Cerefolin

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.

Numerous multivitamin preparations are marketed, with little standardization of formulas. Useful multivitamin preparations should contain only essential vitamins (those for which there is a recommended daily dietary allowance (RDA)). (See Dosage and Administration.) Preparations containing iron and/or calcium supplements may be useful in some patients (e.g., pregnant or lactating women) but other essential minerals are usually obtained from the diet.

The addition of agents such as liver, yeast, and wheat germ to vitamin preparations offers no advantage over pure chemical ingredients, and inclusion of nonessential agents such as choline, bioflavonoids, inositol, betaine, lecithin, and methionine is unwarranted. Combinations of vitamins and other drugs such as hormones are irrational and should not be used.

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

The following dosing information is available for CEREFOLIN (cyanocobalamin/levomefolate calcium/pyridoxine/riboflavin):

Dosing
Administration
CEREFOLIN
Generic

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.)

Vitamins are usually administered orally; however, the drugs may be given parenterally in patients in whom oral administration is not feasible, including those receiving total parenteral nutrition. For IV administration, vitamins should be diluted according to the manufacturers' recommendations. Multivitamin injections are reportedly incompatible with IV solutions containing various drugs.

Published data are too varied and/or limited to permit generalizations, and specialized references should be consulted for specific compatibility information. 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.

Dosing information for CEREFOLIN
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):

Contraindicated
Severe
Moderate

There are 0 contraindications.

There are 0 severe interactions.

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). 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

Contraindication List
Leber's hereditary optic atrophy

Moderate List
Atrophic gastritis
Hypokalemia
No disease contraindications

The following adverse reaction information is available for CEREFOLIN (cyanocobalamin/levomefolate calcium/pyridoxine/riboflavin):

Overview
Severe
Less Severe

Adverse reaction overview.

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):

Pediatric
Pregnant
Lactation
Geriatric

No enhanced Pediatric Use information available for this drug.

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.

Vitamin deficiency
E56.9	Vitamin deficiency, unspecified