Spazmalin injection solution 5ml, No. 5

Pain syndrome with spasms of smooth muscles of internal organs:

• renal colic;

• biliary colic;

• algodismenorrhea.

Short-term symptomatic therapy for:

• arthralgia;

• neuralgia;

• sciatica;

• myalgia.

To reduce pain after surgical and diagnostic interventions (as an adjuvant).

Spasmalin in the form of a solution is administered intravenously or intramuscularly.

For adolescents 15 years and older, as well as for adult patients, the drug is administered 2-3 times a day intramuscularly (2-5 ml) or slowly intravenously (2 ml). The maximum daily dose is 10 ml. Treatment can be carried out for no more than 5 days.

For children and adolescents aged 3 months to 15 years, Spazmalin is administered intravenously or intramuscularly in doses that are set individually and depend on the age and body weight of the child / adolescent:

• infants aged 3 to 11 months (weighing 5Ц8 kg): 0.1Ц0.2 ml intramuscularly (intravenous administration is contraindicated);

• children aged 1 to 2 years (weighing 9-15 kg): 0.2-0.3 ml intramuscularly or 0.1-0.2 ml intravenously;

• children aged 3 to 4 years (weighing 16Ц23 kg): 0.3Ц0.4 ml intramuscularly or 0.2Ц0.3 ml intravenously;

• children aged 5 to 7 years (weighing 24-30 kg): 0.4-0.5 ml intramuscularly or 0.3-0.4 ml intravenously;

• children aged 8 to 12 years (weighing 31Ц45 kg): 0.6Ц0.7 ml intramuscularly or 0.5Ц0.6 ml intravenously;

• adolescents aged 12 to 15 years: 0.8-1 ml intramuscularly or intravenously.

The injection solution must be warmed in the hand before administration. It cannot be mixed in the same syringe with other solutions for parenteral administration.

Solution for injection 1 ml

Active substance:

metamizole sodium - 500 mg

pitofenone hydrochloride - 2 mg

fenpiverinium bromide - 0.02 mg

Excipients:

citric acid monohydrate;

water for injections

Absolute:

• severe renal failure;

• severe liver failure;

• oppression of hematopoiesis in the bone marrow;

• sudden cardiovascular failure (collapse);

• severe angina pectoris;

• tachyarrhythmias (abnormally fast heart rate);

• chronic heart failure in the stage of decompensation;

• hyperplasia of the prostate (with clinical symptoms);

• megacolon; intestinal obstruction;

• angle-closure glaucoma;

• deficiency of the enzyme glucose-6-phosphate dehydrogenase;

• children under 8 years of age (for tablets);

• infancy up to 1 year old or body weight of a child over 1 year old up to 9 kg (for intravenous administration);

• infancy up to 3 months or the body weight of an infant up to 5 kg (for intramuscular administration);

• period of pregnancy (first trimester and last six weeks);

• lactation period;

• increased individual sensitivity to the components of the drug and to pyrazolone derivatives.

Relative (Spazmalin is used with caution):

Renal and / or hepatic insufficiency of mild and moderate severity;

Ј Tendency to low blood pressure;

Ј bronchial asthma;

Ј Increased individual sensitivity to non-steroidal anti-inflammatory drugs;

Incomplete or complete combination of nasal polyposis, bronchial asthma and hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.

Trade name: Spazmalin

Ingredients :

Solution for injection 1 ml

Active substance:

metamizole sodium - 500 mg

pitofenone hydrochloride - 2 mg

fenpiverinium bromide - 0.02 mg

Excipients:

citric acid monohydrate;

water for injections

Pharmacodynamics and pharmacokinetics

Spazmalin is a combined drug, which includes: a non-narcotic analgesic metamizole sodium, a myotropic antispasmodic agent pitofenone and an m-anticholinergic agent fenpiverinium bromide.
Metamizole sodium, a pyrazolone derivative, has analgesic, antipyretic and mild anti-inflammatory effects. Pitofenone, like papaverine, has a direct myotropic effect on the smooth muscles of the internal organs and causes its relaxation. Fenpiverinium bromide, due to its m-anticholinergic action, has an additional myotropic effect on smooth muscles.

Pharmacokinetics

• Metamizole sodium: well and quickly absorbed in the gastrointestinal tract. In the intestinal wall, it is hydrolyzed to form an active metabolite - unchanged sodium metamizole is absent in the blood. The connection of the active metabolite with proteins is 50-60%.

• It is metabolized in the liver, excreted by the kidneys. In therapeutic doses, it passes into breast milk.
  Pitofenone is rapidly absorbed in the gastrointestinal tract; the maximum plasma concentration is reached within 30-60 minutes; quickly distributed in organs and tissues and quickly excreted in the urine.

• The half-life is 1.8 hours.
  Fenpiverinium bromide is also rapidly absorbed from the gastrointestinal tract and reaches its maximum plasma concentration within 1 hour. It is excreted by the kidneys 32.4-40.4% unchanged, 2.5-5.3% of the substance is excreted with bile.

Indications

Pain syndrome with spasms of smooth muscles of internal organs:

• renal colic;

• biliary colic;

• algodismenorrhea.

Short-term symptomatic therapy for:

• arthralgia;

• neuralgia;

• sciatica;

• myalgia.

To reduce pain after surgical and diagnostic interventions (as an adjuvant).

Method of administration and dosage:

Spasmalin in the form of a solution is administered intravenously or intramuscularly.

For adolescents 15 years and older, as well as for adult patients, the drug is administered 2-3 times a day intramuscularly (2-5 ml) or slowly intravenously (2 ml). The maximum daily dose is 10 ml. Treatment can be carried out for no more than 5 days.

For children and adolescents aged 3 months to 15 years, Spazmalin is administered intravenously or intramuscularly in doses that are set individually and depend on the age and body weight of the child / adolescent:

• infants aged 3 to 11 months (weighing 5Ц8 kg): 0.1Ц0.2 ml intramuscularly (intravenous administration is contraindicated);

• children aged 1 to 2 years (weighing 9-15 kg): 0.2-0.3 ml intramuscularly or 0.1-0.2 ml intravenously;

• children aged 3 to 4 years (weighing 16Ц23 kg): 0.3Ц0.4 ml intramuscularly or 0.2Ц0.3 ml intravenously;

• children aged 5 to 7 years (weighing 24-30 kg): 0.4-0.5 ml intramuscularly or 0.3-0.4 ml intravenously;

• children aged 8 to 12 years (weighing 31Ц45 kg): 0.6Ц0.7 ml intramuscularly or 0.5Ц0.6 ml intravenously;

• adolescents aged 12 to 15 years: 0.8-1 ml intramuscularly or intravenously.

The injection solution must be warmed in the hand before administration. It cannot be mixed in the same syringe with other solutions for parenteral administration.

Contraindications

Absolute:

• severe renal failure;

• severe liver failure;

• oppression of hematopoiesis in the bone marrow;

• sudden cardiovascular failure (collapse);

• severe angina pectoris;

• tachyarrhythmias (abnormally fast heart rate);

• chronic heart failure in the stage of decompensation;

• hyperplasia of the prostate (with clinical symptoms);

• megacolon; intestinal obstruction;

• angle-closure glaucoma;

• deficiency of the enzyme glucose-6-phosphate dehydrogenase;

• children under 8 years of age (for tablets);

• infancy up to 1 year old or body weight of a child over 1 year old up to 9 kg (for intravenous administration);

• infancy up to 3 months or the body weight of an infant up to 5 kg (for intramuscular administration);

• period of pregnancy (first trimester and last six weeks);

• lactation period;

• increased individual sensitivity to the components of the drug and to pyrazolone derivatives.

Relative (Spazmalin is used with caution):

Renal and / or hepatic insufficiency of mild and moderate severity;

Ј Tendency to low blood pressure;

Ј bronchial asthma;

Ј Increased individual sensitivity to non-steroidal anti-inflammatory drugs;

Incomplete or complete combination of nasal polyposis, bronchial asthma and hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.

Side effects

• cardiovascular system: drop in blood pressure;

• urinary system: lack of urine flow into the bladder, urine staining red, a decrease in the amount of urine excreted by the kidneys, proteinuria, impaired renal function, interstitial nephritis;

• hematopoietic system: a decrease in the number of leukocytes and platelets, agranulocytosis (manifested by a sore throat, stomatitis, difficulty swallowing, chills, an unmotivated rise in temperature, the development of symptoms of proctitis or vaginitis);

• allergic reactions: Quincke's edema, urticaria (including on the mucous membrane of the nasopharynx and conjunctiva); rarely - toxic epidermal necrolysis, anaphylactic shock, malignant exudative erythema, bronchospastic syndrome;

• anticholinergic side effects: tachycardia, dry mouth, accommodation paresis, stranguria (difficulty urinating), decreased sweating;

• local reactions (with intramuscular injection): infiltrates at the injection site.

Overdose

Symptoms: vomiting, decreased blood pressure, drowsiness, confusion, nausea, pain in the epigastric region, impaired liver and kidney function, convulsions.

Treatment: gastric lavage, the appointment of activated carbon; if necessary, symptomatic therapy is carried out.

Drug interactions

The simultaneous use of Spazmalin with other non-opioid analgesics can lead to a mutual enhancement of the effects.

With the simultaneous use of tricyclic antidepressants, oral contraceptives, allopurinol disrupt the metabolism of metamizole sodium in the liver and increase its toxicity.

With the simultaneous use of barbiturates, phenylbutazone and other inducers of microsomal liver enzymes weaken the effect of sodium metamizole.

With the simultaneous use of Spazmalin reduces the concentration of cyclosporine in the blood plasma.

ѕри одновременном применении седативные средства и транквилизаторы усиливают анальгезирующее действие —пазмалина.

ѕри одновременном применении с блокаторами гистаминовых Ќ1-рецепторов, бутирофенонами, фенотиазинами, амантадином и хинидином возможно усиление м-холинолитического действи¤ препаратов.

ѕри одновременном применении с этанолом возможно взаимное усиление эффектов.

ќсобые указани¤

ѕри подозрении на агранулоцитоз или при наличии тромбоцитопении необходимо прекратить прием препарата.

ѕри длительном (более недели) применении —пазмалина необходим контроль картины периферической крови и функционального состо¤ни¤ печени.

¬ период применени¤ препарата нельз¤ употребл¤ть алкоголь.

¬ли¤ние на способность к вождению автотранспорта и управлению механизмами

During the period of use of the drug, you should not engage in potentially hazardous activities that require increased attention.

Pregnancy and lactation

The drug is contraindicated for use in the first trimester and in the last 6 weeks of pregnancy. If necessary, the appointment of the drug during lactation should stop breastfeeding.

Childhood use

The drug is contraindicated in children under 3 months of age (or body weight less than 5 kg).

The question of prescribing the drug to children and adolescents under 15 years old should be decided individually.

Storage conditions

In a dark place at a temperature not exceeding 30 ? C.

Keep out of the reach of children.

Shelf life

3 years.

Conditions of dispensing from pharmacies

The drug in the form of a solution for intravenous and intramuscular administration is dispensed by prescription.