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    Contact/Stimulant Laxatives

    DEA CLASS

    OTC

    DESCRIPTION

    Anthraquinone stimulant laxative; plant derivative; long history of safe and effective use
    Useful for constipation in adult and pediatric patients 2 years and older; used off-label for occasional use in younger children with prescriber supervision
    Effective in the management of opioid-induced constipation (OIC)

    COMMON BRAND NAMES

    Black Draught, Ex-Lax, Fletchers Laxative, Geri-kot, Lax-Pills, Perdiem, Senexon, Senna, Senna-Lax, Senna-Tabs, Senna-Time, SennaGen, Sennatural, Senokot, Senokot Extra Strength, Senokot Xtra, SenoSol, Uni-Cenna

    HOW SUPPLIED

    Black Draught/Ex-Lax/Geri-kot/Perdiem/Senexon/Senna/SennaGen/Senna-Lax/Senna-Tabs/Senna-Time/Sennatural/Sennosides/Senokot/Senokot Extra Strength/SenoSol/Uni-Cenna Oral Tab: 8.6mg, 10mg, 15mg, 17.2mg, 25mg
    Ex-Lax Oral Tab Chew: 15mg
    Fletchers Laxative Oral Liq: 1mL, 33.3mg
    Senexon/Sennosides/Uni-Cenna Oral Sol: 5mL, 8.8mg
    Senna Concentrate Oral Syrup: 5mL, 176mg

    DOSAGE & INDICATIONS

    For the treatment of constipation.
    Oral dosage (tablets with 8.6 mg sennosides per tablet)
    Adults

    1 to 2 tablets (8.6 to 17.2 mg sennosides) PO twice daily. Max dose: 4 tablets (34.4 mg sennosides) PO twice daily.

    Children and Adolescents 12 to 17 years

    1 to 2 tablets (8.6 to 17.2 mg sennosides) PO twice daily. Max dose: 4 tablets (34.4 mg sennosides) PO twice daily.

    Children 6 to 11 years

    1 tablet (8.6 mg sennosides) PO at bedtime. Max: 2 tablets (17.2 mg sennosides) PO twice daily.

    Children 2 to 5 years

    One-half tablet (4.3 mg sennosides) PO once daily at bedtime. Max: 1 tablet (8.6 mg sennosides) PO twice daily.

    Oral dosage (softgel capsules with 8.6 mg sennosides per capsule)
    Adults

    2 softgel capsules (17.2 mg sennosides) PO at bedtime. Max dose: 4 softgel capsules (34.4 mg sennosides) PO twice daily.

    Children and Adolescents 12 to 17 years

    2 softgel capsules (17.2 mg sennosides) PO at bedtime. Max dose: 4 softgel capsules (34.4 mg sennosides) PO twice daily.

    Children 6 to 11 years

    1 softgel capsule (8.6 mg sennosides) PO at bedtime. Max: 2 softgel capsules (17.2 mg sennosides) PO twice daily.

    Oral dosage (solution or syrup containing 8.8 mg sennosides per 5 mL)
    Adults

    10 to 15 mL (17.6 to 26.4 mg sennosides) PO at bedtime. Max: 15 mL (26.4 mg sennosides) PO twice daily.

    Children and Adolescents 12 to 17 years

    10 to 15 mL (17.6 to 26.4 mg sennosides) PO at bedtime. Max: 15 mL (26.4 mg sennosides) PO twice daily.

    Children 6 to 11 years

    5 to 7.5 mL (8.8 to 13.2 mg sennosides) PO at bedtime. Max: 7.5 mL (13.2 mg sennosides) PO twice daily.

    Children 2 to 5 years

    2.5 to 3.75 mL (4.4 to 6.6 mg sennosides) PO at bedtime. Max: 3.75 mL (6.6 mg sennosides) PO once daily.

    Oral dosage (maximum strength oral solution with 25 mg sennosides per 15 mL)
    Adults

    15 mL to 30 mL (25 mg to 50 mg sennosides) PO once daily. Max: 30 mL (50 mg sennosides) PO twice daily.

    Children and Adolescents 12 to 17 years

    15 mL to 30 mL (25 mg to 50 mg sennosides) PO once daily. Max: 30 mL (50 mg sennosides) PO twice daily.

    MAXIMUM DOSAGE

    Adults

    68.8 mg/day PO of sennosides for capsules and tablets; 52.8 mg/day PO of sennosides for oral solution; 100 mg/day PO of sennosides for maximum strength oral solution.

    Geriatric

    68.8 mg/day PO of sennosides for capsules and tablets; 52.8 mg/day PO of sennosides for oral solution; 100 mg/day PO of sennosides for maximum strength oral solution.

    Adolescents

    68.8 mg/day PO of sennosides for capsules and tablets; 52.8 mg/day PO of sennosides for oral solution; 100 mg/day PO of sennosides for maximum strength oral solution.

    Children

    12 years: 68.8 mg/day PO of sennosides for capsules and tablets; 52.8 mg/day PO of sennosides for oral solution; 100 mg/day PO of sennosides for maximum strength oral solution.
    6 to 11 years: 34.4 mg/day PO of sennosides for capsules and tablets; 26.4 mg/day PO of sennosides for 8.8 mg/5 mL oral solution (not FDA-approved for maximum strength oral solution 25 mg/15 mL).
    2 to 5 years: 17.2 mg/day PO of sennosides for tablets; 6.6 mg/day PO of sennosides for 8.8 mg/5 mL oral solution (not FDA-approved for maximum strength oral solution 25 mg/15 mL). Safety and efficacy have not been established for capsules.
    1 year: Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears no dosage adjustments are needed.

    Renal Impairment

    Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

    ADMINISTRATION

    Oral Administration

    Senna is administered orally.

    Oral Solid Formulations

    It is suggested to administer at bedtime with a full glass of water. However, the products may be given one or two times daily; see the product directions.
    Some marketed tablets are chewable; follow the directions on the product label for the specific product chosen.
    The products usually produce a bowel movement 6 to 12 hours later.

    Oral Liquid Formulations

    Oral solutions, syrups or suspensions:
    Shake well prior to each administration.
    To ensure accurate dosage, use a calibrated oral measuring device to measure each dose.
    The solution or syrup may be administered with milk or juice to mask taste.
    It is suggested to administer at bedtime with a full glass of water. However, the products may be given one or two times daily; follow the directions on the specific product label.
    The products usually produce a bowel movement in 6 to 12 hours.

    STORAGE

    Generic:
    - Protect from light
    - Protect from moisture
    - Store below 86 degrees F
    Black Draught :
    - Store at room temperature (between 59 to 86 degrees F)
    Ex-Lax:
    - Store between 59 to 77 degrees F
    Fletchers Laxative:
    - Store at room temperature (between 59 to 86 degrees F)
    Geri-kot:
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    Lax-Pills:
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    Little Remedies for Tummys:
    - Do not freeze
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Perdiem:
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    Senexon:
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    Senna:
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    SennaGen :
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    Senna-Lax :
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    Senna-Tabs:
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    Senna-Time:
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    Sennatural:
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    Senokot:
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    Senokot Extra Strength :
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    Senokot Xtra:
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    SenoSol:
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    SenoSol-X:
    - Store at room temperature (between 59 to 86 degrees F)
    Uni-Cenna:
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F

    CONTRAINDICATIONS / PRECAUTIONS

    General Information

    Senna or sennosides should not be used in patients with a previous hypersensitivity to senna, sennosides, or any ingredients in the particular product formulation chosen.

    Abdominal pain, diarrhea, GI bleeding, GI disease, GI obstruction, inflammatory bowel disease, vomiting

    Advise patients to consult their healthcare professional before taking senna if they have nausea, vomiting, abdominal pain or if they have notice a sudden change in their bowel habits that lasts for more than 2 weeks. Patients with serious GI disease, such as inflammatory bowel disease, should consult their health care provider prior to nonprescription use. Senna should not be used in patients with undiagnosed abdominal pain. Use of stimulant laxatives is generally contraindicated in patients with bowel or other GI obstruction. Patients should discontinue self-medication and consult their health care provider if they experience diarrhea, rectal GI bleeding or if they fail to have a bowel movement after senna administration; these may be signs of a more serious condition.

    Pregnancy

    In general, avoid stimulant laxatives such as senna when possible during pregnancy as some of the stimulant laxatives may induce premature labor. Systemic absorption of the sennosides is minimal and there have been no reports of teratogenicity or an increased risk of congenital anomalies due to senna use in humans. However, the indiscriminate use of senna may adversely effect hydration and electrolytes in rare circumstances. The intermittent use of senna should be limited to use under the advice of a qualified health care professional and after safer agents have failed to produce intended results. The safest first-line treatments to use for constipation during pregnancy are those that are not absorbed systemically (e.g., fiber, bulk-forming laxatives, stool softeners such as docusate) in order to minimize drug exposure to the fetus. Polyethylene glycol 3350 has minimal systemic absorption and is considered an option for chronic constipation during pregnancy.

    Breast-feeding

    Senna is considered compatible for use during breast-feeding. Senna is not excreted into human milk, but it is a prodrug which is metabolized in vivo to the sennosides. Sennosides are glucosides of rhein, and the sennosides are essentially undetectable in human milk. Rhein appears to be excreted only in minimal amounts. There is a lack of reported adverse events in nursing infants whose mothers ingested sennosides during lactation. Agents that are non-absorbed or poorly absorbed (e.g., bulk-forming laxatives or stool softeners such as docusate) are often the preferred drugs for first-line use in the lactating female when such therapy is necessary. Other agents that may be considered based on lack of systemic effect or lack of reported adverse effects in nursing infants include magnesium hydroxide, polyethylene glycol 3350, and bisacodyl.[27500] [42282] [46842] [46846] [46847] [61291]

    Geriatric

    The federal Omnibus Budget Reconciliation Act (OBRA) regulates the use of medications in residents (e.g., geriatric adults) of long-term care facilities. The OBRA guidelines caution that laxatives may cause flatulence, bloating, and abdominal pain in debilitated or elderly patients.

    Sodium restriction

    Some senna oral solutions or syrups have added sodium; patients who are on a sodium restriction (e.g., low salt diet) should check with their health care professional prior to use.

    Neonates

    Nonprescription use of senna is not recommended in infants. Most nonprescription products may be used in children 2 years and older; the literature describes off-label use of senna for occasional constipation or for bowel preparation in infants as young as 1 month of age, under a prescriber's advice and observation. Most senna liquids are not formulated for infants, some contain alcohol, propylene glycol, or benzyl alcohol that may be toxic to neonates or young infants.

    ADVERSE REACTIONS

    Severe

    anaphylactoid reactions / Rapid / Incidence not known

    Moderate

    hypokalemia / Delayed / Incidence not known
    melanosis coli / Delayed / Incidence not known
    wheezing / Rapid / Incidence not known

    Mild

    nausea / Early / Incidence not known
    vomiting / Early / Incidence not known
    abdominal pain / Early / Incidence not known
    flatulence / Early / Incidence not known
    diarrhea / Early / Incidence not known
    fecal urgency / Early / Incidence not known
    urine discoloration / Early / Incidence not known
    rash / Early / Incidence not known

    DRUG INTERACTIONS

    Atropine; Difenoxin: (Moderate) Diphenoxylate can decrease GI motility. Drugs used to treat constipation, such as laxatives, would counteract the effect of antidiarrheals. In general, it would be illogical to concurrently administer these drugs at the same time. If an antidiarrheal medication is needed, it would be wise to temporarily discontinue use of agents with laxative effects.
    Atropine; Diphenoxylate: (Moderate) Diphenoxylate can decrease GI motility. Drugs used to treat constipation, such as laxatives, would counteract the effect of antidiarrheals. In general, it would be illogical to concurrently administer these drugs at the same time. If an antidiarrheal medication is needed, it would be wise to temporarily discontinue use of agents with laxative effects.
    Bumetanide: (Minor) The risk of hypokalemia due to loop diuretics may be increased in patients receiving prolonged therapy with certain laxatives. Monitor serum potassium levels to determine the need for potassium supplementation and/or alteration in drug therapy in patients receiving loop diuretics. Senna rarely causes hypokalemia with proper use.
    Dichlorphenamide: (Minor) Use dichlorphenamide and senna together with caution. Dichlorphenamide increases potassium excretion and can cause hypokalemia and should be used cautiously with other drugs that may cause hypokalemia including laxatives. Senna very rarely causes hypokalemia. Measure potassium concentrations at baseline and periodically during dichlorphenamide treatment. If hypokalemia occurs or persists, consider reducing the dichlorphenamide dose or discontinuing dichlorphenamide therapy.
    Droperidol: (Minor) Caution is advised when using droperidol in combination with certain laxatives, which may lead to electrolyte abnormalities, especially hypokalemia. Such abnormalities may increase the risk for QT prolongation or cardiac arrhythmias. However, senna very rarely causes hypokalemia or other electrolyte abnormalities.
    Ethacrynic Acid: (Minor) The risk of hypokalemia due to loop diuretics may be increased in patients receiving prolonged therapy with certain laxatives. Monitor serum potassium levels to determine the need for potassium supplementation and/or alteration in drug therapy in patients receiving loop diuretics. Senna rarely causes hypokalemia with proper use.
    Furosemide: (Minor) The risk of hypokalemia due to loop diuretics may be increased in patients receiving prolonged therapy with certain laxatives. Monitor serum potassium levels to determine the need for potassium supplementation and/or alteration in drug therapy in patients receiving loop diuretics. Senna rarely causes hypokalemia with proper use.
    Lactulose: (Major) In general, other laxatives, such as senna, should not be used concurrently with lactulose, especially during the initial phase of therapy for portal-systemic encephalopathy, because the loose stools resulting from their use may falsely suggest that adequate lactulose dosage has been achieved. (Major) In general, other laxatives, such as sennosides, should not be used concurrently with lactulose, especially during the initial phase of therapy for portal-systemic encephalopathy, because the loose stools resulting from their use may falsely suggest that adequate lactulose dosage has been achieved.
    Loop diuretics: (Minor) The risk of hypokalemia due to loop diuretics may be increased in patients receiving prolonged therapy with certain laxatives. Monitor serum potassium levels to determine the need for potassium supplementation and/or alteration in drug therapy in patients receiving loop diuretics. Senna rarely causes hypokalemia with proper use.
    Polyethylene Glycol: (Major) The use of stimulant laxatives should be avoided in combination with some polyethylene glycol bowel preparation products (e.g., Colyte, Golytely, Nulytely, Moviprep, Plenvu). Concurrent use may increase the risk of mucosal ulceration or ischemic colitis.
    Polyethylene Glycol; Electrolytes: (Major) The use of stimulant laxatives should be avoided in combination with some polyethylene glycol bowel preparation products (e.g., Colyte, Golytely, Nulytely, Moviprep, Plenvu). Concurrent use may increase the risk of mucosal ulceration or ischemic colitis.
    Polyethylene Glycol; Electrolytes; Ascorbic Acid: (Major) The use of stimulant laxatives should be avoided in combination with some polyethylene glycol bowel preparation products (e.g., Colyte, Golytely, Nulytely, Moviprep, Plenvu). Concurrent use may increase the risk of mucosal ulceration or ischemic colitis.
    Polyethylene Glycol; Electrolytes; Bisacodyl: (Major) The use of stimulant laxatives should be avoided in combination with some polyethylene glycol bowel preparation products (e.g., Colyte, Golytely, Nulytely, Moviprep, Plenvu). Concurrent use may increase the risk of mucosal ulceration or ischemic colitis.
    Torsemide: (Minor) The risk of hypokalemia due to loop diuretics may be increased in patients receiving prolonged therapy with certain laxatives. Monitor serum potassium levels to determine the need for potassium supplementation and/or alteration in drug therapy in patients receiving loop diuretics. Senna rarely causes hypokalemia with proper use.

    PREGNANCY AND LACTATION

    Pregnancy

    In general, avoid stimulant laxatives such as senna when possible during pregnancy as some of the stimulant laxatives may induce premature labor. Systemic absorption of the sennosides is minimal and there have been no reports of teratogenicity or an increased risk of congenital anomalies due to senna use in humans. However, the indiscriminate use of senna may adversely effect hydration and electrolytes in rare circumstances. The intermittent use of senna should be limited to use under the advice of a qualified health care professional and after safer agents have failed to produce intended results. The safest first-line treatments to use for constipation during pregnancy are those that are not absorbed systemically (e.g., fiber, bulk-forming laxatives, stool softeners such as docusate) in order to minimize drug exposure to the fetus. Polyethylene glycol 3350 has minimal systemic absorption and is considered an option for chronic constipation during pregnancy.

    Senna is considered compatible for use during breast-feeding. Senna is not excreted into human milk, but it is a prodrug which is metabolized in vivo to the sennosides. Sennosides are glucosides of rhein, and the sennosides are essentially undetectable in human milk. Rhein appears to be excreted only in minimal amounts. There is a lack of reported adverse events in nursing infants whose mothers ingested sennosides during lactation. Agents that are non-absorbed or poorly absorbed (e.g., bulk-forming laxatives or stool softeners such as docusate) are often the preferred drugs for first-line use in the lactating female when such therapy is necessary. Other agents that may be considered based on lack of systemic effect or lack of reported adverse effects in nursing infants include magnesium hydroxide, polyethylene glycol 3350, and bisacodyl.[27500] [42282] [46842] [46846] [46847] [61291]

    MECHANISM OF ACTION

    Anthraquinone derivatives such as senna are stimulant laxatives. Stimulant laxatives work by irritating luminal sensory nerve endings, thereby stimulating colonic motility and reducing colonic water absorption. Senna can alter permeability of cell walls in the colon because it increases cyclic 3',5'-adenosine monophosphate, which also regulates active ion secretion. The result is increased fluid accumulation in the colon and a laxative action. Tolerance to stimulant laxatives is uncommon.

    PHARMACOKINETICS

    Senna is administered orally and rectally. The pharmacokinetics of senna are not well characterized. There is insufficient evidence of distribution into breast milk, but amounts are unlikely to be a problem. Absorbed anthraquinones are believed to be metabolized by the liver and may be excreted via the bile in feces, and, possibly, in urine.

    Oral Route

    There is minimal GI absorption following oral administration. Free anthraquinones are released in the colon as a result of enzymatic hydrolysis of the glycosides. With oral dosing, a laxative effect is typically produced in 6—12 hours but may take up to 24 hours.

    Other Route(s)

    Following rectal administration of senna, laxative effect is seen in 30 to 120 minutes.