Aquasol A

Generic Name: vitamin a (Oral route, Intramuscular route)

VYE-ta-min A

Commonly used brand name(s):

In the U.S.

• Aquasol A
• Palmitate-A

Available Dosage Forms:

• Capsule, Liquid Filled
• Capsule
• Tablet
• Liquid
• Solution
• Tablet, Chewable

Therapeutic Class: Nutritive Agent

Pharmacologic Class: Vitamin A (class)

Uses For Aquasol A

Vitamins are compounds that you must have for growth and health. They are needed in small amounts only and are usually available in the foods that you eat. Vitamin A is needed for night vision and for growth of skin, bones, and male and female reproductive organs. In pregnant women vitamin A is necessary for the growth of a healthy fetus.

Lack of vitamin A may lead to a rare condition called night blindness (problems seeing in the dark), as well as dry eyes, eye infections, skin problems, and slowed growth. Your health care professional may treat these problems by prescribing vitamin A for you.

Some conditions may increase your need for vitamin A. These include:

• Diarrhea
• Eye diseases
• Intestine diseases
• Infections (continuing or chronic)
• Measles
• Pancreas disease
• Stomach removal
• Stress (continuing)

In addition, infants receiving unfortified formula may need vitamin A supplements.

Vitamin A absorption will be decreased in any condition in which fat is poorly absorbed.

Increased need for vitamin A should be determined by your health care professional.

Claims that vitamin A is effective for treatment of conditions such as acne or lung diseases, or for treatment of eye problems, wounds, or dry or wrinkled skin not caused by lack of vitamin A have not been proven. Although vitamin A is being used to prevent certain types of cancer, some experts feel there is not enough information to show that this is effective, particularly in well-nourished individuals.

Injectable vitamin A is given by or under the supervision of a health care professional. Other forms of vitamin A are available without a prescription.

Importance of Diet

For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.

Vitamin A is found in various foods including yellow-orange fruits and vegetables; dark green, leafy vegetables; vitamin A-fortified milk; liver; and margarine. Vitamin A comes in two different forms, retinols and beta-carotene. Retinols are found in foods that come from animals (meat, milk, eggs). The form of vitamin A found in plants is called beta-carotene (which is converted to vitamin A in the body). Food processing may destroy some of the vitamins. For example, freezing may reduce the amount of vitamin A in foods.

Vitamins alone will not take the place of a good diet and will not provide energy. Your body needs other substances found in food, such as protein, minerals, carbohydrates, and fat. Vitamins themselves often cannot work without the presence of other foods. For example, small amounts of fat are needed so that vitamin A can be absorbed into the body.

The daily amount of vitamin A needed is defined in several different ways.

• For U.S.—
• Recommended Dietary Allowances (RDAs) are the amount of vitamins and minerals needed to provide for adequate nutrition in most healthy persons. RDAs for a given nutrient may vary depending on a person's age, sex, and physical condition (e.g., pregnancy).
• Daily Values (DVs) are used on food and dietary supplement labels to indicate the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous designation of United States Recommended Daily Allowances (USRDAs).
• Normal daily recommended intakes in the United States for vitamin A are generally defined according to age or condition and to the form of vitamin A as follows:

Note: Based on 1980 U.S. Recommended Dietary Allowances (RDAs) for vitamin A in the diet that is a combination of retinol and beta-carotene.

• For Canada—
• Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed to provide adequate nutrition and lessen the risk of chronic disease.
• Normal daily recommended intakes in Canada for vitamin A are generally defined according to age or condition and to the form of vitamin A as follows:

Note: Based on 1980 U.S. Recommended Dietary Allowances (RDAs) for vitamin A in the diet that is a combination of retinol and beta-carotene.

In the past, the RDA and RNI for vitamin A have been expressed in Units. This term Units has been replaced by retinol equivalents (RE) or micrograms (mcg) of retinol, with 1 RE equal to 1 mcg of retinol. This was done to better describe the two forms of vitamin A, retinol and beta-carotene. One RE of vitamin A is equal to 3.33 Units of retinol and 10 Units of beta-carotene. Some products available have not changed their labels and continue to be labeled in Units.

Before Using Aquasol A

If you are taking this dietary supplement without a prescription, carefully read and follow any precautions on the label. For this supplement, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Problems in children have not been reported with intake of normal daily recommended amounts. However, side effects from high doses and/or prolonged use of vitamin A are more likely to occur in young children than adults.

Geriatric

Problems in older adults have not been reported with intake of normal daily recommended amounts. However, some studies have shown that the elderly may be at risk of high blood levels of vitamin A with long-term use.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using this dietary supplement with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abciximab
• Acenocoumarol
• Ancrod
• Anisindione
• Antithrombin III Human
• Argatroban
• Bexarotene
• Bivalirudin
• Clopidogrel
• Danaparoid
• Defibrotide
• Dermatan Sulfate
• Desirudin
• Dicumarol
• Eptifibatide
• Fondaparinux
• Heparin
• Lamifiban
• Minocycline
• Pentosan Polysulfate Sodium
• Phenindione
• Phenprocoumon
• Sibrafiban
• Tirofiban
• Warfarin
• Xemilofiban

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this dietary supplement. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse (or history of) or
• Liver disease—Vitamin A use may make liver problems worse

• Kidney disease—May cause high blood levels of vitamin A, which may increase the chance of side effects

Proper Use of vitamin a

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

If you miss taking a vitamin for one or more days there is no cause for concern, since it takes some time for your body to become seriously low in vitamins. However, if your health care professional has recommended that you take this vitamin, try to remember to take it as directed every day.

Dosing

The dose of this medicine 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 this medicine. 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 form (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—1000 retinol equivalents (RE) (3330 Units of retinol or 5000 Units as a combination of retinol and beta-carotene) per day.
    • Adult and teenage females—800 RE (2665 Units of retinol or 4000 Units as a combination of retinol and beta-carotene) per day.
    • Pregnant females—800 RE (2665 Units of retinol or 4000 Units as a combination of retinol and beta-carotene) per day.
    • Breast-feeding females—1200 to 1300 RE (4000 to 4330 Units of retinol or 6000 to 6500 Units as a combination of retinol and beta-carotene) per day.
    • Children 7 to 10 years of age—700 RE (2330 Units of retinol or 3500 Units as a combination of retinol and beta-carotene) per day.
    • Children 4 to 6 years of age—500 RE (1665 Units of retinol or 2500 Units as a combination of retinol and beta-carotene) per day.
    • Children birth to 3 years of age—375 to 400 RE (1250 to 1330 Units of retinol or 1875 to 2000 Units as a combination of retinol and beta-carotene) per day.
    • For Canada
    • Adult and teenage males—1000 RE (3330 Units of retinol or 5000 Units as a combination of retinol and beta-carotene) per day.
    • Adult and teenage females—800 RE (2665 Units of retinol or 4000 Units as a combination of retinol and beta-carotene) per day.
    • Pregnant females—900 RE (2665 to 3000 Units of retinol or 4000 to 4500 Units as a combination of retinol and beta-carotene) per day.
    • Breast-feeding females—1200 RE (4000 Units of retinol or 6000 Units as a combination of retinol and beta-carotene) per day.
    • Children 7 to 10 years of age—700 to 800 RE (2330 to 2665 Units of retinol or 3500 Units as a combination of retinol and beta-carotene) per day.
    • Children 4 to 6 years of age—500 RE (1665 Units of retinol or 2500 Units as a combination of retinol and beta-carotene) per day.
    • Children birth to 3 years of age—400 RE (1330 Units or 2000 Units as a combination of retinol and beta-carotene) per day.
  • To treat deficiency:
    • Adults and teenagers—Treatment dose is determined by prescriber for each individual based on severity of deficiency. The following dose has been determined for xerophthalmia (eye disease): Oral, 7500 to 15,000 RE (25,000 to 50,000 Units) a day.
    • Children—Treatment dose is determined by prescriber for each individual based of severity of deficiency. The following doses have been determined:
      • For measles—
        • Children 6 months to 1 year of age: Oral, 30,000 RE (100,000 Units) as a single dose.
        • For children 1 year of age and older: Oral, 60,000 RE (200,000 Units) as a single dose.
      • Xerophthalmia (eye disease)—
        • Children 6 months to 1 year of age: Oral, 30,000 RE (100,000 Units) as a single dose, the same dose being repeated the next day and again at 4 weeks.
        • Children 1 year of age and older: Oral, 60,000 RE (200,000 Units) as a single dose, the same dose being repeated the next day and again at 4 weeks.
        Note: Vitamin A is used in measles and xerophthalmia only when vitamin A deficiency is a problem as determined by your health care professional. Vitamin A deficiency occurs in malnutrition or in certain disease states.

For individuals taking the oral liquid form of vitamin A:

• This preparation is to be taken by mouth even though it comes in a dropper bottle.
• This dietary supplement may be dropped directly into the mouth or mixed with cereal, fruit juice, or other food.

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

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Aquasol A

Vitamin A is stored in the body; therefore, when you take more than the body needs, it will build up in the body. This may lead to poisoning and even death. Problems are more likely to occur in:

• Adults taking 7500 RE (25,000 Units) a day for 8 months in a row, or 450,000 RE (1,500,000 Units) all at once; or
• Children taking 5400 RE (18,000 Units) to 15,000 RE (50,000 Units) a day for several months in a row, or 22,500 RE (75,000 Units) to 105,100 RE (350,000 Units) all at once.
• Pregnant women taking more than 1800 RE (6000 Units) a day.

Remember that the total amount of vitamin A you get every day includes what you get from foods that you eat and what you take as a supplement.

High doses and/or prolonged use of vitamin A may cause bleeding from the gums; dry or sore mouth; or drying, cracking, or peeling of the lips.

Aquasol A 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 immediately if any of the following side effects occur:

• Bleeding from gums or sore mouth
• bulging soft spot on head (in babies)
• confusion or unusual excitement
• diarrhea
• dizziness or drowsiness
• double vision
• headache (severe)
• irritability (severe)
• peeling of skin, especially on lips and palms
• vomiting (severe)

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

• Bone or joint pain
• convulsions (seizures)
• drying or cracking of skin or lips
• dry mouth
• fever
• general feeling of discomfort or illness or weakness
• headache
• increased sensitivity of skin to sunlight
• increase in frequency of urination, especially at night, or in amount of urine
• irritability
• loss of appetite
• loss of hair
• stomach pain
• unusual tiredness
• vomiting
• yellow-orange patches on soles of feet, palms of hands, or skin around nose and lips

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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