RANFERON CAPSULES

Indications

• Iron deficiency anemia
• Prophylaxis of iron deficiency in at-risk populations
• Epithelial tissue changes such as atrophic glossitis and koilonychia

Dosage

Children: For children aged 1 month to 11 years: 0.25 mL per kilogram twice daily, with the total daily dose possibly given in 3 divided doses, not exceeding 20 mL per day. For children aged 12-17 years: 10 mL once daily.

Adults: The dose is calculated according to body weight and the iron deficit, specifying both the iron salt and formulation. For specific dosing, consult product literature.

Mechanism of action

Iron is necessary for the production of hemoglobin. Iron deficiency can lead to decreased production of hemoglobin and a microcytic, hypochromic anemia. Ferrous fumarate releases iron in the gastrointestinal tract, facilitating its absorption and subsequent incorporation into hemoglobin, thus alleviating anemia.

Pharmacodynamics

The major activity of supplemental iron, including ferrous fumarate, is in the prevention and treatment of iron deficiency anemia. Iron also has putative immune-enhancing, anticarcinogenic, and cognition-enhancing activities, supporting overall health and functionality.

Pharmacokinetics

Ferrous fumarate is absorbed in the gastrointestinal tract, with absorption being optimal in an acidic environment. The bioavailability can be influenced by dietary factors, such as the presence of certain foods or medications that may inhibit iron absorption. Once absorbed, iron is transported in the blood bound to transferrin and is stored in tissues as ferritin and hemosiderin. The elimination half-life of iron is variable and depends on the individual's iron status and the amount of iron stored.

Contra-indications

• Iron overload syndromes
• Repeated blood transfusions
• Porphyria cutanea tarda

Adverse effects

• Asthenia
• Drowsiness
• Urine discoloration
• Cold sweat
• Confusion
• Decreased level of consciousness
• Thrombophlebitis
• Headache
• Joint stiffness
• Pain in extremities
• Skin reactions
• Small intestinal bacterial overgrowth
• Thirst
• Nausea
• Constipation
• Diarrhea
• Decreased appetite

Interactions

• Iron absorption may be affected by antacids and certain medications that alter gastric pH.

Precautions

• Monitor iron status to avoid iron overload.
• Caution in patients with intestinal strictures or diverticular disease.
• Care in elderly patients and those on high doses.

Pregnancy

Iron is generally considered safe during pregnancy, but supplementation should be monitored to avoid overload.

Breast-feeding

Iron supplementation may be necessary for exclusively breast-fed infants if maternal iron stores are low.

Storage

Store in a cool, dry place, away from direct sunlight. Keep out of reach of children.

Formulations

• Solution for injection (Iron as Iron sucrose 20 mg per 1 ml)
• Capsules containing iron formulations

Indications

• Iron-deficiency anemia (therapeutic)
• Iron-deficiency anemia (prophylactic)

Dosage

Children: For children aged 1 month to 11 years: 0.25 mL/kilogram twice daily. For children aged 12 to 17 years: 10 mL once daily.

Adults: 280 mg twice daily.

Mechanism of action

Ferrous sulfate acts as a source of iron, which is essential for the synthesis of hemoglobin, the protein in red blood cells that carries oxygen. Iron is absorbed in the intestines, where it is converted into a form that can be incorporated into hemoglobin. The mechanism involves transport proteins that facilitate iron uptake and incorporation into the heme group of hemoglobin.

Pharmacodynamics

The pharmacodynamic effect of ferrous sulfate is the increase in hemoglobin levels and improvement in symptoms of anemia, such as fatigue and weakness. Iron supplementation leads to increased erythropoiesis (red blood cell production) in the bone marrow, effectively correcting the deficit in iron stores and enhancing oxygen-carrying capacity.

Pharmacokinetics

Ferrous sulfate is absorbed in the gastrointestinal tract, particularly in the duodenum and proximal jejunum. The bioavailability of iron from ferrous sulfate can be affected by dietary factors, with enhanced absorption in acidic environments. Peak plasma concentrations typically occur within 2 to 6 hours post-administration. Iron is primarily stored in the liver and bone marrow, and any excess iron is excreted through feces, urine, and sweat.

Contra-indications

• Hypersensitivity to ferrous sulfate or any of its excipients
• Hemochromatosis
• Hemosiderosis
• Thalassemia
• Other anemias not due to iron deficiency

Adverse effects

• Gastrointestinal disturbances (nausea, constipation, diarrhea, abdominal pain)
• Dark stools
• Staining of teeth (with liquid formulations)
• Allergic reactions (rare)

Interactions

• Antacids may reduce the absorption of iron
• Tetracycline antibiotics may interfere with iron absorption
• Ascorbic acid (vitamin C) may enhance iron absorption
• Certain foods and beverages (e.g., tea, coffee, dairy) can decrease iron absorption

Precautions

• Use with caution in patients with peptic ulcer disease
• Monitor for signs of iron overload
• Assess the cause of anemia before initiation of therapy
• Keep out of reach of children to prevent accidental overdose

Pregnancy

Ferrous sulfate is generally considered safe for use during pregnancy to prevent or treat iron-deficiency anemia.

Breast-feeding

Ferrous sulfate is excreted in breast milk in small amounts but is considered safe for breastfeeding mothers.

Storage

Store in a cool, dry place away from direct sunlight. Keep out of reach of children.

Formulations

• Ferrous sulfate 200 mg tablets
• Ferrous sulfate 325 mg modified-release tablets
• Ferrous sulfate oral solution 140 mg/5 mL
• Ferrous sulfate drops

Indications

• Vitamin B12 deficiency
• Megaloblastic anemia
• Peripheral neuropathy
• Scurvy
• General vitamin supplementation

Dosage

Children: Refer to the BNF for Children for

Adults: Refer to specific clinical guidelines for appropriate dosing based on condition and individual patient factors.

Mechanism of action

Cyanocobalamin acts as a coenzyme in the conversion of homocysteine to methionine, facilitating the synthesis of nucleic acids and amino acids. It is crucial for the proper functioning of the nervous system and the formation of red blood cells. Ascorbic acid, on the other hand, acts as an electron donor in many enzymatic reactions and is involved in the hydroxylation of proline and lysine, which are essential for collagen synthesis. The antioxidant properties of ascorbic acid help to protect cellular components from oxidative damage.

Pharmacodynamics

The pharmacodynamics of cyanocobalamin include its role in cellular metabolism, particularly in the methylation processes necessary for DNA synthesis and repair. It also helps in the prevention of megaloblastic anemia by ensuring proper red blood cell formation. Ascorbic acid enhances iron absorption in the gut and contributes to the maintenance of the immune system. Together, these vitamins support overall metabolic health, particularly in populations at risk for deficiency.

Pharmacokinetics

Cyanocobalamin is absorbed in the small intestine through a specific transport mechanism that may be influenced by intrinsic factor. It is stored in the liver and has a half-life of several hours to days. Ascorbic acid is readily absorbed in the gastrointestinal tract and is distributed throughout the body, with a half-life of approximately 16 to 20 days. Both vitamins are eliminated primarily through renal pathways, with excess amounts excreted in urine.

Adverse effects

• Hypersensitivity reactions
• Nausea
• Diarrhea
• Abdominal cramps
• Headache

Precautions

• Use with caution in patients with a history of hypersensitivity to cobalt or any other ingredient
• Monitor patients with renal impairment or those undergoing dialysis

Pregnancy

Generally considered safe for use during pregnancy, but should be used only if clearly needed.

Breast-feeding

Generally considered safe for use during breastfeeding, but consult a healthcare provider.

Storage

Store in a cool, dry place away from light. Keep out of reach of children.

Formulations

• Injectable solution
• Oral tablets
• Oral liquid

Indications

• Zinc deficiency
• Support for immune function
• Wound healing
• Acne treatment
• Common cold management

Dosage

Children: Refer to the BNF for Children for specific dosing recommendations based on age and weight.

Adults: General guidance is to refer to specific dosing guidelines provided in clinical references, as doses may vary based on the indication and individual patient factors.

Mechanism of action

Zinc acetate acts as a source of zinc ions, which are essential for the activity of various enzymes and proteins. The zinc ions interact with specific receptors and enzymes, facilitating numerous biochemical pathways. This interaction can enhance immune response, promote skin health, and improve overall metabolism.

Pharmacodynamics

Zinc acetate exhibits its pharmacological effects primarily through its role as a cofactor for enzymatic activities and its involvement in cellular signaling. The presence of sufficient zinc levels is crucial for maintaining immune homeostasis, and zinc deficiency can lead to impaired immune function and increased susceptibility to infections. Additionally, zinc has antioxidant properties, which help mitigate oxidative stress in cells.

Pharmacokinetics

Zinc acetate is absorbed in the gastrointestinal tract, with absorption efficiency varying based on dietary factors and the presence of other minerals. Once absorbed, zinc is widely distributed throughout the body, with significant concentrations found in the bones, muscles, and organs such as the liver and pancreas. The elimination half-life of zinc ranges from hours to days, primarily excreted through urine, feces, and sweat. The body regulates zinc levels through intestinal absorption and renal excretion.

Pregnancy

Consult with a healthcare provider before use, as safety during pregnancy has not been fully established.

Breast-feeding

Consult with a healthcare provider before use, as safety during breastfeeding has not been fully established.

Storage

Store in a cool, dry place, away from direct sunlight and moisture.

Indications

• Iron deficiency anemia
• Iron deficiency due to inadequate dietary intake
• Anemia associated with chronic disease
• Pregnancy-related anemia

Dosage

Children: Refer to the BNF for Children for specific dosing recommendations based on age and weight.

Adults: Refer to the BNF for specific dosing recommendations, generally, adults may require 100-200 mg of elemental iron daily divided into several doses.

Mechanism of action

Ferrous ions (Fe2+) play a vital role in hemoglobin production by participating in the synthesis of heme, the iron-containing compound essential for oxygen transport in the blood. In addition, iron is a cofactor for various enzymes involved in metabolic pathways, including those related to DNA synthesis and energy production.

Pharmacodynamics

The pharmacodynamic effects of ferrous include increased hemoglobin synthesis, improved oxygen transport, and enhanced cellular energy metabolism. Supplementation leads to an increase in serum ferritin levels and replenishment of iron stores in the body, which is particularly beneficial in cases of iron deficiency anemia.

Pharmacokinetics

Ferrous iron is absorbed primarily in the duodenum and upper jejunum of the small intestine. The absorption rate can be influenced by various factors, including the presence of food, the form of iron, and individual patient characteristics. Once absorbed, ferrous is transported in the bloodstream bound to transferrin, and it is stored in the liver, spleen, and bone marrow as ferritin. The elimination half-life of iron is not well-defined as it is not excreted directly but rather recycled in the body.

Pregnancy

Not contraindicated, but iron supplementation should be done under medical supervision.

Breast-feeding

Iron is excreted in breast milk, but supplementation is generally considered safe.

Storage

Store in a cool, dry place away from sunlight. Keep out of reach of children.

Indications

• Folate deficiency
• Pregnancy-related folate supplementation
• Megaloblastic anemia due to folate deficiency
• Neurological disorders requiring folate supplementation

Dosage

Children: Refer to the BNF for Children for appropriate dosing guidelines.

Adults: Refer to the BNF for specific dosing recommendations based on clinical condition.

Mechanism of action

Fumarate folic acts as a coenzyme in the transfer of one-carbon units in the metabolism of amino acids and nucleic acids. It plays a crucial role in the conversion of homocysteine to methionine, which is an essential process in methylation reactions. This compound is involved in the synthesis of serotonin, dopamine, norepinephrine, and other neurotransmitters, contributing to mood regulation and cognitive function.

Pharmacodynamics

The pharmacodynamic effects of fumarate folic include the enhancement of cellular proliferation and differentiation due to its role in DNA synthesis. It helps maintain normal levels of homocysteine in the blood, which is important for cardiovascular health. Fumarate folic is essential for proper fetal development during pregnancy and is involved in the prevention of neural tube defects.

Pharmacokinetics

Fumarate folic is rapidly absorbed after oral administration, with peak plasma concentrations occurring within 1 to 2 hours. It has a bioavailability of approximately 85% when taken in the active form. The elimination half-life varies but is generally around 6 hours. It is metabolized primarily in the liver and excreted in urine. Fumarate folic can cross the blood-brain barrier, thereby exerting effects on the central nervous system.

Contra-indications

• Hypersensitivity to fumarate or any component of the formulation
• Uncontrolled hypertension
• Active or history of thrombosis or thromboembolic disorders

Adverse effects

• Nausea
• Vomiting
• Diarrhea
• Abdominal pain
• Rash
• Headache
• Dizziness
• Fatigue

Interactions

• Anticoagulants (increased risk of bleeding)
• Antiepileptics (may reduce the effectiveness of some anticonvulsants)
• Other drugs affecting folate metabolism (such as methotrexate)

Precautions

• Monitor blood pressure regularly
• Assess renal function before and during treatment
• Caution in patients with a history of gastrointestinal disorders
• Use with caution in patients with liver impairment

Pregnancy

Use during pregnancy only if clearly needed. Folic acid is essential for fetal development and may be beneficial.

Breast-feeding

Excreted in breast milk. Use with caution and consult a healthcare provider.

Storage

Store in a tightly closed container at room temperature, away from moisture and light.

Formulations

• Oral tablets
• Oral solution

Mechanism of action

Iron is necessary for the production of hemoglobin. Iron-deficiency can lead to decreased production of hemoglobin and a microcytic, hypochromic anemia.

Pharmacodynamics

The major activity of supplemental iron is in the prevention and treatment of iron deficiency anemia. Iron has putative immune-enhancing, anticarcinogenic and cognition-enhancing activities.

Mechanism of action

Iron is necessary for the production of hemoglobin. Iron-deficiency can lead to decreased production of hemoglobin and a microcytic, hypochromic anemia.

Pharmacodynamics

The major activity of supplemental iron is in the prevention and treatment of iron deficiency anemia. Iron has putative immune-enhancing, anticarcinogenic and cognition-enhancing activities.