Medicinal Products

DOXAZOSINE LP MYLAN 8 mg

Generic drug from Zoxan LP
Therapeutic class: Cardiology and angiology
Active ingredients: Doxazosin
laboratory: Mylan

Sustained release tablet
Box of 28
All forms

Indication

Essential hypertension.

Symptomatic treatment of benign prostatic hyperplasia.

Dosage DOXAZOSINE LP MYLAN 8 mg prolonged release tablet Box of 28

The tablets should be swallowed whole with a sufficient amount of liquid. They should not be crunched, split or crushed.

The maximum recommended dose is 8 mg doxazosin once daily.

Essential hypertension

Adults and elderly subjects:

The usual dose is 4 mg doxazosin once a day. If necessary, the dose may be increased to 8 mg once a day. The delay for optimal effect can be up to 4 weeks.

Doxazosin may be used as monotherapy or in combination with another drug, such as thiazide diuretics, beta-blockers, calcium channel blockers or angiotensin converting enzyme inhibitors.

Symptomatic treatment of benign prostatic hyperplasia

Adults and elderly subjects:

The usual dose is 4 mg doxazosin once a day. If necessary, the dose may be increased to 8 mg once a day.

Doxazosin can be given in hypertensive or normotensive patients with benign prostatic hyperplasia. In normotensive patients, the decrease in blood pressure is usually insignificant. The patient should be closely monitored at the beginning of treatment because of the risk of orthostatic side effects.

Dose-response studies were not performed with the extended-release formulation of doxazosin, which means that an increase in effect with increasing dose (up to 8 mg ) has not yet been demonstrated.

Renal failure:

Since the pharmacokinetics of doxazosin are not impaired in patients with renal impairment and there is no evidence that doxazosin aggravates existing renal impairment, the usual dosage may be used in these patients.

Hepatic insufficiency:

Doxazosin should be administered with particular caution in patients with evidence of hepatic impairment. In the absence of clinical experience in patients with severe hepatic impairment, the use of doxazosin is not recommended in these patients (see Warnings and Precautions ).

Pediatric population:

DOXAZOSIN MYLAN LP 8 mg prolonged-release tablets should not be used in children under 18 years of age due to insufficient data on safety and efficacy.

Against indications

· Hypersensitivity to the active substance or to any of the excipients.

· History of orthostatic hypotension.

· Benign prostatic hyperplasia associated with retention of the upper urinary tract, chronic urinary tract infection or bladder stones.

· History of gastrointestinal or esophageal occlusion, or any reduction in the diameter of the lumen of the digestive tract.

· Breastfeeding (see section Pregnancy and breastfeeding ) 1 .

· Hypotension 2 .

1 In the indication of hypertension only.

2 For the indication of benign prostatic hyperplasia only.

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, <1/1 000

Very rare: <1/10 000

Not known: can not be estimated from the available data.

Class of organ systems

Frequency

Side effects

Infections and infestations

Frequent

Respiratory infection, urinary tract infection

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

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

Rare

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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