Spazgan

General characteristics. Structure:

Active ingredients: 500 mg of metamizole sodium (analginum), 2 mg of a pitofenon of a hydrochloride, 0,02 mg bromide fenpiveriniya.

Excipients: water for injections.

Pharmacological properties:

Pharmacodynamics. Spazgan - the combined drug which part are: non-narcotic analgesic metamizole sodium (analginum), myotropic antispasmodic of a pitofenon hydrochloride and M-holinoblokiruyushchee means fenpiveriniya bromide.

Metamizol possesses soothing, febrifugal and weak antiinflammatory action. Pitofenon, like a papaverine, has direct myotropic effect on smooth muscles  of internals and causes its relaxation. 

Fenpiveriniya bromide  at the expense of M-holinoblokiruyushchego actions has additional spasmolytic effect concerning smooth muscles.

Indications to use:

Pain syndrome at spasms of smooth muscles of internals including: renal colic, hepatic colic, bilious colic, intestinal colic, dyskinesia of biliary tract, альгодисменорея.

For a short-term symptomatic treatment: arthralgia, neuralgia, mialgiya, ischialgia.

As auxiliary medicine: a pain syndrome after surgical interventions and diagnostic procedures.

Route of administration and doses:

Parenterally (intravenously, intramusculary). To adults and teenagers 15 years at acute heavy gripes are more senior enter intravenously slowly 2 ml (on 1 ml within 1 minute); if necessary repeatedly in 6-8 hours. For slow intravenous administration 2 ml of drug there are usually enough.

Intramusculary 2 times a day enter 2 ml of solution; the daily dose should not exceed 4 ml. Duration of treatment is no more than 5 days.

Intramusculary or intravenously Spazgan appoint to children depending on age and body weight in the following single doses:

 

Body weight / age	Solution for injections, intravenous administration	Solution for injections, intramuscular introduction
chest babies of 5-8 kg; 3-11 months	Intravenous administration contraindicated	0,1-0,2 ml
children of 9-15 kg; 1-2 years	0,1-0,2 ml	0,2-0,3 ml
children of 16-23 kg; 3-4 years	0,2-0,3 ml	0,3-0,4 ml
children of 24-30 kg; 5-7 years	0,3-0,4 ml	0,4-0,5 ml
children of 31-45 kg; 8-12 years	0,5-0,6 ml	0,6-0,7 ml
children of 46-53 kg; 12-15 years	0,8-1,0 ml	0,8-1,0 ml

If necessary repeated administration of drug in the same doses can be appointed. Solution is incompatible in one syringe with other medicines. Before administration of injection solution it should be warmed in a hand.

Features of use:

Use at pregnancy and during breastfeeding. Use at pregnancy is contraindicated. Use of drug for nursing mothers demands the breastfeeding termination.

Special instructions. Not to use for stopping of acute abdominal pains (before clarification of the reason).

During treatment by drug it is impossible to accept alcohol; it is not recommended to manage vehicles and to be engaged in other potentially dangerous types of activity demanding speed of physical and mental reaction.

Parenteral administration is usually used in case of emergency (renal or hepatic gripes) and when intake is impossible (or absorption from digestive tract is broken).

Extra care at introduction of 2 ml of solution is required and more (risk of a sharp lowering of arterial pressure). The intravenous injection should be carried out slowly, in a prone position and under control of arterial pressure, heart rate and respiration rate.  

At long use of drug (more than a week), control of a picture of peripheral blood and a functional condition of a liver is necessary.

Side effects:

In therapeutic doses drug is usually well transferred. Allergic reactions (skin rash, an itch, it is very rare - an acute anaphylaxis, a small tortoiseshell), a Quincke's disease are sometimes possible. In isolated cases - burning sensation in epigastric area, dryness in a mouth, a headache.

Dizziness, lowering of arterial pressure, tachycardia, cyanosis is possible. At long reception – hemopoiesis disturbances: thrombocytopenia, a leukopenia, an agranulocytosis (it can be shown by the following symptoms: unmotivated rise in temperature, fever, pharyngalgia, swallowing difficulty, stomatitis, and also development of the phenomena of a vaginitis or proctitis). At tendency to a bronchospasm provoking of an attack is possible.

Very seldom – a malignant exudative erythema (Stephens-Johnson's syndrome), a toxic epidermal necrolysis (Lyell's disease).

Seldom (usually at long reception or purpose of high doses) – a renal failure: an oliguria, an anury, a proteinuria, intersticial nephrite, coloring of urine in red color. Very seldom – decrease in sweating, accommodation paresis, the complicated urination.

Local reactions: at intramuscular introduction infiltrates in an injection site are possible.

It is necessary to report about all side effects to the attending physician.

Interaction with other medicines:

Simultaneous use of Spazgan with other non-narcotic analgesics can lead to mutual strengthening of toxic effects. Tricyclic antidepressants, contraceptives for intake, Allopyrinolum break metabolism of metamizole sodium in a liver and increase its toxicity.

Barbiturates, phenylbutazone and other inductors of microsomal enzymes of a liver weaken effect of metamizole sodium.

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

Sedatives and tranquilizers strengthen the anesthetizing effect of metamizole sodium.

At simultaneous use with H1 – gistaminoblokator, phenyl propyl ketones, fenotiazina, amantadiny and quinidine strengthening of M-cholinolytic action is possible.

At simultaneous use with ethanol – mutual strengthening of effects.

Simultaneous use with chlorpro-Promazinum or other derivatives of a fenotiazin can lead to development of the expressed hyperthermia.

X-ray contrast medicines and colloid blood substitutes should not be used during treatment by the drugs containing metamizole sodium.

Metamizole sodium, forcing out peroral hypoglycemic medicines, indirect anticoagulants, glucocorticosteroids and indometacin from communication with proteins of plasma, can increase expressiveness of their action.

Thiamazolum and cytostatics increase risk of development of a leukopenia.

The effect is strengthened by codeine, H2 – gistaminoblokator and propranolol (slows down a metamizole sodium inactivation).

Solution for injections pharmaceutical is incompatible with other medicines.

In need of simultaneous use of the specified and other medicines it is necessary to consult with the doctor.

Contraindications:

- hypersensitivity to metamizole sodium and other derivatives of pyrazyl ketone, and also to other components of drug;

- oppression of a marrowy hemopoiesis;

- stable and unstable stenocardia;

- chronic heart failure in a decompensation stage;

- the expressed abnormal liver functions or kidneys;

- deficit glyukozo-6-fosfatdegidrogenazy;

- tachyarrhythmias;

- the acute "alternating" porphyria;

- closed-angle form of glaucoma;

- a prostate hyperplasia (with clinical manifestations);

- intestinal impassability and megacolon;

- collapse;

- pregnancy;

- lactation period;

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

With care and under control of the doctor patients should use drug with the broken function of a liver or kidneys, at tendency to arterial hypotension, bronchial asthma, the increased individual sensitivity to non-steroidal anti-inflammatory drugs or non-narcotic analgesics, a full or incomplete combination of bronchial asthma, the nose recuring a polypose and okolonosovy bosoms and intolerance of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (including in the anamnesis).

Children and teenagers up to 18 years should use drug only on doctor's orders.

Overdose:

Symptoms: vomiting, a lowering of arterial pressure, drowsiness, confusion of consciousness, nausea, pains in epigastric area, an abnormal liver function and kidneys, a spasm.

Treatment: symptomatic therapy.

Storage conditions:

Period of validity - 3 years. Not to use after the period of validity specified on packaging. To store the place, vzashchishchenny from light, at a temperature not above 25 °C, not to freeze. To store in the place, unavailable to children!

Issue conditions:

According to the recipe

Packaging:

Solution for intravenous and intramuscular administration. On 5,0 ml in ampoules from glass of brown color. On 5 ampoules in the plastic pallet, on 1 or 5 pallets together with the application instruction in a cardboard pack.