Temomedak (temozolomide) capsules 100 mg. №5 vial

Temomedak (temozolomide) capsules 100 mg. №5 vial

$432.00

Manufacturer: Germany

Treatment: adult patients with newly diagnosed glioblastoma multiforme accompanied by radiotherapy and then as monotherapy; children over 3 years of age and adult patients with malignant glioma in the form of glioblastoma multiforme or anaplastic astrocytoma in the presence of recurrence or progression of the disease after standard therapy.

Category:

Description

Temomedak (temozolomide) capsules 100 mg. №5 vial

Composition

active substance: temozolomide;

1 capsule contains 5 mg, 20 mg, 100 mg, 140 mg, 180 mg or 250 mg temozolomide;

Excipients: lactose anhydrous, sodium starch glycolate (type A), colloidal anhydrous silica, tartaric acid, stearic acid;

  • 5 mg capsules: titanium dioxide (E 171), gelatin, shellac, propylene glycol, indigo carmine (E 132), iron oxide yellow (E 172);
  • 20 mg capsules: titanium dioxide (E 171), gelatin, shellac, propylene glycol, yellow FCF (E 110);
  • 100 mg capsules: titanium dioxide (E 171), gelatin, shellac, propylene glycol, iron oxide yellow (E 172), iron oxide red (E 172);
  • 140 mg capsules: titanium dioxide (E 171), gelatin, shellac, propylene glycol, indigo carmine (E 132);
  • capsules 180 mg: titanium dioxide (E 171), gelatin, shellac, propylene glycol, iron oxide red (E 172);
  • 250 mg capsules: titanium dioxide (E 171), gelatin, shellac, propylene glycol, iron oxide black (E 172).

Dosage form

Capsules.

Main physical and chemical properties: hard gelatin capsules. The capsules contain a white to light yellowish-brown / light pink powder. Two strips are applied on the opaque lid of the capsules, on the opaque body – the inscriptions “T 5 mg”, “T 20 mg”, “T 100 mg”, “T 140 mg”, “T 180 mg”, “T 250 mg”. The color of the stripes and inscriptions and the size of the capsule correspond to the dosage: for 5 mg – green; for 20 mg – orange; for 100 mg – pink; for 140 mg – blue; for 180 mg – red; for 250 mg – black.

Pharmacotherapeutic group

Antineoplastic agents. Alkylating compounds.
ATX code L01A X03.

Pharmacological properties

This is a drug with anticancer activity. It is used for oncological diseases of the nervous system (in particular, the brain).

Indications

Temomedak capsules 100 mg is indicated for the treatment of adult patients with glioblastoma multiforme (in combination with radiotherapy or as monotherapy), as well as adults and children over three years of age with malignant glioma, anaplastic astrocytoma (with relapses, disease progression after standard treatment).

Contraindications

The use of Temomedak capsules 100 mg is prohibited in case of hypersensitivity to this drug, in the presence of signs of severe myelosuppression (suppression of bone marrow hematopoiesis).
Not applicable to children under three years of age.

Application during pregnancy and lactation

Do not use the medicine in pregnant women. Women of reproductive age need to use reliable methods of contraception when therapy with this drug.
During treatment with this pharmaceutical preparation, breastfeeding must be stopped.

Method of administration and dosage

Therapy with this drug can only be carried out by a doctor with experience in treating the above-mentioned oncological diseases. Therapy is selected depending on the disease and the patient’s age. So, for adult patients with newly diagnosed glioblastoma multiforme, the drug is used daily orally at a dose of 75 mg / m2 for 42 days, accompanied by radiotherapy; followed by a course of monotherapy (adjuvant therapy) for six cycles. In each cycle, the drug is applied for five consecutive days, followed by a 23-day break.
The maximum duration of therapy is two years. If signs of disease progression occur, this drug should be discontinued.
The drug is taken on an empty stomach, one hour before meals. The capsules are taken orally whole, they cannot be chewed or opened; should be taken with one glass of water.

Overdose

The drug has a dose-dependent hematological toxicity (the higher the dose of a given antitumor agent, the more pronounced blood disorders).
In case of an overdose, pancytopenia (a decrease in the number of all blood cells), pyrexia (fever), multiorgan failure are observed; with a significant overdose, there is a high probability of death.
In case of an overdose with this pharmaceutical, a hematological study should be performed; maintenance therapy is indicated.

Side effects

The most common adverse reactions with this medication are nausea, fatigue, vomiting, anorexia, constipation, and headache. The development of seizures and rashes in patients was very often reported. Also, when using this drug, the following side effects may be observed: infections (including herpes simplex, candidiasis), weight loss, dizziness, anxiety, a decrease in the number of blood cells (anemia, neutropenia, leukopenia, thrombocytopenia, leukopenia, lymphopenia), hemorrhages on the skin, emotional lability, dry eyes, insomnia, blurred vision, edema, alopecia (baldness), arthralgia (joint pain), sweating, back pain, urinary disorders (including incontinence), chills, allergic reactions, impotence in men, pain in the mammary glands and amenorrhea and / or metrorrhagia in women.
There may also be an increase in the activity of hepatic transaminases (liver enzymes).

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