PHENOXYBENZAMINE Capsules (2015)
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Περιεχόμενα
Name of the medicinal product
Dibenyline 10mg Capsules. Phenoxybenzamine 10mg Capsules.
Qualitative and quantitative composition
Each capsule contains 10 mg Phenoxybenzamine hydrochloride BP.
Pharmaceutical form
Capsules. Size no. three hard gelatin capsule with opaque body and a clear red cap, both printed with P10 in grey. The capsules are filled with a white powder.
Therapeutic indications
Hypertensive episodes associated with Phaeochromocytoma.
Posology and method of administration
Method of Administration Oral. Posology Adults The usual starting dose is 10 mg daily. This may be increased by 10 mg daily until control of hypertensive episodes is achieved, or postural hypotension occurs. ...
Contraindications
Do not use in patients who have had a cerebrovascular accident; or in the recovery period (usually 3-4 weeks) after acute myocardial infarction.
Special warnings and precautions for use
Use with great caution in patients in whom a fall in blood pressure and/or tachycardia may be undesirable, such as the elderly or those with severe heart disease, congestive heart failure, cerebrovascular ...
Interaction with other medicinal products and other forms of interaction
See under Special Precautions and Warnings.
Pregnancy and lactation
There is little evidence of safety of Dibenyline in pregnancy and it should not be used in pregnancy unless essential.
Effects on ability to drive and use machines
None known.
Undesirable effects
Side effects are generally mild and transient, but may include postural hypotension with dizziness and compensatory tachycardia, nasal congestion, inhibition of ejaculation, miosis and lassitude. Gastro-intestinal ...
Overdose
The main effect of overdosage is profound hypotension, which may last several hours, tachycardia and collapse. Treatment consists of the induction of vomiting and/or gastric lavage together with appropriate ...
Pharmacodynamic properties
Phenoxybenzamine is a non competitive long acting α-adrenergic receptor antagonist.
Pharmacokinetic properties
Phenoxybenzamine is incompletely absorbed from the gastrointestinal tract. The maximum effect is attained in about 1 hour after an intravenous dose. Following oral administration the onset of action is ...
Preclinical safety data
No further information of relevance.
List of excipients
Lactose Talc Hard Gelatin Capsules: Titanium dioxide E171 Indigotin E132 Erythrosine E127 Edible grey ink
Incompatibilities
None known.
Shelf life
Shelf life: 24 months.
Special precautions for storage
Store in a dry place and protect from light.
Nature and contents of container
Polypropylene securitainers, amber glass bottles, polythene containers and blisters. (PVC/PVDC/Aluminium foil). In packs of 30 and 100.
Special precautions for disposal and other handling
No special instructions.
Marketing authorization holder
Mercury Pharmaceuticals Ltd, Capital House, 85 King William Street, London EC4N 7BL, UK
Marketing authorization number(s)
PL 12762/0224
Date of first authorization / renewal of the authorization
28/02/1994 / 12/09/2006
Date of revision of the text
30/11/2015
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