Sumamed Overdose

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Did you have any side effects with this medicine?

What happens if I overdose Sumamed?

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately.

Proper storage of Sumamed drops:

Store unopened bottles of Sumamed drops in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Once the bottle is opened, it may be stored in the refrigerator or at room temperature below 77 degrees F (25 degrees C). Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Throw away any unused medicine after the bottle has been open for 14 days. Keep Sumamed drops out of the reach of children and away from pets.

Overdose of Sumamed 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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There are no data available on overdosage with Sumamed. Typical symptoms of overdosage with macrolide antibiotic include hearing loss, severe nausea, vomiting and diarrhea. In case of overdosage, gastric lavage and general supportive measures are indicated.

What should I avoid while taking Sumamed?

Do not take antacids that contain aluminum or magnesium within 2 hours before or after you take Sumamed. This includes Acid Gone, Aldroxicon, Alternagel, Di-Gel, Gaviscon, Gelusil, Genaton, Maalox, Maldroxal, Milk of Magnesia, Mintox, Mylagen, Mylanta, Pepcid Complete, Rolaids, Rulox, and others. These antacids can make Sumamed less effective when taken at the same time.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking Sumamed and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Avoid exposure to sunlight or tanning beds. Sumamed can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Sumamed 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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Allergic and Skin Reactions

​Serious allergic reactions, including angioedema, anaphylaxis, Stevens Johnson syndrome, toxic epidermal necrolysis, and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have been reported in patients on Sumamed therapy using other formulations. Fatalities have been reported. Despite initially successful symptomatic treatment of the allergic symptoms, when symptomatic therapy was discontinued, the allergic symptoms recurred soon thereafter in some patients without further Sumamed exposure. These patients required prolonged periods of observation and symptomatic treatment. The relationship of these episodes to the long tissue half-life of Sumamed and subsequent exposure to antigen has not been determined.

If an allergic reaction occurs, appropriate therapy should be instituted. Physicians should be aware that reappearance of the allergic symptoms may occur when symptomatic therapy is discontinued.

Hepatotoxicity

Abnormal liver function, hepatitis, cholestatic jaundice, hepatic necrosis, and hepatic failure have been reported, some of which have resulted in death. Discontinue Sumamed immediately if signs and symptoms of hepatitis occur.

QT Prolongation

Prolonged cardiac repolarization and QT interval, imparting a risk of developing cardiac arrhythmia and torsades de pointes, have been seen in treatment with macrolides, including Sumamed. Cases of torsades de pointes have been spontaneously reported during postmarketing surveillance in patients receiving Sumamed. Providers should consider the risk of QT prolongation which can be fatal when weighing the risks and benefits of Sumamed for at-risk groups including:

  • patients with known prolongation of the QT interval, a history of torsades de pointes, congenital long QT syndrome, bradyarrhythmias or uncompensated heart failure
  • patients on drugs known to prolong the QT interval
  • patients with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia, and in patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents

Elderly patients may be more susceptible to drug-associated effects on the QT interval.

Clostridium difficile-Associated Diarrhea (CDAD)

Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Sumamed, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Exacerbation of Myasthenia Gravis

Exacerbation of symptoms of myasthenia gravis and new onset of myasthenic syndrome have been reported in patients receiving Sumamed therapy.

Gastrointestinal Disturbances

A higher incidence of gastrointestinal adverse events (8 of 19 subjects) was observed when Sumamed was administered to a limited number of subjects with GFR<10 mL/min.

Development of Drug Resistant Bacteria

Prescribing Sumamed in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

What should I discuss with my healthcare provider before taking Sumamed?

Some medical conditions may interact with Sumamed single-dose packet. 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 liver or kidney problems, a slow or irregular heartbeat, or myasthenia gravis
  • if you have a history of low blood potassium or magnesium levels
  • if you are taking any medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat

Some MEDICINES MAY INTERACT with Sumamed single-dose packet. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Many other prescription and nonprescription medicines (eg, used for allergies, blood thinning, cancer, depression or other mental or mood problems, heartburn, infections, involuntary movements, irregular heartbeat or other heart problems, narcotic addiction, nausea and vomiting, pain, Tourette disorder), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, St. John's wort) may interact with Sumamed single-dose packet. Ask your doctor or pharmacist if you are unsure if any of your medicines might interact with Sumamed single-dose packet

This may not be a complete list of all interactions that may occur. Ask your health care provider if Sumamed single-dose packet 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.

Sumamed 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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As with erythromycin and other macrolides, rare serious allergic reactions including angioedema and anaphylaxis (rarely fatal), have been reported. Some of these reactions with Sumamed have resulted in recurrent symptoms, and required a longer period of observation and treatment. Since liver is the principal route of elimination for Sumamed, the use of Sumamed should be undertaken with caution in patients with significant hepatic diseases. In patients receiving ergot derivatives, ergotism has been precipitated by co-administration of some macrolide antibiotics. There are no data concerning the possibility of an interaction between ergot and Sumamed. However, because of the theoretical possibility of ergotism, Sumamed and ergot derivatives should not be co-administered. As with any antibiotics preparation, observation for signs of superinfection with nonsusceptible organisms, including fungi is recommended. Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents including Sumamed and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. It produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents. In patients with severe renal impairment (GFR <10 mL/min), a 33% increase in systemic exposure to Sumamed was observed. Prolonged cardiac repolarisation and QT interval, imparting a risk of developing cardiac arryhtmia and Torsade de pointes, have been seen in treatment with other macrolides. A similar effect with Sumamed cannot be completely ruled out in patients at increased risk for prolonged cardiac repolarisation.

Use in pregnancy & lactation: Animal reproduction studies have demonstrated that Sumamed crosses the placenta, but have revealed no evidence of harm to the foetus. There are no adequate and well controlled studies in pregnant women. Since animal studies are not always predictive of human response, Sumamed should be used during pregnancy only if adequate alternatives are not available.

No data on secretion of Sumamed in breast milk are available, so that Sumamed should only be used in lactating women where adequate alternatives are not available.

What happens if I miss a dose of Sumamed?

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

  1. DailyMed. "AZITHROMYCIN: 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).
  2. DrugBank. "azithromycin". http://www.drugbank.ca/drugs/DB00207 (accessed September 17, 2018).
  3. MeSH. "Anti-Bacterial Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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