Medicinal Products

DOXAZOSINE LP MYLAN 4 mg

Generic drug from Zoxan LP
Therapeutic class: Urology nephrology
Active ingredients: Doxazosin
laboratory: Mylan

Sustained release tablet
Box of 28
All forms

Indication

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.

Elderly

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 .

Pediatric population:

The safety and effectiveness of doxazosin in the pediatric population has not been established.

Against indications

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

Frequency

Side effects

Infections and infestations

Frequent

Respiratory infections, urinary tract infections

Blood and lymphatic system disorders

Very rare

Leukopenia, thrombocytopenia

Immune system disorders

Rare

Drug allergic reaction

Metabolism and nutrition disorders

Rare

Anorexia, gout, increased appetite

Psychiatric disorders

Rare

Anxiety, depression, insomnia

Very rare

Agitation, nervousness

Nervous system disorders

Frequent

Dizziness, headache, drowsiness

Rare

Stroke, hypoaesthesia, syncope, tremors

Very rare

Orthostatic vertigo, paresthesia

Eye disorders

Very rare

Blurry vision

Not known frequency

Intraoperative flaccid iris syndrome (see section Warnings and precautions for use )

Affections of the ear and labyrinth

Frequent

Dizziness

Rare

tinnitus

Heart conditions

Frequent

Palpitations, tachycardia

Rare

Angor, myocardial infarction

Very rare

Bradycardia, arrhythmias

Vascular disorders

Frequent

Hypotension, orthostatic hypotension

Very rare

Flushing

Respiratory, thoracic and mediastinal disorders

Frequent

Bronchitis, cough, dyspnea, rhinitis

Rare

Epistaxis

Very rare

bronchospasm

Gastrointestinal disorders

Frequent

Abdominal pain, dyspepsia, dry mouth, nausea

Rare

Constipation, diarrhea, flatulence, vomiting, gastroenteritis

Hepatobiliary disorders

Rare

Abnormal liver parameters

Very rare

Cholestasis, hepatitis, jaundice

Skin and subcutaneous tissue disorders

Frequent

itching

Rare

rash

Very rare

Alopecia, purpura, urticaria

Musculoskeletal and systemic disorders

Frequent

Dorsalgia, myalgia

Rare

arthralgia

Very rare

Cramps, muscle weakness

Renal and urinary disorders

Frequent

Cystitis, urinary incontinence

Rare

Dysuria, hematuria, pollakiuria

Very rare

Micturition disorders, nocturia, polyuria, increased diuresis

Disorders of reproductive organs and breast

Frequent

Incapacity

Very rare

Gynecomastia, priapism

Not known frequency

Retrograde cumshot

General disorders and administration site conditions

Frequent

Asthenia, chest pain, flu-like syndrome, peripheral edema

Rare

Algies, facial edema

Very rare

Fatigue, discomfort

investigations

Rare

Weight gain

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