Valgesic 10 CT PHARMA replacement therapy to increase kidney production in children (6 blisters x 10 tablets)
Dosage form Box of 6 blisters x 10 tablets
Specifications Hydrocortisone
Ingredient
| Composition information | Content |
| Hydrocortisone | 10mg |
Uses
indications
Valgesic drugs indicated treatment in the following cases:
corticosteroid
ATC code: H02A B09
Hydrocortison is a glucocorticoid. Glucocorticoid is a steroid of the adrenal gland shell, produced naturally in the body or synthesized, easy to absorb through the gastrointestinal tract.
Hydrocortison is the main corticosteroid secreted from the adrenal shell. Natural glucocorticoid (hydrocortisone and cortison), salt -holding and is used for replacement treatment in adrenal hormone deficiency. They are used for strong anti -inflammatory effects when disorders of the body's organs. The glucocorticoids have a profound and diverse impact on the metabolic process. In addition, they change the body's immune response with various stimuli.
Pharmacokinetics
absorption
Hydrocortison is easily absorbed through the gastrointestinal tract and over 90% of the drug is linked to protein.
Distribution
Each hydrocortison is linked to two proteins. One is glycoprotein, the other is albumin.
Metabolism and elimination
Hydrocortison is metabolized in the liver and most of the body tissue into hydrogenation and metabolic substances such as tetrahydrocortison and tetrahydrocortisol are excreted in the urine, mainly in the form of glucuronid complex, along with a very small ratio of hydrocortison in constant form.
Hydrocortison's plasma semi -discharged time is about 1.5 hours.
Prelise Clinical Safety Data:
Use of corticosteroids for pregnant animals can cause abnormal developments in the fetus including cleft palate, uterine retardation, affecting the growth and development of the brain.
Before taking Valgesic 10 CT PHARMA replacement therapy to increase kidney production in children (6 blisters x 10 tablets)
How to use
oral tablets.
Dosage
Dosage must be adjusted according to the response of each patient.
alternative treatment
Children
In chronic adrenal failure, the dose is about 0.4 - 0.8 mg/kg/day divided into 2 or 3 times/day, adjusted according to the needs of each child.
In patients who need to be replaced, daily dose should be divided into twice. The first dose in the morning should be higher than the second dose in the evening, to imitate Cortisol's excretion in the body.
Used in serious injury in children with adrenal insufficiency or suspected adrenal shells limiting hormone secretion
Children
The dose is usually higher than when used in chronic adrenal failure and should be chosen to suit the clinical condition. Patients should be closely monitored to be able to adjust the appropriate dose, including clinical changes due to improvement or worse, response to each patient and the effects of stress (for example, surgery, infection, trauma). When stress may need temporary dose.
used before surgery
Anesthesia must be notified if the patient is taking corticosteroids or previously used corticosteroids.
When long -term treatment is stopped, the dose should gradually reduce the dose for several weeks or month, depending on the dose and the treatment time (see the warning and caution).
Unwanted effects can be minimized by using the lowest doses that are effective in the shortest possible time and use a single -time physiological dose single in the morning, or use one -time way in the morning. Need to monitor patients regularly for appropriate dosage titration.
Regularly check the patient to adjust the dose when necessary.
Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.
What to do when overdose?
Symptoms:
There is no typical antidote. Overdose can cause nausea and vomiting, retention of sodium and water, hyperglycemia and possibly gastrointestinal bleeding.
Management:
Symptomatic treatment, using cimetidine (200 - 400 mg intravenously every 6 hours) or ranitidine (50 mg of intravenous intravenous injection every 6 hours) can be used to prevent gastrointestinal bleeding.
In an emergency, call the 115 emergency center immediately or go to the nearest local health station.
What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.
Side Effects
The ratio of unwanted effects can be predicted, including the correlation between the inhibition of the hill - pituitary - the adrenal gland with the relative effect of the drug, the dose, the duration of use and the treatment time.
Special unwanted effects may occur when starting or increasing dose.
The unwanted effects are listed below by the organ system and the frequency are as follows:
blood disorders and lymphatic systems
2 common reactions and can occur in both adults and children. In adults, the frequency of severe reactions has been estimated at 5-6%. Psychological effects have been reported on corticosteroid stops.
Children
Inhibition of growth in infants, young children and adolescents, increased intracranial pressure with gai thi in children, often after treatment.
Symptoms of cessation
The reduction of corticosteroids too fast after prolonged treatment can lead to acute renal failure, lower blood pressure and death (see the warning and caution). The cessation syndrome may also occur including symptoms: fever, muscle pain, joint pain, rhinitis, conjunctivitis, itchy and weight loss skin.
Instructions on how to handle ADR
can minimize fake cushing syndrome and osteoporosis by carefully selecting steroid drugs, the program uses drugs a day or interrupted; Auxiliary therapy can be effective in the treatment of osteoporosis caused by steroids (calcium, vitamin D ..).
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
contraindicated
contraindicated Valgesic drug in the following cases:
Caution when using
Inhibition of adrenal glands
Atrophy of the adrenal shell occurs during prolonged treatment and can survive after stopping treatment for many years. When stopping corticosteroids after prolonged treatment, the dose should be reduced slowly to avoid acute adrenal insufficiency for a few weeks or months depending on the dose and treatment time. During the long -term treatment, if the disease recurs, injured or must be performed by surgery, it is necessary to increase the dosage temporarily. If the corticosteroids have been stopped after prolonged treatment, if necessary, it can still be taken back temporarily.
Patients should have detailed medical records when treating with corticosteroids for clear guidance on prevention measures to be taken to minimize risks and provide detailed information about prescriptions, drugs, dosage and treatment time.
Anti -inflammatory/immunosuppressive and infection effects
Inhibit inflammatory response and immune function increases infection sensitivity and increases severity. Clinical manifestations are usually not typical and serious infections such as blood and tuberculosis can be covered and can reach the stage of progression before being detected. New infections can appear during the use of the drug.
corticosteroids can activate amoeba dysentery or potential e -worm infection or make the disease worse. Therefore, it is necessary to treat the amoeba dysentery and potentially or active raw worms before starting corticosteroids in any patient who is at risk or symptoms that suggest one of the two diseases.
Be careful in immunodeficiency patients
Patients with chickenpox should be paid special attention because this disease can be fatal in patients with immunosuppressive. Patients (or parents of children using hydrocortison) without a history of chickenpox or not yet should avoid contact with people with chickenpox or herpes zoster. If exposed, you should look for emergency medical care. Varicella/zoster immunoglinoma (Varicella/Zoster Immunoglobulin - VZIG) to create passive immunity is necessary in patients with chickenpox exposure without immunity and are using generalized corticosteroids or used within the previous 3 months; Should be injected within 10 days after exposure to chickenpox. If the patient is diagnosed with chickenpox, an emergency treatment is needed. Corticosteroids should not be stopped in this case and may need to increase the dose.
Patients should be specially cared for to avoid contact with measles and need medical advice immediately if exposed to measles. Immunodefrusing prophylaxis may not be necessary to live a living vaccine for people with immunodeficiency due to high doses of Corticoste ROID. Dead vaccine can be used or reduced toxicity, although their effects may be impaired.
corticosteroids should be used in nephrotic ulcerative colon, which is likely to occur, abscess or other pus -causing bacterial infections; intestinal adhesion; Peptic ulcer works or hidden.
It is necessary to have special care when prescribing whole corticosteroids in patients with the following factors and regular monitoring of patients:
a) Osteoporosis (postmenopausal women are especially at risk);
b) Hypertension or congestive heart failure;
c) is suffering from serious emotional disorders or a history of emotional disorders (especially a history of steroid mental disorders);
d) Diabetes (or family history of diabetes);
e) History of tuberculosis or a characteristic sign on chest x-rays. However, the appearance of active labor is prevented by using preventive tuberculosis;
f) glaucoma (or family history of glaucoma);
g) muscle disease caused by corticosteroids;
h) Hepatic failure,
i) renal failure;
j) epilepsy;
k) Peptic ulcer;
l) New heart attack.
During treatment, patients should be monitored with psychotic reactions, weakness, map change, hypertension and the effectiveness of hormone treatment.
Corticosteroids should be used carefully in hypothyroidism patients.
Children
corticosteroids cause retardation in infants, young children and adolescents and may not recover. Treatment for children should be limited to the lowest doses in the shortest possible time.
Symptoms of cessation
In patients with body corticosteroid doses higher than the physiological level (about 30 mg of hydrocortison) for more than 3 weeks, do not stop the drug suddenly. Should assess whether the disease is likely to recur when reducing the body corticosteroids before deciding to reduce the dose. Assessing the clinical activity of the disease may be necessary during the dose cutting process. If the disease is not likely to recur when stopping the whole corticosteroid but not sure about the effect of inhibiting the hypothalamus - pituitary - adrenal (HPA), the body corticosteroid doses can quickly decrease in the physiological dosage. After reaching a dose of 30 mg of hydrocortison daily, a slower dose should be reduced for HPA to recover.
Stop corticosteroids after 3 weeks of treatment is suitable when the disease is not likely to recur. Discounts of up to 160 mg of hydrocortison for 3 weeks are unable to inhibit the HPA axis in most patients. In the group of patients below, it is advisable to gradually stop corticosteroids even when treatment for 3 weeks or less:
Patients and/or caregivers should be warned that serious mental harmful reactions may occur with systemic steroids (see unwanted effects). Symptoms usually appear within a few days or weeks after the beginning of treatment. The risk may be higher when using high doses of body effect. Although the dose is not predicting the onset of time, type, severity, most adverse reactions decrease after reducing the dose or stopping the drug, although it may need specific treatment. Patients/caregivers should be consulted if they are worried about psychological symptoms, especially when the mood is depressed or suspected of suicide.
It is necessary to have special care when considering the use of systemic corticosteroids for patients who are or have a history of serious emotional disorders or in relatives, including depression or manic and mental disorders due to the previous steroid.
visual disorders
visual disorders may be encountered when using systemic and topical corticosteroids. If the patient has symptoms of blurred vision or other visual disorders, it is advisable to examine the science to assess the cause may include cataracts, glaucoma or rare diseases such as the central retinopathy (CSCR) that has been reported after the use of systemic and topical corticosteroids.
Warnings
This drug contains lactose. Patients with rare genetic problems are galactose intolerance, lactase deficiency, or glucose-galactose, which should not be taken.
Use drugs for women during pregnancy and lactation
pregnancy
The ability to cross the placenta of corticosteroids varies between drugs, but cortison easily through the placenta fence.
The use of corticosteroids in pregnant animals can cause abnormalities during the development of the fetus including cleft palate, uterine retardation and impact on brain growth and development. There is no evidence that corticosteroids increase the incidence of congenital abnormalities, such as cleft palate/lips in humans.
However, when used for a long time or continuous use during pregnancy, corticosteroid may increase the risk of growth in the uterus. Theoretically, adrenal insufficiency can occur in newborns if before birth is exposed to corticosteroids but often runs out of birth itself and rarely shows serious clinical manifestations. Like other drugs, corticosteroids should only be prescribed when the benefits for mothers and children are greater than the risk. However, if you need to use corticosteroids, pregnant patients can be treated as normal people.
Breastfeeding period
Corticosteroids are excreted through breast milk, although there is no data for hydrocortison. Babies with mothers who take high doses of corticosteroids for a long time may have adrenal inhibitors at different levels. Mothers who are taking physiological corticosteroid dose should not breastfeed. Any mother's treatment should be carefully recorded in the medical records of babies to support monitoring.
Reproduction
Patients with adrenal impairment may be reduced, but there is no sign that hydrocortisone at the replacement dose will affect fertility.
The effect of the drug on driving and operating machinery
hydrocortison has a small impact on driving and operating machinery. Fatigue and dizziness have been reported.
The adrenal insufficiency is not treated and treated poorly can affect the ability to drive and use machinery.
Drug interaction
Some barbiturates (such as phenobarbital) and phenytoin, rifampicin, rifabutin, primidon,
carbamazepin and aminoglutethimid can increase metabolism and reduce the effects of corticosteroids.
Treatment along with CYP3A inhibitors, including products containing COBICISTAT, will increase the risk of unwanted body effects. Should not be used simultaneously unless the benefits are superior to the risk, in this case the patient needs to be monitored unwanted effects when using systemic corticosteroids.
Mifepriston may reduce the effect of corticosteroids in 3-4 days.
erythromycin and ketoconazole can inhibit corticosteroid metabolism.The single ketoconazole can inhibit the synthesis of adrenal corticosteroids and can cause adrenal failure when stopping corticosteroids.
Ritonavir may increase the concentration of hydrocortison in plasma.
estrogen and other oral contraceptives increase corticosteroid levels in plasma, and may need to adjust oral contraceptives or stop stable doses.
The effect of promoting somatropin growth may be inhibited when used simultaneously with corticosteroids.
The desired effect of hypoglycemic drugs (including insulin), antihypertensive drugs and diuretics are reduced by corticosteroids.
The effect of anticoagulant drugs can be affected when treated simultaneously with corticosteroids and need to closely monitor Inr or prothrombin time to avoid spontaneous bleeding.
Serum concentration of salicylate (such as aspirin and benorilate) may increase significantly if corticosteroid stops and can be toxic. Simultaneous use of Salicylate or nonsteroidal anti -inflammatory drugs (NSAID) with corticosteroids increases the risk of ulcer and gastrointestinal bleeding.
corticosteroids may increase the effect of hematoma of acetazolamid, diuretic, thiazid diuretic and carbenoxolon is enhanced by the signs of hypoglycemia, which should be monitored. The risk of hypokalemia increases when using theophylllin and amphotericin. Simultaneous use of amphotoicin with corticosteroids unless the amphotericin is needed to control the reactions.
The risk of increased hemorrhage if high doses of corticosteroids with high doses of sympathetic stimulants such as bambuterol, fenoterol, formoterol, ritodrin, salbutamol, salmeterol and terbutalin. The toxicity of cardiac glycosides such as digoxin increases when reducing blood potassium.
There is a risk of increased hematology when using corticosteroids with methotrexate.
Corticosteroid high dose reduces immune response, so avoid living vaccines.
Storage
Leave a cool place, avoid light, temperature below 30⁰C.
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