E-Z-Dose with Liquid Polibar Plus

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Overview

What is E-Z-Dose with Liquid Polibar Plus?

E-Z-DOSE™ with LIQUID POLIBAR PLUS® is a single dose, disposable barium sulfate retention enema system which includes the Miller™ Air tip. E-Z-DOSE™ with LIQUID POLIBAR PLUS contains barium sulfate suspension (105% w/v, 58% w/w) for rectal administration. Each 100 mL contains 105 g barium sulfate. Barium sulfate due to its high molecular density is opaque to x-rays and, therefore, acts as a positive contrast agent for radiographic studies. The active ingredient is barium sulfate and its structural formula is BaSO. Barium sulfate occurs as a fine, white, odorless, tasteless, bulky powder which is free from grittiness. Its aqueous suspensions are neutral to litmus. It is practically insoluble in water, solutions of acids and alkalies, and organic solvents.

What does E-Z-Dose with Liquid Polibar Plus look like?

What are the available doses of E-Z-Dose with Liquid Polibar Plus?

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What should I talk to my health care provider before I take E-Z-Dose with Liquid Polibar Plus?

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How should I use E-Z-Dose with Liquid Polibar Plus?

For radiography of the gastrointestinal tract.

The volume and concentration of LIQUID POLIBAR PLUS to be administered will depend on the degree and extent of contrast required in the area(s) under examination and on the equipment and technique employed. See below for typical adult doses.

What interacts with E-Z-Dose with Liquid Polibar Plus?

This product should not be used in patients with known intestinal perforation or hypersensitivity to barium sulfate products.

Enema System

Do not use a retention cuff in a colostomy stoma. A colostomy stoma requires a special colostomy catheter. Do not use a retention cuff following recent rectal surgery or low rectal anastomosis, or when proctitis or other rectal conditions such as inflammatory or neoplastic diseases are suspected. In those cases use soft pediatric Flexi-Tip rectal catheters, E-Z-EM Ref. 9504 (24 Fr) or Ref. 9514 (14 Fr).

What are the warnings of E-Z-Dose with Liquid Polibar Plus?

Because of potential drug interactions, concomitant use of tizanidine with other CYP1A2 inhibitors, such as zileuton, other fluoroquinolones, antiarrythmics (amiodarone, mexiletine, propafenone, and verapamil), cimetidine, famotidine, oral contraceptives, acyclovir and ticlopidine (see ) should ordinarily be avoided. If their use is clinically necessary, they should be used with caution.

Rarely, severe allergic reactions of an anaphylactoid nature, have been reported following administration of barium sulfate contrast agents. Appropriately trained personnel and facilities should be available for emergency treatment of severe reactions and should remain available for at least 30 to 60 minutes following administration, since delayed reactions can occur.

Barium sulfate should not be used proximal to known or suspected obstruction of the colon, or in those cases where the use of barium sulfate is contraindicated. Care must be taken to avoid overinflation of the cuff, since overfilling, or asymmetrical filling with displacement of the tip, may occur. Such displacement can lead to rectal perforation, barium granulomas or vasovagal reactions, or may cause the cuff to deflate. Overinflation may cause the inflatable cuff to rupture with possible injury to the patient. The enema tip should also not be moved unnecessarily once inserted.

What are the precautions of E-Z-Dose with Liquid Polibar Plus?

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, 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.

After any barium study of the GI tract, it is important to rehydrate the patient as quickly as possible to prevent impaction of the bowel by barium sulfate. To prevent barium sulfate impaction in the bowel, the use of mild laxatives such as milk of magnesia or lactulose, following completion of the examination may also be required. These mild laxatives are recommended on a routine basis and in patients with a history of constipation unless contraindicated.

Use with caution when obstructive lesions of the colon are suspected. Care should be taken to minimize the amount of barium sulfate allowed to flow proximal to obstructive lesions of the colon. Care must be taken during insertion of the enema tip into the patient to prevent application of pressure to the vagus nerve which can lead to vasovagal reactions and syncopal episodes. Forceful or deep insertion may also cause tearing or perforation of the rectum.

Inflation of the retention cuff should only be performed by a physician, or qualified personnel under a physician’s supervision, under fluoroscopic control. Do not inflate cuff with more than 100 cc air. Use only with the E-Z-EM Retention Cuff Inflator Ref. 9529. Do not unnecessarily move enema tip and inflated retention cuff once inserted. To ensure maximum rectal visualization, the inflated cuff should be deflated immediately after completion of the fluoroscopic phase of the exam, or after the colon is completely filled.

Information for Patients

Inform their physician if they are pregnant.
Inform their physician if they are allergic to any drugs or food, or if they have had any prior reactions to barium sulfate products or other contrast agents used in x-ray procedures (see ).
Inform their physician about any other medications they are currently taking.

Before administration of this product patients should be instructed to:

Drug Interactions

The presence of barium sulfate formulations in the GI tract may alter the absorption of therapeutic agents taken concomitantly. In order to minimize any potential change in absorption, the separate administration of barium sulfate from that of other agents should be considered.

Usage in Pregnancy

Radiation is known to cause harm to the unborn fetus exposed . Therefore, radiographic procedures should only be used when, in the judgement of the physician, their use is deemed essential to the welfare of the pregnant patient.

Nursing Mothers

Barium sulfate products may be used during lactation.

What are the side effects of E-Z-Dose with Liquid Polibar Plus?

Adverse reactions, such as nausea,vomiting, diarrhea and abdominal cramping, accompanying the use of barium sulfate formulations are infrequent and usually mild. Severe reactions (approximately 1 in 1,000,000) and fatalities (approximately 1 in 10,000,000) 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 reported following or during barium enema procedures. It is of the utmost importance to be completely prepared to treat any such occurrence.

What should I look out for while using E-Z-Dose with Liquid Polibar Plus?

This product should not be used in patients with known intestinal perforation or hypersensitivity to barium sulfate products.

Rarely, severe allergic reactions of an anaphylactoid nature, have been reported following administration of barium sulfate contrast agents. Appropriately trained personnel and facilities should be available for emergency treatment of severe reactions and should remain available for at least 30 to 60 minutes following administration, since delayed reactions can occur.

Barium sulfate should not be used proximal to known or suspected obstruction of the colon, or in those cases where the use of barium sulfate is contraindicated. Care must be taken to avoid overinflation of the cuff, since overfilling, or asymmetrical filling with displacement of the tip, may occur. Such displacement can lead to rectal perforation, barium granulomas or vasovagal reactions, or may cause the cuff to deflate. Overinflation may cause the inflatable cuff to rupture with possible injury to the patient. The enema tip should also not be moved unnecessarily once inserted.

What might happen if I take too much E-Z-Dose with Liquid Polibar Plus?

On rare occasions following repeated administration, severe stomach cramps, nausea, vomiting, diarrhea or constipation may occur. These are transitory in nature and are not considered serious. Symptoms may be treated according to currently accepted standards of medical care.

How should I store and handle E-Z-Dose with Liquid Polibar Plus?

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container.E-Z-DOSE™ is supplied as follows:As a kit, Cat. No. P650PPS, NDC 32909-652-02, which includes 650 mL bottle Cat. No. P650PPS, NDC 32909-651-01 and tubing with a Miller™ Air Tip.Rx Only (USA)SHAKE WELL PRIOR TO USEE-Z-DOSE™ is supplied as follows:As a kit, Cat. No. P650PPS, NDC 32909-652-02, which includes 650 mL bottle Cat. No. P650PPS, NDC 32909-651-01 and tubing with a Miller™ Air Tip.Rx Only (USA)SHAKE WELL PRIOR TO USEE-Z-DOSE™ is supplied as follows:As a kit, Cat. No. P650PPS, NDC 32909-652-02, which includes 650 mL bottle Cat. No. P650PPS, NDC 32909-651-01 and tubing with a Miller™ Air Tip.Rx Only (USA)SHAKE WELL PRIOR TO USE

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Barium sulfate, due to its high molecular density is opaque to x-rays and, therefore, acts as a positive contrast agent for radiographic studies. Barium sulfate is biologically inert and, therefore, is not absorbed or metabolized by the body, and is eliminated unchanged from the body.

Non-Clinical Toxicology

This product should not be used in patients with known intestinal perforation or hypersensitivity to barium sulfate products.

Rarely, severe allergic reactions of an anaphylactoid nature, have been reported following administration of barium sulfate contrast agents. Appropriately trained personnel and facilities should be available for emergency treatment of severe reactions and should remain available for at least 30 to 60 minutes following administration, since delayed reactions can occur.

Barium sulfate should not be used proximal to known or suspected obstruction of the colon, or in those cases where the use of barium sulfate is contraindicated. Care must be taken to avoid overinflation of the cuff, since overfilling, or asymmetrical filling with displacement of the tip, may occur. Such displacement can lead to rectal perforation, barium granulomas or vasovagal reactions, or may cause the cuff to deflate. Overinflation may cause the inflatable cuff to rupture with possible injury to the patient. The enema tip should also not be moved unnecessarily once inserted.

Few systemic data have been collected on the metabolism of bupropion following concomitant administration with other drugs or, alternatively, the effect of concomitant administration of bupropion on the metabolism of other drugs.

Because bupropion is extensively metabolized, the coadministration of other drugs may affect its clinical activity. studies indicate that bupropion is primarily metabolized to hydroxybupropion by the CYP2B6 isoenzyme. Therefore, the potential exists for a drug interaction between bupropion hydrochloride extended-release tablets (XL) and drugs that are substrates of or inhibitors/inducers of the CYP2B6 isoenzyme (e.g., orphenadrine, thiotepa, cyclophosphamide, ticlopidine, and clopidogrel). In addition, studies suggest that paroxetine, sertraline, norfluoxetine, and fluvoxamine as well as nelfinavir and efavirenz inhibit the hydroxylation of bupropion. No clinical studies have been performed to evaluate this finding. The threohydrobupropion metabolite of bupropion does not appear to be produced by the cytochrome P450 isoenzymes. The effects of concomitant administration of cimetidine on the pharmacokinetics of bupropion and its active metabolites were studied in 24 healthy young male volunteers. Following oral administration of two 150-mg tablets of the sustained-release formulation of bupropion with and without 800 mg of cimetidine, the pharmacokinetics of bupropion and hydroxybupropion were unaffected. However, there were 16% and 32% increases in the AUC and C, respectively, of the combined moieties of threohydrobupropion and erythrohydrobupropion.

In a series of studies in healthy volunteers, ritonavir (100 mg twice daily or 600 mg twice daily) or ritonavir 100 mg plus lopinavir (KALETRA) 400 mg twice daily reduced the exposure of bupropion and its major metabolites in a dose dependent manner by approximately 20% to 80%. Similarly, efavirenz 600mg once daily for 2 weeks reduced the exposure of bupropion by approximately 55%. This effect of ritonavir, KALETRA, and efavirenz is thought to be due to the induction of bupropion metabolism. Patients receiving any of these drugs with bupropion may need increased doses of bupropion, but the maximum recommended dose of bupropion should not be exceeded (see ).

While not systematically studied, certain drugs may induce the metabolism of bupropion (e.g., carbamazepine, phenobarbital, phenytoin).

Multiple oral doses of bupropion had no statistically significant effects on the single dose pharmacokinetics of lamotrigine in 12 healthy volunteers.

Animal data indicated that bupropion may be an inducer of drug-metabolizing enzymes in humans. In one study, following chronic administration of bupropion, 100 mg 3 times daily to 8 healthy male volunteers for 14 days, there was no evidence of induction of its own metabolism. Nevertheless, there may be the potential for clinically important alterations of blood levels of coadministered drugs.

Therefore, coadministration of bupropion with drugs that are metabolized by CYP2D6 isoenzyme including certain antidepressants (e.g., nortriptyline, imipramine, desipramine, paroxetine, fluoxetine, sertraline), antipsychotics (e.g., haloperidol, risperidone, thioridazine), beta-blockers (e.g., metoprolol), and Type 1C antiarrhythmics (e.g., propafenone, flecainide), should be approached with caution and should be initiated at the lower end of the dose range of the concomitant medication. If bupropion is added to the treatment regimen of a patient already receiving a drug metabolized by CYP2D6, the need to decrease the dose of the original medication should be considered, particularly for those concomitant medications with a narrow therapeutic index.

Drugs which require metabolic activation by CYP2D6 in order to be effective (e.g., tamoxifen) theoretically could have reduced efficacy when administered concomitantly with inhibitors of CYP2D6 such as bupropion.

Although citalopram is not primarily metabolized by CYP2D6, in one study bupropion increased the C and AUC of citalopram by 30% and 40%, respectively. Citalopram did not affect the pharmacokinetics of bupropion and its three metabolites.

Drug-Laboratory Test Interactions:

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, 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.

After any barium study of the GI tract, it is important to rehydrate the patient as quickly as possible to prevent impaction of the bowel by barium sulfate. To prevent barium sulfate impaction in the bowel, the use of mild laxatives such as milk of magnesia or lactulose, following completion of the examination may also be required. These mild laxatives are recommended on a routine basis and in patients with a history of constipation unless contraindicated.

Use with caution when obstructive lesions of the colon are suspected. Care should be taken to minimize the amount of barium sulfate allowed to flow proximal to obstructive lesions of the colon. Care must be taken during insertion of the enema tip into the patient to prevent application of pressure to the vagus nerve which can lead to vasovagal reactions and syncopal episodes. Forceful or deep insertion may also cause tearing or perforation of the rectum.

Inflation of the retention cuff should only be performed by a physician, or qualified personnel under a physician’s supervision, under fluoroscopic control. Do not inflate cuff with more than 100 cc air. Use only with the E-Z-EM Retention Cuff Inflator Ref. 9529. Do not unnecessarily move enema tip and inflated retention cuff once inserted. To ensure maximum rectal visualization, the inflated cuff should be deflated immediately after completion of the fluoroscopic phase of the exam, or after the colon is completely filled.

Adverse reactions, such as nausea,vomiting, diarrhea and abdominal cramping, accompanying the use of barium sulfate formulations are infrequent and usually mild. Severe reactions (approximately 1 in 1,000,000) and fatalities (approximately 1 in 10,000,000) 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 reported following or during barium enema procedures. It is of the utmost importance to be completely prepared to treat any such occurrence.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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