Auryxia Oral, Parenteral

Name: Auryxia Oral, Parenteral

Commonly used brand name(s)

In the U.S.

  • Auryxia
  • Beef,Iron & Wine
  • Bifera
  • Elite Iron
  • Femiron
  • Feosol
  • Fergon
  • Ferrex 150
  • Hemocyte

In Canada

  • Fer-In-Sol
  • Palafer
  • Pms-Ferrous Sulfate

Available Dosage Forms:

  • Tablet, Chewable
  • Tablet
  • Liquid
  • Capsule
  • Solution
  • Tablet, Enteric Coated
  • Powder
  • Tablet, Extended Release
  • Suspension
  • Capsule, Liquid Filled
  • Syrup
  • Capsule, Extended Release
  • Elixir

Uses For Auryxia

Iron is a mineral that the body needs to produce red blood cells. When the body does not get enough iron, it cannot produce the number of normal red blood cells needed to keep you in good health. This condition is called iron deficiency (iron shortage) or iron deficiency anemia.

Although many people in the U.S. get enough iron from their diet, some must take additional amounts to meet their needs. For example, iron is sometimes lost with slow or small amounts of bleeding in the body that you would not be aware of and which can only be detected by your doctor. Your doctor can determine if you have an iron deficiency, what is causing the deficiency, and if an iron supplement is necessary.

Lack of iron may lead to unusual tiredness, shortness of breath, a decrease in physical performance, and learning problems in children and adults, and may increase your chance of getting an infection.

Some conditions may increase your need for iron. These include:

  • Bleeding problems
  • Burns
  • Hemodialysis
  • Intestinal diseases
  • Stomach problems
  • Stomach removal
  • Use of medicines to increase your red blood cell count

In addition, infants, especially those receiving breast milk or low-iron formulas, may need additional iron.

Increased need for iron supplements should be determined by your health care professional.

Injectable iron is administered only by or under the supervision of your health care professional. Other forms of iron are available without a prescription; however, your health care professional may have special instructions on the proper use and dose for your condition.

Proper Use of iron supplement

This section provides information on the proper use of a number of products that contain iron supplement. It may not be specific to Auryxia. Please read with care.

After you start using this dietary supplement, continue to return to your health care professional to see if you are benefiting from the iron. Some blood tests may be necessary for this.

Iron is best absorbed when taken on an empty stomach, with water or fruit juice (adults: full glass or 8 ounces; children: ½ glass or 4 ounces), about 1 hour before or 2 hours after meals. However, to lessen the possibility of stomach upset, iron may be taken with food or immediately after meals.

For safe and effective use of iron supplements:

  • Follow your health care professional's instructions if this dietary supplement was prescribed.
  • Follow the manufacturer's package directions if you are treating yourself. If you think you still need iron after taking it for 1 or 2 months, check with your health care professional.

Liquid forms of iron supplement tend to stain the teeth. To prevent, reduce, or remove these stains:

  • Mix each dose in water, fruit juice, or tomato juice. You may use a drinking tube or straw to help keep the iron supplement from getting on the teeth.
  • When doses of liquid iron supplement are to be given by dropper, the dose may be placed well back on the tongue and followed with water or juice.
  • Iron stains on teeth can usually be removed by brushing with baking soda (sodium bicarbonate) or medicinal peroxide (hydrogen peroxide 3%).

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage forms (capsules, tablets, oral solution):
    • To prevent deficiency, the amount taken by mouth is based on normal daily recommended intakes:
        For the U.S.
      • Adult and teenage males—10 milligrams (mg) per day.
      • Adult and teenage females—10 to 15 mg per day.
      • Pregnant females—30 mg per day.
      • Breast-feeding females—15 mg per day.
      • Children 7 to 10 years of age—10 mg per day.
      • Children 4 to 6 years of age—10 mg per day.
      • Children birth to 3 years of age—6 to 10 mg per day.
        For Canada
      • Adult and teenage males—8 to 10 mg per day.
      • Adult and teenage females—8 to 13 mg per day.
      • Pregnant females—17 to 22 mg per day.
      • Breast-feeding females—8 to 13 mg per day.
      • Children 7 to 10 years of age—8 to 10 mg per day.
      • Children 4 to 6 years of age—8 mg per day.
      • Children birth to 3 years of age—0.3 to 6 mg per day.
    • To treat deficiency:
      • Adults, teenagers, and children— The dose will be determined by your doctor, based on your condition.
  • For injection dosage forms:
    • Adults, teenagers, and children— The dose will be determined by your doctor, based on your condition.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Auryxia

When iron is combined with certain foods it may lose much of its value. If you are taking iron, the following foods should be avoided, or only taken in very small amounts, for at least 1 hour before or 2 hours after you take iron:

  • Cheese and yogurt
  • Eggs
  • Milk
  • Spinach
  • Tea or coffee
  • Whole-grain breads and cereals and bran

Do not take iron supplements and antacids or calcium supplements at the same time. It is best to space doses of these 2 products 1 to 2 hours apart, to get the full benefit from each medicine or dietary supplement.

If you are taking iron supplements without a prescription:

  • Do not take iron supplements by mouth if you are receiving iron injections. To do so may result in iron poisoning.
  • Do not regularly take large amounts of iron for longer than 6 months without checking with your health care professional. People differ in their need for iron, and those with certain medical conditions can gradually become poisoned by taking too much iron over a period of time. Also, unabsorbed iron can mask the presence of blood in the stool, which may delay discovery of a serious condition.

If you have been taking a long-acting or coated iron tablet and your stools have not become black, check with your health care professional. The tablets may not be breaking down properly in your stomach, and you may not be receiving enough iron.

It is important to keep iron preparations out of the reach of children. Keep a 1-ounce bottle of syrup of ipecac available at home to be taken in case of an iron overdose emergency when a doctor, poison control center, or emergency room orders its use.

If you think you or anyone else has taken an overdose of iron medicine:

  • Call your doctor, a poison control center, or the nearest hospital emergency room at once. Always keep these phone numbers readily available.
  • Follow any instructions given to you. If syrup of ipecac has been ordered and given, do not delay going to the emergency room while waiting for the ipecac syrup to empty the stomach, since it may require 20 to 30 minutes to show results
  • Go to the emergency room without delay
  • Take the container of iron with you.

Early signs of iron overdose may not appear for up to 60 minutes or more. Do not delay going to the emergency room while waiting for signs to appear.

Auryxia Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

More common - with injection only
  • Backache , groin, side, or muscle pain
  • chest pain
  • chills
  • dizziness
  • fainting
  • fast heartbeat
  • fever with increased sweating
  • flushing
  • headache
  • metallic taste
  • nausea or vomiting
  • numbness, pain, or tingling of hands or feet
  • pain or redness at injection site
  • redness of skin
  • skin rash or hives
  • swelling of mouth or throat
  • troubled breathing
More common - when taken by mouth only
  • Abdominal or stomach pain
  • cramping (continuing) or soreness
Less common or rare - with injection only
  • Double vision
  • general unwell feeling
  • weakness without feeling dizzy or faint
Less common or rare - when taken by mouth only
  • Chest or throat pain, especially when swallowing
  • stools with signs of blood (red or black color)
Early symptoms of iron overdose

Symptoms of iron overdose may not occur for up to 60 minutes or more after the overdose was taken. By this time you should have had emergency room treatment. Do not delay going to emergency room while waiting for signs to appear.

  • Diarrhea (may contain blood)
  • fever
  • nausea
  • stomach pain or cramping (sharp)
  • vomiting, severe (may contain blood)
Late symptoms of iron overdose
  • Bluish-colored lips, fingernails, and palms of hands
  • convulsions (seizures)
  • pale, clammy skin
  • shallow and rapid breathing
  • unusual tiredness or weakness
  • weak and fast heartbeat

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Constipation
  • diarrhea
  • leg cramps
  • nausea
  • vomiting
Less common

Stools commonly become dark green or black when iron preparations are taken by mouth. This is caused by unabsorbed iron and is harmless. However, in rare cases, black stools of a sticky consistency may occur along with other side effects such as red streaks in the stool, cramping, soreness, or sharp pains in the stomach or abdominal area. Check with your health care professional immediately if these side effects appear.

If you have been receiving injections of iron, you may notice a brown discoloration of your skin. This color usually fades within several weeks or months.

  • Darkened urine
  • heartburn
  • stained teeth

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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