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No-spa pills 40mg №100
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Composition
No-shpa®
Pills: 1 tab. contains Drotaverine hydrochloride 40 mg,
Excipients: Magnesium stearate, talc, polyvidone, corn starch, lactose;
20 pcs. in a blister, in a box of 1 blister or 100 pcs in polypropylene bottles, in a box of 1 bottle.
Injection: 1 vial (2 ml) contains drotaverine hydrochloride 40 mg;
Excipients: sodium metabisulfite - 2 mg, ethanol 96% - 132 mg, water for injection - up to 2 ml;
2 ml in an ampoule, in a box of 5 or 25 pcs.
1 tab. contains drotaverine hydrochloride 80 mg;
Excipients: magnesium stearate, talc, povidone, corn starch, lactose;
10 pieces. in a blister, in a box of 1 or 2 blisters.
Injection: 1 vial (4 ml) contains drotaverine hydrochloride 80 mg;
4 ml in dark glass ampoules; in the blister of 5 ampoules; in a pack of cardboard 1 or 5 blisters.
pills: round biconvex pills of yellow color, with a greenish or orange shade, on one side - marking “spa”.
No-shpa® forte pills: convex, oblong pills of yellow color with a greenish or orange shade, on one side marking “NOSPA”, on the other side - risk.
No-shpa® injection: transparent liquid greenish-yellow color.
Mechanism of action
Myotropic antispasmodic.
Lowers the tone of smooth muscles of internal organs, reduces their physical activity, moderately dilates blood vessels.
The severity and duration of antispasmodic action exceeds papaverine. It does not affect the autonomic nervous system and the central nervous system.
Due to the fact that No-spa acts directly on smooth muscles, it can be used as an antispasmodic in cases where drugs from the group of holinoblokatori (glaucoma, prostatic hypertrophy) are contraindicated.
When a / in the introduction of the drug effect is manifested in 2-4 minutes. The maximum effect develops in 30 minutes.
Suction
When ingestion of drotaverine hydrochloride is rapidly absorbed from the gastrointestinal tract, the period of semi-absorption is 12 minutes. Bioavailability is about 100%. Cmax in serum is reached in 45-60 minutes.
Distribution
Drotaverine hydrochloride does not penetrate the BBB.
Metabolism
Drotaverine hydrochloride is biotransformed in the liver.
Removal
After 72 hours, it is practically excreted from the body in the form of metabolites — by 50% with urine and by 30% with feces.
Indications and usage
Solution for in / in and in / m introduction:
- smooth muscle spasms associated with diseases of the biliary tract (cholecystolithiasis, cholangiolithiasis, cholecystitis, pericholecystitis, cholangitis, papillitis);
- spasms of smooth muscles of the urinary tract (nephrolithiasis, urethrolithiasis, pyelitis, cystitis, tenesmus of the bladder);
- during the period of stretching during physiological labor, shortening of the cervical dilatation phase and thereby reducing the total duration of labor.
As an adjunct therapy (if oral therapy is not possible):
- with spasms of smooth muscles of gastrointestinal origin (gastric ulcer and duodenal ulcer, gastritis, cardia and pylorus spasms, enteritis, colitis);
- with gynecological diseases (dysmenorrhea, strong labor pains).
Pills:
- smooth muscle spasms associated with diseases of the biliary tract (cholecystolithiasis, cholangiolithiasis, cholecystitis, pericholecystitis, cholangitis, papillitis);
- spasms of smooth muscles of the urinary tract (nephrolithiasis, urethrolithiasis, pyelitis, cystitis, tenesmus of the bladder).
As an adjuvant therapy:
- with spasms of smooth muscles of gastrointestinal origin (gastric ulcer and duodenal ulcer, gastritis, cardia and pylorus spasms, enteritis, colitis, spastic colitis with constipation and meteoric forms of mucous colitis);
- Tension-type headaches;
- with gynecological diseases (dysmenorrhea).
Contraindications
Solution for in / in and in / m introduction. Hypersensitivity to the active substance or to any of the components of the drug (especially to sodium metabisulfite), severe hepatic or renal failure, severe heart failure (low cardiac output syndrome).
With caution - with hypotension.With the on / in the introduction of Drotaverine, the patient should be in a supine position due to the danger of collapse.
Pills. Hypersensitivity to the active substance or to any of the components of the drug, severe hepatic or renal failure, severe heart failure (low cardiac output syndrome), a child under 1 year.
With caution - with hypotension.
Dosage and administration
The drug is prescribed by mouth, sc, c / m or / in.
For adults appoint 1-2 tab. 3 times / day or 2-4 ml 1-3 times / day.
For relieving renal and hepatic colic the drug is introduced into / in slowly 2-4 ml.
At peripheral vascular diseases the drug can be administered intraarterially.
Children under 6 years old prescribe the drug inside a single dose of 10-20 mg, the maximum daily dose of 120 mg;
at the age of from 6 to 12 years - 20 mg; The maximum daily dose is 200 mg.
Adverse reactions
Solution for in / in and in / m introduction - gastrointestinal disturbances (rarely - nausea, constipation); disorders of the nervous system (rarely - headache, dizziness, insomnia); cardiovascular disorders (rarely - rapid heartbeat, very rarely - hypotension); immune system disorders (very rarely - allergic reactions, especially in patients with hypersensitivity to bisulphites).
Pills - gastrointestinal disturbances (rarely - nausea, constipation); disorders of the nervous system (rarely - headache, dizziness, insomnia); cardiovascular disorders (rarely - rapid heartbeat, very rarely - hypotension).
Drug interactions
Care must be taken when combined with levodopa, as antiparkinsonic effect of the latter is reduced and there is an increase in tremor and rigidity.
Pregnancy and Breastfeeding
It is recommended only after a thorough weighing of the balance between benefits and risks. In the absence of the necessary clinical data in the period of lactation is not recommended.
After parenteral, and especially in / in the introduction is recommended to refrain from driving and work on the machines for 1 hour.
When ingested in therapeutic doses, Drotaverine does not affect the ability to drive and perform work requiring increased attention. If any side effects appear, the question of driving a vehicle and working on machine tools requires individual consideration.
Special notes
The solution for injection contains bisulfite, which can cause allergic-type reactions, including anaphylactic symptoms and bronchospasm in sensitive individuals, especially in individuals with asthma or history of allergies. In case of hypersensitivity to sodium metabisulfite, parenteral administration of the drug should be avoided (see “Contraindications”).
Tablets contain 52 mg of lactose. This may cause gastrointestinal disturbances in individuals suffering from lactose intolerance. This form is unacceptable for patients suffering from a deficiency of lactose, galactosemia, or a syndrome of impaired absorption of glucose / galactose.
Storage conditions
The preparation should be stored in a dark place, in tightly closed packaging at a temperature of from 15 ° to 25 ° C.
The drug in the form of a solution for injection is released by prescription.
The drug in the form of pills approved for use as a means of non-prescription.