Gu Hua San Chun Soft Capsule for chronic renal failure. Guhuasanchun Ruanjiaonang. Calcitriol Soft Capsule. (10 capsules*5 boxes/lot).
Calcitriol Soft Capsules
Guhuasanchun Ruanjiaonang
Gu Hua San Chun Ruan Jiao Nang
Guhuasanchun Soft Capsule
Gu Hua San Chun Soft Capsule
骨化三醇软胶囊
FUNCTION and INDICATIONS
1.Postmenopausal osteoporosis
2.Chronic renal failure;
3.Postoperative thyroid dysfunction;
4. Idiopathic hypoparathyroidism;
5. Pseudo-hypothyroidism;
6. Vitamin D-dependent rickets;
7. hypophosphorus vitamin D-resistant rickets and so on.
INGREDIENTS
Calcitriol.
DESCPRIPTION
The contents of this product is light yellow to yellow oily liquid.
SPECIFICATION AND PACKAGE
0.25μg*10 capsules/box.
USAGE AND DOSAGE
For oral use after meals.
1.Postmenopausal osteoporosis: The recommended dose of 0.25μg (1), twice daily. Serum calcium and serum creatinine concentrations were monitored at the 4th week, 3rd and 6th month after taking the medicine, and monitored every 6 months thereafter.
2.Renal osteodystrophy (including dialysis patients): The initial daily dose of 0.25μg. Patients with normal or slightly decreased serum calcium may be given 0.25 μg (1 capsule) every other day. If 2 to 4 weeks no significant improvement in biochemical indicators and disease, then every other 2 to 4 weeks to increase the amount of 0.25μg (1 capsule), during that period measured calcium twice a week at least . The optimal dosage for most patients is between 0.5 (2 capsules) daily doses to 1.0 μg (4 capsules) daily doses;
3.Hypoparathyroidism and rickets: the recommended initial dose of 0.25μg daily (1 capsule) morning take. If no significant improvement in biochemical indicators and disease, then every other 2 to 4 weeks to increase the dose. During this period,measured the serum calcium concentration twice a week at least. Patients with hypoparathyroidism,occasionally appear poor absorption, so that kind of patients requires a larger dose. If the doctor decided to use this product for treatment of pregnant women with hypoparathyroidism, they should be given a higher dose during the later trimester and should be given less during the postpartum and lactation period.
4. Elderly patients:Elderly patients without special dose, but it is recommended to monitor serum calcium and serum creatinine concentrations;
5. Infants and children: The solution form of this product is suitable for infants and children. As adults, the dose shoudl be basis on serum calcium levels;
Children within 2 years of age, the recommended daily reference dose of 0.01-0.1μg / kg body weight. The measuring tube provided in the package accurately measures the dose required for each patient. Dosing volumes can be expressed in milliliters or in drops: 0.1 ml of solution corresponds to 0.1 μg of active ingredient (calcitriol) or 1 drop of solution contains 0.02 μg of calcitriol. The solution can be placed in a spoon and then mixed into children's drinks (such as orange juice, etc.).
Pregnant women medication
Given rabbit maximum amount of calcitriol recommended 2-6 times the appearance and and skeletal of fetal appear deformities; the same dose has no teratogenic effect on rats, there is no appropriate and good control of the experimental study the impact of this product on pregnant women , So pregnant women use this product should be cautious.
REFERENCES
Calcitriol, one of the most important active metabolites of vitamin D3, which is usually converted from its precursor 25-hydroxyvitamin D3 (25-HCC) in the kidneys. The normal physiological daily production is 0.5-1.0 μg , And its production increased slightly during the period of increased osseous synthesis (such as growth or gestation). Calcitriol promotes intestinal absorption of calcium and regulates bone mineralization. The pharmacological effects of a single dose calcitriol can last about 3-5 days.
ADVERSE REACTION
As calcitriol can produce the role of vitamin D, so the possible side effects are similar to vitamin D over dose. Such as hypercalcemia syndrome or calcium poisoning (depending on the severity and duration of hypercalcemia).Occasional acute symptoms include loss of appetite,headache,vomiting and constipation.Chronic symptoms include malnutrition,sensory disturbances,thirsty with fever,excessive urination,dehydration,apathy,developmental cessation,and urinary tract infections.Up to 15 years of clinical use of this product to treat all indications. The results showed that the incidence of adverse reactions is very low, including the incidence of hypercalcemia, including 0.111% or less. Soft tissue calcification may occur in patients with hypercalciuria and hyperphosphatemia at concentrations greater than 6 mg / 100 mmol / l, which can be observed by radiological examination.
CONTRAINDICATIONS
Contraindicated in patients with hypercalcemia-related diseases. It is also prohibited in patients who are already allergic to this or similar drugs and any excipients; prohibited in patients who have signs of vitamin D poisoning.
Warning
1.High blood calcium is closely related with the treatment of this product. Studies of patients with uremic osteodystrophy have shown that hyperlipidemia is found in up to 40% of patients treated with calcitriol. Dietary changes (eg, increased intake of dairy products),calcium intake rapidly increases or uncontrolled consumption of calcium preparations can result in hypercalcemia. Patients and their families should be informed that they must strictly adhere to the prescribed diet and teach them how to recognize the symptoms of hypercalcaemia. Once the serum calcium concentration than normal (9 ~ 11mg / 100ml, or 2250 ~ 2750ugmol / l) higher than 1ml / 100ml, or serum creatinine increased to greater than 120umol / ml, should immediately stop taking this product until serum calcium normal. (Details see "Usage and dosage") Patients with normal renal function, chronic hypercalcemia may be related to increased serum creatinine. Bedridden patients, such as postoperative bedridden patients with hypercalcemia opportunities will be greater;
2.Calcitriol can increase blood levels of inorganic phosphorus, hypophosphatemic patients at this time is beneficial, but for patients with renal failure have to be careful of the dangers caused by abnormal calcium precipitation,In the case, maintain the normal level of phosphorus (2 ~ 5mg / 100ml or 0.65 ~ 1.62mmol / l) by orally taking the appropriate amount of phosphate binding agent or decreasing the amount of phosphorus intake. Suffering from vitamin D resistance rickets patients (familial hypophosphatemia) ,when treated by this product should continue oral phosphate formulations. However,we must consider that this product may promote intestinal absorption of phosphorus, this effect may reduce phosphorus intake requirements. Therefore, the need for regular stable period,measured serum calcium at least twice a week . (See "Usage and dosage")
3.Because calcitriol is the most effective existing vitamin D metabolites,it does not require the use of other vitamin D formulations,so as to avoid high vitamin D hyperlipidemia.If the patient is taking a calcitriol by taking vitamin D3, it may take months to restore blood levels of vitamin D3 to the basal level. (See "use the amount of")
4.Patients with normal renal function when taking this product must avoid dehydration, it should maintain proper water intake;
5. Effects on driving vehicles and operating machinery,based on the reported pharmacodynamic properties of adverse reactions, it is speculated that this product is safe or has little effect on driving the vehicle and operating the machine.
DRUG INTERACTION
If use with the other drugs at the same time may occur drug interactions,details please consult your physician or pharmacist.
PHARMACOLOGIC ACTION
1.The key role of calcitriol is to regulate calcium balance, including stimulation of osteoblast activity in bone, provides an adequate pharmacological basis for the treatment of osteoporosis.
2.Patients with renal osteodystrophy ,oral administration of this product promotes the ability of the intestinal absorption of calcium returned to normal, correct hypocalcemia, and excessive blood alkaline phosphatase and parathyroid hormone concentrations. This product can reduce bone and muscle pain, and correct the occurrence of histological changes in osteitis fibrosa and other mineralization.
3.Vitamin D3-dependent rickets patients blood calcitriol level decreased or missing. Due to lack of calcitriol production in the kidneys, consider this product as an alternative treatment.
4.In patients with vitamin D-resistant rickets and hypophosphatemia patients, serum calcium levels are reduced. This product reduces tubular debridement of phosphorus, in combination with the treatment of phosphorus preparations, restores bone growth.
5.Even at very high doses, there is no evidence that vitamin D has teratogenic effects on humans.
STORAGE
Hermetically sealed,keep in cool and dry places.
PERIOD OF VALIDITY
24 months.
CERTIFICATE NO
Stage Food and Drug Administration Approval number:H20030491.
Manufactured
QINGHAI ZHENGDA HAIER PHARMACEUTICAL CO.,LTD
Tips: Please read the directions for use in retail or directed by physician.
Part of the goods frequent replacement of packaging, such as goods and pictures are not exactly the same, please refer to the goods you receive.
General Cautions
Keep away from animals and children.This product has not been evaluated by the FDA. It is not intended to diagnose, treat, cure, or prevent any disease.We highly recommend that you consult with a Traditional Chinese Medical practitioner or physician before taking any products or if you have any questions regarding your health.