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Description
The instruction for medical use
of NO-SHPA medicine
the Trade name
of No-shpa
the International unlicensed
name Drotaverinum Dosage Form
of the Tablet, 40 mg
One tablet contains Structure:
active agent – Drotaverinum a hydrochloride of 40.0 mg
excipients: lactoses monohydrate, starch corn, povidone, magnesium stearate, talc.
The description
of the Tablet of round shape with a biconvex surface of yellow color with a greenish or orange shade, an engraving of spa on one party, with a diameter about 7 mm and height – about 3.4 mm.
Pharmacotherapeutic group
Drugs for treatment of functional disorders of intestines.
Papaverine and its derivatives. Drotaverinum.
The ATX A03AD02 code
the Pharmacological
Pharmacokinetics Drotaverinum properties is quickly soaked up both after peroral, and after parenteral administration. It highly contacts plasma albumine (for 95-98%), alpha and beta globulins. The maximum concentration in blood serum is reached in 45-60 minutes after oral administration.
After primary metabolism 65% of the accepted Drotaverinum dose come to a system blood stream in not changed form.
Drotaverinum is metabolized in a liver. Its biological elimination half-life makes 8-10 hours. In 72 hours, drug is almost completely removed from an organism, at the same time about 50% are removed with urine, and about 30% with a stake. Drotaverinum is removed generally in the form of metabolites, not changed drug form in urine is not found.
The pharmacodynamics
of No-shpa® represents derivative isoquinoline which has spasmolytic effect directly on smooth muscles.
The inhibition of enzyme of phosphodiesterase and the subsequent increase in the tsAMF level are determinal factors of the mechanism of effect of drug and lead to relaxation of smooth muscles by means of an inactivation of the easy chain of a kinase of myosin (ECKM).
Но-шпа® enzyme inhibits IV in vitro phosphodiesterase (FDE) without inhibition of isoenzymes of FDE III and FDE V. FDE IV plays an important role in decrease in sokratitelny ability of unstriated muscles, in this regard, the FDE IV selection inhibitors can be useful at treatment of the hyperkinetic disturbances and various diseases which are followed by spastic conditions of smooth muscles of digestive tract. The isoenzyme of FDE III hydrolyzes tsAMF in cells of smooth muscles of a myocardium and vessels, the fact that Drotaverinum is the effective antispasmodic which is not causing serious cardiovascular side effects and not possessing the significant therapeutic action on a cardiovascular system is explained by it.
The drug No-shpa® is effective at spasms of smooth muscles of both a nervous, and muscular etiology. Irrespective of type of a vegetative innervation, Drotaverinum equally affects smooth muscles of digestive tract, biliary tract, an urinogenital system and vessels. Thanks to the vasodilating action it improves blood supply of fabrics.
Its action is stronger, than at a papaverine, and absorption faster and full, it contacts serum proteins less. Advantage of Drotaverinum is that it does not possess the stimulating side effect on a respiratory system which is observed after parenteral administration of a papaverine.
Indications
– spasms of smooth muscles in diseases of biliary tract: a cholecystolithiasis, a cholangiolithiasis, cholecystitis, a pericholecystitis, a cholangitis, a papillitis
– spasms of smooth muscles of mochevyvovdyashchy ways: a nephrolithiasis, an ureterolithiasis, a pyelitis, cystitis, bladder tenesmus
as auxiliary therapy:
– at spasms of smooth muscles of digestive tract: a peptic ulcer of a stomach and duodenum, gastritis, spasms of the cardia and the gatekeeper, enteritis, colitis, a spastic colitis with a constipation and a meteorism at a syndrome of the angry intestines
– in tension headaches
– in gynecologic diseases: dysmenorrhea (painful periods)
Route of administration and doses
Adult: the usual dose makes 120-240 mg a day (divided into 2-3 receptions). Clinical trials of use of Drotaverinum for children were not conducted if prescribing of Drotaverinum is necessary:
– to children aged from 6 up to 12 years the maximum daily dose makes 80 mg in two steps,
– to children 12 years the maximum daily dose are more senior makes 160 mg in 2-4 receptions.
Use of the dosing plastic container: before use to remove a protective strip from an upper part of a bottle and a sticker from a bottle bottom.
Then to press on bottle top therefore one tablet will drop out of the dosing opening on a bottom.
Side effects
Seldom (≥1/10,000, & lt, 1/1000)
– a headache, dizziness, insomnia
– nausea, a constipation
– a cardiopalmus, hypotension
– allergic reactions (Quincke’s disease, a small tortoiseshell, rash, an itching)
of the Contraindication
– hypersensitivity to active agent or to any of drug excipients
– a heavy liver or renal failure
– heart failure (syndrome of low warm emission)
– children’s age up to 6 years
Medicinal interactions
phosphodiesterase Inhibitors, such as papaverine, reduce protivoparkinsonichesky effect of a levodopa. At their simultaneous use with a levodopa the protvoparkinsonichesky effect of the last decreases, i.e. strengthening of a tremor and rigidity is possible.
Special instructions
At the lowered arterial blood pressure the use of drug demands the increased care.
Clinical trials with participation of children were not conducted.
Tablet Но-шпы® 40 of mg contains 52 mg of lactose. Patients with seldom found diseases of hereditary intolerance of a galactose, deficiency of Lappa lactase or disturbance of absorption of glucose galactose should not take this drug.
Pregnancy
Preclinical trials did not show any signs of direct or indirect negative impact on a pregnancy course, embryonic development, childbirth or a course of a puerperal period.
Nevertheless, pregnant women can appoint drug only after careful weighing of a ratio of advantage and risk.
The lactation
Owing to lack of these clinical trials is not recommended to appoint drug during breastfeeding.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
of Patients should warn that if after administration of drug they feel dizzy, to them potentially dangerous activity, such as driving or control of other mechanisms should avoid.
Overdose
in case of overdose of the patient has to be under careful observation and receive the symptomatic and supporting treatment, including induction of vomiting and/or gastric lavage.
The form of release and packing
On 10 tablets place in blister strip packagings from aluminum foil or from a film of polyvinylchloride and aluminum foil.
On 2 planimetric packs together with the instruction for medical use in the state and Russian languages put in a pack cardboard.
Or on 24 tablets place in blister strip packagings from a film of polyvinylchloride and aluminum foil.
On 1 planimetric packing together with the instruction for medical use in the state and Russian languages put in a pack from cardboard.
Or on 60 tablets place in the dosing plastic containers, or 100 tablets place in the bottles from polypropylene corked by polyethylene traffic jams.
On bottles and containers paste labels from paper self-adhesive.
The bottle or a container together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.
The Dosing plastic container to store storage conditions at a temperature 15ºС – 25ºС, to store bottles and blister strip packagings at a temperature not above 25ºС in original packing.
To store out of children’s reach!
A period of storage
of 5 years (bottle)
3 years (the dosing plastic container and blister strip packagings).
Not to apply after an expiration date.
Prescription status
Without prescription
HINOIN Producer the plant of Pharmaceutical and Chemical Products of closed joint stock company,
Hungary
the location Address: Levai u. 5, 2112 Veresegyhaz, Hungary
the Owner of the registration certificate
sanofi-aventis closed joint stock company, Hungary
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)
of Sanofi-aventis Kazakhstan LLP
050016 Almaty, Kunayev St. 21B
phone number: 8 (727) 244-50-96
fax: 8 (727) 258-25-96
e-mail:
To develop quality.info@sanofi.com
Additional information
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