Viracept

DRUG DESCRIPTION

VIRACEPT® (nelfinavir mesylate) is an inhibitor of the human immunodeficiency virus (HIV) protease. VIRACEPT (nelfinavir mesylate) Tablets are available for oral administration as a light blue, capsule-shaped tablet with a clear film coating in 250 mg strength (as nelfinavir free base) and as a white oval tablet with a clear film coating in 625 mg strength (as nelfinavir free base). Each tablet contains the following common inactive ingredients: calcium silicate, crospovidone, magnesium stearate, hypromellose, and triacetin. In addition, the 250 mg tablet contains FD&C blue #2 powder and the 625 mg tablet contains colloidal silicon dioxide. VIRACEPT (nelfinavir mesylate) Oral Powder is available for oral administration in a 50 mg/g strength (as nelfinavir free base) in bottles. The oral powder also contains the following inactive ingredients: microcrystalline cellulose, maltodextrin, dibasic potassium phosphate, crospovidone, hypromellose, aspartame, sucrose palmitate, and natural and artificial flavor. The chemical name for nelfinavir mesylate is [3S[2(2S*, 3S*), 3?,4a?,8a?]]-N-(1,1-dimethylethyl)decahydro-2-[2-hydroxy-3-[(3-hydroxy2-methylbenzoyl)amino]-4-(phenylthio)butyl]-3-isoquinoline carboxamide monomethanesulfonate (salt) and the molecular weight is 663.90 (567.79 as the free base). Nelfinavir mesylate has the following structural formula:

VIRACEPT® (nelfinavir mesylate)  Structural Formula Illustration

Nelfinavir mesylate is a white to off-white amorphous powder, slightly soluble in water at pH ? 4 and freely soluble in methanol, ethanol, 2-propanol and propylene glycol.

What are the possible side effects of nelfinavir (Viracept)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking nelfinavir and call your doctor at once if you have any of these serious side effects:

  • increased urination or extreme thirst;
  • easy bruising or bleeding; or
  • signs of a new infection, such as fever or chills, cough, or flu symptoms.

Less serious side effects may include:

  • nausea, vomiting, diarrhea,...

Read All Potential Side Effects and See Pictures of Viracept »

What are the precautions when taking nelfinavir mesylate (Viracept)?

Before taking nelfinavir, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, heart problems (coronary artery disease, heart attack), lipid problems (high cholesterol or triglycerides/fats), hemophilia, liver problems.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Children may be more sensitive to the side effects of this drug, especially diarrhea or rash.

Tell...

Read All Potential Precautions of Viracept »


Viracept Consumer (continued)

SIDE EFFECTS: Diarrhea is a common side effect of this medication. If you have diarrhea, ask your doctor or pharmacist about ways to lessen this side effect, such as using anti-diarrhea medicine. Nausea or gas may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Seek immediate medical attention if any of these rare but serious side effects occur: symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating), easy bruising/bleeding, persistent nausea/vomiting, stomach/abdominal pain, dark urine, yellowing eyes/skin.

This medication may infrequently make your blood sugar level rise, which can cause or worsen diabetes. Tell your doctor immediately if you develop symptoms of high blood sugar such as increased thirst and urination. If you already have diabetes, check your blood sugar levels regularly. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Changes in body fat may occur while you are taking this medication (such as increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of treatment with your doctor, as well as the possible use of exercise to reduce this side effect.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking nelfinavir, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, heart problems (coronary artery disease, heart attack), lipid problems (high cholesterol or triglycerides/fats), hemophilia, liver problems.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Children may be more sensitive to the side effects of this drug, especially diarrhea or rash.

Tell your doctor if you are pregnant before using this medication.

It is unknown if this medication passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.


Viracept Patient Information Including Side Effects

Brand Names: Viracept

Generic Name: nelfinavir (Pronunciation: nel FIN a veer)

  • What is nelfinavir (Viracept)?
  • What are the possible side effects of nelfinavir (Viracept)?
  • What is the most important information I should know about nelfinavir (Viracept)?
  • What should I discuss with my healthcare provider before taking nelfinavir (Viracept)?
  • How should I take nelfinavir (Viracept)?
  • What happens if I miss a dose (Viracept)?
  • What happens if I overdose (Viracept)?
  • What should I avoid while taking nelfinavir (Viracept)?
  • What other drugs will affect nelfinavir (Viracept)?
  • Where can I get more information?

What is nelfinavir (Viracept)?

Nelfinavir is an antiviral medication in a group of HIV medicines called protease (PRO-tee-ayz) inhibitors. Nelfinavir prevents human immunodeficiency virus (HIV) cells from multiplying in your body.

Nelfinavir is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). Nelfinavir is not a cure for HIV or AIDS.

Nelfinavir may also be used for other purposes not listed in this medication guide.

What are the possible side effects of nelfinavir (Viracept)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking nelfinavir and call your doctor at once if you have any of these serious side effects:

  • increased urination or extreme thirst;
  • easy bruising or bleeding; or
  • signs of a new infection, such as fever or chills, cough, or flu symptoms.

Less serious side effects may include:

  • nausea, vomiting, diarrhea, stomach pain, bloating, loss of appetite;
  • tired feeling;
  • headache, mood changes; or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and trunk).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about nelfinavir (Viracept)?

A European version of nelfinavir was found to have high levels of an impurity known to cause cancer in animals. Nelfinavir in the U.S. was found to have lower levels of the impurity, which is created during the manufacturing process but can be minimized.

It is not known whether this impurity has caused harm to anyone taking nelfinavir, and it is important to keep treating your condition. Children and pregnant women should not take nelfinavir as a "first-line" treatment. If you already take nelfinavir your doctor may recommend that you keep taking it. Do not stop taking nelfinavir or change your dose without your doctor's advice.

Do not take nelfinavir with amiodarone (Cordarone, Pacerone), quinidine (Quinaglute, Quinidex), pimozide (Orap), midazolam (Versed), triazolam (Halcion), or an ergot medicine such as Ergomar, Cafergot, Wigraine, D.H.E. 45, Migranal, or Methergine. These drugs can cause life-threatening side effects if you use them while you are taking nelfinavir.

There are many other medicines that can interact with nelfinavir. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors.

Taking this medication will not prevent you from passing HIV to other people. Talk with your doctor about safe methods of preventing HIV transmission during sex.

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