Valz N – description of the drug, instructions for use, reviews

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Manufacturers: Actavis

Active ingredients

• Hydrochlorothiazide

Disease class

• Essential [primary] hypertension
• Secondary hypertension

Clinical and pharmacological group

• Not indicated. See instructions

Pharmacological action

• Diuretic
• Antihypertensive

Pharmacological group

• Angiotensin II receptor antagonists (AT1 subtype) in combinations

Release form and composition

The drug is available in the form of tablets marked “H” on one side and “V” on the other:

• Pink color, containing 80 mg of valsartan and 12.5 mg of hydrochlorothiazide;
• Red-brown in color, containing 160 mg of valsartan and 12.5 mg of hydrochlorothiazide;
• Orange color containing 160 mg of valsartan and 25 mg of hydrochlorothiazide.

Excipients: croscarmellose sodium, microcrystalline cellulose, lactose monohydrate, talc, povidone K29-32, colloidal silicon dioxide, magnesium stearate.

Composition of the film shell of Valz N tablets:

• At a dose of 80/12.5 mg - opadry II 85G34642 pink, including polyvinyl alcohol, titanium dioxide, macrogol 3350, lecithin, iron oxide dye red, yellow and black;
• At a dose of 160/12.5 mg - opadry II 85G25455 red, including polyvinyl alcohol, macrogol 3350, talc, titanium dioxide, lecithin, iron oxide red dye and solar yellow aluminum varnish dye;
• At a dose of 160/25 mg - opadry II 85G23675 orange, including polyvinyl alcohol, macrogol 3350, talc, titanium dioxide, lecithin, iron oxide dye yellow, red and black.

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** Attention! The information presented in this medication guide is intended for medical professionals and should not be used as a basis for self-medication. The description of the drug Valz N is provided for informational purposes and is not intended for prescribing treatment without the participation of a doctor. Patients need to consult a specialist!

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Contraindications

The use of Valza N, according to the instructions, is contraindicated:

• Children and teenagers under 18 years of age;
• Pregnant women;
• Breastfeeding mothers;
• Patients with systemic lupus erythematosus;
• If you have hypersensitivity to any component of the drug;
• For hyponatremia, hypercalcemia, hypokalemia and hyperuricemia, refractory to adequate therapy;
• For liver dysfunction caused by bile duct obstruction, including cholestasis and biliary cirrhosis;
• Patients with chronic renal failure (with CC up to 30 ml/minute), including people on hemodialysis.

Valz N is prescribed, but with extreme caution:

• In conditions that are accompanied by a decrease in BCC (circulating blood volume);
• With stenosis of two renal arteries or stenosis of the artery of a single kidney;
• During the period after kidney transplantation;
• For moderate liver dysfunction (provided there is no cholestasis).

Caution when using Valza N should be observed in patients taking:

• Potassium-sparing diuretics;
• Potassium salt preparations;
• Medicines that may cause an increase in potassium levels in the blood, including heparin;
• Thiazide diuretics.

Directions for use and dosage

The tablets are taken at any convenient time, without reference to meals, but preferably at the same time every day.

The recommended initial dosage of Valza N is 80/12.5 mg once daily. If therapeutic effectiveness is insufficient, after 2-4 weeks (this is the time needed for the development of a stable hypotensive effect), the daily dose is increased to 160/12.5 mg. And only if this dosage is not enough to reduce blood pressure, it is increased to 160/25 mg.

Patients with mild to moderate liver dysfunction, provided there is no cholestasis, as well as people with impaired renal function with CC more than 30 ml/min, do not require dose adjustment.

Valz

Valz (active ingredient valsartan) is an antihypertensive drug belonging to the group of selective angiotensin II receptor blockers (AT1 subtype). Today, the number of people suffering from arterial hypertension has exceeded one billion. This widespread prevalence of arterial hypertension makes a significant contribution to the morbidity and mortality from cardiovascular diseases. It is all the more surprising that, despite the existing abundance of effective methods of treating it, at least a third of patients do not receive adequate pharmacotherapy. A key role in the pathogenesis of arterial hypertension is played by the renin-angiotensin-aldosterone system (hereinafter referred to as RAAS), which regulates fluid and blood volume, as well as electrolyte balance. When the RAAS is activated, its main “tool” - angiotensin II - causes vasoconstriction, stimulates the release of aldosterone and increases sympathetic activity, which together contributes to the onset and progression of arterial hypertension. AT1 receptor blockers (ARBs) control the functioning of the RAAS, disavowing the effects of angiotensin II, which is accompanied by an increase in the lumen of blood vessels, suppression of the secretion of antidiuretic hormone (ADH) and aldosterone. ARBs are a relatively “young” group of antihypertensive drugs, which right off the bat have taken one of the leading positions in the treatment of arterial hypertension and chronic heart failure and the prevention of cardiovascular complications. More and more often, ARBs are used as first-line drugs, which avoids the negative experience of using ACE inhibitors with an inevitable dry cough and an increased risk of angioedema. To date, a solid evidence base has been accumulated on the use of ARBs, and their advantages over other classes of antihypertensive drugs have been demonstrated. Valz is a branded generic version of valsartan from the Icelandic pharmaceutical company. A distinctive feature of this drug is the presence of all three registered medical indications, like Diovan (the original valsartan): arterial hypertension, chronic heart failure, and increased survival of post-infarction patients.

At the State Research Center for Preventive Medicine of the Ministry of Health and Social Development of Russia, a comparative study of the effectiveness and safety of Valz and the original valsartan (Diovan) was conducted in patients suffering from arterial hypertension of 1-2 degrees. An impartial comparison revealed almost the same effectiveness and safety of both drugs.

Valz begins to act 2 hours after oral administration, the maximum of its antihypertensive effectiveness is observed at 4-6 hours, the duration of action is more than a day. Provided regular course intake, stabilization of blood pressure at a given level is achieved in 2-4 weeks. With abrupt cessation of taking the drug, the syndrome (a jump in blood pressure) is not observed. Valz is quickly absorbed from the gastrointestinal tract. Its absolute bioavailability is 23%. Food intake does not affect the bioavailability of the drug. When taking Valz once a day, the degree of its accumulation in the body is insignificant. For arterial hypertension, treatment is recommended to begin with a dose of 80 mg. The antihypertensive effect will clearly manifest itself in the first two weeks of the drug course, reaching its maximum after four weeks of treatment. If the above dose does not produce an adequate therapeutic response, a twofold increase is recommended. In addition to this, an antihypertensive drug of another group can be “connected” to Valz (with the exception of a combination with an ACE inhibitor and a beta-blocker). For persons with chronic heart failure, the drug is prescribed 40 mg 2 times a day with the possibility of increasing the dose to 80, and if well tolerated, to 160 mg. Valz goes well with diuretics, statins, beta-blockers, but its combination with ACE inhibitors increases the risk of side effects. In patients suffering from chronic heart failure, a slight decrease in blood pressure may be observed at the initial stage of treatment.

Side effects

The use of Valza N may be accompanied by such undesirable effects as:

• Feeling tired and dizzy (side effects from the nervous system);
• Nausea, abdominal pain and diarrhea (digestive system reactions);
• Pharyngitis, rhinitis and cough (phenomena from the respiratory system);
• Hypercreatininemia and impaired renal function (effects on the urinary system);
• Hyperkalemia (an undesirable metabolic event);
• Rash, itching, vasculitis, serum sickness, angioedema (allergic reactions);
• Arthralgia, viral infections, chest pain, decreased hematocrit (other side effects).

Potentially possible adverse events caused specifically by valsartan: asthenia, insomnia, edema, decreased libido.

Adverse events caused specifically by hydrochlorothiazide in Valza N:

• Often - loss of appetite, urticaria, nausea, vomiting, decreased potency, orthostatic hypotension;
• Rarely - water and electrolyte imbalance, constipation or diarrhea, photosensitivity, jaundice, headache, abdominal discomfort, arrhythmias, intrahepatic cholestasis, visual impairment, paresthesia, depression, thrombocytopenia (in some cases with purpura);
• Very rarely - leukopenia, exacerbation of skin manifestations of systemic lupus erythematosus or the appearance of skin reactions resembling SLE, necrotizing vasculitis, pancreatitis, hemolytic anemia, pulmonary edema, pneumonitis, bone marrow suppression, toxic epidermal necrolysis.

Valz N tab.pp.o.160mg+12.5mg No. 98 78676

Description

Valz N film-coated tablets 160 mg + 12.5 mg; strip 14, cardboard pack 7; No. LSR-002882/09, 2009-04-13 from Actavis Group hf. (Iceland); manufacturer: Actavis Ltd. (Malta) Latin name Valz H Active ingredient Valsartan* + Hydrochlorothiazide* (Valsartanum + Hydrochlorothiazide) ATC: C09DA03 Valsartan in combination with diuretics Pharmacological group Angiotensin II receptor antagonists (AT1 subtype) in combinations Nosological classification (ICD-10) I10 Essential ( primary) hypertension I15 Secondary hypertension Indications Arterial hypertension (if valsartan monotherapy is ineffective), reducing the risk of cardiovascular morbidity and mortality in patients with arterial hypertension and left ventricular hypertrophy. Contraindications Hypersensitivity; biliary cirrhosis, bile duct obstruction; anuria, chronic renal failure (Cl creatinine <30 ml/min); hyponatremia, hypokalemia, hypercalcemia, hyperuricemia with clinical manifestations refractory to adequate therapy; renal artery stenosis (single kidney or bilateral); systemic lupus erythematosus; pregnancy, lactation period. Use during pregnancy and breastfeeding Category of action on the fetus according to the FDA - D. Side effects According to the State Register, the following side effects were observed in patients receiving the combination of valsartan + hydrochlorothiazide: dizziness, feeling tired, diarrhea, abdominal pain, nausea, cough, rhinitis, pharyngitis, viral infections, decreased hematocrit, hyperkalemia, hypercreatininemia, arthralgia, chest pain, allergic reactions, angioedema, itching, serum sickness, vasculitis, skin rash, renal dysfunction. Potentially possible: caused by valsartan - edema, insomnia, asthenia, decreased libido (less than 1%); caused by hydrochlorothiazide - a disorder of water and electrolyte balance; often - urticaria, loss of appetite, nausea, vomiting, orthostatic hypotension, decreased potency; rarely - photosensitivity, constipation or diarrhea, abdominal discomfort, intrahepatic cholestasis, jaundice, arrhythmia, headache, depression, paresthesia, blurred vision, thrombocytopenia, sometimes with purpura; very rarely - necrotizing vasculitis, toxic epidermal necrolysis (Lyell's syndrome), skin reactions resembling systemic lupus erythematosus, exacerbation of skin manifestations of systemic lupus erythematosus, pancreatitis, leukopenia, agranulocytosis, bone marrow depression, hemolytic anemia, pneumonitis, pulmonary edema. According to PDR, in patients receiving the combination of valsartan + hydrochlorothiazide, during controlled clinical trials, the following adverse effects were noted (which had a frequency of more than 2% and occurred more often against the background of drugs - the first number in parentheses than in the placebo group - the second number in parentheses) : dizziness (9%/7%), viral infections (3%/1%), fatigue (5%/1%), pharyngitis (3%/1%), cough (3%/0%), diarrhea (3 %/0%). Headache, upper respiratory tract infections, sinusitis, back pain and chest pain were observed in more than 2% of patients, but at approximately the same frequency in the control and placebo groups. Dose-related orthostatic effects were noted in less than 1% of patients. A dose-dependent increase in the frequency of dizziness was observed when taking doses of the combination of valsartan + hydrochlorothiazide 80/12.5 mg (6%) and 160/25 mg (16%). Other side effects observed in more than 0.2% of patients during controlled clinical trials, regardless of the causal relationship with the combination: From the nervous system and sensory organs: asthenia, anxiety, depression, insomnia, paresthesia, drowsiness, vertigo, tinnitus , visual impairment. From the cardiovascular system and blood (hematopoiesis, hemostasis): palpitations, syncope, tachycardia. From the respiratory system: bronchospasm, dyspnea, nosebleeds. From the gastrointestinal tract: increased appetite, constipation, dyspepsia, flatulence, dry mouth, abdominal pain, nausea, vomiting. From the musculoskeletal system: arthralgia, muscle spasms, muscle weakness, arm pain, leg pain. From the genitourinary system: dysuria, increased frequency of urination, urinary tract infection. Allergic reactions: rash, anaphylaxis. Other: peripheral edema, flushing, erythema, increased sweating, dehydration, gout, decreased libido, impotence. Precautions Before treatment, the Na+ content in the blood and/or bcc is corrected. Regular monitoring of plasma K+, glucose, uric acid, fat and creatinine levels is necessary. If pregnancy occurs during treatment, the drug should be discontinued. During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions. Storage conditions for the drug Valz N At a temperature not exceeding 30 °C. In closed packaging. Keep out of reach of children. The shelf life of the drug Valz N is 3 years. Do not use after the expiration date stated on the package. 2000-2015. Register of Medicines of Russia The database is intended for healthcare professionals. Commercial use of materials is not permitted.

Analogs

The following drugs are produced with the same composition of active ingredients: Valsacor N 80, Valsacor N 160, Valsacor ND 160, Vanatex Combi, Co-Diovan.

The following drugs can be considered analogues of Valz N according to the mechanism of action: Atacand Plus, Bloktran GT, Vazotenz N, Gizaar and Gizaar Forte, Gisortan, Ibertan Plus, Candecor, Cardosal Plus, Coaprovel, Lakea N, Lozap, Losartan/Hydrochlorothiazide-Teva, Losartan -N Richter, Lorista, Mikardis Plus, Ordiss N, Presartan N, Teveten.