Medicinal Products

DOXAZOSINE TEVA LP 4 mg

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

Sustained release tablet
Box of 28
All forms

Indication

Essential hypertension. DOXAZOSINE TEVA is not suitable for first-line treatment. It can be used as monotherapy in patients who have failed to respond or who have contraindications to other treatments. Alternatively, its use should be limited to second- or third-line treatment in combination with other antihypertensives.

Treatment of symptoms of benign prostatic hyperplasia.

Dosage DOXAZOSINE TEVA LP 4 mg prolonged release tablet Box of 28

DOXAZOSINE TEVA can be taken with or without food. The tablets should be swallowed whole with a sufficient amount of liquid. Sustained-release tablets should not be crushed, crushed or divided (see Warnings and Precautions ) section.

The maximum recommended dosage is 8 mg doxazosin once daily.

Essential hypertension

Adults: usually 4 mg doxazosin once a day. If necessary, the dosage may be increased to 8 mg doxazosin once daily.

DOXAZOSINE TEVA can be used alone or in combination with another medicine such as a thiazide diuretic, a beta-blocker, a calcium antagonist or a conversion enzyme inhibitor (IEC), for example.

Symptomatic treatment of benign prostatic hyperplasia

Adults: usually 4 mg doxazosin once a day. If necessary, the dosage may be increased to 8 mg doxazosin once daily.

DOXAZOSINE TEVA may be used in patients with benign prostatic hyperplasia (BPH) whether hypertensive or normotensive. In normotensive patients, changes in blood pressure are clinically minimal. In hypertensive patients, both pathologies are treated concomitantly. As with all drugs in this class, close medical supervision of the patient during the initial period of treatment is recommended.

Elderly : same dose as in adults.

Patients with renal impairment: As the pharmacokinetics of doxazosin do not significantly change in patients with renal impairment, no dose adjustment is recommended in these patients. Doxazosin tablets are not dialysable.

Patients with hepatic impairment:

As with any drug fully metabolized by the liver, doxazosin should be used with caution in patients with evidence of confirmed hepatic impairment (see Warnings and Precautions ).

Children and adolescents : In the absence of clinical experience, the use of doxazosin is not recommended in children and adolescents.

Against indications

· Known hypersensitivity to quinazolines (eg, prazosin, terazosin) or to any of the excipients.

· History of orthostatic hypotension.

· Benign prostatic hyperplasia associated with upper urinary tract congestion, chronic urinary tract infections or bladder stones.

· History of esophageal or gastrointestinal obstruction or reduction of the diameter of the lumen of the digestive tract, whatever the degree [1] .

· Breastfeeding (see section on Pregnancy and lactation, pregnancy and lactation) [2].

· Patient with hypotension [3] .

DOXAZOSINE TEVA is contraindicated as monotherapy in patients with bladder engorgement, anuria or progressive renal failure.
___________________________________

1 Only for patients treated with prolonged-release tablets.
2 Only for the indication hypertension.
3 Only for the indication benign prostatic hyperplasia.

Adverse effects Doxazosin Teva LP

Postural hypotension and rare cases of syncope may occur at the beginning of treatment, particularly at high doses, but also when treatment is resumed after an interruption.

The occurrence of adverse reactions is mainly due to the pharmacological properties of the drug. The majority of adverse reactions were transient.

The adverse event profile observed in clinical trials in patients with benign prostatic hyperplasia was similar to that seen in hypertension.

The undesirable effects considered as possibly related to the treatment are indicated below by organ system classes and by absolute frequency. Within each frequency group, adverse effects are presented in order of decreasing severity.

Frequencies of adverse reactions are classified according to the following criteria: very common (≥ 1/10), common (≥ 1/100 and <1/10), uncommon (≥ 1/1000 and <1/100), rare ( ≥ 1/10 000 and <1/1000), very rare (<1 / 10, 000) including isolated cases, unknown (can not be estimated from the available data).

Investigations:

Uncommon: weight gain.

Heart conditions:

Frequent: palpitations, tachycardia.

Uncommon: angina pectoris, myocardial infarction.

Very rare: b radycardia, arrhythmias.

Hematological and lymphatic system disorders:

Very rare: leukopenia, thrombocytopenia.

Nervous system disorders:

Common: dizziness, headache, drowsiness

Uncommon: cerebrovascular accident, hypoaesthesia, syncope, tremors.

Very rare: vertiginous sensations to orthostatism, paresthesia.

Eye disorders:

Very rare: blurred vision.

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

Affections of the ear and labyrinth:

Frequent: vertigo.

Uncommon: tinnitus.

Respiratory, thoracic and mediastinal disorders:

Frequent: bronchitis, cough, dyspnoea, rhinitis.

Uncommon: epistaxis.

Very rare: bronchospasm.

Gastrointestinal disorders:

Common: abdominal pain, dry mouth, nausea, dyspepsia

Uncommon: constipation, diarrhea, flatulence, vomiting, gastroenteritis.

Unknown: taste disorders.

Renal and urinary disorders:

Common: Cystitis, urinary incontinence.

Uncommon: hematuria, pollakiuria, dysuria.

Very rare: voiding disorders, nocturia, polyuria, increased diuresis.

Skin and subcutaneous tissue disorders:

Frequency: pruritus.

Uncommon: skin rash.

Very rare: alopecia, urticaria, purpura.

Musculoskeletal and connective tissue disorders:

Frequent: back pain, myalgia.

Uncommon: arthralgia.

Very rare: muscle cramps, muscle weakness.

Metabolism and nutrition disorders:

Uncommon: anorexia, hyperphagia, gout.

Infections and infestations:

Common: Respiratory tract infections, urinary tract infections.

Vascular disorders:

Common: hypotension, postural hypotension

Rare: flush.

General disorders and administration site defects:

Frequent: asthenia, chest pain, flu-like symptoms / symptoms, peripheral edema.

Uncommon: pain.

Very rare: tiredness, feeling unwell, edema of the face.

Immune system disorders:

Uncommon: allergic drug reaction.

Hepatobiliary disorders:

Uncommon: abnormal liver test results.

Very rare: cholestasis, hepatitis, jaundice.

Disorders of the reproductive organs and the breast:

Uncommon: impotence

Very rare: gynecomastia, priapism.

Unknown: Retrograde ejaculation.

Psychiatric disorders:

Uncommon: anxiety, depression, insomnia.

Very rare: agitation, nervousness.

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