HEPDOZE
BIOCON
Biocon Limited 20th KM Hosur Road Electronic City P.O. Bangalore 560 100
us@biocon.com
Tenofovir Disoproxil Fumerate 300mg Injection,
Strength | Rate | Packing Style |
---|---|---|
300mg | 1404.73 | 1 injection |
List of Related Indications:
- Chronic Hepatitis B
List Of Drugs:
- Tenofovir Disoproxyl Fumerate @ - Antiretroviral Agents- (FDC- List )- (Feb 2006)
Indication Type Description:
Drug Interaction
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pregnancy and lactation
Drug Interaction:
Drug interactions - summary-
Atazanavir + Tenofovir / Tenofovir + Atazanavir
Concurrent use increased AUC and Cmax concentrations. Do not coadminister without
the addition of ritonavir
Indinavir + Tenofovir / Tenofovir + indinavir
Coadmin increased Cmax but AUC remained unchanged.
Cmax of indinavir decreased
Lopinnavir/ritonavir + tenofovir
Concurrent use increased tenofovir AUC . Monitor closely
Tenofovir + Abacavir
Concurrent use increased abanavir Cmax but AUC remained unchanged
Tenovir + acyclovir, dipivoxil, cidofovir, gangciclovir, valacyclovir, valganciclovir/
acyclovir, dipivoxil, cidofovir, gangciclovir, valacyclovir, valganciclovir + tenovir
Coadmin of tenofovir with drugs that reduce renal function or compete for active tubular
secretion eg acyclovir, adefovir, dipivoxil, cidofovir, gangciclovir, valacyclovir,
valganciclovir may increase serum concentrations of tenovir and increase the
concentrations of other renally eliminated drugs.
Indication:
Adverse Reaction:
Adverse Reactions-
CNS - anxiety 5% asthenia 5% depression 10% dizziness 3%
headache 12% insomnia 4% peripheral neuropathy 1%
Dermatologic - rash 16%
GI - adominal pain 6% diarrhoea 10% dyspepsia 3% vomiting 7%
Metabolic - lipodystrophy 1%
Musculoskeletal - arthalgia 4% back pain 8% myalgia 3%
Respiratory - pneumonia 4%
Miscellaneous - fever 7% pain 12%
Contra-Indications:
Special precautions/Warnings-
Lactic acidosis/severe hepatomegaly with steatosis- suspend treatment with tenofovir if any patient who develops clinical or laboratory findings suggestive of lactic
acidosis or pronounced hepatotoxicity which may include hepatomegaly and steatosis
even in absence of transaminase elimination
Exacerbation of hepatitis after discontinuation of treatment - monitor hepatic function
closely with both clinical and laboratory follow-up for at least for several months in
patients who discontinue antihepatitis B therapy, including tenofovir. if necessary
resumption of hepatitis B therapy may be warrented
HIV and HBV coinfection- because of the risk of development of of HIV -1 resistence
only use tenofovir in HIV-1 and HBV conifected patients as a part of antiretroviral
combination regimen
Renal impairment impairment - No safety data available in patients with renal function impairment who received. Ascess potential benefit against potential risk of renal toxicity.
Pregnancy- use tenofovir only if needed.
Lactation- instruct mothers not to breast feed if they are receiving tenofovir
Children- safety and efficacy in children younger than 18 years of age have not
been established.
Monitoring- consider bone monitoring for HIV infected patients who have a history of
pathological bone fractures or at risk for osteoporosis
Monitor patients with a history of renal function impairment and patients receiving
concomittant nephrotoxic agents for changes in serum creatinine and phosphorus
Dosages/ Overdosage Etc:
Indication-
Chronic Hepatitis B
Dosage-
Adult 18 year - 300mg once daily
Patient Information:
1. Advice patients not to discontinue tenofovir without first informing their doctor.
2. Inform patients with HIV 1 infection with or without HBV coinfection that it is important
to take tenofovir with combination therapy
3. It is important to tenofovir on a regular dosing schedule and to avoid missing doses.
4. Lactic acidosis and severe hepatomegaly with steatosis including fatal cases have been
reported. suspend treatment with tenofovir in any patient who deelops clinical symptoms
suggestive of lactic acidosis or pronounced hepatoxiciy
5. In patients with chronic hepatitis B it is important to obtain HIC antibody testing prior
to initiating tenofovir
6. Renal impairment including cases of acute renal failure has been reported. Tenofovir
should be avoided with concurrent or recent use a nephrotoxic agent. Dosing interval
of tenofovir may need to adjusted in patients with renal impairment.
6. Do not administer tenofovir in combination with adefovir
Pregnancy and lactation:
Pregnancy-
Use tenofovir only if needed.
Lactation-
Instruct mothers not to breast feed if they are receiving tenofovir
Children-
Safety and efficacy in children younger than 18 years of age have not
been established.