Drug Interaction:
Interacting drugs- summary
+ Vitamin A
Cholestyramine
reduce absorption of vitamin A due to reduced availability of fat
soluble bile salts.
Mineral oil-
interfere with the intestinal absorption of vitamin A.
Contraceptives oral
significantly increase plasma vitamin A levels.
Indication:
New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing (Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Vitamin A Oily As palmiate 2000IU 23-06-2010
+ Vitamin B1 1mg
+ Vitamin B2 1mcg
+ Ascorbic acid 33.3mg
+ Vitamin D3 200iu
+Folic acid 0.3mg
+CalciumPantothenate 1mg
+ Niacinamide 15mg
+ Dibasic Calcium phosphate 100mg
+ Phosphorus 77mg
+ Ferrous Fumarate 50mg
+Copper 0.01mg
+ Potassium iodide 0.0015mg
+ Heavy Magnesium Oxide 1mg
+ Manganese Sulphate 0.01mg
+ Potassium Sulphate 1mg
+ Zinc Sulphate 0.15mg capsule
For the treatment of Vitamin deficiency states in adults
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
1.Vit A oily form as palmitate 2000IU + 23-06-2010
Vit B1 1mg +
Vit B2 1mg +
Vit B6 1.34mg +
Vit B12 1mcg +
Ascorbic acid 33.3mg +
Vit D3 200 IU +
Folic acid 0.3mg +
Cal Pantothenate 1mg +
Nicianamide 15mg +
Dibasic cal Phosphate 100mg +
Phosphurus 77mg +
Ferrous fumarate 50mg
Copper 0.01mg +
Pot Iodide 0.0015mg+
Heavy Mag oxide 1mg +
Manganese sulphate 0.01mg +
Pot sulphate 1mg
Zinc sulphate 0.15mg capsule
For treatment of Vitamin deficiency states in adults
2. Vitamin A ,D.E July 1969
Vitamin A deficiency
Adverse Reaction:
Anaphylactic shock and death have been reported after IV use. Acute toxicity,signs of increased intracranial pressure within 8 to 12 hours.
Hypervitaminosis- manifests as cirrohotic-like liver syndrome,viz., malaise, lethargy, night sweats, abdominal discomfort, anorexia, vomiting. Slow growth, hard tender thickening over radius and tibia, migratory arthalgia, premature closure of epiphysis, bone pain Irritabilty, headache, vertigo, increased intracranial pressure. Lip fissure, drying and cracking of skin, alopecia, scaling, massive desquamation, increased pigmentation, generalised pruritus, erythema, inflammation of tongue, lips and gums
Discontinue vitamin A if hypercalemia persists, Give IV saline, prednisolone and calcitonin as required. Perform liver function tests., liver damage may be permanent
Contra-Indications:
Hypervitaminosis A, oral use in maladsorption syndrome, hypersensitivity,IV use.
Special precautions: Closely supervise prolonged daily administration over 25000 IU. Evaluate vitamin A intake from fortified foods, dietary supplements, self-administered drugs and prescription drug sources. Blood level assays are not a direct measure of liver storage. Liver storage must be adequate before discontinuing therapy.
Single vitamin A deficiency is rare. Multiple vitamin deficiency is expected in any dietary defiency.
Acne- Efficacy of large systemic doses of vitamin A in the treatment of acne has not been established.In view of the potential for toxicity,avoid this use.
Dosages/ Overdosage Etc:
Indications:
Vitamin A deficiency
Dosage:
Severe deficiency- 500,000 IU/day for 3 days, followed by 50,000 IU/day for 2 weeks.
Storage: Protect IM from sunlight
Other Information:
For Availability/supplies
Contact -
1.Indian Drug Manufacturers Association (IDMA)
Phone- 022- 24944624/ 24974308
Fax- 022- 24950723
Email- idma@vsnl.com
Website: www.idma-assn.org
2.Bulk Drug Manufacturers Association (India)(BDMA)
Phone - 040-23703910/ 23706718
Fax- 040-23704804
Email- info@bdmai.org
Website: www.info@bdmai.org
Pseudotumor cerebri- ( 1955 )
In the condition of pseudotumor cerebri ( meningeal hydrops ) the patient more often tha a child or young woman complains of headaches, of some weeks standing and when first eaxamined is found to have papilledema, or choked disks, with slightly constricted visual fields and enlarged blind spots. Drugs causing adverse reactions- ( 388 )
1. Corticosteroids
2. Oral contraceptives
3. Tetracycline
4. Hypervitaminos - A
Patient Information:
1.Avoid prolonged use of mineral oil and cholestyramine while taking the drug.
2. Do not exceed recommended dosage, especially during pregnancy. Notify
physician if signs of overdosage( eg. nausea, vomiting, anorexia, malaise,
dry/cracking skin/lips, irritability, hair loss) or bulging fontanelle in infants occur
Ref - USP PDI Vol II 17th Edition (1997)
VITAMIN A - SYSTEMIC
1.Allergies-
Tell your doctor if you have ever had any unusual or allergic reaction to
Vitamin A . Also tell your healthcare care professional if you are allergic
to any other substances such as foods. preservatives or dyes.
2.Pregnancy-
It is especially important that you are receiving enough vitamins when
you become pregnant and that you continue to receive the right amount
of vitamins throughout your pregnancy. The healthy growth and the
develoment of the fetus depend on the steady supply of nutrients from
the mother.
However, taking too much Vitamin A more than 1800 RE (6000 units) during
the pregnancy can also cause harmful effects as birth defects or slow
reduction of growth of the child.
3. Breast-feeding-
It is especially important that you receive the right amounts of vitamins
so that your baby also gets the vitamins needed to grow properly.
However, taking large amounts of a dietary supplement while breast-feeding
may be harmful to the mother and/or baby and should be avoided
4.Children-
Problems in children have not been reported with normal daily recommended
amounts. However, side effects of high doses and /or prolonged use of
Vitamin A are more likely to occur in young childen than in adults.
5.Older adults-
Problems in older adults have not been reported with normal intake of daily
recommended amounts. However, studies have shown that the elderly may be
at risks of high blood levels of Vitamin A with long term use.
6. Other medicines-
When you taking Vitamin A it is especially important that your doctor know ,
if you are using any of the following medicines.
Eretinate or
Isotretinoin - use with vitamin A may cause high blood levels of Vitamin A
which may increase the chance of side effects.
7. Other medical problems-
The presence of other medical problems may affect the use of Vitamin A.
Make sure you tell your doctor if you have any other medical problems
especially-
Alcohol abuse 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
Pharmacology/ Pharmacokinetics:
Pharmacolgy:
Absorption from aqueous vehicle is greater than from oily solution.
Pharmacology:
Vitamin A is fat soluble; absorption requires bile salts, pancreatic lipase and dietary fat.. The excretion pathways are uncertain; a major portion appears to be excreted in the bile bound to a glucoride and a small amount is excreted in the urine
Interaction with Food:
Not significant
Pregnancy and lactation:
Pregnancy:
Safety for amounts exceeding 5000iu oral or 6000iu parentral daily during pregnancy has not been established.
Lactation:
Human milk supplies sufficient vitamin A for infants unless matenal diet is grossly inadequate.
Manufacturer Details