PEGLYTE POWDER POWDER FOR SOLUTION

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Active ingredient:
MACROGOL; SODIUM SULFATE; SODIUM BICARBONATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE
Available from:
PENDOPHARM DIVISION OF PHARMASCIENCE INC
ATC code:
A06AD10
INN (International Name):
MINERAL SALTS IN COMBINATION
Dosage:
238.18G; 22.96G; 6.76G; 5.85G; 3.05G
Pharmaceutical form:
POWDER FOR SOLUTION
Composition:
MACROGOL 238.18G; SODIUM SULFATE 22.96G; SODIUM BICARBONATE 6.76G; SODIUM CHLORIDE 5.85G; POTASSIUM CHLORIDE 3.05G
Administration route:
ORAL
Units in package:
280G - 4X70G
Prescription type:
Ethical
Therapeutic area:
CATHARTICS AND LAXATIVES
Product summary:
Active ingredient group (AIG) number: 0516978006; AHFS: 56:12.00
Authorization status:
APPROVED
Authorization number:
00777838
Authorization date:
2012-07-24

Documents in other languages

PRESCRIBING INFORMATION

PegLyte

®

Powder

Polyethylene Glycol 3350 and Electrolytes for Oral Solution, USP

Gastrointestinal lavage and laxative

PENDOPHARM, Division of Pharmascience Inc.

6111 Royalmount Ave., Suite 100

Montréal, Québec

H4P 2T4

Date of Revision:

October 2, 2015

Submission Control No: 179538

® Registered trademark of Pharmascience Inc.

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Table of Contents

PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3

SUMMARY PRODUCT INFORMATION ........................................................................3

INDICATIONS AND CLINICAL USE ..............................................................................3

CONTRAINDICATIONS ...................................................................................................3

WARNINGS AND PRECAUTIONS ..................................................................................4

ADVERSE REACTIONS ....................................................................................................5

DRUG INTERACTIONS ....................................................................................................6

DOSAGE AND ADMINISTRATION ................................................................................7

OVERDOSAGE ..................................................................................................................8

ACTION AND CLINICAL PHARMACOLOGY ..............................................................8

STORAGE AND STABILITY ............................................................................................9

DOSAGE FORMS, COMPOSITION AND PACKAGING ...............................................9

PART II: SCIENTIFIC INFORMATION ...............................................................................11

PHARMACEUTICAL INFORMATION ..........................................................................11

CLINICAL TRIALS ..........................................................................................................12

TOXICOLOGY .................................................................................................................14

PART III: CONSUMER INFORMATION..............................................................................18

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PegLyte

®

Powder

Polyethylene Glycol 3350 and Electrolytes for Oral Solution, USP

PART I: HEALTH PROFESSIONAL INFORMATION

SUMMARY PRODUCT INFORMATION

Route of

Administration

Dosage Form / Strength

Clinically Relevant

Nonmedicinal Ingredients

Oral

Powder for oral solution

70 g sachet

280 g bottle

PEG 3350

59.55 g

238.18 g

sodium sulphate

5.74 g

22.96 g

sodium bicarbonate

1.69 g

6.76 g

sodium chloride

1.46 g

5.85 g

potassium chloride

0.76 g

3.05 g

Fruit flavours, Sodium Saccharin

For a complete listing see Dosage

Forms, Composition and

Packaging section.

INDICATIONS AND CLINICAL USE

Adults

PegLyte Powder (PEG 3350 and Electrolytes) is indicated for:

bowel cleansing prior to colonoscopy or barium enema x-ray examination or surgical

procedures requiring a clean colon.

the treatment of constipation

CONTRAINDICATIONS

PegLyte is contraindicated in patients with:

ileus

gastric retention

bowel perforation

gastrointestinal obstruction

toxic colitis

toxic megacolon

hypersensitivity to this drug or to any ingredient in the formulation or component of the

container. For a complete listing, see the Dosage Forms, Composition and Packaging

section of this prescribing information.

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WARNINGS AND PRECAUTIONS

General

Use of PegLyte is not recommended when abdominal pain, nausea, or vomiting are present

Unconscious or semiconscious patients should be observed during the administration of

PegLyte via nasogastric tube.

A laxative should not be taken within 2 hours of another medicine because the desired effect

of the other medicine may be reduced.

For use in the treatment of constipation:

Patients presenting with complaints of constipation should have a thorough medical history

and physical examination to detect associated metabolic, endocrine and neurogenic

conditions, and medications. A diagnostic evaluation should include a structural examination

of the colon.

Do not take PegLyte for more than 1 week, unless recommended by a physician.

The safety of long term use of PEG plus electrolytes, like PegLyte, is unknown.

No additional flavorings or ingredients may be added to the solution.

Gastrointestinal

PegLyte should be used with caution in patients with ulcerative colitis (UC). Patients suffering

from UC or from an acute exacerbation of inflammatory bowel disease have not been studied.

Patients with impaired gag reflex and patients prone to regurgitation or aspiration should be

observed during the administration of PegLyte, especially if it is administered via nasogastric

tube. If gastrointestinal obstruction or perforation is suspected, appropriate studies should be

performed to rule out those conditions before administration of PegLyte.

When a large volume of PegLyte is used for colon preparation, if a patient experiences severe

bloating, distension or abdominal pain, administration of the solution should be slowed or

temporarily discontinued until the symptoms subside.

When used for the treatment of constipation, if diarrhea occurs, the use of PegLyte should be

discontinued.

Immune

Cases of urticaria, rhinorrhea, dermatitis and anaphylactic reactions have been reported with

PEG-based products which may represent allergic reactions.

Neurologic

Use of a 4 L volume of PEG-based colon preparation products has resulted in reports of

generalized tonic-clonic seizures in patients with no prior history of seizures. Electrolyte

abnormalities, such as hyponatremia and hypokalemia, as well as severe vomiting and excessive

beverage consumption have been associated with these cases. A correction of fluid and

electrolyte abnormalities resolved the neurologic irregularity. Therefore, in patients with known

or suspected hyponatremia, or in patients using concomitant medications that increase the risk of

electrolyte abnormalities (such as diuretics), PegLyte should be used with caution. In these

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patients, baseline and post-colonoscopy laboratory tests (sodium, potassium, calcium, creatinine,

and BUN) should be monitored.

Renal

The close monitoring of patients with impaired renal function should be performed, especially if

severe vomiting occurs. Measurement of electrolytes (sodium, potassium, calcium,) and BUN

and creatinine is desirable. Mild hypokalemia was reported in a patient treated for constipation

during 1 month who concurrently received diuretics. Hyperphosphatemia was reported during

long term treatment with PEG-products.

Special Populations

Pregnant Women: Animal reproduction studies have not been conducted with PegLyte, and it

is also not known whether PegLyte can affect reproductive capacity or harm the fetus when

administered to a pregnant patient. PegLyte should be given to a pregnant patient only if clearly

needed.

Nursing Women: It is not known whether this drug is excreted in human milk. Because many

drugs are excreted in human milk, caution should be exercised when PegLyte is administered to

a nursing woman.

Pediatrics : Safety and effectiveness of PegLyte in children have not been established.

Geriatrics (> 60 years of age): There are isolated reports of serious post-marketing events

following the administration of large volumes of PEG-based products for colon preparation in

patients over 60 years of age (acute pulmonary edema after vomiting and aspirating the PEG-

based solution, asystole, esophageal perforation, and upper GI bleeding from a Mallory-Weiss

tear).

Caution is required in patients with renal and cardiac dysfunction in whom fluid and electrolyte

shifts are more risky.

Monitoring and Laboratory Tests

Repeated or prolonged use of PEG-based products may result in electrolyte imbalance;

monitoring of serum electrolytes including phosphate level is advised.

ADVERSE REACTIONS

Adverse Drug Reaction Overview

The most frequent adverse reactions, occurring in up to 50% of patients taking 4 L of PegLyte

solution, are nausea, abdominal fullness and bloating. Abdominal cramps, vomiting and anal

irritation occur less frequently. These adverse effects are transient.

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The most frequent adverse reactions occurring in up to 48% of patients taking the split 4 L dose

(2L in the evening and 2 L in the morning) of PegLyte are abdominal cramps, bloating, nausea,

vomiting, insomnia (from frequent bathroom trips) and headache.

The adverse reactions occurring with PEG products used in the treatment of constipation include:

nausea, abdominal bloating, cramping, diarrhea and/or gas. High doses may produce diarrhea

and excessive stool frequency, particularly in elderly nursing home patients.

Post-Market Adverse Drug Reactions

The following rare adverse events have been reported following administration of 4 L of Peglyte:

Cardiovascular: bradycardia, acute pulmonary edema, hypotension

Eye: sensitivity to light, painful irritated eyes

Gastrointestinal: rectal bleeding (occult blood in stool), sores in mouth

General and Administration Site Conditions: chills, loss of appetite

Hematologic: anemia

Metabolism and Nutrition: fluid imbalance, hypoglycaemia

Musculoskeletal and Connective Tissue: muscle pain

Nervous System: headaches, unconscious, coma, seizures, shakes

Psychiatric: confused feeling, disorientation

Respiratory, Thoracic and Mediastinal: aspiration

Skin and Subcutaneous Tissue: oily hair and skin, facial swelling, leg swelling

Isolated cases of urticaria, rhinorrhea and dermatitis have been reported which may represent

allergic reactions.

The use of large volume (4 L) PEG-based colon preparations has resulted in reports of

generalized tonic-clonic seizures (see Warnings and Precautions).

DRUG INTERACTIONS

Drug-Drug Interactions

PegLyte, as any other laxatives, should not be taken within two (2) hours of another medicine

because the desired effect of the other medicine may be reduced.

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Drug-Food Interactions

When PegLyte is used for a bowel preparation, no food, except clear liquids, should be taken at

least 3 hours prior to administration.

DOSAGE AND ADMINISTRATION

Reconstitution of the Solution

PegLyte Powder (280 g bottle): To prepare PegLyte solution, add tap water to the fill line (total

volume 4 L). Replace cap tightly and mix well until all ingredients have dissolved.

PegLyte Powder (70 g sachet): Dissolve the entire contents of one sachet in 1 L (32 ounces) of

water and stir rapidly to dissolve.

Patients should be instructed not to add any other ingredient (such as flavors, juice, etc) than the

recommended quantity of water. Refrigerate the solution as chilling improves the taste. Using a

straw can help to make the solution more palatable and easier to drink.

Recommended Dose and Dosage Adjustment

Prior to gastrointestinal examination or procedure:

On the day before the procedure, the patient should be instructed to have breakfast no later than

11h00 AM or as specified by the doctor. After breakfast, no solid foods or milk, except clear

liquids, should be taken. Solid foods and milk can be reintroduced after the examination or

procedure. PegLyte can be administered orally or by nasogastric tube.

Oral: PegLyte can be administered either in a full-dose or in a split-dose regimen. Recent data

suggest that the split-dose method of administration may be more effective and better tolerated.

Administration:

The day before the procedure

The day of the procedure

Full-dosing

regimen*

In the evening**, rapidly drink a

glassful (250 mL) of PegLyte every

10-15 minutes until 4 L are

consumed.

Not applicable

Split-dosing

regimen*

In the afternoon**, rapidly drink a

glassful (250 mL) of PegLyte every

10-15 minutes until 2 L are

consumed.

In the morning**, rapidly drink a

glassful (250 mL) of PegLyte

every 10-15 minutes until 2 L are

consumed (must be finished at

least 4 hours before procedure).

* Instructions must be followed as prescribed by the physician. Physicians may choose to

prescribe a full-dosing or split-dosing regimen.

**Time to be confirmed by the physician.

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Nasogastric Tube: PegLyte is administered at a rate of 20 to 30 mL/minute (1.2 to 1.8 L/hour).

The first bowel movement should occur approximately 1 hour after beginning PegLyte

administration. Administration of PegLyte should be continued until the fecal discharge is clear.

Lavage is usually complete after the ingestion of 3 to 4 L of PegLyte solution. The unused

portion should be discarded. A 1-hour waiting period after the appearance of clear liquid stools

should be allowed prior to examination to complete bowel evacuation.

Constipation:

240 to 480 mL/day (equivalent to a PEG dose of 14 to 28 g/day, plus electrolytes) orally for a

week or less, or as recommended by a physician.

Do not take any type of laxatives for more than

one week, unless your physician has ordered a special schedule for you.

Treatment for two to four days may be required to produce a bowel movement. If no bowel

movement is achieved after 4 days, patients should consult their physicians.

OVERDOSAGE

There are no specific antidotes that are required to be administered in the event of overdose;

however, supportive care may be required in order to prevent dehydration and/or electrolyte

imbalance.

For management of a suspected drug overdose, contact your regional

Poison Control Centre immediately.

ACTION AND CLINICAL PHARMACOLOGY

Mechanism of Action

Polyethylene glycol 3350 (PEG 3350) is an osmotic laxative which causes water to be retained

with the stool leading to decreased stool consistency, softening the stools, increasing fecal bulk

and facilitating bowel movements.

Large volume (about 4 L) of PegLyte (PEG 3350 and electrolytes) cleanses the bowel by

induction of diarrhea.

The osmotic activity of PEG 3350, in combination with the electrolyte concentration, results in

virtually no net absorption or secretion of ions, such as sodium or potassium, and water.

Accordingly, large volumes may be administered over a short period of time without significant

changes in fluid and electrolyte balance.

Smaller volumes of PegLyte are used for constipation relief. It may take about 2 to 4 days to

produce a bowel movement.

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Pharmacokinetics

PEG 3350 is poorly absorbed through the gastrointestinal tract, and not is metabolized by the

colonic bacteria.

Pharmacokinetics of PEG 3350 were evaluated in human volunteers after the oral administration

of 17 g doses (as a laxative). Results show minimal absorption (<0.28%), low blood levels, rapid

excretion through feces and lack of substantial accumulation of PEG 3350 on multiple dosing

regardless of age and gender.

STORAGE AND STABILITY

PegLyte Powder for oral solution

Store the sachets and bottle at room temperature, between 15

C and 30

Once reconstituted, the solution should be used within 48 hours after mixing if stored at room

temperature. If kept refrigerated (between 2

C and 8°C), use within 30 days. Discard unused

portion.

DOSAGE FORMS, COMPOSITION AND PACKAGING

PegLyte Powder for oral solution (Fruit flavored)

280 g bottle

Each 280 g bottle of PegLyte powder, to be dissolved in 4 L of water, contains the following

medicinal ingredients:

Polyethylene Glycol 3350

238.18 g

Sodium Sulphate

22.96 g

Sodium Bicarbonate

6.76 g

Sodium Chloride

5.85 g

Potassium Chloride

3.05 g

Non-medicinal ingredients: Sodium Saccharin and Fruit flavours.

Box of 4 x 70 g sachets

Each 70 g sachet of PegLyte powder, to be dissolved in 1 L of water, contains the following

medicinal ingredients:

Polyethylene Glycol 3350

59.55 g

Sodium Sulphate

5.74 g

Sodium Bicarbonate

1.69 g

Sodium Chloride

1.46 g

Potassium Chloride

0.76 g

Non-medicinal ingredients: Sodium Saccharin and Fruit flavours.

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Once reconstituted with the appropriate volume of water, the solution contains:

Polyethylene Glycol 3350

17.8 mmol /L

Sodium

126.0 mmol /L

Potassium

10.2 mmol /L

Chloride

35.3 mmol /L

Sulphate

40.4 mmol /L

Bicarbonate

20.1 mmol /L

The osmolarity of a prepared solution of PEG/Electrolytes ranges from 235-305 mOsmol.

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PART II: SCIENTIFIC INFORMATION

PHARMACEUTICAL INFORMATION

Drug Substance

Drug Substance

Polyethylene

Glycol 3350

Sodium

Sulphate

Sodium

Bicarbonate

Sodium

Chloride

Potassium

Chloride

Proper name:

Polyethylene glycol

Sodium sulfate

Sodium bicarbonate

Sodium chloride

Potassium

chloride

Chemical name:

Ethanol, 2,2'-

(oxybis(2,1-

ethanediyloxy)bis-

Bisodium sulfate;

Dibasic sodium

sulfate

Bicarbonate of soda;

Carbonic acid,

monosodium salt

Sodium chloride

Potassium

chloride

Molecular formula:

HO(C

NaHCO

NaCl

Structural formula:

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CLINICAL TRIALS

A randomized, double-blind controlled clinical study compared the bowel cleansing efficacy and

safety of a PEG electrolyte solution (PEG-E), which is similar to Peglyte, administrated in a full-

dose regimen or a split-dose regimen with or without tegaserod (Abdul-Baki H. et al., 2008).

Efficacy of colon cleansing was the primary outcome. In the study groups (Group A and Group

C) where tegaserod was not used, patients were allowed a liquid diet in the full-dose group

(Group A) or a regular diet in the split-dose group (Group C) with the last meal at 6:00 PM on

the day before the colonoscopy, and after which only water was allowed until the procedure for

both groups. Between 7:00 PM and 9:30 PM on the day before the procedure, patients in the full-

dose group and the split-dose group consumed 4L or 2L of the PEG-E solution, respectively.

Patients in the split-dose group consumed further 2L of the PEG-E solution 2 hours before the

procedure. The quality of bowel preparation was graded as being excellent, good, fair or poor.

Patients in the split-dose group had significantly better colon cleansing than those in the full-dose

group (86% vs 46.1%). The rate of patients who adhered to dose requirement was higher in the

split-dose group than that in the full-dose group (91% vs 68.8%, P<0.05) (Table 1). The reported

adverse events (AEs) were nausea, vomiting, abdominal cramps, headache, sleep disturbance and

bloating in both study groups. However, the rate of the AEs was lower in the split-dose group

than that in the full-dose group except bloating (Table 1).

Table 1 Comparison of bowel cleansing efficacy, patients’ compliance and adverse reactions of a 4 L PEG-E

solution administrated in a full-dose regimen or a split-dose regimen (Abdul-Baki H. et al., 2008)

4L PEG-E solution

Full-dose group

(n=89)

Split-dose group

(n=107)

P value

Patients with good or excellent bowel

cleansing quality (%)*

46.1

86.0

Patients adhered to required volume of

the PEG-E solution (%)**

68.8

91.0

<0.05

Adverse reactions

(%)

Nausea

49.4

28.0

Vomiting

Abdominal cramps

28.1

18.7

Headache

30.7

20.6

Sleep disturbance

23.6

16.0

Bloating

25.0

35.5

*The bowel cleansing quality was rated with a scoring system similar to the Boston Bowel Preparation Score

system.

** Independent of the use of tegaserod.

Constipation

Polyethylene glycol and electrolytes solutions (PEG-ELS) are described as part of the

medications commonly used for the treatment of constipation. The maximal recommended dose

is 17-36 g once or twice a day.

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Study demographics and trial design

Table 4- Summary of patient demographics for clinical trials of polyethylene glycol and electrolyte solutions

(PEG-ELS) in the treatment of chronic constipation

Study

Trial design

Dosage

Duration

Study

subjects

Mean age

(years)

Gender

Andorsky

Goldner

Double-blind,

placebo-controlled,

cross-over study

PEG-ELS

240 mL/day or

480 mL /day

placebo 240 mL/day

or 480 mL /day

2 x 5 days

(range

42-89)

25 F

Chaussade

and Minic

Prospective,

multicenter, double-

blind, randomized,

parallel-group study

PEG3350-ELS

5.9 g/day

PEG3350-ELS

11.8 g /day

PEG4000 10 g/day

PEG4000 20 g/day

1 month

52.2 ± 18.5

39 M

227 F

Attar et al.

Randomized, open-

label, parallel-

group, multicenter

study

PEG-ELS 2x13g/day

Lactulose 2x10g/day

After two weeks of

treatment, patients

could adjust their dose

to 1 to 3 doses per day.

1 month

55 (24)

21 M

94 F

Study results

A double-blind, placebo-controlled, cross-over study by Andorsky and Goldner assessed the

effectiveness of a PEG-ELS for the treatment of chronic constipation. 32 patients were

instructed to drink 240 mL or 480 mL of PEG-ELS or placebo daily during 5 consecutive days,

then received the same volume of the second treatment (PEG-ELS or placebo) after a 2-day

washout period. Daily number of bowel movements and stool consistency were recorded. The

two-factor analysis of variance results confirmed that PEG-ELS was superior to placebo with

regard to the mean stool frequency (7.75 ± 4.55 vs. 4.88 ± 2.62, p < 0,01) and the mean stool

consistency (2.56 ± 1.17 vs. 1.91 ± 0.94, p < 0.05). Furthermore, PEG-ELS 480 mL per day was

superior to all other groups with regard to the measured variables. Side effects reported with the

PEG-ELS solution included cramping, gas, nausea, and loose stools; side effects did not lead to

treatment cessation. The finding that PEG-ELS resulted in significant effects on both stool

frequency and stool consistency further supports its efficacy in the treatment of constipation.

A multicentre, double-blind, randomized, parallel-group study by Chaussade and Minic

compared the efficacy and tolerability of standard and maximum daily doses of PEG-ELS (PEG

3350 and electrolytes) and PEG 4000 in the treatment of chronic constipation. Results showed

that both doses of PEG-ELS and PEG 4000 were similarly effective in treating the symptoms of

constipation (stool frequency and stool consistency were improved when compared to baseline).

Diarrhea was observed in 13% of patients treated with low dose of PEG-ELS and 36% after the

higher dose. Side effects reported were abdominal distention, flatulence and abdominal pain

similarly distributed across all groups. Vital signs were normal in 95% of the patients

A randomized, open-label, parallel-group, multicenter study by Attar et al. compared PEG-ELS

to lactulose for treatment of constipation. 115 patients with chronic idiopathic constipation were

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instructed to take two 13 g sachets of PEG-ELS or two 10 g lactulose sachets, in divided doses.

After two weeks of treatment, dosage could be adjusted to 1 to 3 sachets/day. Treatment lasted

for 4 weeks. PEG was well tolerated in the young and elderly population and the treatment of

constipation was better than lactulose in terms of number of bowel movements, straining and use

of suppositories and minienemas.

TOXICOLOGY

Acute Toxicity:

The oral LD

is >50 g/kg in mice, rats and rabbits.

Rats

Chronic oral toxicity studies were conducted in rats (up to 6 g/kg/day) up to six months duration.

The major target organ of toxicity in the rat appeared to be the kidney (focal or multi focal

cytoplasmic vacuolation in cortical tubular epithelial cells in males at 6 g/kg/day).

Dogs

Chronic oral toxicity studies were conducted in dogs (up to 3 g/kg/day) up to nine months

duration.

Following oral administration of PEG 3350 for 28-days, the target organs of toxicity appeared to

be the lungs (minimal to moderate interstitial fibrosis characterized by thickening of alveolar

septa with associated pneumocyte hypertrophy/hyperplasia and the presence of a small number

of mononuclear inflammatory cells and alveolar histiocytes; foamy or vacuolated histiocytes in

perivascular or peribronchiolar regions characterized as perivascular mononuclear infiltrates),

gastrointestinal tract (minimal subacute inflammation or crypt abscesses, hemorrhage and

lymphoid hyperplasia in cecum, colon, ileum and/or rectum; lymphoid hyperplasia of the gut-

associated lymphoid tissue in females at 3, 6 and 9.3 g/kg/day), testes (hypospermia in the

epididymides and seminiferous tubule degeneration or multiucleated spermatids of the testes)

and salivary gland (atrophy).

Following 9-month oral administration of PEG 3350 in dogs (up to 3 g/kg/day), the target organs

of toxicity appeared to be testes (retarded development) and prostate (lymphocyte infiltrate) in

the males and mammary gland (glandular hyperplasia), liver (vacuolation) and gallbladder

(lymphocyte infiltrate and epithelial hyperplasia) in females.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Carcinogenesis

No tumorigenic effect was seen in mice and rats up to 6 g/kg/day. The carcinogenic potential of

PEG 3350 has also been examined in CD-J mice (l04 weeks) and Sprague Dawley rats (l04

weeks).

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Mutagenesis

PEG 3350 was negative in the Ames test. No clastogenic potential was shown in the

chromosome aberration test with human peripheral blood lymphocytes. It was also negative in

in vivo oral rat micronucleus test.

Development and reproductive toxicity

Reproduction studies with PEG 3350 have been performed in pregnant rats (oral doses up to

2 g/kg/day) and in pregnant rabbits (oral doses up to 2 g/kg/day) and have revealed no adverse

effects on fertility or harm to the fetus.

In pre- and post-natal developmental study in rats up to 2 g/kg/day dose, PEG 3350 did not show

any adverse effect on F

postnatal survival, body weight, developmental landmarks, startle

response, motor activity, learning and memory and reproductive performance, intrauterine

growth and survival of F

fetuses and external and developmental parameters of F

fetuses.

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REFERENCES

Abdul-Baki H, Hashash JG, Elhajj II, Azar C, El Zahabi L, Mourad FH, Barada KA,

Sharara AI. A randomized, controlled, double-blind trial of the adjunct use of tegaserod in

whole-dose or split-dose polyethylene glycol electrolyte solution for colonoscopy

preparation. Gastrointest Endosc. 2008 Aug; 68(2):294-300.

Andorsky RI, Goldner F. Colonic lavage solution (polyethylene glycol electrolyte lavage

solution) as a treatment for chronic constipation: a double-blind, placebo-controlled study.

Am J Gastroenterol. 1990;85(3):261-265.

Attar A, Lémann M, Ferguson A, et al. Comparison of a low dose polyethylene glycol

electrolyte solution with lactulose for treatment of chronic constipation. Gut. 1999

Feb;44(2):226-230.

Barkun A, Chiba N, Enns R, et al. Commonly used preparations for colonoscopy:

efficacy, tolerability and safety - A Canadian Association of Gastroenterology position

paper. Can J Gastroenterol. 2006 Nov;20(110):699-710.

Brandt LJ, Prather CM, Quigley EMM, et al. Systematic review on the management of

chronic constipation in North America. Am J Gastroenterol. 2005;100(S1):S5-22.

Chaussade S, Minic M. Comparison of efficacy and safety of two doses of two different

polyethylene glycol-based laxatives in the treatment of constipation. Aliment Pharmacol

Ther. 2003;17:165-172.

DiPalma JA, Cleveland MB, Herrera JL. A comparison of polyethylene glycol laxative

and placebo for relief of constipation from constipating medications. Southern Med J.

2007 Nov;100(11):1085-1090.

DiPalma JA, DeRidder PH, Orlando RC, Kolts BE, Cleveland MB. A Randomized,

Placebo-Controlled, Multicenter Study of the Safety and Efficacy of a New Polyethylene

Glycol Laxative. Am J of Gastroenterol. 2000;95(2),446-450.

DiPalma JA, MacRae DH, Reichelderfer M, Hamilton JW, Cleveland MB. Braintree

Polyethylene Glycol (PEG) laxative for Ambulatory and Long-Term Care Facility

Constipation Patients: Report of Randomized, Cross-Over Trials. Online J of Digestive

Health. 1999 March;1(2).

Eoff JC, Lembo AJ. Optimal treatment of chronic constipation in managed care: review

and roundtable discussion. Supplement to JMCP. 2008 Nov;14(9):S3-15.

FDA review file, NDA 22-015, Accessed March 2011 from URL:

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/022015s000_TOC.cfm.

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Freedman MD, Schwartz HJ, Roby R, Fleisher S. Tolerance and efficacy of Polyethylene

Glycol 3350/Electrolyte Solution versus Lactulose in relieving opiate induced

Constipation: A double-blinded placebo-controlled trial. J Clin Pharmacol. 1997;37:904-

907.

Hammer HF, Santa Ana CA, Schiller LR, Fordtran JS. Studies of osmotic diarrhea

induced in normal subjects by ingestion of polyethylene glycol and lactulose. J Clin

Invest. 1989 Oct;84(4):1056-62.

Lembo A, Camilleri M. Current Concept. Chronic constipation. Review article. N Engl J

Med. 2003 Oct;349:1360-8.

Pelham RW, Nix LC, Chavira RE, Cleveland MV, Stetson P. Clinical trial: single- and

multi-dose pharmacokinetics of polyethylene glycol (PEG-3350) in healthy young and

elderly subjects. Aliment Pharmacol Ther. 2008;28:256-265.

Ramkumar D, Rao SSC. Efficacy and safety of traditional medical therapies for

chronic constipation: Systemic review. Am J Gastroenterol. 2005;100:936-71.

IMPORTANT: PLEASE READ

PegLyte

®

Prescribing Information

Page 18 of 20

PART III: CONSUMER INFORMATION

PegLyte

®

Powder

Polyethylene Glycol 3350 and Electrolytes for Oral Solution, USP

This leaflet is part III of a three-part "Prescribing

Information" published when PegLyte was approved for sale

in Canada and is designed specifically for Consumers. This

leaflet is a summary and will not tell you everything about

PegLyte. Contact your doctor or pharmacist if you have any

questions about the drug.

ABOUT THIS MEDICATION

What the medication is used for:

Bowel cleansing prior to examination (e.g., colonoscopy) or

surgical procedures requiring a clean colon.

The treatment of constipation following consultation with your

doctor.

What it does:

The polyethylene glycol binds to the water and helps laxation. The

electrolytes help maintain the salt balance in this process.

When it should not be used:

Do not take if you have any of the following conditions (ask your

doctor if you are unsure):

ileus (blockage in the bowel)

gastric retention

bowel perforation

gastrointestinal obstruction

toxic colitis (inflamed large bowel with damage to the intestinal

wall)

toxic megacolon (acute swelling of the large bowel)

or if you are hypersensitive (allergic) to any ingredient in this

formulation (See What the non-medicinal ingredients are).

What the medicinal ingredients are:

70 g sachet

280 g bottle

Polyethylene Glycol 3350

59.55 g

238.18 g

Sodium Sulphate

5.74 g

22.96 g

Sodium Bicarbonate

1.69 g

6.76 g

Sodium Chloride

1.46 g

5.85 g

Potassium Chloride

0.76 g

3.05 g

What the important non-medicinal ingredients are:

Sodium Saccharin, Fruit flavours.

What dosage forms it comes in:

Powder for oral solution (fruit flavoured):

Box of 4 sachets of 70 g powder

Bottle of 280 g powder

WARNINGS AND PRECAUTIONS

BEFORE you use PegLyte, talk to your doctor or pharmacist

if:

You have taken any other medication within 2 hours of when

you plan to start taking PegLyte (you may be removing this

medication from your gastrointestinal tract by taking the

PegLyte).

You have a history of electrolyte imbalance (e.g.,

hyponatremia) or are using diuretics.

You have ulcerative colitis or any other inflammatory bowel

disease (e.g., Crohn’s disease).

You are pregnant or nursing.

You have difficulty swallowing or have a pronounced gag

reflex or are prone to vomiting.

You have any allergies to this drug or its ingredients.

Talk to your doctor if you have kidney or heart problemsor any

tendency to regurgitate (bring up) food from your stomach into

your esophagus or any tendency to accidentally inhale food or

regurgitate food into the trachea (breathing tube to the lungs).

Contact your doctor if the following occurs while taking

PegLyte:

You develop severe bloating, abdominal pain or distension.

Do not take this medication if you have abdominal pain,

nausea or vomiting.

INTERACTIONS WITH THIS MEDICATION

Oral medications taken within 2 hours of the start of

administration of PegLyte may be flushed from the

gastrointestinal tract and not absorbed.

Drug interaction studies have not been done for PegLyte.

PROPER USE OF THIS MEDICATION

Preparation of the solution:

PegLyte 280 g bottle: Add tap water to the fill line (total volume

4 L). Replace cap tightly and mix well until all ingredients have

dissolved.

PegLyte 70 g sachet: Dissolve the entire contents of one sachet

in 1 L (32 ounces) of water and stir rapidly to dissolve. Repeat for

the other 3 sachets, one at a time, as needed.

IMPORTANT: PLEASE READ

PegLyte

®

Prescribing Information

Page 19 of 20

Do not add any other ingredients (e.g., flavouring, juice) to the

solution. Keep refrigerated during treatment, for optimal storage

and to improve the taste. Using a straw can help to make the

solution taste better and easier to drink.

Usual adult dose:

Colon cleansing before examination

On the day before your procedure or examination, have breakfast

no later than 11h00 AM or as specified by your doctor. After

breakfast, no solid foods or milk, except clear liquids, should be

taken. You can resume eating solid foods and milk only after your

procedure or examination.

Dosing regimens your healthcare practitioner might prescribe:

SPLIT-DOSING REGIMEN*

Day before procedure:**

In the afternoon, rapidly drink a glassful (250 mL) of

PegLyte every 10-15 minutes until 2 L are consumed.

Day of the procedure (at least 4 hours before the procedure):**

Rapidly drink a glassful (250 mL) of PegLyte every 10-15

minutes until 2 L are consumed.

FULL-DOSING REGIMEN*

Day before procedure**

In the evening**, rapidly drink a glassful (250 mL) of

PegLyte every 10-15 minutes until 4 L are consumed.

*Follow instructions as prescribed by your physician. Your

physician may choose to prescribe a full-dosing or split-dosing

regimen. **Time to be confirmed by your physician.

The first bowel movement should occur approximately 1 hour

after the start of PegLyte administration. Administration of

PegLyte should be continued until the watery stool is clear and

free of solid matter. Make sure to take the entire bowel

preparation solution as instructed by your doctor. This will

help ensure that the colon will be optimally cleaned and minimize

the need to reschedule your procedure.

Constipation

Drink 240 to 480 mL/day for a week or less or as recommended

by your doctor. Do not take any type of laxatives for more than

one week, unless your doctor has ordered a special schedule for

you. Treatment for 2 to 4 days may be required to produce a

bowel movement. If no bowel movement occurs in 4 days,

contact your doctor.

Overdose:

In case of drug overdose, contact a health care practitioner,

hospital emergency department or regional Poison Control

Centre immediately, even if there are no symptoms.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medications, PegLyte can cause some side effects. You

may not experience any of them. For most patients, these side

effects are likely to be minor and temporary.

The most frequent side effects for a colon preparation (occurring

in up to 50% of patients) are:

nausea

abdominal fullness

IMPORTANT: PLEASE READ

PegLyte

®

Prescribing Information

Page 20 of 20

bloating

Less frequent side effects include:

abdominal cramps

vomiting

anal irritation

Seizures have also occurred in patients using PEG-based colon

preparations.

For patients using PegLyte in the treatment of constipation, the

side effects may include:

nausea

abdominal bloating

cramping

diarrhea. If diarrhea occurs, stop taking PegLyte.

Isolated cases of urticaria (hives), rhinorrhea (nasal discharge) and

dermatitis (skin inflammation) have been reported. These may be

signs of an allergic reaction. If you experience these symptoms,

seek urgent medical attention.

This is not a complete list of side effects. For any unexpected

effects while taking PegLyte, contact your doctor or pharmacist.

HOW TO STORE IT

Store the powder at room temperature (between 15 and 30

Keep out of reach and sight of children.

Once reconstituted, the solution should be used within 48 hours

after mixing if stored at room temperature. If kept refrigerated

(between 2- 8°C), use within 30 days. Discard unused portion.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with

the use of health products to the Canada Vigilance Program by

one of the following 3 ways:

--------------------------------------------------------------------------

Report online at www.healthcanada.gc.ca/medeffect

Call toll-free at 1-866-234-2345

Complete a Canada Vigilance Reporting Form and:

- Fax toll-free to 1-866-678-6789, or

- Mail to:

Canada Vigilance Program

Health Canada

Postal Locator 0701E

Ottawa, Ontario

K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form

and the adverse reaction reporting guidelines are

available on the MedEffect

Canada Web site at

www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management

of side effects, contact your health professional. The Canada

Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full prescribing information, prepared for

health professionals, can be obtained by contacting

PENDOPHARM, Division of Pharmascience Inc. at

1-888-550-6060.

This leaflet was prepared by

PENDOPHARM, Division of Pharmascience Inc.

Montreal, Quebec

H4P 2T4

Last revised: October 2, 2015

Registered trademark of Pharmascience Inc.

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