TRUSTIVA 
                     Trustiva Hetero 
      Tablets
MILLION 
HEALTH 
PHARMACEUTICALS
Drug profile of Trustiva
 Trustiva tablets are containing active 
constituents which are having anti-retroviral 
activity drugs known as Tenofovir disoproxil 
fumarate, Efavirenz, Emtricitabine.
 Trustiva is a FDA approved product, which is 
active against HIV 1 infection condition.
 Trustiva containing components are;
 Efavirenz: Non nucleoside reverse transcriptase 
inhibitor
 Emtricitabine: Nucleoside reverse transcriptase 
inhibitors
Drug profile of Trustiva
 Trustiva tablets are containing active 
constituents which are having anti-retroviral 
activity drugs known as Tenofovir disoproxil 
fumarate, Efavirenz, Emtricitabine.
 Trustiva is a FDA approved product, which is 
active against HIV 1 infection condition.
 Trustiva containing components are;
 Efavirenz: Non nucleoside reverse transcriptase 
inhibitor
 Emtricitabine: Nucleoside reverse transcriptase 
inhibitors
Drug profile of Trustiva
 Tenofovir DF: Nucleoside reverse 
transcriptase inhibitors.
 All these drugs are involved in inhibiting 
reverse transcriptase enzyme which is 
essential for viral multiplication.
 Trustiva tablets are not considered as 
curable medicine, but it will diminish the 
amount of HIV in the body and prevent 
the further progression into AIDS.
PRODUCT 
DETAILS
Brand name: Trustiva
Active substances: Efavirenz + 
Emtricitabine + Tenofovir disoproxil 
fumarate
Strength: 600mg + 200mg + 300mg 
respectively
Mfg: Hetero
Pack: 30 tablets in a container
Category: Anti-retroviral drug
Prescribing information of 
Trustiva
 The common prescribing information of 
Trustiva tablets is used to treat HIV-1 
infection by used alone or by combining 
with other anti-retroviral drugs.
 A Trustiva use is applicable for adults & 
pediatric patients about 12 years of age 
and older.

Mechanism of Trustiva
 Efavirenz:
 Efavirenz exhibits anti-retroviral activity by inhibiting the 
reverse transcriptase enzyme which is essential viral RNA 
directed DNA polymerase enzyme.
 The formation of active triphosphorylated form is necessary 
for the effect of efavirenz, variation occurs intracellularly.
 Based on the cell type present in the body is required for 
phosphorylation.
 The interfering of generation of DNA copies of viral RNA is 
occurred by inhibiting the enzyme RT.
 This new DNA copies is required for new viral production.
 This is concluded as inhibition of cell division.
Mechanism of Trustiva
 Emtricitabine:
 Emtricitabine is converted into active form known as 
Emtricitabine 5’ triphosphate which is essential for 
inhibition of viral proliferation. This metabolite fights with 
deoxycytidine 5’ triphosphate, is a natural substrate and 
get merged into viral DNA which leads to chain elimination.
 Tenofovir DF:
 This is similar to Emtricitabine, tenofovir is struggling with 
substrate called deoxyadenosine 5’ triphosphate and 
merged into DNA of virus which may concluded as 
prohibition of RT activity.
 Finally viral multiplication gets affected.
Absorption
 Efavirenz plasma concentration time is 3 to 5 
hours
 Steady state of efavirenz is reached between 6 
to 10days.
 Emtricitabine plasma concentration time 
reaches within one hour.
 Tenofovir bioavailability occurs by 25%
 Maximum plasma concentration is 1.0 ± 0.4 
hours.
Distribution
 Volume of distribution of tenofovir is 1.3 ± 
0.6L/kg.
 Tenofovir has low plasma protein binding 
capacity with the range of 0.7 to 7.2%
 Emtricitabine is highly bound to plasma 
protein by 80%.
 Blood plasma ratio of Emtricitabine is 1.0
 Human plasma protein binding capacity of 
efavirenz is by 99.5 to 99.7%.
Metabolism
 The metabolism of efavirenz is involved 
by CYP3A & CYP2B6 isoenzymes.
 The efavirenz metabolite is induced 
majorly by cytochrome isoenzymes to 
hydrolyzed metabolites.
 The metabolism of tenofovir is not 
mediated by cytochrome enzymes.
 The metabolism process of Emtricitabine 
is not so clear.
Excretion
 Nearly 70% of Emtricitabine is occurred in urine, 13.7% 
in feces.
 The terminal half life period of Emtricitabine is 10 hours.
 The dose of tenofovir nearly 32% should be recovered in 
urine which is in unchanged form.
 The terminal half life period of tenofovir is 17 hours.
 The elimination of tenofovir is majorly occurs through 
glomerular filteration & tubular secretion.
 The mean half life period of efavirenz is 52 to 76 hours
 Elimination occurs via urine at 14 to 34%; feces at 16 to 
61%.
When to take the Trustiva
 Trustiva tablets should be taken on an 
empty stomach at bed time.
 Dosage regimens of Trustiva Tablet
 The recommended dose of Trustiva for 
both adults & pediatric patients with 12 
years of age or older, one tablet should 
be taken as a single dose.
When to take the 
Trustiva
 In renal impairment:
 Trustiva is a fixed dose combination tablet, if 
patient may require dosage adjustment 
should not recommended in moderate or 
severe conditions with the creatinine 
clearance below 50ml/min.
 Rifampin concomitant use:
 Patients with weigh of 50kg or more, 
Trustiva should be combined with rifampin, 
by increasing dose of efavirenz 200mg/day.
Trustiva caused side 
effects
 The most common adverse effects;
 Severe acute aggravation of hepatitis B
 Lactic acidosis & hepatomegaly with steatosis
 Nervous disorders
 Newly commenced or worsening of renal impairment
 Rash
 Liver injury
 Bone defects
 Immune reconstitution syndrome
 Redistribution of fat
 Common side effects;
 Diarrhea
 Nausea
 Vomiting
 Fatigue
 Infections & infestations
Trustiva caused side 
effects
 Sinusitis
 Respiratory tract infections
 Nasopharyngitis
 Headache
 Dizziness
 Anxiety
 Depression
 Insomnia
 Rash
 Lab abnormality;
 Increased levels of;
 Cholesterol
 Creatine kinase
 Serum amylase
 Alkaline phosphatase
 AST, ALT
 Blood glucose
Trustiva caused side 
effects
 Post marketing reports:
 Palpitations
 Tinnitus
 Vertigo
 Gynecomastia
 Abnormal vision
 Constipation
 Malabsorption
 Asthenia
 Hepatobiliary disorders
 Allergy
 Pancreatitis
 Glycosuria
 Neutropenia
 Triglycerides
Drug- drug interaction
 The substrate of CYP3A or CYP2B6 combined with Trustiva, 
causes decreasing plasma concentration of these substrates.
 Trustiva with CYP3A inducers causes increasing clearance of 
efavirenz leads to decreasing the plasma concentrations.
 Co administration of Trustiva tablets with drugs which 
reduce the renal functions may leads to increase the plasma 
concentration of Emtricitabine & tenofovir DF leads to 
increase the adverse effects.
 Trustiva tablets combined with atazanavir & other protease 
inhibitors, causes decreasing the effect of concentration of 
atazanavir and increasing the tenofovir concentration.
 Trustiva with Didanosine causes increasing effect of 
concentration of Didanosine
Drug- drug interaction
 Trustiva with other NNRTI leads to cause increasing or 
decreasing the effect of concentration of efavirenz.
 Trustiva with anti-coagulant, anti-convulsants, anti-
depressants, or anti-fungals leads to cause decreasing 
the effect of concentration of these following drugs.
 Trustiva tablets combined with any anti-infective, anti-
mycobacterials, anti-malarial or calcium channel blocker 
causes decreasing the effect of concentration of these 
drugs.
 Trustiva with lipid lowering drugs, hormonal 
contraceptives or immuno suppressants, causes 
decreasing effect of concentration of these drugs.
Food drug interaction
 Trustiva tablets are administered on an empty stomach, 
at bedtime because of decreasing neurological problems.
 Possible contraindications
 Anaphylactic reactions may produce due to patients may 
contraindicate to the component present in the Trustiva
 tablets.
 Trustiva is contraindicated to some drugs like;
 Voriconazole
 The co administration of Trustiva with voriconazole, 
efavirenz one of the active component present in Trustiva
 causes depletion of plasma concentration of voriconazole 
which may leads to loss of therapeutic effects.
Safety measures
 Safety precautions should be taken in the patients who are 
suspected with;
 Patients co infected with HIV-1 HBV
 Drug interactions
 Lactic acidosis or hepatomegaly with steatosis: Stop the treatment
 Co administration of some drugs: Some concomitant use of drugs 
should be cause adverse effects.
 QT prolongation: monitor ECG periodically and patients may treat 
with alternative medications.
 Psychiatric symptoms: risk factors should be frequently and 
provided with supportive measures
 Nervous symptoms: To reduce the symptoms, Trustiva should be 
taken at bed time
Safety measures
 Renal impairment: In severe condition, discontinue the 
treatment.
 Reproductive risk: Trustiva is contraindicated to pregnancy 
condition. Avoid becoming pregnant
 Rash: Alternative treatment should be provided
 Liver toxicity: Liver function test should be taken periodically
 Bone defects: Vitamin D supplements should be given to the 
patients, monitor the bone mineral density.
 Convulsions: Provide with anti-convulsants medication and 
monitor the risk of seizures.
 Immune reconstitution syndrome: Discontinue the therapy
 Redistribution of fat: Discontinue the treatment. The major risk 
of fat redistribution is obesity
Pregnancy and lactation
 Pregnancy category D
 Trustiva should not be used in 
pregnancy and lactating period.
 Storage and handling
 Trustiva tablet container should be 
stored at 25oC (77oF)
 Protect the container from moisture, 
heat & light
Missed dose
 Missed dose of Trustiva should be avoided.
 In case of missed dose of Trustiva, must be consult with 
medical practitioner and follow the instructions.
 Over dosage
 The over dosage of Trustiva tablets are occurred due to 
missed dose.
 The over dosage of efavirenz is caused nervous system 
symptoms.
 Nearly 3 hours of dialysis process, eliminates 30% of 
Emtricitabine dose from the body within 1.5 hours of dosing 
time.
 Tenofovir is easily removed with the range of 54% by 
undergoing dialysis.
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