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Monday, September 12, 2016

Banzel

Generic Name: Rufinamide
Class: Anticonvulsants, Miscellaneous
ATC Class: N03AF03
Chemical Name: 1-[(2,6-difluorophenyl)methyl]-1H-1,2,3-triazole-4 carboxamide
Molecular Formula: C₁₀H₈F₂N₄O
CAS Number: 106308-44-5

REMS:

FDA approved a REMS for rufinamide to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page () or the ASHP REMS Resource Center ().

Introduction

Anticonvulsant; a triazole derivative.¹ ⁶ ⁷ ⁹ ¹⁰ ¹¹ ¹² ¹³ ¹⁴ ¹⁵ ¹⁷ ¹⁸

Uses for Banzel

Seizure Disorders

Management (in combination with other anticonvulsants) of seizures associated with Lennox-Gastaut syndrome in adults and children ≥4 years of age.¹ ⁵ ⁶ ⁸ ⁹ ¹⁰ ¹¹ ²⁸ Designated an orphan drug by FDA for use in this condition.⁵ ⁸ ¹⁰

Has been studied with some success in the adjunctive management of refractory or inadequately controlled partial seizures† in adolescents and adults;⁶ ⁷ ¹⁰ ¹¹ ¹² ¹³ ¹⁶ ¹⁷ ¹⁸ ¹⁹ ²¹ ²² ²⁴ ²⁵ ²⁹ ³⁰ further study needed to establish role in therapy.¹¹ ¹⁹

Banzel Dosage and Administration

General

Withdraw rufinamide gradually to minimize the potential for increased seizure frequency or status epilepticus in patients with seizure disorders.¹ (See Dosage under Dosage and Administration.) If abrupt discontinuance is necessary, closely supervise transition to another anticonvulsant.¹

Closely monitor for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.¹ ² ³ ⁴ ²⁰ (See Suicidality Risk under Cautions.)

Administration

Oral Administration

Administer orally as tablets or oral suspension twice daily in equally divided doses with food.¹

Tablets

Administer scored tablets whole, as half tablets, or crushed.¹ ²¹

Scored tablets may not provide the exact mg/kg dosage that has been calculated for use in children; manufacturer's recommended dosages in children are therefore designated as approximate.¹ ²¹

Oral Suspension

Shake well prior to administration of each dose.¹

Administer using bottle adapter and calibrated oral dosing syringe supplied by manufacturer.¹

Firmly insert bottle adapter into neck of bottle before use; allow adapter to remain in place as long as bottle is in use (up to 90 days).¹

To dispense dose, insert oral dosing syringe into adapter in upright bottle, then invert bottle and withdraw appropriate dose into oral dosing syringe.¹ Replace cap over bottle adapter after each use.¹ Consult manufacturer's patient information (medication guide) for detailed information on administration of oral suspension.¹

Dosage

Pediatric Patients

Seizure Disorders

Adjunctive Therapy in Lennox-Gastaut Syndrome

Oral

Children ≥4 years of age: Initially, approximately 10 mg/kg daily administered in 2 equally divided doses.¹ Increase daily dosage in increments of approximately 10 mg/kg every other day up to a target dosage of 45 mg/kg or 3.2 g daily, whichever is lower.¹ Efficacy of dosages lower than the target dosage has not been established.¹

Initiate therapy at a dosage lower than 10 mg/kg daily in children receiving valproic acid.¹ ¹¹ (See Specific Drugs under Interactions.)

Reduce dosage gradually if discontinuing therapy.¹ In clinical trials, rufinamide dosage was tapered by approximately 25% every other day.¹

Adults

Seizure Disorders

Adjunctive Therapy in Lennox-Gastaut Syndrome

Oral

Initially, 400–800 mg daily administered in 2 equally divided doses.¹ Increase dosage in increments of 400–800 mg daily every other day until a maximum dosage of 3.2 g daily is reached.¹ Efficacy of dosages lower than 3.2 g daily has not been established.¹

Initiate therapy at a dosage lower than 400 mg daily in adults receiving valproic acid.¹ ¹¹ (See Specific Drugs under Interactions.)

Reduce dosage gradually if discontinuing therapy.¹ In clinical trials, rufinamide dosage was tapered by approximately 25% every other day.¹

Prescribing Limits

Pediatric Patients

Seizure Disorders

Adjunctive Therapy in Lennox-Gastaut Syndrome

Oral

Children ≥4 years of age: Maximum 45 mg/kg or 3.2 g daily, whichever is less.¹

Adults

Seizure Disorders

Adjunctive Therapy in Lennox-Gastaut Syndrome

Oral

Maximum 3.2 g daily.¹

Special Populations

Hepatic Impairment

Not studied in patients with hepatic impairment.¹ ²¹ Do not use in patients with severe hepatic impairment.¹ ²¹ (See Hepatic Impairment under Cautions.)

Renal Impairment

No dosage adjustment necessary in patients with renal impairment (Cl_cr <30 mL/minute).¹ ¹¹ ²¹

Consider dosage adjustment in hemodialysis patients; hemodialysis within 3 hours after a dose may reduce drug exposure to a limited extent (by about 30%).¹ ¹¹ ²¹

Geriatric Patients

Select dosage carefully, usually initiating therapy at lower end of usual dosage range, because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant disease and drug therapy.¹ ¹⁰

Cautions for Banzel

Contraindications

Familial short QT syndrome.¹ ²¹ (See Shortening of QT Interval under Cautions and see Drugs that Shorten QT Interval under Interactions.)

Warnings/Precautions

Warnings

Suicidality Risk

Increased risk of suicidality (suicidal behavior or ideation) observed in an analysis of studies using various anticonvulsants in patients with epilepsy, psychiatric disorders (e.g., bipolar disorder, depression, anxiety), and other conditions (e.g., migraine, neuropathic pain); risk in patients receiving anticonvulsants (0.43%) was approximately twice that in patients receiving placebo (0.24%).¹ ² ³ ⁴ ²⁰ Increased suicidality risk was observed ≥1 week after initiation of anticonvulsant therapy and continued through 24 weeks.¹ ² ³ ⁴ Risk was higher for patients with epilepsy compared with those receiving anticonvulsants for other conditions.¹ ² ⁴

Closely monitor all patients currently receiving or beginning anticonvulsant therapy for changes in behavior that may indicate emergence or worsening of suicidal thoughts or behavior or depression.¹ ² ³ ⁴ ²⁰ Anxiety, agitation, hostility, hypomania, and mania may be precursors to emerging suicidality.²

Balance risk of suicidality with risk of untreated illness.¹ ² Epilepsy and other illnesses treated with anticonvulsants are themselves associated with morbidity and mortality and an increased risk of suicidality.¹ ²⁰ If suicidal thoughts or behavior emerges during anticonvulsant therapy, consider whether these symptoms may be related to the illness itself.¹ ²⁰ (See Advice to Patients.)

Nervous System Effects

Two general categories of adverse CNS effects reported: 1) somnolence or fatigue, and 2) coordination abnormalities, dizziness, gait disturbances, and ataxia.¹ (See Suicidality Risk under Cautions.)

Sensitivity Reactions

Multiorgan Hypersensitivity Reactions

Multiorgan hypersensitivity syndrome reported with rufinamide and other anticonvulsants; presentation is variable but typically includes fever and rash associated with other organ system involvement.¹ ³²

One case with rash, urticaria, facial edema, fever, elevated eosinophils, stuporous state, and severe hepatitis began on day 29 of rufinamide therapy;¹ other possible cases (with rash accompanied by fever, elevated liver function test results, hematuria, and/or lymphadenopathy) reported in children <12 years of age within 4 weeks of treatment initiation.¹ Cases resolved or improved following drug discontinuance.¹

If multiorgan hypersensitivity reaction is suspected, discontinue rufinamide and initiate alternative treatment.¹ ²¹ Closely monitor patients who develop a rash.¹ ²¹

General Precautions

Shortening of QT Interval

Shortening of QT interval reported;¹ reported degree of shortening (mean of 20 msec at dosages ≥2.4 mg twice daily) is without known clinical risk.¹ ¹¹

Familial short QT syndrome is associated with increased risk of sudden death and ventricular arrhythmias, particularly ventricular fibrillation, primarily when the corrected QT (QT_c) interval is <300 msec.¹ Nonclinical data indicate QT-interval shortening is associated with ventricular fibrillation.¹

Manufacturer and some clinicians state that patients with familial short QT syndrome should not receive rufinamide; caution advised when administering rufinamide with other drugs that shorten the QT interval.¹ ¹¹ ²¹ ²⁸ Some clinicians recommend using rufinamide with caution in patients with a history of an abnormal ECG demonstrating QT-interval shortening or a family history of unexplained cardiac arrhythmia or sudden death.²⁸ (See Contraindications under Cautions and also see Drugs that Shorten QT Interval under Interactions.)

Discontinuance of Anticonvulsants

Abrupt withdrawal of anticonvulsants may result in increased seizure frequency or status epilepticus in patients with seizure disorders.¹ If discontinuing therapy, withdraw rufinamide gradually (see Dosage under Dosage and Administration).¹ If abrupt discontinuance is necessary, closely supervise transition to another anticonvulsant.¹

Status Epilepticus

Incidence of treatment-emergent status epilepticus in rufinamide-treated patients is difficult to estimate because standard definitions were not employed in studies.¹ ⁹ Incidence of possible status epilepticus with rufinamide treatment was 4.1% in one study of Lennox-Gastaut syndrome and 0.9% across all controlled clinical trials of the drug.¹

Specific Populations

Pregnancy

Category C.¹

UCB AED Pregnancy Registry at 888-537-7734 (for clinicians and patients) and North American Antiepileptic Drug (NAAED) Pregnancy Registry at 888-233-2334 (for patients); NAAED registry information also available on the website .¹

Effect on labor and delivery is unknown.¹

Lactation

Likely to be distributed into milk.¹ ²¹ Discontinue nursing or the drug.¹ ²¹

Pediatric Use

Safety and efficacy not established in children <4 years of age.¹ ²¹

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger patients.¹ No clinically important differences in pharmacokinetics between healthy geriatric individuals and younger healthy adults.¹

Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant disease and drug therapy.¹

Hepatic Impairment

Not studied in hepatic impairment.¹ Use with caution in patients with mild to moderate hepatic impairment.¹ Use in severe hepatic impairment not recommended.¹

Renal Impairment

Renal impairment (Cl_cr <30 mL/minute) does not substantially alter pharmacokinetics; hemodialysis may reduce exposure.¹ (See Renal Impairment under Dosage and Administration and also see Absorption: Special Populations and Elimination: Special Populations, under Pharmacokinetics.)

Common Adverse Effects

As adjunctive therapy in pediatric patients: Somnolence, headache, fatigue, dizziness, influenza, nasopharyngitis, nausea, vomiting, decreased appetite.¹ ⁶ ⁹ ¹⁰ ¹¹ ¹³ ¹⁴ ¹⁵ ²¹

As adjunctive therapy in adults: Headache, dizziness, fatigue, somnolence, diplopia, tremor, nystagmus, blurred vision, nausea, vomiting.¹ ⁶ ⁹ ¹⁰ ¹¹ ¹³ ¹⁴ ¹⁵ ²¹

Interactions for Banzel

Metabolized by carboxylesterases.¹

Demonstrates little or no inhibition of most CYP isoenzymes.¹ ⁸ Weak inhibitor of CYP2E1;¹ ²¹ weak inducer of CYP3A4.¹ ¹¹ ¹⁴ ²¹

Unlikely to be involved in clinically important pharmacokinetic interactions.¹

Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes

Substrates of CYP2E1: Potential pharmacokinetic interaction (increased plasma substrate concentrations).¹ ²¹ (See Specific Drugs under Interactions.)

Substrates of CYP3A4: Potential pharmacokinetic interaction (decreased exposure of substrates).¹ ¹¹ ¹⁴ ²¹ (See Specific Drugs under Interactions.)

Inducers of carboxylesterases: Potential pharmacokinetic interaction (increased rufinamide clearance); broad-spectrum inducers may have minor effects on rufinamide metabolism via this mechanism.¹ (See Specific Drugs under Interactions.)

Inhibitors of carboxylesterases: Potential pharmacokinetic interaction (decreased rufinamide metabolism).¹ ⁸

Anticonvulsants

Typical average steady-state plasma rufinamide concentrations generally have little effect on the pharmacokinetics of other anticonvulsants.¹ Effects, when present, are more marked in pediatric patients.¹ (See Specific Drugs under Interactions.)

Clinical importance of drug interactions between rufinamide and potentially interacting anticonvulsants is unknown; some clinicians recommend monitoring plasma concentrations of other anticonvulsants and rufinamide following initiation or withdrawal of anticonvulsant therapy if clinically warranted.²⁸

Drugs that Shorten QT Interval

Potential pharmacologic interaction; use concomitantly with caution.¹ ²¹ ²³ (See Specific Drugs under Interactions and see Shortening of QT Interval under Cautions.)

Protein-bound Drugs

Pharmacokinetic interaction unlikely; not highly bound to plasma proteins.¹

Specific Drugs

Drug	Interaction	Comments
Benzodiazepines	Clinically important pharmacokinetic interactions with benzodiazepines unlikely; possible additive CNS effects¹ ¹³ ²¹ ²⁴ Clonazepam: Pharmacokinetic interaction unlikely⁶ ¹³ ²⁴ Triazolam: Decreased triazolam AUC (by 37%) and peak plasma concentrations (by 23%)¹ ¹¹ ¹²
Carbamazepine	Decreased plasma carbamazepine concentrations (by 7–13%)¹ Decreased plasma rufinamide concentrations (by 19–26% depending on carbamazepine dosage)¹
Chlorzoxazone	Possible increased plasma chlorzoxazone concentrations¹ ²¹
CNS agents (e.g., alcohol, benzodiazepines)	Possible additive CNS effects (e.g., sedation)¹ ²¹
Contraceptives, oral	Decreased AUC and peak plasma concentrations of ethinyl estradiol (by 22 and 31%, respectively) and norethindrone (by 14 and 18%, respectively)¹ ⁸ ¹⁰ ¹¹ ¹² ¹⁴ ¹⁵ ¹⁸ ²³	Additional nonhormonal contraceptive methods recommended¹ ¹⁰ ²¹
Digoxin	Possible additive effect on shortening of QT-interval¹ ²¹ ²³	Use concomitantly with caution¹ ²¹ ²³
Lamotrigine	Decreased plasma lamotrigine concentrations (by 7–13%)¹ Possible additive effect on shortening of QT-interval¹ ²¹ ²³	Use concomitantly with caution¹ ²¹ ²³
Magnesium	Possible additive effect on shortening of QT-interval¹ ²¹ ²³	Use concomitantly with caution¹ ²¹ ²³
Mexiletine	Possible additive effect on shortening of QT-interval¹ ²¹ ²³	Use concomitantly with caution¹ ²¹ ²³
Olanzapine	Pharmacokinetic interaction unlikely¹ ⁸ ¹² ¹⁴ ¹⁸
Oxcarbazepine	Pharmacokinetic interaction unlikely⁶ ¹³ ²⁴
Phenobarbital	Increased plasma phenobarbital concentrations (by 8–13%)¹ Decreased plasma rufinamide concentrations (by 25–46% independent of phenobarbital dosage or concentration)¹
Phenytoin	Increased plasma phenytoin concentrations (by 7–21%)¹ Decreased plasma rufinamide concentrations (by 25–46% independent of phenytoin dosage or concentration)¹	US manufacturer states routine dosage adjustment not recommended;¹ others state reduction in phenytoin dosage may be considered³³
Primidone	Decreased plasma rufinamide concentrations (by 25–46% independent of primidone dosage or concentration)¹
Ranolazine	Possible additive effect on shortening of QT-interval¹ ²¹ ²³	Use concomitantly with caution¹ ²¹ ²³
Topiramate	Pharmacokinetic interaction unlikely¹
Valproate	Increased plasma rufinamide concentrations (by <16 to 70% depending on valproate concentration); may be more pronounced in pediatric patients¹ ¹⁰ ¹¹ ¹² ¹³ ¹⁴ ¹⁶ ¹⁸ ²¹ ²³ ²⁴ ²⁶ ²⁷	In patients stabilized on rufinamide, initiate valproic acid at low dosage and titrate to clinically effective dosage¹ In patients receiving valproic acid, initiate rufinamide at dosage <400 mg daily in adults and <10 mg/kg daily in children¹ ¹¹

Banzel Pharmacokinetics

Absorption

Bioavailability

Well absorbed following oral administration; peak plasma concentrations occur 4–6 hours after a dose.¹ Extent of absorption decreases with increasing doses.¹

Food

Food increased the extent of absorption and peak exposure of a single 400-mg dose by 34 and 56%, respectively.¹

Under fed conditions, ≥85% of a single 600-mg dose was absorbed.¹

Special Populations

Peak plasma concentrations and AUC are decreased by 16 and 29%, respectively, at 3 hours after a hemodialysis session.¹

Distribution

Plasma Protein Binding

34% (mainly albumin).¹ ⁶

Elimination

Metabolism

Extensively metabolized, primarily via carboxylesterase-mediated hydrolysis of the carboxylamide group to an inactive acid derivative (GCP 47292).¹ ⁶ ⁸ ¹⁰ ¹¹ ¹² ¹³ ¹⁴ ¹⁵ ¹⁶ ¹⁷ ¹⁸ ²¹ Metabolic pathways do not involve CYP isoenzymes and glutathione.¹ ⁶ ⁸ ¹⁰ ¹² ¹⁶ ¹⁸

Elimination Route

Eliminated principally in urine (85%), mostly as metabolites (≥66% as CGP 47292); only 2% of dose is excreted as unchanged drug.¹ ⁶ ⁸ ¹⁰ ¹¹ ¹² ¹³ ¹⁵ ¹⁶ ¹⁷ ¹⁸ ²¹

Half-life

Approximately 6–10 hours.¹ ⁶

Special Populations

Effect of hepatic impairment on pharmacokinetics not evaluated.¹

Renal impairment (Cl_cr <30 mL/minute) does not substantially alter pharmacokinetics; hemodialysis may reduce exposure (see Absorption: Special Populations under Pharmacokinetics).¹

Pharmacokinetics in pediatric patients 4–17 years of age similar to pharmacokinetics in adults.¹

No clinically important pharmacokinetic differences between healthy geriatric individuals and younger healthy adults.¹

Stability

Storage

Oral

Suspension

25°C (may be exposed to 15–30°C).¹

Tablets

25°C (may be exposed to 15–30°).¹ Protect from moisture.¹

Actions

Triazole-derivative anticonvulsant; structurally unrelated to other currently available anticonvulsants.¹ ⁶ ⁷ ⁹ ¹⁰ ¹¹ ¹² ¹³ ¹⁴ ¹⁵ ¹⁶ ¹⁷ ¹⁸ ²¹ ²⁸

Exact mechanism(s) of anticonvulsant action is unknown, but may involve modulation of sodium channel activity and, in particular, prolongation of the inactive state of the channel.¹ ⁶ ⁷ ⁹ ¹⁰ ¹¹ ¹² ¹³ ¹⁴ ¹⁵ ¹⁶ ¹⁷ ¹⁸ ²¹

Does not appear to substantially interact with monoaminergic, cholinergic, histaminergic, glycine, GABA, or glutamate receptors or systems.⁶ ⁷ ¹⁰ ¹³ ¹⁴ ¹⁷ ¹⁸

Advice to Patients

Importance of providing copy of written patient information (medication guide) each time rufinamide is dispensed.¹ ²⁰ ³¹ Importance of patients reading this information prior to taking the drug.¹ ³¹

Risk of suicidality (anticonvulsants, including rufinamide, may increase risk of suicidal thoughts or actions in about 1 in 500 people).¹ ² ²⁰ ³⁴ Importance of patients, family members, and caregivers being alert to day-to-day changes in mood, behavior, and actions and immediately informing clinician of any new or worrisome behaviors (e.g., talking or thinking about wanting to hurt oneself or end one's life, withdrawing from friends and family, becoming depressed or experiencing worsening of existing depression, becoming preoccupied with death and dying, giving away prized possessions).¹ ² ³⁴

Risk of multiorgan hypersensitivity reactions.¹ ³⁴ Importance of notifying clinician if rash (with or without fever) occurs.¹ ³⁴

Importance of taking rufinamide only as prescribed.¹ ³⁴

Importance of taking rufinamide with food.¹ ³¹ Importance of informing patients that rufinamide scored tablets may be swallowed whole, broken in half, or crushed.¹ ³¹ Importance of instructing patients in proper techniques for administration of the oral suspension, including use of the bottle adapter and oral dosing syringe.¹

When applicable, advise patients that rufinamide oral suspension does not contain lactose, gluten, or carbohydrates and is dye-free.¹

Risk of sleepiness, difficulty with coordination, and dizziness; importance of advising patients to avoid driving or operating machinery until they gain experience with the drug's effects.¹ ²¹ Risk of additive CNS effects (e.g., sedation) if used with alcohol or other drugs that affect the CNS.¹ ²¹ ³⁴

Importance of informing patients not to stop taking rufinamide without first talking to their clinician since stopping the drug suddenly can cause serious problems, including seizures.¹ ³¹ ³⁴

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹ Importance of clinicians informing women about the existence of and encouraging enrollment in pregnancy registries (see Pregnancy under Cautions).¹ Potential increased risk of pregnancy in women taking hormonal contraceptives; importance of discussing use of additional contraceptive methods.¹ ¹⁰ ²¹

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses (e.g., hepatic disease, depression, bipolar disorder), family history of suicidality or bipolar disorder, or current diagnosis or history of familial short QT syndrome.¹ ³¹ ³⁴

Importance of advising 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.

Rufinamide
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Suspension	40 mg/mL	Banzel	Eisai
	Tablets, film-coated	200 mg	Banzel (scored)	Eisai
		400 mg	Banzel (scored)	Eisai

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 October 27, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Eisai Co., Ltd. Banzel (rufinamide) tablets prescribing information. Woodcliff Lake, NJ; 2011 Mar.

2. Food and Drug Administration. FDA Alert: Information for healthcare professionals: suicidality and antiepileptic drugs. Rockville, MD; 2008 Jan 31. From the FDA website.

3. Food and Drug Administration. FDA News: FDA alerts health care providers to risk of suicidal thoughts and behavior with antiepileptic medications. Rockville, MD; 2008 Jan 31. From the FDA website.

4. Food and Drug Administration. FDA Alert: Suicidality and antiepileptic drugs. Rockville, MD; 2008 Jan 31. From the FDA website.

5. Food and Drug Administration. Orphan designations pursuant to Section 526 of the Federal Food and Cosmetic Act as amended by the Orphan Drug Act (P.L. 97 414). Rockville, MD. From FDA website. Accessed 2009 Apr 22.

6. Heaney D, Walker MC. Rufinamide. Drugs Today (Barc). 2007; 43:455-60. [PubMed 17728846]

7. Rogawski MA. Diverse mechanisms of antiepileptic drugs in the development pipeline. Epilepsy Res. 2006; 69:273-94. [PubMed 16621450]

8. Perucca E, Cloyd J, Critchley D et al. Rufinamide: clinical pharmacokinetics and concentration-response relationships in patients with epilepsy. Epilepsia. 2008; 49:1123-41. [PubMed 18503564]

9. Glauser T, Kluger G, Sachdeo R et al. Rufinamide for generalized seizures associated with Lennox-Gastaut syndrome. Neurology. 2008; 70:1950-8. [PubMed 18401024]

10. Cheng-Hakimian A, Anderson GD, Miller JW. Rufinamide: pharmacology, clinical trials, and role in clinical practice. Int J Clin Pract. 2006; 60:1497-501. [IDIS 564203] [PubMed 17073844]

11. . Rufinamide (Banzel) for epilepsy. Med Lett Drugs Ther. 2009; 51:18-20. [PubMed 19265777]

12. Deeks ED, Scott LJ. Rufinamide. CNS Drugs. 2006; 20:751-60; discussion 761. [PubMed 16953653]

13. Hakimian S, Cheng-Hakimian A, Anderson GD et al. Rufinamide: a new anti-epileptic medication. Expert Opin Pharmacother. 2007; 8:1931-40. [PubMed 17696794]

14. Johannessen Landmark C, Johannessen SI. Pharmacological management of epilepsy: recent advances and future prospects. Drugs. 2008; 68:1925-39. [PubMed 18778117]

15. Chung AM, Eiland LS. Use of second-generation antiepileptic drugs in the pediatric population. Paediatr Drugs. 2008; 10:217-54. [PubMed 18590343]

16. Bialer M, Johannessen SI, Kupferberg HJ et al. Progress report on new antiepileptic drugs: a summary of the Eighth Eilat Conference (EILAT VIII). Epilepsy Res. 2007; 73:1-52. [PubMed 17158031]

17. Bialer M, Johannessen SI, Kupferberg HJ et al. Progress report on new antiepileptic drugs: a summary of the Fifth Eilat Conference (EILAT V). Epilepsy Res. 2001; 43:11-58. [PubMed 11137386]

18. Arroyo S. Rufinamide. Neurotherapeutics. 2007; 4:155-62. [PubMed 17199032]

19. Pålhagen S, Canger R, Henriksen O et al. Rufinamide: a double-blind, placebo-controlled proof of principle trial in patients with epilepsy. Epilepsy Res. 2001; 43:115-24. [PubMed 11164700]

20. Food and Drug Administration. Suicidal behavior and ideation and antiepileptic drugs: update 5/5/2009. Rockville, MD; 2009 May 5. From the FDA website.

21. Hussar DA, Bilbow C. New drugs: Febuxostat, lacosamide, and rufinamide. J Am Pharm Assoc. 2009; 49:460-3.

22. Glauser T, Kluger G, Sachdeo R et al. Open-label study of the efficacy and safety of rufinamide adjunctive therapy in patients with Lennox-Gastaut syndrome. Epilepsia. 2005; 46 (Suppl. 6):408. Abstr. p1356.

23. Eisai Inc., Woodcliff Lake, NJ: Personal communication.

24. Luszczki JJ. Third-generation antiepileptic drugs: mechanisms of action, pharmacokinetics and interactions. Pharmacol Rep. 2009 Mar-Apr; 61:197-216. [PubMed 19443931]

25. Herman ST. Adopting an orphan drug: rufinamide for lennox-gastaut syndrome. Epilepsy Curr. 2009 May-Jun; 9:72-4. [PubMed 19471615]

26. Kluger G, Bauer B. Role of rufinamide in the management of Lennox-Gastaut syndrome (childhood epileptic encephalopathy). Neuropsychiatr Dis Treat. 2007; 3:3-11. [PubMed 19300535]

27. Ferrie CD, Patel A. Treatment of Lennox-Gastaut Syndrome (LGS). Eur J Paediatr Neurol. 2009; : [epub ahead of print].. [PubMed 19211283]

28. Saneto RP, Anderson GD. Onset of action and seizure control in Lennox-Gastaut syndrome. Ther Clin Risk Manag. 2009; 5:271-80. [PubMed 19536315]

29. Brodie MJ, Rosenfeld WE, Vazquez B et al. Rufinamide for the adjunctive treatment of partial seizures in adults and adolescents: a randomized placebo-controlled trial. Epilepsia. 2009; Jun 1: 1-11. [PubMed 19490053]

30. Kluger G, Kurlemann G, Haberlandt E et al. Effectiveness and tolerability of rufinamide in children and adults with refractory epilepsy: first European experience. Epilepsy Behav. 2009; 14:491-5. [PubMed 19162229]

31. American Society of Health-System Pharmacists. AHFS Consumer Medication Information. Rufinamide. 2009 Jan 1.

32. Krivoy N, Taer M, Neuman MG. Antiepileptic drug-induced hypersensitivity syndrome reactions. Curr Drug Safety. 2006; 1:288-99. [PubMed 18690940]

33. Eisai Ltd. Inovelon (rufinamide) film-coated tablets summary of product characteristics. 2007.

34. Eisai Inc. About Banzel (rufinamide). 2009. From the Banzel web site. Accessed 2009 Jul 10.

More Banzel resources

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

Banzel Prescribing Information (FDA)

Banzel Consumer Overview

Banzel Advanced Consumer (Micromedex) - Includes Dosage Information

Banzel MedFacts Consumer Leaflet (Wolters Kluwer)

Rufinamide Professional Patient Advice (Wolters Kluwer)

Compare Banzel with other medications

Lennox-Gastaut Syndrome

Bayer

Generic Name: salicylate (Oral route, Rectal route)

Commonly used brand name(s)

In the U.S.

Amigesic

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In Canada

Alti-Sulfasalazine

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Bismuth Extra Strength

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Mesasal

Pentasa

Pepto-Bismol

Pms-Asa Suppository Adult

Pms-Asa Suppository Children

Salazopyrin

Salofalk

Available Dosage Forms:

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Tablet

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Tablet, Chewable

Tablet, Effervescent

Capsule, Delayed Release

Tablet, Delayed Release

Enema

Capsule, Extended Release

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Solution

Suspension

Uses For Bayer

Aspirin may also be used to lessen the chance of heart attack, stroke, or other problems that may occur when a blood vessel is blocked by blood clots. Aspirin helps prevent dangerous blood clots from forming. However, this effect of aspirin may increase the chance of serious bleeding in some people. Therefore, aspirin should be used for this purpose only when your doctor decides, after studying your medical condition and history, that the danger of blood clots is greater than the risk of bleeding. Do not take aspirin to prevent blood clots or a heart attack unless it has been ordered by your doctor.

Salicylates may also be used for other conditions as determined by your doctor.

The caffeine present in some of these products may provide additional relief of headache pain or faster pain relief.

Some salicylates are available only with your medical doctor's or dentist's prescription. Others are available without a prescription; however, your medical doctor or dentist may have special instructions on the proper dose of these medicines for your medical condition.

Importance of Diet

Make certain your health care professional knows if you are on a low-sodium diet. Regular use of large amounts of sodium salicylate (as for arthritis) can add a large amount of sodium to your diet. Sodium salicylate contains 46 mg of sodium in each 325-mg tablet and 92 mg of sodium in each 650-mg tablet.

Before Using Bayer

Allergies

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

Pediatric

Do not give aspirin or other salicylates to a child or a teenager with a fever or other symptoms of a virus infection, especially flu or chickenpox, without first discussing its use with your child's doctor. This is very important because salicylates may cause a serious illness called Reye's syndrome in children and teenagers with fever caused by a virus infection, especially flu or chickenpox.

Some children may need to take aspirin or another salicylate regularly (as for arthritis). However, your child's doctor may want to stop the medicine for a while if a fever or other symptoms of a virus infection occur. Discuss this with your child's doctor, so that you will know ahead of time what to do if your child gets sick.

Children who do not have a virus infection may also be more sensitive to the effects of salicylates, especially if they have a fever or have lost large amounts of body fluid because of vomiting, diarrhea, or sweating. This may increase the chance of side effects during treatment.

Geriatric

Elderly people are especially sensitive to the effects of salicylates. This may increase the chance of side effects during treatment.

Pregnancy

Salicylates have not been shown to cause birth defects in humans. Studies on birth defects in humans have been done with aspirin but not with other salicylates. However, salicylates caused birth defects in animal studies.

Some reports have suggested that too much use of aspirin late in pregnancy may cause a decrease in the newborn's weight and possible death of the fetus or newborn infant. However, the mothers in these reports had been taking much larger amounts of aspirin than are usually recommended. Studies of mothers taking aspirin in the doses that are usually recommended did not show these unwanted effects. However, there is a chance that regular use of salicylates late in pregnancy may cause unwanted effects on the heart or blood flow in the fetus or in the newborn infant.

Use of salicylates, especially aspirin, during the last 2 weeks of pregnancy may cause bleeding problems in the fetus before or during delivery or in the newborn infant. Also, too much use of salicylates during the last 3 months of pregnancy may increase the length of pregnancy, prolong labor, cause other problems during delivery, or cause severe bleeding in the mother before, during, or after delivery. Do not take aspirin during the last 3 months of pregnancy unless it has been ordered by your doctor.

Studies in humans have not shown that caffeine (present in some aspirin products) causes birth defects. However, studies in animals have shown that caffeine causes birth defects when given in very large doses (amounts equal to those present in 12 to 24 cups of coffee a day).

Breast Feeding

Salicylates pass into the breast milk. Although salicylates have not been reported to cause problems in nursing babies, it is possible that problems may occur if large amounts are taken regularly, as for arthritis (rheumatism).

Caffeine passes into the breast milk in small amounts.

Interactions with Medicines

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

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

Influenza Virus Vaccine, Live

Ketorolac

Pentoxifylline

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

Abciximab

Acenocoumarol

Alteplase, Recombinant

Anisindione

Ardeparin

Argatroban

Beta Glucan

Bivalirudin

Certoparin

Cilostazol

Citalopram

Clopidogrel

Clovoxamine

Dabigatran Etexilate

Dalteparin

Danaparoid

Desirudin

Desvenlafaxine

Dicumarol

Dipyridamole

Duloxetine

Enoxaparin

Eptifibatide

Escitalopram

Femoxetine

Flesinoxan

Fluoxetine

Fluvoxamine

Fondaparinux

Ginkgo

Heparin

Ketoprofen

Lepirudin

Methotrexate

Milnacipran

Nadroparin

Naproxen

Nefazodone

Parnaparin

Paroxetine

Pemetrexed

Phenindione

Phenprocoumon

Protein C

Reteplase, Recombinant

Reviparin

Riluzole

Rivaroxaban

Sertraline

Sibutramine

Tacrolimus

Ticlopidine

Tinzaparin

Tirofiban

Varicella Virus Vaccine

Venlafaxine

Vilazodone

Warfarin

Zimeldine

Interactions with Food/Tobacco/Alcohol

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

Proper Use of salicylate

This section provides information on the proper use of a number of products that contain salicylate. It may not be specific to Bayer. Please read with care.

Take this medicine after meals or with food (except for enteric-coated capsules or tablets and aspirin suppositories) to lessen stomach irritation.

Take tablet or capsule forms of this medicine with a full glass (8 ounces) of water. Also, do not lie down for about 15 to 30 minutes after swallowing the medicine. This helps to prevent irritation that may lead to trouble in swallowing.

For patients taking aspirin (including buffered aspirin and/or products containing caffeine):

Do not use any product that contains aspirin if it has a strong, vinegar-like odor. This odor means the medicine is breaking down. If you have any questions about this, check with your health care professional.

If you are to take any medicine that contains aspirin within 7 days after having your tonsils removed, a tooth pulled, or other dental or mouth surgery, be sure to swallow the aspirin whole. Do not chew aspirin during this time.

Do not place any medicine that contains aspirin directly on a tooth or gum surface. This may cause a burn.

There are several different forms of aspirin or buffered aspirin tablets. If you are using:
- chewable aspirin tablets, they may be chewed, dissolved in liquid, crushed, or swallowed whole.
- delayed-release (enteric-coated) aspirin tablets, they must be swallowed whole. Do not crush them or break them up before taking.
- extended-release (long-acting) aspirin tablets, check with your pharmacist as to how they should be taken. Some may be broken up (but must not be crushed) before swallowing if you cannot swallow them whole. Others should not be broken up and must be swallowed whole.

To use aspirin suppositories:

If the suppository is too soft to insert, chill it in the refrigerator for 30 minutes or run cold water over it before removing the foil wrapper.

To insert the suppository: First remove the foil wrapper and moisten the suppository with cold water. Lie down on your side and use your finger to push the suppository well up into the rectum.

To take choline and magnesium salicylates (e.g., Trilisate) oral solution:

The liquid may be mixed with fruit juice just before taking.

Drink a full glass (8 ounces) of water after taking the medicine.

To take enteric-coated sodium salicylate tablets:

The tablets must be swallowed whole. Do not crush them or break them up before taking.

Unless otherwise directed by your medical doctor or dentist:

Do not take more of this medicine than recommended on the label, to lessen the chance of side effects.

Children up to 12 years of age should not take this medicine more than 5 times a day.

When used for arthritis (rheumatism), this medicine must be taken regularly as ordered by your doctor in order for it to help you. Up to 2 to 3 weeks or longer may pass before you feel the full effects of this medicine.

Dosing

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

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

For aspirin

For oral dosage forms (short-acting tablets, chewable tablets, and delayed-release [enteric-coated] tablets):
- For pain or fever:
  - Adults and teenagers—325 to 500 milligrams (mg) every three or four hours, 650 mg every four to six hours, or 1000 mg every six hours as needed.
  - Children 11 to 12 years of age—320 to 480 mg every four hours as needed.
  - Children 9 to 11 years of age—320 to 400 mg every four hours as needed.
  - Children 6 to 9 years of age—320 to 325 mg every four hours as needed.
  - Children 4 to 6 years of age—240 mg every four hours as needed.
  - Children 2 to 4 years of age—160 mg every four hours as needed.
  - Children up to 2 years of age—Dose must be determined by your doctor.
- For arthritis:
  - Adults and teenagers—A total of 3600 to 5400 mg a day, divided into several smaller doses.
  - Children—A total of 80 to 100 mg per kilogram (kg) (32 to 40 mg per pound) of body weight a day, divided into several smaller doses.
- For preventing a heart attack, stroke, or other problems caused by blood clots:
  - Adults—Most people will take 81, 162.5, or 325 mg a day or 325 mg every other day. Some people taking aspirin to prevent a stroke may need as much as 1000 mg a day.
  - Children—Use and dose must be determined by your doctor.

For oral dosage form (chewing gum):
- For pain:
  - Adults and teenagers—2 tablets every four hours as needed.
  - Children 6 to 12 years of age—1 or 2 tablets (227 mg each) up to four times a day.
  - Children 3 to 6 years of age—1 tablet (227 mg) up to three times a day.
  - Children up to 3 years of age—Dose must be determined by your doctor.

For long-acting oral dosage form (extended-release tablets):
- For pain:
  - Adults and teenagers—1 or 2 tablets twice a day.
  - Children—The long-acting aspirin tablets are too strong for use in children.
- For arthritis:
  - Adults and teenagers—1 or 2 tablets twice a day, at first. Your doctor will then adjust your dose as needed.
  - Children—The long-acting aspirin tablets are too strong for use in children.

For rectal dosage form (suppositories):
- For pain or fever:
  - Adults and teenagers—325 to 650 mg every four hours as needed.
  - Children 11 to 12 years of age—325 to 480 mg every four hours as needed.
  - Children 9 to 11 years of age—325 to 400 mg every four hours as needed.
  - Children 6 to 9 years of age—325 mg every four hours as needed.
  - Children 4 to 6 years of age—240 mg every four hours as needed.
  - Children 2 to 4 years of age—160 mg every four hours as needed.
  - Children up to 2 years of age—Dose must be determined by your doctor.
- For arthritis:
  - Adults and teenagers—A total of 3600 to 5400 mg a day, divided into several smaller doses.
  - Children—A total of 80 to 100 mg per kilogram (kg) (32 to 40 mg per pound) of body weight a day, divided into several smaller doses.

For aspirin and caffeine

For oral dosage forms (capsule):
- For pain or fever:
  - Adults and teenagers—325 to 500 milligrams (mg) of aspirin every three or four hours, 650 mg of aspirin every four to six hours, or 1000 mg of aspirin every six hours as needed.
  - Children 9 to 12 years of age—325 to 400 mg every four hours as needed.
  - Children 6 to 9 years of age—325 mg every four hours as needed.
  - Children up to 6 years of age—Aspirin and caffeine capsules are too strong for use in children up to 6 years of age
- For preventing a heart attack, stroke, or other problems caused by blood clots:
  - Adults—325 mg a day or every other day. People who take smaller doses of aspirin will have to use a different product. Some people taking aspirin to prevent a stroke may need as much as 1000 mg a day.
  - Children—Use and dose must be determined by your doctor.

For oral dosage form (tablets):
- For pain or fever:
  - Adults and teenagers—325 to 500 mg of aspirin every three or four hours, 650 mg of aspirin every four to six hours, or 1000 mg of aspirin every six hours as needed.
  - Children 9 to 12 years of age—325 to 400 mg every four hours as needed.
  - Children up to 9 years of age—Aspirin and caffeine tablets are too strong for use in children up to 9 years of age.
- For arthritis:
  - Adults and teenagers—A total of 3600 to 5400 mg of aspirin a day, divided into several smaller doses.
  - Children—A total of 80 to 100 mg per kg (32 to 40 mg per pound) of body weight a day, divided into several smaller doses.
- For preventing a heart attack, stroke, or other problems caused by blood clots:
  - Adults—325 mg a day or every other day. People who take smaller doses of aspirin will have to use a different product. Some people taking aspirin to prevent a stroke may need as much as 1000 mg a day.
  - Children—Use and dose must be determined by your doctor.

For buffered aspirin

For oral dosage forms (tablets):
- For pain or fever:
  - Adults and teenagers—325 to 500 milligrams (mg) of aspirin every three or four hours, 650 mg of aspirin every four to six hours, or 1000 mg of aspirin every six hours as needed.
  - Children 11 to 12 years of age—One or one and one-half 325-mg tablets every four hours as needed.
  - Children 9 to 11 years of age—One or one and one-fourth 325-mg tablets every four hours as needed.
  - Children 6 to 9 years of age—One 325-mg tablet every four hours as needed.
  - Children 4 to 6 years of age—Three-fourths of a 325-mg tablet every four hours as needed.
  - Children 2 to 4 years of age—One-half of a 325-mg tablet every four hours as needed.
  - Children up to 2 years of age—Dose must be determined by your doctor.
- For arthritis:
  - Adults and teenagers—A total of 3600 to 5400 mg of aspirin a day, divided into several smaller doses.
  - Children—A total of 80 to 100 mg per kilogram (kg) (32 to 40 mg per pound) of body weight a day, divided into several smaller doses.
- For preventing a heart attack, stroke, or other problems caused by blood clots:
  - Adults—325 mg a day or every other day. People who take smaller doses of aspirin will have to use a different product. Some people taking aspirin to prevent a stroke may need as much as 1000 mg a day.
  - Children—Use and dose must be determined by your doctor.

For buffered aspirin and caffeine

For oral dosage form (tablets):
- For pain or fever:
  - Adults and teenagers—325 or 421 milligrams (mg) of aspirin every three or four hours, 650 mg of aspirin every four to six hours, or 842 mg of aspirin every six hours as needed.
  - Children 11 to 12 years of age—One or one and one-half 325-mg tablets, or one 421-mg tablet, every four hours as needed.
  - Children 9 to 11 years of age—One or one and one-fourth 325-mg tablets every four hours as needed.
  - Children 6 to 9 years of age—One 325-mg or 421-mg tablet every four hours as needed.
  - Children 4 to 6 years of age—Three-fourths of a 325-mg tablet every four hours as needed.
  - Children 2 to 4 years of age—One-half of a 325-mg tablet every four hours as needed.
  - Children up to 2 years of age—Dose must be determined by your doctor.
- For arthritis:
  - Adults and teenagers—A total of 3600 to 5400 mg of aspirin a day, divided into several smaller doses.
  - Children—A total of 80 to 100 mg per kilogram (kg) (32 to 40 mg per pound) of body weight a day, divided into several smaller doses.
- For preventing a heart attack, stroke, or other problems caused by blood clots:
  - Adults—162.5 or 325 mg (one-half or one 325-mg tablet) a day or 325 mg every other day. People who need smaller doses of aspirin will have to use a different product. Some people taking aspirin to prevent a stroke may need as much as 1000 mg a day.
  - Children—Use and dose must be determined by your doctor.

For choline salicylate

For oral dosage form (oral solution):
- For pain or fever:
  - Adults and teenagers—One-half or three-fourths of a teaspoonful every three hours, one-half or one teaspoonful every four hours, or one or one and one-half teaspoonfuls every six hours as needed.
  - Children 11 to 12 years of age—2.5 to 3.75 mL (one-half to three-fourths of a teaspoonful) every four hours as needed. This amount should be measured by a special measuring spoon.
  - Children 6 to 11 years of age—2.5 mL (one-half of a teaspoonful) every four hours as needed. This amount should be measured by a special measuring spoon.
  - Children 4 to 6 years of age—1.66 mL every four hours as needed. This amount should be measured by a special dropper or measuring spoon.
  - Children 2 to 4 years of age—1.25 milliliters (mL) (one-fourth of a teaspoonful) every four hours as needed. This amount should be measured by a special dropper or measuring spoon.
  - Children up to 2 years of age—Dose must be determined by your doctor.
- For arthritis:
  - Adults—A total of five and one-half to eight teaspoonfuls a day, divided into several smaller doses.
  - Children—A total of 0.6 to 0.7 mL per kilogram (kg) (0.25 to 0.28 mL per pound) of body weight a day, divided into several smaller doses.

For choline and magnesium salicylates

For oral dosage forms (oral solution or tablets):
- For pain or fever:
  - Adults and teenagers—A total of 2000 to 3000 milligrams (mg) a day, divided into two or three doses.
  - Children weighing more than 37 kg (90 pounds or more)—2200 mg a day, divided into two doses.
  - Children weighing up to 37 kilograms (kg) (about 89 pounds)—A total of 50 mg per kg (20 mg per pound) of body weight a day, divided into two doses.

For magnesium salicylate

For oral dosage form (tablets):
- For pain:
  - Adults and teenagers—2 regular-strength tablets every four hours, up to a maximum of 12 tablets a day, or 2 extra-strength tablets every eight hours, up to a maximum of 8 tablets a day.
  - Children—Dose must be determined by your doctor.

For salsalate

For oral dosage forms (capsules or tablets):
- For arthritis:
  - Adults and teenagers—500 to 1000 milligrams (mg) two or three times a day, to start. Your doctor will then adjust your dose as needed.
  - Children—Dose must be determined by your doctor.

For sodium salicylate

For oral dosage forms (tablets or delayed-release [enteric-coated] tablets):
- For pain or fever:
  - Adults and teenagers—325 or 650 milligrams (mg) every four hours as needed.
  - Children 6 years of age and older—325 mg every four hours as needed.
  - Children up to 6 years of age—This medicine is too strong for use in children younger than 6 years of age.
- For arthritis:
  - Adults and teenagers—A total of 3600 to 5400 mg a day, divided into several smaller doses.
  - Children—A total of 80 to 100 mg per kilogram (kg) (32 to 40 mg per pound) of body weight a day, divided into several smaller doses.

Missed Dose

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

Storage

Keep out of the reach of children.

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

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Bayer

Check the labels of all nonprescription (over-the-counter [OTC]) and prescription medicines you now take. If any contain aspirin or other salicylates (including bismuth subsalicylate [e.g., Pepto-Bismol] or any shampoo or skin medicine that contains salicylic acid or any other salicylate), check with your health care professional. Taking or using them together with this medicine may cause an overdose.

If you will be taking salicylates for a long time (more than 5 days in a row for children or 10 days in a row for adults) or in large amounts, your doctor should check your progress at regular visits.

Serious side effects can occur during treatment with this medicine. Sometimes serious side effects can occur without any warning. However, possible warning signs often occur, including swelling of the face, fingers, feet, and/or lower legs; severe stomach pain, black, tarry stools, and/or vomiting of blood or material that looks like coffee grounds; unusual weight gain; and/or skin rash. Also, signs of serious heart problems could occur such as chest pain, tightness in chest, fast or irregular heartbeat, or unusual flushing or warmth of skin. Stop taking this medicine and check with your doctor immediately if you notice any of these warning signs.

Check with your medical doctor or dentist:

If you are taking this medicine to relieve pain and the pain lasts for more than 10 days (5 days for children) or if the pain gets worse, if new symptoms occur, or if redness or swelling is present. These could be signs of a serious condition that needs medical or dental treatment.

If you are taking this medicine to bring down a fever, and the fever lasts for more than 3 days or returns, if the fever gets worse, if new symptoms occur, or if redness or swelling is present. These could be signs of a serious condition that needs treatment.

If you are taking this medicine for a sore throat, and the sore throat is very painful, lasts for more than 2 days, or occurs together with or is followed by fever, headache, skin rash, nausea, or vomiting.

If you are taking this medicine regularly, as for arthritis (rheumatism), and you notice a ringing or buzzing in your ears or severe or continuing headaches. These are often the first signs that too much salicylate is being taken. Your doctor may want to change the amount of medicine you are taking every day.

For patients taking aspirin to lessen the chance of heart attack, stroke, or other problems caused by blood clots:

Take only the amount of aspirin ordered by your doctor. If you need a medicine to relieve pain, a fever, or arthritis, your doctor may not want you to take extra aspirin. It is a good idea to discuss this with your doctor, so that you will know ahead of time what medicine to take.

Do not stop taking this medicine for any reason without first checking with the doctor who directed you to take it.

Taking certain other medicines together with a salicylate may increase the chance of unwanted effects. The risk will depend on how much of each medicine you take every day, and on how long you take the medicines together. If your doctor directs you to take these medicines together on a regular basis, follow his or her directions carefully. However, do not take any of the following medicines together with a salicylate for more than a few days, unless your doctor has directed you to do so and is following your progress:

Acetaminophen (e.g., Tylenol)

Diclofenac (e.g., Voltaren)

Diflunisal (e.g., Dolobid)

Etodolac (e.g., Lodine)

Fenoprofen (e.g., Nalfon)

Floctafenine (e.g., Idarac)

Flurbiprofen, oral (e.g., Ansaid)

Ibuprofen (e.g., Motrin)

Indomethacin (e.g., Indocin)

Ketoprofen (e.g., Orudis)

Ketorolac (e.g., Toradol)

Meclofenamate (e.g., Meclomen)

Mefenamic acid (e.g., Ponstel)

Nabumetone (e.g., Relafen)

Naproxen (e.g., Naprosyn)

Oxaprozin (e.g., Daypro)

Phenylbutazone (e.g., Butazolidin)

Piroxicam (e.g., Feldene)

Sulindac (e.g., Clinoril)

Tenoxicam (e.g., Mobiflex)

Tiaprofenic acid (e.g., Surgam)

Tolmetin (e.g., Tolectin)

For diabetic patients:

False urine sugar test results may occur if you are regularly taking large amounts of salicylates, such as:
- Aspirin: 8 or more 325-mg (5-grain), or 4 or more 500-mg or 650-mg (10-grain), or 3 or more 800-mg (or higher strength), doses a day.
- Buffered aspirin or
- Sodium salicylate: 8 or more 325-mg (5-grain), or 4 or more 500-mg or 650-mg (10-grain), doses a day.
- Choline salicylate: 4 or more teaspoonfuls (each teaspoonful containing 870 mg) a day.
- Choline and magnesium salicylates: 5 or more 500-mg tablets or teaspoonfuls, 4 or more 750-mg tablets, or 2 or more 1000-mg tablets, a day.
- Magnesium salicylate: 7 or more regular-strength, or 4 or more extra-strength, tablets a day.
- Salsalate: 4 or more 500-mg doses, or 3 or more 750-mg doses, a day.

Smaller doses or occasional use of salicylates usually will not affect urine sugar tests. However, check with your health care professional (especially if your diabetes is not well-controlled) if:
- you are not sure how much salicylate you are taking every day.
- you notice any change in your urine sugar test results.
- you have any other questions about this possible problem.

Do not take aspirin for 5 days before any surgery, including dental surgery, unless otherwise directed by your medical doctor or dentist. Taking aspirin during this time may cause bleeding problems.

For patients taking buffered aspirin, choline and magnesium salicylates (e.g., Trilisate), or magnesium salicylate (e.g., Doan's):

Buffered aspirin, choline and magnesium salicylates, or magnesium salicylate can keep many other medicines, especially some medicines used to treat infections, from working properly. This problem can be prevented by not taking the 2 medicines too close together. Ask your health care professional how long you should wait between taking a medicine for infection and taking buffered aspirin, choline and magnesium salicylates, or magnesium salicylate.

If you are taking a laxative containing cellulose, take the salicylate at least 2 hours before or after you take the laxative. Taking these medicines too close together may lessen the effects of the salicylate.

For patients taking this medicine by mouth:

Stomach problems may be more likely to occur if you drink alcoholic beverages while being treated with this medicine, especially if you are taking it in high doses or for a long time. Check with your doctor if you have any questions about this.

For patients using aspirin suppositories:

Aspirin suppositories may cause irritation of the rectum. Check with your doctor if this occurs.

Salicylates may interfere with the results of some medical tests. Before you have any medical tests, tell the doctor in charge if you have taken any of these medicines within the past week. If possible, it is best to check with the doctor first, to find out whether the medicine may be taken during the week before the test.

For patients taking one of the products that contain caffeine:

Caffeine may interfere with the result of a test that uses adenosine (e.g., Adenocard) or dipyridamole (e.g., Persantine) to help find out how well your blood is flowing through certain blood vessels. Therefore, you should not have any caffeine for at least 8 to 12 hours before the test.

If you think that you or anyone else may have taken an overdose, get emergency help at once. Taking an overdose of these medicines may cause unconsciousness or death. Signs of overdose include convulsions (seizures), hearing loss, confusion, ringing or buzzing in the ears, severe drowsiness or tiredness, severe excitement or nervousness, and fast or deep breathing.

Bayer Side Effects

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

Get emergency help immediately if any of the following side effects occur:

Symptoms of overdose in children

Changes in behavior

drowsiness or tiredness (severe)

fast or deep breathing

Any loss of hearing

bloody urine

confusion

convulsions (seizures)

diarrhea (severe or continuing)

difficulty in swallowing

dizziness, lightheadedness, or feeling faint (severe)

drowsiness (severe)

excitement or nervousness (severe)

fast or deep breathing

flushing, redness, or other change in skin color

hallucinations (seeing, hearing, or feeling things that are not there)

increased sweating

increased thirst

nausea or vomiting (severe or continuing)

shortness of breath, troubled breathing, tightness in chest, or wheezing

stomach pain (severe or continuing)

swelling of eyelids, face, or lips

unexplained fever

uncontrollable flapping movements of the hands (especially in elderly patients)

vision problems

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

Less common or rare

Abdominal or stomach pain, cramping, or burning (severe)

bloody or black, tarry stools

headache (severe or continuing)

ringing or buzzing in ears (continuing)

skin rash, hives, or itching

unusual tiredness or weakness

vomiting of blood or material that looks like coffee grounds

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

More common

Abdominal or stomach cramps, pain, or discomfort (mild to moderate)

heartburn or indigestion

nausea or vomiting

Less common

Trouble in sleeping, nervousness, or jitters (only for products containing caffeine)

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

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

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Barosperse

barium sulfate

Dosage Form: powder, for suspension
LAFAYETTE

Barosperse™

BARIUM SULFATE FOR SUSPENSION

Rx only

Barosperse Description

Barosperse is a vanilla flavored barium sulfate product for use as a contrast medium during x-ray diagnosis of the gastrointestinal tract. An aqueous suspension of the product is to be prepared at the time of administration.

The contrast medium contains 95% barium sulfate USP, dispersing and suspending agents, flavoring, simethicone, and saccharin sodium. Barium sulfate has the empirical formula of BaSO4.

Barosperse - Clinical Pharmacology

Barium sulfate is an insoluble material which, because of its density, provides a positive contrast during x-ray examination. Barium sulfate is an inert radiopaque material which is not absorbed or metabolized and is eliminated intact from the body in a manner similar to other non-absorbed inorganic materials. Excretion rate is a function of gastrointestinal transit time.

Indications and Usage for Barosperse

Barosperse is indicated for use as a contrast medium in x-ray diagnosis of the gastrointestinal tract.

Contraindications

Barium sulfate products are contraindicated in patients with known or suspected obstruction of the colon, known or suspected gastrointestinal tract perforation, suspected tracheoesophageal fistula, obstructing lesions of the small intestine, pyloric stenosis inflammation or neoplastic lesions of the rectum, recent rectal biopsy, or known hypersensitivity to barium sulfate formulations.

Barium sulfate suspensions should not be used for infants with swallowing disorders or for newborns with complete duodenal or jejunal obstruction or when distal small bowel or colon obstruction is suspected. Barium sulfate suspension is not recommended for very small preterm infants and young babies requiring small volumes of contrast media or for infants and young children when there is a possibility of leakage from the gastrointestinal tract, such as necrotizing enterocolitis, unexplained pneumoperitoneum, gasless abdomen, other bowel perforation, esophageal perforation or post operative anastomosis.

Known hypersensitivity or allergy to latex is a contraindication for the use of balloon retention enema tips containing latex. The use of a retention cuff enema tip is not necessary or desirable in patients with normal sphincter tone. The presence of adequate sphincter tone can be judged by preliminary rectal digital examination.

Warnings

Serious adverse reactions, including death, have been reported with the administration of barium sulfate formulations and are usually associated with the technique of administration, the underlying pathological condition and/or patient hypersensitivities.

Vomiting following oral administration of barium sulfate may lead to aspiration pneumonitis. Oral administration of barium sulfate suspension by an infant sucking a bottle and administration of large quantities by catheter are reported to be likely to result in aspiration into the tracheobronchial tree. Cardiopulmonary arrest leading to fatality has been reported in infants following aspiration. Aspiration of smaller amounts may cause inflammation.

Barium sulfate preparations used as radiopaque media contain a number of additives to provide diagnostic properties and patient palatability. Allergic responses following the use of barium sulfate suspensions have been reported. Skin irritation, redness, inflammation and hives have been reported for infants and small children following spillage of barium sulfate suspension on their skin. These responses are thought to be caused by the flavors and/or preservatives used in the product.

Barium sulfate suspension has been reported to cause obstruction of the small bowel (impaction) in pediatric patients with cystic fibrosis. It has also been reported to cause fluid overload from the absorption of water during studies in infants when Hirschsprung’s Disease is suspected.

Barium sulfate suspension intravasation can be a serious complication. Mortality has been reported as a result of vaginal or rectal intravasation and is believed to be due to massive pulmonary embolism occurring within minutes of the inciting event.

In patients with increased cranial pressure, barium sulfate suspension enemas present an additional risk of further increasing intracranial pressure.

Care must be taken during the insertion of an enema tip into the patient to prevent application of pressure to the vagus nerve which can lead to vasovagal reactions and syncopal episodes. Cardiac arrhythmia or other cardiovascular side effects can occur as a result of colon distention.

Precautions

General

Diagnostic procedures which involve the use of radiopaque contrast agents should be carried out under the direction of personnel with the requisite training and with a thorough knowledge of the particular procedure to be performed. A history of bronchial asthma, atopy, as evidenced by hay fever and eczema, a family history of allergy, or a previous reaction to a contrast agent warrant special attention. Caution should be exercised with the use of radiopaque media in severely debilitated patients and in those with marked hypertension or advanced cardiac disease.

Anaphylactic and allergic reactions have been reported during double contrast examinations in which glucagon has been used.

An increased risk of perforation has been reported in neonates with intussusception. In patients with cystic fibrosis or blind loops of the bowel or ileus, there is a risk of inspissation leading to partial or complete obstruction.

In neonates and infants with motility disorders such as Hirschsprung’s Disease retention of large amounts of barium sulfate suspension may result in absorption of water from the suspension and fluid overload. The addition of small amounts of salt to the barium sulfate suspension has been reported to reduce the problem.

Ingestion of barium sulfate suspension is not recommended in patients with a history of food aspiration. If barium sulfate suspension is aspirated into the larynx, further administration of the suspension should be immediately discontinued.

Patient preparation for diagnostic gastrointestinal examinations frequently requires cathartics and a liquid diet. The various preparations can result in water loss for the patient. Patients should be rehydrated quickly following a barium sulfate suspension examination of the gastrointestinal tract. In patients with reduced colon motility, saline cathartics may be required after the barium sulfate suspension enema. Saline cathartics are recommended on a routine basis in patients with a history of constipation unless clinically contraindicated.

Where enema tips are used, care must be taken during insertion into the patient, since forceful or too deep insertion may cause tearing or perforation of the rectum. Insertion of an enema tip should be done only after digital examination by qualified medical personnel. When balloon retention tips are used, care should be taken to avoid overinflation of the balloon, since overfilling or asymmetrical filling may cause displacement of the tip. Such a displacement can lead to rectal perforation or barium sulfate granulomas. Inflation of the balloon should be done under fluoroscopic control by qualified medical personnel. Do not unnecessarily move the enema tip once inserted.

A specially designed enema tip is required for a barium sulfate suspension examination of a colostomy patient.

Intubation of an enteroclysis catheter should be done by qualified medical personnel. Perforation of the duodenum has been reported.

Because of reported anaphylactoid reactions to latex, the use of non-latex gloves during the procedure should be considered.

Pregnancy

Safe use of barium sulfate during pregnancy has not been established. Barium sulfate should be used in pregnant women only if the possible benefits outweigh the potential risks. Elective radiography of the abdomen is considered to be contraindicated during pregnancy due to the risk to the fetus from radiation exposure. Radiation is known to cause harm to the unborn fetus exposed in utero.

Pediatric Use

The radiographic contrast agents used for examination of children do not differ substantially from those used for adults. The variation in physical sizes of pediatric patients requires more thorough attention to individualizing dosage. The volume of barium sulfate suspension and the barium sulfate content required will also depend upon the technique used and the clinical need.

Adverse Reactions

Adverse reactions accompanying the use of barium sulfate formulations are infrequent and usually mild, though severe reactions (approximately 1 in 500,000) and fatalities (approximately 1 in 2,000,000) have occurred. Procedural complications are rare, but may include aspiration pneumonitis, barium sulfate impaction, granuloma formation, intravasation, embolization and peritonitis following intestinal perforation, vasovagal and syncopal episodes, and fatalities. EKG changes have been shown to occur following or during barium sulfate suspension enemas. It is of the utmost importance to be completely prepared to treat any such occurrence.

Due to the increased likelihood of allergic reactions in atopic patients, a complete history of known and suspected allergies as well as allergic-like symptoms, such as rhinitis, bronchial asthma, eczema and urticaria, must be obtained prior to any medical procedure.

Aspiration of large amounts of barium sulfate suspension may cause pneumonitis or nodular granulomas of interstitial lung tissues and lymph nodes; asphyxiation and death have been reported.

Transient bacteremia, beginning almost immediately and lasting up to 15 minutes, may also occur during rectal administration of barium sulfate suspension, and rarely septicemia has been reported.

A rare mild allergic reaction would most likely be generalized pruritus, erythema or urticaria (approximately 1 in 100,000 reactions). Such reactions will often respond to an antihistamine. More serious reactions (approximately 1 in 500,000) may result in laryngeal edema, bronchospasm or hypotension.

Severe reactions which may require emergency measures are often characterized by peripheral vasodilation, hypotension, reflex tachycardia, dyspnea, bronchospasm, agitation, confusion and cyanosis, progressing to unconsciousness. Treatment should be initiated immediately according to established standard of care.

Apprehensive patients may develop weakness, pallor, tinnitus, diaphoresis and bradycardia following the administration of any diagnostic agent. Such reactions are usually non-allergic in nature.

Allergic reactions to the enema accessories, in particular to retention catheters (tips) with latex cuffs, can occur. Such reactions could occur immediately and result in the previously mentioned acute allergic-like responses or might be delayed in appearance and result in a contact dermatitis. Known atopic patients, particularly those with a history of asthma or eczema, should be evaluated for alternative methods of administration in order to avoid these adverse reactions. These plastic/rubber accessories are disposable, single-use devices that must not be reused or left in the body cavity for an extended period of time.

Postmarketing Experiences

The following adverse experiences have been reported in patients receiving products containing barium sulfate. These adverse experiences are listed alphabetically: abdominal cramping, abdominal pain, diarrhea, fever, foreign body trauma relating to procedural complications, headache, laryngeal burning and irritation, leukocytosis, procedural site reactions, rash, and vomiting.

Overdosage

In rare instances, immediate repeat oral examinations utilizing standard dosages may lead to severe stomach cramps and diarrhea. Cases reported implicate a total dose in the range of 30 ounces (900 mL) of suspension. Instances of this type have resolved spontaneously and they are not considered to be life-threatening.

Barosperse Dosage and Administration

Individual technique will determine the suspension quantity and concentration to be used.

Patient Preparation

Successful examination of the upper gastrointestinal tract requires that the stomach be empty and essentially free of fluid. This can usually be accomplished by instructing the patient to abstain from eating or drinking anything after the evening meal before the examination. The preparation for small bowel examinations done separately or combined with an upper gastrointestinal series is the same.

For examinations of the colon, the patient should be given a low solid diet for a minimum of 24 hours before the examination. Laxatives should also be used to clean the colon. In order to obtain thorough cleansing of the colon, a 2 liter water enema one hour before the examination may be necessary.

Administration

Orally administered suspension may be served chilled for more rapid transit from the stomach into the small bowel. Rectally administered suspension should be at room temperature to body temperature.

Suspension Preparation

Barosperse will form stable suspensions when shaken vigorously with water. Add water and shake vigorously for 20 to 30 seconds. Some practitioners prefer to use a blender.

Always shake again just before patient administration.

Suspensions of Barosperse should be used within six (6) hours of preparation. For best results, the Barosperse and the water should be accurately measured.

The following tables will serve as a guide for suspension preparation.

ORAL ADMINISTRATION DILUTION TABLE
Suspension % w/v:	110	95	85	70	60
Concentration % w/w:	60	55	50	45	40
Barosperse Wt.	Water required to prepare suspension (in mLs)
225 gm (8 oz.)	150	185	225	275	335
900 gm	600	735	900	1100	1350

Note: Do not store suspension after mixing; shake vigorously just prior to administration.

Esophagus Swallow Study

Optimum coating is obtained with 2 to 3 teaspoonfuls of a freshly prepared suspension (225 gm Barosperse vigorously mixed with 75 mL of water). For evaluation of distensibility and peristaltic motion use 110% w/v suspension.

Upper Gastrointestinal Series

Initial gastric coating can be accomplished with 75 mL of a 110% w/v suspension. This is followed by 195 mL of a 85% w/v suspension.

Small Bowel Examinations

When done concomitantly with the Upper G.I. Series, the above volumes and concentrations are usually sufficient. However, if desired, an additional 240 mL of 85% w/v suspension may be used. When the small bowel examination is done independently, 240 to 480 mL of 85% w/v suspension may be used.

Note: Do not store suspension after mixing; shake vigorously just prior to administration.

Filled Colon Examination

The usual dose is 2000 mL of a 25% w/v suspension. If low concentration (“see through”) is desired, use 2500 mL of a 17% w/v suspension. (Note: low concentration suspension should be agitated immediately before use.)

RECTAL ADMINISTRATION DILUTION TABLE
Suspension % w/v:	110	35	30	25	20	17
Concentration % w/w:	60	28	23	20	18	15
Barosperse Wt.	Water required to prepare suspension (in mLs)
225 gm (8 oz.)	150	580	755	900	1027	1278
340 gm (12 oz.)	225	875	1140	1360	1550	1925
454 gm (16 oz.)	305	1170	1525	1820	2090	2500
900 gm	600	-	-	-	-	-

Double Contrast Colon Examination

400 mL of 110% w/v suspension is usually adequate for this technique.

Pediatric Use

The quantity of suspension used and the barium sulfate concentration will depend upon patient size, technique used and clinical need.

For single patient use only. Properly discard unused portion.

How is Barosperse Supplied

Catalog No. 179208. NDC 68240-621-08. 225 gm bottle; thirty-six (36) bottles and thirty-six (36) straws per case.

Catalog No. 139132. NDC 68240-626-09. 900 gm bottle; eight (8) bottles per case.

Catalog No. 116412. NDC 68240-621-12. 340 gm (12 oz.) enema kit with screw cap spout and rigid enema tip. Twenty-four (24) kits per case.

Catalog No. 116416. NDC 68240-621-16. 454 gm (16 oz.) enema kit with screw cap spout and rigid enema tip. Twenty-four (24) kits per case.

Catalog No. 116414. NDC 68240-621-32. 340 gm (12 oz.) enema kit with screw cap spout and flexible enema tip with silicone retention cuff. Twenty-four (24) kits per case.

Catalog No. 116418. NDC 68240-621-36. 454 gm (16 oz.) enema kit with screw cap spout and flexible enema tip with silicone retention cuff. Twenty-four (24) kits per case.

Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF).

Barosperse is a trademark of Lafayette Pharmaceuticals, Incorporated.

DIN: 00776629

Distributed in Canada by:

tyco Healthcare

POINTE-CLAIRE, QC, CANADA H9R 5H8

Establishment License # 100689-A

Made in Mexico

Manufactured by:

Mallinckrodt Inc.

St. Louis, MO 63042 USA

www.Mallinckrodt.com

MID 1304679

Rev. 2008/10

SINGLE CONTRAST

G.I. EXAMS

Multi-Purpose

Mix-to-need

Flavored

tyco

Healthcare

Mallinckrodt

Package Label - Principal Display Panel - 225 gm Bottle

L A F A Y E T T E

Barosperse™

BARIUM SULFATE FOR SUSPENSION

Catalog No. 179208

SINGLE CONTRAST / UPPER G.I.

Rx only

225 gm

Barosperse

Barium Sulfate for Suspension

NDC 68240-621-08

Catalog No. 179208

A vanilla flavored 95% barium sulfate USP formulation for aqueous suspension and use in x-ray diagnosis of the gastrointestinal tract.

Contents: Barium sulfate USP, dispersing and suspending agents, flavoring, simethicone, and saccharin sodium.

Contraindications: Do not use in patients with suspected gastrointestinal tract perforation or known hypersensitivity to barium sulfate formulations.

Dosage and Administration: See package insert for complete instructions.

Mixing Directions: For accurate suspension preparation, measure water and add to contents of bottle. The dilution marks may be used for approximate suspension volume.

45% w/w (70% w/v) - 275 mL water

50% w/w (85% w/v) - 225 mL water

60% w/w (110% w/v) - 150 mL water

Add water and shake vigorously for 20 to 30 seconds.

Add water to the desired Final Concentration Line and remix.

Always shake again just before patient administration.

Use within 6 hours of preparation.

For single patient use only. Properly discard unused portion.

Storage: Store at 25°C (77°F); excursions permitted to 15º to 30ºC (59° to 86°F).

Net Contents: 225 gm

DIN: 00776629

Distributed in Canada by:

tyco Healthcare

Pointe-Claire, QC, Canada H9R 5H8

Establishment License # 100689-A

Made in Mexico

Manufactured by:

Mallinckrodt Inc.

St. Louis, MO 63042 USA

www.Mallinckrodt.com

MID 1170085

Rev 02/2009

tyco

Healthcare

Mallinckrodt

Package Label - Principal Display Panel - 454 gm Enema Kit (with Smooth Rigid Enema Tip)

L A F A Y E T T E

Barosperse™ ENEMA KIT

BARIUM SULFATE FOR SUSPENSION ENEMA KIT

(with Smooth Rigid Enema Tip)

Catalog No. 116416

SINGLE CONTRAST / LOWER G.I.

Rx only

454 gm (16 oz.)

NDC 68240-621-16

Catalog No. 116416

A one piece disposable 3 liter enema bag with positive seal closure, attached 5/16” lumen tubing, rigid enema tip and 454 gm of barium sulfate for suspension (95% barium sulfate USP, dispersing and suspending agents, flavoring, simethicone, and saccharin sodium) for aqueous suspension and use in x-ray diagnosis of the colon.

Contraindications: Do not use in patients with suspected gastrointestinal tract perforation or known hypersensitivity to barium sulfate formulations.

Dosage and Administration: See package insert for complete instructions. See reverse side for abbreviated information.

For single patient use only. Properly discard unused portion.

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).

Net Contents: 454 gm (16 oz.)

SMOOTH RIGID ENEMA TIP

Made in Mexico

Manufactured by:

Mallinckrodt Inc.

St. Louis, MO 63042 USA

www.Mallinckrodt.com

DIN: 00776629

Distributed in Canada by:

tyco Healthcare

POINTE-CLAIRE, QC, CANADA H9R 5H8

Establishment License # 100689-A

MID 1304641

Rev. 2008/10

tyco

Healthcare

Mallinckrodt

Package Label - Principal Display Panel - 454 gm Enema Kit (with Flexible Enema Tip)

L A F A Y E T T E

Barosperse™ ENEMA KIT

BARIUM SULFATE FOR SUSPENSION ENEMA KIT

(with Flexible Enema Tip)

Catalog No. 116418

SINGLE CONTRAST / LOWER G.I.

Rx only

454 gm (16 oz.)

NDC 68240-621-36

Catalog No. 116418, screw cap

A one piece disposable 3 liter enema bag with positive seal closure, attached 5/16” lumen tubing, flexible enema tip with SILICONE rubber inflatable cuff and 454 gm of barium sulfate for suspension (95% barium sulfate USP, dispersing and suspending agents, flavoring, simethicone, and saccharin sodium) for aqueous suspension and use in x-ray diagnosis of the colon.

Contraindications: Do not use in patients with suspected gastrointestinal tract perforation or known hypersensitivity to barium sulfate formulations.

Dosage and Administration: See package insert for complete instructions. See reverse side for abbreviated information.

For single patient use only. Properly discard unused portion.

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).

Net Contents: 454 gm (16 oz.)

Flexible Enema Tip with Retention Cuff

Made in Mexico

Manufactured by:

Mallinckrodt Inc.

St. Louis, MO 63042 USA

www.Mallinckrodt.com

DIN: 00776629

Distributed in Canada by:

tyco Healthcare

POINTE-CLAIRE, QC, CANADA H9R 5H8

Establishment License # 100689-A

MID 1304659

Rev. 2008/10

tyco

Healthcare

Mallinckrodt

Package Label - Principal Display Panel - 900 gm Bottle

L A F A Y E T T E

Barosperse™

BARIUM SULFATE FOR SUSPENSION

SINGLE CONTRAST / G.I. EXAMS

Rx only

NDC 68240-626-09

Catalog No. 139132

A vanilla flavored, 95% barium sulfate USP formulation, for aqueous suspension and use in x-ray diagnosis of the gastrointestinal tract.

Contents: Barium sulfate USP, dispersing and suspending agents, flavoring, simethicone, and saccharin sodium.

Contraindications: Do not use in patients with suspected gastrointestinal tract perforation or known hypersensitivity to barium sulfate formulations.

Dosage and Administration: See package insert for complete instructions.

Mixing Directions:

Add water according to the dilution tables found in the package insert.

Shake vigorously for 20 to 30 seconds until thoroughly mixed.

Allow to stand for 1 to 3 minutes.

Always shake again just before patient administration.

Use within 6 hours of preparation.

For single patient use only. Properly discard unused portion.

Storage: Store at 25°C (77°F); excursions permitted to 15º to 30ºC (59º to 86ºF).

Net Contents: 900 gm

DIN: 00776629

Distributed in Canada by:

tyco Healthcare

Pointe-Claire, QC, Canada H9R 5H8

Establishment License # 100689-A

Made in Mexico

Manufactured by:

Mallinckrodt Inc.

St. Louis, MO 63042 USA

www.Mallinckrodt.com

MID 1304697

Rev 02/2009

tyco

Healthcare

Mallinckrodt

Barosperse
barium sulfate powder, for suspension

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	68240-621
Route of Administration	ORAL, RECTAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BARIUM SULFATE (BARIUM CATION)	BARIUM SULFATE	.95 g in 1 g

Inactive Ingredients
Ingredient Name	Strength
SACCHARIN SODIUM
SORBITOL
MANNITOL
ETHYL VANILLIN
SODIUM TRIPOLYPHOSPHATE

Product Characteristics
Color		Score
Shape		Size
Flavor	VANILLA	Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	68240-621-08	36 BOTTLE In 1 CASE	contains a BOTTLE, PLASTIC
1		225 g In 1 BOTTLE, PLASTIC	This package is contained within the CASE (68240-621-08)
2	68240-621-12	24 BAG In 1 CASE	contains a BAG
2		340 g In 1 BAG	This package is contained within the CASE (68240-621-12)
3	68240-621-16	24 BAG In 1 CASE	contains a BAG
3		454 g In 1 BAG	This package is contained within the CASE (68240-621-16)
4	68240-621-32	24 BAG In 1 CASE	contains a BAG
4		340 g In 1 BAG	This package is contained within the CASE (68240-621-32)
5	68240-621-36	24 BAG In 1 CASE	contains a BAG
5		454 g In 1 BAG	This package is contained within the CASE (68240-621-36)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/01/2009	11/30/2011

Barosperse
barium sulfate for suspension powder, for suspension

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	68240-626
Route of Administration	ORAL, RECTAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BARIUM SULFATE (BARIUM CATION)	BARIUM SULFATE	.95 g in 1 g

Inactive Ingredients
Ingredient Name	Strength
SACCHARIN SODIUM
SORBITOL
MANNITOL
ETHYL VANILLIN
SODIUM TRIPOLYPHOSPHATE

Product Characteristics
Color		Score
Shape		Size
Flavor	VANILLA	Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	68240-626-09	8 BOTTLE In 1 CASE	contains a BOTTLE, PLASTIC
1		900 g In 1 BOTTLE, PLASTIC	This package is contained within the CASE (68240-626-09)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/01/2009	11/30/2011

Labeler - Mallinckrodt, Inc. (810407189)

Establishment
Name	Address	ID/FEI	Operations
Mallinckrodt Medical, S.A. de C.V.		810407189	analysis, manufacture

Revised: 08/2010Mallinckrodt, Inc.

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