Health Canada
Symbol of the Government of Canada
Drugs and Health Products

Lithotherapy

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredients.

Notes

  • By submitting a PLA referencing this monograph, the applicant is attesting that the product will comply fully with the recommended conditions of use outlined in this monograph. The conditions of use include methods of preparations, source materials, doses, durations of use, combinations of medicinal ingredients, and risk statements.
  • Text in parentheses is additional optional information which can be included on the PLA and product label at the applicant's discretion.
  • The solidus (/) indicates that the terms and/or the statements are synonymous. Either term or statement may be selected by the applicant.
  • The use of the electronic Product License Application form (ePLA) is not possible for products associated with this monograph.

Date

June 24, 2013

Proper name(s), Common name(s) and Source material(s)

Table 1 Products may contain one or more of the following ingredients

Proper name(s) Common name(s) Source material(s)
Adularia Adularia Adularia
Apatite Apatite Apatite
Azurite Azurite Azurite
Baryte Baryte;
Barytine
Baryte
Bauxite Bauxite Bauxite
Betafite Betafite Betafite
Bornite Bornite Bornite
Calcite Calcite Calcite
Celestine Celestine;
Celestite
Celestine
Cinnabar Cinnabar Cinnabar
Diopside Diopside Diopside
Dolomite Dolomite Dolomite
Erythrite Erythrite Erythrite
Fluorite Fluorite Fluorite
Galena Galena Galena
Garnierite Garnierite Garnierite
Glauconite Glauconite Glauconite
Granite Granite Granite
Graphite Graphite Graphite
Green jasper Green jasper Green jasper
Halite Halite Halite
Hematite Hematite Hematite
Iodargyrite Iodargyrite Iodargyrite
Lazulite Lazulite Lazulite
Lepidolite Lepidolite Lepidolite
Monazite Monazite Monazite
Obsidian Obsidian Obsidian
Orpiment Orpiment Orpiment
Pink sandstone Pink sandstone Pink sandstone
Pyrite Pyrite Pyrite
Pyrolusite Pyrolusite Pyrolusite
Quartz conglomerate Quartz conglomerate Quartz conglomerate
Rhodonite Rhodonite Rhodonite
Saccharoid marble Saccharoid marble Saccharoid marble
Sphalerite Sphalerite;
Blende;
Zinc Blende
Sphalerite
Scapolite Scapolite;
Feldspar
Scapolite
Sea sand Sea sand;
Silica marina
Sea sand
Silver Silver Silver
Sulphur Sulphur Sulphur
Stibnite Stibnite Stibnite
Trachyte Trachyte Trachyte
Ulexite Ulexite Ulexite
Uraninite Uraninite Uraninite

Route(s) of administration

  • Oral
  • Rectal (for Pink sandstone only)

Dosage form(s)

The acceptable pharmaceutical dosage forms must be one listed in Table 2 below

Use(s) or Purpose(s)

Statement(s) to the effect of:

Lithotherapy preparation/remedy/medicine

Dose

Subpopulation(s)

Adults (≥ 18 years)

Quantity(ies)

The dilution for each medicinal ingredient must be equal to or greater than D8 (or equivalent).

Table 2 Dosage information guidelines

Dosage form Maximum Amount per dose Maximum Frequency Maximum Acute Dosing (Optional)
Globules (small pellets, pilules) 1 whole unit dose (tube of container) Once per day 1 unit dose, 3 times per day
Globules (regular and large pellets) 5 granules 3 times per day Every 15-60 minutes (up to 12 times per day) or until improvement of symptoms. Then resume general dosing.
Tablets 4 tablets 4 times per day Every 15-60 minutes (up to 12 times per day) or until improvement of symptoms. Then resume general dosing.
Oral Drops 30 drops 3 times per day Every 15-60 minutes (up to 12 times per day) or until improvement of symptoms. Then resume general dosing.
Liquids (Oral drinkable vials) 1 ampoule 3 times per day Up to three times per day
Oral solutions (Unit dose) Unit oral dose 3 times per day Give one unit dose upon onset of symptoms. Repeat two more times at 15-minute intervals. Repeat process up to 9 times per day if symptoms reappear.
Mouth sprays 1 spray 5 times per day Every 30-60 minutes (up to 12 times per day) or until improvement of symptoms. The resume general dosing.
Suppositories 1 suppository 4 times per day Maximum 5 times per day
Method of preparation

The method of preparation must be:
Ph. Eur. monograph 1038.

Directions for use

Take as directed by a health care practitioner.

Duration of use

No statement required.

Risk information

Cautions and warnings

All products

  • If symptoms persist or worsen, consult a health care practitioner.
  • If you are pregnant or breastfeeding, consult a health care practitioner prior to use.

Products administered rectally
If insertion of the suppository into the rectum causes pain or bleeding, discontinue use and consult a health care practitioner promptly.

Contraindications

No statement required.

Known adverse reactions

No statement required.

Non-medicinal ingredients

Must be chosen from the current NNHPD Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in the database.

Specifications

References reviewed