Instructions Analdim rectal suppositories 250 mg + 20 mg strip No. 10
Composition
active ingredients: metamizole sodium, diphenhydramine hydrochloride;
1 suppository contains metamizole sodium (analgin) 250 mg, diphenhydramine hydrochloride (dimedrol) 20 mg, respectively;
excipients: solid fat, emulsifier N1.
Dosage 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 pyrazolone derivative - has a pronounced analgesic and antipyretic effect, which is due to the inhibition of the synthesis of bradykinin, prostaglandins. Diphenhydramine has antihistamine, sedative, central anticholinergic, anti-inflammatory effects. In addition, diphenhydramine potentiates the effect of analgin.
Pharmacokinetics
Analgin and diphenhydramine are rapidly absorbed in the rectum, and their peak concentrations are quickly (within 1–2 hours) formed in the blood. Analgin and diphenhydramine are widely distributed in the body, easily penetrating 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 manifests itself within 5–6 hours after its use.
Indication
Pain of various origins (headache, pain from burns, neuralgia, radiculitis, myositis, pain in the postoperative period), high body temperature.
Contraindication
Severe liver or kidney dysfunction, 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, hypersensitivity to the drug, suspicion of acute surgical pathology, hypersensitivity to other antihistamines, pheochromocytoma, epilepsy, congenital long QT syndrome or long-term use of drugs that can prolong the QT interval, angle-closure glaucoma, prostatic hyperplasia, stenosing gastric and duodenal ulcers, bladder neck stenosis, bradycardia, cardiac arrhythmias, hypersensitivity to other pyrazolone derivatives (butadione, tribuzone, antipyrine).
Special safety precautions
Metamizole sodium: do not exceed the recommended doses of the drug.
Do not use the drug to relieve acute abdominal pain (until the cause is determined).
Since metamizole sodium has anti-inflammatory and analgesic properties, it can mask signs of infection, symptoms of non-infectious diseases and complications with pain syndrome, which can make their diagnosis difficult.
When using the drug, you should refrain from drinking alcoholic beverages. Use in children should be carried out under the constant supervision of a doctor. The drug should be used with caution in patients: elderly - may lead to an increase in the frequency of adverse reactions, especially from the digestive tract; with existing allergic diseases (including pollinosis) or with these diseases in history - the risk of allergic reactions increases; with impaired renal function, with a history of kidney diseases (pyelonephritis, glomerulonephritis); with inflammatory bowel diseases, including nonspecific ulcerative colitis and Crohn's disease; with severe arterial hypotension, cardiovascular failure; with chronic alcoholism; with simultaneous use of cytostatic drugs (only under the supervision of a doctor).
When used in children, constant medical supervision is required. It is necessary to monitor the qualitative and quantitative composition of peripheral blood.
Patients should be warned before starting treatment that if chills, fever, sore throat, difficulty swallowing, bleeding gums, pale skin, asthenia, vaginitis or proctitis develop without any apparent cause, the use of the drug should be discontinued immediately. The use of the drug should also be discontinued at the first rash on the skin and mucous membranes. If these symptoms appear, you should immediately consult a doctor.
When taking the drug, urine may turn red due to the excretion of the metabolite metamizole sodium.
Diphenhydramine: Use with caution in patients with hyperthyroidism, patients with chronic obstructive pulmonary disease, with increased intraocular pressure, diseases of the cardiovascular system, and in elderly patients.
The drug may cause dry eyes and discomfort when wearing contact lenses.
During treatment with the drug, the use of alcoholic beverages is contraindicated, and exposure to UV radiation should be avoided. The use of diphenhydramine as an antiemetic may complicate the diagnosis of appendicitis and the recognition of symptoms of overdose with other drugs.
Regular long-term use of the drug is not recommended due to the myelotoxicity of metamizole sodium salt.
Interaction with other medicinal products and other types of interactions
Enhances the effect of ethanol and drugs that depress the central nervous system: neuroleptics, tranquilizers, hypnotics, analgesics, narcotics. Monoamine oxidase inhibitors enhance the anticholinergic activity of diphenhydramine.
Antagonistic interaction is observed when used together with psychostimulants. The use of diphenhydramine together with antihypertensive drugs may 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-cholinoblocking activity. Should not be prescribed together with drugs containing diphenhydramine, including those for topical use. When used together with analeptics, the risk of seizures increases.
When used together with tricyclic antidepressants, diphenhydramine may enhance its m-cholinoblocking effect, which can lead to increased intraocular pressure in glaucoma.
Metamizole sodium
X-ray contrast agents, colloidal blood substitutes, and penicillin should not be used during treatment with metamizole sodium.
Chlorpromazine or other phenothiazine derivatives - possible development of severe hypothermia.
Indirect anticoagulants, phenytoin, glucocorticosteroids, indomethacin, ibuprofen - metamizole sodium increases the activity of these drugs by displacing them from protein binding.
Phenylbutazone, glutethimide, barbiturates and other inducers of liver microsomal enzymes - the effectiveness of metamizole sodium is reduced.
Tricyclic antidepressants, hormonal contraceptives and allopurinol, alcohol - possible increase in the toxicity of metamizole sodium. Metamizole sodium enhances the sedative effect of alcohol.
Other nonsteroidal anti-inflammatory drugs (NSAIDs) – their analgesic and antipyretic effects are potentiated and the likelihood of additive undesirable side effects increases.
Sedatives and tranquilizers (sibazon, trioxazine, valocordin), codeine, histamine H2 receptor blockers, propranolol enhance the analgesic effect of metamizole sodium.
Sarcolysin, mercazolil, thiamazole, drugs that suppress bone marrow activity, including gold preparations, 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 an increase in its toxic effects (primarily on the digestive tract and the hematopoietic system). Cyclosporine - the concentration of cyclosporine in the blood plasma decreases.
Sulfonamide oral hypoglycemic drugs - their hypoglycemic effect may be enhanced when used together with NSAIDs, including metamizole sodium. Diuretics (furosemide) - a decrease in the diuretic effect is possible.
Application features
It is prescribed with caution to patients who engage in activities that require speed of psychomotor reactions.
Ability to influence reaction speed when driving vehicles or other mechanisms
During treatment with the drug, driving and other mechanisms should be avoided.
Use during pregnancy or breastfeeding
The drug is contraindicated during pregnancy. Breastfeeding should be discontinued during treatment.
Method of administration and doses
The drug is administered rectally. The frequency of use is 1–3 suppositories per day.
Children aged 1–4 years are prescribed 1 suppository containing 100 mg of analgin and 10 mg of dimedrol.
Children over 5 years of age and adults are prescribed suppositories containing 250 mg of analgin and 20 mg of dimedrol; children over 5 years of age - 1 suppository, adults - 1-2 suppositories.
The duration of treatment is determined individually. The drug is used until the symptoms of fever and pain are relieved; usually from 1 to 3–4 days.
Children
Used for children aged 1 year and over.
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 the respiratory muscles.
Treatment: drug withdrawal, induction of vomiting, gastric lavage, administration of saline laxatives, enterosorbents, forced diuresis, symptomatic therapy aimed at supporting vital functions. In severe cases, hemodialysis, hemoperfusion, peritoneal dialysis are possible.
At the first symptoms of overdose, you should immediately seek medical help!
Adverse reactions
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, tremor, sweating, chills, neuritis, seizures, paresthesia, dilated pupils, diplopia, visual impairment, acute labyrinthitis, tinnitus, dizziness, headache, numbness of the oral mucosa, general weakness.
On the part of the blood system: possible inhibition of hematopoiesis (thrombocytopenia, granulocytopenia, leukopenia, hemolytic anemia, hemolytic jaundice - agranulocytosis).
Gastrointestinal: dry mouth, nausea, vomiting, epigastric pain, diarrhea, constipation.
On the part of the urinary system: frequent and/or difficult urination, urinary retention, transient oliguria, anuria, proteinuria, interstitial nephritis.
Cardiovascular system: chest tightness, palpitations, tachycardia, extrasystole, difficulty breathing, decreased blood pressure.
On the part of the respiratory system: with a tendency to bronchospasm, an attack may be provoked.
Other: increased menstrual frequency, early menstruation; dry nose and throat, nasal congestion; thickening of bronchial secretions; photosensitivity, dry eyes; hepatitis; anorexia; increased intraocular pressure.
Expiration date
2 years.
Storage conditions
Store in original packaging at a temperature not exceeding 15 °C.
Keep out of reach of children.
Packaging
5 suppositories in a strip. 2 strips in a cardboard pack.
Vacation category
According to the recipe.
Producer
PJSC "Monpharm".
Location of the manufacturer and its business address
Ukraine, 19100, Cherkasy region, Monastyryshche, Zavodska st., 8.
