Should overdosage lead to hypotension, the patient should be immediately placed in a supine, head down position. Other supportive measures may be appropriate in individual cases.
If this measure is inadequate, shock should first be treated with volume expanders. If necessary, vasopressor should then be used. Renal function should be monitored and supported as needed.
Since doxazosin is highly protein bound, dialysis is not indicated.
5 years.
Not applicable.
Lactose
Magnesium stearate
Microcrystalline cellulose
Sodium lauril sulfate
Sodium starch glycollate
Hypertension: In clinical trials involving patients with hypertension, the most common reactions associated with Cardura therapy were of a postural type (rarely associated with fainting) or non-specific.
Benign prostatic hyperplasia: Experience in controlled clinical trials in BPH indicates a similar adverse event profile to that seen in hypertension.
The following undesirable effects have been observed and reported during treatment with Cardura with the following frequencies: Very common (>1/10); common (>1/100 to <1/10); uncommon (>1/1,000 to <1/100); rare (>1/10,000 to <1/1,000); very rare (<1/10,000).
|
System Organ Class |
Very Common (>1/10) |
Common (>1/100 to <1/10) |
Uncommon (>1/1,000 to <1/100) |
Rare (>1/10,000 to <1/1,000) |
Very Rare (<1/10,000) |
Unknown |
|
Infections and infestations |
Respiratory tract infection, urinary tract infection | |||||
|
Blood and the lymphatic system disorders |
Leukopenia, thrombocytopenia | |||||
|
Immune system disorders |
Allergic drug reaction | |||||
|
Metabolism and nutrition disorders |
Gout, increased appetite, anorexia | |||||
|
Psychiatric disorders |
Agitation, depression, anxiety, insomnia, nervousness | |||||
|
Nervous system disorders |
Somnolence dizziness, headache |
Cerebrovascular accident, hypoesthesia, syncope, tremor |
Dizziness postural, paresthesia | |||
|
Eye disorders |
Blurred vision |
Intraoperative floppy iris syndrome | ||||
|
Ear and labyrinth disorders |
Vertigo |
Tinnitus | ||||
|
Cardiac disorders |
Palpitation, tachycardia |
Angina pectoris, myocardial infarction |
Bradycardia, cardiac arrhythmias | |||
|
Vascular disorders |
Hypotension, postural hypotension |
Hot flushes | ||||
|
Respiratory, thoracic and mediastinal disorders |
Bronchitis, cough, dyspnea, rhinitis |
Epistaxis, |
Bronchospasm | |||
|
Gastrointestinal disorders |
Abdominal pain, dyspepsia, dry mouth, nausea |
Constipation, flatulence, vomiting, gastroenteritis diarrhoea | ||||
|
Hepato-biliary disorders |
Abnormal liver function tests |
Cholestasis, hepatitis, jaundice, | ||||
|
Skin and subcutaneous tissue disorders |
Pruritus |
Skin rash, |
Urticaria, alopecia, purpura | |||
|
Musculoskeletal, connective tissue and bone disorders |
Back pain, myalgia |
Arthralgia |
Muscle cramps, muscle weakness | |||
|
Renal and urinary disorders |
Cystitis, urinary incontinence |
Dysuria, micturition frequency, hematuria, |
Polyuria |
Increased diuresis, micturition disorder, nocturia | ||
|
Reproductive system and breast disorders |
Impotence |
Gynecomastia, priapism |
Retrograde ejaculation | |||
|
General disorders and administration site conditions |
Asthenia, chest pain, influenza-like symptoms, peripheral oedema |
Pain, facial oedema |
Fatigue, malaise | |||
|
Investigations |
Weight increase |
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
Preclinical data reveal no special hazard for humans based on conventional animal studies in safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenicity.
Although no teratogenic effects were seen in animal testing, reduced foetal survival was observed in animals at doses approximately 300 times greater than the maximum human recommended dose.
Studies in lactating rats given a single oral dose of radioactive doxazosin indicate that doxazosin accumulates in rat milk with a maximum of concentration about 20 times greater than the maternal plasma concentration.
Pharmacotherapeutic group: Alpha-adrenoreceptor antagonists, ATC code: C02CA04
Mechanism of action
Doxazosin is a potent and selective post-junctional alpha-1-adrenoceptor antagonist. This action results in a decrease in systemic blood pressure. Cardura is appropriate for oral administration in a once daily regimen in patients with essential hypertension.
Pharmacodynamic effects
Cardura has been shown to be free of adverse metabolic effects and is suitable for use in patients with coexistent diabetes mellitus, gout and insulin resistance.
Cardura is suitable for use in patients with co-existent asthma, left ventricular hypertrophy and in elderly patients. Treatment with Cardura has been shown to result in regression of left ventricular hypertrophy, inhibition of platelet aggregation and enhanced activity of tissue plasminogen activator. Additionally, Cardura improves insulin sensitivity in patients with impairment.
Cardura, in addition to its antihypertensive effect, has in long term studies produced a modest reduction in plasma total cholesterol, LDL-cholesterol and triglyceride concentrations and therefore may be of particular benefit to hypertensive patients with concomitant hyperlipidaemia.
Administration of Cardura to patients with symptomatic BPH results in a significant improvement in urodynamics and symptoms. The effect in BPH is thought to result from selective blockade of the alpha-adrenoceptors located in the muscular stroma and capsule of the prostate, and in the bladder neck.
Absorption: Following oral administration in humans (young male adults or the elderly of either sex), doxazosin is well absorbed and approximately two thirds of the dose is bioavailable.
Biotransformation/Elimination: Approximately 98% of doxazosin is protein-bound in plasma.
Doxazosin is extensively metabolised in man and in the animal species tested, with the faeces being the predominant route of excretion.
The mean plasma elimination half-life is 22 hours thus making the drug suitable for once daily administration.
After oral administration of doxazosin the plasma concentrations of the metabolites are low. The most active (6' hydroxy) metabolite is present in man at one fortieth of the plasma concentration of the parent compound, which suggests that the antihypertensive activity is in the main due to doxazosin.
There are only limited data in patients with liver impairment and on the effects of drugs known to influence hepatic metabolism (e.g. cimetidine). In a clinical study in 12 subjects with moderate hepatic impairment, single dose administration of doxazosin resulted in an increase in AUC of 43% and a decrease in apparent oral clearance of 40%. As with any drug wholly metabolised by the liver, doxazosin should be administered with caution to patients with impaired liver function.
08/2017
Pfizer Limited
Ramsgate Road
Sandwich
Kent, CT13 9NJ
United Kingdom
Do not store above 30°C.
Calendar packs of 28 tablets. Aluminium/PVC/PVdC blister strips, 14 tablets/strip, 2 strips in a carton box.
PL 00057/0277
For the hypertension indication:
Pregnancy
As there are no adequate and well-controlled studies in pregnant women, the safety of Cardura during pregnancy has not yet been established. Accordingly, during pregnancy, Cardura should be used only when, in the opinion of the physician, the potential benefit outweighs the potential risk. Although no teratogenic effects were seen in animal testing, reduced foetal survival was observed in animals at extremely high doses.
Breast-feeding
The excretion of doxazosin in breast milk was demonstrated to be very low (with the relative infant dose less than 1%) however human data is very limited. A risk to the newborn or infant cannot be excluded and therefore doxazosin should be used only when in the opinion of the physician, the potential benefit outweighs the potential risk.
For the benign prostatic hyperplasia indication: This section is not applicable
The ability to drive or use machinery may be impaired, especially when initiating therapy.
No special requirements.
11 October 2006
