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Drug overview for FOLINIC-PLUS (leucovorin calcium/pyridoxal phosphate/mecobalamin):
Generic name: LEUCOVORIN CALCIUM/PYRIDOXAL PHOSPHATE/MECOBALAMIN
Drug class: Folic Acid
Therapeutic class: Electrolyte Balance-Nutritional Products
Leucovorin calcium is the calcium salt of folinic acid, an active Vitamin B12, a cobalt-containing B complex vitamin, is commercially Vitamin B6 (as pyridoxine, pyridoxal, and pyridoxamine) is a water-soluble, available as cyanocobalamin and hydroxocobalamin, which are synthetic forms B complex vitamin. metabolite of folic acid. of vitamin B12. Hydroxocobalamin (Cyanokit(R)) is an antidote for cyanide poisoning.
No enhanced Uses information available for this drug.
Generic name: LEUCOVORIN CALCIUM/PYRIDOXAL PHOSPHATE/MECOBALAMIN
Drug class: Folic Acid
Therapeutic class: Electrolyte Balance-Nutritional Products
Leucovorin calcium is the calcium salt of folinic acid, an active Vitamin B12, a cobalt-containing B complex vitamin, is commercially Vitamin B6 (as pyridoxine, pyridoxal, and pyridoxamine) is a water-soluble, available as cyanocobalamin and hydroxocobalamin, which are synthetic forms B complex vitamin. metabolite of folic acid. of vitamin B12. Hydroxocobalamin (Cyanokit(R)) is an antidote for cyanide poisoning.
No enhanced Uses information available for this drug.
DRUG IMAGES
FOLINIC-PLUS CAPLET
The following indications for FOLINIC-PLUS (leucovorin calcium/pyridoxal phosphate/mecobalamin) have been approved by the FDA:
Indications:
None.
Professional Synonyms:
None.
Indications:
None.
Professional Synonyms:
None.
The following dosing information is available for FOLINIC-PLUS (leucovorin calcium/pyridoxal phosphate/mecobalamin):
Although pyridoxine was previously considered nontoxic even at high Dosage of leucovorin calcium is expressed in terms of leucovorin.
dosages, current evidence indicates that chronic administration of large dosages (e.g., 2 g daily) for the management of various conditions can cause severe adverse neurologic effects, and the risk to benefit of such dosages must be carefully weighed. (See Chronic Toxicity.)
For the treatment of pernicious anemia, the usual initial IM or subcutaneous dosage of cyanocobalamin is 100 mcg daily for 6-7 days. If clinical manifestations have improved and a reticulocyte response is observed, cyanocobalamin can then be administered in a dosage of 100 mcg every other day for 7 doses and then 100 mcg every 3-4 days for 2-3 weeks. Once hematologic values have returned to normal, cyanocobalamin can be administered IM or subcutaneously in a dosage of 100 mcg once monthly for life.
Folic acid should be used concomitantly if necessary.
For the treatment of vitamin B12 deficiency in adults, the usual IM dosage of hydroxocobalamin is 30 mcg daily for 5-10 days. Once clinical symptoms have subsided and the blood components have returned to normal, monthly IM maintenance doses of 100-200 mcg appear to be sufficient to maintain a normoblastic bone marrow. For the treatment of vitamin B12 deficiency in children, the usual total IM dose of hydroxocobalamin is 1-5 mcg over 2 or more weeks, given in single doses of 100 mcg.
For maintenance, the IM or subcutaneous pediatric dosage is at least 60 mcg per month; however, smaller doses may often suffice for deficiency states not caused by pernicious anemia.
The commercially available cyanocobalamin metered-dose pump delivers 0.1 mL of solution containing 500 mcg of the drug per actuation. The recommended initial dosage of cyanocobalamin nasal spray is 500 mcg (one actuation) administered intranasally once weekly.
The dosage may need to be increased in patients who experience a decline in serum vitamin B12 concentrations after 1 month of therapy with this preparation. Therapy with a parenteral vitamin B12 preparation may be necessary in patients who do not achieve a satisfactory response to intranasal cyanocobalamin.
dosages, current evidence indicates that chronic administration of large dosages (e.g., 2 g daily) for the management of various conditions can cause severe adverse neurologic effects, and the risk to benefit of such dosages must be carefully weighed. (See Chronic Toxicity.)
For the treatment of pernicious anemia, the usual initial IM or subcutaneous dosage of cyanocobalamin is 100 mcg daily for 6-7 days. If clinical manifestations have improved and a reticulocyte response is observed, cyanocobalamin can then be administered in a dosage of 100 mcg every other day for 7 doses and then 100 mcg every 3-4 days for 2-3 weeks. Once hematologic values have returned to normal, cyanocobalamin can be administered IM or subcutaneously in a dosage of 100 mcg once monthly for life.
Folic acid should be used concomitantly if necessary.
For the treatment of vitamin B12 deficiency in adults, the usual IM dosage of hydroxocobalamin is 30 mcg daily for 5-10 days. Once clinical symptoms have subsided and the blood components have returned to normal, monthly IM maintenance doses of 100-200 mcg appear to be sufficient to maintain a normoblastic bone marrow. For the treatment of vitamin B12 deficiency in children, the usual total IM dose of hydroxocobalamin is 1-5 mcg over 2 or more weeks, given in single doses of 100 mcg.
For maintenance, the IM or subcutaneous pediatric dosage is at least 60 mcg per month; however, smaller doses may often suffice for deficiency states not caused by pernicious anemia.
The commercially available cyanocobalamin metered-dose pump delivers 0.1 mL of solution containing 500 mcg of the drug per actuation. The recommended initial dosage of cyanocobalamin nasal spray is 500 mcg (one actuation) administered intranasally once weekly.
The dosage may need to be increased in patients who experience a decline in serum vitamin B12 concentrations after 1 month of therapy with this preparation. Therapy with a parenteral vitamin B12 preparation may be necessary in patients who do not achieve a satisfactory response to intranasal cyanocobalamin.
Cyanocobalamin is administered by IM or deep subcutaneous injection. Cyanocobalamin also is administered orally and intranasally. Hydroxocobalamin is administered by IM injection or IV infusion.
Oral therapy with vitamin B12 preparations is markedly inferior to parenteral therapy and should be used only for the treatment of dietary vitamin B12 deficiency in patients with normal GI absorption. Pyridoxine hydrochloride is usually administered orally; however, the drug may be given by IM, IV, or subcutaneous injection when oral administration is not feasible. In infants with seizures, pyridoxine hydrochloride should be administered by IM or IV injection.
Oral therapy with vitamin B12 preparations is markedly inferior to parenteral therapy and should be used only for the treatment of dietary vitamin B12 deficiency in patients with normal GI absorption. Pyridoxine hydrochloride is usually administered orally; however, the drug may be given by IM, IV, or subcutaneous injection when oral administration is not feasible. In infants with seizures, pyridoxine hydrochloride should be administered by IM or IV injection.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for FOLINIC-PLUS (leucovorin calcium/pyridoxal phosphate/mecobalamin):
There are 0 contraindications.
There are 0 severe interactions.
There are 5 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Hydantoins/Folic Acid; Pyrimethamine SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Unknown, but probably involves altered metabolism of the hydantoin. CLINICAL EFFECTS: May observe decreased effectiveness of hydantoin, resulting in loss of seizure control. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: If both drugs are administered, monitor both the hydantoin plasma levels as well as the seizure control of the patient. Adjust the dose of hydantoin accordingly. DISCUSSION: The effects of an interaction are not expected to occur in the majority of patients. Discontinuation of folic acid has caused phenytoin levels to increase in patients who experienced a decrease in phenytoin levels when folic acid was started. Monitor these patients for hydantoin toxicity. Signs and symptoms of hydantoin toxicity include ataxia, nystagmus and involuntary movements. |
CEREBYX, DILANTIN, DILANTIN-125, FOSPHENYTOIN SODIUM, PHENYTEK, PHENYTOIN, PHENYTOIN SODIUM, PHENYTOIN SODIUM EXTENDED |
| Levodopa/Pyridoxine SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Pyridoxine increases levodopa metabolism, decreasing the amount of levodopa available to the central nervous system. CLINICAL EFFECTS: The pharmacologic effects of levodopa may be decreased. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Avoid pyridoxine in patients receiving levodopa alone; however, the interaction can be minimized by giving levodopa with a peripheral decarboxylase inhibitor (e.g. carbidopa, benserazide). DISCUSSION: In patients with Parkinson's disease, as little as 10 mg of pyridoxine may reverse the clinical benefits as well as the adverse effects of levodopa. Coadministration of levodopa with either carbidopa or benserazide has minimized the effects of this interaction. |
INBRIJA, LEVODOPA |
| Trimethoprim-Sulfamethoxazole/Leucovorin SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Leucovorin may protect Pneumocystis jirovecii from the effects of trimethoprim-sulfamethoxazole by providing a source of folate.(1,2) CLINICAL EFFECTS: Concurrent use of leucovorin in patients undergoing prophylaxis against or being treated for Pneumocystis jiroveci pneumonia (formerly called Pneumocystic carinii) with trimethoprim-sulfamethoxazole has been associated with treatment failure and increased mortality.(1-4) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The concurrent use of leucovorin and trimethoprim-sulfamethoxazole should be avoided in patients undergoing prophylaxis against or being treated for Pneumocystis jiroveci (formerly carinii) pneumonia.(1-4) Leucovorin is an effective treatment for trimethoprim-sulfamethoxazole induced bone marrow suppression.(3) DISCUSSION: In a prospective, double-blind study in 92 AIDS patients with Pneumocystis jiroveci (formerly carinii) pneumonia, concurrent use of leucovorin with trimethoprim-sulfamethoxazole resulted in an increase in treatment failure (15% versus 0) and death (11% versus 0). Leucovorin was also associated with a shorter time to therapeutic failure. Patients receiving leucovorin did have a lower incidence of neutropenia; however, there was no difference in the time to occurrence of neutropenia.(4) In a study in 12 AIDS/ARC patients, leucovorin had no effect on trimethoprim-sulfamethoxazole induced cytopenia.(5) In a study in HIV patients with no history of Pneumocystis jiroveci pneumonia, administration of leucovorin had no effect on patient tolerance to trimethoprim-sulfamethoxazole.(6) In a case report, two renal transplant patients with Pneumocystis jiroveci pneumonia failed to respond to treatment with trimethoprim-sulfamethoxazole until concurrent leucovorin was discontinued.(1) In a case report, an AIDS patient developed Pneumocystis jiroveci pneumonia despite a regimen of concurrent trimethoprim-sulfamethoxazole and leucovorin.(2) |
BACTRIM, BACTRIM DS, SULFAMETHOXAZOLE-TRIMETHOPRIM, SULFATRIM |
| 5-Fluorouracil/Leucovorin SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Leucovorin has been shown to enhance both the therapeutic and toxic effects of fluoropyrimidines, such as 5-fluorouracil(5-FU).(1) CLINICAL EFFECTS: Leucovorin, when used concurrently with 5-FU, has been shown to increase side effects of 5-FU.(1) PREDISPOSING FACTORS: Patients who are intermediate or poor dihydropyrimidine dehydrogenase (DPYD) metabolizers have diminished or no DPYD function. Since DPYD is the rate-limiting enzyme involved in fluoropyrimidine metabolism, these patients may be more susceptible to the effects of this interaction.(3) PATIENT MANAGEMENT: When leucovorin is added to 5-FU therapy, the dose of 5-FU must be reduced from that of the normally administered dose. Patients should be closely monitored for appearance and severity of side effects to determine whether it is appropriate to alter the dose of 5-FU.(1) DISCUSSION: A retrospective study reviewed all patients over the age of 18 years treated with combination fluorouracil and leucovorin either as adjuvant or palliative treatment. A total of 122 patients (60% male) were included in the study. Ninety-four patients received fluorouracil (425 mg/m2, IV) and leucovorin (20 mg/m2, IV) daily for five days and repeated every four weeks. Twenty-eight patients received fluorouracil (400 mg/m2, IV) and leucovorin (80 mg/m2, IV) once per week for six weeks of an eight week course. All patients were treated for up to six months. Forty-eight patients (39%) experienced toxicity including fatigue (21%), mucositis (17%), diarrhea (11%), and nausea (11%).(2) A study involving 35 patients evaluated a combination of cisplatin (20 mg/m2) on Day 1 through Day 3, leucovorin (200 mg/m2) on Day 1 through Day 5, and 5-fluorouracil (500 mg/m2) on Day 1 through Day 5. If patients tolerated the low dose of 5-fluorouracil, the dose was increased to a maximum of 750 mg/m2/day during the remaining courses. Grade I mucositis occurred in three patients, Grade II in 16 patients, and Grade III in 13 patients. The dose of 5-fluorouracil was decreased in patients with Grade II and Grade III mucositis, which helped to decrease symptoms.(3) A randomized trial in advanced colorectal carcinoma patients compared fluorouracil (500 mg/m2 on Days 1-5) every four weeks with escalation as tolerated with high-dose leucovorin (500mg/m2) with fluorouracil (600 mg/m2) given weekly for six weeks with a two-week rest period and with low-dose leucovorin (25 mg/m2) with fluorouracil (600 mg/m2) given weekly for six weeks with a two-week rest period. Severe or worse diarrhea was reported in 25% and 13% of patients receiving high-dose leucovorin and low-dose leucovorin with fluorouracil, respectively. Nine elderly patients experienced fatal toxicity during the initial treatment cycle with combination therapy.(4) A study in five patients with metastatic colorectal carcinoma examined the effects of high dose leucovorin (500 mg/m2) on fluorouracil pharmacokinetics. Subjects received a single dose of fluorouracil (600 mg/m2) with leucovorin and, one week later, without leucovorin. With concurrent leucovorin, the time of distribution of fluorouracil increased 44% (p<0.0005) and fluorouracil volume of distribution increased 84% (p<0.03). There were no changes in fluorouracil plasma clearance or AUC. Although fluorouracil anabolite levels were lower at two minutes and five minutes post-dose when administered following leucovorin, levels were similar thereafter.(5) |
ADRUCIL, CAPECITABINE, FLUOROURACIL, XELODA |
| Pafolacianine/Folic Acid SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Folate, folic acid, and folate-containing supplements may reduce binding of pafolacianine to folate receptors expressed on ovarian cancer cells. CLINICAL EFFECTS: Folate, folic acid, and folate-containing supplements could reduce the detection of malignant lesions with pafolacianine. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Avoid administration of folate, folic acid, or folate-containing supplements within 48 hours before administration of pafolacianine. DISCUSSION: Folate, folic acid, and folate-containing supplements may reduce binding of pafolacianine to folate receptors expressed on cancer cells, which could result in reduced detection of malignant lesions with pafolacianine. |
CYTALUX |
The following contraindication information is available for FOLINIC-PLUS (leucovorin calcium/pyridoxal phosphate/mecobalamin):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Leber's hereditary optic atrophy |
There are 0 severe contraindications.
There are 2 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Atrophic gastritis |
| Hypokalemia |
The following adverse reaction information is available for FOLINIC-PLUS (leucovorin calcium/pyridoxal phosphate/mecobalamin):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 0 severe adverse reactions.
There are 2 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Diarrhea Pruritus of skin |
| Rare/Very Rare |
|---|
| None. |
The following precautions are available for FOLINIC-PLUS (leucovorin calcium/pyridoxal phosphate/mecobalamin):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Animal reproduction studies have not been performed with leucovorin. It is also not known whether leucovorin can cause fetal harm when administered to pregnant women. Leucovorin should be used during pregnancy only when clearly needed.
Adequate and well-controlled studies have not been conducted in pregnant women. However, vitamin B12 requirements are increased in pregnant women. Parenteral preparations should be used during pregnancy only when the potential benefits justify the potential risks to the fetus.
Adequate and well-controlled studies have not been conducted in pregnant women. However, vitamin B12 requirements are increased in pregnant women. Parenteral preparations should be used during pregnancy only when the potential benefits justify the potential risks to the fetus.
Since it is not known if leucovorin is distributed into milk, the drug should be used with caution in nursing women. Vitamin B12 is distributed into human milk. Vitamin B12 requirements are increased in lactating women.
Hydroxocobalamin may be administered to lactating women with suspected or known cyanocobalamin poisoning. There is no data available to determine when breastfeeding may be restarted following administration of IV hydroxocobalamin.
Hydroxocobalamin may be administered to lactating women with suspected or known cyanocobalamin poisoning. There is no data available to determine when breastfeeding may be restarted following administration of IV hydroxocobalamin.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for FOLINIC-PLUS (leucovorin calcium/pyridoxal phosphate/mecobalamin):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for FOLINIC-PLUS (leucovorin calcium/pyridoxal phosphate/mecobalamin)'s list of indications:
No ICD codes found for this drug.
No ICD codes found for this drug.
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