DRAMINA

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT DRAMINA® (DRAMINA)

Composition:

Active substance: dimenhydrinate;

1 tablet contains 50 mg of dimenhydrinate;

Excipients: microcrystalline cellulose; magnesium stearate; lactose monohydrate;

povidone; crospovidone.

Pharmaceutical form. Tablets.

Main physicochemical properties: white, round, flat tablets with beveled edges and a score line on one side.

Pharmacotherapeutic group. Systemic antihistamines.

ATC code R06A A02.

Pharmacological properties.

Pharmacodynamics. Dimenhydrinate belongs to the ethanolamine derivatives. Dimenhydrinate is an H1-receptor blocker with antiemetic, sedative, antimuscarinic, and antihistaminic effects. It reduces excitability of the vomiting center in the central nervous system.

Pharmacokinetics. After oral administration, dimenhydrinate is rapidly absorbed. Maximum plasma concentration is reached within 15–30 minutes after administration and is maintained for 4–6 hours.

Approximately 98–99% of dimenhydrinate is bound to plasma proteins. Dimenhydrinate crosses the placental barrier and penetrates into breast milk.

Metabolism of dimenhydrinate occurs mainly in the liver. It is excreted from the body within 24 hours, primarily as metabolites, and to a lesser extent unchanged via the kidneys. The elimination half-life from plasma is approximately 5–10 hours.

Clinical characteristics.

Indications.

• Prevention and relief of nausea and vomiting due to motion sickness (sea or air sickness), as well as caused by radiation therapy, medications, and postoperatively.
• Symptomatic treatment of Meniere's disease and other vestibular disorders.

Contraindications.

Hypersensitivity to dimenhydrinate or to other structurally related antihistamines, or to any of the excipients contained in the formulation.

Narrow-angle glaucoma, increased intracranial pressure, pheochromocytoma, porphyria, prostatic hyperplasia with urinary retention, seizures (eclampsia, epilepsy), acute bronchial asthma attack, severe hepatic insufficiency, severe renal insufficiency (creatinine clearance ≤ 25 mmol/min), age under 2 years.

Interaction with other medicinal products and other forms of interaction.

Concomitant use of alcohol with dimenhydrinate should be avoided, as it may alter and enhance the effect of dimenhydrinate.

Dimenhydrinate may enhance the anticholinergic effects of other medicinal products (e.g., atropine, antiparkinsonian agents, tricyclic antidepressants) and the central nervous system (CNS) depressant effects of agents such as barbiturates, hypnotics, sedatives, tranquilizers, antidepressants, morphine derivatives (analgesics, antitussives, medications used in substitution therapy), benzodiazepines, neuroleptics, centrally acting antihypertensives, baclofen, and thalidomide.

The medicinal product may enhance the CNS depressant effect of antiepileptic drugs.

Concomitant use with monoamine oxidase inhibitors (MAOIs) may potentiate the anticholinergic effects of dimenhydrinate; in individual cases, paralytic ileus (sometimes life-threatening), urinary retention, increased intraocular pressure have been reported. Additionally, hypotension, sedation, and respiratory depression are possible.

The drug enhances the effect of diazepam and produces effects opposite to those of amphetamines and their derivatives. Administration of dimenhydrinate reduces the efficacy of oral corticosteroids and oral anticoagulants.

Simultaneous use with medications containing bismuth, analgesics, psychotropic agents, and also with scopolamine may cause visual disturbances.

Particular caution is required when prescribing to patients receiving medications that prolong the QT interval (Class I and II antiarrhythmics, certain antibiotics such as erythromycin, antimalarials, antihistamines, neuroleptic drugs) or medications that cause hypokalemia (e.g., certain specific diuretics).

Dimenhydrinate may mask the adverse effects of ototoxic agents, such as aminoglycosides.

Dimenhydrinate therapy should be discontinued at least three days before performing allergy testing, as its use may lead to false-negative results.

Special precautions for use.

The drug should be prescribed with special caution to patients suffering from: liver and kidney diseases, hyperthyroidism, bradycardia, arterial hypertension, chronic respiratory disorders, bronchial asthma, hypokalemia, hypomagnesemia, pylorospasm and pyloro-duodenal obstruction, peptic ulcer, intestinal obstruction, congenital long QT syndrome or other clinically significant cardiac disorders (cardiovascular diseases, circulatory disorders, arrhythmias), concomitant use of other medicinal products that lead to QT interval prolongation, or to hypokalemia. The drug should be used cautiously in elderly patients who have a higher predisposition to orthostatic hypotension, obesity and sedative therapy, chronic constipation (risk of developing paralytic ileus), potential prostatic hypertrophy, or Parkinson's disease. Such patients should be administered the lowest recommended adult dose, as they are sensitive to the anticholinergic effects of the drug.

The drug contains lactose. Patients with rare hereditary disorders of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.

Use during pregnancy or breastfeeding.

The drug is contraindicated during pregnancy.

Diphenhydramine passes into breast milk in small amounts; therefore, breastfeeding should be discontinued during treatment.

Ability to affect reaction rate when driving or operating machinery.

The use of the drug may cause drowsiness, impaired motor coordination, dizziness, prolonged reaction time, and visual disturbances. Therefore, patients should refrain from driving vehicles or operating machinery with a high risk of injury during treatment.

Method of Administration and Dosage.

Prevention and relief of nausea and vomiting due to motion sickness (sea or air sickness), as well as caused by radiation therapy, medications, or following surgery.

Adults and children aged 12 years and older: 50 mg (1 tablet) taken 30–60 minutes before the start of travel; thereafter, 50–100 mg every 4–6 hours if needed, but not exceeding 400 mg/day.

Children aged 6 to 12 years: 25–50 mg (1/2–1 tablet) every 6–8 hours if needed, but not exceeding 150 mg/day.

Children aged 2 to 6 years: 25 mg (1/2 tablet) every 6–8 hours if needed, but not exceeding 75 mg/day.

For Ménière’s disease and other vestibular disorders.

Adults: 50–100 mg (1–2 tablets) every 4–6 hours if needed, without exceeding the maximum daily dose of 400 mg (8 tablets).

Elderly patients should receive an initial dose of 25 mg (1/2 tablet).

Use with caution in patients with renal and/or hepatic impairment. In hepatic impairment, the dose should be reduced by half.

Children.

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 group.

Overdose.

Symptoms. Initial symptoms of overdose appear between 30 minutes and 2 hours after ingestion of a toxic dose (25 mg/kg body weight), and primarily include headache, dizziness, fatigue, and drowsiness.

Additional symptoms may develop later: itching, skin vasoconstriction, pupil dilation with slowed pupillary reflex, cycloplegia, nystagmus, decreased muscle strength, diminished tendon reflexes, and urinary retention. Heart rate increases significantly, and blood pressure may rise or fall.

Symptoms of central nervous system (CNS) depression may also occur (slurred speech, disorientation in time and space, ataxia, coma), or CNS excitation (seizures, hallucinatory psychosis), which progressively worsen.

Treatment: gastric lavage, administration of enterosorbents, and symptomatic therapy.

Adverse Reactions.

Nervous system disorders: dizziness, headache, drowsiness, excitement, insomnia, depressed state, fatigue, increased reaction time, muscle weakness, impaired coordination, tremor, anxiety, impaired concentration and memory, seizures, hallucinations.

Eye disorders: glaucoma, visual disturbances, increased intraocular pressure, possible blurred vision, diplopia.

Ear and labyrinth disorders: tinnitus.

Cardiovascular disorders: palpitations, tachycardia, arrhythmia, angina attacks, arterial hypotension, including orthostatic hypotension.

Gastrointestinal disorders: 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.

Lymphatic system and blood-forming system disorders: hemolytic anemia.

Immune system disorders: angioneurotic edema, rarely – anaphylactic shock.

Renal and urinary disorders: impaired urination (urinary retention due to anticholinergic effect), difficulty in urination.

Hepatobiliary disorders: liver function disorders, cholestatic jaundice.

Respiratory system disorders: nasal congestion, increased viscosity of bronchial secretions.

Other: arthralgia, decreased sweating, dryness of mucous membranes.

Prolonged use of dimenhydrinate may lead to drug dependence.

Shelf life.

5 years.

Storage conditions.

Store at temperatures not exceeding 25 °C. Keep out of reach of children.

Packaging.

5 or 10 tablets in a blister pack; 1 blister pack in a cardboard box.

Availability.

Over-the-counter.

Manufacturer.

Jadran-Galenski Laboratorij d.d.

Manufacturer's address and location of operations.

Svilno 20, 51000 Rijeka, Croatia / Svilno 20, 51000 Rijeka, Croatia