Abacavir Sulfate/Lamivudine
 Abacavir Sulfate/Lamivudine/Zidovudine

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Abacavir Sulfate / Lamivudine

Pronouncation: (ab-ah-KAV-ear SULL-fate/la-MIH-view-deen)
Class: Nucleoside analog reverse transcriptase inhibitor combination

Trade Names:
Epzicom
- Tablets 600 mg abacavir (as sulfate) and 300 mg lamivudine

Mechanism of Action

Pharmacology

Inhibits replication of HIV by incorporation into HIV DNA and producing incomplete, nonfunctional DNA.

Indications and Usage

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

Contraindications

Abacavir has been associated with fatal hypersensitivity reactions and should not be restarted following a hypersensitivity reaction to abacavir; hypersensitivity to any component of product; hepatic function impairment.

Dosage and Administration

Adults

PO 1 tablet daily (abacavir sulfate 600 mg and lamivudine 300 mg), in combination with other antiretroviral agents.

Storage/Stability

Store tablets at controlled room temperature (59° to 86°F).

Drug Interactions

Trimethoprim/Sulfamethoxazole

Lamivudine serum levels may be elevated, increasing the pharmacologic and adverse effects.

Zidovudine

Lamivudine and zidovudine may inhibit the intracellular phosphorylation of each other.

Laboratory Test Interactions

None well documented.

Adverse Reactions

The following adverse reactions were reported during postapproval use of abacavir and lamivudine. Adverse reactions occurring with administration of either abacavir or lamivudine can be found listed in their respective monographs.

CNS

Paresthesia; peripheral neuropathy; seizures.

Dermatologic

Alopecia; erythema multiforme; Stevens-Johnson syndrome.

GI

Stomatitis.

Hematologic-Lymphatic

Aplastic anemia; anemia (including pure red cell aplasia and severe anemia progressing with therapy); lymphadenopathy; splenomegaly.

Hepatic

Hepatic steatosis; posttreatment exacerbation of hepatitis B.

Metabolic

Hyperglycemia; lactic acidosis.

Musculoskeletal

Muscle weakness; CPK elevation; rhabdomyolysis.

Respiratory

Abnormal breath sounds/wheezing.

Miscellaneous

Sensitivity reactions (including anaphylaxis); redistribution/accumulation of body fat; weakness.

Precautions

Warnings

Serious and sometimes fatal hypersensitivity reactions have been associated with abacavir. The hypersensitivity reaction is a multi-organ syndrome usually characterized by signs or symptoms in 2 or more of the following: 1) fever, 2) rash, 3) GI (eg, nausea, vomiting), 4) constitutional (eg, malaise, fatigue), and 5) respiratory (eg, cough). Permanently discontinue if hypersensitivity reaction occurs. Do not restart abacavir following a hypersensitivity reaction. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, may occur. Severe acute exacerbation of hepatitis B has been reported in patient co-infected with hepatitis B virus (HBV) and HIV and who have discontinued lamivudine. Closely monitor hepatic function for at least several months after discontinuation of abacavir/lamivudine in patients who are co-infected with HIV and HBV.


Monitor

Discontinuation

Ensure hepatic function is closely monitored for at least several months following discontinuation of abacavir/lamivudine in patient who is co-infected with HBV and HIV. Ensure anti-hepatitis B therapy has been considered.

Lactic acidosis

Monitor patient for signs of lactic acidosis. If patient develops profound weakness or tiredness, unexpected stomach discomfort, cold feeling, dizziness, or lightheadedness, slow or irregular heartbeat, withhold drug and notify health care provider.


Pregnancy

Category C .

Lactation

Undetermined. HIV-infected mothers should not breast-feed their infants.

Children

Safety and efficacy not established.

Renal Function

Because this is a fixed-dose tablet, do not use for patients requiring dosage adjustment (eg, Ccr less than 50 mL/min).

Hepatic Function

Because this is a fixed-dose tablet and the dosage of the individual components cannot be altered, it is contraindicated in patients with hepatic function impairment.

Abacavir

Do not administer to patient who has previous suspected or documented hypersensitivity reaction to abacavir.

Antiretroviral agents

Must be used in combination with other antiretroviral agents from different pharmacologic classes (not with other nucleoside/nucleotide reverse transcriptase inhibitors).

Fat redistribution

Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, and cushingoid appearance have been observed in patients receiving antiretroviral therapy.

Patient Information

  • Advise patient to review Medication Guide before starting therapy and with each refill of the medication.
  • Advise patient to review, and carry with them at all times, the Warning Card summarizing the symptoms of abacavir hypersensitivity reaction.
  • Instruct patient to take exactly as prescribed and not to change the dose or discontinue therapy unless advised by health care provider.
  • Instruct patient to take 1 tablet once daily without regard to meals but to take with food if stomach upset occurs.
  • Instruct patient that if a dose is missed to take as soon as remembered and to take the next dose at the usual scheduled time.
  • Warn patient that this drug is not to be used by itself but is combined with other antiviral agents and to continue to take other HIV medications as prescribed by health care provider.
  • Instruct patient to discontinue use and notify health care provider immediately if a symptom from 2 or more of the following groups occurs: 1) fever; 2) rash; 3) nausea, vomiting, diarrhea, stomach pain; 4) generalized body discomfort, extreme tiredness, achiness; 5) sore throat, shortness of breath, cough.
  • Caution patient not to restart this medication, or any other abacavir-containing medication, if a hypersensitivity reaction to this medication has occurred. Explain to patient that restarting abacavir or an abacavir-containing product could cause a more serious, and possibly fatal, reaction.
  • Caution patient that if therapy is interrupted for a few days for reasons other than a hypersensitivity reaction (eg, interruption in drug supply) and is then restarted that there is a risk of experiencing a serious or fatal hypersensitivity reaction. Advise patient to talk with health care provider before restarting the medication. Advise patient that if health care provider tells them to take the medication again to start taking it when they are around medical help or people who could call a doctor if necessary.
  • Caution patient that medication can cause a rare but serious condition called lactic acidosis with liver enlargement and that persistent nausea and tiredness may be symptoms of this condition. Instruct patient to inform health care provider if these symptoms develop.
  • Caution patient who has concurrent infection with HBV that hepatitis may worsen if abacavir/lamivudine is stopped and that liver function should be closely followed for several months after stopping abacavir/lamivudine. Advise patient anti-hepatitis B virus medications may be needed.
  • Advise patient that medication may cause changes in body fat distribution (eg, increased amount of fat in upper back and neck, breasts, and around the back, chest, and stomach area; or loss of fat from arms, legs, and face) and that the cause and long-term health effects of these changes is not known at this time. Advise patient to report changes in body fat distribution to health care provider.
  • Inform patient that drug does not completely eliminate HIV virus and therefore does not reduce the risk of transmitting HIV to others through sexual contact or blood contamination. Instruct patient that appropriate precautions must still be followed.
  • Advise patient that drug is not a cure for HIV infection and illnesses associated with HIV infection, including opportunistic infections, may continue to be acquired. Patients should remain under a health care provider"s care.
  • Instruct mother not to breast-feed her infant because of risk of transmitting HIV virus to the infant and the potential for serious adverse effects from medication transmitted to her infant through breast milk.




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abacavir slfate/lamivudine/zidovudine, abacavir sulfate/lamivudine abacavir sufate/lamivudine/zidovudine, abacavir sulfate/lamivudine abacavir sulate/lamivudine/zidovudine, abacavir sulfate/lamivudine abacavir sulfte/lamivudine/zidovudine, abacavir sulfate/lamivudine abacavir sulfae/lamivudine/zidovudine, abacavir sulfate/lamivudine abacavir sulfat/lamivudine/zidovudine, abacavir sulfate/lamivudine abacavir sulfatelamivudine/zidovudine, abacavir sulfate/lamivudine abacavir sulfate/amivudine/zidovudine, abacavir sulfate/lamivudine abacavir sulfate/lmivudine/zidovudine, abacavir sulfate/lamivudine abacavir sulfate/laivudine/zidovudine, abacavir sulfate/lamivudine abacavir sulfate/lamvudine/zidovudine, abacavir sulfate/lamivudine abacavir sulfate/lamiudine/zidovudine, abacavir sulfate/lamivudine abacavir sulfate/lamivdine/zidovudine, abacavir sulfate/lamivudine abacavir sulfate/lamivuine/zidovudine, abacavir sulfate/lamivudine abacavir sulfate/lamivudne/zidovudine, abacavir 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abcaavir sulfate/lamivudine abacavir sulfate/lamivudine/zidovudine, abaacvir sulfate/lamivudine abacavir sulfate/lamivudine/zidovudine, abacvair sulfate/lamivudine abacavir sulfate/lamivudine/zidovudine, abacaivr sulfate/lamivudine abacavir sulfate/lamivudine/zidovudine, abacavri sulfate/lamivudine abacavir sulfate/lamivudine/zidovudine, abacavi rsulfate/lamivudine abacavir sulfate/lamivudine/zidovudine, abacavirs ulfate/lamivudine abacavir sulfate/lamivudine/zidovudine, abacavir uslfate/lamivudine abacavir sulfate/lamivudine/zidovudine, abacavir slufate/lamivudine abacavir sulfate/lamivudine/zidovudine, abacavir suflate/lamivudine abacavir sulfate/lamivudine/zidovudine, abacavir sulafte/lamivudine abacavir sulfate/lamivudine/zidovudine, abacavir sulftae/lamivudine abacavir sulfate/lamivudine/zidovudine, abacavir sulfaet/lamivudine abacavir sulfate/lamivudine/zidovudine, abacavir sulfat/elamivudine abacavir sulfate/lamivudine/zidovudine, abacavir sulfatel/amivudine abacavir 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sulfate/lamivudine abcaavir sulfate/lamivudine/zidovudine, abacavir sulfate/lamivudine abaacvir sulfate/lamivudine/zidovudine, abacavir sulfate/lamivudine abacvair sulfate/lamivudine/zidovudine, abacavir sulfate/lamivudine abacaivr sulfate/lamivudine/zidovudine, abacavir sulfate/lamivudine abacavri sulfate/lamivudine/zidovudine, abacavir sulfate/lamivudine abacavi rsulfate/lamivudine/zidovudine, abacavir sulfate/lamivudine abacavirs ulfate/lamivudine/zidovudine, abacavir sulfate/lamivudine abacavir uslfate/lamivudine/zidovudine, abacavir sulfate/lamivudine abacavir slufate/lamivudine/zidovudine, abacavir sulfate/lamivudine abacavir suflate/lamivudine/zidovudine, abacavir sulfate/lamivudine abacavir sulafte/lamivudine/zidovudine, abacavir sulfate/lamivudine abacavir sulftae/lamivudine/zidovudine, abacavir sulfate/lamivudine abacavir sulfaet/lamivudine/zidovudine, abacavir sulfate/lamivudine abacavir sulfat/elamivudine/zidovudine, abacavir sulfate/lamivudine abacavir sulfatel/amivudine/zidovudine, abacavir sulfate/lamivudine abacavir sulfate/almivudine/zidovudine, abacavir sulfate/lamivudine abacavir sulfate/lmaivudine/zidovudine, abacavir sulfate/lamivudine abacavir sulfate/laimvudine/zidovudine, abacavir sulfate/lamivudine abacavir sulfate/lamviudine/zidovudine, abacavir sulfate/lamivudine abacavir sulfate/lamiuvdine/zidovudine, abacavir sulfate/lamivudine abacavir sulfate/lamivduine/zidovudine, abacavir sulfate/lamivudine abacavir sulfate/lamivuidne/zidovudine, abacavir sulfate/lamivudine abacavir sulfate/lamivudnie/zidovudine, abacavir sulfate/lamivudine abacavir sulfate/lamivudien/zidovudine, abacavir sulfate/lamivudine abacavir sulfate/lamivudin/ezidovudine, abacavir sulfate/lamivudine abacavir sulfate/lamivudinez/idovudine, abacavir sulfate/lamivudine abacavir sulfate/lamivudine/izdovudine, abacavir sulfate/lamivudine abacavir sulfate/lamivudine/zdiovudine, abacavir sulfate/lamivudine abacavir sulfate/lamivudine/ziodvudine, abacavir sulfate/lamivudine abacavir sulfate/lamivudine/zidvoudine, abacavir sulfate/lamivudine abacavir sulfate/lamivudine/zidouvdine, abacavir sulfate/lamivudine abacavir sulfate/lamivudine/zidovduine, abacavir sulfate/lamivudine abacavir sulfate/lamivudine/zidovuidne, abacavir sulfate/lamivudine abacavir sulfate/lamivudine/zidovudnie, abacavir sulfate/lamivudine abacavir sulfate/lamivudine/zidovudien, aabacavir sulfate/lamivudine abacavir sulfate/lamivudine/zidovudine, abbacavir sulfate/lamivudine abacavir sulfate/lamivudine/zidovudine, abaacavir sulfate/lamivudine abacavir sulfate/lamivudine/zidovudine, abaccavir sulfate/lamivudine abacavir sulfate/lamivudine/zidovudine, abacaavir sulfate/lamivudine abacavir sulfate/lamivudine/zidovudine, abacavvir sulfate/lamivudine abacavir sulfate/lamivudine/zidovudine, abacaviir sulfate/lamivudine abacavir sulfate/lamivudine/zidovudine, abacavirr sulfate/lamivudine abacavir sulfate/lamivudine/zidovudine, abacavir sulfate/lamivudine abacavir sulfate/lamivudine/zidovudine, abacavir ssulfate/lamivudine abacavir sulfate/lamivudine/zidovudine, abacavir suulfate/lamivudine abacavir sulfate/lamivudine/zidovudine, abacavir sullfate/lamivudine abacavir sulfate/lamivudine/zidovudine, abacavir sulffate/lamivudine abacavir sulfate/lamivudine/zidovudine, abacavir sulfaate/lamivudine abacavir sulfate/lamivudine/zidovudine, abacavir sulfatte/lamivudine abacavir sulfate/lamivudine/zidovudine, abacavir sulfatee/lamivudine abacavir sulfate/lamivudine/zidovudine, abacavir sulfate//lamivudine abacavir sulfate/lamivudine/zidovudine, abacavir sulfate/llamivudine abacavir sulfate/lamivudine/zidovudine, abacavir sulfate/laamivudine abacavir sulfate/lamivudine/zidovudine, abacavir sulfate/lammivudine abacavir sulfate/lamivudine/zidovudine, abacavir sulfate/lamiivudine abacavir sulfate/lamivudine/zidovudine, abacavir sulfate/lamivvudine abacavir sulfate/lamivudine/zidovudine, abacavir sulfate/lamivuudine abacavir sulfate/lamivudine/zidovudine, abacavir sulfate/lamivuddine abacavir sulfate/lamivudine/zidovudine, abacavir sulfate/lamivudiine abacavir sulfate/lamivudine/zidovudine, abacavir sulfate/lamivudinne abacavir sulfate/lamivudine/zidovudine, abacavir sulfate/lamivudinee abacavir sulfate/lamivudine/zidovudine, abacavir sulfate/lamivudine abacavir sulfate/lamivudine/zidovudine, abacavir sulfate/lamivudine abacavir sulfate/lamivudine/zidovudine, abacavir sulfate/lamivudine aabacavir sulfate/lamivudine/zidovudine, abacavir sulfate/lamivudine abbacavir sulfate/lamivudine/zidovudine, abacavir sulfate/lamivudine abaacavir sulfate/lamivudine/zidovudine, abacavir sulfate/lamivudine abaccavir sulfate/lamivudine/zidovudine, abacavir sulfate/lamivudine abacaavir sulfate/lamivudine/zidovudine, abacavir sulfate/lamivudine abacavvir sulfate/lamivudine/zidovudine, abacavir sulfate/lamivudine abacaviir sulfate/lamivudine/zidovudine, abacavir sulfate/lamivudine abacavirr sulfate/lamivudine/zidovudine, abacavir sulfate/lamivudine abacavir sulfate/lamivudine/zidovudine, abacavir sulfate/lamivudine abacavir ssulfate/lamivudine/zidovudine, abacavir sulfate/lamivudine abacavir suulfate/lamivudine/zidovudine, abacavir sulfate/lamivudine abacavir sullfate/lamivudine/zidovudine, abacavir sulfate/lamivudine abacavir sulffate/lamivudine/zidovudine, abacavir sulfate/lamivudine abacavir sulfaate/lamivudine/zidovudine, abacavir sulfate/lamivudine abacavir sulfatte/lamivudine/zidovudine, abacavir sulfate/lamivudine abacavir sulfatee/lamivudine/zidovudine, abacavir sulfate/lamivudine abacavir sulfate//lamivudine/zidovudine, abacavir sulfate/lamivudine abacavir sulfate/llamivudine/zidovudine, abacavir sulfate/lamivudine abacavir sulfate/laamivudine/zidovudine, abacavir sulfate/lamivudine abacavir sulfate/lammivudine/zidovudine, abacavir sulfate/lamivudine abacavir sulfate/lamiivudine/zidovudine, abacavir sulfate/lamivudine abacavir sulfate/lamivvudine/zidovudine, abacavir sulfate/lamivudine abacavir sulfate/lamivuudine/zidovudine, abacavir sulfate/lamivudine abacavir sulfate/lamivuddine/zidovudine, abacavir sulfate/lamivudine abacavir sulfate/lamivudiine/zidovudine, abacavir sulfate/lamivudine abacavir sulfate/lamivudinne/zidovudine, abacavir sulfate/lamivudine abacavir sulfate/lamivudinee/zidovudine, abacavir sulfate/lamivudine abacavir sulfate/lamivudine//zidovudine, abacavir sulfate/lamivudine abacavir sulfate/lamivudine/zzidovudine, abacavir sulfate/lamivudine abacavir sulfate/lamivudine/ziidovudine, abacavir sulfate/lamivudine abacavir sulfate/lamivudine/ziddovudine, abacavir sulfate/lamivudine abacavir sulfate/lamivudine/zidoovudine, abacavir sulfate/lamivudine abacavir sulfate/lamivudine/zidovvudine, abacavir sulfate/lamivudine abacavir sulfate/lamivudine/zidovuudine, abacavir sulfate/lamivudine abacavir sulfate/lamivudine/zidovuddine, abacavir sulfate/lamivudine abacavir sulfate/lamivudine/zidovudiine, abacavir sulfate/lamivudine abacavir sulfate/lamivudine/zidovudinne, abacavir sulfate/lamivudine abacavir sulfate/lamivudine/zidovudinee, etc.



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