Search This Blog

468x60.

728x90

 


l CONTRA-INDICATIONS Avoid in pre-eclampsia . cardiac

valvulopathy (exclude before treatment). history of

pericardial fibrotic disorders . history of puerperal

psychosis . history of pulmonary fibrotic disorders . history

of retroperitoneal fibrotic disorders

l CAUTIONS Cardiovascular disease . history of peptic ulcer

(particularly in acromegalic patients). history of serious

mental disorders (especially psychotic disorders). Raynaud’s syndrome

CAUTIONS, FURTHER INFORMATION

▶ Hyperprolactinemic patients In hyperprolactinaemic patients,

the source of the hyperprolactinaemia should be

established (i.e. exclude pituitary tumour before

treatment).

l INTERACTIONS → Appendix 1: dopamine receptor agonists

l SIDE-EFFECTS

▶ Common or very common Angina pectoris . asthenia . cardiac valvulopathy . confusion . constipation . dizziness . drowsiness . dyspepsia . dyspnoea . gastritis . hallucination . headache . hypotension . movement disorders . nausea . oedema . pericardial effusion . pericarditis . sexual

dysfunction . sleep disorders . vertigo . vomiting

▶ Uncommon Delusions . erythromelalgia . hepatic function

abnormal . psychotic disorder.rash .respiratory disorders

▶ Rare or very rare Fibrosis

▶ Frequency not known Aggression . alopecia . chest pain . digital vasospasm . leg cramps . pathological gambling . syncope .tremor. visual impairment

l ALLERGY AND CROSS-SENSITIVITY Cabergoline should not

be used in patients with hypersensitivity to ergot alkaloids.

l CONCEPTION AND CONTRACEPTION Exclude pregnancy

before starting and perform monthly pregnancy tests

during the amenorrhoeic period. Caution—advise nonhormonal contraception if pregnancy not desired.

Discontinue 1 month before intended conception

(ovulatory cycles persist for 6 months).

l PREGNANCY Discontinue if pregnancy occurs during

treatment (specialist advice needed).

l BREAST FEEDING Suppresses lactation; avoid breastfeeding if lactation prevention fails.

l HEPATIC IMPAIRMENT Manufacturer advises caution in

severe impairment (risk of increased of exposure).

Dose adjustments Manufacturer advises consider dose

reduction in severe impairment.

l MONITORING REQUIREMENTS

▶ Monitor for fibrotic disease.

▶ Monitor blood pressure for a few days after starting

treatment and following dosage increase.

l TREATMENT CESSATION Antiparkinsonian drug therapy

should never be stopped abruptly as this carries a small

risk of neuroleptic malignant syndrome.

l PRESCRIBING AND DISPENSING INFORMATION Dispense in

original container (contains desiccant).

l PATIENT AND CARER ADVICE

Driving and skilled tasks Sudden onset of sleep Excessive

daytime sleepiness and sudden onset of sleep can occur

with dopamine-receptor agonists.

Patients starting treatment with these drugs should be

warned of the risk and of the need to exercise caution

when driving or operating machinery. Those who have

experienced excessive sedation or sudden onset of sleep

should refrain from driving or operating machines until

these effects have stopped occurring.

Management of excessive daytime sleepiness should

focus on the identification of an underlying cause, such as

depression or concomitant medication. Patients should be

counselled on improving sleep behaviour.

Hypotensive reactions Hypotensive reactions can occur in

some patients taking dopamine-receptor agonists; these

can be particularly problematic during the first few days of

treatment and care should be exercised when driving or

operating machinery.

BNF 78 Parkinson’s disease 421

Nervous system

4

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Tablet

CAUTIONARY AND ADVISORY LABELS 10, 21

▶ Cabergoline (Non-proprietary)

Cabergoline 500 microgram Cabergoline 500microgram tablets | 8 tablet P £34.99 DT = £34.97

Cabergoline 1 mg Cabergoline 1mg tablets | 20 tablet P £66.00

DT = £64.25

Cabergoline 2 mg Cabergoline 2mg tablets | 20 tablet P £73.14

DT = £73.12

▶ Cabaser (Pfizer Ltd)

Cabergoline 1 mg Cabaser 1mg tablets | 20 tablet P £83.00 DT =

£64.25

Cabergoline 2 mg Cabaser 2mg tablets | 20 tablet P £83.00 DT

= £73.12

▶ Dostinex (Pfizer Ltd)

Cabergoline 500 microgram Dostinex 500microgram tablets |

8 tablet P £30.04 DT = £34.97

Pergolide

l INDICATIONS AND DOSE

Monotherapy in Parkinson’s disease where dopaminereceptor agonists other than ergot derivative not

appropriate

▶ BY MOUTH

▶ Adult: Initially 50 micrograms once daily for day 1,

dose to be taken at bedtime, then 50 micrograms twice

daily for days 2–4, then increased in steps of

100–250 micrograms daily, dose to be increased at

intervals of 3–4 days, increased to 1.5 mg daily in

3 divided doses at day 28, then increased in steps of up

to 250 micrograms every 3–4 days, this increase to be

started after day 30; maintenance 2.1–2.5 mg daily;

maximum 3 mg per day

Adjunctive therapy with co-beneldopa or co-careldopa in

Parkinson’s disease where dopamine-receptor agonists

other than ergot derivative not appropriate

▶ BY MOUTH

▶ Adult: Initially 50 micrograms daily for 2 days, then

increased in steps of 100–150 micrograms every 3 days,

dose to be adjusted over next 12 days following initial

dose and usually given in 3 divided doses, then

increased in steps of 250 micrograms every 3 days,

during pergolide titration, levodopa dose may be

reduced cautiously; maximum 3 mg per day

IMPORTANT SAFETY INFORMATION

FIBROTIC REACTIONS

Pergolide has been associated with pulmonary,

retroperitoneal, and pericardial fibrotic reactions.

Exclude cardiac valvulopathy with echocardiography

before starting treatment with pergolide; it may also be

appropriate to measure the erythrocyte sedimentation

rate and serum creatinine and to obtain a chest X-ray.

Patients should be monitored for dyspnoea, persistent

cough, chest pain, cardiac failure, and abdominal pain or

tenderness. If long-term treatment is expected, then

lung-function tests may also be helpful. Patients taking

pergolide should be regularly monitored for cardiac

fibrosis by echocardiography (within 3–6 months of

initiating treatment and subsequently at 6–12 month

intervals).

IMPULSE CONTROL DISORDERS

Treatment with dopamine-receptor agonists is

associated with impulse control disorders, including

pathological gambling, binge eating, and hypersexuality.

Patients and their carers should be informed about the

risk of impulse control disorders. There is no evidence

that ergot- and non-ergot-derived dopamine-receptor

agonists differ in their propensity to cause impulse

control disorders, so switching between dopaminereceptor agonists to control these side-effects is not

recommended. If the patient develops an impulse

control disorder, the dopamine-receptor agonist or

levodopa should be withdrawn or the dose reduced until

the symptoms resolve.

l CONTRA-INDICATIONS Cardiac valvulopathy (exclude

before treatment). history of fibrotic disorders

l CAUTIONS Acute porphyrias p. 1058 . arrhythmias . dyskinesia (may exacerbate). hallucinations . history of

confusion . psychosis . underlying cardiac disease

l INTERACTIONS → Appendix 1: dopamine receptor agonists

l SIDE-EFFECTS Cardiac valve disorders . compulsions . confusion . constipation . diarrhoea . diplopia . dizziness . drowsiness . dyskinesia . dyspnoea . eating disorders . erythromelalgia . gastrointestinal discomfort. hallucination . hiccups . nausea . neuroleptic malignant

syndrome . pain . palpitations . pathological gambling . pericardial effusion . pericarditis . postural hypotension . pulmonary hypertension .rash . Raynaud’s phenomenon . respiratory disorders .retroperitoneal fibrosis .rhinitis . sexual dysfunction . sleep disorders . syncope . vomiting

l PREGNANCY Use only if potential benefit outweighs risk.

l BREAST FEEDING May suppress lactation.

l TREATMENT CESSATION Antiparkinsonian drug therapy

should never be stopped abruptly as this carries a small

risk of neuroleptic malignant syndrome.

l PATIENT AND CARER ADVICE

Driving and skilled tasks Sudden onset of sleep Excessive

daytime sleepiness and sudden onset of sleep can occur

with dopamine-receptor agonists.

Patients starting treatment with these drugs should be

warned of the risk and of the need to exercise caution

when driving or operating machinery. Those who have

experienced excessive sedation or sudden onset of sleep

should refrain from driving or operating machines until

these effects have stopped occurring.

Management of excessive daytime sleepiness should

focus on the identification of an underlying cause, such as

depression or concomitant medication. Patients should be

counselled on improving sleep behaviour.

Hypotensive reactions Hypotensive reactions can occur in

some patients taking dopamine-receptor agonists; these

can be particularly problematic during the first few days of

treatment and care should be exercised when driving or

operating machinery.

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Tablet

CAUTIONARY AND ADVISORY LABELS 10

▶ Pergolide (Non-proprietary)

Pergolide (as Pergolide mesilate) 250 microgram Pergolide

250microgram tablets | 100 tablet P £36.03

Pergolide (as Pergolide mesilate) 1 mg Pergolide 1mg tablets | 100 tablet P £121.38

Pramipexole

l INDICATIONS AND DOSE

Parkinson’s disease, used alone or as an adjunct to cobeneldopa or co-careldopa

▶ BY MOUTH USING IMMEDIATE-RELEASE MEDICINES

▶ Adult: Initially 88 micrograms 3 times a day, if

tolerated dose to be increased by doubling dose every

5–7 days, increased to 350 micrograms 3 times a day,

then increased in steps of 180 micrograms 3 times a

day if required, dose to be increased at weekly

intervals, during dose titration and maintenance,

422 Movement disorders BNF 78

Nervous system

4

levodopa dose may be reduced, maximum daily dose to

be given in 3 divided doses; maximum 3.3 mg per day

▶ BY MOUTH USING MODIFIED-RELEASE MEDICINES

▶ Adult: Initially 260 micrograms once daily, dose to be

increased by doubling dose every 5–7 days, increased

to 1.05 mg once daily, then increased in steps of

520 micrograms every week if required, during dose

titration and maintenance, levodopa dose may be

reduced according to response; maximum 3.15 mg per

day

Moderate to severe restless legs syndrome

▶ BY MOUTH USING IMMEDIATE-RELEASE MEDICINES

▶ Adult: Initially 88 micrograms once daily, dose to be

taken 2–3 hours before bedtime, dose to be increased

by doubling dose every 4–7 days if necessary, repeat

dose titration if restarting treatment after an interval

of more than a few days; maximum 540 micrograms per

day

DOSE EQUIVALENCE AND CONVERSION

▶ Doses and strengths are stated in terms of pramipexole

(base).

▶ Equivalent strengths of pramipexole (base) in terms of

pramipexole dihydrochloride monohydrate (salt) for

immediate-release preparations are as follows:

▶ 88 micrograms base : 125 micrograms salt;

▶ 180 micrograms base : 250 micrograms salt;

▶ 350 micrograms base : 500 micrograms salt;

▶ 700 micrograms base : 1 mg salt.

▶ Equivalent strengths of pramipexole (base) in terms of

pramipexole dihydrochloride monohydrate (salt) for

modified-release preparations are as follows:

▶ 260 micrograms base : 375 micrograms salt;

▶ 520 micrograms base : 750 micrograms salt;

▶ 1.05 mg base : 1.5 mg salt;

▶ 1.57 mg base : 2.25 mg salt;

▶ 2.1 mg base : 3 mg salt;

▶ 2.62 mg base : 3.75 mg salt;

▶ 3.15 mg base : 4.5 mg salt.

IMPORTANT SAFETY INFORMATION

IMPULSE CONTROL DISORDERS

Treatment with dopamine-receptor agonists is

associated with impulse control disorders, including

pathological gambling, binge eating, and hypersexuality.

Patients and their carers should be informed about the

risk of impulse control disorders. There is no evidence

that ergot- and non-ergot-derived dopamine-receptor

agonists differ in their propensity to cause impulse

control disorders, so switching between dopaminereceptor agonists to control these side-effects is not

recommended. If the patient develops an impulse

control disorder, the dopamine-receptor agonist should

be withdrawn or the dose reduced until the symptoms

resolve.

l CAUTIONS Psychotic disorders .risk of visual disorders

(ophthalmological testing recommended). severe

cardiovascular disease

l INTERACTIONS → Appendix 1: dopamine receptor agonists

l SIDE-EFFECTS

▶ Common or very common Appetite abnormal . behaviour

abnormal . confusion . constipation . dizziness . drowsiness . fatigue . hallucination . headache . hypotension . movement disorders . nausea . peripheral oedema . psychiatric disorders . sleep disorders . vision disorders . vomiting . weight changes

▶ Uncommon Anxiety . binge eating . delirium . delusions . dyspnoea . heart failure . hiccups . mania . memory loss . pathological gambling . pneumonia . sexual dysfunction . SIADH . skin reactions . syncope

▶ Frequency not known Depression . dopamine agonist

withdrawal syndrome . generalised pain . sweating

abnormal

l PREGNANCY Use only if potential benefit outweighs risk—

no information available.

l BREAST FEEDING May suppress lactation; avoid—present

in milk in animal studies.

l RENAL IMPAIRMENT For modified-release tablets, avoid if

eGFR less than 30 mL/minute/1.73 m2

.

Dose adjustments For immediate-release tablets in

Parkinson’s disease, initially 88 micrograms twice daily

(max. 1.57 mg daily in 2 divided doses) if eGFR

20–50 mL/minute/1.73 m2

; initially 88 micrograms once

daily (max. 1.1 mg once daily) if eGFR less than

20 mL/minute/1.73 m2

. If renal function declines during

treatment, reduce dose by the same percentage as the

decline in eGFR.

For immediate-release tablets in restless legs syndrome,

reduce dose if eGFR less than 20 mL/minute/1.73 m2

.

For modified-release tablets, initially 260 micrograms on

alternate days if eGFR 30–50 mL/minute/1.73 m2

,

increased to 260 micrograms once daily after 1 week,

further increased if necessary by 260 micrograms daily at

weekly intervals to max. 1.57 mg daily.

l MONITORING REQUIREMENTS Risk of postural hypotension

(especially on initiation)—monitor blood pressure.

l TREATMENT CESSATION Antiparkinsonian drug therapy

should never be stopped abruptly as this carries a small

risk of neuroleptic malignant syndrome.

l PATIENT AND CARER ADVICE

Driving and skilled tasks Sudden onset of sleep Excessive

daytime sleepiness and sudden onset of sleep can occur

with dopamine-receptor agonists.

Patients starting treatment with these drugs should be

warned of the risk and of the need to exercise caution

when driving or operating machinery. Those who have

experienced excessive sedation or sudden onset of sleep

should refrain from driving or operating machines until

these effects have stopped occurring.

Management of excessive daytime sleepiness should

focus on the identification of an underlying cause, such as

depression or concomitant medication. Patients should be

counselled on improving sleep behaviour.

Hypotensive reactions Hypotensive reactions can occur in

some patients taking dopamine-receptor agonists; these

can be particularly problematic during the first few days of

treatment and care should be exercised when driving or

operating machinery.

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Modified-release tablet

CAUTIONARY AND ADVISORY LABELS 10, 25

▶ Pramipexole (Non-proprietary)

Pramipexole (as Pramipexole dihydrochloride monohydrate)

260 microgram Pramipexole 260microgram modified-release tablets

| 30 tablet P £8.50–£30.87 DT = £14.77

Pramipexole (as Pramipexole dihydrochloride monohydrate)

520 microgram Pramipexole 520microgram modified-release tablets

| 30 tablet P £20.00–£61.73 DT = £30.74

Pramipexole (as Pramipexole dihydrochloride monohydrate)

1.05 mg Pramipexole 1.05mg modified-release tablets | 30 tablet P £28.00–£123.46 DT = £56.68

Pramipexole (as Pramipexole dihydrochloride monohydrate)

1.57 mg Pramipexole 1.57mg modified-release tablets | 30 tablet P £80.94–£192.24 DT = £126.82

Pramipexole (as Pramipexole dihydrochloride monohydrate)

2.1 mg Pramipexole 2.1mg modified-release tablets | 30 tablet P £50.00–£246.91 DT = £110.97

Pramipexole (as Pramipexole dihydrochloride monohydrate)

2.62 mg Pramipexole 2.62mg modified-release tablets |

30 tablet P £134.95–£320.41 DT = £222.06

BNF 78 Parkinson’s disease 423

Nervous system

4

Pramipexole (as Pramipexole dihydrochloride monohydrate)

3.15 mg Pramipexole 3.15mg modified-release tablets | 30 tablet P £155.95–£370.38 DT = £210.46

▶ Mirapexin (Boehringer Ingelheim Ltd)

Pramipexole (as Pramipexole dihydrochloride monohydrate)

260 microgram Mirapexin 0.26mg modified-release tablets | 30 tablet P £32.49 DT = £14.77

Pramipexole (as Pramipexole dihydrochloride monohydrate)

520 microgram Mirapexin 0.52mg modified-release tablets |

30 tablet P £64.98 DT = £30.74

Pramipexole (as Pramipexole dihydrochloride monohydrate)

1.05 mg Mirapexin 1.05mg modified-release tablets | 30 tablet P £129.96 DT = £56.68

Pramipexole (as Pramipexole dihydrochloride monohydrate)

1.57 mg Mirapexin 1.57mg modified-release tablets | 30 tablet P £202.36 DT = £126.82

Pramipexole (as Pramipexole dihydrochloride monohydrate)

2.1 mg Mirapexin 2.1mg modified-release tablets | 30 tablet P £259.91 DT = £110.97

Pramipexole (as Pramipexole dihydrochloride monohydrate)

2.62 mg Mirapexin 2.62mg modified-release tablets | 30 tablet P £337.27 DT = £222.06

Pramipexole (as Pramipexole dihydrochloride monohydrate)

3.15 mg Mirapexin 3.15mg modified-release tablets | 30 tablet P £389.87 DT = £210.46

▶ Oprymea (Consilient Health Ltd)

Pramipexole (as Pramipexole dihydrochloride monohydrate)

260 microgram Oprymea 0.26mg modified-release tablets | 30 tablet P £25.56 DT = £14.77

Pramipexole (as Pramipexole dihydrochloride monohydrate)

520 microgram Oprymea 0.52mg modified-release tablets | 30 tablet P £51.14 DT = £30.74

Pramipexole (as Pramipexole dihydrochloride monohydrate)

1.05 mg Oprymea 1.05mg modified-release tablets | 30 tablet P £102.28 DT = £56.68

Pramipexole (as Pramipexole dihydrochloride monohydrate)

1.57 mg Oprymea 1.57mg modified-release tablets | 30 tablet P £159.26 DT = £126.82

Pramipexole (as Pramipexole dihydrochloride monohydrate)

2.1 mg Oprymea 2.1mg modified-release tablets | 30 tablet P £204.56 DT = £110.97

Pramipexole (as Pramipexole dihydrochloride monohydrate)

2.62 mg Oprymea 2.62mg modified-release tablets | 30 tablet P £337.27 DT = £222.06

Pramipexole (as Pramipexole dihydrochloride monohydrate)

3.15 mg Oprymea 3.15mg modified-release tablets | 30 tablet P £389.87 DT = £210.46

▶ Pipexus (Ethypharm UK Ltd)

Pramipexole (as Pramipexole dihydrochloride monohydrate)

260 microgram Pipexus 0.26mg modified-release tablets |

30 tablet P £16.25 DT = £14.77

Pramipexole (as Pramipexole dihydrochloride monohydrate)

520 microgram Pipexus 0.52mg modified-release tablets | 30 tablet P £32.49 DT = £30.74

Pramipexole (as Pramipexole dihydrochloride monohydrate)

1.05 mg Pipexus 1.05mg modified-release tablets | 30 tablet P £64.98 DT = £56.68

Pramipexole (as Pramipexole dihydrochloride monohydrate)

1.57 mg Pipexus 1.57mg modified-release tablets | 30 tablet P £101.18 DT = £126.82

Pramipexole (as Pramipexole dihydrochloride monohydrate)

2.1 mg Pipexus 2.1mg modified-release tablets | 30 tablet P £129.96 DT = £110.97

Pramipexole (as Pramipexole dihydrochloride monohydrate)

2.62 mg Pipexus 2.62mg modified-release tablets | 30 tablet P £168.64 DT = £222.06

Pramipexole (as Pramipexole dihydrochloride monohydrate)

3.15 mg Pipexus 3.15mg modified-release tablets | 30 tablet P £194.94 DT = £210.46

Tablet

CAUTIONARY AND ADVISORY LABELS 10

▶ Pramipexole (Non-proprietary)

Pramipexole (as Pramipexole dihydrochloride monohydrate)

88 microgram Pramipexole 88microgram tablets | 30 tablet P £8.60 DT = £4.38

Pramipexole (as Pramipexole dihydrochloride monohydrate)

180 microgram Pramipexole 180microgram tablets | 30 tablet P £17.19 DT = £2.06 | 100 tablet P £5.90–£6.87

Pramipexole (as Pramipexole dihydrochloride monohydrate)

350 microgram Pramipexole 350microgram tablets | 30 tablet P £34.38 DT = £13.83 | 100 tablet P £46.10–£46.50

Pramipexole (as Pramipexole dihydrochloride monohydrate)

700 microgram Pramipexole 700microgram tablets | 30 tablet P £68.76 DT = £2.52 | 100 tablet P £7.20–£10.73

▶ Mirapexin (Boehringer Ingelheim Ltd)

Pramipexole (as Pramipexole dihydrochloride monohydrate)

88 microgram Mirapexin 0.088mg tablets | 30 tablet P £11.24

DT = £4.38

Pramipexole (as Pramipexole dihydrochloride monohydrate)

180 microgram Mirapexin 0.18mg tablets | 30 tablet P £22.49

DT = £2.06 | 100 tablet P £74.95

Pramipexole (as Pramipexole dihydrochloride monohydrate)

350 microgram Mirapexin 0.35mg tablets | 30 tablet P £44.97

DT = £13.83 | 100 tablet P £149.90

Pramipexole (as Pramipexole dihydrochloride monohydrate)

700 microgram Mirapexin 0.7mg tablets | 30 tablet P £89.94

DT = £2.52 | 100 tablet P £299.82

▶ Oprymea (Consilient Health Ltd)

Pramipexole (as Pramipexole dihydrochloride monohydrate)

88 microgram Oprymea 0.088mg tablets | 30 tablet P £3.23 DT

= £4.38

Pramipexole (as Pramipexole dihydrochloride monohydrate)

180 microgram Oprymea 0.18mg tablets | 30 tablet P £6.09 DT

= £2.06 | 100 tablet P £15.46

Pramipexole (as Pramipexole dihydrochloride monohydrate)

350 microgram Oprymea 0.35mg tablets | 30 tablet P £32.47

DT = £13.83 | 100 tablet P £108.23

Pramipexole (as Pramipexole dihydrochloride monohydrate)

700 microgram Oprymea 0.7mg tablets | 30 tablet P £18.26 DT

= £2.52 | 100 tablet P £117.63

Ropinirole 28-Mar-2019

l INDICATIONS AND DOSE

Parkinson’s disease, either used alone or as adjunct to cobeneldopa or co-careldopa

▶ BY MOUTH USING IMMEDIATE-RELEASE MEDICINES

▶ Adult: Initially 750 micrograms daily in 3 divided doses,

then increased in steps of 750 micrograms daily, dose

to be increased at weekly intervals, increased to 3 mg

daily in 3 divided doses, then increased in steps of

1.5–3 mg daily, adjusted according to response, dose to

be increased at weekly intervals; usual dose 9–16 mg

daily in 3 divided doses, higher doses may be required if

used with levodopa, when administered as adjunct to

levodopa, concurrent dose of levodopa may be reduced

by approx. 20%, daily maximum dose to be given in

3 divided doses; maximum 24 mg per day

▶ BY MOUTH USING MODIFIED-RELEASE MEDICINES

▶ Adult: Initially 2 mg once daily for 1 week, then 4 mg

once daily, increased in steps of 2 mg at intervals of at

least 1 week, adjusted according to response, increased

to up to 8 mg once daily, dose to be increased further if

still no response; increased in steps of 2–4 mg at

intervals of at least 2 weeks if required, consider slower

titration in patients over 75 years, when administered

as adjunct to levodopa, concurrent dose of levodopa

may gradually be reduced by approx. 30%; maximum

24 mg per day

Parkinson’s disease in patients transferring from

ropinirole immediate-release tablets

▶ BY MOUTH USING MODIFIED-RELEASE MEDICINES

▶ Adult: Initially ropinirole modified-release once daily

substituted for total daily dose equivalent of ropinirole

immediate-release tablets; if control not maintained

after switching, titrate dose as above

Moderate to severe restless legs syndrome

▶ BY MOUTH USING IMMEDIATE-RELEASE MEDICINES

▶ Adult: Initially 250 micrograms once daily for 2 days,

increased if tolerated to 500 micrograms once daily for

5 days, then increased if tolerated to 1 mg once daily

424 Movement disorders BNF 78

Nervous system

4

for 7 days, then increased in steps of 500 micrograms

daily, adjusted according to response, dose to be

increased at weekly intervals; usual dose 2 mg once

daily, doses to be taken at night; maximum 4 mg per

day

l UNLICENSED USE Doses in the BNF may differ from those

in product literature.

IMPORTANT SAFETY INFORMATION

SAFE PRACTICE

Ropinirole has been confused with risperidone; care

must be taken to ensure the correct drug is prescribed

and dispensed.

IMPULSE CONTROL DISORDERS

Treatment with dopamine-receptor agonists is

associated with impulse control disorders, including

pathological gambling, binge eating, and hypersexuality.

Patients and their carers should be informed about the

risk of impulse control disorders. There is no evidence

that ergot- and non-ergot-derived dopamine-receptor

agonists differ in their propensity to cause impulse

control disorders, so switching between dopaminereceptor agonists to control these side-effects is not

recommended. If the patient develops an impulse

control disorder, the dopamine-receptor agonist should

be withdrawn or the dose reduced until the symptoms

resolve.

l CAUTIONS Elderly . major psychotic disorders . severe

cardiovascular disease (risk of hypotension—monitor

blood pressure)

l INTERACTIONS → Appendix 1: dopamine receptor agonists

l SIDE-EFFECTS

▶ Common or very common Confusion . dizziness . drowsiness . early morning awakening . fatigue . gastrointestinal discomfort. hallucination . movement

disorders . nausea . nervousness . peripheral oedema . syncope . vertigo . vomiting

▶ Uncommon Hypotension . sexual dysfunction

▶ Rare or very rare Hepatic reaction

▶ Frequency not known Behaviour abnormal . compulsions . delirium . delusions . dopamine dysregulation syndrome . eating disorders . pathological gambling . psychotic

disorder

l PREGNANCY Avoid unless potential benefit outweighs

risk—toxicity in animal studies.

l BREAST FEEDING May suppress lactation—avoid.

l HEPATIC IMPAIRMENT

▶ When used for Parkinson’s disease Manufacturer advises avoid

(no information available).

▶ When used for Restless legs syndrome Manufacturer advises

caution in moderate impairment; avoid in severe

impairment.

l RENAL IMPAIRMENT Avoid if eGFR less than

30 mL/minute/1.73 m2

.

l TREATMENT CESSATION Antiparkinsonian drug therapy

should never be stopped abruptly as this carries a small

risk of neuroleptic malignant syndrome.

l PATIENT AND CARER ADVICE Manufacturer advises

patients and their carers should be informed of the risk of

developing dopamine dysregulation syndrome; addictionlike symptoms should be reported.

Missed doses

▶ When used for Parkinson’s disease Manufacturer advises if

treatment is interrupted for one day or more, re-initiation

by dose titration should be considered—consult product

literature.

▶ When used for Moderate to severe restless legs

syndrome Manufacturer advises if treatment is

interrupted for more than a few days, re-initiation by dose

titration is recommended.

Driving and skilled tasks

Sudden onset of sleep Excessive daytime sleepiness and

sudden onset of sleep can occur with dopamine-receptor

agonists.

Patients starting treatment with these drugs should be

warned of the risk and of the need to exercise caution

when driving or operating machinery. Those who have

experienced excessive sedation or sudden onset of sleep

should refrain from driving or operating machines until

these effects have stopped occurring.

Management of excessive daytime sleepiness should

focus on the identification of an underlying cause, such as

depression or concomitant medication. Patients should be

counselled on improving sleep behaviour.

Hypotensive reactions Hypotensive reactions can occur in

some patients taking dopamine-receptor agonists; these

can be particularly problematic during the first few days of

treatment and care should be exercised when driving or

operating machinery.

l NATIONAL FUNDING/ACCESS DECISIONS

Scottish Medicines Consortium (SMC) decisions

SMC No. 165/05

The Scottish Medicines Consortium has advised (July 2006)

that ropinirole (Adartrel ®) should be restricted for use in

patients with a baseline score of 24 points or more on the

International Restless Legs Scale.

SMC No. 491/08

The Scottish Medicines Consortium has advised

(September 2008) that ropinirole (Requip ® XL) is accepted

for use within NHS Scotland for the treatment of

idiopathic Parkinson’s disease in patients already taking

ropinirole immediate release tablets and in whom

adequate symptomatic control has been established.

l 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

Modified-release tablet

CAUTIONARY AND ADVISORY LABELS 10, 25

▶ Ropinirole (Non-proprietary)

Ropinirole (as Ropinirole hydrochloride) 2 mg Ropinirole 2mg

modified-release tablets | 28 tablet P £10.66 DT = £12.54

Ropinirole (as Ropinirole hydrochloride) 4 mg Ropinirole 4mg

modified-release tablets | 28 tablet P £21.33 DT = £25.09

Ropinirole (as Ropinirole hydrochloride) 8 mg Ropinirole 8mg

modified-release tablets | 28 tablet P £35.79 DT = £42.11

▶ Ipinnia XL (Ethypharm UK Ltd)

Ropinirole (as Ropinirole hydrochloride) 2 mg Ipinnia XL 2mg

tablets | 28 tablet P £5.64 DT = £12.54

Ropinirole (as Ropinirole hydrochloride) 3 mg Ipinnia XL 3mg

tablets | 28 tablet P £8.46 DT = £8.46

Ropinirole (as Ropinirole hydrochloride) 4 mg Ipinnia XL 4mg

tablets | 28 tablet P £11.29 DT = £25.09

Ropinirole (as Ropinirole hydrochloride) 6 mg Ipinnia XL 6mg

tablets | 28 tablet P £15.32 DT = £15.32

Ropinirole (as Ropinirole hydrochloride) 8 mg Ipinnia XL 8mg

tablets | 28 tablet P £18.95 DT = £42.11

▶ Ralnea XL (Consilient Health Ltd)

Ropinirole (as Ropinirole hydrochloride) 2 mg Ralnea XL 2mg

tablets | 28 tablet P £10.65 DT = £12.54

Ropinirole (as Ropinirole hydrochloride) 4 mg Ralnea XL 4mg

tablets | 28 tablet P £21.32 DT = £25.09

Ropinirole (as Ropinirole hydrochloride) 8 mg Ralnea XL 8mg

tablets | 28 tablet P £35.79 DT = £42.11

▶ Raponer XL (Actavis UK Ltd)

Ropinirole (as Ropinirole hydrochloride) 2 mg Raponer XL 2mg

tablets | 28 tablet P £12.54 DT = £12.54

Ropinirole (as Ropinirole hydrochloride) 4 mg Raponer XL 4mg

tablets | 28 tablet P £25.09 DT = £25.09

Ropinirole (as Ropinirole hydrochloride) 8 mg Raponer XL 8mg

tablets | 28 tablet P £42.11 DT = £42.11

BNF 78 Parkinson’s disease 425

Nervous system

4

▶ ReQuip XL (GlaxoSmithKline UK Ltd)

Ropinirole (as Ropinirole hydrochloride) 2 mg ReQuip XL 2mg

tablets | 28 tablet P £12.54 DT = £12.54

Ropinirole (as Ropinirole hydrochloride) 4 mg ReQuip XL 4mg

tablets | 28 tablet P £25.09 DT = £25.09

Ropinirole (as Ropinirole hydrochloride) 8 mg ReQuip XL 8mg

tablets | 28 tablet P £42.11 DT = £42.11

▶ Repinex XL (Aspire Pharma Ltd)

Ropinirole (as Ropinirole hydrochloride) 2 mg Repinex XL 2mg

tablets | 28 tablet P £6.20 DT = £12.54

Ropinirole (as Ropinirole hydrochloride) 4 mg Repinex XL 4mg

tablets | 28 tablet P £12.50 DT = £25.09

Ropinirole (as Ropinirole hydrochloride) 8 mg Repinex XL 8mg

tablets | 28 tablet P £21.00 DT = £42.11

▶ Ropilynz XL (Lupin Healthcare (UK) Ltd)

Ropinirole (as Ropinirole hydrochloride) 4 mg Ropilynz XL 4mg

tablets | 28 tablet P £21.32 DT = £25.09

Ropinirole (as Ropinirole hydrochloride) 8 mg Ropilynz XL 8mg

tablets | 28 tablet P £35.79 DT = £42.11

▶ Ropiqual XL (Milpharm Ltd)

Ropinirole (as Ropinirole hydrochloride) 2 mg Ropiqual XL 2mg

tablets | 28 tablet P £12.54 DT = £12.54

Ropinirole (as Ropinirole hydrochloride) 4 mg Ropiqual XL 4mg

tablets | 28 tablet P £25.09 DT = £25.09

Ropinirole (as Ropinirole hydrochloride) 8 mg Ropiqual XL 8mg

tablets | 28 tablet P £42.11 DT = £42.11

▶ Spiroco XL (Teva UK Ltd)

Ropinirole (as Ropinirole hydrochloride) 2 mg Spiroco XL 2mg

tablets | 28 tablet P £5.63 DT = £12.54

Ropinirole (as Ropinirole hydrochloride) 4 mg Spiroco XL 4mg

tablets | 28 tablet P £11.28 DT = £25.09

Ropinirole (as Ropinirole hydrochloride) 8 mg Spiroco XL 8mg

tablets | 28 tablet P £18.94 DT = £42.11

Tablet

CAUTIONARY AND ADVISORY LABELS 10, 21

▶ Ropinirole (Non-proprietary)

Ropinirole (as Ropinirole hydrochloride)

250 microgram Ropinirole 250microgram tablets | 12 tablet P £15.00 DT = £3.02

Ropinirole (as Ropinirole hydrochloride)

500 microgram Ropinirole 500microgram tablets | 28 tablet P £25.00 DT = £7.32

Ropinirole (as Ropinirole hydrochloride) 1 mg Ropinirole 1mg

tablets | 84 tablet P £56.71 DT = £56.71

Ropinirole (as Ropinirole hydrochloride) 2 mg Ropinirole 2mg

tablets | 28 tablet P £21.25–£49.99 DT = £14.56 | 84 tablet P £33.35–£52.50

Ropinirole (as Ropinirole hydrochloride) 5 mg Ropinirole 5mg

tablets | 84 tablet P £185.63 DT = £185.51

▶ Adartrel (GlaxoSmithKline UK Ltd)

Ropinirole (as Ropinirole hydrochloride) 250 microgram Adartrel

250microgram tablets | 12 tablet P £3.94 DT = £3.02

Ropinirole (as Ropinirole hydrochloride) 500 microgram Adartrel

500microgram tablets | 28 tablet P £15.75 DT = £7.32

Ropinirole (as Ropinirole hydrochloride) 2 mg Adartrel 2mg

tablets | 28 tablet P £31.51 DT = £14.56

▶ ReQuip (GlaxoSmithKline UK Ltd)

Ropinirole (as Ropinirole hydrochloride) 250 microgram ReQuip

250microgram tablets | 21 tablet P £5.70

Ropinirole (as Ropinirole hydrochloride) 1 mg ReQuip 1mg tablets

| 84 tablet P £56.71 DT = £56.71

Ropinirole (as Ropinirole hydrochloride) 2 mg ReQuip 2mg tablets

| 84 tablet P £113.44

Ropinirole (as Ropinirole hydrochloride) 5 mg ReQuip 5mg tablets

| 84 tablet P £195.92 DT = £185.51

Rotigotine 05-Jun-2017

l INDICATIONS AND DOSE

Monotherapy in Parkinson’s disease

▶ BY TRANSDERMAL APPLICATION USING PATCHES

▶ Adult: Initially 2 mg/24 hours, then increased in steps

of 2 mg/24 hours every week if required; maximum

8 mg/24 hours per day

Adjunctive therapy with co-beneldopa or co-careldopa in

Parkinson’s disease

▶ BY TRANSDERMAL APPLICATION USING PATCHES

▶ Adult: Initially 4 mg/24 hours, then increased in steps

of 2 mg/24 hours every week if required; maximum

16 mg/24 hours per day

Moderate to severe restless legs syndrome

▶ BY TRANSDERMAL APPLICATION USING PATCHES

▶ Adult: Initially 1 mg/24 hours, then increased in steps

of 1 mg/24 hours every week if required; maximum

3 mg/24 hours per day

IMPORTANT SAFETY INFORMATION

IMPULSE CONTROL DISORDERS

Treatment with dopamine-receptor agonists is

associated with impulse control disorders, including

pathological gambling, binge eating, and hypersexuality.

Patients and their carers should be informed about the

risk of impulse control disorders. There is no evidence

that ergot- and non-ergot-derived dopamine-receptor

agonists differ in their propensity to cause impulse

control disorders, so switching between dopaminereceptor agonists to control these side-effects is not

recommended. If the patient develops an impulse

control disorder, the dopamine-receptor agonist should

be withdrawn or the dose reduced until the symptoms

resolve.

l CAUTIONS Avoid exposure of patch to heat.remove patch

(aluminium-containing) before magnetic resonance

imaging or cardioversion

l INTERACTIONS → Appendix 1: dopamine receptor agonists

l SIDE-EFFECTS

▶ Common or very common Asthenia . behaviour abnormal . constipation . dizziness . drowsiness . dry mouth . dyskinesia . eating disorders .fall . gastrointestinal

discomfort. hallucinations . headache . hiccups . hyperhidrosis . hypertension . hypotension . loss of

consciousness . malaise . nausea . palpitations . pathological gambling . perception altered . peripheral

oedema . psychiatric disorders . skin reactions . sleep

disorders . syncope . vertigo . vomiting . weight changes

▶ Uncommon Agitation . angioedema . arrhythmias . confusion . sexual dysfunction . vision disorders

▶ Rare or very rare Delirium . delusions . irritability . psychotic disorder. seizure

▶ Frequency not known Dopamine dysregulation syndrome

l PREGNANCY Avoid—no information available.

l BREAST FEEDING May suppress lactation; avoid—present

in milk in animal studies.

l HEPATIC IMPAIRMENT Manufacturer advises caution in

severe impairment (no information available).

Dose adjustments Manufacturer advises consider dose

reduction in severe impairment.

l MONITORING REQUIREMENTS Ophthalmic testing

recommended.

l TREATMENT CESSATION Antiparkinsonian drug therapy

should never be stopped abruptly as this carries a small

risk of neuroleptic malignant syndrome.

l DIRECTIONS FOR ADMINISTRATION Manufacturer advises

apply patch to clean, dry, intact, healthy and non-irritated

skin on torso, thigh, hip, shoulder or upper arm by

pressing the patch firmly against the skin for about

30 seconds. Patches should be removed after 24 hours and

the replacement patch applied on a different area (avoid

using the same area for 14 days)—consult product

literature for further information.

l PATIENT AND CARER ADVICE Manufacturer advises

patients and their carers should be informed of the risk of

426 Movement disorders BNF 78

Nervous system

4

No comments:

Post a Comment

اكتب تعليق حول الموضوع

mcq general

 

Search This Blog