Wednesday, 4 April 2012

Saline Laxatives


Class: Cathartics and Laxatives
ATC Class: A06AX02
VA Class: GA200
CAS Number: 124-38-9
Brands: Ceo-Two, Fleet Enema, Fleet Pedia-Lax, Fleet Prep Kit, LoSo Prep Kit, OsmoPrep, Phillips' Milk of Magnesia, Phillips' M-O, Tridrate Kit, Visicol


REMS:


FDA approved a REMS for sodium phospate to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of sodium phospate and consists of the following: medication guide and communication plan. See the FDA REMS page () or the ASHP REMS Resource Center ().



Introduction

Laxatives containing magnesium cations or phosphate anions.a


Uses for Saline Laxatives


Constipation


Used to relieve occasional constipation.214 215 216 217 218 219 220 224 225 227 231 b


Use of saline laxatives for simple constipation is seldom necessary or desirable; bulk-forming laxatives are drugs of choice.b


Do not use rectal suppositories or enemas if oral laxatives are effective.b


Mild saline laxatives (e.g., oral magnesium hydroxide, milk of magnesia) have been used to treat constipation during pregnancy or the puerperium; bulk-forming laxatives or stool softeners preferred.b


Used rectally, after administration of a stool softener or mineral oil, to evacuate the impacted colon in the treatment of constipation associated with stricture of the colon or fecal impaction.b Alternatively, administer phosphate-containing saline enemas rectally after manual disimpaction to promote evacuation of fecal impactions.b


Bowel Cleansing


Used orally and/or rectally (as suppositories or enemas) to empty the bowel prior to surgery or radiologic, proctoscopic, or endoscopic procedures, when thorough evacuation is essential.212 213 219 220 221 222 223 227 232 b Oral therapy often is supplemented with rectal evacuants.221 222 223 232 b


FDA recommends using OTC oral sodium phosphates preparations for bowel cleansing only when a prescription for such use has been issued by a clinician.239 240 (See Renal Effects under Cautions.)


Poisonings


May hasten removal of some poisons from the GI tract after inducing emesis or performing gastric lavage.b Not for use after poisonings with ingested acids or alkalies.b Magnesium laxatives should not be used to remove poisons that produce CNS depression or renal function impairment.b


Saline Laxatives Dosage and Administration


General


  • Bowel Cleansing


  • Patients must drink sufficient quantities of clear fluids (minimum of 1.9–3.4 L per regimen, depending on the specific regimen).212 213 220 221 222 223 229 230 b Use IV hydration in a hospital setting for fragile patients with inadequate home support or who are unable to drink an appropriate fluid volume.239 b (See Fluid Intake under Cautions.)



Administration


Administer magnesium-containing saline laxatives orally as chewable tablets, suspensions, or solutions.215 216 217 218 222 223 224 225 232


Administer phosphate-containing laxatives orally as solutions or tablets and rectally as enemas.212 213 219 220 221 227 228 229 230 Do not administer commercially available phosphate-containing rectal enema solutions orally.219 227 228


Administer carbon dioxide-releasing suppositories (e.g., CEO-TWO) rectally.214


Select rectal phosphate-containing laxatives carefully to ensure appropriate volume for age to minimize risk of overdosage.219 227 228


Administer laxatives as infrequently as possible at the lowest effect dosage level.b Do not use for >7 days unless directed by prescriber.215 216 b


Administer laxatives with sufficient fluids (i.e., 240 mL) to prevent dehydration from repeated administration.215 216 217 218 224 225 233 b (See Fluid Intake under Cautions.)


Oral Administration


Administer orally as magnesium-containing chewable tablets, suspensions, or solutions or as phosphate-containing solutions or tablets.212 213 215 216 217 218 219 220 221 222 223 224 225 227 228 229 230 232 233 235


Do not administer fixed combination of magnesium hydroxide and mineral oil with meals; typically administered at bedtime.218


Shake suspensions well before use.215 216 218


May refrigerate oral sodium phosphates solutions to improve taste;220 may drink magnesium citrate chilled.222


Reconstitution (Magnesium Sulfate Crystals)

To prepare magnesium sulfate oral solution, dissolve appropriate dose of the crystals in at least 240 mL water; may add lemon juice to mask bitter taste and minimize nausea.225 b


Reconstitution (LoSo Prep Kit)

Prepare magnesium citrate oral solution by dissolving contents of 1 packet (18 g of magnesium citrate) in 240 mL of cold water.232 First, add approximately one-half of the contents of the packet to a large (capacity of ≥480 mL) glass containing 240 mL of cold water, gently stir the mixture until effervescence (fizzing) stops, then add the remaining contents of the packet to the mixture and again stir gently until effervescence stops.232


Reconstitution (Tridrate Dry Kit)

Prepare magnesium citrate oral solution by adding the contents of 1 packet (19 g of magnesium citrate) to 240 mL of room-temperature water; stir the mixture for 30 seconds until complete dissolution occurs.226 Patient should wait ≥20 minutes before ingesting the mixture, occasionally stirring it in the interim.226 May prepare the solution up to 12 hours prior to ingestion and chill to improve taste.226


Dilution (Fleet Prep Kits)

Dilute sodium phosphates oral solution (Fleet Phospho-soda) prior to administration.220 229 230 Mix 45 mL of the solution with 360 mL of cold clear liquid (ginger ale, apple juice, Sprite, or 7-Up may help improve taste).220 229 230


Rectal Administration


Administer rectally as phosphate-containing enemas or carbon dioxide-releasing suppositories.214 219 227 228


Suppositories

Carbon dioxide-releasing suppositories: Remove wrapper and moisten under a warm-water tap for 30 seconds or in a cup of water for ≥10 seconds prior to rectal insertion;214 231 234 do not use mineral oil or petroleum jelly to lubricate.214 231 234


Insert suppository high into the rectum past the largest diameter of the suppository;214 retain for as long as possible (usually 5–30 minutes) before defecating.214 231 b


Enemas

Administer sodium phosphates enema at room temperature.219


Remove protective shield (if present) from tip of enema.219 228


Before administering, lie on left side with knees bent or kneel on the bed with head and chest lowered and forward until the left side of the face is resting on the surface of the bed.219 228 b


With steady pressure, insert enema nozzle into rectum, with nozzle pointed toward the navel.219 b To ease insertion, have patient bear down as if having a bowel movement.219 Squeeze container until nearly all the liquid is expelled.219 228 b Use caution to avoid bowel perforation.219 If resistance is encountered during insertion or administration, discontinue procedure to avoid perforation or rectal abrasion.219


Retain until definite lower abdominal cramping felt.b Complete evacuation of the left colon usually occurs within 1–5 minutes.219


Disposable enemas are for single-use only.219


For children 2–4 years of age, prepare an enema containing dibasic sodium phosphate 1.75 g and monobasic sodium phosphate 4.75 g in approximately 29 mL for administration as follows.227 Unscrew the cap of a pediatric-strength enema containing dibasic sodium phosphate 3.5 g and monobasic sodium phosphate 9.5 g in 59 mL (e.g., Fleet Pedia-Lax Enema) and remove 30 mL of solution.227 Replace the cap and administer the enema as directed.227


Dosage


Most studies suggest that the minimum effective oral laxative dose of magnesium is 80 mEq.a (See Electrolytic Content under Cautions.)


Magnesium sulfate crystals: Each level teaspoonful of crystals provides approximately 5 g of magnesium sulfate and 495 mg (40.7 mEq) of magnesium.225


Sodium phosphates enemas: A 66-mL enema (Fleet Pedia-Lax Enema) delivers a dose of 3.5 g of dibasic sodium phosphate and 9.5 g of monobasic sodium phosphate in 59 mL;227 a 133-mL enema (Fleet Enema) delivers a dose of 7 g of dibasic sodium phosphate and 19 g of monobasic sodium phosphate in 118 mL; a 230-mL enema (Fleet Enema Extra) delivers a dose of 7 g of dibasic sodium phosphate and 19 g of monobasic sodium phosphate in 197 mL.219


Pediatric Patients


Constipation

Laxatives should be used as infrequently as possible, at the lowest effective dosage level, and usually for ≤7 days; laxatives should be used for longer periods only under the management of a clinician and as part of a carefully planned therapeutic regimen.214 215 216 217 218 219 220 221 223 225 232 (See Chronic Use or Overdosage under Cautions.)


Magnesium Citrate

Oral

Children 2–5 years of age: For self-medication, 2.7–6.25 g (usually 60–90 mL [3.5–5.25 g] of a 291-mg/5-mL oral solution224 ) as a single daily dose or in divided doses.234


Children 6–11 years of age: For self-medication, 5.5–12.5 g (usually 90–150 mL [5.25–8.75 g] of a 291-mg/5-mL oral solution224 ) as a single daily dose or in divided doses.234


Children ≥12 years of age: For self-medication, 8.75–25 g (usually 150–300 mL [8.75–17.5 g] of a 291-mg/5-mL oral solution224 ) as a single daily dose or in divided doses.234


Magnesium Hydroxide

Oral

Children 2–5 years of age: For self-medication, 0.4–1.2 g daily given as a single dose (preferably at bedtime), in divided doses, or as directed by a clinician.217 233 234 235


Children 6–11 years of age: For self-medication, 1.2–2.4 g daily given as a single dose (preferably at bedtime), in divided doses, or as directed by a clinician.215 216 217 218 233 234 235


Children ≥12 years of age: For self-medication, 2.4–4.8 g daily given as a single dose (preferably at bedtime), in divided doses, or as directed by a clinician.215 216 217 218 233 234


Magnesium Sulfate

Oral

Children 2–5 years of age: For self-medication, 2.5–5 g daily given as a single dose or in divided doses.234


Children 6–11 years of age: For self-medication, 5–10 g daily given as a single dose or in divided doses.225 234


Children ≥12 years of age: For self-medication, 10–30 g daily given as a single dose or in divided doses.225 234


Fixed Combination of Magnesium Hydroxide and Mineral Oil

Oral

Do not use manufacturer's provided dosage cup for Phillips' M-O for children.218


Children 6–11 years of age: For self-medication, 1.2–1.8 g of magnesium hydroxide (20–30 mL of the fixed-combination suspension) daily given as a single dose (at bedtime), in divided doses, or as directed by a clinician.218


Children ≥12 years of age: For self-medication, 2.7–3.6 g of magnesium hydroxide (45–60 mL of the fixed-combination suspension) daily given as a single dose (at bedtime), in divided doses, or as directed by a clinician.218


Sodium Phosphates Enemas

Rectal

Do not administer adult-size Fleet enemas to children <12 years of age.219 Do not administer a full 59-mL Fleet Pedia-Lax Enema to children <5 years of age.219 227


Children 2–4 years of age: For self-medication, 1.75 g of dibasic sodium phosphate and 4.75 g of monobasic sodium phosphate (½ bottle [approximately 29 mL] of Fleet Pedia-Lax Enema) given as a single daily dose.227 To obtain correct dose, remove 30 mL liquid from Fleet Pedia-Lax Enema prior to administration.227


Children 5–11 years of age: For self-medication, 3.5 g of dibasic sodium phosphate and 9.5 g of monobasic sodium phosphate (1 bottle [approximately 59 mL] of Fleet Pedia-Lax Enema) given as a single daily dose or as directed by a clinician.227


Children ≥12 years of age: For self-medication, 7 g of dibasic sodium phosphate and 19 g of monobasic sodium phosphate (1 bottle of Fleet Enema [approximately 118 mL] or Fleet Enema Extra [approximately 197 mL]) given as a single daily dose.219 228


Carbon Dioxide-releasing Suppositories

Rectal

Children ≥12 years of age: For self-medication, 1 suppository (0.9 g potassium bitartrate and 0.6 g sodium bicarbonate) given as a single daily dose.214 231 234


Bowel Cleansing

Consult manufacturers' instructions for details (e.g., time of administration) of the specific regimen to be used to clear the bowel prior to surgical, radiologic, or endoscopic procedures.222 223 226 232


Fleet Sodium Phosphates Enemas

Rectal

Do not administer adult-size Fleet enemas to children <12 years of age.219 Do not administer a full 59-mL Fleet Pedia-Lax Enema to children <5 years of age.219 227


Children 2–4 years of age: For self-medication, 1.75 g of dibasic sodium phosphate and 4.75 g of monobasic sodium phosphate (½ bottle [approximately 29 mL] of Fleet Pedia-Lax Enema) given as a single daily dose.227 To obtain correct dose, remove 30 mL liquid from Fleet Pedia-Lax Enema prior to administration.227


Children 5–11 years of age: For self-medication, 3.5 g of dibasic sodium phosphate and 9.5 g of monobasic sodium phosphate (1 bottle [approximately 59 mL] of Fleet Pedia-Lax Enema) given as a single daily dose or as directed by a clinician.227


Children ≥12 years of age: For self-medication, 7 g of dibasic sodium phosphate and 19 g of monobasic sodium phosphate (1 bottle of Fleet Enema [approximately 118 mL] or Fleet Enema Extra [approximately 197 mL]) given as a single daily dose.219 228


Liquid LoSo Prep Kit

Oral and Rectal

The regimen begins with liquid meals at prescribed times, followed by scheduled clear liquid intake at various times and scheduled administration of oral laxatives, and concludes with rectal administration of a bisacodyl suppository.223


Children ≥12 years of age: In the usual regimen, 300 mL of magnesium citrate solution (17.45 g of magnesium citrate) is administered orally at 5:30 p.m. the day before the procedure, followed by 20 mg of bisacodyl orally at 7:30 p.m. the day before the procedure, and concludes with a 10-mg bisacodyl rectal suppository inserted at least 2 hours before the procedure.223


LoSo Prep Kit

Oral and Rectal

The regimen begins with liquid meals at prescribed times, followed by scheduled clear liquid intake at various times and scheduled administration of oral laxatives, and concludes with rectal administration of a bisacodyl suppository.232


Children ≥12 years of age: In the usual regimen, 18 g of magnesium citrate (1 packet dissolved in 240 mL water) is administered orally at 5:30 p.m. the day before the procedure, followed by 20 mg of bisacodyl orally at 7:30 p.m. the day before the procedure, and concludes with a 10-mg bisacodyl rectal suppository inserted at least 2 hours before the procedure.232


Tridrate Kit

Oral and Rectal

The regimen begins with a meal (i.e., clear liquids, chicken or turkey white meat sandwich without condiments, skim milk) at a prescribed time, followed by scheduled clear liquid intake at various times and scheduled administration of oral laxatives, and concludes with rectal administration of a bisacodyl suppository.222


Children >12 years of age: In the usual regimen, 300 mL of magnesium citrate solution is administered orally at 8 p.m. the day before the procedure, followed by 15 mg of bisacodyl orally at 10 p.m. the day before the procedure, and concludes with a 10-mg bisacodyl rectal suppository at 7 a.m. the morning of the procedure.222


Tridrate Dry Kit

Oral and Rectal

The regimen begins with liquid meals at prescribed times, followed by scheduled clear liquid intake at various times and scheduled administration of oral laxatives, and concludes with rectal administration of a bisacodyl suppository.226


Children >12 years of age: In the usual regimen, 19 g of magnesium citrate (1 packet dissolved in 240 mL water) is administered orally in 2 divided doses at 6 p.m. and 6:15 p.m. the day before the procedure, followed by 15 mg of bisacodyl orally at bedtime (between 9 p.m. and midnight) the day before the procedure, and concludes with a 10-mg bisacodyl rectal suppository at 7 a.m. the morning of (at least 2 hours before) the procedure.226


Adults


Constipation

Laxatives should be used as infrequently as possible, at the lowest effective dosage level, and usually for ≤7 days; laxatives should be used for longer periods only under the management of a clinician and as part of a carefully planned therapeutic regimen.214 215 216 217 218 219 220 221 223 225 232 b (See Chronic Use or Overdosage under Cautions.)


Magnesium Citrate

Oral

For self-medication: 8.75–25 g (usually 150–300 mL of a 291-mg/5-mL oral solution224 ) as a single daily dose or in divided doses.234


Magnesium Hydroxide

Oral

For self-medication: 2.4–4.8 g daily given as a single dose (preferably at bedtime), in divided doses, or as directed by a clinician.215 216 217 218 233 234


Magnesium Sulfate

Oral

For self-medication: 10–30 g daily given as a single dose or in divided doses.225 234


Fixed Combination of Magnesium Hydroxide and Mineral Oil

Oral

For self-medication: 2.7–3.6 g of magnesium hydroxide (45–60 mL of the fixed-combination suspension) daily given as a single dose (at bedtime), in divided doses, or as directed by a clinician.218


Sodium Phosphates Enemas

Rectal

For self-medication: 7 g of dibasic sodium phosphate and 19 g of monobasic sodium phosphate (1 bottle of Fleet Enema [approximately 118 mL] or Fleet Enema Extra [approximately 197 mL]) given as a single daily dose.219 228


Carbon Dioxide-releasing Suppositories

Rectal

1 suppository (0.9 g potassium bitartrate and 0.6 g sodium bicarbonate) given as a single daily dose.214 231 234


Bowel Cleansing

Fleet Prep Kits

Oral and Rectal

Available in 2 kit combinations containing sodium phosphates oral solution, bisacodyl tablets, and either a bisacodyl suppository (Fleet Prep Kit 1) or a bisacodyl enema (Fleet Prep Kit 3).221


Each kit can be administered in regimens beginning 18 or 24 hours before the procedure; in most cases, the 24-hour regimen is followed.221


Each regimen begins with a light meal at a prescribed time, followed by scheduled clear liquid intake at various times and scheduled administration of oral laxatives, and concludes with rectal administration of either a bisacodyl suppository or bisacodyl enema 1 hour before leaving for the procedure.221


Kit 1, 24-hour regimen: The day before the procedure, 45 mL of sodium phosphates oral solution (Fleet Phospho-soda) is mixed with 360 mL of cold clear liquid and administered orally at 4 p.m. with ≥360 mL of clear liquid, followed by 20 mg (or alternative dose per clinician) of bisacodyl orally at 9 p.m. the day before the procedure, and then by a 10-mg bisacodyl rectal suppository administered 1 hour before leaving for the procedure.221 229


Kit 3, 24-hour regimen: The day before the procedure, 45 mL of sodium phosphates oral solution (Fleet Phospho-soda) is mixed with 360 mL of cold clear liquid and administered orally at 4 p.m. with ≥240 mL of clear liquid, followed by 20 mg (or alternative dose per clinician) of bisacodyl orally at 9 p.m. the day before the procedure, and then by a 10-mg (30-mL) bisacodyl enema administered 1 hour before leaving for the procedure.221 230


Drink as much additional liquid as possible; drink additional liquids after procedure to prevent dehydration.221 229 230


Sodium Phosphates Enemas

Rectal

For self-medication: 7 g of dibasic sodium phosphate and 19 g of monobasic sodium phosphate (1 bottle of Fleet Enema [approximately 118 mL] or Fleet Enema Extra [approximately 197 mL]) given as a single daily dose.219 228


Liquid LoSo Prep Kit

Oral and Rectal

The regimen begins with liquid meals at prescribed times, followed by scheduled clear liquid intake at various times and scheduled administration of oral laxatives, and concludes with rectal administration of a bisacodyl suppository.223


In the usual regimen, 300 mL of magnesium citrate solution (17.45 g of magnesium citrate) is administered orally at 5:30 p.m. the day before the procedure, followed by 20 mg of bisacodyl orally at 7:30 p.m. the day before the procedure, and concludes with a 10-mg bisacodyl rectal suppository inserted at least 2 hours before the procedure.223


LoSo Prep Kit

Oral and Rectal

The regimen begins with liquid meals at prescribed times, followed by scheduled clear liquid intake at various times and scheduled administration of oral laxatives, and concludes with rectal administration of a bisacodyl suppository.232


In the usual regimen, 18 g of magnesium citrate (1 packet dissolved in 240 mL water) is administered orally at 5:30 p.m. the day before the procedure, followed by 20 mg of bisacodyl orally at 7:30 p.m. the day before the procedure, and concludes with a 10-mg bisacodyl rectal suppository inserted at least 2 hours before the procedure.232


OsmoPrep Sodium Phosphates Tablets

Oral

Evening before procedure: 1.592 g of dibasic sodium phosphate and 4.408 g of monobasic sodium phosphate (4 tablets) with 240 mL clear liquids; repeat every 15 minutes for 5 doses.213 Total dose 7.96 g of dibasic sodium phosphate and 22.04 g of monobasic sodium phosphate (20 tablets).213


Day of procedure: 1.592 g of dibasic sodium phosphate and 4.408 g of monobasic sodium phosphate (4 tablets) with 240 mL clear liquids every 15 minutes beginning 3–5 hours before the procedure.213 Repeat every 15 minutes for 3 doses.213 Total dose 4.776 g of dibasic sodium phosphate and 13.224 g of monobasic sodium phosphate (12 tablets).213


Total dosage is 12.736 g of dibasic sodium phosphate and 35.264 g of monobasic sodium phosphate with 1892 mL (2 quarts) of clear fluids.213 No additional enema or laxative is required.213


Tridrate Kit

Oral and Rectal

The regimen begins with a meal (i.e., clear liquids, chicken or turkey white meat sandwich without condiments, skim milk) at a prescribed time, followed by scheduled clear liquid intake at various times and scheduled administration of oral laxatives, and concludes with rectal administration of a bisacodyl suppository.222


In the usual regimen, 300 mL of magnesium citrate solution is administered orally at 8 p.m. the day before the procedure, followed by 15 mg of bisacodyl orally at 10 p.m. the day before the procedure, and concludes with a 10-mg bisacodyl rectal suppository at 7 a.m. the morning of the procedure.222


Tridrate Dry Kit

Oral and Rectal

The regimen begins with liquid meals at prescribed times, followed by scheduled clear liquid intake at various times and scheduled administration of oral laxatives, and concludes with rectal administration of a bisacodyl suppository.226


In the usual regimen, 19 g of magnesium citrate (1 packet dissolved in 240 mL water) is administered orally in 2 divided doses at 6 p.m. and 6:15 p.m. the day before the procedure, followed by 15 mg of bisacodyl orally at bedtime (between 9 p.m. and midnight) the day before the procedure, and concludes with a 10-mg bisacodyl rectal suppository at 7 a.m. the morning of (at least 2 hours before) the procedure.226


Visicol Sodium Phosphates Tablets

Oral

Evening before procedure: 1.194 g of dibasic sodium phosphate and 3.306 g of monobasic sodium phosphate (3 tablets) with 240 mL clear liquids; repeat every 15 minutes for 7 doses (last dose is 2 tablets).212 Total dose 7.96 g of dibasic sodium phosphate and 22.04 g of monobasic sodium phosphate (20 tablets).212


Day of procedure: 1.194 g of dibasic sodium phosphate and 3.306 g of monobasic sodium phosphate (3 tablets) with 240 mL clear liquids every 15 minutes beginning 3–5 hours before the procedure.212 Repeat every 15 minutes for 7 doses (last dose is 2 tablets).212 Total dose 7.96 g of dibasic sodium phosphate and 22.04 g of monobasic sodium phosphate (20 tablets).212


Total dosage is 15.92 g of dibasic sodium phosphate and 44.08 g of monobasic sodium phosphate (40 tablets) with 3405 mL (3.6 quarts) of clear fluids.212 No additional enema or laxative is required.212


Prescribing Limits


Pediatric Patients


Constipation

Laxatives should not be used for self-medication of constipation for ≥7 days without consulting clinician.214 215 216 217 218 219 220 221 223 225 231 232 b


Magnesium Citrate

Oral

Children 2–5 years of age: For self-medication, maximum 6.25 g (usually <90 mL [5.25 g] of a 291-mg/5-mL oral solution) daily.224 234


Children 6–11 years of age: For self-medication, maximum 12.5 g (usually <150 mL [8.75 g] of a 291-mg/5-mL oral solution) daily.224 234


Children ≥12 years of age: For self-medication, maximum 25 g (usually <300 mL [17.5 g] of a 291-mg/5-mL oral solution) daily.224 234


Magnesium Hydroxide

Oral

Children 2–5 years of age: For self-medication, maximum 1.2 g daily.217 233 234 235


Children 6–11 years of age: For self-medication, maximum 2.4 g daily.215 216 217 218 233 234 235


Children ≥12 years of age: For self-medication, maximum 4.8 g daily.215 216 217 218 233 234


Magnesium Sulfate

Oral

Children 2–5 years of age: For self-medication, maximum 5 g daily.234


Children 6–11 years of age: For self-medication, maximum 10 g daily.225 234


Children ≥12 years of age: For self-medication, maximum 30 g daily.225 234


Fixed Combination of Magnesium Hydroxide and Mineral Oil

Oral

Children 6–11 years of age: Maximum 1.8 g of magnesium hydroxide (30 mL of the fixed-combination suspension) daily.218


Children ≥12 years of age: Maximum 3.6 g of magnesium hydroxide (60 mL of the fixed-combination suspension) daily.218


Sodium Phosphates Enemas

Rectal

Children 2–4 years of age: For self-medication, maximum 1.75 g of dibasic sodium phosphate and 4.75 g of monobasic sodium phosphate (½ bottle [approximately 29 mL] of Fleet Pedia-Lax Enema) in 24 hours.227


Children 5–11 years of age: For self-medication, maximum 3.5 g of dibasic sodium phosphate and 9.5 g of monobasic sodium phosphate (1 bottle [approximately 59 mL] of Fleet Pedia-Lax Enema) in 24 hours.227


Children ≥12 years of age: For self-medication, maximum 7 g of dibasic sodium phosphate and 19 g of monobasic sodium phosphate (1 bottle of Fleet Enema [approximately 118 mL] or Fleet Enema Extra [approximately 197 mL]) in 24 hours.219 228


Bowel Cleansing

Sodium Phosphates Enemas

Rectal

Children 2–4 years of age: For self-medication, maximum 1.75 g of dibasic sodium phosphate and 4.75 g of monobasic sodium phosphate (½ bottle [approximately 29 mL] of Fleet Pedia-Lax Enema) in 24 hours.227


Children 5–11 years of age: For self-medication, maximum 3.5 g of dibasic sodium phosphate and 9.5 g of monobasic sodium phosphate (1 bottle [approximately 59 mL] of Fleet Pedia-Lax Enema) in 24 hours.227


Children ≥12 years of age: For self-medication, maximum 7 g of dibasic sodium phosphate and 19 g of monobasic sodium phosphate (1 bottle of Fleet Enema [approximately 118 mL] or Fleet Enema Extra [approximately 197 mL]) in 24 hours.228


Adults


Constipation

Laxatives should not be used for self-medication of constipation for ≥7 days without consulting clinician.214 215 216 217 218 219 220 221 223 225 231 232 b


Magnesium Citrate

Oral

For self-medication: Maximum 25 g (usually 300 mL [17.5 g] of a 291-mg/5-mL oral solution) daily.224 234


Magnesium Hydroxide

Oral

For self-medication: Maximum 4.8 g daily.215 216 217 218 233 234


Magnesium Sulfate

Oral

For self-medication: Maximum 30 g daily.225 234


Fixed Combination of Magnesium Hydroxide and Mineral Oil

Oral

For self-medication: Maximum 3.6 g of magnesium hydroxide (60 mL of the fixed-combination suspension) daily.218


Sodium Phosphates Enemas

Rectal

For self-medication: Maximum 7 g of dibasic sodium phosphate and 19 g of monobasic sodium phosphate (1 bottle of Fleet Enema [approximately 118 mL] or Fleet Enema Extra [approximately 197 mL]) in 24 hours.219 228


Bowel Cleansing

Sodium Phosphates Enemas

Rectal

For self-medication: Maximum 7 g of dibasic sodium phosphate and 19 g of monobasic sodium phosphate (1 bottle of Fleet Enema [approximately 118 mL] or Fleet Enema Extra [approximately 197 mL]) in 24 hours.219 228


OsmoPrep Sodium Phosphates Tablets

Oral

Do not repeat sodium phosphates tablet regimen for bowel cleansing within 7 days of previous administration.213


Visicol Sodium Phosphates Tablets

Oral

Do not repeat sodium phosphates tablet regimen for bowel cleansing within 7 days of previous administration.212


Special Populations


Hepatic Impairment


No specific dosage recommendations at this time.212 213


Renal Impairment


Magnesium laxatives not for self-medication in patients with renal disease.215 216 217 218 222 223 225 232 (See Contraindications under Cautions.)


Sodium phosphates not for use in patients with clinically important renal function impairment.219 220 (See Contraindications and also Renal Effects under Cautions.)


Geriatric Patients


Caution advised, but no specific dosage recommendations; consider possible age-related decrease in renal and/or cardiac function and concomitant disease and drug therapy.212 213 221 (See Geriatric Use under Cautions.)


Cautions for Saline Laxatives


Contraindications



  • Acute abdominal pain, nausea, vomiting, or other symptoms of appendicitis or undiagnosed abdominal pain.214 215 216 217 218 219 220 222 223 225 b



  • Sodium Phosphates Preparations


  • Known hypersensitivity to sodium phosphate salts or any ingredient in the formulation.212 213 220




  • Biopsy-proven acute phosphate nephropathy212 or clinically important renal function impairment.219 220 221 227 228 229 230




  • CHF.219 220 221 227 228 229 230




  • Ascites.219 220 221 227 228




  • Known or suspected GI obstruction,219 220 221 227 228 congenital or acquired megacolon,219 220 221 227 228 perforation,220 221 ileus,220 221 or active inflammatory bowel disease.220 221




  • Oral solution for bowel cleansing: Pediatric patients <18 years of age.220 221 239




  • Rectal solutions: Pediatric patients <2 years of age.219



  • Magnesium Preparations for Self-medication


  • Renal disease.215 216 217 218 223 224 225




  • Magnesium-restricted diet.215 216 217 218 224 225




  • Sudden change in bowel habits that lasts >14 days.215 216 217 218 224 225 b




  • Fixed combination of magnesium hydroxide and mineral oil: Pediatric patients <6 years of age, pregnancy, bedridden patients, or difficulty swallowing.218




  • Fixed combination of magnesium hydroxide and mineral oil: Concomitant use with stool softener laxatives.

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