SPASMALIN 5 ML AMPOULE

Pharmacology

Spasmalin is a combined drug, which includes: non-narcotic analgesic metamizole sodium (analgin), myotropic antispasmodic pitofenone hydrochloride and m-antinoxobloxer fenpiverinii bromide.
Metamizol 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. Due to its m-anticholinergic blocking effect, fenpiverine bromide has an additional antispasmodic effect on smooth muscles.

Indications

Pain in spasms of smooth muscles of internal organs - renal and biliary colic, agegomenorrhea and other spastic states of internal organs. It can be used for short-term symptomatic treatment of arthralgia, neuralgia, sciatica, myalgia.
As an adjunct, it can be used to reduce pain after surgical and diagnostic procedures.

Contraindications

Hypersensitivity to pyrazolone derivatives (butadion) and other components of the drug; granulocytopenia, marked impairment of liver or kidney function; glucose-6-phosphate dehydrogenase deficiency; tachyarrhythmia, acute intermittent porphyria; closed-angle form of glaucoma; prostatic hyperplasia; intestinal obstruction and megacolon; diseases of the blood system; collaptoid states; pregnancy (first trimester and last 6 weeks); lactation period; children's age (up to 3 months or body weight less than 5 kg); increased individual sensitivity to nonsteroidal anti-inflammatory drugs or non-narcotic analgesics.

Carefully

With caution and under the supervision of a physician should use the drug in patients with impaired liver or kidney function, with a tendency to hypotension, bronchospasm. For children and adolescents under 18 years old, the drug should be used only as prescribed by a doctor.

Dosage and administration

For slow intravenous administration, usually 2 ml of the preparation is usually sufficient, 2-5 ml of the solution is injected intramuscularly 2-3 times a day; daily dose should not exceed 10 ml. The duration of treatment is not more than 5 days. Intramuscularly or intravenously Spazmalin administered to children, 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 can be prescribed.
Solution is incompatible in one syringe with other medicines.

Adverse Effects

At therapeutic doses, the drug is usually well tolerated. Sometimes allergic reactions are possible (skin rash, itching, very rarely, anaphylactic shock). In rare cases - a burning sensation in the epigastric region, dry mouth, headache.
Dizziness, lowering blood pressure, tachycardia, cyanosis are possible. With long-term use - cases of violation of the blood system (thrombocytopenia, leukopenia, agranulocytosis). With a tendency to bronchospasm may provoke an attack.
In very rare cases - 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, paresis of accommodation, urinary retention. All side effects should be reported to your doctor.

Overdosage

Symptoms: vomiting, lowering blood pressure, drowsiness, confusion, nausea, epigastric pain, abnormal liver and kidney function, convulsions.
Treatment: gastric lavage appointment of Activated carbon, symptomatic therapy.

Interaction with other drugs

Simultaneous use of SPASMALINE with other non-narcotic analgesics may result in mutual enhancement of effects. Tricyclic antidepressants, oral contraceptives, Allopurinol violate the metabolism of metamizol in the liver and increase its toxicity. Barbiturates, phenylbutazone and other inducers of microsomal liver enzymes weaken the effect of metamizol. Simultaneous use with cyclosporine reduces the level of the latter in the blood. Sedatives and tranquilizers enhance the analgesic effect of SPASMALINE.
When administered jointly with H1-histamine blockers, butyrophenones, phenothiazines, amantadine and quinidine, the m-cholinolytic action may be enhanced. When combined with ethanol - mutual enhancement effects. If necessary, the simultaneous use of these and other drugs should consult with your doctor.

Special notes

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. If you suspect agranulocytosis or in the presence of thrombocytopenia, you must stop taking the drug. 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 when administering 2 ml of solution or more (the risk of a sharp drop in blood pressure). Intravenous injection should be administered slowly, in the supine position and under the control of blood pressure, heart rate and respiration rate. With a long (more than a week) use of the drug, it is necessary to control the picture of peripheral blood and the functional state of the liver.

Storage conditions

At temperatures below 30 ° C in a dark place, out of the reach of children.