Apefol TR Capsule (Timed Release) 150 mg+0.5 mg+61.8 mg
Apefol TR Capsule (Timed Release) 150 mg+0.5 mg+61.8 mg Uses, Dosage, Side Effects, Food Interaction and all others data.
Each timed-release capsule contains- Ferrous Sulphate BP 150 mg (equivalent to 47 mg Iron) Folic Acid BP 500 mcg and Zinc Sulphate Monohydrate USP 61.80 mg (equivalent to 22.50 mg Zinc.)Table Of contents
| Trade Name | Apefol TR Capsule (Timed Release) 150 mg+0.5 mg+61.8 mg |
| Generic | Ferrous Sulfate + Folic Acid + Zinc Sulfate |
| Weight | 150 mg+0.5 mg+61.8 mg |
| Type | Capsule (Timed Release) |
| Therapeutic Class | Iron, Vitamin & Mineral Combined preparation |
| Manufacturer | APC Pharma Ltd. |
| Available Country | Bangladesh |
| Last Updated: | October 19, 2023 at 6:27 am |
Uses
This is indicated for the treatment and prophylaxis of Iron, Folic Acid and Zinc deficiency especially during pregnancy and lactation.Apefol TR Capsule (Timed Release) 150 mg+0.5 mg+61.8 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 supplementationDry Eyes, Local itching, Localized pain, Localized swelling, Nutritional supplementation
How Apefol TR Capsule (Timed Release) 150 mg+0.5 mg+61.8 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.
Zinc inhibits cAMP-induced, chloride-dependent fluid secretion by inhibiting basolateral potassium (K) channels, in in-vitro studies with rat ileum. This study has also shown the specificity of Zn to cAMP-activated K channels, because zinc did not block the calcium (Ca)-mediated K channels. As this study was not performed in Zn-deficient animals, it provides evidence that Zn is probably effective in the absence of Zn deficiency. Zinc also improves the absorption of water and electrolytes, improves regeneration of the intestinal epithelium, increases the levels of brush border enzymes, and enhances the immune response, allowing for a better clearance of the pathogens.
Dosage
Apefol TR Capsule (Timed Release) 150 mg+0.5 mg+61.8 mg dosage
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.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
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 reactionsToxicity
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
Human : TDLo ( Oral) 45mg/kg/7D-C : Normocytic anemia, pulse rate increase without fall inBP Human: TDLo (oral) 106mg/kg : Hypermotylity, diarrhea Mouse ; LD50 Oral : 245mg/kg Mouse : LD50 : subcutaneous : 781mg/kg
Precaution
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.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.
After absorption zinc is bound to protein metallothionein in the intestines. Zinc is widely distributed throughout the body. It is primarily stored in RBCs, WBCs, muscles, bones, Skin, Kidneys, Liver, Pancreas, retina, and prostate.
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.
Approximately 20 to 30% of dietary zinc is absorbed, primarily from the duodenum and ileum. The amount absorbed is dependent on the bioavailability from food. Zinc is the most bioavailable from red meat and oysters. Phytates may impair absorption by chelation and formation of insoluble complexes at an alkaline pH. After absorption, zinc is bound in the intestine to the protein metallothionein. Endogenous zinc can be reabsorbed in the ileum and colon, creating an enteropancreatic circulation of zinc.
Half Life
3 hours
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.
Primarily fecal (approximately 90%); to a lesser extent in the urine and in perspiration.
Pregnancy & Breastfeeding use
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.Contraindication
Do not use in patients hypersensitive to the components of the product or those with iron overload.Acute Overdose
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.Storage Condition
Protected from light and moisture, store below 30˚C. Keep out of reach of children.Innovators Monograph
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