Spasgan injection (Pitofenone + Metamizole sodium + Fenpiverinium bromide)

Release form 

Solution for injection

Composition

1 ampoule ( 5 ml) contains Metamizole sodium 2, 5 g, pitofenon hydrochloride 10 mg, fenpiverinia bromide 100 mcg

Packaging

5 ampoules of 5 ml.

Pharmacological action

Spasgan combined analgesic and antispasmodic, contains three active substances: Metamizole is an analgesic narcotic means, pitofenone hydrochloride has papaverinopodobnoe action and fenpiverinia bromide – M-holinoblokirutuyu action. Has coming fast, long-lasting analgesic and antispasmodic action.

Testimony

Pain (of various etiologies), spasm of smooth muscles: renal colic, biliary colic, algomenorrhea, intestinal colic, biliary dyskinesia, headache (due to vasospasm).

Contraindications

Hypersensitivity, granulocytopenia, acute “intermittent” porphyria, deficiency of glucose-6-phosphate dehydrogenase, tachyarrhythmia, angle-closure glaucoma, prostatic hyperplasia, intestinal obstruction, megacolon, pregnancy (especially I trimester and last 6 weeks). For/in the introduction – infancy (up to 3 months) or body weight less than 5 kg. Caution – hypotension (systolic pressure below 100 mm Hg.St.), bronchial asthma, rheumatism or pain syndrome (possible choking or shock), hypersensitivity to ethanol (for solutions containing ethanol).

Method of application and doses

Adults and adolescents over 15 years single dose of 2 ml in/in or/m, the maximum daily dose is 10 ml (5 ml, 2 times a day).

For children 12-14 years of age (weighing about 50 kg) of single and maximum daily dose of 0.8 ml and 6.4 ml (1.6 ml 4 times per day), respectively,

8-11 years (weighing about 33 kg) – 0.5 ml and 4 ml (1 ml 4 times a day)

5-7 years (with body weight about 24 kg) – 0.4 ml and 3.2 ml (0.8 ml 4 times a day)

3-4 years (weighing about 18 kg) – 0.2 ml and 2.4 ml (0.6 ml 4 times a day)

1-2 years (body weight 12-14 kg) – 0.2 ml, and 1.6 ml (0.4 ml 4 times a day).

Children 6-11 months (weighing 8-10 kg) the drug is administered only in/m, single dose 0.1 ml; maximum daily dose 1.2 ml

3-5 months (weighing 5.5-7.5 kg) single dose 0.1 ml; maximum daily dose – 0.8 ml.

Before the introduction of injectable solution should be warm in his hand.

Side effects

Possible allergic reactions (skin rash, itching, urticaria, angioedema, rarely, anaphylactic shock in very rare cases – malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome). Rarely (usually with prolonged use or high doses) – agranulocytosis, leukopenia, thrombocytopenia, impaired renal function: oliguria, anuria, proteinuria, interstitial nephritis, bronchospasm, decreased blood pressure, gastralgia, urine staining in red. Very rare – anticholinergic effects (dry mouth, decreased sweating, paresis of accommodation, tachycardia, urinary retention).

Special instructions

During the period of drug treatment should not take alcohol. During treatment is not recommended to drive vehicles and engage in potentially hazardous activities that require quick physical and mental reactions. During treatment requires monitoring of the content of leukocytes in peripheral blood. If you suspect a agranulocytosis, or in the presence of thrombocytopenia should stop taking the drug. Use in nursing mothers requires the cessation of breastfeeding. Parenteral administration should be used only in cases where ingestion is not possible (or impaired absorption from the gastrointestinal tract).Particular care is required with the introduction of 2 ml or more (risk of a sharp fall AD). In/in the injection should be performed slowly, in the supine position and under the control of blood pressure, heart rate, and respiratory rate.

Drug interactions

Solution for injection farmatsevticeski incompatible with other drugs. The joint appointment with the H1-histamine antagonists, butyrophenone, phenothiazine, tricyclic antidepressants, amantadine and quinidine may increase m-anticholinergic action. Simultaneous reception with other non-narcotic analgesics can lead to mutual reinforcement of toxic effects. Tricyclic antidepressants, oral contraceptives, and allopurinol increase the toxicity of the drug. Barbiturates and phenylbutazone weaken the effect of metamizol sodium. Sedatives and tranquilizers increase the analgesic effect Palangana. Concomitant use of cyclosporine decreases the concentration of the latter in plasma. When used together with ethanol – mutual enhancement effects.

Overdose

Symptoms: vomiting, decreased blood pressure, drowsiness, confusion, nausea, vomiting, epigastric pain, disorders of the liver and kidneys, cramps. Treatment: gastric lavage, the appointment activated carbon, symptomatic therapy.

Storage conditions

In a dry, protected from light place, at temperature not exceeding 25 °C.