Drugs List

Therapeutic Indications

Uses

Treatment of Rosacea (topical)

Dosage

One application per 24 hours of a small pea size amount of medicinal product to each of the five areas of the face: forehead, chin, nose, each cheek.

The maximum daily recommended dose is 1 gram of gel in total weight.

Initiate treatment with the smallest amount of gel for at least 1 week, then gradually increase dose based on individual response to treatment.

Brimonidine gel should be applied smoothly and evenly as a thin layer.

Contraindications

Children under 18 years
Breastfeeding

Precautions and Warnings

Pregnancy

Contains parabens
Contains propylene glycol: may cause irritation
Advise patient to wash hands after use
Avoid contact with eyes, lips or mouth
Avoid contact with mucous membranes
Avoid laser treatment or chemical peel before or after the treatment
Do not apply to broken or denuded skin
Do not apply to periorbital skin
Discontinue if erythema worsens
Discontinue treatment if severe irritation or contact allergy occurs
Maintain treatment at the lowest effective dose
Start treatment at lowest recommended dose
Advise patient that the effects of alcohol may be potentiated
Patients should not exceed recommended dose

The effects of brimonidine topical gel begins to diminish hours after application. In some patients, erythema and flushing were reported to return with greater severity than was present at baseline. Most of the cases were observed within the first 2 weeks of starting the treatment.

The onset of flushing relative to application of brimonidine gel varied, ranging from approximately 30 minutes to several hours.

In the majority of cases, erythema and flushing resolved after discontinuation of brimonidine topical gel.

If worsening erythema occurs, brimonidine topical gel should be discontinued symptomatic measures, such as cooling, NSAID and antihistamines, may help in alleviating symptoms.

Prior to resuming treatment after temporary discontinuation due to aggravated erythema or flushing, perform a test application on a small area of the face for at least one day before full facial application is resumed.

Pregnancy and Lactation

Pregnancy

Brimonidine gel should be used with caution in pregnancy.

There are no or limited amount of data from the use of brimonidine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. The manufacturer recommends avoiding brimonidine gel in pregnancy.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Brimonidine gel is contraindicated in breastfeeding.

It is unknown whether brimonidine/metabolites are excreted in human milk. As a risk to the newborns/infants cannot be excluded the manufacturer recommends brimonidine gel is not used during breastfeeding.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Acne
Allergic contact dermatitis
Bradycardia
Burning sensation
Contact dermatitis
Dermatitis
Dizziness
Dry skin
Erythema
Eyelid oedema
Feeling hot
Flushing
Headache
Hypotension
Nasal congestion
Papules
Paraesthesia
Peripheral coldness
Pruritus
Rosacea
Skin discomfort
Skin irritation
Skin pain

Presentation

Topical gel containing brimonidine

Drugs List

Therapeutic Indications

Uses

Treatment of Rosacea (topical)

Dosage

One application per 24 hours of a small pea size amount of medicinal product to each of the five areas of the face: forehead, chin, nose, each cheek.

The maximum daily recommended dose is 1 gram of gel in total weight.

Initiate treatment with the smallest amount of gel for at least 1 week, then gradually increase dose based on individual response to treatment.

Brimonidine gel should be applied smoothly and evenly as a thin layer.

Contraindications

Children under 18 years
Breastfeeding

Precautions and Warnings

Pregnancy

Contains parabens
Contains propylene glycol: may cause irritation
Advise patient to wash hands after use
Avoid contact with eyes, lips or mouth
Avoid contact with mucous membranes
Avoid laser treatment or chemical peel before or after the treatment
Do not apply to broken or denuded skin
Do not apply to periorbital skin
Discontinue if erythema worsens
Discontinue treatment if severe irritation or contact allergy occurs
Maintain treatment at the lowest effective dose
Start treatment at lowest recommended dose
Advise patient that the effects of alcohol may be potentiated
Patients should not exceed recommended dose

The effects of brimonidine topical gel begins to diminish hours after application. In some patients, erythema and flushing were reported to return with greater severity than was present at baseline. Most of the cases were observed within the first 2 weeks of starting the treatment.

The onset of flushing relative to application of brimonidine gel varied, ranging from approximately 30 minutes to several hours.

In the majority of cases, erythema and flushing resolved after discontinuation of brimonidine topical gel.

If worsening erythema occurs, brimonidine topical gel should be discontinued symptomatic measures, such as cooling, NSAID and antihistamines, may help in alleviating symptoms.

Prior to resuming treatment after temporary discontinuation due to aggravated erythema or flushing, perform a test application on a small area of the face for at least one day before full facial application is resumed.

Pregnancy and Lactation

Pregnancy

Brimonidine gel should be used with caution in pregnancy.

There are no or limited amount of data from the use of brimonidine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. The manufacturer recommends avoiding brimonidine gel in pregnancy.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Brimonidine gel is contraindicated in breastfeeding.

It is unknown whether brimonidine/metabolites are excreted in human milk. As a risk to the newborns/infants cannot be excluded the manufacturer recommends brimonidine gel is not used during breastfeeding.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Counselling

Brimonidine gel can be used in conjunction with other cutaneous medicinal products for the treatment of inflammatory lesions of rosacea and with cosmetics. These products should not be applied immediately before the daily application of brimonidine gel, they may be used only after the applied brimonidine gel has dried.

Side Effects

Acne
Allergic contact dermatitis
Bradycardia
Burning sensation
Contact dermatitis
Dermatitis
Dizziness
Dry skin
Erythema
Eyelid oedema
Feeling hot
Flushing
Headache
Hypotension
Nasal congestion
Papules
Paraesthesia
Peripheral coldness
Pruritus
Rosacea
Skin discomfort
Skin irritation
Skin pain

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: March 2014

Reference Sources

Summary of Product Characteristics: Mirvaso Gel 3mg/g. Galderma. Revised January 2017 .