Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include cold, clammy skin; change in size of pupil; deep sleep; loss of consciousness; slowed or fast breathing.
Proper storage of Fenbital tablets:
Store Fenbital tablets at room temperature (59 to 86 degrees F; 15 to 30 degrees C) in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Fenbital tablets out of the reach of children and away from pets.
Overdose of Fenbital 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.
Signs and Symptoms
The onset of symptoms following a toxic oral exposure to Fenbital may not occur until several hours following ingestion. The toxic dose of barbiturates varies considerably. In general, an oral dose of 1 g of most barbiturates produces serious poisoning in an adult. Death commonly occurs after 2 to 10 g of ingested barbiturate. The sedated, therapeutic blood levels of Fenbital range between 5 to 40 mcg/mL; the usual lethal blood level ranges from 100 to 200 mcg mL. Barbiturate intoxication may be confused with alcoholism, bromide intoxication, and various neurologic disorders. Potential tolerance must be considered when evaluating significance of dose and plasma concentration.
The manifestations of a long-acting barbiturate in overdose include nystagmus, ataxia, CNS depression, respiratory depression, hypothermia, and hypotension. Other findings may include absent or depressed reflexes and erythematous or hemorrhagic blisters (primarily at pressure points). Following massive exposure to Fenbital, pulmonary edema, circulatory collapse with loss of peripheral vascular tone, cardiac arrest, and death may occur.
In extreme overdose, all electrical activity in the brain may cease, in which case a "flat"EEG normally equated with clinical death should not be accepted. This effect is fully reversible unless hypoxic damage occurs.
Consideration should be given to the possibility of barbiturate intoxication even in situations that appear to involve trauma.
Complications such as pneumonia, pulmonary edema, cardiac arrhythmias, congestive heart failure, and renal failure may occur. Uremia may increase CNS sensitivity to barbiturates if renal function is impaired. Differential diagnosis should include hypoglycemia, head trauma, cerebrovascular accidents, convulsive states and diabetic coma.
To obtain up-to-date information about the treatment of overdose, a good resource is your certified Regional Poison Control Center. Telephone numbers of certified poison control centers are listed in the Physicians' Desk Reference (PDR). In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in your patient.
Protect the patient's airway and support ventilation and perfusion. Meticulously monitor and maintain, within acceptable limits, the patients vital signs, blood gases, serum electrolytes, etc. Absorption of drugs from the gastrointestinal tract may be decreased by giving activated charcoal, which, in many cases, is more effective then emesis or lavage; consider charcoal instead of or in addition to gastric emptying. Repeated doses of charcoal over time may hasten elimination of some drugs that have been absorbed. Safeguard the patient's airway when employing gastric emptying or charcoal.
Alkalinization of urine hastens Fenbital excretion, but dialysis and hemoperfusion are more effective and cause less troublesome alteration in electrolyte equilibrium. If the patient has chronically abused sedatives, withdrawal reactions may be manifest following acute overdose.
What should I avoid while taking Fenbital?
This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
Drinking alcohol can increase some of the side effects of Fenbital.
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.
1. Habit forming: Fenbital may be habit forming. Tolerance, psychological and physical dependence may occur with continued use.. To minimize the possibility of overdosage or the development of dependence, the prescribing and dispensing of sedative-hypnotic barbiturates should be limited to the amount required for the interval until the next appointment. Abrupt cessation after prolonged use in the dependent person may result in withdrawal symptoms, including delirium, convulsions, and possibly death. Fenbital should be withdrawn gradually.
2. Acute or chronic pain: Caution should be exercised when Fenbital is administered to patients with acute or chronic pain, because paradoxical excitement could be induced or important symptoms could be masked. However, the use of Fenbital as a sedative in the postoperative surgical period and as an adjunct to cancer chemotherapy is well established.
3. Use in pregnancy: Fenbital can cause fetal damage when administered to a pregnant woman. Retrospective case-controlled studies have suggested a connection between the maternal consumption of Fenbital and higher than expected incidence of fetal abnormalities. Following oral administration, Fenbital readily crosses the placental barrier and is distributed throughout fetal tissues with highest concentrations found in the placenta, fetal liver, and brain.
Withdrawal symptoms occur in infants born to mothers who receive Fenbital throughout the last trimester of pregnancy. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
4. Synergistic effects: The concomitant use of alcohol or other CNS depressants may produce additive CNS depressant effects.
What should I discuss with my healthcare provider before taking Fenbital?
Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking Fenbital and talk with your doctor about another treatment for your sleep disorder.
You should not take this medication if you are allergic to Fenbital or other barbiturates (Nembutal, Seconal, and others), or if you have:
severe liver disease;
a history of addiction to a barbiturate, sedative (Valium, Xanax, and others); or
severe asthma, chronic obstructive pulmonary disorder (COPD), or other breathing disorder.
To make sure you can safely take Fenbital, tell your doctor if you have any of these other conditions:
temporary or chronic pain;
pheochromocytoma (tumor of the adrenal gland);
a pituitary gland disorder;
a history of depression, mental illness, or suicide attempt; or
a history of drug or alcohol addiction.
Fenbital may be habit forming and should be used only by the person it was prescribed for. Never share Fenbital with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.
FDA pregnancy category D. Do not use Fenbital if you are pregnant. It could harm the unborn baby. Fenbital may also cause addiction or withdrawal symptoms in a newborn if the mother takes the medication during pregnancy. Use effective birth control, and tell your doctor if you become pregnant during treatment.
Fenbital can make birth control pills less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking Fenbital.
Fenbital can pass into breast milk and may harm a nursing baby. Do not use this medication 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.
Fenbital may be habit forming. Tolerance and psychological and physical dependence may occur with continuing use. Fenbital should be administered with caution, if at all, to patients who are mentally depressed, have suicidal tendencies, or a history of drug abuse. Elderly or debilitated patients may react to Fenbital with marked excitement, depression, and confusion. In some persons, Fenbital repeatedly produces excitement rather than depression.
In patients with hepatic damage, Fenbital should be administered with caution and initially reduced doses. Fenbital should not be administered to patients showing the premonitory signs of hepatic coma.
Prolonged therapy with Fenbital should be accompanied by periodic laboratory evaluation of organ systems, including hematopoietic, renal, and hepatic systems
Human-data: A retrospective study of 84 children with brain tumors matched to 73 normal controls and 78 cancer controls (malignant disease other than brain tumors) suggested an association between exposure to barbiturates prenatally and an increased incidence of brain tumors.
Teratogenic effects: Pregnancy Category D.
Nonteratogenic effects: Reports of infants suffering from long- term Fenbital exposure in utero included the acute withdrawal syndrome of seizures and hyperirritability from birth to a delayed onset of up to 14 days.
Labor and Delivery
Hypnotic doses of Fenbital do not appear to significantly impair uterine activity during labor. Full anesthetic doses of Fenbital decrease the force and frequency of uterine contractions. Administration of sedative-hypnotic Fenbital to the mother during labor may result in respiratory depression in the newborn. Premature infants are particularly susceptible to the depressant effects of Fenbital. If Fenbital is used during labor and delivery, resuscitation equipment should be available.
Data are currently not available to evaluate the effect of Fenbital on the later growth, development, and functional maturation of the child.
Caution should be exercised when Fenbital is administered to a nursing woman since small amounts of Fenbital are excreted in the milk.
What happens if I miss a dose of Fenbital?
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.
NITE-CMC. "5-Ethyl-5-phenyl-2,4,6(1H,3H,5H)-pyrimidinetrione; Phenobarbital: 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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