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What happens if I overdose Marpalene 0.1%?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately. Marpalene 0.1% lotion may be harmful if swallowed.
Proper storage of Marpalene 0.1% lotion:
Store Marpalene 0.1% lotion at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat and light. Do not freeze or refrigerate. Keep Marpalene 0.1% lotion out of the reach of children and away from pets.
Overdose of Marpalene 0.1% in details
Marpalene 0.1% 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 Marpalene 0.1% 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.
What should I avoid while taking Marpalene 0.1%?
Avoid getting this medication in your eyes, in the creases of your nose, or on your lips. If it does get into any of these areas, wash with water. Do not use Marpalene 0.1% topical on sunburned, windburned, dry, chapped, irritated, or broken skin. Also avoid using this medication in wounds or on areas of eczema. Wait until these conditions have healed before using Marpalene 0.1% topical.
Do not use skin products that contain alpha hydroxy or glycolic acid while you are also using Marpalene 0.1% topical.
Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medication skin products unless your doctor has told you to.
Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Marpalene 0.1% topical can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.
Marpalene 0.1% warnings
Ultraviolet Light and Environmental Exposure
Exposure to sunlight, including sunlamps, should be avoided during the use of Marpalene 0.1% Lotion. Patients with high levels of sun exposure and those with inherent sensitivity to sun should be warned to exercise caution. Use of sunscreen products and protective apparel (e.g. hat) are recommended when exposure cannot be avoided. Weather extremes, such as wind or cold, may be irritating to patients under treatment with Marpalene 0.1% Lotion.
Local Cutaneous Reactions
Signs and symptoms of local skin irritation (such as erythema, scaling, dryness, stinging/burning) may be experienced with use of Marpalene 0.1% Lotion. These are most likely to occur during the first 2 weeks of treatment, are mostly mild to moderate in severity, and usually lessen with continued use of Marpalene 0.1% Lotion. Depending upon the severity of these side effects, patients should be instructed to use a moisturizer, reduce the frequency of the application of Marpalene 0.1% Lotion 0.1%, or discontinue use. Marpalene 0.1% Lotion 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 Marpalene 0.1% Lotion. Avoid concomitant use of other potentially irritating topical products (abrasive soaps and cleansers, soaps and cosmetics that have strong skin-drying effect and products with high concentrations of alcohol, astringents, spices, or limes).
What should I discuss with my healthcare provider before taking Marpalene 0.1%?
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For Marpalene 0.1%, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to Marpalene 0.1% or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Studies of Marpalene 0.1% have been done only in adult patients, and there is no specific information comparing use of Marpalene 0.1% in children up to 12 years of age with use in other age groups. In teenagers, Marpalene 0.1% is not expected to cause different side effects or problems than it does in adults.
Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of Marpalene 0.1% in the elderly with use in other age groups. Older adults are not likely to develop acne.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Interactions with Medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of Marpalene 0.1%. Make sure you tell your doctor if you have any other medical problems, especially:
- Eczema or
- Seborrheic dermatitis—Use of Marpalene 0.1% may cause or increase the irritation associated with eczema or seborrheic dermatitis
Marpalene 0.1% precautions
Certain cutaneous signs and symptoms of treatment such as erythema, dryness, scaling, burning, or pruritus may be experienced with use of Marpalene 0.1% 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 Marpalene 0.1%. 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 Marpalene 0.1%.
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 Marpalene 0.1%.
Information for Patients:
Patients using Marpalene 0.1% 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.
As Marpalene 0.1% Cream has the potential to produce local irritation in some patients, concomitant use of other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect, and products with high concentrations of alcohol, astringents, spices or lime rind) should be approached with caution. Particular caution should be exercised in using preparations containing sulfur, resorcinol, or salicylic acid in combination with Marpalene 0.1% Cream. If these preparations have been used, it is advisable not to start therapy with Marpalene 0.1% Cream until the effects of such preparations in the skin have subsided.
Carcinogenesis, Mutagenesis, and Impairment of Fertility:
Carcinogenicity studies with Marpalene 0.1% 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 Marpalene 0.1% Cream, which is approximately 1.5 mg/m2 Marpalene 0.1%. 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.
Marpalene 0.1% 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 Marpalene 0.1% in amounts up to 20 mg/kg/day (up to 80 times the MRHD based on mg/m2 comparisons). No effects of Marpalene 0.1% 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 Marpalene 0.1% (up to 20 times the MRHD based on mg/m2 comparisons). However, Marpalene 0.1% 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. Marpalene 0.1% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
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 Marpalene 0.1% Cream is administered to a nursing woman.
Safety and effectiveness in pediatric patients below the age of 12 have not been established.
Clinical studies of Marpalene 0.1% 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.
What happens if I miss a dose of Marpalene 0.1%?
Apply the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not apply extra medicine to make up the missed dose.
- 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/dailyme... (accessed September 17, 2018).
- DrugBank. "ADAPALENE". http://www.drugbank.ca/drugs/DB00210 (accessed September 17, 2018).
- MeSH. "Dermatologic Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology