Drugs Details

Drugs Info of A/Fish Oil, A-25, Aquasol A
Drugs Details
  • Drugs Type  : Multum
  • Date : 7th Jan 2015 10:27 pm
  • Brand Name :  A/Fish Oil, A-25, Aquasol A
  • Generic Name :  vitamin A (Pronunciation: VYE ta min A)
Descriptions

AQUASOL A® Parenteral (water-miscible vitamin A Palmitate) provides 50,000 USP Units of vitamin A per mL as retinol (C20H30O) in the form of vitamin A palmitate, a light yellow to amber oil.The structural formula of retinol is:

 

AQUASOL (vitamin A Palmitate) Structural Formula Illustration

Ordinarily oil-soluble, the vitamin A in this product has been water solubilized by special processing* and is available in a water solution for intramuscular injection.

One USP Unit is equivalent to one international unit (IU) and to 0.3 mcg of retinol or 0.6 mcg of beta-carotene.

*Oil-soluble vitamin A water solubilized with polysorbate 80.

What are the possible side effects of vitamin A (A/Fish Oil, A-25, Aquasol A)?

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.

Less serious side effects are more likely to occur, and you may have none at all.

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...

Read All Potential Side Effects and See Pictures of Aquasol A »


This monograph has been modified to include the generic and brand name in many instances.

Indications

Vitamin A injection is effective for the treatment of vitamin A deficiency.

The parenteral administration is indicated when the oral administration is not feasible as in anorexia, nausea, vomiting, pre- and postoperative conditions, or it is not available as in the "Malabsorption Syndrome" with accompanying steatorrhea.

Pediatric Use: Vitamin A treatment for deficiency states has been recognized as an especially effective and important therapy in the pediatric population.

Vitamin A supplementation for deficiency states in this population has been addressed by the Committee on Clinical Practice Issues of the American Society for Clinical Nutrition, by the American Society for Parenteral and Enteral Nutrition, and by the World Health Organization.

Dosage Administration

For intramuscular use.

I. Adults

100,000 Units daily for three days followed by 50,000 daily for two weeks.

II. Pediatric patients 1 to 8 years old

17,500 to 35,000 Units daily for 10 days.

III. Infants

7,500 to 15,000 Units daily for 10 days.

Follow-up therapy with an oral therapeutic multivitamin preparation, containing 10,000 to 20,000 Units vitamin A for adults and for pediatric patients over 8 years old, and 5,000 to 10,000 Units for infants and other pediatric patients under 8 years old, is recommended daily for two months. Low birth-weight infants may require additional vitamin A though the exact dosing in these pediatric patients has not been established. In malabsorption, the parenteral route must be used for an equivalent preparation.

Poor dietary habits should be corrected and an abundant and well-balanced dietary intake should be prescribed.

How Supplied

AQUASOL A® Parenteral (water-miscible vitamin A Palmitate) is available as: NDC 61703-418-07; 50,000 USP Units (15 mg retinol/mL); 2 mL single-dose vial, box of 10.

Store at 2-8°C (36-46°F). Do not freeze.

Manufactured for: Mayne Pharma (USA) Inc. Paramus, NJ 07652. Manufactured by: AstraZeneca LP, Westborough, MA01581. FDA Rev date: 06/09/00


This monograph has been modified to include the generic and brand name in many instances.

Side Effects

See OVERDOSAGE section. Anaphylactic shock and death have been reported using the intravenous route. Allergic reactions have been reported rarely with administration of AQUASOL A® Parenteral (vitamin a) including one case of an anaphylactoid type reaction.

Read the Aquasol A (vitamin a) Side Effects Center for a complete guide to possible side effects

Interactions

Women on oral contraceptives have shown a significant increase in plasma vitamin A levels.

Carcinogenesis: There are no studies that show that administration of vitamin A will cause or prevent cancer.

Pregnancy Category X: See CONTRAINDICATIONS section.

Nursing Mothers: The U.S. Recommended Daily Allowance (RDA) of vitamin A (5,000 Units) is recommended for nursing mothers.


This monograph has been modified to include the generic and brand name in many instances.

Warnings

Avoid overdosage. Keep out of the reach of children.

Pediatric Use: Polysorbates have been associated with E-Ferol syndrome (thrombocytopenia, renal dysfunction, hepatomegaly, cholestasis, ascites, hypotension and metabolic acidosis) in low birth-weight infants.

Precautions

General: Protect from light. Prolonged daily dose administration over 25,000 Units vitamin Ashould be under close supervision. Blood level assays are not a direct measure of liver storage. Liver storage should be adequate before discontinuing therapy. Single vitamin A deficiency is rare. Multiple vitamin deficiency is expected in any dietary deficiency.


This monograph has been modified to include the generic and brand name in many instances.

OverDose

The following amounts have been found to be toxic orally. Toxicity manifestations depend on the age, dosage, size, and duration of administration.

Acute toxicity - single dose (25,000 Units/kg body weight)

Infant: 350,000 Units

Adult: Over 2 million Units

Chronic toxicity (4,000 Units/kg body weight for 6 to 15 months)

Infants 3 to 6 months old: 18,500 Units (water dispersed)/day for 1 to 3 months.

Adult: 1 million Units daily for three days; 50,000 Units daily for longer than 18 months; 500,000 Units daily for two months.

Hypervitaminosis A Syndrome

  1. General manifestations:
    Fatigue, malaise, lethargy, abdominal discomfort, anorexia, and vomiting.
  2. Specific manifestations:
    1. Skeletal: hepatotoxicity, hard tender cortical thickening over the radius and tibia, migratory arthralgia, slow growth, and premature closure of the epiphysis leading to arrested bone growth in children.
    2. Central Nervous System: irritability, headache, and increased intracranial pressure as manifested by bulging fontanels, papilledema, and exophthal-mos.
    3. Dermatologic: fissures of the lips, drying and cracking of the skin, alopecia, scaling, massive desquamation, and increased pigmentation.
    4. Systemic: hypomenorrhea, hepatosplenomegaly, hepatotoxicity, jaundice, leukopenia, vitamin A plasma level over 1,200 Units/100 mL.

The treatment of hypervitaminosis A consists of immediate withdrawal of the vitamin along with symptomatic and supportive treatment.

ContrainDications

The intravenous administration. Hypervitaminosis A. Sensitivity to any of the ingredients in this preparation.

Use in Pregnancy: Safety of amounts exceeding 6,000 Units of vitamin A daily during pregnancy has not been established at this time. The use of vitamin A in excess of the recommended dietary allowance may cause fetal harm when administered to a pregnant woman. Animal reproduction studies have shown fetal abnormalities associated with over-dosage in several species. Malformations of the central nervous system, the eye, the palate, and the urogenital tract are recorded. Vitamin Ain excess of the recommended dietary allowance is contraindicated in women who are or may become pregnant. If vitamin Ais used during pregnancy, or if the patient becomes pregnant while taking vitamin A, the patient should be apprised of the potential hazard to the fetus.


This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Beta-carotene, retinol, and retinal have effective and reliable vitamin A activity. Retinal and retinol are in chemical equilibrium in the body and have equivalent antixerophthalmic activity. Retinal combines with the rod pigment, opsin, in the retina to form rhodopsin, necessary for visual dark adaptation.

Vitamin A prevents retardation of growth and preserves the epithe-lial cells' integrity. Normal adult liver storage is sufficient to satisfy two years'requirements of vitamin A. Vitamin A is readily absorbed from the gastrointestinal tract, where the biosynthesis of vitamin A from beta-carotene takes place. Vitamin A absorption requires bile salts, pancreatic lipase, and dietary fat. It is transported in the blood to the liver by the chy-lomicron fraction of the lymph. Vitamin Ais stored in Kupffer cells of the liver mainly as the palmitate. Normal serum vitamin A is 80-300 Units per 100 mL (plasma range is 30-70 mcg per dl) and for carotenoids 270-753 Units per 100 mL.The normal adult liver contains approximately 100 to 300 micrograms per gram, mostly as retinol palmitate.


This monograph has been modified to include the generic and brand name in many instances.

Patient Information

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.


This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

No Information Available!

Consumer Overview Side Effect

No Information Available!

Consumer Overview Missed Dose

No Information Available!

Patient Detailed Side Effect

Brand Names: A/Fish Oil, A-25, Aquasol A

Generic Name: vitamin A (Pronunciation: VYE ta min A)

  • What is vitamin A (Aquasol A)?
  • What are the possible side effects of vitamin A (Aquasol A)?
  • What is the most important information I should know about vitamin A (Aquasol A)?
  • What should I discuss with my healthcare provider before taking vitamin A (Aquasol A)?
  • How should I take vitamin A (Aquasol A)?
  • What happens if I miss a dose (Aquasol A)?
  • What happens if I overdose (Aquasol A)?
  • What should I avoid while taking vitamin A (Aquasol A)?
  • What other drugs will affect vitamin A (Aquasol A)?
  • Where can I get more information?

What is vitamin A (Aquasol A)?

Vitamin A is found in foods such as liver, milk, cheese, eggs, carrots, squash, dark green and yellow vegetables, and fruits such as cantaloupe or apricots. Vitamin A is important for the eyes and skin, and for normal growth.

Vitamin A is used to treat vitamin A deficiency.

Vitamin A may also be used for purposes not listed in this medication guide.

What are the possible side effects of vitamin A (Aquasol A)?

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.

Less serious side effects are more likely to occur, and you may have none at all.

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.

Read the Aquasol A (vitamin a) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about vitamin A (Aquasol A)?

Never take more than the recommended dose of vitamin A. Avoid taking more than one vitamin product at the same time unless your doctor tells you to. Taking similar vitamin products together can result in a vitamin overdose or serious side effects.

An overdose of vitamin A can cause serious or life-threatening side effects.

Do not take vitamin A without medical advice if you are pregnant. Vitamin A can cause birth defects if taken in large doses.

Before taking vitamin A, tell your doctor about all other medicines you use.

Side Effects CentersAquasol A

Patient Detailed How Take

What should I discuss with my healthcare provider before taking vitamin A (Aquasol A)?

Before using vitamin A, talk to your doctor, pharmacist, herbalist, or other healthcare provider. You may not be able to use vitamin A if you have certain medical conditions.

Do not take vitamin A without medical advice if you are pregnant. Although some vitamin A is needed for the normal development of a baby, vitamin A can cause birth defects if taken in large doses. You may need to use a prenatal vitamin specially formulated for pregnant women.

Ask your doctor about taking vitamin A if you are breast-feeding a baby. Your dose needs may be different while you are nursing.

How should I take vitamin A (Aquasol A)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Swallow the tablet or capsule whole.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Never take more than the recommended dose of vitamin A. Avoid taking more than one vitamin product at the same time unless your doctor tells you to. Taking similar vitamin products together can result in a vitamin overdose or serious side effects.

Your healthcare provider may occasionally change your dose to make sure you get the best results from vitamin A. The recommended dietary allowance of vitamin A increases with age. Follow your healthcare provider's instructions. You may also consult the National Academy of Sciences "Dietary Reference Intake" or the U.S. Department of Agriculture's "Dietary Reference Intake" (formerly "Recommended Daily Allowances" or RDA) listings for more information.

Store at room temperature away from light, moisture, and heat.

Side Effects CentersAquasol A

Patient Detailed Avoid Taking

What happens if I miss a dose (Aquasol A)?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Aquasol A)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of vitamin A can cause serious or life-threatening side effects.

Overdose symptoms may include nausea, vomiting, loss of appetite, vision changes, hair loss, peeling skin, cracked skin around your mouth, changes in menstrual periods, dizziness, drowsiness, tired feeling, bone or joint pain, severe headache, pain behind your eyes, severe stomach pain, dark urine, or jaundice (yellowing of the skin or eyes).

What should I avoid while taking vitamin A (Aquasol A)?

Avoid taking orlistat (alli, Xenical) or mineral oil while you are taking vitamin A.

What other drugs will affect vitamin A (Aquasol A)?

Do not take vitamin A without your doctor's advice if you are also taking:

  • birth control pills;
  • a blood thinner such as warfarin (Coumadin, Jantoven);
  • bexarotene (Targretin);
  • cholestyramine (Questran, Prevalite);
  • acitretin (Soriatane);
  • tretinoin (Vesanoid); or
  • isotretinoin (Accutane, Sotret, Claravis, Amnesteem).

This list is not complete and other drugs may interact with vitamin A. Tell your healthcare provider about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about vitamin A.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 3.01. Revision date: 12/14/2011.

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