Description
Release form
Injection
Packing
ampoules of dark glass in 2 ml, 10 ampoules per pack.
Pharmacological action of
The composition of the drug includes: non-narcotic analgesic metamizole sodium, myotropic antispasmodic agent pitophenone and m-anticholinergic drug fenpiverinia bromide.
Metamizole sodium – is a derivative of pyrazolone. It has analgesic, antipyretic and anti-inflammatory effects.
Pitophenone – like papaverine, has a direct myotropic effect on the smooth muscles of internal organs and causes its relaxation.
Fenpiverinia bromide – due to m-anticholinergic action it has an additional relaxing effect on smooth muscles.
The combination of the three components of the drug leads to pain relief, relaxation of smooth muscles, and a decrease in elevated body temperature.
Indications
mild to moderate pain for spasms of smooth muscles of the internal organs: renal colic, hepatic colic, spastic pain along the intestines, algodismenorea
can be used for short-term symptomatic treatment for: joint pain, neuralgia,
myalgia as an adjuvant can be used to reduce pain after surgical and diagnostic interventions
if necessary, the drug can be used to reduce fever in colds and infectious and inflammatory diseases.
Contraindications
hypersensitivity to pyrazolone derivatives (butadione, tribuzon), other ingredients
expressed human liver or kidney
inhibition of bone marrow hematopoiesis
stable and unstable angina
chronic heart failure decompensation
tachyarrhythmia
zakratougolnaya form of glaucoma
prostatic hyperplasia
ileus and megacolon
granulocytopenia
deficiency of glucose-6-phosphate dehydrogenase
pregnancy and lactation
children under 6 years of age.
Precautions: mild to moderate hepatic or renal impairment, tendency to hypotension (systolic pressure below 100 mmHg ) tendency to bronchospasm increased individual sensitivity to non-steroidal anti-inflammatory drugs or non-narcotic analgesics.
Use during pregnancy and lactation
Contraindicated in pregnancy.
Breastfeeding should be discontinued during treatment.
Special instructions
When using the drug, it is necessary to control the picture of peripheral blood (white blood cell count) and the functional state of the liver.
If you suspect agranulocytosis or if you have thrombocytopenia, you must stop taking the drug.
Alcohol should not be taken during treatment with the drug.
The use of the drug in nursing mothers requires termination of breastfeeding.
The effect of the drug on the ability to drive vehicles and other mechanisms that require an increased concentration of attention
During treatment, it is not recommended to drive vehicles and engage in potentially dangerous activities that require quick physical and mental reactions.
Composition
1 ml contains metamizole sodium 500 mg, pitophenone hydrochloride 2 mg and
fenpiverinium bromide 20 mcg.
Dosage and administration of
Adults Spazmalgon is injected intramuscularly with 2-5 ml of solution or iv with 2 ml 2-3 times / day. The maximum daily dose should not exceed 10 ml. The duration of treatment is no more than 5 days.
Children in / m and / in appoint depending on age in the following single doses: 3-11 months. 0.1 ml, 1-4 years old 0.2 ml, 5-7 years old 0.4 ml, 8-11 years old 0.5 ml, 12-14 years old 0.8 ml.
If necessary, re-administration of the drug in the same doses is possible.
Side effects of the digestive system: burning sensation in the epigastric region, dry.
From the nervous system: headache, dizziness, anticholinergic effects (decreased sweating, paresis of accommodation, difficulty urinating).
From the cardiovascular system: lowering blood pressure, tachycardia, cyanosis.
From the urinary system: impaired renal function, oliguria, anuria, proteinuria, interstitial nephritis, red staining of urine.
From the side of hematopoietic organs: with prolonged use – thrombocytopenia, leukopenia, agranulocytosis.
Allergic reactions: urticaria, bronchospastic syndrome, anaphylactic shock, Quincke’s edema, erythema multiforme exudative (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome).
Drug Interactions
Concomitant use with radiopaque drugs, colloidal blood substitutes and penicillin is contraindicated.
With the simultaneous use of the drug with cyclosporine, the concentration of the latter in the blood decreases.
With the simultaneous use of metamizole sodium, displacing oral hypoglycemic agents, indirect anticoagulants, corticosteroids, and indomethacin, increases their activity.
With the simultaneous use of phenylbutazone, barbiturates and other inducers of microsomal liver enzymes reduce the effectiveness of metamizole sodium.
When used concomitantly with other non-narcotic analgesics, tricyclic antidepressants, oral hormonal contraceptives and allopurinol, toxicity may increase.
With the simultaneous use of sedatives and anxiolytics (tranquilizers) enhance the analgesic effect of Spazmalgon.
With the simultaneous use of tiamazole and cytostatics increase the risk of developing leukopenia.
With simultaneous use, the effect of the drug is enhanced by codeine, histamine H2 receptor blockers and propranolol (inhibit inactivation).
With the simultaneous use of drugs with myelotoxic effect enhance the hematotoxic effect of Spazmalgon.
When used together with histamine H1 receptor blockers, butyrophenones, phenothiazines, tricyclic antidepressants, amantadine and quinidine, an increase in m-anticholinergic action is possible.
Use in conjunction with chlorpromazine or other phenothiazine derivatives can lead to severe hyperthermia.
With the simultaneous use of Spazmalgon enhances the effects of ethanol.
Pharmaceutical interactions
Due to the high likelihood of developing pharmaceutical incompatibilities, do not mix with other drugs in the same syringe.
Overdose
Symptoms: vomiting, sensation of dryness in the mouth, decreased sweating, impaired accommodation, decreased blood pressure, drowsiness, confusion, impaired liver and kidney function, convulsions.
Treatment: gastric lavage, administration of activated charcoal, symptomatic therapy.
Storage conditions
Store in a dry and light place at a temperature not exceeding 25 ° C.
Keep out of the reach and sight of children.
Shelf life
3 years.
Terms and conditions
prescription
dosage form
injection
Prescribed
Prescribed
Adults prescribed by a doctor, Pregnant only II trimester 4 prescription spf80 p18 , Pregnant women only II trimester as prescribed by the doctor, Children as prescribed by the doctor, For adults, Children over 15 years old
