Spasmalin, tablets 100 pcs

Sodium metamizole, a derivative of pyrazolone, has analgesic, antipyretic and mild anti-inflammatory effects. Pitophenone, like papaverine, has a direct myotropic effect on the smooth muscles of internal organs and causes them to relax. Phenpiverinia bromide due to its m-cholinoblocking action has an additional myotropic effect on the smooth muscles.

Pharmacokinetics

Sodium metamizole: is well and quickly absorbed in the gastrointestinal tract. In the intestinal wall it is hydrolyzed to form the active metabolite – there is no unchanged sodium metamizole in the blood. Binding of the active metabolite with proteins is 50-60%. It is metabolized in the liver and excreted by the kidneys. In therapeutic doses penetrates into breast milk.

Pitophenone is quickly absorbed in the gastrointestinal tract; maximum concentration in plasma is reached within 30-60 minutes; it is rapidly distributed in the organs and tissues and excreted rather quickly in the urine. Elimination half-life is 1.8 hours.

Phenpiperinia bromide is also rapidly absorbed from the gastrointestinal tract and reaches maximum plasma concentration within 1 hour. Excreted by the kidneys 32.4-40.4% unchanged, 2.5-5.3% of the substance is excreted in the bile.

Indications

Colitis, Toothache, Pain after injuries and operations, Radiculitis, Gastrointestinal Spasms, Back Pain, Renal Colic, Tonic Nerve Neuralgia, Migraine, Gallic Colic, Colic, Neck Pain, Lumbago, Headache, Sciatica, Biliary Dyskinesia, ColdsPain syndrome (mild to moderate) in spasms of smooth muscles of internal organs: Renal colic, ureter and bladder spasm; biliary colic, intestinal colic; biliary dyskinesia, postcholecystectomy syndrome, chronic colitis; algodysmenorrhea.

For short-term treatment: arthralgia, myalgia, neuralgia, ischialgia. As an adjunctive medicine: diseases of the pelvic organs, pain syndrome after surgical interventions and diagnostic procedures.

Active ingredient

Sodium metamizole, Pitofenone, Phenpiperinia bromide

Composition

Each tablet contains:

the active ingredients:

Sodium metamizole (analgin) 500 mg,

pitophenone hydrochloride 5 mg

phenpiperinia bromide 0.10 mg;

accessory substances:

Microcrystalline cellulose, sodium carboxymethyl starch, colloidal silicon dioxide, talcum, magnesium stearate.

How to take, the dosage

Adults are prescribed 1-2 tablets. Spasmalin up to 4 times a day.

The maximum daily dose is not more than 8 tablets.

The dosage for children 6-8 years old is 0.5 tablets, 9-12 years old is 3/4 tablets, 13-15 years old is 1 tablet 2-3 times a day.

Other dosage regimens are possible only after consultation with the doctor.

Interaction

Simultaneous use of Spasmalin with other non-opioid analgesics may lead to mutually reinforcing effects.

In concomitant use tricyclic antidepressants, oral contraceptives, allopurinol impair the metabolism of sodium metamizole in the liver and increase its toxicity.

When used concomitantly, barbiturates, phenylbutazone and other inducers of microsomal liver enzymes weaken the effects of sodium metamizole.

Concomitant use of Spasmalin decreases the plasma concentration of cyclosporine.

When used concomitantly, sedatives and tranquilizers increase the analgesic effect of Spasmalin.

Concomitant use with histamine H1-receptor blockers, butyrophenones, phenothiazines, amantadine and quinidine may increase m-cholinolytic effects of the drugs.

In concomitant use with ethanol mutual enhancement of effects is possible.

Special Instructions

During the drug treatment it is not recommended to take ethanol.

During long-term (more than a week) treatment the peripheral blood picture and functional status of the liver should be controlled.

If agranulocytosis is suspected or thrombocytopenia is present the drug should be stopped.
It is unacceptable to use to relieve acute abdominal pain (until the cause is clarified).

Intolerance is very rare, but the risk of anaphylactic shock after intravenous administration of the drug is relatively higher than after oral administration. Patients with atonic bronchial asthma and pollinosis have an increased risk of allergic reactions.

When treating patients receiving cytostatic drugs sodium metamizole should be taken only under medical supervision.

Urine may turn red due to excretion of the metabolite of sodium metamizole (of no clinical significance).

During treatment, caution should be exercised by drivers of vehicles and persons engaged in potentially dangerous activities that require rapid physical and mental reactions.

Contraindications

Hypersensitivity (including to pyrazolone derivatives), inhibition of medullary hematopoiesis, severe hepatic and/or renal insufficiency, glucose-6-phosphate dehydrogenase deficiency, tachyarrhythmia, severe angina pectoris, decompensated chronic heart failure, Closed-angle glaucoma, prostatic hyperplasia (with clinical manifestations), intestinal obstruction, megacolon, collapse, pregnancy, breast-feeding, children (under 8 years).

With caution

Renal/liver failure, bronchial asthma, tendency to arterial hypotension, hypersensitivity to nonsteroidal anti-inflammatory drugs; complete or incomplete combination of bronchial asthma, nasal polyposis and intolerance of acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs.

Side effects

Allergic reactions: urticaria (including conjunctivitis and nasopharyngeal mucosa), angioedema, in rare cases – malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell syndrome), bronchospastic syndrome, anaphylactic shock.

Urinary system disorders: impaired renal function, oliguria, anuria, proteinuria, interstitial nephritis, red coloring of urine.

Cardiovascular system: decreased arterial blood pressure.

Blood organs: thrombocytopenia, leukopenia, agranulocytosis (may manifest with the following symptoms: unexplained fever, chills, sore throat, difficulty in swallowing, stomatitis, and development of vaginitis or proctitis).

Anticholinergic effects: dry mouth, decreased sweating, paresis of accommodation, tachycardia, difficult urination.

Overdose

Symptoms: vomiting, decreased blood pressure, drowsiness, confusion, nausea, epigastric pain, liver and kidney function disorders, seizures.

Treatment: gastric lavage, administration of activated charcoal; symptomatic therapy if necessary.

Similarities

Maxigan, Spasmalgon, Bral, Spazgan, Revalgin