SPAZGAN AMPOULES 5ML

Trade name of the drug: Spazgan

Dosage Form: Solution for intravenous and intramuscular administration

Composition:

1 ml of solution contains:     

active substances:

Metamizole Sodium (Analgin) - 500 mg

Pitofenon hydrochloride - 2 mg

fenpiverinium bromide - 0.02 mg

Excipients:

water - up to 1.0 ml

Description

Transparent, colorless or light yellow liquid.

Pharmacotherapeutic group

Analgesic non-narcotic and antispasmodic.

Pharmacological properties

Spazgan - a combined drug, which consists of: non-narcotic analgesic metamizole sodium (analgin), myotropic antispasmodic Pitofenone hydrochloride and M-holinoblokiruyuschee means fenpiverinium bromide.

Metamizole It has analgesic, antipyretic and weak anti-inflammatory effects. Pitofenon, like papaverine, has a direct myotropic effect on the smooth muscles of the internal organs and causes its relaxation.Fenpiverinium bromidedue to

M-holinoblokiruyuschego action has an additional antispasmodic effect on smooth muscles.

Indications

Pain in spasms of smooth muscles of internal organs including: renal colic, hepatic colic, biliary colic, intestinal colic, biliary dyskinesia, algomenorrhea.

For short-term symptomatic treatment: arthralgia, neuralgia, myalgia, sciatica.

As an auxiliary drug: pain after surgery and diagnostic procedures.

Contraindications

- hypersensitivity to metamizole sodium and other derivatives of pyrazolone, as well as to other components of the drug;

- inhibition of bone marrow hematopoiesis;

- stable and unstable angina;

- chronic heart failure in the stage of decompensation;

- pronounced violations of the liver or kidneys;

- deficiency of glucose-6-phosphate dehydrogenase;

- tachyarrhythmias;

- acute "intermittent" porphyria;

- angle-closure glaucoma;

- prostatic hyperplasia (with clinical manifestations);

- intestinal obstruction and megacolon;

- collapse;

- pregnancy;

- lactation period;

- children's age (up to 3 months or body weight less than 5 kg).

Dosage and administration

Parenteral (intravenous, intramuscular)

Adults and adolescents over 15 years old with acute severe colic should be administered intravenously slowly in 2 ml (1 ml for 1 minute); if necessary, again after 6-8 hours. For slow intravenous administration, usually 2 ml of the preparation is sufficient.

Intramuscularly administered 2 ml of solution 2 times a day; daily dose should not exceed 4 ml.

Intramuscularly or intravenously Spazgan prescribed to children, depending on age and body weight in the following single doses:

If necessary, repeated administration of the drug in the same doses can be prescribed.

Solution is incompatible in one syringe with other medicines.

Before the injection of the injection solution should be heated in the hand.

The duration of treatment for pain syndrome should not exceed more than 5 days and it is necessary to consult a doctor if symptoms persist or worsen.

Precautions for use

Carefully and under the supervision of a physician, the drug should be used in patients with impaired liver or kidney function, with a tendency to hypotension, bronchial asthma, increased individual sensitivity to nonsteroidal anti-inflammatory drugs or non-narcotic analgesics, a complete or incomplete combination of asthma, recurrent nasal polyposis and okolonosovyh sinuses and intolerance Acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (including a history).

For children and adolescents under 18 years old, the drug should be used only as prescribed by a doctor.

Overdosage

Symptoms: vomiting, lowering blood pressure, drowsiness, confusion, nausea, epigastric pain, abnormal liver and kidney function, convulsions.

Treatment: symptomatic therapy.

Adverse Effects

At therapeutic doses, the drug is usually well tolerated. Sometimes allergic reactions (skin rash, itching, very rarely - anaphylactic shock, urticaria), angioedema are possible. In rare cases - a burning sensation in the epigastric region, dry mouth, headache.

Perhaps dizziness, lowering blood pressure, tachycardia, cyanosis. With prolonged use, hematopoietic disorders: thrombocytopenia, leukopenia, agranulocytosis (may include the following symptoms: unmotivated rise in temperature, chills, sore throat, difficulty swallowing, stomatitis, and the development of symptoms of vaginitis or proctitis). With a tendency to bronchospasm may provoke an attack.

Very rarely, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome).

Rarely (usually with long-term use or the appointment of high doses) - renal dysfunction: oliguria, anuria, proteinuria, interstitial nephritis, urine staining in red. Very rarely - a decrease in sweating, accommodation paresis, difficulty urinating.

Local reactions: intramuscular injection may cause infiltrates at the injection site.

All side effects should be reported to your doctor.

Interaction with other drugs

The simultaneous use of spazgan with other non-narcotic analgesics can lead to mutual enhancement of toxic effects.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.

Simultaneous use with cyclosporine reduces the level of the latter in the blood.

Sedatives and tranquilizers enhance the analgesic effect of metamizole sodium.

When applied simultaneously with H1 - histamine blockers, butyrophenones, phenothiazines, amantadine and quinidine may enhance the M-cholinolytic action.

When applied simultaneously with ethanol - mutual enhancement of effects.

Simultaneous use with chlorpropromazine or other phenothiazine derivatives may lead to the development of severe hyperthermia.

Radiocontrast drugs and colloidal blood substitutes should not be used during treatment with drugs containing metamizole sodium.

Metamizole sodium, displacing oral hypoglycemic drugs, indirect anticoagulants, glucocorticosteroids and Indomethacin from the association with plasma proteins , may increase the severity of their action.

Tiamazol and cytostatics increase the risk of leukopenia.

The effect of enhancing codeine, H2 - histamine blockers and propranolol (slows down the inactivation of metamizole sodium).

The injection solution is pharmaceutically incompatible with other drugs.

If necessary, the simultaneous use of these and other drugs should consult with your doctor.

Use during pregnancy and during breastfeeding

Use during pregnancy is contraindicated. The use of the drug in nursing mothers requires the cessation of breastfeeding.

special instructions

Do not use for relief of acute abdominal pain (until the cause is clarified).

During the period of drug treatment can not take alcohol; It is not recommended to drive vehicles or engage in other potentially dangerous activities that require the speed of physical and mental response.

Parenteral administration is usually used in case of emergency (renal or hepatic colic) and in cases where ingestion is not possible (or absorption from the gastrointestinal tract is impaired).

Special care is required with the introduction of 2 ml of solution and more (the risk of a sharp decrease in blood pressure). Intravenous injection should be performed slowly, in the prone position and under the control of blood pressure, heart rate and respiration rate.

With long-term (more than a week) use of the drug, control of the picture of peripheral blood and the functional state of the liver is necessary.

Storage conditions

In the dark place at a temperature not higher than 25 ° C, do not freeze.

Keep out of the reach of children!