Lithotherapy
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(PDF Version - 115 K)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)
| 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
Statement(s) to the effect of:
Subpopulation(s)
Adults (≥ 18 years)
Quantity(ies)
The dilution for each medicinal ingredient must be equal to or greater than D8 (or equivalent).
| 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
- The finished product specifications must be established in accordance with the requirements described in the NNHPD Quality of Natural Health Products Guide.
- The medicinal ingredient must comply with the requirements outlined in the Natural Health Products Ingredients Database.
References reviewed
- Bergeret C, Tétau M. Précis de lithothérapie déchélatrice. (FR) : Éditions Maloine, 1984.
- Binet C. Oligo-éléments et oligothérapie. (FR) : Dangles, 2007.
- Brigo B. Logique thérapeutique des oligoéléments et des remèdes en lithothérapie. (BE) : Marco Pietteur éditeur, 2005.
- IMA 2011:
International Mineralogical Association [Internet]. [Last updated 2011 September 01; Accessed 2013 May 29]. - IMA-CNMNC 2006:
The Commission on New Minerals, Nomenclature and Classification (CNMNC) of the International Mineralogical Association (IMA) Sydney (Australia) [Internet] [Accessed 2013 May 29] .
- MinSoc 1876:
Mineralogical Society of Great Britain and Ireland. Middlesex (UK) [Internet]. [Last update 2011 September 11; Accessed 2013 May 29].