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, a derivative of dihydropyridine, 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 on the background of monotherapy with each drug.
Contraindications
Hypersensitivity to the components of the drug pregnancy.
The safety of Exforge is not established in patients with unilateral or bilateral renal artery stenosis or artery stenosis of a single kidney, in patients after recent kidney transplantation, as well as in children and adolescents under 18 years of age.
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 in pregnant women 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 necessary, cancel beta-blockers before starting Exforge therapy the dose of beta-blockers should be reduced gradually.As amlodipine is not a beta-blocker, the use of Ek Forge does not prevent the development of withdrawal syndrome, which occurs when a dramatic treatment of beta-blockers.
In placebo-controlled trials in patients with uncomplicated hypertension in 0.4% of cases there was severe hypotension. In patients with an activated RAAS (eg, with a deficiency of bcc and / or sodium in patients receiving high doses of diuretics), when taking angiotensin receptor blockers, the development of symptomatic arterial hypotension is possible. 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.
With the simultaneous use of 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), care should be taken and regular monitoring of the concentration of potassium in the blood should be carried out.
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 5 mg, valsartan 160 mg,
excipients: microcrystalline cellulose, crospovidone, magnesium stearate, colloidal silicon dioxide, hypromellose (hydroxypropylmethyl cellulose), titanium dioxide 2 (yellow) iron1 (yellow) 17 (17) 4000 (polyethylene glycol 4000), talc.
Dosage and administration
Exforge should be taken orally with a small amount of water, 1 time per day. regardless of the meal time.
Recommended daily dose of Exforge – 1 tablet in a dose of 5/160 mg.
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.
From the cardiovascular system: sometimes – tachycardia, palpitations, orthostatic hypotension, rarely – syncope, a marked decrease 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 interaction
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 hydroxyhydromine hydroxyhydramine, varixomid hydroxide, hydroxyhydroxide hydroxyhydroxide, aluminum hydroxide, hydroxycarboxylic acid magnesium, simethicone), cimetidine, NSAIDs, antibiotics, and oral hypoglycemic drugs.
Valsartan
It has been established that monotherapy with valsartan has no clinically significant interaction with the following drugs: cimetidine, warfarin, furosemide, digoxin, atenolol, indomethacin, hydrochlorothiazide, amlodipine, glibenclamide.
When used concurrently 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), care should be taken and frequent monitoring of the concentration of potassium in the blood should be carried out.
overdose Symptoms: There are currently no data on overdose. 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: if you accidentally overdose, you should induce vomiting (if the drug was recently taken) or wash your 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.
Shelf life
2 years.
Deystvuyushtee substance
Amlodipine, Valsartan
Prescription terms
Prescription
dosage form
tablets
Possible product names
EXFORGE 0.005 / 0.16 N28 TABLE P / O
Exforge 5 mg + 160 mg No. 28 tab p / pl / o
Exforge 5 mg + 160 mg Tab. p / pl / rev X28
Exforge 5mg + 160mg No. 28 tab
EXFORGE 5MG / 160MG. No. 28 TAB. P / O
Novartis Farm Stein AG, Switzerland
