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Our new product   AMIVIT-ASTERIA
Trade name
AMIVIT-ASTERIA
Composition
Each capsule contains:
Active Ingredient
DL-Methionine ——————————————– 9.2 mg
L-Leucine ———————————————— 9.15 mg
L-Valine —————————————————- 5.0 mg
L-Isoleucine ———————————————– 5.0 mg
L-Threonine ———————————————– 5.0 mg
L- Tryptophan ——————————————— 5.0 mg
L-Phenylalanine —————————————— 5.0 mg
L-Lysine Hydrochloride —————————— 25.0 mg
Retinol Palmitate(Vitamin A) ———————- 1,000 IU
Ergocalciferol(Vitamin D2)—————————- 100 IU
Tocopherol Acetate 50%(Vitamin E)—————10.0 mg
Thiamine Mononitrate (Vitamin B1)—————- 2.5 mg
Riboflavin(Vitamin B2) ——————————– 1.5 mg
Nicotinamide (Vitamin B3)————————– 10.0 mg
Pyridoxine Hydrochloride(Vitamin B6) ———– 5.0 mg
Calcium Pantothenate———————————— 2.5 mg
Cyanocobalamin(Vitamin B12) ———————- 0.5 μg
Folic Acid ———————————————– 100.0 μg
Ascorbic Acid(Vitamin C) ————————— 25.0 mg
Inactive Ingredient
Colloidal Silicon Dioxide——————————–2.3 mg
Talc———————————————————-5.35 mg
Corn Starch————————————————32.5 mg
Sucrose ————————————————— 154.0 mg
Hydroxypropyl Cellulose——————————–6.0 mg
Povidone K-90———————————————-3.0 mg
Hypromellose 2910—————————————-3.0 mg
Polyethylene Glycol 6000——————————-1.0 mg
Sunset Yellow FCF———————————————q.s
Tartrazine ———————————————— 0.346 mg
Brilliant blue FCF———————————————–q.s
Allura red ———————————————————q.s
Pharmaceutical form-Capsules.
Description
Hard capsule, one side red, the other side transparent
body containing film coated granules of white, red,
yellow, green.
Pharmacotherapeutic group
Amino acids and Vitamin complex.
ATC Code-V06DE.
Pharmacodynamic properties
The following account summarizes the pharmacological
effects of the vitamins and minerals in this drug and
describes the conditions caused by deficiency of these.
Essential amino acid
Nine proteinogenic amino acids are called “essential” for
humans because they cannot be created from other
compounds by the human body.
Protein deficiency has been shown to affect all of the
body’s organs and many of its systems, including the
brain and brain function of infants and young children;
the immune system, thus elevating risk of infection; gut
mucosal function and permeability, which affects
absorption and vulnerability to systemic disease; and
kidney function. The physical signs of protein deficiency
include edema, failure to thrive in infants and children,
poor musculature, dull skin, and thin and fragile hair.
Biochemical changes reflecting protein deficiency
include low serum albumin and low serum tranferin.
Vitamin A
Vitamin A plays an important role in the visual process.
It is isomerised to the 11-cis isomer and subsequently
bound to the opsin to form the photoreceptor for vision
under subdued light. One of the earliest symptoms of
deficiency is night blindness which may develop into the
more serious condition xerophthalmia. Vitamin A also
participates in the formation and maintenance of the
integrity of epithelial tissues and mucous membranes.
Deficiency may cause skin changes resulting in a dry
rough skin with lowered resistance to minor skin
infections. Deficiency of Vitamin A, usually
accompanied by protein-energy malnutrition, is linked
with a frequency of infection and with defective
immunological defence mechanisms.
Vitamin D
Vitamin D is required for the absorption of calcium and
phosphate from the gastro-intestinal tract and for their
transport. Its involvement in the control of calcium
metabolism and hence the normal calcification of bones
is well documented. Deficiency of Vitamin D in children
may result in the development of rickets.
Vitamin E
Vitamin E deficiency has been linked to disorders such
as cystic fibrosis where fat absorption is impaired. It is
essential for the normal function of the muscular system
and the blood.
Vitamin B1 (Thiamine)
Thiamine (as the coenzyme, thiamine pyrophosphate) is
associated with carbohydrate metabolism. Thiamine
pyrophosphate also acts as a co-enzyme in the direct
oxidative pathway of glucose metabolism. In thiamine
deficiency, pyruvic and lactic acids accumulate in the
tissues. The pyruvate ion is involved in the biosynthesis
of acetylcholine via its conversion to acetyl co-enzyme A
through a thiamine-dependent process. In thiamine
deficiency, therefore, there are effects on the central
nervous system due either to the effect on acetylcholine
synthesis or to the lactate and pyruvate accumulation.
Deficiency of thiamine results in fatigue, anorexia,
gastro-intestinal disturbances, tachycardia, irritability
and neurological symptoms. Gross deficiency of
thiamine (and other Vitamin B group factors) leads to the
condition beri-beri.
Vitamin B2 (Riboflavine)
Riboflavine is phosphorylated to flavine mononucleotide
and flavine adenine dinucleotide which act as coenzymes
in the respiratory chain and in oxidative
phosphorylation. Riboflavine deficiency presents with
ocular symptoms, as well as lesions on the lips and at
angles of the mouth.
Nicotinamide
The biochemical functions of nicotinamide as NAD and
NADP (nicotinamide adenine dinucleotide phosphate)
include the degradation and synthesis of fatty acids,
carbohydrates and amino acids as well as hydrogen
transfer. Deficiency produces pellagra and mental
neurological changes.
Vitamin B6 (Pyridoxine)
Pyridoxine, once absorbed, is rapidly converted to the
co-enzymes pyridoxal phosphate and pyridoxamine
phosphate which play an essential role in protein
metabolism. Convulsions and hypochromic anaemia
have occurred in infants deficient in pyridoxine.
Calcium
Calcium is an essential body electrolyte. It is involved in
the maintenance of normal muscle and nerve function
and essential for normal cardiac function and the clotting
of blood. Calcium is mainly found in the bones and
teeth. Deficiency of calcium leads to rickets,
osteomalacia in children and osteoporosis in the elderly.
Pantothenic Acid
Pantothenic acid is incorporated into co-enzyme A and is
involved in metabolic pathways involving acetylation
which includes detoxification of drug molecules and
biosynthesis of cholesterol, steroid hormones,
mucopolysaccharides and acetylcholine. CoA has an
essential function in lipid metabolism.
Vitamin B12 (Cyanocobalamin)
Vitamin B12 is present in the body mainly as
methylcobalamin and as adenosylcobalaminand
hydroxocobalamin. These act as co-enzymes in the trans
methylation of homocysteine to methionine; in the
isomerisation of methylmalonyl co-enzyme to succinyl
co-enzyme and with folate in several metabolic pathways
respectively. Deficiency of Vitamin B12 interferes with
haemopoiesis and produces megaloblastic anaemia.
Folic Acid
Folic acid is reduced in the body to tetrahydrofolate
which is a co-enzyme for various metabolic processes,
including the synthesis of purine and pyrimidine
nucleotides and hence in the synthesis of DNA. It is also
involved in some amino acid conversion and in the
formation and utilisation of formate. Deficiency of folic
acid leads to megaloblastic anaemia.
Vitamin C (Ascorbic Acid)
Vitamin C cannot be synthesised by man therefore a
dietary source is necessary. It acts as a cofactor in
numerous biological processes including the
hydroxylation of proline to hydroxyproline. In
deficiency, the formation of collagen is, therefore,
impaired. Ascorbic acid is important in the
hydroxylation of dopamine to noradrenaline and in
hydroxylations occurring in steroid synthesis in the
adrenals. It is a reducing agent in tyrosine metabolism
and by acting as an electron donor in the conversion of
folic acid to tetrahydrofolic acid is indirectly involved in
the synthesis of purine and thymine. Vitamin C is also
necessary for the incorporation of iron into ferritin.
Vitamin C increases the phagocytic function of
leucocytes; it possesses anti-inflammatory activity and it
promotes wound healing. Deficiency can produce
scurvy. Features include swollen inflamed gums,
petechial haemorrhages and subcutaneous bruising. The
deficiency of collagen leads to development of thin
watery ground substances in which blood vessels are
insecurely fixed and readily ruptured. The supportive
components of bone and cartilage are also deficient
causing bones to fracture easily and teeth to become
loose. Anaemia commonly occurs probably due to
Vitamin C’s role in iron metabolism.
Pharmacokinetic properties
The following account describes the absorption and fate
of each of the active constituents of this drug.
Vitamin A
Except when liver function is impaired, Vitamin A is
readily absorbed. β-carotene (as in Amivit-Asteria ) is
Provitamin A and is the biological precursor to Vitamin
A. It is converted to Vitamin A (Retinol) in the liver;
retinol is emulsified by bile salts and phospholipids and
absorbed in a micellar form. Part is conjugated with
glucuronic acid in the kidney and part is metabolised in
the liver and kidney, leaving 30 to 50% of the dose for
storage in the liver. It is bound to a globulin in the blood.
Metabolites of Vitamin A are excreted in the faeces and
the urine.
Vitamin D
The metabolism of ergocalciferol is similar to that of
cholecalciferol. Cholecalciferol is absorbed from the
gastro-intestinal tract into the circulation. In the liver, it
is hydroxylated to 25-hydroxycholecalciferol, is subject
to entero-hepatic circulation and is further hydroxylated
to 1,25-dihydroxycholecalciferol in the renal tubule cells.
Vitamin D metabolites are bound to specific plasma
proteins.
Vitamin E
Vitamin E is absorbed from the gastro-intestinal tract.
Most appears in the lymph and is then widely distributed
to all tissues. Most of a dose is slowly excreted in the
bile and the remainder is eliminated in the urine as
glucuronides of tocopheronic acid or other metabolites.
Vitamin B1 (Thiamine)
Thiamine is absorbed from the gastro-intestinal tract and
is widely distributed to most body tissues. Amounts in
excess of the body’s requirements are not stored but
excreted in the urine as unchanged thiamine or its
metabolites.
Vitamin B2 (Riboflavine)
Riboflavine is absorbed from the gastro-intestinal tract
and in the circulation is bound to plasma proteins. It is
widely distributed. Little is stored and excess amounts
are excreted in the urine. In the body riboflavine is
converted to flavine mononucleotide (FMN) and then to
flavine adenine dinucleotide (FAD).
Nicotinamide
Nicotinic acid is absorbed from the gastro-intestinal
tract, is widely distributed in the body tissues and has a
short half-life.
Vitamin B6 (Pyridoxine)
Pyridoxine is absorbed from the gastro -intestinal tract
and converted to the active pyridoxal phosphate which is
bound to plasma proteins. It is excreted in the urine as 4-
pyridoxic acid.
Calcium Pantothenate
Pantothenic acid is readily absorbed from the gastrointestinal
tract and is widely distributed in the body
tissues. About 70% of pantothenic acid is excreted
unchanged in the urine and about 30% in the faeces.
Vitamin B12 (Cyanocobalamin)
Cyanocobalamin is absorbed from the gastro-intestinal
tract and is extensively bound to specific plasma
proteins. A study with labelled Vitamin B12 showed it
was quickly taken up by the intestinal mucosa and held
there for 2 – 3 hours. Peak concentrations in the blood
and tissues did not occur until 8 – 12 hours after dosage
with maximum concentrations in the liver within 24
hours. Cobalamins are stored in the liver, excreted in the
bile and undergo enterohepatic recycling. Part of a dose
is excreted in the urine, most of it in the first eight hours.
Folic Acid
Folic acid is absorbed mainly from the proximal part of
the small intestine. Folate polyglutamates are considered
to be deconjugated to monoglutamates during
absorption. Folic acid rapidly appears in the blood where
it is extensively bound to plasma proteins. Some folic
acid is distributed in body tissues, some is excreted as
folate in the urine and some is stored in the liver as
folate.
Vitamin C (Ascorbic Acid)
Ascorbic acid is readily absorbed from the gastrointestinal
tract and is widely distributed in the body
tissues. Ascorbic acid in excess of the body’s needs is
rapidly eliminated in the urine and this elimination is
usually accompanied by a mild diuresis.
Indications
1. As a therapeutic nutritional adjunct in conditions
where the absorption of vitamins and minerals is
suboptimal, e.g. malabsorption, inflammatory bowel
disease and fistulae, short bowel syndrome and
Crohn’s disease, and where concurrent medication
decreases vitamin and mineral absorption.
2. As a therapeutic nutritional adjunct in
convalescence from illness, e.g. where anorexia or
cachexia exists and following chemo- or radiotherapy.
3. As a therapeutic nutritional adjunct in
convalescence from surgery, e.g. where nutritional
intake continues to be inadequate.
4. As a therapeutic nutritional adjunct where food
intolerance exists, e.g. exclusion diets.
Dosage and Administration
Adults and children over 15 years of age: 2 capsules, 1-2
times daily. Take after meal with water.
The dosage may be adjusted depending on the age and
symptoms of disease.
Contraindications
– Patients with hypersensitivity to active substances or to
any of the excipients.
-Hypercalcaemia, haemochromatosis, sarcoidosis and
renal disorder patients.
-Vitamin C should be given with care to patients with
hyperoxaluria.
-Amino acid metabolism disorders.
-Severe hyperglycaemia.
-Metabolic acidosis, hyperlactataemia.
– Sepsis, essential hypertension, liver disease, diabetes
mellitus type 2.
-Hypervitaminosis A or D.
-Children under 15 years.
Undesirable effects
Immune system disorders:
Hypersensitivity
Nervous system disorders:
Headache, dizziness, insomnia
Gastro-intestinal disorders:
Nausea, vomiting, diarrhea, abdominal pain,
constipation, anorexia
Skin and subcutaneous tissue disorders:
Itching or skin rednessrash, pruritus.
Overdose
If administered by high dose for long-term, the resistance
may be caused.
If pyridoxine overdose (50mg-2g /day) is taken for longterm,
neuropathy may occur.
If patients who folic acid is insufficient are administrated
by 10g of vitamin B12 daily, the
hematological adverse reaction can appear.
It can cause peptic ulcer, glucose tolerance impairment,
hyperuricemia, and liver damage from a high dose.
Warnings and Precautions
Warnings
-Do not exceed 5,000IU of vitamin A daily in case of
suspected pregnant or less than 3 months pregnant
women. Exceeding the recommended dosage of vitamin
A (5,000IU/day) may cause embryo deformity. (Except
deficiency patient of vitamin A)
Precautions
– Keep the recommended dosage and administration.
– If symptoms are not improved, consult with your
doctor or pharmacist.
– In case of children, administrate under the supervision
of a doctor or pharmacist.
– Since vitamin A has been adequately supplied with the
daily meals, do not exceed 5,000IU of vitamin A daily.
– Detection of blood sugar can be interfered in case of
urinalysis.
– Urine can be changed to yellow and it can affect the
clinical test values.
– Vitamin D is excreted in human milk and it may cause
hypercalcemia to newborn babies.
– Sunset yellow, tartrazine: May cause allergic reactions.
– Sucrose: If you have been told by your doctor, that you
have intolerance to some sugars, contact your doctor
before taking this medicinal product.
-Do not take Amivit-Asteria on an empty stomach.
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use
machines have been performed.
Pregnancy and Lactation
Controlled studies with pregnant women are not
available.
Controlled studies with women using multivitaminmineral
preparations at the usual dosage during the
course of the first trimester resulted in no fetal risks.
There are no signs indicating a risk if this type of
preparation is taken during the second and third
trimesters, and the probability of injuring the fetus
appears to be very low.
Large doses of vitamin A (10,000 IU per day) have been
found to be teratogenic if administered during the first
trimester of pregnancy. Vitamin D given during the last
trimester of pregnancy may cause hypercal caemia in
infants. As with many other medicines an assessment of
benefits versus risks should be made before this product
is administered during this period.
AMIVIT-ASTERIA should not be taken during
pregnancy or lactation.
Interaction
Do not concomitantly use with other drugs containing
vitamins and minerals.
Do not take L-DOPA (L-3, 4-dihydroxyphenylalanine)
while using this drug.
When taking vitamin E, risk of thrombosis can be
increased for women taking oral contraceptives including
estrogen and patients with thrombosis.
Vitamin E containing drugs should be used with caution
in patients receiving anticoagulants.
Cyanocobalamin
Increases the risk of any allergic reactions, as well as
reduce the extent of absorption of vitamin B12, the
following drugs:
 colchicine;
 medicines that address the manifestations of
epilepsy;
 potassium preparations;
 salicylates;
 aminoglycosides.
Vitamin B6
The effect of vitamin B6 present in may be weakened
due to reception:
 oral contraceptives containing estrogen in their
composition;
 cycloserine;
 penicillamine;
Vitamin B6, adopted together with levodopa may
weaken the effect of the latter. A received
simultaneously with diuretics, it may, on the contrary, to
enhance their action.
Pyridoxine hydrochloride well with such drugs:
 glutamic acid;
 cardiac glycosides. In this case, vitamin B6
enhances the degree of synthesis of contractile
proteins in the cardiac muscle – the myocardium.
Vitamin C
 Drugs which induce tissue desaturation of ascorbic acid
include aspirin, nicotine from cigarettes, alcohol, several
appetite suppressants, iron, phenytoin, some anticonvulsant
drugs, the oestrogen component of oral
contraceptives and tetracycline.
 Patients with kidney failure given aluminium antacids
and oral citrate can develop a potentially fatal
encephalopathy due to marked rise in blood aluminium
levels. There is evidence that vitamin C may interact
similarly
 Oral contraceptives lower serum levels of ascorbic acid.
Legal Status
OTC.
Storage
Store in airtight container below 30℃.
Protect from light.
Keep out of reach of children.
Shelf life
3 years.
Package
10 capsules x 3 blisters/box.
Manufacturer
Hankook Korus Pharm Co., Ltd.
30, Gangjeo-ro, Jecheon-si, Chungcheongbuk-do,
Republic of Korea.
Marketing Authorization Holder
GL Corporation, Seoul, Republic of Korea.
Woori Venture Tower #201, 70, Seonyu-ro,
Yeongdeungpo-ku, Seoul, Republic of Korea.