Ultrapenem Overdose

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What happens if I overdose Ultrapenem?

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include seizures; slow breathing; tremors.

Proper storage of Ultrapenem:

Ultrapenem is usually handled and stored by a health care provider. If you are using Ultrapenem at home, store Ultrapenem as directed by your pharmacist or health care provider. Keep Ultrapenem out of the reach of children and away from pets.

Overdose of Ultrapenem 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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In mice and rats, large intravenous doses of Ultrapenem (2200 mg/kg to 4000 mg/kg) have been associated with ataxia, dyspnea, convulsions, and mortalities.

Intentional overdosing of Ultrapenem I.V. is unlikely, although accidental overdosing might occur if large doses are given to patients with reduced renal function. The largest dose of Ultrapenem administered in clinical trials has been 2 grams given intravenously every 8 hours. At this dosage, no adverse pharmacological effects or increased safety risks have been observed.

Limited postmarketing experience indicates that if adverse events occur following overdosage, they are consistent with the adverse event profile described in the Adverse Reactions section and are generally mild in severity and resolve on withdrawal or dose reduction. Consider symptomatic treatments. In individuals with normal renal function, rapid renal elimination takes place. Ultrapenem and its metabolite are readily dialyzable and effectively removed by hemodialysis; however, no information is available on the use of hemodialysis to treat overdosage.

What should I avoid while taking Ultrapenem?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

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

Ultrapenem 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 deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For Ultrapenem, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to Ultrapenem or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of Ultrapenem in children below 3 months of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Ultrapenem in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require an adjustment of dose in patients receiving Ultrapenem.

Pregnancy Category B

Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of Ultrapenem. Make sure you tell your doctor if you have any other medical problems, especially:

Brain infection (e.g., meningitis) caused by bacteria or

Brain lesion (e.g., tumor) or

Seizures, history of—May cause side effects to become worse.

Kidney disease—The effects of Ultrapenem may be increased because of slower removal from the body.

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

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For Ultrapenem, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to Ultrapenem or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Ultrapenem injection in children 3 months of age and older with complicated skin and skin structure infections and bacterial meningitis, and for children with intra-abdominal infections.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Ultrapenem injection in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving Ultrapenem injection.

Pregnancy

Pregnancy Category Explanation
All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving Ultrapenem, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using Ultrapenem with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Using Ultrapenem with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of Ultrapenem. Make sure you tell your doctor if you have any other medical problems, especially:

Ultrapenem 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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The selection of Ultrapenem to treat an individual patient should take into account the appropriateness of using a carbapenem antibacterial agent based on factors eg, severity of the infection, the prevalence of resistance to other suitable antibacterial agents and the risk of selecting for carbapenem-resistant bacteria.

As with all β-lactam antibiotics, serious and occasionally fatal hypersensitivity reactions have been reported.

Patients who have a history of hypersensitivity to carbapenems, penicillins or other β-lactam antibiotics may also be hypersensitive to Ultrapenem. Before initiating therapy with Ultrapenem, careful inquiry should be made concerning previous hypersensitivity reactions to β-lactam antibiotics.

If a severe allergic reaction occurs, Ultrapenem should be discontinued and appropriate measures taken.

Antibiotic-associated colitis and pseudomembranous colitis have been reported with nearly all antibacterial agents, including Ultrapenem, and may range in severity from mild to life threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of Ultrapenem. Discontinuation of therapy with Ultrapenem and the administration of specific treatment for Clostridium difficile should be considered. Medicinal products that inhibit peristalsis should not be given.

Seizures have infrequently been reported during treatment with carbapenems, including Ultrapenem.

Hepatic function should be closely monitored during treatment with Ultrapenem due to the risk of hepatic toxicity (hepatic dysfunction with cholestasis and cytolysis).

A positive direct or indirect Coombs test may develop during treatment with Ultrapenem.

The concomitant use of valproic acid/sodium valproate and Ultrapenem is not recommended.

Ultrapenem may reduce serum valproic acid levels. Subtherapeutic levels may be reached in some patients.

Ultrapenem contains sodium. Ultrapenem contains approximately 2 mEq of sodium per 500 mg dose, which should be taken into consideration by patients on a controlled sodium diet.

Effects on the Ability to Drive or Operate Machinery: No studies on the ability to drive and use machines have been performed. However when driving or operating machines, it should be taken into account that headache, paraesthesia and convulsions have been reported for Ultrapenem.

Hepatic Impairment: Patients with preexisting liver disorders should have liver function monitored during treatment with Ultrapenem. There is no dose adjustment necessary.

Use in pregnancy: The safety of Ultrapenem in human pregnancy has not been evaluated. Animal studies have not shown any adverse effect on the developing foetus. The only adverse effect observed in animal reproductive studies was an increased incidence of abortions in monkeys at 13 times the expected exposure in man.

Ultrapenem should not be used in pregnancy unless the potential benefit justifies the potential risk to the foetus. In every case, it should be used under the direct supervision of the physician.

Use in lactation: Ultrapenem is detectable at very low concentrations in animal breast milk. Ultrapenem should not be used in breastfeeding women unless the potential benefit justifies the potential risk to the baby.

Use in children: Efficacy and tolerability in infants <3 months have not been established; therefore, Ultrapenem is not recommended for use below this age. There is no experience in children with altered hepatic or renal function.

Keep all medicines away from children.

What happens if I miss a dose of Ultrapenem?

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 Ultrapenem is usually administered by a healthcare provider, missing a dose is not likely to occur.



References

  1. DailyMed. "MEROPENEM: 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. "meropenem". http://www.drugbank.ca/drugs/DB00760 (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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