Klenzit

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Klenzit uses

• Indications and usage:
• Clinical studies:
• Contraindications:
• Precautions:
• Adverse reactions:
• Overdosage:
• Dosage and administration:
• How supplied:
• Klenzit reviews

INDICATIONS AND USAGE:

Klenzit 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 Klenzit 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 Klenzit cream, were to be applied to the face during the studies. Klenzit 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	Klenzit Cream, 0.1% N=119	Cream Vehicle N=118	Klenzit 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 Klenzit cream when compared to the cream vehicle.

CONTRAINDICATIONS:

Klenzit cream should not be administered to individuals who are hypersensitive to Klenzit 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 Klenzit 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 Klenzit. 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 Klenzit.

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 Klenzit.

Information for Patients:

Patients using Klenzit 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 Klenzit 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 Klenzit cream. If these preparations have been used, it is advisable not to start therapy with Klenzit cream until the effects of such preparations in the skin have subsided.

Carcinogenesis, Mutagenesis, and Impairment of Fertility:

Carcinogenicity studies with Klenzit 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 Klenzit cream, which is approximately 1.5 mg/m² Klenzit. 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.

Klenzit 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 Klenzit in amounts up to 20 mg/kg/day (up to 80 times the MRHD based on mg/m² comparisons). No effects of Klenzit 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 Klenzit. However, Klenzit 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. Klenzit 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 Klenzit 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 Klenzit 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.

ADVERSE REACTIONS:

In controlled clinical trials, local cutaneous irritation was monitored in 285 acne patients who used Klenzit 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 Klenzit cream from the controlled clinical studies is provided in the following table:

Incidence of Local Cutaneous Irritations with Klenzit 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 Klenzit 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 Klenzit cream included: acne flare, dermatitis and contact dermatitis, eyelid edema, conjunctivitis, erythema, pruritus, skin discoloration, rash, and eczema.

OVERDOSAGE:

Klenzit 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 Klenzit 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:

Klenzit 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 Klenzit cream.

HOW SUPPLIED:

Klenzit 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 ^®

Klenzit 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 ^®

Klenzit CREAM 0.1%

For topical use only.

Not for ophthalmic, oral,

or intravaginal use.

NET WT 45 grams

Klenzit pharmaceutical active ingredients containing related brand and generic drugs:

• Adapalene

Klenzit available forms, composition, doses:

• Gel; Topical; Adapalene 0.1%

Klenzit destination | category:

• Human:
• Acne treatment preparations
• Skin and mucous membrane agents

Klenzit Anatomical Therapeutic Chemical codes:

• D10AD03 - Adapalene

Klenzit pharmaceutical companies:

• Glenmark Pharmaceuticals
• Metro Drug Distribution

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 Klenzit?

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

Review

sdrugs.com conducted a study on Klenzit, 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 Klenzit 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. Rachana Salvi, MD Pharmacology