easiest method Enhancer Barium Sulfate Dosage Form: oral suspension Overview Side Effects Dosage Pregnancy Breastfeeding More User Reviews Support Group Q & A Compare Alternatives Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here. LAFAYETTE ENHANCER BARIUM SULFATE FOR SUSPENSION Rx only Enhancer Barium Sulfate Description Enhancer is a lemon-vanilla flavored, high density barium sulfate formulation for aqueous suspension and use as a contrast medium in air contrast stomach examinations. The product contains 98% w/w barium sulfate USP, sucrose, simethicone, suspending agents, sorbitol, flavoring, sodium citrate and saccharin sodium. Barium sulfate has the empirical formula of BaSO 4 . Slideshow Drug Treatments for Rheumatoid Arthritis - What Are Your Options? Enhancer Barium Sulfate - 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 Enhancer Barium Sulfate Enhancer is indicated for use as a contrast medium in double contrast stomach examinations. 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 or known hypersensitivity to barium sulfate formulations. 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. 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. 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. 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. It is of the utmost importance to be completely prepared to treat any such occurrence. Due to 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. 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. 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 may lead to severe stomach cramps and diarrhea. Cases reported implicate a total dose in the range of 30 ounces (900 mL) of a 115% w/v barium sulfate suspension. Instances of this type have resolved spontaneously and they are not considered to be life-threatening. Enhancer Barium Sulfate Dosage and Administration Individual technique will determine the suspension quantity, concentration, and specific procedure used. The following are suggested for Enhancer s use in double contrast stomach examinations. 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. Mixing Directions • Fill the water measuring cup supplied with Enhancer to overflow (approximately 68 mL) and add to the contents of the bottle. • Secure the bottle cap, invert and shake vigorously for 5 seconds in an up and down motion. • Allow 5 minutes for complete hydration, then vigorously reshake for 5 seconds. • Just prior to patient administration remix to assure suspension uniformity. The Enhancer unit dose bottle prepares approximately 135 mL of 225% w/v high density barium sulfate suspension. Use within 6 hours of preparation. Administration While techniques may vary, it is suggested that the patient place a gas producing agent such as sodium bicarbonate on the tongue and wash down with 10 mL of water. Immediately following the sodium bicarbonate, and while the patient is in the upright position, have the patient drink the Enhancer suspension. Instruct the patient not to burp. (Depending upon physician preference, the barium sulfate suspension may be given prior to sodium bicarbonate). For single patient use only. Properly discard unused portion. How is Enhancer Barium Sulfate Supplied Catalog No. 149811. NDC 68240-527-11. 312 gm bottle; thirty-six (36) bottles with straws and one (1) water measuring cup per case. Store at 25 C (77 F); excursions permitted to 15 to 30 C (59 to 86 F). Enhancer is a trademark of Lafayette Pharmaceuticals, Incorporated. DIN: 02241556 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 1295290 Rev 04/2009 DOUBLE CONTRAST UPPER G.I. Unit dose High density Low viscosity tyco Healthcare Mallinckrodt Package Label - Principal Display Panel - 312 gm Bottle L A F A Y E T T E ENHANCER BARIUM SULFATE FOR SUSPENSION DOUBLE CONTRAST / UPPER G.I. EXAMS Catalog No. 149811 Rx only 312 gm ENHANCER Barium Sulfate for Suspension NDC 68240-527-11 Catalog No. 149811 A lemon-vanilla flavored, high density, 98% w/w barium sulfate formulation for aqueous suspension and use as a contrast medium in air contrast stomach examinations. Contents: Barium sulfate USP, sucrose, simethicone, suspending agents, sorbitol, flavoring, sodium citrate 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: Fill the water measuring cup to overflow and add to the contents of the bottle. Secure the bottle cap, invert and shake vigorously for 5 seconds in an up and down motion. Allow 5 minutes for complete hydration, then vigorously reshake for 5 seconds. Just prior to patient administration, remix to assure suspension uniformity. Use within 6 hours of preparation. For single patient use only. Properly discard unused portion. This bottle prepares approximately 135 mL of 225% w/v high density barium sulfate suspension. Storage: Store at 25 C (77 F); excursions permitted to 15 to 30 C (59 to 86 F). Net Contents: 312 gm DIN: 02241556 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 1170145 Rev 04/2009 tyco /Healthcare MALLINCKRODT ENHANCER barium sulfate for suspension Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68240-527 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BARIUM SULFATE (BARIUM CATION) BARIUM SULFATE .98 g in 1 g Inactive Ingredients Ingredient Name Strength SACCHARIN SODIUM TRISODIUM CITRATE DIHYDRATE SORBITOL CARRAGEENAN CROSCARMELLOSE SODIUM SUCROSE Product Characteristics Color Score Shape Size Flavor LEMON, VANILLA Imprint Code Contains Packaging # Item Code Package Description 1 NDC:68240-527-11 36 BOTTLE, PLASTIC (BOTTLE) in 1 CASE 1 312 g in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 12/01/2009 10/31/2011 Labeler - Mallinckrodt Inc. (810407189) Establishment Name Address ID/FEI Operations Mallinckrodt Medical, S.A. de C.V. 810407189 analysis, manufacture Revised: 08/2010 Mallinckrodt Inc. Print this page Add to My Med List More about barium sulfate Side Effects During Pregnancy or Breastfeeding Dosage Information Compare Alternatives Support Group En Español 11 Reviews Add your own review/rating Drug class: non-iodinated contrast media Consumer resources Barium sulfate oral and rectal ... +5 more Professional resources Other brands: Volumen , Tomocat , Readi-Cat , CheeTah , ... +30 more Related treatment guides Computed Tomography} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only N Pregnancy Category Not classified N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Drug Class Non-iodinated contrast media Related Drugs non-iodinated contrast media barium sulfate , Volumen , Readi-Cat , Tomocat , Liquid E-Z Paque Computed Tomography barium sulfate , iodixanol , Visipaque , Volumen , iopromide , Readi-Cat , Tomocat , CheeTah , Readi-Cat 2 , Esobar , Ultravist , Liquid E-Z Paque , E-Z-Paque , Sitzmarks , Entrobar , Entero VU , Intropaste , Anatrast , Prepcat , ioflupane I 123 , More... Barium sulfate Rating 11 User Reviews 5.2 /10 11 User Reviews 5.2 Rate it!} } financial institution
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