DBL Calcium Folinate

DBL Calcium Folinate

calcium folinate

Manufacturer:

Pfizer

Distributor:

DKSH
Concise Prescribing Info
Contents
Ca folinate
Indications/Uses
Diminish toxicity & counteract effects of folic acid antagonist inadvertent overdosage; as rescue after high-dose MTX therapy. Megaloblastic anaemia due to sprue, nutritional deficiency, pregnancy & infancy when oral therapy is not possible. In combination w/ fluorouracil to prolong survival in palliative treatment of patients w/ advanced CRC.
Dosage/Direction for Use
Leucovorin Ca rescue in impaired MTX elimination or inadvertent overdosage 10 mg/m2 IV or IM every 6 hr until serum MTX level is <10-8 M. If 24-hr serum creatinine >50% or MTX level >5 x 10-6 M or 48-hr level >9 x 10-7 M, increase dose to 100 mg/m2 IV every 3 hr until MTX level <10-8 M. Leucovorin Ca rescue after high-dose MTX therapy 15 mg every 6 hr for 10 doses starting 24 hr after MTX infusion until MTX level <5 x 10-8 M. Megaloblastic anaemia due to folic acid deficiency Up to 1 mg daily. Advanced CRC 200 mg/m2 slow IV inj over min of 3 min, followed by 5-fluorouracil 370 mg/m2 IV inj or 20 mg/m2 IV inj followed by 5-fluorouracil 425 mg/m2 IV inj for 5 days. May be repeated at 4-wk (28 days) intervals for 2 courses & then repeated at 4-5 wk (28-35 days) intervals provided that patient has completely recovered.
Contraindications
Pernicious anaemia & other megaloblastic anaemias secondary to lack of vit B12.
Special Precautions
Not to be administered intrathecally. Not to be initiated or maintained in patients w/ GI toxicity symptoms. Not recommended in patients w/ recurrent neurological symptoms on rechallenge w/ folinic acid. Not to treat macrocytosis w/ folinic acid. Not suitable for pernicious anaemias & other anaemias resulting from lack of vit B12. Severe enterocolitis, diarrhoea & dehydration; CNS metastases; decreased membrane transport. Monitor Ca levels during treatment. Not to be mixed w/ fluorouracil in same IV inj or infusion. Avoid excessive folinic acid doses. Pre-existing or MTX-induced renal insufficiency. Not to be used during pregnancy. Lactation. Elderly or debilitated patients.
Adverse Reactions
Insomnia, agitation, depression after high doses; increased epileptic attacks frequency; abdominal pain; stomatitis, nausea, vomiting, diarrhoea.
Drug Interactions
Counteracted antiepileptic effect of phenobarb, phenytoin, primidone, succinimides. Reduced efficacy of intrathecally administered MTX. Enhanced toxicity of fluorouracil. Reduced or completely neutralized efficacy of folic acid antagonist eg, co-trimoxazole, pyrimethamine. Incompatibility w/ MTX, fluorouracil, droperidol, fosacarnet, phosphonosulphate inj.
MIMS Class
Antidotes & Detoxifying Agents
ATC Classification
V03AF03 - calcium folinate ; Belongs to the class of detoxifying agents used in antineoplastic treatment.
Presentation/Packing
Form
DBL Calcium Folinate inj 10 mg/mL
Packing/Price
30 mL x 1's
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