Noreskin

Rating: 5 - 1 review(s)
What are the side effects you encounter while taking this medicine?
advertisement

Noreskin uses


1 INDICATIONS AND USAGE

Noreskin® (azelaic acid) Gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. Although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated.

Noreskin® (azelaic acid) Gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. Efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated. (1)

2 DOSAGE AND ADMINISTRATION

advertisement

3 DOSAGE FORMS AND STRENGTHS

Noreskin (azelaic acid) Gel, 15% is a white to yellowish white opaque gel. Each gram of Noreskin Gel contains 0.15 gm of Noreskin (15% w/w).

Gel, 15% (3)

4 CONTRAINDICATIONS

None.

None. (4)

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity

Hypersensitivity reactions, including cases of angioedema, eye swelling, facial swelling, dyspnea, urticaria, and adverse skin reactions, have been reported during post marketing surveillance.

Avoid the use of Noreskin Gel in patients with known hypersensitivity to any component of the gel. If hypersensitivity develops during treatment, discontinue Noreskin Gel and institute appropriate therapy.

5.2 Skin Reactions

Skin irritation may occur during use of Noreskin Gel, usually during the first few weeks of treatment. If sensitivity or severe irritation develops and persists, discontinue treatment and institute appropriate therapy.

There have been isolated reports of hypopigmentation after use of Noreskin. Since Noreskin has not been well studied in patients with dark complexion, monitor these patients for early signs of hypopigmentation.

5.3 Eye and Mucous Membranes Irritation

Avoid contact with the eyes, mouth and other mucous membranes. If Noreskin Gel does come in contact with the eyes, wash the eyes with large amounts of water and consult a physician if eye irritation persists .

5.4 Exacerbation of Asthma

Worsening of asthma has been reported in patients using Noreskin formulations including Noreskin Gel. Consult a physician if asthma is exacerbated with use of Noreskin Gel.

advertisement

6 ADVERSE REACTIONS

The most common adverse reactions are burning/stinging/tingling, pruritus (11%), scaling/dry skin/xerosis (8%) and erythema/irritation (4%). (6)

To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare at 1-866-463-3634 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.

In two vehicle-controlled and one active-controlled U.S. clinical trials, treatment safety was monitored in 788 subjects who used twice-daily Noreskin Gel for 12 weeks (N=333) or 15 weeks (N=124), or the gel vehicle (N=331) for 12 weeks. In all three trials, the most common treatment-related adverse events were: burning/stinging/tingling (29%), pruritus (11%), scaling/dry skin/xerosis (8%) and erythema/irritation (4%). In the active-controlled trial, overall adverse reactions (including burning, stinging/tingling, dryness/tightness/scaling, itching, and erythema/irritation/redness) were 19.4% (24/124) for Noreskin Gel compared to 7.1% (9/127) for the active comparator gel at 15 weeks.


Noreskin Gel, 15%

N=457

(100%)


Vehicle

N=331

(100%)


Mild

N=99

(22%)


Moderate

N=61

(13%)


Severe

N=27

(6%)


Mild

N=46

(14%)


Moderate

N=30

(9%)


Severe

N=5

(2%)


Burning/stinging/tingling


71 (16%)


42 (9%)


17 (4%)


8 (2%)


6 (2%)


2 (1%)


Pruritus


29 (6%)


18 (4%)


5 (1%)


9 (3%)


6 (2%)


0 (0%)


Scaling/dry skin/xerosis


21 (5%)


10 (2%)


5 (1%)


31 (9%)


14 (4%)


1 (<1%)


Erythema/irritation


6 (1%)


7 (2%)


2 (<1%)


8 (2%)


4 (1%)


2 (1%)


Contact dermatitis


2 (<1%)


3 (1%)


0 (0%)


1 (<1%)


0 (0%)


0 (0%)


Edema


3 (1%)


2 (<1%)


0 (0%)


3 (1%)


0 (0%)


0 (0%)


Acne


3 (1%)


1 (<1%)


0 (0%)


1 (<1%)


0 (0%)


0 (0%)

  • *Subjects may have >1 cutaneous adverse event; thus, the sum of the frequencies of preferred terms may exceed the number of subjects with at least 1 cutaneous adverse event.

In patients using Noreskin formulations, the following adverse events have been reported: worsening of asthma, vitiligo, depigmentation, small depigmented spots, hypertrichosis, reddening (signs of keratosis pilaris) and exacerbation of recurrent herpes labialis.

Local Tolerability Studies

Noreskin Gel and its vehicle caused irritant reactions at the application site in human dermal safety studies. Noreskin Gel caused significantly more irritation than its vehicle in a cumulative irritation study. Some improvement in irritation was demonstrated over the course of the clinical trials, but this improvement might be attributed to subject dropouts. No phototoxicity or photoallergenicity were reported in human dermal safety studies.

6.2 Post-Marketing Experience

The following adverse reactions have been identified post approval of Noreskin Gel. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure:

Eyes: iridocyclitis upon accidental exposure of the eyes to Noreskin Gel

Hypersensitivity: angioedema, eye swelling, facial swelling, urticaria.

Respiratory: worsening of asthma, dyspnea, wheezing,

advertisement

7 DRUG INTERACTIONS

There have been no formal studies of the interaction of Noreskin Gel with other drugs.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Teratogenic Effects: Pregnancy Category B

There are no adequate and well-controlled studies in pregnant women. Therefore, Noreskin Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Dermal embryofetal developmental toxicology studies have not been performed with Noreskin, 15% gel. Oral embryofetal developmental studies were conducted with Noreskin in rats, rabbits, and cynomolgus monkeys. Noreskin was administered during the period of organogenesis in all three animal species. Embryotoxicity was observed in rats, rabbits, and monkeys at oral doses of Noreskin that generated some maternal toxicity. Embryotoxicity was observed in rats given 2500 mg/kg/day [162 times the maximum recommended human dose based on body surface area (BSA)], rabbits given 150 or 500 mg/kg/day (19 or 65 times the MRHD based on BSA) and cynomolgus monkeys given 500 mg/kg/day (65 times the MRHD based on BSA) Noreskin. No teratogenic effects were observed in the oral embryofetal developmental studies conducted in rats, rabbits and cynomolgus monkeys.

An oral peri- and post-natal developmental study was conducted in rats. Noreskin was administered from gestational day 15 through day 21 postpartum up to a dose level of 2500 mg/kg/day. Embryotoxicity was observed in rats at an oral dose of 2500 mg/kg/day (162 times the MRHD based on BSA) that generated some maternal toxicity. In addition, slight disturbances in the post-natal development of fetuses was noted in rats at oral doses that generated some maternal toxicity (500 and 2500 mg/kg/day; 32 and 162 times the MRHD based on BSA). No effects on sexual maturation of the fetuses were noted in this study.

8.3 Nursing Mothers

It is not known whether Noreskin is excreted in human milk; however, in vitro studies using equilibrium dialysis were conducted to assess the potential for human milk partitioning. The studies demonstrated that, at an Noreskin concentration of 25 µg/mL, the milk/plasma distribution coefficient was 0.7 and the milk/buffer distribution was 1.0. These data indicate that passage of drug into maternal milk may occur. Since less than 4% of a topically applied dose of 20% Noreskin cream is systemically absorbed, the uptake of Noreskin into maternal milk is not expected to cause a significant change from baseline Noreskin levels in the milk. Nevertheless, a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

8.4 Pediatric Use

Safety and effectiveness of Noreskin Gel in pediatric patients have not been established.

8.5 Geriatric Use

Clinical studies of Noreskin Gel did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

advertisement

11 DESCRIPTION

Noreskin (azelaic acid) Gel, 15%, is an aqueous gel which contains Noreskin, a naturally-occurring saturated dicarboxylic acid. Chemically, Noreskin is 1,7-heptanedicarboxylic acid. The molecular formula for Noreskin is C9 H16 O4. It has the following structure:

Noreskin has a molecular weight of 188.22. It is a white, odorless crystalline solid. It is poorly soluble in water at 20°C (0.24%) but freely soluble in boiling water and in ethanol.

Noreskin Gel is a white to yellowish white opaque gel for topical use; each gram contains 0.15 gm Noreskin (15%w/w) in an aqueous gel base containing benzoic acid (as a preservative), disodium EDTA, lecithin, medium-chain triglycerides, polyacrylic acid, polysorbate 80, propylene glycol, purified water, and sodium hydroxide to adjust pH.

structure

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

The mechanism by which Noreskin interferes with the pathogenic events in rosacea are unknown.

12.2 Pharmacodynamics

The pharmacodynamics of Noreskin in association with the treatment of rosacea is unknown.

12.3 Pharmacokinetics

The percutaneous absorption of Noreskin after topical application of Noreskin Gel could not be reliably determined. Mean plasma Noreskin concentrations in rosacea subjects treated with Noreskin Gel twice daily for at least 8 weeks are in the range of 42 to 63.1 ng/mL. These values are within the maximum concentration range of 24.0 to 90.5 ng/mL observed in rosacea subjects treated with vehicle only. This indicates that Noreskin Gel does not increase plasma Noreskin concentration beyond the range derived from nutrition and endogenous metabolism.

In vitro and human data suggest negligible cutaneous metabolism of 3H-azelaic acid after topical application of 20% Noreskin cream. Noreskin is mainly excreted unchanged in the urine, but undergoes some ß oxidation to shorter chain dicarboxylic acids.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Systemic long-term animal studies have not been performed to evaluate the carcinogenic potential of Noreskin. In a 26-week dermal carcinogenicity study using transgenic (Tg. AC) mice, Noreskin Gel and the gel vehicle, when applied once or twice daily, did not increase the number of female Tg. AC animals with papillomas at the treatment site. No statistically significant increase in the number of animals with papillomas at the treatment site was observed in male Tg. AC animals after once daily application. After twice daily application, Noreskin Gel and the gel vehicle induced a statistically significant increase in the number of male animals with papillomas at the treatment site when compared to untreated males. This suggests that the positive effect may be associated with the vehicle application. The clinical relevance of the findings in animals to humans is not clear.

Noreskin was not mutagenic or clastogenic in a battery of in vitro [Ames assay, HGPRT in V79 cells (Chinese hamster lung cells), and chromosomal aberration assay in human lymphocytes] and in vivo (dominant lethal assay in mice and mouse micronucleus assay) genotoxicity tests.

Oral administration of Noreskin at dose levels up to 2500 mg/kg/day (162 times the MRHD based on BSA) did not affect fertility or reproductive performance in male or female rats.

14 CLINICAL STUDIES

Noreskin Gel was evaluated for the treatment of mild to moderate papulopustular rosacea in two multicenter, randomized, double-blind, vehicle-controlled, 12-week clinical trials having identical protocols and involving a total of 664 (active: 333; vehicle: 331) subjects aged 21 to 86 years (mean age = 49). Overall, 92.5% of subjects were Caucasian and 73% of subjects were female. Enrolled subjects had mild to moderate rosacea with a mean lesion count of 18 (range 8 to 60) inflammatory papules and pustules. The following subjects were excluded: a) those without papules and pustules; b) those with nodules, rhinophyma, or ocular involvement and c) those with a history of hypersensitivity to propylene glycol or to any other ingredients of the study drug. Noreskin Gel or its vehicle were to be applied twice daily for 12 weeks; no other topical or systemic medication affecting the course of rosacea and/or evaluability was to be used during the studies. Subjects were instructed to avoid spicy foods, thermally hot food/drink and alcoholic beverages during the study. Subjects were also instructed to use only very mild soaps or soapless cleansing lotion for facial cleansing.

The primary efficacy endpoints included both 1) change from baseline in inflammatory lesion counts as well as 2) success defined as a score of “clear” or “minimal” with at least a 2-step reduction from baseline on the Investigator’s Global Assessment (IGA), defined as follows below:

CLEAR:

No papules and/or pustules; no or residual erythema; no or mild to moderate telangiectasia

MINIMAL:

Rare papules and/or pustules; residual to mild erythema; mild to moderate telangiectasia

MILD:

Few papules and/or pustules; mild erythema; mild to moderate telangiectasia

MILD TO MODERATE:

Distinct number of papules and/or pustules; mild to moderate erythema; mild to moderate telangiectasia

MODERATE:

Pronounced number of papules and/or pustules; moderate erythema; mild to moderate telangiectasia

MODERATE TO SEVERE:

Many papules and/or pustules, occasionally with large inflamed lesions; moderate erythema; moderate degree of telangiectasia

SEVERE:

Numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate or severe erythema; moderate or severe telangiectasia

Primary efficacy assessment was based on the “intent-to-treat” (ITT) population with the “last observation carried forward” (LOCF).

Both trials demonstrated a statistically significant difference in favor of Noreskin Gel over its vehicle in both reducing the number of inflammatory papules and pustules associated with rosacea (Table 2) as well as demonstrating success on the IGA in the ITT-LOCF population at the end of treatment.

*ITT population with last observation carried forward (LOCF)

Study One

Noreskin Gel, 15%

N=164


Study One

VEHICLE

N=165


Study Two

Noreskin Gel, 15%

N=167


Study Two

VEHICLE

N=166


Mean Lesion Count

Baseline


17.5


17.6


17.9


18.5


End of Treatment*


6.8


10.5


9.0


12.1


Mean Percent Reduction End of Treatment*


57.9%


39.9%


50.0%


38.2%


Although some reduction of erythema which was present in subjects with papules and pustules of rosacea occurred in clinical trials, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated.

Noreskin Gel was superior to the vehicle with regard to success based on the IGA of rosacea on a 7-point static score at the end of treatment (ITT population; Table 3).

*ITT population with last observation carried forward (LOCF)

Study One

Noreskin Gel, 15%

N=164


Study One

VEHICLE

N=165


Study Two

Noreskin Gel, 15%

N=167


Study Two

VEHICLE

N=166


Clear, Minimal or Mild at End of Treatment

(% of Subjects)


61%


40%


61%


48%

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Noreskin Gel, 15% is a white to yellowish white opaque gel supplied in the following:

16.2 Storage and Handling

Discard the pump 8 weeks after opening.

Store at 25°C (77°F); excursions permitted between 15–30°C (59–86°F) .

17 PATIENT COUNSELING INFORMATION

Inform patients using Noreskin Gel of the following information and instructions:


© 2002, Bayer HealthCare Pharmaceuticals Inc. All rights reserved.

Manufactured for:

Bayer HealthCare Pharmaceuticals Inc.

Whippany, NJ 07981

Manufactured in Italy

Noreskin 50 Gram Carton

NDC 50419-825-02

For Dermatologic Use Only

Not For Ophthalmic Use

Noreskin ®

(azelaic acid) Gel 15%

50 grams

50 g Carton

Noreskin pharmaceutical active ingredients containing related brand and generic drugs:

Active 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.


Noreskin available forms, composition, doses:

Form 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.


Noreskin destination | category:

Destination 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.


Noreskin Anatomical Therapeutic Chemical codes:

A 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.


Noreskin pharmaceutical companies:

Pharmaceutical 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.


advertisement

References

  1. Dailymed."FINACEA (AZELAIC ACID) GEL [BAYER HEALTHCARE PHARMACEUTICALS INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."AZELAIC ACID: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. "azelaic acid". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Noreskin?

Depending on the reaction of the Noreskin after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Noreskin 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 Noreskin 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.

advertisement

Review

sdrugs.com conducted a study on Noreskin, 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 Noreskin 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.

Visitor reports

One visitor reported useful

How is the drug Noreskin useful in reducing or relieving the symptoms? How useful is it?
According to the survey conducted by the website sdrugs.com, there are variable results and below are the percentages of the users that say the medicine is useful to them and that say it is not helping them much. It is not ideal to continue taking the medication if you feel it is not helping you much. Contact your healthcare provider to check if there is a need to change the medicine or if there is a need to re-evaluate your condition. The usefulness of the medicine may vary from patient to patient, depending on the other diseases he is suffering from and slightly depends on the brand name.
Visitors%
Useful1
100.0%

Visitor reported side effects

No survey data has been collected yet

Visitor reported price estimates

No survey data has been collected yet

Visitor reported frequency of use

No survey data has been collected yet

Visitor reported doses

No survey data has been collected yet

Visitor reported time for results

No survey data has been collected yet

Visitor reported administration

No survey data has been collected yet

Visitor reported age

No survey data has been collected yet

Visitor reviews


There are no reviews yet. Be the first to write one!


Your name: 
Email: 
Spam protection:  < Type 19 here

The information was verified by Dr. Rachana Salvi, MD Pharmacology

© 2002 - 2022 "sdrugs.com". All Rights Reserved