Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include chest pain; fast or irregular heartbeat; flushing; severe headache; shock.
Proper storage of Apresoline injection:
Apresoline injection is usually handled and stored by a health care provider. If you are using Apresoline injection at home, store Apresoline injection as directed by your pharmacist or health care provider. Keep Apresoline injection out of the reach of children and away from pets.
Overdose of Apresoline 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.
No deaths due to acute poisoning have been reported.
Highest known dose survived: adults, 10g orally.
Oral LD50 in rats: 173 and 187 mg/kg.
Signs and Symptoms
Signs and symptoms of overdosage include hypotension, tachycardia, head- ache, and generalized skin flushing.
Complications can include myocardial ischemia and subsequent myocardial infarction, cardiac arrhythmia, and profound shock.
There is no specific antidote.
The gastric contents should be evacuated, taking adequate precautions against aspiration and for protection of the airway. An activated charcoal slurry may be instilled if conditions permit. These manipulations may have to be omitted or carried out after cardiovascular status has been stabilized, since they might precipitate cardiac arrhythmias or increase the depth of shock.
Support of the cardiovascular system is of primary importance. Shock should be treated with plasma expanders. If possible, vasopressors should not be given, but if a vasopressor is required, care should be taken not to precipitate or aggravate cardiac arrhythmia. Tachycardia responds to beta blockers. Digitalization may be necessary, and renal function should be monitored and supported as required.
No experience has been reported with extracorporeal or peritoneal dialysis.
What should I avoid while taking Apresoline?
Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.
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.
In a few patients, Apresoline may produce a clinical picture simulating systemic lupus erythematosus including glomerulonephritis. In such patients, Apresoline should be discontinued unless the benefit-to-risk determination requires continued antihypertensive therapy with this drug. Symptoms and signs usually regress when the drug is discontinued but residua have been detected many years later. Long-term treatment with steroids may be necessary.
What should I discuss with my healthcare provider before taking Apresoline?
Some medical conditions may interact with Apresoline injection. 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 blood problems (eg, porphyria), blood vessel problems, heart problems, low blood pressure, low levels of vitamin B in your blood, kidney problems, or lupus
if you have a history of stroke
Some MEDICINES MAY INTERACT with Apresoline injection. Tell your health care provider if you are taking any other medicines, especially any of the following:
Medicines that may affect your blood vessels, medicines that treat high blood pressure (eg, diazoxide), or other vasodilators (eg, isosorbide, nitroglycerin) because they may increase the risk of Apresoline's side effects. Check with your doctor or pharmacist if you have questions about which medicines may affect your blood vessels.
Monoamine oxidase (MAO) inhibitors (eg, phenelzine) because the risk of serious side effects may be increased
Beta-blockers (eg, propranolol) because the risk of their side effects may be increased by Apresoline injection
Epinephrine because its effectiveness may be decreased by Apresoline injection
This may not be a complete list of all interactions that may occur. Ask your health care provider if Apresoline 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.
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.
Myocardial stimulation produced by Apresoline (Apresoline) can cause anginal attacks and ECG changes of myocardial ischemia. The drug has been implicated in the production of myocardial infarction. It must, therefore, be used with caution in patients with suspected coronary artery disease.
The “hyperdynamic" circulation caused by Apresoline (Apresoline) may accentuate specific cardiovascular inadequacies. For example, Apresoline (Apresoline) may increase pulmonary artery pressure in patients with mitral valvular disease. The drug may reduce the pressor responses to epinephrine. Postural hypotension may result from Apresoline (Apresoline) but is less common than with ganglionic blocking agents. It should be used with caution in patients with cerebral vascular accidents.
In hypertensive patients with normal kidneys who are treated with Apresoline (Apresoline), there is evidence of increased renal blood flow and a maintenance of glomerular filtration rate. In some instances where control values were below normal, improved renal function has been noted after administration of Apresoline (Apresoline). However, as with any antihypertensive agent, Apresoline (Apresoline) should be used with caution in patients with advanced renal damage.
Peripheral neuritis, evidenced by paresthesia, numbness, and tingling, has been observed. Published evidence suggests an antipyridoxine effect, and that pyridoxine should be added to the regimen if symptoms develop. The Apresoline (Apresoline) tablets (100 mg) contain FD&C Yellow No. 5 (tartrazine), which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who are also hypersensitive to aspirin.
Information for Patients
Patients should be informed of possible side effects and advised to take the medication regularly and continuously as directed.
Complete blood counts and antinuclear antibody titer determinations are indicated before and periodically during prolonged therapy with Apresoline even though the patient is asymptomatic. These studies are also indicated if the patient develops arthralgia, fever, chest pain, continued malaise, or other unexplained signs or symptoms.
A positive antinuclear antibody titer requires that the physician carefully weigh the implications of the test results against the benefits to be derived from antihypertensive therapy with Apresoline.
Blood dyscrasias, consisting of reduction in hemoglobin and red cell count, leukopenia, agranulocytosis, and purpura, have been reported. If such abnormalities develop, therapy should be discontinued.
MAO inhibitors should be used with caution in patients receiving Apresoline.
When other potent parental antihypertensive drugs, such as diazoxide, are used in combination with Apresoline, patients should be continuously observed for several hours for any excessive fall in blood pressure. Profound hypotensive episodes may occur when diazoxide infection and Apresoline (Apresoline) are used concomitantly.
Administration of Apresoline with food results in higher plasma levels.
Carcinogenesis, Mutagenesis, Impairment of Fertility
In a lifetime study in Swiss albino mice, there was a statistically significant increase in the incidence of lung tumors (adenomas and adenocarcinomas) of both male and female mice given Apresoline continuously in their drinking water at a dosage of about 250 mg/kg per day (about 80 times the maximum recommended human dose). In a P-year carcinogenicity study of rats given Apresoline by lavage at dose levels of 15, 30, and 60 mg/kg/day (approximately 5 to 20 times the recommended human daily dosage), microscopic examination of the liver revealed a small, but statistically significant, increase in benign neoplastic nodules in male and female rats from the high-dose group and in female rats from the intermediate-dose group. Benign interstitial cell tumors of the testes were also significantly increased in male rats from the high-dose group. The tumors observed are common in aged rats and a significantly increased incidence was not observed until 18 months of treatment. Apresoline was shown to be mutagenic in bacterial systems (Gene Mutation and DNA Repair) and in one of two rat and one rabbit hepatocyte in vitro DNA repair studies. Additional in vim and in vitro studies using lymphoma cells, germinal cells, and fibroblasts from mice, bone marrow cells from Chinese hamsters and fibroblasts from human cell lines did not demonstrate any mutagenic potential for Apresoline.
The extent to which these findings indicate a risk to man is uncertain. While long-term clinical observation has not suggested that human cancer is associated with Apresoline use, epidemiologic studies have so far been insufficient to arrive at any conclusions.
Pregnancy Category C
Animal studies indicate that Apresoline is teratogenic in mice at 20 to 30 times the maximum daily human dose of 200 to 300 mg and possibly in rabbits at 10 to 15 times the maximum daily human dose, but that it is nonteratogenic in rats. Teratogenic effects observed were cleft palate and malformations of facial and cranial bones.
There are no adequate and well-controlled studies in pregnant women. Although clinical experience does not include any positive evidence of adverse effects on the human fetus, Apresoline should be used during pregnancy only if the expected benefit justifies the potential risk to the fetus.
Apresoline has been shown to be excreted in breast milk.
Safety and effectiveness in pediatric patients have not been established in controlled clinical trials, although there is experience with the use of Apresoline (Apresoline) in these patients. The usual recommended oral starting dosage is 0.75 mg/kg of body weight daily in four divided doses. Dosage may be increased gradually over the next 3-4 weeks to a maximum of 7.5 mg/kg or 200 mg daily.
What happens if I miss a dose of Apresoline?
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. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.
NITE-CMC. "Hydralazine: The chemical classification in this section was conducted by the Chemical Management Center (CMC) of Japan National Institute of Technology and Evaluation (NITE) in accordance with GHS Classification Guidance for the Japanese Government, and is intended to provide a reference for preparing GHS labelling and SDS for users.". http://www.safe.nite.go.jp/english/g... (accessed September 17, 2018).
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