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Tenofovir disoproxil: Indications, Dosing, Side Effects and Interactions
Tenofovir disoproxil clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 3 min read
Tenofovir disoproxil: Indications, Dosing, Side Effects and Interactions
Tenofovir disoproxil clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**HIV infection in combination with other antiretroviral drugs,Chronic hepatitis B infection with compensated liver disease (with evidence of viral replication, and histologically documented active liver inflammation or fibrosis),Chronic hepatitis B infection with decompensated liver disease**
- **Adult** (By Mouth): 245 mg once daily.
**HIV infection in combination with other antiretroviral drugs when first-line nucleoside reverse transcriptase inhibitors cannot be used because of resistance or contra-indications for tenofovir disoproxil**
- **Child 2-17 years** (By mouth): 6.5 mg/kg once daily (max. per dose 245 mg).
- **Child 6-17 years (body-weight 17-21 kg)** (By mouth): 123 mg once daily.
- **Child 6-17 years (body-weight 22-27 kg)** (By mouth): 163 mg once daily.
- **Child 6-17 years (body-weight 28-34 kg)** (By mouth): 204 mg once daily.
- **Child 6-17 years (body-weight 35 kg and above)** (By mouth): 245 mg once daily.
**Chronic hepatitis B infection with compensated liver disease (with evidence of viral replication, and histology of active liver inflammation or fibrosis) for tenofovir disoproxil**
- **Child 12-17 years (body-weight 35 kg and above)** (By mouth): 245 mg once daily.
Side effects
For all nucleoside reverse transcriptase inhibitors Common or very common Abdominal pain; anaemia (may require transfusion); asthenia; diarrhoea; dizziness; fever; flatulence; headache; insomnia; nausea; neutropenia; skin reactions; vomiting Uncommon Angioedema; pancreatitis Rare or very rare Lactic acidosis Frequency not known Immune reconstitution inflammatory syndrome; osteonecrosis; weight increased Side-effects, further information Osteonecrosis has been reported in patients with advanced HIV disease or following long-term exposure to combination antiretroviral therapy. Side-effects For tenofovir disoproxil Common or very common Abdominal distension Uncommon Proximal renal tubulopathy Rare or very rare Acute tubular necrosis; hepatic disorders; nephritis; nephrogenic diabetes insipidus; renal impairment
Interactions
**Severe interactions:**
- Darunavir/Ritonavir (300/100 b.i.d.) Darunavir: No significant effect on darunavir/ritonavir PK parameters.
- Entecavir AUC: C max : No clinically significant pharmacokinetic interactions when tenofovir disoproxil was co-administered with entecavir.
- Studies conducted with other medicinal products There were no clinically significant pharmacokinetic interactions when tenofovir disoproxil was co-administered with emtricitabine, lamivudine,...
**Other interactions (23):**
- Didanosine Co-administration of tenofovir disoproxil and didanosine is not recommended (see section 4.4 and Table 1).
- Renally eliminated medicinal products Since tenofovir is primarily eliminated by the kidneys, co-administration of tenofovir disoproxil with medicinal products that reduce renal function or compete...
- Some examples include, but are not limited to, aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, cidofovir or interleukin-2 (see section 4.4).
- Given that tacrolimus can affect renal function, close monitoring is recommended when it is co-administered with tenofovir disoproxil.
- Table 1: Interactions between tenofovir disoproxil and other medicinal products Medicinal product by therapeutic areas (dose in mg) Effects on drug levels Mean percent change in AUC, C max , C min...
- NRTIs Didanosine Co-administration of tenofovir disoproxil and didanosine results in a 40-60% increase in systemic exposure to didanosine Co-administration of tenofovir disoproxil and didanosine is...
Pregnancy
For all nucleoside reverse transcriptase inhibitors Monitoring in pregnancy Mitochondrial dysfunction has been reported in infants exposed to nucleoside reverse transcriptase inhibitors in utero; the main effects include haematological, metabolic, and neurological disorders; all infants whose mothers received nucleoside reverse transcriptase inhibitors during pregnancy should be monitored for relevant signs or symptoms.
Hepatic impairment
For all nucleoside reverse transcriptase inhibitors In general, manufacturers advise caution in patients with chronic hepatitis B or C (increased risk of hepatic side-effects). Hepatic impairment For tenofovir disoproxil Manufacturer advises caution in decompensated hepatic disease (limited information available).
Renal impairment
Dose adjustments Granules : 132 mg once daily if creatinine clearance 30-50 mL/minute; 66 mg once daily if creatinine clearance 20-30 mL/minute; 33 mg once daily if creatinine clearance 10-20 mL/minute (limited information available; consult product literature). M Tablets : 245 mg every 2 days if creatinine clearance 30-50 mL/minute; 245 mg every 3-4 days if creatinine clearance 10-30 mL/minute (limited information available; consult product literature). M See Prescribing in renal impairment .
Medicinal forms
Tablet,Granules
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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