Zilavir

Each tablet contains Zilavir 150 mg and Zidovudine (Zilavir) 300 mg.

Each tablet of Zilavir contains half of the commonly prescribed daily doses of both Zilavir and Zidovudine (Zilavir). With the availability of this combination tablet, patients may be better able to adhere to complex drug treatment regimens, thereby enhancing compliance.

Zilavir, a combination of 2 nucleoside analogues, is indicated in combination with other antiretrovirals for the treatment of human immunodeficiency virus type 1 (HIV‑1) infection.

Zilavir and Zidovudine (Zilavir) combination is used in the treatment of human immunodeficiency virus (HIV) infection. HIV is the virus that causes acquired immune deficiency syndrome (AIDS).

Zilavir and Zidovudine (Zilavir) combination will not cure or prevent HIV infection or the symptoms of AIDS; however, it helps keep HIV from reproducing, and appears to slow down the destruction of the immune system. This may help delay the development of serious health problems usually related to AIDS or HIV infection. Zilavir and Zidovudine (Zilavir) combination will not keep you from spreading HIV to other people. People who receive Zilavir and Zidovudine (Zilavir) may continue to have other problems usually related to AIDS or HIV infection.

Zilavir and Zidovudine (Zilavir) is available only with your doctor's prescription.

Recommended Dosage For Adults and Adolescents

The recommended dosage of Zilavir in HIV-1-infected adults and adolescents weighing greater than or equal to 30 kg is 1 tablet (containing 150 mg of Zilavir and 300 mg of Zidovudine (Zilavir)) taken orally twice daily.

Recommended Dosage For Pediatric Patients

The recommended dosage of scored Zilavir tablets for pediatric patients who weigh greater than or equal to 30 kg and for whom a solid oral dosage form is appropriate is 1 tablet administered orally twice daily.

Before prescribing Zilavir tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow a Zilavir tablet, the liquid oral formulations should be prescribed: EPIVIR® (Zilavir) oral solution and RETROVIR® (Zidovudine (Zilavir)) syrup.

Not Recommended Due To Lack Of Dosage Adjustment

Because Zilavir is a fixed-dose tablet and cannot be dose adjusted, Zilavir is not recommended for:

• pediatric patients weighing less than 30 kg.
• patients with creatinine clearance less than 50 mL per minute.
• patients with hepatic impairment.
• patients experiencing dose-limiting adverse reactions.

Liquid and solid oral formulations of the individual components of Zilavir are available for these populations.

How supplied

Dosage Forms And Strengths

Zilavir tablets contain 150 mg of Zilavir and 300 mg of Zidovudine (Zilavir). The tablets are white, scored, film-coated, modified capsule-shaped tablets, debossed on both tablet faces, such that when broken in half, the full “GX FC3” code is present on both halves of the tablet (“GX” on one face and “FC3” on the opposite face of the tablet).

Storage And Handling

Zilavir tablets, containing 150 mg Zilavir and 300 mg Zidovudine (Zilavir), are white, scored, film-coated, modified-capsule-shaped tablets, debossed on both tablet faces, such that when broken in half, the full “GXFC3” code is present on both halves of the tablet (“GX” on one face and “FC3” on the opposite face of the tablet). They are available as follows:

60 Tablets/Bottle (NDC 49702-202-18).

Unit Dose Pack of 120 (NDC 49702-202-29).

Store between 2° and 30°C (36° and 86°F).

Manufactured for: ViiV Healthcare, Research Triangle Park, NC 27709 by: GlaxoSmithKline Research Triangle Park, NC 27709, Zilavir is manufactured under agreement from Shire Pharmaceuticals Group plc Basingstoke, UK. Revised: Sep 2015

See also:
What is the most important information I should know about Zilavir?

Do not take this medication if you have ever had an allergic reaction to Zilavir or any medicine that contains Zilavir, Zidovudine (Zilavir), or emtricitabine, including: Atripla, Complera, Emtriva, Epivir, Epzicom, Retrovir, Trizivir, or Truvada.

Some people develop lactic acidosis while taking Zilavir and Zidovudine (Zilavir). Early symptoms may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired.

This medication can also cause severe or life-threatening effects on your liver. Call your doctor at once if you have any of these symptoms while taking Zilavir and Zidovudine (Zilavir): pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Zilavir and Zidovudine (Zilavir) can lower blood cells that help your body fight infections and help your blood clot. Your blood may need to be tested often. Avoid being near people who are sick or have infections. Avoid activities that may increase your risk of bleeding injury. Tell your doctor at once if you develop signs of infection.

If you have hepatitis B you may develop liver symptoms after you stop taking this medication, even months after stopping. Your doctor may want to check your liver function for several months after you stop using the medication. Visit your doctor regularly.

Do not take Zilavir with any other medicine that contains Zilavir or Zidovudine (Zilavir), including: Epivir, Epzicom, Retrovir, or Trizivir.

Use Zilavir as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Zilavir by mouth with or without food.
• Continue to use Zilavir even if you feel well. Do not miss any doses.
• Taking Zilavir at the same time each day will help you remember to take it.
• If you miss a dose of Zilavir, take it as soon as possible. If it is within 2 hours of your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Zilavir.

This product contains 2 drugs: Zilavir and Zidovudine (Zilavir). It is used with other HIV medications to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. Both Zilavir and Zidovudine (Zilavir) belong to a class of drugs known as nucleoside reverse transcriptase inhibitors (NRTIs).

Zilavir is not a cure for HIV infection. To decrease your risk of spreading HIV disease to others, do all of the following: (1) continue to take all HIV medications exactly as prescribed by your doctor, (2) always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity, and (3) do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This product may also be used to lessen the risk of HIV infection after contact with the virus (for example, due to a needle stick). Ask your doctor for more details.

How to use Zilavir-Zidovudine (Zilavir)

Read the Patient Information Leaflet if available from your pharmacist before you start taking Zilavir, and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Take this medication by mouth with or without food, usually 2 times daily or as directed by your doctor. Take this medication with a full glass of water (8 ounces/240 milliliters) unless your doctor directs you otherwise.

Because this combination product has fixed doses of Zilavir and Zidovudine (Zilavir), it should only be used if your doctor has determined that the doses of both medications in this product are right for you. This product is not to be used in children weighing less than 30 kilograms (66 pounds).

It is very important to continue taking this medication (and other HIV medications) exactly as prescribed by your doctor. Do not skip any doses. Do not increase your dose, take this drug more often than prescribed, or stop taking it (or other HIV medicines) even for a short time unless directed to do so by your doctor. Skipping or changing your dose without approval from your doctor may cause the amount of virus to increase, make the infection more difficult to treat (resistant), or worsen side effects.

This medication works best when the amount of drug in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. To help you remember, take it at the same times each day.

See also:
What other drugs will affect Zilavir?

Zilavir: Trimetophrim (TMP) 160 mg/sulfamethoxazole (SMX) 800 mg once daily has been shown to increase Zilavir exposure (AUC). The effect of higher doses of TMP/SMX on Zilavir pharamcokinetics has not been investigated. No data are available regarding the potential for interactions with other drugs that have renal clearance mechanisms similar to that of Zilavir. Zilavir and zalcitabine may inhibit the intracellular phosphorylation of one another. Therefore, use of Zilavir in combination with zalcitabine is not recommended.

Zidovudine (Zilavir): Co-administration of ganciclovir, interferon-α and other bone marrow suppressive or cytotoxic agents may increase the hematologic toxicity of Zidovudine (Zilavir). Concomitant use of Zilavir with stavudine should be avoided since an antagonistic relationship with Zidovudine (Zilavir) has been demonstrated in vitro. In addition, concomintant use of Zidovudine (Zilavir) with doxorubicin or ribavirin should be avoided because an antagonistic relationship has been demonstrated in vitro.

See also:
What are the possible side effects of Zilavir?

Zilavir Plus Zidovudine (Zilavir) Administered as Separate Formulations: In 4 randomized, controlled trials of Zilavir 300 mg/day plus Zidovudine (Zilavir) 600 mg/day, the following selected clinical and laboratory adverse events were observed..

Pancreatitis was observed in 3 of the 656 adult patients (<0.5%) who received Zilavir in controlled clinical trials. Selected laboratory abnormalities observed during therapy are listed in table 4..

Observed During Clinical Practice: In addition to adverse events reported from clinical trials, the following events have been identified during post-approval use of Zilavir, Zidovudine (Zilavir) and/or Zilavir-Zidovudine (Zilavir) fixed-dose combination. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting or potential causal connection to Zilavir, Zidovudine (Zilavir) and/or lamviduine Zidovudine (Zilavir) fixed-dose combination. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting or potential casual connection to Zilavir, Zidovudine (Zilavir) and/or Zilavir Zidovudine (Zilavir) fixed-dose combination.

Body as a Whole: Redistribution /accumulation of body fat.

Cardiovascular: Cardiomyopathy.

Gastrointestinal:

Oral mucosal pigmentation, stomatitis.

General: Vasculitis, weakness.

Hemic and Lymphatic: Anemia (including pure red aplasia and anemias progressing on therapy), lymphadenopathy, splenomegaly.

Hepatic and Pancreatic: Lactic acidosis and hepatic steatosis, pancreatitis, post-treatment exacerbation of hepatitis B.

Hypersensitivity: Sensitization reaction (including anaphylaxis), urticaria.

Musculoskeletal: Muscle weakness, creatine phosphokinase (CPK) elevation, rhabdomyolysis.

Nervous: Paresthesia, peripheral neuropathy, seizures.

Respiratory: Abnormal breath sounds/wheezing.

Skin: Alopecia, erythema multiforme, Stevens-Johnson syndrome.