Risperidone 3 mg Tablets

1. Name Of The Medicinal Product

Risperidone 3mg Tablets

2. Qualitative And Quantitative Composition

Each tablet contains 3 mg risperidone

Excipients:

Each tablet contains 120 mg Lactose-Monohydrate.

For a full list of excipients, see section 6.1

3. Pharmaceutical Form

Film-coated tablet

Product description:

Yellow, biconvex, oblong tablets with score line on one side

4. Clinical Particulars

4.1 Therapeutic Indications

Risperidone is indicated for the treatment of schizophrenia.

Risperidone is indicated for the treatment of moderate to severe manic episodes associated with bipolar disorders.

Risperidone is indicated for the short-term treatment (up to 6 weeks) of persistent aggression in patients with moderate to severe Alzheimer's dementia unresponsive to non pharmacological approaches and when there is a risk of harm to self or others.

Risperidone is indicated for the short-term symptomatic treatment (up to 6 weeks) of persistent aggression in conduct disorder in children from the age of 5 years and adolescents with subaverage intellectual functioning or mental retardation diagnosed according to DSM-IV criteria, in whom the severity of aggressive or other disruptive behaviours require pharmacologic treatment. Pharmacological treatment should be an integral part of a more comprehensive treatment programme, including psychosocial and educational intervention. It is recommended that risperidone be prescribed by a specialist in child neurology and child and adolescent psychiatry or physicians well familiar with the treatment of conduct disorder of children and adolescents.

4.2 Posology And Method Of Administration

Schizophrenia

Adults

Risperidone may be given once daily or twice daily. Patients should start with 2 mg/day risperidone. The dosage may be increased on the second day to 4 mg.

Subsequently, the dosage can be maintained unchanged, or further individualised, if needed. Most patients will benefit from daily doses between 4 and 6 mg. In some patients, a slower titration phase and a lower starting and maintenance dose may be appropriate.

Doses above 10 mg/day have not demonstrated superior efficacy to lower doses and may cause increased incidence of extrapyramidal symptoms. Safety of doses above 16 mg/day has not been evaluated, and are therefore not recommended.

Elderly

A starting dose of 0.5 mg* twice daily is recommended. This dosage can be individually adjusted with 0.5 mg* twice daily increments to 1 to 2 mg twice daily.

* for doses not achievable with Risperidone other risperidone presentations are available

Paediatric population

Risperidone is not recommended for use in children below age 18 with schizophrenia due to a lack of data on efficacy.

Manic episodes in bipolar disorder

Adults

Risperidone should be administered on a once daily schedule, starting with 2 mg risperidone. Dosage adjustments, if indicated, should occur at intervals of not less than 24 hours and in dosage increments of 1 mg per day. Risperidone can be administered in flexible doses over a range of 1 to 6 mg per day to optimize each patient's level of efficacy and tolerability. Daily doses over 6 mg risperidone have not been investigated in patients with manic episodes.

As with all symptomatic treatments, the continued use of Risperidone must be evaluated and justified on an ongoing basis.

Elderly

A starting dose of 0.5 mg* twice daily is recommended. This dosage can be individually adjusted with 0.5 mg* twice daily increments to 1 to 2 mg twice daily. Since clinical experience in elderly is limited, caution should be exercised.

* for doses not achievable with Risperidone other risperidone presentations are available

Paediatric population

Risperidone is not recommended for use in children below age 18 with bipolar mania due to a lack of data on efficacy.

Persistent aggression in patients with moderate to severe Alzheimer's dementia

A starting dose of 0.25 mg* twice daily is recommended. This dosage can be individually adjusted by increments of 0.25 mg* twice daily, not more frequently than every other day, if needed. The optimum dose is 0.5 mg* twice daily for most patients. Some patients, however, may benefit from doses up to 1 mg twice daily.

Risperidone should not be used more than 6 weeks in patients with persistent aggression in Alzheimer's dementia. During treatment, patients must be evaluated frequently and regularly, and the need for continuing treatment reassessed.

* for doses not achievable with Risperidone other risperidone presentations are available

Conduct disorder

Children and adolescents from 5 to 18 years of age

For subjects

* for doses not achievable with Risperidone other risperidone presentations are available

As with all symptomatic treatments, the continued use of Risperidone must be evaluated and justified on an ongoing basis.

Risperidone is not recommended in children less than 5 years of age, as there is no experience in children less than 5 years of age with this disorder.

Renal and hepatic impairment

Patients with renal impairment have less ability to eliminate the active antipsychotic fraction than in adults with normal renal function. Patients with impaired hepatic function have increases in plasma concentration of the free fraction of risperidone.

Irrespective of the indication, starting and consecutive dosing should be halved, and dose titration should be slower for patients with renal or hepatic impairment.

Risperidone should be used with caution in these groups of patients.

Method of administration

Risperidone is for oral use. Food does not affect the absorption of Risperidone.

Upon discontinuation, gradual withdrawal is advised. Acute withdrawal symptoms, including nausea, vomiting, sweating, and insomnia have very rarely been described after abrupt cessation of high doses of antipsychotic medicines (see section 4.8). Recurrence of psychotic symptoms may also occur, and the emergence of involuntary movement disorders (such as akathisia, dystonia and dyskinesia) has been reported.

Switching from other antipsychotics.

When medically appropriate, gradual discontinuation of the previous treatment while Risperidone therapy is initiated is recommended. Also, if medically appropriate, when switching patients from depot antipsychotics, initiate Risperidone therapy in place of the next scheduled injection. The need for continuing existing anti-Parkinson medicines should be re-evaluated periodically.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients. (for excipients see section 6.1)

4.4 Special Warnings And Precautions For Use

Elderly patients with dementia

Overall mortality

Elderly patients with dementia treated with atypical antipsychotics have an increased mortality compared to placebo in a meta-analysis of 17 controlled trials of atypical antipsychotics, including Risperidone. In placebo-controlled trials with Risperidone in this population, the incidence of mortality was 4.0% for Risperidone -treated patients compared to 3.1% for placebo-treated patients. The odds ratio (95% exact confidence interval) was 1.21 (0.7, 2.1). The mean age (range) of patients who died was 86 years (range 67-100).

Concomitant use with furosemide

In the Risperidone placebo-controlled trials in elderly patients with dementia, a higher incidence of mortality was observed in patients treated with furosemide plus risperidone (7.3%; mean age 89 years, range 75-97) when compared to patients treated with risperidone alone (3.1%; mean age 84 years, range 70-96) or furosemide alone (4.1%; mean age 80 years, range 67-90). The increase in mortality in patients treated with furosemide plus risperidone was observed in two of the four clinical trials. Concomitant use of risperidone with other diuretics (mainly thiazide diuretics used in low dose) was not associated with similar findings.

No pathophysiological mechanism has been identified to explain this finding, and no consistent pattern for cause of death observed. Nevertheless, caution should be exercised and the risks and benefits of this combination or co-treatment with other potent diuretics should be considered prior to the decision to use.

There was no increased incidence of mortality among patients taking other diuretics as concomitant treatment with risperidone. Irrespective of treatment, dehydration was an overall risk factor for mortality and should therefore be carefully avoided in elderly patients with dementia.

Cerebrovascular Adverse Events (CVAE)

In placebo-controlled trials in elderly patients with dementia there was a significantly higher incidence (approximately 3-fold increased) of CVAEs, such as stroke (including fatalities) and transient ischaemic attack in patients treated with Risperidone compared with patients treated with placebo (mean age 85 years; range 73 to 97). The pooled data from six placebo-controlled studies in mainly elderly patients (>65 years of age) with dementia showed that CVAEs (serious and non-serious, combined) occurred in 3.3% (33/1009) of patients treated with risperidone and 1.2% (8/712) of patients treated with placebo. The odds ratio (95% exact confidence interval) was 2.96 (1.34, 7.50). The mechanism for this increased risk is not known. An increased risk cannot be excluded for other antipsychotics or other patient populations.

Risperidone should be used with caution in patients with risk factors for stroke.

The risk of CVAEs was significantly higher in patients with mixed or vascular type of dementia when compared to Alzheimer's dementia. Therefore, patients with other types of dementias than Alzheimer's should not be treated with risperidone.

Physicians are advised to assess the risks and benefits of the use of Risperidone in elderly patients with dementia, taking into account risk predictors for stroke in the individual patient. Patients/caregivers should be cautioned to immediately report signs and symptoms of potential CVAEs such as sudden weakness or numbness in the face, arms or legs, and speech or vision problems. All treatment options should be considered without delay, including discontinuation of risperidone.

Risperidone should only be used short term for persistent aggression in patients with moderate to severe Alzheimer's dementia to supplement non-pharmacological approaches which have had limited or no efficacy and when there is potential risk of harm to self or others.

Patients should be reassessed regularly, and the need for continuing treatment reassessed.

Orthostatic hypotension

Due to the alpha-blocking activity of risperidone, (orthostatic) hypotension can occur, especially during the initial dose-titration period. Clinically significant hypotension has been observed postmarketing with concomitant use of risperidone and antihypertensive treatment. Risperidone should be used with caution in patients with known cardiovascular disease (e.g., heart failure, myocardial infarction, conduction abnormalities, dehydration, hypovolemia, or cerebrovascular disease), and the dosage should be gradually titrated as recommended (see section 4.2). A dose reduction should be considered if hypotension occurs.

Tardive dyskinesia/extrapyramidal symptoms (TD/EPS)

Medicines with dopamine receptor antagonistic properties have been associated with the induction of tardive dyskinesia characterised by rhythmical involuntary movements, predominantly of the tongue and/or face.

The onset of extrapyramidal symptoms is a risk factor for tardive dyskinesia. If signs and symptoms of tardive dyskinesia appear, the discontinuation of all antipsychotics should be considered.

Neuroleptic malignant syndrome (NMS)

Neuroleptic Malignant Syndrome, characterised by hyperthermia, muscle rigidity, autonomic instability, altered consciousness and elevated serum creatine phosphokinase levels has been reported to occur with antipsychotics. Additional signs may include myoglobinuria (rhabdomyolysis) and acute renal failure. In this event, all antipsychotics, including Risperidone, should be discontinued.

Parkinson's disease and dementia with Lewy bodies

Physicians should weigh the risks versus the benefits when prescribing antipsychotics, including Risperidone, to patients with Parkinson's Disease or Dementia with Lewy Bodies (DLB). Parkinson's Disease may worsen with risperidone. Both groups may be at increased risk of Neuroleptic Malignant Syndrome as well as having an increased sensitivity to antipsychotic medicinal products; these patients were excluded from clinical trials. Manifestation of this increased sensitivity can include confusion, obtundation, postural instability with frequent falls, in addition to extrapyramidal symptoms.

Hyperglycemia

Hyperglycemia or exacerbation of pre-existing diabetes has been reported in very rare cases during treatment with Risperidone. Appropriate clinical monitoring is advisable in diabetic patients and in patients with risk factors for the development of diabetes mellitus.

Hyperprolactinaemia

Tissue culture studies suggest that cell growth in human breast tumours may be stimulated by prolactin.

Although no clear association with the administration of antipsychotics has so far been demonstrated in clinical and epidemiological studies, caution is recommended in patients with relevant medical history.

Risperidone should be used with caution in patients with pre-existing hyperprolactinaemia and in patients with possible prolactin-dependent tumours.

QT prolongation

QT prolongation has very rarely been reported postmarketing. As with other antipsychotics, caution should be exercised when risperidone is prescribed in patients with known cardiovascular disease, family history of QT prolongation, bradycardia, or electrolyte disturbances (hypokalaemia, hypomagnesaemia), as it may increase the risk of arrhythmogenic effects, and in concomitant use with medicines known to prolong the QT interval.

Seizures

Risperidone should be used cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold.

Priapism

Priapism may occur with Risperidone treatment due to its alpha-adrenergic blocking effects.

Body temperature regulation

Disruption of the body's ability to reduce core body temperature has been attributed to antipsychotic medicines. Appropriate care is advised when prescribing Risperidone to patients who will be experiencing conditions which may contribute to an elevation in core body temperature, e.g., exercising strenuously, exposure to extreme heat, receiving concomitant treatment with anticholinergic activity, or being subject to dehydration.

Venous thromboembolism

Cases of venous thromboembolism (VTE) have been reported with antipsychotic drugs. Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with Risperidone and preventive measures undertaken.

Children and adolescents

Before risperidone is prescribed to a child or adolescent with conduct disorder they should be fully assessed for physical and social causes of the aggressive behaviour such as pain or inappropriate environmental demands.

The sedative effect of risperidone should be closely monitored in this population because of possible consequences on learning ability. A change in the time of administration of risperidone could improve the impact of the sedation on attention faculties of children and adolescents.

Risperidone was associated with mean increases in body weight and body mass index (BMI). Changes in height in the long-term open-label extension studies were within expected age-appropriate norms. The effect of long-term risperidone treatment on sexual maturation and height have not been adequately studied. Because of the potential effects of prolonged hyperprolactinemia on growth and sexual maturation in children and adolescents, regular clinical evaluation of endocrinological status should be considered, including measurements of height, weight, sexual maturation, monitoring of menstrual functioning, and other potential prolactin-related effects.

During treatment with risperidone regular examination for extrapyramidal symptoms and other movement disorders should also be conducted.

For specific posology recommendations in children and adolescents see Section 4.2.

Excipients

The film-coated tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

As with other antipsychotics, caution is advised when prescribing risperidone with medicinal products known to prolong the QT interval, e.g., class Ia antiarrhythmics (e.g., quinidine, dysopiramide, procainamide), class III antiarrhythmics (e.g., amiodarone, sotalol), tricyclic antidepressant (i.e., amitriptyline), tetracyclic antidepressants (i.e., maprotiline), some antihistaminics, other antipsychotics, some antimalarials (i.e., chinice and mefloquine), and with medicines causing electrolyte imbalance (hypokalaemia, hypomagnesiaemia), bradycardia, or those which inhibit the hepatic metabolism of risperidone. This list is indicative and not exhaustive.

Potential for Risperidone to affect other medicinal products

Risperidone should be used with caution in combination with other centrally-acting substances notably including alcohol, opiates, antihistamines and benzodiazepines due to the increased risk of sedation.

Risperidone may antagonise the effect of levodopa and other dopamine agonists. If this combination is deemed necessary, particularly in end-stage Parkinson's disease, the lowest effective dose of each treatment should be prescribed.

Clinically significant hypotension has been observed postmarketing with concomitant use of risperidone and antihypertensive treatment.

Risperidone does not show a clinically relevant effect on the pharmacokinetics of lithium, valproate, digoxin or topiramate.

Potential for other medicinal products to affect Risperidone

Carbamazepine has been shown to decrease the plasma concentrations of the active antipsychotic fraction of risperidone. Similar effects may be observed with e.g. rifampicin, phenytoin and phenobarbital which also induce CYP 3A4 hepatic enzyme as well as P-glycoprotein. When carbamazepine or other CYP 3A4 hepatic enzyme/P-glycoprotein (P-gp) inducers are initiated or discontinued, the physician should re-evaluate the dosing of Risperidone.

Fluoxetine and paroxetine, CYP 2D6 inhibitors, increase the plasma concentration of risperidone, but less so of the active antipsychotic fraction. It is expected that other CYP 2D6 inhibitors, such as quinidine, may affect the plasma concentrations of risperidone in a similar way. When concomitant fluoxetine or paroxetine is initiated or discontinued, the physician should re-evaluate the dosing of Risperidone.

Verapamil, an inhibitor of CYP 3A4 and P-gp, increases the plasma concentration of risperidone. Galantamine and donepezil do not show a clinically relevant effect on the pharmacokinetics of risperidone and on the active antipsychotic fraction.

Phenothiazines, tricyclic antidepressants, and some beta-blockers may increase the plasma concentrations of risperidone but not those of the active antipsychotic fraction. Amitriptyline does not affect the pharmacokinetics of risperidone or the active antipsychotic fraction. Cimetidine and ranitidine increase the bioavailability of risperidone, but only marginally that of the active antipsychotic fraction. Erythromycin, a CYP 3A4 inhibitor, does not change the pharmacokinetics of risperidone and the active antipsychotic fraction.

The combined use of psychostimulants (e.g., methylphenidate) with Risperidone in children and adolescents did not alter the pharmacokinetics and efficacy of Risperidone.

See section 4.4 regarding increased mortality in elderly patients with dementia concomitantly receiving furosemide.

Concomitant use of oral Risperidone with paliperidone is not recommended as paliperidone is the active metabolite of risperidone and the combination of the two may lead to additive active antipsychotic fraction exposure.

4.6 Pregnancy And Lactation

Pregnancy

There are no adequate data from the use of risperidone in pregnant women. According to postmarketing data reversible extrapyramidal symptoms in the neonate were observed following the use of risperidone during the last trimester of pregnancy. Consequently newborns should be monitored carefully. Risperidone was not teratogenic in animal studies but other types of reproductive toxicity were seen (see section 5.3). The potential risk for humans is unknown. Therefore, Risperidone should not be used during pregnancy unless clearly necessary. If discontinuation during pregnancy is necessary, it should not be done abruptly.

Lactation

In animal studies, risperidone and 9-hydroxy-risperidone are excreted in the milk. It has been demonstrated that risperidone and 9-hydroxy-risperidone are also excreted in human breast milk in small quantities. There are no data available on adverse reactions in breast-feeding infants. Therefore, the advantage of breastfeeding should be weighed against the potential risks for the child.

4.7 Effects On Ability To Drive And Use Machines

Risperidone can have minor or moderate influence on the ability to drive and use machines due to potential nervous system and visual effects (see section 4.8). Therefore, patients should be advised not to drive or operate machinery until their individual susceptibility is known.

4.8 Undesirable Effects

The most frequently reported adverse drug reactions (ADRs) (incidence

The following are all the ADRs that were reported in clinical trials and postmarketing. The following terms and frequencies are applied: very common (

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Adverse Drug Reactions by System Organ Class and Frequency

Investigations
Common	Blood prolactin increaseda, Weight increased
Uncommon	Electrocardiogram QT prolonged, Electrocardiogram abnormal, Blood glucose increased, Transaminases increased, White blood cell count decreased Body temperature increased, Eosinophil count increased,Haemoglobin decreased, Blood creatine phosphokinase increased
Rare	Body temperature decreased
Cardiac disorders
Common	Tachycardia
Uncommon	Atrioventricular block, Bundle branch block, Atrial fibrillation, Sinus bradycardia, Palpitations
Blood and lymphatic system disorders
Uncommon	Anaemia, Thrombocytopenia
Rare	Granulocytopenia
Not known	Agranulocytosis
Nervous system disorders
Very common	Parkinsonismb, Headache
Common	Akathisiab, Dizziness, Tremorb, Dystoniab, Somnolence, Sedation, Lethargy, Dyskinesiab
Uncommon	Unresponsive to stimuli, Loss of consciousness, Syncope, Depressed level of consciousness, Cerebrovascular accident, Transient ischaemic attack, Dysarthria, Disturbance in attention, Hypersomnia, Dizziness postural, Balance disorder, Tardive dyskinesia, Speech disorder, Coordination abnormal, Hypoaesthesia
Rare	Neuroleptic malignant syndrome, Diabetic coma, Cerebrovascular disorder, Cerebral ischaemia, Movement disorder
Eye disorders
Common	Vision blurred
Uncommon	Conjunctivitis, Ocular hyperaemia, Eye discharge, Eye swelling, Dry eye, Lacrimation increased, Photophobia
Rare	Visual acuity reduced, Eye rolling, Glaucoma
Ear and labyrinth disorders
Uncommon	Ear pain, Tinnitus
Respiratory, thoracic and mediastinal disorders
Common	Dyspnoea, Epistaxis, Cough, Nasal congestion, Pharyngolaryngeal Pain
Uncommon	Wheezing, Pneumonia aspiration, Pulmonary congestion, Respiratory disorder, Rales, Respiratory tract congestion, Dysphonia
Rare	Sleep apnea syndrome, Hyperventilation
Gastrointestinal disorders
Common	Vomiting, Diarrhoea, Constipation, Nausea, Abdominal pain, Dyspepsia, Dry mouth, Stomach discomfort
Uncommon	Dysphagia, Gastritis, Faecal incontinence, Faecaloma
Rare	Intestinal obstruction, Pancreatitis, Lip swelling, Cheilitis
Renal and urinary disorders
Common	Enuresis
Uncommon	Dysuria, Urinary incontinence, Pollakiuria
Skin and subcutaneous tissue disorders
Common	Rash, Erythema
Uncommon	Angioedema, Skin lesion, Skin disorder, Pruritus, Acne, Skin discolouration, Alopecia, Seborrhoeic dermatitis, Dry skin, Hyperkeratosis
Rare	Dandruff
Musculoskeletal and connective tissue disorders
Common	Arthralgia, Back pain, Pain in extremity
Uncommon	Muscular weakness, Myalgia, Neck pain, Joint swelling, Posture abnormal, Joint stiffness, Musculoskeletal chest pain
Rare	Rhabdomyolysis
Endocrine disorders
Rare	Inappropriate antidiuretic hormone secretion
Metabolism and nutrition disorders
Common	Increased appetite, Decreased appetite
Uncommon	Anorexia, Polydipsia
Very rare	Diabetic ketoacidosis
Not known	Water intoxication
Infections and infestations
Common	Pneumonia, Influenza, Bronchitis, Upper respiratory tract infection, Urinary tract infection
Uncommon	Sinusitis, Viral infection, Ear infection, Tonsillitis, Cellulitis, Otitis media, Eye infection, Localised infection, Acarodermatitis, Respiratory tract infection, Cystitis, Onychomycosis
Rare	Otitis media chronic
Vascular disorders
Uncommon	Hypotension, Orthostatic hypotension, Flushing
Not known	Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis have been reported with antipsychotic drugs
General disorders and administration site conditions
Common	Pyrexia, Fatigue, Peripheral oedema, Asthenia, Chest pain
Uncommon	Face oedema, Gait disturbance, Feeling abnormal, Sluggishness, Influenza like illness, Thirst, Chest discomfort, Chills
Rare	Generalised oedema, Hypothermia, Drug withdrawal syndrome, Peripheral coldness
Immune system disorders
Uncommon	Hypersensitivity
Rare	Drug hypersensitivity
Not known	Anaphylactic reaction
Hepatobiliary disorders
Rare	Jaundice
Reproductive system and breast disorders
Uncommon	Amenorrhoea, Sexual dysfunction, Erectile dysfunction, Ejaculation disorder, Galactorrhoea, Gynaecomastia, Menstrual disorder, Vaginal discharge,
Not known	Priapism
Psychiatric disorders
Very common	Insomnia
Common	Anxiety, Agitation, Sleep disorder
Uncommon	Confusional state, Mania, Libido decreased, Listless, Nervousness
Rare	Anorgasmia, Blunted affect

^a) Hyperprolactinemia can in some cases lead to gynaecomastia, menstrual disturbances, amenorrhoea, galactorrhea.

^b) Extrapyramidal disorder may occur: Parkinsonism (salivary hypersecretion, musculoskeletal stiffness, parkinsonism, drooling, cogwheel rigidity, bradykinesia, hypokinesia, masked facies, muscle tightness, akinesia, nuchal rigidity, muscle rigidity, parkinsonian gait, and glabellar reflex abnormal),akathisia ( akathisia, restlessness, hyperkinesia, and restless leg syndrome), tremor, dyskinesia (dyskinesia, muscle twitching, choreoathetosis, athetosis, and myoclonus), dystonia.

Dystonia includes dystonia, muscle spasms, hypertonia, torticollis, muscle contractions involuntary, muscle contracture, blepharospasm, oculogyration, tongue paralysis, facial spasm, laryngospasm, myotonia, opisthotonus, oropharyngeal spasm, pleurothotonus, tongue spasm, and trismus. Tremor includes tremor and parkinsonian rest tremor. It should be noted that a broader spectrum of symptoms are included, that do not necessarily have an extrapyramidal origin.

Class effects

As with other antipsychotics, very rare cases of QT prolongation have been reported postmarketing with risperidone. Other class-related cardiac effects reported with antipsychotics which prolong QT interval include ventricular arrhythmia, ventricular fibrillation, ventricular tachycardia, sudden death, cardiac arrest and Torsades de Pointes.

Weight gain

The proportions of Risperidone and placebo-treated adult patients with schizophrenia meeting a weight gain criterion of

In a population of children and adolescents with conduct and other disruptive behaviour disorders, in longterm studies, weight increased by a mean of 7.3 kg after 12 months of treatment. The expected weight gain for normal children between 5-12 years of age is 3 to 5 kg per year. From 12-16 years of age, this magnitude of gaining 3 to 5 kg per year is maintained for girls, while boys gain approximately 5 kg per year.

Additional information on special populations

Adverse drug reactions that were reported with higher incidence in elderly patients with dementia or paediatric patients than in adult populations are described below:

Elderly patients with dementia

Transient ischaemic attack and cerebrovascular accident were ADRs reported in clinical trials with a frequency of 1.4% and 1.5%, respectively, in elderly patients with dementia. In addition, the following ADRs were reported with a frequency

Paediatric patients

The following ADRs were reported with a frequency

4.9 Overdose

Symptoms

In general, reported signs and symptoms have been those resulting from an exaggeration of the known pharmacological effects of risperidone. These include drowsiness and sedation, tachycardia and hypotension, and extrapyramidal symptoms. In overdose, QT-prolongation and convulsions have been reported. Torsade de Pointes has been reported in association with combined overdose of Risperidone and paroxetine.

In case of acute overdose, the possibility of multiple drug involvement should be considered.

Treatment

Establish and maintain a clear airway and ensure adequate oxygenation and ventilation. Gastric lavage (after intubation, if the patient is unconscious) and administration of activated charcoal together with a laxative should be considered only when drug intake was less than one hour before. Cardiovascular monitoring should commence immediately and should include continuous electrocardiographic monitoring to detect possible arrhythmias.

There is no specific antidote to Risperidone. Therefore, appropriate supportive measures should be instituted. Hypotension and circulatory collapse should be treated with appropriate measures such as intravenous fluids and/or sympathomimetic agents. In case of severe extrapyramidal symptoms, an anticholinergic medicinal product should be administered. Close medical supervision and monitoring should continue until the patient recovers.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Other antipsychotics, ATC-code: N05AX08

Mechanism of action

Risperidone is a selective monoaminergic antagonist with unique properties. It has a high affinity for serotoninergic 5-HT2 and dopaminergic D2 receptors. Risperidone binds also to alpha1-adrenergic receptors, and, with lower affinity, to H1-histaminergic and alpha2 adrenergic receptors. Risperidone has no affinity for cholinergic receptors. Although risperidone is a potent D2 antagonist, which is considered to improve the positive symptoms of schizophrenia, it causes less depression of mot

Aprotinin

Pronunciation: a-proe-TYE-nin
Generic Name: Aprotinin
Brand Name: Trasylol

Aprotinin may cause severe and sometimes fatal allergic reactions (eg, rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; fast heartbeat; pale skin; severe low blood pressure; loss of consciousness possibly leading to a lack of heartbeat or breathing). The risk is increased in patients who have previously received Aprotinin. The risk of fatal allergic reactions may be greater in patients who receive Aprotinin more than once in a 12-month period of time. Tell your doctor if you think you have ever had Aprotinin in the past.

Aprotinin is used for:

Reducing blood loss and the need for blood transfusions in patients undergoing certain types of heart surgery.

Aprotinin is a protease inhibitor. It works by reducing the inflammatory response associated with cardiopulmonary bypass surgery.

Do NOT use Aprotinin if:

• you are allergic to any ingredient in Aprotinin


• you have received Aprotinin within the past 12 months

Contact your doctor or health care provider right away if any of these apply to you.

Before using Aprotinin:

Some medical conditions may interact with Aprotinin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have kidney problems


• if you have previously had heart surgery

Some MEDICINES MAY INTERACT with Aprotinin. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Aminoglycosides (eg, gentamicin) or medicines that alter kidney function because the risk of kidney damage may be increased


• Angiotensin-converting enzyme (ACE) inhibitors (eg, captopril) or fibrinolytics (eg, streptokinase) because the effectiveness of these medicines may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Aprotinin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Aprotinin:

Use Aprotinin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Aprotinin. Talk to your pharmacist if you have questions about this information.


• Aprotinin is administered as an intravenous (IV; into a vein) injection only in a medical setting.


• If you miss a dose of Aprotinin, contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Aprotinin.

Important safety information:

• Lab tests, including kidney function and blood clotting tests, may be performed while you use Aprotinin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Aprotinin should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Aprotinin while you are pregnant. It is not known if Aprotinin is found in breast milk. If you are or will be breast-feeding while you use Aprotinin, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Aprotinin:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; difficulty urinating; infection (eg, fever, chills, sore throat); lightheadedness; sleeplessness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); asthma; chest pain; confusion; decreased urination; fast or irregular heartbeat; lung disorder; nausea; numbness of an arm or leg; one-sided weakness; severe stomach pain; sudden severe headache, dizziness, fainting, or vomiting; sudden weight gain; swelling of the hands, legs, or feet; vision or speech changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Aprotinin side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800 -222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Aprotinin:

Aprotinin is usually handled and stored by a health care provider. Keep Aprotinin out of the reach of children and away from pets.

General information:

• If you have any questions about Aprotinin, please talk with your doctor, pharmacist, or other health care provider.


• Aprotinin is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Aprotinin. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Aprotinin resources

• Aprotinin Side Effects (in more detail)
• Aprotinin Use in Pregnancy & Breastfeeding
• Aprotinin Drug Interactions
• Aprotinin Support Group
• 0 Reviews for Aprotinin - Add your own review/rating

• Aprotinin Monograph (AHFS DI)


• Trasylol Prescribing Information (FDA)

Compare Aprotinin with other medications

• Bleeding Disorder

miglustat

mi-GLOO-stat

Commonly used brand name(s)

In the U.S.

• Zavesca

Available Dosage Forms:

• Capsule

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Glucosylceramide Synthase Inhibitor

Uses For miglustat

Miglustat is used to treat adults with mild to moderate type 1 Gaucher disease. Miglustat is only used in people who cannot be treated with enzyme replacement therapy. Type 1 Gaucher disease is a disease you get from both your parents. People with type 1 Gaucher disease are missing an enzyme (naturally occurring substance in your body) that breaks down a chemical in your body called glucosylceramide. Too much glucosylceramide causes liver and spleen enlargement, changes in the blood, and bone disease. Miglustat works by stopping the body from making glucosylceramide.

miglustat is available only with your doctor's prescription.

Before Using miglustat

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For miglustat, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to miglustat or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

miglustat is not used in children under 18 years of age.

Geriatric

Many medicines have not been specifically studied in older people. Therefore, it may not be known whether they work the same way the do in younger adults. miglustat is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of miglustat. Make sure you tell your doctor if you have any other medical problems, especially:

• Gaucher disease, Type 1, severe—miglustat is not currently being used in patients with severe Type 1 Gaucher disease

• Kidney disease—this condition may cause you to have more miglustat in your body; your doctor may want to change the amount of miglustat that you take

Proper Use of miglustat

It is important to take miglustat exactly as your doctor prescribed. You should take your medicine at the same time or at the same times each day.

The capsules should be swallowed whole with water and may be taken with or without food. Check with your doctor or pharmacist if you have any questions.

Your doctor may recommend changes to your diet to help with some side effects. It is important that you follow these changes.

Dosing

The dose of miglustat will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of miglustat. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  
  • For Mild to Moderate Type 1 Gaucher disease
    
    • Adults—One 100 milligram (mg) capsule given three times a day; your doctor may change this dose as needed
    
    
    • Children—Use is not recommended in children under the age of 18
    
    
  
  

Missed Dose

If you miss a dose of miglustat, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using miglustat

Miglustat can cause problems affecting your nerves. If you have hand tremors (shaky movements) or if miglustat worsens a hand tremor you already have call your doctor. Your doctor might want to change your dose of miglustat.

If you experience numbness and tingling in your hands, arms, legs, or feet (peripheral neuropathy) call your doctor right away.

It is very important that your doctor check you at regular visits. Your doctor will also want to test your nerves (neurological exam) before you start taking miglustat and may repeat this test at a later time.

Diarrhea is the most common side effect for people taking miglustat. Your doctor may give you another medicine (anti-diarrheal) to help treat diarrhea if it is a problem for you. Your doctor may also recommend changes to your diet. You may also lose weight when you start treatment with miglustat.

It is very important to discuss with your doctor if you are pregnant or plan to become pregnant before starting miglustat. You should use effective birth control while taking miglustat. Miglustat may also harm a man's sperm. All men should use effective birth control during treatment and for three months after stopping treatment.

miglustat Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Black, tarry stools


• bleeding gums


• blood in urine or stools


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• pinpoint red spots on skin


• unusual bleeding or bruising

Unknown

• Painful sensations


• shakiness in legs, arms, hands, feet


• trembling or shaking of hands or feet


• unsteadiness or awkwardness


• weakness in arms, hands, legs, or feet

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

• Acid or sour stomach


• back pain


• belching


• bloated, full feeling


• change in vision


• cramps


• diarrhea


• difficulty having a bowel movement (stool)


• dizziness


• dry mouth


• excess air or gas in stomach or intestines


• full or bloated feeling or pressure in the stomach


• headache


• heartburn


• heaviness in limbs


• indigestion


• leg cramps


• loss of appetite


• memory loss


• menstrual changes


• nausea


• pain or discomfort in chest, upper stomach, or throat


• passing gas


• stomach discomfort, upset or pain


• swelling


• swelling of abdominal or stomach area


• unsteady walk


• vomiting


• weakness


• weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: miglustat side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More miglustat resources

• Miglustat Side Effects (in more detail)
• Miglustat Dosage
• Miglustat Use in Pregnancy & Breastfeeding
• Miglustat Drug Interactions
• Miglustat Support Group
• 0 Reviews for Miglustat - Add your own review/rating

• Miglustat Professional Patient Advice (Wolters Kluwer)


• Miglustat Monograph (AHFS DI)


• Miglustat MedFacts Consumer Leaflet (Wolters Kluwer)


• Zavesca Prescribing Information (FDA)


• Zavesca Consumer Overview

Compare miglustat with other medications

• Gaucher Disease

sulfonamide

Class Name: sulfonamide (Oral route)

Commonly used brand name(s)

In the U.S.

• Azulfidine


• Azulfidine Entabs


• Diamox Sequels


• Gantrisin Pediatric


• Sulfazine


• Sulfazine EC


• Truxazole


• Zonegran

In Canada

• Alti-Sulfasalazine


• Salazopyrin

Available Dosage Forms:

• Tablet


• Capsule, Extended Release


• Syrup


• Suspension


• Capsule


• Tablet, Enteric Coated

Uses For This Medicine

Sulfonamides or sulfa medicines are used to treat infections. They will not work for colds, flu, or other virus infections.

Sulfonamides are available only with your doctor's prescription.

Before Using This Medicine

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Sulfonamides should not be given to infants under 2 months of age unless directed by the child's doctor, because they may cause unwanted effects.

Geriatric

Elderly people are especially sensitive to the effects of sulfonamides. Severe skin problems and blood problems may be more likely to occur in the elderly. These problems may also be more likely to occur in patients who are taking diuretics (water pills) along with this medicine.

Pregnancy

Studies have not been done in pregnant women. However, studies in mice, rats, and rabbits have shown that some sulfonamides cause birth defects, including cleft palate and bone problems. Sulfonamides are not recommended for use at the time of labor and delivery. These medicines may cause unwanted effects in the baby.

Breast Feeding

Sulfonamides pass into the breast milk. This medicine is not recommended for use during breast-feeding. It may cause liver problems, anemia, and other unwanted effects in nursing babies, especially those with glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

• Bepridil


• Cisapride


• Dofetilide


• Levomethadyl


• Mesoridazine


• Pimozide


• Terfenadine


• Thioridazine

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acecainide


• Acenocoumarol


• Ajmaline


• Amiodarone


• Amisulpride


• Amitriptyline


• Amoxapine


• Aprindine


• Arsenic Trioxide


• Astemizole


• Azimilide


• Bretylium


• Chloral Hydrate


• Chloroquine


• Chlorpromazine


• Clarithromycin


• Desipramine


• Dibenzepin


• Digitalis


• Disopyramide


• Dolasetron


• Doxepin


• Droperidol


• Enflurane


• Erythromycin


• Flecainide


• Fluconazole


• Fluoxetine


• Foscarnet


• Gemifloxacin


• Halofantrine


• Haloperidol


• Halothane


• Hydroquinidine


• Ibutilide


• Imipramine


• Isoflurane


• Isradipine


• Ketorolac


• Levomethadyl


• Lidoflazine


• Lorcainide


• Mefloquine


• Metformin


• Methotrexate


• Naproxen


• Nortriptyline


• Octreotide


• Pentamidine


• Pirmenol


• Prajmaline


• Probucol


• Procainamide


• Prochlorperazine


• Propafenone


• Proscillaridin


• Pyrimethamine


• Quetiapine


• Quinidine


• Riluzole


• Risperidone


• Sematilide


• Sertindole


• Sotalol


• Spiramycin


• Sultopride


• Tedisamil


• Telithromycin


• Trifluoperazine


• Trimipramine


• Vasopressin


• Warfarin


• Zotepine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using medicines in this class with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use your medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia or other blood problems or


• Glucose-6-phosphate dehydrogenase (G6PD) deficiency—Patients with these problems may have an increase in side effects affecting the blood.

• Kidney disease or


• Liver disease—Patients with kidney and/or liver disease may have an increased chance of side effects.

• Porphyria—This medicine may bring on an attack of porphyria.

Proper Use of This Medicine

Sulfonamides should not be given to infants less than 2 months of age unless directed by the patient's doctor because sulfonamides may cause serious unwanted effects.

Sulfonamides are best taken with a full glass (8 ounces) of water. Several additional glasses of water should be taken every day, unless otherwise directed by your doctor. Drinking extra water will help to prevent some unwanted effects of sulfonamides.

For patients taking the oral liquid form of this medicine:

• Use a specially marked measuring spoon or other device to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid.

To help clear up your infection completely, keep taking this medicine for the full time of treatment, even if you begin to feel better after a few days. If you stop taking this medicine too soon, your symptoms may return.

This medicine works best when there is a constant amount in the blood or urine. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times day and night. If you need help in planning the best times to take your medicine, check with your health care professional.

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For sulfadiazine


• For oral dosage form (tablet):
  
  • For bacterial or protozoal infections:
    
    • Adults and teenagers—2 to 4 grams for the first dose, then 1 gram every four to six hours.
    
    
    • Children 2 months of age and older—Dose is based on body weight. The usual dose is 75 milligrams (mg) per kilogram (kg) (34 mg per pound) of body weight for the first dose, then 37.5 mg per kg (17 mg per pound) of body weight every six hours, or 25 mg per kg (11.4 mg per pound) of body weight every four hours.
    
    
    • Children up to 2 months of age—Use is not recommended.
    
    
  
  

• For sulfamethizole


• For oral dosage form (tablets):
  
  • For bacterial infections:
    
    • Adults and teenagers—500 milligrams (mg) to 1 gram every six to eight hours.
    
    
    • Children 2 months of age and older—Dose is based on body weight. The usual dose is 7.5 to 11.25 mg per kilogram (kg) (3.4 to 5.1 mg per pound) of body weight every six hours.
    
    
    • Children up to 2 months of age—Use is not recommended.
    
    
  
  

• For sulfamethoxazole


• For oral dosage form (tablets):
  
  • For bacterial or protozoal infections:
    
    • Adults and teenagers—2 to 4 grams for the first dose, then 1 to 2 grams every eight to twelve hours.
    
    
    • Children 2 months of age and older—Dose is based on body weight. The usual dose is 50 to 60 milligrams (mg) per kilogram (kg) (22.7 to 27.3 mg per pound) of body weight for the first dose, then 25 to 30 mg per kg (11.4 to 13.6 mg per pound) of body weight every twelve hours.
    
    
    • Children up to 2 months of age—Use and dose must be determined by your doctor.
    
    
  
  

• For sulfisoxazole


• For oral dosage forms (suspension, syrup, or tablets):
  
  • 
    
    • Adults and teenagers—2 to 4 grams for the first dose, then 750 milligrams (mg) to 1.5 grams every four hours; or 1 to 2 grams every six hours.
    
    
    • Children 2 months of age and older—Dose is based on body weight. The usual dose is 75 mg per kilogram (kg) (34 mg per pound) of body weight for the first dose, then 25 mg per kg (11.4 mg per pound) of body weight every four hours, or 37.5 mg per kg (17 mg per pound) of body weight every six hours.
    
    
    • Children up to 2 months of age—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using This Medicine

It is very important that your doctor check your progress at regular visits. This medicine may cause blood problems, especially if it is taken for a long time.

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

Sulfonamides may cause blood problems. These problems may result in a greater chance of certain infections, slow healing, and bleeding of the gums. Therefore, you should be careful when using regular toothbrushes, dental floss, and toothpicks. Dental work should be delayed until your blood counts have returned to normal. Check with your medical doctor or dentist if you have any questions about proper oral hygiene (mouth care) during treatment.

Sulfonamides may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this medicine:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.


• Wear protective clothing, including a hat. Also, wear sunglasses.


• Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional.


• Apply a sun block lipstick that has an SPF of at least 15 to protect your lips.


• Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor.

This medicine may also cause some people to become dizzy. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert. If this reaction is especially bothersome, check with your doctor.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Itching


• skin rash

Less common

• Aching of joints and muscles


• difficulty in swallowing


• pale skin


• redness, blistering, peeling, or loosening of skin


• sore throat and fever


• unusual bleeding or bruising


• unusual tiredness or weakness


• yellow eyes or skin

Rare

Some of the above side effects (severe abdominal or stomach cramps and pain, and watery and severe diarrhea, which may also be bloody) may also occur up to several weeks after you stop taking any of these medicines.

• Abdominal or stomach cramps and pain (severe)


• abdominal tenderness


• blood in urine


• diarrhea (watery and severe), which may also be bloody


• greatly increased or decreased frequency of urination or amount of urine


• increased thirst


• lower back pain


• mood or mental changes


• pain or burning while urinating


• swelling of front part of neck

Check with your doctor as soon as possible if any of the following side effects occur:

More common

• Increased sensitivity of skin to sunlight

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Diarrhea


• dizziness


• headache


• loss of appetite


• nausea or vomiting


• tiredness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Healthcare (Micromedex) products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Healthcare does not assume any responsibility or risk for your use of the Thomson Healthcare products.

Cognex

Generic Name: tacrine (TAK rin)

Brand Names: Cognex

What is Cognex (tacrine)?

Tacrine improves the function of nerve cells in the brain. It works by preventing the breakdown of a chemical called acetylcholine (ah see til KO leen). People with dementia usually have lower levels of this chemical, which is important for the processes of memory, thinking, and reasoning.

Tacrine is used to treat mild to moderate dementia caused by Alzheimer's disease.

Tacrine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Cognex (tacrine)?

Before taking tacrine, tell your doctor if you have heart disease or a heart rhythm disorder such as "sick sinus syndrome" (slow heartbeats), an enlarged prostate, urination problems, asthma, obstructive pulmonary disease, or a seizure disorder such as epilepsy.

Tacrine is most effective when taken between meals on an empty stomach, but you may take it with food if it upsets your stomach.

It is important to use tacrine regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Do not change your tacrine dose without your doctor's advice. Taking this medication improperly can lead to serious behavioral side effects or a worsening of Alzheimer's symptoms. Call your doctor at once if you have serious side effects such as confusion, hallucinations, extreme or sudden changes in behavior, seizure (convulsions), pain or burning when you urinate, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes). Do not stop taking this medication without first talking to your doctor. If you stop taking tacrine suddenly, your condition may become worse. Tacrine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

What should I discuss with my healthcare provider before taking Cognex (tacrine)?

Do not use this medication if you are allergic to tacrine, or if you have ever had jaundice or other liver problems while taking tacrine.

Before taking tacrine, tell your doctor if you are allergic to any drugs, or if you have:

• liver disease;


• 
  

  heart disease;

  
  


• 
  

  a heart rhythm disorder such as "sick sinus syndrome" (slow heartbeats);

  
  


• 
  

  a history of stomach ulcers;

  
  


• 
  

  an enlarged prostate or urination problems;

  
  


• 
  

  epilepsy or other seizure disorder; or

  
  


• 
  

  asthma or chronic obstructive pulmonary disease (COPD).

  
  

If you have any of these conditions, you may not be able to use tacrine, or you may need dosage adjustments or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether tacrine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Cognex (tacrine)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take this medication with a full glass of water. Tacrine is most effective when taken between meals on an empty stomach, but you may take it with food if it upsets your stomach.

It is important to use tacrine regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Do not change your tacrine dose without your doctor's advice. Taking this medication improperly can lead to serious behavioral side effects or a worsening of Alzheimer's symptoms.

When you first start using tacrine, you may have minor side effects such as nausea, vomiting, or diarrhea. These side effects may also occur whenever your dose is changed, or if you start taking tacrine again after being off the drug for awhile.

Do not stop taking this medication without first talking to your doctor. If you stop taking tacrine suddenly, your condition may become worse.

To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled visits to your doctor.

If you need to have any type of surgery, tell the surgeon ahead of time that you are taking tacrine. You may need to stop using the medicine for a short time.

Store tacrine at room temperature away from moisture and heat.

See also: Cognex dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include severe nausea or vomiting, drooling, sweating, slow heart rate, feeling light-headed, fainting, muscle weakness, seizure (convulsions), coma, or respiratory failure (breathing stops).

What should I avoid while taking Cognex (tacrine)?

Tacrine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Cognex (tacrine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

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  confusion, hallucinations;

  
  


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  extreme or sudden changes in behavior;

  
  


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  seizure (convulsions);

  
  


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  pain or burning when you urinate; or

  
  


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  nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

  
  

Less serious side effects of tacrine include:

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  mild nausea, vomiting, diarrhea, upset stomach;

  
  


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  weight loss;

  
  


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  urinating more than usual;

  
  


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  agitation, depressed mood;

  
  


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  skin rash, increased sweating;

  
  


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  fever or chills, runny nose, cough;

  
  


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  dizziness, drowsiness, tired feeling;

  
  


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  joint or muscle pain; or

  
  


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  weakness, lack of coordination.

  
  

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Cognex (tacrine)?

Before taking tacrine, tell your doctor if you are using any of the following drugs:

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  atropine (Atreza, Sal-Tropine, and others);

  
  


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  cimetidine (Tagamet);

  
  


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  dicyclomine (Bentyl);

  
  


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  donepezil (Aricept);

  
  


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  fluvoxamine (Luvox);

  
  


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  galantamine (Razadyne);

  
  


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  glycopyrrolate (Robinul);

  
  


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  hyoscyamine (Anaspaz, Levbid, Levsin, Nulev, and others);

  
  


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  mepenzolate (Cantil);

  
  


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  methscopolamine (Pamine);

  
  


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  propantheline (Pro-Banthine);

  
  


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  rivastigmine (Exelon);

  
  


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  scopolamine (Maldemar, Scopace, Transderm-Scop); or

  
  


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  theophylline (Theo-Dur, Elixophyllin, Theolair, Slo-Bid, Uniphyl).

  
  

If you are using any of these drugs, you may not be able to use tacrine, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect tacrine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Cognex resources

• Cognex Side Effects (in more detail)
• Cognex Dosage
• Cognex Use in Pregnancy & Breastfeeding
• Drug Images
• Cognex Drug Interactions
• Cognex Support Group
• 0 Reviews for Cognex - Add your own review/rating

• Cognex Prescribing Information (FDA)


• Cognex Monograph (AHFS DI)


• Cognex Advanced Consumer (Micromedex) - Includes Dosage Information


• Cognex MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Cognex with other medications

• Alzheimer's Disease

Where can I get more information?

• Your pharmacist has information about tacrine written for health professionals that you may read.

See also: Cognex side effects (in more detail)