Ethical Drug

Vita-D Inj. 300,000 IU

Cholecalciferol 7.5mg/mL (300,000 IU)

Vit.D3

Intramuscular

Vitamin D3 Cholecalciferol(EP) 7.5mg/mL (300,000 IU)

 Vita-D Inj. 300,000 IU

Cholecalciferol 7.5mg/mL (300,000 IU)

What is Vitamin D?
As a fat-soluble vitamin, Vitamin D contributes to the absorption of calcium necessary for bone formation in the large
intestine and kidneys. Also, in cooperation with parathormone and calcitonin produced in the parathyroid gland, vitamin D
transports calcium properly to the bone marrow so that the skeleton develops according to the suitable shapes and size.

Category Content

VitaminD2 (ergocalciferol) Synthesized in invertebrates

Synthesized in vertebrates, generated from the skin by exposing the skin to ultraviolet
VitaminD3 (cholecalciferol)
light B Excellent efficacy compared to the basic form of vitamin D2 produced in the body
Ref) 1. Hee-Jeong Choi. New Insight into the Action of vitamin D. Feb 2011.
2. Leventis P, Kiely PD. The tolerability and biochemical effects of high-dose bolus vitamin D2 and D3 supplementation in patients with vitamin D insufficiency. 2009 Mar-Apr.

Cutoff line of Vitamin D level in the blood

Toxicity Overdose Normal Insufficient Deficient

150ng/mL 100ng/mL 30ng/mL 20ng/mL 0ng/mL

※ When the level of vitamin 25(OH) in the blood is less than 30ng/mL, PTH increases, and calcium released from bones into the blood increases.

It is recommended to maintain the level of vitamin25(OH)D in the blood at least at 30ng/mL.

Lack of vitamin D for Korean

100 93.3% Men

90
86.8% Women

80

70 64.5%
60

50
47.3%
40

30

20

10

25(OH) blood level less than 20ng/mL 25(OH) blood level less than 30ng/mL

When the level of 25(OH)D in blood was less than 20ng/mL, 47.3% of men and 64.5% of women had vitamin D deficiency.
When the level of 25(OH)D in blood was less than 30ng/mL, 86.8% of men and 93.3% of women had vitamin D deficiency.
In vivo action of vitamin D

Solar UVB radiation Solar UVB radiation

7-dehydrocholesterol(skin) Previtamin D3 Inactive photoproducts
(290~315nm)
Heat ion
diat
UV B ra
Vitamin D3 S olar

Chylomicrons
Diet Vitamin D Fat cell

Circulation

Vitamin D-25-hydroxylase

Circulation

Liver

25(OH)D
(major circulating metabolite)

Phosphorus, Calcium,
FGF-23 and other factors +/- 1-OHase 1.25(OH)2D 24-OHase

Calcitroic acid
1.25(OH)2D Calcium Absorption
Calcium Resorption
Bile
Kidneys
Preosteoclast
Osteoblast
VDR-RXR
Excreted
TRPV6
Parathyroid Calcium
VDR-RXR
Rank homone
Rankl

Osteoclast

Parathyroid glnds
Ca2+&HPO42- (Decrease of parathyroid hormone) Intestine

Ca2+&HPO42-
Calcification Absorption
(Increase of calcium &
phosphorus absorption)
Increase of calcium &
phosphorus level in blood

Ref) N Engl J Med. 2007 Jul 19;357(3):266-81

 Relationship between vitamin D and and health

D i s e as e I n c i d e n c e P re v e n t i o n b y S e r u m 2 5 ( O H ) D Le v e l
Serum 25(OH)D,ng/mL 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50 52 54 56 58 60 62 64 66 68

Individual study
Cancer(all types) 77% With calcium
Breast cancer 30% 83%
Ovarian cancer 12% 17%
Colon cancer 31% 60%
Serum Reference Level

Non-Hodgkin lymphoma 12% 18%

Type 1 diabetes 25% 66%
Fractures(all areas) 25% 50%
Injury from falls(Female) 72%
Multiple Sclerosis 33% 45%
46% 54%
Heart attack(Male) 30%
Natural test
Kidney cancer 23% 49%
Endometritis 37%
Rickets 50% 99%
Chart prepared by : Garland CF.Baqqerlv CA

- In the case of breast cancer, it reduces the onset of breast cancer by 30% if the level of vitamin D in the blood is at 32ng/mL
while it is 83% if the level is 52ng/mL.
- If the vitamin D level in blood is less than 20ng/mL, only the risk of having rickets ifs reduced.

Global vitamin D research trend

Number of Publications Per Year

Vitamin D study 3000

Publication = PubMed search :
“vitamin D” [Title/Abstract] 2500

2000

1500

1000

500

0
1960

1962

1964

1966

1968

1970

1972

1974

1976

1978

1980

1982

1984

1986

1988

1990

1992

1994

1996

1998

2000

2002

2004

2006

2008

*Actual 2011=3097;First 48 days of 2012=571;extrapolated for all of 2012->4342 publications

- With more than 4,000 papers published a year, interest in vitamin D is increasing worldwide.
- Research on vitamin D is being conducted worldwide at 300,000 IU.
Articles on vitamin D 300,000 IU injection

300,000 IU of vitamin D every 3 months may not have been enough Hypovitaminosis D in the Middle East and North Africa - May 201
- July 2010 Hypovitaminosis D in the Middle East and North Africa: Prevalence, risk factors
Heterogeneity in Serum25-Hydroxy-Vitamin DResponse to Cholecalciferol in and impact on Outcomes.
Elderly Women with Secondary Hyperparathyroidism and Vitamin D Deficiency.
150,000 IU vitamin D reduced pain in immigrants - RCT Dec 2012
300,000 IU vitamin D monthly may treat MS - May 2011 Vitamin D Supplementation for Nonspecific Musculoskeletal Pain in Non Western
Therapeutic Effect of Vitamin D3 in Multiple Sclerosis Patients. Immigrants :
A Randomized Controlled Trial.
300,000 IU vitamin Dhelped seniors in many ways - May 2011
The effect of oral and parenteral vitamin D supplementation in the elderly : a Big increase invitamin D supplementation injust 2 years after Swiss
prospective, double-blinded, randomized, placebo-controlled study. rheumatology report - Dec 2013
Changing the awareness of low vitamin D status in a rheumatology population:
Diabetes (Type II) reduced by single injection of 300,000 IU of Vitamin D3 a pre/post-study.
- RCT March 2014
Effect of large doses of parenteral vitamin D on glycaemic control and calcium/ Insulin resistance during pregnancy improved with 50,000 IU of vitamin D
phosphate metabolism in patients with stable type2 diabetes mellitus : a rando every 2 weeks - April 2013
mised placebo-controlled, prospective pilot study. The effect of different doses of vitamin D supplementation on insulin resistance
during pregnancy.
300,000 IU injection ofvitamin D3- Mar 2010
The effect of intramuscular vitamin D (cholecalciferol) on serum 25OH vitamin D Most immigrant women in Sweden had little vitamin D and lots of muscle
levels in older female acute hospital admissions. pain-May 2013
Vitamin Dintake and status in immigrant and native Swedish Women: a study at
300,000 IU loading dose of vitamin D3 stopped gestational diabetes in a primary healthcare Centre located at 600N in Sweden.
RCT - Oct 2011
Effects of a single post-partum injection of a high dose of vitamin D on glucose Vitamin D and Bone Health-UK National Osteoporosis Society - April 2013
tolerance and insulin resistance in mothers with first-time gestational diabetes Vitamin D and Bone Health: A Practical Clinical Guideline for Patient Management.
mellitus.
HIV children in UK-Vitamin Drecommendations - Feb 2014
Reduced depression with single 300,000 IU injection of vitamin D - RCT
June 2013 Pain reduction with 600,000 IU Vitamin D: RCT announced Dec 201
The effect of 2 different single injections of high dose of vitamin D on improving Chronic Pain and Vitamin D(DOVID) France.
the depression in depressed patients with vitamin D deficiency: a randomized
clinical trial. Half of children with chronic illness had low levels of vitamin D - April 2013
Vitamin D Deficiency in Children with a Chronic Illness-Seasonal and Age-Related
Vitamin D deficiency in adolescents, with 300,000 IU loading dose - Variations in Serum 25-hydroxy Vitamin D Concentrat.
Nov 2014
Vitamin D deficiency in adolescents. Child bone conference; many vitamin Dandricket abstracts - June 2013
6th International Conference on Children's bone Health June 22-25, 2013, Rotterdam
Injection of 300,000 IU of vitamin D3 similar to 10 months of oral Netherlands.
25,000 IU-Jan 2014
Different strategies of 25OH vitamin D supplementation in HIV+subjects. Gestational Diabetes reduced 40 percent by 5,000 IU of vitamin D -
RCT April 2014
Angina dramatically reduced by injections of vitamin D twice amonth Vitamin DSupplementation and the Effects on Glucose Metabolism During
(300,000 IU).―Jan 2015 Pregnancy : A Randomized Controlled Trial.
Vitamin D replacement therapy in patients with cardiac syndrome X.
Vitamin D and Calcium-AHRQ rejected most studies - Sept 2014
300,000 IU every 3 months helped raise vitamin D levels in half of RA
patients-April 2012 Chronic pain in seniors associated with low levels of active, not measured
Can one or two high doses of oral vitamin D3 correct insufficiency in a non- vitamin D (strange) - Aug 2014
supplemented rheumatologic population? Active Vitamin D (1,25Dihydroxyvitamin D) is Associated With Chronic Pain in
Older Australian Men : The Concord Health and Ageing in Men Project.
Large single dose of more than 300,000 IU of vitamin D Works well for
3 months-Review Nov 2013 600,000 IU intramuscular D3 helped BMD after pancreatic surgery -
Large, Single-Dose, Oral Vitamin D Supplementation in Adult Populations. June 2010
Effect of a Single "Megadose' intramuscular Vitamin D (600,000 IU) Injection on
Loading dose of 300,000 IU of vitamin D does not last long-March 2014 Vitamin D Concentrations and Bone Mineral Density Following Biliopancreatic
Is the response to high dose oral vitamin Dreplacement predictable? Diversion Surgery.

Osteoporosis Society UK:20ng vitamin D is sufficient, loading dose Bronchial Asthma reduced with 60,000 IU monthly vitamin D - RCT
300,000 IU - Sept 2014 Nov 2013
National Osteoporosis Society Vitamin D Guideline Summary. Effect of Vitamin D Supplementation on Moderate to Severe Bronchial Asthma.
Vita-D Inj. 300,000 IU
Classification No.
311
Cholecalciferol 7.5mg/mL (300,000 IU)

DRUG INFORMATION

Cholecalciferol (EP) in 1mL ------------------------- 7.5mg (300,000 IU)

Component [Solvent: Refined Olive Oil (EP)]

Identification Colorless to greenish-yellow cholecalciferol emulsion in a brown glass ampoule

Prevention and treatment of vitamin D deficiency in adults at high risk of vitamin D

Efficacy / Effect
deficiency with malabsorption

Use according to the doctor's prescription but adjust the dose according to the level
of 25-hydroxy vitamin D in the blood. Adverse reactions increase with overdose, so
Dosage do not administer more than necessary.
Adult: As cholecalciferol, 300,000 IU is injected intramuscularly.
The annual dose should not exceed 600,000 IU as cholecalciferol.

1. Warning
1) To avoid overdose, take treatment containing vitamin D and food intake enhancing
vitamin D level into consideration.
2) Observe calcium level; if the level of serum calcium exceeds 10.5mg/dl or urinary
calcium in adults exceeds 4mg/kg day, stop dosing.
3) If calcium intake is high, regularly monitor the blood and calcium level.
2. Do not administer this drug to the following patients:
1) Patients with hypersensitivity to the components of this drug
2) Patients with hypercalcemia, hypercalciuria
Precautions 3) Patients with calcium oxalate stones
for use 4) Patients with renal impairment
5) Patients who are immobilized in a hospital bed
6) Sarcoidosis
7) Patients with pseudoparathyroidism
3. Adverse reaction
1) If overdose, the following adverse reactions may occur: Headache, asthenia,
fatigue, muscle pain, Loss of appetite, weight loss, growth disorder, nausea,
vomiting, constipation, diarrhea, polydipsia, polyuria, dehydration, high blood
pressure, calcium oxalate stones, tissue calcification, kidney disease, vascular
disease, and kidney failure. In addition, hypercalcemia, hyperphosphatemia,
and hyperphosphateuria may occur.

Shelf life 36 months from the date of manufacture

Storage Hermetic container, store at room temperature (1~30 ℃ ) in a Light-resistant

Packing unit 1mL X 5Amp.

Distributor : Wellspharmtech Co.,Ltd.

(Distribution center B101, B101-1) 1202, 12F, 24, Gasan digital 1-ro,
Geumcheon-gu, Seoul, Republic of Korea TEL: +82-2-6954-0814 FAX: +82-2-2659-2258

2020-10-07-01