Diocor 160 (valsartan, hydrochlorothiazide) coated tablets 160 mg/12.5 mg. №90

Description

Diocor 160 mg/12.5 mg. №90 Composition

active substances: valsartan, hydrochlorothiazide;

1 film-coated tablet contains:

80 mg of valsartan and 12.5 mg of hydrochlorothiazide (Diocor 80)

or 160 mg of valsartan and 12.5 mg of hydrochlorothiazide (Diocor 160);

Excipients: microcrystalline cellulose, potato starch, corn starch, sodium lauryl sulfate, talc, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, coating coating Diocor 80 – Opadry II dioxide, polyethylene, polyethylene and polyethylene 171)); Diocor 160 – Opadry II Orange (talc, polyvinyl alcohol, quinoline yellow (E 104), polyethylene glycol, iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171)).

Dosage form
Film-coated tablets.

Basic physical and chemical properties:

Diocor 80 – round tablets with a biconvex surface, coated with a white film coating.

Diocor 160 – round tablets with a biconvex surface, coated with a film-coated brown-orange color.

Pharmacotherapeutic group
Combined drugs of angiotensin II inhibitors. Valsartan and diuretics.

ATX code C09D A03.

Pharmacological properties
Pharmacodynamics.

Diocor 160 mg/12.5 mg.  is an antihypertensive drug that contains an angiotensin II receptor antagonist and a thiazide diuretic.

The active hormone of the renin-angiotensin-aldosterone system is angiotensin II, formed from angiotensin I with the participation of angiotensin-converting enzyme (ACE).

Angiotensin II binds to specific receptors located on cell membranes in various tissues. It has a wide range of physiological effects, including both direct and indirect involvement in the regulation of blood pressure.

As a powerful vasoconstrictor, angiotensin II has a direct vasopressor effect. In addition, it promotes sodium retention and stimulates aldosterone secretion.

Valsartan is an active and specific angiotensin II receptor antagonist for internal use. It acts selectively on AT1 subtype receptors, which are responsible for the effects of angiotensin II. Increased levels of angiotensin II due to blockade of AT1 receptors by valsartan may stimulate free AT2 receptors, which balances the effect of AT1 receptors. Valsartan does not have any partial agonist activity against AT1 receptors and is much more (approximately 20,000 times) related to AT1 receptors than to AT2 receptors.

Valsartan does not inhibit ACE (kininase II), which converts angiotensin I to angiotensin II and destroys bradykinin. There are no side effects due to bradykinin.

Indication
Essential hypertension in patients whose blood pressure is not regulated by monotherapy.

Children

The safety and effectiveness of Diocor in children have not been established, so it should not be used in pediatric practice.

Contraindication

• Hypersensitivity to any of the components of the drug and to other drugs that are derivatives of sulfonamides.
• Severe liver dysfunction, liver cirrhosis and cholestasis.
• Severe renal impairment (creatinine clearance <30 ml / min), anuria.
• Refractory hypokalemia, hyponatremia, hypercalcemia, symptomatic hyperuricemia.
• Pregnant women and women planning to become pregnant.
• Concomitant use of angiotensin receptor antagonists (ARAs), including valsartan, or angiotensin converting enzyme (ACE) inhibitors with aliskiren in patients with diabetes mellitus or renal impairment (glomerular filtration rate) (GFR) <1.7 ml / min / min.

Use during pregnancy or breastfeeding

Pregnancy.

The use of Diocor 160 mg/12.5 mg.  is contraindicated in pregnant women and women planning to become pregnant.

If pregnancy is detected during treatment with Diocor, it should be discontinued immediately and, if necessary, replaced with another medicinal product approved for use by pregnant women.

Women who are planning to become pregnant should be given alternative antihypertensive therapy with an established safety profile for use during pregnancy.

Breastfeeding period.

If the use of the drug is absolutely necessary, breastfeeding should be stopped. There are no data on the use of valsartan during breast-feeding. Hydrochlorothiazide passes into breast milk in small amounts. Thiazides in high doses cause diuresis, which may lead to decreased breast milk production. During breastfeeding, alternative treatments with better known safety profiles should be preferred for use during breastfeeding of a newborn or premature infant.

Side effects
The most commonly reported adverse reactions in clinical trials and laboratory studies with valsartan hydrochlorothiazide compared with placebo and in individual post-marketing reports are listed below by system organ class.

Adverse reactions that may occur with each component but not observed in clinical trials may occur during treatment with valsartan / hydrochlorothiazide.

From the nervous system: headache, fatigue, asthenia, dizziness, insomnia, anxiety, paresthesia.

From the respiratory system, chest and mediastinum: cough, runny nose, pharyngitis, upper respiratory tract infections.

From the musculoskeletal system and connective tissue: back pain, arthralgia.