Palmitate-A (Oral, Intramuscular)

Vitamins are substances that your body needs for growth and health. You only need them in small amounts, and they are usually found in the foods you eat. Vitamin A is important for seeing at night and for the growth of skin, bones, and male and female reproductive organs. Pregnant women need vitamin A for the healthy growth of their babies.

Not getting enough vitamin A can cause a rare condition called night blindness (difficulty seeing in the dark), along with dry eyes, eye infections, skin problems, and slow growth. Your healthcare provider may prescribe vitamin A to help with these issues.

Certain conditions can increase your need for vitamin A. These include:

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

Additionally, infants who are given formula that does not have added nutrients may need vitamin A supplements.

Your body may not absorb vitamin A well if fat is not absorbed properly.

Your healthcare provider should determine if you need more vitamin A.

There is no proof that vitamin A effectively treats conditions such as acne, lung diseases, or eye problems, wounds, or dry or wrinkled skin that are not caused by a lack of vitamin A. Although vitamin A is being studied for preventing certain types of cancer, some experts believe there is not enough information to show that it works, especially in people who are already well-nourished.

Injectable vitamin A should be given by or under the supervision of a healthcare provider. Other forms of vitamin A can be obtained without a prescription.

To be healthy, it is important to eat a balanced and varied diet. Follow any diet plan your healthcare provider recommends. For information on specific dietary vitamin and/or mineral needs, ask your healthcare provider for a list of suitable foods. If you think you are not getting enough vitamins and/or minerals in your diet, you might consider taking a dietary supplement.

Vitamin A can be found in many foods, including yellow-orange fruits and vegetables, dark green leafy vegetables, vitamin A-fortified milk, liver, and margarine. There are two forms of vitamin A: retinols and beta-carotene. Retinols come from animal sources (meat, milk, eggs). Beta-carotene, found in plants, is converted into vitamin A by the body. Food processing can destroy some vitamins; for example, freezing can lower the amount of vitamin A in foods.

Vitamins alone cannot replace a healthy diet and do not provide energy. Your body also needs other nutrients found in food, like protein, minerals, carbohydrates, and fat. Vitamins often cannot work without other foods. For instance, small amounts of fat are needed for your body to absorb vitamin A.

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

• For U.S.—
• Recommended Dietary Allowances (RDAs) are the amounts of vitamins and minerals needed for adequate nutrition in most healthy people. RDAs may vary based on age, sex, and physical condition (e.g., pregnancy).
• Daily Values (DVs) are used on food and dietary supplement labels to show the percentage of the recommended daily amount of each nutrient that a serving provides. DV replaces the earlier term United States Recommended Daily Allowances (USRDAs).
• Normal daily recommended intakes in the United States for vitamin A are generally defined by age or condition and the type 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 for adequate nutrition and to reduce the risk of chronic disease.
• Normal daily recommended intakes in Canada for vitamin A are generally defined by age or condition and the type 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 were 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 change was made 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 still use the older labeling and continue to show Units.

Vitamin A is stored in the body, so taking more than what your body needs can cause it to build up. This can lead to poisoning and even death. Problems are more likely to happen in:

• Adults taking 7500 RE (25,000 Units) a day for 8 months straight, 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 straight, 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.

Keep in mind that the total amount of vitamin A you get each day includes both the vitamin A from the foods you eat and any supplements you take.

Taking high doses or using vitamin A for a long time may lead to bleeding from the gums, a dry or sore mouth, or drying, cracking, or peeling of the lips.

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

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, inform your healthcare professional about 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

No problems have been reported in children when taking normal daily recommended amounts. However, side effects from high doses and/or long-term use of vitamin A are more likely to occur in young children than in adults.

Geriatric

No problems have been reported in older adults when taking normal daily recommended amounts. However, some studies suggest that older adults may be at risk of high blood levels of vitamin A with long-term use.

Breast Feeding

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

Interactions with Medicines

While some medicines should not be used together at all, it is sometimes possible to use two different medicines together even if an interaction might occur. In these cases, your doctor may want to adjust the dose or take other precautions. When you take this dietary supplement, it is especially important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been selected for their potential significance and are not necessarily all-inclusive.

Using this dietary supplement with any of the following medicines is usually not recommended, but may be needed in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Palovarotene

Using this dietary supplement with any of the following medicines may increase the 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 certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

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

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

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require 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.

In the U.S.

• Aquasol A
• Palmitate-A

Available Dosage Forms:

• Tablet
• Capsule
• Capsule, Liquid Filled
• Solution

Therapeutic Class: Nutritive Agent

Pharmacologic Class: Vitamin A (class)

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.

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