Suggested Use:

INDICATIONS AND USAGE:
L-Methyl-MC is indicated for the distinct nutritional requirements of patients in need of dietary supplementation as determined by a licensed medical practitioner.
L-Methyl-MC should be administered under the supervision of a licensed medical practitioner.

Warnings:

WARNINGS: Caution is recommended in patients with a history of bipolar illness.

DRUG INTERACTIONS: Drugs which may interact with folate include:
- Antiepileptic drugs (AED): The AED class including, but not limited to, phenytoin, carbamazepine, primidone, valproic acid, fosphenytoin, valproate, phenobarbital and lamotrigine have been shown to impair folate absorption and increase the metabolism of circulating folate.
- Additionally, concurrent use of folic acid has been associated with enhanced phenytoin metabolism, lowering the level of the AED in the blood and allowing breakthrough seizures to occur. Caution should be used when prescribing this product among patients who are receiving treatment with phenytoin and other anticonvulsants.
- Capecitabine: Folinic acid (5-formyltetrahydrofolate) may increase the toxicity of Capecitabine.
- Cholestyramine: Reduces folic acid absorption and reduces serum folate levels.
- Colestipol: Reduces folic acid absorption and reduces serum folate levels.
- Cycloserine: Reduces folic acid absorption and reduces serum folate levels.
- Dihydrofolate Reductase Inhibitors (DHFRI): DHFRIs block the conversion of folic acid to its active forms, and lower plasma and red blood cell folate levels. DHFRIs include aminopterin, methotrexate, pyrimethamine, triamterene, and trimethoprim.
- Fluoxetine: Fluoxetine exerts a noncompetitive inhibition of the 5-methyltetrahydrofolate active transport in the intestine.
- Isotretinoin: Reduced folate levels have occurred in some patients taking isotretinoin.
- L-dopa, triamterene, colchicine, and trimethoprim may decrease plasma folate levels.
- Nonsteroidal Anti-inflammatory Drugs (NSAIDs): NSAIDs have been shown to inhibit some folate dependent enzymes in laboratory experiments. NSAIDs include ibuprofen, naproxen, indomethacin and sulindac.
- Oral Contraceptives: Serum folate levels may be depressed by oral contraceptive therapy.
- Methylprednisolone: Reduced serum folate levels have been noted after treatment with methylprednisolone.
- Pancreatic Enzymes: Reduced serum folate levels have occurred in some patients taking pancreatic extracts, such a pancreatin and pancrelipase.
- Pentamidine: Reduced folate levels have been seen with prolonged intravenous pentamidine. • Pyrimethamine: High levels of folic acid may result in decreased serum levels of pyrimethamine.

Call your medical practitioner about side effects.

KEEP THIS OUT OF THE REACH OF CHILDREN.

PRECAUTIONS: General: Folate, when administered as a single agent in doses about 0.1 mg daily, may obscure the detection of vitamin B12 deficiency (specifically, the administration of folic acid may reverse the hematological manifestations of B12 deficiency, including pernicious anemia, while not addressing the neurological manifestations). Folate therapy alone is inadequate for treatment of a vitamin B12 deficiency.

ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parental administration of folic acid, and may possibly occur with other forms of folate.

CONTRAINDICATIONS: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

- Smoking and Alcohol: Reduced serum folate levels have been noted.

PREGNANCY and NURSING MOTHERS
L-Methyl-MC is not intended for use as a prenatal/postnatal multivitamin for lactating and non-lactating mothers. This product contains B vitamins. Talk with your medical practitioner before using L-Methyl-MC if pregnant or lactating.

Paresthesia, somnolence, nausea, and headaches have been reported with vitamin B6.
Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body have been associated with vitamin B12.
If headaches occur with the use of this product, consult your medical practitioner.

- Sulfasalazine: Inhibits the absorption and metabolism of folic acid.
- Metformin treatment in patients with type 2 diabetes decreases serum folate.
- Warfarin can produce significant impairment in folate status after a 6-month therapy.
- Folinic acid may enhance the toxicity of fluorouracil.
- Concurrent administration of chloramphenicol and folinic acid in folate-deficient patients may result in antagonism of the haematopoietic response to folate.
- Caution should be exercised with the concomitant use of folinic acid and trimethoprim-sulfamethoxazole for the acute treatment of Pneumocystis carinii pneumonia in patients with HIV infection as it is associated with increased rates of treatment failure and mortality in a placebo controlled study.
Drugs which interact with vitamin B6:
- Vitamin B6 should not be given to patients receiving the drug levodopa because the action of levodopa is antagonized by vitamin B6. However, vitamin B6 may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa.
Drugs which may interact with vitamin B12:
• Antibiotics, cholestyramine, colchicines, colestipol, metformin, para-aminosalicylic, and potassium chloride may decrease the absorption of vitamin B12.
• Nitrous oxide can produce a functional vitamin B12 deficiency.

L-Methyl-MC should be administered under the supervision of a licensed medical practitioner.

L-Methyl-MC is not recommended for use in children under the age of twelve.

If you are pregnant or nursing a baby, please ask a health professional.

KEEP THIS OUT OF REACH OF CHILDREN.

All prescriptions using this product shall be pursuant to state statues as applicable. This is not an Orange Book product.

Storage:

STORAGE: Store at Controlled Room Temperature 15(0)-30(0)C (59(0)-86(0)F). [See USP]. Protect from light and moisture. Dispense in a tight, light-resistant container.