Did you have any side effects with this medicine?
What happens if I overdose Hydrocortison-Rotexmedica?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately.
Proper storage of Hydrocortison-Rotexmedica solution:
Hydrocortison-Rotexmedica solution is usually handled and stored by a health care provider. If you are using Hydrocortison-Rotexmedica solution at home, store Hydrocortison-Rotexmedica solution as directed by your pharmacist or health care provider. Keep Hydrocortison-Rotexmedica solution out of the reach of children and away from pets.
Overdose of Hydrocortison-Rotexmedica in details
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 Hydrocortison-Rotexmedica in female mice was 1740 mg/kg.
What should I avoid while taking Hydrocortison-Rotexmedica?
Do not use aloe polysaccharides, Hydrocortison-Rotexmedica, and iodoquinol for any condition that has not been checked by a doctor.
Avoid getting this medication in your eyes. If this does happen, rinse with water.
Avoid getting this medication in your nose, mouth, rectum, or vagina. If this does happen, rinse with water.
Avoid getting the medication on your hair or clothing. Aloe polysaccharides, Hydrocortison-Rotexmedica, and iodoquinol topical may stain these surfaces.
Avoid using other medications on the areas you treat with aloe polysaccharides, Hydrocortison-Rotexmedica, and iodoquinol topical unless your doctor tells you to.
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 Hydrocortison-Rotexmedica in 48-72 hours and the need for more long-term therapy should be replaced by Hydrocortison-Rotexmedica at different glucocorticoid preparation does not cause sodium retention in the body. During treatment with Hydrocortison-Rotexmedica Micronised Xepa-Soul Pattinson should appoint a diet with restriction of sodium and high potassium content. Hydrocortison-Rotexmedica 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 Hydrocortison-Rotexmedica 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 Hydrocortison-Rotexmedica?
Some medical conditions may interact with Hydrocortison-Rotexmedica enema. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a weakened immune system; a parasitic, bacterial, fungal, or viral infection; heart failure; diabetes; diarrhea; swelling of the esophagus; stomach problems; blockage of the bowel or other bowel problems; abnormal blood electrolyte (eg, potassium, sodium) levels; measles; tuberculosis (TB); chickenpox; shingles; or herpes infection of the eye; or if you have received a recent vaccination
- if you have a history of glaucoma, cataracts, or other eye problems; high blood pressure; weak bones; heart attack; ulcers; kidney problems; liver problems (eg, cirrhosis); underactive thyroid; nerve problems (eg, myasthenia gravis); or a positive TB skin test
Some MEDICINES MAY INTERACT with Hydrocortison-Rotexmedica enema. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Aprepitant, clarithromycin, or hormonal contraceptives (eg, birth control pills) because they may increase the risk of Hydrocortison-Rotexmedica enema's side effects
- Barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), or rifampin because they may decrease Hydrocortison-Rotexmedica enema's effectiveness
- Anticoagulants (eg, warfarin), ritodrine, or smallpox vaccine because the risk of their side effects may be increased by Hydrocortison-Rotexmedica enema
- Interleukin-2 or mifepristone because their effectiveness may be decreased by Hydrocortison-Rotexmedica enema
This may not be a complete list of all interactions that may occur. Ask your health care provider if Hydrocortison-Rotexmedica 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.
Hypothalamic-pituitary-adrenal (HPA) Axis Suppression
Systemic effects of topical corticosteroids may include reversible HPA axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria.
Studies conducted in pediatric subjects demonstrated reversible HPA axis suppression after use of Hydrocortison-Rotexmedica (Hydrocortison-Rotexmedica butyrate). Pediatric patients may be more susceptible than adults to systemic toxicity from equivalent doses of Hydrocortison-Rotexmedica (Hydrocortison-Rotexmedica butyrate) due to their larger skin surface-to-body-mass ratios.
Patients applying a topical corticosteroid to a large surface area or to areas under occlusion should be considered for periodic evaluation of the HPA axis. This may be done by using cosyntropin (ACTH1-24) stimulation testing (CST).
If HPA axis suppression is noted, the frequency of application should be reduced or the drug should be withdrawn, or a less potent corticosteroid should be substituted. Signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids.
Concomitant Skin Infections
If skin infections are present or develop, an appropriate antifungal, antibacterial or antiviral agent should be used. If a favorable response does not occur promptly, use of Hydrocortison-Rotexmedica (Hydrocortison-Rotexmedica butyrate) should be discontinued until the infection has been adequately controlled.
Hydrocortison-Rotexmedica (Hydrocortison-Rotexmedica butyrate) may cause local skin adverse reactions.
If irritation develops, Hydrocortison-Rotexmedica (Hydrocortison-Rotexmedica butyrate) should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noticing a clinical exacerbation. Such an observation should be corroborated with appropriate patch testing.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No studies were conducted to determine the photoco-carcinogenic or dermal carcinogenic potential of Hydrocortison-Rotexmedica.
Hydrocortison-Rotexmedica butyrate revealed no evidence of mutagenic or clastogenic potential based on the results of two in vitro genotoxicity tests (Ames test and L5178Y/TK+ mouse lymphoma assay) and one in vivo genotoxicity test (mouse micronucleus assay).
No evidence of impairment of fertility or effect on mating performance was observed in a fertility and general reproductive performance study conducted in male and female rats at subcutaneous doses up to and including 1.8 mg/kg/day (0.7X MTHD). Mild effects on maternal animals, such as reduced food consumption and a subsequent reduction in body weight gain, were seen at doses ≥ 0.6 mg/kg/day (0.2X MTHD).
Use In Specific Populations
Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Therefore, Hydrocortison-Rotexmedica (Hydrocortison-Rotexmedica butyrate) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 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.
Note: The animal multiples of human exposure calculations in this label were based on body surface area comparisons for an adult (i.e., mg/m²/day dose comparisons) assuming 100% human percutaneous absorption of a maximum topical human dose (MTHD) for Hydrocortison-Rotexmedica butyrate cream (25 g).
Systemic embryofetal development studies were conducted in rats and rabbits. Subcutaneous doses of 0.6, 1.8 and 5.4 mg/kg/day Hydrocortison-Rotexmedica butyrate were administered to pregnant female rats during gestation days 6 – 17. In the presence of maternal toxicity, fetal effects noted at 5.4 mg/kg/day (2X MTHD) included an increased incidence of ossification variations and unossified sternebra. No treatment related effects on embryofetal toxicity or teratogenicity were noted at doses of 5.4 mg/kg/day and 1.8 mg/kg/day, respectively (2X MTHD and 0.7X MTHD, respectively).
Subcutaneous doses of 0.1, 0.2 and 0.3 mg/kg/day Hydrocortison-Rotexmedica butyrate were administered to pregnant female rabbits during gestation days 7 – 20. An increased incidence of abortion was noted at 0.3 mg/kg/day (0.2X MTHD). In the absence of maternal toxicity, a dose dependent decrease in fetal body weight was noted at doses ≥ 0.1 mg/kg/day (0.1X MTHD). Additional indicators of embyrofetal toxicity (reduction in litter size, decreased number of viable fetuses, increased post-implantation loss) were noted at doses ≥ 0.2 mg/kg/day (0.2X MTHD). Additional fetal effects noted in this study included delayed ossification noted at doses ≥ 0.1 mg/kg/day and an increased incidence of fetal malformations (primarily skeletal malformations) noted at doses ≥ 0.2 mg/kg/day. A dose at which no treatment related effects on embryofetal toxicity or teratogenicity were observed was not established in this study.
Additional systemic embryofetal development studies were conducted in rats and mice. Subcutaneous doses of 0.1 and 9 mg/kg/day Hydrocortison-Rotexmedica butyrate were administered to pregnant female rats during gestation days 9 – 15. In the presence of maternal toxicity, an increase in fetal deaths and fetal resorptions and an increase in the number of ossifications in caudal vertebrae were noted at a dose of 9 mg/kg/day (3X MTHD). No treatment related effects on embryofetal toxicity or teratogenicity were noted at 0.1 mg/kg/day (0.1X MTHD).
Subcutaneous doses of 0.2 and 1 mg/kg/day Hydrocortison-Rotexmedica butyrate were administered to pregnant female mice during gestation days 7 – 13. In the absence of maternal toxicity, an increased number of cervical ribs and one fetus with clubbed legs were noted at a dose of 1 mg/kg/day (0.2X MTHD). No treatment related effects on embryofetal toxicity or teratogenicity were noted at doses of 1 and 0.2 mg/kg/day, respectively (0.2X MTHD and 0.1X MTHD, respectively).
No topical embryofetal development studies were conducted with Hydrocortison-Rotexmedica butyrate cream. However, topical embryofetal development studies were conducted in rats and rabbits with a Hydrocortison-Rotexmedica butyrate ointment formulation.
Topical doses of 1% and 10% Hydrocortison-Rotexmedica butyrate ointment were administered to pregnant female rats during gestation days 6 – 15 or pregnant female rabbits during gestation days 6 – 18. A dose-dependent increase in fetal resorptions was noted in rabbits (0.2 – 2X MTHD) and fetal resorptions were noted in rats at the 10% Hydrocortison-Rotexmedica butyrate ointment dose (80X MTHD). No treatment related effects on embyrofetal toxicity were noted at the 1% Hydrocortison-Rotexmedica butyrate ointment dose in rats (8 MTHD). A dose at which no treatment related effects on embryofetal toxicity were observed in rabbits after topical administration of Hydrocortison-Rotexmedica butyrate ointment was not established in this study. No treatment related effects on teratogenicity were noted at a dose of 10% Hydrocortison-Rotexmedica butyrate ointment in rats or rabbits (80X MTHD and 2X MTHD, respectively).
A peri- and post-natal development study was conducted in rats. Subcutaneous doses of 0.6, 1.8 and 5.4 mg/kg/day Hydrocortison-Rotexmedica butyrate were administered to pregnant female rats from gestation day 6 – lactation day 20. In the presence of maternal toxicity, a dose dependent decrease in fetal weight was noted at doses ≥ 1.8 mg/kg/day (0.7X MTHD). No treatment related effects on fetal toxicity were noted at 0.6 mg/kg/day (0.2X MTHD). A delay in sexual maturation was noted at 5.4 mg/kg/day (2X MTHD). No treatment related effects on sexual maturation were noted at 1.8 mg/kg/day. No treatment related effects on behavioral development or subsequent reproductive performance were noted at 5.4 mg/kg/day.
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 Hydrocortison-Rotexmedica (Hydrocortison-Rotexmedica butyrate) is administered to a nursing woman.
Safety and efficacy in pediatric patients below 3 months of age have not been established.
Because of higher skin surface-to-body-mass ratios, pediatric patients are at a greater risk than adults of HPA axis suppression when they are treated with topical corticosteroids. They are therefore also at a greater risk of glucocorticosteroid insufficiency after withdrawal of treatment and of Cushing's syndrome while on treatment.
Eighty-six (86) pediatric subjects (between 5 months and 18 years of age) with moderate to severe atopic dermatitis affecting at least 25% of body surface area (BSA) treated with Hydrocortison-Rotexmedica (Hydrocortison-Rotexmedica butyrate) three times daily for up to 4 weeks were assessed for HPA axis suppression in two separate studies. The disease severity (moderate to severe atopic dermatitis) and the dosing regimen (three times daily) in these HPA axis studies were different from the subject population (mild to moderate atopic dermatitis) and the dosing regimen (two times daily) for which Hydrocortison-Rotexmedica (Hydrocortison-Rotexmedica butyrate) is indicated in this population. Five of the 82 evaluable subjects (6.1%) demonstrated evidence of suppression, where the criterion for defining HPA axis suppression was a serum cortisol level of less than or equal to 18 micrograms per deciliter after cosyntropin stimulation. Suppressed subjects ranged in age from 5 months to 16 years and, at the time of enrollment, had 25% to 95% BSA involvement. These subjects did not demonstrate any clinical signs or symptoms despite evidence of HPA axis suppression. At the first follow up visit, approximately one month after the conclusion of treatment, cosyntropin stimulation results of all subjects had returned to normal, with the exception of one subject. This last subject recovered adrenal function by 65 days post-treatment.
Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have also been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients include low plasma cortisol levels to an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
Clinical studies of Hydrocortison-Rotexmedica (Hydrocortison-Rotexmedica butyrate) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
What happens if I miss a dose of Hydrocortison-Rotexmedica?
Since this medication is used as needed, you may not be on a dosing schedule. If you are using the medication regularly, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.
- 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).
- DrugBank. "hydrocortisone". http://www.drugbank.ca/drugs/DB00741 (accessed September 17, 2018).
- MeSH. "Anti-Inflammatory Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
There are no reviews yet. Be the first to write one!
Information checked by Dr. Sachin Kumar, MD Pharmacology