Spazmalin - instructions for use, dose, side effects, contraindications

solution for intravenous and intramuscular administration Composition: 1 ml of the solution contains: active ingredients: metamizole sodium (analgin) 500 mg, pituopenona hydrochloride 2 mg and fenpiverinia bromide 0.02 mg; Excipients: citric acid monohydrate, water for injection.

Description

Transparent solution from light yellow to yellow.

Pharmacotherapeutic group: combined analgesic

(analgesic non-narcotic remedy + antispasmodic)

Description:

Transparent solution from light yellow to yellow.

Pharmacotherapeutic group:Analgesic combined (analgesic non-narcotic agent + antispasmodic)

ATX: & nbsp

N.02.B.B.52 Metamizole sodium in combination with other drugs, excluding psycholeptics

Pharmacodynamics:

Spasmalin® is a combined preparation that includes: non-narcotic analgesic metamizol sodium, myotropic antispasmodic agent pitofenon and m-cholinoblocking agent fenpiverinia bromide.

Metamizole sodium, a derivative of pyrazolone, has an analgesic, antipyretic and weak anti-inflammatory effect. Pitophenone, like papaverine, has a direct myotropic effect on the smooth muscles of the internal organs and causes it to relax. Fenpiverinia bromide due to m-holinoblokiruyuschego action has an additional myotropic effect on smooth muscles.

Pharmacokinetics:

Metamizole sodium is subjected to intensive biotransformation in the body, only after intravenous injection, a small concentration of unchanged metamizole sodium is detected in the plasma. The association of the active metabolite with proteins is 50-60%. It is mainly excreted by the kidneys. In therapeutic doses penetrates into breast milk.

The pitophenon is excreted in the urine; the maximum concentration in the plasma is reached within 30 - 60 min; the half-life is 1.8 hours.

Fenpiverinia bromide is excreted by the kidneys 32.4-40.4% unchanged, 2.5-5.3% of the substance is excreted with bile.

Indications:

Pain syndrome (mild or moderate) with spasms of smooth muscles of internal organs: renal colic, spasm of ureter and bladder; biliary colic, intestinal colic; dyskinesia biliary tract, postcholecystectomy syndrome, chronic colitis; algodismenorea.

For short-term treatment: arthralgia, myalgia, neuralgia, ischialgia.

pain syndrome after surgical interventions and diagnostic procedures.

Contraindications:

Hypersensitivity (including pyrazolone derivatives), oppression of bone marrow hematopoiesis, marked hepatic and / or renal insufficiency, deficiency of glucose-6-phosphate dehydrogenase, tachyarrhythmias, severe angina pectoris, decompensated chronic heart failure, closed angle glaucoma, prostatic hyperplasia with clinical manifestations), intestinal obstruction, megacolon, collapse, pregnancy, the period of breastfeeding.

For IV introduction - infant age (up to 1 year) or body weight less than 9 kg.For the / m introduction - infant age (up to 3 months) or body weight less than 5 kg.

Carefully:

Renal / hepatic insufficiency, bronchial asthma, propensity to arterial hypotension, hypersensitivity to nonsteroidal anti-inflammatory drugs, Complete or incomplete combination of bronchial asthma, nasal polyposis and intolerance to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs.

Pregnancy and lactation:contraindicated

Dosing and Administration:

Parenterally (intravenously, intramuscularly).

Adults and adolescents over 15 years of age are injected slowly 2 ml each; intramuscularly inject 2-5 ml of solution 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, Spasmalin® is administered to children, depending on

Age (body weight)	Intravenous administration	Intramuscular injection
3-11 months (5 - 8 kg)	Contraindicated	0.1-0.2 ml
1-2 years (9-15 kg)	0.1 -0.2 ml	0.2 - 0.3 ml
3-4 years (16-23 kg)	0.2 - 0.3 ml	0.3 - 0.4 ml
5-7 lay down (24-30 kg)	0.3 - 0.4 ml	0.4 - 0.5 ml
8-12 lay down (31-45 kg)	0.5 - 0.6 ml	0.6 - 0.7 ml
12-15 years old	0.8-1 ml	0.8-1 ml

Before the injection of the injection solution, it should be warmed in the hand.

The solution is incompatible in one syringe with other drugs.

Side effects:

Allergic reactions: urticaria (including conjunctiva and mucous membranes of the nasopharynx), angioedema, in rare cases - malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), bronchospastic syndrome, anaphylactic shock.

From the urinary system: a violation of kidney function, oliguria, anuria, proteinuria, interstitial nephritis, urine staining in red. From the side of the cardiovascular system: lowering blood pressure.

From the hematopoiesis: thrombocytopenia, leukopenia, agranulocytosis (may be manifested by the following symptoms: unmotivated rise in temperature, chills, sore throat, difficulty swallowing, stomatitis, as well as the development of the phenomena of vaginitis.

Anticholinergic effects: dry mouth, decreased sweating, paresis of accommodation, tachycardia, difficulty urinating.

Local reactions: with the / m introduction, infiltrates are possible at the injection site.

Overdose:

Symptoms: vomiting, lowering blood pressure, drowsiness, confusion, nausea, pain in the epigastric region, impaired liver and kidney function, convulsions. Treatment: symptomatic therapy.

Interaction:

The solution for injection is pharmaceutically incompatible with other drugs.

When coupled with a histamine H1 receptor blockers, derivatives of phenothiazine and butyrophenone, tricyclic antidepressants, amantadine and possibly increasing quinidine m-anticholinergic action.

Metamizole sodium enhances the effects of ethanol; simultaneous use with chlorpromazine or other phenothiazine derivatives can lead to the development of severe hyperthermia.

Tricyclic antidepressants, oral contraceptives and allopurinol increase the toxicity of the drug.

Phenylbutazone, barbiturates and other inducers of microsomal liver enzymes with simultaneous use reduce the effectiveness of metamizole sodium. Sedative and anxiolytic drugs (tranquilizers) increase the analgesic effect of metamizole sodium.

Radiopaque drugs, colloidal blood substitutes and penicillins should not be used during treatment with drugs containing metamizol sodium.

With the simultaneous use of cyclosporine, the concentration of the latter in the blood decreases.

Metamizole sodium, displacing from the connection with plasma proteins, oral hypoglycemic drugs, indirect anticoagulants, glucocorticosteroids and indomethacin, can increase the severity of their action.

Thiamazole and cytostatics increase the risk of developing leukopenia.

The effect is enhanced codeine, H2-histamine receptor blockers and propranolol (slow inactivation of metamizole sodium).

Special instructions:

During treatment with the drug is not recommended to take ethanol. With prolonged (more than a week) treatment, control of the peripheral blood picture and the functional state of the liver is necessary.

If suspected of agranulocytosis or in the presence of thrombocytopenia should stop taking the drug.

It is not allowed to use acute pains in the abdomen for relief (until the cause is clarified).

Intolerance is very rare, but the threat of anaphylactic shock after IV injection is relatively higher than after taking the drug inside.

Patients with atopic bronchial asthma and pollinosis have an increased risk of developing allergic reactions.

Parenteral administration should be used only in cases where oral administration is not possible (or absorption from the gastrointestinal tract is impaired). Special care is required when introducing more than 2 ml of solution (the risk of a sharp drop in blood pressure). Intravenous injection should be done slowly, in the "lying" position and under the control of blood pressure, heart rate and respiratory rate.

When treating children under 5 years and patients receiving cytotoxic drugs, metamizole sodium intake should be performed only under the supervision of a doctor. For intramuscular injection, a long needle should be used. It is possible to stain urine red due to the release of metamizole metabolite sodium (it has no clinical significance).

Effect on the ability to drive transp. cf. and fur:Care should be taken during the treatment of drivers of vehicles and persons engaged in potentially hazardous activities requiring quick physical and mental reactions.

Form release / dosage:

Solution for intravenous and intramuscular injection. 5 ml in a vial of transparent amber glass. Type of glass - USP Type 1. 5 ampoules are placed in a blister of aluminum foil and PVC film. 1 or 5 blisters with instructions for use are placed in a cardboard box.

Packaging:ampoules of dark glass (5) -packaging

Storage conditions:

At temperatures below 30 ° C in a dark place.

Keep out of the reach of children.

Shelf life:

3 years. Do not use later than the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N015008 / 01

Date of registration:22.04.2008

The owner of the registration certificate:Torrent Pharmaceuticals Co., Ltd.Torrent Pharmaceuticals Co., Ltd. India

Manufacturer: & nbsp

TORRENT PHARMACEUTICALS, Ltd. India

Representation: & nbspTORRENT PHARMACEUTICALS LTD. TORRENT PHARMACEUTICALS LTD. India

Information update date: & nbsp23.07.2010

Illustrated instructions

Instructions

Spazmaline® (Spasmalin®)