Finalgon® [Nicoboxil, Nonivamide]

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Available since: 2019-09-19

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Clinical Pharmacology

Pharmacodynamics

Nonivamide is a synthetic analogue of capsaicin and has analgesic properties, which manifest themselves as a result of the gradual penetration of the active substance into the peripheral nociceptive C-fibers and A-delta nerve fibers upon repeated application of the drug to the skin.

Nonivamide has a vasodilating effect, which is accompanied by an intense, long-lasting sensation of heat, due to the stimulation of afferent nerve endings in the skin. Nicoboxyl is a derivative of nicotinic acid, which has vasodilating properties with the participation of prostaglandins I2 and E2. The hyperemic effect of nicoboxil (nicotinic acid butoxyethyl ester) develops faster and has a greater intensity than the hyperemic effect of nonivamide.

Combined action

Nonivamide and nikoboksil possess complementary vasodilating properties, cause flushing of the skin, increase the rate of enzymatic reactions, activate metabolism.

The appearance of hyperemia and an increase in skin temperature within a few minutes after application indicate the rapid penetration of the active ingredients of the preparation into the skin.

The action of Finalgon is manifested locally, it develops in a few minutes and reaches a maximum in 20-30 minutes.

Pharmacokinetics

Data on the pharmacokinetics of Finalgon® is not provided.

Indications

Arthritis;
arthralgia and myalgia of rheumatic genesis;
sports injuries, bruises and damage to the ligament apparatus;
myalgia caused by excessive exercise;
lumbago;
neuritis;
ischalgia;
bursitis and tendovaginitis;
for preliminary "warming up" muscles before physical exercises, sports competitions;
as part of a complex vasodilator therapy for disorders of peripheral circulation.

Composition

Excipients: decyl oleate - 50 mg, emulsifier F - 10 mg, macrogol cetostearyl ether - 30 mg, stearic acid - 2 mg, cetostearyl alcohol - 20 mg, liquid paraffin - 30 mg, sorbic acid - 2 mg, vegetable perfume oil - 2 mg, purified water - 823.5 mg.

Nicoboxil, Nonivamide is marketed under different brands and generic names, and comes in different dosage forms:

Brand name	Manufacturer	Country	Dosage form
			cream
Finalgon	Boehringer Ingelheim	Austria	ointment

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Dosage and Administration

Treatment should begin with the application of a small amount of the drug on a small area of skin to assess the individual reaction. An individual reaction to a drug may differ significantly: some people will only need to apply a small amount of ointment in order to cause the necessary warming effect.

With the help of the attached applicator, a column of the drug, no larger than 0.5 cm in size, is applied to the corresponding skin area the size of a palm with light rubbing movements. To enhance the therapeutic effect of the skin on which the drug is applied, you can cover with woolen cloth.

With repeated use, the reaction to the ointment may decrease, which requires an increase in the dose, which is selected individually.

If necessary, use the cream 2-3 times / day.

To preheat the muscles before exercise, sports competitions are recommended to be rubbed about 30 minutes before they start.

The patient should be warned that in the absence of the desired effect within 10 days, you should consult a doctor.

After applying the product to the skin, wash your hands thoroughly with soap and water.

Adverse reactions

During the long experience of using the drug, the following side effects were identified:

On the part of the immune system: anaphylactic reactions, hypersensitivity.

From the nervous system: paresthesia, burning sensation of the skin.

On the part of the respiratory system: cough, shortness of breath.

On the part of the skin and subcutaneous tissues: vesicles or pustules at the site of application, local skin reaction (for example, contact dermatitis), itching, rash, swelling of the face, urticaria, sensation of heat at the site of application.

Contraindications

Hypersensitivity to nikoboksil, nonivamid or excipients of the drug;
children's age up to 12 years.
the drug should not be applied to sensitive skin, open wounds, inflamed skin areas, skin areas with increased permeability: neck, lower abdomen, inner thighs.

Drug interactions

Drug interaction of the drug Finalgon® with other drugs used topically or systemically, was not detected.

Pregnancy and Lactation

Since clinical experience with the drug during pregnancy and lactation is insufficient, it is not recommended to prescribe Finalgon® of this category of patients.

It is not known whether the active ingredients in the composition of the Finalgon are excreted in breast milk.

Special instructions

The drug causes flushing of the skin, resulting in redness, a sensation of heat, itching and burning at the site of use. These symptoms may be more pronounced when applying an excess amount of the drug or in case of intense rubbing on the skin surface. The use of excessive amounts of the drug or intensive rubbing on the skin surface can lead to the appearance of vesicles or pustules at the site of application of the ointment.

After using Finalgon®, wash your hands with soap and water immediately.

Care must be taken to avoid accidental contact with other areas of the skin or contact with another person.

Avoid accidental contact with the face, eyes, nose or mouth. This can lead to temporary swelling of the face, pain in the face, inflammation of the conjunctiva, eye flushes, burning eyes, blurred vision, discomfort in the mouth and stomatitis.

Before or after applying the drug to the skin should not take a hot bath or shower.

Sweat or application of heat to the site of application of the drug can cause reddening of the skin and an intense sensation of heat even a few hours after the application of Finalgon.

The preparation contains sorbic acid, which can cause local skin irritation (for example, contact dermatitis).

Impact on the ability to drive vehicles and other mechanisms that require high concentration of attention

Special clinical studies of the effect of the drug on the ability to drive and mechanisms were not conducted. However, caution should be exercised when using the drug while driving and working with machinery.

Overdosage

Symptoms: the effect of skin hyperemia and the severity of dose-dependent side effects may be exacerbated after applying an excessive amount of Finalgon® ointment. The use of excessive amounts of the drug can lead to the appearance of vesicles or pustules at the site of application of the ointment.

An overdose of the drug can cause systemic reactions (redness of the upper body, increased body temperature, "hot flushes" of blood, painful hyperemia, decrease in blood pressure), because Nicotinic esters have good transdermal absorption.

Treatment: when using an excess amount of the drug, the effect can be reduced if the ointment is removed from the skin surface with vegetable oil or cosmetic cream on a greasy basis, from the eye mucosa (in case of accidental contact) with medical petroleum jelly. If necessary, symptomatic treatment should be carried out.