Instruction for use: Promethazine

The Latin name of the substance Promethazine

Promethazinum (genus. Promethazini)

Chemical name

N, N, alpha-Trimethyl-10H-phenothiazine-10-ethanamine (as hydrochloride or camsylate)

Gross formula

C₁₇H₂₀N₂S

Pharmacological group

H1-Antihistamines

The nosological classification (ICD-10)

F10.5 Alcoholic alcohol: Alcoholic hallucinations; Psycho-organic syndrome in chronic alcoholism; Alcoholic psychosis; White fever alcoholic; Delirium; Delirium with alcoholism; Acute alcoholic psychosis; Delirious condition with alcoholism and drug addiction; Acute alcoholic psychosis with autonomic disorders

F29 Inorganic psychosis, unspecified: Childhood psychoses; Psychomotor agitation in psychoses; Hallucinatory-delusional disorders; Hallucinatory-delusional syndrome; Intoxication psychosis; Manic-delusional disorders; Manic chronic psychosis; Manic psychosis; Acute psychosis; paranoid psychosis; Paranoid psychosis; Subacute psychosis; Presenile psychosis; Psychosis; Intoxicating psychosis; Psychosis is paranoid; Psychosis in children; Reactive psychosis; Chronic psychosis; Chronic hallucinatory psychosis; Chronic psychosis; Chronic psychotic disorder; Schizophrenic psychosis

G25.5 Other types of chorea: Hyperkinesis of chorea; Chorea; Chorea small; Secondary chorea; Acute chorea; Chronic chorea; St Witt's Dance; Chorea Sidengama (small, rheumatic); Senile chorea; Sydenham chorea

G43 Migraine: The pain of migraine; Migraine; hemiplegic migraine; Migraine headache; A migraine attack; Continuous headache; hemicranias

G50.0 Trigeminal neuralgia: trigeminal neuritis; Painful tic; Idiopathic trigeminal neuralgia; Neuralgia of the trigeminal nerve; Essential neuralgia of the trigeminal nerve; Pain syndrome in trigeminal neuralgia; Painful tic; Trigeminal neuralgia; Neuralgia of the trigeminal nerve

H81.0 Meniere's disease: Meniere's syndrome/ disease; Meniere's disease; Meniere's syndrome; Labyrinth dropsy; endolymphatic hydrops

J30 Vasomotor and allergic rhinitis: Allergic rhinopathy; Allergic rhinosinusopathy; Allergic diseases of the upper respiratory tract; Allergic rhinitis; Allergic rhinitis seasonal; Vasomotor runny nose; Prolonged allergic rhinitis; All-year-round allergic rhinitis; All-year allergic rhinitis; Year-round or seasonal allergic rhinitis; All-the-year-round rhinitis of an allergic nature; Rhinitis vasomotor allergic; Exacerbation of pollinosis in the form of rhinoconjunctival syndrome; Acute allergic rhinitis; Edema of the nasal mucosa; Edema of the nasal mucosa; Edema of the mucous membrane of the nasal cavity; Swelling of the nasal mucosa; Swelling of the nasal mucosa; Pollinosis; Permanent allergic rhinitis; Rhinoconjunctivitis; Rhinosinusitis; Rhinosinusopathy; Seasonal allergic rhinitis; Seasonal allergic rhinitis; Hay rhinitis; Chronic allergic rhinitis; Allergic diseases of the respiratory tract

J44 Other chronic obstructive pulmonary disease: Allergic bronchitis; Bronchitis allergic; Asthmatic bronchitis; Bronchitis obstructive; Disease of the bronchi; Difficult sputum separation in acute and chronic respiratory diseases; Cough with inflammatory diseases of the lungs and bronchi; Reversible bronchial obstruction; Reversible obstructive airway disease; Obstructive bronchial disease; Obstructive pulmonary disease; Obstructive bronchitis; Spastic bronchitis; Chronic lung diseases; Chronic nonspecific lung diseases; Chronic Obstructive Pulmonary Diseases; Chronic obstructive bronchitis; Chronic obstructive airways disease; Chronic obstructive pulmonary disease; Restrictive pathology of the lungs

J45 Asthma: Asthma of physical effort; Asthmatic conditions; Bronchial asthma; Bronchial asthma of light course; Bronchial asthma with difficulty in sputum discharge; Bronchial asthma of severe course; Bronchial asthma physical effort; Hypersecretory asthma; The hormone-dependent form of bronchial asthma; Curbing asthma attacks with bronchial asthma; Non-allergic bronchial asthma; Night Asthma; Exacerbation of bronchial asthma; Attack of bronchial asthma; Endogenous forms of asthma; Night attacks of asthma; Cough with bronchial asthma

L20 Atopic dermatitis: Allergic diseases of the skin; Allergic skin disease noninfectious etiology; Allergic skin disease etiology nemikrobnoy; Allergic skin diseases; Allergic skin lesions; Allergic reactions on the skin; atopic dermatitis; Allergic dermatosis; Allergic diathesis; Allergic itching dermatosis; Allergic skin disease; Allergic skin irritation; allergic Dermatitis; atopic Dermatitis; allergic dermatoses; exudative diathesis; Itchy atopic eczema Itchy allergic dermatosis; Allergic skin disease; Cutaneous allergic reaction to drugs and chemicals; Cutaneous reactions to medications; Skin and allergic disease; Acute eczema; common neurodermatitis; Chronic atopic dermatitis; Exudative diathesis

L23 Allergic contact dermatitis: Allergic dermatitis;Purulent allergic dermatopathies; Contact allergic reaction; Contact allergic dermatitis; Contact allergic dermatitis; Photoallergic contact dermatitis

L28 Simple chronic lichen and prurigo: Pox; Prurigo; Bacterial prurigo; Limited prurigo with a strong lichenization; Nodular pruritis

L29 Itching: Itching with partial obstruction of the biliary tract; Dermatitis itchy; Dermatosis with persistent itching; Other itching dermatoses; Itching dermatoses; Itching allergic dermatosis; Itching dermatitis; Itching dermatosis; Itching itch; Excruciating itching; Severe itching; Endogenous itching; Skin itching with dermatosis; Restricted itchy dermatitis; Itching of the skin; Itchy scalp; Itching eczema

L30.9 Unspecified Dermatitis: Allergic dermatoses complicated by a secondary bacterial infection; Anal eczema; Bacterial maturation; Varicose Eczema; Venous dermatitis; Inflammation of the skin; Inflammation of the skin upon contact with plants; Inflammatory Skin Disease; Inflammatory Skin Diseases; Inflammatory Skin Diseases; Inflammatory skin reactions; Inflammatory processes of the skin; Hypostatic dermatitis; Fungal Eczema; Fungal dermatosis; Dermatitis; Dermatitis is stagnant; Dermatitis and eczema in the anal area; Dermatitis acute contact; Perianal dermatitis; Dermatosis; Dermatosis of the scalp; Dermatosis of psoriasis; Dermatosis with persistent itching; Dermatoses; Dermatoses itchy; Other itching dermatoses; Significant eczematous manifestations; Itching with dermatoses; Itching eczema; Itching dermatoses; Itching dermatitis; Itching dermatosis; True eczema; Skin reaction to insect bites; Skin itching with dermatosis; Constitutional eczema; Weeping eczema; Drowsing inflammatory skin disease; Dying Infectious-Inflammatory Skin Disease; Non-allergic dermatitis; Nummular eczema; Acute contact eczema; Acute inflammatory skin disease; Acute dermatosis; Acute severe dermatosis; Perianal dermatitis; Superficial dermatosis; Subacute Contact Eczema; Simple dermatitis; Occupational dermatitis; Psychogenic dermatosis; Bubble dermatitis of newborns; Pustular eruptions; Irritation and redness of the skin; Low-flammable eczema; Dry atrophic eczema; Dry eczema; Toxic dermatitis; Ear eczema like dermatitis; Chronic eczema; Chronic dermatosis; Chronic dermatosis; Chronic common dermatosis; Scaly papular dermatosis; Eczema; Eczema anal region; Eczema of the hands; Eczema Contact; Eczema lichenized; Eczema Nummular; Eczema acute; Eczema acute contact; Eczema subacute; Eczematous dermatitis; Eczema-like rashes; Ecome exogenous; Endogenous eczema; Gluteal dermatitis; Limited itching dermatitis

M79.0 Rheumatism, unspecified: Degenerative rheumatic disease; Degenerative and rheumatic diseases of the tendons; Degenerative rheumatic diseases; Localized forms of rheumatism of soft tissues; Rheumatism; Rheumatism with a pronounced allergic component; Rheumatism of the articular and extraarticular; Rheumatic attack; Rheumatic complaints; Rheumatic diseases; Rheumatic disease; Rheumatic disease of the spine; Relapses of rheumatism; Articular and extra-articular rheumatism; Articular and muscular rheumatism; Articular rheumatism; Articular syndrome with rheumatism; Chronic rheumatic pain; Chronic articular rheumatism; Rheumatoid diseases; Rheumatic diseases of the intervertebral disc

R11 Nausea and vomiting: Postoperative vomiting; Nausea; Vomiting; Vomiting in the postoperative period; Vomiting medication; Vomiting in the background of radiation therapy; Vomiting uncontrollable; Vomiting in radiation therapy; Persistent vomiting; Indomitable vomiting; Postoperative nausea; Vomiting with chemotherapy; Vomiting of the central genesis; Vomiting with cytotoxic chemotherapy; Persistent hiccups; Repeated vomiting

R42 Dizziness and disturbance stability: vertigo; Dizziness; Dizziness and nausea during travel on transport; disorders of balance; vestibular disorders; disequilibrium; Ischemic disorders of hearing and balance

R45.1 Anxiety and agitation: Agitation; Anxiety; Explosive excitability; Internal stimulation; Excitability; Excitation; Excitation acute; Psychomotor agitation; Hyperexcitability; Motor excitement; Cessation of psychomotor agitation; Nervous excitement; Restlessness; Night trouble; Acute stage of schizophrenia with excitation; Acute mental agitation; Paroxysm of excitation; Overexcitation; Increased excitability; Increased nervous excitability; Increased emotional and cardiac excitability; Increased agitation; Mental arousal; Psychomotor agitation; Psychomotor agitation in psychoses; Psychomotor agitation of an epileptic nature; Psychomotor paroxysm; Psychomotor fit; Symptoms of Excitation; Symptoms of psychomotor agitation; The state of agitation; A state of anxiety; Excitation status; A state of heightened concern; The state of psychomotor agitation; Conditions of anxiety; Excitation conditions; The state of excitement in somatic diseases; Excitation level; Feelings of anxiety; Emotional arousal

R50 Fever of unknown origin: Malignant hyperthermia; Hyperthermia malignant

T75.3 Motion Slewing: Movement Disease; Disease of the air; Disease of the sea; Kinetosis; Airsickness; Seasickness; Swaying; Symptoms of motion sickness; Kinetosis; The motion sickness syndrome

T78.2 Anaphylactic shock, unspecified: Anaphylactic shock; Anaphylactoid reaction; Anaphylactoid shock; Anaphylactic shock; Anaphylactic reactions; Anaphylactic shock to drugs

T78.3 Angioedema: Edema Quincke; Laryngeal exacerbation with angioneurotic edema; Recurrent angioedema; Allergic edema; Recurrent swelling of Quincy

T78.4 Unspecified Allergy: Allergic reactions to insulin; Allergic reactions to insect stings; Allergic reactions similar to systemic lupus erythematosus; Allergic diseases; Allergic diseases of mucous membranes; Allergic diseases and conditions resulting from increased release of histamine; Allergic diseases of mucous membranes; Allergic symptoms; Allergic symptoms in the mucous membranes; Allergic reactions; Allergic reactions caused by insect bites; Allergic reactions; Allergic conditions; Allergic laryngeal edema; allergopathy; allergic conditions; Allergy; House dust allergy; Anaphylaxis; Cutaneous reactions to medications; Skin reaction to insect stings; Cosmetic allergy; Drug allergy; Acute allergic reaction; Laryngeal edema allergic genesis and background radiation; Food and drug allergy

T80.6 Other serum reactions: Serum disease; Allergic reaction like serum sickness; Serous disease accelerated

W57 Bite or sting with a non-toxic insect and other non-venous arthropods: An allergic reaction to insect bites; Skin reaction after insect bite; Reactions to insect bites; Mosquito bite; Bite of bloodsucking insects; A bite of an insect; The bite of the wasp

Y57 Adverse reactions in the therapeutic use of other and unspecified drugs and medications

Z100 * CLASS XXII Surgical practice: Abdominal surgery; adenomectomy; Amputation; Coronary angioplasty; Angioplasty of the carotid arteries; Antiseptic skin treatment for wounds; Antiseptic Hand; Appendectomy; atherectomy; Balloon coronary angioplasty; Vaginal hysterectomy; The coronary bypass; Interventions in the vagina and cervix; Interventions on the bladder; Intervention in the mouth; Restoration and reconstructive surgery; Hand hygiene of medical personnel; Gynecologic surgery; Gynecological intervention; Gynecological surgery; Hypovolemic shock during operations; Disinfection of purulent wounds; Disinfection of wounds edges; Diagnostic intervention; Diagnostic procedures; Cervical Diathermocoagulation; Long-surgery; Replacing the fistula catheters; Infection in orthopedic surgery; Artificial heart valve; cystectomy; Short-term outpatient surgery; Short-term operation; Short surgical procedures; Krikotireotomiya; Blood loss during surgery; Bleeding during surgery and in the postoperative period; Kuldotsentez; laser photocoagulation; laser coagulation; retinal laser coagulation; Laparoscopy; Laparoscopy in Gynecology; CSF fistula; Small gynecological operations; Small surgical procedures; Mastectomy and subsequent plastic; mediastinotomy; Microsurgical operations on the ear; Mukogingivalnye operation; suturing; Minor surgery; neurosurgical operation; Immobilization of the eyeball in ophthalmic surgery; testectomy; pancreatectomy; Perikardektomiya; The period of rehabilitation after surgery; The period of convalescence after surgery; Percutaneous transluminal coronary angioplasty; Pleural thoracentesis; Pneumonia postoperative and posttraumatic; Preparation for surgical procedures; Preparation for surgery; Preparation of the surgeon's hands before surgery; Preparation of the colon for surgical procedures; Postoperative aspiration pneumonia in neurosurgical and thoracic surgery; Postoperative nausea; Postoperative bleeding; postoperative granuloma; postoperative shock; The early postoperative period; myocardial revascularization; Radiectomy; gastric Resection; bowel resection; uterine Resection; liver Resection; enterectomy; Resection of part of the stomach; Reocclusion of the operated vessel; Bonding tissues during surgical procedures; Removal of sutures; Condition after eye surgery; Condition after surgery; Condition after surgery in the nasal cavity; Condition after gastrectomy; Status after resection of the small intestine; Condition after tonsillectomy; Condition after removal of the duodenum; Condition after phlebectomy; Vascular surgery; Splenectomy; Sterilization of surgical instruments; Sterilization of surgical instruments; sternotomy; Dental surgery; Dental intervention in periodontal tissues; strumectomy; Tonsillectomy; Thoracic surgery; Thoracic surgery; total gastrectomy; Transdermal intravascular coronary angioplasty; Transurethral resection; Turbinektomiya; Removal of a tooth; cataract surgery; Removal of cysts; tonsillectomy; Removal of fibroids; Removing the mobile primary teeth; Removing polyps; Removing broken tooth; Removal of the uterus body; Removal of sutures; Fistula likvoroprovodyaschih ways; Frontoetmoidogaymorotomiya; Surgical infection; Surgical treatment of chronic limb ulcers; Surgery; The surgery in the anal area; The surgery on the colon; Surgical practice; The surgical procedure; Surgical interventions; Surgery on the gastrointestinal tract; Surgical procedures on the urinary tract; Surgical procedures on the urinary system; Surgical intervention of the genitourinary system; Surgical procedures on the heart; Surgical manipulation; surgery; Surgery on the veins; Surgical intervention; Vascular surgery; Surgical treatment of thrombosis; Surgery; cholecystectomy; Partial gastric resection; hysterectomy; Percutaneous transluminal coronary angioplasty; Percutaneous transluminal angioplasty; Coronary artery bypass; tooth Extirpation; Extirpation of milk teeth; pulpectomy; pulsative cardiopulmonary bypass; tooth Extraction; teeth Extraction; cataract extraction; Electrocoagulation; endourological intervention; episiotomy; Etmoidotomiya; Complications after tooth extraction

CAS Code

60-87-7

Characteristics of the substance Dimetindene

The phenothiazine derivative. Crystalline powder of white or soft yellow color, odorless. Slowly oxidized in air, becoming blue. Very easily soluble in water, very soluble in alcohol.

Pharmacology

Pharmacological action - antiallergic, local anesthetic, antihistamine, antipruritic, antiemetic, hypnotic, sedative.

Competitively blocks H1-histamine receptors, has antiexudative, anti-allergic, anti-inflammatory, local anesthetic effect. Reduces the permeability of capillaries, swelling of the mucous membranes, itching. Has adrenolytic, moderate peripheral and central cholinolytic action. Inhibits histamine-N-methyltransferase, blocks central histamine H3 receptors. Oppresses the central nervous system, has a sedative, anxiolytic, antipsychotic and hypnotic effect, lowers body temperature. Reduces the excitability of the vestibular receptors, depresses the function of the labyrinth, eliminates dizziness. The antiemetic effect is due to blockade of the receptors of the chemoreceptor zone of the medulla oblongata. It penetrates through the BBB. At appointment for 2 weeks before sorts or labors can oppress an aggregation of thrombocytes at newborns. In experimental studies, there was no mutagenic effect and adverse effects on fetal development.

Quickly and completely absorbed from the digestive tract. When ingestion effects are manifested after 15-60 minutes, with the / m introduction - after 20 minutes, with the / in - in 3-5 minutes. The duration of action is 4-6 hours (after oral administration - up to 12 hours). It binds to blood plasma proteins by 65-90%. Metabolised in the liver and, partially, in the kidneys, with the formation of promoxazine sulfoxides, N-desmethylpromethazine and other derivatives. T1 / 2 - 7-14 hours. It is excreted mainly with urine, incl. In the form of metabolites.

Application of the substance Promethazine

Allergic dermatosis, prurigo, eczema, exudative diathesis, urticaria, rash and other skin allergic reactions to medicinal and chemical preparations, itching, allergic conjunctivitis, allergic rhinitis, pollinosis, bites of bees, bees, scorpions, bumblebees, serum sickness, angioedema, false groats , Asthmatic bronchitis, atopic bronchial asthma, anaphylactic and anaphylactoid reactions (as part of complex therapy), rheumatism with a pronounced allergic component; Meniere's syndrome, dizziness, nausea and vomiting, motion sickness syndrome; Anxiety, neuroses and neurosis-like conditions, psychoses, insomnia, extrapyramidal disorders (against the background of neuroleptics), neuralgia of the trigeminal nerve, migraine, chorea, hyperthermia; Premedication and postoperative period (as a sedative, for artificial hibernation, potentiation of anesthesia and local anesthesia), study of gastric secretion (when used as a stimulant secretion of histamine).

Contraindications

Hypersensitivity (including to other phenothiazines), coma, simultaneous use of MAO inhibitors and the period within 14 days after completion of their intake, alcohol intoxication, hepatic and / or renal failure, pregnancy, breast-feeding, episodic vomiting in children Unspecified genesis, early childhood to 2 months (for parenteral administration), children under 6 years (for oral administration).

Restrictions

Jaundice, prostatic hypertrophy, predisposition to urinary retention, stenosis of the neck of the bladder, open-angle or angle-closure glaucoma, peptic ulcer disease, lower respiratory tract diseases, bone marrow depression, cardiovascular diseases (severe angina, hypertension, Decompensated chronic heart failure, ciliary tachyarrhythmia), epilepsy, sleep apnea syndrome, Reye syndrome, pregnancy, yu, old age.

Application in pregnancy and breastfeeding

Contraindicated in pregnancy.

Action category for fetus by FDA - C.

For the duration of treatment, breastfeeding should be stopped.

Side effects of the substance Promethazine

From the nervous system and sensory organs: sedation, dizziness, drowsiness, anxiety, agitation, nightmares, more frequent nighttime apnea; Rarely - disorientation, confusion, extrapyramidal disorders, increased convulsive activity (in children); Disturbance of accommodation and sight, noise or ringing in the ears.

From the side of the cardiovascular system and blood (hematopoiesis, hemostasis): orthostatic hypotension (with intravenous administration), hypertension, tachycardia or bradycardia; Rarely - leukopenia, thrombocytopenia, agranulocytosis.

On the part of the digestive tract: anesthesia and dry mouth, nausea, vomiting, cholestasis, constipation.

On the part of the respiratory system: dryness in the nose, pharynx.

From the genitourinary system: rarely - labored or painful urination.

Allergic reactions: urticaria, dermatitis, asthma.

Other: increased sweating, photosensitivity, soreness (with an / m introduction).

Interaction

Strengthens the effects of analgesics, hypnotics, tranquilizers, neuroleptics, anesthesia, local anesthetics, m-holinoblokatorov, hypotensive drugs (requires dose adjustment). Weaken the action of derivatives of amphetamine, m-cholinomimetics, anticholinesterase drugs, ephedrine, guanethidine, levodopa, dopamine. Barbiturates accelerate elimination and decrease activity. Beta-adrenoblockers increase (mutually) the concentration in the plasma (possible severe hypotension, arrhythmias, irreversible retinopathy, tardive dyskinesia). Weaken the effect of bromocriptine and increase the concentration of prolactin in the serum. Tricyclic antidepressants and anticholinergic agents potentiate m-holinoblokiruyuschee activity, ethyl alcohol, clonidine, antiepileptic drugs - oppression of the central nervous system. MAO inhibitors (concurrent use is not recommended) and phenothiazine derivatives increase the risk of hypotension and extrapyramidal disorders. Quinidine increases the likelihood of cardiodepressive action.

Overdose

Symptoms: skin hyperemia, dyspnea, dry mucous membranes, mydriasis, anxiety, motor hyperactivity, agitation, delirium (in children), extrapyramidal disorders, tremor, epileptiform seizures (rare), hypotension, respiratory depression, loss of consciousness.

Treatment: induction of vomiting, gastric lavage, the appointment of activated charcoal, saline laxatives (with ingestion), intravenous fluids; Monitoring and maintenance of vital functions; Symptomatic therapy: vasoconstrictor (with hypotension), oxygen (to maintain adequate oxygenation).

It is not recommended the use of analeptics (can cause seizures) and epinephrine (possibly strengthening hypotension). When developing extrapyramidal reactions, anticholinergics used to treat Parkinson's disease, diphenhydramine or barbiturates are used. Dialysis is ineffective.

Routes of administration

Inside (after eating), IM, IV.

Precautions for the substance Promethazine

Can suppress cough reflex, so caution is necessary in patients (especially children) with exacerbation of chronic respiratory diseases. With caution should be used in people with impaired liver function, diseases of the cardiovascular system and oppression of bone marrow hematopoiesis. In the elderly, caution is necessary for parenteral administration of high doses, because Extrapyramidal disorders and acute urinary retention are possible. With prolonged use, the cellular composition of the peripheral blood should be periodically monitored. As an antiemetic it is necessary to use only with prolonged vomiting of a known etiology. To prevent oppression of the central nervous system, caffeine is recommended. With prolonged use, the risk of developing dental diseases (caries, periodontitis, candidiasis) is increased due to a decrease in salivation. May mask ototoxic effect (tinnitus and dizziness) of the drugs used together. Increases the need for riboflavin. Do not use during work drivers of vehicles and people whose profession is associated with increased concentration of attention (especially at the beginning of the course). It is necessary to exclude the use of alcohol at the time of treatment.

Special instructions

The solution is not intended for intra / a and / or administration. Some dosage forms of promethazine contain sodium metabisulphite, which can cause allergic reactions, including anaphylactoid and asthmatic. To prevent distortion of skin scarification test results for allergens, it is necessary to cancel 72 hours prior to allergological testing. During treatment, false-positive pregnancy test results are possible.