polyethylene glycol, potassium chloride, sodium bicarbonate, sodium chloride, and sodium sulfate

pol-ee-ETH-i-leen GLYE-kol 3350, poe-TAS-ee-um KLOR-ide, SOE-dee-um bye-KAR-bo-nate, SOE-dee-um KLOR-ide, SOE-dee-um SUL-fate

Commonly used brand name(s)

In the U.S.

• Colyte


• Colyte with Flavor Packs


• GaviLyte-C with Flavor Pack


• Golytely

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Laxative, Hyperosmotic

Uses For polyethylene glycol, potassium chloride, sodium bicarbonate, sodium chloride, and sodium sulfate

The polyethylene glycol (PEG) and electrolytes solution is used to clean the colon (large bowel or lower intestine) before certain tests or surgery of the colon. The PEG-electrolyte solution is usually taken by mouth. However, sometimes it is given in the hospital through a nasogastric tube (a tube inserted through the nose).

The PEG-electrolyte solution acts like a laxative. It causes liquid stools or mild diarrhea. In this way, it flushes all solid material from the colon, so the doctor can have a clear view of the colon.

The PEG-electrolyte solution is available only with your doctor's prescription.

Before Using polyethylene glycol, potassium chloride, sodium bicarbonate, sodium chloride, and sodium sulfate

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For polyethylene glycol, potassium chloride, sodium bicarbonate, sodium chloride, and sodium sulfate, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to polyethylene glycol, potassium chloride, sodium bicarbonate, sodium chloride, and sodium sulfate 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

Although there is no specific information comparing use of PEG-electrolyte solution in children with use in other age groups, polyethylene glycol, potassium chloride, sodium bicarbonate, sodium chloride, and sodium sulfate is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

polyethylene glycol, potassium chloride, sodium bicarbonate, sodium chloride, and sodium sulfate has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

PotassiumPolyethylene Glycol

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Sodium BicarbonateSodium Chloride

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

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 polyethylene glycol, potassium chloride, sodium bicarbonate, sodium chloride, and sodium sulfate, 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 polyethylene glycol, potassium chloride, sodium bicarbonate, sodium chloride, and sodium sulfate with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Amantadine


• Atropine


• Belladonna


• Belladonna Alkaloids


• Benztropine


• Biperiden


• Clidinium


• Darifenacin


• Dicyclomine


• Eplerenone


• Glycopyrrolate


• Hyoscyamine


• Methscopolamine


• Oxybutynin


• Procyclidine


• Scopolamine


• Solifenacin


• Tolterodine


• Trihexyphenidyl

Using polyethylene glycol, potassium chloride, sodium bicarbonate, sodium chloride, and sodium sulfate 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.

• Alacepril


• Amiloride


• Benazepril


• Canrenoate


• Captopril


• Cilazapril


• Delapril


• Enalaprilat


• Enalapril Maleate


• Fosinopril


• Imidapril


• Indomethacin


• Licorice


• Lisinopril


• Moexipril


• Pentopril


• Perindopril


• Quinapril


• Ramipril


• Spirapril


• Spironolactone


• Temocapril


• Trandolapril


• Triamterene


• Zofenopril

Using polyethylene glycol, potassium chloride, sodium bicarbonate, sodium chloride, and sodium sulfate with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Dasatinib


• Itraconazole


• Licorice

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.

Other Medical Problems

The presence of other medical problems may affect the use of polyethylene glycol, potassium chloride, sodium bicarbonate, sodium chloride, and sodium sulfate. Make sure you tell your doctor if you have any other medical problems, especially:

• Blockage or obstruction of the intestine or


• Paralytic ileus or


• Perforated bowel or


• Toxic colitis or


• Toxic megacolon—PEG-electrolyte solution may make these conditions worse; in some cases the colon may rip open or tear

Proper Use of polyethylene glycol, potassium chloride, sodium bicarbonate, sodium chloride, and sodium sulfate

Your doctor may have special instructions for you, depending on the type of test you are going to have. If you have not received such instructions or if you do not understand them, check with your doctor in advance.

Take the PEG-electrolyte solution exactly as directed . Otherwise, the test you are going to have may not work and may have to be done again.

It will take close to 3 hours to drink all of the PEG-electrolyte solution. The first bowel movement may start an hour or so after you start drinking the solution. Continue drinking all the solution to get the best results, unless otherwise directed by your doctor.

Do not eat anything for at least 3 hours before taking the PEG-electrolyte solution. If you do so, the colon may not get completely clean. If you are drinking the PEG-electrolyte solution the evening before the test, you may drink clear liquids (e.g., water, ginger ale, decaffeinated cola, decaffeinated tea, broth, gelatin) up until the time of the test. However, check first with your doctor.

For patients using the powder form of polyethylene glycol, potassium chloride, sodium bicarbonate, sodium chloride, and sodium sulfate :

• The powder must be mixed with water before it is used. Add lukewarm water to the fill mark on the bottle.


• Shake well until all the ingredients are dissolved.


• Do not add any other ingredients, such as flavoring, to the solution.


• After you mix the solution, you must use it within 48 hours.

Dosing

The dose of polyethylene glycol, potassium chloride, sodium bicarbonate, sodium chloride, and sodium sulfate 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 polyethylene glycol, potassium chloride, sodium bicarbonate, sodium chloride, and sodium sulfate. 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 cleaning the colon:
  
  • For oral dosage forms (oral solution and powder for oral solution):
    
    • Adults and teenagers—Drink one full glass (8 ounces) of the PEG-electrolyte solution rapidly every ten minutes. If you sip small amounts of the solution, it will not work as well.
    
    
    • Children—The amount of PEG-electrolyte solution taken is based on body weight and must be determined by your doctor. It is usually 25 to 40 milliliters (mL) per kilogram (kg) (11.3 to 18.2 mL per pound) of body weight per hour.
    
    
  
  

Storage

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

polyethylene glycol, potassium chloride, sodium bicarbonate, sodium chloride, and sodium sulfate 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.

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

Rare

• Skin rash

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

• Bloating


• nausea

Less common

• Abdominal or stomach cramps


• irritation of the anus


• vomiting

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.

More polyethylene glycol, potassium chloride, sodium bicarbonate, sodium chloride, and sodium sulfate resources

• Polyethylene glycol, potassium chloride, sodium bicarbonate, sodium chloride, and sodium sulfate Use in Pregnancy & Breastfeeding
• Polyethylene glycol, potassium chloride, sodium bicarbonate, sodium chloride, and sodium sulfate Support Group
• 39 Reviews for Polyethylene glycol, potassium chloride, sodium bicarbonate, sodium chloride, and sodium sulfate - Add your own review/rating

Compare polyethylene glycol, potassium chloride, sodium bicarbonate, sodium chloride, and sodium sulfate with other medications

• Bowel Preparation
• Constipation, Chronic
• Gastrointestinal Decontamination

Portia

Generic Name: ethinyl estradiol and levonorgestrel (ETH in ill ess tra DYE ol and LEE vo nor JESS trel)

Brand Names: Alesse, Aviane, Enpresse, Lessina, Levlen, Levlite, Levora, Lutera, Lybrel, Nordette, Portia, Sronyx, Tri-Levlen, Triphasil-21, Triphasil-28, Trivora-28

What is Portia (ethinyl estradiol and levonorgestrel)?

Ethinyl estradiol and levonorgestrel contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Ethinyl estradiol and levonorgestrel are used as contraception to prevent pregnancy.

Ethinyl estradiol and levonorgestrel may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Portia (ethinyl estradiol and levonorgestrel)?

Do not use ethinyl estradiol and levonorgestrel if you are pregnant or if you recently had a baby. Do not use this medication if you have a history of stroke or blood clot, circulation problems (especially if caused by diabetes), a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, severe high blood pressure, migraine headaches, a heart valve disorder, or a history of jaundice caused by birth control pills. Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

What should I discuss with my healthcare provider before taking Portia (ethinyl estradiol and levonorgestrel)?

This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills (6 weeks if you are breast-feeding). Do not use this medication if you have:

• 
  

  a history of a stroke or blood clot;

  
  


• 
  

  circulation problems (especially if caused by diabetes);

  
  


• 
  

  a hormone-related cancer such as breast or uterine cancer;

  
  


• 
  

  abnormal vaginal bleeding;

  
  


• 
  

  liver disease or liver cancer;

  
  


• 
  

  severe high blood pressure;

  
  


• 
  

  severe migraine headaches;

  
  


• 
  

  a heart valve disorder; or

  
  


• 
  

  a history of jaundice caused by birth control pills.

  
  

Before using this medication, tell your doctor if you have:

• 
  

  high blood pressure, heart disease, congestive heart failure, angina (chest pain), or a history of heart attack;

  
  


• 
  

  high cholesterol or if you are overweight;

  
  


• 
  

  a history of depression;

  
  


• 
  

  gallbladder disease;

  
  


• 
  

  diabetes;

  
  


• 
  

  seizures or epilepsy;

  
  


• 
  

  a history of irregular menstrual cycles;

  
  


• 
  

  a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram;

  
  


• 
  

  uterine fibroid tumors;

  
  


• 
  

  varicose veins; or

  
  


• 
  

  tuberculosis.

  
  

The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby.

How should I take Portia (ethinyl estradiol and levonorgestrel)?

Take this medication exactly as it was prescribed for you. Do not take larger amounts, or take it for longer than recommended by your doctor. You will take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

Some 28-day birth control packs contain seven "reminder" pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.

Breakthrough bleeding may occur, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the next day. You may get pregnant if you do not use this medication regularly.

If you need to have any type of medical tests or surgery, or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.

Store this medication at room temperature away from moisture and heat.

What happens if I miss a dose?

Missing a pill increases your risk of becoming pregnant.

If you miss one "active" pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.

If you miss two "active" pills in a row in week one or two, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.

If you miss two "active" pills in a row in week three, or if you miss three pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new one the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.

If you miss three "active" pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new pack on the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.

If you miss two or more pills, you may not have a period during the month. If you miss a period for two months in a row, call your doctor because you might be pregnant.

If you miss any reminder pills, throw them away and keep taking one pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

What should I avoid while taking Portia (ethinyl estradiol and levonorgestrel)?

Do not smoke while using birth control pills, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.

Birth control pills will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Portia (ethinyl estradiol and levonorgestrel) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

• 
  

  sudden numbness or weakness, especially on one side of the body;

  
  


• 
  

  sudden headache, confusion, pain behind the eyes, problems with vision, speech, or balance;

  
  


• 
  

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

  
  


• 
  

  a change in the pattern or severity of migraine headaches;

  
  


• 
  

  nausea, stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);

  
  


• 
  

  swelling in your hands, ankles, or feet; or

  
  


• 
  

  symptoms of depression (sleep problems, weakness, mood changes).

  
  

Less serious side effects may include:

• 
  

  mild nausea, vomiting, bloating, stomach cramps;

  
  


• 
  

  breast pain, tenderness, or swelling;

  
  


• 
  

  freckles or darkening of facial skin;

  
  


• 
  

  increased hair growth, loss of scalp hair;

  
  


• 
  

  changes in weight or appetite;

  
  


• 
  

  problems with contact lenses;

  
  


• 
  

  vaginal itching or discharge;

  
  


• 
  

  changes in your menstrual periods, decreased sex drive; or

  
  


• 
  

  headache, nervousness, dizziness, tired feeling.

  
  

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

What other drugs will affect Portia (ethinyl estradiol and levonorgestrel)?

Some drugs can make birth control pills less effective, which may result in pregnancy. Before using birth control pills, tell your doctor if you are using any of the following drugs:

• 
  

  acetaminophen (Tylenol) or ascorbic acid (vitamin C);

  
  


• 
  

  prednisolone (Orapred);

  
  


• 
  

  theophylline (Respbid, Theo-Dur);

  
  


• 
  

  cyclosporine (Neoral, Sandimmune, Gengraf);

  
  


• 
  

  St. John's wort;

  
  


• 
  

  an antibiotic;

  
  


• 
  

  seizure medications;

  
  


• 
  

  a barbiturate sedative such as secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or

  
  


• 
  

  HIV or AIDS medications.

  
  

This list is not complete and there may be other drugs not listed that can affect birth control pills. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Portia resources

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

• Portia Prescribing Information (FDA)


• Alesse Advanced Consumer (Micromedex) - Includes Dosage Information


• Alesse Prescribing Information (FDA)


• Alesse Consumer Overview


• Alesse MedFacts Consumer Leaflet (Wolters Kluwer)


• Altavera Prescribing Information (FDA)


• Amethia Prescribing Information (FDA)


• Amethyst Prescribing Information (FDA)


• Aviane Consumer Overview


• Camrese Prescribing Information (FDA)


• Enpresse Prescribing Information (FDA)


• Jolessa Prescribing Information (FDA)


• Jolessa MedFacts Consumer Leaflet (Wolters Kluwer)


• Lessina Prescribing Information (FDA)


• Levlite Prescribing Information (FDA)


• Levora Prescribing Information (FDA)


• LoSeasonique MedFacts Consumer Leaflet (Wolters Kluwer)


• LoSeasonique Prescribing Information (FDA)


• LoSeasonique Consumer Overview


• Lybrel Consumer Overview


• Lybrel MedFacts Consumer Leaflet (Wolters Kluwer)


• Lybrel Prescribing Information (FDA)


• Nordette Prescribing Information (FDA)


• Orsythia Prescribing Information (FDA)


• Preven EC Consumer Overview


• Quasense Prescribing Information (FDA)


• Seasonale Consumer Overview


• Seasonale Prescribing Information (FDA)


• Seasonique Prescribing Information (FDA)


• Seasonique Consumer Overview


• Sronyx Prescribing Information (FDA)


• Tri-Levlen Advanced Consumer (Micromedex) - Includes Dosage Information


• Triphasil Prescribing Information (FDA)


• Triphasil Consumer Overview

Compare Portia with other medications

• Abnormal Uterine Bleeding
• Birth Control
• Endometriosis
• Gonadotropin Inhibition
• Ovarian Cysts
• Polycystic Ovary Syndrome

Where can I get more information?

• Your pharmacist can provide more information about ethinyl estradiol and levonorgestrel.

See also: Portia side effects (in more detail)

Potassium Acetate

Potassium Acetate

Injection, USP

40 mEq in 20 mL

(2 mEq K+ and 2 mEq CH3COO−/mL)

FOR ADDITIVE USE ONLY AFTER

DILUTION IN I.V. FLUIDS

Plastic Vial

Rx only

Potassium Acetate Description

Potassium Acetate Injection, USP, 40 mEq (2 mEq/mL) is a sterile, nonpyrogenic, concentrated solution of Potassium Acetate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted.

Each 20 mL vial contains 3.93 g of Potassium Acetate which provides 40 mEq each of potassium (K+) and acetate (CH3COO−). It contains no bacteriostat, antimicrobial agent or added buffer. May contain acetic acid for pH adjustment. pH 6.2 (5.5 to 8.0). The osmolar concentration is 4 mOsmol/mL (calc.).

The solution is intended as an alternative to potassium chloride to provide potassium ion (K+) for addition to large volume infusion fluids for intravenous use.

Potassium Acetate, USP is chemically designated CH3COOK, colorless crystals or white crystalline powder very soluble in water.

The semi-rigid vial is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration.

Potassium Acetate - Clinical Pharmacology

As the principal cation of the intracellular fluid, potassium plays an important role in fluid and electrolyte balance. The normal potassium concentration in the intracellular fluid compartment is about 160 mEq/liter. The normal serum potassium range is 3.5 to 5.0 mEq/liter. The kidney normally regulates potassium balance but does not conserve potassium as well or as promptly as it conserves sodium. The daily turnover of potassium in the normal adult averages 50 to 150 mEq (milliequivalents) and represents 1.5 to 5% of the total potassium content of the body.

Acetate (CH3COO−), a source of hydrogen ion acceptors, is an alternate source of bicarbonate (HCO3−) by metabolic conversion in the liver. This has been shown to proceed readily, even in the presence of severe liver disease.

Indications and Usage for Potassium Acetate

Potassium Acetate Injection, USP, 40 mEq is indicated as a source of potassium, for the addition to large volume intravenous fluids, to prevent or correct hypokalemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.

Contraindications

Potassium administration is contraindicated in patients with severe renal insufficiency or adrenal insufficiency and in diseases where high potassium levels may be encountered.

Warnings

Potassium Acetate Injection, USP, 40 mEq must be diluted before use.

To avoid potassium intoxication, infuse potassium-containing solutions slowly. Potassium replacement therapy should be monitored whenever possible by continuous or serial electrocardiography (ECG). Serum potassium levels are not necessarily dependable indicators of tissue potassium levels.

Solutions which contain potassium ions should be used with great care, if at all, in patients with hyperkalemia, severe renal failure and in conditions in which potassium retention is present.

In patients with diminished renal function, administration of solutions containing potassium ions may result in potassium retention.

Solutions containing acetate ions should be used with great care in patients with metabolic or respiratory alkalosis. Acetate should be administered with great care in those conditions in which there is an increased level or an impaired utilization of this ion, such as severe hepatic insufficiency.

WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

Precautions

Do not administer unless solution is clear and seal is intact. Discard unused portion.

Potassium replacement therapy should be guided primarily by ECG monitoring and secondarily by the serum potassium level.

High plasma concentrations of potassium may cause death by cardiac depression, arrhythmias or arrest.

Use with caution in the presence of cardiac disease, particularly in digitalized patients or in the presence of renal disease.

Solutions containing acetate ion should be used with caution as excess administration may result in metabolic alkalosis.

Pregnancy Category C.

Animal reproduction studies have not been conducted with Potassium Acetate. It is also not known whether Potassium Acetate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Potassium Acetate should be given to a pregnant woman only if clearly needed.

Pediatric Use: The safety and effectiveness of Potassium Acetate have been established in pediatric patients.

Geriatric Use: An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Potassium ions are known to be substantially excreted by the kidney, and the risk of toxic reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Adverse Reactions

Adverse reactions involve the possibility of potassium intoxication. The signs and symptoms of potassium intoxication include paresthesias of the extremities, flaccid paralysis, listlessness, mental confusion, weakness and heaviness of the legs, hypotension, cardiac arrhythmias, heart block, electrocardiographic abnormalities such as disappearance of P waves, spreading and slurring of the QRS complex with development of a biphasic curve and cardiac arrest. See WARNINGS and PRECAUTIONS.

Overdosage

In the event of overdosage, discontinue infusion containing Potassium Acetate immediately and institute corrective therapy as indicated to reduce elevated serum potassium levels and restore acid-base balance if necessary. See WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS.

Potassium Acetate Dosage and Administration

Potassium Acetate Injection, USP, 40 mEq is administered intravenously only after dilution in a larger volume of fluid. The dose and rate of administration are dependent upon the individual needs of the patient. ECG and serum potassium should be monitored as a guide to dosage. Using aseptic technique, all or part of the contents of one or more vials may be added to other intravenous fluids to provide any desired number of milliequivalents (mEq) of potassium (K+) with an equal number of milliequivalents of acetate (CH3COO−).

Maximum infusion rate: The infusion rate should not exceed 1 mEq/kg/hr.

Normal daily requirements:

Newborn:    2-6 mEq/kg/24 hr.

Children:        2-3 mEq/kg/24 hr.

Adult:            40-80 mEq/24 hr.

Intraosseous infusion can be an alternate route for drug administration when intravenous access is not readily available.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.

How is Potassium Acetate Supplied

Potassium Acetate Injection, USP, 40 mEq (2 mEq/mL) of K+ is supplied in a 20 mL partial-fill single-dose fliptop vial (List 8183).

Each container is partially filled to provide air space for complete vacuum withdrawal of the contents into the I.V. container.

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

Revised: October, 2004

 

©Hospira 2004        EN - 0501        Printed in USA

HOSPIRA, INC., LAKE FOREST, IL 60045 USA

RL-0587

Potassium Acetate  Potassium Acetate  injection, solution, concentrate

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0409-8183 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Potassium Acetate (POTASSIUM CATION) Potassium Acetate 3.93 g  in 20 mL

Inactive Ingredients Ingredient Name Strength WATER   ACETIC ACID

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0409-8183-01 25 VIAL In 1 TRAY contains a VIAL, SINGLE-DOSE 1 20 mL In 1 VIAL, SINGLE-DOSE This package is contained within the TRAY (0409-8183-01)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA018896	08/16/2011

Labeler - Hospira, Inc. (141588017)

Revised: 08/2011Hospira, Inc.

More Potassium Acetate resources

• Potassium Acetate Side Effects (in more detail)
• Potassium Acetate Drug Interactions
• Potassium Acetate Support Group
• 0 Reviews · Be the first to review/rate this drug

Polycitra-K

Generic Name: citric acid and potassium citrate (SIT rik AS id and poe TASS ee um SIT rayt)

Brand Names: Cytra-K, Poly-Citra K Crystals, Polycitra-K

What is Polycitra-K (citric acid and potassium citrate)?

Citric acid is an alkalinizing agent that make the urine less acidic.

Potassium is a mineral that is found in many foods and is needed for several functions of your body, especially the beating of your heart.

The combination of citric acid and potassium citrate is used to treat or prevent hypokalemia (low levels of potassium in the blood). Citric acid and potassium citrate is also used to treat digitalis overdose.

Citric acid and potassium citrate may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Polycitra-K (citric acid and potassium citrate)?

You should not use this medication if you have kidney failure, a urinary tract infection, uncontrolled diabetes, a peptic ulcer in your stomach, Addison's disease, severe burns or other tissue injury, if you are dehydrated, if you take certain diuretics (water pills), or if you have high levels of potassium in your blood (hyperkalemia).

You should not take citric acid and potassium citrate tablets if you have problems with your esophagus, stomach, or intestines that make it difficult for you to swallow or digest pills.

Avoid lying down for at least 30 minutes after you take this medication.

To be sure this medication is helping your condition, your blood may need to be tested often. Your heart rate may also be checked using an electrocardiograph or ECG (sometimes called an EKG) to measure electrical activity of the heart. This test will help your doctor determine how long to treat you with potassium. Do not miss any scheduled appointments.

Serious side effects of citric acid and potassium citrate include uneven heartbeat, muscle weakness or limp feeling, severe stomach pain, and numbness or tingling in your hands, feet, or around your mouth.

Do not stop taking this medication without first talking to your doctor. If you stop taking potassium suddenly, your condition may become worse.

What should I discuss with my healthcare provider before taking Polycitra-K (citric acid and potassium citrate)?

You should not use this medication if you are allergic to it, or if you have certain conditions. Be sure your doctor knows if you have:

• 
  

  high levels of potassium in your blood (hyperkalemia);

  
  


• 
  

  a serious heart rhythm disorder called ventricular fibrillation;

  
  


• 
  

  kidney failure with sodium loss;

  
  


• 
  

  Addison's disease (an adrenal gland disorder);

  
  


• 
  

  a large tissue injury such as a severe burn; or

  
  


• 
  

  if you are severely dehydrated.

  
  

You should not take citric acid and potassium citrate tablets if you have problems with your esophagus, stomach, or intestines that make it difficult for you to swallow or digest pills.

Before using citric acid and potassium citrate, tell your doctor if you are allergic to any drugs, or if you have:

• kidney disease;


• 
  

  if you are taking a "potassium-sparing" diuretic (water pill) such as amiloride (Midamor, Moduretic), spironolactone (Aldactone, Aldactazide), triamterene (Dyrenium, Dyazide, Maxzide).

  
  


• 
  

  a urinary tract infection;

  
  


• 
  

  untreated or uncontrolled diabetes;

  
  


• 
  

  a peptic ulcer in your stomach;

  
  


• 
  

  congestive heart failure, enlarged heart, or history of heart attack;

  
  


• 
  

  other heart disease or high blood pressure;

  
  


• 
  

  diabetes;

  
  


• 
  

  a blockage in your stomach or intestines; or

  
  


• 
  

  chronic diarrhea (such as ulcerative colitis, Crohn's disease).

  
  

If you have any of these conditions, you may need a dose adjustment or special tests to safely take citric acid and potassium citrate.

It is not known whether this medication is harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether potassium passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Polycitra-K (citric acid and potassium citrate)?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Measure the liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

The liquid form of this medication should be mixed with at least 8 ounces (one cup) of cold water or fruit juice. Drink the mixture slowly, over 5 to 10 minutes in all. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

Citric acid and potassium citrate is usually taken 3 times daily after meals. Follow your doctor's instructions.

Avoid lying down for at least 30 minutes after you take this medication. Your treatment may include a special diet. It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you should eat or avoid to help control your condition.

To be sure this medication is helping your condition, your blood may need to be tested often. Your heart rate may also be checked using an electrocardiograph or ECG (sometimes called an EKG) to measure electrical activity of the heart. This test will help your doctor determine how long to treat you with potassium. Do not miss any scheduled appointments.

Do not stop taking this medication without first talking to your doctor. If you stop taking potassium suddenly, your condition may become worse. Store citric acid and potassium citrate at room temperature away from moisture, heat, or freezing. Keep the medication in a closed container.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include numbness and tingling, confusion, heavy feeling in your arms or legs, muscle weakness, limp feeling, slow heart rate, weak pulse, fainting, and slow breathing (breathing may stop).

What should I avoid while taking Polycitra-K (citric acid and potassium citrate)?

Avoid taking potassium supplements or using other foods or products that contain potassium without first asking your doctor. Salt substitutes or low-salt dietary products often contain potassium. If you take certain products together you may accidentally get too much potassium. Read the label of any other medicine you are using to see if it contains potassium.

You may also need to avoid eating potassium-rich foods while you are taking this medication. Foods that are high in potassium include many green leafy vegetables, squash, yams, beets, avocado, lima beans, kidney beans, pinto beans, lentils, split peas, soybeans, papaya, figs, prunes, and fish such as halibut, cod, snapper, and tuna.

It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you must avoid to help control your condition.

Polycitra-K (citric acid and potassium citrate) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

• 
  

  severe stomach pain, ongoing diarrhea or vomiting;

  
  


• 
  

  black, bloody, or tarry stools;

  
  


• 
  

  coughing up blood;

  
  


• 
  

  fast, slow, or uneven heart rate;

  
  


• 
  

  muscle weakness, pain, or twitching;

  
  


• 
  

  numbness or tingly feeling in your hands or feet, or around your mouth;

  
  


• 
  

  confusion, anxiety, weakness, mood changes, or feeling irritable;

  
  


• 
  

  swelling in your ankles or feet; or

  
  


• 
  

  seizure (convulsions).

  
  

Less serious side effects may include:

• 
  

  mild nausea, vomiting, or upset stomach;

  
  


• 
  

  mild or occasional diarrhea; or

  
  


• 
  

  appearance of a citric acid and potassium citrate tablet in your stool.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Polycitra-K (citric acid and potassium citrate)?

The following drugs can interact with citric acid and potassium citrate. Tell your doctor if you are using any of these:

• 
  

  eplerenone (Inspra);

  
  


• 
  

  candesartan (Atacand), losartan (Cozaar, Hyzaar), valsartan (Diovan), or telmisartan (Micardis);

  
  


• 
  

  quinidine (Quinaglute, Quinidex, Quin-Release);

  
  


• 
  

  an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), or trandolapril (Mavik); or

  
  


• 
  

  any type of diuretic (water pill) such as bumetanide (Bumex), chlorothiazide (Diuril), chlorthalidone (Hygroton, Thalitone), ethacrynic acid (Edecrin), furosemide (Lasix), hydrochlorothiazide (HCTZ, HydroDiuril, Hyzaar, Lopressor, Vasoretic, Zestoretic), indapamide (Lozol), metolazone (Mykrox, Zarxolyn), or torsemide (Demadex).

  
  

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

More Polycitra-K resources

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

• Polycitra-K Advanced Consumer (Micromedex) - Includes Dosage Information


• Polycitra-K Powder Pack MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Polycitra-K with other medications

• Urinary Alkalinization
• Urinary Tract Stones

Where can I get more information?

• Your pharmacist can provide more information about citric acid and potassium citrate.

See also: Polycitra-K side effects (in more detail)

Polymyxin B Injection

Polymyxin B for Injection, USP

500,000 units

SAGENT™

Rx Only

To reduce the development of drug-resistant bacteria and maintain the effectiveness of polymyxin B and other antibacterial drugs, polymyxin B should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

WARNING

CAUTION: WHEN THIS DRUG IS GIVEN INTRAMUSCULARLY AND/OR INTRATHECALLY, IT SHOULD BE GIVEN ONLY TO HOSPITALIZED PATIENTS, SO AS TO PROVIDE CONSTANT SUPERVISION BY A PHYSICIAN.

RENAL FUNCTION SHOULD BE CAREFULLY DETERMINED AND PATIENTS WITH RENAL DAMAGE AND NITROGEN RETENTION SHOULD HAVE REDUCED DOSAGE. PATIENTS WITH NEPHROTOXICITY DUE TO POLYMYXIN B SULFATE USUALLY SHOW ALBUMINURIA, CELLULAR CASTS, AND AZOTEMIA. DIMINISHING URINE OUTPUT AND A RISING BUN ARE INDICATIONS FOR DISCONTINUING THERAPY WITH THIS DRUG.

NEUROTOXIC REACTIONS MAY BE MANIFESTED BY IRRITABILITY, WEAKNESS, DROWSINESS, ATAXIA, PERIORAL PARESTHESIA, NUMBNESS OF THE EXTREMITIES, AND BLURRING OF VISION. THESE ARE USUALLY ASSOCIATED WITH HIGH SERUM LEVELS FOUND IN PATIENTS WITH IMPAIRED RENAL FUNCTION AND/OR NEPHROTOXICITY.

THE CONCURRENT OR SEQUENTIAL USE OF OTHER NEUROTOXIC AND/OR NEPHROTOXIC DRUGS WITH POLYMYXIN B SULFATE, PARTICULARLY BACITRACIN, STREPTOMYCIN, NEOMYCIN, KANAMYCIN, GENTAMICIN, TOBRAMYCIN, AMIKACIN, CEPHALORIDINE, PAROMOMYCIN, VIOMYCIN, AND COLISTIN SHOULD BE AVOIDED.

THE NEUROTOXICITY OF POLYMYXIN B SULFATE CAN RESULT IN RESPIRATORY PARALYSIS FROM NEUROMUSCULAR BLOCKADE, ESPECIALLY WHEN THE DRUG IS GIVEN SOON AFTER ANESTHESIA AND/OR MUSCLE RELAXANTS.

USAGE IN PREGNANCY: THE SAFETY OF THIS DRUG IN HUMAN PREGNANCY HAS NOT BEEN ESTABLISHED.

DESCRIPTION

Polymyxin B for Injection, USP is one of a group of basic polypeptide antibiotics derived from B polymyxa (B aerosporous). Polymyxin B sulfate is the sulfate salt of Polymyxins B1 and B2, which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillacea). The chemical name of polymyxin B sulfate is N - [4 - amino - 1 - [[1 - [[4 - amino - 1 - oxo - 1 - [[6,9,18 - tris(2 - aminoethyl) - 15 - benzyl - 3 - (1 - hydroxyethyl) - 12 - (2 - methylpropyl) - 2,5,8,11,14,17,20 - heptaoxo - 1,4,7,10,13,16,19 - heptazacyclotricos - 21 - yl]amino]butan - 2 - yl]amino] - 3 - hydroxy - 1 - oxobutan - 2 - yl]amino] - 1 - oxobutan - 2 - yl] - 6 - methyloctanamide; sulfuric acid. It has a potency of not less than 6000 polymyxin B units per mg, calculated on the anhydrous basis. The structural formulae are:

Each vial contains Polymyxin B Sulfate equivalent to 500,000 polymyxin B units for parenteral or ophthalmic administration.

Polymyxin B for Injection, USP is a white to almost white colored powder suitable for preparation of sterile solutions for intramuscular, intravenous drip, intrathecal, or ophthalmic use.

In the medical literature, dosages have frequently been given in terms of equivalent weights of pure polymyxin B base. Each milligram of pure polymyxin B base is equivalent to 10,000 units of polymyxin B and each microgram of pure polymyxin B base is equivalent to 10 units of polymyxin B.

Aqueous solutions of polymyxin B sulfate may be stored up to 12 months without significant loss of potency if kept under refrigeration. In the interest of safety, solutions for parenteral use should be stored under refrigeration and any unused portion should be discarded after 72 hours. Polymyxin B sulfate should not be stored in alkaline solutions since they are less stable.

CLINICAL PHARMACOLOGY

Polymyxin B sulfate has a bactericidal action against almost all gram-negative bacilli except the Proteus group. Polymyxins increase the permeability of bacterial cell wall membranes. All gram-positive bacteria, fungi, and the gram-negative cocci, N gonorrhoeae and N meningitidis, are resistant.

Polymyxin B has bactericidal action against almost all Gram-negative bacilli except the Proteus group. Polymyxins increase the permeability of the bacterial cell membrane leading to death of the cell. All Gram-positive bacteria, fungi, and Gram-negative cocci, are resistant to polymyxin B. Appropriate methods should be used when performing in vitro susceptibility testing of polymyxin B (1,2,3). The following in vitro susceptibility test criteria should only be used for interpreting the results of polymyxin B susceptibility testing against P. aeruginosa when the indicated quality control parameters are met during testing.

In vitro susceptibility test interpretive criteria for polymyxin B sulfate against Pseudomonas aeruginosa
	Minimal Inhibitory Concentration (MIC) (mcg/mL)				Disk Diffusion Interpretive Criteria (mm) (300 unit disk)
Pathogen	Susceptible	Intermediate	Resistant		Susceptible	Intermediate	Resistant
Pseudomonas aeruginosa	≤2	4	≥8		≥12	-	≤11

In vitro susceptibility test quality control ranges for polymyxin B sulfate against Pseudomonas aeruginosa
Quality Control Organism (ATCC* Number)	Minimal Inhibitory Concentration (MIC) Range (mcg/mL)	Disk Diffusion Quality Control Range (300 unit disk) (mm)
Pseudomonas aeruginosa (27853)	1 - 4	14 - 18

Polymyxin B sulfate is not absorbed from the normal alimentary tract. Since the drug loses 50 percent of its activity in the presence of serum, active blood levels are low. Repeated injections may give a cumulative effect. Levels tend to be higher in infants and children. The drug is excreted slowly by the kidneys. Tissue diffusion is poor and the drug does not pass the blood brain barrier into the cerebrospinal fluid. In therapeutic dosage, polymyxin B sulfate causes some nephrotoxicity with tubule damage to a slight degree.

INDICATIONS AND USAGE

Acute Infections Caused by Susceptible Strains of Pseudomonas aeruginosa.

Polymyxin B sulfate is a drug of choice in the treatment of infections of the urinary tract, meninges, and bloodstream caused by susceptible strains of Ps. aeruginosa. It may also be used topically and subconjunctivally in the treatment of infections of the eye caused by susceptible strains of Ps. aeruginosa.

It may be indicated in serious infections caused by susceptible strains of the following organisms, when less potentially toxic drugs are ineffective or contraindicated:

H influenzae, specifically meningeal infections.

Escherichia coli, specifically urinary tract infections.

Aerobacter aerogenes, specifically bacteremia.

Klebsiella pneumoniae, specifically bacteremia.

NOTE: IN MENINGEAL INFECTIONS, POLYMYXIN B SULFATE SHOULD BE ADMINISTERED ONLY BY THE INTRATHECAL ROUTE.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of polymyxin B and other antibacterial drugs, polymyxin B should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

CONTRAINDICATIONS

This drug is contraindicated in persons with a prior history of hypersensitivity reactions to polymyxins.

WARNINGS

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Polymyxin B for Injection, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile and surgical evaluation should be instituted as clinically indicated.

PRECAUTIONS

General. Prescribing polymyxin B in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

See WARNING box.

Baseline renal function should be done prior to therapy, with frequent monitoring of renal function and blood levels of the drug during parenteral therapy.

Avoid concurrent use of a curariform muscle relaxant and other neurotoxic drugs (ether, tubocurarine, succinylcholine, gallamine, decamethonium and sodium citrate) which may precipitate respiratory depression. If signs of respiratory paralysis appear, respiration should be assisted as required, and the drug discontinued.

As with other antibiotics, use of this drug may result in overgrowth of nonsusceptible organisms, including fungi.

If superinfection occurs, appropriate therapy should be instituted.

Information for Patients. Patients should be counseled that antibacterial drugs including polymyxin B should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When polymyxin B is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by polymyxin B or other antibacterial drugs in the future.

Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

Adverse Reactions

See WARNING box.

Nephrotoxic reactions: Albuminuria, cylinduria, azotemia, and rising blood levels without any increase in dosage.

Neurotoxic reactions: Facial flushing, dizziness progressing to ataxia, drowsiness, peripheral paresthesias (circumoral and stocking glove), apnea due to concurrent use of curariform muscle relaxants, other neurotoxic drugs or inadvertent overdosage, and signs of meningeal irritation with intrathecal administration, e.g., fever, headache, stiff neck and increased cell count and protein cerebrospinal fluid.

Other reactions occasionally reported: Drug fever, urticarial rash, pain (severe) at intramuscular injection sites, and thrombophlebitis at intravenous injection sites.

To report SUSPECTED ADVERSE EVENTS, contact FDA at 1-800-FDA-1088 or www.fda.gov.

DOSAGE AND ADMINISTRATION

PARENTERAL:

Intravenous. Dissolve 500,000 polymyxin B units in 300 to 500 mL of 5% Dextrose Injection for continuous intravenous drip.

Adults and children. 15,000 to 25,000 units/kg body weight/day in individuals with normal kidney function. This amount should be reduced from 15,000 units/kg downward for individuals with kidney impairment. Infusions may be given every 12 hours; however, the total daily dose must not exceed 25,000 units/kg/day.

Infants. Infants with normal kidney function may receive up to 40,000 units/kg/day without adverse effects.

Intramuscular. Not recommended routinely because of severe pain at injection sites, particularly in infants and children. Dissolve 500,000 polymyxin B units in 2 mL sterile water for injection or 0.9% Sodium Chloride Injection or procaine hydrochloride injection 1%.

Adults and children. 25,000 to 30,000 units/kg/day. This should be reduced in the presence of renal impairment. The dosage may be divided and given at either 4 or 6 hour intervals.

Infants. Infants with normal kidney function may receive up to 40,000 units/kg/day without adverse effects.

Note: Doses as high as 45,000 units/kg/day have been used in limited clinical studies in treating prematures and newborn infants for sepsis caused by Ps aeruginosa.

Intrathecal. A treatment of choice for Ps aeruginosa meningitis. Dissolve 500,000 polymyxin B units in 10 mL 0.9% Sodium Chloride Injection for 50,000 units per mL dosage unit.

Adults and children over 2 years of age. Dosage is 50,000 units once daily intrathecally for 3 to 4 days, then 50,000 units once every other day for at least 2 weeks after cultures of the cerebrospinal fluid are negative and sugar content has returned to normal.

Children under 2 years of age. 20,000 units once daily, intrathecally for 3 to 4 days or 25,000 units once every other day. Continue with a dose of 25,000 units once every other day for at least 2 weeks after cultures of the cerebrospinal fluid are negative and sugar content has returned to normal.

IN THE INTEREST OF SAFETY, SOLUTIONS OF PARENTERAL USE SHOULD BE STORED UNDER REFRIGERATION, AND ANY UNUSED PORTIONS SHOULD BE DISCARDED AFTER 72 HOURS.

TOPICAL:

Ophthalmic. Dissolve 500,000 polymyxin B units in 20 to 50 mL sterile water for injection or 0.9% Sodium Chloride Injection for a 10,000 to 25,000 units per mL concentration.

For the treatment of Ps aeruginosa infections of the eye, a concentration of 0.1 percent to 0.25 percent (10,000 units to 25,000 units per mL) is administered 1 to 3 drops every hour, increasing the intervals as response indicates.

Subconjunctival injection of up to 100,000 units per day may be used for the treatment of Ps aeruginosa infections of the cornea and conjunctiva.

Note: Avoid total systemic and ophthalmic instillation over 25,000 units/kg/day.

HOW SUPPLIED

Each vial contains Polymyxin B Sulfate equivalent to 500,000 polymyxin B units and is supplied as follows:

NDC	Polymyxin B for Injection, USP	Package Factor
25021-117-10	500,000 units per vial	10 vials per carton

Storage Conditions

Before reconstitution: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Protect from light. Retain in carton until time of use.

After reconstitution: Product must be stored under refrigeration, between 2° and 8°C (36° and 46°F) and any unused portion should be discarded after 72 hours.

Sterile, Nonpyrogenic, Preservative-free.

The container closure is not made with natural rubber latex.

REFERENCES

1. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Test for Bacteria That Grow Aerobically; Approved Standard-8th edition. CLSI document M07-A8. CLSI, 940 West Valley Road, Suite 1400, Wayne, PA, 2009.


2. CLSI. Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard-10th edition. CLSI document M02-A10, 2009.


3. Clinical Laboratory and Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing: 21st Informational Supplement. CLSI document M100-S21. CLSI, 940 West Valley Rd., Suite 1400, Wayne, PA 19087, 2011.

SAGENT™

Mfd. for SAGENT Pharmaceuticals

Schaumburg, IL 60195 (USA)

Made in India

©2011 Sagent Pharmaceuticals, Inc.

Revised: May 2011

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – VIAL LABEL

NDC 25021-117-10 Rx only

Polymyxin B for Injection, USP

500,000 units per vial

Each vial contains Polymyxin B Sulfate equivalent to 500,000 polymyxin B units

Sterile

POLYMYXIN B  polymyxin b  injection, powder, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 25021-117 Route of Administration INTRAMUSCULAR, INTRATHECAL, INTRAVENOUS, OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Polymyxin B Sulfate (Polymyxin B) Polymyxin B Sulfate 500000 [iU]

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 25021-117-10 10 VIAL In 1 CARTON contains a VIAL 1 1 VIAL In 1 VIAL This package is contained within the CARTON (25021-117-10)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090110	08/01/2011

Labeler - Sagent Pharmaceuticals (796852890)

Revised: 08/2011Sagent Pharmaceuticals

More Polymyxin B Injection resources

• Polymyxin B Injection Use in Pregnancy & Breastfeeding
• Polymyxin B Injection Drug Interactions
• Polymyxin B Injection Support Group
• 0 Reviews · Be the first to review/rate this drug

Positive Skin Test Control Histamine

Dosage Form: injection

POSITIVE SKIN TEST CONTROL - HISTAMINE

For Percutaneous (Scratch, Prick or Puncture) Administration

Histamine Base: 6mg/mL

(Histamine Dihydrochloride: 10mg/mL)

This product is to be used by a physician or under the supervision of a physician.

Positive Skin Test Control Histamine Description

Histamine Dihydrochloride contains histamine, a potent vasodilator having the chemical name 2-(4-Imidazolyl) ethylamine. Histamine has an empirical formula of C5H9N3, a molecular weight of 111.15, and the following chemical structure:

Histamine Dihydrochloride is available in the following strengths:

1. SCRATCH, PRICK or PUNCTURE TEST CONTROL:

Positive Skin Test Control - Histamine contains 6.0 mg/mL Histamine Base and is a clear, colorless, sterile solution. It consists of Histamine Dihydrochloride 10mg/mL, Sodium Chloride 0.5%, Sodium Bicarbonate 0.275%, and Glycerin 50.0% (v/v) as a preservative.

Positive Skin Test Control Histamine - Clinical Pharmacology

Pharmacological actions of histamine include the increase of capillary and post capillary venular permeability. This vascular change leads to the wheal-flare response. Large reactions can cause an amplification of a reaction to a nearby skin test. Histamine is degraded either by oxidative deamination or by methylation and oxidative deamination so that the principal excretion products are imidazoleacetic acid-riboside and 1-methyl imidazoleacetic acid respectively.2

10 atopic subjects and 10 non-atopics were tested with Positive Skin Test Control - Histamine Solutions, and to negative control solutions. Thirteen females (35-49 years old; mean age 36.5) and 7 males (23-45 years old; mean age 36.4) were tested. This study included 19 Caucasian subjects and 1 African American subject. Different skin test devices produce different skin test responses. (14,15) Study results are summarized in Table 1 and Table 2. Atopic and non-atopic subject information was combined, as there were no significant differences in their skin responses.

Summation of wheal (∑W) or summation of erythema (∑E) was determined by measuring the longest diameter and the mid-point orthoganol diameter of the wheal or erythema response and summing the two measurements.

Malling tested 25 subjects using a straight needle prick technique with Histamine Dihydrochloride 10mg/mL and found wheal single diameters of 5.4-8.5mm (mean 7 mm). 13

Histamine Dihydrochloride at 10mg/mL has been shown to elicit fewer false negative and false positive reactions than Histamine Dihydrochloride at 1mg/mL. 12 10mg/mL Histamine Dihydrochloride has been shown to be the appropriate strength to perform biological standardization using skin reactivity to histamine as a standard of comparison.11,13

Indications and Usage for Positive Skin Test Control Histamine

Positive Skin Test Control - Histamine is indicated as an adjunct in allergy skin test for diagnosis, as a positive control to test wheal-flare response of skin for evaluation of skin test response to allergenic extracts.

Contraindications

Positive Skin Test Control - Histamine is contraindicated in patients with a history of hypersensitivity to histamine products, and in patients with hypotension, severe hypertension, vasomotor instability, severe cardiac, pulmonary or renal disease.

Warnings

Attacks of severe asthma or other serious allergic conditions may be precipitated by the administration of Histamine Dihydrochloride in patients with bronchial disease. Caution is advised in using histamine in such patients and in those with a history of bronchial asthma. Histamine Dihydrochloride has not been approved for unlabeled use as gastric acid stimulus or for detecting bronchial hyperactivity.

Precautions

(1) General: It is necessary that scarifiers, syringes, and needles be properly sterilized before use on each patient to prevent the possibility of accidental transfer of serum hepatitis and other infectious agents from one person to another. Disposable products may also be used.

Always have injectable epinephrine and a tourniquet available when any skin tests are being made. (See ADVERSE REACTIONS Section)

Patients should be observed in the office for 30 minutes after administration of the test and instructed to return to the office promptly if symptoms of an allergic reaction or shock occur.

(2) Drug Interactions: Certain medications may lessen the skin test wheal and erythema responses elicited by histamine for varying time periods. Conventional antihistamines should be discontinued at least 5 days before skin testing. Long acting antihistamines should be discontinued for at least 3 weeks prior to skin testing.7 Topical steroids should be discontinued at the skin test site for at least 2-3 weeks before skin testing.7,8

Tricyclic antidepressants such as Doxepin should be withheld for at least 7 days before skin testing.9 The physician must determine whether the risk of severe depression occurring in patients who discontinue their medication outweighs the benefits that could be obtained from skin testing. Topical local anesthetics may suppress the flare responses and should be avoided in skin test sites.10

(3) Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies have not been performed on Positive Skin Test Control-Histamine.

(4) Pregnancy: Pregnancy Category C. Positive Skin Test Control-Histamine. Animal reproduction studies have not been conducted on Histamine Dihydrochloride. It is also not known whether Histamine Dihydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Histamine Dihydrochloride should be given to a pregnant woman only if clearly needed.

(5) Nursing Mothers: It is unknown whether Histamine Dihydrochloride affects lactation or is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Positive Skin Test Control-Histamine is administered to a nursing woman.

(6) Pediatric Use: Indications and dosage for the pediatric population are the same as for adults; however, the reactions to histamine are smaller. Studies have shown that the use of histamine solutions for skin test is safe in infants and young children.4,5,6

Adverse Reactions

Large doses of histamine may precipitate systemic reactions. These reactions may include flushing, dizziness, headache, bronchial constriction, urticaria, asthma, marked hypotension or hypertension, abdominal cramps, vomiting, metallic taste, local or generalized allergic manifestations.

An antihistamine preparation may be given orally, I.M. or I.V. to prevent or ameliorate systemic reactions to the drug.

If a systemic or anaphylactic reaction does occur, apply a tourniquet above the site of injection and inject 1:1000 epinephrine-hydrochloride intramuscularly or subcutaneously into the opposite arm. Loosen the tourniquet at least every 10 minutes. Do not obstruct arterial blood flow with the tourniquet.

Epinephrine Dosage:

ADULT: 0.3 to 0.5 mL should be injected. Repeat in 5 to 10 minutes if necessary.

PEDIATRIC: The usual initial dose is 0.01 mg (mL) per kg body weight or 0.3 mg(mL) per square meter of body surface area. Suggested dosage for infants to 2 years of age is 0.05 mL to 0.1 mL; for children 2 to 6 years, 0.15 mL; and children 6 to 12 years, 0.2 mL. Single pediatric doses should not exceed 0.3 mg (mL). Doses may be repeated as frequently as every 20 minutes, depending on the severity of the condition and the response of the patient.

After administration of epinephrine, profound shock or vasomotor collapse should be treated with intravenous fluids, and possibly vasoactive drugs. Oxygen should be given by mask. Aminophylline or adrenal corticosteroids may be used if necessary after adequate epinephrine and circulatory support has been given.

Emergency resuscitation measures and personnel trained in their use should be available immediately in the event of a serious systemic or anaphylactic reaction not responsive to the above measures (Ref. J. ALLERGY AND CLINICAL IMMUNOLOGY 77 (2): p. 271-273, 1986).16

Rarely are all of the above measures necessary, the tourniquet and epinephrine usually producing prompt responses. However, the physician should be prepared in advance for all contingencies. Promptness in beginning emergency treatment measures is of utmost importance.

Overdosage

Overdosage may cause severe symptoms, including circulatory collapse, shock, and even death. Intravenous administration of histamine in normal volunteers at doses of up to 1.0 µg/kg/min produced flushing, headaches, tachycardia and decreased diastolic blood pressure. 1,2,3

See ADVERSE REACTIONS Section for emergency treatment steps.

Positive Skin Test Control Histamine Dosage and Administration

(1) General

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Prior to testing, clean the skin area with ether or alcohol and allow to dry. The back or the volar surface of the arms are the most satisfactory sites for testing.

Skin of the posterior thighs or abdomen may be used if necessary. Avoid very hairy areas where possible, since the reactions will be smaller and more difficult to interpret there. The most satisfactory areas of the back are from the posterior axillary fold to 2.5 cm from the spinal column, and from the top of the scapula to the lower rib margins. The best areas of the arms are the volar surfaces from the axilla to 2.5 or 5 cm above the wrist, skipping the anti-cubital space.

The histamine test should be applied in the same test area as other allergenic extracts tests, but spaced no closer than 4 to 5 cm from adjacent test sites. Use the same technique or procedure that you use for allergen testing.

The negative control is the diluent used in the extract to be tested (e.g. 50% glycerin, Sterile Albumin Saline with Phenol, Sterile Buffered Saline with Phenol).

With each skin testing method, in order for the reaction to Positive Skin Test Control-Histamine (6 mg/mL Histamine Base) to be considered valid, erythema must be present which exceeds the respective negative control by 4 mm (∑E). A wheal reaction does not have to be elicited unless there is a wheal reaction to the respective negative control. In this case, the wheal of the positive control must exceed the negative control by 4 mm (∑W) in order to be considered appropriate. Record measurement of erythema and wheal diameters.

Tables 1 and 2 summarize skin testing results with histamine base and controls in atopic and non-atopic subjects using four different devices and methods.

(2) Scratch, Prick or Puncture Test: Positive Skin Test Control-Histamine, 6.0 mg/mL Histamine Base.

The Scratch, Prick or Puncture test should be read in 15 minutes. If a large wheal reaction occurs before that time, wipe excess histamine solution from test site.

a) Use a sterile scarifier for each patient.

Hold the scarifier between the thumb and index finger, press the sharp edge of the instrument against the skin and twirl instrument rapidly. The scratch should disrupt the outer layers of epidermis down to the germinal layer, but should not produce immediate oozing of blood. The amount of pressure needed to produce a satisfactory scratch will vary between patients according to the thickness or fragility of their skin.

Apply one drop of Positive Skin Test Control-Histamine to the scratch test site.


b) Prick or Puncture Test: Prick tests are performed by placing a drop of extract on the skin and piercing through the drop into the skin with a slight lifting motion. Puncture tests are performed by placing a drop of extract on the skin and piercing through the drop perpendicular to the skin with a device such as a Prick Lancetter. After about 1 minute the extract may be wiped away with a dry sponge.

How is Positive Skin Test Control Histamine Supplied

SCRATCH, PRICK or PUNCTURE TEST: Positive Skin Test Control-Histamine (6.0 mg/mL Histamine Base), 5 mL sterile amber vial with dropper assembly.

STORAGE

Store at 2°- 8°C. Protect from light when not in use.

REFERENCES

1. Lawlor, Glenn Jr., Thomas J. Fischer, ed., Immediate hypersensitivity: approach to diagnosis. Manual of Allergy and Immunology Diagnosis and Therapy. Little Brown and Company, Boston, 19, 95, 1981.

2. Samter, Max, K. Frank Austin, ed.. Histamine and other mediators of allergic reactions. Immunological Diseases. Little, Brown and Company, Boston, pp. 332-335, 1971.

3. Summers, Richard, Robert Sigler, James H. Schelhamer, and Michael Kaliner. Effects of infused histamine on asthmatic and normal subjects: comparison of skin test responses. J. Allergy Clin. Immunol. 67 (6): 456-464, June 1981.

4. Gary, T.N., L.N. Gay. Skin reactions in infants: Susceptibility of the skin of the newborn to positive atopic sensitization, comparison with reaction to histamine. J. Allergy. 5:488, 1934.

5. Kaliner, M., J. H. Shelhamer, and E.A. Ottesen. Effects of infused histamine: Correlation of plasma histamine levels and symptoms. J. Allergy Clin. Immunol. 69 (3): 283-289.

6. Smith, M.A., L.E. Mansfeld, R. deShazo and H.S. Nelson. An evaluation of the pharmacologic inhibition of the immediate and late cutaneous effect to allergen. J. Allergy Clin. Immunol. 65: 188, 1980.

7. Pipkorn, Ulf. Pharmacological influence of anti-allergic medication on In Vivo allergen testing. Allergy. 43: 81-86, 1988.

8. Andersson, M. and U. Pipkorn. Inhibition of the dermal immediate allergic reaction through prolonged treatment with topical glucocorticosteroids. J. Allergy Clinical Immunology. 79(2): 345-349, February 1987.

9. Rao, Kamineni S., et al. Duration of suppressive effect of tricyclic anti-depressants on histamine induced wheal and flare reactions on human skin. J. Allergy Clinical Immunology. 82: 752-757, November 1988.

10. Pipkorn, Ulf, and M. Andersson. Topical dermal anesthesia inhibits the flare but not the wheal response to allergen and histamine in the skin prick test. Clinical Allergy. 17: 307-311, 1987.

11. Harris, R.I., M.A. Stern, H.K. Watson. Dose response curve of allergen and histamine in skin prick tests. Allergy. 43(8): 565-572, 1988.

12. Berkowitz, R.B., D.G. Tinkleman, C. Lutz, et al. Evaluation of the multi test device for immediate hypersensitivity skin testing. J. Allergy Clin. Immunol. 90:979-985, 1992.

13. Malling, H. J. Skin prick testing and the use of histamine references. Allergy. 39:596-601, 1984.

14. Demoly, P., J. Bousquet, J.C. Manderscheid, et al. Precision of skin prick and puncture tests with nine methods. J. Allergy Clin. Immunol. 88(5):758-762, Nov. 1991.

15. Nelson, H.S., D.M. Rosloniec, L.L. McCall, D. Ikle. Comparative performance of five commercial prick skin test devices. J. Allergy Clin. Immunol. 92:750-756, 1993.

16. Personnel and equipment to treat systemic reactions caused by immunotherapy with allergenic extracts. J. Allergy Clin. Immunol. 77(2):271-273, February 1986.

POSITIVE SKIN TEST CONTROL - HISTAMINE  histamine  injection

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-9998 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength histamine (histamine) histamine 6 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength sodium chloride   sodium bicarbonate   glycerin

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-9998-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103891	06/15/1995

Labeler - Hollister-Stier Laboratories LLC (069263643)

Registrant - Hollister-Stier Laboratories LLC (069263643)

Establishment
Name	Address	ID/FEI	Operations
Hollister-Stier Laboratories LLC		069263643	manufacture

Revised: 12/2009Hollister-Stier Laboratories LLC