Product Monograph - Senokot S
1 INDICATIONS
Senokot®•S (senna and docusate sodium tablets) is indicated for:
- gentle overnight relief of occasional constipation
- softens the stool
1.1 Pediatrics
Pediatrics (6 years and older): The safety and efficacy of Senokot•S∙ in pediatric patients 6 years and older has been established; therefore, an indication for pediatric use in children 6 years and older has been authorized (see Section 3.2).
1.2 Geriatrics
Geriatrics (> 65 years of age): Evidence from literature and experience suggests that use in the geriatric population is not associated with differences in safety or effectiveness.
2 CONTRAINDICATIONS
Senna and docusate sodium tablets are contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see DOSAGE FORMS, STRENGTHS, COMPOSITION and PACKAGING.
- acute surgical abdomen
- abnormal constrictions of the gastrointestinal tract
- potential or existing intestinal obstruction and stenosis
- ileus
- atonic bowel
- appendicitis
- inflammatory bowel disease such as Crohn’s disease or ulcerative colitis
- abdominal pain of unknown origin
- undiagnosed rectal bleeding
- severe dehydration
3 DOSAGE AND ADMINISTRATION
3.1 Dosing Considerations
Not recommended when:
- pregnant
- breastfeeding
3.2 Recommended Dose and Dosage Adjustment
Adults and children 12 years and older
1 to 2 tablets at bedtime, as required. Maximum 4 tablets twice a day. Do not take more than 8 tablets in 24 hours.
Children (6 to 11 years)
½ to 1 tablet at bedtime. Maximum 1 tablet, twice a day. Do not take more than 2 tablets in 24 hours.
3.3 Administration
It is recommended to take Senokot•S (senna and docusate sodium tablets) at night to have a bowel movement the following morning. Evacuation generally occurs within 6 to 12 hours following ingestion.
The correct dose of the sennosides-containing laxatives is the smallest required to produce comfortable soft-formed stool and varies between individuals.
Drink increased fluids (one full glass or more) with each dose.
4 OVERDOSAGE
The major symptoms of overdose/abuse of stimulant laxatives, including those containing senna, are griping pain and severe diarrhea, leading to excessive water loss (dehydration) and possible electrolyte imbalance (i.e., hypokalemia). Symptoms of dehydration may include thirst and oliguria.
Treatment should be supportive with generous amounts of fluid. Electrolytes, especially potassium, should be monitored. This is especially important in the elderly and the young.
Administration of antispasmodics may be of value.
For management of a suspected drug overdose, contact your regional poison control centre.
5 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
| Route of Administration | Dosage Form / Strength/Composition | Non-medicinal Ingredients |
|---|---|---|
| oral | orange, film-coated tablet, stamped S/S on one side 8.6 mg / 50 mg | Corn starch, D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, guar gum, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, sodium benzoate, talc and titanium dioxide |
Also contains corn starch. Sodium: <1 mmol (2.6 mg). Tartrazine free. Supplied in blisters of 10 tablets and bottles of 20, 60, 120 and 1,000 tablets.
6 WARNINGS AND PRECAUTIONS
General
As with all laxatives, patients should be advised to not take Senokot•S (senna and docusate sodium tablets) for more than one week. If symptoms continue to occur or worsen and laxatives are needed every day or if there has been a sudden change in bowel movements that persists over a period of 2 weeks, the cause of the constipation should be investigated.
For patients on a sodium-restricted diet, there is a very small amount of sodium in Senokot•S
(see DOSAGE FORMS, STRENGTHS, COMPOSITION and PACKAGING).
Dependence/Tolerance
Long-term use of stimulant laxatives should be avoided as it may lead to impaired function of the intestine, dependence on laxatives, dehydration and electrolyte imbalance (including hypokalemia).
Prolonged excessive use or misuse of laxatives may also result in the development of atonic colon.
Reversible pigmentation of the colon, i.e., melanosis coli, may also result from prolonged use of senna containing preparations.
Driving and Operating Machinery
No studies on the effects of the ability to drive and use machines have been performed. However, patients should be advised that due to a vasovagal response (e.g., to abdominal spasm) they may experience dizziness and/or syncope. If patients experience abdominal spasm they should avoid potentially hazardous tasks such as driving or operating machinery.
Gastrointestinal
Reduce dose or discontinue use in the presence of abdominal pain, griping (cramps or spasms) and/or diarrhea.
Do not use in the presence of fecal impaction and undiagnosed, acute or persistent gastrointestinal complaints (e.g., abdominal pain, nausea, fever or vomiting) as these symptoms can be signs of a potential or existing intestinal blockage or ileus, appendicitis or inflamed bowel.
If rectal bleeding or failure to have a bowel movement (after use of a laxative) occurs, therapy should be discontinued as it may indicate a more serious condition.
Genitourinary
Urine discolouration (chromaturia), if present, may interfere with the interpretation of laboratory tests (see Monitoring and Laboratory Tests).
Monitoring and Laboratory Tests
Due to the presence of chrysophanic acid in natural senna, Senokot·S (senna and docusate sodium tablets) may cause discolouration of urine, or feces depending on the acidity (yellow- brown discolouration) or alkalinity (red-violet discolouration) of the substance. There is no pathologic significance to this discolouration.
Renal
Patients with kidney disorders should be aware of possible electrolyte imbalance.
6.1 Special Populations
6.1.1 Pregnant Women
There are no reports of adverse or damaging effects during pregnancy or on the fetus associated with senna preparations when used in accordance to the recommended dosage schedule. However, as a consequence of experimental data concerning a genotoxic risk of several anthranoids (e.g., emodin and aloe-emodin), use is not recommended during pregnancy.
6.1.2 Breastfeeding
Small amounts of active metabolites (rhein) are excreted in breast milk. A laxative effect in breast fed babies has not been reported. However, use during breastfeeding is not recommended as there are insufficient data on the excretion of metabolites in breast milk.
6.1.3 Pediatrics
Pediatrics (6 to 11 years): The safety and efficacy of Senokot•S in pediatric patients under the age of 6 years has not been established; therefore, an indication for pediatric use has only been authorized in children 6 years and older (see Section 3.2).
6.1.4 Geriatrics
Intestinal loss of fluids can promote dehydration. Symptoms may include thirst and oliguria. In patients suffering from fluid loss where dehydration may be harmful (e.g., renal insufficiency, elderly patients). Senokot-S should be discontinued and only be restarted under medical supervision.
7 ADVERSE REACTIONS
7.1 Adverse Reaction Overview
The most common reported adverse event in clinical trials was abdominal pain/discomfort. The following adverse events are those obtained through extensive post-marketing use and/or literature, not clinical trials (see Section 7.3).
7.2 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data
Due to the presence of chrysophanic acid in natural senna, sennoside-containing laxatives may cause discoloration of feces and / or pH dependent discoloration of the urine (yellow-brown discoloration in acidic urine and red-violet discoloration in alkaline urine). There is no pathologic significance to this discoloration. Urine discoloration (chromaturia), if present, may interfere with the interpretation of laboratory tests.
7.3 Post-Market Adverse Reactions
The undesirable effects listed below are classified by body system according to their incidence. Common undesirable effects have an incidence of > 1% and uncommon undesirable effects have an incidence of < 1%.
Gastrointestinal Disorders Common: abdominal pain
Uncommon: faeces discoloured, nausea, perianal irritation, rectal hemorrhage, vomiting Not known: diarrhea
Immune System Disorders Uncommon: urticaria
Very rare: anaphylactic reaction, anaphylactoid reaction Not known: hypersensitivity
Renal and Urinary Disorders Uncommon: chromaturia
Skin and Subcutaneous Tissue Disorders
Uncommon: rash erythematous, rash maculo-papular Not known: pruritus
8 DRUG INTERACTIONS
8.1 Overview
Laxatives should not be taken within two hours of another medicine because the desired effect of the other medicine may be reduced.
8.2 Drug-Drug Interactions
Interactions with other drugs have not been clinically established.
Concomitant therapy with other drugs known to induce hypokalemia (e.g., thiazide diuretics, adreno corticosteroids) may enhance the electrolyte imbalance. Hypokalemia potentiates the action of cardiac glycosides and interacts with antiarrhythmic medications.
Use with caution in patients taking mineral oil as the docusate sodium component of Senokot•S (senna and docusate sodium tablets) may increase absorption of oil from the gastrointestinal tract, leading to toxicity.
8.3 Drug-Food Interactions
Interactions with food have not been established.
8.4 Drug-Herb Interactions
Concomitant therapy with other herbal substances known to induce hypokalemia (e.g., liquorice root) may enhance the electrolyte imbalance. Hypokalemia potentiates the action of cardiac glycosides and interacts with antiarrhythmic medications.
8.5 Drug-Laboratory Test Interactions
Due to the presence of chrysophanic acid in natural senna, Senokot•S (senna and docusate sodium tablets) may cause discolouration of urine, or feces depending on the acidity (yellow- brown discolouration) or alkalinity (red-violet discolouration) of the substance. There is no pathologic significance to this discolouration.
9 ACTION AND CLINICAL PHARMACOLOGY
9.1 Mechanism of Action
The laxative agent in Senokot•S (senna and docusate sodium tablets) is a natural vegetable derivative (senna) standardized for predictable results. The principal constituents of Senokot•S are senna glycosides. These include sennosides A & B, and the glycoside derivatives of rhein and chrysophanic acid. These glycosides, when converted into aglycones in the colon, function as laxative agents.
Only minimal amounts of the metabolites of senna (aglycones) are absorbed systemically. The actual extent to which such metabolites are distributed to body tissues and fluids is unknown; they may be excreted in the bile and have been detected in small amounts in breast milk.
Docusate sodium is a surface-active agent that acts by allowing water and fats to enter the stools, which helps hydrate and soften the stools making it useful in the relief of occasional constipation.
Senokot•S has potential benefits for palliative care and postpartum patients, for patients with heart disease where straining when passing stool must be avoided, and in constipation in the presence of hemorrhoids, anal fissures or other conditions where hard, dry stools may cause discomfort.
9.2 Pharmacodynamics
The laxative principles of the senna plant have been identified as sennosides (senna glycosides). Enzymatic action by colonic bacteria converts the glycosides into aglycones, which induce colonic peristalsis through stimulation of the intrinsic peristaltic mechanism in the colonic wall. This action is virtually colon-specific, since these compounds have little or no action in the stomach and small intestine. The stimulant effect on the Myenteric (Auerbach's) plexus in the colonic wall is reportedly free of mucosal injury. Senna also has effects on electrolyte and water transport.
9.3 Preclinical Safety Data
Results from published acute, sub-chronic and chronic toxicology studies as well as genotoxicity and reproductive studies with senna or docusate sodium indicate that these ingredients are safe when used as recommended. In a GLP compliant carcinogenicity study, lifetime exposure to senna did not result in any evidence of carcinogenicity in rats dosed at levels as high as 300 mg/kg/day. Finally, in a published (non-GLP compliant) two-year carcinogenicity study, rats fed diets containing as high as 1% docusate sodium (about 200 mg/day) showed no treatment-related lesions.
10 STORAGE, STABILITY AND DISPOSAL
Store at 15°C to 25ºC.
Keep out of the sight and reach of children.
11 SPECIAL HANDLING INSTRUCTIONS
None.