Spegra 90 Tables

Spegra 90 Tablets

Active Ingredients:

• Dolutegravir 50 mg
• Emtricitabine 200 mg
• Tenofovir alafenamide 25 mg
  (Each tablet contains this combination.)

Dosage Form & Packaging:

Film-coated oral tablets. One bottle contains 90 tablets.

Manufacturer:

Emcure Pharmaceuticals Ltd (India)

What it is & how it works

Spegra is an antiretroviral combination medicine used in the treatment of infection with the Human Immunodeficiency Virus type 1 (HIV-1). It contains three active-substances with complementary mechanisms of action:

• Dolutegravir: an integrase strand transfer inhibitor (INSTI) that blocks the integrase enzyme HIV uses to insert its genetic material into host cells.
• Emtricitabine: a nucleoside reverse transcriptase inhibitor (NRTI) that prevents viral RNA from being converted into DNA.
• Tenofovir alafenamide: a non-nucleoside / nucleotide reverse transcriptase inhibitor (NtRTI) that also acts to inhibit viral replication.Together, these agents help reduce the amount of virus (viral load) in the body, increase CD4 counts, and improve immune function.

Indication

Spegra 90 Tablets are indicated for the treatment of HIV-1 infection in adults and in adolescents aged 12 years and older who weigh at least 40 kg.

Note: This medicine is not a cure for HIV/AIDS; rather it is part of a long-term antiretroviral therapy (ART) plan.

Dosage & Administration

• Take one tablet of Spegra once daily at approximately the same time each day.
• The tablet may be taken with or without food, unless otherwise instructed by the physician.
• Swallow the tablet whole. Do not crush, chew, break or split it.
• It is imperative not to interrupt therapy or skip doses, as doing so may lead to viral rebound or development of resistance.
• A missed dose: take it as soon as you remember unless it is almost time for the next dose. Do not double the next dose to make up for a missed one

Benefits & Key Features

• Once-daily convenient dosing simplifies therapy adherence.
• Combination tablet reduces pill burden versus multiple individual medications.
• Effective in suppressing HIV replication, thereby helping preserve immune function, reduce risk of HIV-related complications, and improve quality of life.

Contraindications & Important Warnings

• Do not use Spegra if you are hypersensitive to any of the active ingredients or excipients.
• Patients with severe hepatic impairment or certain renal impairments may require special monitoring; caution is needed.
• Immune reactivation syndrome (IRIS) has been reported; any new inflammatory symptoms after starting therapy should be evaluated.
• Not recommended for use in children under 12 years of age or adolescents weighing less than 40 kg (unless specifically authorised) without specialist guidance.
• Use during pregnancy & breastfeeding: The doctor must weigh the benefit vs risk; limited data are available.

Side Effects

Common side effects may include:

• Headache
• Nausea, vomiting
• Abdominal pain, flatulence
• Fatigue, dizziness
• Insomnia, sleep disturbance

Serious side-effects (require prompt medical attention):

• Liver damage (jaundice, dark urine)
• Kidney dysfunction / Fanconi syndrome
• Lactic acidosis
• Immune reconstitution inflammatory syndrome (IRIS)

Drug Interactions

• Many antiretroviral agents or other medicines may interact with Spegra; always inform your physician of all other medications, supplements or herbal products you take.
• Alcohol consumption should be avoided or limited as it may increase liver burden.

Storage & Handling

• Store in a cool, dry place, below 30 °C (86 °F), protected from moisture and direct sunlight.
• Keep out of reach of children.
• Do not use after the expiry date printed on the bottle.

Important Note / Disclaimer

This description is provided for informational purposes only and is not a substitute for professional medical advice. Always consult your treating physician or a qualified healthcare provider before initiating, altering or discontinuing any medication. The prescribing information, local approvals, dosage and formulations may vary by country.

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