Hydrocortistab Overdose

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What happens if I overdose Hydrocortistab?

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately.

Proper storage of Hydrocortistab solution:

Hydrocortistab solution is usually handled and stored by a health care provider. If you are using Hydrocortistab solution at home, store Hydrocortistab solution as directed by your pharmacist or health care provider. Keep Hydrocortistab solution out of the reach of children and away from pets.

Overdose of Hydrocortistab in details

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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Reports of acute toxicity and/or death following overdosage of glucocorticoids are rare. In the event of overdosage, no specific antidote is available, treatment is supportive and symptomatic.

The intraperitoneal LD50 of Hydrocortistab in female mice was 1740 mg/kg.

What should I avoid while taking Hydrocortistab?

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.

Do not receive a "live" vaccine while you are being treated with Hydrocortistab. Vaccines may not work as well while you are taking a steroid.

Avoid drinking alcohol while you are taking Hydrocortistab.

Hydrocortistab 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.

With caution use in parasitic and infectious diseases of viral, fungal or bacterial origin (currently or recently transferred, including the recent contact with a patient) - herpes simplex, herpes zoster (viremic phase), chickenpox, measles, amoebiasis, strongyloidiasis (set or suspected), systemic mycosis, active and latent tuberculosis. Application for serious infectious diseases is permissible only against the background of specific therapy.

Precautions to apply for 8 weeks before and 2 weeks after vaccination, with lymphadenitis after BCG, with immunodeficiency (including AIDS or HIV infection).

Precautions to apply for gastrointestinal diseases: gastric ulcer and duodenal ulcer, esophagitis, gastritis, acute or latent peptic ulcer, the newly formed anastomosis of the intestine, ulcerative colitis with perforation or abscess formation threat, diverticulitis.

With caution used in diseases of the cardiovascular system, including after recent myocardial infarction (in patients with acute and subacute myocardial necrosis may spread the fire, slowing the formation of scar tissue and therefore break the heart muscle), with decompensated chronic heart failure, hypertension, hyperlipidemia) and endocrine diseases - diabetes mellitus (including breach of tolerance to carbohydrates), thyrotoxicosis, hypothyroidism, Itsenko-Cushing disease, with severe chronic renal and / or hepatic failure, nefrourolitiaze, with hypoalbuminemia and conditions that predispose to its occurrence, with systemic osteoporosis, myasthenia gravis, acute psychosis, obesity (III-IV degree), and polio (except bulbar form of encephalitis), open-and angle-closure glaucoma, pregnancy, lactation.

If necessary of intraarticular injection use with caution to patients with severe general condition, failure (or brevity) of the 2 previous injections (based on the individual properties used GCS).

For lack of effectiveness of Hydrocortistab in 48-72 hours and the need for more long-term therapy should be replaced by Hydrocortistab at different glucocorticoid preparation does not cause sodium retention in the body. During treatment with Hydrocortistab Micronised Xepa-Soul Pattinson should appoint a diet with restriction of sodium and high potassium content. Hydrocortistab caused a relative adrenal insufficiency may persist for several months after its cancellation. Given this under stressful situations that arise during the period, hormone therapy resume with simultaneous appointment of salts and / or mineral corticoids.

Patients with active tuberculosis Hydrocortistab should be used in conjunction with the appropriate anti tuberculosis therapy. In latent tuberculosis or during superelevation tuberculin tests should carefully monitor the status of the patient, and if necessary to chemoprophylaxis.

What should I discuss with my healthcare provider before taking Hydrocortistab?

Some medical conditions may interact with Hydrocortistab enema. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

Some MEDICINES MAY INTERACT with Hydrocortistab enema. Tell your health care provider if you are taking any other medicines, especially any of the following:

This may not be a complete list of all interactions that may occur. Ask your health care provider if Hydrocortistab enema may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Hydrocortistab 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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General -

Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment.

Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. This may be done by using the ACTH stimulation, A.M. plasma cortisol, and urinary free cortisol tests.

Hydrocortistab Valerate Cream USP, 0.2% has produced mild, reversible adrenal suppression in adult patients when used under occlusion for 5 days, 15 grams twice a day over 25 to 60% body surface area or when used three times a day over 20 to 30% body surface area to treat psoriasis for 3-4 weeks. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for these products.

Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios.

If irritation develops, Hydrocortistab Valerate Cream USP, 0.2% should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noting a clinical exacerbation, as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing. If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of Hydrocortistab Valerate Cream USP, 0.2% should be discontinued until the infection has been adequately controlled.

Information for Patients -

Patients using topical corticosteroids should receive the following information and instructions:

1.
This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
2.
This medication should not be used for any disorder other than that for which it was prescribed.
3.
The treated skin area should not be bandaged, otherwise covered or wrapped, so as to be occlusive unless directed by the physician.
4.
Patients should report to their physician any signs of local adverse reactions.
5.
Hydrocortistab Valerate Cream USP, 0.2% should not be applied in the diaper areas as diapers or plastic pants may constitute occlusive dressings.
6.
This medication should not be used on the face, underarms, or groin areas unless directed by the physician.
7.
As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician.

Laboratory Tests -

The following tests may be helpful in evaluating patients for HPA axis suppression:

ACTH stimulation test

A.M. plasma cortisol test

Urinary free cortisol test

Carcinogenesis, Mutagenesis, Impairment of Fertility -

Long-term animal studies have not been performed to evaluate the carcinogenic potential of Hydrocortistab valerate. Hydrocortistab Valerate Cream USP, 0.2% was shown to be non-mutagenic in the Ames-Salmonella/Microsome Plate Test. There are no studies which assess the effects of Hydrocortistab valerate on fertility and general reproductive performance.

Pregnancy:

Teratogenic Effects:

Pregnancy Category C -

Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.

Dermal embryofetal developmental studies were conducted in rabbits and rats with Hydrocortistab Valerate Cream, 0.2%. Hydrocortistab Valerate Cream, 0.2%, was administered topically for 4 hours/day, rather than the preferred 24 hours/day, during the period of organogenesis in rats (gestational days 5-16) and rabbits (gestational days 6-19).

Topical doses of Hydrocortistab valerate up to 9 mg/kg/day (54 mg/m2/day) were administered to rats and 5 mg/kg/day (60 mg/m2/day) were administered to rabbits. In the absence of maternal toxicity, a significant increase in delayed skeletal ossification in fetuses was noted at 9 mg/kg/day [2.5X the Maximum Recommended Human Dose (MRHD) based on body surface area (BSA) comparisons] in the rat study. No malformations in the fetuses were noted at 9 mg/kg/day (2.5X MRHD based on BSA comparisons) in the rat study. Indicators of embryofetal toxicity, significant decrease in fetal weight at 2 mg/kg/day (1X MRHD based on BSA) and a significant increase in post-implantation loss and embryo resorption at 5 mg/kg (3X MRHD based on BSA), were noted in the rabbit study. A significant increase in delayed skeletal ossification in fetuses was noted at 5 mg/kg/day (3X the MRHD based on BSA comparisons) in the rabbit study. Increased numbers of fetal malformations (e.g., cleft palate, omphalocele and clubbed feet) were noted at 5 mg/kg/day (3X MRHD based on BSA comparisons) in the rabbit study.

There are no adequate and well-controlled studies in pregnant women. Hydrocortistab Valerate Cream USP, 0.2% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers -

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Hydrocortistab Valerate Cream USP, 0.2% is administered to a nursing woman.

Pediatric Use -

Safety of this product in pediatric patients has not been established. There is no data on adrenal suppression and/or growth suppression.

Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing's syndrome when they are treated with topical corticosteroids. They are therefore also at a greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children.

HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels, and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Geriatric Use -

Clinical studies of Hydrocortistab Valerate Cream, 0.2% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from 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 Hydrocortistab?

When you miss a dose, you should take it as soon as you remember, but you should take care that it should be well spaced from the next dose. You should not take an extra dose at the time of the second dose as it will become a double dose. The double dose can give unwanted side effects, so be careful. In chronic conditions or when you have a serious health issue, if you miss a dose, you should inform your health care provider and ask his suggestion.

Call your doctor for instructions if you miss an appointment for your Hydrocortistab injection.


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References

  1. DailyMed. "CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE: 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).
  2. DrugBank. "hydrocortisone". http://www.drugbank.ca/drugs/DB00741 (accessed September 17, 2018).
  3. MeSH. "Anti-Inflammatory Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

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