Virem 300mg (Darunavir )

DESCRIPTION

Virem 300mg is a type of HIV drugs known as protease inhibitors (PIs). These inhibitors stops the HIV enzyme (protease). Thereby blocking of protease, the PIs will prevent HIV from reproduce and can lower the amount of HIV in the body.

Virem 300mg is a prescription drug provide under the proper supervision of medical practioners , t he drug with combination of other HIV medicine (Ritonavir and other ) is used for the prevention of HIV infection in adult and children(3 yrs of age and older).

INDICATION

Virem 300mg with combination of cobicistate or ritonavir or other antiretroviral is indicated for the treatment of HIV-1 infection in adult patients. Virem 300mg with Ritonavir combination is indicated for the treatment of HIV-1 infection for pediatric patients

MECHANISM OF ACTION

Virem 300mg is an human immunodeficiency virus (HIV)-1 protease inhibitors . It specifically prohibit the separation of HIV-1 encoded Gag-Pol polyproteins in infected cells, hence Virem 300mg will inhibits the formation of mature virus molecule.

ADME PROPERTIES

ABSORPTION

the time to high plasma level is 2.5-4 hr and bioavailability without Ritonavir 37% and with Ritonavir is 82%

DISTRIBUTION

Human plasma bounding is 95%

METABOLISM

CYP344

ELIMINATION

Combination with Ritonavir will excreted approx 79.5% in feces and 13.9% in urine. The end excretion half life is 15hrs

DOSAGE MANAGEMENT

In oral administration The usual dose 300mg given as 2 dose of 300mg taken twice daily (BD) with food. Treatment for no Virem resistance associate substitutions is 800mg Virem OD with ritonavir OD with food in adult patients Treatment for at least one Virem resistance associated substitution is Virem 300mg with ritonavir 100mg twice daily with food.

SIDE EFFECTS
COMMON EFFECTS

Insomnia Itching and rashes, Change in body shape (fat). Mild nausea, Stomach ache,

SERIOUS SIDE EFFECTS

Severe hepatomegaly with steatosis; Chest discomfort; Wheezing; Cold sore; Signs of allergic reaction like Hives, Dyspnae, Swelling of (face, lips, throat, tongue); Increased heart rate; Lumbar pain

PRECAUTION

Discuss with the doctor about allergic to any drugs or Allergy to darunavir, ritonavir, or any other drug which involves about rash; hives; itching; Dyspnea; wheezing; cough; swelling of (face, lips, tongue, or throat); or any other signs. Heptotoxicity: Drug induced hepatitis is resulted with Virem 300mg with Ritonavir combination. When the patients with pre existing liver problems receiving the combination drug will increase risk of liver function abnormalities and serious hepatic side effects Sulfa allergy: Patient has a sulfa allergy, if you are not taking Ritonavir then talk with your doctor. It will leads to incidents and severity rash occurs.

CONTRAINDICATION

While interaction of Virem 300mg with Ritonavir co-administration are more based on CYP3A for clearance and increased plasma concentration causes life threatening reactions similarly 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

Interaction Virem 300mg with ritonavir combined with drugs metabolized by CYP3A & CYP2D6, causes elevation of plasma concentration of these drugs which leads to cause extended therapeutic effect. Concomitant use with ritonavir are metabolized by CYP3A, drug which promote the CYP3A effect leads to elevate the clearance of darunavir & ritonavir which concluded as diminishing the plasma concentration of darunavir & ritonavir.

When Virem 300mg & ritonavir interaction with drugs which inhibits the CYP3A may leads to cause depleting the clearance of darunavir & ritonavir results as elevation of concentration of darunavir & ritonavir.

Combination of Virem 300mg with Didanosine, affect the exposure of Didanosine. To overcome the problem Didanosine should be administered one hour earlier or two hours after the dose of Virem 300mg Concomitant use with indinavir, causes increasing the effect of concentration of both darunavir & indinavir

PREGNANCY

Category C: In animal studies shows that in reproduction there is an adverse effects on fetus. There are no adequate and well developed studies in human but the drug usage in pregnant women distributes potential risk for fetus.

LACTATION

While using the drug breast feeding is not recommended. Excretion into human milk is unknown. If feeding replacement is not an option other than different drug can be preferred

STORAGE

Store at room temperature Store the medicine in airtight container Keep away from children’s and pets.

MISSED DOSE

if patients have missed single dose then have it immediately before to next dose or skip the missed dose and continue the normal schedule. Please consult with doctor for further enquire.