Instructions for Dramamine tablets 50 mg No. 10
Composition
active ingredient: dimenhydrinate;
1 tablet contains 50 mg of dimenhydrinate;
excipients: microcrystalline cellulose; magnesium stearate; lactose monohydrate;
povidone; crospovidone.
Dosage form
Pills.
Main physicochemical properties: round, flat, white tablets with bevels and a score on one side.
Pharmacotherapeutic group
Antihistamines for systemic use.
ATX code R06A A02.
Pharmacological properties
Pharmacodynamics
Dimenhydrinate belongs to ethanolamine derivatives. Dimenhydrinate is a blocker of H1-receptors, has antiemetic, sedative, antimuscarinic, antihistamine effects. Reduces the excitability of the vomiting center of the central nervous system.
Pharmacokinetics
After oral administration, dimenhydrinate is rapidly absorbed. Maximum plasma concentration is reached 15-30 minutes after administration and persists for 4-6 hours.
Approximately 98–99% of dimenhydrinate is bound to plasma proteins. Dimenhydrinate crosses the placental barrier and is excreted in breast milk.
Dimenhydrinate is metabolized mainly in the liver. It is excreted from the body within 24 hours, mainly in the form of metabolites, to a lesser extent - unchanged by the kidneys. The half-life from blood plasma is almost 5-10 hours.
Indication
Prevention and elimination of nausea and vomiting due to sea and air sickness, during radiation therapy, medications, and after surgery.
Symptomatic treatment of Meniere's disease and other vestibular disorders.
Contraindication
Hypersensitivity to dimenhydrinate and other antihistamines of similar structure or to any of the excipients included in the product.
Narrow-angle glaucoma, increased intracranial pressure, pheochromocytoma, porphyria, prostatic hyperplasia with urinary retention, convulsions (eclampsia, epilepsy), acute attack of bronchial asthma, severe hepatic insufficiency, severe renal insufficiency (creatinine clearance ≤ 25 mmol/min), children under 2 years of age.
Interaction with other medicinal products and other types of interactions
Simultaneous intake of alcohol with dimenhydrinate should be avoided, as it may alter and enhance the effects of dimenhydrinate.
Dimenhydrinate may enhance the anticholinergic effects of other drugs (e.g. atropine, antiparkinsonian drugs, tricyclic antidepressants) and the central nervous system (CNS) depressant effects of drugs such as barbiturates, hypnotics, sedatives, tranquilizers, antidepressants, morphine derivatives (analgesics, antitussives, drugs for substitution therapy), benzodiazepines, neuroleptics, centrally acting antihypertensive drugs, baclofen, thalidomide.
The drug may enhance the CNS depressant effect of antiepileptic drugs.
Concomitant administration with monoamine oxidase inhibitors (MAOIs) may enhance the anticholinergic effects of dimenhydrinate; in isolated cases, paralytic syndrome (sometimes life-threatening), urinary retention, increased intraocular pressure, and possible reduction in blood pressure, central nervous system sedation, and respiratory depression have been reported.
The drug enhances the effect of diazepam, leads to an action opposite to the action of amphetamines and their derivatives. Taking dimenhydrinate reduces the effectiveness of corticosteroid drugs and oral anticoagulants.
Concomitant use with bismuth-containing drugs, analgesics and psychotropic drugs, as well as scopolamine may cause visual impairment.
Particular caution should be exercised when prescribing to patients who are treated with drugs that prolong the QT interval (class I and II antiarrhythmics, some antibiotics, e.g. erythromycin, antimalarials, antihistamines, drugs with neuroleptic effects) or drugs that cause hypokalemia (e.g. some specific diuretics).
Dimenhydrinate may mask the side effects of ototoxic drugs, such as aminoglycosides.
Dimenhydrinate therapy should be discontinued at least three days before allergy testing, as its use may result in a false-negative result.
Application features
With special caution, the drug should be prescribed to patients suffering from: liver and kidney diseases, hyperthyroidism, bradycardia, arterial hypertension, chronic respiratory diseases, bronchial asthma, hypokalemia, hypomagnesemia, pyloric stenosis and pyloroduodenal obstruction, gastric ulcer, intestinal obstruction, congenital QT prolongation syndrome or other clinically significant heart disorders (cardiovascular diseases, circulatory disorders, arrhythmias), while taking other drugs that lead to QT prolongation or hypokalemia. With caution, the drug should be prescribed to elderly patients with a higher tendency to develop orthostatic hypotension, obesity and sedative therapy, chronic constipation (risk of developing paralytic syndrome), potential prostatic hypertrophy, Pankirson's disease. Such patients should take the lowest recommended adult dose because they are sensitive to the anticholinergic effects of the drug.
This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Use during pregnancy or breastfeeding
The drug is contraindicated during pregnancy.
Dimenhydrinate passes into breast milk in small amounts, so breastfeeding should be discontinued during treatment.
The ability to influence the reaction speed when driving or working with other mechanisms
Taking the drug may cause drowsiness, impaired coordination of movements, dizziness, increased reaction time, and visual impairment, therefore, while using the drug, you should refrain from driving vehicles or working with mechanisms with an increased risk of injury.
Method of administration and doses
Prevention and elimination of nausea and vomiting due to sea and air sickness, during radiation therapy, medications, and after surgery.
Adults and children over 12 years of age: 50 mg (1 tablet) 30-60 minutes before the start of the trip, then, if necessary, 50-100 mg every 4-6 hours, but not more than 400 mg/day.
Children aged 6 to 12 years: 25-50 mg (1/2-1 tablet) every 6-8 hours as needed, but not more than 150 mg/day.
Children aged 2 to 6 years: 25 mg (1/2 tablet) every 6-8 hours as needed, but not more than 75 mg/day.
For Meniere's disease and other vestibular disorders.
Adults: 50-100 mg (1-2 tablets) every 4-6 hours as needed, not to exceed a maximum daily dose of 400 mg (8 tablets).
Elderly patients should use an initial dose of 25 mg (1/2 tablet).
Use with caution in patients with renal and/or hepatic insufficiency. In hepatic insufficiency, the dose should be reduced by 2 times.
Children
The safety and efficacy of the drug in children under 2 years of age have not been established, therefore the drug is not prescribed to children in this age category.
Overdose
Symptoms: The first symptoms of overdose appear within 30 minutes to
2 hours after taking a toxic dose (25 mg/kg body weight), and manifest mainly as headache, dizziness, fatigue and drowsiness.
After some time, additional symptoms appear: itching, constriction of skin vessels, dilation of the pupils with slowing of the pupillary reflex, cycloplegia, nystagmus, decreased muscle strength, tendon reflex, and urinary retention. The heart rate increases significantly, and blood pressure increases or decreases.
Symptoms of central nervous system (CNS) depression (slurred speech, disorientation in time and space, ataxia, coma) or CNS excitation (convulsions, psychosis with hallucinations) are also observed, which gradually increase.
Treatment: gastric lavage, administration of enterosorbents, symptomatic therapy.
Side effects
From the nervous system: dizziness, headache, drowsiness, agitation, insomnia, depression, fatigue, increased reaction time, muscle weakness, impaired coordination of movements, tremor, anxiety, impaired concentration and memory, seizures, hallucinations.
On the part of the organs of vision: glaucoma, visual impairment, increased intraocular pressure, possible blurred vision, diplopia.
On the part of the auditory system: tinnitus.
From the cardiovascular system: palpitations, tachycardia, arrhythmia, angina attacks, arterial hypotension, including orthostatic.
Gastrointestinal: stomach pain, diarrhea, constipation, dry mouth, nausea, vomiting, increased or decreased appetite, weight gain.
Skin and subcutaneous tissue disorders: allergic reactions, photosensitivity, exfoliative dermatitis, rash, urticaria.
From the lymphatic system and hematopoietic system: hemolytic anemia.
Immune system disorders: angioedema, rarely anaphylactic shock
On the part of the urinary system: urination disorders (urinary retention due to anticholinergic effect), difficulty urinating.
On the part of the respiratory system: nasal congestion, increased viscosity of bronchial secretions.
Others: arthralgia, decreased sweating, dry mucous membranes.
Long-term use of dimenhydrinate may lead to dependence on the drug.
Expiration date
5 years.
Storage conditions
Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
5 or 10 tablets in a blister; 1 blister in a cardboard box.
Vacation category
Without a prescription.
Producer
Jadran-Galenski Laboratorij dd/Jadran-Galenski Laboratorij dd
Address
Svilno 20, 51000 Rijeka, Croatia/ Svilno 20, 51000 Rijeka, Croatia
