Site Nicaragua: October 2016

Wednesday, October 12, 2016

Bexxar

Generic Name: Tositumomab
Class: Antineoplastic Agents
VA Class: AN600
CAS Number: 192391-48-3

Use only by qualified clinicians who are experienced in the safe use and handling of therapeutic radionuclides and who have been or are in the process of being certified by GlaxoSmithKline in dose calculation and administration.¹ ⁷

Serious, including fatal, hypersensitivity reactions reported.¹ Drugs for treatment of severe hypersensitivity reactions should be available for immediate use.¹ If severe tositumomab-induced reactions occur, discontinue therapy immediately and initiate appropriate medical treatment.⁷ (See Anaphylaxis under Cautions.)

Risk of severe thrombocytopenia and neutropenia.¹ Do not use in patients with >25% lymphoma marrow involvement and/or impaired bone marrow reserve.¹ (See Hematologic Effects under Cautions.)

Risk of fetal harm.¹ Pregnancy category X.¹ (See Contraindications and see Fetal/Neonatal Morbidity and Mortality under Cautions.)

Introduction

Radioimmunotherapeutic agent; a murine anti-human antigen CD20 monoclonal antibody that covalently binds the radioisotope iodine I 131.¹ ³ ⁷

Uses for Bexxar

Non-Hodgkin’s Lymphoma

Used as part of a specific therapeutic regimen (tositumomab therapeutic regimen) for treatment of antigen CD20-expressing relapsed or refractory, low-grade, follicular, or transformed non-Hodgkin’s lymphoma, including rituximab-refractory disease (designated an orphan drug by FDA for this use).¹ ² ⁷

Efficacy determined based on durable responses; actual clinical benefits (e.g., effects on survival) not clearly elucidated.¹

Has been used in rituximab-naive patients with follicular non-Hodgkin’s lymphoma, with or without transformation, whose disease was refractory to or had progressed following therapy with other antineoplastic agents.¹ ⁴ ⁵ ⁶ ⁷

Safety and efficacy not evaluated in patients with >25% lymphoma marrow involvement and/or impaired bone marrow reserve (e.g., platelet count <100,000/mm³, neutrophil count <1500/mm³).¹ ⁷

Under investigation for use in the initial treatment of antigen CD20-positive advanced follicular lymphoma†.⁸ ¹¹

Bexxar Dosage and Administration

General

Use only by qualified clinicians who have completed or are participating in the certification program created by GlaxoSmithKline, which is designed to ensure proper preparation, dosage calculation, and administration of the tositumomab therapeutic regimen.¹ ⁷

Consult manufacturer’s labeling and associated literature (e.g., Workbook for Dosimetry Methodology and Administration Set-Up, provided with the Bexxar Dosimetric Package⁷ ) prior to use.¹

The tositumomab therapeutic regimen consists of daily administration of thyroid protective agents, 2 doses of unlabeled tositumomab (to decrease splenic targeting and increase the terminal half-life of the radiolabeled antibody),⁷ a dosimetric dose of iodine I 131 tositumomab followed by whole body dosimetry and biodistribution evaluation, and a therapeutic dose of iodine I 131 tositumomab.¹ Regimen administered in 2 steps: dosimetric step and therapeutic step.¹ ⁷

Intended for use as a single course of treatment.¹ ⁷ Safety of multiple courses or of other forms of therapeutic irradiation in combination with the tositumomab therapeutic regimen not established.¹ ⁷

Premedication

To minimize risk of severe infusion-related reactions, administer oral acetaminophen (650 mg) and diphenhydramine hydrochloride (50 mg) 30 minutes prior to infusion of tositumomab in both the dosimetric and therapeutic steps.¹ ⁷ (See Infusion-related Effects under Cautions.)

Initiate thyroid protective therapy at least 24 hours prior to administration of the first dose of iodine I 131 tositumomab (in the dosimetric step); continue for 14 days after administration of the iodine I 131 tositumomab therapeutic dose.¹ ⁷ Recommended regimens of thyroid protective agents include: 4 drops of a potassium iodide solution containing 1 g/mL (i.e., SSKI) orally 3 times daily, 20 drops of strong iodine solution (Lugol’s solution) orally 3 times daily, or 130 mg of potassium iodide (as tablets) orally once daily.¹ Do not administer dosimetric dose of iodine I 131 tositumomab if patients have not yet received at least 3 doses of potassium iodide solution, 3 doses of strong iodine solution, or 1 dose (130 mg) of potassium iodide (as tablets).¹

Whole Body Dosimetry and Biodistribution Evaluation

To determine biodistribution of iodine I 131 tositumomab⁷ and therapeutic dose, perform whole body scans at 3 time points following administration of the dosimetric dose: within 1 hour of infusion (prior to urination), 2–4 days after infusion (immediately following urination), and 6–7 days after infusion (immediately following urination).¹ ⁷

If biodistribution is acceptable, the therapeutic step may be administered; do not initiate therapeutic step in patients with altered biodistribution.¹ ⁷

Administration

IV Administration

For solution compatibility information, see Compatibility under Stability.

Administer tositumomab and iodine I 131 tositumomab by IV infusion.¹

Administer via an IV tubing set with an inline 0.22-mcm filter.¹ Must use same IV tubing set and filter throughout entire dosimetric or therapeutic step; may lose up to 7% of iodine I 131 tositumomab dose if filter changed.¹

Administer tositumomab therapeutic regimen in 2 steps (dosimetric step and the therapeutic step);¹ ⁷ each step consists of sequential IV infusion of an unlabeled dose of tositumomab followed by iodine I 131 tositumomab.¹ Administer therapeutic step 7–14 days after the dosimetric step.¹

Generally can be administered on an outpatient basis.⁷ Follow institutional radiation safety practices and applicable federal guidelines during preparation and administration of iodine I 131 tositumomab to minimize exposure of patients and medical personnel to radiation.¹

Dilution

To prepare dosimetric dose (tositumomab), withdraw 32 mL from a 50 mL bag of sterile 0.9% sodium chloride for injection.¹ Add 450 mg tositumomab (entire contents of two 225-mg vials) to infusion bag containing 18 mL of 0.9% sodium chloride to yield a final volume of 50 mL.¹

Invert or rotate bag to mix solution; do not shake.¹

Tositumomab must be diluted prior to IV infusion and should not be mixed or diluted with other drugs.¹ ⁷

Consult manufacturer’s labeling and associated literature (e.g., Workbook for Dosimetry Methodology and Administration Set-Up, provided with the Bexxar Dosimetric Package⁷ ) for detailed information on the preparation of iodine I 131 tositumomab.¹

Rate of Administration

Tositumomab: Administer over 60 minutes.¹

Iodine I 131 tositumomab: Administer over 20 minutes.¹

If mild to moderate infusion-related reactions occur, reduce infusion rate by 50%.¹ If severe infusion-related reactions occur, temporarily interrupt infusion; once manifestations of infusion reactions have resolved completely, resume infusion but reduce infusion rate by 50%.¹

Dosage

Adults

Non-Hodgkin’s Lymphoma

IV

Dosimetric step (day 0): 450 mg tositumomab (over 60 minutes), followed by 5 mCi iodine I 131 tositumomab (containing 35 mg of tositumomab).¹ ⁷ Determine biodistribution of iodine I 131 tositumomab⁷ and therapeutic dose.¹ ⁷ Do not proceed with therapy in patients with altered distribution.¹ ⁷ (See Whole Body Dosimetry and Biodistribution Evaluation under Dosage and Administration.)

Therapeutic step (given on 1 day between days 7–14): 450 mg tositumomab (over 60 minutes), followed by iodine I 131 tositumomab at a therapeutic dose (i.e., activity of iodine 131) calculated to deliver 75 centigrays (cGy) total body irradiation (with 35 mg of tositumomab) for patients with platelet counts of ≥150,000/mm³ or 65 cGy (with 35 mg of tositumomab) for those with platelet counts ≥100,000 but <150,000/mm³.⁷ Calculate activity of iodine I 131 required to deliver desired total body irradiation (i.e., 75 or 65 cGy) using the following equation:

Iodine I 131 activity (mCi) = (activity hours [mCi hr] / residence time [hr]) × (desired total body dose [cGy] / 75 cGy)

(To determine activity hours and residence time, see Workbook for Dosimetry Methodology and Administration Set-Up, provided with the Bexxar Dosimetric Package.) For assistance with calculations, call the Bexxar Service Center at 1-877-423-9927.¹

Prescribing Limits

Adults

Non-Hodgkin’s Lymphoma

IV

Maximum 88 cGy iodine I 131 tositumomab used in clinical studies.¹

Cautions for Bexxar

Contraindications

Iodine I 131 tositumomab contraindicated in pregnant women.¹ (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Known hypersensitivity to tositumomab, murine proteins, iodine I 131, or any ingredient in the formulation.¹ ⁷

Platelet counts <100,000/mm³.¹

Warnings/Precautions

Warnings

Consult prescribing information for thyroid protective agents for detailed information on usual cautions, precautions, and contraindications of these agents.⁷

Hematologic Effects

Risk of severe, potentially life-threatening cytopenias (e.g., neutropenia, thrombocytopenia, anemia);¹ ⁷ granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), epoetin alfa, platelet transfusions, or red blood cell transfusions required in some patients.¹ Time to nadir was 4–7 weeks following therapeutic dose;¹ ⁴ ⁵ ⁶ median duration of cytopenia was approximately 30 days.¹ ⁷ Possible prolonged cytopenia (>90 days following treatment).¹ ⁷ (See Laboratory Monitoring under Cautions.)

Safety not established in patients with >25% lymphoma marrow involvement and/or impaired bone marrow reserve (e.g., platelet count <100,000/mm³, neutrophil count <1500/mm³); do not administer tositumomab therapeutic regimen in such patients.¹ ⁷

Secondary Malignancies

Risk of secondary malignancies (e.g., myelodysplastic syndrome,¹ ⁴ ⁵ ⁷ acute myelogenous leukemia,¹ ⁷ nonmelanomatous skin cancers).¹ Median time to development of myelodysplastic syndrome was 31–34 months.¹

Fetal/Neonatal Morbidity and Mortality

Iodine I 131 may cause fetal harm (e.g., severe and potentially irreversible hypothyroidism).¹ (See Contraindications under Cautions.) Rule out pregnancy prior to initiation of therapy; avoid pregnancy during and for up to 12 months following completion of therapy.¹ If patient becomes pregnant, apprise of potential fetal hazard.¹

Hypothyroidism

Risk of hypothyroidism.¹ ⁵ ⁷

To minimize uptake of radioactive iodine by thyroid gland and to reduce occurrence of hypothyroidism, initiate thyroid protective therapy in all patients at least 24 hours prior to administration of the iodine I 131 tositumomab dosimetric dose and continue for 14 days after administration of the iodine I 131 tositumomab therapeutic dose.¹ ⁷ (See Premedication under Dosage and Administration.)

Do not administer tositumomab therapeutic regimen to patients unable to tolerate thyroid protective agents or in those who have not yet received adequate prophylaxis with these agents.¹

Evaluate patients for manifestations of hypothyroidism before beginning therapy and annually thereafter.¹ (See Laboratory Monitoring under Cautions.)

Altered Biodistribution

Do not initiate therapeutic step in patients with altered biodistribution of iodine I 131 tositumomab (as determined by imaging studies and dosimetry evaluation with the dosimetric dose of iodine I 131 tositumomab).¹ ⁷ (See Whole Body Dosimetry and Biodistribution Evaluation under Dosage and Administration.)

Sensitivity Reactions

Anaphylaxis

Severe and occasionally fatal hypersensitivity reactions, including anaphylaxis, reported.¹

Risk of anaphylaxis (e.g., angioedema, bronchospasm) or other hypersensitivity reactions (e.g., injection site hypersensitivity, laryngismus, serum sickness).¹ Risk increased in patients with human antimurine antibodies (HAMA).¹ (See Human Antimurine Antibodies [HAMA] under Cautions.)

Drugs for the treatment of hypersensitivity reactions (e.g., epinephrine, antihistamines, corticosteroids) should be available for immediate use in case a reaction occurs during administration.¹ If severe tositumomab-induced reactions occur, discontinue therapy immediately and initiate appropriate medical treatment.⁷

Major Toxicities

Infectious Complications

Viral infections (e.g., rhinitis, pharyngitis, flu symptoms, herpes)¹ ⁵ ⁶ ⁷ and serious infections requiring hospitalization (e.g., pneumonia, bacteremia, septicemia, bronchitis, skin infections) reported.¹

General Precautions

Radionuclide Precautions

Due to presence of radioactive component (iodine I 131 tositumomab), follow institutional radiation safety practices and applicable federal guidelines to minimize exposure of patients and medical personnel to radiation.¹ Provide patients with oral and written instructions for minimizing radiation exposure to family members, other close contacts, or the general public for approximately 1–2 weeks after completion of therapy.¹ ⁷

Laboratory Monitoring

Monitor CBCs with differential and platelet counts prior to initiation of therapy and weekly for at least 10–12 weeks after completion of therapy or until severe cytopenias have completely resolved; more frequent monitoring recommended in patients with evidence of moderate or severe cytopenias.¹

Monitor serum thyrotropin (thyroid-stimulating hormone, TSH) concentrations prior to initiation of therapy and annually thereafter.¹

Measure S_cr immediately prior to initiation of therapy.¹

Human Antimurine Antibodies (HAMA)

Development of HAMA¹ ⁴ ⁵ ⁶ reported.¹ ⁷ Presence of HAMA may affect accuracy of diagnostic tests and may affect toxicity profile and efficacy of therapeutic agents that rely on murine antibody technology.¹ HAMA-positive patients may be at increased risk of severe hypersensitivity reactions (e.g., anaphylaxis) or other adverse effects if they undergo in vivo diagnostic testing or treatment with murine monoclonal antibodies.¹ ⁷

Screen patients previously treated with murine proteins for presence of HAMA prior to initiation of therapy.¹

GI Effects

Nausea,¹ ⁴ ⁵ ⁶ ⁷ vomiting,¹ ⁵ ⁶ abdominal pain,¹ ⁷ anorexia,¹ ⁵ diarrhea,¹ constipation,¹ or dyspepsia¹ reported; effects temporally related to infusion of tositumomab.¹ Nausea, vomiting, and abdominal pain typically reported within days of administration; diarrhea generally reported days to weeks after infusion.¹

Infusion-related Effects

Infusion-related effects (e.g., fever,¹ ⁴ ⁵ ⁶ ⁷ rigors or chills,¹ ⁴ ⁵ ⁷ sweating,¹ hypotension,¹ ⁵ dyspnea,¹ bronchospasm,¹ nausea¹ ) reported during or within 48 hours of first dose.¹ Adjustment of infusion rate, temporary interruption of infusion, or permanent discontinuance of therapy required in some patients.¹ Symptomatic management required in more severe cases.¹

Value of premedication (e.g., acetaminophen, diphenhydramine) in preventing infusion-related toxicity not evaluated.¹

Specific Populations

Pregnancy

Category X.¹ (See Contraindications and see Fetal/Neonatal Morbidity and Mortality under Cautions.)

Lactation

Iodine I 131 is distributed into milk and may reach concentrations that equal or exceed maternal plasma concentrations.¹ Immunoglobulins are known to distribute into milk; potential for absorption and adverse effects of tositumomab in infants not known.¹ Discontinue nursing and substitute infant formula for breast milk prior to initiation of therapy.¹

Pediatric Use

Safety and efficacy not established in children ≤18 years of age.¹ ⁷

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.¹ Lower overall response rate, shorter duration of response, and lower incidence (but longer duration) of severe adverse hematologic effects observed in these patients.¹ Possibility of increased sensitivity cannot be ruled out.¹

Renal Impairment

Safety of tositumomab therapeutic regimen not established.¹ Iodine I 131 tositumomab and iodine I 131 excreted principally by the kidneys; possible decreased clearance and increased exposure to iodine I 131.¹

Common Adverse Effects

Neutropenia, thrombocytopenia, anemia, asthenia,¹ ⁴ ⁷ infection,¹ fever,¹ nausea.¹ ⁴

Interactions for Bexxar

No formal drug interaction studies to date.¹

Specific Drugs

Drug	Interaction	Comments
Anticoagulants and drugs affecting platelet function	Possible increased risk of bleeding and hemorrhage¹
Vaccines	Safety of immunization with live virus vaccines following therapy not studied¹ Ability to generate primary or anamnestic humoral response to any vaccine following therapy not studied¹

Bexxar Pharmacokinetics

Absorption

Onset

Median number of circulating B cells drops to 0 (range: 0–490 cells/mm³) at 7 weeks following treatment.¹

Duration

Recovery of B cells begins at approximately 12 weeks; median levels of B cells return to normal by 6 months.¹ ⁷

Distribution

Special Populations

Larger volume of distribution in patients with high tumor burden, splenomegaly, or bone marrow involvement.¹

Elimination

Elimination Route

Approximately 67% of IV dose of iodine I 131 tositumomab is cleared from the body within 5 days; 98% of excreted drug recovered in urine.¹ ⁷

Half-life

Iodine I 131: Physical half-life is 8 days.¹ ⁷

Iodine I 131 tositumomab: Median total-body effective half-life is 67 hours (range 28–115 hours).¹

Special Populations

Faster clearance and shorter terminal half-life in patients with high tumor burden, splenomegaly, or bone marrow involvement.¹

Renal impairment may reduce clearance.¹

Stability

Storage

Parenteral

Tositumomab Injection

2–8°C; do not freeze.¹ Protect from strong light.¹ Do not shake.¹ Discard unused portion.¹

Following dilution, 2–8°C up to 24 hours or at room temperature up to 8 hours; do not freeze.¹ Refrigeration (at 2–8°C) preferred since product contains no preservatives.¹ Discard unused portion.¹

Iodine I 131 Tositumomab Injection

Freeze at -20°C or below in original lead pots.¹

Following thawing, 2–8°C or at room temperature up to 8 hours.¹

Following dilution, 2–8°C; do not freeze.¹ Discard unused portion according to federal and state laws.¹

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution Compatibility

Compatible
Sodium chloride 0.9%

ActionsActions

Tositumomab binds specifically to antigen CD20 (expressed on pre-B cells and at higher density on mature B cells and on essentially all B-cell non-Hodgkin’s lymphomas),¹ ⁴ ⁷ triggering apoptosis, complement-dependent cytotoxicity, and antibody-dependent cell-mediated cytotoxicity of normal and malignant B cells.¹ ⁴ ⁷

Iodine I 131 (radioactive component of iodine I 131 tositumomab) triggers cell death.¹

Depletes B cells.⁷ Median serum IgM concentrations decline at week 7 and week 13 but return to normal by 6 months following treatment; median serum concentrations of IgG and IgA remain within normal range.⁷

Advice to Patients

Importance of advising patients that a radioactive material may be present in their body for several days after treatment.¹ Importance of providing patient-specific oral and written instructions for minimizing radiation exposure to family members, other close contacts, or the general public for approximately 1–2 weeks following therapy.¹ ⁷

Necessity of advising male and female patients to use an effective method of contraception while receiving the tositumomab therapeutic regimen and for up to 12 months following completion of therapy.¹

Importance of women informing clinicians immediately if they are or plan to become pregnant or plan to breast-feed.¹ Importance of women avoiding pregnancy during therapy; advise pregnant women of risk to the fetus.¹ Importance of advising women to discontinue nursing and to substitute infant formula for breast milk prior to initiation of therapy.¹

Risk of cytopenia, secondary malignancies, and hypothyroidism.¹ Importance of adhering to thyroid protective therapy and periodic hematologic monitoring.¹

Possibility of developing a HAMA immune response that could affect results of in vitro or in vivo diagnostic tests or of therapies that rely on murine antibody technology.¹

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.¹

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

Preparations

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

Distribution restricted to qualified clinicians and facilities equipped to handle radionuclides (e.g., nuclear pharmacies);⁷ not available through community pharmacies.⁷ Qualified clinicians may order by calling 877-4BEXXAR (877-423-9927).⁷

Commercially available as 2 separate package configurations, the Bexxar Dosimetric Package and the Bexxar Therapeutic Package.¹ The radioactive (iodine I 131 tositumomab) and nonradioactive ingredients (tositumomab) of each package arrive separately (but to the same nuclear pharmacy) from MDS Nordion and McKesson BioServices, respectively.⁷

Tositumomab
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Kit	2 Vials (225 mg/16.1 mL) and 1 Vial (35 mg/2.5 mL) Tositumomab 1 Vial Iodine I 131 Tositumomab (0.61 mCi/mL at calibration)	Bexxar Dosimetric Packaging	GlaxoSmithKline
		2 Vials (225 mg/16.1 mL) and 1 Vial (35 mg/2.5 mL) Tositumomab 1 or 2 Vials Iodine I 131 Tositumomab (5.6 mCi/mL at calibration)	Bexxar Therapeutic Packaging	GlaxoSmithKline

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 March 01, 2009. 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. GlaxoSmithKline. Bexxar (tositumomab and iodine I 131 tositumomab) prescribing information. Research Triangle Park, NC; 2005 Oct.

2. Food and Drug Administration. List of all orphan products designated and approved. From FDA web site. 2003 May.

3. Horning SJ, Younes A, Jain V et al. Efficacy and safety of tositumomab and iodine-131 tositumomab (Bexxar) in B-cell lymphoma, progressive after rituximab. J Clin Oncol. 2005;23:712-9

4. Kaminski, Estes J, Zasadny et al. Radioimmunotherapy with³I tositumomab for relapsed or refractory B-cell non-Hodgkin lymphoma: updated results and long-term follow-up of the University of Michigan experience. Blood. 2000; 96:1259-66. [IDIS 451112] [PubMed 10942366]

5. Kaminski MS, Zelenetz AD, Press OW et al. Pivotal study of iodine I 131 tositumomab for chemotherapy-refractory low-grade or transformed low-grade B-cell non-Hodgkin’s Lymphomas. J Clin Oncol. 2001; 19:3918-28. [IDIS 470962] [PubMed 11579112]

6. Vose JM, Wahl RL, Saleh M et al. Multicenter phase II study of iodine I 131 tositumomab for chemotherapy-relapsed/refractory low-grade and transformed low-grade B-cell non-Hodgkin’s Lymphomas. J Clin Oncol. 2000; 18:1316-23. [IDIS 444942] [PubMed 10715303]

7. GlaxoSmithKline, Philadelphia, PA: Personal communication.

8. Kaminski MS, Tuck M, Estes J et al. 131I-tositumomab therapy as initial treatment for follicular lymphoma. N Engl J Med. 2005; 352:441-9. [PubMed 15689582]

9. Davies AJ, Rohatiner AZ, Howell S et al. Tositumomab and iodine I 131 tositumomab for recurrent indolent and transformed B-cell non-Hodgkin’s lymphoma. J Clin Oncol. 2004; 22:1469-79. [PubMed 15084620]

10. Fisher RI, Kaminski MS, Wahl RL et al. Tositumomab and iodine-131 tositumomab produces durable complete remissions in a subset of heavily pretreated patients with low-grade and transformed non-Hodgkin’s lymphomas. J Clin Oncol. 2005; 23:7565-73. [PubMed 16186600]

11. Press OW, Unger JM, Braziel RM et al. Phase II trial of CHOP chemotherapy followed by tositumomab/iodine I-131 tositumomab for previously untreated follicular non-Hodgkin’s lymphoma: five-year follow-up of Southwest Oncology Group Protocol S9911. J Clin Oncol. 2006; 24:4143-9. [PubMed 16896003]

a. AHFS drug information 2003. McEvoy GK, ed. Asparaginase. Bethesda, MD: American Society of Health-System Pharmacists; 2003:892-5.

e. Trissel LA. Handbook on injectable drugs. 12 ed. Bethesda, MD: American Society of Health-System Pharmacists; 2003:521-31.

More Bexxar resources

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

Compare Bexxar with other medications

Diagnosis and Investigation

Bactrim

Pronunciation: SUL-fa-meth-OX-a-zole/trye-METH-oh-prim
Generic Name: Sulfamethoxazole/Trimethoprim
Brand Name: Examples include Bactrim and Septra

Bactrim is used for:

Treating infections caused by certain bacteria.

Bactrim is an antibiotic combination containing a sulfonamide antibiotic. It works by killing sensitive bacteria.

Do NOT use Bactrim if:

you are allergic to any ingredient in Bactrim or to similar medicines

you had a severe allergic reaction to any other sulfonamide (sulfa) medicine (eg, glipizide, hydrochlorothiazide)

you are taking dofetilide

you have anemia caused by low levels of folate in the blood

you are in week 38 of pregnancy or later (full-term) or you are breast-feeding

the patient is a child younger than 2 months old

you will be receiving a live oral typhoid vaccine

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

Before using Bactrim:

Some medical conditions may interact with Bactrim. 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 (especially seizure medications) or nonprescription medicine, herbal preparation, or dietary supplement

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

if you have liver or kidney problems, blood problems (eg, anemia, porphyria), asthma, or HIV infection

if you have severe allergies, glucose-6-phosphate dehydrogenase deficiency, or an enzyme deficiency

if you are at risk for low levels of folate in the blood (eg, you have alcoholism, you are elderly, you do not absorb nutrients from food properly, you are in a poor nutritional state, you are taking medicine for seizures)

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

Leucovorin because it may decrease Bactrim's effectiveness

Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril) or diuretics (eg, hydrochlorothiazide) because they may increase the risk of Bactrim's side effects

Anticoagulants (eg, warfarin) because the risk of bleeding may be increased

Dofetilide because the risk of severe heart problems may be increased

Digoxin, methotrexate, phenytoin, sulfones (eg, dapsone), or sulfonylureas (eg, glipizide) because the risk of their side effects may be increased by Bactrim

BCG vaccine or oral typhoid vaccine because their effectiveness may be decreased by Bactrim

Cyclosporine because its effectiveness may be decreased and the risk of liver side effects may be increased

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

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

Take Bactrim by mouth with or without food.

Bactrim works best if it is taken at the same time each day.

Take Bactrim with a full glass of water (8 oz/240 mL). Drinking extra fluids while you are taking Bactrim is recommended. Check with your doctor for instructions.

To clear up your infection completely, take Bactrim for the full course of treatment. Keep taking it even if you feel better in a few days.

If you miss a dose of Bactrim, 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 Bactrim.

Important safety information:

Bactrim may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Bactrim. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.

Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.

Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur during treatment or within several months after treatment with Bactrim. Do not treat diarrhea without first checking with your doctor.

Be sure to use Bactrim 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.

Bactrim only works against bacteria; it does not treat viral infections (eg, the common cold).

Long-term or repeated use of Bactrim 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.

Diabetes patients - Bactrim may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.

Bactrim may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Bactrim.

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

Use Bactrim with caution in the ELDERLY; they may be more sensitive to its effects, especially severe skin reactions, bone marrow suppression, or high blood potassium levels.

Bactrim should not be used in CHILDREN younger than 2 months 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 Bactrim while you are pregnant. Do not use Bactrim if you are in week 38 of pregnancy or later (full-term). Bactrim is found in breast milk. Do not breast-feed while taking Bactrim.

Possible side effects of Bactrim:

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:

Appetite loss; diarrhea; nausea; vomiting.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); blistered, peeling, red, or swollen skin; bloody or black, tarry stools; chest pain; chills, fever, or sore throat; confusion; dark urine; decreased urination; depression; hallucinations; irregular heartbeat; joint or muscle pain; mental or mood changes; painful or stiff neck; purple patches under the skin; seizures; severe diarrhea; severe or persistent cough; severe or persistent headache; severe or persistent nausea or vomiting; shortness of breath; stomach cramps/pain; unusual bruising or bleeding; unusual tiredness or weakness; unusually pale skin; vaginal irritation or discharge; yellowing of the skin or eyes.

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: Bactrim 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 blood in urine; confusion; depression; dizziness; drowsiness; loss of consciousness; severe nausea or vomiting; severe or prolonged headache; unusual bruising or bleeding.

Proper storage of Bactrim:

Store Bactrim at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Keep in a tight, light-resistant container. Do not store in the bathroom. Keep Bactrim out of the reach of children and away from pets.

General information:

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

Bactrim 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 Bactrim. 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

More Bactrim resources

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

Bactrim Prescribing Information (FDA)

Bactrim Consumer Overview

Bactrim Advanced Consumer (Micromedex) - Includes Dosage Information

Bactrim DS Prescribing Information (FDA)

Cotrim Consumer Overview

Septra Prescribing Information (FDA)

Septra Consumer Overview

Compare Bactrim with other medications

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Diverticulitis
Epiglottitis
Granuloma Inguinale
Infection Prophylaxis
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Melioidosis
Meningitis
Nocardiosis
Otitis Media
Pneumocystis Pneumonia
Pneumocystis Pneumonia Prophylaxis
Pneumonia
Prevention of Bladder infection
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Bismuth Extra Strength Oral, Rectal

Generic Name: salicylate (Oral route, Rectal route)

Commonly used brand name(s)

In the U.S.

Amigesic

Asacol

Azulfidine

Azulfidine Entabs

Bayer

Canasa

Colazal

Dipentum

Doan's Extra Strength

Doan's Regular

Dolobid

Ecotrin

Kaopectate

Pepto Bismol

Salflex

Tricosal

Trilisate

In Canada

Alti-Sulfasalazine

Arthropan

Asacol 800

Bismuth Extra Strength

Bismuth Original Formula

Mesasal

Pentasa

Pepto-Bismol

Pms-Asa Suppository Adult

Pms-Asa Suppository Children

Salazopyrin

Salofalk

Available Dosage Forms:

Tablet, Enteric Coated

Tablet, Extended Release

Suppository

Tablet

Capsule

Tablet, Chewable

Tablet, Effervescent

Capsule, Delayed Release

Tablet, Delayed Release

Enema

Capsule, Extended Release

Liquid

Solution

Suspension

Uses For Bismuth Extra Strength

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 Bismuth Extra Strength

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 Bismuth Extra Strength. 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 Bismuth Extra Strength

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.

Bismuth Extra Strength 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.

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

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

Barobag Suspension

barium sulfate

Dosage Form: suspension
LAFAYETTE

BAROBAG™ ENEMA KIT

BARIUM SULFATE FOR SUSPENSION ENEMA KIT

Rx only

Barobag Suspension Description

Barobag is a complete 3 liter enema kit containing a barium sulfate formulation for aqueous suspension and use in filled colon examinations. The contrast medium contains approximately 97% w/w barium sulfate USP, suspending agents, dispersing agents, and simethicone. Barium sulfate has the empirical formula of BaSO4.

Barobag Suspension - 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 Barobag Suspension

Barobag is indicated for use as a contrast medium in filled colon examinations.

Contraindications

Barium sulfate products are contraindicated in patients with known or suspected obstruction of the colon, known or suspected gastrointestinal tract perforation, inflammation or neoplastic lesions of the rectum, recent rectal biopsy or known hypersensitivity to barium sulfate formulation.

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.

Barium sulfate preparations used as radiopaque media contain a number of additives to provide diagnostic properties. Allergic responses following the use of barium sulfate suspensions have been reported.

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.

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.

Care must be taken during insertion of the enema tip 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 over-inflation 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.

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.

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.

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, nausea, 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.

Barobag Suspension Dosage and Administration

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

Patient Preparation

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.

Suspension Preparation

Fill Barobag to desired level (see Density Chart below) using warm water.

12 oz. BAROBAG DENSITY CHART
% w/v Barium Sulfate	Total Suspension Volume, mLs	% w/w Barium Sulfate	Approximate Specific Gravity
33.0	1000	26.1	1.266
22.0	1500	18.6	1.178
16.5	2000	14.6	1.129
13.2	2500	11.9	1.105

16 oz. BAROBAG DENSITY CHART
% w/v Barium Sulfate	Total Suspension Volume, mLs	% w/w Barium Sulfate	Approximate Specific Gravity
44.0	1000	33.2	1.352
29.3	1500	23.8	1.233
22.0	2000	18.7	1.178
17.6	2500	15.3	1.136
14.9	3000	13.5	1.107

Close cap securely. Shake Barobag vigorously until the barium sulfate formulation is completely suspended (normally 30 seconds).

Administration

Rectally administered suspension should be at room temperature to body temperature.

Just prior to administration, shake Barobag again several times to ensure the proper mixture. Turn the bag upside down and squeeze the plug at the top of the tubing into the bag. Return the bag to an upright position. Open the clamp and move it down the tubing to a position near the tip to allow air to bleed from the tubing. Close the clamp. Barobag is now ready to use.

Lubricate the enema tip and carefully insert. The enema tip should be inserted and the retention cuff (if a cuff tip is used) inflated by a physician or by qualified medical personnel under a physician’s supervision only.

If a retention cuff enema tip is used, do not insert the retention cuff beyond the anal-rectal junction. The inflated cuff should be at the level of the anal sphincter for best retention and maximum safety. If the cuff is beyond the anal-rectal junction, gently pull it back until its proximal end can be seen. Use only the single puff inflator included in the Barobag carton to inflate the retention cuff. Before inflating the cuff, visualize the rectum with contrast medium to ensure the absence of contraindications. Squeeze the inflator once only and close the clamp for the retention cuff inflation line.

Open the slide clamp on the enema bag tubing and allow the barium sulfate suspension to enter the colon. When the examination is complete, lower the enema bag and allow the barium sulfate suspension to reenter the enema bag.

Release the air in the retention cuff (if one is used) and gently remove the enema tip, using a slight twisting motion if necessary.

For single patient use only. Properly discard unused portion.

How is Barobag Suspension Supplied

Catalog No. 116112. NDC 68240-066-12. 340 gm (12 oz.) enema kit, SCREW cap spout, rigid enema tip. Twenty-four (24) kits per case.

Catalog No. 114312. NDC 68240-067-12. 340 gm (12 oz.) enema kit, SCREW cap spout, flexible enema tip with SILICONE retention cuff and single puff inflator (2 per case). Twenty-four (24) kits per case.

Catalog No. 116116. NDC 68240-066-16. 454 gm (16 oz.) enema kit, SCREW cap spout, rigid enema tip. Twenty-four (24) kits per case.

Catalog No. 114316. NDC 68240-067-16. 454 gm (16 oz.) enema kit, SCREW cap spout, flexible enema tip with SILICONE retention cuff and single puff inflator (2 per case). Twenty-four (24) kits per case.

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

Barobag is a trademark of Lafayette Pharmaceuticals, Incorporated.

DIN: 00626937

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 1295085 Rev 06/2009

SINGLE CONTRAST

LOWER G.I.

Complete kit

Rapidly suspending

tyco

Healthcare

Mallinckrodt

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 340 gm Bag

LAFAYETTE

BAROBAG™ ENEMA KIT

BARIUM SULFATE FOR SUSPENSION ENEMA KIT

(with Flexible Enema Tip)

Catalog No. 114312

SINGLE CONTRAST / LOWER G.I.

Rx only

340 gm (12 oz.)

NDC 68240-067-12

Catalog No. 114312

A one piece disposable 3 liter enema bag with positive seal closure, attached 5/16” lumen tubing, flexible enema tip with SILICONE inflatable retention cuff and 340 gm of 97% w/w barium sulfate USP formulation for aqueous suspension and use in filled colon examinations.

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

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: 340 gm (12 oz.)

Flexible Enema Tip with Retention Cuff

DIN: 00626937

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 1304677 Rev 06/2009

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 454 gm Bag

LAFAYETTE

BAROBAG™ ENEMA KIT

BARIUM SULFATE FOR SUSPENSION ENEMA KIT

(with Flexible Enema Tip)

Catalog No. 114316

SINGLE CONTRAST / LOWER G.I.

Rx only

454 gm (16 oz.)

NDC 68240-067-16

Catalog No. 114316

A one piece disposable 3 liter enema bag with positive seal closure, attached 5/16” lumen tubing, flexible enema tip with SILICONE inflatable retention cuff and 454 gm of 97% w/w barium sulfate USP formulation for aqueous suspension and use in filled colon examinations.

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

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

MID 1295001 Rev 06/2009

BAROBAG ENEMA KIT
barium sulfate powder, for suspension

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	68240-066
Route of Administration	RECTAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BARIUM SULFATE (BARIUM CATION)	BARIUM SULFATE	.97 g in 1 g

Inactive Ingredients
Ingredient Name	Strength
No Inactive Ingredients Found

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	68240-066-12	24 BAG In 1 CASE	contains a BAG
1		340 g In 1 BAG	This package is contained within the CASE (68240-066-12)
2	68240-066-16	24 BAG In 1 CASE	contains a BAG
2		454 g In 1 BAG	This package is contained within the CASE (68240-066-16)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/01/2009	10/31/2011

BAROBAG ENEMA KIT
barium sulfate powder, for suspension

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	68240-067
Route of Administration	RECTAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BARIUM SULFATE (BARIUM CATION)	BARIUM SULFATE	.97 g in 1 g

Inactive Ingredients
Ingredient Name	Strength
No Inactive Ingredients Found

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	68240-067-12	24 BAG In 1 CASE	contains a BAG
1		340 g In 1 BAG	This package is contained within the CASE (68240-067-12)
2	68240-067-16	24 BAG In 1 CASE	contains a BAG
2		454 g In 1 BAG	This package is contained within the CASE (68240-067-16)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/01/2009	10/31/2011

Labeler - Mallinckrodt Inc. (810407189)

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

Revised: 08/2010Mallinckrodt Inc.

More Barobag Suspension resources

Barobag Suspension Side Effects (in more detail)
Barobag Suspension Use in Pregnancy & Breastfeeding
Barobag Suspension Support Group
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Computed Tomography