Prescribing information (package insert) - Folinex
FACTS
Folinex™ is an orally administered prescription folate
product for the dietary management of patients with
unique nutritional needs requiring increased folate
levels and other nutritional supplementation.
Folinex™ should be administered under the supervision
of a licensed medical practitioner.
Folinex™ is used for dietary management of patients
with unique nutritional needs requiring increased
folate levels, or are in need of other nutritional
supplementation. Folinex™ can be taken by women
of childbearing age, pregnant women, and lactating
and nonlactating mothers under the supervision of a
licensed medical practitioner.
PRECAUTIONS
Tell your doctor if you have: kidney problems or thyroid
disease. This medication should be used as directed
during pregnancy or while breast-feeding. Consult
your doctor about the risks and benefits. Folic acid alone is
improper therapy in the treatment of pernicious anemia
and other megaloblastic anemias where vitamin B12 is
deficient. Folic acid in doses above 0.1 mg daily may
obscure pernicious anemia in that hematologic remission
can occur while neurological manifestations progress.
WARNINGS
Allergic sensitization has been reported following both
oral and parenteral administration of folic acid. You
should call your doctor for medical advice about serious
adverse events.
DOSAGE AND ADMINISTRATION
Usual adult dose is one (1) tablet once or twice daily or as
prescribed by a licensed medical practitioner.*
If you are pregnant or nursing, ask a
healthcare professional.
KEEP OUT OF THE REACH OF CHILDREN.
Store at 20°-25°C (68°-77°F); excursions permitted
to 15°-30°C (59°-86°F) [See USP Controlled Room
Temperature.] Protect from heat, light and moisture.
Do not use if seal is broken or missing.
Folinex™ capsules are supplied as a solid, opaque,
white, oblong capsule with “916” printed on one
side, dispensed in child-resistant bottles of 30ct
(72380-916-30*).
* This product is a prescription-folate with or without other dietary
ingredients that – due to increased folate levels (AUG 2 1973 FR
20750), requires an Rx on the label because of increased risk
associated with masking of B12 deficiency (pernicious anemia). Based
on our assessment of the risk of obscuring pernicious anemia, this
product requires licensed medical supervision, an Rx status, and a
National Drug Code (NDC) – or similarly-formatted product code, as
required by pedigree reporting requirements and supply-chain control
as well as – in some cases, for insurance-reimbursement applications.