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All about: Lexiva

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Generic name: Fosamprenavir calcium
Brand names: Lexiva

Why is Lexiva prescribed?

Lexiva is prescribed for adults with human immunodeficiency virus (HIV) infection. HIV undermines the immune system, reducing the body's ability to fight off other infections and eventually leading to the deadly condition known as acquired immune deficiency syndrome (AIDS).

Lexiva slows the progression of HIV by interfering with an important step in the virus's reproductive cycle. The drug is a member of the group of "protease inhibitors." Lexiva is prescribed only as part of a "drug cocktail" that attacks the virus on several fronts. It is not to be used alone.

Lexiva is not a cure for HIV infection or AIDS. It does not completely eliminate HIV from the body, nor does it totally restore the immune system. There is still a danger of developing serious opportunistic infections (that is, infections that develop when the immune system falters). It is important, therefore, to continue seeing your doctor for regular blood counts and tests. Notify your health care provider immediately of any change in your general health.

Most important fact about Lexiva

Combining Lexiva with certain drugs can cause serious--and possibly life-threatening--side effects (see "Possible food and drug interactions when taking Lexiva"). Be sure to tell your doctor and pharmacist what medications you are taking, both prescription and over-the-counter, and let them know when you stop taking any medication.

How should you take Lexiva?

Lexiva can be taken with or without food. Take Lexiva every day as prescribed. Do not change your dose or stop taking Lexiva without talking to your doctor.

--If you miss a dose...

Take the forgotten dose as soon as you remember, then return to your normal schedule. However, if it is almost time for your next dose, skip the one you missed and return to your regular schedule. Do not take two doses at once.

--Storage instructions...

Store at room temperature. Keep the container tightly closed.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe to continue using Lexiva.

  • More common side effects may include:
    Diarrhea, headache, nausea, rash, vomiting

Why should Lexiva not be prescribed?

If Lexiva causes an allergic reaction, you will not be able to use it. If you have severe liver damage, you should not use Lexiva.

Certain drugs should never be combined with Lexiva due to the risk of serious--and possible life-threatening--side effects (see "Possible food and drug interactions when taking Lexiva").

Special warnings about Lexiva

There is no reason to believe that taking Lexiva lowers your chances of transmitting HIV to others. Continue to take precautions to prevent transmission of virus.

Lexiva can interfere with oral contraceptives. Use a backup form of birth control to avoid an unwanted pregnancy.

Lexiva must be used with caution if you have liver problems. If you have any liver disorder, make sure your doctor is aware of it.

One serious potential side effect of Lexiva is a rash that occasionally becomes so severe as to be life-threatening. If you notice any signs of rash, inform your doctor immediately. If the rash gets worse or is accompanied by fever, blisters, mouth sores, red eyes, swelling, or flu-like symptoms, stop taking the drug and call your doctor.

Lexiva may trigger diabetes or make it worse. If this occurs, you may have to start taking insulin or oral diabetes drugs, or have your dosage of these medications adjusted. Lexiva plus ritonavir can increase levels of a lipid called triglyceride, possibly resulting in the need for treatment.

Like other HIV drugs, Lexiva sometimes causes a redistribution of body fat, resulting in added weight around the waist, a "buffalo hump" of fat on the upper back, breast enlargement, and wasting of the face, arms, and legs. It's not known why this occurs, or what long-term effects it might have.

Lexiva belongs to the sulfonamide family of drugs. If you have an allergy to sulfa drugs such as Bactrim or Septra, be sure to tell your doctor.

Possible food and drug interactions when taking Lexiva

Be sure to check with your doctor about the medicines and herbal remedies that should NOT be taken with Lexiva. Due to the danger of life-threatening side effects, Lexiva should never be combined with any of the following:

Cisapride
Dihydroergotamine (Migranal)
Ergonovine (Ergotrate)
Ergotamine (Cafergot)
Lovastatin (Mevacor)
Methylergonovine (Methergine)
Pimozide (Orap)
Midazolam (Versed)
Simvastatin (Zocor)
Triazolam (Halcion)

Due to the potential for serious or life-threatening side effects, your doctor will monitor you closely if you must take Lexiva with any of the following:

Amiodarone (Cordarone)
Antidepressants known as tricyclics, such as amitriptyline (Elavil) and imipramine (Tofranil)
Certain cholesterol-lowering drugs in the statin family, such as atorvastatin (Lipitor)
Bepridil (Vascor)
Lidocaine (systemic)
Quinidine (Quinidex)

If you are taking both Lexiva and the HIV drug ritonavir (Norvir), you must be careful to avoid the heart medications flecainide (Tambocor) and propafenone (Rythmol).

Rifampin (Rifadin, Rifamate, Rifater) and St. John's wort should never be given with Lexiva because they combat the antiviral effects of Lexiva. Delavirdine should not be given with Lexiva as the combination may lead to resistance to delavirdine.

Be careful about combining Lexiva with Viagra or other erectile dysfunction drugs such as Cialis or Levitra. The combination increases the risk of the side effects of those agents, such as low blood pressure, changes in your vision, and persistent painful erection.

If Lexiva is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Lexiva with the following:

Acid reflux medications classified as "proton pump inhibitors" such as AcipHex and Nexium
Antifungal medications such as Nizoral and Sporanox
Antiulcer medications classified as H2-receptor antagonists, such as Zantac and Tagamet
Anxiety medications (tranquilizers) such as Tranxene, Valium, and Xanax
Dexamethasone (Decadron)
Efavirenz (Sustiva)
Flurazepam (Dalmane)
High blood pressure and angina medications (calcium channel blockers), such as Adalat, Calan, Cardene, Cardizem, Dilacor, DynaCirc, Nimotop, Norvasc, Plendil, Procardia, and Sular
HIV medications such as Crixivan and Viracept
Immune-suppressing drugs such as Neoral, Prograf, Rapamune, Sandimmune
Lopinavir/ritonavir (Kaletra)
Methadone
Nevirapine (Viramune)
Oral contraceptives
Rifabutin (Mycobutin)
Ritonavir (Norvir)
Saquinavir (Fortovase)
Seizure medications such as Dilantin, Tegretol, and phenobarbital
Warfarin (Coumadin)

Special information if you are pregnant or breastfeeding

The effects of Lexiva during pregnancy have not been adequately studied. If you are pregnant or plan to become pregnant, tell your doctor immediately.

Since HIV infection can be passed to your baby through breast milk, you should not breastfeed.

Recommended dosage

ADULTS

If you have never taken anti-HIV medication before

Your doctor will prescribe one of the following regimens:

  • Lexiva 1,400 milligrams (two 700-milligram tablets) twice daily (without ritonavir)
  • Lexiva 1,400 milligrams (two 700-milligram tablets) once daily plus ritonavir 200 milligrams once daily
  • Lexiva 700 milligrams (one 700-milligram tablet) twice daily plus ritonavir 100 milligrams twice daily

If you have taken anti-HIV medication anytime before

The recommended dose of Lexiva is 700 milligrams twice daily plus ritonavir 100 milligrams twice daily. HIV-infected persons who have taken protease inhibitors before should NOT take Lexiva plus ritonavir once daily.

If you are taking Lexiva and ritonavir with efavirenz

If you are taking this combination once a day, your doctor will increase the usual dose of ritonavir to 300 milligrams. No dosage adjustment is needed if you are taking this combination twice a day.

CHILDREN

Lexiva is not recommended for use in children.

THOSE WITH REDUCED LIVER FUNCTION

Your doctor may prescribe Lexiva at a reduced dose of 700 milligrams twice daily if you have mild or moderate liver damage and are not also taking ritonavir. Lexiva is not recommended for people with severe liver damage.

Overdosage

Little is known about the symptoms of Lexiva overdose. However, any medication taken in excess can have serious consequences. If you suspect an overdose, seek medical attention immediately.

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