Laxatives: Stimulant

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Labelling Standard

Note: In the case of applications for drugs which fit the criteria of this labelling standard, it is not necessary to conduct an assessment to determine if bioequivalence, pharmacodynamic/clinical studies or pharmaceutical equivalence data must be submitted.

I Medicinal Ingredients

  1. Aloe
  2. Bisacodyl
  3. Cascara Sagrada ingredients
    1. Casanthranol
    2. Cascara fluid extract, aromatic
    3. Cascara Sagrada bark
    4. Cascara Sagrada extract
    5. Cascara Sagrada fluid extract
  4. Castor Oil
  5. Dehydrocholic Acid
  6. Bile Salts
  7. Sennosides A and B
    1. Senna leaf powder
    2. Senna fluid extract
    3. Senna fruit extract
    4. Senna syrup
    5. Senna pod concentrate
    6. Sennosides A and B crystalline

II Stimulant Action

Promotes bowel movement by direct action on the intestine.

III Usual Claims

  1. stimulant laxative
  2. cathartic
  3. relief of occasional constipation

IV Warnings

As for all classes.

V Directions

  1. Oral products produce action in 6 to 12 hours.
  2. Rectal products produce action in 1/4 to 1 hour.
  3. Do not chew tablets or take with milk or antacid (bisacodyl enteric-coated tablets only).
  4. Do not take late in day, results within 2 to 6 hours (Castor oil only) (O.K. if reflected in directions for use).

Note: This labelling standard describes those requirements that are specific to this class of drugs. Other requirements described in the Regulations to the Food and Drugs Act and in the Guide for the Labelling of Drugs for Human Use should also be met.

VI Dosage

  1. Children under 2 years - consult physician (for DIN's).
  2. Children under 6 years - consult physician (for GP's)
Ingredients Adult to 12 years Maximum Children 6 to 12 years Children less than 6 years
Aloes 120 to 250 mg single dose 80 to 120 mg consult physician
Bisacodyl
- Oral 5 to 15 mg single dose 5 mg consult physician
- Rectal 10 mg single dose 5 mg consult physician
Cascara Sagrada
a. Casanthranol 30 to 90 mg single dose 15 to 45 mg 15 to 45 mg
b. Cascara Fluid Extract Aromatic 2 to 6 ml single dose 1 to 5 ml 1 to 5 ml
c. Cascara Sagrada Bark 300 to 1000 mg single dose 150 to 500 mg 150 to 500 mg
d. Cascara Sagrada Extract 200 to 400 mg single dose 100 to 200 mg 100 to 200 mg
e. Cascara Sagrada Fluid Extract 0.5 to 1.5 ml single dose .25 to .75 ml .25 to .75 ml
Castor Oil 15 to 50 ml single dose 5 to 15 ml 5 to 15 ml
Dehydrocholic Acid 250 to 500 mg 3 times daily p.c. 150 mg in 24 hours consult physician consult physician
Sennosides A & B
- Oral 12 to 50 mg once or twice daily
- Rectal 30 mg once or twice daily
Senna Leaves 0.5 to 2 gm once daily consult physician consult physician
Senna Fluid Extract 1:1 2 ml once daily consult physician consult physician
Preparing for Colon X-Ray (Oral) 160 mg single dose consult physician consult physician
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