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Spegra Tablet
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Spegra Tablet

Manufactured byEMCURE PHARMACEUTICALS LTD
ContainsDolutegravir (50 mg) + Emtricitabine (200 mg) + Tenofovir Alafenamide (25 mg)
Description
Spegra Tablet is a combination medicine used for the treatment of human immunodeficiency virus (HIV) infections in adult patients weighing more than 40 kg. This medicine is not a cure for HIV; it only prevents the virus from multiplying in your body. Monitoring of liver function and kidney function may be necessary while receiving this medicine based on the clinical condition.
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Side effectsConcernsUsage

Side effects

Major & minor side effects for Spegra Tablet

  • Headache
  • Back pain
  • Nausea and Vomiting
  • Troubled breathing
  • Swelling of face, feet, or lower legs
  • Unusual tiredness or weakness
  • Increased blood pressure
  • Sleepiness
  • Loss of appetite
  • Diarrhea
  • Black or tarry stools
  • Stomach pain
  • Dark urine
  • Weight gain
  • Yellow eyes or skin
  • Chest pain
  • Cough or hoarseness
  • Fever or chills
  • Painful or burning urination
  • Pale skin
  • Dizziness
  • Joint pain

Uses of Spegra Tablet

What is it prescribed for?

  • HIV infection
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Concerns

Commonly asked questions

  • How long does it take for this medicine to take effect?
    The amount of time required for this medicine to show its action is not clinically established.
  • How long do the effects of this medicine last?
    The amount of time for which this medicine remains active in the body is not clinically established.
  • Is it safe to consume alcohol while taking this medicine?
    Interaction with alcohol is unknown. It is advisable to consult your doctor before consumption.
  • Is this a habit forming medicine?
    No habit-forming tendencies were reported.
  • Can this medicine be taken during pregnancy?
    This medicine is not recommended for use in pregnant women unless absolutely necessary. All the risks and benefits should be discussed with the doctor before taking this medicine.
  • Can this medicine be taken while breast-feeding?
    This medicine is not recommended for use in breastfeeding women unless absolutely necessary. All the risks and benefits should be discussed with the doctor before taking this medicine. Your doctor may advise you to discontinue the drug or to discontinue breastfeeding based on your clinical condition.

Allergy

This medicine is not recommended for use in patients with a known allergy to dolutegravir, emtricitabine, tenofovir alafenamide, or any other inactive ingredients present in the formulation.

Dofetilide

This medicine is not recommended for use in patients receiving dofetilide as it may increase the undesired effects of dofetilide which may lead to potentially serious and life-threatening side effects.
Warnings for special population

Pregnancy

This medicine is not recommended for use in pregnant women unless absolutely necessary. All the risks and benefits should be discussed with the doctor before taking this medicine.

Breast-feeding

This medicine is not recommended for use in breastfeeding women unless absolutely necessary. All the risks and benefits should be discussed with the doctor before taking this medicine. Your doctor may advise you to discontinue the drug or to discontinue breastfeeding based on your clinical condition.
General warnings

Lactic acidosis

This medicine should be used with caution due to the increased risk of lactic acidosis. Report any unusual symptoms to the doctor on priority. Appropriate corrective measures, dose adjustments, or replacement with a suitable alternative may be necessary based on the clinical condition.

Decreased bone mineral density

This medicine should be used with caution due to the increased risk of decreased bone mineral density. Report any unusual symptoms to the doctor on priority. Close monitoring of bone mineral density, appropriate corrective measures, and dose adjustments may be required in some cases based on the clinical condition.

Liver Toxicity

This medicine should be used with caution in patients with liver diseases and active liver disease due to the increased risk of worsening of the patient's condition. Hepatotoxicity has been reported in rare cases during treatment with this medicine. Report any unusual symptoms to the doctor immediately. Appropriate dose adjustments or replacement with a suitable alternative may be necessary based on the clinical condition.

Driving or operating machinery

This medicine may cause dizziness or drowsiness in some patients. It is advised that you do not perform any activities that require high mental alertness like driving a vehicle or operating machinery if you experience any of these symptoms during treatment with this medicine.

Kidney Disease

This medicine should be used with extreme caution in patients suffering from kidney diseases due to the increased risk of worsening of the patient's condition. Close monitoring of kidney function is necessary while receiving this medicine. Appropriate dose adjustments or replacement with a suitable alternative may be required in some cases based on the clinical condition of the patient.

Immune reconstitution syndrome

This medicine should be used with caution due to the increased risk of Immune reconstitution syndrome. Report any unusual symptoms to the doctor immediately. Appropriate dose adjustments or replacement with a suitable alternative may be required based on the clinical condition.

Hypersensitivity reactions

This medicine may cause severe allergic reactions such as skin rash, organ dysfunction, liver injury, etc. in some patients on therapy. Appropriate corrective measures, dose adjustments or replacement with a suitable alternative may be required based on the clinical condition.

Fat redistribution

This medicine may cause fat gain or fat loss from the body. This may result in peripheral wasting, facial wasting, breast enlargement, and Cushingoid appearance. Close monitoring of body weight and body fat distribution is necessary while receiving this medicine. Any changes in the body should be informed to the doctor on priority. Appropriate dose adjustments or replacement with a suitable alternative may be required based on the clinical condition.

Opportunistic infections

The patients receiving this medicine may develop opportunistic infections such as pneumonia, herpes virus infections, etc. Report any unusual symptoms to the doctor immediately. Appropriate patient/caregiver education, corrective measures, dose adjustments, or replacement with a suitable alternative may be required based on the clinical condition.

Use in children

This medicine is not recommended for use in patients less than 18 years of age since the safety and efficacy of use are not clinically established.

Missed Dose

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up for the missed dose.

Overdose

Seek emergency medical treatment or contact the doctor in case of an overdose.
All drugs interact differently for person to person. You should check all the possible interactions with your doctor before starting any medicine.
Interaction with Alcohol

Description

Interaction with alcohol is unknown. It is advisable to consult your doctor before consumption.

Instructions

Interaction with alcohol is unknown. It is advisable to consult your doctor before consumption.
Interaction with Medicine

Leflunomide

Aluminium Hydroxide

Neomycin

Efavirenz

Lamivudine

Ranitidine

Phenytoin

Methotrexate

Cyclosporine

Ibuprofen

Zalcitabine

Metformin

Dofetilide

Rifabutin

Disease interactions

Kidney Disease

This medicine should be used with extreme caution in patients with kidney dysfunction due to increased risk of worsening of the patient's condition. Regular monitoring of kidney function tests is necessary for such patients. Appropriate dose adjustments or replacement with a suitable alternative may be required in some cases based on the clinical condition.

Hepatotoxicity

This medicine should be used with caution in patients with pre-existing liver disease, history of alcohol abuse, or hepatitis due to increased risk of worsening of patient's condition. Close monitoring of liver function is recommended during treatment with this medicine. Appropriate dose adjustments or replacement with a suitable alternative may be necessary based on the clinical condition.
Food interactions
Information not available.
Lab interactions
Information not available.
This is not an exhaustive list of possible drug interactions. You should consult your doctor about all the possible interactions of the drugs you’re taking.
Take this medicine exactly as instructed by the doctor. Do not take in larger or smaller quantities than recommended. Ensure that proper hygiene measures are adopted. Complete the course of treatment to prevent the spread of the infection. Close monitoring of liver function and kidney function may be necessary while receiving this medicine based on the clinical condition.
Miscelleneous

Can be taken with or without food, as advised by your doctor

To be taken as instructed by doctor

May cause sleepiness

How it works
This medicine works by stopping the human immunodeficiency virus (HIV) from multiplying. This helps in reducing the chances of development of acquired immunodeficiency syndrome (AIDS) and other HIV-related illnesses.
Legal Status

Approved

Unknown

Unknown

Unknown

Classification

Category

Integrase strand transfer inhibitor, Nucleoside reverse transcriptase inhibitors (NRTIs), Antiviral combinations

Schedule

Schedule H

Dolutegravir - DrugBank [Internet]. Drugbank.ca. 2018 [cited 26 December 2018]. Available from:

https://www.drugbank.ca/drugs/DB08930

Dolutegravir: MedlinePlus Drug Information [Internet]. Medlineplus.gov. 2019 [cited 27 March 2019]. Available from:

https://medlineplus.gov/druginfo/meds/a613043.html

Emtricitabine: MedlinePlus Drug Information [Internet]. Medlineplus.gov. 2018 [cited 21 March 2018]. Available from:

https://medlineplus.gov/druginfo/meds/a604004.html

Emtricitabine - DrugBank [Internet]. Drugbank.ca. 2018 [cited 21 March 2018]. Available from:

https://www.drugbank.ca/drugs/DB00879

Tenofovir alafenamide - DrugBank [Internet]. Drugbank.ca. 2018 [cited 21 December 2018]. Available from:

https://www.drugbank.ca/drugs/DB09299

[Internet]. Dailymed.nlm.nih.gov. 2018 [cited 21 December 2018]. Available from:

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=72e6b33c-0351-4070-9172-eeaa186c01d2
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Information on this page was last updated on 19 Sep 2019

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