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What happens if I overdose Hibernal?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include agitation; coma; confusion; difficulty breathing; fainting; fast, slow, or irregular heartbeat; loss of consciousness; muscle spasms or uncontrolled muscle movements; restlessness; seizures; severe constipation or stomach pain; severe drowsiness or dizziness; tremors; or trouble urinating.
Proper storage of Hibernal tablets:
Store Hibernal tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Hibernal tablets out of the reach of children and away from pets.
Overdose of Hibernal in details
Primarily symptoms of central nervous system depression to the point of somnolence or coma.
Hypotension and extrapyramidal symptoms.
Other possible manifestations include agitation and restlessness, convulsions, fever, autonomic reactions such as dry mouth and ileus. EKG changes and cardiac arrhythmias.
It is important to determine other medications taken by the patient since multiple drug therapy is common in overdosage situations. Treatment is essentially symptomatic and supportive. Early gastric lavage is helpful. Keep patient under observation and maintain an open airway, since involvement of the extrapyramidal mechanism may produce dysphagia and respiratory difficulty in severe overdosage. Do not attempt to induce emesis because a dystonic reaction of the head or neck may develop that could result in aspiration of vomitus. Extrapyramidal symptoms may be treated with anti-parkinsonism drugs, barbiturates, or diphenhydramine hydrochloride. See prescribing information for these products. Care should be taken to avoid increasing respiratory depression.
If administration of a stimulant is desirable, amphetamine, dextroamphetamine, or caffeine with sodium benzoate is recommended. Stimulants that may cause convulsions (e.g., picrotoxin or pentylenetetrazol) should be avoided.
If hypotension occurs, the standard measures for managing circulatory shock should be initiated. If it is desirable to administer a vasoconstrictor, norepinephrine and phenylephrine are most suitable. Other pressor agents, including epinephrine, are not recommended because phenothiazine derivatives may reverse the usual elevating action of these agents and cause a further lowering of blood pressure.
Limited experience indicates that phenothiazines are not dialyzable.
DOSAGE AND ADMINISTRATION–ADULTS
Adjust dosage to individual and the severity of his condition, recognizing that the milligram for milligram potency relationship among all dosage forms has not been precisely established clinically. It is important to increase dosage until symptoms are controlled. Dosage should be increased more gradually in debilitated or emaciated patients. In continued therapy, gradually reduce dosage to the lowest effective maintenance level, after symptoms have been controlled for a reasonable period.
The 100 mg and 200 mg tablets are for use in severe neuropsychiatric conditions.
Elderly Patients – In general, dosages in the lower range are sufficient for most elderly patients. Since they appear to be more susceptible to hypotension and neuromuscular reactions, such patients should be observed closely. Dosage should be tailored to the individual, response carefully monitored, and dosage adjusted accordingly. Dosage should be increased more gradually in elderly patients.
Psychotic Disorders – Increase dosage gradually until symptoms are controlled. Maximum improvement may not be seen for weeks or even months. Continue optimum dosage for 2 weeks; then gradually reduce dosage to the lowest effective maintenance level. Daily dosage of 200 mg is not unusual. Some patients require higher dosages (e.g., 800 mg daily is not uncommon in discharged mental patients).
Acute Schizophrenic or Manic States – It is recommended that initial treatment be with Hibernal HCI injection until patient is controlled. Usually patient becomes quiet and co-operative within 24 to 48 hours and oral doses may be substituted and increased until the patient is calm. 500 mg a day is generally sufficient. While gradual increases to 2,000 mg a day or more may be necessary, there is usually little therapeutic gain to be achieved by exceeding 1,000 mg a day for extended periods. In general, dosage levels should be lower in the elderly, the emaciated and the debilitated.
Less Acutely Disturbed – 25 mg t.i.d. Increase gradually until effective dose is reached – usually 400 mg daily.
Outpatients – 10 mg t.i.d. or q.i.d., or 25 mg b.i.d. or t.i.d.
More Severe Cases – 25 mg t.i.d. After 1 or 2 days, daily dosage may be increased by 20 to 50 mg at semi-weekly intervals until patient becomes calm and cooperative.
Prompt Control of Severe Symptoms – Initial treatment should be with intramuscular Hibernal. Subsequent doses should be oral, 25 to 50 mg t.i.d.
Nausea and Vomiting– 10 to 25 mg q4 to 6h, p.r.n., increased, if necessary.
Presurgical Apprehension– 25 to 50 mg, 2 to 3 hours before the operation.
Intractable Hiccups– 25 to 50 mg t.i.d. or q.i.d. If symptoms persist for 2 to 3 days, parenteral therapy is indicated.
Acute Intermittent Porphyria– 25 to 50 mg t.i.d. or q.i.d. Can usually be discontinued after several weeks, but maintenance therapy may be necessary for some patients.
DOSAGE AND ADMINISTRATION – PEDIATRIC PATIENTS (6 months to 12 years of age)
Hibernal should generally not be used in pediatric patients under 6 months of age except where potentially lifesaving. It should not be used in conditions for which specific pediatric dosages have not been established.
Severe Behavioral Problems
Outpatients – Select route of administration according to severity of patient's condition and increase dosage gradually as required.
Oral: ¼ mg/lb body weight q4 to 6h, p.r.n. (e.g., for 40 lb child – 10 mg q4 to 6h).
Hospitalized Patients – As with outpatients, start with low doses and increase dosage gradually. In severe behavior disorders higher dosages (50 to 100 mg daily and in older children, 200 mg daily or more) may be necessary. There is little evidence that behavior improvement in severely disturbed mentally retarded patients is further enhanced by doses beyond 500 mg per day.
Nausea and Vomiting– Dosage and frequency of administration should be adjusted according to the severity of the symptoms and response of the patient. The duration of activity following intramuscular administration may last up to 12 hours. Subsequent doses may be given by the same route if necessary.
Oral: ¼ mg/lb body weight (e.g., 40 lb child – 10 mg q4 to 6h).
Presurgical Apprehension–¼ mg/lb body weight orally 2 to 3 hours before operation.
What should I avoid while taking Hibernal?
Hibernal may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.
Avoid drinking alcohol. It can increase some of the side effects of Hibernal.
Avoid exposure to sunlight or tanning beds. Hibernal can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.
The extrapyramidal symptoms which can occur secondary to Hibernal (Hibernal) may be confused with the central nervous system signs of an undiagnosed primary disease responsible for the vomiting, e.g., Reye's syndrome or other encephalopathy. The use of Hibernal (Hibernal) and other potential hepatotoxins should be avoided in children and adolescents whose signs and symptoms suggest Reye's syndrome.
Tardive Dyskinesia: Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements, may develop in patients treated with antipsychotic drugs. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of antipsychotic treatment, which patients are likely to develop the syndrome. Whether antipsychotic drug products differ in their potential to cause tardive dyskinesia is unknown.
Both the risk of developing the syndrome and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs administered to the patient increase. However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses.
There is no known treatment for established cases of tardive dyskinesia, although the syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn. Antipsychotic treatment itself, however, may suppress (or partially suppress) the signs and symptoms of the syndrome and thereby may possibly mask the underlying disease process. The effect that symptomatic suppression has upon the long-term course of the syndrome is unknown.
Given these considerations, antipsychotics should be prescribed in a manner that is most likely to minimize the occurrence of tardive dyskinesia. Chronic antipsychotic treatment should generally be reserved for patients who suffer from a chronic illness that, 1) is known to respond to antipsychotic drugs, and, 2) for whom alternative, equally effective, but potentially less harmful treatments are not available or appropriate. In patients who do require chronic treatment, the smallest dose and the shortest duration of treatment producing a satisfactory clinical response should be sought. The need for continued treatment should be reassessed periodically.
If signs and symptoms of tardive dyskinesia appear in a patient on antipsychotics, drug discontinuation should be considered. However, some patients may require treatment despite the presence of the syndrome.
For further information about the description of tardive dyskinesia and its clinical detection, please refer to the sections on PRECAUTIONS and ADVERSE REACTIONS.
Neuroleptic Malignant Syndrome (NMS): A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmias).
The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology.
The management of NMS should include 1) immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS.
If a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy should be carefully considered. The patient should be carefully monitored, since recurrences of NMS have been reported.
An encephalopathic syndrome (characterized by weakness, lethargy, fever, tremulousness and confusion, extrapyramidal symptoms, leukocytosis, elevated serum enzymes, BUN and FBS) has occurred in a few patients treated with lithium plus an antipsychotic. In some instances, the syndrome was followed by irreversible brain damage. Because of a possible causal relationship between these events and the concomitant administration of lithium and antipsychotics, patients receiving such combined therapy should be monitored closely for early evidence of neurologic toxicity and treatment discontinued promptly if such signs appear. This encephalopathic syndrome may be similar to or the same as neuroleptic malignant syndrome (NMS).
Hibernal (Hibernal) ampuls and multi-dose vials contain sodium bisulfite and sodium sulfite, sulfites 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.
Patients with bone marrow depression or who have previously demonstrated a hypersensitivity reaction (e.g., blood dyscrasias, jaundice) with a phenothiazine should not receive any phenothiazine, including Hibernal (Hibernal), unless in the judgment of the physician the potential benefits of treatment outweigh the possible hazard.
Hibernal (Hibernal) may impair mental and/or physical abilities, especially during the first few days of therapy. Therefore, caution patients about activities requiring alertness (e.g., operating vehicles or machinery).
The use of alcohol with this drug should be avoided due to possible additive effects and hypotension. Hibernal (Hibernal) may counteract the antihypertensive effect of guanethidine and related compounds.
Usage in Pregnancy: Safety for the use of Hibernal (Hibernal) during pregnancy has not been established. Therefore, it is not recommended that the drug be given to pregnant patients except when, in the judgment of the physician, it is essential. The potential benefits should clearly outweigh possible hazards. There are reported instances of prolonged jaundice, extrapyramidal signs, hyperreflexia or hyporeflexia in newborn infants whose mothers received phenothiazines.
Reproductive studies in rodents have demonstrated potential for embryotoxicity, increased neonatal mortality and nursing transfer of the drug. Tests in the offspring of the drug-treated rodents demonstrate decreased performance. The possibility of permanent neurological damage cannot be excluded.
Nursing Mothers: There is evidence that Hibernal is excreted in the breast milk of nursing mothers. Because of the potential for serious adverse reactions in nursing infants from Hibernal, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
What should I discuss with my healthcare provider before taking Hibernal?
Some medical conditions may interact with Hibernal syrup. 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 a history of heart problems, low blood pressure, blood problems, bone marrow problems, low white blood cell count, diabetes, liver problems (eg, cirrhosis), kidney problems, neuroleptic malignant syndrome (NMS), enlarged prostate gland, seizures or epilepsy, or an adrenal gland tumor (pheochromocytoma)
- if you have asthma, lung infection, or other lung problems (eg, emphysema); increased pressure in the eyes; glaucoma; or if you are at risk for glaucoma
- if you have Alzheimer disease, dementia, Parkinson disease, or Reye syndrome
- if you have had high blood prolactin levels or a history of certain types of cancer (eg, breast, pancreas, pituitary, brain), or if you are at risk of breast cancer
- if you are regularly exposed to extreme heat or organophosphate insecticides
- if you have a history of alcohol abuse or if you consume more than 3 alcoholic drinks per day
Some MEDICINES MAY INTERACT with Hibernal syrup. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Lithium because the risk of a severe and sometimes permanent nervous system problem (encephalopathic syndrome) characterized by weakness, lethargy, fever, tremor, confusion, or uncontrolled muscle movements may be increased
- Certain antiarrhythmic medicines (eg, amiodarone, dofetilide, dronedarone, quinidine, sotalol), cisapride, pergolide, pimozide, quetiapine, or ziprasidone because the risk of side effects, such as racing heartbeat, dizziness, fainting, and life-threatening irregular heartbeat leading to unconsciousness, may be increased by Hibernal syrup
- Many prescription and nonprescription medicines (eg, used for allergies, blood clotting problems, cancer, infections, inflammation, aches and pains, heart problems, high blood pressure, high cholesterol, mental or mood problems, nausea or vomiting, Parkinson disease, seizures, stomach problems), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, gingko, St. John's wort) may interact with Hibernal syrup, increasing the risk of side effects
This may not be a complete list of all interactions that may occur. Ask your health care provider if Hibernal syrup 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.
Given the likelihood that some patients exposed chronically to antipsychotics will develop tardive dyskinesia, it is advised that all patients in whom chronic use is contemplated be given, if possible, full information about this risk. The decision to inform patients and/or their guardians must obviously take into account the clinical circumstances and the competency of the patient to understand the information provided.
Hibernal (Hibernal) should be administered cautiously to persons with cardiovascular, liver or renal disease. There is evidence that patients with a history of hepatic encephalopathy due to cirrhosis have increased sensitivity to the CNS effects of Hibernal (Hibernal) (i.e., impaired cerebration and abnormal slowing of the EEG).
Because of its CNS depressant effect, Hibernal (Hibernal) should be used with caution in patients with chronic respiratory disorders such as severe asthma, emphysema and acute respiratory infections, particularly in children (1 to 12 years of age).
Because Hibernal (Hibernal) can suppress the cough reflex, aspiration of vomitus is possible.
Hibernal (Hibernal) prolongs and intensifies the action of CNS depressants such as anesthetics, barbiturates and narcotics. When Hibernal (Hibernal) is administered concomitantly, about 1 / 4 to 1 / 2 the usual dosage of such agents is required. When Hibernal (Hibernal) is not being administered to reduce requirements of CNS depressants, it is best to stop such depressants before starting Hibernal (Hibernal) treatment. These agents may subsequently be reinstated at low doses and increased as needed.
Note: Hibernal (Hibernal) does not intensify the anticonvulsant action of barbiturates. Therefore, dosage of anticonvulsants, including barbiturates, should not be reduced if Hibernal (Hibernal) is started. Instead, start Hibernal (Hibernal) at low doses and increase as needed.
Use with caution in persons who will be exposed to extreme heat, organophosphorus insecticides, and in persons receiving atropine or related drugs.
Antipsychotic drugs elevate prolactin levels; the elevation persists during chronic administration. Tissue culture experiments indicate that approximately 1 / 3 of human breast cancers are prolactin-dependent in vitro, a factor of potential importance if the prescribing of these drugs is contemplated in a patient with a previously detected breast cancer. Although disturbances such as galactorrhea, amenorrhea, gynecomastia and impotence have been reported, the clinical significance of elevated serum prolactin levels is unknown for most patients. An increase in mammary neoplasms has been found in rodents after chronic administration of antipsychotic drugs. Neither clinical nor epidemiologic studies conducted to date, however, have shown an association between chronic administration of these drugs and mammary tumorigenesis; the available evidence is considered too limited to be conclusive at this time.
Chromosomal aberrations in spermatocytes and abnormal sperm have been demonstrated in rodents treated with certain antipsychotics.
As with all drugs which exert an anticholinergic effect, and/or cause mydriasis, Hibernal should be used with caution in patients with glaucoma.
Hibernal diminishes the effect of oral anticoagulants.
Phenothiazines can produce alpha-adrenergic blockade.
Hibernal may lower the convulsive threshold; dosage adjustments of anticonvulsants may be necessary. Potentiation of anticonvulsant effects does not occur. However, it has been reported that Hibernal may interfere with the metabolism of Dilantin® * and thus precipitate Dilantin toxicity.
Concomitant administration with propranolol results in increased plasma levels of both drugs.
Thiazide diuretics may accentuate the orthostatic hypotension that may occur with phenothiazines.
The presence of phenothiazines may produce false-positive phenylketonuria (PKU) test results.
Drugs which lower the seizure threshold, including phenothiazine derivatives, should not be used with Amipaque®†. As with other phenothiazine derivatives, Hibernal (Hibernal) should be discontinued at least 48 hours before myelography, should not be resumed for at least 24 hours postprocedure, and should not be used for the control of nausea and vomiting occurring either prior to myelography or postprocedure with Amipaque.
Long-Term Therapy: To lessen the likelihood of adverse reactions related to cumulative drug effect, patients with a history of long-term therapy with Hibernal (Hibernal) and/or other antipsychotics should be evaluated periodically to decide whether the maintenance dosage could be lowered or drug therapy discontinued.
Antiemetic Effect: The antiemetic action of Hibernal (Hibernal) may mask the signs and symptoms of overdosage of other drugs and may obscure the diagnosis and treatment of other conditions such as intestinal obstruction, brain tumor and Reye's syndrome.
When Hibernal (Hibernal) is used with cancer chemotherapeutic drugs, vomiting as a sign of the toxicity of these agents may be obscured by the antiemetic effect of Hibernal (Hibernal).
Abrupt Withdrawal: Like other phenothiazines, Hibernal (Hibernal) is not known to cause psychic dependence and does not produce tolerance or addiction. There may be, however, following abrupt withdrawal of high-dose therapy, some symptoms resembling those of physical dependence such as gastritis, nausea and vomiting, dizziness and tremulousness. These symptoms can usually be avoided or reduced by gradual reduction of the dosage or by continuing concomitant anti-parkinsonism agents for several weeks after Hibernal (Hibernal) is withdrawn.
What happens if I miss a dose of Hibernal?
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.
- DailyMed. "CHLORPROMAZINE: 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).
- DrugBank. "chlorpromazine". http://www.drugbank.ca/drugs/DB00477 (accessed September 17, 2018).
- MeSH. "Antipsychotic 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