Efaviren

 Indications Treatment of HIV-1 infection in combination with other antiretroviral agents.

 

 Contraindications Concomitant use with cisapride, ergot derivatives, midazolam, or triazolam.

 

 Route/Dosage

Adults: PO 600 mg/day in combination with other antiretroviral agents. Children 10 to less than 15 kg: PO 200 mg/day in combination with other antiretroviral agents. Children 15 to less than 20 kg: PO 250 mg/day in combination with other antiretroviral agents. Children 20 to less than 25 kg: PO 300 mg/day in combination with other antiretroviral agents. Children 25 to less than 32.5 kg: PO 350 mg/day in combination with other antiretroviral agents. Children 32.5 to less than 40 kg: PO 400 mg/day in combination with other antiretroviral agents. Children at least 40 kg: PO 600 mg/day in combination with other antiretroviral agents.

 

 Interactions

Alprazolam, Midazolam, Triazolam: May increase blood levels of these drugs, which may produce extreme sedation and respiratory depression. Do not administer concurrently. Clarithromycin, Indinavir, Saquinavir: Efavirenz may decrease plasma concentrations, which could reduce activity of these agents. Cisapride, Ergot Derivatives: May elevate levels of these drugs, which may increase the risk of arrhythmias, hematologic abnormalities, or other potentially serious adverse effects. Do not coadminister. Ethinyl Estradiol, Nelfinavir, Ritonavir: Efavirenz may increase plasma concentrations, which could increase activity or toxicity of these agents. Rifampin: May decrease plasma levels of efavirenz, which may reduce antiviral activity. Ritonavir: May increase efavirenz plasma level, which could increase side effects. Warfarin: Plasma concentrations may be increased or decreased.

 

 Lab Test Interferences False-positive urine assay screening test for cannabinoid may occur.

 

 Adverse Reactions

CARDIOVASCULAR: Flushing; palpitations; tachycardia; thrombophlebitis. CNS: Dizziness; fatigue; headache; migraines; hypesthesia; impaired concentration; insomnia; abnormal dreams; somnolence; depression; anorexia; nervousness; ataxia; confusion; impaired coordination; neuralgia; paresthesia; peripheral neuropathy; speech disorder; tremor; vertigo; agitation; amnesia; apathy; emotional lability; euphoria; hallucination; psychosis. DERMATOLOGIC: Maculopapular rash; rash (eg, blistering, desquamation, mucosal involvement, fever); pruritus; increased sweating; alopecia; eczema; folliculitis; skin exfoliation; urticaria. EENT: Abnormal vision; diplopia; parosmia; taste perversion; tinnitus. GI: Nausea; vomiting; diarrhea; dyspepsia; abdominal pain; flatulence. GU: Renal calculus; hematuria. HEPATIC: Hepatitis. METABOLIC: Increased total cholesterol. RESPIRATORY: Cough; asthma. OTHER: Arthralgia; myalgia; asthenia; fever; hot flashes; malaise; pain; syncope; peripheral edema.

 

 Precautions

Pregnancy: Category C. Lactation: HIV-infected mothers should not breastfeed their infants. Children: Ongoing study. CNS Symptoms: Reported in 53% of patients Hepatitis: Monitor liver enzymes in patients with known or suspected history of hepatitis B or C infection and in patients receiving medication associated with liver toxicity. Monotherapy: Resistant virus may emerge rapidly. Psychiatric symptoms: Serious adverse psychiatric experiences have been reported. Patients with a prior history of psychiatric disorders may be at greater risk. There have been occasional reports of death by suicide, delusions, and psychosis-like behavior. Skin Rash: Reported in 26% of adults and 40% of pediatric patients.

PATIENT CARE CONSIDERATIONS

 

 Administration/Storage

• Store oral capsules at room temperature 25°C (77°F); excursions permitted 15° to 30°C (59° to 86°F).
• Administer with or without food or on an empty stomach.
• Avoid high fat meal, as it may increase absorption.
• Administer at bedtime initially and when CNS symptoms are present to improve tolerance of these symptoms.
• Always give in combination with other antiviral agents.
• Do not administer to nursing women.

 

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies.
• Monitor for signs of hypersensitivity (eg, fever, rash, fatigue, nausea, vomiting, diarrhea, abdominal pain, malaise, lethargy, myalgia, arthralgia, edema, shortness of breath, paresthesia); discontinue use immediately if signs of hypersensitivity are present and notify primary health care provider.
• Monitor for adverse reactions, the most significant of which are CNS symptoms and rash.
• Monitor liver enzymes in patients with hepatitis B or C infections and in patients treated with other medications with known liver toxicity.
• Conduct pregnancy test prior to initial administration of efavirenz.

OVERDOSAGE: SIGNS & SYMPTOMS   Increased CNS symptoms, muscle contractions

 

 Patient/Family Education

• Instruct patient to take efavirenz at the same time each day as prescribed in combination with other antiviral drugs and not to skip doses, which could increase the viral load.
• Patient should not alter the dose or discontinue therapy without consulting primary care provider.
• Inform patient that efavirenz may cause dizziness, impaired concentration, or drowsiness, and to avoid potentially hazardous tasks such as driving or operating machinery if experiencing these symptoms.
• Inform patient that dosing at bedtime improves the tolerability of CNS symptoms.
• Alert patient to the potential for additive CNS effects when efavirenz is used concomitantly with alcohol or psychoactive drugs.
• Instruct patient to avoid otc medications unless prescribed by primary health care provider.
• Caution patient or family that long-term effects and adverse effects are not known. Therefore, report any problems to the primary care provider.
• Warn patient of the potential adverse effects and drug/drug interactions.
• Instruct patient to notify health care provider immediately if signs of rash or rash accompanied by fever, blistering, oral lesions, conjunctivitis, swelling, muscle or joint aches, or general malaise, infection such as a sore throat, fever, cough, and respiratory congestion occur.
• Instruct patient to notify health care provider immediately if symptoms of serious psychiatric adverse experiences occur.
• Inform patient of potential false-positive urine cannabinoid test results.
• Inform patient that efavirenz has not been shown to reduce the risk of passing HIV to others through sexual contact or blood contamination. Encourage abstinence or practicing safe sex and not sharing needles.
• Advise women to use barrier contraception in combination with other methods of contraception (eg, oral or other hormonal contraceptives).
• Caution mothers to discontinue nursing while receiving efavirenz as there is potential for adverse effects from the drug in nursing infants and well as transmission of the HIV virus.
• Caution women to inform health care provider if pregnant, planning to become pregnant, or planning to breastfeed.
• Stress the importance of regular exams and laboratory work.

Indications for Drugs ::

(EH-fah-VIE-renz)

Sustiva

Capsules

50 mg

Capsules

100 mg

Capsules

200 mg

Class: Antiviral

 

 Action Noncompetitive inhibition of HIV-1 reverse transcriptase.

 

 Indications Treatment of HIV-1 infection in combination with other antiretroviral agents.

 

 Contraindications Concomitant use with cisapride, ergot derivatives, midazolam, or triazolam.

 

 Route/Dosage

Adults: PO 600 mg/day in combination with other antiretroviral agents. Children 10 to less than 15 kg: PO 200 mg/day in combination with other antiretroviral agents. Children 15 to less than 20 kg: PO 250 mg/day in combination with other antiretroviral agents. Children 20 to less than 25 kg: PO 300 mg/day in combination with other antiretroviral agents. Children 25 to less than 32.5 kg: PO 350 mg/day in combination with other antiretroviral agents. Children 32.5 to less than 40 kg: PO 400 mg/day in combination with other antiretroviral agents. Children at least 40 kg: PO 600 mg/day in combination with other antiretroviral agents.

 

 Interactions

Alprazolam, Midazolam, Triazolam: May increase blood levels of these drugs, which may produce extreme sedation and respiratory depression. Do not administer concurrently. Clarithromycin, Indinavir, Saquinavir: Efavirenz may decrease plasma concentrations, which could reduce activity of these agents. Cisapride, Ergot Derivatives: May elevate levels of these drugs, which may increase the risk of arrhythmias, hematologic abnormalities, or other potentially serious adverse effects. Do not coadminister. Ethinyl Estradiol, Nelfinavir, Ritonavir: Efavirenz may increase plasma concentrations, which could increase activity or toxicity of these agents. Rifampin: May decrease plasma levels of efavirenz, which may reduce antiviral activity. Ritonavir: May increase efavirenz plasma level, which could increase side effects. Warfarin: Plasma concentrations may be increased or decreased.

 

 Lab Test Interferences False-positive urine assay screening test for cannabinoid may occur.

 

 Adverse Reactions

CARDIOVASCULAR: Flushing; palpitations; tachycardia; thrombophlebitis. CNS: Dizziness; fatigue; headache; migraines; hypesthesia; impaired concentration; insomnia; abnormal dreams; somnolence; depression; anorexia; nervousness; ataxia; confusion; impaired coordination; neuralgia; paresthesia; peripheral neuropathy; speech disorder; tremor; vertigo; agitation; amnesia; apathy; emotional lability; euphoria; hallucination; psychosis. DERMATOLOGIC: Maculopapular rash; rash (eg, blistering, desquamation, mucosal involvement, fever); pruritus; increased sweating; alopecia; eczema; folliculitis; skin exfoliation; urticaria. EENT: Abnormal vision; diplopia; parosmia; taste perversion; tinnitus. GI: Nausea; vomiting; diarrhea; dyspepsia; abdominal pain; flatulence. GU: Renal calculus; hematuria. HEPATIC: Hepatitis. METABOLIC: Increased total cholesterol. RESPIRATORY: Cough; asthma. OTHER: Arthralgia; myalgia; asthenia; fever; hot flashes; malaise; pain; syncope; peripheral edema.

 

 Precautions

Pregnancy: Category C. Lactation: HIV-infected mothers should not breastfeed their infants. Children: Ongoing study. CNS Symptoms: Reported in 53% of patients Hepatitis: Monitor liver enzymes in patients with known or suspected history of hepatitis B or C infection and in patients receiving medication associated with liver toxicity. Monotherapy: Resistant virus may emerge rapidly. Psychiatric symptoms: Serious adverse psychiatric experiences have been reported. Patients with a prior history of psychiatric disorders may be at greater risk. There have been occasional reports of death by suicide, delusions, and psychosis-like behavior. Skin Rash: Reported in 26% of adults and 40% of pediatric patients.

PATIENT CARE CONSIDERATIONS

 

 Administration/Storage

• Store oral capsules at room temperature 25°C (77°F); excursions permitted 15° to 30°C (59° to 86°F).
• Administer with or without food or on an empty stomach.
• Avoid high fat meal, as it may increase absorption.
• Administer at bedtime initially and when CNS symptoms are present to improve tolerance of these symptoms.
• Always give in combination with other antiviral agents.
• Do not administer to nursing women.

 

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies.
• Monitor for signs of hypersensitivity (eg, fever, rash, fatigue, nausea, vomiting, diarrhea, abdominal pain, malaise, lethargy, myalgia, arthralgia, edema, shortness of breath, paresthesia); discontinue use immediately if signs of hypersensitivity are present and notify primary health care provider.
• Monitor for adverse reactions, the most significant of which are CNS symptoms and rash.
• Monitor liver enzymes in patients with hepatitis B or C infections and in patients treated with other medications with known liver toxicity.
• Conduct pregnancy test prior to initial administration of efavirenz.

OVERDOSAGE: SIGNS & SYMPTOMS   Increased CNS symptoms, muscle contractions

 

 Patient/Family Education

• Instruct patient to take efavirenz at the same time each day as prescribed in combination with other antiviral drugs and not to skip doses, which could increase the viral load.
• Patient should not alter the dose or discontinue therapy without consulting primary care provider.
• Inform patient that efavirenz may cause dizziness, impaired concentration, or drowsiness, and to avoid potentially hazardous tasks such as driving or operating machinery if experiencing these symptoms.
• Inform patient that dosing at bedtime improves the tolerability of CNS symptoms.
• Alert patient to the potential for additive CNS effects when efavirenz is used concomitantly with alcohol or psychoactive drugs.
• Instruct patient to avoid otc medications unless prescribed by primary health care provider.
• Caution patient or family that long-term effects and adverse effects are not known. Therefore, report any problems to the primary care provider.
• Warn patient of the potential adverse effects and drug/drug interactions.
• Instruct patient to notify health care provider immediately if signs of rash or rash accompanied by fever, blistering, oral lesions, conjunctivitis, swelling, muscle or joint aches, or general malaise, infection such as a sore throat, fever, cough, and respiratory congestion occur.
• Instruct patient to notify health care provider immediately if symptoms of serious psychiatric adverse experiences occur.
• Inform patient of potential false-positive urine cannabinoid test results.
• Inform patient that efavirenz has not been shown to reduce the risk of passing HIV to others through sexual contact or blood contamination. Encourage abstinence or practicing safe sex and not sharing needles.
• Advise women to use barrier contraception in combination with other methods of contraception (eg, oral or other hormonal contraceptives).
• Caution mothers to discontinue nursing while receiving efavirenz as there is potential for adverse effects from the drug in nursing infants and well as transmission of the HIV virus.
• Caution women to inform health care provider if pregnant, planning to become pregnant, or planning to breastfeed.
• Stress the importance of regular exams and laboratory work.

Drug Dose ::

(EH-fah-VIE-renz)

Sustiva

Capsules

50 mg

Capsules

100 mg

Capsules

200 mg

Class: Antiviral

 

 Action Noncompetitive inhibition of HIV-1 reverse transcriptase.

 

 Indications Treatment of HIV-1 infection in combination with other antiretroviral agents.

 

 Contraindications Concomitant use with cisapride, ergot derivatives, midazolam, or triazolam.

 

 Route/Dosage

Adults: PO 600 mg/day in combination with other antiretroviral agents. Children 10 to less than 15 kg: PO 200 mg/day in combination with other antiretroviral agents. Children 15 to less than 20 kg: PO 250 mg/day in combination with other antiretroviral agents. Children 20 to less than 25 kg: PO 300 mg/day in combination with other antiretroviral agents. Children 25 to less than 32.5 kg: PO 350 mg/day in combination with other antiretroviral agents. Children 32.5 to less than 40 kg: PO 400 mg/day in combination with other antiretroviral agents. Children at least 40 kg: PO 600 mg/day in combination with other antiretroviral agents.

 

 Interactions

Alprazolam, Midazolam, Triazolam: May increase blood levels of these drugs, which may produce extreme sedation and respiratory depression. Do not administer concurrently. Clarithromycin, Indinavir, Saquinavir: Efavirenz may decrease plasma concentrations, which could reduce activity of these agents. Cisapride, Ergot Derivatives: May elevate levels of these drugs, which may increase the risk of arrhythmias, hematologic abnormalities, or other potentially serious adverse effects. Do not coadminister. Ethinyl Estradiol, Nelfinavir, Ritonavir: Efavirenz may increase plasma concentrations, which could increase activity or toxicity of these agents. Rifampin: May decrease plasma levels of efavirenz, which may reduce antiviral activity. Ritonavir: May increase efavirenz plasma level, which could increase side effects. Warfarin: Plasma concentrations may be increased or decreased.

 

 Lab Test Interferences False-positive urine assay screening test for cannabinoid may occur.

 

 Adverse Reactions

CARDIOVASCULAR: Flushing; palpitations; tachycardia; thrombophlebitis. CNS: Dizziness; fatigue; headache; migraines; hypesthesia; impaired concentration; insomnia; abnormal dreams; somnolence; depression; anorexia; nervousness; ataxia; confusion; impaired coordination; neuralgia; paresthesia; peripheral neuropathy; speech disorder; tremor; vertigo; agitation; amnesia; apathy; emotional lability; euphoria; hallucination; psychosis. DERMATOLOGIC: Maculopapular rash; rash (eg, blistering, desquamation, mucosal involvement, fever); pruritus; increased sweating; alopecia; eczema; folliculitis; skin exfoliation; urticaria. EENT: Abnormal vision; diplopia; parosmia; taste perversion; tinnitus. GI: Nausea; vomiting; diarrhea; dyspepsia; abdominal pain; flatulence. GU: Renal calculus; hematuria. HEPATIC: Hepatitis. METABOLIC: Increased total cholesterol. RESPIRATORY: Cough; asthma. OTHER: Arthralgia; myalgia; asthenia; fever; hot flashes; malaise; pain; syncope; peripheral edema.

 

 Precautions

Pregnancy: Category C. Lactation: HIV-infected mothers should not breastfeed their infants. Children: Ongoing study. CNS Symptoms: Reported in 53% of patients Hepatitis: Monitor liver enzymes in patients with known or suspected history of hepatitis B or C infection and in patients receiving medication associated with liver toxicity. Monotherapy: Resistant virus may emerge rapidly. Psychiatric symptoms: Serious adverse psychiatric experiences have been reported. Patients with a prior history of psychiatric disorders may be at greater risk. There have been occasional reports of death by suicide, delusions, and psychosis-like behavior. Skin Rash: Reported in 26% of adults and 40% of pediatric patients.

PATIENT CARE CONSIDERATIONS

 

 Administration/Storage

• Store oral capsules at room temperature 25°C (77°F); excursions permitted 15° to 30°C (59° to 86°F).
• Administer with or without food or on an empty stomach.
• Avoid high fat meal, as it may increase absorption.
• Administer at bedtime initially and when CNS symptoms are present to improve tolerance of these symptoms.
• Always give in combination with other antiviral agents.
• Do not administer to nursing women.

 

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies.
• Monitor for signs of hypersensitivity (eg, fever, rash, fatigue, nausea, vomiting, diarrhea, abdominal pain, malaise, lethargy, myalgia, arthralgia, edema, shortness of breath, paresthesia); discontinue use immediately if signs of hypersensitivity are present and notify primary health care provider.
• Monitor for adverse reactions, the most significant of which are CNS symptoms and rash.
• Monitor liver enzymes in patients with hepatitis B or C infections and in patients treated with other medications with known liver toxicity.
• Conduct pregnancy test prior to initial administration of efavirenz.

OVERDOSAGE: SIGNS & SYMPTOMS   Increased CNS symptoms, muscle contractions

 

 Patient/Family Education

• Instruct patient to take efavirenz at the same time each day as prescribed in combination with other antiviral drugs and not to skip doses, which could increase the viral load.
• Patient should not alter the dose or discontinue therapy without consulting primary care provider.
• Inform patient that efavirenz may cause dizziness, impaired concentration, or drowsiness, and to avoid potentially hazardous tasks such as driving or operating machinery if experiencing these symptoms.
• Inform patient that dosing at bedtime improves the tolerability of CNS symptoms.
• Alert patient to the potential for additive CNS effects when efavirenz is used concomitantly with alcohol or psychoactive drugs.
• Instruct patient to avoid otc medications unless prescribed by primary health care provider.
• Caution patient or family that long-term effects and adverse effects are not known. Therefore, report any problems to the primary care provider.
• Warn patient of the potential adverse effects and drug/drug interactions.
• Instruct patient to notify health care provider immediately if signs of rash or rash accompanied by fever, blistering, oral lesions, conjunctivitis, swelling, muscle or joint aches, or general malaise, infection such as a sore throat, fever, cough, and respiratory congestion occur.
• Instruct patient to notify health care provider immediately if symptoms of serious psychiatric adverse experiences occur.
• Inform patient of potential false-positive urine cannabinoid test results.
• Inform patient that efavirenz has not been shown to reduce the risk of passing HIV to others through sexual contact or blood contamination. Encourage abstinence or practicing safe sex and not sharing needles.
• Advise women to use barrier contraception in combination with other methods of contraception (eg, oral or other hormonal contraceptives).
• Caution mothers to discontinue nursing while receiving efavirenz as there is potential for adverse effects from the drug in nursing infants and well as transmission of the HIV virus.
• Caution women to inform health care provider if pregnant, planning to become pregnant, or planning to breastfeed.
• Stress the importance of regular exams and laboratory work.

Contraindication ::

(EH-fah-VIE-renz)

Sustiva

Capsules

50 mg

Capsules

100 mg

Capsules

200 mg

Class: Antiviral

 

 Action Noncompetitive inhibition of HIV-1 reverse transcriptase.

 

 Indications Treatment of HIV-1 infection in combination with other antiretroviral agents.

 

 Contraindications Concomitant use with cisapride, ergot derivatives, midazolam, or triazolam.

 

 Route/Dosage

Adults: PO 600 mg/day in combination with other antiretroviral agents. Children 10 to less than 15 kg: PO 200 mg/day in combination with other antiretroviral agents. Children 15 to less than 20 kg: PO 250 mg/day in combination with other antiretroviral agents. Children 20 to less than 25 kg: PO 300 mg/day in combination with other antiretroviral agents. Children 25 to less than 32.5 kg: PO 350 mg/day in combination with other antiretroviral agents. Children 32.5 to less than 40 kg: PO 400 mg/day in combination with other antiretroviral agents. Children at least 40 kg: PO 600 mg/day in combination with other antiretroviral agents.

 

 Interactions

Alprazolam, Midazolam, Triazolam: May increase blood levels of these drugs, which may produce extreme sedation and respiratory depression. Do not administer concurrently. Clarithromycin, Indinavir, Saquinavir: Efavirenz may decrease plasma concentrations, which could reduce activity of these agents. Cisapride, Ergot Derivatives: May elevate levels of these drugs, which may increase the risk of arrhythmias, hematologic abnormalities, or other potentially serious adverse effects. Do not coadminister. Ethinyl Estradiol, Nelfinavir, Ritonavir: Efavirenz may increase plasma concentrations, which could increase activity or toxicity of these agents. Rifampin: May decrease plasma levels of efavirenz, which may reduce antiviral activity. Ritonavir: May increase efavirenz plasma level, which could increase side effects. Warfarin: Plasma concentrations may be increased or decreased.

 

 Lab Test Interferences False-positive urine assay screening test for cannabinoid may occur.

 

 Adverse Reactions

CARDIOVASCULAR: Flushing; palpitations; tachycardia; thrombophlebitis. CNS: Dizziness; fatigue; headache; migraines; hypesthesia; impaired concentration; insomnia; abnormal dreams; somnolence; depression; anorexia; nervousness; ataxia; confusion; impaired coordination; neuralgia; paresthesia; peripheral neuropathy; speech disorder; tremor; vertigo; agitation; amnesia; apathy; emotional lability; euphoria; hallucination; psychosis. DERMATOLOGIC: Maculopapular rash; rash (eg, blistering, desquamation, mucosal involvement, fever); pruritus; increased sweating; alopecia; eczema; folliculitis; skin exfoliation; urticaria. EENT: Abnormal vision; diplopia; parosmia; taste perversion; tinnitus. GI: Nausea; vomiting; diarrhea; dyspepsia; abdominal pain; flatulence. GU: Renal calculus; hematuria. HEPATIC: Hepatitis. METABOLIC: Increased total cholesterol. RESPIRATORY: Cough; asthma. OTHER: Arthralgia; myalgia; asthenia; fever; hot flashes; malaise; pain; syncope; peripheral edema.

 

 Precautions

Pregnancy: Category C. Lactation: HIV-infected mothers should not breastfeed their infants. Children: Ongoing study. CNS Symptoms: Reported in 53% of patients Hepatitis: Monitor liver enzymes in patients with known or suspected history of hepatitis B or C infection and in patients receiving medication associated with liver toxicity. Monotherapy: Resistant virus may emerge rapidly. Psychiatric symptoms: Serious adverse psychiatric experiences have been reported. Patients with a prior history of psychiatric disorders may be at greater risk. There have been occasional reports of death by suicide, delusions, and psychosis-like behavior. Skin Rash: Reported in 26% of adults and 40% of pediatric patients.

PATIENT CARE CONSIDERATIONS

 

 Administration/Storage

• Store oral capsules at room temperature 25°C (77°F); excursions permitted 15° to 30°C (59° to 86°F).
• Administer with or without food or on an empty stomach.
• Avoid high fat meal, as it may increase absorption.
• Administer at bedtime initially and when CNS symptoms are present to improve tolerance of these symptoms.
• Always give in combination with other antiviral agents.
• Do not administer to nursing women.

 

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies.
• Monitor for signs of hypersensitivity (eg, fever, rash, fatigue, nausea, vomiting, diarrhea, abdominal pain, malaise, lethargy, myalgia, arthralgia, edema, shortness of breath, paresthesia); discontinue use immediately if signs of hypersensitivity are present and notify primary health care provider.
• Monitor for adverse reactions, the most significant of which are CNS symptoms and rash.
• Monitor liver enzymes in patients with hepatitis B or C infections and in patients treated with other medications with known liver toxicity.
• Conduct pregnancy test prior to initial administration of efavirenz.

OVERDOSAGE: SIGNS & SYMPTOMS   Increased CNS symptoms, muscle contractions

 

 Patient/Family Education

• Instruct patient to take efavirenz at the same time each day as prescribed in combination with other antiviral drugs and not to skip doses, which could increase the viral load.
• Patient should not alter the dose or discontinue therapy without consulting primary care provider.
• Inform patient that efavirenz may cause dizziness, impaired concentration, or drowsiness, and to avoid potentially hazardous tasks such as driving or operating machinery if experiencing these symptoms.
• Inform patient that dosing at bedtime improves the tolerability of CNS symptoms.
• Alert patient to the potential for additive CNS effects when efavirenz is used concomitantly with alcohol or psychoactive drugs.
• Instruct patient to avoid otc medications unless prescribed by primary health care provider.
• Caution patient or family that long-term effects and adverse effects are not known. Therefore, report any problems to the primary care provider.
• Warn patient of the potential adverse effects and drug/drug interactions.
• Instruct patient to notify health care provider immediately if signs of rash or rash accompanied by fever, blistering, oral lesions, conjunctivitis, swelling, muscle or joint aches, or general malaise, infection such as a sore throat, fever, cough, and respiratory congestion occur.
• Instruct patient to notify health care provider immediately if symptoms of serious psychiatric adverse experiences occur.
• Inform patient of potential false-positive urine cannabinoid test results.
• Inform patient that efavirenz has not been shown to reduce the risk of passing HIV to others through sexual contact or blood contamination. Encourage abstinence or practicing safe sex and not sharing needles.
• Advise women to use barrier contraception in combination with other methods of contraception (eg, oral or other hormonal contraceptives).
• Caution mothers to discontinue nursing while receiving efavirenz as there is potential for adverse effects from the drug in nursing infants and well as transmission of the HIV virus.
• Caution women to inform health care provider if pregnant, planning to become pregnant, or planning to breastfeed.
• Stress the importance of regular exams and laboratory work.

Drug Precautions ::

(EH-fah-VIE-renz)

Sustiva

Capsules

50 mg

Capsules

100 mg

Capsules

200 mg

Class: Antiviral

 

 Action Noncompetitive inhibition of HIV-1 reverse transcriptase.

 

 Indications Treatment of HIV-1 infection in combination with other antiretroviral agents.

 

 Contraindications Concomitant use with cisapride, ergot derivatives, midazolam, or triazolam.

 

 Route/Dosage

Adults: PO 600 mg/day in combination with other antiretroviral agents. Children 10 to less than 15 kg: PO 200 mg/day in combination with other antiretroviral agents. Children 15 to less than 20 kg: PO 250 mg/day in combination with other antiretroviral agents. Children 20 to less than 25 kg: PO 300 mg/day in combination with other antiretroviral agents. Children 25 to less than 32.5 kg: PO 350 mg/day in combination with other antiretroviral agents. Children 32.5 to less than 40 kg: PO 400 mg/day in combination with other antiretroviral agents. Children at least 40 kg: PO 600 mg/day in combination with other antiretroviral agents.

 

 Interactions

Alprazolam, Midazolam, Triazolam: May increase blood levels of these drugs, which may produce extreme sedation and respiratory depression. Do not administer concurrently. Clarithromycin, Indinavir, Saquinavir: Efavirenz may decrease plasma concentrations, which could reduce activity of these agents. Cisapride, Ergot Derivatives: May elevate levels of these drugs, which may increase the risk of arrhythmias, hematologic abnormalities, or other potentially serious adverse effects. Do not coadminister. Ethinyl Estradiol, Nelfinavir, Ritonavir: Efavirenz may increase plasma concentrations, which could increase activity or toxicity of these agents. Rifampin: May decrease plasma levels of efavirenz, which may reduce antiviral activity. Ritonavir: May increase efavirenz plasma level, which could increase side effects. Warfarin: Plasma concentrations may be increased or decreased.

 

 Lab Test Interferences False-positive urine assay screening test for cannabinoid may occur.

 

 Adverse Reactions

CARDIOVASCULAR: Flushing; palpitations; tachycardia; thrombophlebitis. CNS: Dizziness; fatigue; headache; migraines; hypesthesia; impaired concentration; insomnia; abnormal dreams; somnolence; depression; anorexia; nervousness; ataxia; confusion; impaired coordination; neuralgia; paresthesia; peripheral neuropathy; speech disorder; tremor; vertigo; agitation; amnesia; apathy; emotional lability; euphoria; hallucination; psychosis. DERMATOLOGIC: Maculopapular rash; rash (eg, blistering, desquamation, mucosal involvement, fever); pruritus; increased sweating; alopecia; eczema; folliculitis; skin exfoliation; urticaria. EENT: Abnormal vision; diplopia; parosmia; taste perversion; tinnitus. GI: Nausea; vomiting; diarrhea; dyspepsia; abdominal pain; flatulence. GU: Renal calculus; hematuria. HEPATIC: Hepatitis. METABOLIC: Increased total cholesterol. RESPIRATORY: Cough; asthma. OTHER: Arthralgia; myalgia; asthenia; fever; hot flashes; malaise; pain; syncope; peripheral edema.

 

 Precautions

Pregnancy: Category C. Lactation: HIV-infected mothers should not breastfeed their infants. Children: Ongoing study. CNS Symptoms: Reported in 53% of patients Hepatitis: Monitor liver enzymes in patients with known or suspected history of hepatitis B or C infection and in patients receiving medication associated with liver toxicity. Monotherapy: Resistant virus may emerge rapidly. Psychiatric symptoms: Serious adverse psychiatric experiences have been reported. Patients with a prior history of psychiatric disorders may be at greater risk. There have been occasional reports of death by suicide, delusions, and psychosis-like behavior. Skin Rash: Reported in 26% of adults and 40% of pediatric patients.

PATIENT CARE CONSIDERATIONS

 

 Administration/Storage

• Store oral capsules at room temperature 25°C (77°F); excursions permitted 15° to 30°C (59° to 86°F).
• Administer with or without food or on an empty stomach.
• Avoid high fat meal, as it may increase absorption.
• Administer at bedtime initially and when CNS symptoms are present to improve tolerance of these symptoms.
• Always give in combination with other antiviral agents.
• Do not administer to nursing women.

 

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies.
• Monitor for signs of hypersensitivity (eg, fever, rash, fatigue, nausea, vomiting, diarrhea, abdominal pain, malaise, lethargy, myalgia, arthralgia, edema, shortness of breath, paresthesia); discontinue use immediately if signs of hypersensitivity are present and notify primary health care provider.
• Monitor for adverse reactions, the most significant of which are CNS symptoms and rash.
• Monitor liver enzymes in patients with hepatitis B or C infections and in patients treated with other medications with known liver toxicity.
• Conduct pregnancy test prior to initial administration of efavirenz.

OVERDOSAGE: SIGNS & SYMPTOMS   Increased CNS symptoms, muscle contractions

 

 Patient/Family Education

• Instruct patient to take efavirenz at the same time each day as prescribed in combination with other antiviral drugs and not to skip doses, which could increase the viral load.
• Patient should not alter the dose or discontinue therapy without consulting primary care provider.
• Inform patient that efavirenz may cause dizziness, impaired concentration, or drowsiness, and to avoid potentially hazardous tasks such as driving or operating machinery if experiencing these symptoms.
• Inform patient that dosing at bedtime improves the tolerability of CNS symptoms.
• Alert patient to the potential for additive CNS effects when efavirenz is used concomitantly with alcohol or psychoactive drugs.
• Instruct patient to avoid otc medications unless prescribed by primary health care provider.
• Caution patient or family that long-term effects and adverse effects are not known. Therefore, report any problems to the primary care provider.
• Warn patient of the potential adverse effects and drug/drug interactions.
• Instruct patient to notify health care provider immediately if signs of rash or rash accompanied by fever, blistering, oral lesions, conjunctivitis, swelling, muscle or joint aches, or general malaise, infection such as a sore throat, fever, cough, and respiratory congestion occur.
• Instruct patient to notify health care provider immediately if symptoms of serious psychiatric adverse experiences occur.
• Inform patient of potential false-positive urine cannabinoid test results.
• Inform patient that efavirenz has not been shown to reduce the risk of passing HIV to others through sexual contact or blood contamination. Encourage abstinence or practicing safe sex and not sharing needles.
• Advise women to use barrier contraception in combination with other methods of contraception (eg, oral or other hormonal contraceptives).
• Caution mothers to discontinue nursing while receiving efavirenz as there is potential for adverse effects from the drug in nursing infants and well as transmission of the HIV virus.
• Caution women to inform health care provider if pregnant, planning to become pregnant, or planning to breastfeed.
• Stress the importance of regular exams and laboratory work.

Drug Side Effects ::

(EH-fah-VIE-renz)

Sustiva

Capsules

50 mg

Capsules

100 mg

Capsules

200 mg

Class: Antiviral

 

 Action Noncompetitive inhibition of HIV-1 reverse transcriptase.

 

 Indications Treatment of HIV-1 infection in combination with other antiretroviral agents.

 

 Contraindications Concomitant use with cisapride, ergot derivatives, midazolam, or triazolam.

 

 Route/Dosage

Adults: PO 600 mg/day in combination with other antiretroviral agents. Children 10 to less than 15 kg: PO 200 mg/day in combination with other antiretroviral agents. Children 15 to less than 20 kg: PO 250 mg/day in combination with other antiretroviral agents. Children 20 to less than 25 kg: PO 300 mg/day in combination with other antiretroviral agents. Children 25 to less than 32.5 kg: PO 350 mg/day in combination with other antiretroviral agents. Children 32.5 to less than 40 kg: PO 400 mg/day in combination with other antiretroviral agents. Children at least 40 kg: PO 600 mg/day in combination with other antiretroviral agents.

 

 Interactions

Alprazolam, Midazolam, Triazolam: May increase blood levels of these drugs, which may produce extreme sedation and respiratory depression. Do not administer concurrently. Clarithromycin, Indinavir, Saquinavir: Efavirenz may decrease plasma concentrations, which could reduce activity of these agents. Cisapride, Ergot Derivatives: May elevate levels of these drugs, which may increase the risk of arrhythmias, hematologic abnormalities, or other potentially serious adverse effects. Do not coadminister. Ethinyl Estradiol, Nelfinavir, Ritonavir: Efavirenz may increase plasma concentrations, which could increase activity or toxicity of these agents. Rifampin: May decrease plasma levels of efavirenz, which may reduce antiviral activity. Ritonavir: May increase efavirenz plasma level, which could increase side effects. Warfarin: Plasma concentrations may be increased or decreased.

 

 Lab Test Interferences False-positive urine assay screening test for cannabinoid may occur.

 

 Adverse Reactions

CARDIOVASCULAR: Flushing; palpitations; tachycardia; thrombophlebitis. CNS: Dizziness; fatigue; headache; migraines; hypesthesia; impaired concentration; insomnia; abnormal dreams; somnolence; depression; anorexia; nervousness; ataxia; confusion; impaired coordination; neuralgia; paresthesia; peripheral neuropathy; speech disorder; tremor; vertigo; agitation; amnesia; apathy; emotional lability; euphoria; hallucination; psychosis. DERMATOLOGIC: Maculopapular rash; rash (eg, blistering, desquamation, mucosal involvement, fever); pruritus; increased sweating; alopecia; eczema; folliculitis; skin exfoliation; urticaria. EENT: Abnormal vision; diplopia; parosmia; taste perversion; tinnitus. GI: Nausea; vomiting; diarrhea; dyspepsia; abdominal pain; flatulence. GU: Renal calculus; hematuria. HEPATIC: Hepatitis. METABOLIC: Increased total cholesterol. RESPIRATORY: Cough; asthma. OTHER: Arthralgia; myalgia; asthenia; fever; hot flashes; malaise; pain; syncope; peripheral edema.

 

 Precautions

Pregnancy: Category C. Lactation: HIV-infected mothers should not breastfeed their infants. Children: Ongoing study. CNS Symptoms: Reported in 53% of patients Hepatitis: Monitor liver enzymes in patients with known or suspected history of hepatitis B or C infection and in patients receiving medication associated with liver toxicity. Monotherapy: Resistant virus may emerge rapidly. Psychiatric symptoms: Serious adverse psychiatric experiences have been reported. Patients with a prior history of psychiatric disorders may be at greater risk. There have been occasional reports of death by suicide, delusions, and psychosis-like behavior. Skin Rash: Reported in 26% of adults and 40% of pediatric patients.

PATIENT CARE CONSIDERATIONS

 

 Administration/Storage

• Store oral capsules at room temperature 25°C (77°F); excursions permitted 15° to 30°C (59° to 86°F).
• Administer with or without food or on an empty stomach.
• Avoid high fat meal, as it may increase absorption.
• Administer at bedtime initially and when CNS symptoms are present to improve tolerance of these symptoms.
• Always give in combination with other antiviral agents.
• Do not administer to nursing women.

 

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies.
• Monitor for signs of hypersensitivity (eg, fever, rash, fatigue, nausea, vomiting, diarrhea, abdominal pain, malaise, lethargy, myalgia, arthralgia, edema, shortness of breath, paresthesia); discontinue use immediately if signs of hypersensitivity are present and notify primary health care provider.
• Monitor for adverse reactions, the most significant of which are CNS symptoms and rash.
• Monitor liver enzymes in patients with hepatitis B or C infections and in patients treated with other medications with known liver toxicity.
• Conduct pregnancy test prior to initial administration of efavirenz.

OVERDOSAGE: SIGNS & SYMPTOMS   Increased CNS symptoms, muscle contractions

 

 Patient/Family Education

• Instruct patient to take efavirenz at the same time each day as prescribed in combination with other antiviral drugs and not to skip doses, which could increase the viral load.
• Patient should not alter the dose or discontinue therapy without consulting primary care provider.
• Inform patient that efavirenz may cause dizziness, impaired concentration, or drowsiness, and to avoid potentially hazardous tasks such as driving or operating machinery if experiencing these symptoms.
• Inform patient that dosing at bedtime improves the tolerability of CNS symptoms.
• Alert patient to the potential for additive CNS effects when efavirenz is used concomitantly with alcohol or psychoactive drugs.
• Instruct patient to avoid otc medications unless prescribed by primary health care provider.
• Caution patient or family that long-term effects and adverse effects are not known. Therefore, report any problems to the primary care provider.
• Warn patient of the potential adverse effects and drug/drug interactions.
• Instruct patient to notify health care provider immediately if signs of rash or rash accompanied by fever, blistering, oral lesions, conjunctivitis, swelling, muscle or joint aches, or general malaise, infection such as a sore throat, fever, cough, and respiratory congestion occur.
• Instruct patient to notify health care provider immediately if symptoms of serious psychiatric adverse experiences occur.
• Inform patient of potential false-positive urine cannabinoid test results.
• Inform patient that efavirenz has not been shown to reduce the risk of passing HIV to others through sexual contact or blood contamination. Encourage abstinence or practicing safe sex and not sharing needles.
• Advise women to use barrier contraception in combination with other methods of contraception (eg, oral or other hormonal contraceptives).
• Caution mothers to discontinue nursing while receiving efavirenz as there is potential for adverse effects from the drug in nursing infants and well as transmission of the HIV virus.
• Caution women to inform health care provider if pregnant, planning to become pregnant, or planning to breastfeed.
• Stress the importance of regular exams and laboratory work.

Drug Mode of Action ::  

(EH-fah-VIE-renz)

Sustiva

Capsules

50 mg

Capsules

100 mg

Capsules

200 mg

Class: Antiviral

 

 Action Noncompetitive inhibition of HIV-1 reverse transcriptase.