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DOXZOGEN XL is a brand name for Doxazosin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Essential hypertension - Symptomatic treatment of benign prostatic hyperplasia.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The maximum recommended dose is 8 mg doxazosin once daily.
Essential hypertension:
Adult patients Usually 4 mg doxazosin once daily. If necessary, the dosage may be increased to 8 mg doxazosin once daily. g. a thiazide diuretic, beta- adrenoceptor blocking agent, calcium antagonist or an ACE-inhibitor.
Symptomatic treatment of prostatic hyperplasia:
Adult patients Usually 4 mg doxazosin once daily. If necessary, the dosage may be increased to 8 mg doxazosin once daily. It can take up to 4 weeks to reach the full effect. Doxzogen XL 4 mg prolonged-release tablets may be used in benign prostatic hyperplasia (BPH) patients who are either hypertensive or normotensive, as the blood pressure changes in normotensive patients are clinically insignificant.
In hypertensive patients both conditions are treated concomitantly. Elderly patients Same dosage as for adults. Renal impairment Since there is no change in pharmacokinetics in patients with impaired renal function, and since there are no signs that doxazosin aggravates existing renal impairment, the usual dose can be used in these patients.
Hepatic impairment Doxazosin should be given with particular caution to patients with evidence of impaired liver function. In patients with severe hepatic impairment clinical experience is lacking and therefore the use of doxazosin is not recommended.
4). Paediatric population The safety and efficacy of doxazosin in children below 18 years of age has not yet been established. Doxzogen XL 4 mg prolonged-release tablets are not recommended for patients under the age of 18 years. Method of administration Doxzogen XL 4 mg prolonged-release tablets can be taken with or without food.
The tablets must be swallowed whole with a sufficient amount of liquid. 4).
The occurrence of adverse reactions is mainly due to the pharmacological properties of the medicinal product. The majority of the adverse reactions were transient. The adverse reaction profile in clinical trials with patients with benign prostatic hyperplasia corresponded to the one seen in hypertension.
The following undesirable effects have been observed and reported during treatment with Doxzogen 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) and not known (frequency cannot be estimated from the available data).
System Organ Class Common Uncommon Rare Very Rare Not known Infections and infestations Respiratory tract infection, urinary tract infection Blood and lymphatic system disorders Leukopenia, thrombocytopenia, erythrocytopenia Immune system disorders Allergic drug reaction Metabolism and nutrition disorders Anorexia, gout, increased appetite, hypokalaemia, thirst Hypoglycaemia Increase in serum urea.
4) Ear and labyrinth disorders Vertigo Tinnitus Cardiac disorders Palpitation, tachycardia Angina pectoris, myocardial infarction Bradycardia, cardiac arrhythmias Vascular disorders Hypotension, postural hypotension, oedema Peripheral ischaemia Flush Respiratory, thoracic and mediastinal disorders Bronchitis, cough, dyspnoea, rhinitis Epistaxis, pharyngitis Oedema of larynx Bronchospasm Gastrointestinal disorders Abdominal pain, dyspepsia, dry mouth, nausea Constipation, diarrhoea, flatulence, vomiting, gastroenteritis, taste disturbances Gastrointestinal obstruction Hepatobiliary disorders Abnormal liver function tests Cholestasis, hepatitis, jaundice, icterus, increased liver values Skin and subcutaneous tissue disorders Pruritus Skin rash Alopecia, purpura, urticaria Musculoskeletal, and connective tissue disorders Back pain, myalgia, Arthralgia, muscle stiffness Muscle cramps, muscle weakness Renal and urinary disorders Cystitis, urinary incontinence Dysuria, haematuria, micturition frequency Micturition disorder, nocturia, polyuria, increased diuresis, increase of serum creatinine Reproductive Delayed Impotence Gynaecomastia, Retrograde system and breast disorders ejaculation priapism ejaculation General disorders and administration site conditions Asthenia, chest pain, influenza- like symptoms, peripheral oedema Pain, facial oedema, fever/shiver, paleness, general oedema Fatigue, malaise, low body temperature in elderly Investigations Weight increase Particular caution: Postural hypotension and in rare cases syncope may occur at the beginning of therapy, especially at very high doses but also when treatment is recommenced after a break.
Information to be given to the Patient Patients should be informed that doxazosin tablets should be swallowed whole. Patients should not chew, divide or crush the tablets. For some prolonged-release formulations the active compound is surrounded by an inert, non- absorbable coating that is designed to control the release of the drug over a prolonged period.
After transit through the gastrointestinal tract, the empty tablet shell is excreted. Patients should be advised not to be concerned if they occasionally observe remains in their stools that look like a tablet. Gastrointestinal diseases There have been rare incidences of obstructive symptoms in patients with known stricture in connection with the ingestion of other medicinal products that are formulated in the same way as Doxazosin 4 mg prolonged release tablets that is, with a non-deformable shell and modified excretion.
g. following surgical resection) could result in incomplete absorption. In view of the long half-life of doxazosin the clinical significance of this is unclear. Initiation of Therapy In relation with the alpha-blocking properties of doxazosin, patients may experience postural hypotension evidenced by dizziness and weakness, or rarely loss of consciousness (syncope), particularly with the commencement of therapy.
Therefore, it is prudent medical practice to monitor blood pressure on initiation of therapy to minimise the potential for postural effects. The patient should be cautioned to avoid situations where injury could result should dizziness or weakness occur during the initiation of doxazosin therapy.
Use in patients with Acute Cardiac Conditions As with any other vasodilatory anti-hypertensive agent it is prudent medical practice to advise caution when administering doxazosin to patients with the following acute heart diseases: • pulmonary oedema as a result of aortic or mitral stenosis, • heart failure at high output, • right sided heart failure as a result of pulmonary embolism or pericardial effusion and left sided ventricular heart insufficiency with low filling pressure.
g. prazosin, terazosin) - Patients with a history of orthostatic hypotension - Patients with benign prostatic hyperplasia and concomitant congestion of the upper urinary tract, chronic urinary tract infections or bladder stones - Patients with a history of gastro-intestinal obstruction, oesophageal obstruction, or any degree of decreased lumen diameter of the gastro-intestinal tract.
- Patients with hypotension1 Doxazogen is contraindictaed as monotherapy in patients with either overflow bladder or anuria with or without progressive renal insufficiency. 1 For the benign prostatic hyperplasia indication only
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.
In hypertensive patients with one or more additional risk factors for cardiovascular disease, doxazosin should not be used as a single agent for the first-line treatment of hypertension due to a possible increased risk for development of heart failure.
g. hypotension and syncope. In patients treated for benign prostatic hyperplasia and without hypertension mean blood pressure changes are small, but hypotension, dizziness, fatigue occur in 10 – 20% of the patients and oedema and dyspnoea occur in less than 5% of patients.
Special care should be taken with hypotensive patients or patients with known orthostatic dysregulation taking doxazosin to treat benign prostatic hyperplasia (BPH). They should be informed about the potential risk form injuries and measures of precaution to minimize orthostatic symptoms.
2). Since there is no clinical experience in patients with severe hepatic impairment, use in these patients is not recommended. g. cimetidine). Doxazosin should be used with care in patients with Diabetic Autonomic Neuropathy. Doxazosin may influence plasma renin activity and urinary excretion of vanillylmandelic acid.
This should be considered when interpreting laboratory data. g. sildenafil, tadalafil, vardenafil) should be done with caution as both drugs have vasodilating effects and may lead to symptomatic hypotension in some patients. In order to minimize the risk for developing orthostatic hypotension the patient should be haemodynamically stabilised on the alpha-blocker therapy before initiating use of phospodiesterase-5-inhibitors.
Furthermore, it is recommended to initiate phosphodiesterase-5-inhibitor treatment with the lowest possible dose and to respect a 6-hour time interval from intake of doxazosin. No studies have been conducted with doxazosin prolonged release formulations.
In addition, physicians should advise patients what to do in the event of orthostatic hypotensive symptoms. Inoperative Floppy Iris Syndrome The ‘Intraoperative Floppy Iris Syndrome’ (IFIS, a variant of small pupil syndrome) has been observed during cataract surgery in some patients on or previously treated with tamsulosin.
Isolated reports have also been received with other alpha-1 blockers and the possibility of a class effect cannot be excluded. As IFIS may lead to increased procedural complications during the cataract operation current or past use of alpha-1 blockers should be made known to the ophthalmic surgeon in advance of surgery.
Priapism Prolonged erections and priapism have been reported with α-1 blockers including doxazosin in post-marketing experience. If priapism is not treated immediately, it could result in penile tissue damage and permanent loss of potency, therefore the patient should seek immediate medical assistance.
Screening for prostate cancer Prostate cancer causes many of the symptoms that can be associated with benign prostatic hyperplasia (BPH), and the two conditions can occur at the same time. Prostate cancer should be ruled out before the treatment of BPH symptoms with doxazosin is started.
Sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially “sodium free”.