Sydnopharmum
Producer: Sopharma (JSC Sofarm) Bulgaria
Code of automatic telephone exchange: C01DX12
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
Active agent: Molsidominum of 2 mg
Other ingredients: lactoses monohydrate, mannitol (Е 421), starch wheat, cellulose microcrystallic, gipromelloza, silicon dioxide colloid anhydrous, magnesium stearate, peppermint oil, yellow decline of FCF (Е 110).
Pharmacological properties:
Pharmacodynamics. Sydnopharmum has anti-anginal effect (6–12 h). Favorably influences preloading and metabolism of a myocardium therefore oxygen requirement sharply decreases. In an organism it biotransformirutsya spontaneously in an active metabolite of SIN-1A which has the expressed vazodilatiruyushchy effect, first of all on capacity (main) venous vessels. Increases diameter of subendocardial vessels, improves coronary circulation and providing a myocardium with oxygen that, in turn, increases tolerance to an exercise stress of patients with an ischemic heart disease. Molsidominum is a donor NO. It activates guanylate cyclase and increases intracellular concentration of tsGMF.
At long reception of Molsidominum to it clinically significant tolerance does not develop. It is possible to apply at intolerance of nitrates and at development of tolerance to nitrates.
Pharmacokinetics. Cmax in a blood plasma — 4,4 mkg/ml, time of achievement of Cmax — on average 1 h. Metabolism takes place intensively (it is metabolized in CYN-1/3-morfolinosidnonimin which by spontaneous biotransformation passes into pharmacological active SIN-1A); T½ is 3,5 h; it eliminirutsya in the form of metabolites (with urine for 1 days almost all quantity of SIN-1A is removed).
Indications to use:
Ischemic heart disease — for prevention of attacks of stable and unstable stenocardia (especially at patients of advanced age and at individual intolerance of nitrates). As a part of a combination therapy of chronic heart failure.
Route of administration and doses:
Sydnopharmum is applied inside in time or after food, washing down with enough liquid.
For prevention of attacks of stenocardia appoint in the 1st and 2nd day of therapy 1–2 mg (on ½–1 to a tablet) 4–6 times a day then if necessary the dose is raised to 2–4 mg by 2–3 times a day.
The dosing mode — individual also depends on a look, a stage of a disease, expressiveness of clinical symptoms. The daily dose usually makes 2–4 mg (1–2 tablets) divided into 2 uniform receptions. Sometimes it is raised to 6–8 mg (3–4 tablets) divided into 3–4 receptions.
The maximum daily dose — 12 mg.
Duration of a therapeutic course is determined by the doctor depending on the course of a disease.
Features of use:
The special attention at treatment by drug is required by patients after a hemorrhagic stroke of a brain, with disturbance of cerebral circulation and the increased intracranial pressure, with recently postponed myocardial infarction, patients with glaucoma and tendency to hypotensive reactions or in the presence of arterial hypotension.
At prolonged use of nitrates it is recommended to include in the scheme of treatment Molsidominum for the prevention of development of tolerance to nitrates.
To patients of advanced age with a functional hepatic unsufficiency or kidneys drug is appointed in lower doses.
Each dose contains up to 0,06 g of lactose of monohydrate. Drug should not be used at patients with rare hereditary forms of intolerance of a galactose, deficit of lactase of Lapp or a glyukozo-galaktozny sprue.
Starch wheat, being a part of drug, may contain gluten in insignificant quantity therefore it is considered safe for patients with a Gee's disease.
E110 dye can cause allergic reactions.
Period of pregnancy and feeding by a breast. During pregnancy (after the I trimester) carrying out the careful analysis of a ratio of advantage for mother and potential risk for a fruit is required.
During feeding by a breast use of drug is contraindicated. In case of need uses of drug during feeding by a breast for the period of treatment feeding by a breast should be stopped.
Children. Use of drug is contraindicated at children aged up to 18 years.
Ability to influence speed of response at control of vehicles or in operating time with other mechanisms. Considering side effects of drug (dizziness) and possible negative influence on concentration of attention at the persons managing vehicles or working with exact mechanisms, drug is appointed with care after careful assessment of probable risk.
Side effects:
From cardiovascular system: arterial hypotension, up to a collapse, tachycardia.
From TsNS: in an initiation of treatment — a headache, dizziness, heavy feeling in the head.
From a GIT: anorexia, nausea, vomiting.
Others: hyperemia of the person, bystry fatigue, general weakness, allergic reactions (skin rash, bronchospasm).
Interaction with other medicines:
Drug can be accepted along with blockers of β-adrenoceptors and antagonists of calcium.
Alcohol intake during treatment by Sydnopharmum is completely excluded.
At simultaneous use of Molsidominum with peripheral vazodilatator, antagonists of calcium ions, antihypertensives the hypotensive effect is exponentiated. At the combined use of Molsidominum with acetylsalicylic acid the antiagregantny effect is exponentiated.
Use of a sildenafil at treatment by Molsidominum is contraindicated. Sildenafil causes strengthening of hypotensive action of Molsidominum therefore there can be irreversible arterial hypotension and deterioration in ischemia of a myocardium.
Contraindications:
Hypersensitivity to any component of drug, heavy arterial hypotension, cardiogenic shock, glaucoma, especially closed-angle form, an acute stage of a myocardial infarction, especially with decrease in the ABP, І a pregnancy trimester, the feeding period a breast, children's age.
Overdose:
Symptoms: the severe headache, dizziness and arterial hypotension, tachycardia which are followed by nausea and vomiting; in hard cases — a collapse.
Treatment: the measures directed to bystry removal of drug from an organism (a gastric lavage, an artificial diuresis), symptomatic therapy are taken.
There are no data on efficiency of dialysis at overdose.
Storage conditions:
In original packaging (in the dry, protected from light place) at a temperature not above 25 °C.
Issue conditions:
According to the recipe
Packaging:
Tab. of 2 mg, No. 30.