Nevirapine 200mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Nevirapine

Available from:

Sandoz Ltd

ATC code:

J05AG01

INN (International Name):

Nevirapine

Dosage:

200mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05030100

Summary of Product characteristics

NEVIRAPINE 200 MG TABLETS
Summary of Product Characteristics Updated 20-Mar-2015 | Sandoz
Limited
1. Name of the medicinal product
Nevirapine 200 mg tablets
2. Qualitative and quantitative composition
Each tablet contains 200 mg of nevirapine (as anhydrate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet.
Off-white to pale yellow coloured, capsule shaped, biconvex tablets,
debossed with 'H' on one side and '7'
on the other side with breakline on both sides.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4. Clinical particulars
4.1 Therapeutic indications
Nevirapine is indicated in combination with other anti-retroviral
medicinal products for the treatment of
HIV-1 infected adults, adolescents, and children of any age (see
section 4.4.).
Most of the experience with nevirapine is in combination with
nucleoside reverse transcriptase inhibitors
(NRTIs). The choice of a subsequent therapy after Nevirapine should be
based on clinical experience and
resistance testing (see section 5.1).
4.2 Posology and method of administration
Nevirapine should be administered by physicians who are experienced in
the treatment of HIV infection.
Posology
_Patients 16 years and older_
The recommended dose of Nevirapine is one 200 mg tablet daily for the
first 14 days (this lead-in period
should be used because it has been found to lessen the frequency of
rash), followed by one 200 mg tablet
twice daily, in combination with at least two additional
antiretroviral agents.
If a dose is recognized as missed within 8 hours of when it was due,
the patient should take the missed
dose as soon as possible. If a dose is missed and it is more than 8
hours later, the patient should only take
the next dose at the usual time.
_Dose management considerations_
Patients experiencing rash during the 14-day lead-in period of 200
mg/day should not have their
Nevirapine dose increased until the rash has resolved. The isolated
rash should be closely monitored (see
sectio