Nikoshpan - instructions for use, dose, side effects, contraindications

Each tablet contains 22 mg of nicotinic acid and 78 mg of drotaverine hydrochloride as active ingredients. Excipients: polyvidone, magnesium stearate, talc, starch, lactose

Description:Pale yellow, flat pills.

Pharmacotherapeutic group:Vasodilator

ATX: & nbsp

A.03.A.D.02 Drotaverine

Pharmacodynamics:

Nicotinic acid acts in the body after conversion to nicotinamide-adenine dinucleotide (NAD⁺) or nicotinamide-adenine dinucleotide phosphate (NADP⁺), which are involved in the process of electron transfer in the respiratory chain and in tissue respiration. In high doses, it has a beneficial effect on the fat content of the blood, and in combination with other lipid-regulating drugs, is used in hyperlipidemia.

Drotaverina hydrochloride is an isoquinoline derivative that exhibits spasmolytic effect on smooth muscle, by inhibiting the enzyme phosphodiesterase IV (PDE IV). The consequence of this inhibitory action is an increase in the concentration of cAMP, which, inactivating the kinase enzyme of the light chain of myosin, leads to relaxation of the smooth muscle. It works on smooth muscles, but its effectiveness depends on different levels of PDE IV, as the PDE IV content in tissues is not the same.

Pharmacokinetics:

A nicotinic acid Quickly absorbed from the gastrointestinal tract after ingestion and widely distributed in the tissues of the body i. Penetrates in breast milk. Metabolized by conversion into N- methylnicotinamide and derivatives of 2-pyridone and 4-pyridone, nicotine-uric acid is also formed. Small amounts of nicotinic acid after taking therapeutic doses are excreted unchanged in urine.

Drotaverina hydrochloride rapidly absorbed after parenteral and after oral administration. It is highly associated with plasma proteins, especially with albumin, gamma and beta globulins, as well as with alpha (HDL) -lipoproteins.

The maximum serum concentration is reached within 4f -60 minutes after ingestion.

Metabolism of drotaverin occurs in the liver. After 72 hours after ingestion, it is almost completely removed from the body, approximately 50% - with urine and about 30% - with feces. It is derived mainly in the form of metabolites, an unchanged form of the substance in the urine is not detected.

Data on the pharmacokinetic interactions between nicotinic acid and drotaverine hydrochloride are not currently available.

Indications:

Angiospastic manifestations of atherosclerotic and hypertensive encephalopathy, cerebral angiospasm, obliterating endarteritis, coronary artery atherosclerosis, angiopasms associated with menopause, migraine.

Contraindications:

Hypersensitivity, severe hepatic, renal and cardiac failure.

Pregnancy and lactation:

According to the data of animal experiments and retrospective clinical studies of pregnant women, neither teratogenic nor embryotoxic phenomena were observed with the use of drotaverine hydrochloride.

In the absence of sufficient experimental results, during lactation the drug can be used only after a thorough weighing of the benefit / risk relationship.

Dosing and Administration:

Inside, in a daily dose of 1-3 tablets, in the case of angiospasm or migraine - on an empty stomach, in other cases - after eating.

Side effects:

Usually:

hyperemia of the face, a feeling of heat, dizziness, headache, skin rash, itching, nausea, acidity, indigestion.

Rarely:

Arterial hypotension, dizziness, heart palpitations, insomnia, constipation, fainting, loss of consciousness

Overdose:

Information is not available.

Interaction:

Reduces the effect of oral hypoglycemic agents and contraceptives. With simultaneous use of nicotinic acid with statins, the risk of myopathy or acute necrosis of skeletal muscles may increase.

With the combined use of drotaverine hydrochloride with levodopa, the antiparkinsonian effect of the latter decreases.

Special instructions:

In connection with the content of lactose in the preparation, it can cause gastrointestinal complaints in patients suffering from intolerance to lactose.

Effect on the ability to drive transp. cf. and fur:

Information is not available.

Form release / dosage:

Pills.

Packaging:50 tablets in a polypropylene vial with a polyethylene lid.

Storage conditions:

At room temperature (15-25 ° C), out of the reach of children

Shelf life:5 years.Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:P N015060 / 01-2003

Date of registration:02.06.2008

Expiration Date:Unlimited

Date of cancellation:2017-10-24

The owner of the registration certificate:HINOIN Pharmaceutical and Chemical Products Plant, ZAO HINOIN Pharmaceutical and Chemical Products Plant, ZAO Hungary

Manufacturer: & nbsp

CHINOIN Pharmaceutical and Chemical Works, Co. Ltd. Hungary

Representation: & nbspSanofi Russia, JSCSanofi Russia, JSCRussia

Information update date: & nbsp20.06.2018

Illustrated instructions

Instructions

Nikospan (Nicospan)