Generic drug from Zoxan LP
Therapeutic class: Urology nephrology
Active ingredients: Doxazosin
Sustained release tablet
Box of 28
DOXAZOSINE MYLAN LP is used in the treatment of clinical symptoms of benign prostatic hyperplasia (BPH) and in the treatment of urinary volume reduction associated with BPH.
DOXAZOSINE MYLAN LP can be used in patients with BPH whether they are hypertensive or normotensive.
Dosage DOXAZOSINE LP MYLAN 4 mg prolonged release tablet Box of 28
DOXAZOSINE MYLAN LP can be taken with or without food.
The tablets should be swallowed whole with a sufficient amount of liquid. They should not be crunched, divided or crushed (see Warnings and Precautions section ).
The recommended dosage is 4 mg doxazosin once daily. If necessary, the dosage may be increased to 8 mg once daily. The delay for optimal effect can be up to 4 weeks.
The maximum recommended dose is 8 mg doxazosin once daily.
The same dose as in adults is recommended.
Renal failure :
Since the pharmacokinetics of doxazosin are not impaired in patients with renal impairment and there is no evidence that DOXAZOSINE MYLAN LP worsens existing renal impairment, the usual dosage may be used in these patients.
Hepatic insufficiency :
See Warnings and precautions for use .
The safety and effectiveness of doxazosin in the pediatric population has not been established.
DOXAZOSINE MYLAN LP is contraindicated in:
· Patients with known hypersensitivity to quinazolines (eg, prazosin, terazosin, doxazosin), or to any of the excipients,
· Patients with a history of orthostatic hypotension,
· Patients with benign prostatic hyperplasia associated with retention of the upper urinary tract, chronic urinary tract infection or bladder stones,
· Patients with a history of gastrointestinal or oesophageal occlusion, or any reduction in the diameter of the lumen of the digestive tract,
· Patients with hypotension.
Doxazosin is contraindicated as monotherapy in patients with engorgement incontinence or anuria with or without progressive renal impairment.
Adverse effects Doxazosin LP Mylan
The frequencies are presented according to the following convention:
Very common: ≥ 1/10
Frequency: ≥ 1/100, <1/10
Uncommon: ≥ 1/1000, <1/100
Rare: ≥ 1/10 000, <1/1000
Very rare: <1/10 000
Not known: can not be estimated from the available data.
MedDRA Database of Organ System Classes
Infections and infestations
Respiratory infections, urinary tract infections
Blood and lymphatic system disorders
Immune system disorders
Drug allergic reaction
Metabolism and nutrition disorders
Anorexia, gout, increased appetite
Anxiety, depression, insomnia
Nervous system disorders
Dizziness, headache, drowsiness
Stroke, hypoaesthesia, syncope, tremors
Orthostatic vertigo, paresthesia
Not known frequency
Intraoperative flaccid iris syndrome (see section Warnings and precautions for use )
Affections of the ear and labyrinth
Angor, myocardial infarction
Hypotension, orthostatic hypotension
Respiratory, thoracic and mediastinal disorders
Bronchitis, cough, dyspnea, rhinitis
Abdominal pain, dyspepsia, dry mouth, nausea
Constipation, diarrhea, flatulence, vomiting, gastroenteritis
Abnormal liver parameters
Cholestasis, hepatitis, jaundice
Skin and subcutaneous tissue disorders
Alopecia, purpura, urticaria
Musculoskeletal and systemic disorders
Cramps, muscle weakness
Renal and urinary disorders
Cystitis, urinary incontinence
Dysuria, hematuria, pollakiuria
Micturition disorders, nocturia, polyuria, increased diuresis
Disorders of reproductive organs and breast
Not known frequency
General disorders and administration site conditions
Asthenia, chest pain, flu-like syndrome, peripheral edema
Algies, facial edema