Paolucci davipharm medicine for excess iron in the body (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Deferiprone

Ingredient

Composition information	Content
Deferiprone	500mg

Uses

indications

Paolucci davi 3x10 drugs are indicated for treatment of excess iron in the body, mainly in thalassemia patients whose deferoxamine therapy is contraindicated or insufficient.

Pharmacology

The active ingredient of hard capsules Paoluci is Deferipron, a two -binding coordination that creates a chelate complex with iron in a molecular ratio of 3: 1.

Dynamic pharmacokinetics

Deferipron is quickly absorbed in the upper part of the digestive tract. The peak concentration of plasma is achieved after 45 - 60 minutes after a single dose in patients at hunger. This time can be up to 2 hours in patients who have eaten. After taking the dose of 25 mg/kg, the peak concentration of plasma in patients with NO (85 mol/l) is lower than that of hunger (126 mol/l), although there is no reduction in Deferipron when used with food.

Deferipron is metabolized largely into a glucuronid complex. This metabolic substance is not capable of binding to iron due to the inactivity of Deferipron's 3-hydroxy group. The peak concentration of glucuronid plasma reaches 2-3 hours after using Deferipron.

In humans, Deferipron is excreted mainly through the kidneys; 75-90% of oral dose detected in urine for the first 24 hours, in the form of free deferipron, glucuronid metabolism and iron-deceripron complex. The drug is also eliminated through feces. The sale time of the drug is 2 - 3 hours.

Before taking Paolucci davipharm medicine for excess iron in the body (3 blisters x 10 tablets)

How to use

oral medication.

Dosage

Deferipron usually uses 25 mg/kg of body weight, oral, 3 times/day, so the total daily dose is 75 mg/kg of body weight.

Do not recommend the dose of over 100 mg/kg/day because of the ability to increase the risk of unwanted effects.

The effect of deferipron in reducing iron storage in the body is directly affected by the dosage and the level of iron overload. After starting treatment, plasma ferritin index (or any index indicates the amount of iron in the body) should be monitored every 2-3 months to evaluate the chelate effect when long -term treatment in the body's iron load control.

Dosage adjustment should be changed according to the response of each patient and treatment goals (preserving, reducing body iron burden). Deferipron stops should be considered if the serum ferritin drops below 500 µg/l.

Children: There is not much information about the use of Deferipron in children from 6 to 10 years old and there is no data on the use of Deferipron in children under 6 years old.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose? However, neurological disorders (such as cerebellum symptoms, double vision, eyeball shaking, dynamic neurological decline, hand movements and reduced axial tone) have been observed in children volunteering more than 2.5 times compared to the maximum dose proposed 100 mg/kg/day for several years. Neurological disorders decrease after deferipron. In case of overdose, the patient's clinical monitoring is needed.

What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

Side Effects

When using Paolucci Davi 3x10 you can experience unwanted effects (ADR).

Common, ADR> 1/100

Hematology: loss of granulocytes.

Unknown frequency, ADR

Digestive: vomiting, nausea, abdominal pain, diarrhea.

musculoskeletal joints: joint pain, joint effusion.

Other: increased liver enzymes, dyed urine.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

contraindicated

Paolucci davi 3x10 drugs in the following cases:

Patients with hypersensitivity to any ingredients of the drug.

Being or having a history of neutropenia.

History of granulocytes.

Pregnant or lactating women.

Due to the unknown mechanism that causes deferipron neutropenia, Deferipron should not be used with drugs that can cause neutropenia or grain leukocytes.

Caution when using

Deferipron has been shown to cause neutropenia, including granulocytes. The number of neutrophils of patients needs to be monitored every week.

Monitoring Zn2+ plasma concentrations and additional recommendations in case of deficiency.

There is no information on the use of Deferipron in HIV patients positive or patients with immune system damage. As is known, Deferipron can lead to neutropenia and grain leukocytes. Therefore, in patients with immune system damage should not be used when starting, unless the benefits are greater than the risk.

There is no information on deferipron's use in patients with renal failure or liver failure. Because Deferipron is excreted mainly through the kidneys, it is at risk of increasing complications in patients with renal function. Similarly, Deferipron is metabolized in the liver, so it is necessary to be cautious in patients with liver dysfunction.

In thalassemia patients who have the relationship between cirrhosis and overloaded iron and/or hepatitis C, make sure that iron chelate complex in hepatitis C patients is optimal. For this patient recommends carefully monitor liver tissue.

Patients should be informed that their urine may change red/brown due to the excretion of iron-deceripron.

Neurological disorders have been observed in children treated at 2.5 - 3 times higher than the recommended dose for many years. Do not recommend the use of over 100 mg/kg/day.

To be out of reach of children.

The ability to drive and operate machinery

There is no information on the effect of drugs on driving and operating machinery.

Pregnancy

There is no adequate information about the use of Deferipron in pregnant women. Animal studies have shown toxicity on the reproductive system. Potential risks to humans.

Women who have the ability to give birth must be advised to avoid pregnancy due to cancer and teratogenic effects of the drug. Những phụ nữ này nên được khuyên nên dùng biện pháp tránh thai và ngưng deferipron ngay nếu họ có thai hoặc dự định mang thai.

The period of breastfeeding

is unknown about the ability to excrete through Deferipron's breast milk. Do not use Deferipron for nursing women. If the treatment is required, to stop breastfeeding.

Drug interaction

Due to the unknown mechanism of Deferipron causing neutropenia, patients should not be used with drugs that are well -related to neutropenia or may cause grain leukocytes.

There is no report on the interaction between Deferipron and other drugs. However, due to Deferipron linked to metal cations, it is likely that the interaction between Deferipron and drugs related to the cylinder cations like aluminum -based antacids. Therefore, it is not recommended to simultaneously drink aluminum and deferipron antacids.

Safety of simultaneous use of deferipron and vitamin C has not been officially studied. Based on the adverse interactive reports that may occur between Deferoxamine and Vitamin C, be cautious when using simultaneously deferipron and vitamin C.

Storage

Store in a dry place, avoid light, temperature below 30 ° C.

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