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Drug overview for VITALETS (multivitamins with iron):
Generic name: MULTIVITAMINS WITH IRON
Drug class: Iron
Therapeutic class: Electrolyte Balance-Nutritional Products
Ferrous fumarate, ferrous gluconate, ferrous sulfate, carbonyl iron, and polysaccharide-iron complex are iron preparations that are commercially available in the US for oral administration in the prevention and treatment of iron deficiency.
Numerous multivitamin preparations are marketed, with little standardization of formulas. Useful multivitamin preparations should contain only essential vitamins (those for which there is a recommended daily dietary allowance (RDA)). (See Dosage and Administration.) Preparations containing iron and/or calcium supplements may be useful in some patients (e.g., pregnant or lactating women) but other essential minerals are usually obtained from the diet.
The addition of agents such as liver, yeast, and wheat germ to vitamin preparations offers no advantage over pure chemical ingredients, and inclusion of nonessential agents such as choline, bioflavonoids, inositol, betaine, lecithin, and methionine is unwarranted. Combinations of vitamins and other drugs such as hormones are irrational and should not be used.
Generic name: MULTIVITAMINS WITH IRON
Drug class: Iron
Therapeutic class: Electrolyte Balance-Nutritional Products
Ferrous fumarate, ferrous gluconate, ferrous sulfate, carbonyl iron, and polysaccharide-iron complex are iron preparations that are commercially available in the US for oral administration in the prevention and treatment of iron deficiency.
Numerous multivitamin preparations are marketed, with little standardization of formulas. Useful multivitamin preparations should contain only essential vitamins (those for which there is a recommended daily dietary allowance (RDA)). (See Dosage and Administration.) Preparations containing iron and/or calcium supplements may be useful in some patients (e.g., pregnant or lactating women) but other essential minerals are usually obtained from the diet.
The addition of agents such as liver, yeast, and wheat germ to vitamin preparations offers no advantage over pure chemical ingredients, and inclusion of nonessential agents such as choline, bioflavonoids, inositol, betaine, lecithin, and methionine is unwarranted. Combinations of vitamins and other drugs such as hormones are irrational and should not be used.
DRUG IMAGES
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The following indications for VITALETS (multivitamins with iron) have been approved by the FDA:
Indications:
Mineral deficiency prevention
Mineral deficiency
Vitamin deficiency prevention
Vitamin deficiency
Professional Synonyms:
Vitamin deficiency prophylaxis
Indications:
Mineral deficiency prevention
Mineral deficiency
Vitamin deficiency prevention
Vitamin deficiency
Professional Synonyms:
Vitamin deficiency prophylaxis
The following dosing information is available for VITALETS (multivitamins with iron):
Dosage of oral iron preparations should be expressed in terms of elemental iron. The elemental iron content of the various preparations is approximately:
Table 1.
Drug Elemental Iron ferric pyrophosphate 120 mg/g ferrous gluconate 120 mg/g ferrous sulfate 200 mg/g ferrous sulfate, dried 300 mg/g ferrous fumarate 330 mg/g ferrous carbonate, anhydrous 480 mg/g carbonyl iron 1000 mg/g
carbonyl iron is elemental iron, not an iron salt.
Table 1.
Drug Elemental Iron ferric pyrophosphate 120 mg/g ferrous gluconate 120 mg/g ferrous sulfate 200 mg/g ferrous sulfate, dried 300 mg/g ferrous fumarate 330 mg/g ferrous carbonate, anhydrous 480 mg/g carbonyl iron 1000 mg/g
carbonyl iron is elemental iron, not an iron salt.
Vitamins are usually administered orally; however, the drugs may be given parenterally in patients in whom oral administration is not feasible, including those receiving total parenteral nutrition. For IV administration, vitamins should be diluted according to the manufacturers' recommendations. Multivitamin injections are reportedly incompatible with IV solutions containing various drugs.
Published data are too varied and/or limited to permit generalizations, and specialized references should be consulted for specific compatibility information. Oral iron preparations generally should be taken between meals (e.g., 1 hour before or 2 hours after a meal) for maximum absorption but may be taken with or after meals, if necessary, to minimize adverse GI effects. Patients who have difficulty tolerating oral iron supplements also may benefit from smaller, more frequent doses, starting with a lower dose and increasing slowly to the target dose, trying a different form or preparation, or taking the supplement at bedtime.
Published data are too varied and/or limited to permit generalizations, and specialized references should be consulted for specific compatibility information. Oral iron preparations generally should be taken between meals (e.g., 1 hour before or 2 hours after a meal) for maximum absorption but may be taken with or after meals, if necessary, to minimize adverse GI effects. Patients who have difficulty tolerating oral iron supplements also may benefit from smaller, more frequent doses, starting with a lower dose and increasing slowly to the target dose, trying a different form or preparation, or taking the supplement at bedtime.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for VITALETS (multivitamins with iron):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for VITALETS (multivitamins with iron):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 6 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Hemochromatosis |
| Hypercalcemia |
| Hypercalcinuria |
| Hypervitaminosis D |
| Leber's hereditary optic atrophy |
| Sarcoidosis |
There are 10 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Chronic iron overload due to repeated blood transfusions |
| Dehydration |
| Diarrhea |
| Diverticular disease |
| Hemolytic anemia |
| Hemosiderosis |
| Hypercalcemia |
| Hyperphosphatemia |
| Kidney stone |
| Ulcerative colitis |
There are 7 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Atrophic gastritis |
| Constipation |
| Gastritis |
| Hypokalemia |
| Kidney disease with reduction in glomerular filtration rate (GFr) |
| Peptic ulcer |
| Sarcoidosis |
The following adverse reaction information is available for VITALETS (multivitamins with iron):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
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 14 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| 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 VITALETS (multivitamins with iron):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
During the first and second trimester of pregnancy, iron-deficiency anemia is associated with a twofold increased risk of premature delivery and a threefold increased risk of a low-birthweight delivery. Although iron supplementation during pregnancy has been shown to decrease the incidence of anemia, evidence on the effect of routine iron supplementation during pregnancy on adverse maternal and infant outcomes is inconclusive. Blood volume expands by about 35% during pregnancy, and growth of the fetus, placenta, and other maternal tissues increases the iron requirement threefold during the second and third trimesters of pregnancy to about 5 mg of iron daily.
Although menstruation ceases and iron absorption increases during pregnancy, most pregnant women who do not use iron supplements to meet increased iron requirements cannot maintain adequate iron stores, particularly during the last 2 trimesters. Following delivery, iron in the fetus and placenta are lost to the woman, although some of the iron in the expanded blood volume may return to blood stores. Among low-income pregnant women enrolled in health programs in the US, the prevalence of iron-deficiency anemia is 9, 14, and 37% during the first, second, and third trimesters, respectively.
While similar data currently are not available for all pregnant women in the US, the low dietary iron intake among US women of childbearing age, the high prevalence of iron deficiency and associated anemia among such women, and the increased iron requirements during pregnancy suggest that anemia during pregnancy may extend beyond low-income women. In addition, use of prenatal multivitamin and mineral supplements among African-Americans, native American and Alaskan Indians, women younger than 20 years of age, and those having less than a high school education is substantially lower than in the general US pregnant population. The principal reasons for the current lack of widespread adoption of a recommended iron supplementation regimen during pregnancy in US women may include lack of health-care provider and patient perceptions that iron supplements improve maternal and infant outcomes, complicated dose schedules, and adverse effects (e.g., constipation, nausea, vomiting).
However, adequate dietary iron intake and iron supplementation generally are recommended for primary prevention of iron deficiency during pregnancy. By employing low-dose (i.e., 30 mg of iron daily) regimens with simplified dose schedules (i.e., once-daily dosing), patient compliance may be improved; low-dose regimens have been shown to increase patient tolerance and are as effective as higher dosages (e.g., 60-120 mg iron daily) in preventing iron-deficiency anemia.
Although menstruation ceases and iron absorption increases during pregnancy, most pregnant women who do not use iron supplements to meet increased iron requirements cannot maintain adequate iron stores, particularly during the last 2 trimesters. Following delivery, iron in the fetus and placenta are lost to the woman, although some of the iron in the expanded blood volume may return to blood stores. Among low-income pregnant women enrolled in health programs in the US, the prevalence of iron-deficiency anemia is 9, 14, and 37% during the first, second, and third trimesters, respectively.
While similar data currently are not available for all pregnant women in the US, the low dietary iron intake among US women of childbearing age, the high prevalence of iron deficiency and associated anemia among such women, and the increased iron requirements during pregnancy suggest that anemia during pregnancy may extend beyond low-income women. In addition, use of prenatal multivitamin and mineral supplements among African-Americans, native American and Alaskan Indians, women younger than 20 years of age, and those having less than a high school education is substantially lower than in the general US pregnant population. The principal reasons for the current lack of widespread adoption of a recommended iron supplementation regimen during pregnancy in US women may include lack of health-care provider and patient perceptions that iron supplements improve maternal and infant outcomes, complicated dose schedules, and adverse effects (e.g., constipation, nausea, vomiting).
However, adequate dietary iron intake and iron supplementation generally are recommended for primary prevention of iron deficiency during pregnancy. By employing low-dose (i.e., 30 mg of iron daily) regimens with simplified dose schedules (i.e., once-daily dosing), patient compliance may be improved; low-dose regimens have been shown to increase patient tolerance and are as effective as higher dosages (e.g., 60-120 mg iron daily) in preventing iron-deficiency anemia.
No enhanced Lactation information available for this drug.
No Known Risk
No known risk. This drug has no known risks to nursing infants and does not adversely affect lactation.
No Known Risk
No known risk. This drug has no known risks to nursing infants and does not adversely affect lactation.
| Drug Name | Excretion Potential | Effect on Infant | Notes |
|---|---|---|---|
| Thiamine (vitamin B-1) | Excreted.This drug is known to be excreted in human breast milk. | This drug has been shown not to have an adverse effect on the nursing infant. | Breastfeeding can continue during treatment |
| Vitamin E (systemic) | Excreted.This drug is known to be excreted in human breast milk. | This drug has been shown not to have an adverse effect on the nursing infant. | May accumulate in liver;Maternal suppl not rec unless diet insuffic in vit e |
| Zinc | Excreted.This drug is known to be excreted in human breast milk. | This drug has been shown not to have an adverse effect on the nursing infant. | None |
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for VITALETS (multivitamins with iron):
WARNING: Accidental overdose of iron-containing products is a WARNING: If your brand of multivitamin contains iron, it is important to keep this product out of reach of children. leading cause of fatal poisoning in children younger than 6 Accidental overdose of iron-containing products is a leading years. Keep this product out of reach of children.
If overdose cause of fatal poisoning in children younger than 6 years. If does occur, get medical help right away or call a poison control center. overdose does occur, get medical help right away or call a poison control center.
WARNING: Accidental overdose of iron-containing products is a WARNING: If your brand of multivitamin contains iron, it is important to keep this product out of reach of children. leading cause of fatal poisoning in children younger than 6 Accidental overdose of iron-containing products is a leading years. Keep this product out of reach of children.
If overdose cause of fatal poisoning in children younger than 6 years. If does occur, get medical help right away or call a poison control center. overdose does occur, get medical help right away or call a poison control center.
The following icd codes are available for VITALETS (multivitamins with iron)'s list of indications:
| Mineral deficiency | |
| E61.9 | Deficiency of nutrient element, unspecified |
| Vitamin deficiency | |
| E56.9 | Vitamin deficiency, unspecified |
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