Sunday, June 10, 2012

Amphetamine Sulfate


Class: Amphetamines
VA Class: CN801
CAS Number: 60-13-9
Brands: Adderall, Adderall XR


  • Abuse Potential


  • Amphetamines have a high potential for abuse.a c




  • Administration of amphetamines for prolonged periods of time may lead to drug dependence.a b c




  • Particular attention should be paid to the possibility of individuals obtaining amphetamines for nontherapeutic use or distribution to others, and the drugs should be prescribed or dispensed sparingly.a c




  • The possibility that family members may abuse the patient’s medication should be considered.e



  • Sudden Death and Serious Cardiovascular Events


  • Possible sudden death and serious cardiovascular events, particularly in individuals who abuse amphetamines.a c g (See Sudden Death and Serious Cardiovascular Events under Cautions.)




Introduction

Noncatechol, sympathomimetic amine with CNS-stimulating activity.a b c


Uses for Amphetamine Sulfate


Attention Deficit Hyperactivity Disorder


Used as an adjunct to psychological, educational, social, and other remedial measures in the treatment of attention deficit hyperactivity disorder (ADHD) (hyperkinetic disorder, hyperkinetic syndrome of childhood, minimal brain dysfunction).a b c e


Can be used for ADHD in pediatric (children, adolescents) as well as adult patients.d e


Almost all studies comparing behavioral therapy versus stimulants alone have shown a much stronger therapeutic effect from stimulants than from behavioral therapy, and stimulants (e.g., amphetamines, methylphenidate) remain the drugs of choice for the management of ADHD.d e


Drug therapy is not indicated in all patients with ADHD, and such therapy should be considered only after a complete evaluation including medical history has been performed.b e


Use should depend on age, adequate diagnosis (based on medical, special psychological, educational, and social resources), and the clinician’s assessment of the severity and duration of symptoms and should not depend solely on one or more behavioral characteristics.b c e


Not recommended for ADHD symptoms associated with acute stress reactions.b


Narcolepsy


Used as a stimulant to reduce daytime sleepiness in the management of narcolepsy.a b


Amphetamines remain the mainstay of treatment for narcolepsy based on a long record of clinical experience.f


Tolerance to the clinical effects may develop with long-term therapy, particularly at high dosages.f


Exogenous Obesity


Has been used as an adjunct to caloric restriction and behavioral modification in the short-term treatment of exogenous obesity.d However, because of the limited efficacy (short-lived) and risk of abuse, such use no longer is included in the FDA-approved labelinga c and is discouraged.d


The anorexigenic effect appears to be temporary, seldom lasting more than a few weeks, and tolerance may occur.b


Obesity usually is a chronic disease, and short-term or intermittent therapy with anorexigenic drugs is unlikely to maintain a long-term benefit.b


Amphetamine Sulfate Dosage and Administration


Administration


Oral Administration


Conventional Tablets

Administer initial dose on awakening.a b When daily dosage is administered in 2 or 3 divided doses, administer the doses at intervals of 4–6 hours.a b Because of potential for insomnia, avoid administering doses in the late evening.a


Extended-release Capsules

Administer on awakening.c Because of potential for insomnia, avoid administering in the afternoon.c


Administer capsules with or without food;c capsules may be swallowed intact or the entire contents of a capsule(s) may be sprinkled on a small amount of applesauce immediately prior to administration.b c Do not subdivide the capsule contents.b c Do not chew or crush the pellets contained in the capsules and do not store the sprinkle/food mixture for later use.b c


Dosage


Fixed-combination extended-release capsules containing various salts of amphetamine and dextroamphetamine can be substituted for their respective conventional short-acting preparations if less-frequent daily dosing is desirable.b c


Dosage of fixed-combination preparations containing various salts of amphetamine and dextroamphetamine is expressed as total amphetamine base equivalence.a b c


Adjust dosage according to individual response and tolerance; the smallest dose required to produce the desired response should always be used.a b c


When possible, therapy should be interrupted occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued treatment.a b c


Pediatric Patients


Attention Deficit Hyperactivity Disorder

Dosage titration usually requires 2–4 weeks.e


Conventional Tablets

Oral

Dosing in pediatric patients may begin with once-daily administration in the early morning, adding a noon dose if the effect does not last throughout the school day.e Increasing the morning dose may extend its duration.e A third dose may be added at around 4 p.m. if necessary.e


Children 3–5 years of age: Initially, 2.5 mg daily; the daily dosage is increased in 2.5-mg increments at weekly intervals until the optimum response is attained.a b e


Children ≥6 years of age: Initially, 5 mg once or twice daily; the daily dosage is increased in 5-mg increments at weekly intervals until the optimum response is attained.a b e Total daily dosage rarely should exceed 40 mg.a b e


Extended-release Capsules (Adderall XR)

Oral

Children 6–12 years of age: Initially, 10 mg once daily; daily dosage may be increased in 5- or 10-mg increments at weekly intervals to a maximum dosage of 30 mg daily.b c Alternatively, initiate with 5 mg once daily when lower initial dosage is appropriate.b c


Adolescents 13–17 years of age: Initially, 10 mg once daily.c Increase to 20 mg once daily after 1 week if symptoms not adequately controlled.c No evidence that dosages >20 mg daily provide any additional benefit.c


When switching from conventional tablets to extended-release capsules, the total daily dosage may remain the same but may be given once daily.b c


Narcolepsy

When intolerable adverse effects occur (e.g., insomnia, anorexia), dosage should be reduced.a b


Conventional Tablets

Oral

Children 6–12 years of age: Initially, 5 mg daily; daily dosage is increased in 5-mg increments at weekly intervals until the optimum response is attained.a b


Children ≥12 years of age: Initially, 10 mg daily; daily dosage is increased in 10-mg increments at weekly intervals until the optimum response is attained.a b


Maintenance: Usually, 5–60 mg daily, depending on patient age and response, given in divided doses.a b


Adults


Attention Deficit Hyperactivity Disorder

Conventional Tablets

Dosage titration usually requires 2–4 weeks.e


Oral

Initially, 5 mg once or twice daily; the daily dosage is increased in 5- to 10-mg increments at weekly intervals until the optimum response is attained.a b e Total daily dosage rarely should exceed 40 mg.a b e


Extended-release Capsules (Adderall XR)

Oral

20 mg once daily as initial therapy or when switching from other drugs.c No evidence that dosages >20 mg daily provide any additional benefit.c


When switching from conventional tablets to extended-release capsules, the total daily dosage may remain the same but may be given once daily.b c


Narcolepsy

When intolerable adverse effects occur (e.g., insomnia, anorexia), dosage should be reduced.a b


Conventional Tablets

Oral

Initially, 10 mg daily; daily dosage is increased in 10-mg increments at weekly intervals until the optimum response is attained.a b


Maintenance: Usually, 5–60 mg daily, depending on response, given in divided doses.a b


Prescribing Limits


Pediatric Patients


Attention Deficit Hyperactivity Disorder

Excessive dosage can cause pediatric patients to become overfocused on the medication or to appear dull or overly restricted. Rarely, psychotic reactions, mood disturbances, or hallucinations can occur.


Conventional Tablets

Oral

Dosage rarely should exceed a total daily dosage of 40 mg.a b e Individual doses rarely should exceed 10 mg each in children <25 kg.e


Long-term use has not been studied systematically.a If used for long-term therapy, periodically reevaluate the usefulness of the drug.a


Extended-release Capsules (Adderall XR)

Oral

Children 6–12 years of age: Dosages >30 mg daily have not been studied systematically.b c


Adolescents 13–17 years of age: Dosages up to 60 mg daily have been evaluated in clinical studies; however, no evidence that dosages >20 mg daily provide any additional benefit.c


Long-term use (>3 weeks in children or >4 weeks in adolescents) has not been studied systematically.c If used for long-term therapy, periodically reevaluate the usefulness of the drug.c


Adults


Attention Deficit Hyperactivity Disorder

Conventional Tablets

Oral

Dosages up to 0.9 mg/kg daily but rarely exceeding 40 mg daily.a b e Such higher doses may be more likely in adults than in school-aged children because of increased dosing frequency to cover a longer work day.e


Tolerance is more likely with relatively high dosages.e


Long-term use has not been studied systematically.a If used for long-term therapy, periodically reevaluate the usefulness of the drug.a


Extended-release Capsules (Adderall XR)

Oral

Dosages up to 60 mg daily have been evaluated in clinical studies; however, no evidence that dosages >20 mg daily provide any additional benefit.c


Long-term use (>4 weeks) has not been studied systematically.c If used for long-term therapy, periodically reevaluate the usefulness of the drug.c


Special Populations


Hepatic Impairment


No specific hepatic dosage recommendations.a c


Renal Impairment


No specific renal dosage recommendations.a c


Geriatric Patients


No specific geriatric dosage recommendations.a c


Cautions for Amphetamine Sulfate


Contraindications



  • Contraindicated in patients with hypersensitivity or idiosyncrasy to the sympathomimetic amines,a c d symptomatic cardiovascular disease,a c d hyperthyroidism,a c d moderate to severe hypertension,a c d glaucoma,a c d e or advanced arteriosclerosis;a c d within 14 days of MAO inhibitor therapy;a c d e and in agitated patients.a c d




  • Although amphetamines generally should not be used in patients with a history of drug abuse,a c d e some experts state that this is not an absolute contraindication, provided the patient can be monitored more carefully than would otherwise be indicated.e



Warnings/Precautions


Warnings


Sudden Death and Serious Cardiovascular Events

Sudden unexplained death, stroke, and MI reported in adults with ADHD receiving usual dosages of stimulants; sudden death also reported in children and adolescents with structural cardiac abnormalities or other serious cardiac conditions receiving usual dosages of the drugs.a c g


Epidemiologic data suggest a possible association between use of stimulants and sudden unexplained death in healthy children and adolescents.h i j FDA unable to conclude that these data affect evaluation of overall risk and benefit of stimulants used to treat ADHD in children and adolescents.h FDA is conducting an ongoing safety review of amphetamines and other stimulants to evaluate possible link between use of these agents and sudden death in children.h i j Pediatric patients with ADHD and their parents should avoid discontinuing the child’s use of such stimulants before consulting a clinician.h


Thoroughly review medical history (including evaluation for family history of sudden death or ventricular arrhythmia) and perform physical examination in all children, adolescents, and adults being considered for stimulant therapy; if initial findings suggest presence of cardiac disease, perform further cardiac evaluation (e.g., ECG, echocardiogram).a c


In general, avoid use of CNS stimulants in patients with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, CAD, or other serious cardiac conditions.a c g (See Contraindications under Cautions.)


Patients who develop exertional chest pain, unexplained syncope, or other manifestations suggestive of cardiac disease during stimulant therapy should undergo prompt cardiac evaluation.a c


Effects on BP and Heart Rate

Possible modest increases in average BP (i.e., by about 2–4 mm Hg) and heart rate (i.e., by about 3–6 bpm); larger increases may occur.a c Modest increases not expected to have short-term sequelae; however, monitor all patients for larger changes in BP and heart rate.a c


Caution advised in patients with underlying medical conditions that might be affected by increases in BP or heart rate (e.g., hypertension, heart failure, recent MI, ventricular arrhythmia).a c


Exacerbation or Precipitation of Psychotic Symptoms

May exacerbate symptoms of behavior disturbance and thought disorder in patients with preexisting psychotic disorder.a c


Psychotic symptoms (e.g., hallucinations, delusional thinking) may occur with usual dosages in children and adolescents without prior history of psychotic illness.a c If psychotic symptoms occur, consider causal relationship to stimulants, and discontinue therapy as appropriate.a c


Precipitation of Manic Symptoms

May precipitate mixed or manic episodes in ADHD patients with comorbid bipolar disorder; use with caution in these patients.a c Prior to initiating therapy, carefully screen patients with ADHD and comorbid depressive symptoms to identify risk for bipolar disorder; screening should include a detailed psychiatric history (e.g., family history of suicide, bipolar disorder, or depression).a c


Manic symptoms may occur with usual dosages in children and adolescents without prior history of mania.a c If manic symptoms occur, consider causal relationship to stimulants, and discontinue therapy as appropriate.a c


Aggression

Aggressive behavior and hostility (frequently observed in children and adolescents with ADHD) reported in patients receiving drug therapy for ADHD.a c No systematic evidence that stimulants cause these adverse effects; however, monitor patients beginning treatment for ADHD for onset or worsening of aggressive behavior or hostility.a c


Growth Suppression

Long-term (i.e., >14 months) administration expected to cause at least a temporary suppression of normal weight and/or height patterns in some children and adolescents.a c Dose-related weight loss reported in adolescents during first 4 weeks of therapy with extended-release capsules.c


Manufacturers recommend monitoring growth during treatment; patients not growing or gaining weight as expected may require temporary discontinuance of treatment.a c However, AAP states that studies of stimulants in children found little or no decrease in expected height, with any decrease in growth early in treatment being compensated for later on.


Seizures

Possible lowering of seizure threshold in patients with history of seizures, in those with prior EEG abnormalities but no history of seizures, and, very rarely, in those without history of seizures and with no prior evidence of EEG abnormalities.a c If seizures occur, discontinue therapy.a c


Visual Effects

Visual disturbances (difficulty with accommodation, blurred vision) reported with stimulants.a c


General Precautions


Least amount of amphetamine feasible should be prescribed or dispensed at one time in order to minimize possible overdosage.a c


Tics

Amphetamines reported to exacerbate motor and phonic tics and Tourette’s syndrome.a c d However, a history of tics or their development during therapy is not an absolute contraindication to continued use.e Several controlled studies have not found stimulants to worsen or precipitate tics or Tourette’s syndrome.e Nevertheless, evaluate for presence of tics and Tourette’s syndrome in children and their families prior to initiating stimulant therapy.a c d


Use of Fixed Combination

When used in fixed combination with other agents, consider the cautions, precautions, and contraindications associated with the concomitant agents.


Specific Populations


Pregnancy

Category C.a c f


Risk of prematurity, low birth weight, and withdrawal symptoms (e.g., dysphoria, lassitude, agitation) in infants born to dependent women.a c f


Lactation

Distributed into milk.a c f Discontinue nursing or the drug.a c


Pediatric Use

Not recommended for ADHD in children <3 years of age.a c e


Aggressive behavior, hostility, and psychotic (e.g., hallucinations, delusional thinking) or manic symptoms reported in children and adolescents receiving stimulants for management of ADHD.a c (See Warnings under Cautions.)


Sudden death reported in children and adolescents with structural cardiac abnormalities or other serious cardiac conditions receiving usual dosages of stimulants.a c Epidemiologic data also suggest a possible association between use of stimulants and sudden death in healthy children and adolescents.h i j (See Sudden Death and Serious Cardiovascular Events under Cautions.)


Long-term administration expected to cause at least a temporary suppression of normal weight and/or height patterns in some children and adolescents.a c (See Growth Suppression under Cautions.)


Geriatric Use

Not studied in geriatric patients.a c


Hepatic Impairment

Possible inhibition of drug elimination, resulting in prolonged exposure.a c


Renal Impairment

Possible inhibition of drug elimination, resulting in prolonged exposure.a c


Common Adverse Effects


Palpitations,a c tachycardia,a c elevation of BP,a c overstimulation,a c restlessness,a c dizziness,a c insomnia,a c euphoria,a c dyskinesia,a c dysphoria,a c tremor,a c headache,a c dryness of mouth,a c taste aberration,a c diarrhea,a c constipation,a c abdominal bloating,a c impotence and changes in libido.a c


Isolated reports of cardiomyopathy associated with chronic amphetamine use.a b c


Anorexia and weight loss may occur as undesirable effects when amphetamines are used for other than the anorectic effect.a c


Interactions for Amphetamine Sulfate


Inhibits MAO.a c


Amphetamine or metabolites modestly inhibit CYP2D6, 1A2, and 3A4 in vitro.a c In vivo effects on metabolism of drugs metabolized by CYP isoenzymes not known.a c


Specific Drugs and Laboratory Tests











































































Drug or Test



Interaction



Comments



Acidifying agents, GI (ascorbic acid, glutamic acid hydrochloride, reserpine)



Decreases absorption, serum concentrations, and efficacy of amphetaminesa c



Acidifying agents, urinary (ammonium chloride, sodium acid phosphate)



Increases urinary excretion and decreases serum concentrations and efficacy of amphetaminesa c



Adrenergic blockers



Potential inhibition of adrenergic blockadea c



Alkalinizing agents, GI (antacids, sodium bicarbonate)



Increases absorption and serum concentrations and potentiates the effects of amphetaminesa c



Avoid concomitant usea c



Alkalinizing agents, urinary (acetazolamide and some thiazides)



Decreases urinary excretion and increases serum concentrations and potentiates the effects of amphetaminesa c



Antidepressants, tricyclic (desipramine, protriptyline)



Enhanced activity of tricyclic antidepressants; desipramine or protriptyline cause striking and sustained increases in the concentration of dextroamphetamine in the brain; cardiovascular effects can be potentiateda c



Antihistamines



May counteract the sedative effects of antihistaminesa c



Antihypertensives



May antagonize the hypotensive effects of antihypertensivesa c



Chlorpromazine



Inhibits the central stimulant effects of amphetamines by blocking dopamine and norepinephrine receptorsa c



Can be used to treat amphetamine poisoninga d



Ethosuximide



Intestinal absorption may be delayed by amphetaminesa c



Haloperidol



Inhibits the central stimulant effects of amphetamines by blocking dopamine receptorsa c



Lithium carbonate



May inhibit the anorectic and stimulatory effects of amphetaminea c



MAO inhibitors



Slow the metabolism of amphetamines, increasing their effect on the release of norepinephrine and other monoamines leading to headaches and other signs of hypertensive crisisa c


Toxic neurologic effects, hypertensive crisis, and malignant hyperpyrexia can occur, sometimes with fatal resultsa c



Amphetamines contraindicated in patients currently or recently (within 14 days) receiving MAO inhibitora c d e



Meperidine



Amphetamines potentiate the analgesic effect of meperidinea c



Methenamine



Acidifying agents used with methenamine increase urinary excretion and decrease efficacy of amphetaminesa c



Norepinephrine



Amphetamines enhance the adrenergic effects of norepinephrinea c



Phenobarbital



Amphetamines may delay absorption of phenobarbital; concomitant use may produce a synergistic anticonvulsant actiona c



Phenytoin



Amphetamines may delay absorption of phenytoin; concomitant use may produce a synergistic anticonvulsant actiona c



Propoxyphene



In propoxyphene overdosage, amphetamine CNS stimulation is potentiated and fatal convulsions can occura c



Sympathomimetic agents



Enhanced activity of sympathomimetic agentsa c



Test, plasma corticosteroids



Can elevate plasma corticosteroid concentrations; this increase is greatest in the eveninga c



Test, urinary steroids



May interfere with urinary steroid determinationsa c



Veratrum alkaloids



Amphetamines inhibit the hypotensive effect of veratruma c


Amphetamine Sulfate Pharmacokinetics


Absorption


Bioavailability


Plasma concentration-time profiles similar for single 20-mg extended-release dose versus two 10-mg immediate-release doses given 4 hours apart.c


Peak plasma concentration and AUC decrease with increasing body weight.c


Rapidly absorbed from the GI tract.PDH


Duration


Therapeutic effects persist for 4–24 hours.PDH


Food


Food does not affect the extent of absorption of the extended-release preparation (Adderall XR), but prolongs Tmax by 2.5 hours (for d-amphetamine) and 2.1 hours (for l-amphetamine).c Opening the capsule and sprinkling the contents on applesauce results in comparable absorption to the intact capsule taken in the fasted state.c


Plasma Concentrations


Tmax, immediate-release: About 3 hours.a c


Tmax, extended-release: About 7 hours.c


Therapeutic plasma concentrations are 5–10 mcg/dL.PDH


Distribution


Extent


Distributed widely throughout body, with high levels in the brain.PDH


Apparently crosses the placenta since withdrawal manifestations have occurred in neonates.a c f


Distributed into milk in concentrations 3–7 times maternal blood concentrations.f


Volume of distribution increases with increasing body weight.c


Elimination


Metabolism


Metabolized to several active metabolites.a c


Enzymes involved in metabolism not clearly defined; however, CYP2D6 is involved with formation of at least one metabolite.a c Because CYP2D6 is genetically polymorphic, potential variability in metabolism among patients exists.a c


Elimination Route


With normal urinary pH, excreted in urine as unchanged drug (approximately 30–40%) and metabolites (approximately 50%).a c Changes in urinary pH may alter excretion; urinary recovery of unchanged drug reported to range from 1–75%, depending on urinary pH.a c (See Specific Drugs and Laboratory Tests under Interactions.)


Clearance increases with increasing body weight.c On a mg/kg basis, however, children have higher clearance than adolescents or adults.c


Half-life


Children 6–12 years of age: 9 hours (for d-amphetamine) or 11 hours (for l-amphetamine).c


Adolescents 13–17 years of age: 11 hours (for d-amphetamine) or 13–14 hours (for l-amphetamine).c


Adults: 10 hours (for d-amphetamine) or 13 hours (for l-amphetamine).c


Elimination half-life increases with increasing body weight.c


Stability


Storage


Oral


Extended-release Capsules and Conventional Tablets

Tight, light-resistant containers at 25°C (may be exposed to 15–30°C).a c


ActionsActions



  • Amphetamines are sympathomimetic amines with CNS stimulant activity.a c d




  • May block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneural space.a c d




  • Pharmacologic actions of amphetamines are qualitatively similar to those of ephedrine and include CNS and respiratory stimulation and sympathomimetic activity including pressor response, mydriasis, bronchodilation, and contraction of the urinary bladder sphincter.d




  • On a weight basis, dextroamphetamine has a stronger CNS action and a lesser activity on the peripheral nervous system than does the racemic amphetamine.d The CNS stimulating effect of dextroamphetamine is approximately twice that of amphetamine.d




  • Mechanism of action on peripheral structures is thought to be a combination of release of norepinephrine from stores in adrenergic nerve terminals and a direct action on both alpha and beta receptor sites.d




  • Mechanism of action involved in the central effect has not been determined.d The main sites of CNS action appear to be the cerebral cortex and possibly the reticular-activating system; stimulation by an amphetamine causes an increase in motor activity, mental alertness, diminished sense of fatigue, brighter spirits, and mild euphoria.d




  • Theories of dysfunction in ADHD focus on the prefrontal cortex, which controls many executive functions (e.g., planning, impulse control).e Stimulants have putative effects on central dopamine and norepinephrine pathways that are crucial in frontal lobe function.e




  • Produces an anorexigenic effect, leading to loss of weight.d No primary effect on appetite has been demonstrated in humans and it has been postulated that anorexigenic effects are secondary to increased sympathetic activity resulting from release of norepinephrine and dopamine. May also cause a loss of acuity of smell and taste, which may contribute to the anorexigenic effect of the drugs.d



Advice to Patients



  • Provide patient or caregiver with a copy of the manufacturer’s patient information (medication guide); discuss and answer questions about its contents as needed.c Instruct patient or caregiver to read and understand contents of medication guide before initiating therapy and each time the prescription is refilled.c




  • Advise parents with concerns about long-term effects (e.g., effects on weight) and the need for continued therapy that drug holidays can be considered in consultation with the patient’s clinician.e PDH However, the benefits versus risks of such interruptions in therapy have not been established.e




  • Advise to take drug, particularly extended-release capsules, early in the day to minimize insomnia.b PDH




  • Advise not to chew or crush the pellets contained in the capsules and not to store the sprinkle/food mixture for later use.b




  • Advise not to increase dosage unless instructed by their clinician.b PDH




  • Advise that appetite suppression may occur.a c d e


    Giving the morning dose with a meal and providing a high-caloric drink or snack late in the evening when the stimulant effects have subsided may be helpful.e




  • Question about possible substance abuse,c including in family members (since they may abuse the patient’s medication supply).e




  • Advise to inform clinician immediately if adverse cardiovascular (e.g., chest pain, shortness of breath, fainting) or psychiatric effects (e.g., hallucinations, delusional thinking, mania) occur.c




  • Instruct about the potential for amphetamine to impair patient’s ability to perform potentially hazardous activities, such as driving or operating heavy machinery.a c




  • Advise narcoleptic patients with severe sleepiness as a manifestation of their disease to avoid potentially dangerous activities at home and work and to not operate a motor vehicle until sleepiness is appropriately controlled by stimulant drug therapy.f




  • Advise narcoleptic patients about occupational and social accommodation for disabilities associated with their disease (e.g., advise about legal guidance provided by the Americans with Disabilities Act).f




  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, dietary supplements, and herbal products, as well as any concomitant illnesses/conditions (e.g., cardiac/cardiovascular disease, thyroid disease, glaucoma, suicidal ideation or behaviors, mental/psychiatric disorder, seizures, hepatic or renal disease).a b c




  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.a




  • Importance of informing patients of other important precautionary information. (See Cautions.)a b



Preparations


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.


Subject to control under the Federal Controlled Substances Act of 1970 as schedule II (C-II) drugs.b




































Amphetamine Sulfate Combinations

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Capsules, extended-release



5 mg total amphetamine (as 1.25 mg, with Amphetamine Aspartate 1.25 mg, Dextroamphetamine Saccharate 1.25 mg, and Dextroamphetamine Sulfate 1.25 mg)



Adderall XR ( C-II)



Shire



10 mg total amphetamine (as 2.5 mg, with Amphetamine Aspartate 2.5 mg, Dextroamphetamine Saccharate 2.5 mg, and Dextroamphetamine Sulfate 2.5 mg)



Adderall XR ( C-II)



Shire



15 mg total amphetamine (as 3.75 mg, with Amphetamine Aspartate 3.75 mg, Dextroamphetamine Saccharate 3.75 mg, and Dextroamphetamine Sulfate 3.75 mg)



Adderall XR ( C-II)



Shire



20 mg total amphetamine (as 5 mg, with Amphetamine Aspartate 5 mg, Dextroamphetamine Saccharate 5 mg, and Dextroamphetamine Sulfate 5 mg)



Adderall XR ( C-II)



Shire



25 mg total amphetamine (as 6.25 mg, with Amphetamine Aspartate 6.25 mg, Dextroamphetamine Saccharate 6.25 mg, and Dextroamphetamine Sulfate 6.25 mg)



Adderall XR ( C-II)



Shire



30 mg total amphetamine (as 7.5 mg, with Amphetamine Aspartate 7.5 mg, Dextroamphetamine Saccharate 7.5 mg, and Dextroamphetamine Sulfate 7.5 mg)



Salofalk 1000mg Granules






Salofalk 1000mg



gastro-resistant prolonged release granules


mesalazine



Read all of this leaflet carefully before you start taking this medicine.


  • Keep this leaflet. You may need to read it again.

  • If you have any further questions, ask your doctor or pharmacist.

  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.


In this leaflet:


1. What Salofalk 1000mg granules are and what they are used for

2. Before you use Salofalk 1000mg granules

3. How to use Salofalk 1000mg granules

4. Possible side effects

5. How to store Salofalk 1000mg granules

6. Further information




WHAT SALOFALK 1000mg GRANULES ARE AND WHAT THEY ARE USED FOR


Salofalk granules contain the active substance mesalazine, an anti-inflammatory agent used to treat inflammatory bowel disease.


Salofalk 1000mg granules are used for:


  • the treatment of acute episodes and prevention of further episodes (recurrence) of an inflammatory disease of the large intestine (colon), known by doctors as ulcerative colitis.



BEFORE YOU TAKE SALOFALK 1000mg GRANULES



Do not take Salofalk granules


  • If you are or have been told you are allergic (hypersensitive) to salicylic acid, to salicylates such as Aspirin or to any of the other ingredients of Salofalk 1000mg granules (these are listed in section 6, Further information)

  • If you have a serious liver and/or kidney disease

  • If you have a stomach or duodenal ulcer

  • If you have a tendency to bleed easily or you have ever been told that there is a problem with the clotting of your blood



Take special care with Salofalk granules.



Before you start taking this medicine you should tell your doctor


  • If you have a history of problems with your lungs, particularly if you suffer from bronchial asthma

  • If you have a history of allergy to sulphasalazine, a substance related to mesalazine

  • If you suffer with problems of your liver

  • If you suffer with problems of your kidney


Further precautions


During treatment your doctor may want to keep you under close medical supervision, where you will have regular blood and urine tests.




Using other medicines


Please tell your doctor if you take or use any of the medicines mentioned below as the effects of these medicines may change (interactions):



  • Certain agents that inhibit blood clotting (medicines for thrombosis or to thin your blood)


  • Glucocorticoids (certain steroid-like anti-inflammatory agents, such as prednisolone)


  • Sulphonyl ureas (substances used to control your blood sugar, such as glibenclamide)


  • Methotrexate (an agent used to treat leukaemia or immune disorders)


  • Probenecid/sulphinpyrazone (agents used to treat gout)


  • Spironolactone/frusemide (agents used to treat heart problems)


  • Rifampicin (substance used against tuberculosis)


  • Medicines containing azathioprine or 6-mercaptopurine (used to treat immune disorders)


  • Lactulose (substance used for treating constipation) or other preparations that can change the acidity of your stools

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. It may still be all right for you to use Salofalk granules and your doctor will be able to decide what is suitable for you.




Pregnancy and breast-feeding


Ask your doctor or pharmacist for advice before taking any medicine.


You should only use Salofalk granules during pregnancy if your doctor tells you to.


Salofalk granules should not be used during breast-feeding as the drug and its metabolite may pass into breast milk.




Driving and using machines


There are no effects on the ability to drive and use machines.




Important information about some of the ingredients of Salofalk 1000mg granules


This medicine contains the sweetening agent aspartame. Aspartame is a source of phenylalanine and may be harmful if you suffer from phenylketonuria. One sachet of Salofalk 1000mg granules contains the equivalent to 1.12 mg phenylalanine.





HOW TO TAKE SALOFALK 1000mg GRANULES


Always take Salofalk granules exactly as your doctor has told you.


You should check with your doctor or pharmacist if you are not sure.



Method of administration


Salofalk granules are for oral use only.


Salofalk granules should not be chewed. You should take the Salofalk granules by placing the granules directly on the tongue and then swallowing them with plenty of liquid without chewing.




Dosage




Adults and the elderly


Unless otherwise prescribed by your doctor, the normal dosage for the treatment of acute episodes of ulcerative colitis is:


3 sachets of Salofalk 1000mg granules once daily preferably in the morning or 1 sachet of Salofalk 1000mg granules three times daily (equivalent to 3 g mesalazine per day), depending on the clinical requirements in the individual case.


If 500 mg dosages are required, Salofalk 500mg granules should be used.



To prevent a relapse of ulcerative colitis


Use 1 sachet of Salofalk 500mg granules three times daily (equivalent to 1.5 g mesalazine per day).



Children


There is only limited documentation for an effect in children (age 6-18 years).



Children 6 years and older


Please ask your doctor about the precise dosage of Salofalk granules for your child.



In acute episodes: to be determined individually, starting with 30-50 mg mesalazine per kg body weight per day that should be given once daily preferably in the morning or in divided doses. The maximum dose is 75 mg mesalazine per kg body weight per day. The total dose should not exceed the maximum adult dose.



To prevent a relapse: to be determined individually, starting with 15-30 mg mesalazine per kg body weight per day that should be given in divided doses. The total dose should not exceed the recommended adult dose.


It is generally recommended that half the adult dose should be given to children up to a body weight of 40 kg; and the normal adult dose to those above 40 kg.




Duration of treatment


How long you will use the medicine depends upon your condition. Your doctor will decide how long you are to continue the medication.


You should follow the treatment with Salofalk granules regularly and consistently both during the acute episode of inflammation and also as long-term treatment, because this is the only way to achieve the desired therapeutic effect.


If you think that the effect of Salofalk granules is too strong or too weak, talk to your doctor.




If you take more Salofalk granules than you should


Contact a doctor if you are in doubt, so he or she can decide what to do. If you use too much Salofalk granules on one occasion, just take your next dose as prescribed. Do not use a smaller amount.




If you forget to take Salofalk granules


Do not take a larger than normal dose of Salofalk granules next time, but continue treatment at the prescribed dosage.




If you stop taking Salofalk granules


Do not stop taking this product until you have talked to your doctor.



If you have any further questions on the use of this product, ask your doctor or pharmacist.




Possible Side Effects


Like all medicines, Salofalk granules can cause side effects, although not everybody gets them.



All medicines can cause allergic reactions although serious allergic reactions are very rare. If you get any of the following symptoms after taking this medicine, you should contact your doctor immediately:



  • Allergic skin rash


  • Fever


  • Breathing difficulties

If you experience the following serious side effects, stop taking the medicine and contact your doctor immediately:


If you experience a serious reduction of your general health condition with fever, and/or sore throat and mouth, please report to your doctor immediately. The symptoms might derive from a reduction in the number of white blood cells in your blood (agranulocytosis). This may increase your chances of suffering from a serious infection.


A blood test will be taken to check possible reduction of white blood cells.


It is important to inform your doctor about your medicine.


The following side effects have also been reported:



Rare side effects (that affect less than 1 in 1,000 patients):


  • Abdominal pain, diarrhoea, wind, nausea and vomiting

  • Headache, dizziness


Very rare side effects (that affect less than 1 in 10,000 patients):


  • Changes in kidney function, sometimes with swollen limbs or flank pain because of renal disorders

  • Chest pain, breathlessness or swollen limbs because of heart disorders

  • Severe abdominal pain because of acute inflammation of the pancreas

  • Severe breathlessness because of allergic inflammation of the lung

  • Severe diarrhoea and abdominal pain because of allergic inflammation of the intestine

  • Skin rash or inflammation

  • Muscle and joint pain

  • Fever, sore throat, or malaise because of blood count changes

  • Jaundice or abdominal pain because of liver and bile flow disorders

  • Hair loss and the development of baldness

  • Numbness and tingling in the hands and feet (peripheral neuropathy)

  • Reversible decrease in semen production


If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.




HOW TO STORE SALOFALK 1000mg GRANULES


Keep out of the reach and sight of children.


Do not use Salofalk granules after the expiry date which is stated on the carton and the sachet. The expiry date refers to the last day of that month.


This medicinal product does not require any special storage conditions.


Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.




Further Information



What Salofalk 1000mg granules contain


The active substance in Salofalk 1000mg granules is mesalazine and one sachet of Salofalk 1000mg granules contains 1000 mg mesalazine.


The other ingredients are aspartame (E 951); carmellose sodium; cellulose, microcrystalline; citric acid, anhydrous; silica, colloidal anhydrous; hypromellose; magnesium stearate; methacrylic acid-methyl methacrylate copolymer (1:1) (Eudragit L 100); methylcellulose; polyacrylate dispersion 40 per cent (Eudragit NE 40 D containing 2 per cent nonoxynol 100); povidone K 25; simeticone; sorbic acid; talc; titanium dioxide (E 171); triethyl citrate; vanilla custard flavour (containing propylene glycol).




What Salofalk 1000mg granules look like and contents of the pack


Salofalk 1000mg granules are rod-shaped or round, grey-white granules.


Salofalk 1000mg granules are available in packs of 20,50,60, 100 and 150 sachets.


Not all package sizes may be marketed.




Marketing Authorisation Holder and Manufacturer



DR. FALK PHARMA GmbH

Leinenweberstr. 5

79108 Freiburg

Germany

Tel.: 0761/1514-0

Fax:0761/1514-321

E-Mail:zentrale@drfalkpharma.de

www.drfalkpharma.de




This medicinal product is authorised in the Member States of the EEA under the following names:


Denmark, Finland, Germany, Great Britain, Greece, Ireland, The Netherlands, Norway, Portugal, Slovenia, Sweden and Spain: Salofalk

Belgium, Luxembourg: Colitofalk

Austria: Mesagran.




This leaflet was last approved in May 2010


1042800


GB-IE/06.10






Wednesday, June 6, 2012

NitroMist Aerosol


Pronunciation: NYE-troe-GLIS-er-in
Generic Name: Nitroglycerin
Brand Name: NitroMist


NitroMist Aerosol is used for:

Preventing or relieving a sudden attack of angina (chest pain) caused by heart disease. It may also be used for other conditions as determined by your doctor.


NitroMist Aerosol is a nitrate. It works by dilating (widening) blood vessels. Chest pain occurs when the heart needs more oxygen than it can get. Dilating blood vessels allows blood to flow more easily. This reduces the heart's workload and the amount of oxygen needed by the heart.


Do NOT use NitroMist Aerosol if:


  • you are allergic to any ingredient in NitroMist Aerosol, to other nitrates (eg, isosorbide mononitrate), or to nitrites

  • you have severe anemia or increased pressure in the head

  • you are also taking a phosphodiesterase type 5 inhibitor (eg, sildenafil, tadalafil, vardenafil)

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



Before using NitroMist Aerosol:


Some medical conditions may interact with NitroMist Aerosol. 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 a history of other heart problems (eg, heart failure, enlarged heart, heart attack), overactive thyroid, stroke or other bleeding in the brain, or recent head injury

  • if you have anemia, low blood pressure, dehydration, or low blood volume

  • if you drink alcoholic beverages

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


  • Beta-blockers (eg, propranolol), calcium channel blockers (eg, diltiazem), diuretics (eg, furosemide, hydrochlorothiazide), medicines for high blood pressure, phenothiazines (eg, thioridazine), or phosphodiesterase type 5 inhibitors (eg, sildenafil, tadalafil, vardenafil) because the risk of low blood pressure and dizziness on standing may be increased

  • Salicylates (eg, aspirin) because they may increase the risk of NitroMist Aerosol's side effects

  • Long-acting nitrates (eg, nitroglycerin patch) because they may decrease NitroMist Aerosol's effectiveness

  • Ergot derivatives (eg, ergotamine, dihydroergotamine) because the risk of their side effects may be increased by NitroMist Aerosol

  • Alteplase because its effectiveness may be decreased by NitroMist Aerosol

This may not be a complete list of all interactions that may occur. Ask your health care provider if NitroMist Aerosol 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 NitroMist Aerosol:


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


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

  • Do NOT shake NitroMist Aerosol.

  • Do NOT inhale the spray. NitroMist Aerosol is to be used on or under the tongue.

  • Before using the medicine for the first time, prime the pump by spraying 10 times into the air away from yourself and others. If you do not use NitroMist Aerosol within 6 weeks, reprime by spraying twice into the air.

  • To use NitroMist Aerosol, remove the plastic cover. Hold the container upright with your forefinger on top of the grooved button. Open your mouth and bring the container as close to your mouth as possible. Press the button firmly to release the spray onto or under your tongue. Release the button and close your mouth after each dose.

  • Replace the plastic cover after you are finished using NitroMist Aerosol.

  • Do not swallow right away after you use a dose. Do not spit or rinse your mouth for 5 to 10 minutes after you use NitroMist Aerosol.

  • To treat an angina attack, use 1 to 2 sprays on or under the tongue as directed by your doctor. Sit quietly after using a dose. A spray may be repeated approximately every 5 minutes as directed by your doctor. Do not use more than 3 sprays in 15 minutes unless your doctor tells you otherwise. If chest pain continues after a total of 3 sprays, seek medical attention at once, unless your doctor gives you different instructions.

  • If you use NitroMist Aerosol to prevent angina caused by physical activity, use it 5 to 10 minutes before activity unless your doctor tells you otherwise.

  • Check the level of fluid in your container regularly. While the container is in the upright position, if the fluid level reaches the top or middle of the hole on the side of the container, you should get a refill of NitroMist Aerosol.

  • If you miss a dose of NitroMist Aerosol and you are still having chest pain, contact your doctor right away. Ask your health care provider any questions you may have about the proper use of NitroMist Aerosol.

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



Important safety information:


  • NitroMist Aerosol may cause dizziness or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use NitroMist Aerosol with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Check with your doctor before you drink alcohol while you are using NitroMist Aerosol. Drinking alcohol may increase the risk of low blood pressure with NitroMist Aerosol.

  • NitroMist Aerosol may cause dizziness, light-headedness, or fainting. Sit down while taking NitroMist Aerosol to avoid falling caused by light-headedness or dizziness.

  • Contact your doctor right away if you develop slow heartbeat or new or worsening chest pain after you take NitroMist Aerosol.

  • The risk of tolerance to NitroMist Aerosol may be greater if you take NitroMist Aerosol in high doses or more often than prescribed. Do NOT take more than the recommended dose or use more often than prescribed without checking with your doctor.

  • NitroMist Aerosol is flammable. Do not store or use near an open flame. Do not force open or burn the container.

  • Tell your doctor or dentist that you take NitroMist Aerosol before you receive any medical or dental care, emergency care, or surgery.

  • NitroMist Aerosol should be used with extreme caution 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 NitroMist Aerosol while you are pregnant. It is not known if NitroMist Aerosol is found in breast milk. If you are or will be breast-feeding while you are using NitroMist Aerosol, check with your doctor. Discuss any possible risks to your baby.

When used at higher doses or more often than prescribed, NitroMist Aerosol may not work as well. This is known as TOLERANCE. Tolerance to other nitrates and nitrites may also occur. Increasing the dose is not effective in managing tolerance to NitroMist Aerosol. Talk with your doctor if NitroMist Aerosol stops working well. Do not take more than prescribed.



Possible side effects of NitroMist Aerosol:


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:



Dizziness; headache; light-headedness.



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); blurred vision; dry mouth; fainting; fast, slow, or irregular heartbeat; flushing; heavy sweating; nausea; new or worsening chest pain; pale skin; redness or scaling of the skin; severe or persistent dizziness, light-headedness, or headache; shortness of breath; swelling of the hands, ankles, or feet; unusual weakness; vomiting.



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: NitroMist 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. Symptoms may include changes in vision; cold and clammy skin; confusion; dizziness; fainting; fast, slow, or irregular heartbeat; fever; flushing; light-headedness; nausea; paralysis; persistent, throbbing headache; seizures; shortness of breath; sweating; vomiting; weakness.


Proper storage of NitroMist Aerosol:

Store NitroMist Aerosol at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Protect from heat, moisture, and light. Do not store in bathroom. Keep NitroMist Aerosol out of the reach of children and away from pets.


General information:


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

  • NitroMist Aerosol 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 NitroMist Aerosol. 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 NitroMist resources


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


Compare NitroMist with other medications


  • Angina
  • Angina Pectoris Prophylaxis
  • Heart Attack
  • Heart Failure
  • High Blood Pressure

Sunday, June 3, 2012

Amilon


Generic Name: chlorpheniramine/phenindamine/phenylpropanolamine (klor fen IR a meen/fen in DA meen/fen ill proe pa NOLE a meen)

Brand Names: Amilon, Nolamine


What is Amilon (chlorpheniramine/phenindamine/phenylpropanolamine)?

Chlorpheniramine and phenindamine are antihistamines. They block the effects of the naturally occurring chemical histamine in the body. Chlorpheniramine and phenindamine prevent sneezing; itchy, watery eyes and nose; and other symptoms of allergies and hay fever.


Phenylpropanolamine is a decongestant. It constricts (shrinks) blood vessels (veins and arteries). This reduces the blood flow to certain areas and allows nasal and respiratory (breathing) passages to open up.


Chlorpheniramine/phenindamine/phenylpropanolamine is used to treat nasal congestion and sinusitis (inflammation of the sinuses) associated with allergies, hay fever, and the common cold.


Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.


Chlorpheniramine/phenindamine/phenylpropanolamine may also be used for purposes other than those listed in this medication guide.


What is the most important information I should know about Amilon (chlorpheniramine/phenindamine/phenylpropanolamine)?


Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.


Use caution when driving, operating machinery, or performing other hazardous activities. Chlorpheniramine/phenindamine/phenylpropanolamine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking chlorpheniramine/phenindamine/phenylpropanolamine.

Do not take more of this medication than is recommended. If your symptoms do not improve, or if they worsen, talk to your doctor.


Who should not take Amilon (chlorpheniramine/phenindamine/phenylpropanolamine)?


Do not take chlorpheniramine/phenindamine/phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Before taking this medication, tell your doctor if you have


  • kidney disease,

  • liver disease,


  • diabetes,




  • glaucoma,




  • any type of heart disease or high blood pressure;




  • thyroid disease;




  • emphysema or chronic bronchitis; or




  • difficulty urinating or have an enlarged prostate.



You may not be able to take chlorpheniramine/phenindamine/phenylpropanolamine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.


Chlorpheniramine/phenindamine/phenylpropanolamine is in the FDA pregnancy category B. This means that it is unlikely to harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. This medication passes into breast milk and may harm a nursing baby. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. If you are over 65 years of age, you may be more likely to experience side effects from chlorpheniramine/phenindamine/phenylpropanolamine. You may require a lower dose of this medication. Read the package label for directions or consult your doctor or pharmacist before treating a child with this medication. Children are more susceptible than adults to the effects of medicines and may have unusual reactions.

How should I take Amilon (chlorpheniramine/phenindamine/phenylpropanolamine)?


Take chlorpheniramine/phenindamine/phenylpropanolamine exactly as directed. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.


Take each dose with a full glass of water. Do not crush, chew, or break the long-acting or sustained-release forms of this medication. Swallow it whole. If you are unsure about the formulation of the medicine, ask your pharmacist for help.

If you cannot swallow the tablets or capsules, look for a liquid form of the medication.


Do not take more of this medication than is recommended. An overdose of this medication can cause serious harm.

Do not take chlorpheniramine/phenindamine/phenylpropanolamine for longer than 7 days in a row. If your symptoms do not improve, if they get worse, or if you have a fever, talk to your doctor.


Store chlorpheniramine/phenindamine/phenylpropanolamine at room temperature away from moisture and heat.

What happens if I miss a dose?


Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.


What happens if I overdose?


Seek emergency medical attention.

Symptoms of a chlorpheniramine/phenindamine/phenylpropanolamine overdose include a dry mouth, large pupils, flushing, nausea, and vomiting.


What should I avoid while taking Amilon (chlorpheniramine/phenindamine/phenylpropanolamine)?


Use caution when driving, operating machinery, or performing other hazardous activities. Chlorpheniramine/phenindamine/phenylpropanolamine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking chlorpheniramine/phenindamine/phenylpropanolamine.

Amilon (chlorpheniramine/phenindamine/phenylpropanolamine) side effects


Serious side effects are unlikely to occur. Stop taking chlorpheniramine/phenindamine/phenylpropanolamine and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Other, less serious side effects may be more likely to occur. Continue to take chlorpheniramine/phenindamine/phenylpropanolamine and talk to your doctor or try another similar medication if you experience



  • dryness of the eyes, nose, and mouth;




  • drowsiness or dizziness;




  • blurred vision;




  • difficulty urinating; or




  • excitation in children.



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.


What other drugs will affect Amilon (chlorpheniramine/phenindamine/phenylpropanolamine)?


Do not take chlorpheniramine/phenindamine/phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Do not take other over-the-counter cough, cold, allergy, diet, or sleep aids while taking chlorpheniramine/phenindamine/phenylpropanolamine without first talking to your doctor or pharmacist. Other medications may also contain chlorpheniramine, phenindamine, phenylpropanolamine, or other similar drugs. You may accidentally take too much of these medicines.


Chlorpheniramine/phenindamine/phenylpropanolamine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if chlorpheniramine/phenindamine/phenylpropanolamine is taken with any of these medications.


Drugs other than those listed here may also interact with chlorpheniramine/phenindamine/phenylpropanolamine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.



More Amilon resources


  • Amilon Drug Interactions
  • Amilon Support Group
  • 0 Reviews for Amilon - Add your own review/rating


Compare Amilon with other medications


  • Cold Symptoms


Where can I get more information?


  • Your pharmacist has additional information about chlorpheniramine/phenindamine/ phenylpropanolamine written for health professionals that you may read.

What does my medication look like?


Chlorpheniramine/phenindamine/phenylpropanolamine is available with a prescription under the brand name Nolamine. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.



  • Nolamine 4 mg of chlorpheniramine, 24 mg of phenindamine and 50 mg of phenylpropanolamine--pink, round tablets




insulin isophane and insulin regular


Generic Name: insulin isophane and insulin regular (IN su lin EYE soe fane and IN su lin REG ue lar)

Brand names: HumuLIN 50/50, HumuLIN 70/30, HumuLIN 70/30 Pen, NovoLIN 70/30, NovoLIN 70/30 Innolet, NovoLIN 70/30 PenFill, Relion NovoLIN 70/30 Innolet, ReliOn/NovoLIN 70/30, Insulin Pork Mix


What is insulin isophane and insulin regular?

Insulin isophane and insulin regular is a man-made form of a hormone that is produced in the body. It works by lowering levels of glucose (sugar) in the blood. Insulin isophane and insulin regular is a long-acting form of insulin that is slightly different from other forms of insulin that are not man-made.


Insulin isophane and insulin regular is used to treat diabetes.


Insulin isophane and insulin regular may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about insulin isophane and insulin regular?


Take care to keep your blood sugar from getting too low, causing hypoglycemia. Symptoms of low blood sugar may include headache, nausea, hunger, confusion, drowsiness, weakness, dizziness, blurred vision, fast heartbeat, sweating, tremor, or trouble concentrating. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar. Also be sure your family and close friends know how to help you in an emergency.


Also watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, loss of appetite, increased urination, nausea, vomiting, drowsiness, dry skin, and dry mouth. Check your blood sugar levels and ask your doctor how to adjust your insulin doses if needed.


Never share an injection pen or cartridge with another person. Sharing injection pens or cartridges can allow disease such as hepatitis or HIV to pass from one person to another.

Insulin isophane and insulin regular is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.


What should I discuss with my healthcare provider before using insulin isophane and insulin regular?


Do not use this medication if you are allergic to insulin, or if you are having an episode of hypoglycemia (low blood sugar).

Before using insulin isophane and insulin regular, tell your doctor if you have liver or kidney disease.


Tell your doctor about all other medications you use, including any oral (by mouth) diabetes medications.


Insulin isophane and insulin regular is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.


Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.


FDA pregnancy category B. This medication is not expected to 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 insulin isophane and insulin regular 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 use insulin isophane and insulin regular?


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


Insulin isophane and insulin regular is given as an injection (shot) under your skin. Your doctor, nurse, or pharmacist will give you specific instructions on how and where to inject this medicine. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.


Choose a different place in your injection skin area each time you use this medication. Do not inject into the same place two times in a row.


Carefully shake or rotate the insulin vial (bottle) several times to thoroughly mix the insulin isophane and insulin regular before each use. Shake the mixture until it looks cloudy or milky. Do not use the mixture if has clumps or white particles in it after mixing, or if the white substance remains at the bottom of the vial. Call your doctor for a new prescription.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.


Some insulin needles can be used more than once, depending on needle brand and type. But a reused needle must be properly cleaned, recapped, and inspected for bending or breakage. Reusing needles also increases your risk of infection. Ask your doctor or pharmacist whether you are able to reuse your insulin needles.


Never share an injection pen or cartridge with another person. Sharing injection pens or cartridges can allow disease such as hepatitis or HIV to pass from one person to another.

Check your blood sugar carefully during a time of stress or illness, if you travel, exercise more than usual, or skip meals. These things can affect your glucose levels and your insulin dose needs may also change.


Watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, loss of appetite, increased urination, nausea, vomiting, drowsiness, dry skin, and dry mouth. Check your blood sugar levels and ask your doctor how to adjust your insulin doses if needed.


Ask your doctor how to adjust your insulin isophane and insulin regular dose if needed. Do not change your dose without first talking to your doctor. Carry an ID card or wear a medical alert bracelet stating that you have diabetes, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are diabetic. Storing unopened vials or injection pens: Keep in the carton and store in a refrigerator. Do not freeze. Throw away any insulin not used before the expiration date on the medicine label. Storing after your first use: Keep the "in-use" vials or injection pens at cool room temperature, away from heat and light, and use prior to the expiration date. Throw an in-use injection pen 10 days after the first use, even if there is still medicine left in it.

Do not freeze insulin isophane and insulin regular, and throw away the medication if it has become frozen.


What happens if I miss a dose?


Since insulin isophane and insulin regular is used before meals or snacks, you may not be on a timed dosing schedule. Whenever you use insulin isophane and insulin regular, be sure to eat a meal or snack within 30 to 60 minutes. Do not use extra insulin isophane and insulin regular to make up a missed dose.


It is important to keep insulin isophane and insulin regular on hand at all times. Get your prescription refilled before you run out of medicine completely.


What happens if I overdose?


Seek emergency medical attention if you think you have used too much of this medicine. An insulin overdose can cause life-threatening hypoglycemia.

Symptoms of severe hypoglycemia include extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, seizure (convulsions), or coma.


What should I avoid while using insulin isophane and insulin regular?


Do not change the brand of insulin isophane and insulin regular or syringe you are using without first talking to your doctor or pharmacist. Avoid drinking alcohol. Your blood sugar may become dangerously low if you drink alcohol while using insulin isophane and insulin regular.

Insulin isophane and insulin regular side effects


Get emergency medical help if you have any of these signs of insulin allergy: itching skin rash over the entire body, wheezing, trouble breathing, fast heart rate, sweating, or feeling like you might pass out.

Hypoglycemia, or low blood sugar, is the most common side effect of insulin isophane and insulin regular. Symptoms of low blood sugar may include headache, nausea, hunger, confusion, drowsiness, weakness, dizziness, blurred vision, fast heartbeat, sweating, tremor, trouble concentrating, confusion, or seizure (convulsions). Watch for signs of low blood sugar. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar.


Tell your doctor if you have itching, swelling, redness, or thickening of the skin where you inject insulin isophane and insulin regular.


This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.


Insulin isophane and insulin regular Dosing Information


Usual Adult Dose for Gestational Diabetes:

Isophane (NPH)-regular insulin is a mixture of intermediate and a short-acting insulins and is generally injected subcutaneously 1 to 3 times daily within 30 to 60 minutes before a meal.

Insulin dosage should be individualized to achieve/maintain a target blood glucose level and is determined by various factors including body weight, body fat, physical activity, insulin sensitivity, blood glucose levels, and target blood glucose.

Conventional regimen: The total daily insulin dose is administered as a mixture of rapid/short-acting and intermediate-acting insulins in 1 to 2 injections. Twice daily injections are preferred for better glycemic control. With the 2-injection regimen, generally two-thirds of the daily dose is given before breakfast and one-third is given before the evening meal.

Intensive regimen: The total daily dose is administered as 3 or more injections or by continuous subcutaneous infusion to cover basal and pre-meal bolus insulin requirements. The basal requirement is approximately 30 to 50% of the total dose, given as intermediate or long-acting insulin (NPH, zinc, extended zinc, lispro-protamine, glargine), 1 to 2 times daily. Meal boluses are approximately 50 to 70% of the total dose, given as rapid/short-acting insulin (regular, aspart, lispro) 2 to 5 times daily before meals. Common regimens include injections of rapid/short acting insulin before each meal along with injections of intermediate or long-acting insulin in the morning and/or evening. Dosage adjustments are made to achieve target blood glucose levels and are based on frequent blood glucose measurements, diet and exercise levels.

Total daily insulin requirements:
Initial dose: 0.5 to 0.8 unit/kg/day subcutaneously
Honeymoon phase: 0.2 to 0.5 unit/kg/day subcutaneously
Split dose therapy: 0.5 to 1.2 unit/kg/day subcutaneously
Insulin resistance: 0.7 to 2.5 units/kg/day subcutaneously

Usual Adult Dose for Diabetes Mellitus Type I:

Isophane (NPH)-regular insulin is a mixture of intermediate and a short-acting insulins and is generally injected subcutaneously 1 to 3 times daily within 30 to 60 minutes before a meal.

Insulin dosage should be individualized to achieve/maintain a target blood glucose level and is determined by various factors including body weight, body fat, physical activity, insulin sensitivity, blood glucose levels, and target blood glucose.

Conventional regimen: The total daily insulin dose is administered as a mixture of rapid/short-acting and intermediate-acting insulins in 1 to 2 injections. Twice daily injections are preferred for better glycemic control. With the 2-injection regimen, generally two-thirds of the daily dose is given before breakfast and one-third is given before the evening meal.

Intensive regimen: The total daily dose is administered as 3 or more injections or by continuous subcutaneous infusion to cover basal and pre-meal bolus insulin requirements. The basal requirement is approximately 30 to 50% of the total dose, given as intermediate or long-acting insulin (NPH, zinc, extended zinc, lispro-protamine, glargine), 1 to 2 times daily. Meal boluses are approximately 50 to 70% of the total dose, given as rapid/short-acting insulin (regular, aspart, lispro) 2 to 5 times daily before meals. Common regimens include injections of rapid/short acting insulin before each meal along with injections of intermediate or long-acting insulin in the morning and/or evening. Dosage adjustments are made to achieve target blood glucose levels and are based on frequent blood glucose measurements, diet and exercise levels.

Total daily insulin requirements:
Initial dose: 0.5 to 0.8 unit/kg/day subcutaneously
Honeymoon phase: 0.2 to 0.5 unit/kg/day subcutaneously
Split dose therapy: 0.5 to 1.2 unit/kg/day subcutaneously
Insulin resistance: 0.7 to 2.5 units/kg/day subcutaneously

Usual Adult Dose for Diabetes Mellitus Type II:

Isophane-regular insulin is a mixture of intermediate and a short-acting insulins and is generally injected subcutaneously 1 to 3 times daily within 30 to 60 minutes before a meal.

Diet and lifestyle modifications are recommended as initial treatment for type II diabetes, followed by oral agents. Insulin may be considered if patients are very hyperglycemic or symptomatic and/or not controlled with oral agents. Insulin may exacerbate obesity, further increase insulin resistance, and increase the frequency of hypoglycemia.

Insulin dosage should be individualized to achieve/maintain a target blood glucose level and is determined by various factors including body weight, body fat, physical activity, insulin sensitivity, blood glucose levels, and target blood glucose.

Conventional regimen:
Initial dose, monotherapy: Total insulin requirement: 0.1 unit/kg/day. When insulin is used alone, twice daily injections are recommended for better glycemic control. The total daily insulin dose is administered as a mixture of rapid/short-acting and intermediate-acting insulins in 1 to 2 injections. With the 2-injection regimen, generally two-thirds of the daily dose is given before breakfast and one-third is given before the evening meal. Once daily injections are sometimes used in children with suboptimal compliance; however, this may lead to more nocturia, fasting hyperglycemia, morning glucosuria, and a risk of ketoacidosis if the doses are missed.
Maintenance dose, monotherapy: Total daily insulin requirements may progress to 1.5 to 2.5 units/kg or higher in patients with obesity and insulin resistance.

Intensive regimen:
The necessity for and efficacy of intensive insulin therapy in type II diabetes has been controversial. The total daily dose is administered as 3 or more injections or by continuous subcutaneous infusion to cover basal and pre-meal bolus insulin requirements. This method may be appropriate for closely supervised and highly motivated older children or adolescents who are able to inject their insulin, monitor their blood glucose, and recognize hypoglycemia. The basal requirement is approximately 30 to 50% of the total dose, given as intermediate or long-acting insulin (NPH, zinc, extended zinc, lispro-protamine, glargine), 1 to 2 times daily. Meal boluses are approximately 50 to 70% of the total dose, given as rapid/short-acting insulin (regular, aspart, lispro) 2 to 5 times daily before meals. Common regimens include injections of rapid/short acting insulin before each meal along with injections of intermediate or long-acting insulin in the morning and/or evening. Dosage adjustments are made to achieve target blood glucose levels and are based on frequent blood glucose measurements, diet and exercise levels.
Initial dose, monotherapy: 0.5 to 1.5 unit/kg/day subcutaneously.
Maintenance dose, monotherapy: Total daily insulin requirements may progress to 2.5 units/kg or higher in patients with obesity and insulin resistance.

Usual Pediatric Dose for Diabetes Mellitus Type I:

Isophane (NPH)-regular insulin is a mixture of intermediate and a short-acting insulins and is generally injected subcutaneously 1 to 3 times daily within 30 to 60 minutes before a meal.

Insulin dosage should be individualized to achieve/maintain a target blood glucose level and is determined by various factors including body weight, body fat, physical activity, insulin sensitivity, blood glucose levels, and target blood glucose.

Conventional regimen: The total daily insulin dose is administered as a mixture of rapid/short-acting and intermediate-acting insulins in 1 to 2 injections. Twice daily injections are recommended for better glycemic control. With the 2-injection regimen, generally two-thirds of the daily dose is given before breakfast and one-third is given before the evening meal. Once daily injections are sometimes used in children with suboptimal compliance; however, this may lead to more nocturia, fasting hyperglycemia, morning glucosuria, and a risk of ketoacidosis if the doses are missed.

Intensive regimen: The total daily dose is administered as 3 or more injections or by continuous subcutaneous infusion to cover basal and pre-meal bolus insulin requirements. This method may be appropriate for closely supervised and highly motivated older children or adolescents who are able to inject their insulin, monitor their blood glucose, and recognize hypoglycemia. The basal requirement is approximately 30 to 50% of the total dose, given as intermediate or long-acting insulin (NPH, zinc, extended zinc, glargine), 1 to 2 times daily. Meal boluses are approximately 50 to 70% of the total dose, given as rapid/short-acting insulin (regular, lispro) 2 to 5 times daily before meals. Common regimens include injections of rapid/short acting insulin before each meal along with injections of intermediate or long-acting insulin in the morning and/or evening. Dosage adjustments are made to achieve target blood glucose levels and are based on frequent blood glucose measurements, diet and exercise levels.

Total daily insulin requirements:
Initial dose: 0.5 to 0.8 unit/kg/day subcutaneously
Honeymoon phase: 0.2 to 0.5 unit/kg/day subcutaneously
Split dose therapy: 0.5 to 1.2 unit/kg/day subcutaneously
Adolescents during growth spurts. 0.8 to 1.5 units/kg/day subcutaneously

Usual Pediatric Dose for Diabetes Mellitus Type II:

Isophane-regular insulin is a mixture of intermediate and a short-acting insulins and is generally injected subcutaneously 1 to 3 times daily within 30 to 60 minutes before a meal.

Diet and lifestyle modifications are recommended as initial treatment for type II diabetes, followed by oral agents (metformin). Insulin may be considered if children are very hyperglycemic or symptomatic and/or not controlled with oral agents. Insulin may exacerbate obesity, further increase insulin resistance, and increase the frequency of hypoglycemia.

Insulin dosage should be individualized to achieve/maintain a target blood glucose level and is determined by various factors including body weight, body fat, physical activity, insulin sensitivity, blood glucose levels, and target blood glucose.

Conventional regimen:
Initial dose, monotherapy: Total insulin requirement: 0.1 unit/kg/day. When insulin is used alone, twice daily injections are recommended for better glycemic control. The total daily insulin dose is administered as a mixture of rapid/short-acting and intermediate-acting insulins in 1 to 2 injections. With the 2-injection regimen, generally two-thirds of the daily dose is given before breakfast and one-third is given before the evening meal. Once daily injections are sometimes used in children with suboptimal compliance; however, this may lead to more nocturia, fasting hyperglycemia, morning glucosuria, and a risk of ketoacidosis if the doses are missed.
Maintenance dose, monotherapy: Total daily insulin requirements may progress to 1.5 to 2.5 units/kg or higher in patients with obesity and insulin resistance.

Intensive regimen:
The necessity for and efficacy of intensive insulin therapy in type II diabetes has been controversial. The total daily dose is administered as 3 or more injections or by continuous subcutaneous infusion to cover basal and pre-meal bolus insulin requirements. This method may be appropriate for closely supervised and highly motivated older children or adolescents who are able to inject their insulin, monitor their blood glucose, and recognize hypoglycemia. The basal requirement is approximately 30 to 50% of the total dose, given as intermediate or long-acting insulin (NPH, zinc, extended zinc, glargine), 1 to 2 times daily. Meal boluses are approximately 50 to 70% of the total dose, given as rapid/short-acting insulin (regular, lispro) 2 to 5 times daily before meals. Common regimens include injections of rapid/short acting insulin before each meal along with injections of intermediate or long-acting insulin in the morning and/or evening. Dosage adjustments are made to achieve target blood glucose levels and are based on frequent blood glucose measurements, diet and exercise levels.
Initial dose, monotherapy: 0.5 to 1.5 unit/kg/day subcutaneously.
Maintenance dose, monotherapy: Total daily insulin requirements may progress to 2.5 units/kg or higher in patients with obesity and insulin resistance.


What other drugs will affect insulin isophane and insulin regular?


Using certain medicines can make it harder for you to tell when you have low blood sugar. Tell your doctor if you use any of the following:



  • albuterol (Proventil, Ventolin);




  • clonidine (Catapres);




  • reserpine;




  • guanethidine (Ismelin); or




  • beta-blockers such as atenolol (Tenormin), bisoprolol (Zebeta), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), timolol (Blocadren), and others.




There are many other medicines that can increase or decrease the effects of insulin isophane and insulin regular on lowering your blood sugar. 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. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

More insulin isophane and insulin regular resources


  • Insulin isophane and insulin regular Use in Pregnancy & Breastfeeding
  • Insulin isophane and insulin regular Drug Interactions
  • Insulin isophane and insulin regular Support Group
  • 2 Reviews for Insulin isophane and insulin regular - Add your own review/rating


Compare insulin isophane and insulin regular with other medications


  • Diabetes, Type 1
  • Diabetes, Type 2
  • Gestational Diabetes


Where can I get more information?


  • Your pharmacist can provide more information about insulin isophane and insulin regular.