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| Product NDC Code | 63629-9616 | ||||
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| Drug Name | Brimonidine |
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| Type | Generic | ||||
| Pharm Class | Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 1437707 | ||||
| Application Number | ANDA209158 | ||||
| Labeler Name | Bryant Ranch Prepack | ||||
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Overdosage of brimonidine
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.10 OVERDOSAGE No information is available on overdose in adults with brimonidine topical gel. Oral overdoses of other alpha-2 adrenergic agonists have been reported to cause symptoms such as hypotension, asthenia, vomiting, lethargy, sedation, bradycardia, arrhythmias, miosis, apnoea, hypotonia, hypothermia, respiratory depression, and seizure. Treatment of an oral overdose includes supportive and symptomatic therapy; a patent airway should be maintained.
Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.6 ADVERSE REACTIONS The following adverse drug reactions are discussed in greater detail in other sections of the label: • Systemic Adverse Reactions of Alpha-2 Adrenergic Agonists [ see Warnings and Precautions ( 5.4 ) ] • Local Vasomotor Adverse Reactions [ see Warnings and Precautions ( 5.5 ) ] • Hypersensitivity [ see Warnings and Precautions ( 5.6 ) ] In controlled clinical trials with brimonidine topical gel the most common adverse reactions (incidence ≥ 1%) included erythema, flushing, skin burning sensation, and contact dermatitis. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Padagis at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. During clinical trials, 1210 subjects were exposed to brimonidine topical gel. A total of 833 subjects were treated for persistent (nontransient) erythema associated with rosacea, and 330 of those were treated once daily for 29 days in vehicle-controlled trials. Adverse reactions that occurred in at least 1% of subjects treated with brimonidine topical gel once daily for 29 days and for which the rate for brimonidine topical gel exceeded the rate for vehicle are presented in Table 1. Table 1 - Adverse Reactions Reported in Clinical Trials by at Least 1% of Subjects Treated for 29 Days Preferred Term Brimonidine Topical Gel (N=330) n (%) Vehicle Gel (N=331) n (%) Subjects with at least one adverse reaction, Number (%) of Subjects 109 (33) 91 (28) Erythema 12 (4%) 3 (1%) Flushing 9 (3%) 0 Skin burning sensation 5 (2%) 2 (1%) Dermatitis contact 3 (1%) 1 (˂1%) Dermatitis 3 (1%) 1 (˂1%) Skin warm 3 (1%) 0 Paraesthesia 2 (1%) 1 (˂1%) Acne 2 (1%) 1 (˂1%) Pain of skin 2 (1%) 0 Vision blurred 2 (1%) 0 Nasal congestion 2 (1%) 0 Open-label, Long-term Study An open-label study of brimonidine topical gel when applied once daily for up to one year was conducted in subjects with persistent (nontransient) facial erythema of rosacea. Subjects were allowed to use other rosacea therapies. A total of 276 subjects applied brimonidine topical gel for at least one year. The most common adverse events (≥ 4% of subjects) for the entire study were flushing (10%), erythema (8%), rosacea (5%), nasopharyngitis (5%), skin burning sensation (4%), increased intraocular pressure (4%), and headache (4%). Allergic contact dermatitis Allergic contact dermatitis to brimonidine topical gel was reported in approximately 1% of subjects across the clinical development program. Two subjects underwent patch testing with individual product ingredients. One subject was found to be sensitive to brimonidine tartrate, and one subject was sensitive to phenoxyethanol (a preservative). 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of brimonidine topical gel. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure. Cardiovascular disorders: bradycardia, hypotension (including orthostatic hypotension) Immune system disorders: angioedema, hypersensitivity, lip swelling, swollen tongue, throat tightness, urticaria Nervous system disorders: dizziness Skin and subcutaneous disorders: pallor
brimonidine Drug Interactions
Information about and practical guidance on preventing clinically significant drug/drug and drug/food interactions that may occur in people taking the drug.7 DRUG INTERACTIONS 7.1 Anti-hypertensives/Cardiac Glycosides Alpha-2 agonists, as a class, may reduce blood pressure. Caution in using drugs such as beta-blockers, anti-hypertensives and/or cardiac glycosides is advised. 7.2 CNS Depressants Although specific drug-drug interactions studies have not been conducted with brimonidine topical gel, the possibility of an additive or potentiating effect with CNS depressants (alcohol, barbiturates, opiates, sedatives, or anaesthetics) should be considered. 7.3 Monoamine Oxidase Inhibitors Monoamine oxidase (MAO) inhibitors may theoretically interfere with the metabolism of brimonidine and potentially result in an increased systemic side-effect such as hypotension. Caution is advised in patients taking MAO inhibitors which can affect the metabolism and uptake of circulating amines.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Brimonidine is a relatively selective alpha-2 adrenergic agonist. Topical application of brimonidine topical gel may reduce erythema through direct vasoconstriction. 12.3 Pharmacokinetics Absorption The absorption of brimonidine from brimonidine topical gel was evaluated in a clinical trial in 24 adult subjects with facial erythema associated with rosacea. All enrolled subjects received once daily topical application of brimonidine topical gel 1 gram to the entire face for 29 days. Pharmacokinetic assessments were performed on Day 1, Day 15, and Day 29. The mean plasma maximum concentration (C max ) and area under the concentration-time curve (AUC) were highest on Day 15, with C max and AUC values (± standard deviation) of 46 ± 62 pg/mL and 417 ± 264 pg.hr/mL, respectively. The systemic drug exposure was slightly lower on Day 29 indicating no further drug accumulation. Metabolism Brimonidine is extensively metabolized by the liver. Excretion Urinary excretion is the major route of elimination of brimonidine and its metabolites.
Mechanism of action
Information about the established mechanism(s) of the drugÕs action in humans at various levels (for example receptor, membrane, tissue, organ, whole body). If the mechanism of action is not known, this field contains a statement about the lack of information.12.1 Mechanism of Action Brimonidine is a relatively selective alpha-2 adrenergic agonist. Topical application of brimonidine topical gel may reduce erythema through direct vasoconstriction.
Pharmacokinetics
Information about the clinically significant pharmacokinetics of a drug or active metabolites, for instance pertinent absorption, distribution, metabolism, and excretion parameters.12.3 Pharmacokinetics Absorption The absorption of brimonidine from brimonidine topical gel was evaluated in a clinical trial in 24 adult subjects with facial erythema associated with rosacea. All enrolled subjects received once daily topical application of brimonidine topical gel 1 gram to the entire face for 29 days. Pharmacokinetic assessments were performed on Day 1, Day 15, and Day 29. The mean plasma maximum concentration (C max ) and area under the concentration-time curve (AUC) were highest on Day 15, with C max and AUC values (± standard deviation) of 46 ± 62 pg/mL and 417 ± 264 pg.hr/mL, respectively. The systemic drug exposure was slightly lower on Day 29 indicating no further drug accumulation. Metabolism Brimonidine is extensively metabolized by the liver. Excretion Urinary excretion is the major route of elimination of brimonidine and its metabolites.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.4 CONTRAINDICATIONS Brimonidine topical gel is contraindicated in patients who have experienced a hypersensitivity reaction to any component. Reactions have included angioedema, urticarial, and contact dermatitis [ see Warnings and Precautions ( 5.6 ) and Adverse Reactions ( 6.1 , 6.2 ) ]. Known hypersensitivity to any component of brimonidine topical gel ( 4 )
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.11 DESCRIPTION Brimonidine Topical Gel, 0.33% contains brimonidine tartrate, an alpha adrenergic agonist. The molecular formula of brimonidine tartrate is C 11 H 10 BrN 5 • C 4 H 6 O 6 . It has the following structural formula: Chemically, brimonidine tartrate is 5-Bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate. Brimonidine tartrate has a molecular weight of 442.24 and appears as white to slightly yellowish powder. Each gram of Brimonidine Topical Gel, 0.33% contains 5 mg of the active ingredient brimonidine tartrate (equivalent to 3.3 mg of brimonidine free base), in a white to light yellow opaque gel composed of the inactive ingredients benzalkonium chloride, carbomer homopolymer type B, glycerin, propylene glycol, purified water, sodium hydroxide, and talc.
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.2 DOSAGE AND ADMINISTRATION Apply a pea-sized amount once daily to each of the five areas of the face: central forehead, chin, nose, each cheek. Brimonidine topical gel should be applied smoothly and evenly as a thin layer across the entire face avoiding the eyes and lips. Wash hands after applying brimonidine topical gel. Brimonidine topical gel is for topical use only and not for oral, ophthalmic, or intravaginal use. • Apply a pea-sized amount once daily to each of the five areas of the face (forehead, chin, nose, each cheek) avoiding the eyes and lips. ( 2 ) • Hands should be washed immediately after applying brimonidine topical gel. ( 2 ) • For topical use only ( 2 ) • Not for oral, ophthalmic, or intravaginal use. ( 2 )
Dosage forms and strengths
Information about all available dosage forms and strengths for the drug product to which the labeling applies. This field may contain descriptions of product appearance.3 DOSAGE FORMS AND STRENGTHS Brimonidine Topical Gel, 0.33% is a white to light yellow opaque aqueous gel. Each gram of gel contains 5 mg of brimonidine tartrate, equivalent to 3.3 mg of brimonidine free base. Gel, 0.33%; Each gram of gel contains 5 mg of brimonidine tartrate, equivalent to 3.3 mg of brimonidine free base. ( 3 )
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.1 INDICATIONS AND USAGE Brimonidine topical gel, 0.33% is an alpha adrenergic agonist indicated for the topical treatment of persistent (nontransient) erythema of rosacea in adults 18 years of age or older. Brimonidine topical gel, 0.33% is an alpha adrenergic agonist indicated for the topical treatment of persistent (nontransient) facial erythema of rosacea in adults 18 years of age or older. ( 1 )
Spl product data elements
Usually a list of ingredients in a drug product.BRIMONIDINE brimonidine BRIMONIDINE TARTRATE BRIMONIDINE BENZALKONIUM CHLORIDE CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) GLYCERIN PROPYLENE GLYCOL WATER SODIUM HYDROXIDE TALC Brimonidine Structure.jpg Figure 1 Day 1.jpg Figure 1 Day 15.jpg Figure 1 Day 29.jpg Figure 2 Day 1.jpg Figure 2 Day 15.jpg Figure 2 Day 29.jpg Figure A Figure B Figure C Figure D
Carcinogenesis and mutagenesis and impairment of fertility
Information about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the warnings field.13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis In a 21-month oral (diet) mouse carcinogenicity study and a 24-month oral (diet) rat carcinogenicity study, no drug-related neoplasms were observed in mice at oral doses of brimonidine tartrate up to 2.5 mg/kg/day or in rats at oral doses of brimonidine tartrate up to 1 mg/kg/day. In a dermal rat carcinogenicity study with brimonidine topical gel, brimonidine tartrate was administered to Wistar rats at topical doses of 0.9 (0.03% gel), 1.8 (0.06% gel), and 5.4 mg/kg/day (0.18% gel) in males and 5.4 (0.18% gel), 30 (1% gel) during Days 1-343/10.8 (0.36% gel) thereafter, and 60 (2% gel) during Days 1-343/21.6 mg/kg/day (0.72% gel) thereafter in females once daily for 24 months. No drug-related neoplasms were observed in this study. In a 12-month dermal photo-carcinogenicity study, topical doses of 0% (brimonidine topical gel vehicle), 0.18%, 1% and 2% brimonidine tartrate gel were administered to hairless albino mice once daily, five days per week, with concurrent exposure to simulated sunlight. No drug-related adverse effects were observed in this study. The results of this study suggest that topical treatment with brimonidine topical gel would not enhance photo-carcinogenesis. Mutagenesis Brimonidine tartrate was not mutagenic or clastogenic in a series of in vitro and in vivo studies, including the Ames test, a chromosomal aberration assay in Chinese Hamster Ovary (CHO) cells, and three studies in CD1 mice (a host-mediated assay, a cytogenetic study, and a dominant lethal assay). Impairment of Fertility Reproduction and fertility studies in rats with brimonidine tartrate demonstrated no adverse effects on male or female fertility at oral doses up to 1 mg/kg/day.
Nonclinical toxicology
Information about toxicology in non-human subjects.13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis In a 21-month oral (diet) mouse carcinogenicity study and a 24-month oral (diet) rat carcinogenicity study, no drug-related neoplasms were observed in mice at oral doses of brimonidine tartrate up to 2.5 mg/kg/day or in rats at oral doses of brimonidine tartrate up to 1 mg/kg/day. In a dermal rat carcinogenicity study with brimonidine topical gel, brimonidine tartrate was administered to Wistar rats at topical doses of 0.9 (0.03% gel), 1.8 (0.06% gel), and 5.4 mg/kg/day (0.18% gel) in males and 5.4 (0.18% gel), 30 (1% gel) during Days 1-343/10.8 (0.36% gel) thereafter, and 60 (2% gel) during Days 1-343/21.6 mg/kg/day (0.72% gel) thereafter in females once daily for 24 months. No drug-related neoplasms were observed in this study. In a 12-month dermal photo-carcinogenicity study, topical doses of 0% (brimonidine topical gel vehicle), 0.18%, 1% and 2% brimonidine tartrate gel were administered to hairless albino mice once daily, five days per week, with concurrent exposure to simulated sunlight. No drug-related adverse effects were observed in this study. The results of this study suggest that topical treatment with brimonidine topical gel would not enhance photo-carcinogenesis. Mutagenesis Brimonidine tartrate was not mutagenic or clastogenic in a series of in vitro and in vivo studies, including the Ames test, a chromosomal aberration assay in Chinese Hamster Ovary (CHO) cells, and three studies in CD1 mice (a host-mediated assay, a cytogenetic study, and a dominant lethal assay). Impairment of Fertility Reproduction and fertility studies in rats with brimonidine tartrate demonstrated no adverse effects on male or female fertility at oral doses up to 1 mg/kg/day.
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Brimonidine Tartrate 0.33% Gel #30 Label
brimonidine: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information and Instructions for Use). Patients using brimonidine topical gel should receive the following information and instructions: • This medication is to be used as directed by the physician. • It is for external use only. • Brimonidine Topical Gel should not be applied to irritated skin or open wounds. • Avoid contact with the eyes and lips. • Patients should wash their hands immediately after applying the medication. • Some patients using Brimonidine Topical Gel may experience erythema, flushing or excessive whitening. • Patients should report any adverse reactions to their physician. • Keep out of reach of children. Manufactured by Padagis, Yeruham, Israel Distributed by Padagis, Allegan, MI 49010 • www.padagis.com Rev 06-22 7M15B RC J1
Instructions for use
Information about safe handling and use of the drug product.Instructions for Use Instructions for Use Brimonidine (bri-MOE-ni-deen) Topical Gel, 0.33% Pump Important: Brimonidine topical gel is for use on the face only. Do not use brimonidine topical gel in your eyes, mouth, or vagina. Keep brimonidine topical gel out of the reach of children. If anyone, especially a child, accidentally swallows brimonidine topical gel, they may have serious side effects and need to be treated in a hospital. Get medical help right away if you, a child, or anyone else swallows brimonidine topical gel and has any of these symptoms: • lack of energy, trouble breathing or stops breathing, a slow heart beat, confusion, sweating, restlessness, muscle spasms, or twitching. Read and follow the steps below so that you use your brimonidine topical gel pump correctly: 1. Push the cap down and turn it counter-clockwise until the cap can be removed. See Figures A and B. The clear sticker will break when opening for the first time. Figure A Figure B Figure C Before the first use, prime the pump by pressing down several times until the medicine is dispensed onto your fingertip. 2. To apply brimonidine topical gel to your face, squeeze a pea-sized amount of brimonidine topical gel from the pump onto your fingertip. See Figure C. 3. Apply a pea-sized amount of brimonidine topical gel onto each of the five areas of your face (forehead, chin, nose, each cheek) 1 time each day. You will use a total of 5 pea-sized amounts of brimonidine topical gel. Spread the gel smoothly and evenly in a thin layer over your face. Avoid contact with your eyes and lips. Do not apply brimonidine topical gel to irritated skin or open wounds. 4. To close your brimonidine topical gel pump, place the cap back on the pump. Push down and turn the cap to the right (clockwise) until it stops. This pump is child-resistant again. See Figure D. Figure D 5. Wash your hands right away after applying brimonidine topical gel. How should I store brimonidine topical gel? Store brimonidine topical gel at room temperature between 68°F to 77°F (20°C to 25°C). Keep brimonidine topical gel and all medicines out of the reach of children. This Instructions for Use has been approved by the U.S. Food and Drug Administration. Manufactured by Padagis, Yeruham, Israel Distributed by Padagis, Allegan, MI 49010 • www.padagis.com Rev 06-22 7M15B RC IC1
Spl patient package insert
Information necessary for patients to use the drug safely and effectively.PATIENT INFORMATION PATIENT INFORMATION Brimonidine (bri-MOE-ni-deen) Topical Gel, 0.33% Important Information: Brimonidine topical gel is for use on the face only. Do not use brimonidine topical gel in your eyes, mouth, or vagina. Keep brimonidine topical gel out of the reach of children. If anyone, especially a child, accidentally swallows brimonidine topical gel, they may have serious side effects and need to be treated in a hospital. Get medical help right away if you, a child, or anyone else swallows brimonidine topical gel and has any of these symptoms: • lack of energy, trouble breathing or stops breathing, a slow heart beat, confusion, sweating, restlessness, muscle spasms, or twitching. What is brimonidine topical gel? Brimonidine topical gel is a prescription medicine that is used on your skin (topical) to treat facial redness due to rosacea that does not go away (persistent) in adults who are 18 years of age or older. It is not known if brimonidine topical gel is safe and effective in children. Who should not use brimonidine topical gel? Do not use brimonidine topical gel if you have had a serious allergic reaction to any of the ingredients in brimonidine topical gel. See the end of this Patient Information leaflet for a list of ingredients in brimonidine topical gel. See “What are the possible side effects of brimonidine topical gel?” What should I tell my doctor before using brimonidine topical gel? Before using brimonidine topical gel, tell your doctor about all of your medical conditions including if you: • have depression • have heart or blood vessel problems • have dizziness or blood pressure problems • have problems with blood circulation or have had a stroke • have dry mouth or Sjögren’s Syndrome • have skin tightening or Scleroderma • have Raynaud’s phenomenon • have irritated skin or open sores • plan to have any laser procedures • are pregnant or plan to become pregnant. It is not known if brimonidine topical gel will harm your unborn baby. • are breastfeeding. It is not known if brimonidine passes into your breast milk. You and your doctor should decide if you will use brimonidine topical gel or breastfeed. You should not do both. have heart or blood vessel problems have dizziness or blood pressure problems have problems with blood circulation or have had a stroke have dry mouth or Sjögren’s Syndrome have skin tightening or Scleroderma have Raynaud’s phenomenon have irritated skin or open sores plan to have any laser procedures are pregnant or plan to become pregnant. It is not known if brimonidine topical gel will harm your unborn baby. are breastfeeding. It is not known if brimonidine passes into your breast milk. You and your doctor should decide if you will use brimonidine topical gel or breastfeed. You should not do both. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, skin products, vitamins, and herbal supplements. Using brimonidine topical gel with certain other medicines may affect each other and can cause serious side effects. How should I use brimonidine topical gel? See the detailed Instructions for Use that comes with your brimonidine topical gel tube for information about how to apply Brimonidine Topical Gel correctly. • Use brimonidine topical gel exactly as your doctor tells you. Do not use more brimonidine topical gel than prescribed. Call your doctor if you are not sure. • You should not apply brimonidine topical gel to irritated skin or open wounds. • Brimonidine topical gel is for use on your skin only. Do not use brimonidine topical gel in your eyes, mouth, or vagina. Avoid contact with your lips and eyes. You should not apply brimonidine topical gel to irritated skin or open wounds. Brimonidine topical gel is for use on your skin only. Do not use brimonidine topical gel in your eyes, mouth, or vagina. Avoid contact with your lips and eyes. What are the possible side effects of brimonidine topical gel? Brimonidine topical gel may cause serious side effects, including: • See “Important information” at the beginning of this Patient Information leaflet. • Problems with blood circulation. People who use brimonidine topical gel can have problems with blood circulation, including a slow heart rate, low blood pressure, and dizziness. These problems may sometimes be serious and lead to hospitalization. See “What should I tell my doctor before using brimonidine topical gel?” • Serious allergic (hypersensitivity) reactions have happened in people who use brimonidine topical gel. Stop using brimonidine topical gel and go to the nearest hospital emergency room right away if you have any of the following signs and symptoms of a serious allergic reaction including: o swelling of your face, lips, tongue, or throat o hives o trouble breathing Problems with blood circulation. People who use brimonidine topical gel can have problems with blood circulation, including a slow heart rate, low blood pressure, and dizziness. These problems may sometimes be serious and lead to hospitalization. See “What should I tell my doctor before using brimonidine topical gel?” Serious allergic (hypersensitivity) reactions have happened in people who use brimonidine topical gel. Stop using brimonidine topical gel and go to the nearest hospital emergency room right away if you have any of the following signs and symptoms of a serious allergic reaction including: swelling of your face, lips, tongue, or throat hives trouble breathing The most common side effects of brimonidine topical gel include: • redness • flushing • burning sensation of the skin • skin reactions (contact dermatitis). flushing burning sensation of the skin skin reactions (contact dermatitis). Skin redness is common after applying brimonidine topical gel, and may be worse than before you applied it. You may also develop redness on areas of your face that were not affected by rosacea, as well as on your neck and chest. Skin flushing is common and may happen off and on after applying brimonidine topical gel. In some cases, the flushing may be new, may happen more often, or you may have increased redness with flushing. Pale colored skin or very white skin (excessive whitening) can happen at or outside the treated area. Tell your doctor if you get skin redness, flushing, and pale colored skin that is uncomfortable for you. These are not all the possible side effects of brimonidine topical gel. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. General information about the safe and effective use of brimonidine topical gel Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or doctor for information about brimonidine topical gel that is written for health professionals. Do not use brimonidine topical gel for a condition for which it was not prescribed. Do not give brimonidine topical gel to other people, even if they have the same symptoms that you have. It may harm them. What are the ingredients in brimonidine topical gel? Active ingredient: brimonidine tartrate Inactive ingredients: benzalkonium chloride, carbomer homopolymer type B, glycerin, propylene glycol, purified water, sodium hydroxide, talc. This Patient Information has been approved by the U.S. Food and Drug Administration. Manufactured by Padagis, Yeruham, Israel Distributed by Padagis, Allegan, MI 49010 Rev 06-22 7M15B RC J1
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Clinical studies
This field may contain references to clinical studies in place of detailed discussion in other sections of the labeling.14 CLINICAL STUDIES Brimonidine topical gel was evaluated for the treatment of moderate to severe, persistent (nontransient) facial erythema of rosacea in two randomized, double-blind, vehicle-controlled clinical trials, which were identical in design. The trials were conducted in 553 subjects aged 18 years and older who were treated once daily for 4 weeks with either brimonidine topical gel or vehicle. Overall, 99% of subjects were Caucasian and 76% were female. Baseline disease severity was graded using a 5-point Clinical Erythema Assessment (CEA) scale and a 5-point Patient Self Assessment (PSA) scale, on which subjects scored either “moderate” or “severe” on both scales. The primary efficacy endpoint in both pivotal trials was 2-grade Composite Success, defined as the proportion of subjects with a 2-grade improvement on both CEA and PSA measured at hours 3, 6, 9, and 12 on Day 29. Table 2 presents the efficacy results. In addition to Day 29, efficacy was evaluated on Day 15 and Day 1, and the results are presented in Figures 1 and 2 for Studies 1 and 2, respectively. Table 2: Summary of 2-grade Composite Success on Day 29 Success Study 1 Study 2 Brimonidine Topical Gel (N=129) Vehicle Gel (N=131) Brimonidine Topical Gel (N=148) Vehicle Gel (N=145) Hour 3 31% 11% 25% 9% Hour 6 30% 10% 25% 9% Hour 9 26% 10% 18% 11% Hour 12 23% 9% 22% 10% 2-grade Composite Success: 2-grade improvement on CEA and 2-grade improvement on PSA. Figure 1: 2-grade Composite Success by Hour and Day for Study 1 Figure 2: 2-grade Composite Success by Hour and Day for Study 2
Geriatric use
Information about any limitations on any geriatric indications, needs for specific monitoring, hazards associated with use of the drug in the geriatric population.8.5 Geriatric Use One hundred and five subjects aged 65 and older were included in clinical trials with brimonidine topical gel. No overall differences in safety or effectiveness were observed between subjects ≥ 65 years of age and younger adult subjects. Clinical studies of brimonidine topical gel did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Nursing mothers
Information about excretion of the drug in human milk and effects on the nursing infant, including pertinent adverse effects observed in animal offspring.8.3 Nursing Mothers It is not known whether brimonidine tartrate is excreted in human milk, although in animal studies, brimonidine tartrate has been shown to be excreted in breast milk. Because of the potential for serious adverse reactions from brimonidine topical gel in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric use
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.8.4 Pediatric Use Keep brimonidine topical gel out of reach of children. Serious adverse reactions were experienced by two children of a subject in a clinical trial who accidentally ingested brimonidine topical gel [ see Warnings and Precautions ( 5.3 ) ]. Safety and effectiveness in pediatric patients have not been established.
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)8.1 Pregnancy Pregnancy Category B. There are no adequate and well-controlled studies of brimonidine topical gel in pregnant women. In animal studies, brimonidine crossed the placenta and entered into the fetal circulation to a limited extent. Brimonidine topical gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Brimonidine tartrate was not teratogenic when given at oral doses up to 2.5 mg/kg/day in pregnant rats during gestation days 6 through 15 and 5 mg/kg/day in pregnant rabbits during gestation days 6 through 18.
Use in specific populations
Information about use of the drug by patients in specific populations, including pregnant women and nursing mothers, pediatric patients, and geriatric patients.8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category B. There are no adequate and well-controlled studies of brimonidine topical gel in pregnant women. In animal studies, brimonidine crossed the placenta and entered into the fetal circulation to a limited extent. Brimonidine topical gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Brimonidine tartrate was not teratogenic when given at oral doses up to 2.5 mg/kg/day in pregnant rats during gestation days 6 through 15 and 5 mg/kg/day in pregnant rabbits during gestation days 6 through 18. 8.3 Nursing Mothers It is not known whether brimonidine tartrate is excreted in human milk, although in animal studies, brimonidine tartrate has been shown to be excreted in breast milk. Because of the potential for serious adverse reactions from brimonidine topical gel in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. 8.4 Pediatric Use Keep brimonidine topical gel out of reach of children. Serious adverse reactions were experienced by two children of a subject in a clinical trial who accidentally ingested brimonidine topical gel [ see Warnings and Precautions ( 5.3 ) ]. Safety and effectiveness in pediatric patients have not been established. 8.5 Geriatric Use One hundred and five subjects aged 65 and older were included in clinical trials with brimonidine topical gel. No overall differences in safety or effectiveness were observed between subjects ≥ 65 years of age and younger adult subjects. Clinical studies of brimonidine topical gel did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.16 HOW SUPPLIED/STORAGE AND HANDLING Brimonidine Topical Gel, 0.33% is a white to light yellow opaque gel, supplied in a laminated tube or pump with a child resistant cap in the following sizes: 30 gram pump NDC: 63629-9616-1 Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) [See USP Controlled Room Temperature].
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API