- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
1. Name of the medicinal product
Dexamfetamine Sulfate 1mg/ml Oral Solution
2. Qualitative and quantitative composition
Each ml of the oral solution contains 1mg of dexamfetamine sulfate.Each 1 ml of solution contains 2 mg of Sodium Methyl Hydroxybenzoate and 0.25mg of Sodium Propyl Hydroxybenzoate.
3. Pharmaceutical form
4. Clinical particulars
4.1 Therapeutic indications
Dexamfetamine sulfate is a symphathomimetic amine with central stimulant and anorectic activity. It is indicated in narcolepsy. It is also indicated for children with refractory hyperkinetic states under the supervision of a physician specialising in child psychiatry.
4.2 Posology and method of administration
Adults: In narcolepsy, the usual starting dose is 10mg dexamfetamine a day, given in divided doses. Individual dose titration is recommended, and dosage may be increased if necessary, by 10mg a day at weekly intervals to a suggested maximum of 60mg a day. Elderly: Start with 5mg a day, and increase by increments of 5mg at weekly intervals. Children: In hyperkinetic states, individualisation of treatment is important. The usual starting dosage for children aged 3-5 years is 2.5mg a day, increased if necessary by 2.5mg a day at weekly intervals; for children aged 6 years and over, the usual starting dose is 5-10mg a day, increasing if necessary by 5mg at weekly intervals. The usual upper limit is 20mg a day, though some older children have needed 40mg or more for optimal response.
Hypersensitivity to dexamfetamine or other amfetamine derivatives or any of the excipients. Patients with symptomatic cardiovascular disease, structural cardiac abnormalities and/or moderate or severe hypertensive disease. Patients with advanced arteriosclerosis. During or for 14 days after treatment with an MAO inhibitor. Patients with a history of drug abuse or alcohol abuse. Patients with hyperthyroidism, glaucoma, porphyria or hyperexcitability. Patients with Gilles de la Tourette syndrome or similar dystonias. Pregnancy and lactation.
4.4 Special warnings and precautions for use
Use with caution in patients on guanethidine and patients with mild hypertension or a family history of dystonias. If tics develop, discontinue treatment with dexamfetamine. Dexamfetamine is likely to reduce the convulsant threshold; therefore caution is advised in patients with epilepsy. Height and weight should be carefully monitored in children as growth retardation may occur. Children who are not gaining weight as expected should have their treatment interrupted temporarily.Caution should be used when administering dexamfetamine to patients with impaired kidney function or an unstable personality.Drug dependence, with consumption of increasing doses to levels many times those recommended, may occur as tolerance develops. At such levels, a psychosis which may be clinically indistinguishable from schizophrenia can occur.Treatment should be stopped gradually since abrupt cessation may produce extreme fatigue and mental depression.Cardiomyopathy has been reported with chronic amfetamine use.Due to the potential decreased appetite associated with dexamfetamine use, caution is advised in the presence of anorexia nervosa.Pre-existing structural cardiac abnormalities: Sudden death has been reported in association with the use of stimulants of the central nervous system at usual doses in children with structural cardiac abnormalities. Although some structural cardiac abnormalities alone may carry an increased risk of sudden death, stimulant products are not recommended in children, adolescents, or adults with known structural cardiac abnormalities (see 4.3 Contraindications).Blood pressure should be monitored at appropriate intervals in all patients taking dexamfetamine, especially those with hypertension.Psychiatric adverse events: Administration of stimulants may exacerbate symptoms of behaviour disturbance and thought disorders in patients with a pre-existing psychotic disorder. Particular care should be taken in using stimulants to treat ADHD in patients with comorbid bipolar disorder because of concern for possible induction of a mixed/manic episode in such patients. Prior to initiating treatment with a stimulant, patients with comorbid depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder. Such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder and depression. Treatment emergent psychotic or manic symptoms, e.g. hallucinations, delusional thinking or mania in children or adolescents without a prior history of psychotic illness or mania can be caused by stimulants at usual doses. If such symptoms occur, consideration should be given to a possible causal role of the stimulant and discontinuation of treatment may be appropriate. Patients beginning treatment with stimulants for ADHD should be monitored for the appearance, or worsening of, aggressive behaviour or hostility.
Excipients in the formulationThe medicine also contains sodium methyl and propyl hydroxybenzoates which may cause allergic reactions. The signs may include a rash, swallowing or breathing problems and swelling of the lips, face, throat or tongue.
4.5 Interaction with other medicinal products and other forms of interaction
Adrenoreceptor blocking agents (e.g. propanolol), lithium and α- methyltyrosine may antagonise the effects of dexamfetamine. Disulfiram may inhibit metabolism and excretion. The concurrent use of tricyclic antidepressants may increase the risk of cardiovascular side effects.Concurrent use of MAOIs or use within the preceding 14 days may precipitate hypertensive crisis.Concurrent use of beta-blockers may result in severe hypertension and dexamphetamine may result in diminished effect of other anti-hypertensives such as guanethidine.Phenothiazines may inhibit the actions of dexamfetamine.Amphetamines may delay the absorption of ethosuximide, phenobarbitone and phenytoin.Acute dystonia has been noted with concurrent administration of haloperidol.Haloperidol blocks dopamine and norepinephrine re-uptake, thus inhibiting the central stimulant effects of amfetamines.The analgesic effect of morphine may be increased and its respiratory depressant effects increased with concurrent use of morphine and dexamfetamine.Amfetamines potentiate the analgesic effects of meperidine.Concomitant administration of clonidine and dexamfetamine may result in an increased duration of action of dexamfetamine.Gastrointestinal acidifying agents (guanethidine, reserpine, glutamic acid HCl, ascorbic acid, fruit juices, etc.) lower absorption of dexamfetamine. Urinary acidifying agents (ammonium chloride, sodium acid phosphate, etc.) increase urinary excretion of dexamfetamine. Both groups of agents lower blood levels and efficacy of dexamfetamine.Gastrointestinal alkalizing agents (sodium bicarbonate, etc) increase the absorption of amfetamines. Urinary alkalizing agents (acetazolamide, some thiazides) increase the concentration of the non-ionized species of the amfetamine molecule, thereby decreasing urinary excretion. Both groups of agents increase blood levels and efficacy of amfetamines.Alcohol may exacerbate the CNS adverse reactions of psychoactive drugs, including dexamfetamine. It is therefore advisable for patients to abstain from alcohol during treatment.Chlorpromazine blocks dopamine and norepinephrine re-uptake, thus inhibiting the central stimulant effects of amfetamines, and can be used to treat amfetamine poisoning.
4.6 Pregnancy and lactation
PregnancyDexamfetamine has been thought to produce embryotoxic effects in rodents and retrospective evidence of certain significance in man has suggested a similar possibility. Dexamfetamine sulfate is contraindicated during pregnancy.
Breast-feedingDexamfetamine passes into breast milk.Because of the potential for adverse reactions in nursing infants from dexamfetamine, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
4.7 Effects on ability to drive and use machines
Dexamfetamine may affect ability to drive or operate machinery.This medicine can impair cognitive function and can affect a patient's ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When prescribing this medicine, patients should be told: • The medicine is likely to affect your ability to drive • Do not drive until you know how the medicine affects you • It is an offence to drive while under the influence of this medicine • However, you would not be committing an offence (called 'statutory defence') if: o The medicine has been prescribed to treat a medical or dental problem and o You have taken it according to the instructions given by the prescriber and in the information provided with the medicine and o It was not affecting your ability to drive safely
4.8 Undesirable effects
Cardiac disorders: cardiomyopathy, myocardial infarction, palpitations, tachycardiaEye disorders: mydriasis, visual disturbanceGastrointestinal disorders: abdominal cramps, colitis ischaemic, diarrhoea, dry mouth, nauseaGeneral disorders and administration site conditions: chest pain, death due to cardiovascular collapse, growth retardation, hyperpyrexia, hypersensitivity including angioedema and anaphylaxis, sudden death (see 4.4 Special Warnings and Special Precautions for Use)Investigations: blood pressure decreased, blood pressure increasedMetabolism and nutrition disorders: acidosis, anorexia, weight lossMusculoskeletal and connective tissue disorders: rhabdomyolysisNervous system disorders: ataxia, choreoathetoid movements, concentration difficulties, convulsion, dizziness, dyskinesia, dysgeusia, fatigue, headache, hyperactivity, hyperreflexia, intracranial haemorrhage, neuroleptic malignant syndrome, stroke, tremor, Tourette's syndromePsychiatric disorders: aggressive behaviour, anxiety, confusion, delirium, depression, drug dependence, dysphoria, emotional lability, euphoria, hallucination, impaired cognitive test performance, insomnia, irritability, libido altered, nervousness, night terrors, obsessive-compulsive behaviour, panic states, paranoia, psychosis/ psychotic reactions, restlessness, ticsRenal and urinary disorders: renal damageReproductive system and breast disorders: impotenceSkin and subcutaneous tissue disorders: alopecia, rash, sweating, urticariaVascular disorders: cardiovascular collapse, cerebral vasculitisA toxic hypermetabolic state characterised by transient hyperactivity, hyperpyrexia, acidosis and death due to cardiovascular collapse have been reported.Cessation of, or reduction in amfetamine use that has been heavy and prolonged can result in withdrawal symptoms. Symptoms include dysphoric mood, fatigue, vivid and unpleasant dreams, insomnia or hypersomnia, increased appetite, psychomotor retardation or agitation, anhedonia and drug craving.
In acute overdosage, the adverse effects are accentuated and may be accompanied by hyperpyrexia, mydriasis, hyperreflexia, chest pain, tachycardia, cardiac arrhythmias, confusion, panic states, aggressive behaviour, hallucinations, delirium, convulsions, respiratory depression, coma, circulatory collapse, and death. Individual patient response may vary widely and toxic manifestations may occur with quite small overdoses.Treatment consists of the induction of vomiting and/or gastric lavage together with supportive and symptomatic measures. Excessive stimulation or convulsions may be treated with diazepam. Excretion of dexamfetamine may be increased by forced acid diuresis. Chlorpromazine antagonises the central stimulant effects of amfetamines and can be used to treat amfetamine intoxication
5. Pharmacological properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Centrally acting sympathomimetics; ATC code: N06BA02Dexamfetamine is a sympathomimetic amine with a central stimulant and anorectic activity.
5.2 Pharmacokinetic properties
Dexamfetamine is readily absorbed from the gastrointestinal tract. It is resistant to metabolism by monoamine oxidase. It is excreted in the urine as unchanged parent drug together with some hydroxylated metabolites. Elimination is increased in acidic urine. After high doses, elimination in the urine may take several days.
5.3 Preclinical safety data
Dexamfetamine has been thought to produce embryotoxic effects in rodents, and retrospective evidence of uncertain significance in man has suggested a similar possibility. Dexamfetamine should therefore be avoided in pregnancy, especially during the first trimester. Dexamfetamine passes into breast milk.
6. Pharmaceutical particulars
6.1 List of excipients
Quinolene Yellow (E104)Methyl Hydroxybenzoate Sodium (E219) (preservative)Propyl Hydroxybenzoate Sodium (E217) (preservative)Lemon Flavour No.1 (contains propylene glycol E1520)Carmellose Sodium (E466)Saccharin SodiumLiquid MaltitolHydrochloric acid (for pH adjustment)Sodium Hydroxide (for pH adjustment)Purified Water
6.3 Shelf life
2 years Shelf-life after first opening: 30 days
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container
Dexamfetamine Sulfate 1mg/ml Oral Solution is presented in a 500ml glass bottle with tamper evident child resistant cap
6.6 Special precautions for disposal and other handling
7. Marketing authorisation holder
Martindale Pharmaceuticals Ltdt/s Martindale PharmaBampton RoadHarold HillRomfordEssexRM3 8UG
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
10. Date of revision of the text
Bampton Road, Harold Hill, Romford, Essex, RM3 8UG
+44 (0)1277 848 976
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+(0)800 137 627
+44 (0)1277 266 600
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