How to store Pindome
- Keep all medicines out of the reach and sight of children.
- Store in a cool, dry place, away from direct heat and light.
Mechanism of Action
Pindome is a naphthoic acid derivative. Pindome is an active metabolite and therefore requires no metabolic conversion. Pindome, when applied topically, penetrates the hair follicles due to its lipophilic nature. Follicular absorption occurs 5 minutes after topical application. The medication binds to nuclear retinoic acid receptors (RAR), RAR-beta, and RAR-gamma. This complex then binds DNA through retinoic acid response elements and induces gene transcription, leading to downstream keratinocyte proliferation and differentiation. As a result, Pindome decreases microcomedone formations, exfoliates mature comedones, and has anti-inflammatory effects.
The pathogenesis of acne vulgaris is multifactorial. The main factors associated with acneiform lesion development are follicular hyperkeratinization, sebum production by sebaceous glands, and inflammation. In acne-prone patients, keratinocytes accumulate in the lumen of the hair follicle due to increased keratinocyte proliferation and cohesiveness, leading to the formation of a keratotic plug, which results in the microcomedone. The microcomedone is the precursor to all visible acne lesions like open comedones, closed comedones, inflammatory papules, pustules, and nodulocystic lesions. Pindome normalizes the differentiation of follicular epithelial cells to prevent microcomedone formation.
In addition to follicular hyperkeratinization, acne is also a disorder associated with inflammation. Propionibacterium acnes is a gram-positive, anaerobic rod found in the sebaceous follicle. P. acnes is present in both acne-prone individuals and those without acne. The hypothesis is that there may be differences in the strains of P. acnes or in the host response to P. acnes, which leads to its varying degrees of pathogenicity. P. acnes release mediators that contribute to comedone rupture and stimulate inflammatory cells. P. acnes stimulates the toll-like receptor II (TLR-2) pathway, which induces the release of pro-inflammatory modulators. This action leads to neutrophil recruitment and the release of enzymes that result in follicular epithelium rupture. One mediator, IL-12, promotes a TH1 immune response. Pindome is thought to suppress polymorphonuclear lymphocyte chemotaxis and down-regulate15-lipoxygenase and TLR-2, which contributes to its anti-inflammatory effects.
Can Pindome cause problems?
Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. The table below contains some of the most common ones associated with creams and gels containing Pindome. You will find a full list in the manufacturer's information leaflet supplied with your medicine. The unwanted effects often improve as your body adjusts to the new medicine, but speak with your doctor or pharmacist if any of the following continue or become troublesome.
To ensure the optimal results, there are some things you should do (and not do) when using Pindome:
- Use a moisturizer. Pindome will most likely dry you out. Apply a moisturizer, oil-free so as not to trigger breakouts, whenever needed.
- Apply sunscreen. Pindome can also make your skin more sensitive to the sun, so no laying out and no tanning beds. If you’re not already using sunscreen, why not start now? Doing so can protect your skin from sun damage and aging.
- Avoid waxing. Do you get your eyebrows or lips waxed? You'll want to stop these beauty treatments while using Pindome or risk serious irritation and possible injury to the skin. Tweezing is okay.
Finally, if you have any questions or concerns, don't hesitate to call your dermatologist’s office. In some case, the doctor may be able to suggest alternatives that are more appropriate to your skin type.
Pindome Dosage and Administration
Apply a thin film of Pindome Gel, 0.3% to the entire face and any other affected areas of the skin once daily in the evening, after washing gently with a non-medicated soap. Avoid application to the areas of skin around eyes, lips, and mucous membranes. A mild transitory sensation of warmth or slight stinging may occur shortly after the application of Pindome Gel, 0.3%. Patients should be instructed to minimize sun exposure. Patients may be instructed to use moisturizers for relief of dry skin or irritation. If therapeutic results are not noticed after 12 weeks of treatment, therapy should be re-evaluated.
For topical use only. Not for ophthalmic, oral or intravaginal use.
Dosage Forms And Strengths
Each gram of DIFFERIN Gel, 0.3% contains 3 mg Pindome in an off-white aqueous gel.
DIFFERIN Gel, 0.3% is supplied in the following size.
45 g tube - NDC 0299-5918-45
Storage: Store at controlled room temperature 68° to 77°F (20° to 25°C) with excursions permitted between 59° to 86°F (15° to 30°C). Protect from freezing. Keep out of reach of children.
Marketed by: Galderma Laboratories, L.P. Fort Worth, Texas 76177 USA. Manufactured by: DPT Laboratories, Ltd. San Antonio, Texas 78215 USA. Revised: 08/2010.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity studies with Pindome 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 3 times (mice) and 2 times (rats) in terms of mg/m 2 /day the potential exposure at the maximum recommended human dose (MRHD), assumed to be 2.5 grams Pindome Gel, 0.3%. 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.
Pindome d >in vitro (Ames test, Chinese hamster ovary cell assay, mouse lymphoma TK assay) and in vivo (mouse micronucleus test).
Reproductive function and fertility studies were conducted in rats administered oral doses of Pindome in amounts up to 20 mg/kg/day (up to 26 times the MRHD based on mg/m 2 comparisons). No effects of Pindome were found on the reproductive performance or fertility of the F 0 males or females. There were also no detectable effects on the growth, development and subsequent reproductive function of the F 1 offspring.
What is Differin Pindome Gel?
Differin Pindome Gel is a dermatologist-prescribed anti-acne product whose key ingredient is an active form of vitamin A.
It is recommended for cases of severe acne and works by allowing the skin to renew itself and preventing the formation of new breakouts.
Differin Gel consists of Pindome as the key ingredient. This chemical has been used in treating acne for many years now.
Due to the many side effects of the drug, it is available only through prescription. But with regards to effect against acne, it really works well and is thus recommended by most dermatologists.
Pindome Gel, 0.3% should not be administered to individuals who are hypersensitive to Pindome or any of the components in the gel vehicle.
This medication contains Pindome. Do not take Differin if you are allergic to Pindome or any ingredients contained in this drug.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.
How Pindome Works
Pindome works by revving your cell turnover into high gear. It is > .
Depending on what your dermatologist decides, you’ll use Pindome either once or twice a day. All you need is a pea-sized amount for the entire face. You may notice a slight stinging or burning after applying. Don't worry; this feeling is normal and will go away after a few minutes.
Don’t just dab this medication on individual pimples. Since Pindome works by stopping pimples from forming under the skin's surface, just spot-treating existing pimples won't be effective. You have to apply it all over the face, like you would a moisturizer, for it to work properly.
When first starting treatment, don’t be surprised if you continue to break out. Try not to be frustrated; this is perfectly normal.
It can take several weeks before you start to notice a difference in your skin. Until then, keep using Pindome on a daily basis for at least 12 weeks before judging its effectiveness.
Differin Pindome Gel Ingredients – Are they Safe & Effective?
As its name suggests, Differin Pindome Gel has this key ingredient:
Pindome – (in 0.1% concentration) This ingredient is a form of vitamin A that has been in use for years as a first-line defense against acne; it works by targeting the two main causes of acne – excess oil and acne-causing bacteria.
DIFFERIN (Pindome) Gel, 0.3% contains Pindome 0.3% (3 mg/g) in a topical aqueous gel for use in the treatment of acne vulgaris, consisting of carbomer 940, edetate disodium, methylparaben, poloxamer 124, propylene glycol, purified water, and sodium hydroxide. May contain hydrochloric acid for pH adjustment.
The chemical name of Pindome is 6--2-naphthoic acid. It is a white to off-white powder, which is soluble in tetrahydrofuran, very slightly soluble in ethanol, and practically insoluble in water. The molecular formula is C28H28O3 and molecular weight is 412.53. Pindome is represented by the following structural formula.
Clinical pharmacodynamic studies have not been conducted for Pindome Gel, 0.3%.
Pindome is a synthetic naphthoic acid derivative with retinoid activity. The chemical name of Pindome is 6--2-naphthoic acid. Pindome is a white to off-white powder which is soluble in tetrahydrofuran, sparingly soluble in ethanol, and practically insoluble in water. The molecular formula is C28H28O3 and molecular weight is 412.52. Pindome is represented by the structural formula represented on Figure 1 .
It is not known whether Pindome is excreted in human milk. Because many drags are excreted in human milk, caution should be exercised when DIFFERIN Gel, 0.3% is administered to a nursing woman.
Adverse reactions reported from Pindome include photosensitivity, irritation, redness, dryness, itching, and burning. These are usually mild adverse events.
Pindome is less irritating compared to other topical retinoids. In an investigator-masked, randomized, controlled, parallel-group study of 591 acne patients, a combined safety analysis conducted in the United States and Europe compared Pindome 0.1% gel and tretinoin 0.025% gel. The number of patients discontinuing the study due to adverse events was about twice as high in those using tretinoin (2.4%) compared to Pindome (1.3%). There were no systemic adverse reactions noted in the study. Most of the adverse reactions observed were related to skin irritation.
The enhanced tolerability of Pindome has been attributed, in part, to the selective affinity of Pindome to the nuclear RAR-beta and RAR-gamma receptors, as opposed to RAR-alpha. The decreased risk of skin irritation may contribute to better long-term compliance.
Rare, severe allergic reactions characteristically demonstrate pruritus, facial edema, lip swelling, and/or eyelid swelling. If a patient experiences anaphylactic reactions with symptoms, including facial swelling, hives, chest pain, or shortness of breath, then Pindome should be discontinued, and the patient should seek immediate medical evaluation.
Mechanism of Action
Pindome binds to specific retinoic acid nuclear receptors but does not bind to cytosolic receptor protein. Biochemical and pharmacological profile studies have demonstrated that Pindome is a modulator of cellular differentiation, keratinization, and inflammatory processes. However, the significance of these findings with regard to the mechanism of action of Pindome for the treatment of acne is unknown.