No-spa injections: instructions for use. No-shpa: instructions for use No-shpa Shpa injections for children

No-spa is an antispasmodic drug.

Release form and composition

No-shpu is produced in the following dosage forms:

• Tablets: biconvex, round, yellow with an orangish or greenish tint, with “spa” engraved on one side (6 or 24 pcs in polyvinyl chloride/aluminum blisters, 1 blister in a cardboard box; 20 pcs in blisters made of aluminum/aluminum (laminated with polymer), 2 blisters in a cardboard box; 60 or 100 pieces in polypropylene bottles, 1 bottle in a cardboard box);
• Solution for intravenous and intramuscular injection: greenish-yellow, transparent (2 ml in dark glass ampoules, 5 ampoules in blister plastic packages, 1 or 5 packages in a cardboard box).

1 tablet contains:

• Auxiliary components: magnesium stearate – 3 mg; talc – 4 mg; povidone – 6 mg; corn starch – 35 mg; lactose monohydrate – 52 mg.

1 ampoule (2 ml) contains:

• Active substance: drotaverine hydrochloride – 40 mg;
• Auxiliary components: sodium disulfite (sodium metabisulfite) – 2 mg; 96% ethanol – 132 mg; water for injection – up to 2 ml.

Indications for use

• Spasms of smooth muscles in diseases of the biliary tract: papillitis, cholangiolithiasis, cholecystolithiasis, cholecystitis, cholangitis, pericholecystitis;
• Spasms of smooth muscles of the urinary tract: urethrolithiasis, nephrolithiasis, pyelitis, spasms Bladder, cystitis;
• Smooth muscle spasms gastrointestinal tract: gastritis, peptic ulcer stomach and duodenum, colitis, spasms of the cardia and pylorus, enteritis, spastic colitis with irritable bowel syndrome with flatulence and constipation (simultaneously with other drugs);
• Dysmenorrhea (simultaneously with other drugs);
• Tension headaches (tablets, along with other drugs);
• The period of stretching during physiological labor in order to shorten the dilatation phase of the cervix and reduce the total duration of labor (injection solution).

Contraindications

• Severe heart failure (low cardiac output syndrome);
• Severe liver or kidney failure;
• Lactase deficiency, hereditary galactose intolerance, galactose-glucose malabsorption syndrome (tablets, due to the presence of lactose monohydrate in their composition);
• Age up to 6 years (tablets);
• Period breastfeeding(due to the lack of necessary clinical data confirming the safety and effectiveness of No-shpa for this group of patients);
• Hypersensitivity to the components of the drug.

No-shpa should be used with caution against the background of arterial hypotension, in children and during pregnancy.

When administering an injection solution intravenously, due to the risk of collapse, the patient must lie down.

Directions for use and dosage

Pills

• Adults: single dose – 1-2 tablets, frequency of administration – 2-3 times a day (maximum – 240 mg);
• Children from 12 years of age: single dose – 1-2 tablets, frequency of administration – 1-4 times a day (maximum – 160 mg);
• Children 6-12 years old: single dose – 1 tablet, frequency of administration – 1-2 times a day.

The recommended duration of taking No-shpa without consulting a doctor is usually 1-2 days. If the drug is used for auxiliary therapy, the duration of the course without medical advice can be increased to 3 days. If there is no improvement, you should consult a doctor.

If the patient can independently diagnose the symptoms of his illness, since they are well known to him, he can also evaluate the effectiveness of therapy (disappearance of pain). If, within several hours after taking No-shpa at the maximum single dose, the pain decreases moderately or does not decrease at all, or if there is no significant improvement in the condition after taking the maximum daily dose, you should consult a doctor.

Injection solution

No-shpa solution is administered intravenously or intramuscularly.

Average adult daily dose is 40-240 mg of drotaverine hydrochloride (divided into 1-3 doses) intramuscularly.

For acute stone colic (cholelithiasis and/or kidney stones), the solution is administered intravenously at a dose of 40-80 mg.

In order to shorten the dilatation phase of the cervix at the beginning of the stretching period during physiological labor, 40 mg of No-shpa is administered intramuscularly; within 2 hours, if the effect is unsatisfactory, the solution can be re-administered.

Side effects

During the use of No-shpa at any dosage form the following disorders may develop (>10% - very common; >1% and<10% – часто; >0.1% and<1% – нечасто; >0.01% and<0,1% – редко; <0,01%, включая отдельные сообщения – очень редко; с неизвестной частотой – при невозможности определить частоту развития побочных действий по имеющимся данным):

• Nervous system: rarely - dizziness, headache, insomnia;
• Digestive system: rarely - constipation, nausea;
• Cardiovascular system: rarely - palpitations, decreased blood pressure;
• Immune system: rarely - allergic reactions (in the form of angioedema, itching, urticaria, rash).

special instructions

1 tablet contains 52 mg of lactose monohydrate, which is why patients with lactose intolerance may experience problems with the digestive system. No-shpa in this dosage form should not be taken by patients with lactase deficiency, galactosemia, or galactose/glucose malabsorption syndrome.

The injection solution contains bisulfite, which can lead to the development of allergic-type reactions, including anaphylactic symptoms and bronchospasm, especially in patients with a history of asthma or allergic diseases. In case of hypersensitivity to sodium metabisulfite, parenteral use of No-shpa is not recommended.

If any adverse reactions develop while taking the drug orally, the question of the ability to drive vehicles and operate machinery requires individual consideration. If dizziness occurs after taking No-shpa, it is recommended to avoid performing potentially hazardous types of work. After parenteral, especially intravenous administration, you should refrain from working on machines and driving a vehicle for 1 hour after using the drug. 4.91 Rating: 4.9 - 22 votes

Registration number: P N011854/01-050713
Tradename: No-shpa®.
International nonproprietary name: drotaverine.
Dosage form: solution for intravenous and intramuscular administration.

Compound
One ampoule (2 ml) contains the active ingredient: drotaverine hydrochloride - 40 mg;
excipients: sodium disulfite (sodium metabisulfite) - 2.0 mg, ethanol 96% - 132.0 mg, water for injection up to 2.0 ml.

Description: transparent liquid of greenish-yellow color.

Pharmacotherapeutic group: antispasmodic.
ATX code: A03AD02.

Pharmacological properties:

Drotaverine is an isoquinoline derivative that exhibits a powerful antispasmodic effect on smooth muscle by inhibiting the enzyme phosphodiesterase (PDE). The phosphodiesterase enzyme is necessary for the hydrolysis of c-AMP to AMP. Inhibition of the phosphodiesterase enzyme leads to an increase in the concentration of c-AMP, which triggers the following cascade reaction: high concentrations of c-AMP activate c-AMP-dependent phosphorylation of myosin light chain kinase (MLCK). Phosphorylation of MLCK leads to a decrease in its affinity for the calcium (Ca2+)-calmodulin complex, resulting in an inactivated form of MLCK supporting muscle relaxation. c-AMP also affects the cytosolic concentration of Ca2+ by stimulating the transport of Ca2+ into the extracellular space and the sarcoplasmic reticulum. This C2+-lowering effect of drotaverine through c-AMP explains the antagonistic effect of drotaverine on Ca2+.
In vitro, drotaverine inhibits the PDE-4 isoenzyme, without inhibiting the PDE-3 and PDE-5 isoenzymes. Therefore, the effectiveness of drotaverine depends on the concentrations of PDE-4 in tissues, the content of which varies in different tissues. PDE-4 is most important for suppressing the contractile activity of smooth muscles, and therefore selective inhibition of PDE-4 may be useful for the treatment of hyperkinetic dyskinesias and various diseases accompanied by a spastic state of the gastrointestinal tract.
The hydrolysis of c-AMP in the myocardium and vascular smooth muscle occurs mainly with the help of the PDE-3 isoenzyme, which explains the fact that with high antispasmodic activity, drotaverine has no serious side effects on the heart and blood vessels and no pronounced effects on the cardiovascular system .
Drotaverine is effective against smooth muscle spasms of both neurogenic and muscular origin. Regardless of the type of autonomic innervation, drotaverine has a relaxing effect on the smooth muscles of the gastrointestinal tract, biliary tract, and genitourinary system.

Pharmacokinetics
Drotaverine and/or its metabolites may slightly penetrate the placental barrier.
In vitro - drotaverine has a high binding to plasma proteins (95-97%), especially with albumin, γ and β-globumin, as well as α-HDL (high density lipoprotein).
In humans, drotaverine is almost completely metabolized by O-desethylation. Its metabolites quickly conjugate with glucuronic acid. The main metabolite is 4"-desethyldrotaverine, in addition to which 6-desethyldrotaverine and 4"-desethyldrotaveraldine have been identified.
In humans, a two-chamber mathematical model was used to assess the pharmacokinetics of drotaverine. The terminal half-life of plasma radioactivity was 16 hours.
The half-life is 8-10 hours. Within 72 hours, it is almost completely eliminated from the body, more than 50% through the kidneys (mainly in the form of metabolites) and about 30% through the intestines. Unchanged drotaverine is not detected in urine.

Indications for use

Spasms of smooth muscles 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, bladder tenesmus.
As an adjuvant therapy (when the tablet form cannot be used):
- for spasms of smooth muscles of gastrointestinal origin: peptic ulcer of the stomach and duodenum, gastritis, spasms of the cardia and pylorus, enteritis, colitis
- for gynecological diseases: dysmenorrhea.

Contraindications

Hypersensitivity to the active substance or to any of the excipients of the drug.
Hypersensitivity to sodium disulfite (see section "Special instructions").
- Severe liver or kidney failure.
- Severe chronic heart failure.
- Children's age (the use of drotaverine in children has not been studied in clinical studies).
- Breastfeeding period.

Carefully:

In case of arterial hypotension (danger of collapse, see section “Special instructions”);
- In pregnant women (see section “Pregnancy and lactation”)

Pregnancy and lactation period

As shown by studies on reproductive toxicity in animals and retrospective studies of clinical data, the use of drotaverine during pregnancy had neither teratogenic nor embryotoxic effects. Despite this, when prescribing drotaverine to pregnant women, caution should be exercised and it should be used only in cases where the potential benefit to the mother outweighs the potential risk to the fetus, and the injection dosage form of the drug No-shpa® should be avoided in pregnant women. The drug should not be used during childbirth (potential risk of developing postpartum atonic hemorrhage).
Due to the lack of necessary clinical data, it is not recommended to prescribe the drug during lactation.

Directions for use and doses

Adults:
The average daily dose is 40-240 mg of drotaverine hydrochloride (divided into 1-3 doses per day) intramuscularly.
For acute colic (renal or cholelithiasis) - 40-80 mg intravenously slowly (duration of administration is approximately 30 seconds).

Side effect

Below are the adverse reactions observed in clinical studies, divided by organ system, indicating the frequency of their occurrence in accordance with the following gradations: very common (≥10%), common (≥1% and<10%); нечастые (≥0,1 и <1%); редкие (≥0,01% и <0,1%) и очень редкие, включая отдельные сообщения (<0,01%), неизвестная частота (по имеющимся данным частоту определить нельзя).
From the cardiovascular system
Rare - increased heart rate, decreased blood pressure.
From the nervous system
Rare - headache, dizziness, insomnia.
From the gastrointestinal tract
Rarely - nausea, constipation.
From the immune system
Rare - allergic reactions (angioedema, urticaria, rash, itching) (see section “Contraindications”).
Unknown frequency
Fatal and non-fatal anaphylactic shock has been reported with the use of the drug.
Local reactions
Rare - reactions at the injection site.

Overdose

Drotaverine overdose has been associated with cardiac rhythm and conduction disturbances, including complete bundle branch block and cardiac arrest, which can be fatal.
In case of overdose, patients should be under close medical supervision and should receive symptomatic therapy and treatment aimed at maintaining basic body functions.

Interaction with other drugs

With levodopa
Phosphodiesterase inhibitors like papaverine reduce the antiparkinsonian effect of levodopa. When prescribing drotaverine simultaneously with levodopa, increased rigidity and tremor may occur.
With papaverine, bendazole and other antispasmodics (including m-anticholinergics)
Drotaverine enhances the antispasmodic effect of papaverine, bendazole and other antispasmodics, including m-anticholinergics.
With tricyclic antidepressants, quinidine and procainamide
Increases hypotension caused by tricyclic antidepressants, quinidine and procainamide.
With morphine
Reduces the spasmogenic activity of morphine.
With phenobarbital
Phenobarbital enhances the antispasmodic effect of drotaverine.

special instructions
This medicine contains disulfite, which may cause allergic-type reactions, including anaphylactic symptoms and bronchospasm in sensitive individuals, especially those with a history of asthma or allergic diseases. In case of hypersensitivity to disulfite, parenteral use of the drug should be avoided (see section “Contraindications”).
When administering drotaverine intravenously in patients with low blood pressure, the patient should be in a horizontal position due to the risk of collapse.

Impact on the ability to drive a car and other mechanisms:

During the treatment period, it is necessary to refrain from driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Release form
Solution for intravenous and intramuscular administration 20 mg/ml.
2 ml in dark glass ampoules (hydrolytic class, type I) with a marked break point.
5 ampoules in a plastic blister pack without coating (pallet).
1 or 5 pallets with instructions for use in a cardboard box.

Storage conditions
Store in a place protected from light at a temperature of 15-25 ° C.
Keep out of the reach of children.

Best before date
5 years.
Do not use after the expiration date stated on the package.

Conditions for dispensing from pharmacies

Injection.

Pharmacological

Medicines used for functional gastrointestinal disorders. ATS code A0ZA D02.

Indications

Smooth muscle spasms associated with diseases of the biliary tract: cholecystolithiasis, cholangiolithiasis, cholecystitis, pericholecystitis, cholangitis, papillitis.

Smooth muscle spasms in diseases of the urinary tract: nephrolithiasis, urethrolithiasis, pyelitis, cystitis, bladder tenesmus.

As an auxiliary treatment (when the use of the drug in tablet form is not possible)

• for spasms of smooth muscles of the gastrointestinal tract: peptic ulcer of the stomach and duodenum, gastritis, cardio- and / or pylorospasm, enteritis, colitis;
• for gynecological diseases: dysmenorrhea.

Contraindications

Hypersensitivity to the active substance or to any of the components of the drug (especially sodium metabisulfite). Severe liver, kidney or heart failure (low cardiac output syndrome).

Application

Usual average daily dose for adults is 40-240 mg (for 1-3 separate injections) intramuscularly.

At acute colic in adult patients with stones in the urinary or biliary tract - 40-80 mg.

Adverse reactions

Side effects observed during clinical trials and possibly caused by drotaverine, distributed by organ and frequency of occurrence: very common (> 1/10), common (> 1/100,< 1/10), нечасто (> 1/1 000, < 1/100), единичные (> 1/10 000, < 1/1 000), очень редкие (< 1/10 000).

From the immune system.

Single - allergic reactions, including angioedema, urticaria, rash, itching, fever, chills, fever, weakness, especially in patients with hypersensitivity to metabisulfite.

The frequency is not known - there have been reports of cases of anaphylactic shock with fatal and non-fatal consequences when using the injectable form.

The drug contains metabisulfite, which may cause allergic-type reactions, including symptoms of anaphylactic shock and bronchospasm in sensitive patients, especially those with a history of asthma or allergies.

From the cardiovascular system.

Single - rapid heartbeat, arterial hypotension.

From the nervous system.

Single - headache, dizziness, insomnia.

From the gastrointestinal tract.

Single nausea, constipation, vomiting.

General disorders and reactions at the injection site: local reactions at the injection site.

Overdose

Symptoms: With a significant overdose of drotaverine, disturbances in heart rhythm and conduction have been observed, including complete block of the His bundle and cardiac arrest, which can be fatal.

In case of overdose, the patient should be under close medical supervision and receive symptomatic and supportive treatment.

Use during pregnancy or breastfeeding

Pregnancy. As shown by the results of retrospective clinical studies and animal studies, the use of the drug did not cause any signs of any direct or indirect effect on pregnancy, embryonic development, childbirth or postpartum development. However, caution should be exercised when prescribing the drug to pregnant women. Drotaverine should not be used during childbirth.

Lactation. Due to the lack of data from relevant animal studies, administration of the drug during lactation is not recommended.

Children

The drug is used for children.

Features of application

Due to the risk of collapse When administering No-shpa ® intravenously, the patient should be in a supine position.

Use with caution in case of arterial hypotension.

The drug contains metabisulfite, which may cause allergic-type reactions, including symptoms of anaphylactic shock and bronchospasm in sensitive patients, especially those with a history of asthma or allergies. In case of hypersensitivity to sodium metabisulfite, parenteral administration of the drug should be avoided.

Caution should be exercised when administering the drug parenterally to pregnant women (see Section “Use during pregnancy or lactation”).

The ability to influence reaction speed when driving a vehicle or operating machinery

It is necessary to warn patients that after parenteral, especially intravenous administration of the drug, it is recommended to refrain from driving and performing work that requires increased attention.

Interaction with other drugs and other types of interactions

Phosphodiesterase inhibitors (No-shpa ® , papaverine) reduce the antiparkinsonian effect of levodopa. No-shpa ® should be used with caution simultaneously with levodopa, since the antiparkinsonian effect of the latter decreases, and rigidity and tremor increase.

Pharmacological properties

Pharmacological. Drotaverine is an isoquinoline derivative that has an antispasmodic effect on smooth muscles by inhibiting the action of the enzyme phosphodiesterase IV (PDE IV), which leads to an increase in the concentration of cAMP and, due to the inactivation of myosin light chain kinase (MLCK), to relaxation of smooth muscles.

In vitro drotaverine inhibits the action of the enzyme PDE IV and does not affect the action of the isoenzymes phosphodiesterase III (PDE iii) and phosphodiesterase V (PDE V). PDE IV is of great functional importance in reducing the contractile activity of smooth muscles, so selective inhibitors of this enzyme may be useful in the treatment of diseases that are accompanied by hypermotility, as well as various diseases during which spasms of the gastrointestinal tract occur.

In the smooth muscle cells of the myocardium and blood vessels, cAMP is hydrolyzed mainly by the PDE III isoenzyme, therefore drotaverine is an effective antispasmodic agent that does not have significant side effects on the cardiovascular system and a strong therapeutic effect on this system.

Drotaverine is effective against smooth muscle spasms of both nervous and muscular origin. Drotaverine acts on the smooth muscles of the gastrointestinal, biliary, genitourinary and vascular systems, regardless of the type of their autonomous innervation. It increases blood circulation in tissues due to its ability to dilate blood vessels.

SANOFI SANOFI-AVENTIS Quinoine Plant Pharmaceutical. and Chemical Products, JSC Hinoin Pharmaceutical and Chemical Product Plant

Country of origin

Australia Hungary

Product group

Painkillers

Antispasmodic.

Release forms

• 100 - polypropylene bottles (1) - cardboard packs. 10 - blisters (2) - cardboard packs. 2 ml - dark glass ampoules (5) - plastic cell packaging (1) - cardboard packs. 2 ml - dark glass ampoules (5) - plastic cell packaging (5) - cardboard packs. 6 - blisters (1) - cardboard packs 60 - polypropylene bottles with a piece dispenser (1) - cardboard packs. 100 - polypropylene bottles (1) - cardboard packs. 6 - aluminum blisters (2) - cardboard packs. pack of 100 tablets, pack of 24 tablets, pack of 24 tablets, pack of 25 ampoules of 2 ml each, pack of 5 ampoules of 2 ml each, pack of 60 tablets

Description of the dosage form

• The solution for intravenous and intramuscular administration is transparent, greenish-yellow in color. solution for intravenous and intramuscular administration solution for intravenous and intramuscular administration Tablets Tablets are convex, oblong, yellow in color with a greenish or orange tint, marked “NOSPA” on one side and marked on the other side Tablets are round, biconvex, yellow with a greenish or orange tint , with "spa" marking on one side. The tablets are light yellow, interspersed with lighter and darker colors, elongated in shape, with a dividing line on both sides. Tablets Tablets

pharmachologic effect

An antispasmodic agent, an isoquinoline derivative, similar in chemical structure and pharmacological properties to papaverine, but with a stronger and longer-lasting effect. It has a powerful antispasmodic effect on smooth muscles due to inhibition of the PDE enzyme. The enzyme PDE is necessary for the hydrolysis of cAMP to AMP. Inhibition of PDE leads to an increase in cAMP concentration, which triggers the following cascade reaction: high concentrations of cAMP activate cAMP-dependent phosphorylation of myosin light chain kinase (MLCK). Phosphorylation of MLCK leads to a decrease in its affinity for the Ca2+-calmodulin complex, as a result of which the inactivated form of MLCK maintains muscle relaxation. In addition, cAMP affects the cytosolic concentration of Ca2+ ion by stimulating the transport of Ca2+ into the extracellular space and the sarcoplasmic reticulum. This lowering Ca2+ ion concentration effect of drotaverine through cAMP explains the antagonistic effect of drotaverine towards Ca2+. In vitro, drotaverine inhibits the PDE4 isoenzyme without inhibiting the PDE3 and PDE5 isoenzymes. Therefore, the effectiveness of drotaverine depends on the concentration of PDE4 in tissues (the content of PDE4 in different tissues varies). PDE4 is most important for suppressing the contractile activity of smooth muscles, and therefore selective inhibition of PDE4 may be useful for the treatment of hyperkinetic dyskinesias and various diseases accompanied by a spastic state of the gastrointestinal tract. The hydrolysis of cAMP in the myocardium and vascular smooth muscle occurs mainly with the help of the PDE3 isoenzyme, which explains the fact that with high antispasmodic activity, drotaverine has no serious side effects on the heart and blood vessels and no pronounced effects on the cardiovascular system. Drotaverine is effective against smooth muscle spasms of both neurogenic and muscular origin. Regardless of the type of autonomic innervation, drotaverine relaxes the smooth muscles of the gastrointestinal tract, biliary tract, and genitourinary system. Due to its vasodilating effect, drotaverine improves blood supply to tissues.

Pharmacokinetics

In humans, a two-chamber mathematical model was used to assess the pharmacokinetics of drotaverine. Absorption After oral administration, drotaverine is quickly and completely absorbed. After first-pass metabolism, 65% of the administered dose of drotaverine enters the systemic circulation. Cmax in blood plasma is reached after 45-60 minutes. Distribution In vitro, drotaverine is highly bound to plasma proteins (95-98%), especially albumin, beta and gamma globulins. Drotaverine is evenly distributed in tissues and penetrates smooth muscle cells. Does not penetrate the BBB. Drotaverine and/or its metabolites are able to slightly penetrate the placental barrier. Metabolism In humans, drotaverine is almost completely metabolized in the liver by O-desethylation. Its metabolites quickly conjugate with glucuronic acid. The main metabolite is 4"-desethyldrotaverine, in addition to which 6-desethyldrotaverine and 4"-desethyldrotaveraldine have been identified. Elimination T1/2 is 8-10 hours. The final T1/2 of plasma radioactivity was 16 hours. Within 72 hours, drotaverine is almost completely eliminated from the body. More than 50% of drotaverine is excreted by the kidneys and about 30% through the intestines (excretion into bile). Drotaverine is mainly excreted in the form of metabolites; unchanged drotaverine is not found in the urine.

Special conditions

The tablets contain 52 mg of lactose, as a result of which complaints from the digestive system are possible in patients with lactose intolerance. Therefore, the drug in tablet form is not prescribed to patients with lactase deficiency, galactosemia or impaired glucose/galactose absorption syndrome. The solution for intravenous and intramuscular administration contains sodium bisulfite, which can cause allergic reactions, including anaphylactic and bronchospasm, in sensitive individuals (especially in individuals with bronchial asthma or a history of allergic reactions). In case of hypersensitivity to sodium metabisulfite, parenteral use of the drug should be avoided. When administering the drug intravenously to patients with low blood pressure, the patient should be in a horizontal position due to the risk of collapse. Effect on the ability to drive vehicles and operate machinery When taken orally in therapeutic doses, drotaverine does not affect the ability to drive vehicles and perform work that requires increased concentration. If any adverse reactions occur, the issue of driving and operating machinery requires individual consideration. If dizziness occurs after taking the drug, you should avoid engaging in potentially hazardous activities, such as driving vehicles and working with machinery. After parenteral administration of the drug, it is recommended to refrain from driving vehicles and engaging in other potentially hazardous activities that require high concentration and speed of psychomotor reactions.

Compound

• drotaverine hydrochloride 40 mg Excipients: magnesium stearate - 3 mg, talc - 4 mg, povidone - 6 mg, corn starch - 35 mg, lactose monohydrate - 52 mg. drotaverine hydrochloride 20 mg Excipients: sodium metabisulfite, ethanol 96%, water for injection. Drotaverine hydrochloride 40 mg Excipients: magnesium stearate, talc, polyvidone, corn starch, lactose monohydrate. drotaverine hydrochloride 80 mg Excipients: magnesium stearate, talc, povidone, corn starch, lactose monohydrate. drotaverine hydrochloride 20 mg/40 mg - ampoule/ Excipients: sodium metabisulfite 2.0 mg, ethanol 96% 132.0 mg, water for injection up to 2.0 ml. paracetamol 500 mg drotaverine hydrochloride 40 mg codeine phosphate (in the form of hemihydrate) 8 mg Excipients: polyvidone, iron oxide yellow (E172), magnesium stearate, ascorbic acid, crospovidone, talc, corn starch, microcrystalline cellulose, pregelatinized starch

No-spa indications for use

• - spasms of smooth muscles associated with diseases of the biliary tract: cholelithiasis, cholecystitis, pericholecystitis, cholangitis, papillitis; - spasms of smooth muscles of the urinary system: urolithiasis, pyelitis, cystitis, bladder tenesmus; - during physiological childbirth - shortening the dilatation phase of the cervix and thereby reducing the total duration of labor (for solution for intravenous and intramuscular administration). As an auxiliary therapy: - for spasms of smooth muscles of the gastrointestinal tract: peptic ulcer of the stomach and duodenum, gastritis, spasms of the cardia and pylorus, enteritis, colitis, accompanied by constipation and flatulence; - tension headaches (for oral administration); - for gynecological diseases (dysmenorrhea); - strong labor pains (for solution for IV and IM administration). When used as an adjuvant, the drug is administered parenterally if it is not possible to use tablets.

No-spa contraindications

• - severe renal failure; - severe liver failure; - severe heart failure (low cardiac output syndrome); - children under 6 years of age (for tablets); - children's age (for parenteral administration, since clinical studies have not been conducted in children); - breastfeeding period (no clinical data); - rare hereditary galactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome (for tablets, due to the presence of lactose in their composition); - hypersensitivity to the components of the drug; - hypersensitivity to sodium disulfite (for solution for intravenous and intramuscular administration). Use the drug with caution in case of arterial hypotension (due to the risk of collapse), during pregnancy; in children (for tablets).

No-spa dosage

• 20 mg/ml 40 mg 80 mg

No-spa side effects

• From the central nervous system: headache, dizziness, drowsiness. From the cardiovascular system: arterial hypotension, tachycardia, hot flashes. From the digestive system: nausea, constipation; rarely (when taken in high doses and long-term use) - toxic liver damage. From the hematopoietic system: agranulocytosis, thrombocytopenia. Allergic reactions: skin rash; very rarely - bronchospasm, swelling of the nasal mucosa. When taking the drug in very high doses, death (irreversible tissue necrosis) is possible. When using the drug according to indications in recommended doses, side effects are rare.

Drug interactions

Drug interactions caused by drotaverine When No-shpalgin is used simultaneously with levodopa, drotaverine reduces its effect, which can lead to increased tremor and muscle rigidity. Drug interactions caused by paracetamol When No-shpalgin is used simultaneously with inducers of microsomal liver enzymes (salicylamide, barbiturates, antiepileptic drugs, tricyclic antidepressants, ethanol, rifampicin), an increase in the toxicity of paracetamol is observed. With the simultaneous use of No-shpalgin with chloramphenicol, the half-life of chloramphenicol is prolonged and its toxicity increases. When No-shpalgin is used simultaneously with doxorubicin, there is a risk of developing a hepatotoxic effect. Paracetamol, when used simultaneously, reduces the effectiveness of uricosuric drugs. Metoclopramide and domperidone enhance the absorption of paracetamol, and cholestyramine reduces it

Overdose

nausea, vomiting, circulatory disorders and respiratory depression are the main symptoms of a codeine overdose. The condition of a patient who has taken an excessively high dose of paracetamol may be satisfactory during the first 3 days, and only after that signs of liver damage appear.

Storage conditions

• keep away from children
• store in a place protected from light

Information provided by the State Register of Medicines.

Synonyms

• Drotaverine, No-shpa, Nosh-Bra, Spasmol, Spakovin.

pharmachologic effect

Antispasmodic myotropic action.
Reduces the tone of the smooth muscles of internal organs, reduces their motor activity, and moderately dilates blood vessels.
It is superior to papaverine in terms of severity and duration of antispasmodic action. Has no effect on the autonomic nervous system and 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 anticholinergics are contraindicated (glaucoma, prostate hypertrophy).
When administered intravenously, the effect of the drug appears within 2-4 minutes. The maximum effect develops after 30 minutes.

Pharmacokinetics

Suction
When taken orally, drotaverine hydrochloride is quickly absorbed from the gastrointestinal tract, the half-absorption period is 12 minutes. Bioavailability is about 100%. Cmax in serum is reached after 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 - 50% in urine and 30% in feces.

Indications

– prevention and treatment of functional conditions and pain syndrome caused by spasms of smooth muscles (including spasms of the gastrointestinal tract, urinary tract associated with cholelithiasis, cholecystitis, gastric ulcer, duodenal ulcer; spasm of the pyloric and cardiac part of the stomach; spastic constipation, spastic colitis; proctitis, tenesmus; postoperative colic due to gas retention; due to nephrolithiasis, pyelitis; due to instrumental interventions);
– algodismenorrhea;
– to reduce the excitability of the uterus during pregnancy; with spasm of the uterine pharynx during childbirth, prolonged opening of the pharynx, postpartum contractions, threatened abortion;
– spasms of peripheral vessels (including with endarteritis);
– prevention of smooth muscle spasm during instrumental research methods.

Instructions for use / dosage

Inside, subcutaneously and intravenously. SC or IM, adults: 40-240 mg in 1-3 doses per day; to relieve acute nephrolithiasis and/or gallstone colic: 40-80 mg IV, slowly;
other abdominal spastic pain: 40-80 mg IM or SC, if necessary, up to 3 times a day (no more), followed by switching to oral administration of 120-240 mg;
spasm of the cardia or esophagus: 80 mg IM.

Orally, adults: 120-240 mg in 2-3 divided doses. Children: from 1 to 6 years old - 40-120 mg in 2-3 divided doses, over 6 years old - 80-200 mg in 2-5 divided doses.

Side effect

Maybe: dizziness, palpitations, feeling hot, increased sweating.
At intravenous introduction There have been cases of a decrease in blood pressure (up to collapse), the development of AV blockade, the appearance of arrhythmias, and depression of the respiratory center.

Contraindications

– hypersensitivity to the drug.

Pregnancy and lactation

Use the drug No-shpa with caution during pregnancy and lactation (breastfeeding).

special instructions

Caution should be exercised when prescribing the drug to patients with severe atherosclerosis of the coronary arteries.
No-spa can be used as part of combination therapy to relieve a hypertensive crisis.
In the treatment of gastric and duodenal ulcers, No-shpu is used in combination with anticholinergics.

Overdose

To date, no cases of overdose of the drug No-shpa have been reported.

Drug interactions

With simultaneous use, No-shpa can reduce the antiparkinsonian effect of levodopa.

Storage conditions and periods

The drug should be stored in a place protected from light, in tightly closed packaging at a temperature of 15° to 25°C. Shelf life - 5 years.