Heferol® [Iron Fumarate]

HEFEROL (HEFEROL)

FERRI FUMARAS * B03A A02

Alkaloid

COMPOSITION AND FORM OF ISSUE:

caps. 350 mg blister, No. 10, No. 30

caps. 350 mg vial, No. 30

No. UA / 0263/01/01 from 03/11/2009 to 03/11/2014

PHARMACOLOGICAL PROPERTIES:

Pharmacodynamics Heferol contains elemental iron in the form of iron fumarate. About ²/₃ iron in the body is contained in the hemoglobin of the circulating mass of red blood cells. With insufficient intake of iron with food or a violation of its absorption, a latent or clinically pronounced deficiency of iron in the body develops (iron deficiency anemia). The appropriate intake of iron in the body is of particular importance during pregnancy to ensure the normal development of the fetus and prevent low birth weight.
The dosage form of Heferol (capsules) helps prevent iron from contacting the gastric mucosa. Reception of capsules provides tooth protection, and a quick passage of iron through the stomach prevents the development of side effects that are caused by the irritating effect of iron on the gastric mucosa. In the intestines, iron is gradually released from the capsule and absorbed.
Pharmacokinetics Iron fumarate provides a gradual and uniform release of iron from the digestive tract. Iron absorption occurs almost entirely through active transfer in the duodenum and jejunum. In healthy people, about 5–10% of the oral dose is absorbed, and with iron deficiency, absorption increases to 80–95%. Muscle tissue (proteins that contain cysteine) and oral ascorbic acid stimulate iron absorption. Foods containing phytic acid (soybeans, legumes and cereals) and polyphenols (tea, coffee, chocolate, red wine) complicate the absorption of iron. Hydrolyzed tea tannins are major inhibitors; calcium - in organic substances or food, some proteins (soy, eggs, casein).
WITH_max iron fumarate is achieved 4 hours after ingestion. Iron in the form of ferritin and hemosiderin creates a depot of iron in the body. Biological T_½ iron is 12.9 hours. T_½ when taken orally and parenterally, iron is 6 hours. Only in minimal amounts is iron excreted from the body with bile and sweating, and 12–30 mg of iron is excreted during the normal menstrual cycle. During normal lactation, about 0.25 mg / day (0.15–0.3 mg) of iron passes into breast milk.

INDICATIONS:

treatment and prevention of iron deficiency anemia.
Increased iron loss: GI bleeding (gastric and duodenal ulcers, ulcerative colitis, polyposis, hemorrhoids), urogenital tract bleeding (polymenorrhea, hypermenorrhea, metrorrhagia, hematuria), with fibromyomatosis, bleeding of various origins.
Increased body need for iron: period of intensive growth and puberty; period of pregnancy and lactation.
Iron deficiency: reduced food intake, malabsorption of iron in malabsorption syndrome, the presence of inflammatory diseases of the digestive tract.

APPLICATION:

take the capsules on an empty stomach 30 minutes before breakfast, drink plenty of fluids.
Adults and children over 12 years of age: for prevention - 1 capsule per day; for treatment - 1 capsule 2 times a day.
For treatment and dose prevention, pregnant women in the second and third trimester are prescribed the usual ones, as for adults.
Elderly patients
For treatment and prevention, the doses are the same as for adults.
The course of treatment is 6-12 weeks. The drug should be continued for some time after the normalization of the picture of peripheral blood in order to replenish the iron depot in the body.
In some patients, a dose in excess of 30 mg / kg body weight can cause overdose symptoms. For children, a dose of the drug above 75 mg / kg body weight may be toxic.

CONTRAINDICATIONS:

hypersensitivity to any of the components of the drug.
Hemochromatosis, hemosiderosis and other types of anemia not associated with iron deficiency in the body (hemolytic anemia, aplastic anemia, thalassemia). Childrens age up to 12 years.

SIDE EFFECTS:

most often during treatment with iron preparations, gastrointestinal tract disorders are noted: epigastric pain, nausea, vomiting, stool staining black, diarrhea, metallic taste in the mouth; allergic reactions. Prolonged unjustified use can lead to constipation and hemosiderosis.

SPECIAL INSTRUCTIONS:

Heferol should not be taken by patients who use repeated transfusion of blood, since enough iron is released from hemoglobin and red blood cells.
You should not take the drug for more than 6 months, except for patients with prolonged bleeding, menorrhagia, or repeated pregnancy.
Particular care must be taken in patients with peptic ulcer, regional enteritis (Crohns disease), ulcerative colitis and hepatitis.
To prevent constipation, the drug should be washed down with plenty of fluids. If taking the drug causes pain in the stomach, it must be taken with food.
Before prescribing iron therapy, patients over the age of 50 need to find out the cause of anemia, since anemia at this age can be caused by bleeding in the digestive tract.
Heferol contains lactose monohydrate, so patients with rare hereditary galactose intolerance, with lactase deficiency and glucose-galactose malabsorption should not take this drug.
Capsules contain dyes (azorubine and brilliant black), preservatives (methyl parahydroxybenzoate and propyl parahydroxybenzoate, which can cause an allergic reaction).
Use during pregnancy and lactation.
No adverse effects on the fetus (and on the baby) were found with Heferol during pregnancy and lactation.
Children. Capsules cannot be divided, so there are no recommendations regarding the use of heferol in children under the age of 12 years.
The ability to influence the reaction rate when driving vehicles or working with other mechanisms. Does not affect.

INTERACTIONS:

in case of concomitant use of Heferol and tetracycline (or ciprofloxacin) it is recommended to take these antibiotics 3 hours before taking the iron preparation or 2 hours after taking it.
The simultaneous use of antacids and food that reduce iron absorption is not recommended.
Ascorbic acid and proteins that contain cysteine ​​increase iron absorption. Colestyramine, food, and antacids reduce iron absorption in the digestive tract.
Iron delays the absorption in the gastrointestinal tract of tetracycline, some quinolone drugs (ciprofloxacin), and methyldopa.
Iron preparations reduce the absorption of penicillamine while using them.
A hematological response to iron therapy develops later in patients who are simultaneously receiving chloramphenicol therapy.
Iron salts reduce the absorption in the gastrointestinal tract of antibiotics from the group of quinolones (ciprofloxacin, ofloxacin), levodopa, methyldopa, penicillamine, bisphosphonates, entacapone. Their simultaneous use is not recommended or should be taken 2 hours before or after taking Heferol.
Iron salts delay the absorption of tetracycline and colestyramine, so this combination should not be used. If you need to take these drugs at the same time, it is recommended to take them with an interval of at least 2 hours. Iron salts can reduce the effectiveness of levothyroxine.

OVERDOSE:

taking the drug at a dose of 400 mg / kg of elemental iron leads to death. Symptoms of an overdose: epigastric pain, diarrhea, vomiting.With an overdose in the liver, vacuole hepatocyte degeneration can develop, the number of hepatocytic lysosomes, hemosiderin and ferritin may increase, and acidophilic bodies may appear as a sign of liver necrosis. A large amount of elemental iron has a corrosive effect on the gastric mucosa. Cyanosis, hyperventilation as a result of acidosis and cardiovascular collapse may develop. An acute massive overdose of iron preparations can cause shock.
Treatment symptomatic. Induce vomiting, rinse stomach. Care must be taken because of possible perforation due to gastric necrosis caused by iron. Electrolyte replenishment, treatment of shock, arterial hypotension and hyperglycemia. Prescribing a specific antidote to deferoxamine if the blood concentration is> 500 mcg / dl. Conducting such therapy as with lesions caused by iron preparations.

STORAGE CONDITIONS:

at a temperature not exceeding 25 ° C