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ANALDYM
Release form
Rectal suppositories
For children
Used for children over 1 year old.
For pregnant women
Contraindicated
For nursing mothers
Contraindicated
For drivers
Contraindicated
Storage temperature
to 25 °C
INSTRUCTION
storage
active substances:metamizole sodium, diphenhydramine hydrochloride; 1 suppository contains metamizole sodium (analgin) 100 mg or 250 mg, diphenhydramine hydrochloride (diphenhydramine) 10 mg or 20 mg, respectively; auxiliary substances: solid fat, emulsifier No. 1.
Medicinal form
Rectal suppositories. Main physicochemical properties: suppositories from white to white with a yellowish or cream tint.
Pharmacotherapeutic group
Analgesics and antipyretics. ATX code N02B B52.
Pharmacological properties
Pharmacodynamics. Analgin - a derivative of pyrazolone - has a pronounced analgesic and antipyretic effect due to inhibition of the synthesis of bradykinin and prostaglandins. Diphenhydramine has an antihistamine, sedative, central cholinolytic, anti-inflammatory effect. In addition, diphenhydramine potentiates the effect of analgin. Pharmacokinetics. Analgin and diphenhydramine are quickly absorbed in the rectum, and their peak concentrations are formed in the blood quickly (within 1–2 hours). Analgin and diphenhydramine are widely distributed in the body and easily penetrate the central nervous system. Analgin is excreted from the body with urine in an unchanged state and in compounds with sulfuric and glucuronic acids; Diphenhydramine is metabolized in the liver. The effect of the drug is manifested within 5-6 hours after its use.
Indication
Pains of various origins (headache, pain from burns, neuralgia, radiculitis, myositis, pain in the postoperative period), high body temperature.
Contraindication
Pronounced disorders of liver or kidney function, blood diseases (anemia of any etiology, cytostatic or infectious neutropenia; agranulocytosis, leukopenia), glucose-6-phosphate dehydrogenase deficiency, rhinitis, conjunctivitis or bronchospasm when taking nonsteroidal anti-inflammatory drugs, bronchial asthma, increased sensitivity to the drug, suspicion of acute surgical pathology, hypersensitivity to other antihistamines, pheochromocytoma, epilepsy, congenital long QT interval syndrome or long-term use of drugs that can prolong the QT interval, angle-closure glaucoma, prostate hyperplasia, stenotic gastric ulcer and duodenum, bladder neck stenosis, bradycardia, heart rhythm disturbances, hypersensitivity to other pyrazolone derivatives (butadione, tribuzone, antipyrine).
Interaction with other medicinal products and other forms of interaction
Diphenhydramine Enhances the effect of ethanol and drugs that depress the central nervous system: neuroleptics, tranquilizers, sleeping pills, analgesics, narcotics. Monoamine oxidase inhibitors enhance the anticholinergic activity of Diphenhydramine. Antagonistic interaction is noted when combined with psychostimulants. The use of Diphenhydramine together with antihypertensive drugs can increase the feeling of fatigue. Reduces the effectiveness of apomorphine as an emetic in the treatment of poisoning. Enhances the anticholinergic effects of drugs with m-cholinergic activity. It should not be prescribed together with drugs that contain diphenhydramine, including for local use. With simultaneous use with analeptics, the risk of convulsions increases. With the simultaneous use of diphenhydramine with tricyclic antidepressants, its m-cholinergic effect can be enhanced, which can lead to an increase in intraocular pressure in glaucoma. Metamizole sodium Radiopaque substances, colloidal blood substitutes, penicillin should not be used during treatment with metamizole sodium. Chlorpromazine or other phenothiazine derivatives may cause severe hypothermia. Indirect anticoagulants, phenytoin, glucocorticosteroids, indomethacin, ibuprofen - sodium metamizole increases the activity of these drugs by displacing them from the connection with the protein. Phenylbutazone, glutethimide, barbiturates and other inducers of microsomal liver enzymes - the effectiveness of metamizole sodium decreases. Tricyclic antidepressants, hormonal contraceptives and allopurinol, alcohol may increase the toxicity of metamizole sodium. Metamizole sodium enhances the sedative effect of alcohol. Other non-steroidal anti-inflammatory drugs (NSAIDs) – potentiate their analgesic and antipyretic effects and increase the likelihood of additive unwanted side effects. Sedatives and tranquilizers (sibazone, trioxazine, valocordin), codeine, histamine H2-receptor blockers, propranolol enhance the analgesic effect of metamizole sodium. Sarcolysin, Mercazolil, Thiamazole, drugs that inhibit bone marrow activity, including gold drugs, increase the likelihood of hematotoxicity, including the development of leukopenia. Methotrexate - metamizole in high doses can lead to an increase in the concentration of methotrexate in the blood plasma and increase its toxic effects (primarily on the digestive tract and hematopoietic system). Cyclosporine - the concentration of cyclosporine in the blood plasma decreases. Sulfonylamide oral hypoglycemic drugs - their hypoglycemic effect may be enhanced when used together with NSAIDs, including metamizole sodium. Diuretics (furosemide) - a possible decrease in the diuretic effect.
Features of use
It is prescribed with caution to patients who are engaged in activities that require the speed of psychomotor reactions. Use during pregnancy or breastfeeding. The drug is contraindicated during pregnancy. Breastfeeding should be stopped during treatment. The ability to influence the speed of reaction when driving vehicles or other mechanisms. During treatment with the drug, you should avoid driving vehicles and other mechanisms.
Methods of application
The drug is injected into the rectum. Frequency of use – 1–3 suppositories per day. Children aged 1–4 years are prescribed 1 suppository containing 100 mg of analgin and 10 mg of diphenhydramine. Children over 5 years of age and adults are prescribed suppositories containing 250 mg of analgin and 20 mg of diphenhydramine; children over 5 years old – 1 suppository, adults – 1–2 suppositories. The duration of treatment is set individually. The drug is used to relieve the symptoms of fever and pain; usually - from 1 to 3-4 days.
Overdose
Symptoms: hypothermia, palpitations, pronounced decrease in blood pressure, tachycardia, dysphagia, shortness of breath, tinnitus, nausea, vomiting, gastralgia/gastritis, weakness, drowsiness, delirium, impaired consciousness, convulsive syndrome; possible development of acute agranulocytosis, hemorrhagic syndrome, oliguria, anuria, acute renal or hepatic failure, paralysis of respiratory muscles. Treatment: withdrawal of the drug, induction of vomiting, gastric lavage, administration of saline laxatives, enterosorbents, forced diuresis, symptomatic therapy aimed at maintaining vital functions. In severe cases, hemodialysis, hemoperfusion, peritoneal dialysis is possible. At the first symptoms of overdose, you should immediately seek medical help!
Side effects
From the side of the skin and subcutaneous tissue: severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) have been reported with metamizole (see section 4.4). The frequency is unknown. On the part of the hepatobiliary system: increased activity of hepatic transaminases, impaired liver function, hepatitis, jaundice, drug-induced liver damage, including acute hepatitis (see section "Particulars of use"). From the side of the immune system: allergic reactions, skin rashes (papular, small papular, erythematous-urticarial), urticaria, skin itching, Quincke's edema, contact dermatitis, rashes on mucous membranes, conjunctivitis, skin hyperemia, angioneurotic edema, bronchospastic syndrome , anaphylactic shock, Stevens-Johnson syndrome, Lyell's syndrome. From the side of the central nervous system: due to the action of Diphenhydramine - drowsiness, insomnia, decreased attention, decreased speed of psychomotor reactions, anxiety, impaired coordination of movements, increased excitability (especially in children), nervousness, irritability, euphoria, confusion, tremors, sweating, chills , neuritis, convulsions, paresthesias, pupil dilation, diplopia, visual disturbances, acute labyrinthitis, tinnitus, dizziness, headache, numbness of the mucous membrane of the oral cavity, general weakness. From the side of the blood system: suppression of hematopoiesis is possible (thrombocytopenia, granulocytopenia, leukopenia, hemolytic anemia, hemolytic jaundice - agranulocytosis). From the gastrointestinal tract: dry mouth, nausea, vomiting, pain in the epigastrium, diarrhea, constipation. From the urinary system: frequent and/or difficult urination, urinary retention, transient oliguria, anuria, proteinuria, interstitial nephritis. From the side of the cardiovascular system: compression in the chest, palpitations, tachycardia, extrasystole, difficulty breathing, decrease in blood pressure. On the part of the respiratory system: with a tendency to bronchospasm, it is possible to provoke an attack. Other: increased frequency of menstruation, early menstruation; dryness in the nose and throat, nasal congestion; thickening of bronchial secretions; photosensitization, dry eyes; hepatitis; anorexia; increased intraocular pressure.
Expiration date
2 years.
Storage conditions
Store in the original packaging at a temperature not higher than 25 °C. Keep out of the reach of children.
Packaging
5 suppositories in a strip. 2 strips in a cardboard pack.
Leave category
By prescription
Producer
Monfarm PJSC.
Address
Ukraine, 19161, Cherkasy region, Uman district, village Avramivka, str. Zavodska, 8.