Difol TR Capsule (Timed Release) 150 mg+0.5 mg
Difol TR Capsule (Timed Release) 150 mg+0.5 mg Uses, Dosage, Side Effects, Food Interaction and all others data.
Ferrous Sulphate has the general properties of iron salts and is one of the most widely used iron salts in the treatment of iron deficiency anaemia.
Ferrous sulfate facilitates O2 transport via haemoglobin. It is used as iron source as it replaces iron found in haemoglobin, myoglobin and other enzymes.
Folic acid is essential for the production of certain coenzymes in many metabolic systems such as purine and pyrimidine synthesis. It is also essential in the synthesis and maintenance of nucleoprotein in erythropoesis. It also promotes WBC and platelet production in folate-deficiency anaemia.
Folic acid is a water-soluble B-complex vitamin found in foods such as liver, kidney, yeast, and leafy, green vegetables. Also known as folate or Vitamin B9, folic acid is an essential cofactor for enzymes involved in DNA and RNA synthesis. More specifically, folic acid is required by the body for the synthesis of purines, pyrimidines, and methionine before incorporation into DNA or protein. Folic acid is the precursor of tetrahydrofolic acid, which is involved as a cofactor for transformylation reactions in the biosynthesis of purines and thymidylates of nucleic acids. Impairment of thymidylate synthesis in patients with folic acid deficiency is thought to account for the defective deoxyribonucleic acid (DNA) synthesis that leads to megaloblast formation and megaloblastic and macrocytic anemias. Folic acid is particularly important during phases of rapid cell division, such as infancy, pregnancy, and erythropoiesis, and plays a protective factor in the development of cancer. As humans are unable to synthesize folic acid endogenously, diet and supplementation is necessary to prevent deficiencies. In order to function properly within the body, folic acid must first be reduced by the enzyme dihydrofolate reductase (DHFR) into the cofactors dihydrofolate (DHF) and tetrahydrofolate (THF). This important pathway, which is required for de novo synthesis of nucleic acids and amino acids, is disrupted by anti-metabolite therapies such as Methotrexate as they function as DHFR inhibitors to prevent DNA synthesis in rapidly dividing cells, and therefore prevent the formation of DHF and THF.
In general, folate serum levels below 5 ng/mL indicate folate deficiency, and levels below 2 ng/mL usually result in megaloblastic anemia.
| Trade Name | Difol TR Capsule (Timed Release) 150 mg+0.5 mg |
| Generic | Ferrous Sulfate + Folic Acid |
| Weight | 150 mg+0.5 mg |
| Type | Capsule (Timed Release) |
| Therapeutic Class | |
| Manufacturer | Desh Pharmaceuticals Ltd. |
| Available Country | Bangladesh |
| Last Updated: | October 19, 2023 at 6:27 am |
Uses
Ferrous Sulfate is used for the treatment and prevention of iron deficiency anaemia and anaemia of pregnancy where routine administration of iron is necessary.
Prophylaxis of megaloblastic anaemia in pregnancy, Supplement for women of child-bearing potential, Folate-deficient megaloblastic anaemia, Prophylaxis of neural tube defect in pregnancy
Difol TR Capsule (Timed Release) 150 mg+0.5 mg is also used to associated treatment for these conditions: Anaemia folate deficiency, Folate deficiency, Iron Deficiency (ID), Iron Deficiency Anemia (IDA), Latent Iron Deficiency, Neural Tube Defects (NTDs), Vitamin Deficiency, Methotrexate toxicity, Nutritional supplementation
How Difol TR Capsule (Timed Release) 150 mg+0.5 mg works
Folic acid, as it is biochemically inactive, is converted to tetrahydrofolic acid and methyltetrahydrofolate by dihydrofolate reductase (DHFR). These folic acid congeners are transported across cells by receptor-mediated endocytosis where they are needed to maintain normal erythropoiesis, synthesize purine and thymidylate nucleic acids, interconvert amino acids, methylate tRNA, and generate and use formate. Using vitamin B12 as a cofactor, folic acid can normalize high homocysteine levels by remethylation of homocysteine to methionine via methionine synthetase.
Dosage
Difol TR Capsule (Timed Release) 150 mg+0.5 mg dosage
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.
Supplement for women of child-bearing potential: 0.4 mg daily.
Folate-deficient megaloblastic anaemia: 5 mg daily for 4 mth, up to 15 mg daily in malabsorption states. Continued dosing at 5 mg every 1-7 days may be needed in chronic haemolytic states, depending on the diet and rate of haemolysis.
Prophylaxis of neural tube defect in pregnancy: 4 or 5 mg daily starting before pregnancy and continued through the 1st trimester.
Prophylaxis of megaloblastic anaemia in pregnancy: 0.2-0.5 mg daily.
Should be taken on an empty stomach. Best taken on an empty stomach. May be taken with meals to reduce GI discomfort. Mix with water or fruit juice to avoid temporary staining of teeth. Do not mix with milk.
May be taken with or without food.
Side Effects
GI irritation, abdominal pain and cramps, nausea, vomiting, constipation, diarrhoea, dark stool and discoloration of urine; heartburn.
GI disturbances, hypersensitivity reactions; bronchospasm.
Toxicity
IPR-MUS LD50 85 mg/kg,IVN-GPG LD50 120 mg/kg, IVN-MUS LD50 239 mg/kg, IVN-RAT LD50 500 mg/kg, IVN-RBT LD50 410 mg/kg
Precaution
Should be administered with caution when given to patients with iron storage or iron absorption disease, haemoglobinopathies or existing gastrointestinal disease.
Treatment resistance may occur in patients with depressed haematopoiesis, alcoholism, deficiencies of other vitamins. Neonates.
Interaction
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.
Antiepileptics, oral contraceptives, anti-TB drugs, alcohol, aminopterin, methotrexate, pyrimethamine, trimethoprim and sulphonamides may result to decrease in serum folate contrations. Decreases serum phenytoin concentrations.
Volume of Distribution
Tetrahydrofolic acid derivatives are distributed to all body tissues but are stored primarily in the liver.
Elimination Route
Folic acid is absorbed rapidly from the small intestine, primarily from the proximal portion. Naturally occurring conjugated folates are reduced enzymatically to folic acid in the gastrointestinal tract prior to absorption. Folic acid appears in the plasma approximately 15 to 30 minutes after an oral dose; peak levels are generally reached within 1 hour.
Elimination Route
After a single oral dose of 100 mcg of folic acid in a limited number of normal adults, only a trace amount of the drug appeared in the urine. An oral dose of 5 mg in 1 study and a dose of 40 mcg/kg of body weight in another study resulted in approximately 50% of the dose appearing in the urine. After a single oral dose of 15 mg, up to 90% of the dose was recovered in the urine. A majority of the metabolic products appeared in the urine after 6 hours; excretion was generally complete within 24 hours. Small amounts of orally administered folic acid have also been recovered in the feces. Folic acid is also excreted in the milk of lactating mothers.
Pregnancy & Breastfeeding use
Pregnancy Category- Not Classified. FDA has not yet classified the drug into a specified pregnancy category.
Pregnancy Category A. Adequate and well-controlled human studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).
Contraindication
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.
Undiagnosed megaloblastic anaemia; pernicious, aplastic or normocytic anaemias.
Acute Overdose
Symptoms: Nausea, vomiting, abdominal pain, diarrhoea of green or tarry stools, haematemesis, seizures, drowsiness, metabolic acidosis, hepatic dysfunction, renal failure, coma.
Treatment: Empty stomach contents by gastric lavage. In severe toxicity, IV desferrioxamine may be given. Treatment is supportive. Haemodialysis is unlikely to be useful.
Storage Condition
Store at 15-30° C.
Innovators Monograph
You find simplified version here Difol TR Capsule (Timed Release) 150 mg+0.5 mg
