Daruvir 800mg Tablet 30'S

Introduction About DARUVIR 800MG TABLET

DARUVIR 800MG TABLET contains Darunavir, which belongs to the group of medicines called Protease Inhibitors. It is used to manage Human Immunodeficiency Virus (HIV) infection. HIV (Human Immunodeficiency Virus) is a virus that impairs the immune system of the human body, and its symptoms may include weight loss, fever or night sweats, fatigue, recurrent infections, etc.

DARUVIR 800MG TABLET is not recommended for use in patients allergic to darunavir, cobicistat, ritonavir, and/or sulphonamides and patients suffering from severe liver problems. Before taking DARUVIR 800MG TABLET, inform your doctor if you have diabetes, haemophilia, and/or kidney problems (such as impaired kidney function).

DARUVIR 800MG TABLET should be used with caution during pregnancy, only if recommended by your doctor. Women infected with HIV are advised not to breastfeed their children to avoid the spread of infection to the baby. However, consult your doctor for advice with regard to breastfeeding your baby. DARUVIR 800MG TABLET is also not recommended for use in children less than 3 years of age or weighing less than 40 kg. Consult your doctor before taking the DARUVIR 800MG TABLET.

The most common side effects of taking DARUVIR 800MG TABLET are diarrhoea, vomiting, nausea, abdominal pain/distension, indigestion, flatulence, and/or headache. Consult your doctor if any of your symptoms get worse or persist.

Uses Of DARUVIR 800MG TABLET

• Manage Human Immunodeficiency Virus (HIV) infection

How DARUVIR 800MG TABLET Works

DARUVIR 800MG TABLET works by interfering with protease (an enzyme required by HIV-infected cells to make new viruses) which inhibits the production of the new viruses in the body. As a result, it helps to manage the Human Immunodeficiency Virus (HIV) and provides relief from its associated symptoms in affected individuals.

How to use DARUVIR 800MG TABLET

Take DARUVIR 800MG TABLET as advised by your physician. Do not crush or chew the medicine. Swallow the medicine with a glass of water. Your doctor will decide the correct dose and duration for you depending upon your age, body weight, and disease condition.

Side Effects Of DARUVIR 800MG TABLET

How To Manage Side Effects

Diarrhoea:

Drink plenty of water and stay hydrated. Try to avoid taking any medicine on your own to manage diarrhoea. Consult your doctor and inform them if the symptom gets worse.

Nausea / Vomiting:

Try to take DARUVIR 800MG TABLET with or just after a meal or a snack. Stick to simple meals. Avoid eating rich or spicy food. Consult your doctor if your symptom gets worse.

Indigestion:

Try to have smaller and more frequent meals, and drink slowly. Reduce your consumption of coffee, cola, tea, or alcohol and lose weight if you are obese.  Try to avoid smoking and don’t have rich, fatty, or spicy foods. Consult your doctor if the symptom does not improve.

Headache:

Rest and relax. Drink plenty of fluids such as water or electrolytes. Apply a pain-relieving balm on the head if required. Do not consume alcohol. Consult your doctor if the symptom does not improve.

Dizziness:

Try to rest and get enough sleep. Avoid driving or operating tools or machines while you feel dizzy. Limit consumption of alcohol as it can aggravate dizziness. Consult and inform your doctor if the symptom gets worse.

Tiredness:

Make sure you rest and drink plenty of fluids. Avoid or limit the consumption of alcohol. Try to take DARUVIR 800MG TABLET at a time when you can sit down (or lie down) when the symptoms are at their worst. Avoid driving or using tools or machinery until you feel well.

Warning & Precautions

Pregnancy

DARUVIR 800MG TABLET should be used with caution during pregnancy only if recommended by your doctor. Consult your doctor before taking DARUVIR 800MG TABLET.

Breastfeeding

DARUVIR 800MG TABLET is not recommended for use by breastfeeding women as it may pass through the breast milk and may result in causing unknown effects on the breastfed baby. However, women infected with HIV are advised not to breastfeed to manage the spread of infection to the baby.  Consult your doctor before taking DARUVIR 800MG TABLET.

Driving and Using Machines

Do not drive or operate any machines if you feel dizzy after taking DARUVIR 800MG TABLET.

Alcohol

Avoid consumption of alcohol while taking DARUVIR 800MG TABLET since it may increase the risk of developing osteonecrosis (death of bone tissue due to lack of blood supply).

Kidney

DARUVIR 800MG TABLET should be used with caution in patients with impaired kidney function. Consult your doctor before taking the DARUVIR 800MG TABLET.

Liver

DARUVIR 800MG TABLET is not recommended for use in patients with severe liver problems. It should be used with caution in patients with liver problems such as hepatitis B or hepatitis C infection.

Allergy

Do not take DARUVIR 800MG TABLET if you are allergic to darunavir, cobicistat, ritonavir, sulphonamides, and/or any of the other ingredients in this medicine. Consult your doctor before taking DARUVIR 800MG TABLET.

Interactions

A. Drug-Drug interactions:

Before taking DARUVIR 800MG TABLET, inform your doctor if you are taking any of the following medicines:

• avanafil (used to manage erectile dysfunction)
• astemizole, terfenadine (medicines used to manage allergy symptoms)
• triazolam, midazolam (medicines used to manage insomnia and anxiety)
• protease inhibitors (medicines used to slow the progression of HIV) Ex. saquinavir, indinavir
• cisapride (used to manage stomach conditions)
• colchicine (used to manage gout/familial mediterranean fever)
• lurasidone, pimozide, quetiapine, sertindole, perphenazine, thioridazine, risperidone (medicines used to manage psychiatric conditions)
• medicines used to manage migraine headaches such as ergot alkaloids (Ex. dihydroergotamine, ergometrine, methylergonovine)
• amiodarone, bepridil, ivabradine, quinidine, dronedarone, ranolazine (medicines used to manage certain heart disorders)
• lovastatin, simvastatin, lomitapide (medicines used to lower cholesterol levels)
• rifampicin (to manage tuberculosis)
• lopinavir, ritonavir, efavirenz, saquinavir, cobicistat, raltegravir, maraviroc (medicines used to manage HIV infection)
• elbasvir, grazoprevir (used to manage hepatitis C infection)
• alfuzosin (to manage enlarged prostate)
• sildenafil (to manage high blood pressure in the pulmonary circulation)
• dabigatran, ticagrelor (to help stop the clumping of platelets in the management of patients with a history of a heart attack)
• naloxegol (to manage opioid-induced constipation)
• dapoxetine (to manage premature ejaculation)
• domperidone (to manage nausea and vomiting)
• st. john’s wort (herbal medicine used to manage depression)
• antiviral medicines used to manage AIDS such as non-nucleoside reverse transcriptase inhibitors (Ex. delavirdine, efavirenz), nucleoside reverse transcriptase inhibitors (Ex. lamivudine, emtricitabine), ccr5 antagonists (Ex. maraviroc, vicriviroc), fusion inhibitors (Ex. fuzeon, enfuvirtide)
• phenytoin, phenobarbital (used to manage seizures)
• dexamethasone (used to manage inflammation)
• rifapentine, rifabutin (used to manage tuberculosis)
• amlodipine, diltiazem, disopyramide, mexiletine, nifedipine, nicardipine, carvedilol, felodipine, flecainide, lidocaine, metoprolol, propafenone, timolol, verapamil (medicines used to manage heart disease)
• apixaban, rivaroxaban, warfarin, clopidogrel, edoxaban (medicines used to reduce clotting of the blood)
• medicines used as a hormonal replacement therapy and oestrogen-based hormonal contraceptives (Ex. drospirenone, ethinyl estradiol)
• pravastatin, rosuvastatin, atorvastatin (medicines used to lower cholesterol levels)
• clarithromycin (a medicine used to manage bacterial infections)
• tacrolimus, sirolimus, ciclosporin, everolimus (medicines used to dampen down the immune system)
• corticosteroids (medicines used to manage inflammation) Ex. betamethasone, fluticasone, mometasone, prednisone, triamcinolone, budesonide
• buprenorphine, naloxone (medicines used to manage opiate dependence)
• salmeterol (medicine to manage asthma)
• lumefantrine, artemether (medicines used to manage malaria)
• irinotecan, nilotinib, vinblastine, dasatinib, everolimus, vincristine (used to manage cancer)
• sildenafil, tadalafil, vardenafil (medicines used to manage erectile dysfunction or manage a heart and lung disorder such as pulmonary arterial hypertension)
• pibrentasvir/glecaprevir (medicines used to manage hepatitis C infection)
• oxycodone, tramadol, fentanyl (medicines used to manage pain)
• solifenacin, and fesoterodine (medicines used to manage urologic disorders)
• alfentanil (a medicine used as a short-acting painkiller during surgical procedures)
• digoxin (used to manage heart disorders)
• clarithromycin, rifabutin (medicines used to manage bacterial infections)
• itraconazole, fluconazole, posaconazole, isavuconazole, clotrimazole (medicines used to manage fungal infections)
• amitriptyline, paroxetine, desipramine, imipramine, nortriptyline, sertraline, trazodone (medicines used to manage depression and anxiety)
• methadone (to manage opiate dependence)
• clonazepam, carbamazepine (medicines used to manage seizures or to manage nerve pain)
• colchicine (to manage gout or familial Mediterranean fever)
• bosentan (to manage high blood pressure)
• estazolam, flurazepam, midazolam, buspirone, clorazepate, diazepam, when used as an injection, zolpidem (sedative agents)
• metformin (used to manage type 2 diabetes)

Over dosage:

If you or anyone else accidentally receive too much of DARUVIR 800MG TABLET, consult your doctor immediately or visit the nearby hospital.

Synopsis

More Information

• Keep DARUVIR 800MG TABLET out of reach from children
• Store the medicine at room temperature

FAQs About DARUVIR 800MG TABLET

What does DARUVIR 800MG TABLET manage?

DARUVIR 800MG TABLET is used to manage Human Immunodeficiency Virus (HIV) infection in adults and children (aged 3 years and above) with at least 40kgs of body weight who had not used earlier any antiretroviral medicines to manage the disease. DARUVIR 800MG TABLET is also used in combination with cobicistat/ritonavir/other anti-viral medicines to manage HIV infection.

What are the side effects of DARUVIR 800MG TABLET?

The most common side effects of taking DARUVIR 800MG TABLET are diarrhoea, vomiting, nausea, abdominal pain/distension, indigestion, flatulence, and/or headache. Consult your doctor if any of these symptoms worsen.

Is DARUVIR 800MG TABLET safe for use by pregnant?

DARUVIR 800MG TABLET should be used with caution during pregnancy, if recommended by your doctor. However, it is advised not to take DARUVIR 800MG TABLET by pregnant women taking ritonavir, cobicistat and other medicines.

Is DARUVIR 800MG TABLET safe for use by breastfeeding women?

DARUVIR 800MG TABLET is not recommended for use by breast-feeding women, unless recommended by your doctor. However, Women infected by HIV are advised not to breastfeed the baby to avoid the spread of infection. Consult your doctor before taking the DARUVIR 800MG TABLET.

How DARUVIR 800MG TABLET work?

DARUVIR 800MG TABLET works by interfering with protease (an enzyme required by HIV-infected cells to make new viruses) which leads to inhibition of the production of new viruses in the body thus managing the condition caused by Human Immunodeficiency Virus (HIV) and providing relief from its associated symptoms in affected individuals.

How to take DARUVIR 800MG TABLET?

Take DARUVIR 800MG TABLET as advised by your physician. Do not crush or chew the medicine. Swallow DARUVIR 800MG TABLET with a glass of water. Your doctor will decide the correct dose and duration for you depending upon your age, body weight, and disease condition.

References

1. Paul Volberding, Merle Sande, Joep Lange. Overview of Antiretroviral Therapy. Global HIV/AIDS Medicine. Sixth edition. 2008. Page 141.

2. Erika Tyrberg, Arvid Edén, Jaran Eriksen, Staffan Nilsson, Carl Johan Treutiger, Anders Thalme, Åsa Mellgren, Magnus Gisslén, Lars-Magnus Andersson. Higher plasma drug levels in elderly people living with HIV treated with darunavir. NIH National Library of Medicine. National Center for Biotechnology Information. [Revised in February 2021] [Accessed on 13th May 2022] https://pubmed.ncbi.nlm.nih.gov/33539440/

3. S.C. Laropharm S.R.L. Electronic medicines compendium (EMC) [Revised in July 2022] [Accessed on 18th May 2022] https://www.medicines.org.uk/emc/files/pil.10124.pdf

Useful Diagnostic Tests

• antigen/antibody test

Author Details

Written By Dr. Dhivakaran R - BDS

Reviewed For Accuracy By Dr. Nitin Sattiwale - MBBS

Last updated on 30 Sep 2022 | 11:46 AM(IST)