Friday, September 30, 2016

Posatex Otic Suspension





Dosage Form: FOR ANIMAL USE ONLY
Posatex™ Otic Suspension

(Orbifloxacin, Mometasone Furoate Monohydrate and Posaconazole, Suspension)

Antibacterial, anti-inflammatory, antifungal


For Otic Use in Dogs Only


CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.


Federal law prohibits the extralabel use of this drug in food-producing animals.



Posatex Otic Suspension Description


Each gram of POSATEX™ Otic Suspension contains 10 mg of orbifloxacin; mometasone furoate monohydrate equivalent to 1 mg mometasone furoate; and 1 mg of posaconazole in a mineral oil based system containing a plasticized hydrocarbon gel.


Four drops of POSATEX™ Otic Suspension delivers approximately 1.0 mg orbifloxacin, 0.1 mg of mometasone furoate monohydrate, and 0.1 mg of posaconazole.



INDICATIONS


POSATEX™ Otic Suspension is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (coagulase positive staphylococci, Pseudomonas aeruginosa, and Enterococcus faecalis).



Posatex Otic Suspension Dosage and Administration


Shake well before use. For dogs weighing less than 30 lbs. instill 4 drops of POSATEX™ Otic Suspension once daily into the ear canal. For dogs weighing 30 lbs. or more, instill 8 drops once daily into the ear canal. Therapy should continue for 7 consecutive days.



Contraindications


POSATEX™ Otic Suspension is contraindicated in dogs with known or suspected hypersensitivity to quinolones, mometasone furoate monohydrate, or posaconazole. Do not use in dogs with known tympanic perforation (see PRECAUTIONS).



Warnings



Human Warnings


Not for use in humans. Keep out of reach of children.



Animal Warnings


Do not administer orally. Immediately discontinue use of POSATEX™ Otic Suspension if hearing loss is observed during treatment (see ADVERSE REACTIONS).



Precautions


The use of POSATEX™ Otic Suspension in dogs with perforated tympanic membranes has not been evaluated. The integrity of the tympanic membranes should be confirmed before administering this product.


Avoid prolonged or repeated use of POSATEX™ Otic Suspension. Long-term use of topical otic corticosteroids has been associated with adrenocortical suppression and iatrogenic hyperadrenocorticism in dogs (see ANIMAL SAFETY).


The safe use of POSATEX™ Otic Suspension in dogs used for breeding purposes, during pregnancy or in lactating bitches, has not been evaluated. The systemic administration of quinolones has been shown to produce cartilage erosions of weight bearing joints and other signs of arthropathy in immature animals of various species.



Adverse Reactions


In the field study, 143 dogs were treated with POSATEX™ Otic Suspension. Of those, 1 dog with bilateral otitis externa developed hearing loss. POSATEX™ Otic Suspension treatment was discontinued and the condition resolved after one week.


To report suspected adverse reactions, call 1-800-224-5318.


For a copy of the Material Safety Data Sheet (MSDS) call 1-800-770-8878.



Posatex Otic Suspension - Clinical Pharmacology



Orbifloxacin


Orbifloxacin is a synthetic fluoroquinolone antibacterial agent. The bactericidal action of fluoroquinolones is concentration-dependent and results from interference with bacterial DNA gyrase and topoisomerase IV. Since these enzymes are needed for bacterial DNA synthesis and transcription, fluoroquinolones disrupt bacterial replication and lead to bacterial cell death.



Mometasone


Mometasone furoate monohydrate is a topical corticosteroid characterized by a (2') furoate 17-ester having chlorine at the 9 and 21 positions.



Posaconazole


Posaconazole is a broad-spectrum triazole antifungal agent. The mechanism by which triazoles exert fungicidal action involves the selective inhibition of the enzyme lanosterol a C14 demethylase (a microsomal cytochrome P-450- dependent enzyme) involved in ergosterol biosynthesis in yeasts and filamentous fungi.


Systemic absorption of the active ingredients was determined in single-dose radiolabelled studies with 14C-orbifloxacin, 3H-mometasone furoate, and 14C-posaconazole contained within the POSATEX™ Otic Suspension formulation and placed into the ear canals of normal beagle dogs. Most of the absorption occurred in the first few days after administration. The extent of percutaneous absorption of topical medications is influenced by many factors including the integrity of the epidermal barrier. Inflammation can increase the percutaneous absorption of drugs.



EFFECTIVENESS


The effectiveness of POSATEX™ Otic Suspension was evaluated in a placebo-controlled, double-blind, multi-site field study. One hundred and ninety one dogs with naturally occurring clinical otitis externa associated with both yeast and bacteria were randomly allocated to either POSATEX™ Otic Suspension or placebo ointment. Of the 160 dogs evaluated for effectiveness, 122 were treated with POSATEX™ Otic Suspension and 38 were treated with placebo ointment. Treatments were administered once daily for 7 consecutive days. Assessment of effectiveness was based on improvement in clinical signs at re-evaluation 2-7 days following administration of the last dose.


Compared to the placebo, a significant percent of dogs treated with POSATEX™ Otic Suspension showed improvement in clinical signs (discomfort, erythema, and swelling) caused by otitis externa associated with one or more of the following organisms: Malassezia pachydermatis, coagulase positive staphylococci, Pseudomonas aeruginosa, and Enterococcus faecalis.



















Percent of Dogs Showing Improvement in Clinical Signs of Otitis Externa
Clinical SignPOSATEX™ Otic Suspension GroupPlacebo GroupSignificance
Discomfort88%45%p<0.0001
External Ear Canal Erythema81%39%p<0.0001
External Ear Canal Swelling83%49%p=0.0001

ANIMAL SAFETY


POSATEX™ Otic Suspension was administered at 1,3, and 5 times the recommended dosage for 21 consecutive days. The control group received the vehicle in both ears at the clinical dose given five times per day. There was a slight decrease in serum cortisol concentration after ACTH stimulation on Day 21 in the 5X group. Erythema was noted in all groups. Aural pain, swelling, or heat were each noted in 3 separate dogs in the 5X group.



STORAGE INFORMATION


Store at temperatures between 2°-30°C (35.6°-86°F).


Shake well before use.



How is Posatex Otic Suspension Supplied


POSATEX™ Otic Suspension is available in 7.5 g, 15 g, and 30 g plastic bottles.


NADA# 141-266, Approved by FDA.



Made in Germany.


Intervet Inc./Schering-Plough Animal Health.

© 2009 Intervet Inc., Roseland, NJ 07068.


All rights reserved.

Website Address 6/10


US 3093 V


US 3093 R



PRINCIPAL DISPLAY PANEL - 7.5 mg. Bottle Carton


NDC 0061-0089-01

7.5g


POSATEX™

OTIC SUSPENSION


(Orbifloxacin, Mometasone

Furoate Monohydrate and

Posaconazole, Suspension)


Antibacterial,

Anti-inflammatory, Antifungal


Caution: Federal law restricts this drug to use

by or on the order of a licensed veterinarian.

Federal law prohibits the extralabel use of this

drug in food-producing animals.


KEEP OUT

OF REACH

OF CHILDREN.

NADA# 141-266,

Approved by FDA.


Intervet










POSATEX 
orbifloxacin, mometasone furoate, and posaconazole  suspension










Product Information
Product TypePRESCRIPTION ANIMAL DRUGNDC Product Code (Source)0061-0089
Route of AdministrationORALDEA Schedule    














Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Orbifloxacin (Orbifloxacin)Orbifloxacin10 mg  in 1 g
Mometasone Furoate (Mometasone)Mometasone Furoate1 mg  in 1 g
posaconazole (posaconazole)posaconazole1 mg  in 1 g






Inactive Ingredients
Ingredient NameStrength
Mineral Oil 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      






























Packaging
#NDCPackage DescriptionMultilevel Packaging
10061-0089-011 BOTTLE In 1 CARTONcontains a BOTTLE, PLASTIC
17.5 g In 1 BOTTLE, PLASTICThis package is contained within the CARTON (0061-0089-01)
20061-0089-021 BOTTLE In 1 CARTONcontains a BOTTLE, PLASTIC
215 g In 1 BOTTLE, PLASTICThis package is contained within the CARTON (0061-0089-02)
30061-0089-031 BOTTLE In 1 CARTONcontains a BOTTLE, PLASTIC
330 g In 1 BOTTLE, PLASTICThis package is contained within the CARTON (0061-0089-03)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA14126609/01/2010


Labeler - Schering Corporation (001317601)









Establishment
NameAddressID/FEIOperations
Essex Animal Health Friesoythe330363511MANUFACTURE
Revised: 09/2010Schering Corporation

Potassium and Sodium Citrates/Citric Acid Solution


Pronunciation: poe-TAS-ee-um and SOE-dee-um SIT-rates/SIT-rik AS-id
Generic Name: Potassium and Sodium Citrates/Citric Acid
Brand Name: Examples include Cytra-3 and Tricitrates


Potassium and Sodium Citrates/Citric Acid Solution is used for:

Preventing certain types of kidney stones. It also may be used for other conditions as determined by your doctor.


Potassium and Sodium Citrates/Citric Acid Solution is a urinary alkalinizing agent. It neutralizes some of the acid in your urine, which reduces the formation of crystals in your urine that could become kidney stones.


Do NOT use Potassium and Sodium Citrates/Citric Acid Solution if:


  • you are allergic to any ingredient in Potassium and Sodium Citrates/Citric Acid Solution

  • you have high potassium levels in the blood, high aluminum levels in the blood, severe kidney problems, or you are unable to urinate

  • you have untreated Addison disease (an adrenal gland problem) or certain heart problems (heart failure or heart damage)

  • you are taking a product that contains aluminum (eg, antacids)

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



Before using Potassium and Sodium Citrates/Citric Acid Solution:


Some medical conditions may interact with Potassium and Sodium Citrates/Citric Acid Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

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

  • if you have heart problems (eg, heart failure), high blood pressure, adrenal gland problems, kidney problems, or diabetes

  • if you have stomach or bowel problems (eg, ulcer, diarrhea), a urinary tract infection, or you are dehydrated

  • if you have high blood acid levels; swelling of the hands, ankles, or feet; fluid buildup in the lungs; decreased urination; or trouble urinating

  • if you have preeclampsia (high blood pressure during pregnancy)

  • if you have low blood calcium levels, or you are on a sodium-restricted or potassium-restricted diet

  • if you have a condition in which your skin is breaking down (eg, severe burns)

Some MEDICINES MAY INTERACT with Potassium and Sodium Citrates/Citric Acid Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Aldosterone blockers (eg, eplerenone), aliskiren, angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), potassium-sparing diuretics (eg, triamterene), or potassium supplements because the risk of high potassium levels, possibly with irregular heartbeat or a heart attack, may be increased

  • Products that contain aluminum (eg, antacids), digoxin, certain stimulants (eg, amphetamine), or sympathomimetics (eg, albuterol, pseudoephedrine) because the risk of their side effects may be increased by Potassium and Sodium Citrates/Citric Acid Solution

  • Lithium or tetracyclines (eg, doxycycline) because their effectiveness may be decreased by Potassium and Sodium Citrates/Citric Acid Solution

This may not be a complete list of all interactions that may occur. Ask your health care provider if Potassium and Sodium Citrates/Citric Acid Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Potassium and Sodium Citrates/Citric Acid Solution:


Use Potassium and Sodium Citrates/Citric Acid Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Take Potassium and Sodium Citrates/Citric Acid Solution by mouth after meals and at bedtime, unless your doctor tells you otherwise.

  • Be sure to dilute Potassium and Sodium Citrates/Citric Acid Solution in water as directed on the packaging or by your doctor. Do not take Potassium and Sodium Citrates/Citric Acid Solution without mixing it.

  • Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.

  • Shake well before each use.

  • Potassium and Sodium Citrates/Citric Acid Solution may taste better if it is chilled before you take it.

  • Drinking extra fluids while you are taking Potassium and Sodium Citrates/Citric Acid Solution is recommended. Check with your doctor for instructions.

  • If you take a tetracycline antibiotic (eg, doxycycline), do not take Potassium and Sodium Citrates/Citric Acid Solution within 2 hours before or after taking the tetracycline. Check with your doctor if you have questions.

  • If you miss a dose of Potassium and Sodium Citrates/Citric Acid Solution, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Potassium and Sodium Citrates/Citric Acid Solution.



Important safety information:


  • Potassium and Sodium Citrates/Citric Acid Solution may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Potassium and Sodium Citrates/Citric Acid Solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Check with your doctor before you use a salt substitute or a product that has potassium in it.

  • Lab tests, including blood potassium levels, other blood electrolyte levels (eg, sodium, calcium, bicarbonate), and kidney function, may be performed while you use Potassium and Sodium Citrates/Citric Acid Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Potassium and Sodium Citrates/Citric Acid Solution while you are pregnant. It is not known if Potassium and Sodium Citrates/Citric Acid Solution is found in breast milk. If you are or will be breast-feeding while you use Potassium and Sodium Citrates/Citric Acid Solution, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of Potassium and Sodium Citrates/Citric Acid Solution:


All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Potassium and Sodium Citrates/Citric Acid Solution. Seek medical attention right away if any of these SEVERE side effects occur:



Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; dizziness; irregular heartbeat; muscle cramps; numbness or tingling around the lips; numbness, tingling, pain, or weakness in the hands or feet; shortness of breath; unusual tiredness; unusual weakness or heaviness of the legs; weakness.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.



If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include confusion; fainting; irregular heartbeat; nausea, vomiting, or diarrhea; seizures; sluggishness; weakness.


Proper storage of Potassium and Sodium Citrates/Citric Acid Solution:

Store Potassium and Sodium Citrates/Citric Acid Solution at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Potassium and Sodium Citrates/Citric Acid Solution out of the reach of children and away from pets.


General information:


  • If you have any questions about Potassium and Sodium Citrates/Citric Acid Solution, please talk with your doctor, pharmacist, or other health care provider.

  • Potassium and Sodium Citrates/Citric Acid Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Potassium and Sodium Citrates/Citric Acid Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Potassium and Sodium Citrates/Citric Acid resources


  • Potassium and Sodium Citrates/Citric Acid Use in Pregnancy & Breastfeeding
  • Potassium and Sodium Citrates/Citric Acid Drug Interactions
  • Potassium and Sodium Citrates/Citric Acid Support Group
  • 0 Reviews for Potassium and Sodium Citrates/Citric Acid - Add your own review/rating


Compare Potassium and Sodium Citrates/Citric Acid with other medications


  • Metabolic Acidosis
  • Urinary Alkalinization

Polyethylene Glycol/Propylene Glycol Gel


Pronunciation: pol-ee-ETH-i-leen/PROE-pi-leen
Generic Name: Polyethylene Glycol/Propylene Glycol
Brand Name: Rhinaris


Polyethylene Glycol/Propylene Glycol Gel is used for:

Relieving minor nosebleeds or dry, crusty, stuffy, or irritated nasal passages (nostrils) caused by dry room air, allergies, colds, or other conditions. It may also be used for other conditions as determined by your doctor.


Polyethylene Glycol/Propylene Glycol Gel is nasal lubricant. It works by moisturizing the nose and washing away thick secretions.


Do NOT use Polyethylene Glycol/Propylene Glycol Gel if:


  • you are allergic to any ingredient in Polyethylene Glycol/Propylene Glycol Gel

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



Before using Polyethylene Glycol/Propylene Glycol Gel:


Some medical conditions may interact with Polyethylene Glycol/Propylene Glycol Gel. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

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

Some MEDICINES MAY INTERACT with Polyethylene Glycol/Propylene Glycol Gel. However, no specific interactions are known at this time.


Ask your health care provider if Polyethylene Glycol/Propylene Glycol Gel may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Polyethylene Glycol/Propylene Glycol Gel:


Use Polyethylene Glycol/Propylene Glycol Gel as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Apply a small amount of Polyethylene Glycol/Propylene Glycol Gel into each nostril as needed for dry or irritated nasal passages, or as directed by your doctor.

  • If the patient is an infant, apply a small amount of Polyethylene Glycol/Propylene Glycol Gel to the inside of each nostril with the tip of your little finger. Avoid using cotton swabs or other means of application as these could irritate or damage nasal skin.

  • Use Polyethylene Glycol/Propylene Glycol Gel on a regular schedule to get the most benefit from it.

  • If you miss a dose of Polyethylene Glycol/Propylene Glycol Gel and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Polyethylene Glycol/Propylene Glycol Gel.



Important safety information:


  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Polyethylene Glycol/Propylene Glycol Gel while you are pregnant. If you are or will be breast-feeding while you use Polyethylene Glycol/Propylene Glycol Gel, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of Polyethylene Glycol/Propylene Glycol Gel:


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Mild, temporary stinging sensation.



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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.



If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.


Proper storage of Polyethylene Glycol/Propylene Glycol Gel:

Store Polyethylene Glycol/Propylene Glycol Gel at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Polyethylene Glycol/Propylene Glycol Gel out of the reach of children and away from pets.


General information:


  • If you have any questions about Polyethylene Glycol/Propylene Glycol Gel, please talk with your doctor, pharmacist, or other health care provider.

  • Polyethylene Glycol/Propylene Glycol Gel is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Polyethylene Glycol/Propylene Glycol Gel. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

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  • Polyethylene Glycol/Propylene Glycol Support Group
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Polyethylene Glycol Drug Facts




Generic Name: polyethylene glycol 3350

Dosage Form: powder, for solution
Drug Facts

Active ingredient


Polyethylene Glycol 3350, 17 grams (cap filled to line)



Purpose


Laxative



Uses


  • relieves occasional constipation (irregularity)

  • generally produces a bowel movement in 1 to 3 days


Warnings


Allergy alert: Do not use if you are allergic to polyethylene glycol



Do not use


if you have kidney disease, except under the advice


and supervision of a doctor



Ask a doctor before use if you have


  • nausea, vomiting or abdominal pain

  • a sudden change in bowel habits that lasts over 2 weeks

  • irritable bowel syndrome


Ask a doctor or pharmacist before use if you are


taking a prescription drug



When using this product


you may have loose, watery, more frequent stools



Stop use and ask a doctor if


  • you have rectal bleeding or your nausea, bloating, cramping or

    abdominal pain gets worse. These may be signs of a serious


    condition.



  • you get diarrhea

  • you need to use a laxative for longer than 1 week


If pregnant or breast feeding


ask a health professional before use.


Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.



Directions


  • do not take more than directed unless advised by your doctor

  • the bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line

  • adults and children 17 years of age and older:
    • fill to 17 grams line in cap for the correct dose

    • stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink

    • use once daily

    • use no more than 7 days


  • children 16 years of age or under: ask a doctor


Other information


  • store at 20° - 25°C (68° - 77°F)

  • tamper-evident: do not use if printed foil seal under cap is missing, open or broken


Inactive ingredients


none



Questions or comments?


1-800-477-7877


Distributed by


Kremers Urban, LLC


Princeton, NJ 08540 USA


Rev. 1E



Principal Display Panel


Original Prescription Strength


  • Relieves Occasional Constipation

  • Softens Stool


  • 4.1 oz Label. Drug Facts on ECL.





  • 8.9 oz Label. Drug Facts on ECL.





  • 18.5 oz Label. Drug Facts on ECL.











POLYETHYLENE GLYCOL 3350 
polyethylene glycol 3350  powder, for solution










Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)62175-195
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYETHYLENE GLYCOL 3350 (POLYETHYLENE GLYCOL 3350)POLYETHYLENE GLYCOL 335017 g  in 17 g





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      


















Packaging
#NDCPackage DescriptionMultilevel Packaging
162175-195-07119 g In 1 BOTTLENone
262175-195-15255 g In 1 BOTTLENone
362175-195-31527 g In 1 BOTTLENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09060010/06/2009


Labeler - Kremers Urban (015411751)
Revised: 03/2010Kremers Urban




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  • Bowel Preparation
  • Constipation
  • Constipation, Acute

potassium chloride



Generic Name: potassium chloride (poe TASS ee um)

Brand names: EPIKLOR, EPIKLOR/25, K-Dur 10, K-Lor, K-Tab, Kal Potassium 99, Kaochlor S-F, Kaon-CL 10, Kaon-CL 20%, Kay Ciel, KCl-20, Klor-Con, Klor-Con 10, Klor-Con 8, Klor-Con M10, Klor-Con M15, Klor-Con M20, Klor-Con/25, Micro-K, Micro-K 10, Rum-K, ...show all 41 brand names.


What is potassium chloride?

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.


Potassium chloride is used to prevent or to treat low blood levels of potassium (hypokalemia). Potassium levels can be low as a result of a disease or from taking certain medicines, or after a prolonged illness with diarrhea or vomiting.


Potassium chloride may also be used for purposes not listed in this medication guide.


What is the most important information I should know about potassium chloride?


You should not use this medication if you have kidney failure, 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). Do not crush, chew, break, or suck on an extended-release tablet or capsule. Swallow the pill whole. Breaking or crushing the pill may cause too much of the drug to be released at one time. Sucking on a potassium tablet can irritate your mouth or throat. Take this medication with food or just after a meal.

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 potassium include uneven heartbeat, muscle weakness or limp feeling, severe stomach pain, and numbness or tingling in your hands, feet, or 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 potassium chloride?


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);




  • kidney failure;




  • Addison's disease (an adrenal gland disorder);




  • a large tissue injury such as a severe burn;




  • if you are severely dehydrated; or




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



To make sure you can safely take potassium chloride, tell your doctor if you have any of these other conditions:


  • kidney disease;


  • heart disease or high blood pressure;




  • a blockage in your stomach or intestines; or




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




FDA pregnancy category C. It is not known whether potassium chloride will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether potassium chloride 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 potassium chloride?


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


Mix the powder, granule, or liquid form of this medicine with at least 4 ounces (one-half cup) of cold water or fruit juice before taking. 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.


Do not crush, chew, break, or suck on an extended-release tablet or capsule. Swallow the pill whole. Breaking or crushing the pill may cause too much of the drug to be released at one time. Sucking on a potassium tablet can irritate your mouth or throat.

Take this medication with food or just after a meal.


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.

Potassium-rich foods include: squash, baked potatoes (skin on), spinach, lentils, broccoli, brussels sprouts, zucchini, kidney or navy beans, raisins, watermelon, orange juice, bananas, cantaloupe, and low-fat milk or yogurt. Consume only the daily amounts recommended by your doctor or nutrition counselor.


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 at room temperature away from moisture and heat. Keep the medication in a closed container.

What happens if I miss a dose?


Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include heavy feeling in your arms or legs, confusion, weak or shallow breathing, slow or uneven heartbeat, seizure (convulsions), or feeling like you might pass out.


What should I avoid while taking potassium chloride?


Avoid taking potassium supplements or using other 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.

Potassium chloride 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:

  • confusion, anxiety, feeling like you might pass out;




  • uneven heartbeat;




  • extreme thirst, increased urination;




  • leg discomfort;




  • muscle weakness or limp feeling;




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




  • severe stomach pain, ongoing diarrhea or vomiting;




  • black, bloody, or tarry stools; or




  • coughing up blood or vomit that looks like coffee grounds.



Less serious side effects may include:



  • mild nausea or upset stomach;




  • mild or occasional diarrhea;




  • slight tingling in your hands or feet; or




  • appearance of a potassium chloride tablet in your stool.



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.


Potassium chloride Dosing Information


Usual Adult Dose for Hypokalemia:

Parenteral:
40 to 100 mEq potassium chloride for injection diluted in an appropriate amount and type of solution to be intravenously infused once at a rate not to exceed 10 to 40 mEq/hour.

Oral:
40 to 100 mEq orally once a day given in equally divided doses using formulations which include normal-release tablets or capsules, extended-release tablets or capsules, dissolvable tablets, oral solution or powder for dissolution mixed with an appropriate volume of water or juice.

Usual Adult Dose for Prevention of Hypokalemia:

Parenteral:
10 to 40 mEq potassium chloride for injection diluted in an appropriate amount and type of solution to be intravenously infused once at a rate not to exceed 40 mEq/hour.

Oral:
10 to 20 mEq orally once a day given in equally divided doses using formulations which include normal-release tablets or capsules, extended-release tablets or capsules, dissolvable tablets, oral solution or powder for dissolution mixed with an appropriate volume of water or juice.

Usual Pediatric Dose for Hypokalemia:

Treatment of hypokalemia: Note: High variability exists in dosing/infusion rate recommendations; therapy should be guided by patient condition and specific institutional guidelines.

Infants and Children:

Oral: 2 to 5 mEq/kg/day in divided doses; not to exceed 1 to 2 mEq/kg as a single dose; if deficits are severe or ongoing losses are great, IV route should be considered preferred route of administration.

Intermittent IV infusion (must be diluted prior to administration): 0.5 to 1 mEq/kg/dose (maximum dose: 40 mEq) to infuse at 0.3 to 0.5 mEq/kg/hour (maximum dose/rate: 1 mEq/kg/hour); then repeated as needed based on frequently obtained lab values; severe depletion or ongoing losses may require more than 200% of normal daily limit needs.

Usual Pediatric Dose for Prevention of Hypokalemia:

IV doses in children should be incorporated into the maintenance IV fluids. Intermittent IV potassium administration should be reserved for severe depletion situations. Continuous ECG monitoring should be used for intermittent doses greater than 0.5 mEq/kg/hour.

Normal daily requirements: Oral or IV:
Infants: 2 to 6 mEq/kg/day
Children: 2 to 3 mEq/kg/day

Prevention of hypokalemia during diuretic therapy:
Infants and Children: 1 to 2 mEq/kg/day orally in 1 to 2 divided doses


What other drugs will affect potassium chloride?


Tell your doctor about all other medicines you use, especially:



  • eplerenone (Inspra);




  • digoxin (digitalis, Lanoxin);




  • quinidine (Quinaglute, Quinidex, Quin-Release);




  • a bronchodilator such as ipratroprium (Atrovent) or tiotropium (Spiriva);




  • 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 other drugs may interact with potassium chloride. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.



More potassium chloride resources


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


  • Potassium Chloride Prescribing Information (FDA)

  • Potassium Chloride Controlled-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Potassium Chloride Advanced Consumer (Micromedex) - Includes Dosage Information

  • Epiklor Prescribing Information (FDA)

  • K-Tab Prescribing Information (FDA)

  • Klor-Con Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Klor-Con Prescribing Information (FDA)

  • Klor-con Consumer Overview

  • Klor-con Powder MedFacts Consumer Leaflet (Wolters Kluwer)

  • Klotrix Prescribing Information (FDA)

  • Micro-K Extended-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

  • Micro-K Prescribing Information (FDA)

  • Rum-K Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

  • Slow-K Prescribing Information (FDA)



Compare potassium chloride with other medications


  • Hypokalemia
  • Prevention of Hypokalemia


Where can I get more information?


  • Your pharmacist can provide more information about potassium chloride.

See also: potassium chloride side effects (in more detail)


potassium acetate, bicarbonate, and citrate


Generic Name: potassium acetate, bicarbonate, and citrate (poe tass EE um)

Brand Names: Tri-K


What is potassium acetate, bicarbonate, and citrate?

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


Potassium acetate, bicarbonate, and citrate are salts of potassium. They are used together to prevent or to treat a potassium deficiency.


Potassium acetate, bicarbonate, and citrate may also be used for purposes other than those listed in this medication guide.


What is the most important information I should know about potassium acetate, bicarbonate, and citrate?


Take each dose with a full glass of water. Take potassium acetate, bicarbonate, and citrate with food or milk to lessen stomach upset.

Mix the liquid with at least 4 ounces (one-half cup) of water or juice. Mix it thoroughly and drink it immediately. Do not drink the liquid without diluting it first.


Do not take salt substitutes or drink low-salt milk while taking potassium acetate, bicarbonate, and citrate unless your doctor approves. Salt substitutes and low-salt milk usually contain potassium. You may get too much potassium and suffer from side effects if you use these products.

Who should not take potassium acetate, bicarbonate, and citrate?


Before taking this medication, tell your doctor if you


  • have kidney disease;


  • are taking a potassium-sparing diuretic such as triamterene (Dyrenium, Dyazide, Maxzide), spironolactone (Aldactone, Aldactazide), or amiloride (Midamor, Moduretic);




  • have Addison's disease;




  • have an ulcer or an intestinal blockage; or




  • have chronic diarrhea.



You may not be able to take potassium acetate, bicarbonate, and citrate, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above.


Potassium acetate, bicarbonate, and citrate is in the FDA pregnancy category C. This means that it is not known whether this medication will harm an unborn baby. Do not take potassium acetate, bicarbonate, and citrate without first talking to your doctor if you are pregnant. It is also not known whether potassium passes into breast milk. As long as potassium levels in your body are within the normal range, this medication is not expected to harm a nursing infant. Talk to your doctor if you are breast-feeding a baby.

How should I take potassium acetate, bicarbonate, and citrate?


Take potassium acetate, bicarbonate, and citrate exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.


Take each dose with a full glass of water. Take potassium acetate, bicarbonate, and citrate with food or milk to lessen stomach upset.

Mix the liquid with at least 4 ounces (one-half cup) of water or juice. Mix it thoroughly and drink it immediately.


Store potassium acetate, bicarbonate, and citrate at room temperature away from moisture and heat.

What happens if I miss a dose?


Take the missed dose as soon as you remember up to 2 hours late. If more than 2 hours have passed, skip the missed dose and take only your next regularly scheduled dose. Do not take a double dose of this medication.


What happens if I overdose?


Seek emergency medical attention.

Symptoms of a potassium acetate, bicarbonate, and citrate overdose include paralysis; numbness or tingling in the hands, arms, legs, or feet; an irregular heartbeat; low blood pressure (dizziness, confusion, weakness, fatigue); seizures; coma; and heart attack.


What should I avoid while taking potassium acetate, bicarbonate, and citrate?


Do not take salt substitutes or drink low-salt milk while taking potassium acetate, bicarbonate, and citrate unless your doctor approves. Salt substitutes and low-salt milk usually contain potassium. You may get too much potassium and suffer from side effects if you use these products.


Do not stop taking this medication unless your doctor approves. Stopping could make your condition much worse.

Potassium acetate, bicarbonate, and citrate side effects


If you experience any of the following serious side effects, stop taking potassium acetate, bicarbonate, and citrate and seek emergency medical attention:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);




  • confusion;




  • an irregular heartbeat;




  • difficulty breathing;




  • unusual fatigue, weakness, or heavy legs;




  • abdominal pain or severe cramping; or




  • black, bloody, or tarry stools.



Other, less serious side effects may be more likely to occur. Continue to take potassium acetate, bicarbonate, and citrate and talk to your doctor if you experience



  • nausea, vomiting, diarrhea, or abdominal discomfort;




  • a rash;




  • slight tingling in the hands or feet; or




  • anxiety.



Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.


What other drugs will affect potassium acetate, bicarbonate, and citrate?


The following drugs may increase the effects of potassium acetate, bicarbonate, and citrate:


  • angiotensin-converting-enzyme inhibitors (ACE inhibitors) such as benazepril (Lotensin) and captopril (Capoten);

  • other commonly used ACE inhibitors, including enalapril (Vasotec), fosinopril (Monopril), lisinopril (Zestril, Prinivil), moexipril (Univasc), quinapril (Accupril), and ramipril (Altace);


  • potassium-sparing diuretics such as triamterene (Dyrenium, Dyazide, Maxzide), spironolactone (Aldactone, Aldactazide), and amiloride (Midamor, Moduretic);



  • beta-blockers such as atenolol (Tenormin) and propranolol (Inderal); and

  • other commonly used beta-blockers, including acebutolol (Sectral), bisoprolol (Zebeta), carteolol (Cartrol), labetalol (Normodyne, Trandate), nadolol (Corgard), metoprolol (Lopressor), and pindolol (Visken).

Do not take any of the medicines listed above with potassium acetate, bicarbonate, and citrate except under the supervision of your doctor.


Before taking this medication, tell your doctor if you are taking any of the following medicines:



  • the heart medicine digoxin (Lanoxin);




  • a diuretic (water pill) such as hydrochlorothiazide (Hydrodiuril, HCTZ, others), chlorothiazide (Diuril, others), metolazone (Zaroxolyn),or indapamide (Lozol);




  • a steroid such as prednisone (Deltasone, Orasone, others), cortisone (Cortone), hydrocortisone (Cortef, Hydrocortone, others), dexamethasone (Decadron, Hexadrol); or



  • an anti-inflammatory drug such as ibuprofen (Motrin, Advil, others), naproxen (Aleve, Anaprox, Naprosyn, others), or ketoprofen (Orudis KT, Orudis, Oruvail).

Drugs other than those listed here may also interact with potassium acetate, bicarbonate, and citrate or affect your condition. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.



More potassium acetate, bicarbonate, and citrate resources


  • Potassium acetate, bicarbonate, and citrate Drug Interactions
  • Potassium acetate, bicarbonate, and citrate Support Group
  • 0 Reviews for Potassium acetate, bicarbonate, and citrate - Add your own review/rating


Compare potassium acetate, bicarbonate, and citrate with other medications


  • Hypokalemia
  • Prevention of Hypokalemia


Where can I get more information?


  • Your pharmacist has more information about potassium acetate, bicarbonate, and citrate written for health professionals that you may read.

What does my medication look like?


Potassium acetate, bicarbonate, and citrate is available with a prescription under the brand name Tri-K as a liquid. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.



Polyethylene Glycol/Electrolytes Solution (Jug)


Pronunciation: pol-ee-ETH-i-leen GLYE-kole/e-LECK-troe-lites
Generic Name: Polyethylene Glycol/Electrolytes
Brand Name: GoLYTELY


Polyethylene Glycol/Electrolytes Solution (Jug) is used for:

Cleaning out the bowel before surgery or other procedures. It may also be used for other conditions as determined by your doctor.


Polyethylene Glycol/Electrolytes Solution (Jug) is a laxative. It works by causing the colon to move contents along more quickly.


Do NOT use Polyethylene Glycol/Electrolytes Solution (Jug) if:


  • you are allergic to any ingredient in Polyethylene Glycol/Electrolytes Solution (Jug)

  • you have appendicitis or certain stomach or bowel problems (eg, blockage, retention, perforation, toxic inflammation, megacolon, ileus)

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



Before using Polyethylene Glycol/Electrolytes Solution (Jug):


Some medical conditions may interact with Polyethylene Glycol/Electrolytes Solution (Jug). Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

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

  • if you have a throat (esophagus) disease, ulcerative colitis, heart disease (eg, irregular heartbeat, congestive heart failure), swallowing problems (eg, history of aspiration or regurgitation), impaired gag reflex, electrolyte imbalances (eg, high blood potassium levels), or rectal bleeding of unknown cause

  • if you have a history of alcohol use

Some MEDICINES MAY INTERACT with Polyethylene Glycol/Electrolytes Solution (Jug). However, no specific interactions with Polyethylene Glycol/Electrolytes Solution (Jug) are known at this time.


Ask your health care provider if Polyethylene Glycol/Electrolytes Solution (Jug) may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Polyethylene Glycol/Electrolytes Solution (Jug):


Use Polyethylene Glycol/Electrolytes Solution (Jug) as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Your doctor will tell you when to start using Polyethylene Glycol/Electrolytes Solution (Jug). Do not eat any solid foods for at least 2 hours before beginning Polyethylene Glycol/Electrolytes Solution (Jug). It is preferred that you do not eat for 3 to 4 hours before beginning Polyethylene Glycol/Electrolytes Solution (Jug).

  • Drink only clear liquids and do not eat any solid foods from the time you start Polyethylene Glycol/Electrolytes Solution (Jug) until your procedure is complete.

  • Before using Polyethylene Glycol/Electrolytes Solution (Jug), fill the container with the amount of water indicated on the package label. Use lukewarm water to mix Polyethylene Glycol/Electrolytes Solution (Jug) to help the medicine dissolve faster. Shake well.

  • Chilling Polyethylene Glycol/Electrolytes Solution (Jug) improves the taste. Do not add sugar, sweetening agents, or other additives to Polyethylene Glycol/Electrolytes Solution (Jug).

  • Shake well before each use.

  • Drink 8 ounces (240 mL) of Polyethylene Glycol/Electrolytes Solution (Jug) every 10 minutes until the stool is watery, clear, and free of all solid matter, or until the medicine is gone. At least 3 liters is usually required to produce the watery stool. It is best to drink all of Polyethylene Glycol/Electrolytes Solution (Jug). Be sure to follow the instructions provided by your doctor. It is best to drink each portion quickly rather than sipping it. Rinsing your mouth with mouthwash after each glass of medicine may help get rid of the taste.

  • Other medicines taken by mouth within 1 hour of taking Polyethylene Glycol/Electrolytes Solution (Jug) may not be absorbed or be effective. Contact your doctor or pharmacist with any concerns you might have about taking your other medicines.

  • If you miss a dose of Polyethylene Glycol/Electrolytes Solution (Jug), take it as soon as you remember. Continue to take it as directed by your doctor. Notify your doctor if you are unable to finish taking Polyethylene Glycol/Electrolytes Solution (Jug) before your test.

Ask your health care provider any questions you may have about how to use Polyethylene Glycol/Electrolytes Solution (Jug).



Important safety information:


  • The first bowel movement usually occurs about 1 hour after you begin drinking Polyethylene Glycol/Electrolytes Solution (Jug).

  • Keep all doctor and lab appointments while you are taking Polyethylene Glycol/Electrolytes Solution (Jug).

  • Use Polyethylene Glycol/Electrolytes Solution (Jug) with caution in patients who are unconscious or partially conscious because they may be at greater risk for vomiting and inhaling Polyethylene Glycol/Electrolytes Solution (Jug).

  • Use Polyethylene Glycol/Electrolytes Solution (Jug) with caution in the ELDERLY; they may be more sensitive to its effects.

  • Polyethylene Glycol/Electrolytes Solution (Jug) should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Polyethylene Glycol/Electrolytes Solution (Jug) while you are pregnant. It is not known if Polyethylene Glycol/Electrolytes Solution (Jug) is found in breast milk. If you are or will be breast-feeding while you use Polyethylene Glycol/Electrolytes Solution (Jug), check with your doctor. Discuss any possible risks to your baby.


Possible side effects of Polyethylene Glycol/Electrolytes Solution (Jug):


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Bloating; nausea; rectal irritation; stomach fullness or cramps; vomiting.



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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; muscle weakness; persistent or severe nausea and vomiting; severe bloating or abdominal swelling; severe stomach pain; slow or irregular heartbeat; vomiting of blood.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.



If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.


Proper storage of Polyethylene Glycol/Electrolytes Solution (Jug):

Before mixing, store Polyethylene Glycol/Electrolytes Solution (Jug) at room temperature, 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. After preparing the solution, store Polyethylene Glycol/Electrolytes Solution (Jug) in the refrigerator in a tightly closed container. Use within 48 hours. Discard any unused portion of Polyethylene Glycol/Electrolytes Solution (Jug). Keep Polyethylene Glycol/Electrolytes Solution (Jug) out of the reach of children and away from pets.


General information:


  • If you have any questions about Polyethylene Glycol/Electrolytes Solution (Jug), please talk with your doctor, pharmacist, or other health care provider.

  • Polyethylene Glycol/Electrolytes Solution (Jug) is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Polyethylene Glycol/Electrolytes Solution (Jug). If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Polyethylene Glycol/Electrolytes Solution (Jug) resources


  • Polyethylene Glycol/Electrolytes Solution (Jug) Use in Pregnancy & Breastfeeding
  • Polyethylene Glycol/Electrolytes Solution (Jug) Support Group
  • 39 Reviews for Polyethylene Glycol/Electrolytes (Jug) - Add your own review/rating


Compare Polyethylene Glycol/Electrolytes Solution (Jug) with other medications


  • Bowel Preparation
  • Constipation, Chronic
  • Gastrointestinal Decontamination

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 CategoryExplanation
All TrimestersCAnimal 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)