Spazmalin injection solution ampoules 5ml N5
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Active ingredients
Metamizole sodium + Pitofenon + Fenpiverinium bromide
Composition
1 ml of 1 amp. Metamizole sodium 500 mg 2.5 g Pitofenone hydrochloride 2 mg 10 mg fenpiverinium bromide 20 μg 100 μg. Excipients: citric acid monohydrate, water d / and.
Pharmacological effect
Combined spazmoangetic. Metamizole, a derivative of pyrazolone, is an antipyretic analgesic with pronounced analgesic, antipyretic and weak anti-inflammatory action, the mechanism of which is associated with inhibition of prostaglandin synthesis. Pitofenon - myotropic antispasmodic, has a direct effect on the smooth muscles of the internal organs and causes its relaxation. Fenpiverinium bromide - m-anticholinergic, has an additional antispasmodic effect on smooth muscles.
Pharmacokinetics
Data on the pharmacokinetics of the drug Spasmalin is not provided.
Indications
Pain in spasms of smooth muscles of internal organs: - renal colic - biliary colic - algomenorrhea. Short-term symptomatic therapy for: - arthralgia - neuralgia - ischialgia - myalgia. To reduce pain after surgical and diagnostic interventions (as an aid). Spasmalin in pill form is used for headaches and migraines.
Contraindications
- granulocytopenia, - disorders of the hematopoietic system - expressed human liver - expressed human kidney - deficiency of glucose-6-phosphate dehydrogenase - tachyarrhythmia - acute intermittent porphyria - closure glaucoma - benign prostatic hyperplasia - ileus - megacolon - kollaptoidnye state - I trimester and the last 6 weeks of pregnancy - lactation (breastfeeding) - children up to 3 months (or body weight less than 5 kg) - increased sensitivity s to the drug, a pyrazolone derivative (e.g. to butadionu) to NSAID-antipyretics and analgesics. With caution and under the supervision of a physician should use the drug for violations of the function of the liver or kidneys, with a tendency to arterial hypotension, bronchospasm. The question of the appointment of the drug to children and adolescents under 15 should be addressed individually.
Use during 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.
Dosage and administration
For adults and adolescents over 15 years old, the drug is usually prescribed in 1-2 tab. 2-3 times / day. The maximum daily dose - 6 tab. Reception duration no more than 5 days. The increase in the daily dose of the drug or the duration of treatment is possible only under medical supervision. For children, the drug is prescribed according to strict indications; the dose of the drug is set depending on age: at the age of 6-8 years, the recommended single dose is 1/2 tab., 9-12 years - 3/4 tab., 13-15 years - 1 tab. The multiplicity of reception - 2-3 times / day. Tablets should be taken after meals. Parenteral administration is usually used in emergency cases (renal or biliary colic) and in cases where ingestion is not possible (or absorption from the gastrointestinal tract is impaired). For adults, the average dose for IV administration is 2 ml. V / m injected 2-5 ml of solution 2-3 times / day; the maximum daily dose is 10 ml. The duration of treatment is not more than 5 days. Children doses of Spasmalin for the / m or / in the introduction set, depending on age. Age Recommended dose 3–11 months 0.1 ml 1–4 years 0.2 ml 5–7 years 0.4 ml 8–11 years 0.5 ml 12–14 years 0.8 ml If necessary, repeated administration of the drug in the same doses is possible. Special care is required with the introduction of 2 ml of solution and more (the risk of a sharp decrease in blood pressure). In / in the injection should be done slowly, in the position of the patient lying, under the control of blood pressure, heart rate and respiratory rate. Spasmalin solution is incompatible in the same syringe with other drugs.
Side effects
On the part of the digestive system: in isolated cases - a burning sensation in the epigastric region, dry mouth. Since the cardiovascular system: possible - lowering blood pressure, tachycardia, cyanosis. On the part of the hematopoietic system: with prolonged use in some cases - thrombocytopenia, leukopenia, agranulocytosis. From the side of the central nervous system: possible dizziness; very rarely - accommodation paresis; in rare cases - headache. On the part of the urinary system: rarely (usually with long-term use or when used in high doses) - renal dysfunction, oliguria, anuria, proteinuria, interstitial nephritis, urine staining in red; very rarely - urinary retention.Allergic reactions: sometimes - skin rash, itching; very rarely - anaphylactic shock; in some cases - malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome); with predisposition to bronchospasm - provoking an attack. Other: very rarely - decreased sweating. At therapeutic doses, the drug is usually well tolerated.
Overdose
Symptoms: vomiting, decreased blood pressure, drowsiness, confusion, nausea, epigastric pain, abnormal liver and kidney function, convulsions. Treatment: gastric lavage, the appointment of activated carbon; if necessary, conduct symptomatic therapy.
Interaction with other drugs
The simultaneous use of spasmalin with other non-opioid analgesics may result in mutual enhancement of effects. With the simultaneous use of tricyclic antidepressants, oral contraceptives, allopurinol violate 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 action of metamizole sodium. With the simultaneous use of Spazmalin reduces the concentration of cyclosporine in the blood plasma. With simultaneous use of sedatives and tranquilizers enhance the analgesic effect of Spazmalin. With simultaneous use of histamine H1 receptors with blockers, butyrophenones, phenothiazines, amantadine and quinidine, the m-cholinolytic action of drugs can be enhanced. When applied simultaneously with ethanol, mutual enhancement of effects is possible.
special instructions
If you suspect agranulocytosis or in the presence of thrombocytopenia, you must stop taking the drug. With long-term (more than a week) application of Spazmalin, control of the pattern of peripheral blood and the functional state of the liver is necessary. During the period of use of the drug should not consume alcohol. Impact on the ability to drive vehicles and control mechanisms During the period of use of the drug should not engage in potentially hazardous activities that require increased attention.