Prograf 0.5mg Astellas prevents the excavation of kidney transplant or liver (5 blisters x 10 tablets)

Dosage form Box of 5 blisters x 10 tablets
Specifications Tacrolimus

Ingredient

Composition information	Content
Tacrolimus	0.5mg

Uses

indications

Prograf® 0.5 mg drug is indicated in the following cases:

Prevention of transplantation organs in kidney transplant patients or heterozygous liver. Prograf is proposed to use simultaneously with corticosteroids. Due to hypersensitivity, Prograf should be given to the case of patients who cannot take prograf capsules.

Pharmacology

tacrolimus inhibits T lymphocytic activity, although the mechanism of exact impact is not known. Evidence of experiments shows that Tacrolimus is connected to intracellular protein, FKBP - 12. Then form the Tacrolimus FKBP - 12.

Pharmacokinetics

absorption

After indicated, the absorption of Tacrolimus in the gastrointestinal tract is incomplete and variable. The absolute bioavailability of Tacrolimus is 17 10% in adult kidney transplant patients (n = 26); It is 22.6% in mature liver transplant patients (n = 17) and 18.5% in healthy people (n = 16).

Should take prograf capsules every day with or not with food because of the presence and food ingredients that reduce the bioavailability of Prograf.

Distribution

The cohesion of plasma protein of Tacrolimus is about 99% and does not depend on the concentration of about 5-50 ng/ml. Tacrolimus is mainly connected to albumin and alpha - 1 glycoprotein acid and has a high level of bond with red blood cells. The distribution of Tacrolimus between whole blood and plasma depends on many factors such as hematocrit, temperature at the time of plasma separation, drug concentration and plasma protein levels.

Metabolism

tacrolimus is completely metabolized by the system of oxygen enzymes with mixed functions, mainly the Cytochrome P450 (CYP3A) system. The metabolic path leads to 8 metabolites. Dimethylation and hydroxylation process are considered to be the main mechanism of In vitro biological transfer. The metabolites are mainly identified in an incubation environment with human liver microsom enzyme as 13 - Demethyl tacrolimus. In In vitro study, the metabolic 31 - Demethyl has been reported and active as Tacrolimus.

Excretion

The average clearance of Tacrolimus after using intravenously is 0.04 liters/hour/kg on healthy people, 0.083 liters/hour/kg on adult liver transplant patients and 0.053 liters/hour/kg in adult liver transplant patients. In humans,

Before taking Prograf 0.5mg Astellas prevents the excavation of kidney transplant or liver (5 blisters x 10 tablets)

How to use

oral medication.

Dosage

Adult kidney transplant: Start 0.2 mg/kg/day.

Liver transplant adults: Starting 0.10 - 0.15 mg/kg/day.

Liver transplantation: 0.15 - 0.20 mg/kg/day, the dose is divided in half every hour.

Patients with liver and kidney dysfunction should receive the lowest dose of treatment of the proposed dose range that allows oral or intravenously. Sometimes it requires a lower dose lower than the recommended dose. Prograf treatment should be delayed for up to 48 hours or longer in patients with less urination after surgery.

Converts from one immunosuppressant regimen to another: Prograf should not be used at the same time as cyclosporin. Prograf or cyclosporin should be stopped at least 24 hours before starting the other drug.

Monitoring blood concentration: Monitoring Tacrolimus concentration in the blood combined with other clinical test parameters is considered as the main tool to manage patients to assess transplantation, toxicity, dose adjustment and compatibility.

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 using overdose?

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using the 0.5 mg Prograf®, you may experience unwanted effects (ADR).

kidney transplant

The most common adultery reactions (> 30%)

Infections, tremor, hypertension, abnormal kidney function, constipation, diarrhea, headache, abdominal pain, insomnia, nausea, decreased blood magnesium, urinary tract infections, hypoglycemia, peripheral edema, weakness, pain, hyperpid, hyperkalemia and anemia.

The adverse reactions occur at> 15% of kidney transplant patients treated with prograf in combination with azathioprin

Nervous system: Run, headache, insomnia, paresthesia, dizziness.

gastrointestinal tract: diarrhea, trafficking, constipation, vomiting, indigestion.

Cardiovascular system: Hypertension, chest pain.

Genital urinary: increased creatinine, urinary tract infection.

Metabolism and nutrition: Hematomy phosphate, decreased blood magnesium, hyperemia, hyperkalemia, diabetes, hypokalemia, hyperglycemia, edema.

Blood and lymphatic system: Anemia, leukemia.

Other: infection, peripheral edema, weakness, abdominal pain, pain, fever, back pain.

Respiratory system: Difficulty, cough increases.

Muscle muscle: joint pain.

skin: rash, itching.

Liver transplant

The most common adultery reactions (> 30%)

The main adverse reactions are tremor, headache, diarrhea, hypertension, nausea and kidney dysfunction. Diarrhea sometimes comes with other stomach complications such as nausea and vomiting. Hyperbonia and decreased blood magnesium occur in patients using prograf therapy.

New diabetes started after organ transplant

Reported in 20% of kidney transplant patients with program/azathioprin without a history of diabetes before grafting in a phase 3 test. Insulin dependency can recover in 15% of these patients 1 year and at 50% 2 years after transplant.

The adverse reactions are reported less often (> 3% and

Nervous system: nightmares, agitation, forgetting, anxiety, disorders of the arms of arms, confusion, convulsions, shouting, depression, mood increase, dizziness, ease of emotion, brain disease, hemorrhage, hallucinations, muscle tone, loss of coordination, mild paralysis, nerve, nerve, nerve, nerve, nerve, nerve, nerve, nerve, nerve, nerve, nerve, nerve Reduce mental skills, mental disorders, limb paralysis, drowsiness, abnormal thoughts, dizziness, impaired writing ability.

Special senses: visual abnormalities, vision loss, ear pain, otitis media, tinnitus.

Digestive gastrointestinal gastrointestinal, jaundice, jaundice, duodenitis, indigestion, esophagitis, flatulence, gastritis, gastritis, gastric bowel hemorrhage, GGT, gastrointestinal disorders, gastrointestinal perforation, Hepatitis, granular liver disease, liver damage, intestinal obstruction, increased craving for appetite colon, stomatitis.

Cardiovascular: ECG (ECG) abnormal, angina, arrhythmia, atrial fibrillation, atrial fertility, slow heart rate, heart vibration, lung failure, cardiovascular disorders, congestive heart failure, deep thrombosis, abnormal echocardioccitis, abnormal QRS complex on electrocardiograms, abnormal ST segments on olive, heart rate, hemorrhage, hemorrhagic heart rate, hemorrhagic heart rate, disorder of disorders vessels, posture hypotension, fainting, tachycardia, thrombosis, vasodilation.

Genital urinary: Acute renal failure, albuminuria, BK virus kidney disease, bladder spasms, bladder inflammation, difficulty urination, urinary blood, kidney, kidney failure, kidney necrosis, night urine, pus, kidney disease, non -control urine due to urge, regular urine, beams, urinary tract

Metabolism/Nutrition: Acid infection, alkaline phosphatase, alkaline infection, alt hyperplation (SGPT), AST (SGOT), decreased bicarbonate, urinary bilirubin, dehydration, diabetes, girges, gout, abnormal skin, hyperlemia, hypercholular cholesterol) hyperlipidemia) Calcium blood calcium, hypoglycemia, sodium hypoclines, lactic dehydrogenase hypertension, weight gain.

Endocrine: Cushing syndrome.

blood/lymph: coagulation disorders, blood bruises, hematocrit hyperka, abnormal hemoglobin, blemishes, leukemia, red blood cells, decreased prothrombin, decreased serum iron.

Other cases: big abdomen, abscess, accidental injury, allergic reactions, cell inflammation, chills, falling, abnormal sensation, influenza syndrome, edema, hernia, peritonitis, light sensitive reactions, blood infections, intolerance to temperature, ulcers.

Muscle muscle: joint pain, reduced exercise, muscle spasms, joint disorders, muscle pain, myasthenia gravis, osteoporosis.

Respiratory: Asthma, piercing, hiccups, discomfort in the lungs, reducing lung function, pneumonia pharyngitis, pneumothorax, pulmonary edema, respiratory disorders, rhinitis, sinusitis), exchanging sounds.

Skin: acne, hair loss, skin peeling, fungal dermatitis, herpes Simplex infection, herpes zoster infection (shingles), him, benign skin tumor, skin color change, skin disorders, dermatitis, foul surgery.

Rarely have spontaneous reports of myocardial hypertrophy with a centralized dysfunction of clinical manifestations in patients using treatment regimen with Prograf.

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

Prograf® 0.5 mg contraindicated drug in the following cases:

Contraindicated use of program in patients with hypersensitivity to tacrolimus or any excipients of the drug.

Hypersensitivity to HCO - 60. Symptoms of hypersensitivity have been reported including shortness of breath, rash, itching and acute respiratory failure syndrome.

Be cautious when using

Mauses of drug use, including replacing the Tacrolimus formula that released quickly or released accidentally, without attention or no supervision has been observed. This has led to serious adverse reactions, including disposal or other adverse reactions that may be the result of Tacrolimus concentration below treatment or excessive level.

Managing immunosuppressive treatment: Only doctors who have experience in treating immunosuppressive and managing organ transplant patients should use Prograf.

Patients who are using immunosuppressants including program may increase risk: lymphoma and other malignant diseases; Bacterial infection, virus, fungus and single -cell animals, including opportunistic infections, polyoma virus infections, cytomegalovirus infections; new diabetes after organ transplantation; nerve and kidney toxicity; hypertension; Anaphylaxis reaction with Prograf injection; Use with CYP3A4 inhibitors and CYP3A4 induction drugs; extending the QT/QTC range and can cause torsion; hyperboly blood; Heart hypertrophy.

Vaccination: avoid using live vaccines during treatment with tacrolimus; Soldier murdered red blood cell line; gastrointestinal perforation.

Caution in pregnant and lactating patients, when driving and operating the machine.

The ability to drive and operate machinery

Caution when driving and operating machinery while using the drug.

Pregnancy

type C for pregnant women. There is no sufficient bottom studying and well controlled in pregnant women. Tacrolimus is transmitted through the placenta. The use of tacrolimus during pregnancy in humans is associated with hyperkalemia in newborns and kidney dysfunction.

The period of breastfeeding

tacrolimus is excreted in breast milk. Because the effect of long -term Tacrolimus exposure in healthy young children, patients who are taking prograf should stop breastfeeding, taking into account the importance of the drug on the mother.

Drug interaction

Take a certain dose of mycophenolic acid product (MPA) simultaneously with Prograf, the concentration of MPa is higher than when used to close with cyclosporin because cyclosporin interrupts the liver cycle of MPA while tacrolimus does not have this effect.

Concentrated with grapefruit juice increases the bottom concentration of tacrolimus in the whole blood.

Protease inhibitors, calcium channel blockers, antibacterial drugs, Azol antifungal drugs (voriconazole, posaconazole, otraconazole, ketoconazole, fluconazole and clotrimazol) have the effect of inhibiting enzyme CYP3A and can increase the concentration of tacrolimus in chalk blood.

Anti -mycobacterium, anti -convulsions (Phenytoin, Carbamazepin and Phenobarbital), ST. John's Wort (Hypericum Perforatum), Caspofungin causes CYP3A enzyme induction and can reduce the concentration of Tacrolimus in the whole blood.

lansoprazol and omeprazole, cimetidin, antacids containing magnesi and aluminum hydroxid, bromocriptin, nefazodon, metoclopramid, danazol, ethinyl estradiol, amiodaron, methylprednisolon and schisandra Sphenanthera extract in the blood tacrolimus in all blood concentration. part.

Storage

Store at a temperature not exceeding 30⁰C.

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