Colircusi Dexametasona may be available in the countries listed below.
Dexamethasone 21-(sodium sulfate) (a derivative of Dexamethasone) is reported as an ingredient of Colircusi Dexametasona in the following countries:
International Drug Name Search
RiUP may be available in the countries listed below.
Minoxidil is reported as an ingredient of RiUP in the following countries:
International Drug Name Search
Indinavir Sulfate may be available in the countries listed below.
Indinavir Sulfate (USAN) is known as Indinavir in the US.
International Drug Name Search
Glossary
| USAN | United States Adopted Name |
Metothyrin may be available in the countries listed below.
Thiamazole is reported as an ingredient of Metothyrin in the following countries:
International Drug Name Search
Ecadiu may be available in the countries listed below.
Captopril is reported as an ingredient of Ecadiu in the following countries:
Hydrochlorothiazide is reported as an ingredient of Ecadiu in the following countries:
International Drug Name Search
Ambrocol may be available in the countries listed below.
Ambroxol hydrochloride (a derivative of Ambroxol) is reported as an ingredient of Ambrocol in the following countries:
Clenbuterol hydrochloride (a derivative of Clenbuterol) is reported as an ingredient of Ambrocol in the following countries:
International Drug Name Search
Acridinsalbe may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Ethacridine lactate (a derivative of Ethacridine) is reported as an ingredient of Acridinsalbe in the following countries:
International Drug Name Search
Topibrain may be available in the countries listed below.
Topiramate is reported as an ingredient of Topibrain in the following countries:
International Drug Name Search
Azopi may be available in the countries listed below.
Azathioprine is reported as an ingredient of Azopi in the following countries:
International Drug Name Search
Glycerol PSM may be available in the countries listed below.
Glycerol is reported as an ingredient of Glycerol PSM in the following countries:
International Drug Name Search
Apamox may be available in the countries listed below.
Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Apamox in the following countries:
International Drug Name Search
Antiflogil may be available in the countries listed below.
Nimesulide is reported as an ingredient of Antiflogil in the following countries:
International Drug Name Search
Clindamycine PCH may be available in the countries listed below.
Clindamycin hydrochloride (a derivative of Clindamycin) is reported as an ingredient of Clindamycine PCH in the following countries:
International Drug Name Search
Tramadol Bexal may be available in the countries listed below.
Tramadol hydrochloride (a derivative of Tramadol) is reported as an ingredient of Tramadol Bexal in the following countries:
International Drug Name Search
Prostarinol may be available in the countries listed below.
Finasteride is reported as an ingredient of Prostarinol in the following countries:
International Drug Name Search
Probenecid Weimer may be available in the countries listed below.
Probenecid is reported as an ingredient of Probenecid Weimer in the following countries:
International Drug Name Search
Farmotal may be available in the countries listed below.
Thiopental Sodium is reported as an ingredient of Farmotal in the following countries:
International Drug Name Search
Lamotrigine ratiopharm may be available in the countries listed below.
Lamotrigine is reported as an ingredient of Lamotrigine ratiopharm in the following countries:
International Drug Name Search
ratio-Atenolol may be available in the countries listed below.
Atenolol is reported as an ingredient of ratio-Atenolol in the following countries:
International Drug Name Search
Repaglinid-ratiopharm may be available in the countries listed below.
Repaglinide is reported as an ingredient of Repaglinid-ratiopharm in the following countries:
International Drug Name Search
Turupinate may be available in the countries listed below.
Pipethanate hydrochloride (a derivative of Pipethanate) is reported as an ingredient of Turupinate in the following countries:
International Drug Name Search
Medoclor may be available in the countries listed below.
Cefaclor is reported as an ingredient of Medoclor in the following countries:
International Drug Name Search
Molsidomine Winthrop may be available in the countries listed below.
Molsidomine is reported as an ingredient of Molsidomine Winthrop in the following countries:
International Drug Name Search
In the US, Bradosol is a member of the following drug classes: mouth and throat products, topical anti-infectives.
UK matches:
Benzalkonium chloride (a derivative of Benzalkonium) is reported as an ingredient of Bradosol in the following countries:
Domiphen Bromide is reported as an ingredient of Bradosol in the following countries:
International Drug Name Search
Glossary
| SPC | Summary of Product Characteristics (UK) |
Asabium may be available in the countries listed below.
Clobazam is reported as an ingredient of Asabium in the following countries:
International Drug Name Search
Acic-Ophtal may be available in the countries listed below.
Aciclovir is reported as an ingredient of Acic-Ophtal in the following countries:
International Drug Name Search
Puricos may be available in the countries listed below.
Allopurinol is reported as an ingredient of Puricos in the following countries:
International Drug Name Search
Colchimax may be available in the countries listed below.
Colchicine is reported as an ingredient of Colchimax in the following countries:
Dicycloverine hydrochloride (a derivative of Dicycloverine) is reported as an ingredient of Colchimax in the following countries:
International Drug Name Search
Palatable may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Piperazine phosphate (a derivative of Piperazine) is reported as an ingredient of Palatable in the following countries:
International Drug Name Search
Thyrox may be available in the countries listed below.
Levothyroxine is reported as an ingredient of Thyrox in the following countries:
International Drug Name Search
Rec.INN
M01AH06
0220991-20-8
C15-H13-Cl-F-N-O2
293
Analgesic, antipyretic and anti-inflammatory agent
Non-steroidal anti-inflammatory drug, NSAID
Cyclo-oxygenase 2 (COX-2) inhibitor
[2-[(2-Chloro-6-fluorophenyl)amino]-5-methylphenyl]acetic acid (WHO)
2-[2-(2-Chlor-6-fluorphenylamino)-5-methylphenyl]essigsäure (IUPAC)
Benzeneacetic acid, 2-[(2-chloro-6-fluorophenyl)amino]-5-methyl- (USAN)
International Drug Name Search
Glossary
| BAN | British Approved Name |
| IUPAC | International Union of Pure and Applied Chemistry |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
| WHO | World Health Organization |
Modal may be available in the countries listed below.
Sulpiride is reported as an ingredient of Modal in the following countries:
International Drug Name Search
Gen-Lisinopril HCTZ may be available in the countries listed below.
Hydrochlorothiazide is reported as an ingredient of Gen-Lisinopril HCTZ in the following countries:
Lisinopril is reported as an ingredient of Gen-Lisinopril HCTZ in the following countries:
International Drug Name Search
Fluconazol AC Farma may be available in the countries listed below.
Fluconazole is reported as an ingredient of Fluconazol AC Farma in the following countries:
International Drug Name Search
Miozac may be available in the countries listed below.
Dobutamine hydrochloride (a derivative of Dobutamine) is reported as an ingredient of Miozac in the following countries:
International Drug Name Search
Glevo may be available in the countries listed below.
Levofloxacin is reported as an ingredient of Glevo in the following countries:
Levofloxacin hemihydrate (a derivative of Levofloxacin) is reported as an ingredient of Glevo in the following countries:
International Drug Name Search
Glycan Udder may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Glycerol is reported as an ingredient of Glycan Udder in the following countries:
Sorbitol is reported as an ingredient of Glycan Udder in the following countries:
International Drug Name Search
Bieluzon S may be available in the countries listed below.
Nicergoline is reported as an ingredient of Bieluzon S in the following countries:
International Drug Name Search
Cardiopril may be available in the countries listed below.
Ramipril is reported as an ingredient of Cardiopril in the following countries:
International Drug Name Search
Bioflen may be available in the countries listed below.
Pefloxacin mesilate (a derivative of Pefloxacin) is reported as an ingredient of Bioflen in the following countries:
International Drug Name Search
Iroviton Vitamin C may be available in the countries listed below.
Ascorbic Acid is reported as an ingredient of Iroviton Vitamin C in the following countries:
International Drug Name Search
Pamax may be available in the countries listed below.
Paroxetine is reported as an ingredient of Pamax in the following countries:
International Drug Name Search
Loperamida Fabra may be available in the countries listed below.
Loperamide hydrochloride (a derivative of Loperamide) is reported as an ingredient of Loperamida Fabra in the following countries:
International Drug Name Search
Burana-C may be available in the countries listed below.
Ascorbic Acid is reported as an ingredient of Burana-C in the following countries:
Ibuprofen is reported as an ingredient of Burana-C in the following countries:
International Drug Name Search
Mical may be available in the countries listed below.
Carbocisteine is reported as an ingredient of Mical in the following countries:
International Drug Name Search
Gastromax may be available in the countries listed below.
Pantoprazole sodium (a derivative of Pantoprazole) is reported as an ingredient of Gastromax in the following countries:
International Drug Name Search
Acetylsalicylzuur EB may be available in the countries listed below.
Acetylsalicylic Acid is reported as an ingredient of Acetylsalicylzuur EB in the following countries:
International Drug Name Search
Meblin may be available in the countries listed below.
Mebhydrolin napadisilate (a derivative of Mebhydrolin) is reported as an ingredient of Meblin in the following countries:
International Drug Name Search
Mirtazapina Medineo may be available in the countries listed below.
Mirtazapine is reported as an ingredient of Mirtazapina Medineo in the following countries:
International Drug Name Search
Co-Enatec may be available in the countries listed below.
Enalapril maleate (a derivative of Enalapril) is reported as an ingredient of Co-Enatec in the following countries:
Hydrochlorothiazide is reported as an ingredient of Co-Enatec in the following countries:
International Drug Name Search
Merck-Captopril may be available in the countries listed below.
Captopril is reported as an ingredient of Merck-Captopril in the following countries:
International Drug Name Search
Amlodipino Acost may be available in the countries listed below.
Amlodipine besilate (a derivative of Amlodipine) is reported as an ingredient of Amlodipino Acost in the following countries:
International Drug Name Search
Homatropinehydrobromide Ratiopharm may be available in the countries listed below.
Homatropine Hydrobromide is reported as an ingredient of Homatropinehydrobromide Ratiopharm in the following countries:
International Drug Name Search
Terbifil may be available in the countries listed below.
Terbinafine hydrochloride (a derivative of Terbinafine) is reported as an ingredient of Terbifil in the following countries:
International Drug Name Search
Glycerine Suppo's Enfant et Bébé may be available in the countries listed below.
Glycerol is reported as an ingredient of Glycerine Suppo's Enfant et Bébé in the following countries:
International Drug Name Search
Pedrox may be available in the countries listed below.
Roxithromycin is reported as an ingredient of Pedrox in the following countries:
International Drug Name Search
Rec.INN
N05BA22
0024166-13-0
C17-H14-Cl2-N2-O2
349
Anxiolytic agent
Benzodiazepine derivative
Agent for premedication
Oxazolo[3,2-d][1,4]benzodiazepin-6(5H)-one, 10-chloro-11b-(2-chlorophenyl)-2,3,7,11b-tetrahydro-
International Drug Name Search
Glossary
| DCF | Dénomination Commune Française |
| DCIT | Denominazione Comune Italiana |
| IS | Inofficial Synonym |
| JAN | Japanese Accepted Name |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Furosemide Actavis may be available in the countries listed below.
Furosemide is reported as an ingredient of Furosemide Actavis in the following countries:
International Drug Name Search
Prostal may be available in the countries listed below.
Chlormadinone 17α-acetate (a derivative of Chlormadinone) is reported as an ingredient of Prostal in the following countries:
International Drug Name Search
Epinat may be available in the countries listed below.
Phenytoin sodium salt (a derivative of Phenytoin) is reported as an ingredient of Epinat in the following countries:
International Drug Name Search
Panzytrat may be available in the countries listed below.
Pancreatin is reported as an ingredient of Panzytrat in the following countries:
Pancrelipase is reported as an ingredient of Panzytrat in the following countries:
International Drug Name Search
ratio-Ketorolac may be available in the countries listed below.
Ketorolac tromethamine (a derivative of Ketorolac) is reported as an ingredient of ratio-Ketorolac in the following countries:
International Drug Name Search
Pulmicort SinGad may be available in the countries listed below.
Budesonide is reported as an ingredient of Pulmicort SinGad in the following countries:
International Drug Name Search
Biseptol may be available in the countries listed below.
Sulfamethoxazole is reported as an ingredient of Biseptol in the following countries:
Trimethoprim is reported as an ingredient of Biseptol in the following countries:
International Drug Name Search
Erybenz may be available in the countries listed below.
Benzoyl Peroxide is reported as an ingredient of Erybenz in the following countries:
Erythromycin is reported as an ingredient of Erybenz in the following countries:
International Drug Name Search
Itraconazol Generis may be available in the countries listed below.
Itraconazole is reported as an ingredient of Itraconazol Generis in the following countries:
International Drug Name Search
Gaseovet may be available in the countries listed below.
Simeticone is reported as an ingredient of Gaseovet in the following countries:
International Drug Name Search
Tricodein may be available in the countries listed below.
Codeine phosphate hemihydrate (a derivative of Codeine) is reported as an ingredient of Tricodein in the following countries:
International Drug Name Search
Eliosid may be available in the countries listed below.
Flunisolide is reported as an ingredient of Eliosid in the following countries:
International Drug Name Search
Calcigran Forte may be available in the countries listed below.
Calcium Carbonate is reported as an ingredient of Calcigran Forte in the following countries:
Colecalciferol is reported as an ingredient of Calcigran Forte in the following countries:
International Drug Name Search
Brumixol may be available in the countries listed below.
Ciclopirox olamine (a derivative of Ciclopirox) is reported as an ingredient of Brumixol in the following countries:
International Drug Name Search
Aquadon may be available in the countries listed below.
Chlortalidone is reported as an ingredient of Aquadon in the following countries:
International Drug Name Search
EnaLich may be available in the countries listed below.
Enalapril maleate (a derivative of Enalapril) is reported as an ingredient of EnaLich in the following countries:
International Drug Name Search
Bicalutamid dura may be available in the countries listed below.
Bicalutamide is reported as an ingredient of Bicalutamid dura in the following countries:
International Drug Name Search
Crono-Gest PMSG may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Gonadotrophin, Serum is reported as an ingredient of Crono-Gest PMSG in the following countries:
International Drug Name Search
Glymod may be available in the countries listed below.
Glibenclamide is reported as an ingredient of Glymod in the following countries:
International Drug Name Search
Ellisek may be available in the countries listed below.
Butamirate citrate (a derivative of Butamirate) is reported as an ingredient of Ellisek in the following countries:
International Drug Name Search
Medotaxime may be available in the countries listed below.
Cefotaxime sodium salt (a derivative of Cefotaxime) is reported as an ingredient of Medotaxime in the following countries:
International Drug Name Search
Potasio may be available in the countries listed below.
Potassium Chloride is reported as an ingredient of Potasio in the following countries:
International Drug Name Search
Tiaprid Sandoz may be available in the countries listed below.
Tiapride hydrochloride (a derivative of Tiapride) is reported as an ingredient of Tiaprid Sandoz in the following countries:
International Drug Name Search
Terpenone may be available in the countries listed below.
Teprenone is reported as an ingredient of Terpenone in the following countries:
International Drug Name Search
Atol may be available in the countries listed below.
Atenolol is reported as an ingredient of Atol in the following countries:
International Drug Name Search
Eril may be available in the countries listed below.
Enalapril maleate (a derivative of Enalapril) is reported as an ingredient of Eril in the following countries:
Fasudil hydrochloride (a derivative of Fasudil) is reported as an ingredient of Eril in the following countries:
International Drug Name Search
In the US, Etanercept (etanercept systemic) is a member of the following drug classes: antirheumatics, TNF alfa inhibitors and is used to treat Ankylosing Spondylitis, Behcet's Disease, Bullous Pemphigoid, Cogan's Syndrome, Histiocytosis, Juvenile Idiopathic Arthritis, Juvenile Rheumatoid Arthritis, Macrophage Activation Syndrome, Pemphigoid, Pemphigus, Psoriasis, Psoriatic Arthritis, Rheumatoid Arthritis, SAPHO Syndrome, Still's Disease, Uveitis and Wegener's Granulomatosus.
US matches:
Rec.INN
L04AA11,L04AB01
0185243-69-0
C2224-H3472-N618-O701-S36
51238
Immunosuppressant
Anti-inflammatory agent
Disease-modifying antirheumatic drug, DMARD
Biological response modifier, BRM
Tumor necrosis factor alpha (TNF-α) inhibitor
Dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1
International Drug Name Search
Glossary
| BAN | British Approved Name |
| DCF | Dénomination Commune Française |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
Hexocil may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Hexetidine is reported as an ingredient of Hexocil in the following countries:
International Drug Name Search
Limcee may be available in the countries listed below.
Ascorbic Acid is reported as an ingredient of Limcee in the following countries:
Ascorbic Acid sodium salt (a derivative of Ascorbic Acid) is reported as an ingredient of Limcee in the following countries:
International Drug Name Search
In the US, Tiopronin (tiopronin systemic) is a member of the drug class miscellaneous genitourinary tract agents and is used to treat Cystinuria.
US matches:
Rec.INN
R05CB12
0001953-02-2
C5-H9-N-O3-S
163
Mucolytic agent
Antidote: Chelating agent
Hepatoprotective agent
Glycine, N-(2-mercapto-1-oxopropyl)-
International Drug Name Search
Glossary
| DCF | Dénomination Commune Française |
| DCIT | Denominazione Comune Italiana |
| IS | Inofficial Synonym |
| JAN | Japanese Accepted Name |
| OS | Official Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Trasik may be available in the countries listed below.
Tramadol hydrochloride (a derivative of Tramadol) is reported as an ingredient of Trasik in the following countries:
International Drug Name Search
Borocaina may be available in the countries listed below.
Cetylpyridinium chloride (a derivative of Cetylpyridinium) is reported as an ingredient of Borocaina in the following countries:
International Drug Name Search
Medofadin may be available in the countries listed below.
Famotidine is reported as an ingredient of Medofadin in the following countries:
International Drug Name Search
Avero may be available in the countries listed below.
Betahistine dihydrochloride (a derivative of Betahistine) is reported as an ingredient of Avero in the following countries:
International Drug Name Search
Kenacort A Tinktur may be available in the countries listed below.
Salicylic Acid is reported as an ingredient of Kenacort A Tinktur in the following countries:
Triamcinolone 16α,17α-acetonide (a derivative of Triamcinolone) is reported as an ingredient of Kenacort A Tinktur in the following countries:
International Drug Name Search
Furosemid 1A Farma may be available in the countries listed below.
Furosemide is reported as an ingredient of Furosemid 1A Farma in the following countries:
International Drug Name Search
Egualen Sodium may be available in the countries listed below.
Egualen Sodium (JAN) is also known as Egualen (Rec.INN)
International Drug Name Search
Glossary
| JAN | Japanese Accepted Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Peptonorm may be available in the countries listed below.
Sucralfate is reported as an ingredient of Peptonorm in the following countries:
International Drug Name Search
Inza may be available in the countries listed below.
Ibuprofen is reported as an ingredient of Inza in the following countries:
Naproxen is reported as an ingredient of Inza in the following countries:
International Drug Name Search
Humulin may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
UK matches:
Insulin Injection, Biphasic Isophane human (a derivative of Insulin Injection, Biphasic Isophane) is reported as an ingredient of Humulin in the following countries:
Insulin Injection, Soluble human (a derivative of Insulin Injection, Soluble) is reported as an ingredient of Humulin in the following countries:
Insulin, Isophane human (a derivative of Insulin, Isophane) is reported as an ingredient of Humulin in the following countries:
International Drug Name Search
Glossary
| SPC | Summary of Product Characteristics (UK) |
Algopyrin may be available in the countries listed below.
Metamizole sodium anhydrous (a derivative of Metamizole) is reported as an ingredient of Algopyrin in the following countries:
International Drug Name Search
Beclazone may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Beclometasone 17α,21-dipropionate (a derivative of Beclometasone) is reported as an ingredient of Beclazone in the following countries:
International Drug Name Search
Ranitidina Durban may be available in the countries listed below.
Ranitidine hydrochloride (a derivative of Ranitidine) is reported as an ingredient of Ranitidina Durban in the following countries:
International Drug Name Search
Moxaverina may be available in the countries listed below.
Moxaverina (DCIT) is also known as Moxaverine (Rec.INN)
International Drug Name Search
Glossary
| DCIT | Denominazione Comune Italiana |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Picodarm may be available in the countries listed below.
Sodium Picosulfate monohydrate (a derivative of Sodium Picosulfate) is reported as an ingredient of Picodarm in the following countries:
International Drug Name Search
Monophyllin may be available in the countries listed below.
Proxyphylline is reported as an ingredient of Monophyllin in the following countries:
International Drug Name Search
In some countries, this medicine may only be approved for veterinary use.
Emodepside is reported as an ingredient of Profender in the following countries:
Praziquantel is reported as an ingredient of Profender in the following countries:
International Drug Name Search
Fluoxetina Pliva may be available in the countries listed below.
Fluoxetine hydrochloride (a derivative of Fluoxetine) is reported as an ingredient of Fluoxetina Pliva in the following countries:
International Drug Name Search
Famotidina EG may be available in the countries listed below.
Famotidine is reported as an ingredient of Famotidina EG in the following countries:
International Drug Name Search
Amitriptyline hydrochloride (a derivative of Amitriptyline) is reported as an ingredient of Perphenazine and Amitriptyline hydrochloride in the following countries:
Perphenazine is reported as an ingredient of Perphenazine and Amitriptyline hydrochloride in the following countries:
International Drug Name Search
Gestodène/Ethinylestradiol Actavis may be available in the countries listed below.
Ethinylestradiol is reported as an ingredient of Gestodène/Ethinylestradiol Actavis in the following countries:
Gestodene is reported as an ingredient of Gestodène/Ethinylestradiol Actavis in the following countries:
International Drug Name Search
Apitropine may be available in the countries listed below.
Atropine sulfate (a derivative of Atropine) is reported as an ingredient of Apitropine in the following countries:
International Drug Name Search
Acide Aléndronique Zydus may be available in the countries listed below.
Alendronic Acid sodium trihydrate (a derivative of Alendronic Acid) is reported as an ingredient of Acide Aléndronique Zydus in the following countries:
International Drug Name Search
Lanomycin may be available in the countries listed below.
Amikacin sulfate (a derivative of Amikacin) is reported as an ingredient of Lanomycin in the following countries:
International Drug Name Search
Cardotek-30 may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Ivermectin is reported as an ingredient of Cardotek-30 in the following countries:
International Drug Name Search
Crisasma may be available in the countries listed below.
Theophylline is reported as an ingredient of Crisasma in the following countries:
International Drug Name Search
RELPAX 20mg and 40mg Film-Coated Tablets.
Each film-coated tablet contains 20mg, and 40mg eletriptan (as hydrobromide).
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For full list of excipients, see section 6.1.
Film-coated tablet.
Round, convex orange tablets debossed with 'REP 20' and 'REP 40' on one side and 'Pfizer' on the other.
Acute treatment of the headache phase of migraine attacks, with or without aura.
RELPAX tablets should be taken as early as possible after the onset of migraine headache but they are also effective if taken at a later stage during a migraine attack.
RELPAX, if taken during the aura phase, has not been demonstrated to prevent migraine headache and therefore RELPAX should only be taken during the headache phase of migraine.
RELPAX tablets should not be used prophylactically.
The tablets should be swallowed whole with water.
Adults (18-65 years of age):
The recommended initial dose is 40mg.
If headache returns within 24 hours: If the migraine headache recurs within 24 hours of an initial response, a second dose of the same strength of RELPAX has been shown to be effective in treating the recurrence. If a second dose is required, it should not be taken within 2 hours of the initial dose.
If no response is obtained: If a patient does not achieve a headache response to the first dose of RELPAX within 2 hours, a second dose should not be taken for the same attack as clinical trials have not adequately established efficacy with the second dose. Clinical trials show that patients who do not respond to the treatment of an attack are still likely to respond to the treatment of a subsequent attack.
Patients who do not obtain satisfactory efficacy after an appropriate trial of 40mg, (e.g. good tolerability and failure to respond in 2 out of 3 attacks), may be effectively treated with 80mg (2 x 40mg) in subsequent migraine attacks (see section 5.1 Pharmacodynamic Properties – Further information on Clinical Trials). A second dose of 80mg should not be taken within 24 hours.
The maximum daily dose should not exceed 80mg (see section 4.8 Undesirable effects).
Elderly (over 65 years of age)
The safety and effectiveness of eletriptan in patients over 65 years of age have not been systematically evaluated due to the small number of such patients in clinical trials. Use of RELPAX in the elderly is therefore not recommended.
Adolescents (12-17 years of age)
The efficacy of RELPAX has not been established in this population and its use is therefore not recommended in this age group.
Children (6-11 years of age)
The safety and efficacy of RELPAX in children have not been evaluated. Therefore the use of RELPAX is not recommended in this age group (see 5.2 Pharmacokinetic Properties).
Hepatic Impairment
No dose adjustment is required in patients with mild or moderate hepatic impairment. As RELPAX has not been studied in patients with severe hepatic impairment, it is contra-indicated in these patients.
Renal Impairment
As the blood pressure effects of RELPAX are amplified in renal impairment (see 4.4 Special Warnings and Precautions for Use), a 20mg initial dose, is recommended in patients with mild or moderate renal impairment. The maximum daily dose should not exceed 40mg. RELPAX is contra-indicated, in patients with severe renal impairment.
Hypersensitivity to eletriptan hydrobromide or to any of the excipients.
Patients with severe hepatic or severe renal impairment.
Moderately severe or severe hypertension, or untreated mild hypertension.
Patients with confirmed coronary heart disease, including ischaemic heart disease (angina pectoris, previous myocardial infarction or confirmed silent ischaemia), objective or subjective symptoms of ischaemic heart disease or Prinzmetal's angina.
Patients with significant arrhythmias or heart failure.
Patients with peripheral vascular disease.
Patients with a history of cerebrovascular accident (CVA) or transient ischaemic attack (TIA).
Administration of ergotamine, or derivatives of ergotamine (including methysergide), within 24hr before or after treatment with eletriptan (see 4.5 Interactions with other medicinal products and other forms of interaction). Concomitant administration of other 5-HT1 receptor agonists with eletriptan.
This medicinal product contains lactose . Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
This medicinal product also contains sunset yellow which may cause allergic reactions.
RELPAX should not be used together with potent CYP3A4 inhibitors eg. ketoconazole, itraconazole, erythromycin, clarithromycin, josamycin and protease inhibitors (ritonavir, indinavir and nelfinavir).
RELPAX should only be used where a clear diagnosis of migraine has been established. RELPAX is not indicated for the management of hemiplegic, ophthalmoplegic, or basilar migraine.
RELPAX should not be given for the treatment of 'atypical' headaches, i.e. headaches, which may be related to a possibly serious condition (stroke, aneurysm rupture) where cerebrovascular vasoconstriction may be harmful.
Eletriptan can be associated with transient symptoms including chest pain and tightness, which may be intense and involve the throat (see 4.8 Undesirable effects). Where such symptoms are thought to indicate ischaemic heart disease, no further dose should be taken and appropriate evaluation should be carried out.
RELPAX should not be given without prior evaluation, to patients in whom unrecognised cardiac disease is likely, or to patients at risk of coronary artery disease (CAD) [e.g. patients with hypertension, diabetes, smokers or users of nicotine substitution therapy, men over 40 years of age, post-menopausal women and those with a strong family history of CAD]. Cardiac evaluations may not identify every patient who has cardiac disease and, in very rare cases, serious cardiac events have occurred, in patients without underlying cardiovascular disease when 5-HT1 agonists have been administered. Patients in whom CAD is established, should not be given RELPAX (see 4.3 Contra-indications).
5-HT1 receptor agonists have been associated with coronary vasospasm. In rare cases, myocardial ischaemia or infarction, have been reported with 5-HT1 receptor agonists.
Undesirable effects may be more common during concomitant use of triptans and herbal preparations containing St. John's wort (Hypericum perforatum)
Within the clinical dose range, slight and transient increases in blood pressure have been seen with eletriptan doses of 60mg or greater. However, these increases have not been associated with clinical sequelae in the clinical trial programme. The effect was much more pronounced in renally impaired and elderly subjects. In renally impaired subjects, the range of mean maximum increases in systolic blood pressure was 14 -17mmHg (normal 3mmHg) and for diastolic blood pressure was 14 -21mmHg (normal 4mmHg). In elderly subjects, the mean maximum increase in systolic blood pressure was 23mmHg compared with 13mmHg in young adults (placebo 8mmHg). Post-marketing reports of increases in blood pressure have also been received for patients taking 20 and 40 mg doses of eletriptan, and in non-renally impaired and non-elderly patients.
Excessive use of any anti-migraine medicinal product can lead to daily chronic headaches requiring a therapeutic window. Overuse of all triptans has been reported primarily in patients with chronic daily headache. Overuse of all triptans has been reported primarily in patients with chronic daily headache.
Serotonin syndrome (including altered mental status, autonomic instability and neuromuscular abnormalities) has been reported following concomitant treatment with triptans and selective serotonin reuptake inhibitors (SSRIs) or serotonin noradrenaline reuptake inhibitors (SNRIs). These reactions can be severe. If concomitant treatment with eletriptan and an SSRI or SNRI is clinically warranted, appropriate observation of the patient is advised, particularly during treatment initiation, with dose increases, or with addition of another serotonergic medication (see section 4.5).
Effect of other medicinal products on eletriptan
In the pivotal clinical trials of eletriptan no evidence of interaction with beta-blockers, tricyclic antidepressants, selective serotonin re-uptake inhibitors and flunarizine was reported but data from formal clinical interaction studies with these medicinal products are not available (other than propranolol, see below).
Population pharmacokinetic analysis of clinical studies has suggested that the following medicinal products (beta-blockers, tricyclic antidepressants, selective serotonin re-uptake inhibitors, oestrogen based hormone replacement therapy, oestrogen containing oral contraceptives and calcium channel blockers) are unlikely to have an effect on the pharmacokinetic properties of eletriptan.
Eletriptan is not a substrate for MAO. Therefore there is no expectation of an interaction between eletriptan and MAO inhibitors. Therefore no formal interaction study has been undertaken.
In clinical studies with propranolol (160mg), verapamil (480mg) and fluconazole (100mg) the Cmax of eletriptan was increased 1.1 fold, 2.2 fold and 1.4 fold respectively. The increase in eletriptan's AUC being 1.3 fold, 2.7 fold and 2.0 fold respectively. These effects are not considered clinically significant as there were no associated increases in blood pressure or adverse events compared to administering eletriptan alone.
In clinical studies with erythromycin (1000mg) and ketoconazole (400mg), specific and potent inhibitors of CYP3A4, significant increases in eletriptan Cmax (2 and 2.7- fold) and AUC (3.6 and 5.9- fold) respectively, were observed. This increased exposure was associated with an increase in eletriptan t1/2 from 4.6 to 7.1 hours for erythromycin and from 4.8 to 8.3 hours for ketoconazole (see 5.2 Pharmacokinetic Properties). Therefore, RELPAX should not be used together with potent CYP3A4 inhibitors eg. ketoconazole, itraconazole, erythromycin, clarithromycin, josamycin and protease inhibitors (ritonavir, indinavir and nelfinavir).
In clinical studies with oral (caffeine/ergotamine) administered 1 and 2 hours after eletriptan, minor though additive increases in blood pressure were observed which are predictable based on the pharmacology of the two drugs. Therefore it is recommended that either ergotamine-containing or ergot-type medications (e.g. dihydroergotamine) should not be taken within 24 hours of eletriptan dosing. Conversely, at least 24 hours should elapse after the administration of an ergotamine-containing preparation before eletriptan is given.
Effect of eletriptan on other medicinal products
There is no in vitro or in vivo evidence that clinical doses (and associated concentrations) of eletriptan will inhibit or induce cytochrome P450 enzymes including CYP3A4 drug metabolising enzymes and therefore it is considered that eletriptan is unlikely to cause clinically important drug interactions mediated by these enzymes.
Selective Serotonin Reuptake Inhibitors (SSRIs) /Serotonin Norepinephrine Reuptake Inhibitors (SNRIs) and Serotonin Syndrome:
There have been reports describing patients with symptoms compatible with serotonin syndrome (including altered mental status, autonomic instability and neuromuscular abnormalities) following the use of selective serotonin reuptake inhibitors (SSRIs) or serotonin noradrenaline reuptake inhibitors (SNRIs) and triptans (see section 4.4).
Pregnancy: For RELPAX no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development. RELPAX should be used during pregnancy only if clearly needed.
Lactation: Eletriptan is excreted in human breast milk. In one study of 8 women given a single dose of 80mg, the mean total amount of eletriptan in breast milk over 24 hours in this group was 0.02% of the dose. Nevertheless, caution should be exercised when considering the administration of RELPAX to women who are breast-feeding. Infant exposure can be minimised by avoiding breast-feeding for 24 hours after treatment.
Migraine or treatment with RELPAX may cause drowsiness or dizziness in some patients. Patients should be advised to evaluate their ability to perform complex tasks such as driving during migraine attacks and following administration of RELPAX.
RELPAX has been administered in clinical trials to over 5000 subjects, taking one or two doses of RELPAX 20 or 40 or 80mg. The most common adverse reactions noted were asthenia, somnolence, nausea and dizziness. In randomised clinical studies using doses of 20, 40 and 80mg, a trend for a dose-dependency of the incidence of adverse events has been shown. The following adverse reactions (with an incidence
Infections and infestations:
Common: pharyngitis, and rhinitis
Rare: respiratory tract infection
Blood and the lymphatic system disorders:
Rare: lymphadenopathy
Metabolism and nutrition disorders:
Uncommon: anorexia
Psychiatric disorders:
Uncommon: thinking abnormal, agitation, confusion, depersonalisation, euphoria, depression, and insomnia
Rare: emotional lability
Nervous system disorders:
Common: somnolence, headache, dizziness, tingling or abnormal sensation, hypertonia, hypoaesthesia, and myasthenia
Uncommon: tremor, hyperaesthesia, ataxia, hypokinesia, speech disorder, stupor, and taste perversion
Eye disorders:
Uncommon: abnormal vision, eye pain, photophobia, and lacrimation disorder
Rare: conjuntivitis
Ear and labyrinth disorders:
Common: vertigo
Uncommon: ear pain, tinnitus
Cardiac disorders:
Common: palpitation, and tachycardia
Rare: bradycardia
Vascular disorders:
Common: flushing
Uncommon: peripheral vascular disorder
Rare: shock
Respiratory, thoracic and mediastinal disorders:
Common: throat tightness
Uncommon: dyspnea, respiratory disorder and yawning
Rare: asthma and voice alteration
Gastrointestinal disorders:
Common: abdominal pain, nausea, dry mouth, and dyspepsia
Uncommon: diarrhoea, and glossitis
Rare: constipation, oesophagitis, tongue oedema and eructation
Hepato-biliary disorders:
Rare: bilirubinaemia, and increased AST
Skin and subcutaneous tissue disorders:
Common: sweating
Uncommon: rash and pruritis
Rare: skin disorder and urticaria
Musculoskeletal, connective tissue and bone disorders:
Common: back pain, myalgia
Uncommon: arthralgia, arthrosis and bone pain
Rare: arthritis, myopathy and twitching
Renal and urinary disorders:
Uncommon: increased urinary frequency, urinary tract disorder and polyuria
Reproductive system and breast disorders:
Rare: breast pain and menorrhagia
General disorders and administration site conditions:
Common: feeling hot, asthenia, chest symptoms (pain, tightness, pressure), and chills
Uncommon: malaise, face oedema, thirst, oedema and peripheral oedema
The common adverse events seen with eletriptan are typical of adverse events reported with 5-HT1 agonists as a class.
In post-marketing experience, the following undesirable effects have been reported:
Immune System Disorders: Allergic reactions, some of which may be serious
Nervous system disorders: Serotonin syndrome, Rare cases of syncope
Vascular Disorders: hypertension
Gastrointestinal disorders: As with some other 5HT 1B/1D agonists, rare reports of ischaemic colitis have been received., vomiting
Subjects have received single doses of 120mg without significant adverse effects. However, based on the pharmacology of this class, hypertension or other more serious cardiovascular symptoms could occur on overdose.
In cases of overdose, standard supportive measures should be adopted as required. The elimination half-life of eletriptan is about 4 hours, and therefore monitoring of patients and provision of general supportive therapy after overdose with eletriptan should continue for at least 20 hours or while signs and symptoms persist.
It is unknown what effect haemodialysis or peritoneal dialysis has on the serum concentrations of eletriptan.
Pharmacotherapeutic group: Selective Serotonin (5HT1) receptor agonists ATC code: NO2CC06
Mode of action/pharmacology: Eletriptan is a selective agonist at the vascular 5-HT1B and neuronal 5-HT1D receptors. Eletriptan also exhibits high affinity for the 5-HT1F receptor which may contribute to its anti-migraine mechanism of action. Eletriptan has modest affinity for the human recombinant 5-HT1A, 5-HT2B, 5-HT1E and 5-HT7 receptors.
Further Information on Clinical Trials
The efficacy of RELPAX in the acute treatment of migraine has been evaluated in 10 placebo-controlled trials that included about 4000 patients who received RELPAX at doses of 20 to 80mg. Headache relief occurred as early as 30 minutes following oral dosing. Response rates (i.e. reduction of moderate or severe headache pain to no or mild pain) 2 hours after dosing were 59-77% for the 80mg dose, 54-65% for the 40mg dose, 47-54% for the 20mg dose, and 19-40% following placebo. RELPAX was also effective in the treatment of associated symptoms of migraine such as vomiting, nausea, photophobia and phonophobia.
The recommendation for dose titration to 80mg, is derived from open label long term studies and from a short term double blind study, where only a trend towards statistical significance was observed.
RELPAX remains effective in menstrually associated migraine. RELPAX, if taken during the aura phase, has not been demonstrated to prevent migraine headache and therefore RELPAX should only be taken during the headache phase of migraine.
In a non placebo controlled pharmacokinetic study of patients with renal impairment, larger elevations in blood pressure were recorded after an 80mg dose of RELPAX than with normal volunteers (see Section 4.4). This cannot be explained by any pharmacokinetic changes and so may represent a specific pharmacodynamic response to eletriptan in patients with renal impairment.
Absorption:
Eletriptan is rapidly and well absorbed across the gastro-intestinal tract (at least 81%) after oral administration. Absolute oral bioavailability across males and females is approximately 50%. The median Tmax is 1.5 hours after oral dosing. Linear pharmacokinetics were demonstrated over the clinical dose range (20-80mg).
The AUC and Cmax of eletriptan were increased by approximately 20-30% following oral administration with a high fat meal. Following oral administration during a migraine attack, there was a reduction of approximately 30% in AUC and Tmax was increased to 2.8 hours.
Following repeated doses (20mg tid) for 5-7 days, the pharmacokinetics of eletriptan remained linear and accumulation was predictable. On multiple dosing of larger doses (40mg tid and 80mg bid), the accumulation of eletriptan over 7 days was greater than predicted (approximately 40%).
Distribution:
The volume of distribution of eletriptan following IV administration is 138L indicating distribution into the tissues. Eletriptan is only moderately protein bound (approximately 85%).
Metabolism:
In vitro studies indicate that eletriptan is primarily metabolised by hepatic cytochrome P-450 enzyme CYP3A4. This finding is substantiated by increased plasma concentrations of eletriptan following co-administration with erythromycin and ketoconazole, known selective and potent CYP3A4 inhibitors. In vitro studies also indicate a small involvement of CYP2D6 although clinical studies do not indicate any evidence of polymorphism with this enzyme.
There are two major circulating metabolites identified that significantly contribute to plasma radioactivity following administration of C14-labelled eletriptan. The metabolite formed by N-oxidation, has demonstrated no activity in animal in vitro models. The metabolite formed by N-demethylation, has been demonstrated to have similar activity to eletriptan in animal in vitro models. A third area of radioactivity in plasma has not been formally identified, but is most likely to be a mixture of hydroxylated metabolites which have also been observed excreted in urine and faeces.
The plasma concentrations of the N-demethylated active metabolite are only 10-20% of those of parent and so would not be expected to significantly contribute to the therapeutic action of eletriptan.
Elimination:
Mean total plasma clearance of eletriptan following IV administration is 36 L/h with a resultant plasma half-life of approximately 4 hours. The mean renal clearance following oral administration is approximately 3.9 L/h. Non-renal clearance accounts for approximately 90% of the total clearance indicating that eletriptan is eliminated primarily by metabolism.
Pharmacokinetics in Special Patient Groups
Gender
A meta analysis across clinical pharmacology studies and a population pharmacokinetic analysis of clinical trial data indicate that gender does not have any clinically significant influence on plasma concentrations of eletriptan.
Elderly (over 65 years of age)
Though not statistically significant, there is a small reduction (16%) in clearance associated with a statistically significant increased half-life (from approximately 4.4 hours to 5.7 hours) between elderly (65-93 years) and younger adult subjects.
Adolescents (12-17 years of age)
The pharmacokinetics of eletriptan (40mg and 80mg) in adolescent migraine patients dosed between attacks, were similar to those seen in healthy adults.
Children (6-11 years of age)
The clearance of eletriptan is unchanged in children relative to adolescents. However the volume of distribution is lower in children resulting in higher plasma levels than would be predicted following the same dose in adults.
Hepatic Impairment
Subjects with hepatic impairment (Child-Pugh A and B) demonstrated a statistically significant increase in both AUC (34%) and half-life. There was a small increase in Cmax (18%). This small change in exposure is not considered clinically relevant.
Renal Impairment
Subjects with mild (creatinine clearance 61-89ml/min), moderate (creatinine clearance 31-60ml/min) or severe (creatinine clearance <30ml/min) renal impairment did not have any statistically significant alterations in their eletriptan pharmacokinetics or plasma protein binding. Blood pressure elevations were observed in this group.
Preclinical data, revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenicity and toxicity to reproduction.
Core Tablet: Microcrystalline cellulose, lactose monohydrate, croscarmellose sodium and magnesium stearate.
Film Coat: titanium dioxide (E171), hypromellose, lactose monohydrate, triacetin and Sunset Yellow Aluminium Lake (E110).
Not Applicable.
3 years
Opaque PVC/Aclar/Aluminium blister: this medicinal product does not require any special storage conditions HDPE bottles: keep the container tightly closed, in order to protect from moisture
Opaque PVC/Aclar/Aluminium blister packs containing 2, 3, 4, 6, 10, 18, 30 and 100 tablets (20, 40mg).
HDPE bottles with child-resistant HDPE/PP closures containing 30 and 100 tablets (20, 40mg).
Not all pack sizes may be marketed.
No special requirements.
Pfizer Limited
Sandwich
Kent, CT13 9NJ
United Kingdom
PL 00057/0452
PL 00057/0453
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May 2011
POM
Company reference: RP 6_0
