Combid 300

Combid 300, 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.

Combid 300 and Zidovudine (Combid 300) combination is used in the treatment of human immunodeficiency virus (HIV) infection. HIV is the virus that causes acquired immune deficiency syndrome (AIDS).

Combid 300 and Zidovudine (Combid 300) 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. Combid 300 and Zidovudine (Combid 300) combination will not keep you from spreading HIV to other people. People who receive Combid 300 and Zidovudine (Combid 300) may continue to have other problems usually related to AIDS or HIV infection.

Combid 300 and Zidovudine (Combid 300) is available only with your doctor's prescription.

Recommended Dosage For Adults and Adolescents

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

Recommended Dosage For Pediatric Patients

The recommended dosage of scored Combid 300 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 Combid 300 tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow a Combid 300 tablet, the liquid oral formulations should be prescribed: EPIVIR® (Combid 300) oral solution and RETROVIR® (Zidovudine (Combid 300)) syrup.

Not Recommended Due To Lack Of Dosage Adjustment

Because Combid 300 is a fixed-dose tablet and cannot be dose adjusted, Combid 300 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 Combid 300 are available for these populations.

How supplied

Dosage Forms And Strengths

Combid 300 tablets contain 150 mg of Combid 300 and 300 mg of Zidovudine (Combid 300). 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

Combid 300 tablets, containing 150 mg Combid 300 and 300 mg Zidovudine (Combid 300), 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, Combid 300 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 Combid 300?

Do not take this medication if you have ever had an allergic reaction to Combid 300 or any medicine that contains Combid 300, Zidovudine (Combid 300), or emtricitabine, including: Atripla, Complera, Emtriva, Epivir, Epzicom, Retrovir, Trizivir, or Truvada.

Some people develop lactic acidosis while taking Combid 300 and Zidovudine (Combid 300). 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 Combid 300 and Zidovudine (Combid 300): pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Combid 300 and Zidovudine (Combid 300) 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 Combid 300 with any other medicine that contains Combid 300 or Zidovudine (Combid 300), including: Epivir, Epzicom, Retrovir, or Trizivir.

Use Combid 300 as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Combid 300 by mouth with or without food.
• Continue to use Combid 300 even if you feel well. Do not miss any doses.
• Taking Combid 300 at the same time each day will help you remember to take it.
• If you miss a dose of Combid 300, 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 Combid 300.

This product contains 2 drugs: Combid 300 and Zidovudine (Combid 300). 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 Combid 300 and Zidovudine (Combid 300) belong to a class of drugs known as nucleoside reverse transcriptase inhibitors (NRTIs).

Combid 300 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 Combid 300-Zidovudine (Combid 300)

Read the Patient Information Leaflet if available from your pharmacist before you start taking Combid 300, 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 Combid 300 and Zidovudine (Combid 300), 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 Combid 300?

Combid 300: Trimetophrim (TMP) 160 mg/sulfamethoxazole (SMX) 800 mg once daily has been shown to increase Combid 300 exposure (AUC). The effect of higher doses of TMP/SMX on Combid 300 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 Combid 300. Combid 300 and zalcitabine may inhibit the intracellular phosphorylation of one another. Therefore, use of Combid 300 in combination with zalcitabine is not recommended.

Zidovudine (Combid 300): Co-administration of ganciclovir, interferon-α and other bone marrow suppressive or cytotoxic agents may increase the hematologic toxicity of Zidovudine (Combid 300). Concomitant use of Combid 300 with stavudine should be avoided since an antagonistic relationship with Zidovudine (Combid 300) has been demonstrated in vitro. In addition, concomintant use of Zidovudine (Combid 300) 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 Combid 300?

Combid 300 Plus Zidovudine (Combid 300) Administered as Separate Formulations: In 4 randomized, controlled trials of Combid 300 300 mg/day plus Zidovudine (Combid 300) 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 Combid 300 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 Combid 300, Zidovudine (Combid 300) and/or Combid 300-Zidovudine (Combid 300) 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 Combid 300, Zidovudine (Combid 300) and/or lamviduine Zidovudine (Combid 300) 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 Combid 300, Zidovudine (Combid 300) and/or Combid 300 Zidovudine (Combid 300) 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.

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

Each tablet of Combid 300 contains half of the commonly prescribed daily doses of both Combid 300 and Zidovudine (Combid 300). With the availability of this combination tablet, patients may be better able to adhere to complex drug treatment regimens, thereby enhancing compliance.