Viassan-LF - instructions for use, doses, side effects, contraindications

Active ingredient: sildenafil (in the form of citrate) - 50 mg or 100 mg; Excipients: microcrystalline cellulose, potato starch, magnesium stearate, milk sugar (lactose), opadrai II (talc (14.8%), macrogol (20.2%), titanium dioxide (23.85%), polyvinyl alcohol (40.0% ), lacquer aluminum based on the dye sunset yellow sunset (E110) (0.02%), aluminum dye based on indigo carmine dye (E132) (0.75%), lacquer aluminum based on dye shiny blue (E133) (0.38) %).

Description:

Round, biconvex tablets, film-coated, blue. View of the fracture core - white or almost white, the shell - blue.

Pharmacotherapeutic group:Treatment for erectile dysfunction PDE5-inhibitor

ATX: & nbsp

G.04.B.E Drugs for the treatment of erectile dysfunction

G.04.B.E.03 Sildenafil

Pharmacodynamics:

Selective inhibitor of cyclic guanosine monophosphate (cGMP) -specific phosphodiesterase-5 (PDE5), which is responsible for the disintegration of cGMP in the cavernous body of the penis. Actively enhances the relaxing effect of nitric oxide on the smooth muscles of the cavernous body and increases the blood flow in the penis. When the chain is activated NO-cGMP, observed during sexual stimulation, oppression of PDE5 leads to an increase in cGMP in the cavernous body. The pharmacological effect is achieved only with the presence of sexual stimulation. Activity with respect to PDE5 is 10-10000 times higher than that for other isoenzymes of PDE (1, 2, 3, 4, 6).

Pharmacokinetics:

Time to reach the maximum concentration in plasma (T_Сmах) after oral administration, on an empty stomach - 0.5-2 h, bioavailability - 25-60%. When taken with fatty foods C_maxdecreases by 20-40% and is achieved after 1.5-3 hours. The volume of distribution in the equilibrium state is 105 liters. The connection with plasma proteins is 96%. Metabolized mainly by action CYP3A4, CYP3A5, CYP3A7 (main path) and CYP2C9 (an additional pathway) of microsomal isoenzymes of the liver with the formation of metabolites. The main circulating active metabolite is N-dezmethylmetabolite, the activity of which is 50% of the activity of sildenafil. The total ground clearance is 41 l / h. The half-life (T1/2) sildenafil and N-dezmetilmetabolita -. 3-5 hours is derived as inactive metabolites in the feces (80%) and kidneys (15%). In patients with renal insufficiency (creatinine clearance less than 30 ml / min), cirrhosis of the liver and in elderly people, the clearance of sildenafil is reduced.

Indications:

Erectile dysfunction (organic, psychogenic, mixed).

Contraindications:

Hypersensitivity; simultaneous reception of donators of nitric oxide or nitrates in any form; severe arterial hypertension and hypotension, anamnestic indications carried in the previous 6 months, heart attack and stroke, a life-threatening arrhythmia, heart failure, unstable angina; Severe violations of liver and kidney function, hereditary retinitis pigmentosa; age to 18 years.

Patients with rare hereditary disorders such as galactose intolerance, lactase deficiency or glucose-galactose malabsorption of the drug is contraindicated.

Carefully:

With caution apply the drug in patients with heart disease,anatomical deformations of the penis, sickle-cell anemia, multiple myeloma, leukemia; increased predilection for bleeding, peptic ulcer of the stomach and duodenal ulcer in the stage of exacerbation.

Caution is prescribed to patients with arterial hypertension (blood pressure (BP) 170/110 mm Hg) and arterial hypotension (blood pressure 90/50 mm Hg). With special caution appoint patients with concomitant arterial hypertension receiving multicomponent antihypertensive pharmacotherapy.

Dosing and Administration:

Before you start taking the drug to diagnose erectile dysfunction, determine its possible causes and choose methods of treatment should consult a doctor, inform the doctor about the drugs taken.

Take inside once a day, about 1 hour before sexual intercourse. For most patients, the recommended dose is 50 mg. With regard to efficacy and tolerability, the dose can be increased to 100 mg (maximum single dose).

Side effects:

The most common headache, flush of blood to the face; rarer - digestive disorders, dizziness, nasal congestion, temporary violation of light and color perception, clear vision, hearing loss, until its complete loss.Reactions of hypersensitivity, lowering blood pressure, fainting, epistaxis, vomiting, pain and redness of the eyes, prolonged erections and / or priapism. Manifestations of side effects, as a rule, are easy or moderately expressed and persist for a short time.

Overdose:

Symptoms: sensation of fever, dizziness, redness of the face, headache, impaired vision, dyspeptic phenomena, lowering blood pressure.

Treatment: symptomatic therapy; Dialysis is ineffective.

Interaction:

Do not combine the drug with nitrate treatment (nitroglycerine and other drugs of this group), molsidomine, other donors of nitric oxide.

Strengthens the hypotensive effect of nitrates (the combination of sildenafil with nitrates can lead to death), a potentially life-threatening joint appointment with slow calcium channel blockers (BCCs), beta-adrenoblockers and oral hypoglycemic drugs.

Strengthens the antiaggregant effect of sodium nitroprusside.

Itraconazole, saquinavir, ritonavir increase the concentration of sildenafil in blood plasma, rifampicin reduces the concentration of sildenafil in blood plasma.

Cimetidine, ketoconazole, erythromycin reduce clearance and increase the concentration of sildenafil in blood plasma.

Special instructions:

The drug is not intended for use in patients under the age of 18 years.

It is not recommended to combine with other drugs to treat erectile dysfunction.

Form release / dosage:

Tablets, film-coated, 50 mg and 100 mg.

Packaging:For 2, 4 or 10 tablets in a planar cell package. One contour pack together with the instructions for use is put in a cardboard box.

Storage conditions:

In a dry, protected from light, place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years. Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-008888/09

Date of registration:05.11.2009

Expiration Date:Unlimited

The owner of the registration certificate:LEKFARM, SOOO LEKFARM, SOOO Republic of Belarus

Manufacturer: & nbsp

LEKFARM, SOOO Republic of Belarus

Representation: & nbspРомфарма ОООРомфарма ООО

Information update date: & nbsp09.01.2017

Illustrated instructions

Instructions

Viassan-LF (Viasan-LF)