Indications/Uses
Iberet Active is indicated for prevention and treatment of iron-deficiency anemia, or for treatment of iron deficiency, especially when there is a concomitant need for vitamin C or the B vitamins.
Dosage/Direction for Use
Iberet Active is administered orally and may be taken on an empty stomach.
Usual adult dose, including pregnant females: One tablet daily, or as directed by a physician.
Effectiveness of iron therapy should be monitored via standard hematology tests.
Do not chew or crush tablet, swallow whole .
Usual adult dose, including pregnant females: One tablet daily, or as directed by a physician.
Effectiveness of iron therapy should be monitored via standard hematology tests.
Do not chew or crush tablet, swallow whole .
Overdosage
Due to the controlled-release nature of the preparation, effects of overdosage could be delayed.
Acute overdosage of iron may cause nausea and vomiting and, in severe cases, hepatic necrosis, cardiovascular collapse, and death. The lethal dose of orally ingested elemental iron is estimated to be 180 to 300 mg/kg of body weight. However, a dose of elemental iron as low as 30 mg/kg may be toxic in some individuals and ingestion of doses as low as 60 mg/kg have resulted in death. In small children, however, it is estimated that as little as 400 mg of elemental iron could be fatal.
Toxicity that occurs with an acute iron overdosage results from a combination of the corrosive effects on the gastrointestinal mucosa and the metabolic and hemodynamic effects caused by the presence of excessive elemental iron.
The signs and symptoms of acute iron poisoning may occur within 10 to 60 minutes or be delayed for several hours. Initial clinical manifestations may encompass acute gastrointestinal irritation, including epigastric pain, nausea, vomiting, diarrhea of green and subsequently tarry stools, melena and hematemesis which may be associated with drowsiness, pallor, cyanosis, lassitude, seizures, shock and coma. Hepatic necrosis and hepatic failure may develop. Because of potential toxic effects of overdosage, immediate medical attention is warranted.
Iron poisoning should be treated by emptying the stomach via ipecac-induced vomiting or preferably, by gastric lavage with a large bore tube. If the patient has experienced multiple episodes of vomiting, especially if the vomitus contains blood, ipecac syrup should not be administered.
Vomitus should be examined for returned Gradumet tablets. If sufficient tablets are not returned, the possibility of whole gut lavage with 0.9% sodium chloride solution plus a saline cathartic should be considered. Surgical removal of iron tablets which are visible in abdominal radiographs may be required if other means of removing the drug are unsuccessful.
The best method for assessing the severity of an iron ingestion is to measure the serum iron and the total iron binding capacity (TIBC). If the serum iron level is greater than TIBC, the potential for systemic toxicity exists. Serum iron and total iron-binding capacity levels may be used as guidelines for use of deferoxamine, an agent used to chelate elemental iron.
Chelation therapy with deferoxamine should be considered when the following conditions exist: 1. A potentially lethal dose (180 to 300 mg/kg or more) of elemental iron has been ingested; 2. Serum iron concentrations are greater than 400 to 500 μg/dL; 3. Serum iron concentrations exceed total iron binding capacity, and/or; 4. Patients have severe symptoms of iron intoxication such as coma, shock, seizure. Hemodialysis of little value in the treatment of iron intoxication.
Supportive treatment, including suction and maintenance of airway; correction of acidosis and control of shock and dehydration with intravenous fluids or blood, oxygen and vasopressors, should be administered as required.
High doses of individual components of the product have been associated with eczematous and exanthematous skin lesions, fatigue and insomnia.
In higher niacinamide doses, liver damage, gout and ulcer formation have been noted.
Vasodilatory effects such as giddiness, faintness, vasovagal attacks and anaphylactic shock have also been reported. In high doses of pyridoxine, peripheral sensory neuropathy and vesicular skin lesions have been reported.
Hemolysis has been reported at high doses of ascorbic acid, especially in patients with glucose-6-phosphate deficiency.
Acute overdosage of iron may cause nausea and vomiting and, in severe cases, hepatic necrosis, cardiovascular collapse, and death. The lethal dose of orally ingested elemental iron is estimated to be 180 to 300 mg/kg of body weight. However, a dose of elemental iron as low as 30 mg/kg may be toxic in some individuals and ingestion of doses as low as 60 mg/kg have resulted in death. In small children, however, it is estimated that as little as 400 mg of elemental iron could be fatal.
Toxicity that occurs with an acute iron overdosage results from a combination of the corrosive effects on the gastrointestinal mucosa and the metabolic and hemodynamic effects caused by the presence of excessive elemental iron.
The signs and symptoms of acute iron poisoning may occur within 10 to 60 minutes or be delayed for several hours. Initial clinical manifestations may encompass acute gastrointestinal irritation, including epigastric pain, nausea, vomiting, diarrhea of green and subsequently tarry stools, melena and hematemesis which may be associated with drowsiness, pallor, cyanosis, lassitude, seizures, shock and coma. Hepatic necrosis and hepatic failure may develop. Because of potential toxic effects of overdosage, immediate medical attention is warranted.
Iron poisoning should be treated by emptying the stomach via ipecac-induced vomiting or preferably, by gastric lavage with a large bore tube. If the patient has experienced multiple episodes of vomiting, especially if the vomitus contains blood, ipecac syrup should not be administered.
Vomitus should be examined for returned Gradumet tablets. If sufficient tablets are not returned, the possibility of whole gut lavage with 0.9% sodium chloride solution plus a saline cathartic should be considered. Surgical removal of iron tablets which are visible in abdominal radiographs may be required if other means of removing the drug are unsuccessful.
The best method for assessing the severity of an iron ingestion is to measure the serum iron and the total iron binding capacity (TIBC). If the serum iron level is greater than TIBC, the potential for systemic toxicity exists. Serum iron and total iron-binding capacity levels may be used as guidelines for use of deferoxamine, an agent used to chelate elemental iron.
Chelation therapy with deferoxamine should be considered when the following conditions exist: 1. A potentially lethal dose (180 to 300 mg/kg or more) of elemental iron has been ingested; 2. Serum iron concentrations are greater than 400 to 500 μg/dL; 3. Serum iron concentrations exceed total iron binding capacity, and/or; 4. Patients have severe symptoms of iron intoxication such as coma, shock, seizure. Hemodialysis of little value in the treatment of iron intoxication.
Supportive treatment, including suction and maintenance of airway; correction of acidosis and control of shock and dehydration with intravenous fluids or blood, oxygen and vasopressors, should be administered as required.
High doses of individual components of the product have been associated with eczematous and exanthematous skin lesions, fatigue and insomnia.
In higher niacinamide doses, liver damage, gout and ulcer formation have been noted.
Vasodilatory effects such as giddiness, faintness, vasovagal attacks and anaphylactic shock have also been reported. In high doses of pyridoxine, peripheral sensory neuropathy and vesicular skin lesions have been reported.
Hemolysis has been reported at high doses of ascorbic acid, especially in patients with glucose-6-phosphate deficiency.
Administration
Should be taken on an empty stomach: Swallow whole, do not chew/crush.
Contraindications
Iberet Active is contraindicated in individuals known to be hypersensitive to any of its components.
Iron therapy is contraindicated in patients with thalassemia, sideroblastic anemia, hemochromatosis and hemosiderosis.
Repeated blood transfusions or parenteral iron therapy contraindicate concurrent oral iron therapy. Intestinal diverticula or any intestinal obstruction contraindicate use of the Gradumet matrix.
Niacinamide: This is contraindicated in patients with liver disease or active peptic ulcer. Niacin is also contraindicated in patients with arterial hemorrhaging or severe hypotension.
This product should not be used in pediatric patients.
Iron therapy is contraindicated in patients with thalassemia, sideroblastic anemia, hemochromatosis and hemosiderosis.
Repeated blood transfusions or parenteral iron therapy contraindicate concurrent oral iron therapy. Intestinal diverticula or any intestinal obstruction contraindicate use of the Gradumet matrix.
Niacinamide: This is contraindicated in patients with liver disease or active peptic ulcer. Niacin is also contraindicated in patients with arterial hemorrhaging or severe hypotension.
This product should not be used in pediatric patients.
Special Precautions
General: Patients should be advised to keep these products out of the reach of children.
Acute iron poisoning occurs rarely in adults, but it could happen if children swallow this medication. See the Signs and Symptoms of Overdosage under Overdosage for symptoms and treatment of acute iron poisoning.
Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under six years of age. Keep this product out of the reach of children. In cases of accidental overdose, call a doctor or seek medical advice immediately.
Iron therapy could induce relapse of erythropoietic protoporphyria. Iron overload has been suggested as being involved in the pathogenesis of porphyria cutanea tarda.
Where anemia exists, its nature should be established and underlying cause determined. As is the case with most medications, these should be stored out of reach of children.
Concomitant parenteral therapy with vitamin B12 may be necessary in patients with deficiency of vitamin B12.
Caution should be exercised when dosing ascorbic acid in patients with chronic renal failure and in patients receiving acetylsalicylic acid.
Acute iron poisoning occurs rarely in adults, but it could happen if children swallow this medication. See the Signs and Symptoms of Overdosage under Overdosage for symptoms and treatment of acute iron poisoning.
Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under six years of age. Keep this product out of the reach of children. In cases of accidental overdose, call a doctor or seek medical advice immediately.
Iron therapy could induce relapse of erythropoietic protoporphyria. Iron overload has been suggested as being involved in the pathogenesis of porphyria cutanea tarda.
Where anemia exists, its nature should be established and underlying cause determined. As is the case with most medications, these should be stored out of reach of children.
Concomitant parenteral therapy with vitamin B12 may be necessary in patients with deficiency of vitamin B12.
Caution should be exercised when dosing ascorbic acid in patients with chronic renal failure and in patients receiving acetylsalicylic acid.
Use In Pregnancy & Lactation
Lactation: B-complex vitamins diffuse across the placenta and also appear in breast milk.
Adverse Reactions
Reported side effects are similar to those associated with conventional oral iron preparations i.e., nausea, vomiting, abdominal pain or discomfort, diarrhea or constipation. However, the incidence of side effects is lower due to the controlled-release nature of the formulation. If such reactions occur, the tablet may be taken after a meal.
Allergic reactions, including rash, pruritus and anaphylaxis have been reported with vitamin use. Components of products have been associated with gastrointestinal effects such as heartburn, eructation, abdominal pain and cramps, diarrhea, vomiting, nausea and anorexia.
Hepatic dysfunction with abdominal liver function tests, including hyperbilirubinemia, has been noted.
Deterioration of acneiform vulgaris, or eruption of acneiform exanthema, has been noted with several components. Bright yellow urine discoloration has been reported with riboflavin usage.
Niacinamide has strong vasodilator effects, most often characterized by flushing, dizziness or faintness. Peripheral sensory neuropathies have been noted with usage of pyridoxine.
Stone formation, crystalluria and oxalosis, with ascorbic acid usage, have been reported in the literature. Black discoloration of the stool has been reported with iron usage.
Isolated cases of injury to mouth and pharynx, esophageal ulcer, hematemesis and ileus have been reported.
Acute iron intoxication may result in increased capillary permeability, reduced plasma volume, increased cardiac output and sudden cardiovascular collapse.
Ascorbic acid is usually well tolerated. Large doses are reported to cause diarrhea and other gastrointestinal disturbances and are associated with the formation of renal calcium oxalate calculi.
Allergic reactions, including rash, pruritus and anaphylaxis have been reported with vitamin use. Components of products have been associated with gastrointestinal effects such as heartburn, eructation, abdominal pain and cramps, diarrhea, vomiting, nausea and anorexia.
Hepatic dysfunction with abdominal liver function tests, including hyperbilirubinemia, has been noted.
Deterioration of acneiform vulgaris, or eruption of acneiform exanthema, has been noted with several components. Bright yellow urine discoloration has been reported with riboflavin usage.
Niacinamide has strong vasodilator effects, most often characterized by flushing, dizziness or faintness. Peripheral sensory neuropathies have been noted with usage of pyridoxine.
Stone formation, crystalluria and oxalosis, with ascorbic acid usage, have been reported in the literature. Black discoloration of the stool has been reported with iron usage.
Isolated cases of injury to mouth and pharynx, esophageal ulcer, hematemesis and ileus have been reported.
Acute iron intoxication may result in increased capillary permeability, reduced plasma volume, increased cardiac output and sudden cardiovascular collapse.
Ascorbic acid is usually well tolerated. Large doses are reported to cause diarrhea and other gastrointestinal disturbances and are associated with the formation of renal calcium oxalate calculi.
Drug Interactions
Alcohol: Niacin with concomitant use of alcohol, toxic delirium and lactic acidosis has been noted.
Nicotine: Niacin with concomitant use of nicotine; increased flushing and dizziness have been reported.
Tetracyclines: Iron inhibits absorption of tetracyclines from the GI tract and vice versa. If both drugs must be given, administer tetracycline three hours after or two hours before oral iron supplements.
Chloramphenicol: Chloramphenicol may delay response to iron therapy, and may diminish response to B12-deficient patients; alternate anti-infective therapy should be considered.
Antacids: Antacids may decrease iron absorption.
Cholestyramine: Cholestyramine may decrease iron absorption.
Quinolone Anti-infective Agents: Concurrent administration of oral iron preparations may interfere with the oral absorption of some quinolone anti-infective agents (e.g. ciprofloxacin, norftoxacin, ofloxacin) resulting in decreased serum and urine concentrations of the quinolones. Therefore, oral iron preparations should not be ingested with or within two hours of a dose of an oral quinolone.
Penicillamine: Iron decreases the cupruretic effect of penicillamines. If both drugs must be administered, then administration should be at least two hours apart.
Anti-diabetic agents: Dosage requirements for these agents may change while taking niacinamide.
Ganglionic Blocking Drugs: Niacin may potentiate the hypotensive effect of these agents.
Neuromuscular Blocking Agents: Thiamine may enhance the effect of these agents.
Propantheline Bromide: Prior administration of propantheline bromide may delay the absorption time but increase the absorption concentration of riboflavin.
Levodopa: Since pyridoxine is noted to have effects on dopamine, drug interactions are possible. A drug interaction with levodopa is noted, but can be avoided if levodopa is given in combination with a decarboxylase inhibitor.
Phenobarbital and Phenytoin: High doses of pyridoxine hydrochloride (greater than the 5 mg/day from lberet Active) have been reported to decrease serum concentrations of phenobarbital or phenytoin.
Vitamin B12 Absorption From the GI Tract Can Be Diminished By Various Agents: Aminoglycoside antibiotics, colchicine, extended-release potassium preparations, aminosalicylic acid and its salts, anticonvulsants, cobalt irradiation of the small bowel, or chronic excessive alcohol intake. In older patients, serum B12 levels should be regularly assessed during treatment with lberet Active.
Anticoagulants: Prothrombin times are decreased when ascorbic acid is used concomitantly with anticoagulants.
Drug Food Interactions: Absorption of iron is inhibited by ingestion of eggs, milk, phytate-containing substances such as bran, or tannins in tea.
Oral iron preparations should not be taken within one hour or two hours after ingestion of the above mentioned products.
Laboratory Tests: Iron: Iron preparations may turn stools black, which could hinder detection of occult blood in feces. The guaiac test also occasionally yields false-positive tests.
Ascorbic acid: As a strong reducing agent, ascorbic acid may interfere with tests based on oxidation- reduction reactions. Ascorbic acid In the urine may produce false results in glucosuria determinations. Prothrombin times are decreased when ascorbic acid Is used concomitantly with anticoagulants.
Niacin: Niacin may cause false elevations in fluorometric tests of urinary catecholamines. It may also give false positive results when a cupric sulfate solution (such as Benedict's reagent) is used for urinary glucose determination.
Thiamine and Pyridoxine Hydrochloride: Thiamine may cause false positive results in the phosphotungstate method for determination of uric acid. Thiamine or pyridoxine hydrochloride may cause false positive results for urobilinogen in the spot test using Ehrlich's reagent.
Riboflavin: Large doses of riboflavin may result in bright yellow urine, which may interfere with urinalysis based on spectrometry or color reactions. Riboflavin may also cause false elevations in fluorometric determinations of catecholamines or urobilinogen.
Vitamin B12: Methotrexate, pyrimethamine, and most anti-infectives invalidate diagnostic microbiologic blood assays for vitamin B12. Prior administration of this vitamin may result in false-positive test results for IF antibodies, which are present in approximately 50% of patients with pernicious anemia.
Nicotine: Niacin with concomitant use of nicotine; increased flushing and dizziness have been reported.
Tetracyclines: Iron inhibits absorption of tetracyclines from the GI tract and vice versa. If both drugs must be given, administer tetracycline three hours after or two hours before oral iron supplements.
Chloramphenicol: Chloramphenicol may delay response to iron therapy, and may diminish response to B12-deficient patients; alternate anti-infective therapy should be considered.
Antacids: Antacids may decrease iron absorption.
Cholestyramine: Cholestyramine may decrease iron absorption.
Quinolone Anti-infective Agents: Concurrent administration of oral iron preparations may interfere with the oral absorption of some quinolone anti-infective agents (e.g. ciprofloxacin, norftoxacin, ofloxacin) resulting in decreased serum and urine concentrations of the quinolones. Therefore, oral iron preparations should not be ingested with or within two hours of a dose of an oral quinolone.
Penicillamine: Iron decreases the cupruretic effect of penicillamines. If both drugs must be administered, then administration should be at least two hours apart.
Anti-diabetic agents: Dosage requirements for these agents may change while taking niacinamide.
Ganglionic Blocking Drugs: Niacin may potentiate the hypotensive effect of these agents.
Neuromuscular Blocking Agents: Thiamine may enhance the effect of these agents.
Propantheline Bromide: Prior administration of propantheline bromide may delay the absorption time but increase the absorption concentration of riboflavin.
Levodopa: Since pyridoxine is noted to have effects on dopamine, drug interactions are possible. A drug interaction with levodopa is noted, but can be avoided if levodopa is given in combination with a decarboxylase inhibitor.
Phenobarbital and Phenytoin: High doses of pyridoxine hydrochloride (greater than the 5 mg/day from lberet Active) have been reported to decrease serum concentrations of phenobarbital or phenytoin.
Vitamin B12 Absorption From the GI Tract Can Be Diminished By Various Agents: Aminoglycoside antibiotics, colchicine, extended-release potassium preparations, aminosalicylic acid and its salts, anticonvulsants, cobalt irradiation of the small bowel, or chronic excessive alcohol intake. In older patients, serum B12 levels should be regularly assessed during treatment with lberet Active.
Anticoagulants: Prothrombin times are decreased when ascorbic acid is used concomitantly with anticoagulants.
Drug Food Interactions: Absorption of iron is inhibited by ingestion of eggs, milk, phytate-containing substances such as bran, or tannins in tea.
Oral iron preparations should not be taken within one hour or two hours after ingestion of the above mentioned products.
Laboratory Tests: Iron: Iron preparations may turn stools black, which could hinder detection of occult blood in feces. The guaiac test also occasionally yields false-positive tests.
Ascorbic acid: As a strong reducing agent, ascorbic acid may interfere with tests based on oxidation- reduction reactions. Ascorbic acid In the urine may produce false results in glucosuria determinations. Prothrombin times are decreased when ascorbic acid Is used concomitantly with anticoagulants.
Niacin: Niacin may cause false elevations in fluorometric tests of urinary catecholamines. It may also give false positive results when a cupric sulfate solution (such as Benedict's reagent) is used for urinary glucose determination.
Thiamine and Pyridoxine Hydrochloride: Thiamine may cause false positive results in the phosphotungstate method for determination of uric acid. Thiamine or pyridoxine hydrochloride may cause false positive results for urobilinogen in the spot test using Ehrlich's reagent.
Riboflavin: Large doses of riboflavin may result in bright yellow urine, which may interfere with urinalysis based on spectrometry or color reactions. Riboflavin may also cause false elevations in fluorometric determinations of catecholamines or urobilinogen.
Vitamin B12: Methotrexate, pyrimethamine, and most anti-infectives invalidate diagnostic microbiologic blood assays for vitamin B12. Prior administration of this vitamin may result in false-positive test results for IF antibodies, which are present in approximately 50% of patients with pernicious anemia.
Storage
Store at temperatures not exceeding 30°C.
Shelf-life: 24 months.
Shelf-life: 24 months.
MedsGo Class
Vitamins & Minerals (Pre & Post Natal) / Antianemics
Features
Brand
Iberet Active
Full Details
Dosage Strength
6 mg / 6 mg / 30 mg / 5 mg / 25 mcg / 10 mg / 500 mg / 525 mg
Drug Ingredients
- Ascorbic Acid
- Calcium Pantothenate
- Iron
- Multivitamins
- Vit. B1
- Vit. B12
- Vit. B2
- Vit. B3
- Vit. B6
Drug Packaging
Film-Coated Tablet 1's
Generic Name
Vit. B1 / Vit. B2 / Vit. B3 / Vit. B6 / Vit. B12 / Calcium Pantothenate / Ascorbic Acid / Ferrous Sulfate
Dosage Form
Film-Coated Tablet
Registration Number
DR-XY47318
Drug Classification
Over-The-Counter (OTC)
View all variations as list
| CODE | Dosage Strength | Drug Packaging | Availability | Price | ||
|---|---|---|---|---|---|---|
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NONRXDRUG-DR-XY47318-1pc
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In stock
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₱3300 |