Setegys (terazosin) tablets 2 mg. №30

Description

Setegys (terazosin) tablets 2 mg. №30

Composition

active substance: 1 tablet contains 1 mg or 2 mg, or 5 mg, or 10 mg of terazosin (in the form of 1.187 mg or 2.374 mg or 5.935 mg or 11.87 mg of terazosin hydrochloride dihydrate, respectively);

excipients: lactose monohydrate, pregelatinized starch, povidone, magnesium stearate, talc;

• 2 mg tablets contain quinoline yellow (E 104);
• tablets 5 mg or 10 mg: FCF yellow sunset (E 110).

Medicinal form

Tablets.

The main physical and chemical properties:

• tablets 1 mg – round flat tablets of white color, with a chamfer, smooth on one side and engraved with the stylized letter E and the number 451 on the other side, odorless;
• tablets 2 mg – round flat tablets of yellow color, with a chamfer, smooth on one side and engraved with the stylized letter E and the number 452 on the other side, odorless;
• tablets 5 mg – round flat tablets of light orange color, with a chamfer, smooth on one side and engraved with the stylized letter E and the number 453 on the other side, odorless;
• tablets 10 mg – round flat tablets of orange color, with a chamfer, smooth on one side and engraved with a stylized letter E and the number 454 on the other side, odorless.

Pharmacotherapeutic group

Drugs used in benign prostatic hypertrophy. Antagonists of α-adrenoceptors. Terazosin.
ATX code G04C A03.

Pharmacological properties

Terazosin selectively blocks peripheral postsynaptic α1-adrenoceptors. Blockade of these receptors causes dilation of arterial vessels, reduction of total peripheral resistance, blood pressure and postload on the heart. The tone of the venous vessels also decreases, which leads to a decrease in venous return and congestion on the heart. Prolonged treatment with terazosin is usually not accompanied by reflex tachycardia; Terazosin has little effect on cardiac output, renal perfusion, and glomerular filtration rate. The drug helps to normalize lipid metabolism: lowers total cholesterol, triglycerides, LDL and VLDL, increases HDL. With systematic use of the drug there is a regression of left ventricular hypertrophy.
By blocking postsynaptic α1-adrenoceptors of smooth muscle of the bladder outlet, proximal urethra and prostate, terazosin reduces urinary flow resistance and normalizes urination in patients with benign prostatic hyperplasia. The size of the prostate is not affected by the drug Setegys tablets.

Indication

Symptomatic therapy of urinary retention due to benign prostatic hypertrophy.
Hypertension (as monotherapy or in combination with other antihypertensive drugs).

Contraindication

Hypersensitivity to the active substance or to any of the excipients and to other similar α-adrenoceptor antagonists.

Method of application and dosage

The Setegys tablets should be taken with or without food, without chewing, once a day. The duration of treatment is determined by the doctor individually.

• Benign prostatic hypertrophy.
  The initial dose of the drug is 1 mg. The maintenance dose of the drug is 5-10 mg 1 time per day. The maximum daily dose of the drug is 20 mg. The therapeutic effect is usually observed 2 weeks after the start of treatment. To achieve a lasting effect, the course of treatment with a maintenance dose should be 4 weeks.
• Hypertension
  Individual selection of the daily dose for each patient is recommended.
  The initial dose of the drug is 1 mg, which should be administered at night. Gradually increase the maintenance daily dose to 2 mg once daily, doubling it at weekly intervals until the desired blood pressure level is reached. The maximum daily dose of the drug is 20 mg.

Children

The safety and effectiveness of the drug Setegys tablets in children have not been established, so it should not be prescribed to this category of patients.

Overdose

Symptoms: orthostatic collapse, hypotension, tachycardia, circulatory shock, electrolyte imbalance and severe renal failure.
Treatment: symptomatic therapy. The patient should be placed in a horizontal position and his legs should be raised. If necessary, prescribe anti-shock therapy with the introduction of fluids and vasoconstrictors. It is necessary to restore the water-electrolyte balance. Because terazosin is highly protein bound, it cannot be removed by dialysis.

Side effects

At the beginning of treatment may develop a “first dose effect” – orthostatic hypotension to fainting.
If fainting occurs, the patient should be placed in a supine position. Dizziness, mild headache, or fainting may occur with rapid lifting from a supine or sitting position. Patients should be warned of such conditions and should be encouraged to lie down if these symptoms occur. You should lie down for a few more minutes before getting up to prevent recurrence of symptoms.

• Laboratory studies: Terazosin treatment for 24 months had no significant effect on prostate-specific antigen (PSA) levels.
• From the cardiovascular system: arrhythmia (unknown connection with the use of terazosin). Orthostatic hypotension, vasodilation, peripheral edema, palpitations, tachycardia, postural hypotension, atrial fibrillation, ventricular fibrillation.
• From the blood: thrombocytopenia, decreased hemoglobin, leukocytes, hematocrit, total protein, albumin, indicating the possibility of hemodilution.
• From the nervous system: fainting, dizziness, drowsiness, headache, paresthesia.
• From the eyes: blurred vision, amblyopia. Intraoperative flaccid iris syndrome (ISDR) was observed in cataract surgeons in patients treated with α1-blockers. Visual impairment and conjunctivitis (unknown relationship with the use of terazosin).
• From the hearing organs: vertigo, ringing in the ears (unidentified connection with the use of terazosin).
• From the respiratory system: nasal congestion, rhinitis, shortness of breath, sinusitis. Bronchitis, nosebleeds, flu symptoms, pharyngitis, cough (unidentified connection with the use of terazosin).
• From the gastrointestinal tract: nausea.
• Abdominal pain, constipation, diarrhea, dry mouth, dyspepsia, flatulence, vomiting (unknown connection with the use of terazosin).
• From the urinary system: increased urge to urinate, urinary tract infections, urinary incontinence in women in the postmenopausal period (no connection with the use of terazosin).
• From the skin and subcutaneous tissue: itching, rash, increased sweating (no connection with the use of terazosin).
• From the musculoskeletal system: back pain, pain in the extremities.
• Pain in the neck, shoulders, arthralgia, arthritis, joint pain, myalgia (not associated with the use of terazosin).
• Endocrine disorders: gout (not associated with the use of terazosin).
• General disorders: fatigue, asthenia, edema, weight gain. Chest pain, swelling of the face, fever (no connection with the use of terazosin).
• From the immune system: anaphylactoid reaction, allergic reactions.
• From the reproductive system: impotence, priapism.
• Mental disorders: decreased libido, depression, nervousness. Fear, insomnia (no connection with the use of terazosin).