Thông tin thuốc của Sodium calcium edetate

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Thông tin thuốc gốc

Chỉ định và Liều dùng

Intramuscular
Lead poisoning

Adult: Asymptomatic poisoning with blood lead levels >70 mcg/dL or symptomatic poisoning without encephalopathy: 167 mg/m² every 4 hr for 3-5 days; may treat with dimercaprol until blood lead level is <50 mcg/dL. Blood lead levels >70 mcg/dL and/or symptoms of lead encephalopathy: 250 mg/m² every 4 hr for 5 days with dimercaprol; 1st dose to be given at least 4 hr after the 1st dose of dimercaprol; both drugs may be given simultaneously via deep IM inj at separate sites; if needed, course may be repeated after at least 2 treatment-free days.

Intravenous
Lead poisoning

Adult: Asymptomatic with blood lead levels >70 mcg/dL or symptomatic poisoning without encephalopathy: 1 g/m²/day either via 8-24 hr IV infusion or in divided doses every 12 hr for 3-5 days, repeat if needed, after an interval of at least 2 days without treatment. Symptomatic poisoning with lead encepahlopathy and/or blood lead levels >70 mcg/dL: Initally, dimercaprol 4 mg/kg via IM inj. At least 4 hr later and when adequate urine flow is established, administer dimercaprol at 4 mg/kg every 4 hr via IM inj and sodium calcium edetate at 50 mg/kg/day via 24-hr continuous IV infusion or 1-1.5 g/m²/day either via 8-24 hr infusion or in divided doses every 12 hr for 5 days. Further courses may be repeated after at least 2 days without treatment.
Child: Asymptomatic with blood lead level 45-69 mcg/dl: 25 mg/kg/day for 5 days either via 8-24 hr infusion or divided into 2 doses every 12 hr. Depending on the blood lead level, further courses may be repeated after at least 2-4 treatment-free days.

Parenteral
Lead nephropathy

Adult: Dosage is based on serum creatinine level. For level ≤2 mg/dL: 1 g daily for 5 days; For level 2-3 mg/dL: 500 mg every 24 hr for 5 days; For level 3-4 mg/dL: 500 mg every 48 hr for 3 doses; For level >4 mg/dL: 500 mg once wkly. May repeat course at 1-mth intervals until lead excretion is reduced toward normal. Doses may be given via slow IV infusion over 8-12 hr (as single daily dose) or deep IM inj.

Parenteral
Diagnosis of lead poisoning

Adult: Mobilisation test: 500 mg/m² (max: 1 g) by IV infusion over 1 hr or as single IM inj. Urine is collected in lead-free collection container for 24 hr (3-4 days if renally impaired) from the time of drug admin and analysed for lead content. Test is considered positive if ratio of lead (in mcg) excreted in urine to sodium calcium edetate (in mg) administered is >1.
Child: Mobilisation test: 500 mg/m² (max: 1 g) by IV infusion over 1 hr or as single IM inj. Urine is collected for 24 hr in the lead-free collection container from the time of drug admin and analysed for lead content. Test is considered positive if ratio of lead (in mcg) excreted in urine to sodium calcium edetate (in mg) administered is >1.

Suy thận

Dose reduction may be needed.

Hướng dẫn pha thuốc

Intramuscular:
IM inj: Add lidocaine or procaine so as to minimise pain at the inj site. The final lidocaine or procaine concentration should be 5 mg/ml (0.5%).
Intravenous:
IV infusion: Total daily dose to be added to 250-500 ml of 5% dextrose or 0.9% sodium chloride inj and infused over 8-12 hr.
Parenteral:
Diagnosis of lead poisoning.: IV infusion: Total daily dose to be added to 250-500 ml of 5% dextrose or 0.9% sodium chloride inj and infused over 8-12 hr. IM inj: Add lidocaine or procaine so as to minimise pain at the inj site. The final lidocaine or procaine concentration should be 5 mg/ml (0.5%),

Tương kỵ

Intramuscular:
10% dextrose, 10% invert sugar in 0.9% sodium chloride, lactate Ringer's, Ringer's, ¹/₆ molar sodium lactate, amphotericin B and hydralazine hydrochloride inj.
Intravenous:
10% dextrose, 10% invert sugar in 0.9% sodium chloride, lactate Ringer's, Ringer's, ¹/₆ molar sodium lactate, amphotericin B and hydralazine hydrochloride inj.
Parenteral:
Diagnosis of lead poisoning.: 10% dextrose, 10% invert sugar in 0.9% sodium chloride, lactate Ringer's, Ringer's, ¹/₆ molar sodium lactate, amphotericin B and hydralazine hydrochloride inj.

Chống chỉ định

Anuria, active renal disease or hepatitis.

Thận trọng

Renal impairment. Do not confuse with sodium edetate. Admin IV fluid where possible before 1st dose of sodium calcium edetate. Stop therapy at first sign of renal toxicity or if anuria or severe oliguria develops. Instruct patient to inform their doctor if no urine output for a period of 12 hr. Urinalysis, urine sediment, serum electrolytes, renal and hepatic function to be checked at baseline and daily in severe poisoning, and after the 2nd and 5th day for less severe poisoning. Monitor ECG during IV therapy. Avoid rapid infusion. IM route is preferred for lead encephalopathy and in cases with increased cranial pressure. Monitor blood lead concentration 10-14 days after completion of chelation therapy. Pregnancy and lactation.

Tác dụng không mong muốn

Fever, chills, fatigue, myalgia, hypotension, irregularities in cardiac rhythm, glycosuria, proteinuria, numbness, headache, nausea, vomiting, excessive thirst, transient increase in LFT, transient bone marrow depression, anaemia, zinc deficiency, hypercalcaemia.
Potentially Fatal: Nephrotoxicity.

Phân loại thai kỳ (US FDA)

IM/IV/Parenteral: B

Tác dụng

Description:
Mechanism of Action: Sodium calcium edetate or calcium EDTA (the calcium chelate of edetate disodium) chelates divalent and trivalent metals. A stable chelate will be formed with any metal that can displace calcium from the molecule and this water soluble complex is then excreted by the kidneys. In the body, only lead and zinc may chelate with sodium calcium edetate as the rest of the metal ions are either not mobilised or too tightly bound to body structures.
Onset: Urinary excretion of chelated lead: 1 hr (IV)
Duration: Urinary excretion of chelated lead: 24-48 hr (IV)
Pharmacokinetics:
Absorption: Poorly absorbed from GI tract. Well absorbed after IM or SC inj.
Distribution: Distributes mainly to extracellular fluid. Does not enter CSF or cells.
Metabolism: Not metabolised.
Excretion: Excreted in urine as unchanged drug or as metal chelates. Plasma half life: 20-60 minutes (IV); 1.5 hr (IM).

Bảo quản

Store 15-30°C (59-86°F).

Phân loại MIMS

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