Dibulin (Liniment) Instructions for Use

Marketing Authorization Holder

Nizhpharm JSC (Russia)

ATC Code

D03AX (Other drugs that promote normal scarring)

Active Substance

Butylated hydroxytoluene

Dosage Form

Dibulin

Liniment 5%: tube 25 g

Dosage Form, Packaging, and Composition

25 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

A drug improving trophism and tissue regeneration, for external use

Pharmacotherapeutic Group

Antioxidant agent

Pharmacological Action

The drug has an antioxidant effect and stimulates regeneration processes.

Indications

5% liniment

Superficial burns; first- and second-degree frostbite (treatment, prevention); long-term non-healing, trophic, and radiation ulcers; sluggishly healing wounds.

10% liniment

Bladder cancer and papillomatosis (in the preoperative period to reduce tumor size and combat perifocal inflammatory process; in combination with radiation therapy for bladder tumors to reduce tumor size and treat early radiation cystitis); late radiation injuries of the bladder; cystitis complicating the course of bladder tumor; conservative therapy of bladder tumors in cases where surgical intervention and radiation therapy are not possible.

ICD codes

Dosage Regimen

The 5% liniment should be applied topically, in a thin layer to the wound or bandage. The bandage should be changed daily.

The course of treatment for burns and frostbite is 7-10 days; for ulcer treatment – 20-30 days.

For frostbite prevention, the drug is applied in a thin layer to exposed parts of the face 1-2 times/day.

The 10% liniment is used as intravesical instillations.

For this, immediately before use, 10 ml of liniment is diluted in 25-30 ml of a 0.25-1% procaine solution to a consistency suitable for intravesical administration, and then the resulting solution (35-40 ml) is injected with a syringe via a catheter into a previously emptied bladder.

Before instillation, it is recommended to rinse the bladder with an antiseptic solution. The patient should retain the drug in the bladder until the next urination, preferably for at least 2-3 hours.

In cases of a painful reaction to catheter insertion, in the absence of mechanical strictures of the urethra, it is permissible to administer butylated hydroxytoluene through the urethra under pressure. Instillations are performed daily.

The course of treatment to obtain an anti-inflammatory effect is 10-15 instillations; for an antitumor effect – at least 25 instillations.

If there is no improvement within the specified timeframes, treatment is discontinued. If a reduction in the size of the lesion is detected, treatment can be continued for 30-45 days. If necessary, courses of instillations are repeated.

Adverse Reactions

For the 5% liniment

Allergic reactions: itching and redness of the skin around the ulcer.

For the 10% liniment

When administered intravesically, it does not cause systemic side effects.

From the urinary system: urethritis, prostatitis, orchiepididymitis, wet necrosis (with repeated catheterization).

Contraindications

Tumor invasion into the perivesical tissue; tumor metastasis; massive hematuria; azotemia; acute pyelonephritis; vesicoureteral reflux; hypersensitivity to the active substance.

The drug should be used with caution for tumors in the area of the bladder neck, due to the risk of injuring the tumor during repeated catheterizations.

Use in Renal Impairment

Contraindicated in acute pyelonephritis.

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

Over-the-Counter

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.