Ferate

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if you think you have used too much of this medicine, or if a child has accidentally swallowed it. An overdose of ferrous gluconate can be fatal to a child.

Overdose symptoms may include drowsiness, severe nausea or stomach pain, vomiting, bloody diarrhea, coughing up blood or vomit that looks like coffee grounds, shallow breathing, weak and rapid pulse, cold or clammy skin, blue lips, and seizure (convulsions).

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• bright red blood in your stools; or

• pain in your chest or throat when swallowing a ferrous gluconate tablet.

Common side effects may include:

• constipation, diarrhea;

• nausea, vomiting, heartburn;

• stomach pain, upset stomach;

• black or dark-colored stools or urine; or

• temporary staining of the teeth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Use Ferate as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• This medicine works better if you take it on an empty stomach. You may take this medicine with food if it causes an upset stomach. Some foods like eggs, whole grain breads, cereal, dairy products, coffee, and tea may make Ferate not work as well. If this medicine causes an upset stomach, talk with your doctor about the best way to take Ferate with food.
• Take with a full glass of water.
• If antacids are used, they may need to be taken at some other time than this medicine. Talk with your doctor or pharmacist.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Belly pain.
• Loose stools (diarrhea).
• Hard stools (constipation).
• Change in color of stool to green.
• Not hungry.
• Upset stomach or throwing up.
• Stomach cramps.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Belly pain.
• Loose stools (diarrhea).
• Hard stools (constipation).
• Change in color of stool to green.
• Not hungry.
• Upset stomach or throwing up.
• Stomach cramps.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Initial dose: 1 tablet orally three to four times a day

or

Initial dose: 48 to 144 mg/day ferrous gluconate (6 to 18 mg/day elemental iron) orally, in divided doses (1 to 3 times daily)

51 and over: 40 to 64 mg/day ferrous gluconate (5 to 8 mg/day elemental) orally, in divided doses (1 to 3 times daily)

0 to 5 years: 24 to 48 mg/kg/day ferrous gluconate (3 to 6 mg/kg/day elemental iron)
5 to 12 years: 480 mg ferrous gluconate (60 mg/day elemental)
12 to 18 years male: 480 mg ferrous gluconate (60 mg elemental) orally daily
12 to 18 years female: 480 to 960 mg/day ferrous gluconate (60 to 120 mg/day elemental)
-Give in divided doses (1 to 3 times daily)

No adjustments recommended

Iron supplementation is routinely provided to peritoneal dialysis and hemodialysis patients for prevention or treatment of anemia associated with chronic renal failure.

Maternal anemia increases the risk of low birthweight, premature delivery, and impaired cognitive and behavioral development. Randomized trials show that supplementation can prevent iron deficiency anemia and related adverse consequences to the infant. Recent studies have linked high serum iron with an increased risk of gestational diabetes. AU Exempt: Medications exempted from pregnancy classification are not absolutely safe for use in pregnancy in all circumstances. Some exempted medicines, for example the complementary medicine, St John's Wort, may interact with other medicines and induce unexpected adverse effects in the mother and/or fetus. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

Use is considered acceptable. AU TGA pregnancy category: Exempt US FDA pregnancy category: Not assigned Comments: -Routine screening for anemia, including in asymptomatic patients, is generally recommended. -Routine supplementation during pregnancy is recommended by many organizations.