Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3078
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AQUASOL A (Injection, Solution)
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| dailymed-instance:dosage |
For intramuscular use. 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.
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| dailymed-instance:descripti... |
AQUASOL A Parenteral (water-miscible vitamin A Palmitate) provides 50,000 USP Units of
vitamin A per mL as retinol (CHO) in the
form of vitamin A palmitate, a light yellow to amber oil. The structural
formula of retinol is: Ordinarily oil-soluble,
the vitamin A in this product has been water solubilized by special
processingand 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.
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| dailymed-instance:clinicalP... |
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 epithelial 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 chylomicron fraction of the lymph.
Vitamin A is 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.
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| dailymed-instance:contraind... |
The intravenous administration.
Hypervitaminosis A. Sensitivity to any of the ingredients in this
preparation.<br/>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
overdosage in several species. Malformations of the central nervous
system, the eye, the palate, and the urogenital tract are recorded.
Vitamin A in excess of the recommended dietary allowance is contraindicatedin women who are or may become pregnant.
If vitamin A is 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.
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| dailymed-instance:supply |
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.
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| dailymed-instance:inactiveI... | |
| dailymed-instance:precautio... |
General:: Protect from light.
Prolonged daily dose administration over 25,000 Units vitamin A should
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.<br/>Drug Interactions:: Women on oral contraceptives
have shown a significant increase in plasma vitamin A levels.<br/>Carcinogenesis:: There are no studies
that show that administration of vitamin A will cause or prevent cancer.<br/>Pregnancy Category X:: See CONTRAINDICATIONS
section.<br/>Nursing Mothers:: The U.S. Recommended
Daily Allowance (RDA) of vitamin A (5,000 Units) is recommended for
nursing mothers.
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| dailymed-instance:overdosag... |
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) Chronic toxicity (4,000 Units/kg body weight for 6 to 15 months)<br/>Hypervitaminosis A Syndrome:: The treatment of hypervitaminosis
A consists of immediate withdrawal of the vitamin along with symptomatic
and supportive treatment.
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| dailymed-instance:genericMe... |
Vitamin A Palmitate
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| dailymed-instance:fullName |
AQUASOL A (Injection, Solution)
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| dailymed-instance:adverseRe... |
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 including one case of an anaphylactoid type reaction.
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| dailymed-instance:warning |
Avoid overdosage. Keep out
of the reach of children.<br/>Pediatric Use:: Polysorbates have been associated with
E-Ferol syndrome (thrombocytopenia, renal dysfunction, hepatomegaly,
cholestasis, ascites, hypotension and metabolic acidosis) in low birthweight
infants.
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| dailymed-instance:name |
AQUASOL A
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