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Pipolphenum 50 mg / 2 ml 10s solution for injection in ampoules




Trade name:

PipolfenMezhdunarodnyy name:
Promethazine Group accessory:
H1 – histamine receptors a blocker
the Description of active ingredient (MNN):
PrometazinLekarstvennyy form:
solution for intravenous and intramuscular administration

Pharmacological action:
Drug of a fenotiazinovy row, has high antihistaminic activity and the significant influence on central nervous system. Renders sedative, somnolent, antiemetic, antipsychotic, hypothermal action. Warns and calms a hiccups. Prevents, but does not eliminate the effects mediated by a histamine (including urticaria and an itching). Anticholinergic action causes the drying effect on mucous membranes of nasal cavities and a mouth. The antiemetic, eliminating dizziness action, can be connected with the central anticholinergic action. Reduces stimulation of vestibular receptors and oppresses function of a labyrinth. Antiemetic action can be caused by action on a hemoretseptorny trigger zone of a medulla. Sedative action is caused by inhibition of histamine-N-methyltransferase and blockade of the central gistaminergichesky receptors. Also blockade, etc. receptors of central nervous system, such as serotoninovy and atsetilkholinovy, stimulation of alpha and adrenergic receptors indirectly weakens stimulation of a reticular formation of a brainstem is possible. The clinical effect beginsat intake – in 15-60 min., at introduction in oil – 20 min., at in in introduction – 3-5 min. also proceed during 6, sometimes 12 h. Indications:
Allergic diseases (rash, rheumatism with the expressed allergic component, a pruritic dermatosis, prurigo, eczema, exudative diathesis, medicinal rash, a serum disease, a Quincke’s disease, hay fever, bronchial asthma, an acute anaphylaxis, rheumatism with the expressed allergic component, stings of insects), a research of gastric secretion (for prevention of complications when using as a histamine secretagogue). In anesthesiology: premedication, the postoperative period, as a component of the lytic mixes applied to strengthening of the general anesthesia and a hypothermia, effect of analgetics and local anesthetics at artificial hibernation. In neurology: kinetoza, migraine, for reduction of extrapyramidal disorders at use of antipsychotic HP (neuroleptics), a trochee, encephalitis, etc. the central nervous system diseases which are followed by increase in permeability of vessels, a tremens, an epileptiform neuralgia, Menyer’s syndrome, dizziness, nausea and vomiting, a hyperthermia in poisonings, sea and airsickness, psychoses, neurosises (excitement, uneasiness, sleep disorders) – as a part of complex therapy. In pediatrics: change of integuments and mucous membranes at babies against the background of exudative diathesis, eczema, an asthmatic bronchitis, a false croup, allergic dermatitis, a serum disease. Contraindications:
Hypersensitivity (including to other fenotiazina), simultaneous use of MAO inhibitors, the lactation period, early children’s age (up to 3 months). With care. Obstruction of a neck of a bladder, a prostatauxe with clinical manifestations, predisposition to an ischuria, epilepsy, open or closed-angle angle glaucoma, a coma, a liver failure, jaundice, oppression of function of marrow, a disease of CCC (heavy stenocardia, arterial hypertension, dekompensirovanny HSN, a ciliary tachyarrhythmia), a syndrome to Reja, pregnancy, children’s (up to 2 years) and advanced age. Side effects:
From nervous system: sedation, dizziness, drowsiness, uneasiness, psychomotor excitement, ‘dreadful’ dreams, increase of a night apnoea, it is rare – a disorientation, confusion of consciousness, extrapyramidal disorders, increase in convulsive activity (at children). From sense bodys: disturbance of accommodation and sight, noise or a ring in ears. From CCC: orthostatic hypotension (at in in introduction), decrease in the ABP, tachycardia or bradycardia. From digestive system: anesthesia of a mucous membrane of an oral cavity, dryness in a mouth (at intake), nausea, vomiting, a cholestasia, constipations. From a respiratory system: dryness in a nose, a throat. From an urinary system: seldom – complicated or urodynia. Laboratory indicators: seldom – a leukopenia, thrombocytopenia, an agranulocytosis. Allergic reactions: urticaria, dermatitis, asthma. Local reactions: at introduction in oil – painful infiltrate in the injection site. Other: the increased sweating, a photosensitization. Overdose. Symptoms: children have an excitement, uneasiness, hallucinations, an ataxy, an athetosis, spasms, a mydriasis and immovability of pupils, a dermahemia of the person, a hyperthermia, then – vascular collapse, a coma, adults have a block, a depression, a coma, then – psychomotor excitement, spasms. Treatment: gastric lavage, prescribing of activated carbon inside (when carrying out desintoxication in early terms after oral administration of drug), according to indications – antiepileptic HP, IVL, etc. resuscitation actions, dialysis it is inefficient. Route of administration and doses:
Inside, intramuscular and intravenous. P / to do not enter, considering irritant action. Inside, the adult – on 75-100 mg/days in 3-4 receptions, the evening dose can make 50 mg. The highest single dose – 75 mg, daily – 500 mg. In oil – on 1-2 ml of 2.5% of solution 3-4 times a day, in/in, as a part of lytic mixes – 2 ml. The highest single dose for introduction in oil – 50 mg, daily – 250 mg. At a preparation for surgery for strengthening of the general anesthesia: the night before take 25-50 mg together with the LS other hypnotic drugs, for 2.5 h before operation – 50 mg in oil with other components of lytic mix in one syringe. Inside, to children of 1-2 years – 5-10 mg 1-2 times a day, 2-5 years – 5-10 mg 1-3 times a day, 5-10 years – 5-15 mg 1-3 times a day, are more senior than 10 years and to teenagers – 5-20 mg 1-3 times a day. In oil – 0.5-1 mg/kg, frequency rate of introduction – 3-5 times a day. In case of emergency – 1-2 mg/kg. In/in – 1/3 doses, used for introduction in oil. For prevention of a motion desease: once for 1 h prior to a trip, adult – 25-50 mg, to children – 10-20 mg. Special instructions:
At long-term treatment it is necessary to carry out systematically the general blood test, to estimate function of a liver. In the course of further treatment the extent of restrictions is defined depending on individual shipping. Together with narcotic analgetics, anxiolytics – for complex preoperative training of patients, it is applied under stringent medical control. During treatment the ethanol use is forbidden. At advanced age the care is necessary at parenteral maintaining high doses since extrapyramidal disturbances and a sharp ischuria are possible. Use of promethazine for children up to 2 years can be followed by increase in frequency of night attacks of apnoea. As antiemetic the HP needs to be used only in long vomiting of the known etiology. At prolonged use the risk of developing dental diseases (caries, a periodontal disease, candidiasis) because of salivation reduction increases. For prevention of oppression of central nervous system the prescribing of caffeine is recommended. Can mask ototoksichesky action (sonitus and dizziness) of in common applied HP. Increases the need for Riboflavinum. Solution is not intended for in / and and p / to introduction. Some dosage forms of promethazine contain sodium metabisulphite which can cause allergic reactions (including anaphylactoid) and a bronchospasm. For prevention of distortion of results of skin scarifying tests on allergens it is necessary to cancel for 72 h before allergological testing. During treatment, false positive test results on pregnancy existence are possible. In the initial, individually defined treatment period, it is necessary to be careful during the driving of motor transport and occupation other. potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions. Interaction:
Enhances effects of narcotic analgetics, somnolent, anxiolytic (tranquilizers) and antipsychotic HP (neuroleptics) and also HP for the general anesthesia, local anesthetics, m-holinoblokatorov and hypotensive HP (correction of doses is required). Weakens action of derivatives of amphetamine, m-holinostimulyatorov, antikholinesterazny HP, ephedrine, a guanetidin, a levodopa, a dopamine. Barbiturates accelerate elimination and reduce activity. Beta blockers increase (mutually) concentration in plasma (arrhythmias, an irreversible retinopathy, late dyskinesia are possible the significant decrease in the ABP). Weakens effect of Bromocriptinum and increases concentration of prolactin in blood serum. Tricyclic antidepressants and anticholinergic HP strengthen m-holinoblokiruyushchuyu activity, ethanol, clonidine, antiepileptic HP – oppression of central nervous system. MAO inhibitors (co-administration is not recommended) and derivatives of a fenotiazin increase risk of developing of arterial hypotension and extrapyramidal disorders. Quinidine increases the probability of cardiodepressive action. Myelotoxic HP strengthen manifestations of a gematotoksichnost of drug.

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