Freedox (Solution) Instructions for Use

ATC Code

N07XX01 (Tirilazad)

Active Substance

Tirilazad (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Antioxidant and cytoprotector used for subarachnoid hemorrhage

Pharmacotherapeutic Group

Antioxidant agent

Pharmacological Action

Antioxidant and cytoprotective agent. It prevents or reduces secondary damage to the tissues surrounding the focus of subarachnoid hemorrhage.

This effect is due to the inhibition of lipid peroxidation, as well as the enhancement of the utilization of reactive free radicals, which are formed during peroxidation and cause damage to the structure of nucleic acids, enzymes, etc.

Tirilazad promotes the preservation of vitamin E, which is a natural antioxidant, in cell membranes.

The clearance of tirilazad is significantly higher in women than in men, therefore the concentrations of the active substance in plasma are greater in the latter.

Indications

Use exclusively for the treatment of patients following a confirmed diagnosis of subarachnoid hemorrhage.

• This medication is indicated for use in male patients only, due to pharmacokinetic differences resulting in lower plasma concentrations in females.
• Initiate therapy as an integral part of the standard management protocol for this neurological emergency.

ICD codes

Dosage Regimen

Administer the solution by intravenous drip infusion at a dosage of 1.5 mg per kg of body weight every 6 hours.

Continue this regimen for a total duration of 8 to 10 days. It is critical to initiate the first infusion no later than 8 hours after the onset of the subarachnoid hemorrhage to maximize therapeutic efficacy.

Adverse Reactions

Monitor for potential cardiovascular effects such as tachycardia. Hematological disturbances including thrombocytopenia and laboratory abnormalities like hyperbilirubinemia may occur.

Serious adverse events reported in some cases encompass pulmonary edema, intracerebral hemorrhages, and sepsis. Local infusion site reactions, including tissue irritation and phlebitis, are also possible.

Contraindications

Do not administer this medication under any circumstances to patients with a known hypersensitivity to the active substance or any component of the formulation.

• Hypersensitivity to tirilazad is an absolute contraindication.
• This product is not indicated for use in women due to significantly higher clearance leading to subtherapeutic plasma levels.

Special Precautions

Venous irritation phenomena are more pronounced if several infusions are performed through one catheter. Therefore, it is recommended to change catheters when signs of inflammation appear.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.