neobookRx
DrugsLevel 4 LocalisationS4TABEML

Pramipexole

Dopamine receptor agonistAntiparkinson agent

Indications

Registered South African indications:

  • Parkinson's disease

Boxed warning

Falling asleep during activities of daily living

Patients treated with pramipexole have reported falling asleep while engaged in activities of daily living, including the operation of motor vehicles, which sometimes resulted in accidents. Although many of these patients reported somnolence while on pramipexole, some perceived that they had no warning signs such as excessive drowsiness, and believed that they were alert immediately prior to the event. Some of these events have been reported as late as one year after the initiation of treatment. Somnolence is a common occurrence in patients receiving pramipexole at doses above 1.5mg/day. Many clinical experts believe that falling asleep while engaged in activities of daily living always occurs in a setting of pre-existing somnolence, although patients may not give such a history. For this reason, prescribers should continually reassess patients for drowsiness or sleepiness, especially since some of the events occur well after the start of treatment. Prescribers should also be aware that patients may not acknowledge drowsiness or sleepiness until directly questioned about drowsiness or sleepiness during specific activities. Before initiating treatment with pramipexole, patients should be advised of the potential to develop drowsiness and specifically asked about factors that may increase the risk with pramipexole such as concomitant sedating medications, the presence of sleep disorders, and concomitant medications that increase pramipexole plasma levels (e.g. cimetidine). If a patient develops significant daytime sleepiness or episodes of falling asleep during activities that require active participation (e.g. conversations, eating, etc.), pramipexole should ordinarily be discontinued. If a decision is made to continue pramipexole, patients should be advised to not drive and to avoid other potentially dangerous activities. While dose reduction clearly reduces the degree of somnolence, there is insufficient information to establish that dose reduction will eliminate episodes of falling asleep while engaged in activities of daily living. 

Cautions

Contraindications

  • Hypersensitivity to the active ingredient or any of its excipients 

Cautions

  • Pregnancy 
  • Breastfeeding 
  • Moderate to severe renal impairment
  • Hepatic impairment 
  • Advanced Parkinson's disease
  • Psychotic disorders
  • Severe cardiovascular disease
  • Abrupt withdrawal
  • May impair ability to drive and operate machinery

Adult dosage

Forms avail. in SA and covered in this monograph: tab, extended release tablet (ER tab) 

Parkinson's disease
- Adjunctive or monotherapy

  • Oral (tab): Initial: Week 1: 0.125mg, 8hrly; Week 2: 0.25mg, 8hrly; Week 3: 0.5mg, 8hrly; Then titrate 0.75mg at intervals of 1 week; Maintenance: 0.5-1.5mg, 8hrly; Max: 4.5mg/24hrs
  • Oral (ER tab): Initial: Week 1: 0.375mg, dly; Week 2: 0.75mg, dly; Week 3: 1.5mg, dly; Then titrate 0.75mg at intervals of 1 week; Maintenance: 0.375-4.5mg, dly; Max: 4.5mg/24hrs

Should be taken at the same time each day

Do not cut/chew/dissolve

In patients with concomitant levodopa therapy it is recommended that the dosage of levodopa is reduced during both dose escalation and maintenance treatment

Missed doses may be taken up to 12 hours after the regularly scheduled time. After 12 hours, the missed dose should be left out and the next dose should be taken on the following day (ER tab)

Paediatric dosage

Not established for use in children below 18 years

Special populations

Pregnancy

  • Caution
  • The effect on pregnancy has not been investigated in humans. Pramipexole was not teratogenic in rats and rabbits, but was embryotoxic in the rat at maternotoxic doses. Pramipexole should not be used during pregnancy unless clearly necessary, i.e. if the potential benefit justifies the potential risk to the foetus

Breastfeeding

  • Caution; not recommended
  • As pramipexole treatment inhibits secretion of prolactin in humans, inhibition of lactation is expected. The excretion of pramipexole into breast milk has not been studied in women. In rats, the concentration of active substance-related radioactivity was higher in breast milk than in plasma
  • In the absence of human data, pramipexole should not be used during breastfeeding. However, if its use is unavoidable, breastfeeding should be discontinued

Renal Impairment 

CrCl (ml/minute) Dose (Immediate release)
>50 Oral (tab): No adjustment necessary
20-50 Oral (tab): Initial: 0.125mg twice daily
(max. 2.25mg/day)
<20 Oral (tab): Initial: 0.125mg once daily
(max. 1.5mg/day)

 

CrCl (ml/minute) Dose (Extended-release)
>50 No adjustment necessary
30-50 Oral (ER tab): Initial: 0.375mg every other day; Monitor therapeutic response and titrate by 0.375mg at  intervals of 1 week
(max. 2.25mg/day)
<30 Use not recommended; Consider immediate release tablets

Hepatic Impairment

Elderly

Porphyria Information

Drugs in Sport

  • Permitted - No warnings

Adverse reactions

Central Nervous System Disorders

  • Insomnia
  • Hallucinations
  • Abnormal dreams
  • Confusion
  • Behavioural symptoms of impulse control disorders
  • Compulsive shopping
  • Pathological gambling
  • Restlessness
  • Hypersexuality
  • Delusion
  • Libido disorder
  • Paranoia
  • Delirium
  • Binge eating
  • Hyperphagia
  • Mania
  • Somnolence
  • Dizziness
  • Dyskinesia
  • Headache
  • Sudden onset of sleep
  • Amnesia
  • Hyperkinesia
  • Syncope
  • Fatigue 
  • Withdrawal syndrome 

Cardiovascular Disorders

  • Cardiac failure
  • Hypotension
  • Peripheral oedema

Respiratory Disorders

  • Dyspnoea
  • Hiccups
  • Pneumonia 

Gastrointestinal Disorders

  • Nausea and vomiting 
  • Constipation

Endocrine and Metabolic Disorders

  • Inappropriate antidiuretic hormone secretion
  • Decreased weight
  • Decreased appetite
  • Increased weight

Skin and Subcutaneous Tissue Disorders

  • Pruritus
  • Rash

Immune, Blood and Lymphatic System Disorders

  • Hypersensitivity

Sensory Disorders

  • Visual impairment
  • Diplopia
  • Blurred vision
  • Decreased visual acuity

Interactions

  • Cimetidine
  • Amantadine
  • Mexiletine
  • Zidovudine
  • Cisplatin
  • Quinine
  • Procainamide
  • Levodopa 
  • Antipsychotics 
  • Sedatives 
  • Alcohol

Monitoring

  • Vital signs 
  • Weight 
  • Dermatological examination
  • Mental state 

Specific cases may require

  • Ophthalmic examination

Mechanism of action

Pramipexole is a non-ergot dopamine agonist with specificity for the D2 subfamily dopamine receptor, and has also been shown to bind to D3 and D4 receptors. This results in stimulation of dopamine activity on the nerves of the striatum and substantia nigra, thereby alleviating parkinsonian motor deficits.

Dosage forms

  • Tablet

Formulation

Tablet 0.125mg

  • Pazoram (Ranbaxy)
  • Pramex (Thebe) 
  • Pexasp (Pharmacare)
  • Pexola (Ingelheim) originator
  • Mylan Pramipexole (Mylan)
  • Oxpola (Gulf)

Tablet 0.25mg

  • Pazoram (Ranbaxy)
  • Pramex (Thebe)
  • Pexasp (Pharmacare)
  • Pexola (Ingelheim) originator
  • Mylan Pramipexole (Mylan)
  • Oxpola (Gulf)

Tablet 1mg

  • Pazoram (Ranbaxy)
  • Pramex (Thebe)
  • Pexasp (Pharmacare)
  • Pexola (Ingelheim) originator
  • Pazoram (Ranbaxy)
  • Mylan Pramipexole (Mylan)
  • Oxpola (Gulf)

Tablet 0.375mg

  • Pexola ER (Ingelheim) originator
  • Pramipexole ER 0.375 Teva (Teva Pharmaceuticals)

Tablet 0.75mg

  • Pexola ER (Ingelheim) originator
  • Pramipexole ER 0.75 Teva (Teva Pharmaceuticals)

Tablet 1.5mg

  • Pexola ER (Ingelheim) originator
  • Pramipexole ER 1.5 Teva (Teva Pharmaceuticals)

Tablet 3mg

  • Pexola ER (Ingelheim) originator
  • Pramipexole ER 3 Teva (Teva Pharmaceuticals)

Tablet 4.5mg

  • Pexola ER (Ingelheim) originator

References

1. SAMF_12th Edition_Page 468 2. https://www.medicines.org.uk/emc/product/7694 (16/02/2018_Boehringer_Mirapexin_tab) 3. https://drive.google.com/drive/folders/1T_tIl7Du1QbYBtIGUNpeo9lD-JcFH04M (19/04/2013_Ingelheim_Pexola_all) 4. https://www.uptodate.com/contents/pramipexole-drug-information?source=search_result&search=pramipexole&selectedTitle=1~30 5. https://www.drugs.com/pregnancy/pramipexole.html 6. https://www.drugbank.ca/drugs/DB00413 7. NAPOS The Drug Database for Acute Porphyria: N04BC05 Pramipexole; Accessed online 03 Jan 2019 [http://www.drugs-porphyria.org/languages/UnitedKingdom/s3.php?l=gbr&atc_code=N04BC05] 8. South African Institute for Drug-Free Sport; Pexola; Accessed online 03 Jan 2019 [http://www.drugfreesport.org.za/online-medication-check/] 9. https://www.medicines.org.uk/emc/product/4455/smpc 10. AfriTox: Pramipexole hydrochloride; Accessed online: 2020/09/09 [https://www.afritox.co.za/hp/SingleToxin/SingleToxin.aspx?SingleToxinID=12692]

Brands & products

28 products · stale NAPPI snapshot · refreshed 5/28/2026 · 159 days old

tabletGeneric· 23 products

from R3.92/unit
ProductStrengthPackSchedSEPUnitDisp feeNAPPI
Pramiola 0,125- mg100S4R392.02R3.92R133.05717741001
Pexasp- mg100S4R411.93R4.12R138.53723741001
Oxpola0.125 mg100S4R412.13R4.12R138.59719542001
Mylan pramipexole- mg100S4R469.08R4.69R153.47722748001
Pramiola 0,25- mg100S4R470.04R4.70R154.52717742001
Oxpola0.25 mg100S4R490.73R4.91R156.65719543001
Pexasp- mg100S4R490.96R4.91R156.69723740001
Mylan Pramipexole 0.25 Mg- mg100S4R549.85R5.50R165.35722749001
Pramex- mg100S4R586.68R5.87R170.77719844001
Pazoram- mg100S4R595.55R5.96R172.08721393001
Pazoram- mg100S4R703.97R7.04R188.03721392001
Pexola- mg100S4R809.33R8.09R203.53898836007
Pexasp 1Mg1 mg100S4R1329.94R13.30R280.12723742001
Pexola- mg100S4R1499.24R14.99R297.23898848008
Oxpola1 mg100S4R1555.89R15.56R300.31719545001
Mylan pramipexole1 mg100S4R1566.62R15.67R300.89722750001
Pramipexole Er 0,375 Teva0.375 mg30S4R573.43R19.11R168.823004925001
Pramex 1.01 mg100S4R1992.05R19.92R324.03719845001
Pazoram1 mg100S4R2023.44R20.23R325.73721391001
Pramipexole Er 0,75 Teva0.75 mg30S4R712.15R23.74R189.233004926001
Pramipexole Er 1,5 Teva1.5 mg30S4R777.17R25.91R198.803004927001
Pexola1 mg100S4R2627.39R26.27R358.57898828012
Pramipexole Er 3 Teva3 mg30S4R1097.81R36.59R245.973004928001

SrtGeneric· 5 products

from R25.90/unit
ProductStrengthPackSchedSEPUnitDisp feeNAPPI
Pexola er- mg30S4R777.04R25.90R198.78718253001
Pexola er- mg30S4R1428.57R47.62R293.39718255001
Pexola er1.5 mg30S4R1531.36R51.05R298.98718256001
Pexola er3 mg30S4R2125.60R70.85R331.29718257001
Pexola er- mg30S4R2609.50R86.98R357.60718258001
Trade names (8)
  • Pazoram
  • Pexasp
  • Pexola
  • Mylan Pramipexole
  • Oxpola
  • Prames
  • Pramex
  • Pramipexole Teva

Medical aid coverage

data not yet integrated
Discovery Health
not yet integrated
  • Comprehensive Series—
  • Executive Plan—
  • KeyCare Series—
  • Priority Series—
  • Saver Series—

Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.

Bonitas Medical Fund
not yet integrated
  • BonClassic—
  • BonComprehensive—
  • BonEssential—
  • BonFit Select—
  • BonSave—
  • BonStart—

Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.

GEMS — Government Employees Medical Scheme
not yet integrated
  • Beryl—
  • Emerald—
  • Onyx—
  • Ruby—
  • Sapphire—
  • Tanzanite One—

Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.

POLMED — Police Medical Aid Scheme
not yet integrated
  • Aquarium Option—
  • Efficiency Option—
  • Marine Option—

Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.

Interacts with 5 known drugs

Check against other drugs →

Cited in 2 documents

NeoHealth® ID 15494 · updated 11/11/2024