DOLUTEGRAVIR - ORAL

DOLUTEGRAVIR - ORAL

PHONETIC PRONUNCIATION: (DOE-loo-TEG-ra-vir)

COMMON BRAND NAME(S): Tivicay

GENERIC NAME(S): dolutegravir sodium

Uses

USES: Dolutegravir 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. Dolutegravir belongs to a class of drugs known as integrase inhibitors. It blocks the virus from growing and infecting more cells. Dolutegravir 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.


How to use DOLUTEGRAVIR - ORAL

HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking dolutegravir and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with or without food as directed by your doctor, usually 1 to 2 times daily. Take this medication at least 2 hours before or 6 hours after taking sucralfate and products containing aluminum or magnesium (such as antacids, laxatives, buffered medications). These products bind with dolutegravir, decreasing its effectiveness. If you are also taking calcium or iron supplements (including vitamins/minerals that contain calcium or iron), take dolutegravir at least 2 hours before or 6 hours after these products. Or you can take dolutegravir and calcium or iron supplements together at the same time with food. The dosage is based on your medical condition, response to treatment, age, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). In children, the dosage is also based on weight. It is very important to continue taking this medication (and other HIV medications) exactly as prescribed by your doctor. Do not skip any doses. For the best effect, take this medication at evenly spaced times. To help you remember, take this medication at the same time(s) every day. Do not take more or less of this drug than prescribed or stop taking it (or other HIV medicines) even for a short time unless directed to do so by your doctor. Doing so may cause the amount of virus to increase, make the infection more difficult to treat (resistant), or worsen side effects.

Side Effects

SIDE EFFECTS: Headache and 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: dark urine, persistent nausea/vomiting/loss of appetite, stomach/abdominal pain, yellowing eyes/skin, signs of kidney problems (such as change in the amount of urine), mental/mood changes (such as depression, thoughts of suicide). 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. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash (especially if you also have fever, blisters, mouth sores, eye redness/swelling, muscle/joint pain), itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

PRECAUTIONS: Before taking dolutegravir, tell your doctor or pharmacist if you are allergic to it; 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. Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease (such as hepatitis B, hepatitis C), kidney disease. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or if you plan to become pregnant. Your doctor should direct you to get a pregnancy test before starting this medication. You should not become pregnant while using dolutegravir. Dolutegravir may harm an unborn baby, especially during the first few months of pregnancy. Ask about reliable forms of birth control while using this medication. It is unknown if this medication passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.

Interactions

DRUG INTERACTIONS: See also How to Use section. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: dofetilide, orlistat.

Overdose

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

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TIVICAY 50 MG TABLET

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Faq for DOLUTEGRAVIR - ORAL

Dolutegravir is an antiretroviral medication used in the treatment of HIV infection. It belongs to a class of drugs called integrase strand transfer inhibitors (INSTIs).

Dolutegravir works by blocking the integrase enzyme, which is necessary for HIV to replicate and integrate its genetic material into the DNA of human cells. By inhibiting this enzyme, Dolutegravir helps to prevent the virus from multiplying and spreading throughout the body.

Dolutegravir is used as part of combination therapy for the treatment of HIV infection in adults and children above a certain age and weight. It is usually prescribed along with other antiretroviral drugs to achieve viral suppression and improve immune function.

Dolutegravir is available as oral tablets or oral granules. The dosage and frequency of administration may vary depending on the individual's age, weight, and overall health condition. It is important to follow the instructions provided by the healthcare provider and to take the medication consistently as directed.

Common side effects of Dolutegravir may include insomnia, headache, nausea, diarrhea, and rash. In rare cases, it can cause serious allergic reactions or liver problems. It is recommended to report any unusual or severe side effects to the healthcare provider immediately.

Dolutegravir can interact with certain medications, including antacids, anticonvulsants, antibiotics, and other HIV medications. It is important to inform the healthcare provider about all the medications, supplements, and herbal products being taken to avoid potential drug interactions.

Dolutegravir can be used during pregnancy and is recommended as an option for pregnant individuals with HIV. However, it is important to consult with a healthcare provider for proper evaluation and guidance. Regarding breastfeeding, it is advisable to discuss the potential risks and benefits with a healthcare professional.

No, Dolutegravir is not a cure for HIV. It is an antiretroviral drug that helps in managing HIV infection by reducing the viral load and improving immune function. It needs to be taken continuously and as prescribed to maintain viral suppression.

Dolutegravir is not intended or approved for use as pre-exposure prophylaxis (PrEP) to prevent HIV infection in individuals at high risk. It is primarily used as a treatment for those already diagnosed with HIV.



Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.