Drugs List

Therapeutic Indications

Uses

Treatment of peripheral neuropathic pain

Administration

Nitrile gloves should be worn at all times whilst administering capsaicin and cleaning treatment areas. Use of a mask and protective glasses is recommended, particularly during application and removal of the patch.

Clip hairs in the affected area to promote patch adherence (do not shave).

Gently wash the treatment area(s) with soap and water. Following hair removal and washing, dry the skin thoroughly.

The treatment area may be pre-treated with a topical anaesthetic or the patient may be administered an oral analgesic prior to application of the capsaicin patches to reduce application related discomfort. The topical anaesthetic should be used in accordance with the product's instructions for use and applied to cover the entire treatment area and surrounding 1 to 2 cm. Prior to application of the capsaicin patch, topical anaesthetic should be removed and the skin should be washed and dryed thoroughly.

Capsaicin patch is a single use patch and can be cut to match the size and shape of the treatment area. Cut the patch prior to removal of the release liner.

Do not remove the release liner until just prior to application. There is a diagonal cut in the release liner to aid in its removal. Peel and fold a section of the release liner and place the adhesive side of the printed patch on the treatment area. Hold the patch in place and slowly and carefully peel the release liner from underneath with one hand while simultaneously smoothing the patch onto the skin with the other.

Stretchable socks or rolled gauze may be used to ensure the capsaicin patches maintain contact to the treatment area.

Remove the capsaicin patches gently and slowly by rolling them inward to minimise the risk of aerosolisation of capsaicin. After removal of the capsaicin patches, apply cleansing gel liberally to the treatment area and leave on for at least one minute. Wipe off the cleansing gel with dry gauze to remove any remaining capsaicin from the skin. After the cleansing gel has been wiped off, gently wash the area with soap and water.

Treat acute pain during and following the procedure with local cooling (such as a cool compress) and oral analgesics (e.g. short-acting opioids).

Used and unused patches and all other materials that have been in contact with the treated area should be disposed of be sealing them in the polyethylene medical waste bag and placing in an appropriate medical waste container.

Contraindications

Children under 18 years
Breastfeeding

Precautions and Warnings

Diabetes mellitus
Diabetic peripheral neuropathy
History of cardiovascular disorder
Ischaemic heart disease
Pregnancy
Uncontrolled hypertension

Cleansing gel contains butylhydroxyanisole -May cause local skin irritation
Treatment to be applied/supervised by a physician
Avoid application to moist or broken skin
Avoid contact with eyes
Avoid contact with mucous membranes
Avoid contact with skin not being treated
Dispose of used units safely - see product information
Dry skin thoroughly before application
If accidental contact with eyes or mucous membranes - rinse with cool water
Not to be applied above the hairline of the scalp
Not to be applied to the face
Use in a well ventilated area
Monitor blood pressure
Sensory loss: Consider discontinuation if worsens or detected
If pain increases use oral analgesia and local cooling
Avoid inhalation of the product

In patients with painful diabetic peripheral neuropathy, a visual examination of the feet should be carefully undertaken prior to each application of capsaicin and at further clinical visits to detect skin lesions related to underlying neuropathy and vascular insufficiency.

Decreases in sensory function have been reported in patients using capsaicin. This reduction in sensory function is normally minor and temporary. Use capsaicin with caution in patients with reduced sensation in the feet and in patients with an increased risk for such changes in sensory function. Any patients with an existing sensory deficit should be assessed for signs of sensory loss before each application of capsaicin. Capsaicin treatment should be reconsidered if sensory loss occurs or worsens.

In patients reporting severe pain, it is advisable to remove the patch and examine the skin for chemical burns.

If capsaicin patches come in contact with skin not intended to be treated; apply cleansing gel for one minute and wipe off with dry gauze to remove any remaining capsaicin from the skin surface, then wash the area gently with soap and water. In case of burning of the eyes, skin, or airway; remove the affected individual from the vicinity of capsaicin. Flush or rinse eyes or mucous membranes with cold water. Provide appropriate medical care if shortness of breath develops.

Transient increases in blood pressure may occur during and shortly after the capsaicin treatment as a result of treatment-related increases in pain. Monitor blood pressure during the treatment procedure. In patients with uncontrolled hypertension or a history of cardiovascular disease, the potential for adverse cardiovascular events should be assessed before initiating treatment, particularly in diabetic patients with comorbidities of coronary artery disease, hypertension and cardiovascular autonomic neuropathy.

Care must be taken to avoid unintentional contact with the patches or other materials that have come in contact with the treated areas. Exposure of the skin to capsaicin results in transient erythema and burning sensation, with mucous membranes being particularly susceptible. Inhalation of airborne capsaicin can result in coughing or sneezing.

Provide patients experiencing increased pain with supportive treatment such as local cooling or oral analgesics. Particular attention should be given to diabetic patients with co-morbidities of coronary artery disease, hypertension and cardiovascular autonomic neuropathy.

Pregnancy and Lactation

Pregnancy

Use capsaicin with caution during pregnancy.

There are limited data available on the use of capsaicin in pregnant women. However, the likelihood that capsaicin increases the risk of developmental abnormalities when given during pregnancy is very low based on human pharmacokinetics, which show transient, low systemic exposure to capsaicin.

Lactation

Capsaicin is contraindicated during breastfeeding.

It is unknown whether capsaicin is excreted in human breast milk. Data in animals has shown that capsaicin is excreted into milk. Consequently a risk to nursing infants cannot be excluded and thus breastfeeding should be discontinued during treatment with capsaicin.

Side Effects

Application site reaction
Bruising
Burning sensation
Burning sensation (local)
Chemical burns
Cough
Dermatitis
Disturbances of sensation
Dry skin
Dysgeusia
Erythema at application site
Eye irritation
Eye pain
First degree AV block
Herpes zoster
Hyperesthesia
Hypertension
Hypoesthesia
Increased blood pressure
Inflammation (application site)
Irritation at application site
Local burning
Muscle spasm
Nausea
Oedema at application site
Pain at application site
Painful extremities
Palpitations
Papules
Paraesthesia
Peripheral oedema
Pruritus
Swelling
Tachycardia
Throat irritation
Urticaria
Vesicles

Presentation

Cutaneous patch containing capsaicin.

Drugs List

Therapeutic Indications

Uses

Treatment of peripheral neuropathic pain

Dosage

Adults

Administration

Nitrile gloves should be worn at all times whilst administering capsaicin and cleaning treatment areas. Use of a mask and protective glasses is recommended, particularly during application and removal of the patch.

Clip hairs in the affected area to promote patch adherence (do not shave).

Gently wash the treatment area(s) with soap and water. Following hair removal and washing, dry the skin thoroughly.

The treatment area may be pre-treated with a topical anaesthetic or the patient may be administered an oral analgesic prior to application of the capsaicin patches to reduce application related discomfort. The topical anaesthetic should be used in accordance with the product's instructions for use and applied to cover the entire treatment area and surrounding 1 to 2 cm. Prior to application of the capsaicin patch, topical anaesthetic should be removed and the skin should be washed and dryed thoroughly.

Capsaicin patch is a single use patch and can be cut to match the size and shape of the treatment area. Cut the patch prior to removal of the release liner.

Do not remove the release liner until just prior to application. There is a diagonal cut in the release liner to aid in its removal. Peel and fold a section of the release liner and place the adhesive side of the printed patch on the treatment area. Hold the patch in place and slowly and carefully peel the release liner from underneath with one hand while simultaneously smoothing the patch onto the skin with the other.

Stretchable socks or rolled gauze may be used to ensure the capsaicin patches maintain contact to the treatment area.

Remove the capsaicin patches gently and slowly by rolling them inward to minimise the risk of aerosolisation of capsaicin. After removal of the capsaicin patches, apply cleansing gel liberally to the treatment area and leave on for at least one minute. Wipe off the cleansing gel with dry gauze to remove any remaining capsaicin from the skin. After the cleansing gel has been wiped off, gently wash the area with soap and water.

Treat acute pain during and following the procedure with local cooling (such as a cool compress) and oral analgesics (e.g. short-acting opioids).

Used and unused patches and all other materials that have been in contact with the treated area should be disposed of be sealing them in the polyethylene medical waste bag and placing in an appropriate medical waste container.

Contraindications

Children under 18 years
Breastfeeding

Precautions and Warnings

Diabetes mellitus
Diabetic peripheral neuropathy
History of cardiovascular disorder
Ischaemic heart disease
Pregnancy
Uncontrolled hypertension

Cleansing gel contains butylhydroxyanisole -May cause local skin irritation
Treatment to be applied/supervised by a physician
Avoid application to moist or broken skin
Avoid contact with eyes
Avoid contact with mucous membranes
Avoid contact with skin not being treated
Dispose of used units safely - see product information
Dry skin thoroughly before application
If accidental contact with eyes or mucous membranes - rinse with cool water
Not to be applied above the hairline of the scalp
Not to be applied to the face
Use in a well ventilated area
Monitor blood pressure
Sensory loss: Consider discontinuation if worsens or detected
If pain increases use oral analgesia and local cooling
Avoid inhalation of the product

In patients with painful diabetic peripheral neuropathy, a visual examination of the feet should be carefully undertaken prior to each application of capsaicin and at further clinical visits to detect skin lesions related to underlying neuropathy and vascular insufficiency.

Decreases in sensory function have been reported in patients using capsaicin. This reduction in sensory function is normally minor and temporary. Use capsaicin with caution in patients with reduced sensation in the feet and in patients with an increased risk for such changes in sensory function. Any patients with an existing sensory deficit should be assessed for signs of sensory loss before each application of capsaicin. Capsaicin treatment should be reconsidered if sensory loss occurs or worsens.

In patients reporting severe pain, it is advisable to remove the patch and examine the skin for chemical burns.

If capsaicin patches come in contact with skin not intended to be treated; apply cleansing gel for one minute and wipe off with dry gauze to remove any remaining capsaicin from the skin surface, then wash the area gently with soap and water. In case of burning of the eyes, skin, or airway; remove the affected individual from the vicinity of capsaicin. Flush or rinse eyes or mucous membranes with cold water. Provide appropriate medical care if shortness of breath develops.

Transient increases in blood pressure may occur during and shortly after the capsaicin treatment as a result of treatment-related increases in pain. Monitor blood pressure during the treatment procedure. In patients with uncontrolled hypertension or a history of cardiovascular disease, the potential for adverse cardiovascular events should be assessed before initiating treatment, particularly in diabetic patients with comorbidities of coronary artery disease, hypertension and cardiovascular autonomic neuropathy.

Care must be taken to avoid unintentional contact with the patches or other materials that have come in contact with the treated areas. Exposure of the skin to capsaicin results in transient erythema and burning sensation, with mucous membranes being particularly susceptible. Inhalation of airborne capsaicin can result in coughing or sneezing.

Provide patients experiencing increased pain with supportive treatment such as local cooling or oral analgesics. Particular attention should be given to diabetic patients with co-morbidities of coronary artery disease, hypertension and cardiovascular autonomic neuropathy.

Pregnancy and Lactation

Pregnancy

Use capsaicin with caution during pregnancy.

There are limited data available on the use of capsaicin in pregnant women. However, the likelihood that capsaicin increases the risk of developmental abnormalities when given during pregnancy is very low based on human pharmacokinetics, which show transient, low systemic exposure to capsaicin.

Lactation

Capsaicin is contraindicated during breastfeeding.

It is unknown whether capsaicin is excreted in human breast milk. Data in animals has shown that capsaicin is excreted into milk. Consequently a risk to nursing infants cannot be excluded and thus breastfeeding should be discontinued during treatment with capsaicin.

Side Effects

Application site reaction
Bruising
Burning sensation
Burning sensation (local)
Chemical burns
Cough
Dermatitis
Disturbances of sensation
Dry skin
Dysgeusia
Erythema at application site
Eye irritation
Eye pain
First degree AV block
Herpes zoster
Hyperesthesia
Hypertension
Hypoesthesia
Increased blood pressure
Inflammation (application site)
Irritation at application site
Local burning
Muscle spasm
Nausea
Oedema at application site
Pain at application site
Painful extremities
Palpitations
Papules
Paraesthesia
Peripheral oedema
Pruritus
Swelling
Tachycardia
Throat irritation
Urticaria
Vesicles

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last full review date: July 2021

Reference Sources

Summary of Product Characteristics: Qutenza 179mg cutaneous patch. Grunenthal Ltd. Revised March 2021.