Nephronex (vitamin B complex and vitamin C no.10/folic acid)
Folic Acid Oral Liquid (Ml)
Last reviewed · Source: First Databank (FDB) drug data
Overview
USES: This product is a combination of B vitamins used to treat or prevent vitamin deficiency due to poor diet, certain illnesses, alcoholism, or during pregnancy. Vitamins are important building blocks of the body and help keep you in good health. B vitamins include thiamine, riboflavin, niacin/niacinamide, vitamin B6, vitamin B12, folic acid, and pantothenic acid.
Some brands of B vitamins also contain ingredients such as vitamin C, vitamin E, biotin, or zinc. Consult your doctor or pharmacist if you have questions about the ingredients in your brand.
Generic name: vitamin B complex and vitamin C no.10/folic acid
Drug class: Folic Acid
Therapeutic class: Electrolyte Balance-Nutritional Products
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
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Indications
The following indications are listed for Nephronex:
- Vitamin Deficiency
- Vitamin Deficiency Prevention
Also known as: Vitamin Deficiency Prophylaxis.
Dosing
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No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
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There are no contraindication interactions for this drug.
Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
Folic Acid/Fluorouracil & Fluorouracil Prodrugs
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)
Moderate Interaction: Assess the risk to the patient and take action as needed.
Ascorbic Acid (Vitamin C)/Deferoxamine
SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.
MECHANISM OF ACTION: It is believed that ascorbic acid increases the iron available for chelation from an labile intracellular iron pool. Ascorbic acid may then facilitate iron-induced oxidative tissue damage.(1)
CLINICAL EFFECTS: Dietary ascorbic acid may increase the absorption of dietary iron. Supplemental ascorbic acid therapy given during chelation therapy may improve iron output;(1-9) however, excessive dosages may result in cardiac toxicity from iron-induced oxidative tissue damage.(1,2,11-13)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: Ascorbic acid intake is often restricted in patients with iron overload; however, it has been used in conjunction with deferoxamine to increase iron excretion.(2) Supplemental ascorbic acid therapy should only be initiated after one month of deferoxamine therapy. Ascorbic acid therapy should only be given in patients receiving deferoxamine regularly and the dose should be given after the infusion has started. The dosage of ascorbic acid should be limited to 50 mg daily in children under 10 years of age; 100 mg daily in older children; and 200 mg daily, in divided doses, in adults.(2) Cardiac function should be monitored in patients receiving concurrent therapy. Discontinue ascorbic acid therapy in patients who develop cardiac dysfunction.(2)
DISCUSSION: Supplemental ascorbic acid therapy given during chelation therapy has been shown to improve iron output,(1-9) possibly by increasing iron available for chelation from an labile intracellular iron pool.(1) However, dosages in excess of 500 mg daily have been associated with cardiac dysfunction.(1,2,11-13)
Folic Acid/Pafolacianine
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.
Folic Acid; Pyrimethamine/Hydantoins
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.
Pyridoxine/Levodopa
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.
Thiamine/Patiromer
SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.
MECHANISM OF ACTION: Patiromer may bind to thiamine.(1)
CLINICAL EFFECTS: Concurrent use may result in decreased gastrointestinal absorption and loss of efficacy of thiamine.(1)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The US manufacturer of patiromer recommends administering patiromer at least 3 hours before or 3 hours after thiamine.(1)
DISCUSSION: An in vitro binding study found potentially clinically significant binding of thiamine by patiromer. It is recommended to take these drugs 3 hours apart.(1)
Contraindications
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- Leber's hereditary optic atrophy
There are no severe contraindications for this drug.
- Atrophic gastritis
- Hypokalemia
Adverse reactions
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Rare or Very Rare
- Bronchospastic pulmonary disease
- Concentration difficulty
Rare or Very Rare
- Abdominal distension
- Acute cognitive impairment
- Anorexia
- Depression
- Dysgeusia
- Erythema
- Excitement
- Flatulence
- Irritability
- Malaise
- Nausea
- Pruritus of skin
- Skin rash
- Sleep disorder
Precautions
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ICD codes
| Code | Type | Description |
|---|---|---|
| Vitamin deficiency | ||
| E56.9 | ICD10CM | Vitamin deficiency, unspecified |
ICD code information from First Databank (FDB).
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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