Spazmol
Spazmol: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Drug interactions
- 14. Analogs
- 15. Terms and conditions of storage
- 16. Terms of dispensing from pharmacies
- 17. Reviews
- 18. Price in pharmacies
Latin name: Spasmol
ATX code: A03AD02
Active ingredient: drotaverine (Drotaverine)
Producer: JSC "Pharmstandard-Leksredstva" (Russia)
Description and photo update: 2019-08-07
Spasmol is an antispasmodic agent.
Release form and composition
- tablets: flat-cylindrical, yellow or yellow with a greenish tinge (in a cardboard box 1–3 or 5 cell contour packs containing 10, 20 or 50 tablets, or 1 tube containing 30, 50 or 100 tablets);
- solution for injection: transparent, yellow with a greenish tinge color (in a cardboard box / box 10 dark glass ampoules of 2 ml or 1, 2, 30 or 40 cell contour packs containing 5 dark glass ampoules of 2 ml).
Each pack also contains instructions for using Spazmol.
Composition of 1 tablet:
- active substance: drotaverine hydrochloride - 40 mg;
- auxiliary components: calcium stearate, stearic acid, potato starch, povidone (low molecular weight medical polyvinylpyrrolidone), lactose (milk sugar).
Composition of 1 ml solution:
- active substance: drotaverine hydrochloride - 20 mg;
- auxiliary components: sodium disulfite (sodium metabisulfite), benzethonium chloride, sodium sulfite anhydrous, disodium edetate (disodium salt of ethylenediaminetetraacetic acid), ethanol (ethyl alcohol 95%), water for injection.
Pharmacological properties
Pharmacodynamics
Drotaverine hydrochloride is a myotropic antispasmodic. Reduces the flow of calcium ions into smooth muscle cells [inhibits phosphodiesterase, promotes the accumulation of intracellular cyclic adenosine monophosphate (cAMP)]. Expands the blood vessels. Reduces intestinal peristalsis and smooth muscle tone of internal organs. Does not penetrate into the central nervous system, does not affect the autonomic nervous system.
Due to the direct effect of drotaverine on smooth muscles, Spazmol can be used as an antispasmodic in patients who are contraindicated in the use of M-anticholinergic antagonists, for example, with angle-closure glaucoma or prostatic hypertrophy.
When administered parenterally, the effect of Spazmol appears within 2–4 minutes, reaching a maximum after 30 minutes.
Pharmacokinetics
After oral administration, drotaverine is well and highly absorbed from the gastrointestinal tract. The half-absorption period is 12 minutes. Has 100% bioavailability. The maximum plasma concentration (C max) reaches within 2 hours.
After oral and parenteral administration, the drug is evenly distributed over the tissues, penetrates into smooth muscle cells. Plasma proteins bind 95–98% of the dose received. Does not penetrate the blood-brain barrier.
It is excreted mainly by the kidneys, in small quantities - with bile. The half-life (T ½) is 2.4 hours.
Indications for use
Spazmol is used for the prevention and treatment of pain syndrome and functional conditions caused by spasm of smooth muscles of internal organs. In particular, the drug is prescribed in the following cases:
- spastic colitis, chronic gastroduodenitis, postcholecystectomy syndrome, kidney stone disease, cholelithiasis, chronic cholecystitis, pylorospasm, gastric ulcer and duodenal ulcer, cardiospasm, renal colic;
- spasm of cerebral vessels and peripheral arterial vessels;
- algodismenorrhea;
- threatening miscarriage, threatening premature birth, cervical spasm during childbirth, postpartum spasms;
- instrumental research.
Contraindications
Absolute contraindications for both dosage forms:
- severe renal / hepatic / heart failure;
- arterial hypotension;
- cardiogenic shock;
- atrioventricular block II – III degree;
- hypersensitivity to any component of the drug.
Additionally for tablets:
- lactose intolerance, lactase deficiency, glucose / galactose malabsorption syndrome (due to the presence of lactose in the composition);
- lactation period;
- children under 6 years of age.
Relative contraindications (Spazmol can only be used after assessing the benefits and risks, caution is required):
- glaucoma;
- hyperplasia of the prostate;
- severe atherosclerosis of the coronary arteries;
- pregnancy, especially the first trimester;
- lactation period (for injection solution).
Spazmol, instructions for use: method and dosage
Injection
Spazmol is administered intramuscularly or subcutaneously.
Recommended doses:
- adults: 40–80 mg (2–4 ml of solution) 1–3 times a day;
- children over 6 years old: 20 mg (1 ml of solution) 1-2 times a day;
- children under 6 years of age: 10–20 mg (0.5–1 ml of solution) 1–2 times a day.
The course of treatment is 1-2 weeks. If it is necessary to continue therapy, the patient is transferred to the oral form of the drug.
In some cases, when the fastest achievement of the effect is required, slow intravenous administration of Spazmol is allowed: 2-4 ml in 10-20 ml of 0.9% sodium chloride solution or 5% dextrose solution.
Pills
Spazmol tablets are taken orally.
Recommended doses:
- adults: 40-80 mg (1-2 tablets) 2-3 times a day. If necessary, the daily dose is increased, but not more than up to 240 mg (6 tablets);
- children 6-12 years old: 20 mg (½ tablet) 1-2 times a day.
The doctor determines the duration of the course of treatment individually, depending on the indication and characteristics of the course of the disease / condition.
Side effects
Spasmol is generally well tolerated. In some cases, the following side effects occur: feeling of heat, sweating, lowering blood pressure, palpitations, insomnia, headache, dizziness, nausea, constipation. Allergic skin reactions are possible.
In the case of intravenous administration, there is a risk of developing arrhythmia, atrioventricular blockade and collapse, as well as oppression of the respiratory center.
With rapid intravenous administration, nausea and vomiting may occur.
Overdose
In excessive doses, drotaverine can disrupt atrioventricular conduction, reduce the excitability of the heart muscle, cause paralysis of the respiratory center and cardiac arrest.
special instructions
Each Spazmol tablet contains 66 mg of lactose. The drug is contraindicated in patients with lactase deficiency, lactose intolerance, glucose / galactose malabsorption syndrome, since it can cause serious disorders of the gastrointestinal tract.
Influence on the ability to drive vehicles and complex mechanisms
When taken orally, drotaverine generally does not impair the ability to concentrate and the speed of reactions. However, in the event of dizziness (one of the side effects), it is recommended to refrain from performing potentially hazardous activities.
After parenteral administration of Spazmol (especially intravenous) for 1 hour, it is not recommended to drive and perform work that requires increased attention and speed of psychomotor reactions.
Application during pregnancy and lactation
In the course of studies on animals and according to the data of clinical experience with the use of drotaverine in humans, neither teratogenic nor embryotoxic effect was revealed. Nevertheless, it is recommended to use Spazmol during pregnancy only after a careful assessment of the benefits and possible risks.
There are no necessary clinical data on the use of the drug during breastfeeding, therefore it is not recommended to take the drug in tablets during lactation, in the form of an injection solution should be used with caution
Pediatric use
Spazmol tablets are contraindicated in children under 6 years of age.
There are no age restrictions for the appointment of a solution for injection.
With impaired renal function
Spazmol is contraindicated in patients with severe renal impairment.
For violations of liver function
Spazmol is contraindicated in patients with severe hepatic impairment.
Drug interactions
Phenobarbital, when used simultaneously, enhances the spasmolytic effect of drotaverine.
In case of joint use of drotaverin:
- enhances the action of bendazole, papaverine and antispasmodics, including M-anticholinergics;
- reduces the spasmogenic property of morphine;
- enhances the decrease in blood pressure caused by procainamide, quinidine or tricyclic antidepressants;
- weakens the antiparkinsonian activity of levodopa.
Analogs
Spazmol's analogs are: Bellastezin, Bekarbon, Besalol, Veremed, Galidor, Doverin, Drotaverin, Droverin, Dyutan, Duspatalin, Meteospazmil, Mebeverin, Nikoshpan, No-shpa, Niaspam, Novitropan, Papazol, Papaveri-Spa, Spa, Spa Sparex, Spazoverin, Trigan, Enablex and others.
Terms and conditions of storage
Store at a temperature of 15-25 ° C, protected from light, out of reach of children.
Shelf life of solution for injection is 2 years, tablets - 4 years.
Terms of dispensing from pharmacies
The tablets are available without a prescription. A doctor's prescription is required to purchase an injection solution.
Reviews of Spasmol
Reviews of Spazmol are positive. Patients confirm the effectiveness of the drug in various conditions accompanied by spasm of smooth muscles. It is noted that this remedy is no less effective analogue of the advertised drug No-shpa, but it costs an order of magnitude cheaper. However, it is difficult to find it in pharmacies.
Price for Spazmol in pharmacies
The price of Spazmol is currently unknown due to the lack of the drug in pharmacies. The cost of some popular analogues:
- No-shpa, 40 mg tablets: 6 pcs. in the package - 46–63 rubles, 24 pcs. in the package - 112-142 rubles;
- Spazmonet, 40 mg tablets: 20 pcs. in the package - 65–80 rubles;
- Spazoverin, 40 mg tablets: 30 pcs. in the package - 117–130 rubles;
- Droverin, solution for injection 20 mg / ml: 10 ampoules of 2 ml in a package - 35-40 rubles.
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
