Ebastine/Phenylephrine Overdose

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Consists of Ebastine, Phenylephrine

Ebastine 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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Caution is advised when used in hepatic impairment, renal insufficiency, QTc interval prolongation. Pregnancy, lactation.

Ebastine 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.

Avoid alcohol. Hepatic or renal dysfunction. May affect ability to drive or operate machinery. Pregnancy & lactation. Elderly.

What happens if I overdose Phenylephrine?

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room right away. Symptoms may include confusion; hallucinations; irregular or unusually slow or rapid heartbeat; rapid breathing; seizures.

Proper storage of Phenylephrine:

Store Phenylephrine at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Phenylephrine out of the reach of children and away from pets.

Overdose of Phenylephrine 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.

Overdose of Phenylephrine (phenylephrine hydrochloride) can cause a rapid rise in blood pressure. Symptoms of overdose include headache, vomiting, hypertension, reflex bradycardia, a sensation of fullness in the head, tingling of the extremities, and cardiac arrhythmias including ventricular extrasystoles and ventricular tachycardia.

What should I avoid while taking Phenylephrine?

Do not take phenylephrine rectal rectal suppository by mouth. It is for use only in your rectum.

Ask a doctor or pharmacist before taking any cough, cold, or allergy medicine. Phenylephrine is contained in many combination medicines. Taking certain products together can cause you to get too much phenylephrine. Check the label to see if a medicine contains phenylephrine, or a decongestant.

Phenylephrine 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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Exacerbation of Angina, Heart Failure, or Pulmonary Arterial Hypertension

Because of its increasing blood pressure effects, Phenylephrine can precipitate angina in patients with severe arteriosclerosis or history of angina, exacerbate underlying heart failure, and increase pulmonary arterial pressure.

Peripheral and Visceral Ischemia

Phenylephrine can cause excessive peripheral and visceral vasoconstriction and ischemia to vital organs, particularly in patients with extensive peripheral vascular disease.

Skin and Subcutaneous Necrosis

Extravasation of Phenylephrine can cause necrosis or sloughing of tissue. The infusion site should be checked for free flow. Care should be taken to avoid extravasation of Phenylephrine.

Bradycardia

Phenylephrine can cause severe bradycardia and decreased cardiac output.

Allergic Reactions

Phenylephrine contains sodium metabisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

Renal Toxicity

Phenylephrine can increase the need for renal replacement therapy in patients with septic shock. Monitor renal function.

Risk of Augmented Pressor Affect in Patients with Autonomic Dysfunction

The increasing blood pressure response to adrenergic drugs, including Phenylephrine, can be increased in patients with autonomic dysfunction, as may occur with spinal cord injuries.

Pressor Effect with Concomitant Oxytocic Drugs

Oxytocic drugs potentiate the increasing blood pressure effect of sympathomimetic pressor amines including Phenylephrine, with the potential for hemorrhagic stroke.

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

Some medical conditions may interact with Phenylephrine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

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

This may not be a complete list of all interactions that may occur. Ask your health care provider if Phenylephrine 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.

Phenylephrine 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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Exacerbation Of Angina, Heart Failure, Or Pulmonary Arterial Hypertension

Because of its increasing blood pressure effects, Phenylephrine can precipitate angina in patients with severe arteriosclerosis or history of angina, exacerbate underlying heart failure, and increase pulmonary arterial pressure.

Peripheral And Visceral Ischemia

Phenylephrine can cause excessive peripheral and visceral vasoconstriction and ischemia to vital organs, particularly in patients with extensive peripheral vascular disease.

Skin And Subcutaneous Necrosis

Extravasation of Phenylephrine can cause necrosis or sloughing of tissue. The infusion site should be checked for free flow. Care should be taken to avoid extravasation of Phenylephrine.

Bradycardia

Phenylephrine can cause severe bradycardia and decreased cardiac output.

Allergic Reactions

Phenylephrine contains sodium metabisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

Renal Toxicity

Phenylephrine can increase the need for renal replacement therapy in patients with septic shock. Monitor renal function.

Risk Of Augmented Pressor Affect In Patients With Autonomic Dysfunction

The increasing blood pressure response to adrenergic drugs, including Phenylephrine, can be increased in patients with autonomic dysfunction, as may occur with spinal cord injuries.

Pressor Effect With Concomitant Oxytocic Drugs

Oxytocic drugs potentiate the increasing blood pressure effect of sympathomimetic pressor amines including Phenylephrine, with the potential for hemorrhagic stroke.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Carcinogenesis

Long-term animal studies that evaluated the carcinogenic potential of orally administered phenylephrine hydrochloride in F344/N rats and B6C3F1 mice were completed by the National Toxicology Program using the dietary route of administration. There was no evidence of carcinogenicity in mice administered approximately 270 mg/kg/day (131-times the maximum recommended daily dose of < 10 mg/day) or rats administered approximately 50 mg/kg/day (48-times the maximum recommended daily dose of < 10 mg/day) based on body surface area comparisons.

Mutagenesis

Phenylephrine hydrochloride tested negative in the in vitro bacterial reverse mutation assay (S.typhimurium strains TA98, TA100, TA1535 and TA1537), the in vitro chromosomal aberrations assay, the in vitro sister chromatid exchange assay, and the in vivo rat micronucleus assay. Positive results were reported in only one of two replicates of the in vitro mouse lymphoma assay.

Impairment of Fertility

Studies to evaluate the effect of phenylephrine on fertility have not been conducted.

Use In Specific Populations

Pregnancy

Pregnancy Category C

Risk Summary

There are no adequate or well-controlled studies with phenylephrine hydrochloride injection in pregnant women, nor have animal reproduction studies been conducted. Published studies in normotensive pregnant rabbits report early onset labor, increased fetal lethality, and adverse placental effects with subcutaneous phenylephrine administration during gestation at doses approximately 1.9-times the total daily human dose. Published studies in normotensive pregnant sheep report decreased uterine blood flow and decreased PaO2 in the fetus with intravenous phenylephrine administration during late gestation at doses less than and similar to the human dose. It is not known whether Phenylephrine, can cause fetal harm when administered to a pregnant woman. Phenylephrine, should be given to a pregnant woman only if the potential benefit justifies the potential risk to the fetus.

Clinical Considerations

Labor and Delivery

The most common maternal adverse reactions reported in published studies of phenylephrine use during neuraxial anesthesia during Cesarean delivery include nausea and vomiting, bradycardia, reactive hypertension, and transient arrhythmias. Phenylephrine, when administered during labor or delivery, does not appear to alter either neonatal Apgar scores or umbilical artery blood-gas status.

Data

Animal Data

Studies in the published literature evaluating subcutaneously administered phenylephrine (0.33 mg/kg, TID) in normotensive pregnant rabbits reported fetal deaths, adverse histopathology findings in the placenta (necrosis, calcification and thickened vascular walls with narrowed lumen) and possible teratogenic effects (one incidence of clubbed feet, partial development of the intestine) when treatment was initiated during the first trimester or later; and premature labor when treatment was initiated at the second trimester or later. The doses administered were 1.9- times the total daily human dose of 10 mg/day based on a body surface area comparison. Published studies in pregnant normotensive sheep demonstrate that intravenous phenylephrine (4 mcg/kg/min for 30 minutes, equivalent to 3.6 to 4.1 mcg/kg/min human equivalent dose based on body surface area) administered during the third trimester of pregnancy decreased uterine blood flow by 42%. This dose is 1.1- to 1.2-times the human bolus dose of 200 mcg/60 kg person based on body surface area. Mean fetal blood pressure and heart rate fluctuated above and below controls by about 7% during the infusion. Fetal PaO2 was significantly decreased by approximately 26% of control during the infusion. Likewise, PaCO2 was increased and pH was decreased. The clinical significance of these findings is not clear; however, the results suggest the potential for cardiovascular effects on the fetus when phenylephrine is used during pregnancy.

Nursing Mothers

It is not known whether phenylephrine is present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Phenylephrine and any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition. Exercise caution when Phenylephrine is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies of phenylephrine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Hepatic Impairment

In patients with liver cirrhosis [Child Pugh Class B and Class C], dose-response data indicate decreased responsiveness to phenylephrine. Start dosing in the recommended dose range but consider that you may need to give more phenylephrine in this population.

Renal Impairment

In patients with end stage renal disease (ESRD), dose-response data indicate increased responsiveness to phenylephrine. Consider starting at the lower end of the recommended dose range, and adjusting dose based on the target blood pressure goal.

What happens if I miss a dose of Phenylephrine?

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 phenylephrine rectal is used on an as needed basis, you are not likely to miss a dose. Do not use phenylephrine rectal more than 4 times per day.



References

  1. DrugBank. "Ebastine". http://www.drugbank.ca/drugs/DB11742 (accessed September 17, 2018).
  2. DrugBank. "phenylephrine". http://www.drugbank.ca/drugs/DB00388 (accessed September 17, 2018).
  3. MeSH. "Histamine H1 Antagonists". 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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