 3 dosage levels to separate groups of mice and rats (60 females and 60 males in each group). The anti-HIV-1 activity of nevirapine was not antagonistic in combination with the NRTIs abacavir, didanosine, emtricitabine, lamivudine, stavudine, tenofovir and zidovudine, and the protease inhibitors amprenavir, atazanavir, indinavir, lopinavir, nelfinavir, saquinavir and tipranavir. 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