Vitafol Fe Plus
Generic: DOCONEXENT, NIACINAMIDE, .ALPHA.-TOCOPHEROL ACETATE, DL-, CHOLECALCIFEROL, BETA CAROTENE, ASCORBIC ACID, THIAMINE MONONITRATE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, IRON, ZINC OXIDE, CUPRIC OXIDE, POTASSIUM IODIDE, MAGNESIUM OXIDE, FOLIC A
Basic Information
Manufacturer
Exeltis USA, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
3927b074-d72a-4d8c-9f7e-15c42a830945
Indications & Usage
USAGE: Vitafol ® Fe + prenatal supplement provides vitamin, mineral and omega-3 fatty acid supplementation throughout pregnancy, including individuals with known allergies to fish.* Vitafol ® Fe + does not contain fish oils, fish proteins, or fish by-products.
Warnings
WARNINGS/PRECAUTIONS: This product is intended for use as directed by your healthcare provider.
Do not share with others.
Vitafol ® Fe + must be used with caution in patients with known sensitivity or allergy to soy.
Vitamin D supplementation should be used with caution in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones.
High doses of vitamin D can lead to elevated levels of calcium that reside in the blood and soft tissues.
Bone pain, high blood pressure, formation of kidney stones, renal failure, and increased risk of heart disease can occur.
Iodine should be used with caution in patients with an overactive thyroid.
Prolonged use of iron salts may produce iron storage disease.
Folic acid, especially in doses above 0.1 mg daily, may obscure pernicious anemia, in that hematologic remission may occur while neurological manifestations remain progressive.
The use of folic acid doses above 1 mg daily may precipitate or exacerbate the neurological damage of vitamin B12 deficiency.
Consumption of more than 3 grams of omega-3 fatty acids per day from all sources may lead to excessive bleeding.
Supplemental intake of omega-3 fatty acids such as DHA exceeding 2 grams per day is not recommended.
Avoid Overdosage.
Keep out of the reach of children.
DRUG INTERACTIONS Medications for an overactive thyroid (anti-thyroid drugs) used in conjunction with iodine supplementation may lead to hypothyroidism.
Medications for hypertension used in conjunction with iodine supplementation may increase potassium levels in blood.
High doses of folic acid may result in decreased serum levels of the anticonvulsant drugs; carbamazepine, fosphenytoin, phenytoin, phenobarbital, valproic acid.
Folic acid may decrease a patient's response to methotrexate.
Vitamin D supplementation should not be given with large amounts of calcium in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones.
Zinc can inhibit the absorption of certain antibiotics; take at least 2 hours apart to minimize interactions.
Consult appropriate references for additional specific vitamin-drug interactions INFORMATION FOR PATIENTS Patients should be counseled to disclose all medical conditions, including use of all medications, vitamins and supplements, pregnancy, and breast-feeding.
PEDIATRIC USE Not for pediatric use.
Do not share with others.
Vitafol ® Fe + must be used with caution in patients with known sensitivity or allergy to soy.
Vitamin D supplementation should be used with caution in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones.
High doses of vitamin D can lead to elevated levels of calcium that reside in the blood and soft tissues.
Bone pain, high blood pressure, formation of kidney stones, renal failure, and increased risk of heart disease can occur.
Iodine should be used with caution in patients with an overactive thyroid.
Prolonged use of iron salts may produce iron storage disease.
Folic acid, especially in doses above 0.1 mg daily, may obscure pernicious anemia, in that hematologic remission may occur while neurological manifestations remain progressive.
The use of folic acid doses above 1 mg daily may precipitate or exacerbate the neurological damage of vitamin B12 deficiency.
Consumption of more than 3 grams of omega-3 fatty acids per day from all sources may lead to excessive bleeding.
Supplemental intake of omega-3 fatty acids such as DHA exceeding 2 grams per day is not recommended.
Avoid Overdosage.
Keep out of the reach of children.
DRUG INTERACTIONS Medications for an overactive thyroid (anti-thyroid drugs) used in conjunction with iodine supplementation may lead to hypothyroidism.
Medications for hypertension used in conjunction with iodine supplementation may increase potassium levels in blood.
High doses of folic acid may result in decreased serum levels of the anticonvulsant drugs; carbamazepine, fosphenytoin, phenytoin, phenobarbital, valproic acid.
Folic acid may decrease a patient's response to methotrexate.
Vitamin D supplementation should not be given with large amounts of calcium in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones.
Zinc can inhibit the absorption of certain antibiotics; take at least 2 hours apart to minimize interactions.
Consult appropriate references for additional specific vitamin-drug interactions INFORMATION FOR PATIENTS Patients should be counseled to disclose all medical conditions, including use of all medications, vitamins and supplements, pregnancy, and breast-feeding.
PEDIATRIC USE Not for pediatric use.
Adverse Reactions
ADVERSE REACTIONS: Adverse reactions have been reported with specific vitamins and minerals, but generally at doses substantially higher than those in Vitafol ® Fe + .
However, allergic and idiosyncratic reactions are possible at any dose.
Reported adverse events include skin ailments, gastrointestinal complaints, glucose abnormalities, and visual problems.
You should call your doctor for medical advice about adverse or unexpected reactions.
To report to the company an adverse event or obtain product information, call 1-877-324-9349.
However, allergic and idiosyncratic reactions are possible at any dose.
Reported adverse events include skin ailments, gastrointestinal complaints, glucose abnormalities, and visual problems.
You should call your doctor for medical advice about adverse or unexpected reactions.
To report to the company an adverse event or obtain product information, call 1-877-324-9349.