Ferrogradumet (Tablets) Instructions for Use

Marketing Authorization Holder

Abbott Laboratories, Ltd. (United Kingdom)

Manufactured By

Aesica Queenborough, Limited (United Kingdom)

ATC Code

B03AA07 (Ferrous sulfate)

Active Substance

Ferrous sulfate (USP United States Pharmacopoeia)

Dosage Form

Ferrogradumet

Coated tablets, 325 mg: 30 pcs.

Dosage Form, Packaging, and Composition

Coated tablets red in color, biconvex, flat, with the applied company trademark; on the break – the tablet is grayish-white in color; the red film coating is clearly visible.

Excipients: methacrylate and methylmethacrylate copolymer, lactose, povidone K90, magnesium stearate.

Shell composition: hypromellose, ethylcellulose, sodium saccharin, triethyl citrate, sorbitan monooleate, castor oil, titanium dioxide, dye yellow No. 6 (FD&C Yellow), dye red No. 40 (FD&C Red).

10 pcs. – blisters (3) – cardboard boxes.

Clinical-Pharmacological Group

Antianemic drug

Pharmacotherapeutic Group

Hematopoiesis stimulant – iron preparation

Pharmacological Action

Antianemic drug. Iron is a trace element that is a component of hemoglobin, myoglobin, and various enzymes. About 2/3 of all iron in the body is found in the hemoglobin of the circulating red blood cell mass. With insufficient intake of iron from food or impaired absorption, latent or clinically pronounced iron deficiency in the body (iron deficiency anemia) develops.

The dosage form of the drug Ferrogradumet is a tablet with controlled release of Fe²⁺ from an inert, porous plastic matrix called Gradumet. Iron is released from Gradumet as it passes through the gastrointestinal tract, the matrix is excreted with the intestinal contents.

Pharmacokinetics

Absorption

Iron is absorbed mainly from the duodenum and the upper part of the jejunum. Absorption increases with iron deficiency. High iron content in the blood reduces absorption. The average dietary iron intake is from 18 mg to 20 mg per day. About 10% of this amount of iron is absorbed in healthy individuals and 20-30% in iron deficiency in the body. Iron is absorbed most effectively when taken between meals. Simple iron salts often cause irritation of the gastric mucosa when taken on an empty stomach.

Distribution

Plasma protein binding – 90% or more. It is deposited as ferritin or hemosiderin in hepatocytes and cells of the reticuloendothelial system, a small amount – as myoglobin in muscles.

Elimination

The T_1/2 of ferrous sulfate is about 6 hours. Norms of physiological iron losses: for men and postmenopausal women – 1 mg/day, for premenopausal women – 1.5-2 mg/day.

Indications

• Treatment of latent and clinically pronounced iron deficiency;
• Prevention of iron deficiency (including before and during pregnancy, during lactation).

ICD codes

Dosage Regimen

Ferrogradumet is administered orally.

For adults and children over 12 years of age for prevention of iron deficiency, 1 tab./day is prescribed.

For treatment of iron deficiency anemia, 1-2 tab./day is prescribed.

The maximum daily dose of Ferrogradumet is 2 tab. (1 tab. 2 times/day).

The duration of treatment is determined individually. The average duration of the treatment course is 2-3 months until the hemoglobin level normalizes.

To replenish iron stores in the body, subsequent administration of Ferrogradumet at a dose of 1 tab./day for 3-6 months until the serum ferritin concentration normalizes is recommended.

The drug can be taken on an empty stomach. The tablet should be swallowed whole, without chewing.

Adverse Reactions

From the central nervous system: headache, dizziness, irritability; rarely – encephalopathy with epileptic syndrome.

Allergic reactions: skin rash, itching; rarely – anaphylactic shock.

Dermatological reactions: skin hyperemia.

From the digestive system: rarely – nausea, vomiting, pain or discomfort in the epigastric region, black stool staining, diarrhea and constipation.

Other: toothache, sore throat, weakness, feeling of pressure behind the breastbone.

Contraindications

• Excess iron in the body (e.g., hemochromatosis);
• Disorders of iron utilization mechanisms (e.g., lead anemia, sideroachrestic anemia);
• Anemias not caused by iron deficiency (e.g., hemolytic anemia or megaloblastic anemia caused by vitamin B₁₂ deficiency);
• Presence of intestinal diverticulum or intestinal obstruction;
• Simultaneous therapy with parenteral iron preparations;
• Children under 12 years of age;
• Hypersensitivity to the components of the drug.

Use with caution in gastric and duodenal ulcers, inflammatory bowel diseases (enteritis, diverticulitis, ulcerative colitis, Crohn’s disease), chronic alcoholism (active or in remission), in allergic diseases, bronchial asthma, hepatitis, hepatic or renal failure, rheumatoid arthritis, concomitant blood transfusion.

Use in Pregnancy and Lactation

There are no clinical study data indicating a possible risk of using the drug during pregnancy for the mother and fetus, as well as for the mother and infant during breastfeeding.

Use in Hepatic Impairment

Use with caution in hepatic insufficiency. In hepatic insufficiency, the risk of iron accumulation increases.

Use in Renal Impairment

Use with caution in renal insufficiency. In renal insufficiency, the risk of iron accumulation increases.

Pediatric Use

Contraindication: children under 12 years of age.

Special Precautions

Iron preparations stain stools black, which has no clinical significance but may lead to false positive results when determining the presence of blood in the stool (e.g., when performing a guaiac test). Persistent darkening of teeth is possible.

For elderly patients, Ferrogradumet may be required in higher doses due to impaired iron absorption and concomitant achlorhydria.

In hepatic or renal insufficiency, the risk of iron accumulation increases. Taking Ferrogradumet may exacerbate ulcerative and inflammatory bowel diseases, rheumatoid arthritis.

To avoid the risk of erythremia, caution should be exercised during blood transfusion.

Overdose

Symptoms: in case of acute iron overdose, nausea, vomiting, and in severe cases, collapse and death are possible. The lethal dose of ingested elemental iron is 180-300 mg/kg of body weight. In some cases, a dose of 30 mg/kg may also be toxic.

Symptoms of acute iron poisoning may develop within the first hour or after several hours. Initially, pronounced unusual fatigue or weakness, hyperemia, paresthesia, pallor or cyanosis of the skin, symptoms of gastrointestinal irritation, including epigastric pain, nausea, vomiting, diarrhea, melena may occur. These symptoms may be accompanied by drowsiness, cold clammy sweat, acrocyanosis, weak pulse, lethargy, decreased blood pressure and palpitations.

In some cases, necrosis of the gastrointestinal mucosa, convulsive seizures, shock or coma develop. Signs of peripheral circulatory collapse appear within 30 minutes after ingestion; metabolic acidosis, convulsions, fever, leukocytosis. Coma – within 12-24 hours; acute liver necrosis – after 2-4 days.

Treatment: before qualified medical care is provided, it is recommended to artificially induce vomiting and rinse the stomach by taking a large amount of fluid, orally raw egg, milk (to bind iron ions in the gastrointestinal tract).

Indications for the use of deferoxamine as a chelating agent

• A potentially lethal dose (180-300 mg/kg or more) of elemental iron was taken;
• Serum iron concentration above 400-500 mcg/dL;
• Serum iron concentration exceeds the total iron-binding capacity;
• Seizures associated with iron intoxication, or shock or coma.

In case of severe poisoning, deferoxamine is administered intravenously slowly: children – 15 mg/h, adults – 5 mg/kg/h (up to 80 mg/kg/day). In mild poisoning, deferoxamine is administered intramuscularly children – 1 g every 4-6 hours, adults – 50 mg/kg (up to 4 g/day).

Hemodialysis is not very effective in the treatment of iron intoxication but can be used to accelerate the elimination of the Fe-deferoxamine complex and may also be prescribed for oligo- or anuria. Peritoneal dialysis is also possible.

Supportive therapy includes monitoring of vital body functions, the patient’s clinical condition, including respiratory support (oxygenation, vasoconstrictors), correction of acidosis, prevention of shock due to dehydration (intravenous fluid administration or blood transfusion).

Drug Interactions

Absorption of iron from the gastrointestinal tract is reduced by antacids, the specific antidote deferoxamine, calcium preparations, etidronic acid, drugs that reduce gastric acidity (including cimetidine, drugs containing carbonates, bicarbonates, phosphates, oxalates), pancreatin, pancrelipase, eggs, milk, vegetables, cereals, coffee, tea. Ferrogradumet should be taken 1 hour before or 2 hours after their consumption.

Iron delays the absorption from the gastrointestinal tract of tetracycline, penicillamine, some quinolones (e.g., ciprofloxacin, norfloxacin, ofloxacin), zinc preparations. Ferrogradumet should be taken 2 hours after their consumption.

Chloramphenicol may delay the clinical response to iron therapy.

Ascorbic acid increases iron absorption.

Ethanol increases iron absorption and the risk of toxic complications.

It is recommended to observe an interval between taking Ferrogradumet and the above-mentioned drugs (food products).

Storage Conditions

List B. The drug should be stored out of the reach of children, protected from light, at a temperature not exceeding 25°C (77°F).

Shelf Life

The shelf life is 5 years.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.