Individual generic drug information

pregabalin

Reference monograph

Part of registered formulation

PREGABALIN

Reference record: Pregabalin
Source: BNF 80 (2020–2021)
Printed source pages: 363, 364
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 Pregabalin only.

Indications And Dose

Peripheral and central neuropathic pain ▶BY MOUTH ▶Adult: Initially 150 mg daily in 2–3 divided doses, then increased if necessary to 300 mg daily in 2–3 divided doses, dose to be increased after 3–7 days, then increased if necessary up to 600 mg daily in 2–3 divided doses, dose to be increased after 7 days Adjunctive therapy for focal seizures with or without secondary generalisation ▶BY MOUTH ▶Adult: Initially 25 mg twice daily, then increased in steps of 50 mg daily, dose to be increased at 7 day intervals, increased to 300 mg daily in 2–3 divided doses for 7 days, then increased if necessary up to 600 mg daily in 2–3 divided doses Generalised anxiety disorder ▶BY MOUTH ▶Adult: Initially 150 mg daily in 2–3 divided doses, then increased in steps of 150 mg daily if required, dose to be increased at 7 day intervals, increased if necessary up to 600 mg daily in 2–3 divided doses l UNLICENSED USE Pregabalin doses in BNF may differ from those in product literature.

Source page 363

Cautions

Conditions that may precipitate encephalopathy. history of substance abuse. severe congestive heart failure

Source page 363

Prescribing And Dispensing Information

Flavours of oral liquid formulations may include strawberry.

Source page 363

National Funding Access Decisions

Scottish Medicines Consortium (SMC) decisions The Scottish Medicines Consortium has advised (July 2007) that pregabalin (Lyrica ®) is not recommended for the treatment of central neuropathic pain. The Scottish Medicines Consortium has advised (April 2009) that pregabalin (Lyrica ®) is accepted for restricted use within NHS Scotland for the treatment of peripheral neuropathic pain in adults who have not achieved adequate pain relief with, or have not tolerated, ﬁrst- or second-line treatments; discontinue treatment if sufﬁcient beneﬁt is not achieved within 8 weeks of reaching the maximum tolerated dose.

Source page 363

Safety

Extracted information for Pregabalin only.

Important Safety Information

MHRA/CHM ADVICE: PREGABALIN (LYRICA ®) AND RISK OF ABUSE AND DEPENDENCE: NEW SCHEDULING REQUIREMENTS FROM 1 APRIL (APRIL 2019) Following concerns about abuse, pregabalin has been reclassiﬁed as a Class C controlled substance and is now a Schedule 3 drug, but is exempt from safe custody requirements. Healthcare professionals should evaluate patients carefully for a history of drug abuse before prescribing pregabalin, and observe patients for signs of abuse and dependence. Patients should be informed of the potentially fatal risks of interactions between pregabalin and alcohol, and with other medicines that cause CNS depression, particularly opioids.

Source page 363

Interactions

→Appendix 1: antiepileptics Nervous system

Source page 363

Side Effects

▶Common or very common Abdominal distension. appetite abnormal. asthenia. cervical spasm. concentration impaired. confusion. constipation. diarrhoea. dizziness. drowsiness. dry mouth. feeling abnormal. gait abnormal. gastrointestinal disorders. headache. increased risk of infection. joint disorders. memory loss. mood altered. movement disorders. muscle complaints. nausea. oedema . pain. sensation abnormal. sexual dysfunction. sleep disorders. speech impairment. vertigo. vision disorders. vomiting. weight changes ▶Uncommon Aggression. anxiety. arrhythmias. atrioventricular block. breast abnormalities. chest tightness. chills. consciousness impaired. cough. depression. dry eye. dyspnoea. epistaxis. eye discomfort. eye disorders. eye inﬂammation. fever. hallucination. hyperacusia. hypertension. hypoglycaemia. hypotension. malaise. menstrual cycle irregularities. nasal complaints. neutropenia. oral disorders. peripheral coldness. psychiatric disorders. reﬂexes decreased. skin reactions. snoring. sweat changes. syncope. taste loss. thirst. urinary disorders. vasodilation ▶Rare or very rare Altered smell sensation. ascites. dysgraphia. dysphagia. gynaecomastia. hepatic disorders . pancreatitis. QT interval prolongation. renal impairment . rhabdomyolysis. Stevens-Johnson syndrome. throat tightness ▶Frequency not known Drug use disorders

Source page 363

Pregnancy

Manufacturer advises avoid unless potential beneﬁt outweighs risk — toxicity in animal studies. See also Pregnancy in Epilepsy p. 321.

Source page 363

Breast Feeding

See Breast-feeding in Epilepsy p. 321.

Source page 363

Renal Impairment

Dose adjustments Initially 75 mg daily and maximum 300 mg daily if eGFR 30–60 mL/minute/1.73 m2. Initially 25–50 mg daily and maximum 150 mg daily in 1–2 divided doses if eGFR 15–30 mL/minute/1.73 m2. Initially 25 mg once daily and maximum 75 mg once daily if eGFR less than 15 mL/minute/1.73 m2.

Source page 363

Monitoring Requirements

Monitor for signs of pregabalin abuse.

Source page 363

Dose and formulations

Extracted information for Pregabalin only.

Medicinal Forms

There can be variation in the licensing of different medicines containing the same drug. Forms available from special-order manufacturers include: oral suspension, oral solution Oral solution CAUTIONARY AND ADVISORY LABELS 3, 8 ▶Pregabalin (Non-proprietary) Nervous system Pregabalin 20 mg per 1 ml Pregabalin 20mg/ml oral solution sugar free sugar-free | 473 ml P £99.48 DT = £99.48 Schedule 3 (CD No Register Exempt Safe Custody) sugar-free | 500 ml P £75.00– £105.16 c ▶Lyrica (Upjohn UK Ltd) Pregabalin 20 mg per 1 ml Lyrica 20mg/ml oral solution sugar-free | 473 ml P £99.48 DT = £99.48 c Capsule CAUTIONARY AND ADVISORY LABELS 3, 8 ▶Pregabalin (Non-proprietary) Pregabalin 25 mg Pregabalin 25mg capsules | 56 capsule P £64.40 DT = £2.16 c | 84 capsule P £2.76–£96.60 c Pregabalin 50 mg Pregabalin 50mg capsules | 56 capsule P £8.96 c | 84 capsule P £96.60 DT = £2.92 c Pregabalin 75 mg Pregabalin 75mg capsules | 14 capsule P £3.21 c | 56 capsule P £64.40 DT = £2.24 c Pregabalin 100 mg Pregabalin 100mg capsules | 84 capsule P £96.60 DT = £3.66 c Pregabalin 150 mg Pregabalin 150mg capsules | 56 capsule P £64.40 DT = £3.01 c Pregabalin 200 mg Pregabalin 200mg capsules | 84 capsule P £96.60 DT = £5.07 c Pregabalin 225 mg Pregabalin 225mg capsules | 56 capsule P £64.40 DT = £3.81 c Pregabalin 300 mg Pregabalin 300mg capsules | 56 capsule P £64.40 DT = £4.86 c ▶Alzain (Dr Reddy’s Laboratories (UK) Ltd) Pregabalin 25 mg Alzain 25mg capsules | 56 capsule P £4.99 DT = £2.16 c Pregabalin 50 mg Alzain 50mg capsules | 56 capsule P £5.99 c | 84 capsule P £6.99 DT = £2.92 c Pregabalin 75 mg Alzain 75mg capsules | 56 capsule P £5.99 DT = £2.24 c Pregabalin 100 mg Alzain 100mg capsules | 84 capsule P £6.99 DT = £3.66 c Pregabalin 150 mg Alzain 150mg capsules | 56 capsule P £6.99 DT = £3.01 c Pregabalin 200 mg Alzain 200mg capsules | 84 capsule P £8.99 DT = £5.07 c Pregabalin 225 mg Alzain 225mg capsules | 56 capsule P £7.99 DT = £3.81 c Pregabalin 300 mg Alzain 300mg capsules | 56 capsule P £8.99 DT = £4.86 c ▶Axalid (Kent Pharmaceuticals Ltd) Pregabalin 25 mg Axalid 25mg capsules | 56 capsule P £19.95 DT = £2.16 c Pregabalin 50 mg Axalid 50mg capsules | 56 capsule P £19.95 c Pregabalin 75 mg Axalid 75mg capsules | 56 capsule P £19.95 DT = £2.24 c Pregabalin 100 mg Axalid 100mg capsules | 56 capsule P £19.95 c Pregabalin 150 mg Axalid 150mg capsules | 56 capsule P £19.95 DT = £3.01 c Pregabalin 200 mg Axalid 200mg capsules | 56 capsule P £19.95 c Pregabalin 225 mg Axalid 225mg capsules | 56 capsule P £19.95 DT = £3.81 c Pregabalin 300 mg Axalid 300mg capsules | 56 capsule P £19.95 DT = £4.86 c ▶Lecaent (Accord Healthcare Ltd) Pregabalin 25 mg Lecaent 25mg capsules | 56 capsule P £64.39 DT = £2.16 c Pregabalin 50 mg Lecaent 50mg capsules | 84 capsule P £96.59 DT = £2.92 c Pregabalin 100 mg Lecaent 100mg capsules | 84 capsule P £96.59 DT = £3.66 c Pregabalin 150 mg Lecaent 150mg capsules | 56 capsule P £64.39 DT = £3.01 c Pregabalin 200 mg Lecaent 200mg capsules | 84 capsule P £96.59 DT = £5.07 c ▶Lyrica (Upjohn UK Ltd) Pregabalin 25 mg Lyrica 25mg capsules | 56 capsule P £64.40 DT = £2.16 c | 84 capsule P £96.60 c Pregabalin 50 mg Lyrica 50mg capsules | 84 capsule P £96.60 DT = £2.92 c Pregabalin 75 mg Lyrica 75mg capsules | 56 capsule P £64.40 DT = £2.24 c Pregabalin 100 mg Lyrica 100mg capsules | 84 capsule P £96.60 DT = £3.66 c Pregabalin 150 mg Lyrica 150mg capsules | 56 capsule P £64.40 DT = £3.01 c Pregabalin 200 mg Lyrica 200mg capsules | 84 capsule P £96.60 DT = £5.07 c Pregabalin 225 mg Lyrica 225mg capsules | 56 capsule P £64.40 DT = £3.81 c Pregabalin 300 mg Lyrica 300mg capsules | 56 capsule P £64.40 DT = £4.86 c

Source page 364

Clinical care

Extracted information for Pregabalin only.

Treatment Cessation

Avoid abrupt withdrawal (taper over at least 1 week).

Source page 363

Patient And Carer Advice

Patient leaflet NHS England has produced a patient leaﬂet with information on the reclassiﬁcation of pregabalin.

Source page 363

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 150 mg daily in 2–3 divided doses, then

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

Candidate age grouping · source page 363

Adults

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

Initially 25 mg twice daily, then increased in

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

Candidate age grouping · source page 363

Adults

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

Initially 150 mg daily in 2–3 divided doses, then

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

Candidate age grouping · source page 363

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

pregabalin

Reference monograph

Part of registered formulation

PREGABALIN

Reference record: Pregabalin
Source: BNF 80 (2020–2021)
Printed source pages: 363, 364
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 Pregabalin only.

Indications And Dose

Source page 363

Cautions

Conditions that may precipitate encephalopathy. history of substance abuse. severe congestive heart failure

Source page 363

Prescribing And Dispensing Information

Flavours of oral liquid formulations may include strawberry.

Source page 363

National Funding Access Decisions

Source page 363

Safety

Extracted information for Pregabalin only.

Important Safety Information

Source page 363

Interactions

→Appendix 1: antiepileptics Nervous system

Source page 363

Side Effects

Source page 363

Pregnancy

Manufacturer advises avoid unless potential beneﬁt outweighs risk — toxicity in animal studies. See also Pregnancy in Epilepsy p. 321.

Source page 363

Breast Feeding

See Breast-feeding in Epilepsy p. 321.

Source page 363

Renal Impairment

Source page 363

Monitoring Requirements

Monitor for signs of pregabalin abuse.

Source page 363

Dose and formulations

Extracted information for Pregabalin only.

Medicinal Forms

Source page 364

Clinical care

Extracted information for Pregabalin only.

Treatment Cessation

Avoid abrupt withdrawal (taper over at least 1 week).

Source page 363

Patient And Carer Advice

Patient leaflet NHS England has produced a patient leaﬂet with information on the reclassiﬁcation of pregabalin.

Source page 363

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 150 mg daily in 2–3 divided doses, then

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

Candidate age grouping · source page 363

Adults

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

Initially 25 mg twice daily, then increased in

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

Candidate age grouping · source page 363

Adults

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

Initially 150 mg daily in 2–3 divided doses, then

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

Candidate age grouping · source page 363

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.