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This tablet is indicated for the treatment and prevention of Iron, Folic Acid and Zinc deficiencies.

Iron, Vitamin & Mineral Combined preparation

This tablet is the preparation of Iron, Folic Acid and Zinc. In this preparation, Iron is present as Iron (III) Hydroxide Polymaltose Complex, a noble Iron preparation. It contains non-ionic Ferric Iron and Polymaltose in a stable complex. This complex facilitates a controlled absorption of the Iron when it comes in contact with the mucosal cell surface. Due to non-ionic nature, Iron (III) Hydroxide Polymaltose Complex is more stable than conventional Iron form. Folic Acid helps in the proper development of the fetus. Zinc keeps enzymes working and helps to metabolize proteins.

One tablet daily. Two tablets may be required a day in severe cases or as directed by the physician.

This tablet is generally well tolerated. However, a few side effects of oral Iron preparations, including nausea, vomiting, constipation or diarrhoea may occur rarely.

This tablet is contraindicated in patients with a known hypersensitivity to any of the ingredients of this product.

As with all Iron preparations, dark coloration of the stool may occur which is without clinical significance.

Since Iron is complex bound, ionic interaction with foodstuff components (phytates, oxalates, tannin etc.) and concomitant administration of medicaments (tetracyclines, antacids) are unlikely to occur.

Use of any drug during the first trimester of pregnancy should be avoided if possible. Thus administration of Iron in the first trimester requires definite evidence of Iron deficiency.

No intoxication or Iron overloaded has been reported in case of overdose.

Keep in a cool & dry place away from light and moisture. Keep out of the reach of children.

It is indicated for the treatment and prophylaxis of Iron, Folic Acid and Zinc deficiency especially during pregnancy and lactation.

Iron, Vitamin & Mineral Combined preparation

This timed-release capsule is the combined preparation of Carbonyl Iron, Folic Acid and Zinc Sulphate Monohydrate. It contains Carbonyl Iron with not less than 98% Iron content. Carbinyl Iron, having high bioavailability and low toxicity is safer and more effective choice for iron supplementation.

Adult: One Capsule daily before food or as directed by the physician.

Gastrointestinal irritations such as nausea, anorexia, vomiting, discomfort, constipation and diarrhoea may occur. Patients may complain of dark stool. Carbonyl Iron pellets incorporated into the capsules to reduce the possibility of gastrointestinal irritations. Rarely there may be allergic reactions.

It is contraindicated in patients with known hypersensitivity to any of its component or those with Iron overload.

Special care should be taken in patients with Iron overload states, such as haemochromatosis, haemolytic anaemia or red blood cell aplasia. Failure to response to the treatment requires further investigations to exclude other causes of anaemia. In patients with renal failure there may be the risk of Zinc accumulation.

Carbonyl Iron decreases the absorption of tetracycline antibiotics, quinolone antibiotics, levodopa, levothyroxine, methyldopa and penecillamine. Folic Acid interacts with antiepileptics, so plasma concentrations of phenobarbital, phenytoin and primidone are possibly reduced.

Use of any drug during first trimester of pregnancy should be avoided if possible. Thus administration of Iron during the first trimester requires definite evidence of Iron deficiency. Prophylaxis of Iron deficiency where inadequate diet calls for supplementary Zinc and Folic acid is justified during the remainder of pregnancy.

Symptoms of Carbonyl Iron include decreased energy, nausea, abdominal pain, tarry stool, weak, rapid pulse, fever, coma, seizures.

Store below 30°C. and keep away from light and moisture. Keep all medicines out of the reach of children.

This is indicated for the treatment and prophylaxis of Iron, Folic Acid and Zinc deficiency especially during pregnancy and lactation.

Iron, Vitamin & Mineral Combined preparation

Adult or Elderly: 1 capsule daily. In more severe cases, 2 capsules daily may be required.

Children: Aged over 1 year: 1 capsule daily. The capsule may be opened and the pellets to be mixed with soft cool food, but they must not be chewed.

Dark stools are usual during iron therapy and nausea and other symptoms of gastrointestinal irritation such as anorexia, vomiting, discomfort, constipation and diarrhoea are sometimes encountered. Zinc may also produce a gastrointestinal upset. These timed-release capsules are designed to reduce the possibility of gastrointestinal irritation. There have been rare reports of allergic reactions

Do not use in patients hypersensitive to the components of the product or those with iron overload.

Care should be taken in patients who may develop Iron overloads, such as those with haemochromatosis, haemolytic anaemia or red cell aplasia. Failure to respond to treatment may indicate other causes of anaemia and should be further investigated. Iron & Zinc chelate with tetracycline and absorption of all three agents may be impaired. The absorption of Zinc may be reduced in the presence of Iron. Absorption of Iron may be impaired by penicillamine and by antacids. Such potential interactions can be reduced by separating the administration of each product by several hours. In patients with renal failure a risk of Zinc accumulation could exist.

Use of any drug during the first trimester of pregnancy should be avoided if possible. Thus administration of Iron during the first trimester requires definite evidence of Iron deficiency where inadequate diet calls for supplementary Zinc and Folic acid is justified during the remainder of the pregnancy.

Iron overdosage is dangerous, particularly in children and requires immediate attention. Gastric lavage should be carried out in the early stages, or if this is not possible vomiting should be induced. These procedures should not be undertaken where signs of the corrosive effects of zinc are present. Give oral desferrioxamine (2 gm for a child or 5 gm for an adult) and demulcent. If serum Iron levels at 4 hours or more post-ingestion are over 5mg/l in a child or 8 mg/l in adults, or if the patient is in shock of coma, intravenous desferrioxamine should be used. Zinc Sulphate in gross over dosage is corrosive. Symptoms are those of gastrointestinal irritation leading in severe cases to haemorrhage, corrosion of the mucosa and possible later stricture formation. Gastric lavage or emesis should be avoided. Demulcents such as milk should be given. Chelating agents such as Dimercaprol, Penicillamine or Edetic Acid have been recommended.

Symptomatic and supportive measures should be given as required. The timed-release capsule presentation may delay excessive absorption of Iron and Zinc and allow more time for initiation of appropriate counter-measure.

Protected from light and moisture, store below 30˚C. Keep out of reach of children.

Parenteral Iron Preparations

The therapeutic class of Iron Sucrose is haematinic. Iron Sucrose Injection USP is a brown, sterile, aqueous, complex of Polynuclear Iron (III) Hydroxide in Sucrose for Intravenous use. The drug product contains approximately 30% Sucrose w/v (300 mg/ml) and has a pH of 10.5-11.1. Following intravenous administration, Iron Sucrose Injection is dissociated into Iron and Sucrose by the reticuloendothelial system, and Iron is transferred from the blood to a pool of Iron in the liver and bone marrow. Ferritin, an Iron storage protein, binds and sequesters Iron in a nontoxic form, from which Iron is easily available. Iron binds to plasma transferrin, which carries Iron within the plasma and the extracellular fluid to supply the tissues. The transferrin receptor, located in the cell, and the transferrin-receptor complex is returned to the cell membrane. Transferrin without Iron (apotransferrin) is then released to the plasma. The intracellular Iron becomes (mostly) haemoglobin in circulating red blood cells (RBCs). Transferrin synthesis is increased and ferritin production reduced in Iron deficiency. The converse is true when Iron is plentiful. Its elimination halflife is 6 h, total clearance is 1.2 L/h, non-steady state apparent volume of distribution is 10.0 L and steady state apparent volume of distribution is 7.9 L. In Iron Sucrose, its Iron component appears to distribute mainly in blood and to some extent in extravascular fluid. A significant amount of the administered Iron distributes in the liver, spleen and bone marrow and that the bone marrow is an Iron trapping compartment and not a reversible volume distribution. The sucrose component is eliminated mainly through urinary excretion.

Adults and Elderly: 5-10 ml Iron Sucrose Injection (100-200 mg Iron) once to three times a week depending on the hemoglobin level.

Children: There is limited data on children under study conditions. If there is a clinical need, it is recommended not to exceed 0.15 ml Iron Sucrose Injection (3 mg Iron) per kg body weight once to three times per week depending on the haemoglobin level.

Intravenous injection: Iron Sucrose Injection can also be administered undiluted by slow intravenous injection at the (normal) recommended rate of 1 ml Iron Sucrose Injection (20 mg Iron) per minute [5 ml Iron Sucrose Injection (100 mg Iron) in 2 to 5 minutes]. A maximum of 10 ml Iron Sucrose Injection (200 mg Iron) can be injected per injection. Before administration of the therapeutic dose in a new patient, a test dose of 1 ml Iron Sucrose Injection (20 mg Iron) in adults and in children with a body weight greater than 14 kg and half the daily dose (1.5 mg Iron/kg) in children with a body weight less than 14 kg should be injected over 1 to 2 minutes. If no adverse reactions occur within a waiting period of 15 minutes, the remaining portion of the injection can be administered at recommended speed. After an injection the arm of the patient should be extended.

Infusion: Iron Sucrose Injection should preferably be administered by drip infusion (in order to reduce the risk of hypotensive episodes and paravenous injection) in a dilution of 1 ml Iron Sucrose Injection (20 mg Iron) in max. 20 ml 0.9% w/v Sodium Chloride [5 ml (100 mg Iron) in max. 100 ml 0.9% w/v NaCI etc. up to 25 ml (500 mg Iron) in max. 500 ml 0.9% w/v NaCI]. Dilution must take place immediately prior to infusion and the solution should be administered as follows: 100 mg Iron in at least 15 minutes; 200 mg Iron in at least 30 minutes; 400 mg Iron In at least 1.5 hours, and 500 mg Iron in at least 3.5 hours. Further of the maximum tolerated single dose of 7 mg Iron/kg body weight, an Infusion time of at least 3.5 hours has to be respected, independently of the total dose.

Before administration of the therapeutic dose in a new patient the first 20 mg Iron in adults and in children with a body weight greater than 14 kg and half the daily dose (1.5 mg lron/kg) in children with a body weight less than 14 kg should be infused over 15 minutes as a test dose. If no adverse reactions occur, the remaining portion of the infusion can be administered at recommended speed.

The use of Iron Sucrose is contraindicated in patients with evidence of Iron overload, in patients with known hypersensitivity to Iron Sucrose or any of its inactive components, and in patients with anaemia not caused by Iron deficiency. It is also contraindicated in patients with history of allergic disorders including asthma, eczema and anaphylaxis, liver disease and infections.

General: Because body Iron excretion is limited and excess tissue Iron can be hazardous, caution should be exercised to withhold Iron administration in the presence of evidence of tissue Iron overload. Patients receiving Iron Sucrose require periodic monitoring of hematologic and haematinic parameters (hemoglobin, hematocrit, serum ferritin and transferrin saturation). Iron therapy should be withheld in patients with evidence of Iron overload. Transferrin saturation values increase rapidly after IV administration of Iron Sucrose; thus, serum Iron values may be reliably obtained 48 hours after IV dosing.

Hypersensitivity Reactions: Serious hypersensitivity reactions have been rarely reported in patients receiving Iron Sucrose. Several cases of mild or moderate hypersensitivity reactions were observed in these studies.

Hypotension: Hypotension has been reported frequently in hemodialysis patients receiving intravenous Iron. Hypotension following administration of Iron Sucrose may be related to rate of administration and total dose administered. Caution should be taken to administer Iron Sucrose according to recommended guidelines.

Drug-drug interactions involving Iron Sucrose have not been studied. Iron Sucrose Injection should not be administered concomitantly with oral iron preparations since the absorption of oral Iron is reduced. Even oral Iron therapy should not be given until 5 days after last injection.

Pregnancy Category-B. No adequate and well controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Iron Sucrose is administered to a nursing woman.

Pediatric Use: Safety and effectiveness of Iron Sucrose in pediatric patients have not been established.

Geriatric Use: No overall differences in safety were observed between the elder subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Injection into dialyser: Iron Sucrose Injection may be administered directly into the venous limb of the dialyser under the same conditions as for intravenous injection.

Hemodialysis Dependent-Chronic Kidney Disease Patients (HDD-CKD): Iron Sucrose Injection may be administered undiluted as a 100 mg slow intravenous injection over 2 to 5 minutes or as an infusion of 100 mg, diluted in a maximum of 100 ml of 0.9% NaCI over a period of at least 15 minutes per consecutive hemodialysis session for a total cumulative dose of 1,000 mg.

Non-Dialysis Dependent-Chronic Kidney Disease Patient (NDD-CKD): Iron Sucrose Injection is administered as a total cumulative dose 1000 mg over a 14 day period as a 200 mg slow IV injection undiluted over 2 to 5 minutes on 5 different occasions within the 14 day period.

Dosages of Iron Sucrose Injection in excess of Iron needs may lead to accumulation of Iron in storage sites leading to hemosiderosis. Periodic monitoring of Iron parameters such as serum ferritin and transferrin saturation may assist in recognizing Iron accumulation. Iron Sucrose should not be administered to patients with Iron overload and should be discontinued when serum ferritin levels equal or exceed established guidelines. Particular caution should be exercised to avoid Iron overload where anaemia unresponsive to treatment has been incorrectly diagnosed as Iron deficiency anaemia. Symptoms associated with overdosage or infusing Iron Sucrose too rapidly included hypotension, headache, vomiting, nausea, dizziness, joint aches, paresthesia, abdominal and muscle pain, edema. and cardiovascular collapse. Most symptoms have been successfully treated with IV fluids, hydrocortisone, and/or antihistamines. Infusing the solution as recommended or at a slower rate may also alleviate symptoms.

Store in a cool (15°C- 30°C) & dry place, protected from light. Keep out of the reach of children. Do not freeze.

Ferrous Sulfate is indicated in the treatment and prevention of iron deficiency anaemia and anaemia of pregnancy where routine administration of iron is necessary.

Oral Iron preparations

Adult-

• Initial therapeutic dose: 3-4½ teaspoonful daily in divided doses or as prescribed by the physician.
• Maintenance dose: 1½ teaspoonful daily, but if needed up to 1.8g (9 teaspoonful) daily can be given.

Children-

• Under 1 year: ¼ th teaspoonful thrice daily or as directed by physician
• 1-5 years: 1 teaspoonful thrice daily
• 6-12 years: 1½ teaspoonful twice daily.

Mix with water or fruit juice to avoid temporary staining of teeth. Do not mix with milk.

Therapeutic doses of iron may cause gastrointestinal symptoms like diarrhoea, nausea and vomiting. Although iron is better absorbed between meals, side effects can be reduced by taking it with or immediately after food. Continuous administration may sometimes cause constipation. Iron containing liquid medication may cause temporary staining of teeth (this is less likely when diluted).

Iron therapy is contraindicated in haemachromatosis and haemosiderosis.It should not be given to patients receiving repeated blood transfusion or with anaemia not produced by iron deficiency.

Should be administered with caution when given to patients with iron storage or iron absorption disease, haemoglobinopathies or existing gastrointestinal disease.

Absorption of iron salt and Tetracycline is diminished when taken concomitantly by mouth. If treatment with both drugs is required iron salt should be given 3 hours before or 2 hours after Tetracycline. Absorption of iron is also decreased in the presence of antacids or when taken with tea.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Parenteral Iron Preparations

The therapeutic class of Iron Sucrose is haematinic. Iron Sucrose Injection USP is a brown, sterile, aqueous, complex of Polynuclear Iron (III) Hydroxide in Sucrose for Intravenous use. The drug product contains approximately 30% Sucrose w/v (300 mg/ml) and has a pH of 10.5-11.1. Following intravenous administration, Iron Sucrose Injection is dissociated into Iron and Sucrose by the reticuloendothelial system, and Iron is transferred from the blood to a pool of Iron in the liver and bone marrow. Ferritin, an Iron storage protein, binds and sequesters Iron in a nontoxic form, from which Iron is easily available. Iron binds to plasma transferrin, which carries Iron within the plasma and the extracellular fluid to supply the tissues. The transferrin receptor, located in the cell, and the transferrin-receptor complex is returned to the cell membrane. Transferrin without Iron (apotransferrin) is then released to the plasma. The intracellular Iron becomes (mostly) haemoglobin in circulating red blood cells (RBCs). Transferrin synthesis is increased and ferritin production reduced in Iron deficiency. The converse is true when Iron is plentiful. Its elimination halflife is 6 h, total clearance is 1.2 L/h, non-steady state apparent volume of distribution is 10.0 L and steady state apparent volume of distribution is 7.9 L. In Iron Sucrose, its Iron component appears to distribute mainly in blood and to some extent in extravascular fluid. A significant amount of the administered Iron distributes in the liver, spleen and bone marrow and that the bone marrow is an Iron trapping compartment and not a reversible volume distribution. The sucrose component is eliminated mainly through urinary excretion.

Adults and Elderly: 5-10 ml Iron Sucrose Injection (100-200 mg Iron) once to three times a week depending on the hemoglobin level.

Children: There is limited data on children under study conditions. If there is a clinical need, it is recommended not to exceed 0.15 ml Iron Sucrose Injection (3 mg Iron) per kg body weight once to three times per week depending on the haemoglobin level.

Intravenous injection: Iron Sucrose Injection can also be administered undiluted by slow intravenous injection at the (normal) recommended rate of 1 ml Iron Sucrose Injection (20 mg Iron) per minute [5 ml Iron Sucrose Injection (100 mg Iron) in 2 to 5 minutes]. A maximum of 10 ml Iron Sucrose Injection (200 mg Iron) can be injected per injection. Before administration of the therapeutic dose in a new patient, a test dose of 1 ml Iron Sucrose Injection (20 mg Iron) in adults and in children with a body weight greater than 14 kg and half the daily dose (1.5 mg Iron/kg) in children with a body weight less than 14 kg should be injected over 1 to 2 minutes. If no adverse reactions occur within a waiting period of 15 minutes, the remaining portion of the injection can be administered at recommended speed. After an injection the arm of the patient should be extended.

Infusion: Iron Sucrose Injection should preferably be administered by drip infusion (in order to reduce the risk of hypotensive episodes and paravenous injection) in a dilution of 1 ml Iron Sucrose Injection (20 mg Iron) in max. 20 ml 0.9% w/v Sodium Chloride [5 ml (100 mg Iron) in max. 100 ml 0.9% w/v NaCI etc. up to 25 ml (500 mg Iron) in max. 500 ml 0.9% w/v NaCI]. Dilution must take place immediately prior to infusion and the solution should be administered as follows: 100 mg Iron in at least 15 minutes; 200 mg Iron in at least 30 minutes; 400 mg Iron In at least 1.5 hours, and 500 mg Iron in at least 3.5 hours. Further of the maximum tolerated single dose of 7 mg Iron/kg body weight, an Infusion time of at least 3.5 hours has to be respected, independently of the total dose.

Before administration of the therapeutic dose in a new patient the first 20 mg Iron in adults and in children with a body weight greater than 14 kg and half the daily dose (1.5 mg lron/kg) in children with a body weight less than 14 kg should be infused over 15 minutes as a test dose. If no adverse reactions occur, the remaining portion of the infusion can be administered at recommended speed.

The use of Iron Sucrose is contraindicated in patients with evidence of Iron overload, in patients with known hypersensitivity to Iron Sucrose or any of its inactive components, and in patients with anaemia not caused by Iron deficiency. It is also contraindicated in patients with history of allergic disorders including asthma, eczema and anaphylaxis, liver disease and infections.

General: Because body Iron excretion is limited and excess tissue Iron can be hazardous, caution should be exercised to withhold Iron administration in the presence of evidence of tissue Iron overload. Patients receiving Iron Sucrose require periodic monitoring of hematologic and haematinic parameters (hemoglobin, hematocrit, serum ferritin and transferrin saturation). Iron therapy should be withheld in patients with evidence of Iron overload. Transferrin saturation values increase rapidly after IV administration of Iron Sucrose; thus, serum Iron values may be reliably obtained 48 hours after IV dosing.

Hypersensitivity Reactions: Serious hypersensitivity reactions have been rarely reported in patients receiving Iron Sucrose. Several cases of mild or moderate hypersensitivity reactions were observed in these studies.

Hypotension: Hypotension has been reported frequently in hemodialysis patients receiving intravenous Iron. Hypotension following administration of Iron Sucrose may be related to rate of administration and total dose administered. Caution should be taken to administer Iron Sucrose according to recommended guidelines.

Drug-drug interactions involving Iron Sucrose have not been studied. Iron Sucrose Injection should not be administered concomitantly with oral iron preparations since the absorption of oral Iron is reduced. Even oral Iron therapy should not be given until 5 days after last injection.

Pregnancy Category-B. No adequate and well controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Iron Sucrose is administered to a nursing woman.

Pediatric Use: Safety and effectiveness of Iron Sucrose in pediatric patients have not been established.

Geriatric Use: No overall differences in safety were observed between the elder subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Injection into dialyser: Iron Sucrose Injection may be administered directly into the venous limb of the dialyser under the same conditions as for intravenous injection.

Hemodialysis Dependent-Chronic Kidney Disease Patients (HDD-CKD): Iron Sucrose Injection may be administered undiluted as a 100 mg slow intravenous injection over 2 to 5 minutes or as an infusion of 100 mg, diluted in a maximum of 100 ml of 0.9% NaCI over a period of at least 15 minutes per consecutive hemodialysis session for a total cumulative dose of 1,000 mg.

Non-Dialysis Dependent-Chronic Kidney Disease Patient (NDD-CKD): Iron Sucrose Injection is administered as a total cumulative dose 1000 mg over a 14 day period as a 200 mg slow IV injection undiluted over 2 to 5 minutes on 5 different occasions within the 14 day period.

Dosages of Iron Sucrose Injection in excess of Iron needs may lead to accumulation of Iron in storage sites leading to hemosiderosis. Periodic monitoring of Iron parameters such as serum ferritin and transferrin saturation may assist in recognizing Iron accumulation. Iron Sucrose should not be administered to patients with Iron overload and should be discontinued when serum ferritin levels equal or exceed established guidelines. Particular caution should be exercised to avoid Iron overload where anaemia unresponsive to treatment has been incorrectly diagnosed as Iron deficiency anaemia. Symptoms associated with overdosage or infusing Iron Sucrose too rapidly included hypotension, headache, vomiting, nausea, dizziness, joint aches, paresthesia, abdominal and muscle pain, edema. and cardiovascular collapse. Most symptoms have been successfully treated with IV fluids, hydrocortisone, and/or antihistamines. Infusing the solution as recommended or at a slower rate may also alleviate symptoms.

Store in a cool (15°C- 30°C) & dry place, protected from light. Keep out of the reach of children. Do not freeze.

Ferrous Ascorbate is indicated in the treatment of iron deficiency anemia.

Oral Iron preparations

Ferrous ascorbate, a synthetic molecule of ascorbic acid and iron. Iron replenishes the iron stores in your body and corrects iron deficiency anemia. Vitamin C (ascorbate) is added to enhance the absorption of iron in the body.

Adult & Elderly: One tablet a day before or after meal (food independent absorption) or as directed by the physician. In more severe cases, two tablets a day may be required as prescribed by the physician.

Pediatric patients: Safety and effectiveness in pediatric patients have not been established.

The treatment of a neurotic patient was interrupted because of nausea and regurgitation. In pregnant women, the incidence of pyrosis and chronic constipation is slightly increased.

It is contraindicated in hemosiderosis, hemochromatosis, hemolytic anemia.

Oral iron preparations may aggravate existing peptic ulcer, regional enteritis and ulcerative colitis. Iron compounds taken orally can impair the absorption of tetracycline antibiotics. Antacids given concomitantly with iron compounds decrease iron absorption.

The chance of poisoning is rare in adults with iron overdose.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

It is indicated on prophylaxis of iron deficiency especially when inadequate diet calls for supplementary zinc and iron during pregnancy and anemia.

Iron, Vitamin & Mineral Combined preparation

Ferrous Ascorbate, Folic Acid & Zinc is a combination of three nutritional supplements. Ferrous Ascorbate is a combination of iron and vitamin C. Iron replenishes the iron stores in your body and corrects iron deficiency anemia. Vitamin C (ascorbate) is added to enhance the absorption of iron in the body. Folic Acid is a form of vitamin B. It plays a vital role in the formation of red blood cells, which carry oxygen throughout the body. It is also essential in pregnancy due to its role in the development of the unborn baby's brain and spinal cord. Zinc is a micromineral that provides nutrition.

Adult & Elderly: One tablet a day before or after meal (food independent absorption) or as directed by the physician. In more severe cases, two tablets a day may be required as prescribed by the physician.

Pediatric patients: Safety and effectiveness in pediatric patients have not been established.

Side effects of iron, folic acid and zinc supplementation are mild and transient. These include epigastric pain, nausea, constipation, vomiting, diarrhoea, heart burn, etc. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

It is contraindicated in patients with haemolytic anaemia and in conditions with increased hypersensitivity to any of its components and increased body iron content.

Care should be taken in patients who may develop iron overload, such as those with haemochromatosis, haemolytic anemia or red cell aplasia. Failure to respond to treatment may indicate other causes of anemia and should be further investigated.

Iron chelates with tetracycline. Since oral iron products interfere with absorption of oral tetracycline antibiotics, this product should not be taken within two hours of each other. Occasional gastrointestinal discomfort may be minimized by taking with meals. Absorption of iron may be impaired by concurrent administrations of penicillamine and antacid. In patients with renal failure, a risk of zinc accumulation may exist.

If pregnant, or planning to become pregnant or are currently breast-feeding please contact your physician, before taking or continuing the drug. Administration in first trimester of pregnancy should be avoided unless definite evidence of iron deficiency is observed. Prophylaxis of iron deficiency is justified during the remainder of pregnancy specifically when zinc supplementation is required.

The clinical course of acute iron overdosage can be variable. Initial symptoms may include abdominal pain, nausea, vomiting, diarrhoea, tarry stools, melena, hematemesis, hypotension, tachycardia, metabolic acidosis, hyperglycemia, dehydration, drowsiness, pallor, cyanosis, lassitude, seizures, shock and coma.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

For treatment of iron deficiency and prevention of concomitant Folic acid deficiency in adults. For maintenance of maternal haematopoiesis during pregnancy particularly when diet is abnormal or substandard.

Iron & Vitamin Combined preparations

Iron is an essential constituent of the body being necessary for haemoglobin formation and for the oxidative processes of living tissues. Iron salts should only be given for the treatment and as prophylaxis of Iron deficiency anaemia. Iron deficiency anaemias are most often the result of chronic haemorrhage, nutritional deficiency, pregnancy or parasite infestation or malabsorption of iron.

A deficiency of Folic acid typically during pregnancy has long been known to cause a megaloblastic anaemia. The vitamin is not storable in the body and the combination of fetal demand during pregnancy and malnutrition can lead to a deficiency, hence anaemia. It has been observed that the rapid production of red blood cells following treatment with iron may deplete body folate if there is inadequate intake; combination of folic acid and ferrous fumerate avoids the complication. Iron and Folic acid are absorbed in the proximal small intestine particularly the duodenum. Ferrous Fumerate & Folic acid supplements replenish iron deficiency. Thereby arresting the anaemia process. Absorbed iron is taken upto the bone marrow's tissues that form blood cells where it is used to synthesize haemoglobin.

In anaemia: The usual dose is one tablet or capsule daily.

In severe or refractory iron deficiency anaemia: The usual dose is one tablet or capsule twice daily may be given.

In Pregnancy, it is recommended that the dose should be started at the first antenatal consultation and continued until 3 months after delivery.

Gastric distress, abdominal cramps, diarrhoea, allergic reaction.

This is contraindicated in patients with pernicious anaemia and anaemia other than those due to iron deficiency. The nature and causes of anaemia should be established. Absorption of Ferrous Fumerate & Folic acid is inhibited by Magnesium trisillicate and Antacid containing carbonate.

Administration of Ferrous Fumerate & Folic acid during the first trimester of pregnancy may be undesirable. Very few pregnant women are not protected by physiological doses of Folic acid. If anaemia is developed despite prophylaxis with Ferrous Fumerate & Folic acid, patients should be investigated further. Some postgastrectomy patients show poor absorption of iron. Care is needed when treating patients with peptic ulcer.

When Ferrous Fumerate & Folic acid combination and Tetracycline are taken concomitantly, absorption of both drugs are reduced. Concurrent administration of antacid may reduce absorption of iron. Serum anticonvulsant levels may be reduced by administration of folate.

There is no contraindication in pregnancy and lactation.

Ferric Carboxymaltose is indicated for the treatment of iron deficiency anemia in adult patients-

• Who have intolerance to oral iron or have had unsatisfactory response to oral iron
• Who have non-dialysis dependent chronic kidney disease.

Parenteral Iron Preparations

Non-dextran, IV is a colloidal iron hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron; replaces iron stores found in hemoglobin, myoglobin, and enzymes; works to transport oxygen via hemoglobin Macrophage engulf FCM from blood and control iron release. Transferrin saturates and, Iron into the liver, spleen and Bone marrow.

For patients weighing 50 kg or more: Give Ferric Carboxymaltose in two doses separated by at least 7 days. Give each dose as 750 mg for a total cumulative dose not to exceed 1500 mg of iron per course.

For patients weighing less than 50 kg: Give Ferric Carboxymaltose in two doses separated by at least 7 days. Give each dose as 15 mg/kg body weight for a total cumulative dose not to exceed 1500 mg of iron per course.

The dosage of Ferric Carboxymaltose is expressed in mg of elemental iron. Each mL of Ferric Carboxymaltose contains 50 mg of elemental iron. Ferric Carboxymaltose treatment may be repeated if iron deficiency anemia reoccurs.

Administer Ferric Carboxymaltose intravenously, either as an undiluted slow intravenous push or by infusion. When administering as a slow intravenous push, give at the rate of approximately 100 mg (2 mL) per minute. When administered via infusion, dilute up to 750 mg of iron in no more than 250 mL of sterile 0.9% sodium chloride injection, USP, such that the concentration of the infusion is not less than 2 mg of iron per mL and administer over at least 15 minutes.

When added to an infusion bag containing 0.9% Sodium Chloride Injection, USP, at concentrations ranging from 2 mg to 4 mg of iron per mL, Ferric Carboxymaltose solution is physically and chemically stable for 72 hours when stored at room temperature. To maintain stability, do not dilute to concentrations less than 2 mg iron/mL.

Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration. The product contains no preservatives. Each vial of Ferric Carboxymaltose is intended for single use only. Any unused drug remaining after injection must be discarded.

Avoid extravasation of Ferric Carboxymaltose since brown discoloration of the extravasation site may be long lasting. Monitor for extravasation. If extravasation occurs, discontinue the Ferric Carboxymaltose administration at that site.

Nausea, Hypertension, Flushing, Decreased blood phosphorus, Dizziness, Vomiting, Pruritus, Rash, Urticaria, Wheezing, Injection site discoloration, Headache, Increased alanine aminotransferase), Dysgeusia, Hypotension, Constipation, Serious anaphylactic/anaphylactoid reactions

Hypersensitivity to any of its components.

Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Ferric carboxymaltose. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Ferric carboxymaltose administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Ferric carboxymaltose when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Other serious or severe adverse reactions potentially associated with hypersensitivity which included, but not limited to, pruritus, rash, urticaria, wheezing, or hypotension may occur.

Hypertension: Transient elevations in systolic blood pressure, sometimes occurring with facial flushing, dizziness, or nausea were observed. These elevations generally occurred immediately after dosing and resolved within 30 minutes. Monitor patients for signs and symptoms of hypertension following each Ferric carboxymaltose administration.

There are no known drug interactions and none well documented.

Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks

Do not store above 30°C. Do not freeze.

Ferric Carboxymaltose is indicated for the treatment of iron deficiency anemia in adult patients-

• Who have intolerance to oral iron or have had unsatisfactory response to oral iron
• Who have non-dialysis dependent chronic kidney disease.

Parenteral Iron Preparations

Non-dextran, IV is a colloidal iron hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron; replaces iron stores found in hemoglobin, myoglobin, and enzymes; works to transport oxygen via hemoglobin Macrophage engulf FCM from blood and control iron release. Transferrin saturates and, Iron into the liver, spleen and Bone marrow.

For patients weighing 50 kg or more: Give Ferric Carboxymaltose in two doses separated by at least 7 days. Give each dose as 750 mg for a total cumulative dose not to exceed 1500 mg of iron per course.

For patients weighing less than 50 kg: Give Ferric Carboxymaltose in two doses separated by at least 7 days. Give each dose as 15 mg/kg body weight for a total cumulative dose not to exceed 1500 mg of iron per course.

The dosage of Ferric Carboxymaltose is expressed in mg of elemental iron. Each mL of Ferric Carboxymaltose contains 50 mg of elemental iron. Ferric Carboxymaltose treatment may be repeated if iron deficiency anemia reoccurs.

Administer Ferric Carboxymaltose intravenously, either as an undiluted slow intravenous push or by infusion. When administering as a slow intravenous push, give at the rate of approximately 100 mg (2 mL) per minute. When administered via infusion, dilute up to 750 mg of iron in no more than 250 mL of sterile 0.9% sodium chloride injection, USP, such that the concentration of the infusion is not less than 2 mg of iron per mL and administer over at least 15 minutes.

When added to an infusion bag containing 0.9% Sodium Chloride Injection, USP, at concentrations ranging from 2 mg to 4 mg of iron per mL, Ferric Carboxymaltose solution is physically and chemically stable for 72 hours when stored at room temperature. To maintain stability, do not dilute to concentrations less than 2 mg iron/mL.

Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration. The product contains no preservatives. Each vial of Ferric Carboxymaltose is intended for single use only. Any unused drug remaining after injection must be discarded.

Avoid extravasation of Ferric Carboxymaltose since brown discoloration of the extravasation site may be long lasting. Monitor for extravasation. If extravasation occurs, discontinue the Ferric Carboxymaltose administration at that site.

Nausea, Hypertension, Flushing, Decreased blood phosphorus, Dizziness, Vomiting, Pruritus, Rash, Urticaria, Wheezing, Injection site discoloration, Headache, Increased alanine aminotransferase), Dysgeusia, Hypotension, Constipation, Serious anaphylactic/anaphylactoid reactions

Hypersensitivity to any of its components.

Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Ferric carboxymaltose. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Ferric carboxymaltose administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Ferric carboxymaltose when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Other serious or severe adverse reactions potentially associated with hypersensitivity which included, but not limited to, pruritus, rash, urticaria, wheezing, or hypotension may occur.

Hypertension: Transient elevations in systolic blood pressure, sometimes occurring with facial flushing, dizziness, or nausea were observed. These elevations generally occurred immediately after dosing and resolved within 30 minutes. Monitor patients for signs and symptoms of hypertension following each Ferric carboxymaltose administration.

There are no known drug interactions and none well documented.

Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks

Do not store above 30°C. Do not freeze.

Homatropine Hydrobromide sterile Eye Drops is indicated for use as a mydriatic and cycloplegic agent.

Mydriatic and Cycloplegic agents

Homatropine, a tertiary amine antimuscarinic, produces dilation and loss of accommodation by blocking the response of iris sphincter muscle and the accommodative ciliary muscle to cholinergic stimulation.

Mydriasis and cycloplegia for refraction:

• Adult: Instill 1 or 2 drops of 2% solution, or 1 drop of 5% solution immediately before the procedure, repeat at 5-10 minute intervals if necessary.
• Child: Instill 1 drop of 2% soln immediately before the procedure, repeat at 10-min intervals if necessary.

Uveitis:

• Adult: Instill 1-2 drops of 2% or 5% solution bid-tid up to every 3-4 hr as needed.
• Child: 3 mth- 2 yr: instill 1 drop of 0.5% soln once daily or on alternate days. >2 yr: instill 1 drop of 1% or 2% soln bid.

Hypersensitivity may occur as conjunctivitis.

Contraindicated in patients with closed-angle glaucoma or with a narrow angle between the iris and the cornea.

Should be used with caution in patients with prostatic enlargement and in patients suffering from paralytic ileus or pyloric stenosis.

Effects may be increased by drugs with antimuscarinic effect such as; some antihistamines; phenothiazines; antipsychotics; TCAs; MAOIs or parasympathomimetics.

Use in pregnancy: There are no adequate and well-controlled studies in pregnant women. Matropin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Use in lactation: It is not known whether Homatropine is excreted in human milk. Caution should be exercised when Matropin is administered to a nursing mother.

Use in children: Should not be used in children below the age of 3 months

Ataxia, incoherent speech, restlessness, hallucinations, disorientation, failure to recognize people and tachycardia. Psychotic reactions and behavioural disturbances (in children). SC/IM/IV Physostigmine salicylate 1-2 mg to control central and peripheral effects. Small doses of short-acting barbiturate eg. thiopentone sodium 100 mg to control excitement.

It is indicated in the treatment of-

• Acute hemorrhoidal attacks.
• Chronic hemorrhoidal disease.
• Organic and functional chronic venous insufficiency of the lower limbs with the following symptoms: heavy legs, pain, nocturnal cramps.

Phlebotonic & Vascular protecting preparation

Diosmin and Hesperidin is a phlebotonic drug and a vascular protecting agent. It reinforces venous tone by prolonging the activity of parietal noradrenaline. Thus Diosmin and Hesperidin decreases venous capacitance, venous distensibility, and venous emptying time.

Diosmin and Hesperidin protects the microcirculation by fighting the microcirculation damaging process; It combats venous inflammation by decreasing leukocyte activation, and as a consequence, by inhibiting the release of inflammatory mediators, principally free radicals and prostaglandin. Thus Diosmin and Hesperidin normalizes capillary permeability and strengthens capillary resistance.

Diosmin and Hesperidin acts on the lymphatic system, It improves lymphatic drainage by increasing lymph flow and lymph oncotic pressure.

Diosmin 450 mg & Hesperidin 50 mg-

• Acute hemorrhoidal attacks: 3 tablets twice daily for the first 4 days, then 2 tablets twice daily for three days and if required 1 tablet twice daily as a maintenance dosage.
• Chronic hemorrhoids: 1 tablet twice daily.
• Chronic venous insufficiency: 1 tablet twice daily initially for seven days. Duration may be increased depending on severity.

Diosmin 900 mg & Hesperidin 100 mg-

• Acute Hemorrhoid: 1 tablet thrice daily for first 4 days, followed by 1 tablet twice daily for 3 days & then 1 tablet once daily as maintenance dose.
• Relapse of Internal Hemorrhoid & Chronic Hemorrhoid: 1 tablet once daily for 3 months.
• Chronic venous insufficiency: 1 tablet once daily for 2-6 months.
• Leg Wounds: 1 tablet once daily for 2 months.

Tablet should be taken at meal times.

Some cases of routine gastric disorders and neurovegetative disorders (feeling of discomfort) have been reported. In this cases discontinuation of treatment is not required.

Chronic venous insufficiency and its complications should be diagnosed and management monitored by a physician. It is contraindicated for anyone having a hypersensitivity to any ingredient in the product.

If the hemorrhoidal symptoms do not disappear within 15 days, patient should ask doctor for advice. Diosmin (up to 900 mg/day) has been administered to a small number of breast cancer patients who were experiencing lymphedema following surgical and nodal irradiation treatment with resultant reduction of arm edema but no effect on the cancer. Animal studies and more than 20 years of clinical use in Europe have not found any evidence of carcinogenicity or mutagenicity when the components of Diosmin & Hesperidin are used as recommended. As a precaution, Diosmin & Hesperidin is not recommended for patients with a history of cancer since no specific studies have been performed in this population.

No evidence of drug incompatibility (drug interaction) has been reported in clinical trials.

Experimental studies have not shown any teratogenic effect in animals. In human beings, no harmful effect has so far been reported. In the absence of data concerning excretion into breast milk, breast feeding is not recommended during treatment.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

It is indicated in the treatment of-

• Acute hemorrhoidal attacks.
• Chronic hemorrhoidal disease.
• Organic and functional chronic venous insufficiency of the lower limbs with the following symptoms: heavy legs, pain, nocturnal cramps.

Phlebotonic & Vascular protecting preparation

Diosmin and Hesperidin is a phlebotonic drug and a vascular protecting agent. It reinforces venous tone by prolonging the activity of parietal noradrenaline. Thus Diosmin and Hesperidin decreases venous capacitance, venous distensibility, and venous emptying time.

Diosmin and Hesperidin protects the microcirculation by fighting the microcirculation damaging process; It combats venous inflammation by decreasing leukocyte activation, and as a consequence, by inhibiting the release of inflammatory mediators, principally free radicals and prostaglandin. Thus Diosmin and Hesperidin normalizes capillary permeability and strengthens capillary resistance.

Diosmin and Hesperidin acts on the lymphatic system, It improves lymphatic drainage by increasing lymph flow and lymph oncotic pressure.

Diosmin 450 mg & Hesperidin 50 mg-

• Acute hemorrhoidal attacks: 3 tablets twice daily for the first 4 days, then 2 tablets twice daily for three days and if required 1 tablet twice daily as a maintenance dosage.
• Chronic hemorrhoids: 1 tablet twice daily.
• Chronic venous insufficiency: 1 tablet twice daily initially for seven days. Duration may be increased depending on severity.

Diosmin 900 mg & Hesperidin 100 mg-

• Acute Hemorrhoid: 1 tablet thrice daily for first 4 days, followed by 1 tablet twice daily for 3 days & then 1 tablet once daily as maintenance dose.
• Relapse of Internal Hemorrhoid & Chronic Hemorrhoid: 1 tablet once daily for 3 months.
• Chronic venous insufficiency: 1 tablet once daily for 2-6 months.
• Leg Wounds: 1 tablet once daily for 2 months.

Tablet should be taken at meal times.

Some cases of routine gastric disorders and neurovegetative disorders (feeling of discomfort) have been reported. In this cases discontinuation of treatment is not required.

Chronic venous insufficiency and its complications should be diagnosed and management monitored by a physician. It is contraindicated for anyone having a hypersensitivity to any ingredient in the product.

If the hemorrhoidal symptoms do not disappear within 15 days, patient should ask doctor for advice. Diosmin (up to 900 mg/day) has been administered to a small number of breast cancer patients who were experiencing lymphedema following surgical and nodal irradiation treatment with resultant reduction of arm edema but no effect on the cancer. Animal studies and more than 20 years of clinical use in Europe have not found any evidence of carcinogenicity or mutagenicity when the components of Diosmin & Hesperidin are used as recommended. As a precaution, Diosmin & Hesperidin is not recommended for patients with a history of cancer since no specific studies have been performed in this population.

No evidence of drug incompatibility (drug interaction) has been reported in clinical trials.

Experimental studies have not shown any teratogenic effect in animals. In human beings, no harmful effect has so far been reported. In the absence of data concerning excretion into breast milk, breast feeding is not recommended during treatment.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

It is indicated in the treatment of-

• Acute hemorrhoidal attacks.
• Chronic hemorrhoidal disease.
• Organic and functional chronic venous insufficiency of the lower limbs with the following symptoms: heavy legs, pain, nocturnal cramps.

Phlebotonic & Vascular protecting preparation

Diosmin and Hesperidin is a phlebotonic drug and a vascular protecting agent. It reinforces venous tone by prolonging the activity of parietal noradrenaline. Thus Diosmin and Hesperidin decreases venous capacitance, venous distensibility, and venous emptying time.

Diosmin and Hesperidin protects the microcirculation by fighting the microcirculation damaging process; It combats venous inflammation by decreasing leukocyte activation, and as a consequence, by inhibiting the release of inflammatory mediators, principally free radicals and prostaglandin. Thus Diosmin and Hesperidin normalizes capillary permeability and strengthens capillary resistance.

Diosmin and Hesperidin acts on the lymphatic system, It improves lymphatic drainage by increasing lymph flow and lymph oncotic pressure.

Diosmin 450 mg & Hesperidin 50 mg-

• Acute hemorrhoidal attacks: 3 tablets twice daily for the first 4 days, then 2 tablets twice daily for three days and if required 1 tablet twice daily as a maintenance dosage.
• Chronic hemorrhoids: 1 tablet twice daily.
• Chronic venous insufficiency: 1 tablet twice daily initially for seven days. Duration may be increased depending on severity.

Diosmin 900 mg & Hesperidin 100 mg-

• Acute Hemorrhoid: 1 tablet thrice daily for first 4 days, followed by 1 tablet twice daily for 3 days & then 1 tablet once daily as maintenance dose.
• Relapse of Internal Hemorrhoid & Chronic Hemorrhoid: 1 tablet once daily for 3 months.
• Chronic venous insufficiency: 1 tablet once daily for 2-6 months.
• Leg Wounds: 1 tablet once daily for 2 months.

Tablet should be taken at meal times.

Some cases of routine gastric disorders and neurovegetative disorders (feeling of discomfort) have been reported. In this cases discontinuation of treatment is not required.

Chronic venous insufficiency and its complications should be diagnosed and management monitored by a physician. It is contraindicated for anyone having a hypersensitivity to any ingredient in the product.

If the hemorrhoidal symptoms do not disappear within 15 days, patient should ask doctor for advice. Diosmin (up to 900 mg/day) has been administered to a small number of breast cancer patients who were experiencing lymphedema following surgical and nodal irradiation treatment with resultant reduction of arm edema but no effect on the cancer. Animal studies and more than 20 years of clinical use in Europe have not found any evidence of carcinogenicity or mutagenicity when the components of Diosmin & Hesperidin are used as recommended. As a precaution, Diosmin & Hesperidin is not recommended for patients with a history of cancer since no specific studies have been performed in this population.

No evidence of drug incompatibility (drug interaction) has been reported in clinical trials.

Experimental studies have not shown any teratogenic effect in animals. In human beings, no harmful effect has so far been reported. In the absence of data concerning excretion into breast milk, breast feeding is not recommended during treatment.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Ferric Carboxymaltose is indicated for the treatment of iron deficiency anemia in adult patients-

• Who have intolerance to oral iron or have had unsatisfactory response to oral iron
• Who have non-dialysis dependent chronic kidney disease.

Parenteral Iron Preparations

Non-dextran, IV is a colloidal iron hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron; replaces iron stores found in hemoglobin, myoglobin, and enzymes; works to transport oxygen via hemoglobin Macrophage engulf FCM from blood and control iron release. Transferrin saturates and, Iron into the liver, spleen and Bone marrow.

For patients weighing 50 kg or more: Give Ferric Carboxymaltose in two doses separated by at least 7 days. Give each dose as 750 mg for a total cumulative dose not to exceed 1500 mg of iron per course.

For patients weighing less than 50 kg: Give Ferric Carboxymaltose in two doses separated by at least 7 days. Give each dose as 15 mg/kg body weight for a total cumulative dose not to exceed 1500 mg of iron per course.

The dosage of Ferric Carboxymaltose is expressed in mg of elemental iron. Each mL of Ferric Carboxymaltose contains 50 mg of elemental iron. Ferric Carboxymaltose treatment may be repeated if iron deficiency anemia reoccurs.

Administer Ferric Carboxymaltose intravenously, either as an undiluted slow intravenous push or by infusion. When administering as a slow intravenous push, give at the rate of approximately 100 mg (2 mL) per minute. When administered via infusion, dilute up to 750 mg of iron in no more than 250 mL of sterile 0.9% sodium chloride injection, USP, such that the concentration of the infusion is not less than 2 mg of iron per mL and administer over at least 15 minutes.

When added to an infusion bag containing 0.9% Sodium Chloride Injection, USP, at concentrations ranging from 2 mg to 4 mg of iron per mL, Ferric Carboxymaltose solution is physically and chemically stable for 72 hours when stored at room temperature. To maintain stability, do not dilute to concentrations less than 2 mg iron/mL.

Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration. The product contains no preservatives. Each vial of Ferric Carboxymaltose is intended for single use only. Any unused drug remaining after injection must be discarded.

Avoid extravasation of Ferric Carboxymaltose since brown discoloration of the extravasation site may be long lasting. Monitor for extravasation. If extravasation occurs, discontinue the Ferric Carboxymaltose administration at that site.

Nausea, Hypertension, Flushing, Decreased blood phosphorus, Dizziness, Vomiting, Pruritus, Rash, Urticaria, Wheezing, Injection site discoloration, Headache, Increased alanine aminotransferase), Dysgeusia, Hypotension, Constipation, Serious anaphylactic/anaphylactoid reactions

Hypersensitivity to any of its components.

Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Ferric carboxymaltose. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Ferric carboxymaltose administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Ferric carboxymaltose when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Other serious or severe adverse reactions potentially associated with hypersensitivity which included, but not limited to, pruritus, rash, urticaria, wheezing, or hypotension may occur.

Hypertension: Transient elevations in systolic blood pressure, sometimes occurring with facial flushing, dizziness, or nausea were observed. These elevations generally occurred immediately after dosing and resolved within 30 minutes. Monitor patients for signs and symptoms of hypertension following each Ferric carboxymaltose administration.

There are no known drug interactions and none well documented.

Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks

Do not store above 30°C. Do not freeze.

Ferric Carboxymaltose is indicated for the treatment of iron deficiency anemia in adult patients-

• Who have intolerance to oral iron or have had unsatisfactory response to oral iron
• Who have non-dialysis dependent chronic kidney disease.

Parenteral Iron Preparations

Non-dextran, IV is a colloidal iron hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron; replaces iron stores found in hemoglobin, myoglobin, and enzymes; works to transport oxygen via hemoglobin Macrophage engulf FCM from blood and control iron release. Transferrin saturates and, Iron into the liver, spleen and Bone marrow.

For patients weighing 50 kg or more: Give Ferric Carboxymaltose in two doses separated by at least 7 days. Give each dose as 750 mg for a total cumulative dose not to exceed 1500 mg of iron per course.

For patients weighing less than 50 kg: Give Ferric Carboxymaltose in two doses separated by at least 7 days. Give each dose as 15 mg/kg body weight for a total cumulative dose not to exceed 1500 mg of iron per course.

The dosage of Ferric Carboxymaltose is expressed in mg of elemental iron. Each mL of Ferric Carboxymaltose contains 50 mg of elemental iron. Ferric Carboxymaltose treatment may be repeated if iron deficiency anemia reoccurs.

Administer Ferric Carboxymaltose intravenously, either as an undiluted slow intravenous push or by infusion. When administering as a slow intravenous push, give at the rate of approximately 100 mg (2 mL) per minute. When administered via infusion, dilute up to 750 mg of iron in no more than 250 mL of sterile 0.9% sodium chloride injection, USP, such that the concentration of the infusion is not less than 2 mg of iron per mL and administer over at least 15 minutes.

When added to an infusion bag containing 0.9% Sodium Chloride Injection, USP, at concentrations ranging from 2 mg to 4 mg of iron per mL, Ferric Carboxymaltose solution is physically and chemically stable for 72 hours when stored at room temperature. To maintain stability, do not dilute to concentrations less than 2 mg iron/mL.

Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration. The product contains no preservatives. Each vial of Ferric Carboxymaltose is intended for single use only. Any unused drug remaining after injection must be discarded.

Avoid extravasation of Ferric Carboxymaltose since brown discoloration of the extravasation site may be long lasting. Monitor for extravasation. If extravasation occurs, discontinue the Ferric Carboxymaltose administration at that site.

Nausea, Hypertension, Flushing, Decreased blood phosphorus, Dizziness, Vomiting, Pruritus, Rash, Urticaria, Wheezing, Injection site discoloration, Headache, Increased alanine aminotransferase), Dysgeusia, Hypotension, Constipation, Serious anaphylactic/anaphylactoid reactions

Hypersensitivity to any of its components.

Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Ferric carboxymaltose. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Ferric carboxymaltose administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Ferric carboxymaltose when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Other serious or severe adverse reactions potentially associated with hypersensitivity which included, but not limited to, pruritus, rash, urticaria, wheezing, or hypotension may occur.

Hypertension: Transient elevations in systolic blood pressure, sometimes occurring with facial flushing, dizziness, or nausea were observed. These elevations generally occurred immediately after dosing and resolved within 30 minutes. Monitor patients for signs and symptoms of hypertension following each Ferric carboxymaltose administration.

There are no known drug interactions and none well documented.

Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks

Do not store above 30°C. Do not freeze.

Ferric Carboxymaltose is indicated for the treatment of iron deficiency anemia in adult patients-

• Who have intolerance to oral iron or have had unsatisfactory response to oral iron
• Who have non-dialysis dependent chronic kidney disease.

Parenteral Iron Preparations

Non-dextran, IV is a colloidal iron hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron; replaces iron stores found in hemoglobin, myoglobin, and enzymes; works to transport oxygen via hemoglobin Macrophage engulf FCM from blood and control iron release. Transferrin saturates and, Iron into the liver, spleen and Bone marrow.

For patients weighing 50 kg or more: Give Ferric Carboxymaltose in two doses separated by at least 7 days. Give each dose as 750 mg for a total cumulative dose not to exceed 1500 mg of iron per course.

For patients weighing less than 50 kg: Give Ferric Carboxymaltose in two doses separated by at least 7 days. Give each dose as 15 mg/kg body weight for a total cumulative dose not to exceed 1500 mg of iron per course.

The dosage of Ferric Carboxymaltose is expressed in mg of elemental iron. Each mL of Ferric Carboxymaltose contains 50 mg of elemental iron. Ferric Carboxymaltose treatment may be repeated if iron deficiency anemia reoccurs.

Administer Ferric Carboxymaltose intravenously, either as an undiluted slow intravenous push or by infusion. When administering as a slow intravenous push, give at the rate of approximately 100 mg (2 mL) per minute. When administered via infusion, dilute up to 750 mg of iron in no more than 250 mL of sterile 0.9% sodium chloride injection, USP, such that the concentration of the infusion is not less than 2 mg of iron per mL and administer over at least 15 minutes.

When added to an infusion bag containing 0.9% Sodium Chloride Injection, USP, at concentrations ranging from 2 mg to 4 mg of iron per mL, Ferric Carboxymaltose solution is physically and chemically stable for 72 hours when stored at room temperature. To maintain stability, do not dilute to concentrations less than 2 mg iron/mL.

Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration. The product contains no preservatives. Each vial of Ferric Carboxymaltose is intended for single use only. Any unused drug remaining after injection must be discarded.

Avoid extravasation of Ferric Carboxymaltose since brown discoloration of the extravasation site may be long lasting. Monitor for extravasation. If extravasation occurs, discontinue the Ferric Carboxymaltose administration at that site.

Nausea, Hypertension, Flushing, Decreased blood phosphorus, Dizziness, Vomiting, Pruritus, Rash, Urticaria, Wheezing, Injection site discoloration, Headache, Increased alanine aminotransferase), Dysgeusia, Hypotension, Constipation, Serious anaphylactic/anaphylactoid reactions

Hypersensitivity to any of its components.

Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Ferric carboxymaltose. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Ferric carboxymaltose administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Ferric carboxymaltose when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Other serious or severe adverse reactions potentially associated with hypersensitivity which included, but not limited to, pruritus, rash, urticaria, wheezing, or hypotension may occur.

Hypertension: Transient elevations in systolic blood pressure, sometimes occurring with facial flushing, dizziness, or nausea were observed. These elevations generally occurred immediately after dosing and resolved within 30 minutes. Monitor patients for signs and symptoms of hypertension following each Ferric carboxymaltose administration.

There are no known drug interactions and none well documented.

Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks

Do not store above 30°C. Do not freeze.

This is indicated in-

• Haemorrhoid
• Bleeding piles
• Constipation
• Indigestion
• Hyperacidity
• Carminative

Herbal and Nutraceuticals

Terminalia chebula: It contains chebulinic acid, tannic acid, gallic acid, resin, tannin and glycoside. It prevents haemorrhoid, bleeding, constipation and improve digestive power.

Vitis vinifera: It contains sugar gum, tannin, tartaric, citric, racemic and malic acids, chlondes of potassium and sodium, iron, albumin etc. It is used as demulcent, diuretic, laxative, stomachic and tonic. It is also used in dyspepsia.

Madhuca indica: It contains glycoside saponin, sapogenin, B-sitosterol and sterol glucoside. It is used in haemorrhoids and constipation.

Embelia ribes: It contains hydroquinone embelin alkaloid christembine, tannin, quercifol and volatile oil that have carminative, laxative, stomachic and anthelmintic activities. It is also used to improve digestive power.

Tribulus terrestris: It contains alkaloids, pedalitin, diosmetin and dinatin. It is cooling, tonic, and carminative. It is used in piles and remove inflammation.

Piper chaba: It contains pipperin, pippalartin, pipperleguminin, sterols, glycosides etc. It cures piles, cough and indigestion.

Coriandrum sativum: It contains a-pinene, limonene, B-phellandrene, linalool, geraniol, linalys acetate etc. It has carminative, stomachic, refrigerant and antibacterial activity. It can help to remove dyspepsia.

Zingiber officinale: It contains zingiberenen, zingerfone, terpenes, cineol, borneol, citrol, camphene, phelandrene, gingerol shogaol etc. It is digestive, carminative, stomachic ano stimulant. It also use in dyspepsia, flatulent, colic and constipation.

Operculina turpethum: It contains glycosidium resin, glycoside (turoethin) and volatile oil. If is a good laxative and helpful in other abdominal troubles. It is also helpful in managing the normal body temperature.

Salmalia malabarica: It contains minerals, starch, protein, fatty acid tannic acid and gallic acid. It is cooling, stimulant, tonic and demulcent. It is useful in haemorrhoid.

Adult: 2-4 teaspoonful 2-3 times daily after meal.
Children: 1-2 teaspoonful 2-3 times daily after meal.

There is no significant side effect.

There is no absolute contraindications.

Not recommended for use during pregnancy and lactation.

Keep all medicines out of reach of children. Store in a cool and dry place, protected from light.

Anti-fibrinolytic drugs, Haemostatic drugs

The fibrinolysis-inhibitory effects of Aminocaproic acid appear to be exerted principally via inhibition of plasminogen activators and to a lesser degree through antiplasmin activity.

Dosage of  Aminocaproic acid must be adjusted to individual cases according to the severity of the hemmohagic event. It must however born in mind that Aminocaproic acid cleared rapidly by renal rough, so that administration must be repeated every 4-6 hours. The average dose is 8-16 gm a day.i.e. 1 ampule of Aminocaproic acid according to the case, every 6 hours.

Aminocaproic acid is equally effective by mouth and intarvenous injection. In cases of particular severity, or when it is sought to obtain a high blood concentration quickly it is advisable to start treatment by intravenous rough, with slow injection of two Aminocaproic acid ampules with an interval of 30-60 minutes between them, continuing with divided doses until a dosage of 20-25 grams in the 24 hour is reached.

In any case, administration of the drug must be continued until complete cessation of all symptoms. Aminocaproic acid could be intravenously administered, following suitable dilution in Physiological solution.

Mild muscle pain or weakness; headache, tired feeling; nausea, vomiting, stomach pain, diarrhea; (in men) decreased amount of semen when having an orgasm; stuffy nose, watery eyes; vision problems, ringing in your ears; or Mild skin rash.

Safety and efficacy have not been established in patients younger than 18 years.

Pregnancy Category C. Animal reproduction studies have not been conducted with aminocaproic acid. It is also not known whether aminocaproic acid can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Aminocaproic Acid Injection should be given to a pregnant woman only if clearly needed.

Store in a cool, dry place, protected from light. Store the suspension below 30° C. Keep out of reach of children.