Folbee

Drug overview for FOLBEE (cyanocobalamin/folic acid/pyridoxine):

Generic name: CYANOCOBALAMIN/FOLIC ACID/PYRIDOXINE (vitamin B12/FOH-lick/vitamin B6)
Drug class: Folic Acid
Therapeutic class: Electrolyte Balance-Nutritional Products

Folic acid is a water-soluble, B complex vitamin. 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. of vitamin B12. Hydroxocobalamin (Cyanokit(R)) is an antidote for cyanide poisoning.

Folic acid is used for the treatment of megaloblastic and macrocytic anemias resulting from folate deficiency. The drug is usually indicated in the treatment of nutritional macrocytic anemia; megaloblastic anemias of pregnancy, infancy, and childhood; and megaloblastic anemia associated with primary liver disease, alcoholism and alcoholic cirrhosis, intestinal strictures, anastomoses, or sprue. Folate deficiency may also result from increased loss of folate secondary to renal dialysis or the administration of some drugs such as phenytoin, primidone, barbiturates, methotrexate, nitrofurantoin, or sulfasalazine.

Folic acid is not effective in the treatment of normocytic, refractory, or aplastic anemias or, when used alone, in the treatment of pernicious anemia. Folic acid antagonists (e.g., methotrexate, pyrimethamine, trimethoprim) inhibit folic acid reductases and prevent the formation of tetrahydrofolic acid. Therefore, folic acid is not effective as an antidote following overdosage of these drugs, and leucovorin calcium must be used.

In large doses, folic acid is used in the treatment of tropical sprue. In patients with this disease, the drug appears to exert a beneficial effect on the underlying mucosal abnormality as well as to correct folate deficiency. Although prophylactic administration of folic acid is not required in most individuals, supplemental folic acid may be required to prevent deficiency of the vitamin in patients with conditions that increase folic acid requirements such as pregnancy, nursing, or chronic hemolytic anemia.

In some patients, such as those with nutritional megaloblastic anemia associated with vitamin B12 deficiency or tropical or nontropical sprue, a simultaneous deficiency of folic acid and cyanocobalamin may exist, and combined therapy may be warranted. Likewise, combined folic acid and iron therapy may be indicated for prevention or treatment of megaloblastic anemia associated with iron deficiency as may occur in conditions such as sprue, megaloblastic anemia of pregnancy, and megaloblastic anemia of infants.

DRUG IMAGES

FOLBEE TABLET

The following indications for FOLBEE (cyanocobalamin/folic acid/pyridoxine) have been approved by the FDA:

Indications:
Vitamin deficiency prevention
Vitamin deficiency

Professional Synonyms:
Vitamin deficiency prophylaxis

The following dosing information is available for FOLBEE (cyanocobalamin/folic acid/pyridoxine):

Dosing
Administration
FOLBEE
Generic

Dosage of folic acid injection (sodium folate) is expressed in terms of folic acid. In general, although patient response to folic acid therapy depends on the degree and nature of the deficiency, once proper corrective measures are undertaken, folate-deficient patients generally respond rapidly. During the first 24 hours of treatment, the patient experiences an improved sense of well-being, and within 48 hours, the bone marrow begins to become normoblastic.

Reticulocytosis generally begins within 2-5 days following initiation of folic acid therapy.

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.)

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.

Folic acid is usually administered orally. When oral administration is not feasible or when malabsorption is suspected, the drug may be administered by deep IM, subcutaneous, or IV injection. However, most patients with malabsorption are able to absorb oral folic acid.

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.

Dosing information for FOLBEE
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
FOLBEE TABLET	Maintenance	Adults take 1 tablet by oral route once daily

No generic dosing information available.

The following drug interaction information is available for FOLBEE (cyanocobalamin/folic acid/pyridoxine):

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

The following adverse reaction information is available for FOLBEE (cyanocobalamin/folic acid/pyridoxine):

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 FOLBEE (cyanocobalamin/folic acid/pyridoxine):

Pediatric
Pregnant
Lactation
Geriatric

No enhanced Pediatric Use information available for this drug.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

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.

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.

No enhanced Geriatric Use information available for this drug.