DRUGS & SUPPLEMENTS

Rimonid

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Rimonid uses


  • Contraindications (4) 07/2016
  • Warnings and Precautions (5.4, 5.5, 5.6) 07/2016

1 INDICATIONS AND USAGE

Rimonid (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.

Rimonid (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.

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. Rimonid 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 Rimonid topical gel.

Rimonid 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 Rimonid topical gel. (2)
  • For topical use only (2)
  • Not for oral, ophthalmic, or intravaginal use. (2)
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3 DOSAGE FORMS AND STRENGTHS

Rimonid (brimonidine) topical gel, 0.33% is a white to light yellow opaque aqueous gel. Each gram of gel contains 5 mg of Rimonid, equivalent to 3.3 mg of brimonidine free base.

Gel, 0.33%; Each gram of gel contains 5 mg of Rimonid, equivalent to 3.3 mg of brimonidine free base.

4 CONTRAINDICATIONS

Rimonid topical gel is contratindicated in patients who have experienced a hypersensitivity reaction to any component. Reactions have included angioedema, urticaria, and contact dermatitis [see Warnings and Precautions (5.6) and Adverse Reactions (6.1,6.2)].

Known hypersensitivity to any component of Rimonid topical gel

5 WARNINGS AND PRECAUTIONS

  • Potentiation of Vascular Insufficiency
  • Severe Cardiovascular Disease (5.2)
  • Serious Adverse Reactions Following Ingestion of Rimonid topical gel (5.3)
  • Systemic Adverse Reactions of Alpha-2 Adrenergic Agonists (5.4)

  • Local Vasomotor Adverse Reactions (5.5)


  • Hypersensitivity (5.6)

5.1 Potentiation of Vascular Insufficiency

Rimonid topical gel should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud’s phenomenon, orthostatic hypotension, thrombangiitis obliterans, scleroderma, or Sjögren’s syndrome.

5.2 Severe Cardiovascular Disease

Alpha-2 adrenergic agonists can lower blood pressure. Rimonid topical gel should be used with caution in patients with severe or unstable or uncontrolled cardiovascular disease.

5.3 Serious Adverse Reactions Following Ingestion of Rimonid topical gel

Two young children of a subject in a clinical trial experienced serious adverse reactions following accidental ingestion of Rimonid topical gel. Adverse reactions experienced by one or both children included lethargy, respiratory distress with apneic episodes, sinus bradycardia, confusion, psychomotor hyperactivity, and diaphoresis. Both children were hospitalized overnight and discharged the following day without sequelae.

Keep Rimonid topical gel out of the reach of children.

5.4 Systemic Adverse Reactions of Alpha-2 Adrenergic Agonists

Postmarketing cases of bradycardia, hypotension (including orthostatic hypotension) and dizziness have been reported. Some cases required hospitalization. Some cases involved application of Rimonid topical gel in unapproved dosing regimens and for unapproved indications, including the application of Rimonid topical gel following laser procedures.

Avoid applying Rimonid topical gel to irritated skin or open wounds.

5.5 Local Vasomotor Adverse Reactions

Erythema

Some subjects in the clinical trials discontinued use of Rimonid topical gel because of erythema. Some subjects in the clinical trials reported a rebound phenomenon, where erythema was reported to return worse compared to the severity at baseline.

Erythema appeared to resolve after discontinuation of Rimonid topical gel.[see Adverse Reactions ].

The treatment effect of Rimonid topical gel may begin to diminish hours after application.

From postmarketing reports, some patients have experienced erythema involving areas of the face that were previously not affected by erythema and in areas (e.g., neck and chest) outside of the treatment sites.

Flushing

Some subjects in the clinical trials discontinued use of Rimonid topical gel because of flushing.

Intermittent flushing occurred in some subjects treated with Rimonid topical gel in the clinical trials. The onset of flushing relative to application of Rimonid topical gel varied, ranging from approximately 30 minutes to several hours [see Adverse Reactions (6.1)]. Flushing appeared to resolve after discontinuation of Rimonid topical gel.

From postmarketing reports, some patients have experienced increased frequency of flushing and/or increased depth of

erythema with the flushing. Additionally, some patients reported new onset of flushing.

Pallor and Excessive Whitening

From postmarketing reports, some patients have experienced pallor or excessive whitening at or outside the application site following treatment with Rimonid topical gel.

5.6 Hypersensitivity

Allergic contact dermatitis was reported in the clinical trials for Rimonid topical gel [see Adverse Reactions (6.1)].

Events reported post marketing with the use of Rimonid topical gel include angioedema, throat tightening, tongue swelling, and urticaria, [see Adverse Reactions (6.2)]. Institute appropriate therapy and discontinue Rimonid topical gel, if clinically significant hypersensitivity reaction occurs.

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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 ]
  • Local Vasomotor Adverse Reactions [see Warnings and Precautions (5.5)]
  • Hypersensitivity [see Warnings and Precautions (5.6)]

In controlled clinical trials with Rimonid 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 Galderma Laboratories, L.P. at 1-866-735-4137 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 Rimonid 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 Rimonid topical gel once daily for 29 days and for which the rate for Rimonid 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

Open-label, Long-term Study

An open-label study of Rimonid 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 Rimonid 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 Rimonid 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 Rimonid, and one subject was sensitive to phenoxyethanol (a preservative).

table-1-adverse

6.2 Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Rimonid 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 systemic disorders: dizziness

Skin and subcutaneous disorders: pallor

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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 Rimonid topical gel, the possibility of an additive or potentiating effect with CNS depressants 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.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category B.

There are no adequate and well-controlled studies of Rimonid topical gel in pregnant women. In animal studies, brimonidine crossed the placenta and entered into the fetal circulation to a limited extent. Rimonid topical gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Rimonid 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 Rimonid is excreted in human milk, although in animal studies, Rimonid has been shown to be excreted in breast milk. Because of the potential for serious adverse reactions from Rimonid 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 Rimonid 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 Rimonid topical gel [ See Warnings and Precautions ].

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 Rimonid topical gel. No overall differences in safety or effectiveness were observed between subjects > 65 years of age and younger adult subjects. Clinical studies of Rimonid topical gel did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

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10 OVERDOSAGE

No information is available on overdose in adults with Rimonid 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.

11 DESCRIPTION

Rimonid (brimonidine) topical gel, 0.33% contains Rimonid, an alpha adrenergic agonist.

The molecular formula of Rimonid is C11H10BrN5 - C4H6O6. It has the following structural formula:

Chemically, Rimonid is 5-Bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate. Rimonid has a molecular weight of 442.24 and appears as white to slightly yellowish powder.

Each gram of Rimonid (brimonidine) topical gel, 0.33% contains 5 mg of the active ingredient Rimonid (equivalent to 3.3 mg of brimonidine free base), in a white to light yellow opaque gel composed of the inactive ingredients carbomer homopolymer type B, glycerin, methylparaben, phenoxyethanol, propylene glycol, purified water, sodium hydroxide, and titanium dioxide.

chem-structure

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Brimonidine is a relatively selective alpha-2 adrenergic agonist. Topical application of Rimonid topical gel may reduce erythema through direct vasoconstriction.

12.3 Pharmacokinetics

Absorption

The absorption of brimonidine from Rimonid 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 Rimonid 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 (Cmax) and area under the concentration-time curve (AUC) were highest on Day 15, with Cmax 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.

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 Rimonid up to 2.5 mg/kg/day or in rats at oral doses of Rimonid up to 1 mg/kg/day.

In a dermal rat carcinogenicity study with Rimonid topical gel, Rimonid 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% (MIRVASO topical gel vehicle), 0.18%, 1% and 2% Rimonid 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 Rimonid topical gel would not enhance photo-carcinogenesis.

Mutagenesis

Rimonid 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 Rimonid demonstrated no adverse effects on male or female fertility at oral doses up to 1 mg/kg/day.

14 CLINICAL STUDIES

Rimonid 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 Rimonid 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

p51217-0-aprvd-sec-14-graph figure2-2grade figure1-2grade

16 HOW SUPPLIED/STORAGE AND HANDLING

Rimonid (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 tube NDC 0299-5980-30

30 gram pump NDC 0299-5980-35

45 gram tube NDC 0299-5980-45

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).

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Patient Information and Instructions for Use)

Patients using Rimonid 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.
  • Rimonid 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 Rimonid topical gel may experience erythema, flushing or excessive whitening.
  • Patients should report any adverse reactions to their physician.
  • Keep out of reach of children.

Marketed by:

GALDERMA LABORATORIES, L.P., Fort Worth, Texas 76177 USA

Made in Canada.

All trademarks are the property of their respective owners.

P52849-1 or P51217-3

PATIENT INFORMATION

Rimonid (Mer-VAY-soe)

(brimonidine)

topical gel

Important information: Rimonid® topical gel is for use on the face only. Do not use Rimonid topical gel in your eyes, mouth, or vagina.

Keep Rimonid topical gel out of the reach of children.

If anyone, especially a child, accidentally swallows Rimonid 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 Rimonid 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 Rimonid topical gel?

Rimonid 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 Rimonid topical gel is safe and effective in children.

Who should not use Rimonid topical gel?

Do not use Rimonid topical gel if you have had a serious allergic reaction to any of the ingredients in Rimonid topical gel. See the end of this Patient Information leaflet for a list of ingredients in Rimonid topical gel. See “What are the possible side effects of Rimonid topical gel?”

What should I tell my doctor before using Rimonid topical gel?

Before using Rimonid 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 Rimonid topical gel will harm your unborn baby.

- are breastfeeding. It is not known if Rimonid topical gel passes into your breast milk. You and your doctor should decide if you will use Rimonid 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 Rimonid topical gel with certain other medicines may affect each other and can cause serious side effects.

How should I use Rimonid topical gel?

- Use Rimonid topical gel exactly as your doctor tells you. Do not use more Rimonid topical gel than prescribed. Call your doctor if you are not sure.

- You should not apply Rimonid topical gel to irritated skin or open wounds.

- Rimonid topical gel is for use on your skin only. Do not use Rimonid topical gel in your eyes, mouth, or vagina. Avoid contact with your lips and eyes.

What are the possible side effects of Rimonid topical gel?

Rimonid 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 Rimonid 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 Rimonid topical gel?”

- Serious allergic (hypersensitivity) reactions have happened in people who use Rimonid topical gel. Stop using Rimonid 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

The most common side effects of Rimonid topical gel include:

- redness - flushing - burning sensation of the skin - skin reactions (contact dermatitis).

Skin redness is common after applying Rimonid 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 Rimonid 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 Rimonid 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 Rimonid 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 Rimonid topical gel that is written for health professionals. Do not use Rimonid topical gel for a condition for which it was not prescribed. Do not give Rimonid topical gel to other people, even if they have the same symptoms that you have. It may harm them.

What are the ingredients in Rimonid topical gel?

Active ingredient: brimonidine

Inactive ingredients: carbomer homopolymer type B, glycerin, methylparaben, phenoxyethanol, propylene glycol, purified water, sodium hydroxide, titanium dioxide.

Marketed by: GALDERMA LABORATORIES, L.P., Fort Worth, TX 76177 USA

Made in Canada.

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: July 2016

Instructions for Use

Rimonid (Mer-VAY-soe)

(brimonidine)

topical gel

Tube

Important: Rimonid® topical gel is for use on the face only. Do not use Rimonid topical gel in your eyes, mouth, or vagina.

Keep Rimonid topical gel out of the reach of children.

If anyone, especially a child, accidentally swallows Rimonid 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 Rimonid 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 tube of Rimonid topical gel correctly:

1. Open the tube of Rimonid topical gel by gently pressing down on the child resistant cap and twist in the direction of the arrow as shown below (counterclockwise). See Figures A and B. To avoid spilling, do not squeeze the tube while opening or closing.

Figure A

Figure B

2. To apply Rimonid topical gel to your face, squeeze a pea-sized amount of Rimonid topical gel from the tube onto your fingertip. See Figure C.

Figure C

3. Apply a pea-sized amount of Rimonid 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 Rimonid

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 Rimonid topical gel to irritated skin or open wounds.

4. To close your Rimonid topical gel tube, place the cap back on the tube. Gently press down on the child resistant cap and twist to the right (clockwise). See Figure D.

Figure D

5. Wash your hands right away after applying Rimonid topical gel.

How should I store Rimonid topical gel?

- Store Rimonid topical gel at room temperature between 68°F to 77°F (20°C to 25°C).

Keep Rimonid 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.

Marketed by: GALDERMA LABORATORIES, L.P., Fort Worth, TX 76177 USA

Made in Canada.

Revised: October 2015

twist-off-cap-fig-b twist-off-cap-fig-a pea-size-figertip-fig-c twist-on-cap-fig-d

Instructions for Use

Rimonid (Mer-VAY-soe)

(brimonidine) topical gel

Pump

Important: Rimonid® topical gel is for use on the face only. Do not use Rimonid topical gel in your eyes, mouth, or vagina.

Keep Rimonid topical gel out of the reach of children.

If anyone, especially a child, accidentally swallows Rimonid 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 Rimonid 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 Rimonid 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. Note: when the cap is removed, the pump is not child-resistant.

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 Rimonid topical gel to your face, dispense a pea-sized amount of Rimonid topical gel from the pump onto your fingertip. See Figure C.

3. Apply a pea-sized amount of Rimonid 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 Rimonid 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 Rimonid topical gel to irritated skin or open wounds.

4. To close your Rimonid 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 Rimonid topical gel.

How should I store Rimonid topical gel?

- Store Rimonid topical gel at room temperature between 68°F to 77°F (20°C to 25°C).

Keep Rimonid 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.

Marketed by: GALDERMA LABORATORIES, L.P.,

Fort Worth, TX 76177 USA

Made in Canada.

Issued: October 2015

pump-fig-a pump-fig-b pump-fig-c pump-fig-d

Rx Only NDC 0299-5980-35

Rimonid®

(brimonidine) topical gel, 0.33%*

PUMP

*Each gram of Rimonid topical gel contains 5 mg of Rimonid, equivalent to 3.3 mg of brimonidine free base

For Topical Use Only

Keep Out of Reach of Children

GALDERMA

NET WT. 30 g

Not for oral, ophthalmic or intravaginal use.

To Open Pump: Push the cap down while turning it counter-clockwise to remove the cap.

Usual

Dosage: Apply a pea-size amount once daily to each of the five areas of the face (forehead, chin, nose, and each cheek) avoiding the eyes and lips. See package insert for complete prescribing information.

Each gram contains the active ingredient Rimonid 5mg with the inactive ingredients carbomer homopolymer type B, glycerin, methylparaben, phenoxyethanol, propylene glycol, purified water, sodium hydroxide, and titanium dioxide.

Storage: 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)..

All trademarks are the property of thier respective owners.

Marketed by:

GALDERMA LABORATORIES, L.P.

14501 North Freeway, Forth Worth, TX 76177 USA

Made in Canada

P52848-0

Lot No.:

Exp.:

NDC 0299-5980-30 Rx Only

Rimonid®

(brimonidine) topical gel, 0.33%*

*Each gram of Rimonid topical gel contains 5 mg of Rimonid, equivalent to 3.3 mg of brimonidine free base

NET WT. 30 g

For Topical Use Only

Keep Out of Reach of Children

GALDERMA

Marketed by:

GALDERMA LABORATORIES, L.P.

14501 North Freeway, Forth Worth, TX 76177 USA

Made in Canada

P51218-1

Not for oral, ophthalmic or intravaginal use.

To Open Tube: Push cap in and turn counterclockwise, and remove cap.

Usual

Dosage: Apply a pea-sized amount once daily to each of the five areas of the face (forehead, chin, nose, and each cheek) avoiding the eyes and lips. See package insert for complete prescribing information.

Each gram contains the active ingredient Rimonid 5 mg with the inactive ingredients carbomer homopolymer type B, glycerin, methylparaben, phenoxyethanol, propylene glycol, purified water, sodium hydroxide, and titanium dioxide.

Storage: 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)..

p52848-0-mirvaso-30g-pump-crtn mirvaso

Rimonid pharmaceutical active ingredients containing related brand and generic drugs:

infoActive ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Rimonid available forms, composition, doses:

infoForm of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Rimonid destination | category:

infoDestination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Rimonid Anatomical Therapeutic Chemical codes:

infoA medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Rimonid pharmaceutical companies:

infoPharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."MIRVASO (BRIMONIDINE TARTRATE) GEL [GALDERMA LABORATORIES, L.P.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. "brimonidine". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
  3. "brimonidine". http://www.drugbank.ca/drugs/DB0048... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Rimonid?

Depending on the reaction of the Rimonid after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Rimonid not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Rimonid addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sDrugs.com conducted a study on Rimonid, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Rimonid consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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