- Initiate patient care
- Provide to patients who require increased dosing for loading
- Provide to patients who cannot afford the product
Preprinted prescription pads are also available upon request.
- Mail a request on office letterhead to:
BTR Group, Inc.
P.O. Box 501
Pittsfield, IL 62363
Our warehouse will ship the product.
LOADING & DESIRABLE LEVELS
- Serum 25(OH)D <18-20 ng/ml: 10,000 IU (1 gel cap) daily for 30 days, then 20,000 IU (2 gel caps) weekly
- Serum 25(OH)D >20 ng/ml: 20,000 IU (2 gel caps) weekly
- Then reassess 25 (OH)D levels after 12 weeks.
These recommendations apply only to Maximum D3®.
The ideal range is generally between 30 and 60ng/ml of 25(OH) cholecalciferol.
It is generally recognized that the minimal blood level needed to prevent overt bone disease is 20 ng/ml.
Good evidence exists for a risk of overt bone disease (osteomalacia, Rickets) with levels below 20 ng/ml. There is decent evidence for suboptimal calcium absorption with levels below 32 ng/ml. Primitive sun-exposed populations have 25(OH)D levels predominantly in the 40-60 ng/ml range.
Toxicity from short-term exposure requires levels near or above 150 ng/ml. Studies to assess the long-term safety of levels from 80 to 150 ng/ml are lacking. The Institute of Medicine recommends against doses averaging above 4,000 IU/day in unsupervised patients. The above recommendation is based on lack of evidence for additional benefit, limited data for adverse effect and uncertainty over toxicity from chronic use.
DETAILED CONTENTS OF MAXIMUM D3
The only ingredients in Maximum D3® are vitamin D3 (cholecalciferol), non-GMO soybean lecithin, FD&C Blue 1 on half of the gelatin shell and bovine gelatin.
The pill is a small hard gel cap containing 0.25 mg of pharmaceutical quality cholecalciferol in a digestible oil base. The capsules are manufactured, packaged and warehoused in FDA-registered and inspected facilities. Quality, packaging and stability are to available USP and FDA standards.
|Cereals containing Gluten and products thereof||NO|
|Crustaceans (mussels and shellfish) and products thereof||NO|
|Eggs and products thereof||NO|
|Fish and products thereof||NO|
|Peanuts and products thereof||NO|
|Soybeans and products thereof||YES
(Lecithin derived from soy)
|Milk and dairy products (including lactose)||NO|
|Nuts and products thereof||NO|
|Composition and Origin (weights are approximate)|
|Lecithin derived from soy, Non-GMO (USA)||287mg (0.01 ounce)|
|Pharmaceutical Kosher bovine gelatin caps (France)||73 mg (0.0026 ounce)|
|Cholecalciferol - vitamin D3 (USA)||0.3mg (0.00001 ounce)|
|FD&C Blue 1 (FDA-approved)|
|There is no coloring in the oil.|
The dosage and formulation have been intelligently designed:
- The hard gel cap for stability
- The digestible oil for consistency of potency (mixing), stability and absorption
Maximum D3® conforms to USP standards <581> for purity, <2091> for weight variation, and <2040> for disintegration and dissolution and conforms to available USP standards for ingredients.
PLEASE NOTE: Each production lot is tested prior to distribution. Ingredients are also tested prior to production and later testing is done for evidence of contamination or degradation.