Instructions Drotaverine tablets 40mg No. 10
Composition
active ingredient: drotaverine;
1 tablet contains drotaverine hydrochloride in terms of 100% dry matter 40 mg;
Excipients: microcrystalline cellulose; potato starch; calcium stearate; colloidal anhydrous silicon dioxide; lactose, monohydrate.
Dosage form
Pills.
Main physicochemical properties: solid, regular, round cylinders, the upper and lower surfaces of which are beveled, without a dividing line, from light yellow to greenish-yellow in color, with inclusions.
Pharmacotherapeutic group
Drugs used for functional gastrointestinal disorders.
ATX code A03A D02.
Pharmacological properties
Pharmacodynamics.
Drotaverine hydrochloride is an antispasmodic that acts directly on smooth muscles. By attaching to the surface of smooth muscles, the drug changes the membrane potential and its permeability. In the implementation of the mechanism of action, inhibition of the phosphodiesterase enzyme, a sequential increase in the level of cAMP and an increase in the initial absorption of calcium by cells play a role. The antispasmodic effect of the drug equally affects the smooth muscles of the gastrointestinal, biliary, urogenital and vascular systems. Due to the vasodilator effect, the blood supply to the tissues increases.
Pharmacokinetics.
In small concentrations, it binds to albumins, α- and β-globulins of blood plasma. The maximum concentration in blood serum when administered orally is recorded at 45-60 minutes. The drug is metabolized in the liver. The biological half-life is 16-22 hours. In 72 hours, it is practically eliminated from the body, approximately 30% with urine and 50% with feces. It is mainly excreted in the form of metabolites, it is not detected in unchanged form in urine. It passes through the placenta.
Indication
For therapeutic purposes in:
- smooth muscle spasms associated with biliary tract diseases: cholecystolithiasis, cholangiolithiasis, cholecystitis, pericholecystitis, cholangitis, papillitis;
- smooth muscle spasms in diseases of the urinary tract: nephrolithiasis, urethrolithiasis, pyelitis, cystitis, bladder tenesmus.
As an adjunctive treatment for:
- spasms of smooth muscles of the digestive tract: gastric and duodenal ulcers, gastritis, cardio- and/or pylorospasm, enteritis, colitis, spastic colitis with constipation and irritable bowel syndrome accompanied by flatulence;
- tension headache;
- gynecological diseases (dysmenorrhea).
Contraindication
Hypersensitivity to drotaverine or any other component of the drug. Severe hepatic, renal or heart failure (small cardiac output syndrome).
Interaction with other medicinal products and other types of interactions
Phosphodiesterase inhibitors, such as papaverine, reduce the antiparkinsonian effect of levodopa. Caution should be exercised when Drotaverine hydrochloride is used concomitantly with levodopa, as the antiparkinsonian effect of the latter is reduced and rigidity and tremor are increased.
Application features
Use with caution in cases of arterial hypotension.
The drug contains lactose, so it should not be prescribed to patients with rare hereditary forms of galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome.
Use during pregnancy or breastfeeding
During pregnancy, the drug can be used only when the expected benefit to the mother outweighs the potential risk to the fetus.
Due to the lack of relevant research data, the use of the drug during breastfeeding is not recommended.
Fertility
There is no information on the effect on human fertility.
Ability to influence reaction speed when driving vehicles or other mechanisms
If patients experience dizziness after using the drug, they should avoid potentially dangerous activities, such as driving and performing work that requires increased attention.
Method of administration and doses
Adults: The usual average dose is 120-240 mg per day in 2-3 divided doses.
Children: The use of drotaverine in children has not been studied in clinical trials; if the use of drotaverine is necessary, then:
- for children aged 6-12 years, the maximum daily dose is 80 mg (divided into 2 doses);
- For children over 12 years of age, the maximum daily dose is 160 mg (divided into 2-4 doses).
The duration of treatment is determined by the doctor individually depending on the nature of the disease.
Children.
The efficacy and safety of the drug in children under 6 years of age have not been studied, so it is contraindicated for use in patients of this age category.
Overdose
Treatment: in case of overdose, the patient should be under close medical supervision and receive symptomatic treatment, including induction of vomiting and/or gastric lavage.
To relieve atrioventricular block, use atropine and isoprenaline intravenously, to restore heart rhythm - atropine or adrenaline intravenously with temporary cardiac pacing, in case of paralysis of the respiratory center, artificial ventilation of the lungs is performed.
Adverse reactions
On the part of the immune system: allergic reactions, including angioedema, urticaria, rash, itching, skin hyperemia, fever, chills, increased body temperature, weakness.
From the digestive tract: nausea, constipation, vomiting.
From the nervous system: headache, dizziness, insomnia.
Cardiovascular system: palpitations, hypotension, feeling of heat.
Expiration date
2 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
10 tablets in blisters;
10 tablets in a blister; 2 or 3 blisters in a cardboard pack.
Vacation category
Without a prescription.
Producer
JSC "Lubnypharm".
Location of the manufacturer and address of its place of business.
Ukraine, 37500, Poltava region, Lubny, Barvinkova st., 16.
