If this occurs you should seek medical help immediately. If you are being treated for basal cell carcinoma: Local skin reactions can be a sign that the drug is working as intended. Very Commonly the treated skin may be slightly itchy. If a skin reaction becomes too uncomfortable during treatment, speak to your doctor. If there is pus matter or other suggestion of infection, discuss this with your doctor. Apart from reactions in the skin, other common effects include swollen glands and back pain.
If you are being treated for actinic keratosis: Very commonly the treated skin may be slightly itchy. If higher doses than 2 packets of Aldara Cream are used clinically, then the animal multiple of human exposure would be reduced for that dose. A non-proportional increase in systemic exposure with increased dose of Aldara Cream was noted in the clinical pharmacokinetic study conducted in actinic keratosis subjects see Pharmacokinetics.
The animal multiples of human exposure calculations were based on weekly dose comparisons for the carcinogenicity studies described in this label. The animal multiples of human exposure calculations were based on daily dose comparisons for the reproductive toxicology studies described in this label.
An increased number of skin papillomas was observed in vehicle cream control group animals at the treated site only. The quantitative composition of the vehicle cream used in the dermal mouse carcinogenicity study is the same as the vehicle cream used for Aldara Cream, minus the active moiety imiquimod.
No additional effect on tumor development beyond the vehicle effect was noted with the addition of the active ingredient, imiquimod, to the vehicle cream.
Imiquimod revealed no evidence of mutagenic or clastogenic potential based on the results of five in vitro genotoxicity tests Ames assay, mouse lymphoma LY assay, Chinese hamster ovary cell chromosome aberration assay, human lymphocyte chromosome aberration assay and SHE cell transformation assay and three in vivo genotoxicity tests rat and hamster bone marrow cytogenetics assay and a mouse dominant lethal test. Pregnancy Pregnancy Category C: Systemic embryofetal development studies were conducted in rats and rabbits.
Intravenous doses of 0. A combined fertility and peri- and post-natal development study was conducted in rats. Oral doses of 1, 1. This fetal effect was also noted in the oral rat embryofetal development study conducted with imiquimod. There are no adequate and well-controlled studies in pregnant women.
Aldara Cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. For basal cell carcinomas, sufficient cream should be applied to cover the treatment area, including one centimetre of skin surrounding the tumour, and rubbed in until it vanishes five times a week for example monday to friday before going to bed. The cream should be left on for 8 hours each time and then washed off with mild soap and water.
The treatment is continued for 6 weeks. If it has not fully responded a different treatment will be used. Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Aldara cream.
Some patients have experienced changes in skin colour in the area where Aldara cream was applied. While these changes have tended to improve with time, in some patients they may be permanent.
If your skin reacts badly when using Aldara cream, stop applying the cream, wash the area with mild soap and water and contact your doctor or pharmacist. In some individuals a lowering of blood counts was noted. Do not use Aldara for more than one course if you have problems with your immune system either due to illness or because of the medicines you are already taking. If you think this applies to you, talk to your doctor. Aldara cream has been prescribed for your use only.
Do not give it to anyone else even if you think their condition is the same as yours. If you forget to use Aldara If you forget a dose, apply the missed dose of cream as soon as you remember and then continue on the regular schedule. Do not double the dose at any time to make up the missed dose. Side Effects All medicines can have side effects and this may occur with the normal use of Aldara. Tell your doctor as soon as possible if you do not feel well while you are using Aldara.
If the following occur and are severe enough to worry you, tell your doctor. Application site reactions including redness, wearing away of the skin, flakiness, swelling, hardening under the skin, small open sores, crust that forms during healing, small bubbles under the skin, itching, burning, pain, tenderness, irritation, rash, soreness, stinging, sensitivity, skin colour becomes lighter, bleeding, lumps on the skin, infection and pimples.
Most of these skin reactions are mild to moderate, and are signs that the product is working. If your skin reacts badly or the skin reaction becomes too uncomfortable when using Aldara cream, wash the cream off with mild soap and water and contact your doctor.
Your doctor may recommend that you stop treatment for a few days. Flu symptoms, tiredness, fever, headache, diarrhoea, back pain, muscle pain, and swollen glands in the neck, armpit and groin. Some patients have experienced changes in skin colour lighter or darker in the area where Aldara cream was applied.
These changes may be permanent in some cases. Please tell your doctor if you experience other side effects or you do not feel well while you are using Aldara. If you use too much Aldara Using too much Aldara cream could cause severe skin reactions. If too much cream is applied, simply wash away the extra cream with mild soap and water. When any skin reaction has settled, you may then continue with your treatment.
If the cream is accidentally swallowed, nausea, vomiting, headache, muscle pain, and fever could occur. Discard Aldara pump 4 weeks after opening. Do not store Aldara cream or any other medicine in the bathroom or near a sink. Do not leave it in the car or on window sills.
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