Methylphenidate Hydrochloride

Registered South African indications:

• Attention-deficit/hyperactivity disorder
• Narcolepsy in adults

Contraindications

South African recommendations

• Hypersensitivity to the active ingredient or any of its excipients
• Glaucoma
• Pheochromocytoma
• Hyperthyroidism or thyrotoxicosis
• Anxiety
• Tension
• Agitation
• Family history or diagnosis of Tourette’s syndrome
• Pre-existing cardiovascular disorders including
  - Severe hypertension (PR tab, MR cap)
  - Hypertension (10mg tab) 
  - Heart failure
  - Arterial occlusive disease
  - Angina
  - Haemodynamically significant congenital heart disease
  - Cardiomyopathies
  - Myocardial infarction
  - Potentially life-threatening dysrhythmias
  - Channelopathies (disorders caused by the dysfunction of ion channels)
  - QT prolongation either congenital, familial or caused by medication
• Pre-existing cerebrovascular disorders
  - Cerebral aneurysm
• Vascular abnormalities, including
  - Vasculitis
  - Stroke
• Known risk factors for cerebrovascular disorders (PR tab)
• Coadministration with non-selective, irreversible monoamine oxidase inhibitors or within 14 days of their use
• Diagnosis or history of severe depression, anorexia nervosa/anorexic disorders, suicidal tendencies, psychotic symptoms, severe mood disorders, mania, schizophrenia, psychopathic/borderline personality disorder
• Diagnosis or history of severe and episodic (Type I) bipolar (affective) disorder (that is not well-controlled)
• History of pronounced anacidity of the stomach with a pH value above 5.5, in therapy with H₂ receptor blockers, proton pump inhibitors or in antacid therapy (MR cap)
• Pregnancy
• Lactation

Recommendations in other jurisdictions

• Hypersensitivity to methylphenidate or to any of the excipients
• Glaucoma
• Phaeochromocytoma
• During treatment with non-selective, irreversible monoamine oxidase (MAO) inhibitors, or within a minimum of 14 days of discontinuing those drugs, due to the risk of hypertensive crisis
• Hyperthyroidism or thyrotoxicosis
• Diagnosis or history of severe depression, anorexia nervosa/anorexic disorders, suicidal tendencies, psychotic symptoms, severe mood disorders, mania, schizophrenia, psychopathic/borderline personality disorder
• Diagnosis or history of severe and episodic (Type I) bipolar (affective) disorder (that is not well-controlled)
• Pre-existing cardiovascular disorders including
  - Severe hypertension
  - Heart failure
  - Arterial occlusive disease
  - Angina
  - Haemodynamically significant congenital heart disease
  - Cardiomyopathies
  - Myocardial infarction
  - Potentially life-threatening arrhythmias
  - Channelopathies (disorders caused by the dysfunction of ion channels)
• Pre-existing cerebrovascular disorders
  - Cerebral aneurysm
• Vascular abnormalities, including
  - Vasculitis
  - Stroke
• Known risk factors for cerebrovascular disorders (MR cap)

Cautions

• Pregnancy (Recommendations in other jurisdictions)
• Breastfeeding (Recommendations in other jurisdictions) 
• Renal impairment
• Hepatic impairment
• Elderly
• Porphyria
• Long term use (>1 year) in children and adolescents
• Family history of sudden cardiac or unexplained death or malignant arrhythmia
• Cardiac disease or history of cardiovascular disease
• Underlying medical conditions which might be compromised by increases in blood pressure or heart rate
• Known cardiac structural abnormalities
• Serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant medicine
• Misuse
• Hemiplegic cerebral palsy
• Pre-existing psychiatric disorders
• Aggressive behaviour or hostility
• Tourette's syndrome
• Motor and verbal tics
• Pre-existing anxiety, agitation or tension
• Family history of suicide, bipolar disorder, and depression
• Epilepsy
• Prior history of seizures
• Prior EEG abnormalities in absence of seizures
• Risk of diversion and abuse
• Used in prevention or treatment of normal fatigue states
• Drug or alcohol dependency, or history thereof
• Abrupt withdrawal
• Coadministration with agents that elevate blood pressure
• Fructose intolerance (cap)
• Lapp lactase deficiency (tab, PR tab)  
• Glucose-galactose malabsorption (cap, tab, PR tab)
• Sucrose-isomaltase insufficiency (cap)
• May impair ability to drive and operate machinery

Forms avail. in SA and covered in this monograph: tab, prolonged release tab (PR tab), modified release cap (MR cap)

Dosages below include:

• South African registered indications and dosages

South African registered indications and dosages

Immediate release tablet

Narcolepsy

• Oral (tab): Recommended dose: 20mg, 8-24hrly; Usual dose: 20-30mg, dly taken preferably 30-45min before a meal; Effective dose range: 10-60mg in divided doses

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To minimise the risk of insomnia, the last dose should be taken not later than 18h00

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PR tab

Attention-deficit/hyperactivity disorder (ADHD) in those who meet DSM-IV criteria for ADHD
-  Patients new to methylphenidate or who are on stimulants other than methylphenidate

• Oral (PR tab): 18-36mg, dly; Titrate by 18mg at intervals of 1 week if required; Max: 108mg/24hrs

- Patients currently using methylphenidate

Recommended dose conversion from other methylphenidate hydrochloride regimens to methylphenidate PR tab, shown in table below

• Oral (PR tab): Recommended dose conversion: Titrate by 18mg at intervals of 1 week if required; Max dose: 108mg/24hrs

Previous methylphenidate daily dose	Recommended PR tab dose
5mg, 8-12hrly	18mg, dly
10mg, 8-12hrly	36mg, dly
15mg, 8-12hrly	54mg, dly
20mg, 8-12hrly	72mg, dly

Methylphenidate PR tablet is administered orally once daily. As the effect has been shown to be present 12 hours after dosing, the product should be taken in the morning

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In general, dosage adjustments may proceed at approximately weekly intervals. Daily dosage above 108mg is not recommended in adults

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Methylphenidate PR tab must be swallowed whole with adequate amounts of liquids and must not be chewed, divided, or crushed. Methylphenidate PR tab may be administered with or without food

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Dosage should be individualised according to the need and response of each individual patient. Clinical judgement should be used when selecting the dose for patients currently taking methylphenidate in other regimens

---

The long-term use of methylphenidate has not been systematically evaluated in controlled clinical trials

---

The medical practitioner who elects to use methylphenidate for extended periods in patients with ADHD should periodically re-evaluate the long-term usefulness of the medicine for the individual patient with trials off medication to assess the patient's functioning without pharmacotherapy

---

If paradoxical aggravation of symptoms or other adverse events occur, the dosage should be reduced, or, if necessary, methylphenidate should be discontinued

---

MR cap

Treatment must be initiated and supervised by a doctor specialised in the treatment of ADHD such as an expert paediatrician or a psychiatrist

Attention-deficit/hyperactivity disorder (ADHD) with ADHD onset in childhood when remedial measures alone prove insufficient
- Patients new to methylphenidate or were treated with other methylphenidate formulations in the past

• Oral (MR cap): Initial: 10mg, dly; Titrate by 10mg at intervals of 1 week according to tolerability and degree of efficacy observed; Total daily dose should be given in 2 divided doses in the morning and midday; Max: 80mg/24hrs

- Continuation of methylphenidate therapy in patients who have shown clear benefit from treatment with MR cap in childhood and/or adolescence

• Oral (MR cap): Treatment may be continued with the same daily dose; Dose adjustment should depend on efficacy and tolerability if necessary or if possible must be reviewed regularly; Max: 80mg/24hrs

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Methylphenidate MR capsules are indicated as part of a comprehensive treatment programme for attention-deficit/hyperactivity disorder (ADHD) in adults with ADHD onset in childhood when remedial measures alone prove insufficient

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See special diagnostic considerations for ADHD in adults and pre-treatment screening in additional prescribing points

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Methylphenidate MR capsules should be given in the morning and at lunchtime with or after the meals

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The aim of individual titration should be to find the lowest daily dose that achieves satisfactory symptom control

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Compared to children and adolescents, adult patients may require a higher daily dose, based on the patient's body weight. The maximum daily dose is based on the patient's body weight and must not exceed 1mg/kg body weight. Regardless of body weight, a maximum daily dose of 80mg methylphenidate hydrochloride should not be exceeded because limited experience with daily doses greater than 80mg is available from clinical studies

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

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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 or yoghurt 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

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Methylphenidate MR capsules has to be taken with or after a meal in order to obtain sufficiently prolonged action and to avoid high plasma peaks. Methylphenidate hydrochloride is absorbed much faster from MR capsules when the medicinal product is taken on an empty stomach. In this case, release may not be adequately sustained. Therefore, methylphenidate MR capsules should not be administered without food

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Treatment must be stopped if the symptoms do not improve after appropriate dosage adjustment over a 1 month period. If paradoxical aggravation of symptoms or other serious adverse events occur, the dosage should be reduced or discontinued

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The safety and efficacy of long-term use of methylphenidate MR capsules has not been systematically evaluated in controlled trials

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Methylphenidate treatment should not and need not, be indefinite. The medical practitioner who elects to use methylphenidate MR capsules for extended periods (over 12 months) should periodically re-evaluate the long-term usefulness of the medicinal product for the individual patient with trial periods off medication to assess the patient’s functioning without pharmacotherapy. It is recommended that methylphenidate MR capsules be de-challenged at least once yearly to assess the patient’s condition (for children preferably during times of school holidays). Improvement may be sustained when the medicinal product is either temporarily or permanently discontinued

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Patients should be monitored for the risk of diversion, misuse and abuse of methylphenidate

Paed. forms avail. in SA and covered in this monograph: tab, prolonged release tab (PR tab), modified release cap (MR cap)

Paed. dosages below include:

• South African registered indications and dosages

South African registered indications and dosages

Immediate release tab

The diagnosis should be made according to current DSM criteria or the guidance from International Classification of Diseases (ICD)

Attention-deficit/hyperactivity disorder (ADHD)

Younger than 6 years

• Not established for use

6 years and older

• Oral (tab): 5mg, before breakfast and 5mg, before lunch; Titrate by 5-10mg at intervals of 1 week; Total daily dosage should be administered in divided doses; Max: 60mg/24hrs

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Methylphenidate immediate release 10mg tablets are part of an extended treatment program for attention deficit hyperactivity disorder, which includes psychological, educational and social remedial measures. The dosage should be individually adapted to the patient’s requirements and to the indication, as well as their clinical needs and responses22

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The dosage can also be expressed in terms of body weight; usual doses are 0.25mg/kg daily, doubled each week to 2mg/kg. Methylphenidate’s administration should coincide with periods of greatest academic, behavioural, and social difficulties for the patient. In some children sleeplessness occurs because the effect of the medicine deteriorates in the evening. Such children may then rebound to their usual level of activity or distraction. This problem may be dealt with by administering an additional short-acting dose of the stimulant at about 20h00. A trial dose at bedtime is necessary to clarify the issue

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Methylphenidate 10mg tablets should be periodically discontinued to assess the child’s condition. It is recommended that methylphenidate is de-challenged at least once a year (preferably during school holidays) to perform this assessment. Improvement may be sustained when the medicine is either temporarily or permanently discontinued. Treatment with methylphenidate 10mg tablets should not and need not be indefinite and usually may be discontinued during or after puberty

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PR tab

Attention-deficit/hyperactivity disorder (ADHD) in those who meet DSM-IV criteria for ADHD
-  Patients new to methylphenidate or who are on stimulants other than methylphenidate

Younger than 6 years

• Not established for use

Between 6-12 years

• Oral (PR tab): 18mg, dly in the morning; Titrate by 18mg at intervals of approx. 1 week; Max: 54mg/24hrs

Between 13-18 years

• Oral (PR tab): 18mg, dly in the morning; Titrate by 18mg at intervals of approx. 1 week; Max: 72mg/24hrs

- Patients currently using methylphenidate

Recommended dose conversion from other methylphenidate hydrochloride regimens to methylphenidate PR tab, shown in table below

• Oral (PR tab): Recommended dose conversion: Titrate by 18mg at intervals of 1 week if required; Max dose: Between 6-12 years: 54mg/24hrs; Max dose: Between 13-18 years: 72mg/24hrs

Previous methylphenidate daily dose	Recommended PR tab dose
5mg, 8-12hrly	18mg, dly
10mg, 8-12hrly	36mg, dly
15mg, 8-12hrly	54mg, dly
20mg, 8-12hrly	72mg, dly

Methylphenidate PR tablet is administered orally once daily. As the effect has been shown to be present 12 hours after dosing, the product should be taken in the morning

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Daily dosage above 54mg is not recommended for children aged between 6-12 years

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Daily dosage above 72mg is not recommended for adolescents aged between 13-18 years

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Methylphenidate PR tablet must be swallowed whole with adequate amounts of liquids and must not be chewed, divided, or crushed. Methylphenidate PR tablet may be administered with or without food

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Dosage should be individualised according to the need and response of each individual patient. Clinical judgement should be used when selecting the dose for patients currently taking methylphenidate in other regimens

---

The long-term use of methylphenidate has not been systematically evaluated in controlled clinical trials

---

The physician who elects to use methylphenidate for extended periods in patients with ADHD should periodically re-evaluate the long-term usefulness of the medicine for the individual patient with trials off medication to assess the patient's functioning without pharmacotherapy

---

If paradoxical aggravation of symptoms or other adverse events occur, the dosage should be reduced, or, if necessary, methylphenidate should be discontinued

---

MR cap

Treatment must be initiated and supervised by a doctor specialised in the treatment of ADHD such as an expert paediatrician, a child and adolescent psychiatrist or a psychiatrist. Diagnosis should be made according to current DSM criteria or the guidelines in International Classification of Diseases and should be based on a complete history and evaluation of the patient. Diagnosis cannot be made solely on the presence of one or more symptoms

Attention-deficit/hyperactivity disorder (ADHD)
- Patients new to methylphenidate

Younger than 6 years

• Not established for use

6 years and older

• Oral (MR cap): Initial: Dose titrate with immediate-release formulation; Then: 10mg, dly in the morning; Dose titrate as required; Max: 60mg/24hrs

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

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- Patients currently using methylphenidate

Younger than 6 years

• Not established for use

6 years and older

• Oral (MR cap): Initial: 10mg, dly in the morning; Dose titrate as required; Max: 60mg/24hrs

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Patients currently established on an immediate-release methylphenidate hydrochloride formulation may be switched to the milligram equivalent daily dose of methylphenidate MR capsules

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Methylphenidate MR capsules are indicated as part of a comprehensive treatment programme for attention-deficit/hyperactivity disorder (ADHD) in children aged 6 years of age and older

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If the effect of the medicinal product wears off too early in the evening, disturbed behaviour may recur. A small dose of an immediate-release methylphenidate hydrochloride tablet late in the day may help to solve this problem. In that case, it could be considered that adequate symptom control might be achieved with a twice daily immediate-release methylphenidate regimen. The pros and cons of a small evening dose of immediate-release methylphenidate versus disturbances in falling asleep should be considered

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The regimen that achieves satisfactory symptom control with the lowest total daily dose should be employed

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Treatment should not continue with methylphenidate MR capsules if an additional late dose of immediate-release methylphenidate is required, unless it is known that the same extra dose was also required for a conventional immediate-release regimen at equivalent breakfast/lunchtime dose

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Children should not take methylphenidate MR capsules too late in the morning as it may cause disturbances in sleep

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

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Methylphenidate MR capsules 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 or yoghurt 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

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Methylphenidate MR capsules has to be taken with or after a meal in order to obtain sufficiently prolonged action and to avoid high plasma peaks. Methylphenidate hydrochloride is absorbed much faster from MR capsules when the medicinal product is taken on an empty stomach. In this case, release may not be adequately sustained. Therefore, methylphenidate MR capsules should not be administered without food

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Treatment must be stopped if the symptoms do not improve after appropriate dosage adjustment over a 1 month period. If paradoxical aggravation of symptoms or other serious adverse events occur, the dosage should be reduced or discontinued

---

The safety and efficacy of long term use of methylphenidate MR capsules has not been systematically evaluated in controlled trials

---

Methylphenidate treatment should not and need not, be indefinite. The medical practitioner who elects to use methylphenidate MR capsules for extended periods (over 12 months) should periodically re-evaluate the long term usefulness of the medicinal product for the individual patient with trial periods off medication to assess the patient’s functioning without pharmacotherapy. It is recommended that methylphenidate MR capsules be de-challenged at least once yearly to assess the patient’s condition (for children preferably during times of school holidays). Improvement may be sustained when the medicinal product is either temporarily or permanently discontinued

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See special diagnostic considerations for ADHD in children and pre-treatment in additional prescribing points

Pregnancy

South African recommendations

• Contraindicated
• Methylphenidate is contraindicated in pregnancy, as safety has not been demonstrated
• Cases of neonatal cardiorespiratory toxicity, specifically foetal tachycardia and respiratory distress have been reported in spontaneous reports
• Studies in animals have only shown evidence of reproductive toxicity at maternally toxic doses
• Data from a cohort study of in total approximately 3,400 pregnancies exposed in the first trimester do not suggest an increased risk of overall birth defects
• There was an increased occurrence of cardiac malformations (pooled adjusted relative risk, 1.3; 95 % CI, 1.0-1.6) corresponding to 3 additional infants born with congenital cardiac malformations for every 1000 women who receive methylphenidate during the first trimester of pregnancy, compared with non-exposed pregnancies

Recommendations in other jurisdictions

• Caution; not recommended
• Data from a cohort study of in total approximately 3400 pregnancies exposed in the first trimester do not suggest an increased risk of overall birth defects
• There was a small increased occurrence of cardiac malformations (pooled adjusted relative risk, 1.3; 95 % CI, 1.0-1.6) corresponding to 3 additional infants born with congenital cardiac malformations for every 1000 women who receive methylphenidate during the first trimester of pregnancy, compared with non-exposed pregnancies
• Cases of neonatal cardiorespiratory toxicity, specifically foetal tachycardia and respiratory distress have been reported in spontaneous case reports
• Studies in animals have only shown reproductive toxicity at maternally toxic doses
• Methylphenidate is not recommended for use during pregnancy unless a clinical decision is made that postponing treatment may pose a greater risk to the pregnancy

Breastfeeding

South African recommendations

• Contraindicated
• Methylphenidate is contraindicated and should not be used during lactation as safety has not been demonstrated
• Methylphenidate has been found in the breast milk of women treated with methylphenidate
• Mothers on methylphenidate should not breastfeed their infants

Recommendations in other jurisdictions

• Caution; not recommended
• Methylphenidate is excreted in human milk
• Based on reports of breast milk sampling from five mothers, methylphenidate concentrations in human milk resulted in infant doses of 0.16% to 0.7% of the maternal weight-adjusted dosage, and a milk to maternal plasma ratio ranging between 1.1 and 2.7
• There is one case report of an infant who experienced an unspecified decrease in weight during the period of exposure but recovered and gained weight after the mother discontinued treatment with methylphenidate
• A risk to the suckling child cannot be excluded
• A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from methylphenidate therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman

Fertility

• There were no relevant effects observed in the non-clinical studies

Renal Impairment

• Caution; no information available

Hepatic Impairment

• Caution; no information available

Elderly

• Caution; no information available
  Methylphenidate should not be used in the elderly. Safety and efficacy have not been established in this age group

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Prohibited - In competition

Central Nervous System Disorders

• Insomnia
• Nervousness
• Affect lability
• Aggression
• Agitation
• Anxiety
• Depression
• Irritability
• Abnormal behaviour
• Tics
• Worsening of pre-existing tics or Tourette's syndrome
• Initial insomnia
• Decreased libido
• Libido disorder
• Tension
• Bruxism
• Panic attack
• Psychotic disorders
• Auditory, visual and tactile hallucinations
• Anger
• Suicidal ideation
• Altered mood
• Mood swings
• Restlessness
• Tearfulness
• Hypervigilance
• Logorrhoea
• Sleep disorder
• Mania
• Disorientation
• Confusional state
• Suicidal attempts (including completed suicide)
• Transient depressed mood
• Abnormal thinking
• Apathy
• Repetitive behaviours
• Over-focussing
• Delusions
• Thought disturbances
• Abuse
• Dependence
• Headache
  - Tension headache
• Dizziness
• Dyskinesia
• Psychomotor hyperactivity
• Somnolence
• Paresthaesia
• Tremor
• Sedation
• Akathisia
• Lethargy
• Seizures
• Choreoathetoid movements
• Reversible ischaemic neurological deficit
• Neuroleptic malignant syndrome
• Cerebrovascular disorders
  - Vasculitis
  - Cerebral haemorrhages
  - Cerebrovascular accidents
  - Cerebral arteritis
  - Cerebral occlusion
• Grand mal seizure
• Migraine
• Disphemia
• Fatigue

Cardiovascular Disorders

• Arrhythmias
• Tachycardia
• Palpitations
• Chest pain
• Angina pectoris
• Cardiac arrest
• Myocardial infarction
• Supraventricular tachycardia
• Bradycardia
• Extrasystoles
  - Ventricular extrasystoles
• Hypertension
• Hot flush
• Cerebral arteritis and/or occlusion
• Peripheral coldness
• Raynaud's phenomenon
• Sudden cardiac death
• Chest discomfort
• Changes in blood pressure
• Cardiac murmur

Respiratory Disorders

• Cough
• Pharyngolaryngeal pain
• Dyspnoea
• Nasopharyngitis
• Upper respiratory tract infection
• Sinusitis

Gastrointestinal Disorders

• Abdominal pain
• Diarrhoea
• Nausea and vomiting
• Abdominal discomfort
• Dry mouth
• Dyspepsia
• Constipation
• Toothache

Hepatobiliary Disorders

• Increased hepatic enzymes
  - Increased alanine aminotransferase
• Abnormal hepatic function
• Acute hepatic failure
• Hepatic coma
• Increased blood alkaline phophatase
• Increased blood bilirubin

Genitourinary Disorders

• Haematuria
• Incontinence
• Pollakiuria
• Erectile dysfunction
• Prolonged erection
• Increased erection
• Gynaecomastia
• Priapism

Endocrine and Metabolic Disorders

• Anorexia
• Decreased appetite
• Growth retadartion
  - Moderately reduced weight and height gain in children (during prolonged use)
• Thirst

Musculoskeletal Disorders

• Arthralgia
• Muscle tightness
• Myalgia
• Muscle twitching
• Muscle cramps
• Trismus

Skin and Subcutaneous Tissue Disorders

• Alopecia
• Pruritis
• Rash
• Eruptions
  - Fixed drug eruption
• Urticaria
• Bullous conditions
• Exfoliative conditions
  - Exfoliative dermatitis
• Hyperhidrosis
• Macular rash
• Erythema
• Erythema multiforme

Immune, Blood and Lymphatic System Disorders

• Anaemia
• Leucopenia
• Thrombocytopenia
• Thrombocytopenic purpura
• Pancytopenia
• Hypersensitivity reactions
• Angioneurotic oedema
• Anaphylactic reactions
• Auricular swelling
• Fever
  - Hyperpyrexia
• Decreased platelet count
• Abnormal white blood count

Sensory Disorders

• Accommodation disorder
• Blurred vision
• Dry eye
• Difficulties in visual accommodation
• Visual impairment
• Diplopia
• Mydriasis
• Vertigo

Others

• Feeling jittery

• Non-selective, irreversible monoamine oxidase inhibitors
• Agents that elevate blood pressure
• Anti-hypertensive agents
• Coumarin anticoagulants
• Anticonvulsants
• Phenobarbital
• Phenytoin
• Primidone
• Some antidepressants
• Tricyclic andtidepressants
• Selective serotonin reuptake inhibitors
• Halogenated anaesthetics
• Centrally acting alpha-2 agonists
• Clonidine
• Dopaminergic agents
• Antipsychotics
• Direct and indirect dopamine agonists
• DOPA antidepressants
• Dopamine antagonists

Other interactions

• Alcohol
• Laboratory tests
  - Amphetamines (Particularly with immunoassay screen test)
  (See Additional Prescribing Points)

• Growth (in children)
  - Height
  - Weight
• Weight (in adults)
• Blood pressure
• Pulse
• Heart rate
• Psychiatric status
• Cardiovascular status

Additional observations

• Appetite
• De novo or worsening of pre-existing psychiatric disorders
• Risk of diversion, misuse, addiction and abuse of methylphenidate
• Development of exertional chest pain, unexplained syncope and any symptom of cardiac disease
• Signs of peripheral vasculopathy (e.g. digital changes)
• Sleep and behavioral changes

Pre-treatment screening

• Prior to initiating treatment with methylphenidate, patients should be assessed for their cardiovascular status, including their blood pressure and heart rate
• A comprehensive history should document concomitant medicines, pre-existing and currently present co-morbid medical and psychiatric disorders or symptoms
• Any family history of sudden cardiac/unexplained death should be recorded
• Recording of pre-treatment height and weight on a growth chart is needed
• In case of adults, only weight should be recorded

Special diagnostic considerations for ADHD in children

• Diagnosis should be made according to current DSM criteria or the guidelines in International Classification of Diseases and should be based on a complete history and evaluation of the patient
• Diagnosis cannot be made solely on the presence of one or more symptoms
• The specific aetiology of this syndrome is unknown, and there is no single diagnostic test
• Adequate diagnosis requires the use of medical and specialised psychological, educational, and social resources
• A comprehensive treatment programme typically includes psychological, educational and social measures as well as pharmacotherapy and is aimed at stabilising children with a behavioural syndrome characterised 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
• Methylphenidate MR treatment is not indicated in all children with ADHD and the decision to use the medicinal product must be based on a very thorough assessment of the severity and chronicity of the child’s symptoms in relation to the child’s age
• Appropriate educational placement is essential, and psychosocial intervention is generally necessary
• Where remedial measures alone prove insufficient, the decision to prescribe a stimulant must be based on rigorous assessment of the severity of the child's symptoms
• The use of methylphenidate MR capsules should always be according to the licensed indication and according to prescribing/diagnostic guidelines

Special diagnostic considerations for ADHD in adults

• Diagnosis should be made according to DSM criteria or the guidelines in the International Classification of Diseases and should be based on a complete history and evaluation of the patient
• The specific etiology of this syndrome is unknown, and there is no single diagnostic test
• Adults with ADHD have symptom patterns characterised by restlessness, impatience, and inattentiveness
• Symptoms such as hyperactivity tend to diminish with increasing age possibly due to adaptation, neurodevelopment and self-medication
• Inattentive symptoms are more prominent and have a greater impact on adults with ADHD
• Diagnosis in adults should include a structured patient interview to determine current symptoms
• The preexistence of childhood ADHD is required and has to be determined retrospectively (by patients’ records or if not available by appropriate and structured instruments/interviews)
• Third-party corroboration is desirable and methylphenidate MR capsules should not be initiated when the verification of childhood ADHD symptoms is uncertain
• Diagnosis should not be made solely on the presence of one or more symptoms
• The decision to use a stimulant in adults must be based on a very thorough assessment and diagnosis should include moderate or severe functional impairment in at least 2 settings (for example, social, academic, and/or occupational functioning), affecting several aspects of an individual’s life

Long-term (more than 12 months) use in children and adolescents

• The safety and efficacy of long-term use of methylphenidate has not been systematically evaluated in controlled trials
• Methylphenidate treatment should not and need not, be indefinite. Methylphenidate treatment is usually discontinued during or after puberty
• The medical practitioner who elects to use methylphenidate for extended periods (over 12 months) in children and adolescents with ADHD should periodically re-evaluate the long-term usefulness of the medicine for the individual patient with trial periods off medication to assess the patient's functioning without pharmacotherapy
• It is recommended that methylphenidate is de-challenged at least once yearly to assess the child's condition (preferable during times of school holidays). Improvement may be sustained when the medicinal product is either temporarily or permanently discontinued

Drug screening

• This product contains methylphenidate which may induce a false positive laboratory test for amphetamines, particularly with immunoassay screen test

Methylphenidate is a mild CNS stimulant with more prominent effects on mental than on motor activities. Its mode of action in man is not completely understood but its effects are thought to be due to cortical stimulation and possibly to stimulation of the reticular activating system. The mechanism by which methylphenidate exerts its mental and behavioural effects in children is not clearly established, nor is there conclusive evidence showing how these effects relate to the condition of the central nervous system. It is thought to block the re-uptake of norepinephrine and dopamine into the presynaptic neurone and increase the release of these monoamines into the extraneuronal space. Methylphenidate is a racemic mixture of the d- and l-threo enantiomers. The d-enantiomer is more pharmacologically active than the l-enantiomer.

Tablet 10mg

• Methylphenidate 10 Biotech (Biotech Laboratories)
• Methylphenidate HCl-Douglas (Pharmaplan)
• Ritalin (Novartis) originator

Tablet srt 18mg

• Acerta 18 (Teva Pharmaceuticals)
• Concerta (Janssen) originator
• Contramyl XR (Mylan)
• Mefedinel 18 (Sandoz SA)
• Methylphenidate Unicorn 18 (Sandoz SA)
• Neucon (Janssen)
• Radd 18mg (Pharma Dynamics)

Tablet srt 27mg

• Acerta 27 (Teva Pharmaceuticals)
• Concerta (Janssen) originator
• Contramyl XR (Mylan)
• Mefedinel 27 (Sandoz SA)
• Methylphenidate Unicorn 27 (Sandoz SA)
• Neucon (Janssen)
• Radd 27mg (Pharma Dynamics)

Tablet srt 36mg

• Acerta 36 (Teva Pharmaceuticals)
• Concerta (Janssen) originator
• Contramyl XR (Mylan)
• Mefedinel 36 (Sandoz SA)
• Methylphenidate Unicorn 36 (Sandoz SA)
• Neucon (Janssen) 
• Radd 36mg (Pharma Dynamics)

Tablet srt 54mg

• Acerta 54 (Teva Pharmaceuticals) 
• Concerta (Janssen) originator
• Contramyl XR (Mylan)
• Mefedinel 54 (Sandoz SA)
• Methylphenidate Unicorn 54 (Sandoz SA)
• Neucon (Janssen)
• Radd 54mg (Pharma Dynamics)

Capsule 10mg

• Ritalin LA (Novartis) originator

Capsule 20mg

• Ritalin LA (Novartis) originator

Capsule 30mg

• Ritalin LA (Novartis) originator

Capsule 40mg

• Ritalin LA (Novartis) originator