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";s:4:"text";s:29583:"Ruschitzka F, Meier PJ, Turina M et al. Cyclosporine, sirolimus, tacrolimus: Dosage of immunosuppressive agent may need to be adjusted if used with efavirenz or efavirenz/emtricitabine/tenofovir DF; 1 232 whenever efavirenz or efavirenz/emtricitabine/tenofovir DF is initiated or discontinued, monitor immunosuppressive agent concentrations for at least 2 weeks until stable 1 232 Tacrolimus, sold under the brand names Protopic and Prograf among others, is an immunosuppressive drug.It is used after allogeneic organ transplant to lower the risk of organ rejection, and also as a topical medication in the treatment of T-cell-mediated diseases such as eczema and psoriasis.It also used for severe refractory uveitis after bone marrow transplants, …

Three of 20 fetuses/infants had one or more malformations; there were no malformed fetuses or infants from placebo-treated mothers. Efavirenz plus zidovudine and lamivudine, efavirenz plus indinavir, and indinavir plus zidovudine and lamivudine in the treatment of HIV-1 infection in adults. Nine of these patients developed mild-to-moderate rash while receiving therapy with Sustiva, and two of these patients discontinued because of rash.Selected Grade 3-4 laboratory abnormalities reported in ≥2% of Sustiva-treated patients in two clinical trials are presented in Table 4.Liver function tests should be monitored in patients with a history of hepatitis B and/or C. In the long-term data set from Study 006, 137 patients treated with Sustiva-containing regimens (median duration of therapy, 68 weeks) and 84 treated with a control regimen (median duration, 56 weeks) were seropositive at screening for hepatitis B (surface antigen positive) and/or C (hepatitis C antibody positive). Some events of late-onset neurotoxicity have occurred in patients with CYP2B6 genetic polymorphisms which are associated with increased efavirenz levels despite standard dosing of Sustiva. Inhibition of HIV-1 replication by a nonnucleoside reverse transcriptase inhibitor. Indinavir concentrations and St. John’s wort. Multiple doses of 200-400 mg per day for 10 days resulted in a lower than predicted extent of accumulation (22-42% lower) and a shorter terminal half-life of 40-55 hours (single dose half-life 52-76 hours).Efavirenz has a terminal half-life of 52-76 hours after single doses and 40-55 hours after multiple doses. Antiretroviral drug resistance testing in adults with HIV infection. Mice were dosed with 0, 25, 75, 150, or 300 mg/kg/day for 2 years. Late-onset neurotoxicity, including ataxia and encephalopathy (impaired consciousness, confusion, psychomotor slowing, psychosis, delirium), may occur months to years after beginning efavirenz therapy. Pharmacokinetic interaction of digoxin with an herbal extract from St.John’s wort (66. From HHS AIDS Information (AIDSinfo) website. 50 mg capsules are gold color and white, printed with “Sustiva” on the gold color cap and reverse printed “50 mg” on the white body. If using efavirenz/emtricitabine/tenofovir DF (AtriplaIf using efavirenz/emtricitabine/tenofovir DF (AtriplaAntiretroviral; HIV nonnucleoside reverse transcriptase inhibitor (NNRTI).Treatment of HIV-1 infection in adults, adolescents, and pediatric patients ≥3 months of age weighing ≥3.5 kg;Usually avoid efavirenz in pregnant women during first trimester;Efavirenz/emtricitabine/tenofovir DF fixed combination (AtriplaPostexposure prophylaxis of HIV infection following occupational exposureUSPHS recommends 3-drug regimen of raltegravir in conjunction with emtricitabine and tenofovir DF as the preferred regimen for PEP following occupational exposures to HIV.Management of occupational exposures to HIV is complex and evolving; consult infectious disease specialist, clinician with expertise in administration of antiretroviral agents, and/or National Clinicians’ Postexposure Prophylaxis Hotline (PEPline at 888-448-4911) whenever possible.Postexposure prophylaxis of HIV infection following nonoccupational exposureWhen nPEP indicated in adults and adolescents ≥13 years of age with normal renal function, CDC states preferred regimen is either raltegravir or dolutegravir used in conjunction with emtricitabine and tenofovir DF (given as emtricitabine/tenofovir DF; TruvadaCDC states efavirenz is an alternative antiretroviral that can be used in nPEP regimens, but use in such regimens Consult infectious disease specialist, clinician with expertise in administration of antiretroviral agents, and/or the National Clinicians’ Postexposure Prophylaxis Hotline (PEPline at 888-448-4911) if nPEP indicated in certain exposed individuals (e.g., pregnant women, children, those with medical conditions such as renal impairment) or if considering a regimen not included in CDC guidelines, source virus is known or likely to be resistant to antiretrovirals, or healthcare provider is inexperienced in prescribing antiretrovirals.Administration at bedtime may make adverse CNS effects (dizziness, insomnia, impaired concentration, somnolence, abnormal dreams) more tolerable.For adults and pediatric patients ≥3 months of age not able to swallow capsules or tablets, administer capsule contents by mixing with small amount (1–2 teaspoonfuls) of soft food (capsule sprinkle method).Mixing capsule contents into food: Add 1–2 teaspoonfuls of age-appropriate soft food (e.g., applesauce, grape jelly, yogurt) to a small container.Mixing capsule contents into infant formula: Add 10 mL (2 teaspoonfuls) of reconstituted room temperature infant formula to a 30-mL medicine cup.Swallow tablets whole on an empty stomach; do not break or crush.Initiate PEP as soon as possible following occupational exposure to HIV (preferably within hours); continue for 4 weeks, if tolerated.Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.Efavirenz and efavirenz/emtricitabine/tenofovir DF: History of clinically important hypersensitivity reaction (e.g., Stevens-Johnson syndrome, erythema multiforme, toxic skin eruption) to efavirenz or any ingredient in the formulation.Efavirenz/emtricitabine/tenofovir DF: Consider contraindications associated with each drug in the fixed combination.Efavirenz plasma concentrations may be altered if CYP3A substrates, inhibitors, or inducers used concomitantly.Serious adverse psychiatric symptoms (severe depression, suicidal ideation, nonfatal suicide attempts, aggressive behavior, paranoid reactions) reported rarely in efavirenz clinical studies.Depression, anxiety, and nervousness also reported in clinical studies.Factors associated with increased occurrence of psychiatric symptoms include history of injection drug use, history of psychiatric disorders, and treatment with antipsychotic drugs at study entry.If serious psychiatric adverse events occur, evaluate to determine if symptoms are related to efavirenz; if so, determine whether risks of continued efavirenz outweigh benefits.Dizziness or insomnia reported frequently; abnormal dreams, hallucinations, or impaired concentration also reported.May cause fetal harm if administered during first trimester of pregnancy.Advise women of childbearing potential about the teratogenic potential of efavirenz;Avoid pregnancy during therapy and for 12 weeks after discontinuance of efavirenz or fixed combination containing efavirenz.Rash (maculopapular skin eruptions) reported frequently.Median time to rash onset 11 days in adults and 28 days in pediatric patients; median duration 16 days.Discontinue in patients with life-threatening cutaneous reactions (e.g., Stevens-Johnson syndrome) and consider alternative therapy.Discontinue in patients with serious rash (e.g., rash associated with blistering, desquamation, mucosal involvement, or fever).Substantial increases in serum AST or ALT concentrations (>5 times ULN) reported in clinical studies in HIV-infected patients coinfected with HBV and/or HCV.Hepatic failure and hepatitis reported, some with a fulminant course requiring transplantation or resulting in death.Use with caution in patients with hepatic impairment.Assess serum liver enzyme concentrations prior to and during efavirenz treatment in patients with underlying hepatic disease (including those with HBV and/or HCV infection), patients with markedly increased serum transaminase concentrations, and patients receiving other drugs associated with liver toxicity.Also consider monitoring serum liver enzymes in patients without preexisting hepatic dysfunction or other risk factors.In patients with serum hepatic enzyme concentrations >5 times ULN, consider whether benefits of continued efavirenz therapy outweigh risks of hepatotoxicity.Efavirenz/emtricitabine/tenofovir DF: Consider cautions, precautions, contraindications, and interactions associated with each drug in the fixed combination.Do not use efavirenz/emtricitabine/tenofovir DF concomitantly with single-entity efavirenz, unless needed for adjustment of efavirenz dosage (e.g., when fixed combination used concomitantly with rifampin).Because the antiretrovirals contained in efavirenz/emtricitabine/tenofovir DF also are available in single-entity or other fixed-combination preparations, take care to ensure that therapy is not duplicated if the fixed combination is used in conjunction with other antiretrovirals.Do not use efavirenz/emtricitabine/tenofovir DF concomitantly with any preparation containing emtricitabine or tenofovir DF.Increased serum concentrations of total cholesterol and triglycerides reported.Redistribution or accumulation of body fat, including central obesity, dorsocervical fat enlargement (“buffalo hump”), peripheral wasting, breast enlargement, and general cushingoid appearance, reported in patients receiving antiretroviral therapy.Mechanism and long-term consequences of fat redistribution unknown;During initial treatment, HIV-infected patients who respond to antiretroviral therapy may develop an inflammatory response to indolent or residual opportunistic infections (e.g., Autoimmune disorders (e.g., Graves' disease, polymyositis, Guillain-Barré syndrome) also reported in the setting of immune reconstitution;Efavirenz may cause fetal harm if administered during first trimester of pregnancy.Antiretroviral Pregnancy Registry at 800-258-4263 or Data from the Antiretroviral Pregnancy Registry show no difference in the risk of overall birth defects for efavirenz compared with background rate for birth defects.Women of childbearing potential should use effective contraceptive measures during therapy and for 12 weeks after discontinuance of efavirenz or efavirenz/emtricitabine/tenofovir DF.Manufacturer states avoid use during first trimester of pregnancy.Experts state efavirenz in conjunction with 2 NRTIs is an alternative NNRTI-based regimen for Experts also state that antiretroviral regimens that do not include efavirenz should be strongly considered in women who are planning to become pregnant or are sexually active and not using effective contraception, provided such regimens are acceptable to the provider and not expected to compromise the health of the woman.If a pregnant woman already receiving an efavirenz-containing regimen presents for antenatal care during first trimester, some experts suggest the regimen can be continued if well tolerated and providing adequate virologic suppression.If efavirenz or a fixed combination containing efavirenz is used during first trimester or if pregnancy occurs, apprise patient of potential harm to the fetus.Instruct HIV-infected women not to breast-feed because of risk of HIV transmission and risk of adverse effects in the infant.Adverse effects reported with efavirenz in pediatric patients 3 months to 21 years of age are similar to those reported in adults with the exception of rash.Not recommended in sexually active adolescent females of childbearing potential who desire to become pregnant or when reliable contraception cannot be ensured.Insufficient experience in those ≥65 years of age to determine whether they respond differently than younger adults.Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.Monitor hepatic enzyme concentrations in patients with known or suspected HBV or HCV infection, patients with substantially increased transaminase concentrations, and in patients receiving other drugs associated with hepatotoxicity.Rash, dizziness, nausea, headache, fatigue, insomnia, vomiting.Inhibits CYP2C9 and CYP2C19 and, to a lesser extent, CYP2D6 and CYP1A2.The following drug interactions are based on studies using efavirenz.Pharmacokinetic interactions likely with drugs that are inhibitors, inducers, or substrates of CYP isoenzymes 3A, 2B6, 2C9, or 2C19 with possible alteration in metabolism of efavirenz and/or other drug.In vitro evidence of additive antiretroviral effectsAntacids (aluminum hydroxide, magnesium hydroxide, simethicone)Anticonvulsants (carbamazepine, phenobarbital, phenytoin)Carbamazepine: Decreased concentrations and AUCs of efavirenz and carbamazepinePhenobarbital, phenytoin: Possible decreased concentrations of phenobarbital and phenytoin and/or efavirenzCarbamazepine: Data insufficient to make dosage recommendations for concomitant use with efavirenz;Phenobarbital, phenytoin: Use caution and monitor anticonvulsant concentrations if used with efavirenz;Efavirenz/emtricitabine/tenofovir DF: Data insufficient to make dosage recommendations for concomitant use with carbamazepine;Antifungals, azoles (fluconazole, isavuconazonium, itraconazole, ketoconazole, posaconazole, voriconazole)Fluconazole: No clinically important pharmacokinetic interactionsIsavuconazonium (prodrug of isavuconazole): Possible decreased isavuconazole concentrationsItraconazole: Decreased concentrations of itraconazole; no change in efavirenz concentrationsKetoconazole: Possible decreased concentrations of the antifungalPosaconazole: Decreased posaconazole concentrations and AUC;Voriconazole: Decreased voriconazole concentrations; increased efavirenz concentrationsIsavuconazonium: Consider monitoring isavuconazole concentrations and antifungal efficacy;Itraconazole: Dosage recommendation for concomitant use not available;Posaconazole: Avoid concomitant use unless potential benefits outweigh risks;Voriconazole: Increase voriconazole maintenance dosage to 400 mg every 12 hours and decrease efavirenz dosage to 300 mg once daily (use efavirenz capsules; do not divide tablet);Decreased cetirizine concentrations; no change in efavirenz concentrationsWhen used with cetirizine, dosage adjustments not neededFixed combination of artemether and lumefantrine (artemether/lumefantrine): Decreased concentrations and AUC of artemether and active metabolite of artemether; decreased lumefantrine AUC; may decrease antimalarial effect of artemether/lumefantrine;Fixed combination of atovaquone and proguanil (atovaquone/proguanil): Decreased AUC of atovaquone and proguanil;Artemether/lumefantrine: Consider alternative antimalarial agent;Atovaquone/proguanil: Concomitant use not recommended;Antimycobacterials (bedaquiline, rifabutin, rifampin, rifapentine)Bedaquiline: Possible decreased bedaquiline concentrationsRifabutin: Decreased rifabutin concentrations; no change in efavirenz AUCRifampin: Decreased efavirenz concentrations and AUCRifabutin: Manufacturer of efavirenz states increase daily rifabutin dosage by 50% and consider doubling rifabutin dosage when given 2 or 3 times weekly; experts suggest increase rifabutin dosage to 450–600 mg once daily or 600 mg 3 times weekly, provided regimen does not include a PIRifampin: Manufacturer states increase efavirenz dosage to 800 mg once daily in those weighing ≥50 kg;Unboosted atazanavir: Substantially decreased atazanavir concentrations and AUC;No in vitro evidence of antagonistic antiretroviral effectsEfavirenz/emtricitabine/tenofovir DF: Concomitant use with atazanavir (with or without low-dose ritonavir) not recommendedMidazolam, triazolam: Possible increased midazolam or triazolam concentrationsLorazepam: Increased lorazepam concentrations, but no effect on lorazepam AUCMidazolam (oral), triazolam: Do not use concomitantlyMidazolam (parenteral): Experts state a single parenteral midazolam dose can be used with caution in a monitored situation for procedural sedationAlprazolam: Monitor for benzodiazepine effectivenessBuprenorphine (sublingual or buccal): Decreased buprenorphine and norbuprenorphine AUCsBuprenorphine (subdermal implant): Data not availableBuprenorphine (sublingual or buccal): Some experts state dosage adjustments not recommended, but monitor for withdrawal symptomsBuprenorphine (subdermal implant): If efavirenz initiated after insertion of implant, clinical monitoring recommendedTitrate bupropion dosage based on clinical response;Other calcium-channel blocking agents that are substrates of CYP 3A4 (e.g., felodipine, nicardipine, nifedipine, verapamil): Possible decreased concentrations of the calcium-channel blocking agentDiltiazem: Titrate diltiazem dosage based on clinical response;Other calcium-channel blocking agents that are substrates of CYP 3A4: Titrate dosage of calcium-channel blocking agent according to clinical responseDexamethasone: Possible decreased efavirenz concentrationsNo in vitro evidence of antagonistic antiretroviral effectsIn vitro evidence of additive antiretroviral effectsEfavirenz/emtricitabine/tenofovir DF: Use concomitantly with caution and monitor closely for didanosine-associated adverse effects (e.g., pancreatitis, lactic acidosis, neuropathy)No in vitro evidence of antagonistic antiretroviral effectsAdults: In antiretroviral-naive or antiretroviral-experienced, HIV integrase strand transferase inhibitor-naive (INSTI-naive), use dolutegravir 50 mg twice daily;Pediatric patients: In antiretroviral-naive or antiretroviral-experienced, INSTI-naive weighing 30 kg to <40 kg, use dolutegravir 35 mg twice daily;Fixed combination of elbasvir and grazoprevir (elbasvir/grazoprevir): Substantially decreased elbasvir and grazoprevir concentrations;Elbasvir/grazoprevir: Concomitant use contraindicatedIn vitro evidence of additive antiretroviral effectsIn vitro evidence of additive to synergistic antiretroviral effectsErgot alkaloids (dihydroergotamine, ergotamine, methylergonovine)Possible decreased ergot alkaloid concentrations; possible inadequate treatment effectIf methylergonovine used to treat postpartum hemorrhage in a woman receiving efavirenz, additional uterotonic agents may be neededOral hormonal contraceptive containing ethinyl estradiol and norgestimate: Substantially decreased concentrations and AUC of norelgestromin and levonorgestrel (metabolites of norgestimate);Etonogestrel (subcutaneous implant): Not studied, but decreased etonogestrel concentrations expected;Levonorgestrel (subcutaneous implant): Decreased levonorgestrel concentrations;Levonorgestrel (oral): Decreased levonorgestrel AUCHormonal contraceptives (oral or other hormonal contraceptives): Use a barrier contraceptive as an alternative to or in addition to hormonal contraceptive in women of childbearing potential during and for 12 weeks after efavirenz therapy is discontinuedLevonorgestrel (oral): Efficacy as emergency contraceptive expected to be decreased in women receiving efavirenzDecreased etravirine concentrations and loss of therapeutic effectSubstantially decreased concentrations of amprenavir (active metabolite of fosamprenavir) if used with fosamprenavir (without low-dose ritonavir);In vitro evidence of synergistic antiretroviral effectsFosamprenavir (without low-dose ritonavir): Appropriate dosages for concomitant use with efavirenz or efavirenz/emtricitabine/tenofovir DF with respect to safety and efficacy not establishedEfavirenz/emtricitabine/tenofovir DF: If once-daily regimen of Pharmacokinetic interaction unlikely with famotidineWhen used with famotidine, dosage adjustments not neededAtorvastatin, pravastatin, and simvastatin: Decreased concentrations of the antilipemic agent;Pitavastatin: Decreased AUC and increased concentrations of pitavastatinAtorvastatin: Titrate atorvastatin dosage based on lipid response; do not exceed maximum recommended dosageLovastatin: Titrate lovastatin dosage based on lipid response; do not exceed maximum recommended dosage; avoid lovastatin if efavirenz regimen includes a Pravastatin: Titrate pravastatin dosage based on lipid response; do not exceed the maximum recommended dosageRosuvastatin: Titrate rosuvastatin dosage based on lipid response; do not exceed maximum recommended dosageSimvastatin: Titrate simvastatin dosage based on lipid response; do not exceed maximum recommended dosage;Immunosuppressive agents (cyclosporine, sirolimus, tacrolimus)Cyclosporine, sirolimus, tacrolimus: Possible decreased concentrations of the immunosuppressive agents;Cyclosporine, sirolimus, tacrolimus: Dosage of immunosuppressive agent may need to be adjusted if used with efavirenz or efavirenz/emtricitabine/tenofovir DF;Decreased indinavir AUC; no clinically important effect on efavirenz concentrations or AUCIn vitro evidence of additive antiretroviral effectsOptimum dosage for concomitant use not established; increasing indinavir dosage to 1 g every 8 hours does not compensate for increased indinavir metabolism due to efavirenzIn vitro evidence of additive antiretroviral effectsFixed combination of ledipasvir and sofosbuvir (ledipasvir/sofosbuvir): clinically important pharmacokinetic interactions with efavirenz not expected;Ledipasvir/sofosbuvir: Dosage adjustments not needed if used with efavirenz;In vitro evidence of additive antiretroviral effectsOnce-daily lopinavir/ritonavir regimen not recommended with efavirenzIf efavirenz used with lopinavir in adults, recommended dosage of lopinavir/ritonavir tablets is lopinavir 500 mg/ritonavir 125 mg twice daily;Macrolides (azithromycin, clarithromycin, erythromycin)Clarithromycin: Decreased clarithromycin concentrations and AUC and increased 14-hydroxyclarithromycin concentrations and AUCClarithromycin: Some experts state consider alternative (e.g., azithromycin)No in vitro evidence of antagonistic antiretroviral effectsRecommended maraviroc dosage is 600 mg twice daily when used with efavirenz, provided regimen does Inform patients of potential interaction; closely monitor for signs of opiate withdrawal; increased methadone maintenance dosage may be necessaryIncreased nelfinavir concentrations and AUC; decreased efavirenz concentrations and AUCIn vitro evidence of additive to synergistic antiretroviral effectsFixed combination of ombitasvir, paritaprevir, and ritonavir (ombitasvir/paritaprevir/ritonavir) with or without dasabuvir: Concomitant use poorly tolerated;Ombitasvir/paritaprevir/ritonavir with or without dasabuvir: Concomitant use contraindicatedIn vitro evidence of additive to synergistic antiretroviral effectsIncreased ritonavir AUC and increased efavirenz AUCIn vitro evidence of additive antiretroviral effectsMonitor hepatic enzymes and monitor patient for adverse effects (e.g., dizziness, nausea, paresthesia) if used with efavirenz or efavirenz/emtricitabine/tenofovir DFDecreased efavirenz concentrations; possible loss of virologic response and increased risk of efavirenz resistanceIn vitro evidence of additive antiretroviral effectsSertraline: Decreased sertraline concentrations and AUCSertraline: Adjust sertraline dosage based on clinical responseSubstantially decreased simeprevir concentrations and AUC;No clinically important effect on efavirenz pharmacokineticsNo clinically important effect on sofosbuvir pharmacokineticsEfavirenz/emtricitabine/tenofovir DF): No clinically important effect on pharmacokinetics of sofosbuvir, efavirenz, or emtricitabine;In vitro evidence of additive antiretroviral effectsIn vitro evidence of additive to synergistic antiretroviral effectsFalse-positive urine cannabinoid test when screening test used;Confirm positive cannabinoid screening test with a more specific testIn vitro evidence of additive antiretroviral effectsIn vitro evidence of additive antiretroviral effectsPeak plasma efavirenz concentrations attained within 3–5 hours.Fixed-combination tablet containing efavirenz 600 mg, emtricitabine 200 mg, and tenofovir DF 300 mg (efavirenz/emtricitabine/tenofovir DF; AtriplaAdministration with food increases efavirenz bioavailability.Compared with administration in the fasting state, AUC increased 22 or 17% when a single 600-mg efavirenz dose as capsules was administered with a high-fat, high-calorie meal (894 kcal, 54 g fat, 54% calories from fat) or a reduced-fat normal calorie meal (440 kcal, 2 g fat, 4% calories from fat), respectively.Compared with administration in the fasting state, AUC increased 28% when a single 600-mg efavirenz dose as tablets was administered with a high-fat, high-calorie meal (1000 kcal, 500–600 kcal from fat).In healthy adults, 600-mg efavirenz dose administered by opening 200-mg capsules and mixing contents of 3 capsules with 2 teaspoonfuls of soft food (e.g., applesauce, grape jelly, yogurt) or infant formula resulted in efavirenz AUC that met bioequivalency criteria compared with intact capsules administered in fasting state.Animal studies indicate efavirenz crosses placenta in rats, rabbits, and primates.Metabolized by CYP3A and CYP2B6; undergoes subsequent glucuronidation.16–61% excreted in feces (principally as unchanged drug) and 14–34% eliminated in urine as unchanged drug (<1%) or metabolites.Not removed by hemodialysis; probably not removed by peritoneal dialysis.52–76 hours after a single dose and 50–55 hours after multiple doses.Hepatic impairment: Pharmacokinetics not affected by mild impairment (Child-Pugh class A);Pharmacologically related to other NNRTIs (e.g., delavirdine, etravirine, nevirapine, rilpivirine); differs structurally from these drugs; also differs pharmacologically and structurally from other currently available antiretrovirals.Inhibits replication of HIV-1 by interfering with viral RNA- and DNA-directed polymerase activities of reverse transcriptase.HIV-1 with reduced susceptibility to efavirenz have been selected in vitro and have emerged during therapy with the drug.Strains of HIV-1 resistant to efavirenz may be cross-resistant to some other NNRTIs (e.g., delavirdine, nevirapine).Cross-resistance between efavirenz and NRTIs unlikely since the drugs bind at difference sites on reverse transcriptase and have difference mechanisms of action.Critical nature of compliance with HIV therapy and importance of remaining under the care of a clinician.Importance of using efavirenz in conjunction with other antiretrovirals—not for monotherapy.Antiretroviral therapy is not a cure for HIV infection; opportunistic infections and other complications associated with HIV disease may still occur.Advise patients that effective antiretroviral regimens can decrease HIV concentrations in blood and genital secretions and strict adherence to such regimens in conjunction with risk-reduction measures may decrease, but cannot absolutely eliminate, the risk of secondary transmission of HIV to others.Importance of reading patient information provided by the manufacturer.Importance of taking efavirenz on an empty stomach, preferably at bedtime.In patients not able to swallow capsules or tablets, importance of patient or caregiver reading and carefully following instructions for mixing and administering capsule contents in small amount of soft food or infant formula.If a dose is missed, patient should take the missed dose as soon as it is remembered, unless it is almost time for next dose.Advise patients that adverse CNS effects (e.g., dizziness, insomnia, impaired concentration, drowsiness, abnormal dreams) are common during first weeks of efavirenz therapy.Advise patients that serious psychiatric symptoms (e.g., severe depression, suicide attempts, aggressive behavior, delusions, paranoia, psychosis-like symptoms) have occurred.Redistribution/accumulation of body fat may occur, with as yet unknown long-term health effects.Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal products, and any concomitant illnesses.Importance of women using a reliable barrier method of contraception instead of or in addition to a hormonal contraceptive (oral or other hormonal contraceptive) during and for 12 weeks after efavirenz therapy.Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.Importance of advising patients of other important precautionary information.600 mg with Emtricitabine 200 mg and Tenofovir Disoproxil Fumarate 300 mg3.
68. Table 1 describes the recommended dose of Sustiva for pediatric patients 3 months of age or older and weighing between 3.5 kg and 40 kg [For pediatric patients at least 3 months old and weighing at least 3.5 kg and adults who cannot swallow capsules or tablets, the capsule contents may be administered with a small amount (1 to 2 teaspoons) of food. Scarsi KK, Darin KM, Nakalema S et al. Delavirdine- and/or nevirapine-resistant clinical viral isolates with NNRTI resistance-associated substitutions (A98G, L100I, K101E/P, K103N/S, V106A, Y181X, Y188X, G190X, P225H, F227L, or M230L) showed reduced susceptibility to efavirenz in cell culture. Sevinsky H, Eley T, Persson A et al.
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