Drug Glossary

Antiretroviral Therapy Pneumocystis Prophylaxis Mycobacterium avium Complex (MAC) Infection and Tuberculosis (TB): Treatment and Prophylaxis *** Toxoplasmosis: Treatment and Prophylaxis + Cytomegalovirus (CMV) Infection: Treatment and Prophylaxis Herpes Simplex Virus (HSV) and Varicella-Zoster Virus (VZV) Infections: Treatment and Prophylaxis ++ Fungal Infections: Treatment and Prophylaxis Miscellaneous Therapeutic Agents

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Antiretroviral Therapy

Nucleoside Reverse Transcriptase Inhibitors (NRTIs)*

• Abacavir (ABC, Ziagen)



• Indications: Treatment of HIV infection in combination with other agents.
  
  

• Contraindications: Known or suspected hypersensitivity.

• Dosage: 300 mg po bid. Also available as Trizivir, a fixed dose combination of ZDV 300 mg, 3TC 150 mg, and abacavir 300 mg.

• Toxicity: Four percent of patients develop a hypersensitivity reaction, usually within 6 weeks of initiating therapy. It is manifested by fever, constitutional or respiratory symptoms, gastrointestinal intolerance, and/or rash. Stopping the drug leads to rapid resolution of symptoms. Never rechallenge a patient thought to have had a hypersensitivity reaction to abacavir as severe reactions and death have been reported.

  Other side effects include nausea, vomiting, diarrhea, headache, malaise.

  Pregnancy category C.
  




• Didanosine (ddI, Videx)



• Indications: Treatment of HIV infection in combination with other agents.
  
  

• Contraindications: Known hypersensitivity, history of pancreatitis or significant peripheral neuropathy.

• Dosage: Enteric-coated formulation (Videx EC) has been approved by the FDA for once daily dosing and can be given without regard to meals. Dose is 400 mg po qd for weight > 60 kg and 250 mg po qd for weight < 60 kg.

  Also available in tablets and buffered powder. Tablets: > 60 kg --> 400 mg po qd or 200 mg po bid; < 60 kg --> 250 mg po qd or 125 mg po bid. Tablets must be chewed or dissolved in water. Buffered Powder: > 60 kg --> 250 mg po bid ;< 60 kg --> 167 mg po bid.

  All formulations must be taken on an empty stomach (> 30 minutes before a meal or > 2 hours after a meal).
  Coadministration of hydroxyurea 500 mg po bid may enhance the effectiveness of ddI by increasing intracellular level of drug.

• Toxicity: Peripheral neuropathy, acute pancreatitis, gastrointestinal intolerance, abnormal liver function tests.

  Pregnancy category B.
  




• Lamivudine (3TC, Epivir)



• Indications: Treatment of HIV infection in combination with other agents. Also has activity against hepatitis B virus.
  
  

• Contraindications: Known hypersensitivity.

• Dosage: 150 mg po bid. Also available as Combivir, a fixed dose combination of ZDV 300 mg with 3TC 150 mg; and Trizivir, a fixed dose combination of ZDV 300 mg, 3TC 150 mg, and abacavir 300 mg.

• Toxicity: Uncommon. Headache, gastrointestinal intolerance, and insomnia have been reported.

  Pregnancy category C.
  




• Stavudine (d4T, Zerit)



• Indications: Treatment of HIV infection in combination with other agents.
  
  

• Contraindications: Known hypersensitivity, concurrent ZDV use because of pharmacologic antagonism.

• Dosage: Based on weight: > 60 kg --> 40 mg po bid; < 60 kg --> 30 mg po bid. Dose adjustment for peripheral neuropathy: 20 mg po bid.

• Toxicity: Peripheral neuropathy, acute pancreatitis, abnormal liver function tests.
  
  Pregnancy category C.
  




• Tenofovir
  
  
  • Indications: Treatment of HIV infection in combination with other agents. Tenofovir is a nucleotide agent.
    
    
  • Contraindications: Known hypersensitivity.
    
    
  • Dosage: 300 mg po qd.
    
    
  • Toxicity: Gastrointestinal intolerance.
    
    Pregnancy category B.
    
    
    
• Zalcitabine (ddC, HIVID)
  
  
  • Treatment of HIV infection in combination with other agents.
    
    

  • Contraindications: Known hypersensitivity, significant peripheral neuropathy.

  • Dosage: 0.75 mg po tid.

  • Toxicity: Peripheral neuropathy, aphthous ulcers of mouth and esophagus, acute pancreatitis, abnormal liver function tests.
    
    Pregnancy category C.
    

    
    
    
• Zidovudine (ZDV, AZT, Retrovir)



• Indications: Treatment of HIV infection in combination with other agents. In addition, ZDV may have specific benefits for patients who have HIV-related thrombocytopenia or encephalopathy.

  Prevention of perinatal transmission when given prenatally and during delivery to HIV-infected mother and to infant postpartum.

• Contraindications: Known hypersensitivity.

• Dosage: Treatment of HIV infection in adults: 300 mg po bid. Also available as Combivir, a fixed dose combination of ZDV 300 mg with 3TC 150 mg; and Trizivir, a fixed dose combination of ZDV 300 mg, 3TC 150 mg, and abacavir 300 mg.

  Prevention of perinatal transmission: Pregnancy weeks 14-34 --> 100 mg po 5 times a day; during labor --> 2 mg/kg IV loading dose over 30 minutes to 1 hour, then 1 mg/kg/hr IV through delivery; and infant --> 2 mg/kg syrup q6h for 6 weeks.

• Toxicity: Gastrointestinal intolerance, headache, anemia, leukopenia, myopathy, abnormal liver function tests, macrocytosis, fingernail discoloration.

  Recommended for pregnant women after the first trimester to prevent vertical transmission.
  






Non-nucleoside Reverse Transcriptase Inhibitors (NNRTIs)



• Delavirdine (Rescriptor)



• Indications: Treatment of HIV infection in combination with other agents.
  
  

• Contraindications: Known hypersensitivity.

• Dosage: 400 mg po tid. Two tablets must be dissolved in 3 or more ounces of water to produce a slurry. Antacids and ddI should not be taken one hour before or after the dose. There are many potential drug interactions, some of which require dosage modification; see Physicians Desk Reference or package insert for more information.

• Toxicity: Rash is common and does not require discontinuation of the drug unless accompanied by fever, mucous membrane involvement, or other systemic manifestations. Stevens-Johnson syndrome has been reported infrequently.

  Pregnancy category C.
  




• Efavirenz (Sustiva)



• Indications: Treatment of HIV infection in combination with other agents.
  
  

• Contraindications: Known hypersensitivity.

• Dosage: 600 mg po qhs. Avoid taking with high fat meals. There are many potential drug interactions, some of which require dosage modification; see Physicians Desk Reference or package insert for more information.

• Toxicity: Rash is common and does not require discontinuation of the drug unless accompanied by fever, mucous membrane involvement, or other systemic manifestations. Other side effects include vivid dreams and nightmares, neurocognitive dysfunction, hyperlipidemia, abnormal liver function tests.

  Pregnancy category C; teratogenic in non-human primates. Women taking efavirenz should use two forms of contraception.
  




• Nevirapine (Viramune)



• Indications: Treatment of HIV infection in combination with other agents.
  
  

• Contraindications: Known hypersensitivity.

• Dosage: 200 mg po qd x two weeks; 200 mg po bid thereafter. Patients who develop rash during the first two weeks should not increase the dose until the rash resolves. There are many potential drug interactions, some of which require dosage modification; see Physicians Desk Reference or package insert for more information.

• Toxicity: Rash is common (about 17% of patients, although fewer with dose escalation regimen) and does not require discontinuation of the drug unless accompanied by fever, mucous membrane involvement, or other systemic manifestations. Stevens-Johnson syndrome has been reported infrequently. Other side effects include nausea, headache, abnormal liver function tests.

  Pregnancy category C.
  






Protease Inhibitors (PIs)**



• Amprenavir (Agenerase)
  
  
  • Indications: Treatment of HIV infection in combination with other agents.
    
    
  • Contraindications: Known hypersensitivity.
    
    
  • Dosage: 1200 mg po bid. There are many potential drug interactions, some of which require dosage modification; see Physicians Desk Reference or package insert for more information.
    
    
  • Toxicity: Nausea, diarrhea, rash, headache, oral paresthesias.
    
    Pregnancy category C.
    
    
    
• Indinavir (Crixivan)
  
  
  • Indications: Treatment of HIV infection in combination with other agents.
    
    

  • Contraindications: Known hypersensitivity.

  • Dosage: 800 mg po q8h on an empty stomach or with a non-fat meal. Patients should drink at least 48 ounces of fluid a day. Of note, bid dosing has decreased efficacy and should be avoided. When coadministered with ritonavir (100-200 mg po bid) as pharmacologic booster, dose is 800 mg po bid without food restrictions. There are many potential drug interactions, some of which require dosage modification; see Physicians Desk Reference or package insert for more information.

  • Toxicity: Nephrolithiasis, gastrointestinal intolerance, hyperbilirubinemia.

    Pregnancy category C.
    

  
  
  
• Lopinavir/Ritonavir (Kaletra)
  
  
  • Indications: Treatment of HIV infection in combination with other agents.
    
    Lopinavir is a new protease inhibitor combined with ritonavir, which significantly augments its blood level.
    
    
  • Contraindications: Known hypersensitivity, concurrent use of ritonavir.
    
    
  • Dosage: Three (133 mg lopinavir/33 mg ritonavir) po bid. . There are many potential drug interactions, some of which require dosage modification; see Physicians Desk Reference or package insert for more information.
    
    
  • Toxicity: Diarrhea, nausea, weakness, headache.
    
    Pregnancy category C.
    
    
    
• Nelfinavir (Viracept)
  
  
  • Indications: Treatment of HIV infection in combination with other agents.
    
    

  • Contraindications: Known hypersensitivity.

  • Dosage: 1250 mg po bid or 750 mg po tid with food. There are many potential drug interactions, some of which require dosage modification; see Physicians Desk Reference or package insert for more information.

  • Toxicity: Diarrhea.

    Pregnancy category B.
    

  
  
  
• Ritonavir (Norvir)



• Indications: Treatment of HIV infection in combination with other agents.
  
  
• Contraindications: Known hypersensitivity.
  
  

• Dosage: 600 mg po q12h with food following two week dose escalation regimen (day 1 and 2: 300 mg po bid; days 3-5: 400 mg po bid; days 6-13: 500 mg po bid). When coadministered as pharmacologic booster with other protease inhibitors, dosage is reduced. There are many potential drug interactions, some of which require dosage modification; see Physicians Desk Reference or package insert for more information.

• Toxicity: Gastrointestinal intolerance, circumoral paresthesias, abnormal liver function tests.

  Pregnancy category B.
  




• Saquinavir (Invirase, Fortovase)



• Indications: Treatment of HIV infection in combination with other agents. Fortovase (soft gel cap formulation) is preferred to Invirase (hard gel cap) because of its enhanced absorption and bioavailability.
  
  

• Contraindications: Known hypersensitivity.

• Dosage: 1200 mg po tid with food. When coadministered with ritonavir (400 mg po bid) as pharmacologic booster, dose is 400 mg po bid. There are many potential drug interactions, some of which require dosage modification; see Physicians Desk Reference or package insert for more information.

• Toxicity: Gastrointestinal intolerance, abnormal liver function tests.

  Pregnancy category B.
  






Pneumocystis carinii Pneumonia (PCP): Treatment and Prophylaxis



• Atovaquone (Mepron)



• Indications: Treatment (mild to moderate infection) and prophylaxis of PCP in patients unable to tolerate TMP-SMX or dapsone.
  
  

• Contraindications: Known hypersensitivity.

• Dosage: 750 mg of suspension po bid with food x three weeks for treatment. Same total daily dose for prophylaxis.

• Toxicity: Gastrointestinal intolerance, rash, headache, fever.

  Pregnancy category C.
  




• Clindamycin/Primaquine
  
  
  • Indications: Treatment of PCP in patients unable to tolerate TMP-SMX.
    
    
  • Contraindications: Known hypersensitivity; glucose 6-phosphate dehydrogenase (G6PD) deficiency is contraindication to primaquine use.
    
    
  • Dosage: Clindamycin 600 mg IV q6-8h (or 300-450 mg po qid) and primaquine 15 mg base po qd x three weeks.
    
    
  • Toxicity: Clindamycin: diarrhea, nausea, rash. Primaquine: nausea, dyspepsia, hemolytic anemia (G6PD deficiency).
    
    Pregnancy categories B (clindamycin) and C (primaquine).
    
    
    
• Dapsone
  
  
• Indications: Treatment of PCP (mild to moderate infection) in combination with trimethoprim; prophylaxis of PCP in patients unable to tolerate TMP-SMX; primary prophylaxis of toxoplasmosis in combination with pyrimethamine.
  
  

• Contraindications: Known hypersensitivity, G6PD deficiency.
  

• Dosage: PCP treatment: dapsone 100 mg qd and trimethoprim 15 mg/kg/day x three weeks.

  PCP prophylaxis: 100 mg po qd; toxoplasmosis prophylaxis: add pyrimethamine 50 mg weekly with folinic acid 25 mg.

• Toxicity: Rash, fever, gastrointestinal intolerance, neutropenia, methemoglobinemia.

  Pregnancy category C.
  




• Pentamidine, Aerosol (Nebupent)



• Indications: Treatment and prophylaxis of PCP in patients unable to tolerate TMP-SMX or dapsone.
  
  

• Contraindications: Known hypersensitivity; severe asthma or bronchospasm, active pulmonary tuberculosis (aerosol preparation).

• Dosage: Treatment: intravenous 3-4 mg/kg qd for up to three weeks.

  Prophylaxis: aerosol 300 mg via Respirgard II nebulizer once a month.

• Toxicity: Aerosol: bronchospasm, particularly in patients with history of asthma or chronic obstructive pulmonary disease; pharyngeal irritation; metallic taste. Intravenous: hypotension, nephrotoxicity, hypoglycemia, hyperglycemia, leukopenia, thrombocytopenia, hypokalemia, hypocalcemia.

  Pregnancy category C.
  




• Trimethoprim-sulfamethoxazole (TMP-SMX, Bactrim, Septra)



• Indications: Treatment and prophylaxis of PCP; primary prophylaxis of toxoplasmosis.
  
  
• Contraindications: Known hypersensitivity to trimethoprim or sulfonamides, megaloblastic anemia.
  
  

• Dosage: Treatment of PCP: 5 mg/kg po/IV q8h of trimethoprim component (equivalent to 2 tabs po tid of DS for 65 kg patient) x three weeks.

  Prophylaxis of PCP: one DS or SS tablet po qd. Prophylaxis of toxoplasmosis: one DS tablet po qd.

• Toxicity: Side effects are common in HIV-infected patients and include gastrointestinal intolerance; rash, urticaria, photosensitivity, Stevens-Johnson syndrome; fever; leukopenia, thrombocytopenia, hemolytic anemia; abnormal liver function tests; renal dysfunction, interstitial nephritis; aseptic meningitis.

  Patients with history of mild to moderate drug toxicity should be given retrial of TMP-SMX or desensitized using an established protocol.

  Pregnancy category C; avoid use at term because of risk of kernicterus in newborn.
  






Mycobacterium avium Complex (MAC) Infection and Tuberculosis (TB): Treatment and Prophylaxis ***



• Amikacin (Amikin)



• Indications: Treatment of MAC infection in combination with other agents.
  
  

• Contraindications: Known hypersensitivity to aminoglycoside antibiotics.

• Dosage: 7.5 -15 mg/kg/day IV for first four weeks of MAC therapy.

• Toxicity: Ototoxicity, especially with larger total dose and longer duration (more auditory than vestibular and usually irreversible); nephrotoxicity.

  Pregnancy category D.
  




• Azithromycin (Zithromax)



• Indications: Treatment of MAC infection in combination with other agents; prophylaxis of MAC infection.
  
  
• Contraindications: Known hypersensitivity to macrolide antibiotics.
  
  

• Dosage: MAC treatment: 600 mg po qd; prophylaxis: 1200 mg po weekly.

• Toxicity: Gastrointestinal intolerance.

  Pregnancy category B.
  




• Ciprofloxacin (Cipro)



• Indications: Treatment of MAC infection in combination with other agents; treatment of TB in combination with other agents.
  
  

• Contraindications: Known hypersensitivity.
  

• Dosage: 500-750 mg po bid.
  
  

• Toxicity: Gastrointestinal intolerance, central nervous system dysfunction, rash.

  Pregnancy category C.
  




• Clarithromycin (Biaxin)



• Indications: Treatment of MAC infection in combination with other agents; prophylaxis of MAC infection.
  
  

• Contraindications: Known hypersensitivity to macrolide antibiotics.
  

• Dosage: MAC treatment and prophylaxis: 500 mg po bid.

• Toxicity: Gastrointestinal intolerance, abnormal liver function tests.

  Pregnancy category C; teratogenic in animals.
  




• Ethambutol (Myambutol)



• Indications: Treatment of MAC infection in combination with other agents; treatment of TB in combination with other agents.
  
  
• Contraindications: Known hypersensitivity, history of optic neuritis.
  
  

• Dosage: 25 mg/kg/day po for one to two months, followed by 15 mg/kg/day.

• Toxicity: Optic neuritis, rash, gastrointestinal intolerance, hepatotoxicity.

  Pregnancy category C; teratogenic in animals.
  




• Isoniazid (INH)



• Indications: Treatment of TB in combination with other agents; prophylaxis of TB in context of positive PPD.
  
  
• Contraindications: Known hypersensitivity, significant hepatic disease.
  
  
• Dosage: Treatment: 300 mg po qd (or 900 mg twice a week [DOT]); prophylaxis: 300 mg po qd for nine months. Pyridoxine should be given concurrently for prevention of peripheral neuropathy.
  
  

• Toxicity: Hepatotoxicity, especially in alcoholics and persons older than 50; peripheral neuropathy; fever; rash.

  Pregnancy category C.
  




• Pyrazinamide (PZA)



• Indications: Treatment of TB in combination with other agents.
  
  

• Contraindications: Known hypersensitivity, significant hepatic disease.

• Dosage: 25 mg/kg po qd.

• Toxicity: Abnormal liver function tests, hyperuricemia, rash.

  Pregnancy category C.
  




• Rifabutin (Mycobutin)



• Indications: Treatment of MAC infection in combination with other agents; treatment of TB in combination with other agents; prophylaxis of MAC infection in patients unable to tolerate clarithromycin or azithromycin.
  
  
• Contraindications: Known hypersensitivity.
  
  

• Dosage: Treatment and prophylaxis: 300 mg po qd (or 600 mg 2-3 times a week [DOT]). There are many potential drug interactions, some of which require dosage modification; see Physicians Desk Reference or package insert for more information.

• Toxicity: Orange discoloration of body secretions, gastrointestinal intolerance, abnormal liver function tests. Acute uveitis has been reported when used in association with clarithromycin.

  Pregnancy category C.
  




• Rifampin



• Indications: Treatment of TB in combination with other agents.
  
  

• Contraindications: Known hypersensitivity.

• Dosage: 600 mg po qd. There are many potential drug interactions, some of which require dosage modification; see Physicians Desk Reference or package insert for more information.

• Toxicity: Orange discoloration of body secretions, gastrointestinal intolerance, abnormal liver function tests, rash.
  
  Pregnancy category C.
  




• Streptomycin



• Indications: Treatment of TB in combination with other agents.
  
  

• Contraindications: Hypersensitivity to aminoglycoside antibiotics.

• Dosage: 15 mg/kg IM qd.

• Toxicity: Ototoxicity, vestibular toxicity.

  Pregnancy category D.
  

Toxoplasmosis: Treatment and Prophylaxis +

• Clindamycin
  
  
  • Indications: Treatment of toxoplasmic encephalitis (for patients unable to tolerate sulfadiazine) in combination with pyrimethamine.
    
    
  • Contraindications: Known hypersensitivity.
    
    
  • Dosage: Initial therapy: 900 mg IV q8h for initial therapy or 300-450 mg po q6h.
    
    Maintenance therapy (secondary prophylaxis): 300-450 mg po q6h.
    
    
  • Toxicity: Diarrhea, nausea, rash.
    
    Pregnancy category B.
    
    
    
• Pyrimethamine
  
  
  • Indications: Treatment of toxoplasmic encephalitis in combination with sulfadiazine or clindamycin.
    
    Primary prophylaxis of toxoplasmosis in combination with dapsone.
    
    
  • Contraindications: Known hypersensitivity.
    
    
  • Dosage: Initial therapy: 100-200 mg po loading dose, followed by 50-100 mg po qd x 6 weeks in conjunction with folinic acid 10 mg po qd.
    
    Maintenance therapy (secondary prophylaxis): 25-75 mg po with folinic acid 10 mg po qd.
    
    Prophylaxis: 50 mg weekly with folinic acid 25 mg.
    
    
  • Toxicity: Reversible bone marrow suppression, gastrointestinal intolerance.
    
    Pregnancy category C; teratogenic in animals.
    

   

• Sulfadiazine
  
  
  • Indications: Treatment of toxoplasmic encephalitis in combination with pyrimethamine.
    
    
  • Contraindications: Known hypersensitivity to sulfonamides.
    
    
  • Dosage: Initial therapy: 1-2 grams po qid x 6 weeks.
    
    Maintenance therapy (secondary prophylaxis): 0.5-1 grams po qid.
    
    
  • Toxicity: Fever, rash, pruritus, bone marrow suppression.
    
    Pregnancy category C; avoid use at term because of risk of kernicterus in newborn.
    

   

Cytomegalovirus (CMV) Infection: Treatment and Prophylaxis

• Cidofovir (Vistide)
  
  
  • Indications: Treatment of CMV infection, including ganciclovir-resistant strains.
    
    
  • Contraindications: Known hypersensitivity, significant renal dysfunction, use of other nephrotoxic medications.
    
    
  • Dosage: Initial therapy: 5 mg/kg IV once a week x 2.
    
    Maintenance therapy (secondary prophylaxis): 5 mg/kg IV once every other week.
    
    Probenecid 2 gm po 3 hr prior, and 1 gm po 2 hr prior and 8 hr after infusion should be administered to prevent nephrotoxicity; 1 liter normal saline is also given prior to cidofovir dosing.
    
    
  • Toxicity: Nephrotoxicity, neutropenia. Probenecid is associated with fever, chills, headache, rash, nausea.
    
    Pregnancy category C.
    

   

• Foscarnet (Foscavir)
  
  
  • Indications: Treatment of CMV infection, including ganciclovir-resistant strains.
    
    
  • Contraindications: Known hypersensitivity, significant renal dysfunction.
    
    
  • Dosage: Initial therapy: 60 mg/kg IV q8h or 90 mg/kg IV q12h x 14 days.
    
    Maintenance therapy (secondary prophylaxis): 90-120 mg/kg IV qd.
    
    
  • Toxicity: Nephrotoxicity, hypocalcemia, hypophosphatemia, hypokalemia, headache, fatigue, nausea, anemia, seizures.
    
    Pregnancy category C.
    

   

• Ganciclovir (Cytovene)
  
  
  • Indications: Treatment and prophylaxis of CMV infection.
    
    
  • Contraindications: Known hypersensitivity, neutropenia, thrombocytopenia.
    
    
  • Dosage: Initial therapy: 5 mg/kg IV q12h x 14-21 days.
    
    Maintenance therapy (secondary prophylaxis): 5 mg/kg IV qd or oral ganciclovir
    1 gm po tid.
    
    Also available as vitreal implant requiring ophthalmologic surgery.
    
    
  • Toxicity: Neutropenia, thrombocytopenia, anemia, nausea, abdominal pain, headache, confusion.
    
    Pregnancy category C; teratogenic in animals.
    

   

• Valganciclovir (Valcyte)
  
  
  • Indications: Treatment and prophylaxis of CMV infection.
    
    
  • Contraindications: Known hypersensitivity, neutropenia, thrombocytopenia.
    
    
  • Dosage: Initial therapy: 900 mg po bid.
    
    Maintenance therapy (secondary prophylaxis): 900 mg po qd.
    
    
  • Toxicity: Neutropenia, thrombocytopenia, anemia, nausea, abdominal pain, headache, confusion.
    
    Pregnancy category C.
    

   

Herpes Simplex Virus (HSV) and Varicella-Zoster Virus (VZV) Infections: Treatment and Prophylaxis ++

• Acyclovir (Zovirax)
  
  
  • Indications: Treatment and prophylaxis of HSV and VZV infections.
    
    
  • Contraindications: Known hypersensitivity.
    
    
  • Dosage: HSV treatment: 400 mg po tid x 5-7 days; secondary prophylaxis: 400 mg po bid is standard dose but larger doses may be necessary in advanced HIV disease. For extensive or disseminated disease, intravenous therapy (5-10 mg/kg q8h) is given.
    
    VZV treatment: 800 mg po 5x/day for 7 days. For disseminated zoster or ophthalmic involvement, intravenous therapy (10-12 mg/kg q8h) is given. Secondary prophylaxis generally is not indicated.
    
    
  • Toxicity: Nausea, renal dysfunction.
    
    Pregnancy category C.
    

   

• Famciclovir (Famvir)
  
  
  • Indications: Treatment and prophylaxis of HSV and VZV infections.
    
    
  • Contraindications: Known hypersensitivity.
    
    
  • Dosage: HSV treatment: 125 mg po bid x 5-7 days; secondary prophylaxis: 125-250 mg po bid.
    
    VZV treatment: 500 mg po tid x 7 days. Secondary prophylaxis generally is not indicated.
    
    
  • Toxicity: Headache, nausea.
    
    Pregnancy category B.
    

   

Fungal Infections: Treatment and Prophylaxis

• Amphotericin B
  
  
  • Indications: Pharmacist-prepared suspension for treatment of oral candidiasis; intravenous drug for treatment of systemic fungal infections.
    
    
  • Contraindications: Known hypersensitivity.
    
    
  • Dosage: Oral candidiasis: 1-5 ml of suspension po qid x 14 days.
    
    Systemic fungal infections: intravenous doses range from 0.3-1.0 mg/kg/day depending on the pathogen and type of infection. Lipid complex preparations are less toxic but very expensive.
    
    
  • Toxicity: Oral suspension: nausea, vomiting, diarrhea, rash; intravenous drug: infusion-related chills, hypotension, nausea, vomiting, nephrotoxicity, hypokalemia, hypomagnesemia, hypocalcemia, anemia.
    
    Pregnancy category B.
    

   

• Clotrimazole
  
  
  • Indications: Treatment of mucosal candidiasis.
    
    
  • Contraindications: Known hypersensitivity.
    
    
  • Dosage: Oral candidiasis: 10 mg lozenge dissolved in the mouth 5 times a day; vaginal candidiasis: 100 mg tablet per vagina bid x 3 days.
    
    
  • Toxicity: Nausea, abnormal liver function tests.
    
    Pregnancy category C.
    

   

• Fluconazole (Diflucan)
  
  
  • Indications: Treatment and secondary prophylaxis of mucosal candidiasis; secondary prophylaxis of cryptococcal infection.
    
    
  • Contraindications: Known hypersensitivity.
    
    
  • Dosage: Treatment of oral candidiasis: 50-100 mg po qd x 7-14 days; candida esophagitis: 200 mg po qd x 14-21 days; vaginal candidiasis: 150 mg po x one. Secondary prophylaxis of mucosal candidiasis: 50-200 mg po qd. There are many potential drug interactions, some of which require dosage modification; see Physicians Desk Reference or package insert for more information.
    
    Cryptococcal infection maintenance therapy (secondary prophylaxis): 200 mg po qd. Most experts recommend initial treatment of cryptococcal infection with amphotericin B; if using fluconazole, dose 400 mg po qd x 8 weeks.
    
    
  • Toxicity: Nausea, headache, hepatotoxicity.
    
    Pregnancy category C.
    

   

• Nystatin
  
  
  • Indications: Treatment of mucosal candidiasis.
    
    
  • Contraindications: Known hypersensitivity.
    
    
  • Dosage: Oral candidiasis: 5 ml suspension to be gargled and swallowed 5 times a day x 7-14 days; vaginal candidiasis: 100,000 unit tab intravaginally 1-2 times a day x 7-14 days.
    
    
  • Toxicity: Nausea, vomiting, diarrhea
    
    Pregnancy category C.
    

   

Miscellaneous Therapeutic Agents

• Dronabinol (Marinol)
  
  
  • Indications: Appetite stimulant for treatment of AIDS wasting syndrome.
    
    
  • Contraindications: Known hypersensitivity, significant cognitive dysfunction.
    
    
  • Dosage: 2.5 mg po bid.
    
    
  • Toxicity: Neuropsychiatric symptoms, gastrointestinal intolerance.
    
    Pregnancy category C.
    

   

• Erythropoietin (Procrit)
  
  
  • Indications: Treatment of HIV- or ZDV-associated anemia (HCT < 30) in patients with serum erythropoietin levels < 500 milliunits/ml.
    
    
  • Contraindications: Known hypersensitivity to mammalian cell derived products or human albumin, uncontrolled hypertension.
    
    
  • Dosage: 40,000 units SC once a week; response usually seen between 2 and 6 weeks.
    
    
  • Toxicity: Headache, nausea, arthralgia, hypertension, seizures.
    
    Pregnancy category C; teratogenic in animals.
    

   

• Granulocyte-Colony Stimulating Factor (G-CSF, Filgrastim)
  
  
  • Indications: Treatment of neutropenia, defined as ANC < 500-750/mm3, as a result of HIV disease, chemotherapy, or other drugs (hydroxyurea, ganciclovir, ZDV, TMP-SMX).
    
    
  • Contraindications: Known hypersensitivity to drug or Escherichia coli-derived products.
    
    
  • Dosage: 5-10 mcg/kg/day SC. Complete blood count should be checked twice a week, and ANC should be maintained at > 1,000-2,000/ml. G-CSF should be stopped if there is no response after 7 days at a dose of 10 mcg/kg/day.
    
    
  • Toxicity: Bone pain.
    
    Pregnancy category C.
    

   

• Human Growth Hormone (Somatropin, Serostim)
  
  
  • Indications: Hormonal treatment of AIDS wasting syndrome.
    
    
  • Contraindications: Known hypersensitivity, presence of an actively growing intracranial tumor.
    
    
  • Dosage: For patients > 55 kg, dose is 6 mg SC qd; for patients 45-55 kg, dose is 5 mg SC qd; for patients 35-45 kg, dose is 4 mg SC qd.
    
    
  • Toxicity: Arthralgia, edema, hypertension, hyperglycemia.
    
    Pregnancy category B.
    

   

• Hydroxyurea (Hydrea)
  
  
  • Indications: Has been shown to act synergistically with ddI and possibly d4T; not FDA-approved for management of HIV infection.
    
    
  • Contraindications: Known hypersensitivity, significant bone marrow suppression, pregnancy.
    
    
  • Dosage: 500 mg po bid.
    
    
  • Toxicity: Bone marrow suppression, stomatitis, nausea, vomiting, rash; severe pancreatitis has been described infrequently.
    
    Pregnancy category D.
    

   

• Megestrol Acetate (Megace)
  
  
  • Indications: Appetite stimulant for treatment of AIDS wasting syndrome.
    
    
  • Contraindications: Known hypersensitivity, pregnancy.
    
    
  • Dosage: Oral suspension: 400-800 mg po qd; tablets: 80 mg po qid up to 800 mg/day.
    
    
  • Toxicity: Hypogonadism, adrenal insufficiency, diarrhea, impotence, hyperglycemia, rash.
    
    Pregnancy category D.
    

   

• Oxandrolone (Oxandrin)
  
  
  • Indications: Anabolic steroid for treatment of AIDS wasting syndrome.
    
    
  • Contraindications: Known hypersensitivity, history of breast or prostate cancer, significant hepatic dysfunction, nephrosis, pregnancy.
    
    
  • Dosage: 5-10 mg po bid.
    
    
  • Toxicity: Edema, hypertension, virilization, glucose intolerance, hyperlipidemia, abnormal liver function tests.
    
    Pregnancy category X.
    

   

• Testosterone
  
  
  • Indications: Treatment of hypogonadism; treatment of AIDS wasting syndrome.
    
    
  • Contraindications: Known hypersensitivity, history of male breast or prostate cancer, pregnancy.
    
    
  • Dosage: 200-400 mg IM q 2 weeks. Topical treatment is also available: 1) gel preparation (Androgel) 5 g topically qd; and 2) transdermal systems via non-scrotal patch including Androderm and Testoderm.
    
    
  • Toxicity: Coagulopathy, cholestatic jaundice, increased libido, edema, flushing, priapism, local reaction with patches.
    
    Pregnancy category X.
    

   

• Thalidomide (Thalomid)
  
  
  • Indications: Treatment of refractory aphthous ulcers; treatment of refractory AIDS wasting syndrome.
    
    
  • Contraindications: Known hypersensitivity, pregnancy.
    
    
  • Dosage: 50-200 mg po qd. Physicians and pharmacists must be registered in the STEPS program (System for Thalidomide Education and Prescribing Safety at 1-888-4-Celgene) to prescribe thalidomide. Female patients must have a negative pregnancy test within 24 hours of starting therapy, weekly pregnancy tests in the first month of therapy, monthly pregnancy tests thereafter, and agree to use two forms of contraception. Male patients must use a condom for contraception.
    
    
  • Toxicity: Peripheral neuropathy, drowsiness, orthostatic hypotension, fever, rash, neutropenia.
    
    Pregnancy category X.
    

   

Footnotes

* Lactic acidosis, rarely with hepatomegaly and steatosis, has been associated with all drugs in this class.

** Hyperlipidemia, glucose intolerance/diabetes mellitus, and body fat redistribution have been associated with combination antiretroviral therapy, especially regimens containing protease inhibitors.

*** Drugs for TB can also be administered as directly observed therapy (DOT) in different dosage regimens. Consultation with an expert clinician in this area is recommended.

+ For primary prophylaxis, see PCP Treatment and Prophylaxis section.

++ Cidofovir and forcarnet also have activity against HSV and VZV and may have a role in the treatment of resistant strains. Valacyclovir, an acyclovir analogue, has been associated with cases of thrombotic thrombocytopenic purpura (TTP) in patients with advanced HIV disease.

Pregnancy Categories: A: Controlled studies show no risk; B: No evidence of risk in humans; C: Risk cannot be excluded; D: Evidence of risk; X: Contraindicated in pregnancy.

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Comments about these guidelines are welcome and can be sent to the author at hlibman@caregroup.harvard.edu