24 Jun 2009

Medikinet XL - United Kingdom

Updated: 24 Jun 2009

Medikinet XL

Medikinet XL is indicated as part of a comprehensive treatment programme for attention-deficit/hyperactivity disorder (ADHD) in children over 6 years of age when remedial measures alone prove insufficient.

Treatment must be under the supervision of a specialist in childhood behavioural disorders. Diagnosis should be made according to DSM-IV criteria or the guidelines in ICD-10. Additional information on the safe use of the medicinal product: The specific aetiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use of medical and special psychological, educational, and social resources. A comprehensive treatment programme typically includes psychological, educational and social measures and is aimed at stabilizing children with a behavioural syndrome characterized by symptoms which may include chronic history of short attention span, distractibility, emotional lability, impulsivity, moderate to severe hyperactivity, minor neurological signs and abnormal EEG.

Learning may or may not be impaired. Medikinet XL treatment is not indicated in all children with this syndrome and the decision to use these medicinal product must be based on a very thorough assessment of the severity of the child's symptoms.

Medikinet XL Description, Presentation and Dosage

Medikinet XL Description

Medikinet XL Drug Description

Prolonged-release capsules

Medikinet XL Presentation

Medikinet XL Presentation

Prolonged-release capsule, hard. 10mg - Mauve-white opaque capsules containing white and blue pellets. 20mg - Mauve capsules containing white and blue pellets. 30mg - Dark violet opaque cap and a light grey opaque body containing white and blue pellets. 40mg - Dark violet opaque cap and a grey opaque body containing white and blue pellets.

Medikinet XL Manufacturer

Medice Arzneimittel Pütter GmbH & Co. KG

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Medikinet XL Dosage

Medikinet XL Adult Dosage

Medikinet XL is taken in the morning with or after breakfast in order to obtain sufficiently prolonged action and to avoid high plasma peaks. Methylphenidate is absorbed much faster from Medikinet XL when the medicinal product is taken on an empty stomach. In this case, release may not be adequately sustained.

Medikinet XL consists of an immediate release component (50% of the dose) and a modified release component (50% of the dose). Hence Medikinet XL 10 mg yields an immediate-release dose of 5 mg and an extended release dose of 5 mg methylphenidate hydrochloride. The extended-release portion of each dose is designed to maintain a treatment response through the afternoon without the need for a midday dose. It is designed to deliver therapeutic plasma levels for a period of approximately 8 hours, which is consistent with the school day rather than the whole day (see section 5.2 “Pharmacokinetic properties”). For example, 20 mg of Medikinet XL is intended to take the place of 10 mg at breakfast and 10 mg at lunchtime of immediate release methylphenidate hydrochloride.

Adults: Not applicable.

Medikinet XL Child Dosage

Children (over 6 years) and adolescents.

Dose titration:

Careful dose titration is necessary at the start of treatment with methylphenidate. This is normally achieved using an immediate release formulation taken in divided doses. The recommended starting daily dose is 5 mg once daily or twice daily (e.g. at breakfast and lunch), increasing if necessary by weekly increments of 5-10 mg in the daily dose according to tolerability and degree of efficacy observed. Medikinet XL 10 mg once daily may be used in place of immediate release methylphenidate hydrochloride 5 mg twice daily from the beginning of treatment where the treating physician considers that twice daily dosing is appropriate from the outset and twice daily treatment administration is impracticable.

For doses not realisable/practicable with this strength, other strengths of this medicinal product and other methylphenidate containing products are available.

Patients Currently Using Methylphenidate: Patients established on an immediate release methylphenidate hydrochloride formulation may be switched to the milligram equivalent daily dose of Medikinet XL.

If the effect of the medicinal product wears off too early in the late afternoon or evening, disturbed behaviour and/or inability to go to sleep may recur. A small dose of an immediate-release methylphenidate hydrochloride tablet late in the day may help to solve this problem. The regimen that achieves satisfactory symptom control with the lowest total daily dose should be employed.

The maximum daily dose of methylphenidate hydrochloride is 60 mg.

Medikinet XL should not be used in children less than 6 years due to a lack of data on safety and efficacy.

Medikinet XL should be given in the morning with or after breakfast.

The capsules may be swallowed whole with the aid of liquids, or alternatively, the capsule may be opened and the capsule contents sprinkled onto a small amount (tablespoon) of applesauce and given immediately, and not stored for future use. Drinking some fluids, e.g. water, should follow the intake of the sprinkles with applesauce. The capsules and the capsule contents must not be crushed or chewed.

Maintenance/Extended treatment:

The long term use of methylphenidate has not been systematically evaluated in controlled trials. The physician who elects to use Medikinet XL for extended periods in patients with ADHD should periodically re-evaluate the long term usefulness of the drug for the individual patient with trial periods off medication to assess the patient's functioning without pharmacotherapy. Improvement may be sustained when the drug is either temporarily or permanently discontinued.

Note: If improvement of symptoms is not observed after appropriate dosage adjustment over a one-month period, the treatment should be discontinued. Methylphenidate should be discontinued periodically to assess the child's condition. Medicinal product treatment is usually discontinued during or after puberty.

Medikinet XL Elderly Dosage

Elderly: Not applicable.

Medikinet XL Precautions, Reactions and Contraindications

Medikinet XL Special Precautions

Medikinet XL Special Precautions

Warnings: Medikinet XL should not be used in children less than 6 years of age due to a lack of data on safety and efficacy.

Medikinet XL should not be used to treat severe exogenous or endogenous depression.

Clinical experience suggests that Medikinet XL may exacerbate symptoms of behavioural disturbance and thought disorder in psychotic children.

Medikinet XL should be administered with caution to patients with severe depression or with suicidal thoughts or actions because there is a risk of aggravation of this condition.

Available clinical evidence suggests that treatment with methylphenidate during childhood does not increase the likelihood of addiction in later life, though this should always be carefully monitored in each individual case.

Chronic abuse of methylphenidate can lead to marked tolerance and psychological dependence with varying degrees of abnormal behaviour. Frank psychotic episodes can occur, especially in response to parenteral abuse.

The choice between treatment with either Medikinet XL or an immediate release methylphenidate formulation should be determined on an individual basis with particular consideration of the requirement for symptom control in the latter part of the day.

Methylphenidate should not be used for the prevention or treatment of normal fatigue states.

Precautions: Treatment with methylphenidate is not indicated in all cases of ADHD, and should be considered only after detailed history takingand evaluation. The decision to prescribe methylphenidate depend on an assessment of the severity of symptoms and their appropriateness to the child's age and not simply on the presence of one or more abnormal behavioural characteristics. Where these symptoms are associated with acute stress reactions, treatment with methylphenidate is usuallynot indicated.

Reduced weight gain and slight growth XLation have been reported with the long term use of stimulants in children. Careful monitoring of growth is recommended during extended treatment with methylphenidate. Patients who are not growing or gaining weight as expected should have their treatment interrupted temporarily.

Blood pressure should be monitored at appropriate intervals in all patients taking methylphenidate, especially those with hypertension.

Exacerbation of motor and phonic tics and Tourette's syndrome has been reported. Therefore, clinical evaluation for tics and Tourette's syndrome should precede use of stimulant medications.

Due to the potential decreased appetite associated with methylphenidate use, caution is advised in the presence of anorexia nervosa.

Caution is called for in emotionally unstable patients, such as those with a history of drug dependence or alcoholism, because such patients may increase the dosage on their own initiative.

There is some clinical evidence that methylphenidate may lower the convulsive threshold in patients with prior history of seizures, in patients with prior EEG abnormalities in absence of seizures, and, very rarely, in absence of history of seizures and no prior EEG evidence of seizures. In the presence of seizures, the drug should be discontinued.

The long term safety and efficacy profiles of methylphenidate are not fully known. Patients requiring long term therapy should therefore be carefully monitored and complete and differential blood counts and a platelet count performed periodically.

Careful supervision is required during drug withdrawal, since this may unmask depression as well as chronic over-activity. Some patients may require long-term follow up.

There is no experience with the use of Medikinet XL in patients with renal insufficiency or hepatic insufficiency.

Women of childbearing potential should use effective contraceptive measures.

This medicinal product contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Sport: This medicinal product contains methylphenidate which could result in a positive result during drug testing

Medikinet XL Adverse Reactions

Medikinet XL Adverse Reactions

Side-effect assessment is based on the following frequency data:

Very common (GREATER-THAN OR EQUAL TO (8805)1/10)

Common (GREATER-THAN OR EQUAL TO (8805)1/100 to <1/10)

Occasional (GREATER-THAN OR EQUAL TO (8805)1/1.000 to <1/100)

Rare (GREATER-THAN OR EQUAL TO (8805)1/10.000 to <1/1.000)

Very rare (<1/10.000)

Nervousness and insomnia are very common adverse reactions occurring at the beginningof treatment but can usually be controlled by reducing the dosage.

Decreased appetite is also common but usually transient.

Blood and lymphatic system disorders

Very rare: Anaemia,leucopenia, thrombocytopenia, thrombocytopenic purpura.

Cardiac disorders

Common: Arrhythmia, palpitations, tachycardia.

Rare: Angina pectoris.

Very rare: Cardiac arrest.

Congenital, familial and genetic disorders:

Very rare: Tourette's syndrome.

Eye disorders:

Rare: Difficulties in visual accommodation, blurred vision.

Gastrointestinal disorders

Common: Abdominal pain, nausea and vomiting. These usually occur at the beginning of treatment and may be alleviated by concomitant food intake. Dry mouth.

General disorders and administration site conditions

Rare: Growth XLation during prolonged use in children.

Very rare: Sudden death.

Hepatobiliary disorders

Very rare: Abnormal liver function, ranging from transaminase elevation to hepatic coma.

Investigations

Common: Changes in blood pressure and heart rate (usually an increase).

Metabolism and nutrition disorders

Common: Decreased appetite, reduced weight gain during prolonged use in children.

Musculoskeletal and connective tissue disorders

Common: Arthralgia.

Very rare: Muscle spasms.

Nervous system disorders

Common: Dizziness, drowsiness, dyskinesia, headaches, hyperactivity.

Very rare: Convulsions, choreo-athetoid movements.

Very rare reportsof poorly documented neuroleptic malignant syndrome (NMS) have been received. In most of these reports patients were also receiving other medications. It is uncertain what role methylphenidate played in these cases.

Psychiatric disorders

Very common: Insomnia, nervousness

Common: Abnormal behaviour, aggression, agitation, anorexia, anxiety, depression,

irritability

Very rare: Hallucinations, psychotic disorder, suicidal behaviour (including

completed suicide), tics or exacerbation of pre-existing tics, transient

depressed mood

Skin and subcutaneous tissue disorders

Common: Alopecia,pruritus, rash, urticaria.

Very rare: Erythema multiforme thromobocytopenic purpura, exfoliative dermatitis, fixed drug eruption.

Vascular disorders

Very rare: Cerebral arteritis and/or occlusion

Medikinet XL Contraindications

Medikinet XL Contraindications

Medikinet XL is contra-indicated:

  • in patients known to be hypersensitive to methylphenidate or to any of the excipients.
  • in patients with marked anxiety, agitation or tension as the use of Medikinet XL may aggravate these symptoms
  • in patients with glaucoma
  • in patients with hyperthyroidism
  • in patients with thyrotoxicosis
  • in patients with severe angina pectoris
  • in patients with cardiac arrhythmia,
  • in patients with severe hypertension
  • in patients with heart failure
  • in patients with myocardial infarction
  • in patients who currently exhibit severe depression, psychotic symptoms, psychopathological personality structure, history of aggression or suicidal tendency, since methylphenidate might worsen these conditions
  • in patients with known drug dependence or alcoholism
  • in combination with non-selective, irreversible monoamine oxydase inhibitors, and also within a minimum of 14 days following discontinuation of a non-selective irreversible MAO inhibitor (hypertensive crises and hyperthermia may result) 
  • in patients with motor tics, tics in siblings, or a family history or diagnosis of Tourette's syndrome.
  • during pregnancy.
  • a history of pronounced anacidity of the stomach with a pH value above 5.5, in therapy with H2-receptor blockers or in antacid therapy,

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