When a dose is taken in higher dose than the recommended doses, it is called Overdose. Overdose always needs a clinical supervision. Any medicine or drug when consumed in Overdose produces untoward side effects on one or various organs in the body. A medicine is excreted in the kidney or metabolized in the liver most of the times. This process goes without any hurdles when taken in normal dose, but when taken in an overdose, the body is not able to metabolize it or send it out properly which causes the effects of anoverdose.
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Gel: Use above the recommended dose may cause elevated serum calcium which should rapidly subside when treatment is discontinued.
Excessive prolonged use of topical corticosteroids may suppress the pituitary-adrenal functions, resulting in secondary adrenal insufficiency which is usually reversible. In such cases, symptomatic treatment is indicated.
In case of chronic toxicity, the corticosteroid treatment must be discontinued gradually.
It has been reported that due to misuse, 1 patient with extensive erythrodermic psoriasis treated with Psori-Bet ointment 240 g weekly (maximum dose 100 g weekly) for 5 months developed Cushing’s syndrome and pustular psoriasis after abruptly stopping treatment.
Psori-Bet warnings
Warnings are a mix of Precautions. Contraindications and interactions and serious harmful effects associated with the medicine intake. A diabetic or Hypertensive patient need to be warned about few drug interactions. A known hypersensitivity patient needs to be careful about the reactions or anaphylactic shock. A pregnant woman or a breastfeeding woman should be warned of certain medications. A Hepatitis [liver disease] patient or a cardiac patient should avoid few drugs.
This medication is not recommended for use if you have the following medical conditions: skin infections caused by bacteria, fungus, or a virus (e.g., chicken pox, herpes). Tell your doctor your medical history, especially of: high calcium levels in the blood (hypercalcemia), open wounds or sores on the skin, any allergies. Though very unlikely, it is possible this medication will be absorbed into your bloodstream. This may have undesirable consequences that may require additional corticosteroid treatment. This is especially true for children and for those who have used this for an extended period of time and if they also have serious medical problems such as serious infections, injuries or surgeries. This precaution applies for up to one year after stopping use of this drug. Tell your doctor immediately if any of the following side effects occur: vision problems, persistent headache, increased thirst or urination, unusual weakness or weight loss, dizziness. Consult your doctor or pharmacist for more details, and inform them that you use (or have used) this medication. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.
Psori-Bet precautions
Certain people who are very sick or very old or who are sensitive show an exacerbation of side effect of the drug which can turn dangerous at times. So, it is very important to remember the precautions while taking the medicine. Pregnancy and Breastfeeding are also special categories wherein extra care or precaution is needed when taking a drug. Few patients may have a hypersensitivity reaction to few medications, and that can be life-threatening rarely. Penicillin hypersensitivity is one example. Diarrhea, rashes are few other symptoms which need a watch. A patient with other co-existing diseases like liver disease, heart disease, kidney disease should take special precautions.
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Psori-Bet contains a potent group III steroid and concurrent treatment with other steroids on the scalp must be avoided. Adverse effects found in connection with systemic corticosteroid treatment eg, adrenocortical suppression or impact on the metabolic control of diabetes mellitus, may also occur during topical corticosteroid treatment due to systemic absorption. Application under occlusive dressings should be avoided since it increases the systemic absorption of corticosteroids.
In a study in patients with both extensive scalp and extensive body psoriasis using a combination of high doses of Psori-Bet (scalp application) and high doses of Psori-Bet (body application), 5 of 32 patients showed a borderline decrease in cortisol response to adrenocorticotropic hormone (ACTH) challenge after 4 weeks of treatment.
Due to the Calcipotriol (Psori-Bet) content, hypercalcaemia may occur if the maximum weekly dose (100 g) is exceeded. Serum calcium is, however, quickly normalised when treatment is discontinued. The risk of hypercalcaemia is minimal when the recommendations relevant to Calcipotriol (Psori-Bet) are followed.
Efficacy and safety of Psori-Bet use on areas other than the scalp have not been established.
Treatment of >30% of the body surface should be avoided. Application on large areas of damaged skin or on mucous membranes or in skin folds should be avoided since it increases the systemic absorption of corticosteroids. Skin of the face and genitals are very sensitive to corticosteroids. These areas should only be treated with weaker corticosteroids. Uncommon local adverse reactions (eg, eye irritation or irritation of facial skin) were observed, when Psori-Bet was accidentally administered in the area of face, or accidentally to the eyes or conjunctives. The patient must be instructed in the correct use of Psori-Bet to avoid application and accidental transfer to the face, mouth and eyes. Hands must be washed after each application to avoid accidental transfer to these areas.
When lesions become secondarily infected, they should be treated with antimicrobiological therapy. However, if infection worsens, treatment with corticosteroids should be stopped.
When treating psoriasis with topical corticosteroids, there may be a risk of generalised pustular psoriasis or of rebound effects when discontinuing treatment. Medical supervision should therefore continue in the post-treatment period.
With long-term use, there is an increased risk of local and systemic corticosteroid undesirable effects. The treatment should be discontinued in case of undesirable effects related to long-term use of corticosteroid.
There is no experience with concurrent use of other antipsoriatic products administered systemically or with phototherapy.
During Psori-Bet treatment, physicians are recommended to advise patients to limit or avoid excessive exposure to either natural or artificial sunlight.
Topical Calcipotriol (Psori-Bet) should be used with UVR only if the physician and patient consider that the potential benefits outweigh the potential risks.
Psori-Bet contains butylated hydroxytoluene (E321) which may cause local skin reactions (eg, contact dermatitis) or irritation to the eyes and mucous membranes.
Use in pregnancy: There are no adequate data from the use of Psori-Bet in pregnant women. Studies in animals with glucocorticoids have shown reproductive toxicity, but a number of epidemiological studies have not revealed congenital anomalies among infants born to women treated with corticosteroids during pregnancy. The potential risk for humans is uncertain. Therefore, during pregnancy, Psori-Bet should only be used when the potential benefit justifies the potential risk.
Use in lactation:Betamethasone (Psori-Bet) passes into the breast milk, but risk of an adverse effect on the infant seems unlikely with therapeutic doses. There are no data on the excretion of Calcipotriol (Psori-Bet) in breast milk. Caution should be exercised when prescribing Psori-Bet to women who is breastfeeding.
Use in children: Psori-Bet is not recommended for use in children <18 years due to lack of data on safety and efficacy.
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References
DailyMed. "CALCIPOTRIENE HYDRATE: 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).
DailyMed. "BETAMETHASONE: 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).
