Vitamin D3 -
Tedagel®
Generic name
Cholecalciferol
Category
Vitamin – fat soluble
Dosage form
This product is produced in the form of soft gelatin capsule, in strengths
of 1000, 2000 international units and scored tablets in strengths of 1000 and
2000 international units by Tehran Darou pharmaceutical company.
Introduction
Vitamin D3, often referred to as the "sunshine vitamin,"
is a key player in maintaining optimal bone health, immune function, and
overall vitality. Produced in response to sunlight, this vitamin contributes to
the regulation of calcium and phosphorus levels, bolstering bone strength and
integrity.
The active form of vitamin D3 increases the
intestinal absorption of calcium and the absorption of calcium into bones and
stimulates the release of calcium from tissue. It enhances the absorption of
phosphate in the small intestine and prevents the secretion of calcium and
phosphate in the kidney. It also inhibits the production of parathyroid
hormone.
Use
Low levels of phosphate in the blood due to an inherited disorder called
familial hypophosphatemia
Low levels of phosphate in the blood due to a condition called Fanconi
syndrome
Low blood calcium levels due to low parathyroid hormone levels
Osteomalacia in adults
Rickets (bone softening or rickets) in babies
Regulating the immune system and protecting nerve cells from damage, and
slowing the progression of multiple sclerosis (MS)
Vitamin D3
insufficiency / deficiency
osteoporosis
prevention
Dosing and administration
Help to prevent
rickets (soft bones or rickets) and osteomalacia in children and adults: daily
equivalent to 500 units of vitamin D3.
Help prevent
rickets in premature newborns: daily equivalent to 1000 units of vitamin D3.
Prevention of
vitamin D deficiency in children over one year old, teenagers and adults: daily
equivalent to 500-1000 units of vitamin D3.
Prevention and
treatment of osteoporosis and fractures in adults: equivalent to 1000 units of
vitamin D3 daily.
Vitamin D is best
absorbed when taken after meal.
Pregnancy and breastfeeding
In case of being pregnant or breastfeeding consult your doctor or
pharmacists before taking vitamin D3
Warning and Precautions
Too much vitamin D can cause harmful high calcium levels
You should not take vitamin D if you have had an allergic
reaction to vitamin D, or if you have high levels of calcium or vitamin D in
your body
Vitamin D3 In
People with sarcoidosis, Williams syndrome, patients with severe kidney
failure, hyperphosphatemia (increased blood phosphate), primary hyperthyroidism
should be used with caution and doctor's advice.
Contraindications
People suffering from the following conditions
should avoid using the product:
Allergy to any of the main and side components of this product
High blood calcium level (hypercalcemia)
High level of calcium in the urine (hypercalciuria)
High level of vitamin D in the blood
kidney stones
Drug interactions
Simultaneous treatment with phenytoin, barbiturates and glucocorticoids
reduces the effect of vitamin D3.
The effects of cardiac glycosides such as Digoxin are intensified in the
simultaneous administration of calcium and vitamin D3. Therefore, ECG and serum
calcium level should be checked.
Simultaneous treatment with ion exchange resins such as cholestyramine or
laxatives such as paraffin oil reduces the absorption of vitamin D3.
Thiazide diuretics and its analogues (hydrochlorothiazide, Chlorthalidone)
interfere with vitamin D3.
Cytotoxic drugs such as actinomycin and imidazole inhibit the conversion of
vitamin D3 into the active form of this vitamin in the kidney.
Concomitant use with weight-reducing drugs, cholestyramine (cholesterol-lowering),
digestive drugs such as aluminum and sucralfate, and some chemotherapy drugs is
not recommended.
Side effects
Vitamin D3 at normal doses usually has no side effects.
However Severe allergic reactions such as swelling
of the face, lips, tongue or throat, difficulty swallowing, hives and
difficulty breathing, Increased calcium levels in the blood (hypercalcemia) and
urine (hypercalciuria), gastrointestinal disorders such as constipation,
abdominal bloating, nausea, abdominal pain, diarrhea, allergic reactions such
as itching, skin rash or hives may occur.
If you have any unusual effects, contact your
doctor or pharmacist promptly.
Storage
Keep out of
reach of children.
Keep away from
light, humidity and Store at below 30°C.
Avoid using and
storing expired medicine.