Prograf: instructions for use, contraindications, composition

Prograf suppresses immune system of the body to avoid rejection of a transplanted heart, liver, or kidney.

Active substance: Tacrolimus

Therapeutic

Immunosuppressant macrolide [Immunosuppressive]

The nosological classification (ICD-10)

T86.1 withering away and rejection of kidney transplant

T86.2 dieback and heart transplant rejection

T86.4 withering away and liver transplant rejection

Prograf. Indications: Prevention and treatment of allograft rejection of the liver, kidneys and heart, including with resistance to standard immunosuppressive regimes.

Prograf. Indications: Prevention and treatment of allograft rejection of the liver, kidneys and heart, including with resistance to standard immunosuppressive regimes.

Structure and Composition

The concentrate for solution for intravenous injection 1 ml

Tacrolimus 5 mg

Excipients: polyoxyethylene hydrogenated castor oil (HCO-60) — 200 mg; Anhydrous alcohol — 638 mg

in ampoules of a colorless transparent glass (USP Type I) at 1 ml in blisters 10 pcs .; In the paper cartons 1 pack.

The capsules 1 caps.

0.5 mg tacrolimus

excipients: hydroxypropyl — 0.5 mg; Croscarmellose Sodium — 0.5 mg; lactose, — 62.85 mg; magnesium stearate — 0.65 mg

Capsule composition: Titanium dioxide — 0,338 mg; iron oxide yellow — 0,048 mg; Purified water — 4.2 mg; gelatin — 23.414 mg

in blister PVC / aluminum foil — 10 pcs in an aluminum bag — 5 blisters.; In the paper cartons — 1 aluminum bag.

The capsules 1 caps.

1 mg tacrolimus

excipients: hydroxypropyl — 1 mg; Croscarmellose Sodium — 1 mg; lactose, — 61.35 mg; magnesium stearate — 0.65 mg

Capsule composition: Titanium dioxide — 0,395 mg; Purified water — 4.2 mg; gelatin — 23.405 mg

in blister PVC / aluminum foil 10 pieces, in an aluminum bag 5 blisters.; In the paper cartons 1 aluminum bag.

The capsules 1 caps.

Tacrolimus 5 mg

excipients: hydroxypropyl — 5 mg; Croscarmellose sodium — 5 mg; Lactose — 123.6 mg; Magnesium stearate — 1.4 mg

Capsule composition: titanium dioxide — 0.564 mg; iron oxide red — 0,008 mg; Purified water — 6 mg; gelatin — 33.428 mg

in blister PVC / aluminum foil 10 pieces, in an aluminum bag 5 blisters.; In the paper cartons 1 aluminum bag.

Indications for use

Prevention and treatment of allograft rejection liver, kidney and heart, including with resistance to standard immunosuppressive regimes.

Contraindications

known hypersensitivity to tacrolimus or other macrolides;

known hypersensitivity to polyoxyethylated hydrogenated castor oil (HCO-60) or structurally related components.

Cardiovascular system: very often — hypertension; often — hypotension, tachycardia, cardiac arrhythmias and conduction disturbances, thromboembolic and ischemic events, angina pectoris, cerebrovascular disease; seldom — abnormalities in the ECG parameters, heart attack, heart failure, shock, myocardial hypertrophy, cardiac arrest.

Diseases of the digestive tract and liver: very often — diarrhea, nausea and / or vomiting; frequently — gastrointestinal dysfunction (such as dyspepsia), variations in the levels of liver enzymes, abdominal pain, constipation, changes in weight or appetite, inflammation and ulcers in the gastrointestinal tract, jaundice, biliary tract and gall bladder; rarely — ascites, intestinal obstruction (ileus), liver damage tissue, pancreatitis; seldom — hepatic insufficiency.

Blood and lymphatic system: often — anemia, leukopenia, thrombocytopenia, hemorrhage, leukocytosis, coagulation disorders; infrequently — failure of the hematopoietic system, including pancytopenia, thrombotic microangiopathy.

Kidney: very often — impaired renal function (eg increased creatinine level in blood serum); often — loss of kidney tissue, kidney failure; infrequently — proteinuria.

Metabolism and electrolytes: very often — hyperglycemia, hyperkalemia, diabetes mellitus; often — hypomagnesemia, hyperlipidemia, hypophosphatemia, hypokalemia, hyperuricemia, hypocalcemia, acidosis, hyponatremia, hypovolemia, dehydration; infrequently — gipoproteinuriya, hyperphosphatemia, increased amylase, hypoglycemia.

Musculoskeletal System: often — convulsions; rarely — myasthenia gravis, joint diseases.

The nervous system / senses system: very often — tremor, headache, insomnia; often — the sensitivity of the violation (eg paraesthesia), blurred vision, confusion, depression, dizziness, agitation, neuropathy, seizures, psychosis, anxiety, nervousness, sleep disturbances, impaired consciousness, emotional lability, hallucinations, hearing loss, impaired thinking, encephalopathy; seldom — hypertension, eye diseases, amnesia, cataract, impaired speech, paralysis, coma, deafness; very rarely — blindness.

Respiratory system: often — a violation of the respiratory function (eg shortness of breath), pleural effusion; infrequently — atelectasis, bronchospasm.

Skin: often — itching, alopecia, rash, sweating, acne, photosensitivity; infrequently — hirsutism; rarely — Lyell’s syndrome; very rarely — Stevens-Johnson syndrome.

Mixed symptoms: very often — localized pain (such as arthralgia); often — fever, peripheral edema, fatigue, impaired urination; seldom — disorders of the genitals in women, including puffiness.

Hypersensitivity reactions: allergic and anaphylactic reactions.

Infections: patients receiving tacrolimus as treatment with other immunosuppressive drugs, increased risk of infections (viral, bacterial, fungal, protozoal). It may get worse for the previously diagnosed infectious diseases.