Formulated Dosage Forms

HEMCLOFER Capsules

COMPOSITION
Each Serving size: 1 capsule contains

Ferrous fumerate 60mg

Calcium L-5-Methyltetrahydrofolate 1mg

Methylcobalamin 500mcg

Pyridoxine Hcl 10mg

PRODUCT DESCRIPTION

Hemclofer capsules are used for the treatment of Anemias as indicated below. It contains the common substances used in the prevention and treatment of anemic conditions.

MECHANISM OF ACTION AND PHARMACOKINETICS
FERROUS FUMERATE
Ferrous fumerate is used as a source of Iron for Iron-deficiency anemia. Iron formulations exert haematinic action by being an essential constituent of Haemoglobin. It is necessary for the oxidative process of living tissues. Ferrous fumerate has strong efficacy and it does not precipitate proteins and does not interfere with enzymes of digestive system.

CALCIUM L-5-METHYLTETRAHYDROFOLATE
Calcium L-5- Methyltetrahydrofolate is the active form of folate which need not be activated by the variants of folate dependent enzymes. Directly absorbed as L-Methylfolate and directly involved in lowering homocysteine blood levels. The only form of folate able to cross the blood brain barrier with 100 % bioavailabilty. It is a Hematologic agent (concerned with blood, the blood-forming organs, and blood diseases), which stimulates the hematopoietic system. Childrens, adults and old age require Folic acid to produce healthy red blood cells and prevent anemia. safe as demonstrated by extensive toxicological studies. Calcium L-5- Methyltetrahydrofolate increases the RBC Count and Heamoglobin in anemic patients and pregnancy periods.

METHYLCOBALAMIN
Methylcobalamin is an essential constituent for growth, Cell Reproduction, Hematopoiesis, and nucleoprotein and myelin synthesis. Absorbed in the tissues which is essential for conversion of methyl-malonate to succinate and synthesis of methionine from homocystine. It is also associated with fat and carbohydrate metabolism and protein synthesis. Cells characterized by rapid division such as epithelial cells, bone marrow, and myeloid cells appear to have greatest requirement of Methylcobalamin.

PYRIDOXINE
Vitamin B6 is a collective term for Pyridoxine, Pyridoxal, Pyridoxamine and their phosphorylated derivatives such as Pyridoxine phosphate, Pyridoxal phosphate and Pyridoxamine derivatives respectively. Vitamin B6 is essential for the metabolism of amino acid, glycogen and fatty acids, for nerve functions, for the formation of red blood cells and also helps the skin healthy. Vitamin B6 is also used for the synthesis of nucleic acid, Haemoglobin, Sphingomyelin, other Sphingolipids, Serotonin, Dopamine, Noradrenaline and GABA.

PHARMACOLOGY
Hematopoiesis, the production from undifferentiated stem cells of circulating erythrocytes, platelets and leukocytes, is a remarkable process that produces over 200 billion new cells per day in normal person and even greater numbers of blood cells in people with conditions that cause loss or destruction of blood cells. The hematopoietic machinery resides primarily in the bone marrow in adults and requires a constant supply of three essential nutrients – iron, vitamin B12 and folic acid.

Iron deficiency is the most common cause of chronic anemia. Like other forms of chronic anemia, iron deficiency anemia leads to pallor, fatigue, dizziness, exertional dyspnea and other generalized symptoms of tissue ischemia. The cardiovascular adaptations to chronic anemia – tachycardia, increased cardiac output, and vasodilatation – can worsen the condition of patients with underlying cardiovascular disease. Normally, only small amount of iron is lost from the body each day, so dietary requirement is small and easily fulfilled by the iron available in a wide variety of foods. However, in special populations with either increased iron requirements, e.g., growing children, pregnant women, or increased losses of iron, For example menstruating women iron requirements can exceed normal dietary supplies and iron deficiency can develop.

Reduced forms of folic acid are required for essential biochemical reactions that provide precursors for the synthesis of amino acids, purines and DNA. Folate deficiency is not uncommon, even though the deficiency is easily corrected by administration of folic acid. The consequences of folate deficiency not only include megaloblastic anemia but also go beyond, and is a cause of congenital malformation in newborns and play a role in vascular disease Methycobalamin serves as a cofactor for several essential biochemical reactions in humans. Deficiency of vitamin B12 leads to anemia, gastrointestinal symptoms and neurological abnormalities. Humans get most of their vitamin B12 from meat; bacteria in human colon synthesize it but it is not absorbed from this part of the intestine. Dietary deficiency of vitamin B12 is virtually confined to vegetarians.

Vitamin B6 is a coenzyme for transamination and is concerned with many metabolic processes. Pyridoxine-responsive anemia is a well-documented condition. Vitamin B6 in improves hematopoiesis in up to 50% of patients with either hereditary or acquired sideroblastic anemia. Characteristically, these patients show impairment in hemoglobin synthesis and an accumulation of iron in the Perinuclear mitochondria of Erythroid precursor cells, so-called ringed sideroblasts. Oral therapy with vitamin B6 is of proven benefit in correcting the sideroblastic Anemias associated with the Antitubercular drugs, which act as formers antagonists. Vitamin B6 is also used for a variety of conditions including premenstrual tension, vomiting in pregnancy and radiation sickness.

INDICATIONS
Hemclofer Capsules is indicated in Iron deficiency anemia. The conditions, which predispose to Anemia include Nutritional deficiency, Pregnancy, Lactation, Mal absorption syndrome, Megaloblastic Anemia, Folic acid deficiency, Anemias of pregnancy, Nutritional anemia

CONTRA-INDICATIONS
Hypersensitivity to any of the ingredients with Symptoms of iron intolerance

PRECAUTIONS
Occasional gastrointestinal discomfort with the use of iron preparations may be minimized by taking with meals and by slowly increasing to the recommended dosage. The use of this formulation is to be discontinued if symptoms of intolerance develop. Egg and milk inhibit absorption of iron.

PREGNANCY & LACTATION
Hemclofer Capsules may be used during pregnancy and lactation.

DOSAGE & ADMINISTRATION
The Usual Recommended dose of Hemclofer is one capsule daily or as prescribed by the Healthcare professional.

STORAGE CONDITIONS:
Store in a cool dry and dark place

PRESENTATION
Hemclofer is available in a Alu Alu pack of 10 capsules.

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