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danavir-300mg

PRODUCT DETAILS

Brand name : Danavir
Active substances : Darunavir
Strength : 300 mg
Manufactured by : Hetero drugs Ltd
Pack : 60 Tablets

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Danavir 300mg tablets are consist of an active substance known as Darunavir which evacuate anti-retroviral activity, the main ingredient which is used as darunavir. Because appearance of anti-viral medicine resistance which occurred during single use of Danavir, the drug administered by combining with other anti-retroviral drugs. Danavir 300mg is belongs to HIV protease inhibitor, includes in the treatment of AIDS & HIV infections.

DOSAGE

In usual dose 600mg (2 dose of 300mg) taken twice daily (BD) with food in oral administration. While in adult patients the Treatment for no Danavirresistance associate substitutions is 800mg DanavirOD with Ritonavir OD (once daily) with food. Danavir600mg combination with Ritonavir 100mg BD with food provide treatment for at least one Danavirresistance associated substitution is.

PHARMACOLOGY

Darunavir is drive out an anti-retroviral effect by prohibiting the protease enzyme which is needed for HIV viral multiplication, Dimerization and catalytic effect of HIV-1 protease also forbidden. In virus infected cells, darunavir includes in inhibits the separation of HIV encoded Gag-pol polyproteins, thus the prevention which blocks the production of mature infectious virus particle. Darunavir has molecular affability, so it can easily adapts for changing shape of protease enzymes.

PHARMACOKINETICS

Absorption:
while administration with Ritonavir will produce Tmax( peak plasma concentration)of approx 2.5-4 hrs and bioavailabilty is 37% and 82% of Danavir 300mg and ritonavir 100mg.
Distribution:
The human plasma protein bound is 95%.
Metabolism:
basically Danavir 300mg 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

Pediatric age of 3 to less than 18 years :

In pediatric patients, Danavirshould not be used as single dosing for daily. Dose recommendation should be based on weighing at least 10kg but less than 15 kg; Greater or equal to 10kg to less tan 11kg: The prescribed dose is 200mg of Danavirwith 32mg of ritonavir Greater or equal to 11kg to less than 12 kg: The prescribed dose is 220mg of Danavirwith 32mg of ritonavir Greater or equal to 12kg to less than 13kg: The prescribed dose is 240mg of Danavirwith 40mg of ritonavir Greater or equal to 13kg to less than 14kg: The prescribed dose is 260mg of Danavirwith 40mg of ritonavir Greater or equal to 14kg to less than 15kg: The prescribed dose is 280mg of Danavirwith 48mg of ritonavir. Dose recommendation for weighing at least 15kg; ≥ 15kg to <30kg: 375mg of Danavirwith 50mg ritonavir ≥30kg to <40kg: 450mg of Danavirwith 60mg of ritonavir ≥40kg: 600mg of Danavirwith 100mg of ritonavir For liver impairment: In mild to moderate hepatic impairment patients, dosage adjustment should not be suggested. In severe hepatic impairment patients, the use of Danavirshould not be allowed.

PRECAUTIONS

Darunavir is a sulfonamide moiety, use with cautiously if patients are allergy to sulfonamide. Due to Drug interactions: Some drug – drug interaction may causes severe life threatening conditions. Avoid the combinational therapy. Hemophilia: In protease inhibitor therapies, there is a chance of getting increased bleeding condition leads to skin hematomas & hemarthrosis in patients suffered with hemophilia type A or B Diabetes mellitus: Increasing blood glucose level during the Danavir 300mg therapy is a major adverse effect. Monitor the patient’s glucose level during the treatment periodically. Redistribution of fat: The major adverse risk of this condition is obesity. This may generally occurs in anti-retroviral treatments. Immune reconstitution syndrome: This may occurs in Danavir 300mg therapy; to overcome the problem therapy should be discontinued.

CONTRAINDICATION

Interaction of Danavir with ritonavir are mostly based on CYP3A for clearance and increased plasma concentration causes life threatening reactions similarily with Interaction with Alfuzosin cause hypotension Interaction with Dihydroergotamine causes peripheral vasospasm sand ischemia. Interaction with Cisapride and pimozide causes cardiac arrhythmias Conicomitant use of Midazolam and triazolam causes respiratory depression.

PREGNANCY

Category C: In animal studies revealed that in reproduction has an adverse reaction on fetus and there has been no acceptable and well illustrate studies in human but the drug usage in pregnant women assign potential risk for fetus.

LACTATION

Danavir 300mg is probably unsafe to use during breastfeeding. Please consult with doctor

MISSED DOSE

The dose is missed by patient, administer the missed dose before the next dose timing reaches or leave the missed dose and follow the regular schedule Please consult the doctor.

SIDE EFFECTS

Common side effects: Mild nausea,stomach ache, insomnia, itching and rashes,Change in body shape (fat).

Serious side effects :
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

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