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ABACAVIR AND LAMIVUDINE- abacavir sulfate and lamivudine tablet, film coated


  1. Patient Information
  2. Inform Patients:
  3. Abacavir And Lamivudine Tablets Can Cause Serious Side Effects, Including:
  4. What Are Abacavir And Lamivudine Tablets?
  5. When Used With Other Antiretroviral Medicines To Treat Hiv-1 Infection, Abacavir And Lamivudine Tablets May Help:
  6. Do Not Take Abacavir And Lamivudine Tablets If You:
  7. Before You Take Abacavir And Lamivudine Tablets Tell Your Healthcare Provider If You:
  8. Tell Your Healthcare Provider If You Take:
  9. How Should I Take Abacavir And Lamivudine Tablets?
  10. Abacavir And Lamivudine Tablets Can Cause Serious Side Effects Including:
  11. What Are The Ingredients In Abacavir And Lamivudine Tablets?
  12. Notice To Authorized Dispenser:
  13. Distributed By:
  14. Manufactured By:
  15. Revised: 7/2019document Id:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Hypersensitivity Reactions

Inform Patients: 

that a Medication Guide and Warning Card summarizing the symptoms of the abacavir hypersensitivity reaction and other product information will be dispensed by the pharmacist with each new prescription and refill of Abacavir and Lamivudine tablets and instruct the patient to read the Medication Guide and Warning Card every time to obtain any new information that may be present about Abacavir and Lamivudine tablets. The complete text of the Medication Guide is reprinted at the end of this document.
to carry the Warning Card with them.
how to identify a hypersensitivity reaction[

Abacavir And Lamivudine Tablets Can Cause Serious Side Effects, Including: 

Serious allergic reactions (hypersensitivity reaction)that can cause death have happened with Abacavir and Lamivudine tablets and other abacavir-containing products. Your risk of this allergic reaction is much higher if you have a gene variation called HLA-B*5701. Your healthcare provider can determine with a blood test if you have this gene variation.
If you get a symptom from 2 or more of the following groups while taking Abacavir and Lamivudine tablets, call your healthcare provider right away to find out if you should stop taking Abacavir and Lamivudine tablets.

Symptom(s)

Group 1

Fever

Group 2

Rash

Group 3

Nausea, vomiting, diarrhea, abdominal (stomach area) pain

Group 4

Generally ill feeling, extreme tiredness, or achiness

Group 5

Shortness of breath, cough, sore throat

A list of these symptoms is on the Warning Card your pharmacist gives you.Carry this Warning Card with you at all times.
If you stop Abacavir and Lamivudine tablets because of an allergic reaction, never take Abacavir and Lamivudine tablets or any other abacavir-containing medicine (EPZICOM, TRIUMEQ, TRIZIVIR, or ZIAGEN) again.
If you have an allergic reaction, dispose of any unused Abacavir and Lamivudine tablets. Ask your pharmacist how to properly dispose of medicines.
If you take Abacavir and Lamivudine tablets or any other abacavir-containing medicine again after you have had an allergic reaction,within hoursyou may getlife-threatening symptomsthat may includevery low blood pressure or death.
If you stop Abacavir and Lamivudine tablets for any other reason, even for a few days, and you are not allergic to Abacavir and Lamivudine tablets, talk with your healthcare provider before taking it again. Taking Abacavir and Lamivudine tablets again can cause a serious allergic or life-threatening reaction, even if you never had an allergic reaction to it before.

If your healthcare provider tells you that you can take Abacavir and Lamivudine tablets again, start taking it when you are around medical help or people who can call a healthcare provider if you need one.

Worsening of hepatitis B virus in people who have HIV-1 infection.If you have HIV-1 and hepatitis B virus (HBV) infection, your HBV may get worse (flare-up) if you stop taking Abacavir and Lamivudine tablets. A flare-up is when your HBV infection suddenly returns in a worse way than before. Worsening liver disease can be serious and may lead to death.
Do not run out of Abacavir and Lamivudine tablets. Refill your prescription or talk to your healthcare provider before your Abacavir and Lamivudine tablets are all gone.
Do not stop Abacavir and Lamivudine tablets without first talking to your healthcare provider.
If you stop taking Abacavir and Lamivudine tablets, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your liver.
Resistant Hepatitis B Virus (HBV).If you have HIV-1 and hepatitis B, the hepatitis B virus can change (mutate) during your treatment with Abacavir and Lamivudine tablets and become harder to treat (resistant).

What Are Abacavir And Lamivudine Tablets? 

Abacavir and Lamivudine tablets are a prescription HIV-1 (Human Immunodeficiency Virus-type 1) medicine used with other antiretroviral medicines to treat HIV-1 infection. HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS). Abacavir and Lamivudine tablets contain 2 prescription medicines, abacavir (ZIAGEN) and lamivudine (EPIVIR).

Abacavir and Lamivudine tablets should not be used in children weighing less than 55 pounds (25 kg).

When Used With Other Antiretroviral Medicines To Treat Hiv-1 Infection, Abacavir And Lamivudine Tablets May Help: 

1.
reduce the amount of HIV-1 in your blood. This is called viral load .
2.
increase the number of CD4+ (T) cells in your blood, that help fight off other infections.

Reducing the amount of HIV-1 and increasing the CD4+ (T) cells in your blood may help improve your immune system. This may reduce your risk of death or getting infections that can happen when your immune system is weak (opportunistic infections).

Abacavir and Lamivudine tablets do not cure HIV-1 infection or AIDS.You must keep taking HIV-1 medicines to control HIV-1 infection and decrease HIV-related illnesses.

Do Not Take Abacavir And Lamivudine Tablets If You: 

have a certain type of gene variation called the HLA-B*5701 allele. Your healthcare provider will test you for this before prescribing treatment with Abacavir and Lamivudine tablets.
are allergic to abacavir or any of the ingredients in Abacavir and Lamivudine tablets.

Before You Take Abacavir And Lamivudine Tablets Tell Your Healthcare Provider If You: 

have been tested and know whether or not you have a particular gene variation called HLA-B*5701.
have or have had liver problems, including hepatitis B or C virus infection.
have kidney problems.
have heart problems, smoke, or have diseases that increase your risk of heart disease such as high blood pressure, high cholesterol, or diabetes.
drink alcohol or take medicines that contain alcohol.
are pregnant or plan to become pregnant. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
Pregnancy Registry.There is a pregnancy registry for women who take antiretroviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.
are breastfeeding or plan to breastfeed.Do not breastfeed if you take Abacavir and Lamivudine tablets.
You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.

Tell your healthcare provider about all the medicines you take,including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Some medicines interact with Abacavir and Lamivudine tablets.Keep a list of your medicines to show your healthcare provider and pharmacist.You can ask your healthcare provider or pharmacist for a list of medicines that interact with Abacavir and Lamivudine tablets.Do not start taking a new medicine without telling your healthcare provider.Your healthcare provider can tell you if it is safe to take Abacavir and Lamivudine tablets with other medicines.

Tell Your Healthcare Provider If You Take: 

any other medicine to treat HIV-1
medicines to treat hepatitis viruses such as interferon or ribavirin
methadone

How Should I Take Abacavir And Lamivudine Tablets? 

Take Abacavir and Lamivudine tablets exactly as your healthcare provider tells you.
Do not change your dose or stop taking Abacavir and Lamivudine tablets without talking with your healthcare provider. If you miss a dose of Abacavir and Lamivudine tablets, take it as soon as you remember. Do not take 2 doses at the same time. If you are not sure about your dosing, call your healthcare provider.
Stay under the care of a healthcare provider while taking Abacavir and Lamivudine tablets.
Abacavir and Lamivudine tablets may be taken with or without food.
Tell your healthcare provider if your child has trouble swallowing Abacavir and Lamivudine tablets.
Do not run out of Abacavir and Lamivudine tablets. The virus in your blood may increase and the virus may become harder to treat. When your supply starts to run low, get more from your healthcare provider or pharmacy.
If you take too much Abacavir and Lamivudine tablets, call your healthcare provider or go to the nearest hospital emergency room right away.

Abacavir And Lamivudine Tablets Can Cause Serious Side Effects Including: 

Store Abacavir and Lamivudine tablets at 59 F to 86 F (15 C to 30 C).

Keep Abacavir and Lamivudine tablets and all medicines out of the reach of children.

General information for safe and effective use of Abacavir and Lamivudine tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Abacavir and Lamivudine tablets for a condition for which it was not prescribed. Do not give Abacavir and Lamivudine tablets to other people, even if they have the same symptoms that you have. It may harm them.

If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for the information about Abacavir and Lamivudine tablets that is written for health professionals.

What Are The Ingredients In Abacavir And Lamivudine Tablets? 

Active ingredients: abacavir sulfate and lamivudine

Inactive ingredients: magnesium stearate, microcrystalline cellulose, sodium starch glycolate.

Tablet film coating contains: OPADRY orange YS-1-13065-A made of FD&C Yellow No. 6, hypromellose, polyethylene glycol 400, polysorbate 80, and titanium dioxide.

Manufactured for: by:
Prasco LaboratoriesGlaxoSmithKline
Mason, OH 45040 USA Research Triangle Park, NC 27709

The brands listed are trademarks owned by or licensed to their respective owners and are not trademarks owned by or licensed to Prasco Laboratories. The makers of these brands are not affiliated with and do not endorse Prasco Laboratories or its products.

EPZ-PS:4MG

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised: 07/2019

Principal Display Panel

NDC 66993-482-30

Abacavir and Lamivudine Tablets

600 mg 300 mg

Each tablet contains 600 mg of abacavir as abacavir sulfate and 300 mg of lamivudine.

See prescribing information for dosage information.

Store at 25oC (77oF); excursions permitted to 15oto 30oC (59oto 86oF) (see USP Controlled Room Temperature).

Notice To Authorized Dispenser: 

Each time Abacavir and Lamivudine Tablets are dispensed, give the patient a Medication Guide and Warning Card from the carton.

Rxonly

30 Tablets

Lamivudine is manufactured under agreement fromShire Pharmaceuticals Group plc,Basingstoke, UK

Distributed By: 

Prasco Laboratories

Mason, OH 45040 USA

Manufactured By: 

GlaxoSmithKline

Research Triangle Park, NC 27709

Made in England

10000000140156 Rev. 4/16
Abacavir and Lamivudine Tablets 30 count carton
ABACAVIR AND LAMIVUDINE
abacavir sulfate and lamivudine tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66993-482
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ABACAVIR SULFATE(UNII: J220T4J9Q2) (ABACAVIR - UNII:WR2TIP26VS)ABACAVIR600 mg
LAMIVUDINE(UNII: 2T8Q726O95) (LAMIVUDINE - UNII:2T8Q726O95)LAMIVUDINE300 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
ColorORANGEScoreno score
ShapeOVAL (capsule-shaped)Size20mm
FlavorImprint CodeGS;FC2
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66993-482-3030 in 1 BOTTLE; Type 0: Not a Combination Product09/29/201612/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDA authorized genericNDA02165209/29/201612/31/2020
Labeler -Prasco Laboratories (065969375)

Revised: 7/2019document Id: 

ee69959a-8c33-497b-a309-1c4a50a2b127Set id: 133490fc-26eb-4c92-a21d-52be4c226b74Version: 7Effective Time: 20190718Prasco Laboratories



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