Lansoprazol Bluefish may be available in the countries listed below.
Lansoprazole is reported as an ingredient of Lansoprazol Bluefish in the following countries:
International Drug Name Search
Indapress may be available in the countries listed below.
Indapamide is reported as an ingredient of Indapress in the following countries:
International Drug Name Search
Leviben may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Albendazole is reported as an ingredient of Leviben in the following countries:
Levamisole hydrochloride (a derivative of Levamisole) is reported as an ingredient of Leviben in the following countries:
International Drug Name Search
Pacid may be available in the countries listed below.
Pantoprazole is reported as an ingredient of Pacid in the following countries:
International Drug Name Search
Losartan-HCT acis may be available in the countries listed below.
Hydrochlorothiazide is reported as an ingredient of Losartan-HCT acis in the following countries:
Losartan potassium salt (a derivative of Losartan) is reported as an ingredient of Losartan-HCT acis in the following countries:
International Drug Name Search
Fentanyl WZF Polfa may be available in the countries listed below.
Fentanyl is reported as an ingredient of Fentanyl WZF Polfa in the following countries:
International Drug Name Search
Rosalgin may be available in the countries listed below.
Benzydamine hydrochloride (a derivative of Benzydamine) is reported as an ingredient of Rosalgin in the following countries:
International Drug Name Search
Risperlet may be available in the countries listed below.
Risperidone is reported as an ingredient of Risperlet in the following countries:
International Drug Name Search
Rhinogen may be available in the countries listed below.
Budesonide is reported as an ingredient of Rhinogen in the following countries:
Hyaluronic Acid sodium salt (a derivative of Hyaluronic Acid) is reported as an ingredient of Rhinogen in the following countries:
International Drug Name Search
Fortonol may be available in the countries listed below.
Acenocoumarol is reported as an ingredient of Fortonol in the following countries:
International Drug Name Search
Caffeine monohydrate may be available in the countries listed below.
Caffeine monohydrate (JAN) is known as Caffeine in the US.
International Drug Name Search
Glossary
| JAN | Japanese Accepted Name |
Bicasan may be available in the countries listed below.
Dextromethorphan hydrobromide (a derivative of Dextromethorphan) is reported as an ingredient of Bicasan in the following countries:
International Drug Name Search
Glucomide may be available in the countries listed below.
Glibenclamide is reported as an ingredient of Glucomide in the following countries:
Metformin hydrochloride (a derivative of Metformin) is reported as an ingredient of Glucomide in the following countries:
International Drug Name Search
Amfotericina B may be available in the countries listed below.
Amfotericina B (DCIT) is known as Amphotericin B in the US.
International Drug Name Search
Glossary
| DCIT | Denominazione Comune Italiana |
Emetal may be available in the countries listed below.
Metoclopramide hydrochloride (a derivative of Metoclopramide) is reported as an ingredient of Emetal in the following countries:
International Drug Name Search
Citara may be available in the countries listed below.
Citalopram hydrobromide (a derivative of Citalopram) is reported as an ingredient of Citara in the following countries:
International Drug Name Search
Bactalin may be available in the countries listed below.
Piperacillin is reported as an ingredient of Bactalin in the following countries:
Tazobactam is reported as an ingredient of Bactalin in the following countries:
International Drug Name Search
Balzide may be available in the countries listed below.
Balsalazide disodium salt, dihydrate (a derivative of Balsalazide) is reported as an ingredient of Balzide in the following countries:
International Drug Name Search
Alertine may be available in the countries listed below.
Prednisolone is reported as an ingredient of Alertine in the following countries:
International Drug Name Search
Croma may be available in the countries listed below.
Cromoglicic Acid disodium salt (a derivative of Cromoglicic Acid) is reported as an ingredient of Croma in the following countries:
Tetryzoline hydrochloride (a derivative of Tetryzoline) is reported as an ingredient of Croma in the following countries:
International Drug Name Search
Folinato di calcio may be available in the countries listed below.
Folinato di calcio (DCIT) is also known as Calcium Folinate (Rec.INN)
International Drug Name Search
Glossary
| DCIT | Denominazione Comune Italiana |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Remisan may be available in the countries listed below.
Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Remisan in the following countries:
International Drug Name Search
Rec.INN
0135459-90-4
C12-H10-N2-O8-S
342
Calcium regulator
5-[Bis(carboxymethyl)amino]-2-carboxy-4-cyano-3-thiopheneacetic acid (WHO)
5-[Bis(carboxymethyl)amino]-2-carboxy-4-cyanothiophen-3-essigsäure (IUPAC)
International Drug Name Search
Glossary
| DCF | Dénomination Commune Française |
| IUPAC | International Union of Pure and Applied Chemistry |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| WHO | World Health Organization |
Lobeline Harvest Pharm may be available in the countries listed below.
Lobeline hydrochloride (a derivative of Lobeline) is reported as an ingredient of Lobeline Harvest Pharm in the following countries:
International Drug Name Search
Gentabiotic may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Gentamicin sulfate (a derivative of Gentamicin) is reported as an ingredient of Gentabiotic in the following countries:
International Drug Name Search
Genesis Injection may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Abamectin is reported as an ingredient of Genesis Injection in the following countries:
International Drug Name Search
Bromocriptine-Richter may be available in the countries listed below.
Bromocriptine mesilate (a derivative of Bromocriptine) is reported as an ingredient of Bromocriptine-Richter in the following countries:
International Drug Name Search
Acido Alendronico Semanal Rubio may be available in the countries listed below.
Alendronic Acid sodium trihydrate (a derivative of Alendronic Acid) is reported as an ingredient of Acido Alendronico Semanal Rubio in the following countries:
International Drug Name Search
Estrogens, Conjugated may be available in the countries listed below.
Estrogens, Conjugated (JAN) is known as Conjugated Estrogens in the US.
International Drug Name Search
Glossary
| JAN | Japanese Accepted Name |
0001327-41-9
Al2-Cl-O5-H5
174
Dermatological agent: Antiperspirant
Aluminum chloride hydroxide
International Drug Name Search
Glossary
| IS | Inofficial Synonym |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
| USAN | United States Adopted Name |
Bremon may be available in the countries listed below.
Clarithromycin is reported as an ingredient of Bremon in the following countries:
International Drug Name Search
Renapur may be available in the countries listed below.
Potassium Sodium Hydrogen Citrate is reported as an ingredient of Renapur in the following countries:
International Drug Name Search
Pravastatina may be available in the countries listed below.
Pravastatina (DCIT) is known as Pravastatin in the US.
International Drug Name Search
Glossary
| DCIT | Denominazione Comune Italiana |
Carboplatine Mayne may be available in the countries listed below.
Carboplatin is reported as an ingredient of Carboplatine Mayne in the following countries:
International Drug Name Search
Ciplaflucon may be available in the countries listed below.
Fluconazole is reported as an ingredient of Ciplaflucon in the following countries:
International Drug Name Search
Cliovyl may be available in the countries listed below.
Nimesulide is reported as an ingredient of Cliovyl in the following countries:
International Drug Name Search
Ferro Gluconato EG may be available in the countries listed below.
Ferrous Gluconate is reported as an ingredient of Ferro Gluconato EG in the following countries:
International Drug Name Search
Metoclopramid AWD may be available in the countries listed below.
Metoclopramide hydrochloride (a derivative of Metoclopramide) is reported as an ingredient of Metoclopramid AWD in the following countries:
International Drug Name Search
Bifort may be available in the countries listed below.
Sildenafil citrate (a derivative of Sildenafil) is reported as an ingredient of Bifort in the following countries:
International Drug Name Search
Blubatosine may be available in the countries listed below.
Arbekacin sulfate (a derivative of Arbekacin) is reported as an ingredient of Blubatosine in the following countries:
International Drug Name Search
Kachilet may be available in the countries listed below.
Prazosin hydrochloride (a derivative of Prazosin) is reported as an ingredient of Kachilet in the following countries:
International Drug Name Search
Mianeurin may be available in the countries listed below.
Mianserin hydrochloride (a derivative of Mianserin) is reported as an ingredient of Mianeurin in the following countries:
International Drug Name Search
Claritromicina Northia may be available in the countries listed below.
Clarithromycin is reported as an ingredient of Claritromicina Northia in the following countries:
International Drug Name Search
Aflaxil may be available in the countries listed below.
Naproxen sodium salt (a derivative of Naproxen) is reported as an ingredient of Aflaxil in the following countries:
International Drug Name Search
Clindacne may be available in the countries listed below.
Clindamycin is reported as an ingredient of Clindacne in the following countries:
Clindamycin dihydrogen phosphate (a derivative of Clindamycin) is reported as an ingredient of Clindacne in the following countries:
International Drug Name Search
Rosiced may be available in the countries listed below.
UK matches:
Metronidazole is reported as an ingredient of Rosiced in the following countries:
International Drug Name Search
Glossary
| SPC | Summary of Product Characteristics (UK) |
Bellissima may be available in the countries listed below.
Chlormadinone 17α-acetate (a derivative of Chlormadinone) is reported as an ingredient of Bellissima in the following countries:
Ethinylestradiol is reported as an ingredient of Bellissima in the following countries:
International Drug Name Search
Risperidon real may be available in the countries listed below.
Risperidone is reported as an ingredient of Risperidon real in the following countries:
International Drug Name Search
Totalip may be available in the countries listed below.
Atorvastatin calcium (a derivative of Atorvastatin) is reported as an ingredient of Totalip in the following countries:
International Drug Name Search
Aeromuc may be available in the countries listed below.
Acetylcysteine is reported as an ingredient of Aeromuc in the following countries:
International Drug Name Search
In some countries, this medicine may only be approved for veterinary use.
In the US, Allopurinol (allopurinol systemic) is a member of the following drug classes: antigout agents, antihyperuricemic agents and is used to treat Calcium Oxalate Calculi with Hyperuricosuria, Cardiothoracic Surgery, Gout, Heart Failure, High Risk Percutaneous Transluminal Angioplasty, Hyperuricemia Secondary to Chemotherapy, Leishmaniasis, Mania, Reactive Perforating Collangenosis and Urinary Tract Stones.
US matches:
UK matches:
Rec.INN
M04AA01
0000315-30-0
C5-H4-N4-O
136
Uricostatic agent
4H-Pyrazolo[3,4-d]pyrimidin-4-one, 1,5-dihydro-
International Drug Name Search
Glossary
| BAN | British Approved Name |
| DCF | Dénomination Commune Française |
| DCIT | Denominazione Comune Italiana |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| SPC | Summary of Product Characteristics (UK) |
| USAN | United States Adopted Name |
Rec.INN
A02BX11
0030751-05-4
C15-H22-N2-O4
294
Treatment of peptic ulcer
Benzamide, 3,4,5-trimethoxy-N-3-piperidinyl-, (±)-
International Drug Name Search
Glossary
| IS | Inofficial Synonym |
| JAN | Japanese Accepted Name |
| OS | Official Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
In some countries, this medicine may only be approved for veterinary use.
In the US, Phenoxybenzamine (phenoxybenzamine systemic) is a member of the drug class miscellaneous cardiovascular agents and is used to treat Pheochromocytoma.
US matches:
Rec.INN
C04AX02
0000059-96-1
C18-H22-Cl-N-O
303
Vasodilator, peripheric
Antihypertensive agent
α-Adrenergic blocking agent
Benzenemethanamine, N-(2-chloroethyl)-N-(1-methyl-2-phenoxyethyl)-
International Drug Name Search
Glossary
| BAN | British Approved Name |
| BANM | British Approved Name (Modified) |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Gamespir may be available in the countries listed below.
Acemetacin is reported as an ingredient of Gamespir in the following countries:
International Drug Name Search
Pharex Amoxicillin Trihydrate may be available in the countries listed below.
Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Pharex Amoxicillin Trihydrate in the following countries:
International Drug Name Search
Clavucilline may be available in the countries listed below.
Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Clavucilline in the following countries:
Clavulanic Acid potassium (a derivative of Clavulanic Acid) is reported as an ingredient of Clavucilline in the following countries:
International Drug Name Search
Ranitab may be available in the countries listed below.
Ranitidine hydrochloride (a derivative of Ranitidine) is reported as an ingredient of Ranitab in the following countries:
International Drug Name Search
Phenazopyridine hydrochloride (a derivative of Phenazopyridine) is reported as an ingredient of Azo-Dine in the following countries:
International Drug Name Search
Xorimax may be available in the countries listed below.
Cefuroxime axetil (a derivative of Cefuroxime) is reported as an ingredient of Xorimax in the following countries:
International Drug Name Search
Metformine HCL Apotex may be available in the countries listed below.
Metformin hydrochloride (a derivative of Metformin) is reported as an ingredient of Metformine HCL Apotex in the following countries:
International Drug Name Search
Citramin may be available in the countries listed below.
Sodium Citrate dihydrate (a derivative of Sodium Citrate) is reported as an ingredient of Citramin in the following countries:
International Drug Name Search
Miol may be available in the countries listed below.
Omeprazole is reported as an ingredient of Miol in the following countries:
International Drug Name Search
Pediatrin may be available in the countries listed below.
Ibuprofen is reported as an ingredient of Pediatrin in the following countries:
International Drug Name Search
Benproperine Phosphate may be available in the countries listed below.
Benproperine Phosphate (JAN) is also known as Benproperine (Rec.INN)
International Drug Name Search
Glossary
| JAN | Japanese Accepted Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Placol may be available in the countries listed below.
Simvastatin is reported as an ingredient of Placol in the following countries:
International Drug Name Search
Grunamox may be available in the countries listed below.
Amoxicillin is reported as an ingredient of Grunamox in the following countries:
Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Grunamox in the following countries:
International Drug Name Search
Formodual may be available in the countries listed below.
Beclometasone 17α,21-dipropionate (a derivative of Beclometasone) is reported as an ingredient of Formodual in the following countries:
Formoterol fumarate (a derivative of Formoterol) is reported as an ingredient of Formodual in the following countries:
Formoterol fumarate dihydrate (a derivative of Formoterol) is reported as an ingredient of Formodual in the following countries:
International Drug Name Search
Ghinix may be available in the countries listed below.
Benzalkonium chloride (a derivative of Benzalkonium) is reported as an ingredient of Ghinix in the following countries:
International Drug Name Search
Enalapril / Hydrochloorthiazide Ratiopharm may be available in the countries listed below.
Enalapril maleate (a derivative of Enalapril) is reported as an ingredient of Enalapril / Hydrochloorthiazide Ratiopharm in the following countries:
Hydrochlorothiazide is reported as an ingredient of Enalapril / Hydrochloorthiazide Ratiopharm in the following countries:
International Drug Name Search
Fenilefrina Cloridrato Afom may be available in the countries listed below.
Phenylephrine hydrochloride (a derivative of Phenylephrine) is reported as an ingredient of Fenilefrina Cloridrato Afom in the following countries:
International Drug Name Search
Eulexine may be available in the countries listed below.
Flutamide is reported as an ingredient of Eulexine in the following countries:
International Drug Name Search
Hexadent may be available in the countries listed below.
Chlorhexidine digluconate (a derivative of Chlorhexidine) is reported as an ingredient of Hexadent in the following countries:
International Drug Name Search
Brolin may be available in the countries listed below.
Aminophylline is reported as an ingredient of Brolin in the following countries:
International Drug Name Search
Azitromin may be available in the countries listed below.
Azithromycin is reported as an ingredient of Azitromin in the following countries:
Azithromycin dihydrate (a derivative of Azithromycin) is reported as an ingredient of Azitromin in the following countries:
International Drug Name Search
Lactulac may be available in the countries listed below.
Lactulose is reported as an ingredient of Lactulac in the following countries:
International Drug Name Search
Katopril may be available in the countries listed below.
Captopril is reported as an ingredient of Katopril in the following countries:
International Drug Name Search
Alfaprostololo may be available in the countries listed below.
Alfaprostololo (DCIT) is also known as Alfaprostol (Rec.INN)
International Drug Name Search
Glossary
| DCIT | Denominazione Comune Italiana |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Risperidone 2mg Tablets
Each tablet contains 2 mg risperidone
Excipients:
Each tablet contains 80 mg Lactose-Monohydrate.
For a full list of excipients, see section 6.1
Film-coated tablet
Product description:
Pink, biconvex, oblong tablets with score line on both side
Risperidone is indicated for the treatment of schizophrenia.
Risperidone is indicated for the treatment of moderate to severe manic episodes associated with bipolar disorders.
Risperidone is indicated for the short-term treatment (up to 6 weeks) of persistent aggression in patients with moderate to severe Alzheimer's dementia unresponsive to non pharmacological approaches and when there is a risk of harm to self or others.
Risperidone is indicated for the short-term symptomatic treatment (up to 6 weeks) of persistent aggression in conduct disorder in children from the age of 5 years and adolescents with subaverage intellectual functioning or mental retardation diagnosed according to DSM-IV criteria, in whom the severity of aggressive or other disruptive behaviours require pharmacologic treatment. Pharmacological treatment should be an integral part of a more comprehensive treatment programme, including psychosocial and educational intervention. It is recommended that risperidone be prescribed by a specialist in child neurology and child and adolescent psychiatry or physicians well familiar with the treatment of conduct disorder of children and adolescents.
Schizophrenia
Adults
Risperidone may be given once daily or twice daily. Patients should start with 2 mg/day risperidone. The dosage may be increased on the second day to 4 mg.
Subsequently, the dosage can be maintained unchanged, or further individualised, if needed. Most patients will benefit from daily doses between 4 and 6 mg. In some patients, a slower titration phase and a lower starting and maintenance dose may be appropriate.
Doses above 10 mg/day have not demonstrated superior efficacy to lower doses and may cause increased incidence of extrapyramidal symptoms. Safety of doses above 16 mg/day has not been evaluated, and are therefore not recommended.
Elderly
A starting dose of 0.5 mg* twice daily is recommended. This dosage can be individually adjusted with 0.5 mg* twice daily increments to 1 to 2 mg twice daily.
* for doses not achievable with Risperidone other risperidone presentations are available
Paediatric population
Risperidone is not recommended for use in children below age 18 with schizophrenia due to a lack of data on efficacy.
Manic episodes in bipolar disorder
Adults
Risperidone should be administered on a once daily schedule, starting with 2 mg risperidone. Dosage adjustments, if indicated, should occur at intervals of not less than 24 hours and in dosage increments of 1 mg per day. Risperidone can be administered in flexible doses over a range of 1 to 6 mg per day to optimize each patient's level of efficacy and tolerability. Daily doses over 6 mg risperidone have not been investigated in patients with manic episodes.
As with all symptomatic treatments, the continued use of Risperidone must be evaluated and justified on an ongoing basis.
Elderly
A starting dose of 0.5 mg* twice daily is recommended. This dosage can be individually adjusted with 0.5 mg* twice daily increments to 1 to 2 mg twice daily. Since clinical experience in elderly is limited, caution should be exercised.
* for doses not achievable with Risperidone other risperidone presentations are available
Paediatric population
Risperidone is not recommended for use in children below age 18 with bipolar mania due to a lack of data on efficacy.
Persistent aggression in patients with moderate to severe Alzheimer's dementia
A starting dose of 0.25 mg* twice daily is recommended. This dosage can be individually adjusted by increments of 0.25 mg* twice daily, not more frequently than every other day, if needed. The optimum dose is 0.5 mg* twice daily for most patients. Some patients, however, may benefit from doses up to 1 mg twice daily.
Risperidone should not be used more than 6 weeks in patients with persistent aggression in Alzheimer's dementia. During treatment, patients must be evaluated frequently and regularly, and the need for continuing treatment reassessed.
* for doses not achievable with Risperidone other risperidone presentations are available
Conduct disorder
Children and adolescents from 5 to 18 years of age
For subjects
* for doses not achievable with Risperidone other risperidone presentations are available
As with all symptomatic treatments, the continued use of Risperidone must be evaluated and justified on an ongoing basis.
Risperidone is not recommended in children less than 5 years of age, as there is no experience in children less than 5 years of age with this disorder.
Renal and hepatic impairment
Patients with renal impairment have less ability to eliminate the active antipsychotic fraction than in adults with normal renal function. Patients with impaired hepatic function have increases in plasma concentration of the free fraction of risperidone.
Irrespective of the indication, starting and consecutive dosing should be halved, and dose titration should be slower for patients with renal or hepatic impairment.
Risperidone should be used with caution in these groups of patients.
Method of administration
Risperidone is for oral use. Food does not affect the absorption of Risperidone.
Upon discontinuation, gradual withdrawal is advised. Acute withdrawal symptoms, including nausea, vomiting, sweating, and insomnia have very rarely been described after abrupt cessation of high doses of antipsychotic medicines (see section 4.8). Recurrence of psychotic symptoms may also occur, and the emergence of involuntary movement disorders (such as akathisia, dystonia and dyskinesia) has been reported.
Switching from other antipsychotics.
When medically appropriate, gradual discontinuation of the previous treatment while Risperidone therapy is initiated is recommended. Also, if medically appropriate, when switching patients from depot antipsychotics, initiate Risperidone therapy in place of the next scheduled injection. The need for continuing existing anti-Parkinson medicines should be re-evaluated periodically.
Hypersensitivity to the active substance or to any of the excipients. (for excipients see section 6.1)
Elderly patients with dementia
Overall mortality
Elderly patients with dementia treated with atypical antipsychotics have an increased mortality compared to placebo in a meta-analysis of 17 controlled trials of atypical antipsychotics, including Risperidone. In placebo-controlled trials with Risperidone in this population, the incidence of mortality was 4.0% for Risperidone -treated patients compared to 3.1% for placebo-treated patients. The odds ratio (95% exact confidence interval) was 1.21 (0.7, 2.1). The mean age (range) of patients who died was 86 years (range 67-100).
Concomitant use with furosemide
In the Risperidone placebo-controlled trials in elderly patients with dementia, a higher incidence of mortality was observed in patients treated with furosemide plus risperidone (7.3%; mean age 89 years, range 75-97) when compared to patients treated with risperidone alone (3.1%; mean age 84 years, range 70-96) or furosemide alone (4.1%; mean age 80 years, range 67-90). The increase in mortality in patients treated with furosemide plus risperidone was observed in two of the four clinical trials. Concomitant use of risperidone with other diuretics (mainly thiazide diuretics used in low dose) was not associated with similar findings.
No pathophysiological mechanism has been identified to explain this finding, and no consistent pattern for cause of death observed. Nevertheless, caution should be exercised and the risks and benefits of this combination or co-treatment with other potent diuretics should be considered prior to the decision to use.
There was no increased incidence of mortality among patients taking other diuretics as concomitant treatment with risperidone. Irrespective of treatment, dehydration was an overall risk factor for mortality and should therefore be carefully avoided in elderly patients with dementia.
Cerebrovascular Adverse Events (CVAE)
In placebo-controlled trials in elderly patients with dementia there was a significantly higher incidence (approximately 3-fold increased) of CVAEs, such as stroke (including fatalities) and transient ischaemic attack in patients treated with Risperidone compared with patients treated with placebo (mean age 85 years; range 73 to 97). The pooled data from six placebo-controlled studies in mainly elderly patients >65 years of age) with dementia showed that CVAEs (serious and non-serious, combined) occurred in 3.3% (33/1009) of patients treated with risperidone and 1.2% (8/712) of patients treated with placebo. The odds ratio (95% exact confidence interval) was 2.96 (1.34, 7.50). The mechanism for this increased risk is not known. An increased risk cannot be excluded for other antipsychotics or other patient populations.
Risperidone should be used with caution in patients with risk factors for stroke.
The risk of CVAEs was significantly higher in patients with mixed or vascular type of dementia when compared to Alzheimer's dementia. Therefore, patients with other types of dementias than Alzheimer's should not be treated with risperidone.
Physicians are advised to assess the risks and benefits of the use of Risperidone in elderly patients with dementia, taking into account risk predictors for stroke in the individual patient. Patients/caregivers should be cautioned to immediately report signs and symptoms of potential CVAEs such as sudden weakness or numbness in the face, arms or legs, and speech or vision problems. All treatment options should be considered without delay, including discontinuation of risperidone.
Risperidone should only be used short term for persistent aggression in patients with moderate to severe Alzheimer's dementia to supplement non-pharmacological approaches which have had limited or no efficacy and when there is potential risk of harm to self or others.
Patients should be reassessed regularly, and the need for continuing treatment reassessed.
Orthostatic hypotension
Due to the alpha-blocking activity of risperidone, (orthostatic) hypotension can occur, especially during the initial dose-titration period. Clinically significant hypotension has been observed postmarketing with concomitant use of risperidone and antihypertensive treatment. Risperidone should be used with caution in patients with known cardiovascular disease (e.g., heart failure, myocardial infarction, conduction abnormalities, dehydration, hypovolemia, or cerebrovascular disease), and the dosage should be gradually titrated as recommended (see section 4.2). A dose reduction should be considered if hypotension occurs.
Tardive dyskinesia/extrapyramidal symptoms (TD/EPS)
Medicines with dopamine receptor antagonistic properties have been associated with the induction of tardive dyskinesia characterised by rhythmical involuntary movements, predominantly of the tongue and/or face.
The onset of extrapyramidal symptoms is a risk factor for tardive dyskinesia. If signs and symptoms of tardive dyskinesia appear, the discontinuation of all antipsychotics should be considered.
Neuroleptic malignant syndrome (NMS)
Neuroleptic Malignant Syndrome, characterised by hyperthermia, muscle rigidity, autonomic instability, altered consciousness and elevated serum creatine phosphokinase levels has been reported to occur with antipsychotics. Additional signs may include myoglobinuria (rhabdomyolysis) and acute renal failure. In this event, all antipsychotics, including Risperidone, should be discontinued.
Parkinson's disease and dementia with Lewy bodies
Physicians should weigh the risks versus the benefits when prescribing antipsychotics, including Risperidone, to patients with Parkinson's Disease or Dementia with Lewy Bodies (DLB). Parkinson's Disease may worsen with risperidone. Both groups may be at increased risk of Neuroleptic Malignant Syndrome as well as having an increased sensitivity to antipsychotic medicinal products; these patients were excluded from clinical trials. Manifestation of this increased sensitivity can include confusion, obtundation, postural instability with frequent falls, in addition to extrapyramidal symptoms.
Hyperglycemia
Hyperglycemia or exacerbation of pre-existing diabetes has been reported in very rare cases during treatment with Risperidone. Appropriate clinical monitoring is advisable in diabetic patients and in patients with risk factors for the development of diabetes mellitus.
Hyperprolactinaemia
Tissue culture studies suggest that cell growth in human breast tumours may be stimulated by prolactin.
Although no clear association with the administration of antipsychotics has so far been demonstrated in clinical and epidemiological studies, caution is recommended in patients with relevant medical history.
Risperidone should be used with caution in patients with pre-existing hyperprolactinaemia and in patients with possible prolactin-dependent tumours.
QT prolongation
QT prolongation has very rarely been reported postmarketing. As with other antipsychotics, caution should be exercised when risperidone is prescribed in patients with known cardiovascular disease, family history of QT prolongation, bradycardia, or electrolyte disturbances (hypokalaemia, hypomagnesaemia), as it may increase the risk of arrhythmogenic effects, and in concomitant use with medicines known to prolong the QT interval.
Seizures
Risperidone should be used cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold.
Priapism
Priapism may occur with Risperidone treatment due to its alpha-adrenergic blocking effects.
Body temperature regulation
Disruption of the body's ability to reduce core body temperature has been attributed to antipsychotic medicines. Appropriate care is advised when prescribing Risperidone to patients who will be experiencing conditions which may contribute to an elevation in core body temperature, e.g., exercising strenuously, exposure to extreme heat, receiving concomitant treatment with anticholinergic activity, or being subject to dehydration.
Venous thromboembolism
Cases of venous thromboembolism (VTE) have been reported with antipsychotic drugs. Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with Risperidone and preventive measures undertaken.
Children and adolescents
Before risperidone is prescribed to a child or adolescent with conduct disorder they should be fully assessed for physical and social causes of the aggressive behaviour such as pain or inappropriate environmental demands.
The sedative effect of risperidone should be closely monitored in this population because of possible consequences on learning ability. A change in the time of administration of risperidone could improve the impact of the sedation on attention faculties of children and adolescents.
Risperidone was associated with mean increases in body weight and body mass index (BMI). Changes in height in the long-term open-label extension studies were within expected age-appropriate norms. The effect of long-term risperidone treatment on sexual maturation and height have not been adequately studied. Because of the potential effects of prolonged hyperprolactinemia on growth and sexual maturation in children and adolescents, regular clinical evaluation of endocrinological status should be considered, including measurements of height, weight, sexual maturation, monitoring of menstrual functioning, and other potential prolactin-related effects.
During treatment with risperidone regular examination for extrapyramidal symptoms and other movement disorders should also be conducted.
For specific posology recommendations in children and adolescents see Section 4.2.
Excipients
The film-coated tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
As with other antipsychotics, caution is advised when prescribing risperidone with medicinal products known to prolong the QT interval, e.g., class Ia antiarrhythmics (e.g., quinidine, dysopiramide, procainamide), class III antiarrhythmics (e.g., amiodarone, sotalol), tricyclic antidepressant (i.e., amitriptyline), tetracyclic antidepressants (i.e., maprotiline), some antihistaminics, other antipsychotics, some antimalarials (i.e., chinice and mefloquine), and with medicines causing electrolyte imbalance (hypokalaemia, hypomagnesiaemia), bradycardia, or those which inhibit the hepatic metabolism of risperidone. This list is indicative and not exhaustive.
Potential for Risperidone to affect other medicinal products
Risperidone should be used with caution in combination with other centrally-acting substances notably including alcohol, opiates, antihistamines and benzodiazepines due to the increased risk of sedation.
Risperidone may antagonise the effect of levodopa and other dopamine agonists. If this combination is deemed necessary, particularly in end-stage Parkinson's disease, the lowest effective dose of each treatment should be prescribed.
Clinically significant hypotension has been observed postmarketing with concomitant use of risperidone and antihypertensive treatment.
Risperidone does not show a clinically relevant effect on the pharmacokinetics of lithium, valproate, digoxin or topiramate.
Potential for other medicinal products to affect Risperidone
Carbamazepine has been shown to decrease the plasma concentrations of the active antipsychotic fraction of risperidone. Similar effects may be observed with e.g. rifampicin, phenytoin and phenobarbital which also induce CYP 3A4 hepatic enzyme as well as P-glycoprotein. When carbamazepine or other CYP 3A4 hepatic enzyme/P-glycoprotein (P-gp) inducers are initiated or discontinued, the physician should re-evaluate the dosing of Risperidone.
Fluoxetine and paroxetine, CYP 2D6 inhibitors, increase the plasma concentration of risperidone, but less so of the active antipsychotic fraction. It is expected that other CYP 2D6 inhibitors, such as quinidine, may affect the plasma concentrations of risperidone in a similar way. When concomitant fluoxetine or paroxetine is initiated or discontinued, the physician should re-evaluate the dosing of Risperidone.
Verapamil, an inhibitor of CYP 3A4 and P-gp, increases the plasma concentration of risperidone. Galantamine and donepezil do not show a clinically relevant effect on the pharmacokinetics of risperidone and on the active antipsychotic fraction.
Phenothiazines, tricyclic antidepressants, and some beta-blockers may increase the plasma concentrations of risperidone but not those of the active antipsychotic fraction. Amitriptyline does not affect the pharmacokinetics of risperidone or the active antipsychotic fraction. Cimetidine and ranitidine increase the bioavailability of risperidone, but only marginally that of the active antipsychotic fraction. Erythromycin, a CYP 3A4 inhibitor, does not change the pharmacokinetics of risperidone and the active antipsychotic fraction.
The combined use of psychostimulants (e.g., methylphenidate) with Risperidone in children and adolescents did not alter the pharmacokinetics and efficacy of Risperidone.
See section 4.4 regarding increased mortality in elderly patients with dementia concomitantly receiving furosemide.
Concomitant use of oral Risperidone with paliperidone is not recommended as paliperidone is the active metabolite of risperidone and the combination of the two may lead to additive active antipsychotic fraction exposure.
Pregnancy
There are no adequate data from the use of risperidone in pregnant women. According to postmarketing data reversible extrapyramidal symptoms in the neonate were observed following the use of risperidone during the last trimester of pregnancy. Consequently newborns should be monitored carefully. Risperidone was not teratogenic in animal studies but other types of reproductive toxicity were seen (see section 5.3). The potential risk for humans is unknown. Therefore, Risperidone should not be used during pregnancy unless clearly necessary. If discontinuation during pregnancy is necessary, it should not be done abruptly.
Lactation
In animal studies, risperidone and 9-hydroxy-risperidone are excreted in the milk. It has been demonstrated that risperidone and 9-hydroxy-risperidone are also excreted in human breast milk in small quantities. There are no data available on adverse reactions in breast-feeding infants. Therefore, the advantage of breastfeeding should be weighed against the potential risks for the child.
Risperidone can have minor or moderate influence on the ability to drive and use machines due to potential nervous system and visual effects (see section 4.8). Therefore, patients should be advised not to drive or operate machinery until their individual susceptibility is known.
The most frequently reported adverse drug reactions (ADRs) (incidence
The following are all the ADRs that were reported in clinical trials and postmarketing. The following terms and frequencies are applied: very common (
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Adverse Drug Reactions by System Organ Class and Frequency
Investigations
| Blood prolactin increaseda, Weight increased |
| Electrocardiogram QT prolonged, Electrocardiogram abnormal, Blood glucose increased, Transaminases increased, White blood cell count decreased Body temperature increased, Eosinophil count increased,Haemoglobin decreased, Blood creatine phosphokinase increased |
Rare | Body temperature decreased |
Cardiac disorders
| Tachycardia |
| Atrioventricular block, Bundle branch block, Atrial fibrillation, Sinus bradycardia, Palpitations |
Blood and lymphatic system disorders
| Anaemia, Thrombocytopenia |
| Granulocytopenia |
| Agranulocytosis |
Nervous system disorders
| Parkinsonismb, Headache |
| Akathisiab, Dizziness, Tremorb, Dystoniab, Somnolence, Sedation, Lethargy, Dyskinesiab |
| Unresponsive to stimuli, Loss of consciousness, Syncope, Depressed level of consciousness, Cerebrovascular accident, Transient ischaemic attack, Dysarthria, Disturbance in attention, Hypersomnia, Dizziness postural, Balance disorder, Tardive dyskinesia, Speech disorder, Coordination abnormal, Hypoaesthesia |
| Neuroleptic malignant syndrome, Diabetic coma, Cerebrovascular disorder, Cerebral ischaemia, Movement disorder |
Eye disorders
| Vision blurred |
| Conjunctivitis, Ocular hyperaemia, Eye discharge, Eye swelling, Dry eye, Lacrimation increased, Photophobia |
| Visual acuity reduced, Eye rolling, Glaucoma |
Ear and labyrinth disorders
| Ear pain, Tinnitus |
Respiratory, thoracic and mediastinal disorders
| Dyspnoea, Epistaxis, Cough, Nasal congestion, Pharyngolaryngeal Pain |
| Wheezing, Pneumonia aspiration, Pulmonary congestion, Respiratory disorder, Rales, Respiratory tract congestion, Dysphonia |
| Sleep apnea syndrome, Hyperventilation |
Gastrointestinal disorders
| Vomiting, Diarrhoea, Constipation, Nausea, Abdominal pain, Dyspepsia, Dry mouth, Stomach discomfort |
| Dysphagia, Gastritis, Faecal incontinence, Faecaloma |
| Intestinal obstruction, Pancreatitis, Lip swelling, Cheilitis |
Renal and urinary disorders
| Enuresis |
| Dysuria, Urinary incontinence, Pollakiuria |
Skin and subcutaneous tissue disorders
| Rash, Erythema |
| Angioedema, Skin lesion, Skin disorder, Pruritus, Acne, Skin discolouration, Alopecia, Seborrhoeic dermatitis, Dry skin, Hyperkeratosis |
| Dandruff |
Musculoskeletal and connective tissue disorders
| Arthralgia, Back pain, Pain in extremity |
| Muscular weakness, Myalgia, Neck pain, Joint swelling, Posture abnormal, Joint stiffness, Musculoskeletal chest pain |
| Rhabdomyolysis |
Endocrine disorders
| Inappropriate antidiuretic hormone secretion |
Metabolism and nutrition disorders
| Increased appetite, Decreased appetite |
| Anorexia, Polydipsia |
| Diabetic ketoacidosis |
| Water intoxication |
Infections and infestations
| Pneumonia, Influenza, Bronchitis, Upper respiratory tract infection, Urinary tract infection |
| Sinusitis, Viral infection, Ear infection, Tonsillitis, Cellulitis, Otitis media, Eye infection, Localised infection, Acarodermatitis, Respiratory tract infection, Cystitis, Onychomycosis |
| Otitis media chronic |
Vascular disorders
| Hypotension, Orthostatic hypotension, Flushing |
| Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis have been reported with antipsychotic drugs |
General disorders and administration site conditions
| Pyrexia, Fatigue, Peripheral oedema, Asthenia, Chest pain |
| Face oedema, Gait disturbance, Feeling abnormal, Sluggishness, Influenza like illness, Thirst, Chest discomfort, Chills |
| Generalised oedema, Hypothermia, Drug withdrawal syndrome, Peripheral coldness |
Immune system disorders
| Hypersensitivity |
| Drug hypersensitivity |
| Anaphylactic reaction |
Hepatobiliary disorders
| Jaundice |
Reproductive system and breast disorders
| Amenorrhoea, Sexual dysfunction, Erectile dysfunction, Ejaculation disorder, Galactorrhoea, Gynaecomastia, Menstrual disorder, Vaginal discharge, |
| Priapism |
Psychiatric disorders
| Insomnia |
| Anxiety, Agitation, Sleep disorder |
| Confusional state, Mania, Libido decreased, Listless, Nervousness |
| Anorgasmia, Blunted affect |
a) Hyperprolactinemia can in some cases lead to gynaecomastia, menstrual disturbances, amenorrhoea, galactorrhea.
b) Extrapyramidal disorder may occur: Parkinsonism (salivary hypersecretion, musculoskeletal stiffness, parkinsonism, drooling, cogwheel rigidity, bradykinesia, hypokinesia, masked facies, muscle tightness, akinesia, nuchal rigidity, muscle rigidity, parkinsonian gait, and glabellar reflex abnormal),akathisia ( akathisia, restlessness, hyperkinesia, and restless leg syndrome), tremor, dyskinesia (dyskinesia, muscle twitching, choreoathetosis, athetosis, and myoclonus), dystonia. Dystonia includes dystonia, muscle spasms, hypertonia, torticollis, muscle contractions involuntary, muscle contracture, blepharospasm, oculogyration, tongue paralysis, facial spasm, laryngospasm, myotonia, opisthotonus, oropharyngeal spasm, pleurothotonus, tongue spasm, and trismus. Tremor includes tremor and parkinsonian rest tremor. It should be noted that a broader spectrum of symptoms are included, that do not necessarily have an extrapyramidal origin.
Class effects
As with other antipsychotics, very rare cases of QT prolongation have been reported postmarketing with risperidone. Other class-related cardiac effects reported with antipsychotics which prolong QT interval include ventricular arrhythmia, ventricular fibrillation, ventricular tachycardia, sudden death, cardiac arrest and Torsades de Pointes.
Weight gain
The proportions of Risperidone and placebo-treated adult patients with schizophrenia meeting a weight gain criterion of
In a population of children and adolescents with conduct and other disruptive behaviour disorders, in longterm studies, weight increased by a mean of 7.3 kg after 12 months of treatment. The expected weight gain for normal children between 5-12 years of age is 3 to 5 kg per year. From 12-16 years of age, this magnitude of gaining 3 to 5 kg per year is maintained for girls, while boys gain approximately 5 kg per year.
Additional information on special populations
Adverse drug reactions that were reported with higher incidence in elderly patients with dementia or paediatric patients than in adult populations are described below:
Elderly patients with dementia
Transient ischaemic attack and cerebrovascular accident were ADRs reported in clinical trials with a frequency of 1.4% and 1.5%, respectively, in elderly patients with dementia. In addition, the following ADRs were reported with a frequency
Paediatric patients
The following ADRs were reported with a frequency
Symptoms
In general, reported signs and symptoms have been those resulting from an exaggeration of the known pharmacological effects of risperidone. These include drowsiness and sedation, tachycardia and hypotension, and extrapyramidal symptoms. In overdose, QT-prolongation and convulsions have been reported. Torsade de Pointes has been reported in association with combined overdose of Risperidone and paroxetine.
In case of acute overdose, the possibility of multiple drug involvement should be considered.
Treatment
Establish and maintain a clear airway and ensure adequate oxygenation and ventilation. Gastric lavage (after intubation, if the patient is unconscious) and administration of activated charcoal together with a laxative should be considered only when drug intake was less than one hour before. Cardiovascular monitoring should commence immediately and should include continuous electrocardiographic monitoring to detect possible arrhythmias.
There is no specific antidote to Risperidone. Therefore, appropriate supportive measures should be instituted. Hypotension and circulatory collapse should be treated with appropriate measures such as intravenous fluids and/or sympathomimetic agents. In case of severe extrapyramidal symptoms, an anticholinergic medicinal product should be administered. Close medical supervision and monitoring should continue until the patient recovers.
Pharmacotherapeutic group: Other antipsychotics, ATC-code: N05AX08
Mechanism of action
Risperidone is a selective monoaminergic antagonist with unique properties. It has a high affinity for serotoninergic 5-HT2 and dopaminergic D2 receptors. Risperidone binds also to alpha1-adrenergic receptors, and, with lower affinity, to H1-histaminergic and alpha2 adrenergic receptors. Risperidone has no affinity for cholinergic receptors. Although risperidone is a potent D2 antagonist, which is considered to improve the positive symptoms of schizophrenia, it causes less depression of motor activity and induction of catalepsy than classical antipsychotics. Balanced central serotonin and dopamine antagonism may reduce extrapyramidal side effect liability and extend the therapeutic activity to the negative and affective symptoms of schizophrenia.
Pharmacodynamic effects
Schizophrenia
The efficacy of risperidone in the short-term treatment of schizophrenia was established in four studies, 4- to 8-weeks in duration, which enrolled over 2500 patients who met DSM-IV criteria for schizophrenia. In a 6-week, placebo-controlled trial involving titration of risperidone in doses up to 10 mg/day administered twice daily, risperidone was superior to placebo on the Brief Psychiatric Rating Scale (BPRS) total score. In an 8- week, placebo-controlled trial involving four fixed doses of risperidone (2, 6, 10, and 16 mg/day, administered twice daily), all four risperidone groups were superior to placebo on the Positive and Negative Syndrome Scale (PANSS) total score. In an 8-week, dose comparison trial involving five fixed doses of risperidone (1, 4, 8, 12, and 16 mg/day administered twice-daily), the 4, 8, and 16 mg/day risperidone dose groups were superior to the 1 mg risperidone dose group on PANSS total score. In a 4-week, placebocontrolled dose comparison trial involving two fixed doses of risperidone (4 and 8 mg/day administered once daily), both risperidone dose groups were superior to placebo on several PANSS measures, including total PANSS and a response measure (>20% reduction in PANSS total score). In a longer-term trial, adult outpatients predominantly meeting DSM-IV criteria for schizophrenia and who had been clinically stable for at least 4 weeks on an antipsychotic medicinal product were randomised to risperidone 2 to 8 mg/day or to haloperidol for 1 to 2 years of observation for relapse. Patients receiving risperidone experienced a significantly longer time to relapse over this time period compared to those receiving haloperidol.
Manic episodes in bipolar disorder
The efficacy of risperidone monotherapy in the acute treatment of manic episodes associated with bipolar I disorder was demonstrated in three double-blind, placebo-controlled monotherapy studies in approximately 820 patients who had bipolar I disorder, based on DSM-IV criteria. In the three studies, risperidone 1 to 6 mg/day (starting dose 3 mg in two studies and 2 mg in one study) was shown to be significantly superior to placebo on the pre-specified primary endpoint, i.e., the change from baseline in total Young Mania Rating Scale (YMRS) score at Week 3. Secondary efficacy outcomes were generally consistent with the primary outcome. The percentage of patients with a decrease of
The efficacy of risperidone in addition to mood stabilisers in the treatment of acute mania was demonstrated in one of two 3-week double-blind studies in approximately 300 patients who met the DSM-IV criteria for bipolar I disorder. In one 3-week study, risperidone 1 to 6 mg/day starting at 2 mg/day in addition to lithium or valproate was superior to lithium or valproate alone on the pre-specified primary endpoint, i.e., the change from baseline in YMRS total score at Week 3. In a second 3-week study, risperidone 1 to 6 mg/da
