[English name] Alfacalcidol Soft Capsules 

[Ingredients] The main ingredients of this product are: alaralciol.

Chemical name: (5Z, 7E) -9,10-ring-opening gall bladder-5,7,10 (19) -triene-1 α, 3 β -diol.

Chemical structure formula: Molecular formula: C27H44O2 Molecular weight: 40.65 [Characteristics] The contents of this product are yellowish or yellow oil-like liquid.

[Indications] osteoporosis.

[Specifications] 0.25 μ g; 0.5 μ g.

[Usage and dosage] Take it orally once daily at 0.5 μ g (0.25 μ g 3; 0.5 μ g 1) or as prescribed.

[Adverse reactions] (1) Digestive system: occasional loss of appetite, nausea, nausea, vomiting, abdominal distension, diarrhea, constipation, stomachache, stomach discomfort, occasional indigestion, oral discomfort, thirst and other symptoms.

(2) Mental nervous system: occasionally headache, head weight, insomnia, trance, fatigue, tiredness, dizziness, numbness, drowsiness, memory loss, tinnitus, senile deafness, back pain, shoulder muscle stiffness, tension of the lower limbs, chest pain and other symptoms.

(3) Circulatory system: occasionally mild blood pressure rise and palpitations.

(4) Liver: occasionally GOT, GPT, LDH, γ -GTP is worth rising.

(5) Kidney: occasional BUN, creatinine value rise (renal function), kidney stones.

(6) Skin: sometimes there is itching, rash, and occasional fever.

(7) Eyes: occasional conjunctival congestion.

(8) Bone: occasional calcification around the joints.

(9) Others: occasionally voice hoarseness, edema.

[Contraindications] Patients with hypercalcemia, vitamin D3 and analogues should not take it.

[Note] This product should be taken under the guidance of a physician.

The blood calcium level should be measured regularly during the medication. If hypercalcemia occurs, you should stop taking it until the blood calcium can be readministered after returning to normal.

[Drug for pregnant women and lactating women] The safety of medication in pregnant women and lactating women has not been established.

[Children medication] to children taking this product, should fully observe the serum calcium value, urinary calcium / chromium ratio, at the same time, carefully grasp the dosage, from a small increase, so as to avoid excessive use.

[Use for elderly patients] Generally speaking, because of the low physiological function of the elderly, we should pay attention to the amount of consumption.

[Drug interaction] Patients who are taking anticoagulants, antiepileptic drugs, acid acids, aluminum agents containing magnesium or calcium, thiazine diuretics, digitinsides, please use this product as your advice.

The use of vitamin D and its analogues should be avoided.

[Drug overdose] In adverse reactions, based on the majority caused by high blood calcium, so when this symptom occurs, the serum calcium value should be measured and treated according to [precautions].

[Pharmacological toxicology] This product is an active metabolite of vitamin D3.

After oral absorption in the liver quickly hydroxylation into active 1- α, 25-dihydroxy vitamin D3, distributed in the gut, bone and other target tissue combined with its receptor, to promote the intestinal absorption of calcium and phosphorus, raise serum calcium level, promote bone calcification, reduce the plasma in the parathyroid hormone level, prevent bone calcium loss.

The LD50 values of the primary perfusion and subcutaneous mice were 472.7-490.9 μ g / kg and 39.2-41.5 μ g / kg, respectively.

[Pharmacokinetics] After oral absorption, this product was metabolized by hepatic 25-hydroxylase to 1- α, 25-dihydroxyvitamin D3, with a peak time of 9 hours, and 45% was excreted from the intestine 24 hours after administration.

[Storage] shaded, sealed and stored in a cool and dry place (not more than 20℃).

[Packaging] Oral solid medicinal high-density polyethylene bottle packaging: 20 grains per bottle; aluminum-plastic packaging (medicinal aluminum foil; polyvinyl chloride solid medicinal hard tablet): 10 plates per plate, 2 plates per box.

[Expiry date] of 24 months 

[Approval No.] H20010618 (0.25 μ g) 

[Drug Marketing License Holder] Shanghai Xinyi Yan'an Pharmaceutical Co., LTD.