T3 ADA

advertisement
What are the side effects you encounter while taking this medicine?

T3 ADA uses


INDICATIONS AND USAGE:

T3 ADA cream is indicated for the topical treatment of acne vulgaris.

CLINICAL STUDIES:

Two vehicle-controlled clinical studies were conducted in patients 12 to 30 years of age with mild to moderate acne vulgaris, in which T3 ADA cream was compared with its vehicle. Patients were instructed to apply their treatment medication once daily at bedtime for 12 weeks. In one study patients were provided with a soapless cleanser and were encouraged to refrain from using moisturizers. No other topical medications, other than T3 ADA cream, were to be applied to the face during the studies. T3 ADA cream was significantly more effective than its vehicle in the reduction of acne lesion counts. The mean percent reduction in lesion counts from baseline after treatment for 12 weeks are presented in the following table:

MEAN PERCENT REDUCTION IN LESION COUNTS

FROM BASELINE TO WEEK 12

Study No. 1 Study No. 2

Efficacy Variable

T3 ADA

Cream, 0.1%

N=119

Cream

Vehicle

N=118

T3 ADA

Cream, 0.1%

N=175

Cream

Vehicle

N=175

Non-inflammatory

lesions

34% 18% 35% 15%
Inflammatory

lesions

32% 17% 14% 6%
Total lesions 34% 18% 30% 15%

The trend in the Investigator's global assessment of severity supported the efficacy of T3 ADA cream when compared to the cream vehicle.

advertisement

CONTRAINDICATIONS:

T3 ADA cream should not be administered to individuals who are hypersensitive to T3 ADA or any of the components in the cream vehicle.

PRECAUTIONS:

General:

Certain cutaneous signs and symptoms of treatment such as erythema, dryness, scaling, burning, or pruritus may be experienced with use of T3 ADA cream. These are most likely to occur during the first two to four weeks of treatment, are mostly mild to moderate in intensity, and usually lessen with continued use of the medication. Depending upon the severity of these side effects, patients should be instructed to reduce the frequency of application or discontinue use.

If a reaction suggesting sensitivity or chemical irritation occurs, use of the medication should be discontinued. Exposure to sunlight, including sunlamps, should be minimized during use of T3 ADA. Patients who normally experience high levels of sun exposure, and those with inherent sensitivity to sun, should be warned to exercise caution. Use of sunscreen products and protective clothing over treated areas is recommended when exposure cannot be avoided. Weather extremes, such as wind or cold, also may be irritating to patients under treatment with T3 ADA.

Avoid contact with the eyes, lips, angles of the nose, and mucous membranes. The product should not be applied to cuts, abrasions, eczematous or sunburned skin. As with other retinoids, use of "waxing" as a depilatory method should be avoided on skin treated with T3 ADA.

Information for Patients:

Patients using T3 ADA cream should receive the following information and instructions:

  • This medication is to be used only as directed by the physician.
  • It is for external use only.
  • Avoid contact with the eyes, lips, angles of the nose, and mucous membranes.
  • Cleanse area with a mild or soapless cleanser before applying this medication.
  • Moisturizers may be used if necessary, however, products containing alpha hydroxyl or glycolic acids should be avoided.
  • Exposure of the eye to this medication may result in reactions such as swelling, conjunctivitis, and eye irritation.
  • This medication should not be applied to cuts, abrasions, eczematous or sunburned skin.
  • Wax epilation should not be performed on treated skin due to the potential for skin erosions.
  • During the early weeks of therapy, an apparent exacerbation of acne may occur. This is due to the action of this medication on previously unseen lesions and should not be considered a reason to discontinue therapy. Overall clinical benefit may be noticed after two weeks of therapy, but at least eight weeks are required to obtain consistent beneficial effects.

Drug Interactions:

As T3 ADA cream has the potential to produce local irritation in some patients, concomitant use of other potentially irritating topical products should be approached with caution. Particular caution should be exercised in using preparations containing sulfur, resorcinol, or salicylic acid in combination with T3 ADA cream. If these preparations have been used, it is advisable not to start therapy with T3 ADA cream until the effects of such preparations in the skin have subsided.

Carcinogenesis, Mutagenesis, and Impairment of Fertility:

Carcinogenicity studies with T3 ADA have been conducted in mice at topical doses of 0.4, 1.3, and 4.0 mg/kg/day, and in rats at oral doses of 0.15, 0.5, and 1.5 mg/kg/day. These doses are up to 8 times (mice) and 6 times (rats) in terms of mg/m2/day the maximum potential exposure at the recommended topical human dose (MRHD), assumed to be 2.5 grams T3 ADA cream, which is approximately 1.5 mg/m2 T3 ADA. In the oral study, increased incidence of benign and malignant pheochromocytomas in the adrenal medullas of male rats was observed.

No photocarcinogenicity studies were conducted. Animal studies have shown an increased risk of skin neoplasms with the use of pharmacologically similar drugs (e.g., retinoids) when exposed to UV irradiation in the laboratory or to sunlight. Although the significance of these studies to human use is not clear, patients should be advised to avoid or minimize exposure to either sunlight or artificial UV irradiation sources.

T3 ADA did not exhibit mutagenic or genotoxic effects in vivo (mouse micronucleous test) and in vitro (Ames test, Chinese hamster ovary cell assay, mouse lymphoma TK assay) studies.

Reproductive function and fertility studies were conducted in rats administered oral doses of T3 ADA in amounts up to 20 mg/kg/day (up to 80 times the MRHD based on mg/m2 comparisons). No effects of T3 ADA were found on the reproductive performance or fertility of the Fo males or females. There were also no detectable effects on the growth, development and subsequent reproductive function of the F1 generation.

Pregnancy: Teratogenic effects. Pregnancy Category C.

No teratogenic effects were seen in rats at oral doses of 0.15 to 5.0 mg/kg/day T3 ADA. However, T3 ADA administered orally at doses of≥ 25 mg/kg, (100 times the MRHD for rats or 200 times MRHD for rabbits) has been shown to be teratogenic. Cutaneous teratology studies in rats and rabbits at doses of 0.6, 2.0, and 6.0 mg/kg/day (24 times the MRHD for rats or 48 times the MRHD for rabbits) exhibited no fetotoxicity and only minimal increases in supernumerary ribs in rats. There are no adequate and well-controlled studies in pregnant women. T3 ADA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers:

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when T3 ADA cream is administered to a nursing woman.

Pediatric Use:

Safety and effectiveness in pediatric patients below the age of 12 have not been established.

Geriatric Use:

Clinical studies of T3 ADA cream were conducted in patients 12 to 30 years of age with acne vulgaris and therefore did not include subjects 65 years and older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

advertisement

ADVERSE REACTIONS:

In controlled clinical trials, local cutaneous irritation was monitored in 285 acne patients who used T3 ADA cream once daily for 12 weeks. The frequency and severity of erythema, scaling, dryness, pruritus and burning were assessed during these studies. The incidence of local cutaneous irritation with T3 ADA cream from the controlled clinical studies is provided in the following table:

Incidence of Local Cutaneous Irritations with T3 ADA Cream

from Controlled Clinical Studies (N=285)

None Mild Moderate Severe
Erythema 52% (148) 38% (108) 10% (28) <1% (1)
Scaling 58% (166) 35% (100) 6% (18) <1% (1)
Dryness 48% (136) 42% (121) 9% (26) <1% (2)
Pruritis (persistent) 74% (211) 21% (61) 4% (12) <1% (1)
Burning/Stinging (persistent) 71% (202) 24% (69) 4% (12) <1% (2)

Other reported local cutaneous adverse events in patients who used T3 ADA cream once daily included: sunburn (2%), skin discomfort-burning and stinging (1%) and skin irritation (1%). Events occurring in less than 1% of patients treated with T3 ADA cream included: acne flare, dermatitis and contact dermatitis, eyelid edema, conjunctivitis, erythema, pruritus, skin discoloration, rash, and eczema.

advertisement

OVERDOSAGE:

T3 ADA cream is intended for cutaneous use only. If the medication is applied excessively, no more rapid or better results will be obtained and marked redness, scaling, or skin discomfort may occur. The acute oral toxicity of T3 ADA cream in mice and rats is greater than 10 mL/kg. Chronic ingestion of the drug may lead to the same side effects as those associated with excessive oral intake of Vitamin A.

DOSAGE AND ADMINISTRATION:

T3 ADA cream should be applied to affected areas of the skin, once daily at nighttime. A thin film of the cream should be applied to the skin areas where acne lesions appear, using enough to cover the entire affected areas lightly. A mild transitory sensation of warmth or slight stinging may occur shortly after the application of T3 ADA cream.

HOW SUPPLIED:

T3 ADA Cream, 0.1% is supplied in a 45 g tube - NDC 0168-0424-46

Storage:

Store at controlled room temperature 68° to 77°F (20° to 25°C). Excursions permitted between 59° and 86° F (15° and 30° C). Protect from freezing.

I2424B

R02/13

#187

E. FOUGERA & CO.

A division of Fougera

PHARMACEUTICALS INC.

Melville, New York 11747

NDC 0168-0424-46

Fougera ®

T3 ADA CREAM 0.1%

Rx only

For topical use only.

Not for ophthalmic, oral or intravaginal use.

NET WT 45 grams

NDC 0168-0424-46

Rx only

Fougera ®

T3 ADA CREAM 0.1%

For topical use only.

Not for ophthalmic, oral,

or intravaginal use.

NET WT 45 grams

advertisement

T3 ADA 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.


T3 ADA 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.


T3 ADA 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.


T3 ADA 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.


T3 ADA 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."ADAPALENE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."ADAPALENE: 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. "ADAPALENE". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming T3 ADA?

Depending on the reaction of the T3 ADA after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider T3 ADA 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 T3 ADA 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 T3 ADA, 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 T3 ADA 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

Visitor reported useful

No survey data has been collected yet

Visitor reported side effects

No survey data has been collected yet

Visitor reported price estimates

No survey data has been collected yet

One visitor reported frequency of use

How often in a day do you take the medicine?
Are you taking the T3 ADA drug as prescribed by the doctor?

Few medications can be taken Twice in a day more than prescribed when the doctor's advice mentions the medicine can be taken according to frequency or severity of symptoms. Most times, be very careful and clear about the number of times you are taking the medication. The report of sdrugs.com website users about the frequency of taking the drug T3 ADA is mentioned below.
Visitors%
Twice in a day1
100.0%

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 27 here

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

© 2002 - 2021 "sdrugs.com". All Rights Reserved