Seek emergency medical attention if you think you have used too much of this medicine.
The first signs of an Hapacol overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.
Overdose of Hapacol 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.
Hapacol in massive overdosage may cause hepatic toxicity in some patients. In adults and children >12 years, hepatic toxicity may occur following ingestion of >7.5-10 g over a period of ≤8 hrs. Fatalities are infrequent (<3-4% of untreated cases) and have rarely been reported with overdoses of <15 g. In children <12 years, acute overdosage with Hapacol <150 mg/kg body weight have not been associated with hepatic toxicity. Early symptoms following a potentially hepatotoxic overdose may include: Nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48-72 hrs after ingestion. In adults and children >12 years, any individual presenting with an unknown amount of Hapacol ingested or with a questionable or unreliable history about the time of ingestion should have a plasma Hapacol level drawn and be treated with N-acetylcysteine. Do not await results of assays for plasma Hapacol levels before initiating treatment with N-acetylcysteine. The following additional procedures are recommended. Promptly initiate decontamination of the stomach. A plasma Hapacol assay should be obtained as early as possible, but not sooner than 4 hrs following ingestion. Liver function studies should be obtained initially and repeated at 24-hr intervals.
Serious toxicity or fatalities have been extremely infrequent following acute overdosage in young children, possibly because of differences in the way they metabolize Hapacol. In children, the maximum potential amount ingested can be more easily estimated. If >150 mg/kg or an unknown amount of Hapacol was ingested, obtain a plasma Hapacol level as soon as possible but no sooner than 4 hrs following ingestion. If an assay cannot be obtained and the estimated Hapacol ingestion exceeds 150 mg/kg, dosing with N-acetylcysteine should be initiated and continued for a full course of therapy.
What should I avoid while taking Hapacol?
Do not use any other over-the-counter cough, cold, allergy, or pain medication without first asking your doctor or pharmacist. Hapacol is contained in many combination medicines. If you use certain products together you may accidentally use too much Hapacol. Read the label of any other medicine you are using to see if it contains Paracetamol, acetaminophen or APAP. Avoid drinking alcohol while taking this medication. Alcohol may increase your risk of liver damage while taking Hapacol.
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.
New Prescribed Uses of Hapacol: Questions and Answers
October 20, 1998 - U.S. Food and Drug Administration
Q. What professional uses of aspirin are now indicated?
1) STROKES: Hapacol use is now recommended in both men and women to treat mini-strokes (transient ischemic attack --TIA) or ischemic stroke to prevent subsequent cardiovascular events or death.
2) HEART ATTACKS:
reduces the risk of death in patients with suspected acute heart attacks (myocardial infarctions)
prevents recurrent heart attacks and
reduces the risk of heart attacks or sudden death in patients with unstable and chronic stable angina pectoris (chest pain).
3) OTHER CORONARY CONDITIONS: Hapacol can be used to treat patients who have had certain revascularization procedures such as angioplasty, and coronary bypass operations -- if they have a vascular condition for which aspirin is already indicated.
4) RHEUMATOLOGIC DISEASES -- Hapacol is indicated for relief of the signs and symptoms of rheumatoid arthritis, juvenile rheumatoid arthritis, osteoarthritis, spondylarthropathies, and arthritis and pleurisy associated with systemic lupus erythematosus.
Q. What does this mean for doctors and medical practice?
A. Doctors and health care professionals will be provided with full prescribing information about the use of aspirin in both men and women who have had a heart attack, stroke, certain other cardiovascular conditions and rheumatologic diseases. For stroke and cardiovascular conditions, lower doses are recommended than those previously prescribed by physicians in practice. Information on the use of aspirin for rheumatologic diseases has also been expanded to include specific dosing information as well as information about side effects and toxicity. Thus, doctors will have full prescribing information on aspirin and the assurance that aspirin is a safe and effective treatment for heart attacks, strokes, certain other vascular conditions and rheumatologic diseases.
Q. What is the basis for the new prescribing information?
A. The new information on the uses of aspirin is based on scientific studies that support treatment with aspirin for heart attacks, strokes, and some related conditions. Convincing data support these uses in lower doses than previously believed to be effective in treating heart attacks and strokes in both men and women.
Q. What does this mean for patients?
A. Physicians will be better able to prescribe the proper doses for these uses for male and female patients with these medical conditions. Dose-related adverse events for patients with stroke and cardiovascular conditions should be minimized because lower dosages are recommended. The full prescribing information now provided for physicians who treat rheumatologic diseases will enhance the safe and effective prescribing of aspirin to these patients as well.
Q. Is FDA concerned that some patients may self-treat?
A. FDA emphasizes that consumers should not self-medicate for these serious conditions because it is very important to make sure that aspirin is their best treatment. In these conditions, the risk and benefit of each available treatment for each patient must be carefully weighed. Patients with these conditions should be under the care and supervision of a doctor.
Q. If a consumer is interested in using aspirin to prevent or treat symptoms of heart problems, what should he or she do?
A. Consumers should always first ask their doctor. In fact, aspirin products are labeled this way: "Important: See your doctor before taking this product for other new uses of aspirin because serious side effects could occur with self treatment."
Q. Do the data on treatment or prevention of cardiovascular effects pertain only to aspirin?
A. Yes. Although acetaminophen, ibuprofen, naproxyn sodium and ketoprofen are good drugs for pain and fever, as is aspirin, only aspirin has demonstrated a beneficial effect for heart attack and stroke.
Q. What should consumers be made aware of?
A. Consumers should be informed that these new professional uses of aspirin may be lifesaving when used upon the recommendation and under the supervision of a doctor. However, they must also be informed that even familiar and readily available products like aspirin may have important risks when used in new ways. For example, because aspirin can cause bleeding; in rare cases bleeding in the brain may occur in people who are using aspirin to prevent stroke. Therefore these new uses should be recommended and monitored by a physician.
Q. What should consumers who are taking low dose aspirin for disease maintenance or prevention know about alcohol use?
A. Patients who consume 3 or more alcoholic drinks every day should be counseled about the bleeding risks involved with chronic, heavy alcohol use while taking aspirin.
Q. Can consumers safely use aspirin to treat suspected acute heart attacks?
A. If consumers suspect they are having a heart attack, their most important action must be to seek emergency medical care immediately. The advise and supervision of a doctor should direct this use of aspirin and patients are encouraged to speak with their doctor about this use.
Q. What do we know about how aspirin works for heart conditions and stroke?
A. The mechanism by which aspirin works in the treatment of heart attack and stroke is not completely understood. However, as an antiplatelet drug, we do know that aspirin help reduce platelet clumping which helps cause blockage in blood vessels.
Q. Who should NOT take aspirin?
A. Generally, people who have:
allergy to aspirin or other salicylates
uncontrolled high blood pressure
severe liver or kidney disease
Always check first with your doctor to determine whether the benefit of these professional uses of aspirin is greater than the risks to you.
Q. What other side effects are associated with aspirin?
A. There is a wide range of adverse reactions that may result from aspirin use including effects on the body as a whole, or on specific body systems and functions.
High doses can cause hearing loss or tinnitus-- ringing in the ears. (Note that this usually only occurs with large doses as prescribed in rheumatologic diseases and is rare in treatment with low doses used for cardiovascular purposes.)
Q. What is key message for Consumers?
A. The results of studies of people with a history of coronary artery disease and those in the immediate phases of a heart attack have proven to be of tremendous importance in the prevention and treatment of cardiovascular and cerebrovascular diseases.
Studies showed that aspirin substantially reduces the risk of death and/ or non-fatal heart attacks in patients with a previous MI or unstable angina pectoris which often occur before a heart attack. Patients with these conditions should be under the care and supervision of a doctor.
Hapacol has potential risks as well as benefits, like any drug. Patients should be careful to ask their doctor or health care professional before deciding whether aspirin is right for them and how much aspirin they should take.
Q. What were the major studies used to verify the effectiveness of aspirin for these indications?
A. Numerous studies both in the United States and abroad were evaluated to establish the safety and efficacy of aspirin for the cardiovascular and cerebrovascular indications and dosing information.
Major studies included:
ISIS - 2 (Second International Study of Infarct Survival) (Ref 7)
W.S. Fields et al., Controlled Trial of Hapacol in Cerebral Ischemia (Ref 10)
* Note the reference numbers refer to the citations in the Final Rule. (Food and Drug Administration. Internal analgesic, antipyretic, and antirheumatic drug products for over the counter human use; final rule for professional labeling of aspirin, buffered aspirin, and aspirin in combination with antacid drug products. Federal Register. October 23, 1998; 63:56802-56819.)
What should I discuss with my healthcare provider before taking Hapacol?
Do not use this medication if you are allergic to acetaminophen or Hapacol.
Ask a doctor or pharmacist if it is safe for you to take Hapacol if you have:
liver disease; or
a history of alcoholism;
It is not known whether Hapacol will harm an unborn baby. Before using Hapacol, tell your doctor if you are pregnant. This medication can pass into breast milk and may harm a nursing baby. Do not use Hapacol without telling your doctor if you are breast-feeding a baby.
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.
Care is advised in the administration of Hapacol to patients with severe renal or severe hepatic impairment. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.
Do not take more medicine than the label instructed. If the patient did not get better, talk to the physician.
Do not take anything else containing Hapacol while taking Hapacol.
Inform the physician at once if the patient take too much of Hapacol, even if the patient feel well. This is because too much Hapacol can cause delayed, serious liver damage.
Patients should be advised that Hapacol may cause severe skin reactions. If a skin reaction eg, skin reddening, blisters or rash occurs, they should stop use and seek medical assistance right away.
Use in pregnancy & lactation: Epidemiological studies in human pregnancy have shown no ill effects due to Hapacol used in the recommended dosage, but patients should follow the advice of the physician regarding its use. Hapacol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breastfeeding.
What happens if I miss a dose of Hapacol?
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.
Since Hapacol is often used only when 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. If it is almost time for your next regularly scheduled dose, skip the missed dose and use your next dose as directed. Do not use extra medicine to make up for a missed dose.
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Information checked by Dr. Sachin Kumar, MD Pharmacology