Vyvanse

Generic Name: Lisdexamfetamine Dimesylate
Class: Amphetamines
VA Class: CN801
Chemical Name: (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethly] hexanamide dimethanesulfonate
Molecular Formula: C₁₅H₂₅N₃O (CH₄O₃S)₂
CAS Number: 608137-32-2

• Abuse Potential


• 
  

  Amphetamines have a high potential for abuse.¹

  
  


• 
  

  Administration of amphetamines for prolonged periods of time may lead to drug dependence.¹

  
  


• 
  

  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.¹

  
  


• 
  

  The possibility that family members may abuse the patient’s medication should be considered.⁵

  
  

• Sudden Death and Serious Cardiovascular Events


• 
  

  Possible sudden death and serious cardiovascular events, particularly in individuals who abuse amphetamines.^{1 6 9} (See Sudden Death and Serious Cardiovascular Events under Cautions.)

  
  

Introduction

Prodrug of dextroamphetamine; noncatechol, sympathomimetic amine with CNS-stimulating activity.^{1 8 28}

Uses for Vyvanse

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).^{1 3 6 7 8 28}

Safety and efficacy established in children 6–12 years of age who met criteria for ADHD (combined type or predominantly hyperactive-impulsive type) and also in adults who met criteria for ADHD.^{1 2 3 4 29 30}

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.^{5 6 7 10 11 12 13 14 15 16 17 18 19 20}

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.^{1 6 17 18}

Use should depend on age, adequate diagnosis (based on medical, special psychological, educational, and social resources), and the clinician’s assessment of the severity, duration, and frequency of symptoms and should not depend solely on one or more behavioral characteristics.^{1 5 6 17}

Vyvanse Dosage and Administration

Administration

Oral Administration

Administer once daily in the morning without regard to meals.¹ Because of potential for insomnia, avoid administering in the afternoon.^{1 28 30}

Capsule may be swallowed whole or may be opened and the entire contents dissolved in water immediately prior to administration; resulting solution should not be stored for use at a later time.^{1 28}

Do not subdivide capsule contents; do not administer a dose less than the entire contents of one capsule.¹

Dosage

Available as lisdexamfetamine dimesylate; dosage expressed in terms of the salt.¹

Adjust dosage according to individual response and tolerance; the smallest dose required to produce the desired response should always be used.^{1 6 30}

When possible, therapy should be interrupted occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued treatment.^{1 6}

Pediatric Patients

Attention Deficit Hyperactivity Disorder

Oral

Children 6–12 years of age: Initially, 30 mg once daily (as initial treatment for ADHD or in patients being switched to lisdexamfetamine from other drugs); dosage may be adjusted in 10- or 20-mg increments at weekly intervals; maximum 70 mg daily.^{1 28 30}

If the initial 30-mg daily dosage is not tolerated, dosage may be decreased to 20 mg daily.²⁷

Adults

Attention Deficit Hyperactivity Disorder

Oral

Initially, 30 mg once daily (as initial treatment for ADHD or in patients being switched to lisdexamfetamine from other drugs); dosage may be adjusted in 10- or 20-mg increments at weekly intervals; maximum 70 mg daily.^{1 28}

If the initial 30-mg daily dosage is not tolerated, dosage may be decreased to 20 mg daily.²⁷

Prescribing Limits

Pediatric Patients

Attention Deficit Hyperactivity Disorder

Oral

Children 6–12 years of age: Maximum 70 mg daily.¹

Long-term use (i.e., >4 weeks) has not been studied systematically.¹ If used for long-term therapy, periodically reevaluate the usefulness of the drug.¹

Adults

Attention Deficit Hyperactivity Disorder

Oral

Maximum 70 mg daily.¹

Long-term use (i.e., >4 weeks) has not been studied systematically.¹ If used for long-term therapy, periodically reevaluate the usefulness of the drug.¹

Special Populations

No special population dosage recommendations at this time.¹

Cautions for Vyvanse

Contraindications

• 
  

  Contraindicated in patients with advanced arteriosclerosis,^{1 5 28} symptomatic cardiovascular disease,^{1 5 28} moderate to severe hypertension,^{1 5 28} hyperthyroidism,^{1 5 28} known hypersensitivity or idiosyncrasy to sympathomimetic amines,^{1 5} glaucoma,^{1 5 28} or a history of drug abuse;^{1 5 28} within 14 days of MAO inhibitor therapy;^{1 5 28} and in agitated patients.^{1 28}

  
  


• 
  

  Although amphetamines generally should not be used in patients with a history of drug abuse,^{1 5} some experts state that this is not an absolute contraindication, provided the patient can be monitored more carefully than would otherwise be indicated.⁵

  
  

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.^{1 9}

Epidemiologic data suggest a possible association between use of stimulants and sudden unexplained death in healthy children and adolescents.^{31 32 33} FDA unable to conclude that these data affect evaluation of overall risk and benefit of stimulants used to treat ADHD in children and adolescents.³¹ 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.^{31 32 33} Pediatric patients with ADHD and their parents should avoid discontinuing the child’s use of such stimulants before consulting a clinician.³¹

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).^{1 5 6}

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.^{1 6 8 9} (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.^{1 28}

Other Warnings and Precautions

Least amount of lisdexamfetamine feasible should be prescribed or dispensed at one time in order to minimize possible overdosage.¹

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.^{1 28} Modest increases not expected to have short-term sequelae; however, monitor all patients for larger changes in BP and heart rate.¹

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).¹

Exacerbation or Precipitation of Psychotic Symptoms

May exacerbate symptoms of behavior disturbance and thought disorder in patients with preexisting psychotic disorder.^{1 5}

Psychotic symptoms (e.g., hallucinations, delusional thinking) may occur with usual dosages in children and adolescents without prior history of psychotic illness.^{1 6} If psychotic symptoms occur, consider causal relationship to stimulants, and discontinue therapy as appropriate.^{1 6}

Precipitation of Manic Symptoms

May precipitate mixed or manic episodes in ADHD patients with comorbid bipolar disorder; use with caution in these patients.¹ 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).¹

Manic symptoms may occur with usual dosages in children and adolescents without prior history of mania.¹ If manic symptoms occur, consider causal relationship to stimulants, and discontinue therapy as appropriate.¹

Aggression

Aggressive behavior and hostility (frequently observed in children and adolescents with ADHD) reported in patients receiving drug therapy for ADHD.¹ 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.^{1 6}

Growth Suppression

Long-term (i.e., >12 months) administration expected to cause at least a temporary suppression of normal weight and/or height patterns in some children and adolescents.^{1 6} Dose-related weight loss reported in children during 4 weeks of therapy with lisdexamfetamine.¹

Manufacturer recommends monitoring growth during treatment; patients not growing or gaining weight as expected may require temporary discontinuance of treatment.^{1 6 28} 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.⁷

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.^{1 28} If seizures occur, discontinue therapy.¹

Visual Effects

Visual disturbances (e.g., difficulty with accommodation, blurred vision) reported with stimulants.^{1 28}

Tics

Amphetamines reported to exacerbate motor and phonic tics and Tourette’s syndrome.¹ However, a history of tics or their development during therapy is not an absolute contraindication to continued use.^{1 5 7} Nevertheless, evaluate for presence of tics and Tourette’s syndrome in children and their families prior to initiating stimulant therapy.¹

Other CNS Effects

Amphetamines may impair the ability to engage in potentially hazardous activities (e.g., operating machinery or vehicles).¹

Specific Populations

Pregnancy

Category C.^{1 25}

Risk of prematurity, low birth weight, and withdrawal symptoms (e.g., dysphoria, lassitude, agitation) in infants born to dependent women.^{1 25}

Lactation

Distributed into milk; discontinue nursing or the drug.^{1 25}

Pediatric Use

Safety and efficacy of lisdexamfetamine not established in children 3–5 years of age.¹ Amphetamines not recommended for ADHD in children <3 years of age.^{1 5 6} Not studied to date in adolescents.¹

Aggressive behavior, hostility, and psychotic (e.g., hallucinations, delusional thinking) or manic symptoms reported in children and adolescents receiving stimulants for management of ADHD.¹ (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.¹ Epidemiologic data also suggest a possible association between use of stimulants and sudden death in healthy children and adolescents.^{31 32 33} (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.¹ (See Growth Suppression under Cautions.)

Geriatric Use

Lisdexamfetamine has not been studied in this population.¹

Hepatic Impairment

Not specifically studied in hepatic impairment.²⁷

Renal Impairment

Not specifically studied in renal impairment.²⁷

Common Adverse Effects

Children 6–12 years of age: Decreased appetite,^{1 6 28 29 30} insomnia,^{1 6 28 29 30} upper abdominal pain,^{1 28 30} irritability,^{1 6 28 30} vomiting, ^{1 28} weight loss,^{1 6 28 30} nausea,^{1 28} dry mouth,^{1 28} dizziness,^{1 28 30} affect lability,¹ rash,¹ tic,¹ pyrexia,¹ somnolence.¹

Adults: Decreased appetite,¹ insomnia,¹ dry mouth,¹ diarrhea,¹ nausea,¹ anxiety,¹ anorexia,¹ jitteriness,¹ increased BP,¹ agitation,¹ restlessness,¹ hyperhidrosis,¹ increased heart rate,¹ tremor,¹ dyspnea.¹

Interactions for Vyvanse

Active metabolite (dextroamphetamine) inhibits MAO.¹

Lisdexamfetamine is not metabolized by CYP isoenzymes.¹ In vitro studies suggest only minor inhibition of CYP isoenzymes 1A2, 2D6, and 3A4 by amphetamine and/or its metabolites.¹

Specific Drugs, Tests, and Foods

Drug, Test, or Food	Interaction	Comments
Acidifying agents, urinary (ammonium chloride, sodium acid phosphate, cranberry juice)	Increased urinary excretion and decreased serum concentrations and efficacy of amphetamines1 8
Adrenergic blockers	Potential inhibition of adrenergic blockade1
Alkalinizing agents (carbonic anhydrase inhibitors, sodium bicarbonate)	Decreased urinary excretion of amphetamines8
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 potentiated1
Antihistamines	Amphetamines may counteract the sedative effects of antihistamines1
Antihypertensives	Amphetamines may antagonize the hypotensive effects of antihypertensives1
Chlorpromazine	Chlorpromazine inhibits the central stimulant effects of amphetamines by blocking dopamine and norepinephrine receptors1	Can be used to treat amphetamine poisoning1
Ethosuximide	Intestinal absorption of ethosuximide may be delayed1
Haloperidol	Haloperidol inhibits the central stimulant effects of amphetamines by blocking dopamine receptors1
Lithium carbonate	Lithium may inhibit the anorectic and stimulatory effects of amphetamine1
MAO inhibitors	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 crisis1 Toxic neurologic effects, hypertensive crisis, and malignant hyperpyrexia can occur, sometimes with fatal results1	Amphetamines contraindicated in patients currently or recently (within 14 days) receiving MAO inhibitor1
Meperidine	Amphetamines potentiate the analgesic effect of meperidine1
Methenamine	Acidifying agents used with methenamine increase urinary excretion and decrease efficacy of amphetamines1
Norepinephrine	Amphetamines enhance the adrenergic effects of norepinephrine1
Phenobarbital	Amphetamines may delay absorption of phenobarbital; concomitant use may produce a synergistic anticonvulsant action1
Phenytoin	Amphetamines may delay absorption of phenytoin; concomitant use may produce a synergistic anticonvulsant action1
Propoxyphene	In propoxyphene overdosage, amphetamine CNS stimulation is potentiated and fatal convulsions can occur1
Sympathomimetic agents	Enhanced activity of sympathomimetic agents1	Use with caution1
Test, plasma corticosteroids	Elevated plasma corticosteroid concentrations; this increase is greatest in the evening1
Test, urinary steroids	Possible interference with urinary steroid determinations1
Veratrum alkaloids	Amphetamines inhibit the hypotensive effect of veratrum1

Vyvanse Pharmacokinetics

Absorption

Bioavailability

Lisdexamfetamine (a prodrug of dextroamphetamine) is rapidly absorbed from the GI tract.^{1 28} Peak plasma concentrations of lisdexamfetamine occur in approximately 1 hour; concentrations are low and transient; nonquantifiable by 8 hours after administration.¹ Peak plasma concentrations of dextroamphetamine occur in approximately 3.5–3.7 hours.^{1 3 30}

Onset

Occurs within 2 hours after oral administration.³

Duration

Approximately 10–12 hours.^{1 8 27}

Food

Food (high-fat meal) delays time to peak plasma concentration of dextroamphetamine by about 1 hour but does not affect magnitude of peak plasma concentration or AUC of dextroamphetamine.¹

Distribution

Extent

Amphetamines readily cross the blood-brain barrier and are distributed into most body tissues.²⁶

Amphetamines are distributed into milk in concentrations 3–7 times maternal blood concentrations.^{21 25}

Elimination

Metabolism

Lisdexamfetamine (a prodrug of dextroamphetamine) is converted to l-lysine and dextroamphetamine by first-pass intestinal and/or hepatic metabolism.¹

Lisdexamfetamine is not metabolized by CYP isoenzymes.¹

Elimination Route

Excreted principally in urine.¹ Approximately 96% of a 70-mg radiolabeled oral dose of lisdexamfetamine was recovered in urine; parent drug accounted for about 2% of the recovered radioactivity.¹

Changes in urinary pH may alter excretion of amphetamines.¹ (See Specific Drugs, Tests, and Foods under Interactions.)

Half-life

Lisdexamfetamine: <1 hour;^{1 8} dextroamphetamine: 9.4–13 hours.^{3 8 30}

Stability

Storage

Oral

Capsules

Tight, light-resistant containers at 25°C (may be exposed to 15–30°C).¹

ActionsActions

• 
  

  Amphetamines are sympathomimetic amines with CNS stimulant activity.^{1 23}

  
  


• 
  

  Lisdexamfetamine is a prodrug of dextroamphetamine; dextroamphetamine may block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneural space.^{1 23 28 30}

  
  


• 
  

  Pharmacologic actions of amphetamines are qualitatively similar to those of ephedrine and include CNS and respiratory stimulation and sympathomimetic activity including pressor response, bronchodilation, and contraction of the urinary bladder sphincter.^{23 24}

  
  


• 
  

  Theories of dysfunction in ADHD focus on the prefrontal cortex, which controls many executive functions (e.g., planning, impulse control).⁵ Stimulants have putative effects on central dopamine and norepinephrine pathways that are crucial in frontal lobe function.⁵

  
  


• 
  

  Produces an anorexigenic effect, leading to loss of weight.^{1 5 23} 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.²²

  
  

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.¹ Instruct patient or caregiver to read and understand contents of medication guide before initiating therapy and each time the prescription is refilled.¹

  
  


• 
  

  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.^{5 6 7} However, the benefits versus risks of such interruptions in therapy have not been established.⁷

  
  


• 
  

  Question about possible substance abuse, including in other family members (since they may abuse the patient’s medication supply).¹

  
  


• 
  

  Advise to take drug in the morning to minimize insomnia.¹

  
  


• 
  

  Advise that appetite suppression may occur.^{1 5} 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.⁵

  
  


• 
  

  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.¹

  
  


• 
  

  Instruct about the potential for amphetamines to impair patient’s ability to perform potentially hazardous activities, such as driving or operating heavy machinery.¹

  
  


• 
  

  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).¹

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹ (See Cautions.)

  
  

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 a schedule II (C-II) drug.¹

Lisdexamfetamine Dimesylate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules	20 mg	Vyvanse (C-II)	Shire
		30 mg	Vyvanse (C-II)	Shire
		40 mg	Vyvanse (C-II)	Shire
		50 mg	Vyvanse (C-II)	Shire
		60 mg	Vyvanse (C-II)	Shire
		70 mg	Vyvanse (C-II)	Shire

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Vyvanse 20MG Capsules (SHIRE US INC.): 20/$125.99 or 30/$177.98

Vyvanse 30MG Capsules (SHIRE US INC.): 20/$126.99 or 30/$189.97

Vyvanse 40MG Capsules (SHIRE US INC.): 20/$113.99 or 30/$170.97

Vyvanse 50MG Capsules (SHIRE US INC.): 20/$118.57 or 30/$171.45

Vyvanse 70MG Capsules (SHIRE US INC.): 20/$117.29 or 30/$171.45

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions June 2010. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Shire US Inc. Vyvanse (lisdexamfetamine dimesylate) capsules prescribing information. Wayne, PA; 2008 Apr.

2. Biederman J, Krishnan S, Zhang Y et al. Efficacy and tolerability of lisdexamfetamine dimesylate (NRP-104) in children with attention-deficit/hyperactivity disorder: a phase III, multicenter, randomized, double-blind, forced-dose, parallel-group study. Clin Ther. 2007; 29:450-63. [PubMed 17577466]

3. Shire US Inc., Wayne, PA: Personal communication.

4. Biederman J, Boellner SW, Childress A et al. Improvements in symptoms of attention-deficit/hyperactivity disorder in school-aged children with lisdexamfetamine (NRP-104) and mixed amphetamine salts, extended-release versus placebo. Poster presented at 159th annual meeting of the American Psychiatric Association. Toronto, Canada: 2006 May 24.

5. American Academy of Child and Adolescent Psychiatry. Practice parameter for the use of stimulant medications in the treatment of children, adolescents and adults. Washington, DC; 2001. From the AACAP website. Accessed 2007 Aug 15.

6. American Academy of Child and Adolescent Psychiatry. Practice parameter for the assessment and treatment of children and adolescents with attention deficit hyperactivity disorder. Washington, DC; 2007. From the AACAP website. Accessed 2007 Aug 15.

7. American Academy of Pediatrics Committee on Quality Improvement and Subcommittee on Attention-Deficit/Hyperactivity Disorder. Clinical treatment guideline: treatment of the school-aged child with attention-deficit/hyperactivity disorder. Pediatrics. 2001; 108:1033-44. [IDIS 470916] [PubMed 11581465]

8. Anon. Lisdexamfetamine dimesylate (Vyvanse) for ADHD. Med Lett Drugs Ther. 2007; 49:58-9.

9. US Food and Drug Administration. Adderall and Adderall XR (amphetamine): sudden death in children. Rockville, MD; 2005 Feb 9. Alert for Healthcare Professionals.

10. National Institutes of Health Office of Medical Applications of Research. NIH Consensus statement: diagnosis and treatment of attention deficit hyperactivity disorder. 1998; 16(Nov 16-18): in press. From NIH web site [1998 Nov 19]).

11. Swanson JM, Sergeant JA, Taylor E et al. Attention-deficit hyperactivity disorder and hyperkinetic disorder. Lancet. 1998; 351:429-33. [IDIS 403568] [PubMed 9482319]

12. Goldman LS, Genel M, Bexman RJ et al for the Council on Scientific Affairs et al. Diagnosis and treatment of attention-deficit/hyperactivity disorder in children and adolescents. JAMA. 1998; 279:1100-7. [IDIS 402940] [PubMed 9546570]

13. Shaffer D. Attention deficit hyperactivity disorder in adults. Am J Psychiatry. 1994; 151:633-8. [PubMed 7909410]

14. Spencer T, Biederman J, Wilens TE et al. Adults with attention-deficit/hyperactivity disorder: a controversial diagnosis. J Clin Psychiatry. 1998; 59(Suupl 7):59-68. [IDIS 409837] [PubMed 9680054]

15. Popper CW. Antidepressants in the treatment of attention-deficit/hyperactivity disorder. J Clin Psychiatry. 1997; 58(Suppl 14):14-29. [IDIS 398614] [PubMed 9418743]

16. Smith BH, Pelham WE, Gnagy E et al. Equivalent effects of stimulant treatment for attention-deficit hyperactivity disorder during childhood and adolescence. J Am Acad Child Adolesc Psychiatry. 1998; 37:314-21. [IDIS 402147] [PubMed 9519637]

17. The MTA Cooperative Group. A 14-month randomized clinical trial of treatment strategies for attention-deficit/hyperactivity disorder. Arch Gen Psychiatry. 1999; 56:1073-86. [IDIS 440533] [PubMed 10591283]

18. Taylor E. Development of clinical services for attention-deficit/hyperactivity disorder. Arch Gen Psychiatry. 1999; 56:10979.

19. The MTA Cooperative Group. Moderators and mediators of treatment response for children with attention-deficit/hyperactivity disorder. Arch Intern Med. 1999; 56:1088-96.

20. Pliszka SR, Greenhill LL, Crismon ML et al. The Texas Children’s Medication Algorithm Project: Report of the Texas Consensus Conference Panel on Medication Treatment of Childhood Attention-Deficit/Hyperactivity Disorder. Part I. J Am Acad Child Adolesc Psychiatry. 2000; 39:908-19. [IDIS 449214] [PubMed 10892234]

21. Drugs used in obesity. In: Drug evaluations subscription. Chicago, IL: American Medical Association; III/PSY-6:1-16, Winter 1992.

22. Littner M, Johnson SF, McCall WV et al for the American Academy of Sleep Medicine Standards of Practice Committee. Practice parameters for the treatment of narcolepsy: an update for 2000. Sleep. 2001; 24:451-66. [PubMed 11403530]

23. Westfall TC, Westfall DP. Adrenergic agonists and antagonists. In: Brunton LL, Lazo JS, Parker KL, eds.Goodman and Gilman’s the pharmacological basis of therapeutics. 11th ed. New York: McGraw-Hill; 2005:237-95.

24. GlaxoSmithKline. Dexedrine (dextroamphetamine sulfate) extended-release capsules and tablets prescribing information. Research Triangle Park, NC; 2007 Mar.

25. Amphetamine. In: Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation. 7th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2005:74-80.

26. Weiner N. Norepinephrine, epinephrine, and the sympathomimetic amines. In: Gilman AG, Goodman LS, Rall TW et al, eds.Goodman and Gilman’s the pharmacological basis of therapeutics. 7th ed. New York: Macmillan; 1985:145-80.

27. Shire Pharmaceuticals, Wayne, PA: Personal communication.

28. Hussar DA. New drugs: aliskiren hemifumarate, lisdexamfetamine dimesylate, and lapatinib. J Am Pharm Assoc. 2007; 47:425-6, 428-30.

29. Biederman J, Boellner SW, Childress A et al. Lisdexamfetamine dimesylate and mixed amphetamine salts extended-release in children with ADHD: a double-blind, placebo-controlled, crossover analog classroom study. Biol Psychiatry. 2007; 62:970-6. [PubMed 17631866]

30. Blick SK, Keating GM. Lisdexamfetamine. Pediatr Drugs. 2007; 9:129-35.

31. Food and Drug Administration. FDA Alert: Information for healthcare professionals: Communication about an ongoing safety review of stimulant medications [dexmethylphenidate (marketed as Focalin, Focalin XR), dextroamphetamine (marketed as Dexedrine, Dexedrine Spansules, Dextrostat, and generics), lisdexamfetamine (marketed as Vyvanse), methamphetamine (marketed as Desoxyn), methylphenidate (marketed as Concerta, Daytrana, Metadate CD, Metadate ER, Methylin, Methylin ER, Ritalin, Ritalin-LA, and Ritalin-SR), mixed salts amphetamine (marketed as Adderall and Adderall XR), and pemoline (marketed as Cylert and generics)] used in children with attention-deficit/hyperactivity disorder (ADHD). Rockville, MD; 2009 Jun 23. From the FDA website.

32. Gould MS, Walsh BT, Munfakh JL et al. Sudden death and use of stimulant medications in youths. Am J Psychiatry. 2009; 166:992-1001. [PubMed 19528194]

33. Vitiello B, Towbin K. Stimulant treatment of ADHD and risk of sudden death in children. Am J Psychiatry. 2009; 166:955-7. [PubMed 19528196]

34. US Food and Drug Administration. AHRQ and FDA to collaborate in largest study ever of possible heart risks with ADHD medications. FDA News September 17, 2007. From FDA web site.

More Vyvanse resources

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

• Vyvanse Prescribing Information (FDA)


• Vyvanse Advanced Consumer (Micromedex) - Includes Dosage Information


• Vyvanse MedFacts Consumer Leaflet (Wolters Kluwer)


• Vyvanse Consumer Overview

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Intron A

Generic Name: interferon alfa-2b (IN ter FEAR on AL fa 2b)

Brand Names: Intron A

What is Intron A (interferon alfa-2b)?

Interferon alfa-2b is made from human proteins. Interferons help the body fight viral infections.

Interferon alfa-2b is used to treat hairy cell leukemia, malignant melanoma, follicular lymphoma, Kaposi's sarcoma caused by AIDS, and certain types of genital warts. Interferon alfa-2b is also used to treat chronic hepatitis B or C.

Interferon alfa-2b is often used in combination with another drug called ribavirin (Rebetol). Some of the information in this medication guide applies to the use of both drugs in this combination.

Interferon alfa-2b may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Intron A (interferon alfa-2b)?

Interferon alfa-2b is often used in combination with another drug called ribavirin (Rebetol). Some of the information in this medication guide applies to the use of both drugs in this combination. Interferon alfa-2b may be harmful to an unborn baby, or may cause a miscarriage. Do not use interferon alfa-2b if you are pregnant, especially if you also take ribavirin (Rebetol). Use 2 forms of effective birth control while you are using this drug combination and for at least 6 months after your treatment ends.

If a man fathers a child while using interferon alfa-2b and ribavirin, the baby may have birth defects. Use a condom to prevent pregnancy during your treatment and for at least 6 months after you stop using this drug combination..

You should not use interferon alfa-2b if you are allergic to interferons, or if you have autoimmune hepatitis, or severe liver problems from causes other than hepatitis B or C.

You should not use the combination of interferon alfa-2b and ribavirin if you have an allergy to either drug, or if you have severe kidney disease, a blood cell disorder, if you are pregnant, or if you are a man and your female sex partner is pregnant.

What should I discuss with my healthcare provider before using Intron A (interferon alfa-2b)?

You should not use this medication if you are allergic to interferons, or if you have autoimmune hepatitis, or severe liver problems from causes other than hepatitis B or C.

You should not use the combination of interferon alfa-2b and ribavirin if you have:

• 
  

  severe kidney disease;

  
  


• 
  

  a blood cell disorder such as thalassemia or sickle cell anemia;

  
  


• 
  

  if you are allergic to interferons or ribavirin;

  
  


• 
  

  if you are pregnant; or

  
  


• 
  

  if you are a man and your female sex partner is pregnant.

  
  

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use interferon alfa-2b:

• 
  

  diabetes;

  
  


• 
  

  cancer;

  
  


• 
  

  bone marrow suppression;

  
  


• 
  

  a bleeding disorder;

  
  


• 
  

  a thyroid disorder;

  
  


• 
  

  breathing problems;

  
  


• 
  

  a history of depression, mental illness, suicidal thoughts, or drug or alcohol addiction;

  
  


• 
  

  heart disease, a heart rhythm disorder, or history of a heart attack or blood clots;

  
  


• 
  

  an autoimmune disorder such as psoriasis, arthritis, or lupus;

  
  


• 
  

  colitis or other intestinal disorder; or

  
  


• 
  

  if you have recently received an organ transplant.

  
  

This medication may be harmful to an unborn baby, or may cause a miscarriage. Do not use interferon alfa-2b if you are pregnant, especially if you also take ribavirin (Rebetol). The combination of interferon alfa-2b and ribavirin can cause birth defects. Tell your doctor right away if you become pregnant during treatment. Use 2 forms of effective birth control while you are using this drug combination and for at least 6 months after your treatment ends.

If a man fathers a child while using interferon alfa-2b and ribavirin, the baby may have birth defects. Use a condom to prevent pregnancy during your treatment. Continue using condoms for at least 6 months after you stop using this drug combination..

It is not known whether interferon alfa-2b 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.

The powder form of interferon alfa-2b contains albumin, but the solution (liquid) form does not. Albumin comes from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

How should I use Intron A (interferon alfa-2b)?

Interferon alfa-2b is given as an injection into a muscle, under the skin, or directly into a genital wart. The medicine may also be given through a needle placed into a vein.

Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to inject your medicine at home. 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.

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.

Do not shake the medication vial (bottle). Vigorous shaking can ruin the medicine. Do not draw your dose into a syringe or IV bag until you are ready to give yourself an injection.

Interferon alfa-2b powder medicine must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medication. Do not use the mixture if it is not clear or light yellow, or if it has any particles in it. Throw it away and mix another dose.

The single-dose vial of interferon alfa-2b is for one use only. Throw the vial away after measuring your dose, even if there is still some medicine in it. Do not save it for later use. Not all brands, forms, and strengths of interferon alfa-2b are used to treat the same medical conditions. Always check your refills to make sure you have received the correct brand and type of medicine prescribed by your doctor. Ask the pharmacist if you have any questions about the medicine you receive at the pharmacy.

To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.

Store interferon alfa-2b in the refrigerator and do not allow it to freeze. After mixing the powder medicine with a diluent, you may store the mixture in the refrigerator but you must use it within 24 hours.

To reduce or prevent certain side effects, your doctor may recommend you take acetaminophen (Tylenol) at the time of your interferon alfa-2b injection. Follow your doctor's instructions about the correct dose.

What happens if I miss a dose?

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use 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. Symptoms of an interferon alfa-2b overdose are not known.

What should I avoid while using Intron A (interferon alfa-2b)?

If you are being treated for hepatitis or genital warts, avoid having unprotected sex or sharing needles, razors, or toothbrushes. Taking this medication will not prevent you from passing hepatitis or genital warts to other people. Talk with your doctor about safe methods of preventing transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person. Avoid drinking alcohol if you are also taking acetaminophen (Tylenol) while using interferon alfa-2b.

Intron A (interferon alfa-2b) 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. Stop using interferon alfa-2b and call your doctor at once if you have a serious side effect such as:

• 
  

  severe depression, aggressive behavior, or thoughts of hurting yourself or others;

  
  


• 
  

  fast, slow, or uneven heart rate, feeling like you might pass out;

  
  


• 
  

  fever, chills, body aches, flu symptoms, pale skin, easy bruising or bleeding, unusual weakness;

  
  


• 
  

  vision or hearing problems;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  severe stomach pain, jaundice (yellowing of the skin or eyes);

  
  


• 
  

  cough with yellow or green mucus, feeling short of breath;

  
  


• 
  

  chest pain, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

  
  


• 
  

  sudden numbness or weakness, headache, confusion, or problems with speech or balance; or

  
  


• 
  

  a severe blistering, peeling, and red skin rash.

  
  

Less serious side effects may include:

• 
  

  dizziness, spinning sensation;

  
  


• 
  

  muscle pain, tired feeling;

  
  


• 
  

  nausea, vomiting, diarrhea, loss of appetite;

  
  


• 
  

  dry mouth, dry cough, sore throat, hair loss;

  
  


• 
  

  mild itching or skin rash; or

  
  


• 
  

  burning, bleeding, pain, itching, or skin changes where the medicine was injected.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Intron A (interferon alfa-2b)?

Tell your doctor about all other medications you use, especially:

• 
  

  zidovudine (Retrovir);

  
  


• 
  

  theophylline (Elixophyllin, Respbid, Slo-Bid, Theobid, Theo-Dur, Theochron, Theolair, and others); or

  
  


• 
  

  medicines used to prevent organ transplant rejection, such as sirolimus (Rapamune) or tacrolimus (Prograf).

  
  

This list is not complete and there may be other drugs that can interact with interferon alfa-2b. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Intron A resources

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

• Intron A Prescribing Information (FDA)


• Intron A Advanced Consumer (Micromedex) - Includes Dosage Information


• Interferon Alfa-2b Powder MedFacts Consumer Leaflet (Wolters Kluwer)


• Interferon Alfa-2b Professional Patient Advice (Wolters Kluwer)

Compare Intron A with other medications

• Angioblastoma
• Condylomata Acuminata
• Conjunctival Mucosa-Associated Lymphoid Tissue Lymphoma
• Follicular Lymphoma
• Hairy Cell Leukemia
• Hepatitis B
• Hepatitis C
• Idiopathic Thrombocytopenic Purpura
• Kaposi's Sarcoma
• Melanoma

Where can I get more information?

• Your pharmacist can provide more information about interferon alfa-2b.

See also: Intron A side effects (in more detail)

TobraDex ST Drops

Pronunciation: TOE-bra-MYE-sin/DEX-a-METH-a-sone
Generic Name: Tobramycin/Dexamethasone
Brand Name: TobraDex ST

TobraDex ST Drops are used for:

Treating certain types of eye inflammation where a bacterial infection exists or may develop.

TobraDex ST Drops are an antibiotic (tobramycin) and a corticosteroid (dexamethasone) combination. The antibiotic works by preventing the growth of, or killing, sensitive bacteria in the eye. The corticosteroid works by reducing inflammatory reactions.

Do NOT use TobraDex ST Drops if:

• you are allergic to any ingredient in TobraDex ST Drops


• you have a mycobacterial, fungal, or viral (eg, herpes simplex, vaccinia, chickenpox) eye infection

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

Before using TobraDex ST Drops:

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

• if you are pregnant, plan 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, especially to other aminoglycosides (eg, gentamicin); foods; or other substances


• if you have thinning of the cornea (the surface of the eye), or oozing from the eye


• if you have diabetes, glaucoma or increased eye pressure, or have recently had cataract surgery


• if you have a history of viral eye infections (eg, herpes simplex)


• if you are using another form of aminoglycoside antibiotic (eg, intravenous)

Some MEDICINES MAY INTERACT with TobraDex ST Drops. Because little, if any, of TobraDex ST Drops are absorbed into the blood, the risk of interacting with another medicine is low.

Ask your health care provider if TobraDex ST Drops 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 TobraDex ST Drops:

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

• TobraDex ST Drops are only for the eye. Do not get it in your nose or mouth. Do not inject it into the eye.


• Shake well before each use.


• To use TobraDex ST Drops in the eye, first wash your hands. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eyelid for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean, dry tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.


• To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.


• Do not wear contact lenses while you are using TobraDex ST Drops. Take care of your contact lenses as directed by the manufacturer. Check with your doctor before you use them.


• Using TobraDex ST Drops at the same time each day will help you to remember to use it.


• To clear up your infection completely, use TobraDex ST Drops for the full course of treatment. Keep using it even if you feel better in a few days.


• If you miss a dose of TobraDex ST Drops, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use TobraDex ST Drops.

Important safety information:

• TobraDex ST Drops may cause blurred vision. Use TobraDex ST Drops with caution. Do not drive or perform other possibly unsafe tasks if you cannot see clearly.


• If your symptoms do not improve within 2 days or if they get worse, check with your doctor.


• Check with your doctor if you have an eye wound or irritation that does not heal.


• Prolonged use of TobraDex ST Drops (eg, 10 days or longer) may increase the risk of glaucoma. Your doctor may monitor the pressure in your eye(s) while you use TobraDex ST Drops. Discuss any questions or concerns with your doctor.


• Be sure to use TobraDex ST Drops for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.


• Long-term or repeated use of TobraDex ST Drops may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.


• Do not use TobraDex ST Drops for future eye problems unless directed by your doctor.


• TobraDex ST Drops should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these 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 TobraDex ST Drops while you are pregnant. It is not known if TobraDex ST Drops are found in breast milk after topical use. If you are or will be breast-feeding while you use TobraDex ST Drops, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of TobraDex ST Drops:

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:

Burning or stinging when you first put the medicine in your eye.

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); changes in vision; itching or swelling of the eyelid; new or worsening eye pain, redness, swelling, or irritation; vision loss.

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: TobraDex ST 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 increased tearing; lid itching; redness or swelling of the eye.

Proper storage of TobraDex ST Drops:

Store TobraDex ST Drops between 36 and 77 degrees F (2 and 25 degrees C). Store upright in the original container, tightly closed, and away from heat, moisture, and light. Do not store in the bathroom. Keep TobraDex ST Drops out of the reach of children and away from pets.

General information:

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


• TobraDex ST Drops are 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 TobraDex ST Drops. 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 TobraDex ST resources

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

Compare TobraDex ST with other medications

• Conjunctivitis, Bacterial
• Keratitis
• Uveitis

PanMist DM Liquid

Pronunciation: dex-troe-meth-OR-fan/gwye-FEN-e-sin/sue-do-eh-FED-rin
Generic Name: Dextromethorphan/Guaifenesin/Pseudoephedrine
Brand Name: Examples include PanMist DM and Robitussin Pediatric

PanMist DM Liquid is used for:

Relieving congestion, cough, and throat and airway irritation due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

PanMist DM Liquid is a decongestant, cough suppressant, and expectorant combination. It works by constricting blood vessels, reducing swelling in the nasal passages, and loosening mucus and lung secretions in the chest, making coughs more productive. The cough suppressant works in the brain to help decrease the cough reflex.

Do NOT use PanMist DM Liquid if:

• you are allergic to any ingredient in PanMist DM Liquid


• you have severe high blood pressure, rapid heartbeat, or other severe heart problems (eg, heart blood vessel disease)


• you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

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

Before using PanMist DM Liquid:

Some medical conditions may interact with PanMist DM Liquid. 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 glaucoma, enlarged prostate gland or other prostate problems, heart problems, diabetes, high blood pressure, blood vessel problems, adrenal gland problems, an overactive thyroid, seizures, or stroke


• if you have a chronic cough, chronic obstructive pulmonary disease (COPD), or other lung problems (eg, asthma, chronic bronchitis, emphysema), or if your cough produces large amounts of mucus

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

• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAOIs (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk PanMist DM Liquid's side effects


• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased


• Bromocriptine because the risk of its side effects may be increased by PanMist DM Liquid


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by PanMist DM Liquid

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

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

• Take PanMist DM Liquid by mouth with or without food.


• Drink plenty of water while taking PanMist DM Liquid.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• If you miss a dose of PanMist DM Liquid, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use PanMist DM Liquid.

Important safety information:

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


• Do not take appetite suppressants while you are taking PanMist DM Liquid without checking with your doctor.


• PanMist DM Liquid has pseudoephedrine and dextromethorphan in it. Before you start any new medicine, check the label to see if it has pseudoephedrine or dextromethorphan in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do NOT exceed the recommended dose or take PanMist DM Liquid for longer than prescribed without checking with your doctor.


• If your symptoms do not improve within 5 to 7 days or if they become worse, check with your doctor.


• PanMist DM Liquid may interfere with certain lab tests. Be sure that your doctor and lab personnel know you are taking PanMist DM Liquid.


• Tell your doctor or dentist that you take PanMist DM Liquid before you receive any medical or dental care, emergency care, or surgery.


• Use PanMist DM Liquid with caution in the ELDERLY; they may be more sensitive to its effects.


• Caution is advised when using PanMist DM Liquid in CHILDREN; they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking PanMist DM Liquid, contact your doctor. You will need to discuss the benefits and risks of using PanMist DM Liquid while you are pregnant. It is not known if PanMist DM Liquid is found in breast milk. Do not breast-feed while taking PanMist DM Liquid.

Possible side effects of PanMist DM Liquid:

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; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; weakness.

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); difficulty urinating; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor.

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: PanMist DM 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 blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of PanMist DM Liquid:

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

General information:

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


• PanMist DM Liquid 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 PanMist DM Liquid. 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 PanMist DM resources

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

Compare PanMist DM with other medications

• Cough and Nasal Congestion

Levothyroxine 50mcg tablets

1. Name Of The Medicinal Product

Levothyroxine 50micrograms Tablets (Thyroxine 50 micrograms Tablets).

2. Qualitative And Quantitative Composition

Each tablet contains 50 micrograms Levothyroxine Sodium anhydrous also known as thyroxine sodium anhydrous.

3. Pharmaceutical Form

Tablet.

White uncoated biconvex tablets engraved on one face FW21 with a breakline on the other.

4. Clinical Particulars

4.1 Therapeutic Indications

Recommended clinical indications: Control of hypothyroidism, congenital hypothyroidism and juvenile myxoedema.

4.2 Posology And Method Of Administration

Adults:

Initially 50 to 100 micrograms daily, preferably taken before breakfast. Adjust at three to four week intervals by 50 micrograms until normal metabolism is steadily maintained: this may require doses of 100 to 200 micrograms daily.

For patients over 50 years, it is not advisable to exceed 50 micrograms daily initially and where there is cardiac disease, 25 micrograms daily or 50 micrograms on alternate days is more suitable initially. In this condition the daily dose may be increased by 25 micrograms at intervals of perhaps 4 weeks.

For patients younger than 50 years, and in the absence of heart disease, a serum Levothyroxine (T4) level of 70 to 160 nanomoles per litre, or a serum thyrotrophin level of less than 5 milli-units per litre should be targeted. For patients aged over 50 years, with or without cardiac disease, clinical response is probably a more acceptable criteria of dosage rather than serum levels.

A pre-therapy ECG is valuable because ECG changes due to hypothyroidism may be confused with ECG evidence of cardiac ischaemia. If too rapid an increase in metabolism is produced (causing diarrhoea, nervousness, rapid pulse, insomnia, tremors, and sometimes anginal pain where there is latent cardiac ischaemia), dosage must be reduced, or withheld for a day or two, and then re-started at a lower dose level.

Elderly: As for patients aged over 50 years.

Paediatric patients:

The maintenance dose is generally 100 to 150 micrograms per m² body surface area.

For neonates and infants with congenital hypothyroidism, where rapid replacement is important the initial recommended dosage is 10 to 15 micrograms per kg BW per day for the first 3 months. Thereafter, the dose should be adjusted individually according to the clinical findings and thyroid hormone and TSH values.

For children with acquired hypothyroidism, the initial recommended dosage is 12.5-50 micrograms per day. The dose should be increased gradually every 2-4 weeks according to the clinical findings and thyroid hormone and TSH values until the full replacement dose is reached. Infants should be given the total daily dose at least half an hour before the first meal of the day.

When applicable:

Tablets are to be disintegrated in some water (10 to 15 mL) and the resultant suspension, which must be prepared freshly as required, is to be administered with some more liquid (5-10 mL).

4.3 Contraindications

Thyrotoxicosis. Hypersensitivity to any components of Levothyroxine tablets.

4.4 Special Warnings And Precautions For Use

Patient with panhypopituitarism or other causes predisposing to adrenal insufficiency may react to Levothyroxine treatment, and it is advisable to start corticosteroid therapy before giving Levothyroxine to such patients.

Special care is needed for the elderly and for patients with symptoms of myocardial insufficiency, or ECG evidence of myocardial infarction. Thyroid replacement therapy may cause an increase in dosage requirements of insulin or other anti-diabetic therapy. Care is needed for patients with diabetes mellitus and diabetes insipidus.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Levothyroxine increases the effect of anticoagulants and it may be necessary to reduce the anticoagulation dosage if excessive, hypoprothrombinaemia and bleeding are to be avoided.

Acenocoumarol, pheninedione and warfarin enhances the effect of Levothyroxine.

Antiepileptics such as carbamazepine, Phenobarbital, phenytoin, and primidone accelerate metabolism of Levothyroxine (may increase requirements in hypothyroidism) and may displace them from plasma proteins.

Initiation or discontinuation of anti-convulsant therapy may alter Levothyroxine dosage requirements.

If co-administered with cardiac glycosides adjustment of dosage may be necessary. The effect of sympathomimetic agents are enhanced.

Blood sugar levels are raised and dosage of anti-diabetic agents may require adjustment.

Tricyclic anti-depressants response may be accelerated because Levothyroxine increases sensitivity to catecholamines.

Manufacturer of lofepramine advises to avoid Levothyroxine.

Coletyramine reduces the gastrointestinal absorption of Levothyroxine. Oral contraceptives may increase the requirement of thyroid therapy dosage. Other drugs may affect thyroid function tests and this must be considered when monitoring a patient on Levothyroxine therapy.

Rifampicin accelerates metabolism of Levothyroxine (may increase requirements in hypothyroidism).

Phenylbutazone shows false low total plasma-Levothyroxine concentration.

Amiodarone contain iodine and can cause disorders of Levothyroxine function; both hypothyroidism and hyperthyroidism may occur.

Metabolism of propranolol reduces the effect of Levothyroxine.

Sucralfate reduces absorption of Levothyroxine.

4.6 Pregnancy And Lactation

The safety of Levothyroxine treatment during pregnancy is not known, but any possible risk of foetal abnormalities should be weighed against the risk to the foetus of untreated hypothyroidism. Levothyroxine is excreted in breast milk in low concentrations, and it is contentious whether this can interfere with neonatal screening.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Side-effects are usually indicative of excessive dosage and usually disappear on reduction of dosage or withdrawal of treatment for a few days. Such effects include: anginal pain, cardiac arrhythmias, palpitations, cramps in skeletal muscles, tachycardia, diarrhoea, vomiting, tremors, restlessness, excitability, insomnia, headache, flushing, sweating, excessive loss of weight, and muscular weakness.

4.9 Overdose

Signs and symptoms may be an exaggeration of the side-effects, as well as agitation, confusion, irritability, hyperactivity, mydriasis, tachypnoea, pyrexia, increased bowel movements and convulsions. The appearance of clinical hyperthyroidism may be delayed for up to five days. Gastric lavage or emesis is required if the patient is seen within several hours of taking the dose. Treatment is symptomatic. Tachycardia may be controlled in an adult by 40mg doses of propanolol given every 6 hours. Other symptoms may be controlled by Diazepam and/or chlorpromazine as appropriate.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Levothyroxine 50 micrograms Tablets are tablets containing Levothyroxine sodium used for the treatment of hypothyroidism. Levothyroxine is deiodinated in peripheral tissues to form triiodothyronine which is thought to be the active tissue form of thyroid hormone. Triiodothyronine has a rapid action but a shorter duration of activity than Levothyroxine.

The chief action of Levothyroxine is to increase the rate of cell metabolism.

5.2 Pharmacokinetic Properties

Levothyroxine sodium is incompletely and variably absorbed from the gastrointestinal tract. It is almost completely bound to plasma proteins and has a half-life in the circulation of about a week in healthy subjects, but longer in patients with myxoedema.

A large portion of the Levothyroxine leaving the circulation is taken up by the liver.

Part of a dose of Levothyroxine is metabolised to triiodothyronine.

Levothyroxine is excreted in the urine as free drug, deiodinated metabolites and conjugates. Some Levothyroxine is excreted in the faeces. There is limited placental transfer of Levothyroxme.

5.3 Preclinical Safety Data

No further data of relevance.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sodium Citrate

Lactose

Maize starch

Powdered Acacia

Magnesium Stearate

Purified Water

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months for polypropylene containers.

24 months for blister packs.

6.4 Special Precautions For Storage

Do not store above 25°C and store in the original container.

6.5 Nature And Contents Of Container

Polypropylene container with tamper-evident low density polyethylene lid, containing 28, 56,100, 112 or 1000 Levothyroxine 50 micrograms tablets.

Blister packaging PVC/PVdC film (heat treated foil/heat seal lacquer) containing 28,56 and 112 Levothyroxine tablets.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Forley Generics Limited

NLA Tower

12-16 Addiscombe Road

Croydon

CR0 OXT

United Kingdom

8. Marketing Authorisation Number(S)

PL 16201/0001

9. Date Of First Authorisation/Renewal Of The Authorisation

Aug 2004

10. Date Of Revision Of The Text

02/09/2010

neomycin/polymyxin B and hydrocortisone ophthalmic

Generic Name: neomycin, polymyxin B, and hydrocortisone ophthalmic (NEE oh MYE sin, POL ee MIX in, HYE droe KOR ti sone off THAL mik)

Brand names: AK-Spore HC Ophthalmic, Cortisporin ophthalmic suspension, Cortomycin Suspension, Neo/PolyB/HC

What is neomycin, polymyxin B and hydrocortisone ophthalmic?

Neomycin and polymyxin B are antibiotics. They are used to treat bacterial infections.

Hydrocortisone is a steroid. It is used to treat the swelling associated with bacterial infections of the eye.

Neomycin, polymyxin B and hydrocortisone ophthalmic is used to treat bacterial infections of the eyes.

Neomycin, polymyxin B and hydrocortisone ophthalmic may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about neomycin, polymyxin B and hydrocortisone ophthalmic?

Contact your doctor if your symptoms begin to get worse or if you do not see any improvement in your condition after a few days.

Do not touch the dropper to any surface, including your eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in your eye.

Apply light pressure to the inside corner of your eye (near your nose) after each drop to prevent the fluid from draining down your tear duct.

Who should not use neomycin, polymyxin B and hydrocortisone ophthalmic?

Do not use neomycin, polymyxin B and hydrocortisone ophthalmic if you have a viral or fungal infection in your eye. It is used to treat infections caused by bacteria only. It is not known whether neomycin, polymyxin B and hydrocortisone ophthalmic will harm an unborn baby. Do not use this medication without first talking to your doctor if you are pregnant. It is not known whether neomycin, polymyxin B and hydrocortisone ophthalmic passes into breast milk. Do not use this medication without first talking to your doctor if you are breast-feeding a baby.

How should I use neomycin, polymyxin B and hydrocortisone ophthalmic?

Use neomycin, polymyxin B and hydrocortisone eyedrops exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before and after using your eyedrops.

To apply the eyedrops:

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  Shake the drops gently to be sure the medicine is well mixed. Tilt your head back slightly and pull down on your lower eyelid. Position the dropper above your eye. Look up and away from the dropper. Squeeze out a drop and close your eye. Apply gentle pressure to the inside corner of your eye (near your nose) for about 1 minute to prevent the liquid from draining down your tear duct. If you are using more than one drop in the same eye or drops in both eyes, repeat the process with about 5 minutes between drops.

  
  

Do not touch the dropper to any surface, including your eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in your eye. Do not use any eyedrop that is discolored or has particles in it. Store neomycin, polymyxin B and hydrocortisone ophthalmic at room temperature away from moisture and heat. Keep the bottle properly capped.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the missed dose and apply the next one as directed. Do not use a double dose of this medication.

What happens if I overdose?

An overdose of this medication is unlikely to occur. If you do suspect an overdose, wash the eye with water and call an emergency room or poison control center near you. If the drops have been ingested, drink plenty of fluid and call an emergency center for advice.

What should I avoid while using neomycin, polymyxin B and hydrocortisone ophthalmic?

Do not touch the dropper to any surface, including your eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in your eye. Use caution when driving, operating machinery, or performing other hazardous activities. Neomycin, polymyxin B and hydrocortisone ophthalmic may cause blurred vision. If you experience blurred vision, avoid these activities.

Use caution with contact lenses. Wear them only if your doctor approves. After applying this medication, wait at least 15 minutes before inserting contact lenses.

Avoid other eye medications unless your doctor approves.

Neomycin, polymyxin B and hydrocortisone ophthalmic side effects

Serious side effects are not expected with this medication.

Some burning, stinging, irritation, itching, redness, blurred vision, eyelid itching, eyelid swelling, or sensitivity to light may occur.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Neomycin, polymyxin B, and hydrocortisone ophthalmic Dosing Information

Usual Adult Dose for Uveitis:

Steroid responsive inflammatory ocular conditions with superficial bacterial infection or risk of infection:
Instill 1 or 2 drops into the conjunctival sac of the affected eye(s) every 3 to 4 hours. May increase frequency depending on the severity of the condition.

Usual Adult Dose for Bacterial Conjunctivitis:

Steroid responsive inflammatory ocular conditions with superficial bacterial infection or risk of infection:
Instill 1 or 2 drops into the conjunctival sac of the affected eye(s) every 3 to 4 hours. May increase frequency depending on the severity of the condition.

Usual Adult Dose for Keratitis:

Steroid responsive inflammatory ocular conditions with superficial bacterial infection or risk of infection:
Instill 1 or 2 drops into the conjunctival sac of the affected eye(s) every 3 to 4 hours. May increase frequency depending on the severity of the condition.

Usual Adult Dose for Keratoconjunctivitis:

Steroid responsive inflammatory ocular conditions with superficial bacterial infection or risk of infection:
Instill 1 or 2 drops into the conjunctival sac of the affected eye(s) every 3 to 4 hours. May increase frequency depending on the severity of the condition.

Usual Adult Dose for Blepharitis:

Steroid responsive inflammatory ocular conditions with superficial bacterial infection or risk of infection:
Instill 1 or 2 drops into the conjunctival sac of the affected eye(s) every 3 to 4 hours. May increase frequency depending on the severity of the condition.

What other drugs will affect neomycin, polymyxin B and hydrocortisone ophthalmic?

Avoid other eye medications unless they are approved by your doctor.

Before using this medication, tell your doctor if you are taking an oral steroid medication such as prednisone (Deltasone, Orasone, others).

Drugs other than those listed here may also interact with neomycin, polymyxin B and hydrocortisone ophthalmic. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More neomycin, polymyxin B, and hydrocortisone ophthalmic resources

• Neomycin, polymyxin B, and hydrocortisone ophthalmic Use in Pregnancy & Breastfeeding
• Neomycin, polymyxin B, and hydrocortisone ophthalmic Drug Interactions
• Neomycin, polymyxin B, and hydrocortisone ophthalmic Support Group
• 0 Reviews for Neomycin, polymyxin B, and hydrocortisone - Add your own review/rating

Compare neomycin, polymyxin B, and hydrocortisone ophthalmic with other medications

• Blepharitis
• Conjunctivitis, Bacterial
• Keratitis
• Keratoconjunctivitis
• Uveitis

Where can I get more information?

• Your pharmacist has additional information about neomycin, polymyxin B and hydrocortisone written for health professionals that you may read.