1 What is Lexiva?

Brand: Lexiva

Generic: Fosamprenavir

Lexiva is a protease inhibitor used in combination with other drugs for the treatment of human immunodeficiency virus infection.

This virus causes acquired immune deficiency syndrome (AIDS). The destruction of the immune system caused by HIV may be slowed down by this drug to help delay problems that are usually related to AIDS or HIV disease.

This drug will not cure, or prevent acquiring or transmitting HIV infection. This drug requires a prescription.

2 What to Know Before Using

Before taking Lexiva, the risks and benefits for your body should be discussed with your healthcare provider. Inform your healthcare provider for any allergic reactions to these drugs or any other drugs, foods, dyes, preservatives, or animals. Carefully read the label of non-prescription drugs for any possible allergic reaction or contraindications.

Studies in infants and children 4 weeks of age and older who have not taken HIV drugs in the past have not demonstrated any pediatric-specific problems that would limit the usefulness of fosamprenavir. Use is not recommended in children younger than 6 months of age who have taken HIV drugs in the past.

The safety and efficacy of this drug is not yet established in infants younger than 4 weeks of age. Problems in the elderly are not expected to limit the utility of fosamprenavir in the elderly. Adjustments in the dose of the elderly may be required since they are more likely to have age-related liver, kidney, or heart problems.

Adverse effects have been reported in animal studies but studies in pregnant women or animals are still inadequate. Infant risk is still undetermined when using this drug during breastfeeding.

Discuss with your healthcare professional about the potential risks and benefits of taking this drug while breastfeeding. Drugs should not be taken together to prevent any interactions but in necessary cases inquire your healthcare provider regarding the adjustments in dosage or any other necessary precautions to prevent any unwanted side effects.

Inform your healthcare professional if you are taking any other drugs such as:

  • Alfuzosin
  • Cisapride
  • Delavirdine
  • Dihydroergotamine
  • Eletriptan
  • Ergoloid Mesylates
  • Ergonovine
  • Ergotamine
  • Everolimus
  • Flibanserin
  • Lomitapide
  • Lovastatin
  • Methylergonovine
  • Midazolam
  • Pimozide
  • Quetiapine
  • Ranolazine
  • Rifampin
  • Sildenafil
  • Simvastatin
  • St John's Wort
  • Triazolam
  • Amiodarone
  • Artemether
  • Atazanavir
  • Atorvastatin
  • Bedaquiline
  • Bepridil
  • Boceprevir
  • Bosentan
  • Bosutinib
  • Carbamazepine
  • Ceritinib
  • Clozapine
  • Cobicistat
  • Colchicine
  • Crizotinib
  • Cyclophosphamide
  • Dabrafenib
  • Darunavir
  • Dexamethasone
  • Dolutegravir
  • Domperidone
  • Doxorubicin
  • Doxorubicin Hydrochloride Liposome
  • Efavirenz
  • Etravirine
  • Fentanyl
  • Garlic
  • Ibrutinib
  • Idelalisib
  • Ifosfamide
  • Ixabepilone
  • Lidocaine
  • Lumefantrine
  • Lurasidone
  • Nevirapine
  • Nilotinib
  • Olaparib
  • Piperaquine
  • Posaconazole
  • Quinidine
  • Raltegravir
  • Rifabutin
  • Rifapentine
  • Rosuvastatin
  • Salmeterol
  • Saquinavir
  • Simeprevir
  • Tacrolimus
  • Tadalafil
  • Telaprevir
  • Tipranavir
  • Tolvaptan
  • Cyclosporine
  • Dapsone
  • Desogestrel
  • Dienogest
  • Drospirenone
  • Estradiol Cypionate
  • Estradiol Valerate
  • Ethinyl, Estradiol
  • Ethynodiol Diacetate
  • Etonogestrel
  • Fosphenytoin
  • Ketoconazole
  • Levonorgestrel
  • Lopinavir
  • Maraviroc
  • Medroxyprogesterone Acetate
  • Mestranol
  • Methadone
  • Norelgestromin
  • Norethindrone
  • Norgestimate
  • Norgestrel
  • Olanzapine
  • Paroxetine
  • Phenytoin
  • Pravastatin
  • Ranitidine
  • Ritonavir
  • or Voriconazole

Intake of specific food or using alcohol or tobacco with this drug is associated with an increased risk of certain side effects. Your healthcare professional can give you special instructions about the use of food, alcohol, or tobacco.

Inform your doctor if you have any other medical problems such as:

3 Proper Usage

To use Lexiva properly, you must follow all instructions given by your doctor.

To prevent any side effects, take this drug exactly as directed in the label or as prescribed by your healthcare professional. Check with your healthcare professional before you stop taking this drug. Contact your healthcare professional or pharmacist ahead of time if your supply of this drug is running low. Do not allow yourself to run out of this drug.

This drug comes with a patient information insert. This drug suspension must be taken without food by adults. It is recommended that children must take the oral suspension with food.

Shake the oral suspension well before each use and use a marked measuring spoon, oral syringe, or drug cup to measure the dose.

Fosamprenavir tablets may be taken with or without food that is not high in fat as this may decrease the amount of fosamprenavir that is absorbed by the body and prevent the drug from working properly. It is recommended to take fosamprenavir as part of a combination treatment.

This dose of this drug will be based on what other drugs you are taking, as well as your weight. It is recommended to take all the drugs your healthcare professional has prescribed for you, including fosamprenavir.

This drug must be taken for the full time of treatment to ensure complete drug therapy. This drug works optimally when there is a constant amount in the blood. It is recommended to take the doses at evenly spaced times, day and night.

The dose of this drug will be variable for different patients. The directions on the label or the prescription by your healthcare professional should be followed. The dosage of this drug you take depends on the medical problem for which you are using this drug.

Adults who have not taken HIV drugs in the past with HIV infection are prescribed 1400 milligrams taken two times a day. Adults with no history protease inhibitors use taking this drug together with ritonavir are prescribed 1400 mg of fosamprenavir with 200 mg of ritonavir once a day or 1400 mg of fosamprenavir with 100 mg of ritonavir once a day or 700 mg fosamprenavir with 100 mg ritonavir two times a day.

Adults who have taken HIV drugs taking this drug with ritonavir are prescribed 700 mg of fosamprenavir with 100 mg of ritonavir two times a day. Adults who have taken protease inhibitors in the past should not take the combination of fosamprenavir with ritonavir only once a day.

Check with your healthcare professional for the correct dosage if you are taking fosamprenavir with ritonavir and efavirenz.

The dose in children 4 weeks of age and older is based on body weight and must be determined by your healthcare professional. 18 milligrams per kilogram of body weight taken two times a day with ritonavir 3 mg per kg two times per day is the usual fosamprenavir suspension dosage for patients weighing more than 20 kilogram.

Fosamprenavir doses up to 45 mg per kg two times per day with ritonavir 7 mg/kg two times per day are used for patients weighing less than 11 kg. However, the dose is usually not more than fosamprenavir 700 mg with ritonavir 100 mg two times per day.

The dose in children 2 years of age and older who have not taken protease inhibitors is based on body weight and must be determined by your healthcare professional. The usual suspension dose is 30 mg per kg of body weight two times per day.

Doses up to 1400 mg two times per day may be used for children weighing 47 kg or more. Using fosamprenavir once a day in children 4 weeks of age and older is not recommended for children. This drug must always be given twice daily unless otherwise determined by your healthcare professional. Use and dose in children younger than 4 weeks of age must be determined by your healthcare professional.

A missed dose should be taken as soon as possible. However, skip the missed dose and go back to your regular dosing schedule if it is almost time for your next dose.

Store the drug in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children. Dispose any outdated or expired drugs and ask your healthcare professional for the proper disposal of the drugs.

4 Precautions to Take

Before using Lexiva, there are some precautions you must take.

Regular visits should be made to your healthcare provider to track your progress and to monitor the effectiveness and unwanted effects of the drug. Unwanted effects can be screened using blood tests. Using this drug with alfuzosin (UroxatralВ®), cisapride (PropulsidВ®), delavirdine (RescriptorВ®), flecainide (TambocorВ®), lovastatin (AltocorВ®, MevacorВ®), oral midazolam (VersedВ®), pimozide (OrapВ®), propafenone (RythmolВ®), rifampin (RifadinВ®, RimactaneВ®), sildenafil (RevatioВ®), simvastatin (SimcorВ®, VytorinВ®, ZocorВ®), triazolam (HalcionВ®), or ergot drugs (e.g., dihydroergotamine, ergonovine, ergotamine, methylergonovine, CafergotВ®, D.H.E. 45В®, ErgomarВ®, ErgostatВ®, ErgotrateВ®, MethergineВ®, MigranalВ®, or WigraineВ®) is not recommended.

Consult with your healthcare professional before you take other drugs such as prescription and nonprescription drugs, and herbal or vitamin supplements. Your immune system may get stronger when taking this drug.

Consult with your healthcare professional if you have infections that are hidden in your body which manifest as new symptoms.

Inform your healthcare professional if you are also taking sildenafil (ViagraВ®), tadalafil (CialisВ®), or vardenafil (LevitraВ®), as taking these drugs together may increase your risk of having side effects such as low blood pressure, changes in vision, or prolonged erection of the penis.

This drug may interfere with the effects of birth control pills. Using additional forms of birth control such as condoms, diaphragms, or contraceptive foams or jellies along with your pills is recommended.

This drug may cause hyperglycemia. Consult with your healthcare professional if you have symptoms of skin reaction such as:

  • Blistering
  • Peeling
  • or Loosening of the skin
  • Itching
  • White spots in the mouth or on the lips
  • or redness of the skin

Excess body fat has been associated with the use of this drug. Inform your healthcare professional if you notice changes in your body shape, such as:

  • An increased amount of fat in the upper back and neck.
  • Around the chest and stomach area.

You might also lose fat from the legs, arms, and face. This drug may increase your cholesterol and fats in the blood. If this condition occurs, your healthcare professional may give you or your child some drugs that can lower the amount of cholesterol and fats in the blood.

This drug may increase your risk of having kidney stones. If you have blood in your urine, nausea and vomiting, pain in the groin or genitals, or sharp back pain just below the ribs, check with your healthcare professional immediately.

The risk of transmitting the HIV infection to others through sexual contact or by contamination through blood is not reduced by this drug. Use protective materials such as condoms to prevent such transmissions. Use of oil-based jelly, cold cream, baby oil, or shortening as a lubricant is not recommended as these products can cause the condom to break. Lubricants without oil, such as K-Y Jelly, are recommended. It discouraged to share needles or equipment with anyone.

Inform the healthcare professional in charge that you or your child are taking this drug before you have any medical tests, since the results of some tests may be affected by this drug.

5 Potential Side Effects

As with many medications, there are several potential side effects associated with Lexiva.

Side effects may vary for each individual and prompt medical attention should be given if they occur. Seek advice from your healthcare professional immediately if you experience any unusual symptoms such as:

  • Large amount of fat in the blood
  • Severe skin rash
  • Abdominal or Stomach pain
  • Blurred vision
  • Depression
  • Dry mouth
  • Fatigue
  • Flushed
  • Dry skin
  • Fruit-like breath odor
  • Increased hunger
  • Increased thirst
  • Increased urination
  • Mood or Mental changes
  • Nausea
  • Sweating
  • Troubled breathing
  • Unexplained weight loss
  • Vomiting
  • Back, Leg, or Stomach pains
  • Bleeding gums
  • Blistering
  • Peeling, or Loosening of the skin
  • Chills
  • Cough
  • Dark urine
  • Diarrhea
  • Difficulty with breathing
  • Fever
  • General body
  • Swelling
  • Itching joint or muscle pain
  • Loss of appetite
  • Nosebleeds
  • Pale skin
  • Red skin lesions often with a purple center
  • Red, Irritated eyes
  • Sore throat
  • Sores, Ulcers, or White spots in the mouth or On the lips
  • Unusual tiredness or Weakness
  • yellowing of the eyes or skin
  • Large, Hive-like swelling on the face
  • Eyelids, Lips, Tongue, Throat, Hands, Legs, Feet, or Sex organs

Some side effects may occur that usually do not need medical attention. As your body adjusts to the drug, the side effects will slowly disappear. Ask your healthcare professional about ways to prevent or reduce some of these side effects.

If any of the following side effects persists, or are inconvenient, or if you notice any other effects, or if you have any questions about them, consult with your health care professional. Report any side effects to the FDA hotline at 1-800-FDA-1088.

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