Approved on.
Revision Date.
Alfa Bone Cortisol Tablets Instructions
Please read the instruction manual carefully and use under the guidance of your physician.
[Drug Name].
Generic Name: Alfacalcidol Tablets
Trade Name: Liqing
English Name: Alfacalcidol Tablets
Hanyu Pinyin: Afaguhuachun Pian
[Ingredients
The main ingredient of this product: Alfacalcidol
Chemical name: (5Z,7E)-9,10-open-loop cholest-5,7,10(19)-triene-1α,3β-diol
Chemical structure formula.
Molecular Formula: C27H44O2
Molecular weight: 400.64
[Properties
This product is a white tablet.
[Indications
1. Osteoporosis
2. Improvement of various symptoms of abnormal vitamin D metabolism (e.g. low blood calcium, hand and foot twitching, bone pain, bone lesions, etc.) due to the following diseases
Chronic renal failure
Hypoparathyroidism
Anti-vitamin D rickets, chondromalacia
[Specifications
(1) 0.25µg (2) 0.5µg
[Dosage].
Adjust the dose of this product based on adequate control of the patient’s normal blood calcium values.
Chronic renal failure, osteoporosis.
Usually, adults take 0.5µg of alfa osteoporosis tablets orally once a day. but the dosage should be increased or decreased according to age and symptoms as appropriate.
Hypoparathyroidism, other disorders due to abnormal vitamin D metabolism.
Usually, adults take 1.0 ~ 4.0 µg of alfacalcidol tablets orally once a day, but the dosage should be increased or decreased according to disease, age, symptoms, and disease type.
[Adverse reactions] According to foreign literature
Treatment of osteoporosis
Adverse reactions were reported in 192 (1.3%) 241 of 14,808 cases. The major ones were rise in blood urea nitrogen (BUN) (0.2%), feeling of vomiting (0.2%), loss of appetite (0.1%), stomach pain (0.1%), and rise in aspartate aminotransferase (AST) (0.09%).
Treatment of chronic renal failure, hypoparathyroidism, anti-vitamin D rickets, chondromalacia, vitamin D in immature children Metabolic abnormalities caused by the improvement of various symptoms
Adverse reactions were reported in 285 (5.7%) 471 of 4,967 cases. The major ones were scratching sensation (2.3%), loss of appetite (1.0%), vomiting sensation (0.9%), diarrhea (0.6%), and rise in alanine aminotransferase (ALT) (0.5%).
Significant adverse reactions
Acute Renal Failure (frequency unknown): Because of the occasional rise in serum calcium associated with the development of acute renal failure, regular observation of serum calcium values and renal function, and when abnormalities are detected, measures such as definitive drug discontinuation should be taken.
Liver dysfunction, jaundice (frequency unknown): Liver dysfunction, jaundice with rise in AST, ALT, alkaline phosphatase (ALP), etc. appear, adequate observation should be performed and when abnormalities are detected, measures such as definitive drug discontinuation should be taken.
Other adverse reactions
Exact dose reduction , discontinuation, etc. should be taken in case of the following adverse reactions.
Frequency
Variety0.1~5%less than 0.1%DigestionLack of appetite, nausea, vomiting sensation, diarrhea, constipation, stomach painVomiting, bloating, upset stomach, indigestion, feeling of discomfort in the mouth, thirstMental nerves
System Headache, heavy head, insomnia, dizziness, weakness , drowsiness, dizziness, numbness, drowsiness, memory loss, tinnitus, senile deafness, back pain, muscle stiffness in the shoulders, tension in the lower extremities, chest painCirculatory system Mildly elevated blood pressure, palpitationsLiverASTRising, ALTRisingRising lactate dehydrogenase (LDH), rising γ-glutamyl transpeptidase (γ-GTP)KidneysRising BUN, rising creatinine ( Cr) rise (hyperalgesia)Kidney stonesskinSensation of scratchingRash, feverish sensationEyeConjunctival congestion Bone Periarticular calcificationOther Heartiness and edema of the voice[Contraindication
Contraindicated in patients with hypercalcemia.
[Precautions
1. Take this product with Calcium supplements, as appropriate, according to medical advice.
2. During the administration of this medication, under the guidance of a physician, the Closely monitor blood calcium and urine calcium levels, adjust the dose, and discontinue the drug immediately if hypercalcemia occurs. After the blood calcium values return to the normal range, the dose can be re-dosed.
3. Adverse reactions in the gastrointestinal system, liver, psychoneurological system, and circulatory system may occur with overdose, such as: stomach pain, constipation,GOTandand >GPTelevation, headache, mildly elevated blood pressure, etc.
4. Patients who are taking anticoagulants, antiepileptics, antacid aluminum agents, magnesium-containing or calcium-containing preparations, thiazide diuretics, and digitalis glycosides should use this product as directed by their physician.
[For pregnant and lactating women]
Pregnant or potentially pregnant Women should weigh the pros and cons of using this product and use it only if the pros outweigh the cons. [The safety of dosing during pregnancy has not been established. Delayed embryonic ossification has been observed in animal studies with massive dosing. Effects on the gonads include decreased conception rates, increased fetal mortality, inhibition of fetal development, and decreased lactation. ]
It is best to avoid medication during breastfeeding and to use it when Stop breastfeeding when medication has to be used. [The safety of the drug during lactation has not been established. In animal studies (rats), the migration rate from lactation to neonatal juvenile white rats was equivalent to 1/20 of the dose administered to the mother animal. ]
[Children’s medication
Unclear.
[Geriatric Use
Generally, due to the low physiological function in the elderly, it is important to pay attention to the dosage.
[Drug Interactions
Caution should be taken when combined with.
Preparation nameclinical symptomsMechanism , risk factorMagnesium-containing preparations (magnesium oxide, magnesium carbonate, etc.)occasional reports of hypomagnesemiaUnknownCardiac agents (digoxin, etc.)Possible arrhythmiaIn hypercalcemia caused by this product, the effect of cardiac agents is enhancedCalcium preparations (calcium lactate hydrate, calcium carbonate, etc.)There is a risk of hypercalcemiaThis product promotes the absorption of calcium in the intestineVitamin D and its derivatives (osteotriol, etc.)There is a risk of hypercalcemia Additive effectParathyroid Hormone (PTH) Preparation (Teriparatide)There is a risk of hypercalcemia Additive effect
[Drug overdose
To prevent overdose, serum calcium values should be measured periodically during the administration of this product and the dose should be adjusted to avoid hypercalcemia.
In the event of hypercalcemia, discontinue immediately. After the serum calcium value returns to normal, then start to reduce the dose of medication.
[Pharmacology and Toxicology
Pharmacological effects
After oral administration of alfacalcidol, it is rapidly absorbed into the bloodstream by the intestine and passes through the hepatic microsomes in the first25position hydroxylase in the side chain of the 25position is hydroxylated to the active substance1α,25-(OH)2D3is distributed in target tissues of the intestine and bone, and binds to receptors to promote intestinal absorption of calcium, producing a series of physiologically active effects such as bone salt dissolution and osteogenesis.
Toxicological studies
Reproductive toxicity
Rats were given alfacalcidol orally before and during early gestation, organogenesis, perinatal period and lactation at a maximum dose of 2.5 μg/kg; rabbits were given orally during organogenesis The results showed that no abnormalities were observed in rats at 0.5 μg/kg and rabbits at 0.02 μg/kg. The animals in the high-dose administration group showed delayed ossification, effects on gonads, decreased conception rate, increased fetal mortality, inhibition of fetal development, and decreased lactation.
[Pharmacokinetics].
According to foreign literature, this product is absorbed in the small intestine and rapidly metabolized by the liver to 1α,25-(OH)2D3. The blood 1α,25-(OH)2D3 concentration peaked in 14 healthy adults at 4 to 24 hours (mean 11.0 hours) on oral administration of alfacalcidol 4µg (1.0µg ×4 tablets) (mean 94.6 pg/ml) and almost returned to pre-dose values at 48 to 72 hours.
[Storage].
Store under shade, airtight, at room temperature (not to exceed 25°C).
[Package
Polyamide/Aluminium/Polyvinyl Chloride Cold Pressed Solid Pharmaceutical Compound Hard Sheet, Pharmaceutical Aluminum Foil
10tablets/Plate x11board/box,10pieces/board x2boards/ box,10pieces/Plate x3Plate/Box
[Valid for].
12 months
[Execution Standard
[Approval Number
0.25µg: 国药准字H10950135
0.5µg: GMP H10950134
[Manufacturer
Company Name: Chongqing Yuyou Pharmaceutical Co.
Production Address: No. 100, Xingguang Avenue, Renhe Town, Yubei District, Chongqing
Postal Code: 401121
Tel: 023-67518018
Fax Number: 023-67527018
Website: http//www.yaopharma.com