Cortone Acetato may be available in the countries listed below.
Cortisone 21-acetate (a derivative of Cortisone) is reported as an ingredient of Cortone Acetato in the following countries:
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Azonit may be available in the countries listed below.
Isoconazole nitrate (a derivative of Isoconazole) is reported as an ingredient of Azonit in the following countries:
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Retemic may be available in the countries listed below.
Oxybutynin hydrochloride (a derivative of Oxybutynin) is reported as an ingredient of Retemic in the following countries:
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Acequin may be available in the countries listed below.
Quinapril hydrochloride (a derivative of Quinapril) is reported as an ingredient of Acequin in the following countries:
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Xintoprost may be available in the countries listed below.
Vinblastine sulfate (a derivative of Vinblastine) is reported as an ingredient of Xintoprost in the following countries:
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Rabeprazole is reported as an ingredient of Rabibit in the following countries:
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In the US, Levodopa (levodopa systemic) is a member of the drug class dopaminergic antiparkinsonism agents and is used to treat Parkinson's Disease, Periodic Limb Movement Disorder and Restless Legs Syndrome.
US matches:
Rec.INN
N04BA01
0000059-92-7
C9-H11-N-O4
197
Treatment of Parkinson's disease
Dopamine agonist
L-Tyrosine, 3-hydroxy-
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) |
| USAN | United States Adopted Name |
Kana-Stulln may be available in the countries listed below.
Kanamycin sulfate (a derivative of Kanamycin) is reported as an ingredient of Kana-Stulln in the following countries:
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Cartens may be available in the countries listed below.
Carteolol hydrochloride (a derivative of Carteolol) is reported as an ingredient of Cartens in the following countries:
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In some countries, this medicine may only be approved for veterinary use.
Ivermectin is reported as an ingredient of Ceva Iver in the following countries:
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Geniquin may be available in the countries listed below.
Hydroxychloroquine sulfate (a derivative of Hydroxychloroquine) is reported as an ingredient of Geniquin in the following countries:
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Ramiplus Stada may be available in the countries listed below.
Hydrochlorothiazide is reported as an ingredient of Ramiplus Stada in the following countries:
Ramipril is reported as an ingredient of Ramiplus Stada in the following countries:
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Mesilex may be available in the countries listed below.
Nimesulide is reported as an ingredient of Mesilex in the following countries:
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Ibumol may be available in the countries listed below.
Ibuprofen is reported as an ingredient of Ibumol in the following countries:
Paracetamol is reported as an ingredient of Ibumol in the following countries:
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Infester may be available in the countries listed below.
Tioconazole is reported as an ingredient of Infester in the following countries:
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Pinavérium Biogaran may be available in the countries listed below.
Pinaverium Bromide is reported as an ingredient of Pinavérium Biogaran in the following countries:
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Rec.INN
J01DD10
0065052-63-3
C14-H15-N5-O5-S2
397
Antibacterial: Cephalosporin, cephalosporinase-resistant
5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[(2-amino-4-thiazolyl)(methoxyimino)acetyl]amino]-3-methyl-8-oxo-, [6R-[6α,7ß(Z)]]-
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Glossary
| DCF | Dénomination Commune Française |
| IS | Inofficial Synonym |
| JAN | Japanese Accepted Name |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
Regadrin B may be available in the countries listed below.
Bezafibrate is reported as an ingredient of Regadrin B in the following countries:
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Psicolit may be available in the countries listed below.
Lithium carbonate (a derivative of Lithium) is reported as an ingredient of Psicolit in the following countries:
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In some countries, this medicine may only be approved for veterinary use.
In the US, Methylprednisolone (methylprednisolone systemic) is a member of the drug class glucocorticoids and is used to treat Adrenogenital Syndrome, Asthma, Asthma - acute, Asthma - Maintenance, Atopic Dermatitis, Dermatologic Lesion, Gout - Acute, Hay Fever, Immunosuppression, Inflammatory Conditions, Neuralgia, Osteoarthritis, Rheumatoid Arthritis and Shock.
US matches:
Rec.INN
D07AA01,D10AA02,H02AB04
0000083-43-2
C22-H30-O5
374
Adrenal cortex hormone, glucocorticoid
Pregna-1,4-diene-3,20-dione, 11,17,21-trihydroxy-6-methyl-, (6α,11ß)-
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Glossary
| BAN | British Approved Name |
| BANM | British Approved Name (Modified) |
| 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) |
Isosorbida Dinitrato may be available in the countries listed below.
Isosorbide Dinitrate is reported as an ingredient of Isosorbida Dinitrato in the following countries:
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Atanaal may be available in the countries listed below.
Nifedipine is reported as an ingredient of Atanaal in the following countries:
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Fostair may be available in the countries listed below.
UK matches:
Beclometasone 17α,21-dipropionate (a derivative of Beclometasone) is reported as an ingredient of Fostair in the following countries:
Formoterol fumarate (a derivative of Formoterol) is reported as an ingredient of Fostair in the following countries:
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Glossary
| SPC | Summary of Product Characteristics (UK) |
Fitina may be available in the countries listed below.
Pyritinol is reported as an ingredient of Fitina in the following countries:
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Tarimyl may be available in the countries listed below.
Atorvastatin calcium (a derivative of Atorvastatin) is reported as an ingredient of Tarimyl in the following countries:
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Flucon may be available in the countries listed below.
Fluconazole is reported as an ingredient of Flucon in the following countries:
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Anaestherit may be available in the countries listed below.
Benzocaine is reported as an ingredient of Anaestherit in the following countries:
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Glovan may be available in the countries listed below.
Nonoxinol 9 (a derivative of Nonoxinol) is reported as an ingredient of Glovan in the following countries:
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Tocosules may be available in the countries listed below.
Tocopherol, α- acetate (a derivative of Tocopherol, α-) is reported as an ingredient of Tocosules in the following countries:
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Piromed may be available in the countries listed below.
Piroxicam is reported as an ingredient of Piromed in the following countries:
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Ketolac may be available in the countries listed below.
Ketorolac tromethamine (a derivative of Ketorolac) is reported as an ingredient of Ketolac in the following countries:
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Alanta may be available in the countries listed below.
Aldioxa is reported as an ingredient of Alanta in the following countries:
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Hycid may be available in the countries listed below.
Omeprazole is reported as an ingredient of Hycid in the following countries:
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Iopaque may be available in the countries listed below.
Iohexol is reported as an ingredient of Iopaque in the following countries:
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Isopto-Pilocarpine may be available in the countries listed below.
Pilocarpine hydrochloride (a derivative of Pilocarpine) is reported as an ingredient of Isopto-Pilocarpine in the following countries:
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Pentavir may be available in the countries listed below.
Famciclovir is reported as an ingredient of Pentavir in the following countries:
Penciclovir is reported as an ingredient of Pentavir in the following countries:
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Andriol may be available in the countries listed below.
Testosterone 17ß-decanoate & 17ß-isocaproate & 17ß-propionate & 17ß-phenp (a derivative of Testosterone) is reported as an ingredient of Andriol in the following countries:
Testosterone undecanoate (a derivative of Testosterone) is reported as an ingredient of Andriol in the following countries:
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Fungonazol may be available in the countries listed below.
Itraconazole is reported as an ingredient of Fungonazol in the following countries:
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Cefalotin Actavis may be available in the countries listed below.
Cefalotin sodium salt (a derivative of Cefalotin) is reported as an ingredient of Cefalotin Actavis in the following countries:
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Gravistat may be available in the countries listed below.
Ethinylestradiol is reported as an ingredient of Gravistat in the following countries:
Levonorgestrel is reported as an ingredient of Gravistat in the following countries:
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Captopril DOC may be available in the countries listed below.
Captopril is reported as an ingredient of Captopril DOC in the following countries:
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Laboxet may be available in the countries listed below.
Levocetirizine is reported as an ingredient of Laboxet in the following countries:
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Pharex Cloxacillin may be available in the countries listed below.
Cloxacillin sodium salt (a derivative of Cloxacillin) is reported as an ingredient of Pharex Cloxacillin in the following countries:
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Topotecin may be available in the countries listed below.
Irinotecan hydrochloride trihydrate (a derivative of Irinotecan) is reported as an ingredient of Topotecin in the following countries:
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Amoxicilline/Acide Clavulanique Alter may be available in the countries listed below.
Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Amoxicilline/Acide Clavulanique Alter in the following countries:
Clavulanic Acid potassium (a derivative of Clavulanic Acid) is reported as an ingredient of Amoxicilline/Acide Clavulanique Alter in the following countries:
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Theraflu KV may be available in the countries listed below.
Guaifenesin is reported as an ingredient of Theraflu KV in the following countries:
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Luminity may be available in the countries listed below.
Perflutren is reported as an ingredient of Luminity in the following countries:
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Andosept-CO may be available in the countries listed below.
Benzydamine hydrochloride (a derivative of Benzydamine) is reported as an ingredient of Andosept-CO in the following countries:
Chlorhexidine digluconate (a derivative of Chlorhexidine) is reported as an ingredient of Andosept-CO in the following countries:
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Fibrocide may be available in the countries listed below.
Pentosan Polysulfate sodium (a derivative of Pentosan Polysulfate) is reported as an ingredient of Fibrocide in the following countries:
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Apo-Moclobemide may be available in the countries listed below.
Moclobemide is reported as an ingredient of Apo-Moclobemide in the following countries:
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Mecloderm may be available in the countries listed below.
Meclocycline sulfosalicylate (a derivative of Meclocycline) is reported as an ingredient of Mecloderm in the following countries:
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Lorazepam Labesfal may be available in the countries listed below.
Lorazepam is reported as an ingredient of Lorazepam Labesfal in the following countries:
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Thaden may be available in the countries listed below.
Dosulepin hydrochloride (a derivative of Dosulepin) is reported as an ingredient of Thaden in the following countries:
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Gliclazid-Teva may be available in the countries listed below.
Gliclazide is reported as an ingredient of Gliclazid-Teva in the following countries:
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Insulina Insulatard HM may be available in the countries listed below.
Insulin, Isophane human (a derivative of Insulin, Isophane) is reported as an ingredient of Insulina Insulatard HM in the following countries:
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Remergon may be available in the countries listed below.
Mirtazapine is reported as an ingredient of Remergon in the following countries:
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Azithromycine Qualimed may be available in the countries listed below.
Azithromycin monohydrate (a derivative of Azithromycin) is reported as an ingredient of Azithromycine Qualimed in the following countries:
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Rythmodan Injection.
Each glass ampoule contains 12.88mg disopyramide phosphate (equivalent to 10mg of disopyramide) per 1ml of solution.
For excipients, see section 6.1.
Intravenous.
Conversion of ventricular and supraventricular arrhythmias after myocardial infarction, including patients not responding to lignocaine or other intravenous treatment.
Control of ventricular and atrial extrasystoles, supraventricular tachycardia, and Wolff–Parkinson–White syndrome.
Control of arrhythmias following digitalis or similar glycosides when Rythmodan cannot be given orally.
Route of Administration: Rythmodan Injection is intended for intravenous use only.
Adults
The recommended dosage can be given by two different regimes:
1. An initial direct intravenous injection of 2mg/kg (but not exceeding 150mg (15ml) irrespective of body weight) should be given slowly over not less than five minutes, ie, the rate of injection must not exceed 30mg (3ml) per minute in order to reduce or avoid unwanted haemodynamic effects. If conversion occurs during this time the injection should be stopped. If the arrhythmia is to respond to Rythmodan it will usually do so within 10–15 minutes after completion of the injection.
If conversion is achieved by intravenous Rythmodan but the arrhythmia subsequently recurs, a further slow direct intravenous injection over not less than five minutes may be administered cautiously and preferably under ECG control. The total administration by the intravenous route should not exceed 4mg/kg (maximum 300mg) in the first hour, nor should the combined administration by the intravenous and oral routes exceed 800mg in 24 hours.
2. An initial direct intravenous injection as above, ie over not less than five minutes, maintained by intravenous infusion by drip of 20–30mg/hour (or 0.4mg/kg/hour) up to a maximum of 800mg daily. This regime should be employed if the patient is unable to take oral medication or in particularly serious arrhythmias being treated in coronary care units.
Children
Not applicable.
Rythmodan Injection is not intended for use in children.
Elderly
A dose reduction due to reduced renal and hepatic function in the elderly (especially elderly non-smokers) should be considered (see section 4.4).
Disopyramide is contra–indicated in un–paced second or third degree atrioventricular block; bundle–branch block associated with first degree atrioventricular block; un-paced bifascicular block; pre-existing long QT syndromes; severe sinus node dysfunction; severe heart failure, unless secondary to cardiac arrhythmia; and hypersensitivity to disopyramide. It is also contra–indicated in concomitant administration with other anti–arrhythmics or other drugs liable to provoke ventricular arrhythmias, especially Torsade de Pointes (see section 4.5). The sustained release formulation is contra–indicated in patients with renal or hepatic impairment.
In view of the serious nature of many of the conditions being treated it is suggested that Rythmodan Injection should only be used when facilities exist for cardiac monitoring or defibrillation, should the need arise.
Antiarrhythmic drugs belonging to the class 1c (Vaughan Williams Classification) were included in the Cardiac Arrhythmia Suppression Trial (CAST), a long term multicentre randomised, double blind study in patients with asymptomatic non life–threatening ventricular arrhythmia who had a myocardial infarction more than six days but less than two years previously. A significant increase in mortality and non–fatal cardiac arrest rate was seen in patients treated with class 1c antiarrhythmic drugs when compared with a matched placebo group. The applicability of the CAST results to other antiarrhythmics and other populations (eg. those without recent infarction) is uncertain. At present, it is best to assume that the risk extends to other antiarrhythmic agents for patients with structural heart disease.
There is no evidence that prolonged suppression of ventricular premature contractions with antiarrhythmic drugs prevents sudden death. For this reason, antiarrhythmic drugs should not be prescribed for the treatment of patients with asymptomatic ventricular premature contractions.
All antiarrhythmic drugs can produce unwanted effects when they are used to treat symptomatic but not life threatening arrhythmia; the expected benefits should be balanced against their risks.
In patients with structural heart disease, proarrhythmia and cardiac decompensation are special risks associated with antiarrhythmic drugs. Special caution should be exercised when prescribing in this taken context.
Disopyramide should not be used in patients with uncompensated congestive heart failure, unless this heart failure is secondary to cardiac arrhythmia. If disopyramide is to be given under these circumstances, special care and monitoring are essential.
Life-threatening and haemodynamically significant arrhythmias are difficult to treat and affected patients have a high mortality risk. Treatment of these arrhythmias, by whatever modality, must be initiated in hospital.
Owing to its negative inotropic effect, disopyramide should be used with caution in patients suffering from significant cardiac failure. This group may be specially sensitive to the negative inotropic properties of disopyramide. Such patients should be fully digitalised or controlled with other therapy before treatment with disopyramide is commenced.
Aggravation of existing arrhythmia, or emergence of a new type of arrhythmia, demands urgent review of disopyramide treatment.
Similarly, if an atrioventricular block or a bifascicular block occurs during treatment, the use of disopyramide should be reviewed.
There have been reports of ventricular tachycardia, ventricular fibrillation and Torsade de Pointes in patients receiving disopyramide. These have usually, but not always, been associated with significant widening of the QRS complex or prolonged QT interval. The QT interval and QRS duration must be monitored and disopyramide should be stopped if these are increased by more than 25%. If these changes or arrhythmias develop the drug should be discontinued. Disopyramide should be used with caution in patients with atrial flutter or atrial tachycardia with block as conversion of a partial AV block to a 1:1 response may occur, leading to a potentially more serious tachyarrhythmia.
The occurrence of hypotension following disopyramide administration, requires prompt discontinuation of the drug. This has been observed especially in patients with cardiomyopathy or uncompensated congestive heart failure. Any resumption of therapy should be at a lower dose with close patient monitoring. Disopyramide should be used with caution in the treatment of digitalis intoxication.
Potassium imbalance: Antiarrhythmic drugs may be hazardous in patients with potassium imbalance, as potassium abnormalities can induce arrhythmias.
During treatment with disopyramide, potassium levels should be checked regularly. Patients treated with diuretics or stimulant laxatives are at particular risk of hypokalaemia.
Renal insufficiency: In renal insufficiency, the dosage of disopyramide should be reduced by adjusting the interval between administrations.
Hepatic insufficiency: Hepatic impairment causes an increase in the plasma half–life of Rythmodan and a reduced dosage may be required.
Hypoglycaemia: Hypoglycaemia has been reported in association with disopyramide administration. The risk of hypoglycaemia, sometimes severe, occurs particularly in elderly or malnourished subjects, treated diabetics and patients with renal insufficiency or cardiac failure. Blood sugar levels should be monitored in all patients. Strict adherence to the dosing recommendations is advised. If hypoglycaemia occurs then treatment with disopyramide should be stopped.
Hypoglycaemia may be associated with interactions with drugs metabolised by hepatic CYP3A (see Section 4.5 Interactions with other medicinal products and other forms of interaction).
Atropine–like effect: There is a risk of:
- ocular hypertension in patients with narrow–angle glaucoma,
- acute urinary retention in patients with prostatic enlargement,
- aggravation of myasthenia gravis
- cognitive disorders, especially in elderly patients (see also section 4.8).
Combination with other antiarrhythmic drugs: Combinations of antiarrhythmic drugs are not well researched and their effect may be unpredictable. Thus, antiarrhythmic combination should be avoided except under certain circumstances, eg. beta–blockers for angina pectoris; digoxin with beta–blocker and/or verapamil for the control of atrial fibrillation, when defined as effective for an individual.
Interaction with drugs associated with risk of Torsade de Pointes, such as:
– tricyclic and tetracyclic antidepressants
– All macrolide antibiotics (e.g. erythromycin, clarithromycin, azithromycin etc)
– astemizole; cisapride; pentamidine; pimozide; sparfloxacin; terfenadine and thioridazone.
Phosphodiesterase Type 5 Inhibitors:
There is evidence that phosphodiesterase Type 5 inhibitors may be potentially associated with a risk of QT prolongation. Concomitant administration of disopyramide with such drugs may potentially enhance this QT prolongation effect and is not recommended.
The concomitant use of these medications whilst undergoing treatment with disopyramide increases the chance of cardiac arrhythmia.
There is some evidence that disopyramide is metabolised by hepatic CYP3A. Concomitant administration of significant inhibitors of this isozyme (e.g. certain macrolide or azole antifungal antibiotics) may therefore increase the serum levels of disopyramide. On the other hand, inducers of CYP3A (e.g. rifampicin and certain anticonvulsants such as phenytoin, primidone and phenobarbital) may reduce disopyramide and increase MN–disopyramide serum levels. Since the magnitude of such potential effects is not foreseeable, such drug combinations are not recommended.
When prescribing a drug metabolised by CYP3A [such as theophylline, HIV protease inhibitors (e.g. ritonavir, indinavir, saquinavir), ciclosporin A, warfarin] it should be kept in mind that disopyramide is probably also a substrate of this isozyme and thus competitive inhibition of metabolism might occur, possibly increasing serum levels of these drugs.
Interactions with hypokalaemia inducing drugs: Concomitant use with drugs that can induce hypokalaemia such as: diuretics, amphotericin B, tetracosactide (corticotropin analogue), gluco and mineralo–corticoids may reduce the action of the drug, or potentiate proarrhythmic effects. Stimulant laxatives are not recommended to be given concomitantly, due to their potassium lowering potential.
Other drug interactions:
Atropine and other anticholinergic drugs, including phenothiazines, may potentiate the atropine–like effects of disopyramide.
Pregnancy: Although Rythmodan has undergone animal tests for teratogenicity without evidence of any effect on the developing foetus, its safety in human pregnancy has not been established. Rythmodan has been reported to stimulate contractions of the pregnant uterus. The drug should only be used during pregnancy if benefits clearly outweigh the possible risks to the mother and foetus.
Lactation: No data for Rythmodan Injection, but studies have shown that oral disopyramide is secreted in breast milk, although no adverse effects to the infant have been noted. However, clinical experience is limited and disopyramide should only be used in lactation if, in the clinician's judgement, it is essential for the welfare of the patient. The infant should be closely supervised, particularly for anticholinergic effects and drug levels determined if necessary. Ideally, if the drug is considered essential, an alternative method of feeding should be used.
Some adverse reactions may impair the patients' ability to concentrate and react, and hence the ability to drive or operate machinery. (See section 4.8).
Cardiac: It is accepted that the arrhythmogenic potential of disopyramide is weak. However, as with all antiarrhythmic drugs, disopyramide may worsen or provoke arrhythmias. This proarrhythmic effect is more likely to occur in the presence of hypokalemia with the associated use of antiarrhythmic drugs, in patients with severe structural heart disease with prolongation of the QT interval.
Intra–cardiac conduction abnormalities may occur: QT interval prolongation, widening of the QRS complex, atrioventricular block and bundle–branch block.
Other types of arrhythmia have been reported: Bradycardia, sinus block, ventricular fibrillation, ventricular tachycardia and torsades de pointes.
Episodes of severe heart failure or even cardiogenic shock have also been described particularly in patients with severe structural heart disease. The resulting low cardiac output can cause hypotension, renal insufficiency and/or acute hepatic ischemia.
Other adverse reactions include:
Atropine-like effects (see also section 4.4):
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Psychiatric disorders.
Skin reactions: very rarely, rashes; isolated reports of anaphylactic–type reactions possibly culminating in shock (only reported in association with the injectable formulation).
Rarely: Hypoglycaemia, sometimes severe (see Section 4.4 Special warnings and precautions for use). In some cases, severe hypoglycaemia resulted in coma.
Very rarely: cholestatic jaundice, headache, dizzy sensation, neutropenia.
Rapid infusion may cause profuse sweating.
There is no specific antidote for disopyramide. Prostigmine derivatives can be used to treat anticholinergic effects. Symptomatic supportive measures may include: early gastric lavage; administration of a cathartic followed by activated charcoal by mouth or stomach tube; IV administration of isoprenaline, other vasopressors and/or positive inotropic agents; if needed - infusion of lactate and/or magnesium, electro–systolic assistance, cardioversion, insertion of an intra–aortic balloon for counterpulsion and mechanically assisted ventilation. Haemodialysis, haemofiltration or haemoperfusion with activated charcoal has been employed to lower the serum concentration of the drug.
Class 1 antiarrhythmic agent.
Following intravenous administration, disopyramide is rapidly distributed. Doses of 1.5–2mg/kg produce plasma levels of about 10microg/ml, declining rapidly to 3.8–4.2microg/ml at 5 minutes and to less than 3microg/ml at 15 minutes.
In multidose studies, direct slow intravenous injection of 2mg/kg followed by an infusion of 20mg/hr, maintained plasma levels of disopyramide between 2.5 and 2.8microg/ml from the first hour onwards.
Distribution T1/2: 2–4 minutes in healthy volunteers. Longer (15 minutes) in patients with acute myocardial infarct.
Elimination Phase Of Plasma T1/2: 5–8 hours. Increased in renal impairment, cardiac and hepatic disease.
Protein Binding: 50–60%. Saturable and concentration dependent.
Volume Of Distribution: Variable according to method of determination
Metabolism: Approximately 25% of a dose metabolised to a mono–n–dealkylated derivative. Additional 10% as other metabolites.
Excretion: 75% unchanged drug via urine, remainder in faeces. Mono–n–dealkylated metabolite 25% in urine, 64% via faeces.
Not applicable.
Benzyl Alcohol
Sorbitol
Water for Injection.
Not applicable.
60 months.
Store below 25°C
Colourless neutral glass ampoules are available as 5ml.
Not Applicable.
Sanofi-aventis
One Onslow Street
Guildford
Surrey GU1 4YS
UK
PL 04425/0660
Date of first authorisation: 10 March 2010
10 March 2010
POM
