Drotaverinum. Instructions for use. Tablets, ampoules, injections intramuscularly, composition, indications, dosage, children, women during pregnancy, breastfeeding. analogs

Drotaverine (Drotaverine) - medicament having spasmolytic, miotropnym, vasodilating, hypotensive action assigned for removal, reduction or tone relief of spasm of smooth muscle of various internal organs origin. Before the start of the application is necessary to study the instructions for use.

General description of the preparation

Drotaverine relates to miotropnym antispasmodics from the group isoquinoline. According to the therapeutic action and chemical structure similar to papaverine, but the effect of it more durable and strong.

Release forms and prices

The drug is available in tablets for oral administration in the form of a solution for administration under the skin, in muscle or vein.

Tablets round, Valium (except for the manufacture of tablets of PJSC "Biosynthesis" they lenticular), yellow color with greenish highlights. They have a chamfer. In tablets JSC "ALSI Pharma", JSC "Tatkhimpharmpreparaty" Company "Ozone" is the risk.

On the production of tablets of CJSC "Upgrading PFC" has the letter «R» on one side. The tablets produced by JSC "Tatkhimpharmpreparaty" JV "Lekpharm" is supposed Valium.

A solution for injection is a clear, yellowish green liquid.

The cost of the drug is dependent on the manufacturer, release forms, the trading margin specific pharmacy. Price vials 30 rub., The tablets starts at 80 rubles.

The chemical composition, the active ingredient

Drotaverine produced by several companies, so the additional composition components may vary slightly. Each tablet contains a therapeutic component 40 mg Drotaverine hydrochloride. In addition to his part of the drug manufactured by JSC "ALSI Pharma", JSC "Veropharm", JSC "pharm", JSC "Synthesis" includes shaping components.

They are as follows:

• potato starch;
• lactose;
• E553b;
• E 1201;
• E 572.

Tablets, produced by JSC "Borisov Medical Preparations Plant" contains the following excipients:

• E 570;
• potato starch;
• E 553b;
• lactose.

The composition of the tablets of "Organics", JSC "Europharm" includes the following formative components:

• lactose;
• potato starch;
• E 1201;
• E 572;
• E 553b;
• E 1202.

produced by "Ozone" tablets contain the following inactive ingredients:

• lactose;
• MCC;
• corn starch;
• E 572;
• E 1201;
• £ 468.

As indifferent components of the tablets from JV "Lekpharm" includes:

• potato starch;
• E 572;
• lactose;
• E 553b.

Tablets of PJSC "Biosynthesis" formative contain the following incidents:

• lactose;
• sodium carboxymethyl starch;
• E 572;
• potato starch.

B contains 20 mg of drotaverine hydrochloride as a therapeutic agent in 1 ml of solution for injection.

Besides him in the production of "Novosybchempharm" solution, CJSC "Vifiteh", JSC "Biomed them. II Mechnikov "includes inactive ingredients:

• ethanol;
• water for injections;
• E223.

The solution produced by FSUE "Armavirskaya biological factory", of "Biochemist" of "Dalkhimpharm" contains additional ingredients.

They are as follows:

• Trilon B;
• ethanol;
• E 223;
• benzethonium chloride;
• water;
• E330;
• sodium sulfate;
• £ 331.

A solution of "Borisov Plant of Medical Preparations" contains the following inactive ingredients:

• sodium sulfate;
• E 262;
• ethanol;
• E 260;
• water.

Pharmacological action mechanism

Drotaverine blocks phosphodiesterase-4, which is necessary for the formation of AMP from cAMP resulting accumulates intracellular cyclic AMP and reduced migration of Ca ions into smooth muscle cells.

It proved that drotaverine blocks PDE4, the enzyme does not inhibit PDE 3 PDEI-5. Most PDE-4 is located in the digestive tract, the uterus, urinary and biliary tract. Disintegration of cAMP in smooth muscle of the myocardium and blood vessels associated with PDE-3, however medicament weaker effect on the cardiovascular system.

The medicament reduces the tonus of smooth muscle tissue of internal organs and intestinal motility, it relaxes the walls of blood vessels and increases clearance therebetween.

Antispasmodic does not migrate into the central nervous system and does not affect the visceral nervous system.

Due to the direct effect on the smooth muscles of the drug can be used for relief of spasms pathologies prohibited when atropinopodobnye means (high intraocular pressure, adenoma prostate). The drug relieves smooth muscle spasm and muscle neurogenic etiology.

The speed and duration

After oral administration, the medicament is rapidly absorbed. When using injection drotaverine action starts after a maximum of 4 minutes after the injection, reaching a peak after half an hour. After oral administration, the maximum concentration of active ingredient is achieved after one hour.

The bioavailability of the drug, regardless of the form of release is 100%. Up to 98% of drunk dosage associated with proteins from binding with which the drug is released gradually, which explains the prolonged effect of the drug.

The active substance does not migrate through the blood-brain barrier, crosses the placenta. Passing through the liver, the drug is metabolized. Half-life may vary from 8 to 10 hours. Within 3 days almost completely evacuated from the body, primarily via the kidney.

Indications

Drotaverinum, according to the instructions can be used in smooth muscle spasms caused by the following pathologies of the biliary system:

• stones in the gall bladder and ducts;
• inflammation of the gallbladder;
• inflammation of the peritoneum, gall bladder coating or connective tissue that separates it liver;
• angiocholitis;
  
• papillitis (enlargement and inflammation of anal papillae).

Drotaverinum in injections and pills prescribed for relief of urinary tract spasms:

• spasms and inflammation of the bladder;
• Stones in the kidney and urethra;
• inflammation of the mucous membrane of the renal pelvis.

Tablets can be used as an aid in smooth muscle spasms provoked pathologies (ampoules are also permitted in these diseases, but only if the patient can not take medication inside).

They are as follows:

• stomach ulcers and 12 duodenal ulcer;
  
• spasm of the sphincter of the stomach;
• inflammation of the small intestine and colon.

Drotaverinum tablets to eliminate spasms, as an additional tool can be used in the following pathologies:

• spastic colitis, accompanied by a delay chair;
• irritable bowel syndrome, in which there is flatulence and bloating;
• tension headache.

Tablets are used for holding a series of instrumental studies, x-ray of the gallbladder.

Drotaverinum in pediatrics

In pediatric practice medicine is used in the same cases as in adults. At what age to take the pills in pediatrics is necessary to specify in the statement.

Because it can vary significantly depending on the manufacturer:

• with 3 s possible to use a tablet manufactured by JSC "ALSI Pharma", JSC "Tatkhimpharmpreparaty", JSC "Upgrading PFC", JSC "Valentine Pharmaceuticals", JSC "Organica";
• with 6 s permissible to take pills manufactured by JSC "Moshimfarmpreparaty them. N. BUT. Semashko ", JSC" Veropharm ", LLC" Atoll ", JSC" pharm ";
• with 12 s allowed to drink tablets, manufactured by PJSC "Biosynthesis";
• with 18 s possible to drink tablets manufactured by JSC "Europharm", JSC "Synthesis".

At what age can use an injection is necessary to specify in the instructions, as Drotaverinum discharged most manufacturers is contraindicated in persons younger than 18 years, except for ZAO "Vifiteh" medicines and JSC "Biomed them. AND. AND. Mechnikov, "which allowed since birth.

Use of the drug in the obstetric practice

Drotaverinum can be taken in obstetrics and gynecology, if there is:

• the threat of spontaneous abortion;
• threat of premature birth;
• painful menstruation;

  

• afterpains.

Instructions for use of tablets

Drink tablets at any time of day without regard to meals. In the presence of risks they can share. The duration of therapy is determined by the individual doctor.

Dosage tablets for adults

In tablets, the recommended medicament dose disposable drink 40-80 mg. Multiplicity reception can vary from 2 to 3 times a day. The highest single dose not exceed 80 mg, and day - 240 mg.

Dosage tablets for kids

The treatment regimen in pediatric patients depends on the age of the child:

• preschool children 3-6 years of drug prescribed in a single dose of 20 mg, the highest daily dosage is 120 mg;
• 6-12 patients are discharged medicament 40 mg on reception, the daily dosage should not exceed 200 mg.

Giving medication to children aged 3 to 12 years can be from 2 to 5 times a day. For the treatment of patients using the dosage for adults older than 12 years.

Instructions for use vials

Before injections Drotaverinum, you need to specify the method of administration to instructions, as depending on the manufacturer, it may be different.

For example:

• Medicines manufactured by JSC "Biomed them. AND. AND. Mechnikov ", JSC" Vifiteh "can be administered subcutaneously, intramuscularly and intravenously.
• Preparations of other companies can not be injected under the skin.

Drotaverinum in the injections can be administered for 7-14 days, if you want a long-term treatment, it is necessary to switch to oral forms of the drug.

Typically, the medicament is administered intramuscularly or subcutaneously, or, only when a strong colics caused by stones kidney or gall medicament is administered intravenously, its pre-diluted in saline or 5% solution glucose. The vein Drotaverine introduced slowly over about 30 seconds at this time the patient must lie.

You can not mix with the solution Drotaverinum eufillin.

Dosages solution for adults

In a muscle or under the skin of the medicament is administered in a single dose of 40 mg or 80, as contained in the 2.4 ml solution. Multiplicity of administration may vary from 1 to 3 times a day. Intravenously injected 4 mL of the medicament, its pre-diluted in 10-20 ml of saline or 5% dextrose solution.

Dosing for children solution

Children who do not have 6 years of drug prescribed in a single dose of 10 mg or 20 mg, in patients older than 6 years, the drug is prescribed in a single dose of 20 mg. Enter Drotaverinum can be 1 or 2 times a day.

Application Drotaverinum during pregnancy and breast-feeding

According to indications, where the benefits to the woman than the potential harm to the child, Drotaverinum can be used during gestation. Because of the possibility of opening atonic postpartum hemorrhage medication can not be used directly during childbirth.

In other cases, the period of gestation Drotaverinum administered in the same dosage as for the treatment of other categories of patients.

The drug is not compatible with breast-feeding, so women, supporting breastfeeding feeding, or need to transfer the baby to the mix, or to find another drug, hung during lactation.

Precautionary measures

Precautions need to prescribe medication if the patient revealed:

• BPH;
  
• low pressure;
• severe atherosclerosis of the coronary arteries;
• period of gestation of the child;
• closure glaucoma.

The therapy has to be careful in the management of motor vehicle and work with potentially dangerous mechanisms, since the drug may cause dizziness, drop in blood pressure. Especially it is not recommended to drive an hour after injection of the medicament into the vein.

Contraindications

Drotaverinum, according to the instructions for use is contraindicated if there is:

• intolerance to the drug composition;
• severe liver disease and kidney.

Tablets are contraindicated if there is:

• lack of lactase;
• intolerance to milk sugar;
• malabsorption of monosaccharides.

You can not apply the product if you experience the following pathologies:

• severe chronic heart failure;
• atrio-gastric blockade step 2 and 3;
• cardiogenic shock.

Adverse reactions

Drotaverinum, according to the instructions for use, can cause the following complications and adverse reactions:

• headache;
• sleep disturbance;
• vertigo;
• palpitations;
• drop in blood pressure;
• allergy, manifested by angioedema, pruritus, rash, urticaria;
• delayed stool;
• heat sensation;
• increased sweating;
• nausea.

the drug can cause collapse when administered intravenously.

Overdose

When exceeding the recommended doses, the medication can cause a number of adverse effects:

• conduction and impaired heart rhythm;
• drop in blood pressure;
• heart failure, which can result in death of the victim;
• respiratory depression.

In case of overdose, the person should be under constant medical supervision. A specific antidote is not known, so the prescribed symptomatic treatment. If overdose is caused by taking medication in tablets, it is carried out gastric lavage and cause vomiting.

drug interactions

When treating Drotaverinum need to consider the following:

• in combination with levodopa, it weakens the antiparkinsonian action of the latter, which manifests increased rigidity and tremor of the individual parts of the body.
• when one-stage appointment with morphine reduces its spasmogenic activity;
• the appointment with other antispasmodics, including atropine means there is mutual reinforcement antispasmodic effect;
• strongly reduces blood pressure, provoked tricyclics, quinidine and procainamide;
• phenobarbital enhances antispasmodic effect on Drotaverinum.

analogs

Full structural analogs Drotaverinum contain the same active ingredient:

1. Nospanum - Hungarian medicament manufactured in tablets and in the form of solution which may be administered in vein, and muscle. The vials are allowed only to adult drug. Tablets may be children from 6 years. Nospanum in injections is not recommended to prescribe to women in the state. The shelf life of the drug - 5 years.
   
2. Doverin - domestic drug production Aveksima Siberia. The medicine is available in tablets of 40 mg. Doverin allowed patients 18 years of age.
3. Plait Spa - Indian medicine marketed tablets at a dosage of 40 mg. It is approved for the treatment of patients who are 12 years old.
4. Spazmol - domestic medication that is available in tablets and capsules. The drug can be used in patients under the age of 6 years. Precautions medicament can be applied in the first 3 months of pregnancy and women supporting breastfeeding. Spazmol can be used to mitigate the contraction of the myometrium and eliminate cervical spasms during labor.

In addition to structural analogs are antispasmodics:

1. Spareks. Antispasmodic available in capsules, therapeutic effect of which is explained mebeverine. Medication prescribed for persons who are 18 years old at spasms of the digestive tract, biliary and intestinal colic, irritable bowel syndrome. Children older than 12 years, the drug can be used in functional disorders of the digestive tract if they are accompanied by pain.
2. Papaverine. Myotropic antispasmodic discharged in suppositories inserted into the anus, tablets, injections for subcutaneous, intravenous, intramuscular. The medicament prescribed for abdominal spasms, peripheral and cerebral blood vessels, the urinary tract. Papaverine can be used as an adjuvant for sedation. Antispasmodic on the testimony allowed women to bear a child or breastfeeding. The injections can prescribe medication babies older than 6 months.
   
3. Dibazol. The drug is available in several domestic companies in tablets and injections. It being prescribed at elevated pressure, for relief of hypertensive crisis, muscular spasms tissue of internal organs, residual effects of Bell's palsy and polio.

Conditions, the shelf life

Regardless of the dosage form, the medication should be kept in a dry, dark place, away from children. Temperature storage varies depending on the manufacturer's.

manufacturing tablets ZAO "EuroPharm" should be stored at temperatures up to 20 C °, preparations from other manufacturers do not deteriorate at temperatures up to 25 C °.

Shelf life depending on the manufacturer may differ significantly:

• Ampoule production Farmzaschita FSUE SPC - 12 months.
• Ampoules of "Biomed them. I.I Mechnikov ", JSC" Vifiteh "- 24 months.
• Ampoules of "Ozone" - 36 months.
• Tablets of OJSC "Veropharm" JV "Lekpharm" - 24 months
• CJSC "Europharm" Tablets of "Ozone" - 36 months.
• Tablets of "Irbitsky CPP" - 48 months.

Drotaverinum relates to potent drugs, so doctors do not recommend to use it without an appointment. In addition to compliance with instructions for use, before starting therapy is necessary to obtain a final medical report rate and the receiving circuit.

Author of the article: Huseynov Natalia

Registration of the article: Lozinski Oleg

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