Exforge, pills 5mg + 160mg, 28pcs

Composition

1 tablet contains

amlodipine 5 mg,

valsartan 160 mg,

excipients:

microcrystalline cellulose,

crospovidone,

magnesium stearate,

colloidal silicon dioxide,

hypromellose (hydroxypropylmethylcellulose),

titanium dioxide (E 171),

yellow iron oxide (E 172),

macrogol 4000 (polyethylene glycol 4000),

talc.

Pharmacological action

Exforge is a combined antihypertensive drug.

Amlodipine, a 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 to that on the background of monotherapy with each drug.

Indications

Arterial hypertension (for patients who are indicated for combination therapy).

Use during pregnancy and lactation

Exforge, like any other drug that has a direct effect on the RAAS, should not be prescribed during pregnancy and to women who want 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 about the possible risk to the fetus associated with the use of drugs that affect the RAAS.

Given the mechanism of action of angiotensin II receptor antagonists, the risk to the fetus cannot be excluded. It is known that the use of ACE inhibitors that affect the RAAS to pregnant women in the second and third trimesters leads to damage or death of the developing fetus.

According to a retrospective analysis, the use of ACE inhibitors in the first trimester of pregnancy was accompanied by the development of fetal and newborn pathology. Cases of spontaneous abortions, lack of water supply, and impaired renal function in newborns have been reported with unintentional use of valsartan in pregnant women.

It is not known whether valsartan and/or amlodipine are excreted in breast milk. Since the isolation of valsartan in breast milk has been noted in experimental studies, Exforge is not recommended to be used during lactation (breastfeeding).

Contraindications

The safety of Exforge in patients with unilateral or bilateral renal artery stenosis or stenosis of the artery of a single kidney, in patients after a recent kidney transplant, as well as in children and adolescents under 18 years of age has not been established.

Hypersensitivity to the components of the drug; pregnancy.

Side effects

Respiratory system disorders:  often-nasopharyngitis, flu; sometimes-cough, pain in the pharynx and larynx.

From the side of the senses:  rarely-visual disturbances, tinnitus; sometimes-dizziness associated with impaired function of the vestibular apparatus.

From the central nervous system and peripheral nervous system:  often – headache; sometimes-dizziness, drowsiness, orthostatic vertigo, paresthesia; rarely-anxiety.

From the cardiovascular system:  sometimes-tachycardia, palpitation, orthostatic hypotension; rarely-syncopal state, 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.

Musculoskeletal disorders:  sometimes-swelling of the joints, back pain, arthralgia; rarely-muscle spasms, a feeling of heaviness throughout the body.

From the urinary system:  rarely-pollakiuria, polyuria.

From the side of the reproductive system:  rarely-erectile dysfunction.

Other services:  often-pastyness, facial edema, peripheral edema, increased fatigue, flushes of blood to the face, asthenia, a feeling of heat.

Interaction

Amlodipine

No clinically significant interactions with thiazide diuretics, beta-blockers, ACE inhibitors, long-acting nitrates, sublingual nitroglycerin, digoxin, warfarin, atorvastatin, sildenafil, maalox (aluminum hydroxide gel, magnesium hydroxide, simethicone), cimetidine, NSAIDs, antibiotics, or oral medications were observed during amlodipine monotherapy. hypoglycemic drugs.

Valsartan

Valsartan monotherapy was found to have no clinically significant interaction with the following drugs: cimetidine, warfarin, furosemide, digoxin, atenolol, Indometacin, hydrochlorothiazide, amlodipine, glibenclamide.

When used concomitantly with dietary supplements containing potassium, potassium-sparing diuretics, potassium-containing salt substitutes, or with other drugs that may 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.

How to take, course of use and dosage

Exforge should be taken orally, with a small amount of water,1 time a day. regardless of the meal time.

The recommended daily dose of Exforge is 1 tablet in a dose of 5/160 mg.

When prescribing to elderly patients, patients with initial or moderate renal impairment (creatinine clearance>30 ml/min), with impaired liver function or with liver diseases, with cholestasis, no dosage regimen changes are required.

Overdose

Symptoms:  data on cases of overdose of the drug are currently unavailable. With an overdose of valsartan, you can expect the development of a pronounced decrease in blood pressure and dizziness.

Overdose of amlodipine can lead to excessive peripheral vasodilation and possible reflex tachycardia. Severe and prolonged systemic hypotension, up to fatal shock, has also been reported.

Treatment:  in case of accidental overdose, you should induce vomiting (if the drug was taken recently) or perform gastric lavage, prescribe activated charcoal. The use of activated charcoal in healthy volunteers immediately or 2 hours after taking amlodipine significantly reduced its absorption.

In case of clinically expressed hypotension caused by Exforge, the patient should be placed with raised legs, take active measures to maintain the activity of the cardiovascular system, including frequent monitoring of the function of the heart and respiratory system, BCC and the amount of urine released.

In the absence of contraindications, a vasoconstrictor may be used (with caution) to restore vascular tone and blood pressure. Intravenous use of calcium gluconate may be effective in eliminating calcium channel blockage. Elimination of valsartan and amlodipine during hemodialysis is unlikely.

Special instructions

Caution should be exercised when prescribing the drug to patients with severe renal impairment (CC) As well as when using other vasodilators, special care should be taken when prescribing the drug to patients with mitral or aortic stenosis, hypertrophic obstructive cardiomyopathy. Caution should be exercised when prescribing Exforge to patients with liver disease (especially obstructive biliary tract diseases). Valsartan is mainly excreted unchanged in the bile, while amlodipine is extensively metabolized in the liver.

Patients with initial and moderate renal impairment (creatinine clearance 30-50 ml/min) do not need to adjust the dose of Exforge.

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 withdrawal syndrome that occurs when treatment with beta-blockers is abruptly discontinued.

In placebo-controlled studies, patients with uncomplicated arterial hypertension experienced severe hypotension in 0.4% of cases. In patients with activated RAAS (for example, with BCC and/or sodium deficiency in patients receiving high doses of diuretics), when taking angiotensin receptor blockers, symptomatic hypotension may develop. Before starting treatment with Exforge, the body’s sodium content and/or BCC should be corrected, or therapy should be initiated under close medical supervision.

If arterial hypotension develops, the patient should be placed with raised legs, if necessary, an intravenous infusion of saline solution should be performed. After blood pressure stabilizes, treatment with Exforge can be continued.

When using the drug concomitantly with dietary supplements containing potassium, potassium-sparing diuretics, potassium-containing salt substitutes, or with other drugs that may 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.

Influence on the ability to drive motor vehicles and manage mechanisms

There are 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.

Form of production

Film-coated tablets.

Storage conditions

In a dry place, at a temperature not exceeding 30 °C

Shelf life

3 years

Active ingredient

Amlodipine, Valsartan

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as directed by your doctor

Indications

Hypertension