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Brand Name :
Agenerase
Synonyms :
Agenerase
Class :
HIV protease inhibitors
Brand Name :
Agenerase
Synonyms :
Agenerase
Class :
HIV protease inhibitors
Dosage Forms & Strengths
Capsules, oral solution
1200mg
1400mg
1200
mg
Capsule
Orally
two times a day
1400mg oral solution two times a day
Dose Adjustments
Renal dose adjustments
The oral solution is not recommended for use by people with renal insufficiency since it includes propylene glycol
Due to the increased risk of adverse effects linked to propylene glycol and the potential impact of its metabolites on acid-base balance, use with caution in individuals with renal impairment
Liver Dose Modifications
Propylene glycol is present in the oral solution, which is contraindicated in hepatic failing patients
Due to an increased risk of adverse effects related to propylene glycol, use with caution in patients with hepatic impairment
No study data is available about the use of amprenavir in children with hepatic complications
Child-Pugh scores of 5 to 8: 450 mg or 513 mg (oral solution in a volume of 34 mL) twice daily
Child-Pugh scores of nine to twelve: 300 mg (two 150 mg capsules) or 342 mg (23 mL oral solution) taken twice daily
Dosage Forms & Strengths
Oral capsules
200mg
For Ages 4 to 12 or 13 to 16 and weights under 50 kg: 20 mg/kg capsules orally twice daily or 15 mg/kg capsules orally, three times daily, with a daily maximum dose of 2400 mg.
13 to 16 years old, at least 50 kg: 200 mg capsules orally taken twice daily
Oral solution
Ages 4 to 12 or 13 to 16 and less than 50 kg: Two doses of 22.5 mg/kg (1.5 mL/kg) or three doses of 17 mg/kg (1.1 mL/kg), not to exceed 2800 mg/day, should be administered orally.
13 to 16 years old, at least 50 kg: 2 oral doses of 1400 mg (93 mL) each day
Refer to adult dosing
may decrease the levels of serum concentration of hormonal contraceptives
may decrease the levels of serum concentration of hormonal contraceptives
may decrease the levels of serum concentration of hormonal contraceptives
may decrease the levels of serum concentration of hormonal contraceptives
may diminish the serum concentration of Hormonal Contraceptives
may enhance the serum concentration of CYP3A4 inhibitors
may enhance the serum concentration of CYP3A4 inhibitors
may enhance the serum concentration of CYP3A4 inhibitors
may enhance the serum concentration of CYP3A4 inhibitors
may enhance the serum concentration of CYP3A4 inhibitors
when both drugs are combined, there may be a decreased metabolism of vincristine
when both drugs are combined, there may be an increased metabolism of vinblastine atazanavir: when both drugs are combined, there may be a decreased metabolism of vinblastine
when both drugs are combined, the metabolism of paclitaxel increases
It may diminish the metabolism when combined with dexamethasone
it may diminish the metabolism when combined with diosmin
Combining levobetaxolol and amprenavir can diminish levobetaxolol’s metabolism
Combining tegafur with amprenavir can reduce tegafur’s metabolism
It may enhance the risk of adverse effects when combined with Protease inhibitors
When dexrabeprazole and amprenavir is used together, this leads to reduction in the dexrabeprazole’s metabolism
When domeperidone and amprenavir is used together, this leads to reduction in the domeperidone’s metabolism
When amprenavir is used together with fluconazole, this leads to reduction in the amprenavir metabolism
When indisulam is used together with amprenavir, this leads to a reduction in amprenavir metabolism
amprenavir has the potential to modify the metabolism of propoxyphene, resulting in increased levels of propoxyphene in the bloodstream
when combined with cholecystokinin, amprenavir may decrease its excretion
the metabolism of amprenavir may be decreased when combined with zimelidine
amprenavir's absorption may be reduced by almasilate, resulting in lower serum concentrations and potentially decreased efficacy
may increase the serum concentration of Artemether and Lumefantrine
cyproterone and ethinyl estradiol
may diminish the serum concentration when combined
It may enhance the serum concentration when combined with CYP3A4 Substrates
It may enhance the serum concentration when combined with CYP3A4 Substrates
It may enhance the serum concentration when combined with CYP3A4 Substrates
tenofovir disoproxil fumarate or tenofovir DF
monitoring of patients who develop TDF-associated adverse reactions in which tenofovir levels increase when taken along with HIV-1 protease inhibitors. If TDF-associated adverse reactions emerge, discontinue tenofovir DF in patients who develop them
the rate of metabolism of tocofersolan may be reduced with amprenavir
the serum levels of dihydroergocornine may be increased
the rate of metabolism of amprenavir may be reduced
the metabolism of dapoxetine may decrease when combined with amprenavir
the rate of metabolism of dydrogesterone may be reduced
the rate of metabolism of amprenavir may be reduced
When amprenavir is used together with oliceridine, this leads to enhanced concentration serum of oliceridine
the rate of metabolism of methoxyflurane may be decreased
the activity of the anthrax vaccine can be reduced when used in combination with amprenavir
the rate of metabolism of fluocortolone may be reduced with amprenavir
Actions and spectrum:
Protease inhibitor amprenavir has anti-Human Immunodeficiency Virus Type 1 (HIV-1) action. The protease component of HIV is blocked by protease inhibitors. The proteolytic cleavage of the viral polyprotein precursors into the individual functional proteins seen in infectious HIV-1 requires the enzyme HIV-1 protease.
Frequency not defined
Nausea
Vomiting
Diarrhea
Enlargement of breast
Seizures
Depression
Dyslipidemia
Potentially serious: hemolytic anemia
Hypersensitivity
Increased levels of glucose
Stevens-Johnson syndrome
Black Box Warning:
Amiodarone, lidocaine (systemic), tricyclic antidepressants, and quinidine may interact with amprenavir in a serious or even fatal way. It is advised to monitor these medicines’ concentrations if they are used concomitantly.
Contraindication/Caution:
Contraindication:
hypersensitivity to amprenavir
rifampin, astemizole, bepridil, cisapride, dihydroergotamine, ergotamine, midazolam, and triazolam concurrent treatment
severe allergic reaction to sulfonamides in the past
Oral solution should not be used by infants or children under the age of 4, pregnant women, people with kidney or liver disease, or anybody taking metronidazole or disulfiram concurrently.
Hepatic failure
Hepatitis B
Caution:
Coadministration of drugs that are CYP3A4 substrates, inhibitors, inducers, or potentially dangerous drugs that are processed by CYP3A4 should be done with caution.
CYP2D6, CYP1A2, CYP2C9, CYP2C19, CYP2E1, UDPGT, or glucuronosyltransferase or uridine are not inhibited by amprenavir.
Comorbidities:
No sufficient data
Pregnancy consideration:
US FDA pregnancy category: C
Lactation:
Data not available
Pregnancy category:
Category A: Studies that were well-controlled and met expectations revealed no risk to the foetus `in either the first or second trimester.
Category B: There were a lack of studies on pregnant women and no evidence of risk to the foetus in animal experiments.
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.
Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.
Category N: There is no data available for the drug under this category
Pharmacology:
amprenavir blocks the processing of viral gag and gag-pol polyprotein precursors by binding to the active site of HIV-1 protease. This results in the creation of immature, non-infectious viral particles
Pharmacodynamics:
amprenavir suppresses the activity of the enzyme by attaching to the protease active site. This inhibition stops the viral polyproteins from being broken down, preventing the development of immature, non-infectious viral particles. In almost all cases, protease inhibitors are used with at least two other anti-HIV medications.
Pharmacokinetics:
Absorption
HIV-1-infected patients who receive amprenavir orally have rapid absorption, with a typical time to peak concentration (Tmax) of 1 to 2 hours following a single oral dose. Amprenavir’s absolute oral bioavailability in people has not been determined.
Distribution
The drug is distributed into body tissues. The protein binding capacity is outstanding (90%). The drug has the strongest affinity for alpha (1)-acid glycoprotein is amprenavir
Metabolism
The liver’s cytochrome P450 3A4 (CYP3A4) enzyme system breaks down amprenavir. The oxidation of the components of tetrahydrofuran and aniline yields the two main metabolites. Minor metabolites seen in urine and faeces have been discovered as glucuronide conjugates of oxidized metabolites.
Elimination and excretion
Minimal amounts of amprenavir is eliminated through urine and faeces
Half life:
7.1 to 10.6 hours
Administration:
Orally as tablets or capsules in doses as prescribed.
Patient information leaflet
Generic name: amprenavir
Why do we use amprenavir?
amprenavir is taken orally to treat HIV infection. AIDS, also known as acquired immune deficiency syndrome, is brought on by the HIV virus. Amprenavir (AGENERASE) is a member of the protease inhibitors class of anti-HIV medications.
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