SPAZMALGON AMPOULE 2ML

Active ingredient and dosage form

injection: 1 ml contains metamizole sodium 500 mg, pitofenone hydrochloride 2 mg and
fenpiverinium bromide 20 μg;
dark glass ampoules of 2 or 5 ml, 10 ampoules per pack.

pills: 1 pill contains metamizol sodium 500 mg, pitofenone hydrochloride 5 mg and fenpiveriniya bromide 0.1 mg;
20 pcs. packaged.

Mechanism of action

Spazmalgon - spasmoangetic combined composition.
Metamizole sodium is a derivative of pyrazolone. It has analgesic, antipyretic and anti-inflammatory effect, the mechanism of which is associated with the inhibition of prostaglandin synthesis.
Pitofenone hydrochloride is a myotropic antispasmodic, has a direct effect on the smooth muscles of the internal organs and causes its relaxation.
Fenpiverinium bromide, being m-anticholinergic, has an additional relaxing effect on smooth muscles.
The combination of the three components of the drug leads to mutual enhancement of their pharmacological action.

Indications and usage

- mild or moderate pain syndrome in spasms of smooth muscles of internal organs (including kidney colic, biliary colic, intestinal colic, dysmenorrhea);
- for short-term symptomatic treatment of arthralgia, neuralgia, ischialgia, myalgia;
- pain after surgical and diagnostic interventions;
- to reduce fever in colds and other infectious and inflammatory diseases.

Contraindications

- severe impaired function of the liver and / or kidneys;
- deficiency of glucose-6-phosphate dehydrogenase;
- tachyarrhythmia;
- angle-closure glaucoma;
- benign prostatic hyperplasia with a tendency to retain urine;
- gastrointestinal obstruction and megacolon;
- diseases of the blood system;
- collaptoid states;
- I term and the last 6 weeks of pregnancy;
- lactation period (breastfeeding);
- children's age up to 3 months;
- Hypersensitivity to the components of the drug and other pyrazolone derivatives.
Tablets are not prescribed to children under 5 years of age. Injection solution is not prescribed to children under the age of 3 months or with a body weight less than 5 kg.

Dosage and administration

For adults Spasmalgon injected into the / m 2-5 ml of solution or in / in 2 ml 2-3 times / day. The maximum daily dose should not exceed 10 ml. The duration of treatment is not more than 5 days.
For children V / m and / in prescribed depending on age in the following single doses:
3-11 months. 0.1 ml, 1-4 years 0.2 ml, 5-7 years 0.4 ml, 8-11 years old 0.5 ml, 12-14 years old 0.8 ml.
If necessary, repeated administration of the drug in the same doses.

Inside, after eating, drinking water. Alltall and children over 15 - 1-2 tab. 2-3 times a day.Daily dose - not more than 6 tablets. Reception duration - no more than 5 days. An increase in the daily dose or duration of treatment is possible only under the supervision of a physician.
Children (only on doctor's prescription): 6-8 years - 1/2 tab., 9-12 years old - 3/4 tab., 13-15 years old - 1 tab. 2-3 times a day.

Allergic reactions: skin rash, itching; very rarely - anaphylactic shock.
Cardiovascular: hypotension, dizziness, tachycardia, cyanosis; in rare cases - headache.
Hemic and lymphatic: with prolonged use - thrombocytopenia, leukopenia, agranulocytosis.
Gastrointestinal: in isolated cases - a burning sensation in the epigastric region, dry mouth.
Respiratory: bronchospasm (in predisposed patients).

Pregnancy and breastfeeding

The drug is contraindicated in the first trimester and in the last 6 weeks of pregnancy.
If necessary, use spazmalgona during lactation, breastfeeding should be discontinued at the time of taking the drug.

Cautions

Carefully and under the supervision of a physician should use the drug for violations of the liver or kidneys, with a tendency to hypotension, bronchospasm, as well as in the history of allergic reactions to taking NSAIDs and antipyretic analgesics.
With prolonged (more than 1 week) use of the drug, it is necessary to monitor the pattern of peripheral blood and the functional state of the liver.

Overdosage

Symptoms: nausea, vomiting, epigastric pain.
Treatment: conduct symptomatic therapy.

Drug Interactions

With the simultaneous use of spazmalgona and other analgesics, antipyretics, mutual reinforcement of side effects is possible.
Tricyclic antidepressants, oral contraceptives, Allopurinol violate the metabolism of metamizole sodium in the liver and increase its toxicity.
Barbiturates, phenylbutazone and other inducers of microsomal liver enzymes weaken the effect of metamizole sodium.
With the simultaneous use of spasmalgona with cyclosporine, the level of the latter in the blood plasma decreases.
Sedatives and tranquilizers enhance the analgesic effect of Spasmalgone.

Storage conditions

The drug should be stored in a dry, dark place at a temperature of from 15 ° to 25 ° C.