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Product Description
SPEGRA is a combination of antiretroviral medicines containing dolutegravir, emtricitabine, and tenofovir alafenamide. It is indicated for the treatment of HIV-1 infection in adults and children above 12years weighing more than 40 kg. It improves the immune system’s ability to fight HIV in order to manage or treat AIDS (acquired immunodeficiency syndrome).
However, the uses of the medicine mentioned are not exhaustive; there may be other reasons or situations in which the medicine might be used.
Spegra Tablet works by interfering with the working of HIV-1 reverse transcriptase enzymes which are necessary for the replication of the virus. Thus, it restricts the growth of HIV in the body and reduces the risk of getting HIV-related complications to improve the lifespan of an individual.
Inform the doctor if you have diabetes, liver problems, hepatitis or any other infection, heart problems, kidney problems, decreased bone mineral density, weak immune system. Your doctor may suggest regular blood tests to check your blood counts, kidney and liver functions, and other health conditions.
Inform the doctor about all your medical conditions, prescription and non-prescription drugs, vitamin supplements, herbal medications, since Spegra can interact with them. Spegra can cause an allergic reaction in some patients therefore it is necessary to read the complete composition list and consult the doctor in case of any ingredient that induces allergies.
Consult the doctor if you are pregnant or planning to get pregnant or breastfeeding.
It is advisable to avoid driving and operating heavy machinery during the course of Spegra.
If you are HIV positive, practice safe sex to prevent transmitting HIV to your partner. Also, do not share personal belongings like razors or toothbrushes.
Indications of SPEGRA Tablet
Spegra tablet is used primarily used for the treatment of HIV-1 infection in adults and adolescents weighing at least 40kg. It is not a cure for HIV, but it helps control the virus and reduces the risk of complications associated with the infection.
Therapeutic
Effects of SPEGRA Tablet
Spegra Tablet works by interfering with the working of HIV-1 reverse transcriptase enzymes which are necessary for the replication of the virus. It contains Dolutegravir, Emtricitabine and Tenofovir alafenamide. Dolutegravir inhibits strand transfer activity of integrase in DNA thus blocks replication of HIV-1. Emtricitabine is an analogue of cytidine that is phosphorylated to its active form Emtricibine 5 triphosphate that inhibits the activity of HIV-1 reverse transcriptase and incorporates themselves into the DNA thus results in termination of the replication process. Tenofovir Alafenamide enters hepatocytes where it is converted to tenofovir by hydrolysis. Hepatocyte tenofovir is then phosphorylated into tenofovir-diphosphate that incorporates themselves into the DNA strand thus stops the replication of viral particles. Thus, the active HIV molecules become inactive and further reproduction and multiplication process is stopped.
Directions for Use
Spegra tablet should be swallowed whole with water and should not be crushed, chewed, or opened. The medicine can be taken with or without food. Taking these medicines regularly at the same time increases their effectiveness. A dose of this medicine should not be missed as it can affect your recovery. The dosage and duration of treatment will depend on the individual’s condition and response to the medication and should be determined by the doctor.
Your doctor will decide the dose and frequency of administration based on your health condition.
A trained healthcare doctor/Nurse will administer Spegra. So, do not self-administer.
Storage
Spegra Tablet should be stored below 30°C temperature at room temperature. Do not freeze.
If you are traveling, carefully follow all patient instructions for storing your medicine during travel. Avoid extreme heat or cold.
Keep in the original container to protect from light and moisture.
Keep Spegra tablets out of sight and reach of children.
Common:
- Fatigue
- Headache
- Dizziness
- Insomnia
- Back Pain
- Rash
- Nausea & Vomiting
Serious:
- Renal impairment
- Liver toxicity
- Hypersensitivity
- Worsening of hepatitis B (viral infection of liver)
- Immune reconstitution syndrome
- Lactic acidosis
- Hepatomegaly (enlarged liver)
- Anxiety
- Weight gain
- Increased risk of fracture
Tell a doctor or nurse straight away, if you notice any of the side effects above.
Contraindications
Spegra Injection is contraindicated in patients with a known hypersensitivity to Spegra ingredients. It is also not indicated in Autoimmune disease, Graves’ disease, Hepatic diseases, Renal failure, Hypophosphatemia, Chronic kidney disease, Fanconi syndrome
Drug Interactions
Spegra might interact with other medicines including
Adefovir.
Atazanavir.
Lamivudine.
Sucralfate.
Rifampicin.
St John’s Wort.
Azithromycin.
Clarithromycin.
Rifabutin.
Cyclosporine.
Phenytoin.
Phenobarbital.
Iron.
Ibuprofen.
Therefore, it is recommended to inform your doctor about all the medications and supplements you take.
Safety Advices for Spegra Tablet
Unsafe
It is not recommended to consume alcohol with Spegra. Consult your doctor.
Unsafe
There is limited information on the use of Spegra during pregnancy. However, if you are pregnant or planning to get pregnant during the treatment, please consult your doctor. Your doctor will prescribe if the benefits are found to outweigh the risks.
Consult Your Doctor
It is recommended that you do not breast-feed to avoid passing the virus to the baby through breast milk. Consult your doctor if you are breastfeeding before taking this medication.
Unsafe
Spegra may cause dizziness or lightheadedness in some patients. Therefore, avoid driving or operating machines that require mental concentration until you are not alert.
Consult Your Doctor
If you have any lung-related symptoms, consult your doctor before taking Spegra, as this medication should be used with caution in such conditions. Your doctor may adjust the dose of this medicine or prescribe a suitable alternative based on your condition.
Consult Your Doctor
If you have a pre-existing or a history of liver problems, consult your doctor before taking this medicine. Spegra should be used cautiously in liver disease patients. Your doctor may adjust the dose of this medicine or prescribe a suitable alternative based on your condition.
Consult Your Doctor
If you have a pre-existing or a history of kidney disease, inform your doctor. Spegra should be used cautiously in patients with mild to moderate kidney disease. Your doctor may adjust the dose of this medicine or prescribe a suitable alternative based on your condition.
Consult Your Doctor
The use of this medicine may change blood pressure. Patients with known history of heart disease or stroke should monitor their blood pressure. Consult your doctor before receiving Spegra.
FAQs
Ans - Spegra Tablet does not completely cure HIV infection. While taking this medicine, you may still develop infections or other diseases associated with HIV infection. Consult your doctor for advice.
Ans - Spegra does not cause addiction.
Ans - If you miss a dose of Spegra Tablet, take it as soon as you remember. However, omit the missed dose if it is almost time for the next dose. Do not take Spegra Tablet twice to make up for a forgotten dose.
Ans - Do not stop taking Spegra Tablet without consulting your doctor as it may reduce the effectiveness of anti-HIV therapy. Continue taking Spegra Tablet for as long as your doctor has prescribed it to you to treat your condition effectually. Do not be reluctant to speak with your doctor if you experience any difficulty while taking Spegra Tablet.
Ans-The elderly are more likely to develop infections than the general population, so it is important to be cautious and consult your doctor before taking the medicine.
- 1. Flexner CW. Antiretroviral Agents and Treatment of HIV Infection. In: Brunton LL, Hilal-Dandan R, Knollmann BC (Editors). Goodman & Gilman’s: The Pharmacological Basis of Therapeutics. 13th ed. New York, NY: McGraw-Hill Education; 2018. pp. 1138-1157.
- 2. Safrin S. Antiviral Agents. In: Katzung BG, Masters SB, Trevor AJ (Editors). Basic and Clinical Pharmacology. 11th ed. New Delhi, India: Tata McGraw Hill Education Private Limited; 2009. pp. 861-890.
- 3. Dolutegravir, emtricitabine and tenofovir alafenamide [FDA Label]. Hyderabad, India: Mylan Laboratories Limited; 2018. [Accessed 16 Apr. 2021] (online) Available from:External Link
- 4. KD Tripathi, Antiviral Drugs (Anti-retrovirus), Essentials of Medical Pharmacology, 8th Edition, 2019, 860-872.
- 5. Laurus Generics Inc., U.S. Food and Drug Administration, [Revised on Dec 2020] [Accessed on 27th Aug 2022], https://www.accessdata.fda.gov/drugsatfda_docs/pepfar/213681PI.pdf
- 6. Guangdi L, et al., Approved HIV reverse transcriptase inhibitors in the past decade, Acta Pharmaceutica Sinica B, Published on Apr 2022, 12(4), 1567-1590, [Accessed on 27th Aug 2022], https://www.sciencedirect.com/science/article/pii/S2211383521004433
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