Individual generic drug information

nevirapine

Reference monograph

Part of registered formulation

LAMIVUDINE + NEVIRAPINE + ZIDOVUDINE

Reference record: Nevirapine
Source: BNF 80 (2020–2021)
Printed source pages: 704, 705
Age groups indexed: 1

Individual active ingredientSource records are displayed separately

Some source sections could not be separated reliably in the extraction. Review the printed source pages when a field is missing or incomplete.

Overview

Extracted information for Nevirapine only.

Indications And Dose

HIV infection in combination with other antiretroviral drugs (initial dose) ▶BY MOUTH USING IMMEDIATE-RELEASE MEDICINES ▶Adult: Initially 200 mg once daily for ﬁrst 14 days, initial dose titration using ‘immediate-release’ preparation should not exceed 28 days; if rash occurs and is not resolved within 28 days, alternative treatment should be sought. If treatment interrupted for more than 7 days, restart using the lower dose of the ‘immediate-release’ preparation for the ﬁrst 14 days as for new treatment HIV infection in combination with other antiretroviral drugs (maintenance dose following initial dose titration if no rash present) ▶BY MOUTH USING IMMEDIATE-RELEASE MEDICINES ▶Adult: 200 mg twice daily ▶BY MOUTH USING MODIFIED-RELEASE MEDICINES ▶Adult: 400 mg once daily

Source page 704

Contra Indications

Acute porphyrias p. 1120. post- exposure prophylaxis

Source page 704

Cautions

Females (at greater risk of hepatic side effects). high CD4 cell count (at greater risk of hepatic side effects) CAUTIONS, FURTHER INFORMATION ▶Hepatic effects Patients with chronic hepatitis B or C, high CD4 cell count, and women are at increased risk of hepatic side effects—if plasma HIV-1 RNA detectable, manufacturer advises avoid in women with CD4 cell count greater than 250 cells/mm3 or in men with CD4 cell count greater than 400 cells/mm3 unless potential beneﬁt outweighs risk.

Source page 704

Safety

Extracted information for Nevirapine only.

Interactions

→Appendix 1: nevirapine

Source page 704

Side Effects

▶Common or very common Abdominal pain. angioedema. diarrhoea. fatigue. fever. headache. hepatic disorders. hypersensitivity. hypertransaminasaemia. nausea. skin reactions. vomiting ▶Uncommon Anaemia. arthralgia. myalgia. severe cutaneous adverse reactions (SCARs) ▶Frequency not known Eosinophilia. osteonecrosis. weight increased SIDE-EFFECTS, FURTHER INFORMATION Hepatic effects Potentially life-threatening hepatotoxicity including fatal fulminant hepatitis reported usually in ﬁrst 6 weeks; discontinue permanently if abnormalities in liver function tests accompanied by hypersensitivity reaction (rash, fever, arthralgia, myalgia, lymphadenopathy, hepatitis, renal impairment, eosinophilia, granulocytopenia); suspend if severe abnormalities in liver function tests but no hypersensitivity reaction—discontinue permanently if signiﬁcant liver function abnormalities recur; monitor patient closely if mild to moderate abnormalities in liver function tests with no hypersensitivity reaction. Rash, usually in ﬁrst 6 weeks, is most common Rash side-effect; incidence reduced if introduced at low dose and dose increased gradually (after 14 days); Discontinue permanently if severe rash or if rash accompanied by blistering, oral lesions, conjunctivitis, facial oedema, general malaise or hypersensitivity reactions; if rash mild or moderate may continue without interruption but dose should not be increased until rash resolves. Osteonecrosis Osteonecrosis has been reported in patients with advanced HIV disease or following long-term exposure to combination antiretroviral therapy.

Source pages 704, 705

Hepatic Impairment

For modiﬁed-release preparations, manufacturer advises avoid (no information available). For immediate-release preparations, manufacturer advises caution in moderate impairment and chronic hepatitis (increased risk of hepatic side effects; consider interrupting or discontinuing treatment if hepatic function worsens); avoid in severe impairment (no information available).

Source page 705

Renal Impairment

Manufacturer advises avoid modiﬁed- release preparation—no information available.

Source page 705

Monitoring Requirements

▶Hepatic disease Close monitoring of liver function required during ﬁrst 18 weeks; monitor liver function before treatment then every 2 weeks for 2 months then after 1 month and then regularly. ▶Rash Monitor closely for skin reactions during ﬁrst 18 weeks.

Source page 705

Dose and formulations

Extracted information for Nevirapine only.

Medicinal Forms

There can be variation in the licensing of different medicines containing the same drug. Oral suspension ▶Viramune (Boehringer Ingelheim Ltd) Nevirapine (as Nevirapine hemihydrate) 10 mg per 1 ml Viramune 50mg/5ml oral suspension | 240 ml P £50.40 Modified-release tablet CAUTIONARY AND ADVISORY LABELS 25 ▶Nevirapine (Non-proprietary) Nevirapine 400 mg Nevirapine 400mg modified-release tablets | 30 tablet P £52.13–£170.00 DT = £81.75 ▶Viramune (Boehringer Ingelheim Ltd) Nevirapine 100 mg Viramune 100mg modified-release tablets | 90 tablet P £127.50 (Hospital only) Tablet ▶Nevirapine (Non-proprietary) Nevirapine 200 mg Nevirapine 200mg tablets | 60 tablet P £21.45–£170.00

Source page 705

Clinical care

Extracted information for Nevirapine only.

Patient And Carer Advice

Hypersensitivity reactions Patients or carers should be told how to recognise hypersensitivity reactions and advised to discontinue treatment and seek immediate medical attention if severe skin reaction, hypersensitivity reactions, or symptoms of hepatitis develop. Missed doses If a dose is more than 8 hours late with the ‘immediate-release’ preparation (or more than 12 hours late with the modiﬁed-release preparation), the missed dose should not be taken and the next dose should be taken at the usual time.

Source page 705

Dose text by age group

Filter the extracted dose blocks for this individual drug.

Adults

First line only; read the complete Indications and dose section above.

Initially 200 mg once daily for ﬁrst 14 days,

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 704

Adults

First line only; read the complete Indications and dose section above.

200 mg twice daily

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 704

Adults

First line only; read the complete Indications and dose section above.

400 mg once daily

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 704

Age labels are extracted from the printed dose headings and require clinical review. Confirm current local guidance, dose, route, formulation, contraindications and interactions before prescribing.

Individual generic drug information

nevirapine

Reference monograph

Part of registered formulation

LAMIVUDINE + NEVIRAPINE + ZIDOVUDINE

Reference record: Nevirapine
Source: BNF 80 (2020–2021)
Printed source pages: 704, 705
Age groups indexed: 1

Individual active ingredientSource records are displayed separately

Some source sections could not be separated reliably in the extraction. Review the printed source pages when a field is missing or incomplete.

Overview

Extracted information for Nevirapine only.

Indications And Dose

Source page 704

Contra Indications

Acute porphyrias p. 1120. post- exposure prophylaxis

Source page 704

Cautions

Source page 704

Safety

Extracted information for Nevirapine only.

Interactions

→Appendix 1: nevirapine

Source page 704

Side Effects

Source pages 704, 705

Hepatic Impairment

Source page 705

Renal Impairment

Manufacturer advises avoid modiﬁed- release preparation—no information available.

Source page 705

Monitoring Requirements

Source page 705

Dose and formulations

Extracted information for Nevirapine only.

Medicinal Forms

Source page 705

Clinical care

Extracted information for Nevirapine only.

Patient And Carer Advice

Source page 705

Dose text by age group

Filter the extracted dose blocks for this individual drug.

Adults

First line only; read the complete Indications and dose section above.

Initially 200 mg once daily for ﬁrst 14 days,

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 704

Adults

First line only; read the complete Indications and dose section above.

200 mg twice daily

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 704

Adults

First line only; read the complete Indications and dose section above.

400 mg once daily

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 704

Age labels are extracted from the printed dose headings and require clinical review. Confirm current local guidance, dose, route, formulation, contraindications and interactions before prescribing.