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 Cltonactil tablets:
Store Cltonactil 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 Cltonactil tablets out of the reach of children and away from pets.
Overdose of Cltonactil 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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Symptoms
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.
Treatment
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).
Hospitalized Patients:
Acute Schizophrenic or Manic States – It is recommended that initial treatment be with Cltonactil 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 Cltonactil. 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)
Cltonactil 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 Cltonactil?
Cltonactil 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 Cltonactil.
Avoid exposure to sunlight or tanning beds. Cltonactil can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.
Cltonactil 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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Cltonactil should be avoided whenever possible in patients with hepatic or renal dysfunction, cardiac failure, phaeochromocytoma, hypothyroidism, bone marrow depression, epilepsy, Parkinson’s disease, myasthenia gravis, prostatic hypertrophy or a history of narrow angle glaucoma.
Cases of venous thromboembolism (VTE) have been reported with antipsychotic drugs. Since patients treated with antipsychotics often present with acquired risk factor for VTE, all possible risk factors for VTE should be identified before and during treatment with Cltonactil and preventive measures undertaken.
Cltonactil should be used with caution in the elderly, especially during very hot or very cold weather because of the risk of hyper- or hypothermia.
Increased Mortality in Elderly people with Dementia
Data from two large observational studies showed that elderly people with dementia who are treated with antipsychotics are at a small increased risk of death compared with those who are not treated. There are insufficient data to give a firm estimate of the precise magnitude of the risk and the cause of the increased risk is not known.
Cltonactil is not licensed for the treatment of dementia-related behavioural disturbances.
What should I discuss with my healthcare provider before taking Cltonactil?
You should not use this medicine if you are allergic to Cltonactil or other phenothiazines (such as fluphenazine, perphenazine, prochlorperazine, promethazine, thioridazine, or trifluoperazine).
Do not take Cltonactil if you have recently used large amounts of alcohol or taken a medicine that makes you sleepy.
Cltonactil is not approved for use in psychotic conditions related to dementia. Cltonactil may increase the risk of death in older adults with dementia-related conditions.
To make sure Cltonactil is safe for you, tell your doctor if you have:
bone marrow suppression;
a brain tumor;
heart disease;
liver or kidney disease;
severe asthma, emphysema, or other breathing problem;
a history of breast cancer;
glaucoma;
seizures or epilepsy;
pheochromocytoma (tumor of the adrenal gland);
an enlarged prostate or urination problems; or
if you also take lithium or a blood thinner (warfarin, Coumadin).
Talk with your doctor before giving Cltonactil to a child who has been ill with a fever or flu symptoms.
Tell your doctor if you will be exposed to extreme heat or cold, or to insecticide poisons while you are taking Cltonactil.
Taking antipsychotic medication during the last 3 months of pregnancy may cause problems in the newborn, such as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles. However, you may have withdrawal symptoms or other problems if you stop taking your medicine during pregnancy. If you become pregnant while taking Cltonactil, do not stop taking it without your doctor's advice.
Cltonactil can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.
Cltonactil 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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General
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.
Cltonactil (Cltonactil) 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 Cltonactil (Cltonactil) (i.e., impaired cerebration and abnormal slowing of the EEG).
Because of its CNS depressant effect, Cltonactil (Cltonactil) 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 Cltonactil (Cltonactil) can suppress the cough reflex, aspiration of vomitus is possible.
Cltonactil (Cltonactil) prolongs and intensifies the action of CNS depressants such as anesthetics, barbiturates and narcotics. When Cltonactil (Cltonactil) is administered concomitantly, about 1 / 4 to 1 / 2 the usual dosage of such agents is required. When Cltonactil (Cltonactil) is not being administered to reduce requirements of CNS depressants, it is best to stop such depressants before starting Cltonactil (Cltonactil) treatment. These agents may subsequently be reinstated at low doses and increased as needed.
Note: Cltonactil (Cltonactil) does not intensify the anticonvulsant action of barbiturates. Therefore, dosage of anticonvulsants, including barbiturates, should not be reduced if Cltonactil (Cltonactil) is started. Instead, start Cltonactil (Cltonactil) 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, Cltonactil should be used with caution in patients with glaucoma.
Cltonactil diminishes the effect of oral anticoagulants.
Phenothiazines can produce alpha-adrenergic blockade.
Cltonactil 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 Cltonactil 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, Cltonactil (Cltonactil) 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 Cltonactil (Cltonactil) 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 Cltonactil (Cltonactil) 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 Cltonactil (Cltonactil) is used with cancer chemotherapeutic drugs, vomiting as a sign of the toxicity of these agents may be obscured by the antiemetic effect of Cltonactil (Cltonactil).
Abrupt Withdrawal: Like other phenothiazines, Cltonactil (Cltonactil) 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 Cltonactil (Cltonactil) is withdrawn.
What happens if I miss a dose of Cltonactil?
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
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).
