Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Proper storage of Pehacort delayed-release tablets:
Store Pehacort delayed-release tablets at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Pehacort delayed-release tablets out of the reach of children and away from pets.
Overdose of Pehacort 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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The effects of accidental ingestion of large quantities of Pehacort over a very short period of time have not been reported, but prolonged use of the drug can produce mental symptoms, moon face, abnormal fat deposits, fluid retention, excessive appetite, weight gain, hypertrichosis, acne, striae, ecchymosis, increased sweating, pigmentation, dry scaly skin, thinning scalp hair, increased blood pressure, tachycardia, thrombophlebitis, decreased resistance to infection, negative nitrogen balance with delayed bone and wound healing, headache, weakness, menstrual disorders, accentuated menopausal symptoms, neuropathy, fractures, osteoporosis, peptic ulcer, decreased glucose tolerance, hypokalemia, and adrenal insufficiency. Hepatomegaly and abdominal distention have been observed in children.
Treatment of acute overdosage is by immediate gastric lavage or emesis followed by supportive and symptomatic therapy. For chronic overdosage in the face of severe disease requiring continuous steroid therapy the dosage of Pehacort may be reduced only temporarily, or alternate day treatment may be introduced.
What should I avoid while taking Pehacort?
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 a steroid.
Do not receive a "live" vaccine while using Pehacort. Pehacort may increase your risk of harmful effects from a live vaccine. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.
Avoid drinking alcohol while you are taking Pehacort.
Pehacort 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.
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In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated.
Corticosteroids may mask some signs of infection, and new infections may appear during their use. Infections with any pathogen including viral, bacterial, fungal, protozoan or helminthic infections, in any location of the body, may be associated with the use of corticosteroids alone or in combination With other immunosuppressive agents that affect cellular immunity, humoral immunity, or neutrophil function. There may be decreased resistance and inability to localize infection when corticosteroids are used. Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses.
Usage in pregnancy: Since adequate human reproduction studies have not been done with corticosteroids, the use of these drugs in pregnancy, nursing mothers or women of childbearing potential requires that the possible benefits of the drug be weighed against the potential hazards to the mother and embryo or fetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy, should be carefully observed for signs of hypoadrenalism.
Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in, large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids Increase calcium excretion.
Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered to patients receiving immunosuppressive doses of corticosteroids; however, the response to such vaccines may be diminished. Indicated immunization procedures may be undertaken in patients receiving nonimmunosuppressive doses of corticosteroids.
The use of Pehacort (Pehacort) Tablets in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate anti-tuberculous regimen.
If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.
Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chicken pox and measles, for example, can have a more serious or even fatal course in non-immune children or adults on corticosteroids. In such children or adults who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affects the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chicken pox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. If chicken pox develops, treatment with antiviral agents may be considered. Similarly, corticosteroids. should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia.
What should I discuss with my healthcare provider before taking Pehacort?
You should not use Pehacort if you are allergic to Pehacort, or if you have a fungal infection anywhere in your body.
Pehacort can weaken your immune system, making it easier for you to get an infection. Steroids can also worsen an infection you already have, or reactivate an infection you recently had. Before taking this medicine, tell your doctor about any illness or infection you have had within the past several weeks.
To make sure you can safely take Pehacort, tell your doctor if you have any of these other conditions:
liver disease (such as cirrhosis);
kidney disease;
a thyroid disorder;
diabetes;
a history of malaria;
tuberculosis;
osteoporosis;
a muscle disorder such as myasthenia gravis;
glaucoma or cataracts;
herpes infection of the eyes;
stomach ulcers, ulcerative colitis, or diverticulitis;
depression or mental illness;
congestive heart failure; or
high blood pressure
FDA pregnancy category D. Taking Pehacort during the first trimester of pregnancy can harm an unborn baby. Pehacort should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Pehacort can pass into breast milk and should only be used in nursing mothers when the benefit outweighs the risk.
Pehacort can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.
Pehacort 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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A Pehacort-based pharmacotherapy should only be given when absolutely necessary and should be accompanied by appropriate anti-infectious therapy in the presence of the following conditions: Acute viral infections (herpes zoster, herpes simplex, varicella, herpetic keratitis); HBsAg-positive chronic active hepatitis, approximately 8 weeks before and 2 weeks after immunization with live vaccines; systemic mycoses and parasitoses (eg, nematodes); poliomyelitis; lymphadenitis following BCG inoculation; acute and chronic bacterial infections; history of tuberculosis (caution: reactivation). Due to their immunosuppressive properties glucocorticoids can induce or aggravate infections. Such patients should be monitored carefully eg, by performing a tuberculin test. Patients at special risk should receive a tuberculostatic treatment.
In addition, a Pehacort-based pharmacotherapy should only be given when necessary and should be accompanied if required by appropriate therapy in the presence of the following conditions: Gastrointestinal ulcers; severe osteoporosis and osteomalacia; hypertension that is difficult to control; severe diabetes mellitus; psychiatric disorders (also if in patient's history); narrow- and wide-angle glaucoma; corneal ulcers and corneal injuries.
Because of the risk of intestinal perforation, Pehacort may only be used if absolutely necessary and with adequate monitoring in cases of: Severe ulcerative colitis with imminent perforation; diverticulitis; entero-anastomoses (immediately postoperative).
Pehacort modified-release tablets cannot achieve the desired blood concentration of Pehacort if taken under fasting conditions. Therefore, Pehacort modified-release tablets should always be taken with or after the evening meal in order to ensure sufficient efficacy. In addition, low plasma concentrations may occur in 6-7% of Pehacort modified-release tablets doses as observed across all pharmacokinetic studies and 11% in a single pharmacokinetic study when taken according to the recommendations. This should be considered if Pehacort modified-release tablets are not sufficiently effective. In these situations a switch to a conventional immediate-release formulation may be considered.
Pehacort should not be substituted by Pehacort immediate-release tablets in the same administration regime because of Pehacort's delayed release mechanism.
In case of substitution, termination or discontinuing prolonged treatment, the following risks must be considered: Recurrence of the rheumatoid arthritis disease activity, acute adrenal failure (especially in stressful situations, eg, during infections, after accidents, with increased physical strain), cortisone withdrawal syndrome.
Pehacort tablets should not be given as for acute indications instead of Pehacort immediate-release tablets due to its pharmacological properties.
During the use of Pehacort, a possibly increased need for insulin or oral antidiabetics should be considered. Patients with diabetes mellitus should therefore be treated under close monitoring.
During the treatment with Pehacort, regular blood pressure checks are required in patients with hypertension that is difficult to control.
Patients with severe cardiac insufficiency have to be closely monitored because of the risk of deterioration of the condition.
Sleep disorder is documented to occur more frequently with Pehacort than with conventional immediate-release formulations which are taken in the morning. If insomnia occurs and does not improve, a switch to a conventional immediate-release formulation may be advisable.
The treatment with Pehacort can also mask signs and symptoms of an existing or developing infection and thus may render diagnostic efforts more difficult.
Even with low doses, long-term use of Pehacort results in an increased risk of infection. These possible infections may also be brought about by microorganisms that rarely cause infection under normal circumstances (so-called opportunistic infections).
Certain viral diseases (varicella, measles) may take a more severe course in patients treated with glucocorticoids. Immunosuppressed individuals without prior varicella or measles infection are at particular risk. If such individuals, while being treated with Pehacort have contact with persons infected with varicella or measles, a preventive treatment should be initiated, if required.
Vaccinations with inactivated vaccines are generally possible. However, it has to be taken into account that the immune response and consequently the success of the vaccination may be impaired with higher doses of glucocorticoids.
In case of long-term therapy with Pehacort, regular medical follow-ups (including ophthalmologic examinations at 3-month intervals) are indicated; if comparatively high doses are given, sufficient supply of potassium supplements and restriction of sodium have to be ensured and serum potassium levels have to be monitored.
If during the treatment with Pehacort high levels of physical stress are caused by certain events (accidents, surgical procedure etc.), a temporary dose increase may become necessary.
Depending on the duration of the treatment and the dosage used, a negative impact on calcium metabolism must be expected. Osteoporosis prophylaxis is therefore recommended and is particularly important if other risk factors are present (including familial predisposition, advanced age, postmenopausal status, insufficient intake of protein and calcium, excessive smoking, excessive alcohol consumption, as well as reduced physical activity). The prophylaxis is based on a sufficient supply of calcium and vitamin D, as well as on physical activity. In case of preexisting osteoporosis, an additional therapy should be considered.
The medicinal product contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
When using high doses of prednisolone for an extended period of time (30 mg/day for a minimum of 4 weeks), reversible disturbances of spermatogenesis were observed that persisted for several months after discontinuation of the medicinal product.
Effects on Ability to Drive and Use Machines: No studies on the effects on the ability to drive and use machines have been performed.
Use in pregnancy & lactation: During pregnancy, Pehacort should only be used when the benefits outweigh the potential risks. The lowest effective dose of Pehacort needed to maintain adequate disease control should be used.
Animal studies indicate that administration of pharmacological doses of glucocorticoids during pregnancy may increase the foetus risk of intrauterine growth retardation, adult cardiovascular and/or metabolic disease and may have an effect on the glucocorticoid receptor density, and neurotransmitter turnover or neurobehavioural development.
Pehacort has caused cleft palate formation in animal experiments. There is an ongoing discussion on the possibility of an increased risk of oral cleft formation in the human foetus as a result of the administration of glucocorticoids during the first trimester.
If glucocorticoids are administered towards the end of pregnancy, there is a risk of atrophy of the foetal adrenal cortex, which may necessitate replacement therapy in the newborn, which has to be slowly reduced.
Glucocorticoids pass in small amounts into breast milk (up to 0.23% of an individual dose). For doses up to 10 mg daily, the amount taken via breast milk lies below the detection threshold. So far, no damage to infants has been reported. Nevertheless, glucocorticoids should only be prescribed when the benefits to mother and child outweigh the risks.
Because the milk/plasma concentration ratio increases with doses above 10 mg/day (eg, 25% of the serum concentration are found in the breast milk with Pehacort 80 mg daily), it is recommended to discontinue breastfeeding in such cases.
Use in children and adolescents: Because of insufficient data on tolerability and efficacy, the use in children and adolescents is not recommended.
What happens if I miss a dose of Pehacort?
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.
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
References
DailyMed. "PREDNISONE: 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).
