Description
Release form
Film-coated tablets.
Packing
28 pcs.
Pharmacological action
Exforge is a combined antihypertensive drug containing active substances with a complementing mechanism of blood pressure control. Amlodipine dihydropyridine derivative, belongs to the class of slow calcium channel blockers (BMCC), valsartan – to the class of angiotensin II receptor antagonists. The combination of these components has a mutually complementary antihypertensive effect, which leads to a more pronounced decrease in blood pressure compared with that of monotherapy with each drug.
Contraindications
Hypersensitivity to the components of the drug pregnancy.
Safety of Exforge in patients with unilateral or bilateral renal artery stenosis or single kidney artery stenosis, in patients after a recent kidney transplant, as well as children and adolescents under 18 years of age not established.
Use during pregnancy and lactation
Exforge, like any other drug that has a direct effect on RAAS, should not be prescribed during pregnancy and women who wish to become pregnant. If pregnancy is detected during Exforge treatment, the drug should be discontinued as soon as possible.
Patients of childbearing age should be informed of the possible risk to the fetus associated with the use of drugs that affect RAAS.
Given the mechanism of action of angiotensin II receptor antagonists, the risk to the fetus cannot be ruled out. It is known that the appointment of ACE inhibitors that affect RAAS, pregnant in the II and III trimesters, leads to damage or death of the developing fetus. According to a retrospective analysis of the use of ACE inhibitors in the first trimester of pregnancy was accompanied by the development of pathology of the fetus and newborn. With the unintended use of valsartan in pregnant women, cases of the development of spontaneous abortion, oligohydramnios and impaired renal function in newborns have been described.
It is not known whether valsartan and / or amlodipine is excreted in breast milk. Since valsartan with breast milk is noted in experimental studies, it is not recommended to use Exforge during lactation (breastfeeding).
Special instructions
Caution should be exercised when prescribing Exforge to patients with liver diseases (especially for obstructive biliary tract diseases). Valsartan is excreted mainly unchanged with bile, while amlodipine is extensively metabolized in the liver.
Patients with primary and moderate impaired renal function (CC 30-50 ml / min) do not need to adjust Exforge dose. Caution should be exercised when prescribing the drug to patients with severe impaired renal function (as well as using other vasodilators, special care should be taken when prescribing the drug to patients with mitral or aortic stenosis, hypertrophic obstructive cardiomyopathy.
If it is necessary to cancel beta-blockers before starting Exforge therapy, the dose of beta-blockers should be reduced gradually. Since amlodipine is not a beta-blocker, the use of Exforge does not prevent the development of the withdrawal syndrome that occurs when abruptly stopping treatment with beta-blockers.
In a placebo-controlled study in patients with uncomplicated arterial hypertension, pronounced arterial hypotension was observed in 0.4% of cases. In patients with activated RAAS (for example, with a deficiency of BCC and / or sodium in patients receiving high doses of diuretics), when taking angiotensin receptor blockers, symptomatic arterial hypotension may develop. Before starting Exforge treatment, a correction of the sodium content in the body and / or BCC should be carried out or therapy should be started under close medical supervision.
If arterial hypotension develops, the patient should be laid with raised legs, and if necessary, be infused with saline. After stabilization of blood pressure, Exforge treatment can be continued.
While using the drug with biologically active additives containing potassium, potassium-sparing diuretics, potassium-containing salt substitutes, or with other drugs that can cause an increase in the concentration of potassium in the blood (for example, with heparin), caution should be exercised and regular monitoring of the concentration of potassium in blood.
Effect on the ability to drive vehicles and control mechanisms
There is no data on the effect of the drug on the ability to drive vehicles and work with mechanisms. Due to the possible occurrence of dizziness or increased fatigue, care should be taken when driving vehicles or working with mechanisms.
Composition
1 tablet contains amlodipine 10 mg, valsartan 160 mg
Excipients: microcrystalline cellulose, crospovidone, magnesium stearate, colloidal silicon dioxide, hypromellose (hydroxypropyl methylcellulose), titanium dioxide (E1), yellow (2) iron (II), yellow oxide (2) macrogol 4000 (polyethylene glycol 4000), talc.
Dosage and administration
Exforge should be taken orally with a little water, 1 time per day. regardless of the meal time.
When prescribing to elderly patients, patients with initial or moderate impaired renal function (CC> 30 ml / min), with impaired liver function or with liver diseases, with cholestasis, changes in the dosage regimen are not required.
Side effects
From the respiratory system: often – nasopharyngitis, flu sometimes – cough, pain in the throat and larynx.
On the part of the sensory organs: rarely – visual impairment, tinnitus sometimes – dizziness associated with impaired function of the vestibular apparatus.
From the side of the central nervous system and peripheral nervous system: often – headache sometimes – dizziness, drowsiness, orthostatic dizziness, paresthesia rarely – anxiety.
On the part of the cardiovascular system: sometimes – tachycardia, palpitations, orthostatic hypotension, rarely – syncope, marked reduction in blood pressure.
From the digestive system: sometimes – diarrhea, nausea, abdominal pain, constipation, dry mouth.
Dermatological reactions: sometimes – skin rash, erythema rarely – hyperhidrosis, exanthema, pruritus.
From the musculoskeletal system: sometimes – swelling of the joints, back pain, arthralgia rarely – muscle cramps, a feeling of heaviness throughout the body.
From the urinary system: rarely – pollakiuria, polyuria.
From the reproductive system: rarely – erectile dysfunction.
Other: often – pastiness, facial edema, peripheral edema, fatigue, flushing, asthenia, a feeling of heat.
Drug Interactions
Amlodipine
When monotherapy with amlodipine there is no clinically significant interaction with thiazide diuretics, beta-adrenergic blocking agents, ACE inhibitors, long-acting nitrates, nitroglycerin, hydroxyfin hydroxide, dihydroxylamine, hydroxyfin hydroxide, varixomid hydroxide, hydroxyalumin hydroxide, varixomid hydroxide, hydroxyhydroxide hydroxycarboxylic acid, hydroxycarboxylic acid, magnesium, simethicone), cimetidine, NSAIDs, antibiotics, and oral hypoglycemic drugs.
valsartan
installed, that with monotherapy with valsartan there is no clinically significant interaction with the following drugs: cimetidine, warfarin, furosemide, digoxin, atenolol, indomethacin, hydrochlorothiazide, amlodipine, glibenclamide.
When used with dietary supplements containing potassium, potassium-sparing diuretics, potassium-containing salt substitutes, or with other drugs that can cause an increase in the concentration of potassium in the blood (for example, with heparin), caution should be exercised and frequent monitoring of the concentration of potassium in the blood .
overdose
Symptoms: There are currently no data on overdoses of the drug. With an overdose of valsartan, a marked decrease in blood pressure and dizziness can be expected. An overdose of amlodipine can lead to excessive peripheral vasodilation and possible reflex tachycardia. The occurrence of pronounced and prolonged systemic arterial hypotension up to the development of lethal shock has also been reported.
Treatment: in case of accidental overdose, you should induce vomiting (if the drug was recently taken) or wash the stomach, appoint activated charcoal. The use of activated charcoal in healthy volunteers immediately or 2 h after administration of amlodipine significantly reduced its absorption. In case of clinically pronounced arterial hypotension caused by Exforge, it is necessary to conclude the patient with his legs elevated, take active measures to maintain the activity of the cardiovascular system, including frequent monitoring of cardiac and respiratory function, BCC and urinary output. In the absence of contraindications to restore vascular tone and blood pressure can be used (with caution) vasoconstrictor. In / in the introduction of calcium gluconate may be effective for eliminating calcium channel blockade. Withdrawal of valsartan and amlodipine during hemodialysis is unlikely.
Storage conditions
Store in a dry place at a temperature not exceeding 30 ° C.
Expiration date
3 years
Deystvuyushtee substance
Amlodipine, Valsartan
dosage form
tablets
Possible product names
EXFORGE 0.01 / 0, 16 N28 TABLE P / O
Exforge 10 mg + 160 mg No. 28 tab p / pl / o
Exforge 10/160 No. 28
Exforge 10 mg + 160 mg Tab. p / pl / rev X28
Exforge 10mg + 160mg Tab. p / pl / rev X28 /! Until 07.12g /
Novartis Farm Stein AG, Switzerland
