Pitofenon

When ATH:
A03DA02

Pharmacological action

The combined analgesic and antispasmodic, the combination of the components of the drug leads to mutual reinforcement of their pharmacological action.

Metamizol sodium – pyrazolone derivative, It has analgesic and antipyretic effect.

Pitofenone myotropic hydrochloride has a direct effect on the smooth muscles (papaverinopodobnoe action).

Fenpiveriniya bromide has m-anticholinergic effect and provides additional myotropic effect on smooth muscles.

Pharmacokinetics

Pitofenone - Myotropic antispasmodic, It has a direct effect on the smooth muscles of internal organs and causes it to relax (papaverinopodobnoe action).

Testimony

Pain syndrome (mild to moderate) spasm of smooth muscles of internal organs: počečnaâ how, spasm of the ureter and bladder; želčnaâ how, kišečnaâ how; biliary dyskinesia, postcholecystectomical syndrome, chronic colitis; algomenorrhea, diseases of the pelvic organs.

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

As a subsidiary of LS: pain following surgical and diagnostic procedures.

Dosage regimen

Inside: Adults and adolescents over 15 years: 1-2 tab. 2-3 time / day, without chewing, drinking a small amount of liquid.

Children 12-14 years: single dose – 1 tab., the maximum daily dose – 6 tab. (1.5 tab. 4 times / day), 8-11 years – 0.5 tab., the maximum daily dose – 4 tab. (by 1 tab. 4 times / day), 5-7 years – 0.5 tab., the maximum daily dose – 2 tab. (by 0.5 tab. 4 times / day).

Parenteral (I /, / m).

Adults and adolescents over 15 years with acute severe colic administered in / in slowly (by 1 ml for 1 m) by 2 ml; if necessary, re-enter through 6-8 no. / M – 2-5 ml 2-3 times / day. The daily dose should not exceed 10 ml. Duration of treatment – no more 5 days.

Calculation of the dose for children when in / and / m introduction: 3-11 Months (5-8 kg) – Only / m – 0.1-0.2 ml; 1-2 year (9-15 kg) – I / – 0.1-0.2 ml, / m – 0.2-0.3 ml; 3-4 year (16-23 kg) – I / – 0.2-0.3, / m – 0.3-0.4 ml; 5-7 years (24-30 kg) – I / – 0.3-0.4 ml, / m – 0.4-0.5 ml; 8-12 years (31-45 kg) – I / – 0.5-0.6 ml, / m – 0.6-0.7 ml; 12-15 years – in / in / m – 0.8-1 ml.

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

Side effect

Allergic reactions: hives (incl. the conjunctiva and mucous membranes of the nasopharynx), angioedema, rarely – malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), bronhospastichesky syndrome, anaphylactic shock.

From the urinary system: impairment of renal function, oligurija, anurija, proteinuria, interstitial nephritis, staining urine red.

Cardio-vascular system: decrease in blood pressure.

From the hematopoietic system: thrombocytopenia, leukopenia, agranulocytosis (It may show the following symptoms: unmotivated rise in temperature, chills, sore throat, difficulty weight management, stomatitis, as well as the development of the phenomena of vaginitis, or proctitis).

Anticholinergic Effects: dry mouth, decreased sweating, Parez akkomodacii, tachycardia, strangury.

Local reactions: when i / m are possible introduction of infiltration at the injection site.

Contraindications

Hypersensitivity (incl. pyrazolone derivatives), suppression of bone marrow hematopoiesis, severe liver and / or kidney failure, deficiency of glucose-6-fosfatdegidrogenazы, taxiaritmii, severe angina, decompensated chronic heart failure, zakrыtougolynaya glaucoma, prostatic hyperplasia (with clinical manifestations), ileus, megacolon, collapse, pregnancy (especially in the I trimester and in the last 6 Sun), lactation.

For i / v administration – infancy (to 3 Months) or body weight less than 5 kg. Pill – childhood (to 5 years).

FROM caution: renal / hepatic insufficiency, bronchial asthma, a tendency to hypotension, hypersensitivity to NSAIDs; urticaria or acute rhinitis, provoked by taking aspirin or other NSAIDs.

Pregnancy and lactation

Contraindicated in pregnancy (especially in the I trimester and in the last 6 Sun),

Use in nursing mothers requires cessation of breastfeeding.

Cautions

In the period of treatment is not recommended to take ethanol.

Prolonged (more than a week) the treatment is necessary to monitor patterns of peripheral blood and functional state of the liver.

If you suspect the presence of agranulocytosis or thrombocytopenia should stop taking the drug.

Must not be used for the relief of acute pain in the abdomen (to determine the cause).

Intolerance occurs rarely, but the threat of development of anaphylactic shock after i / v administration is relatively higher, than after oral administration. In patients with atopic asthma and hay fever have an increased risk of allergic reactions.

Parenteral administration should be used only in cases, When intake is impossible (or impaired absorption from the gastrointestinal tract). Special care is required when a more 2 ml (the risk of a sharp decrease in blood pressure). In / in the injection should be carried out slowly, at position “lying” and under the control of blood pressure, HR and BH.

In the treatment of children under 5 years and patients, receiving cytostatics, receive Metamizole should be done only under medical supervision.

For i / m administration must use a long needle.

Perhaps staining of urine red due to excretion of metabolites (clinical significance has not).

Effects on ability to drive vehicles and management mechanisms

During treatment, care should be taken to drivers of vehicles and persons, engaged in potentially hazardous activities, require the speed of physical and mental reactions.

Drug Interactions

Injectable solution with other pharmaceutically compatible medicaments.

At a joint appointment with the histamine H₁-blokatorami, butyrofenonamy, fenotiazinami, tricyclic antidepressants, amantadine and quinidine may increase m-anticholinergic action.

It enhances the effects of ethanol; the simultaneous application of chlorpromazine and other. phenothiazine derivatives may lead to severe hyperthermia.

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

Phenylbutazone, barbiturates and other inducers of liver enzymes while appointing reduce the effectiveness of Metamizole.

Sedatives and antianxiety drugs (trankvilizatorы) increase analgesic action Metamizole.

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

When concomitant administration of cyclosporine decreased concentration in the blood.

Metamizole, displacing connection with protein oral hypoglycemic drugs , indirect anticoagulants, SCS and indomethacin, may increase the severity of their actions.

Tiamazol cytostatics and increase the risk of leucopenia.

The effect of reinforcing codeine, blockers H₂-histamine receptors and propranolol (slow inactivation Metamizole).