Talofen may be available in the countries listed below.
Promazine hydrochloride (a derivative of Promazine) is reported as an ingredient of Talofen in the following countries:
International Drug Name Search
Terbinafine-Teva may be available in the countries listed below.
Terbinafine hydrochloride (a derivative of Terbinafine) is reported as an ingredient of Terbinafine-Teva in the following countries:
International Drug Name Search
1. CHLORPHENAMINE TABLETS BP 4mg
2. Alpharma Chlorphenamine Hayfever & Allergy Relief Tablets
3. Vantage Chlorphenamine Hayfever & Allergy Relief Tablets
4. ALLERcalm Allergy Relief Tablets
Each tablet contains 4mg Chlorphenamine Maleate.
Yellow uncoated tablets.
1) For the symptomatic control of all allergic conditions which are responsive to antihistamines, including hay fever, urticaria, vasomotor rhinitis, angioneurotic oedema, food allergy, drug and serum reactions, insect bites.
Posology
Adults: 1 tablet every four or six hours to a maximum daily dose of 24mg.
Not recommended for children under 12 years of age unless otherwise directed by a practitioner.
Elderly: As in adults, but the elderly are prone to confusional psychosis and other neurological anticholinergic effects.
Method of Administration
For oral administration.
Hypersensitivity to antihistamines; patients who have received therapy with MAOI's within the previous fourteen days.
In common with other drugs having anticholinergic effects, Chlorphenamine should be used with caution in epilepsy, prostatic hypertrophy, glaucoma, hepatic disease, bronchitis, bronchiectasis, thyrotoxicosis, raised intra-ocular pressure, severe hypertension or cardiovascular disease and bronchial asthma.
Chlorphenamine may have an additive effect when used concurrently with hypnotics and anxiolytics causing potentiation of drowsiness. A similar additive effect will result from concurrent usage of alcohol with Chlorphenamine. MAOI therapy intensifies the anticholinergic effects of Chlorphenamine. Chlorphenamine inhibits phenytoin metabolism and can lead to phenytoin toxicity.
The safety of Chlorphenamine in pregnancy has not been established. Chlorphenamine should therefore only be used when clearly required and when potential benefits outweigh the potential unknown risks to the foetus. Use during the third trimester may result in reactions in the newborn or premature neonates.
Small amounts of antihistamines are excreted in breast milk. Use by nursing mothers is not recommended because of the risks of adverse effects in the infant.
Antihistamines may inhibit lactation.
The anticholinergic properties of Chlorphenamine may cause drowsiness, dizziness, blurred vision and psychomotor impairment, which can seriously hamper the patient's ability to drive and use machinery.
Sedation varying from slight drowsiness to deep sleep. Inability to concentrate, lassitude, blurred vision, GI disturbances such as nausea, vomiting and diarrhoea may occasionally occur. Urinary retention, headaches, dryness of the mouth. Dizziness, palpitation, tachycardia, arrhythmias, hypotension, tightness of the chest, abdominal pain, dyspepsia, anorexia, hepatic including jaundice, thickening of the bronchial secretions, haemolytic anaemia and other blood dyscrasias infrequently occur.
Allergic reactions including exfoliative dermatitis, photosensitivity and skin reactions. Urticaria, twitching, muscular weakness and in co-ordination. Tinnitus, depression, irritability and nightmares infrequently occur.
Paradoxical excitation in children and confusional psychosis in the elderly can occur.
The effects of alcohol may be increased. Children and the elderly are more likely to experience the neurological anticholinergic effects.
The estimated lethal dose of Chlorphenamine is 25-50mg/kg body weight.
Symptoms and signs include sedation, paradoxical stimulation of the CNS, toxic psychosis, seizures, apnoea, convulsions, anticholinergic effects, dystonic reactions and cardiovascular collapse including arrhythmias.
Treatment includes gastric lavage or emesis using ipecacuanha syrup. Following these measures activated charcoal and cathartics may be administered to minimise absorption. Other symptomatic and supportive measures should be provided with special attention to cardiac, respiratory, renal and hepatic functions and fluid and electrolyte balance.
Treat hypotension and arrhythmias vigorously. CNS convulsions may be treated with IV diazepam or phenytoin. Haemoperfusion may be used in severe cases.
Chlorphenamine Maleate is an antihistamine.
Chlorphenamine Maleate is an alkylamine derivative with a plasma half-life of up to 42 hours which is extensively metabolised in the liver and excreted almost exclusively in the urine.
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
Also contains: calcium sulphate, magnesium stearate, maize starch, E172, E460.
None known.
Shelf-life
Three years from the date of manufacture.
Shelf-life after dilution/reconstitution
Not applicable.
Shelf-life after first opening
Not applicable.
Store below 25°C in a dry place.
The product containers are rigid injection moulded polypropylene or injection blow-moulded polyethylene tablet containers with polyfoam wad or polyethylene ullage filler and snap-on polyethylene lids; in case any supply difficulties should arise the alternative is amber glass bottles with screw caps and polyfoam wad or cotton wool.
The product may also be supplied in blister packs in cartons:
a) Carton: Printed carton manufactured from white folding box board.
b) Blister pack: (i) 250µm white rigid PVC. (ii) Surface printed 20µm hard temper aluminium foil with 5-7g/M² PVC and PVdC compatible heat seal lacquer on the reverse side.
Pack sizes: 7, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 168, 180, 250, 500, 1000.
Product may also be supplied in bulk packs, for reassembly purposes only, in polybags contained in tins, skillets or polybuckets filled with suitable cushioning material. Bulk packs are included for temporary storage of the finished product before final packaging into the proposed marketing containers.
Maximum size of bulk packs: 50,000.
Not applicable.
Name or style and permanent address of registered place of business of the holder of the Marketing Authorisation:
Actavis UK Limited
(Trading style: Actavis)
Whiddon Valley
BARNSTAPLE
N Devon EX32 8NS
PL 0142/0209
9.5.86
Renewed: 20.10.02
June 2007
Terbinafina Ratiopharm may be available in the countries listed below.
Terbinafine is reported as an ingredient of Terbinafina Ratiopharm in the following countries:
International Drug Name Search
Vecural may be available in the countries listed below.
Vecuronium Bromide is reported as an ingredient of Vecural in the following countries:
International Drug Name Search
Teobid may be available in the countries listed below.
Theophylline is reported as an ingredient of Teobid in the following countries:
International Drug Name Search
Tamizam may be available in the countries listed below.
Tamoxifen citrate (a derivative of Tamoxifen) is reported as an ingredient of Tamizam in the following countries:
International Drug Name Search
Pymeroxomil may be available in the countries listed below.
Bromazepam is reported as an ingredient of Pymeroxomil in the following countries:
International Drug Name Search
Alendromet may be available in the countries listed below.
Alendronic Acid sodium trihydrate (a derivative of Alendronic Acid) is reported as an ingredient of Alendromet in the following countries:
International Drug Name Search
Flavosten may be available in the countries listed below.
Ipriflavone is reported as an ingredient of Flavosten in the following countries:
International Drug Name Search
Tax-O-Bid may be available in the countries listed below.
Cefotaxime is reported as an ingredient of Tax-O-Bid in the following countries:
International Drug Name Search
Heparin sodium salt (a derivative of Heparin) is reported as an ingredient of Heparin Sodium ADD-Vantage in the following countries:
International Drug Name Search
Tinatrim may be available in the countries listed below.
Clotrimazole is reported as an ingredient of Tinatrim in the following countries:
International Drug Name Search
Terbinafina Genfar may be available in the countries listed below.
Terbinafine is reported as an ingredient of Terbinafina Genfar in the following countries:
International Drug Name Search
Humex allergie cétirizine may be available in the countries listed below.
Cetirizine dihydrochloride (a derivative of Cetirizine) is reported as an ingredient of Humex allergie cétirizine in the following countries:
International Drug Name Search
In the US, Lanreotide (lanreotide systemic) is a member of the drug class somatostatin and somatostatin analogs and is used to treat Acromegaly.
US matches:
Rec.INN
H01CB03
0108736-35-2
C54-H69-N11-O10-S2
1096
Antineoplastic agent
Growth hormone release inhibiting hormone analogue (analogue of somatostatin)
3-(2-Naphthyl)-D-alanyl-L-cysteinyl-L-tyrosyl-D-tryptophyl-L-lysyl-L-valyl-L-cysteinyl-L-threoninamid, cycl.(2-7)-disulfid (IUPAC)
3-(2-Naphthyl)-D-alanyl-L-cysteinyl-L-tyrosyl-D-tryptophyl-L-lysyl-L-valyl-L-cysteinyl-L-threoninamide, cyclic (2->7)-disulfide (WHO)
L-Threoninamide, 3-(2-naphthalenyl)-D-alanyl-L-cysteinyl-L-tyrosyl-D-tryptophyl-L-lysyl-L-valyl-L-cysteinyl-, cyclic (2->7)-disulfide
International Drug Name Search
Glossary
| BAN | British Approved Name |
| 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) |
| USAN | United States Adopted Name |
| WHO | World Health Organization |
In the US, Terfenadine (terfenadine systemic) is a member of the drug class antihistamines and is used to treat Allergies, Conjunctivitis - Allergic, Eye Redness/Itching, Hay Fever and Urticaria.
US matches:
Rec.INN
R06AX12
0050679-08-8
C32-H41-N-O2
471
Antiallergic agent
Histamine, H₁-receptor antagonist
1-Piperidinebutanol, α-[4-(1,1-dimethylethyl)phenyl]-4-(hydroxydiphenylmethyl)-
International Drug Name Search
Glossary
| BAN | British Approved Name |
| 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) |
| USAN | United States Adopted Name |
Tensobon may be available in the countries listed below.
Captopril is reported as an ingredient of Tensobon in the following countries:
International Drug Name Search
Rythmodan 150mg Capsules.
Capsule containing Disopyramide 150mg.
For excipients, see 6.1.
Capsule.
Rythmodan is used in the treatment of cardiac arrhythmias as follows:-
1. The prevention and treatment of arrhythmias occurring after myocardial infarction.
2. Maintenance of normal rhythm following electroconversion eg atrial fibrillation, atrial flutter.
3. Persistent ventricular extrasystoles.
4. Control of arrhythmias following the use of digitalis or similar glycosides.
5. Suppression of arrhythmias during surgical procedures eg cardiac catheterisation.
6. The prevention of paraxysmal supraventricular tachycardia.
7. Other types of arrhythmias e.g. atrial extrasystoles, Wolff-Parkinson-White Syndrome.
Route of administration
Oral
300 mg to 800mg daily in divided doses.
Children :
Not recommended as insufficient data available.
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 ; unpaced bifasicular block; pre-existing long QT syndromes; severe sinus node dysfunction ; severe heart failure, unless of secondary to cardiac arrhythmia ; hypersensitivity to disopyramide. It is also contra–indicated in concomitant administration with other anti–arrhythmics or other drugs liable to provoke ventricular arrythmias, especially Torsade de Pointes (see section 4.5). The sustained release formulation is contra–indicated in patients with renal or hepatic impairment.
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 have 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 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 only 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 effects: 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 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 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: Studies have shown that oral Rythmodan is secreted in breast milk, although no adverse effects to the infant have been noted. However, clinical experience is limited and Rythmodan 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):
urinary: dysuria; acute urinary retention, especially in prostatism
ocular: disorders of accommodation; diplopia
gastrointestinal: dry mouth; abdominal pain; nausea, vomiting, anorexia, diarrhoea; constipation
impotence
cognitive disorders
Psychiatric disorders.
Skin reactions: very rarely, rashes.
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 concentrations of the drug.
Class 1 anti-arrhythmic agent.
It decreases membrane responsiveness, prolongs the effective refractory period (ERP) and slows automaticity in cells with augmented automaticity. Effective refractory period of the atrium is lengthened, ERP of the A-V node is shortened and conduction in accessory pathways is prolonged.
Disopyramide is a myocardial depressant and has anti-cholinergic effects.
Elimination phase of plasma t1/2: 5-8 hours. Increased in hepatic 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.
Maize starch,
Magnesium stearate,
STA-RX 1500 (pregelatinised starch)
Talc.
Capsule shell:
Gelatin
Indigo carmine
Iron oxide
Titanium dioxide (E171)
Not known.
PVC Blister : 36 months
Do not store above 25°C
PVC/PVdC blister strips in cardboard cartons containing 84 capsules.
None.
Sanofi-aventis
One Onslow Street
Guildford
Surrey GU1 4YS
UK
PL 04425/0608
12 February 2009
24 February 2010
POM
Blow may be available in the countries listed below.
Montelukast sodium salt (a derivative of Montelukast) is reported as an ingredient of Blow in the following countries:
International Drug Name Search
