Description of Daruvir
Brand Name : Daruvir
Composition : Darunavir
Manufactured by : Cipla Ltd.
Strength : 600 mg
Dosage Form : Tablets
Packing : Pack of 60 Tablets
Daruvir should used with valid doctor’s prescription. It used for treatment for the infection caused by HIV. Daruvir is not a curable for HIV or prevention against AIDS. The patient who had no treatment for HIV in past will undergo therapy by Daruvir drug. It will target HIV infection from multiplying and decrease the destruction of immune system and delay the occurring HIV or AIDS disease.
Pharmacology of Daruvir
MECHANISM OF ACTION
Daruvir is an human immunodeficiency virus (HIV)-1 protease inhibitors . It especially prevent the separation of HIV-1 encoded Gag-Pol polyproteins in infected cells, therefore daruvir will prevent the formation of mature virus molecule.
ABSORPTION: Daruvir with co-administration with ritonavir 100mg in oral administration willproduce Tmax( peak plasma concentration)of approx 2.5-4 hrs and bioavailabilty is 37% and 82% of Daruvir 600mg and ritonavir 100mg. while administered with food , the Cmax and AUC is 40% similar to fasted state. So Daruvir is recommended with food is efficient.
DISTRIBUTION: Daruvir firstly targets plasma α 1- acid glycoprotein(AAG),therefore plasma protein bound is 95%.
METABOLISM: Daruvir basically undergo oxidative metabolism by CYP3A.
ELIMINATION: After single dose or co administration with ritonavir will excreted approx 79.5% in feces and 13.9% in urine. Constant Daruvir will eliminate approx 41.2% in feces and 7.7% in urine. The end excretion half life is 15hrs.
Indication of Daruvir
In adult daruvir is used with combination of cobicistate or ritonavir or other antiretroviral for the treatment of HIV-1 infection
In pediatric patients, Daruvir with Ritonavir combination is used for the treatment of HIV-1 infection.
Dose & Dosage's of Daruvir
In oral administration prescribed dose 600mg (2 dose of 300mg) taken twice daily (BD) with food.
In adult patients: Treatment for no daruvir resistance associate substitutions is 800mg daruvir OD with ritonavir OD with food.
Treatment for at least one daruvir resistance associated substitution is 600mg daruvir with ritonavir 100mg BD with food.
Side Effects of Daruvir
Signs of allergic reaction like Hives, Dyspnea, Swelling of (face,lips,throat,tongue); Severe hepatomegaly with steatosis; Chest discomfort; Wheezing; Cold sore; increased heart rate; Lumbar pain
Common effects: Mild nausea,stomach ache, insomnia, itching and rashes,Change in body shape (fat).
Contraindication of Daruvir
Daruvir + ritonavir combination are more based on CYP3A for clearance and increased plasma concentration causes life threatening reactions similarily with
1. Alfuzosin cause hypotension
2. Dihydroergotamine causes peripheral vasospasm sand ischemia.
3. Cisapride and pimozide causes cardiac arrhythmias
4. Midazolam and triazolam causes respiratory depression.
Drug Interaction of Daruvir
Precaution of Daruvir
Allergy to darunavir, ritonavir, or any other drug. Inform doctor about allergic to any drugs pirorily. This includes about rash; hives; itching; Dyspnea; wheezing; cough; swelling of (face, lips, tongue, or throat); or any other signs. Patient has a sulfa allergy, talk with your doctor. If you are not taking ritonavir.
Usage & Safety profile of Daruvir Pregnancy & Lactation
Category C: In animal studies described that in reproduction there is an adverse reaction on fetus and there are no sufficient and well described studies in human but the drug usage in pregnant women distribute potential risk for fetus.
Storage of Daruvir
* Daruvir store at room temperature
* Keep the medicine in airtight container
* Keep way from childerns and pets.