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ANEMO-XT

Quick Overview

Our aim is to reach out to the globe with in shortest possible time frame.


To promote this objective, not only we distribute and market our Hematinic range of products globally through our distribution channels but we also undertake ‘contract manufacturing’& ‘formulation development ’of our wide range of generic products such as ANEMO-XT Syrup, which contains: Ferrous Ascorbate equivalent to Elemental Iron 30 mg, Folic acid IP 550 mcg

ANEMO-XT

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Details

Composition:
Each 5 ml contains:
Ferrous Ascorbate equivalent to
Elemental Iron 30 mg
Folic acid IP 550 mcg
In Flavored Syrupy base
Colour: Caramel

Chemical Name
Ferrous Ascorbate: (2R)-2-[(1S)-1,2-dihydroxyethyl]-4,5-dihydroxyfuran-
3-one; iron(2+)
Folic Acid: (2S)-[4-[(2-amino-4-hydroroxypteridin-6-yl).

Category: Nutrient Supplements
Ferrous Ascorbate: Laevo-ascorbic acid iron salt
Folic Acid: B complex vitamin

PHARMACOLOGY
Pharmacodynamic Actions
Ferrous Ascorbate: Ferrous Ascorbate is a synthetic molecule of ascorbic
acid and iron. Iron is critical to a number of synthetic and enzymatic
processes. Most of the body iron is part of the hemoglobin molecule where
iron serves a key role in oxygen transport. Small amounts of iron are found in
myoglobin and in plasma (bound to transferrin). Iron is recycled and thus
conserved by the body.
Folic Acid: Folic Acid acts on megaloblastic bone marrow to produce a
normoblastic marrow. Exogenous source of folate is required for
nucleoprotein synthesis and the maintenance of normal erythropoiesis. Folic
Acid is the precursor of tetrahydro Folic Acid, which is involved as a cofactor
for transformylation reactions in the biosynthesis of purines and thymidylates
of nucleic acids. Impairment of thymidylate synthesis in patients with Folic
Acid deficiency is thought to account for the defective deoxyribonucleic acid
(DNA) synthesis that leads to megaloblast formation and megaloblastic and
macrocytic anemias.

Pharmacokinetic Actions
Ferrous Ascorbate
Absorption: Iron absorption occurs predominantly in the duodenum and
upper jejunum.
Distribution: 90% of iron is bound to protein.
Metabolism: Iron binds to transferrin and is transported to the spleen, bone
marrow and liver, which are the main storage sites for endogenous iron.

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Elimination: Because absorption is low and because iron is recycled in the
body, less than 1 mg/d of endogenous iron is lost by the skin, faeces and
urine.

Folic Acid
Absorption: Folic Acid is absorbed rapidly from the small intestine, primarily
from the proximal portion.
Distribution: Folic Acid appears in the plasma approximately 15 to 30 minutes
after an oral dose; peak levels are generally reached within 1 hour.
TetrahydroFolic Acid derivatives are distributed to all body tissues but are
stored primarily in the liver
Metabolism: Folic Acid is metabolized in the liver to 7, 8-dihydroFolic Acid
and eventually to 5, 6, 7, 8-tetrahydroFolic Acid with the aid of reduced
diphosphopyridine nucleotide (DPNH) and folate reductases.
Elimination: 90% of Foloic Acid is excreted through urine and a small amount
through the feaces.

INDICATIONS AND USAGE

  • In Iron deficiency anemia due to chronic blood loss,
  • hookworm infestation, inadequate intake of iron.
  • In megaloblastic anemias due to a deficiency of Folic Acid
  • (as may be seen in tropical or nontropical sprue).
  • In Dimorphic anaemia.
  • In anemias of nutritional origin, pregnancy, infancy, or childhood.
  • Tonic in general weakness, lack of appetite, r undown
  • conditions and convalescence.
  • Post-surgery and other debilitating conditions.
  • Anaemia due to excess blood loss in menstruation.

DOSAGE AND ADMINISTRATION
Ferrous Ascorbate
275 mg daily, divided into 3 equal doses for treatment of mild iron deficiency
550 mg divided into 3 equal doses for severe anemia.
Folic Acid
Adults and children up to 1 mg daily. When clinical symptoms have subsided
and the blood picture has become normal, a daily maintenance level should
be used, i.e., 0.1 mg for infants and up to 0.3 mg for children under 4 years of
age, 0.4 mg for adults and children 4 or more years of age, and 0.8 mg for
pregnant and lactating women. In the presence of alcoholism, hemolytic
anemia, anticonvulsant therapy, or chronic infection, the maintenance level
may need to be increased.

Adults and children over 12: 15ml to 30ml per day in divided doses.
Infants and Children below 12 years: 10ml to 15ml per day in divided doses.
Maintenance Dose: 5ml once or twice per day

CONTRAINDICATIONS
Ferrous Ascorbate
Ferrous Ascorbate is contraindicated in patients with hypersensitivity to Iron.
Iron supplementation (which circumvents this mechanism) should be
avoided in patients who have active bacterial infections.
Contraindicated in patients with Hemosiderosis, Hemochromatosis,
Hemolytic anemia.
Folic Acid
Folic Acid is contraindicated in patients who have shown previous intolerance
to the drug

SPECIAL WARNINGS & PRECAUTIONS
Ferrous Ascorbate
Oral iron preparations may aggravate existing peptic ulcer, regional enteritis
and ulcerative colitis.
Folic Acid
There is a potential danger in administering Folic Acid to patients with
undiagnosed anemia, since Folic Acid may obscure the diagnosis of
pernicious anemia by alleviating the hematologic manifestations of the
disease while allowing the neurologic complications to progress. This may
result in severe nervous system damage before the correct diagnosis is
made. Adequate doses of vitamin B12 may prevent, halt, or improve the
neurologic changes caused by pernicious anemia.

Drug Interactions
Ferrous Ascorbate
Decreased absorption of both iron and the concomitantly administered
dr ugs: Tetracycline, Penicillamine, Methyldopa, Levodopa,
Bisphosphonates, Quinolones and calcium. An interval of 2-3h between the
iron intake and that of the above drugs is advised.

Folic Acid
Folic Acid Antagonists: Methotrexate
Folic Acid Loss: Renal dialysis, concomitant administration of
anticonvulsants-(diphenylhydantoin, primidone, and barbiturates),
pyrimethamine and nitrofurantoin, antibiotics
( Tetracycline).
Decreased vitamin B12 serum levels may occur in patients receiving
prolonged Folic Acid therapy.

Pregnancy & Lactation
Ferrous Ascorbate
Ferrous Ascorbate can be used during pregnancy if clinically indicated. No
adverse effects of ferrous Ascorbate have been shown in breastfed infants of
treated mothers. Ferrous Ascorbate can be used during breast-feeding if
clinically indicated.

Folic Acid
Folic Acid is usually indicated in the treatment of megaloblastic anemias of
pregnancy as the requirements are markedly increased during pregnancy,
and deficiency will result in fetal damage. However, Folic Acid should be used
during pregnancy only if clearly needed. Folic Acid is excreted in the milk of
lactating mothers. During lactation, Folic Acid requirements are markedly
increased; however, amounts present in human milk are adequate to fulfill
infant requirements.

Effect to Drive & Use the Machine
Based on the pharmacodynamic properties and the adverse events profile, it
is unlikely that Ferrous Ascorbate and Folic Acid combination would cause an
impairment of driving performance or compromise the ability to use
machinery.

ADVERSE REACTIONS
Ferrous Ascorbate
GI: Diarrhoea or constipation, Epigastric abdominal discomfort, Black
colored stools
Folic Acid
GI: Anorexia, nausea, abdominal distention, flatulence, and a bitter or bad
taste,
CNS: Altered sleep patterns, difficulty in concentrating, irritability,
overactivity, excitement, mental depression, confusion, and impaired
judgement.
Allergy: Allergic sensitization has been reported following both oral and
parenteral administration of Folic Acid. Rare instances of allergic responses
include erythema, skin rash, itching, general malaise, and respiratory
difficulty due to bronchospasm.

OVERDOSAGE
Ferrous Ascorbate: Iron poisoning is rare in adults but serious acute
poisoning in children can result from ingestion of doses in excess of 1 g.
Symptoms (may occur within 30 minutes or may be delayed several hours)
are GI irritation and necrosis with vomiting, diarrhea, tarry stools,
hematemesis, fast and weak pulse, lethargy, low blood pressure, coma and
signs of peripheral circulatory collapse. There may be a transient period of
apparent recovery after 4 to 6 hours followed by a second crisis
characterized by cyanosis, pulmonary edema, circulatory collapse,
convulsion, and coma may then occur followed by death in 12 to 48 hours.
Treatment consists of induced emesis, orally eggs and milk should be fed (to
form iron-protein complexes) followed by gastric lavage with 1% sodium
bicarbonate solution (to convert the iron to a less soluble form). Gastric
lavage should not be performed after the first hour of iron ingestion because
of the danger of perforation due to gastric necrosis.
Folic Acid: No cases have been reported; but even extremely high doses are
unlikely to cause harm to the recipient.

Packing: 150 ml bottle.

Storage: Store in a cool and dry place.

Keep out of reach of children.

SHAKE WELL BEFORE USE

 
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