Generic Epzicom® : Abacavir and Lamivudine
Abacavir / Lamivudine is the chemical name of the active ingredient in Epzicom®
Retrovir® is the registered trademark of GlaxoSmithKline Inc.
Epzicom 600MG + 300MG TABLETS
Ingredient Name: ABACAVIR and LAMIVUDINE
Possible Uses of Epzicom:
This product contains 2 drugs: abacavir and lamivudine. 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. Abacavir and lamivudine both belong to a class of drugs known as nucleoside reverse transcriptase inhibitors (NRTIs).
Before using Epzicom:
Before taking abacavir/lamivudine, tell your doctor or pharmacist if you are allergic to either of these drugs; 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.
How to take Epzicom:
Read the Medication Guide and Warning Card provided by your pharmacist before you start taking abacavir/lamivudine and each time you get a refill. Carry the Warning Card with you at all times. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth with or without food, usually once daily or as directed by your doctor.
Because this combination product has fixed doses of abacavir and lamivudine, it should only be used if your doctor has determined that the doses of both medications in this product are right for you.
If you stop taking any medication containing abacavir even for a short time and then restart the drug, you have an increased chance of developing a very serious (possibly fatal) allergic reaction. Refill your medication before you run out. Do not stop treatment unless directed by your doctor. Before restarting any medication containing abacavir, consult your doctor or pharmacist, and be sure you have easy access to medical care.
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.
For the best effect, take this medication at evenly spaced times. To help you remember, take this medication at the same time every day.
Precautions When Using Epzicom:
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, liver problems (such as hepatitis B or C, cirrhosis), disease of the pancreas (pancreatitis), alcohol use.
Abacavir may increase your risk of a heart attack. Discuss the risks and benefits of treatment with your doctor and ways to lower your risk of heart disease. Tell your doctor if you have heart problems, if you smoke, or if you have other conditions that increase your risk of heart disease, such as high blood pressure, diabetes, or high cholesterol levels.
This drug may make you dizzy. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Alcohol may also increase the risk of liver problems and pancreatitis. Talk to your doctor if you are using marijuana.
Children may be more sensitive to the side effects of this drug, especially pancreatitis.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Tell your doctor if you are pregnant before using this medication. Treatment can lower the risk of passing HIV infection to your baby. Discuss the risks and benefits with your doctor.
This medication passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.
Side Effects of Epzicom:
Headache, nausea, diarrhea, dizziness, tiredness, or trouble sleeping may 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.
As your immune system gets stronger, it can begin to fight off infections you already had, possibly causing disease symptoms to come back. You could also have symptoms if your immune system becomes overactive. This reaction may happen at any time (soon after starting HIV treatment or many months later). Get medical help right away if you have any serious symptoms, including: unexplained weight loss, severe tiredness, muscle aches/weakness that doesn't go away, headaches that are severe or don't go away, joint pain, numbness/tingling of the hands/feet/arms/legs, vision changes, signs of infection (such as fever, chills, swollen lymph nodes, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre syndrome (such as trouble breathing/swallowing/moving your eyes, drooping face, paralysis, trouble speaking).
Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as depression, anxiety), easy bruising/bleeding, signs of anemia (such as unusual tiredness, fast breathing, pale skin, fast heartbeat).
Get medical help right away if you have any very serious side effects, including: signs of pancreatitis (such as nausea, vomiting, stomach/abdominal/back pain, fever).
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.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
Overdose of Epzicom:
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call a poison control center right away.
Other Information of Epzicom:
Always carry the warning card that describes the symptoms of a hypersensitivity reaction to this medicine. DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.
This information is not intended to substitute for professional medical advice. Be sure to contact your physician, pharmacist or other health care provider for more information about this medication.
atazanavir (VIRATAZ-R) - atazanavir (VIRATAZ-R) is an antiviral medication in a group of HIV medicines called protease (PRO-tee-ayz) inhibitors. atazanavir (VIRATAZ-R) prevents human immunodeficiency virus (HIV) cells from multiplying in your body.
atazanavir (VIRATAZ-R) is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). atazanavir (VIRATAZ-R) is not a cure for HIV or AIDS.
atazanavir (VIRATAZ-R) may also be used for purposes not listed in this medication guide.
atazanavir (VIRATAZ-R) (ATV) is an azapeptide HIV-1 protease inhibitor (PI) with activity against Human Immunodeficiency Virus Type 1 (HIV-1). HIV-1 protease is an enzyme required for the proteolytic cleavage of the viral polyprotein precursors into the individual functional proteins found in infectious HIV-1. atazanavir (VIRATAZ-R) binds to the protease active site and inhibits the activity of the enzyme. This inhibition prevents cleavage of the viral polyproteins resulting in the formation of immature non-infectious viral particles. Protease inhibitors are almost always used in combination with at least two other anti-HIV drugs. Atazanivir is pharmacologically related but structurally different from other protease inhibitors and other currently available antiretrovirals.
Possible Uses of Virataz-R:Atazanavir is a combination of an HIV protease inhibitor and an inhibitor of medicine metabolism. The HIV protease inhibitor works by blocking the growth of HIV. The inhibitor of medicine metabolism works by boosting the action of other HIV medicines.
Norvir (ritonavir) is an antiviral medicine that prevents human immunodeficiency virus (HIV) cells from multiplying in your body. Ritonavir is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). It is not a cure for HIV or AIDS. Ritonavir may also be used for purposes not listed in this medication guide.
Before using Virataz-R:Some medical conditions may interact with atazanavir. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have hemophilia, diabetes or high blood sugar, heart problems (eg, irregular heartbeat), or kidney problems
if you have a history of kidney stones, gallstones, or hepatitis B or C
You should not take Ritonavir if you are allergic to ritonavir. There are certain medicines that can cause life-threatening drug interactions with ritonavir, and should not be used at the same time. Your doctor may need to change your treatment plan if you use any of the following drugs:
·St. John's wort;
·sildenafil (Revatio) when used to treat pulmonary arterial hypertension (PAH);
·heart rhythm medicine--amiodarone, flecainide, propafenone, quinidine; or
·a sedative--oral midazolam or triazolam.
How to take Virataz-R:Use atazanavir as directed by your doctor. Check the label on the medicine for exact dosing instructions. An extra patient leaflet is available with atazanavir. Talk to your pharmacist if you have questions about this information. Take atazanavir by mouth with food. If you also take an H2 antagonist (eg, cimetidine) or a proton pump inhibitor (PPI) (eg, omeprazole), talk with your doctor about how to take it with atazanavir.
If you also take didanosine, take atazanavir at least 2 hours before or 1 hour after the didanosine. ·If you also take an antacid, take atazanavir at least 2 hours before or 2 hours after the antacid. Take atazanavir on a regular schedule to get the most benefit from it. ·Taking atazanavir at the same time each day will help you remember to take it. Continue to use atazanavir even if you feel well. Do not miss any doses.
Ask your health care provider any questions you may have about how to use atazanavir.
Take Ritonavir exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.
Ritonavir tablets must be taken with meals. Ritonavir capsules or liquid should be taken with food if possible. Do not crush, chew, or break a tablet. Swallow it whole. Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one. Liquid Ritonavir can be mixed with chocolate milk or a nutrition drink such as Ensure. Drink the mixture within 1 hour after mixing.
If a child is using this medicine, tell your doctor if the child has any changes in weight or height. Ritonavir doses are based on body surface area in children. Use this medicine regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely. Your blood will need to be tested on a regular basis. Your liver function may also need to be tested. HIV/AIDS is usually treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice. Every person with HIV or AIDS should remain under the care of a doctor.
Precautions When Using Virataz-R:Tell your doctor or dentist that you take atazanavir before you receive any medical or dental care, emergency care, or surgery. Atazanavir interacts with many other medicines. The risk of atazanavir's side effects may be increased or atazanavir's effectiveness may be decreased. The risk of the other medicines' side effects may also be increased. This may include severe, life-threatening, or fatal side effects. Check with your doctor and pharmacist to make sure that it is safe for you to take atazanavir with all of your other medicines (prescription or OTC, natural products, vitamins).
Atazanavir is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor. ·When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking atazanavir, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat. Atazanavir does not stop the spread of HIV to others through blood or sexual contact. Do not have any kind of sex without protection (eg, latex or polyurethane condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors. Talk with your health care provider about ways to prevent the spread of HIV to others.
Do NOT take more than the recommended dose, change your dose, or stop taking atazanavir without checking with your doctor. Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk; loss of fat from the legs, arms, and face) may occur in some patients taking atazanavir. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor. Hormonal birth control (eg, birth control pills) may not work as well while you are using atazanavir. To prevent pregnancy, use an extra form of birth control (eg, condoms).
Atazanavir may improve immune system function. This may reveal hidden infections in some patients. Tell your doctor right away if you notice symptoms of an infection (eg, fever, sore throat, weakness, cough, shortness of breath) or any other unusual symptoms after you start atazanavir. Severe skin reactions (Stevens-Johnson syndrome/toxic epidermal necrolysis) have happened. They can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
Serious kidney problems (eg, kidney failure) have happened in people taking atazanavir with another HIV medicine (tenofovir). Discuss any questions or concerns with your doctor. Atazanavir may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away. Diabetes patients - Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine. Hemophilia patients - Some people with hemophilia have developed increased bleeding while taking protease inhibitors, such as atazanavir. Report all bleeding episodes to your doctor.
Lab tests may be performed while you use atazanavir. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Atazanavir should not be used in CHILDREN younger than 3 months old; a type of brain damage caused by high blood bilirubin levels (kernicterus) may occur.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using atazanavir while you are pregnant. If you take atazanavir during pregnancy, tell your doctor if your baby's skin or eyes turn yellow. It is not known if this medicine is found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or atazanavir to the baby.
Ritonavir: Ritonavir capsules and oral liquid contain alcohol. Avoid drinking alcoholic beverages while using this medicine, and do not take disulfiram (Antabuse) or you could have an alcohol reaction. Taking this medicine will not prevent you from passing HIV to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.
Side Effects of Virataz-R:All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; dizziness; fainting; fever; irregular heartbeat; light-headedness; muscle or joint aches; painful urination; severe or persistent nausea or vomiting; stomach or back pain; symptoms of kidney problems (eg, not able to pass urine, change in how much urine is passed, blood in the urine, a big weight gain); symptoms of liver problems (eg, dark urine, pale stools, persistent loss of appetite, right-upper stomach pain, yellowing of skin or eyes); yellowing of skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider.
Ritonavir: Get emergency medical help if you have any of these signs of an allergic reaction to Ritonavir : hives, skin sores, mouth sores; joint or muscle pain; wheezing, difficulty breathing, fast or pounding heartbeats; sweating, feeling light-headed; swelling of your face, lips, tongue, or throat.
Stop taking Ritonavir and call your doctor at once if you have:
·a light-headed feeling, like you might pass out;
·easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
·pancreas problems--severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
·liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
·severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Ritonavir may increase your risk of certain infections or autoimmune disorders by changing the way your immune system works. Symptoms may occur weeks or months after you start treatment with Ritonavir. Tell your doctor if you have:
·signs of a new infection--fever, night sweats, swollen glands, mouth sores, diarrhea, stomach pain, weight loss;
·chest pain (especially when you breathe), dry cough, wheezing, feeling short of breath;
·cold sores, sores on your genital or anal area;
·rapid heart rate, feeling anxious or irritable, weakness or prickly feeling, problems with balance or eye movement;
·trouble speaking or swallowing, severe lower back pain, loss of bladder or bowel control; or
·swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence, loss of interest in sex.
Common Ritonavir side effects may include:
·nausea, vomiting, stomach pain, diarrhea;
·numbness or tingling, especially around your mouth;
·weakness, tired feeling;
·mild rash; or
·changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
Missed dose of Virataz-R:If you miss a dose take it as soon as possible. If it has been 12 hours or more since the missed dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Overdose of Virataz-R:Seek emergency medical attention or call the Poison Help line.
Storage of Virataz-R:Store at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep out of the reach of children and away from pets.
Other Information of Virataz-R: DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. KEEP THIS MEDICINE out of the reach of children. IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out.