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Drug overview for CEREFOLIN (cyanocobalamin/levomefolate calcium/pyridoxine/riboflavin):
Generic name: CYANOCOBALAMIN/LEVOMEFOLATE CALCIUM/PYRIDOXINE/RIBOFLAVIN
Drug class: Folic Acid
Therapeutic class: Electrolyte Balance-Nutritional Products
Riboflavin is a water-soluble, B complex vitamin. Vitamin B6 (as pyridoxine, pyridoxal, and pyridoxamine) is a water-soluble, B complex vitamin.
No enhanced Uses information available for this drug.
Generic name: CYANOCOBALAMIN/LEVOMEFOLATE CALCIUM/PYRIDOXINE/RIBOFLAVIN
Drug class: Folic Acid
Therapeutic class: Electrolyte Balance-Nutritional Products
Riboflavin is a water-soluble, B complex vitamin. Vitamin B6 (as pyridoxine, pyridoxal, and pyridoxamine) is a water-soluble, B complex vitamin.
No enhanced Uses information available for this drug.
DRUG IMAGES
CEREFOLIN CAPLET
The following indications for CEREFOLIN (cyanocobalamin/levomefolate calcium/pyridoxine/riboflavin) have been approved by the FDA:
Indications:
Vitamin deficiency prevention
Vitamin deficiency
Professional Synonyms:
Vitamin deficiency prophylaxis
Indications:
Vitamin deficiency prevention
Vitamin deficiency
Professional Synonyms:
Vitamin deficiency prophylaxis
The following dosing information is available for CEREFOLIN (cyanocobalamin/levomefolate calcium/pyridoxine/riboflavin):
Although pyridoxine was previously considered nontoxic even at high 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.)
Riboflavin is usually administered orally. The drug may also be given by IM injection or IV infusion as a component of multivitamin injections. A parenteral formulation containing riboflavin alone is not currently commercially available.
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.
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.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| CEREFOLIN CAPLET | Maintenance | Adults take 1 tablet by oral route once daily |
No generic dosing information available.
The following drug interaction information is available for CEREFOLIN (cyanocobalamin/levomefolate calcium/pyridoxine/riboflavin):
There are 0 contraindications.
There are 1 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Fluorouracil & Fluorouracil Prodrugs/Folic Acid SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Folic acid has been shown to enhance both the therapeutic and toxic effects of fluoropyrimidines, such as 5-fluorouracil (5-FU) and fluorouracil prodrugs.(1-3) Fluorouracil prodrugs include capecitabine and tegafur. CLINICAL EFFECTS: Folic acid, when used concurrently with 5-FU or fluorouracil prodrugs, has been shown to increase side effects of 5-FU.(1-3) 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: Folic acid or folate analog-containing products should not be used concurrently with fluorouracil or fluorouracil prodrugs unless directed by the healthcare provider.(1-3) Fluorouracil prodrugs include capecitabine and tegafur. DISCUSSION: Due to increased toxic effects, stomatitis and diarrhea are observed more commonly, may be more severe, and may occur for a prolonged duration when compared to therapy with 5-FU alone. It is postulated that the lower standard dose of 5-FU in the US versus other regions may be due to increased folic acid supplementation within the US food supply.(2) In a cohort study in 290 patients, the use of dietary supplements with folic acid during treatment compared to nonuse increased the risk of capecitabine toxicities (HR 1.81, 95%CI: 1.15,2.85). The detection of folic acid in plasma also increased the risk of capecitabine toxicities (HR 2.09, 95%CI: 1.24,3.52 and HR 2.31, 95%CI: 1.29,4.13 at diagnosis and during treatment, respectively).(4) In a cohort study of 9 patients, patients taking folate-containing supplements and higher serum folate levels had an increased risk of grade >=2 toxicity. The risk of grade >=2 toxicity increased by 9% for every increase in serum folate level by 10 nmol/L. Patients with grade >=2 toxicity had higher serum folate levels than patients with grade <= 1 toxicity (28 nmol/L [range, 13.2-45.4] vs. 20 nmol/L [range, 12.8-45.4]; p=0.001).(5) In two case reports, patients developed capecitabine toxicity while taking supplements containing folic acid 400-500 mcg.(6) In a case report, a woman developed grade 4 diarrhea, grade 3 vomiting, and grade 3 hand-foot syndrome 8 days after the addition of capecitabine (2500 mg/m2/day) to high-dose folic acid supplementation. She developed necrotic colitis and died, despite the discontinuation of folic acid and capecitabine.(7) There are two other reports of excessive fluorouracil toxicity in patients treated with folic acid.(8) |
ADRUCIL, CAPECITABINE, FLUOROURACIL |
There are 3 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). Treatment with combination carbidopa-levodopa may contribute to reduced vitamin B6 levels. Higher doses of carbidopa-levodopa may increase the risk of vitamin B6 deficiency. Seizures associated with vitamin B6 deficiency have been reported in the postmarketing setting. In patients taking combination therapy with carbidopa/levodopa, evaluate vitamin B6 levels periodically while on treatment or if symptoms associated with vitamin B6 deficiency are identified. Supplement with vitamin B6 as necessary. 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 |
| 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 CEREFOLIN (cyanocobalamin/levomefolate calcium/pyridoxine/riboflavin):
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 3 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 |
| No disease contraindications |
The following adverse reaction information is available for CEREFOLIN (cyanocobalamin/levomefolate calcium/pyridoxine/riboflavin):
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 2 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Bronchospastic pulmonary disease Concentration difficulty |
There are 16 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Diarrhea Pruritus of skin |
| Rare/Very Rare |
|---|
|
Abdominal distension Acute cognitive impairment Anorexia Depression Dysgeusia Erythema Excitement Flatulence Irritability Malaise Nausea Pruritus of skin Skin rash Sleep disorder |
The following precautions are available for CEREFOLIN (cyanocobalamin/levomefolate calcium/pyridoxine/riboflavin):
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 |
No enhanced Pregnancy information available for this drug.
No enhanced Lactation information available for this drug.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for CEREFOLIN (cyanocobalamin/levomefolate calcium/pyridoxine/riboflavin):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for CEREFOLIN (cyanocobalamin/levomefolate calcium/pyridoxine/riboflavin)'s list of indications:
| Vitamin deficiency | |
| E56.9 | Vitamin deficiency, unspecified |
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