Date of approval.
Date of revision.
Calcium acetate tablets instructions for use clinical section
Please read the instructions carefully and use under the guidance of a physician
Drug Name]
Generic name: Calcium Acetate Tablets
English name: Calcium Acetate Tablets
Hanyu Pinyin: Cusuangai Pian
Ingredients
The main ingredient and chemical name of this product is calcium acetate.
Chemical structure formula.
Molecular formula: C4H6CaO4
Molecular weight: 158.17
Product properties]: This product is white or off-white tablets.
Indications】
Calcium acetate tablets are used to control hyperphosphatemia due to end-stage renal failure.
Specification】0.667g
Dosage]
The recommended starting dose of calcium acetate tablets for adult dialysis patients is 2 tablets with each meal. In the absence of hypercalcemia, the dose can be gradually increased to bring the serum phosphate level below 6 mg/dl. Most patients need to take 3-4 tablets with each meal.
[Adverse Reactions].
Hypercalcemia (see [Precautions]).
Clinical Trial Experience.
Calcium acetate was well tolerated in clinical studies (US FDA approved data from the same species insert).
In a 3-month open, non-randomized study with 98 end-stage renal disease hemodialysis patients as subjects, calcium acetate formulations were studied. In a two-week double-blind, placebo-controlled crossover study, an oral calcium acetate formulation was studied in 69 patients on hemodialysis for end-stage renal disease. In the above clinical trial, adverse reactions with an incidence of >2% in the treatment group are shown in Table 1.
Table 1. adverse reactions in patients on hemodialysis for end-stage renal disease
Major adverse reactions Total reported adverse reactions of calcium acetate
n=167
n (%) calcium acetate at 3 months, open study
n=98
n (%) Double-blind, placebo-controlled, crossover study of calcium acetate oral solution
n=69 calcium acetate
n(%) placebo
n (%) nausea 6 (3.6) 6 (6.1) 0 (0.0) 0 (0.0) vomiting 4 (2.4) 4 (4.1) 0 (0.0) 0 (0.0) hypercalcemia 21 (12.6) 16 (16.3) 5 (7.2) 0 (0.0) Mild hypercalcemia (Ca> 10.5 mg/dl) may be asymptomatic or manifest as constipation, anorexia, nausea, and vomiting. More severe hypercalcemia (Ca>12 mg/dl) may cause confusion, delirium, rigidity, and coma. Severe hypercalcemia can be treated by discontinuing calcium acetate and emergency hemodialysis. Decreasing dialysate calcium concentration may reduce the incidence and severity of calcium acetate-induced hypercalcemia.
Isolated cases of pruritus have been reported, possibly due to an allergic reaction.
The long-term effects of calcium acetate tablets on the progression of vascular or soft tissue calcification are not known.
Postmarketing Experience.
The following adverse reactions were identified after marketing approval of the same species: dizziness, edema and weakness. This information was voluntarily reported by a population of uncertain size and does not allow for accurate estimation of their incidence or establishment of a causal relationship with drug exposure.
[Contraindications].
Contraindicated in patients with hypersensitivity to any of the ingredients in this product.
Contraindicated in patients with hypercalcemia.
[Precautions].
Warning.
Calcium taken with meals in patients with end-stage renal failure may lead to hypercalcemia. Calcium acetate tablets should not be used in conjunction with other calcium supplements.
Calcium acetate overdose may result in severe progressive hypercalcemia requiring emergency measures. Chronic hypercalcemia may lead to calcification of blood vessels and other soft tissues. Serum calcium levels should be monitored twice weekly during initial dose adjustment of therapy.
Serum calcium-phosphorus product (Ca x P) should not exceed 66 mg2/dl2.
Imaging evaluation of suspected anatomic areas may be helpful in the early detection of soft tissue calcification.
General Precautions.
Excessive doses of calcium acetate tablets can induce hypercalcemia; therefore, serum calcium levels should be monitored twice weekly during initial dose adjustment of therapy. If hypercalcemia develops, the dose of calcium acetate should be reduced or calcium acetate therapy discontinued depending on the severity of the hypercalcemia. In patients taking digitalis, calcium acetate tablets should not be given because hypercalcemia may lead to cardiac arrhythmias. Treatment should always be initiated with a low dose of calcium acetate tablets, and the dose should not be increased without close monitoring of serum calcium. Daily calcium intake should be estimated first and adjusted as needed. Serum phosphorus should also be measured periodically.
[For pregnant and lactating women].
No animal reproductive toxicity studies have been conducted with calcium acetate. There are no adequate and well-established clinical studies of calcium acetate use in pregnant women. It is not clear whether administration of calcium acetate tablets to pregnant women causes fetal harm or whether it affects fertility. Calcium acetate tablets should be given to pregnant women only if clearly needed.
Pediatric Dosage]
No such trials have been conducted and no reliable references are available.
Geriatric Use
In clinical studies of calcium acetate tablets, 25% of subjects (91 cases) were 65 years of age or older and 7% were 75 years of age or older. No overall differences in safety or efficacy were observed between older and younger subjects, and other reported clinical experiences did not reveal differences in response between older and younger patients, although a higher sensitivity in some older individuals cannot be excluded. In general, dose selection in elderly patients should be cautious, usually starting with a low dose, considering the reduced hepatic, renal and cardiac function, as well as the effects of complications or concomitant administration of other drugs.
Drug Interactions]
The anions in some drugs (e.g., carboxyl and hydroxyl groups) may bind to the calcium in calcium acetate. Through this mechanism, calcium acetate may reduce the bioavailability of tetracyclines or fluoroquinolones.
Empirical data on the avoidance of interactions of calcium acetate with most combinations of drugs are not available. When the reduced bioavailability of an oral drug would have a significant impact on its clinical safety and efficacy, these drugs need to be administered only 1 hour before or 3 hours after calcium acetate administration.
When combined with drugs with a narrow therapeutic index, their blood levels need to be monitored.
Patients taking antiarrhythmic drugs and antiepileptic drugs need to be excluded from clinical trials of all dosage forms of calcium acetate.
Ciprofloxacin: In a study of 15 healthy subjects, the bioavailability of ciprofloxacin was decreased by approximately 50% with a single combination of 4 tablets (approximately 2.7 g) of calcium acetate.
[Drug overdose].
Overdose of calcium acetate may cause hypercalcemia (see [Adverse Reactions] and [Precautions]).
Pharmacology and Toxicology
This product is a phosphorus binding agent, taken with meals, can be combined with dietary phosphorus into insoluble calcium phosphate, excreted through the feces, reducing the absorption of phosphorus and lowering serum phosphorus concentration.
Pharmacokinetics]
Calcium acetate is highly soluble at pH 5 to neutral, and can rapidly release calcium ions to bind with phosphorus in the stomach and small intestine. After oral administration of calcium acetate, it can be absorbed by the intestines of healthy volunteers and dialysis patients at about 40% under fasting conditions and about 30% under non-fasting conditions.
Storage】Seal and store.
Package】Aluminium-plastic package, 12 tablets/plate×2 plates/box, 12 tablets/plate×4 plates/box.
Expiration date】24 months.
【Execution standard
【Approval number】State Drug Administration H20183183
[Drug Marketing Licensee
Company name: Beijing Bemet Biopharmaceutical Co.
Address: No. M2-9, Xinggu A, Pinggu Park, Zhongguancun Science and Technology Park, Pinggu District, Beijing
Postal Code: 101200
Telephone number: 010-59793116
Fax number: 010-59793116-8523
Website: www.bmtpharm.com
【Manufacturer】
Company name: Beijing Bemet Biopharmaceutical Co.
Production Address: No. M2-9, Xinggu A, Pinggu Park, Zhongguancun Science and Technology Park, Pinggu District, Beijing
Postal Code: 101200
Telephone number: 010-59793116
Fax number: 010-59793116-8523
Website: www.bmtpharm.com