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TEVA-HALOPERIDOL is a brand name for Haloperidol, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
TEVA-HALOPERIDOL (haloperidol) prolongs the hypnotic action of barbiturates and may potentiate the effects of alcohol and other central nervous system depressant drugs, such as anesthetics and narcotics; caution should therefore be exercised when it is used with agents of this type and adjustments in its dosage may be required.
Haloperidol may lower the convulsive threshold and has been reported to trigger seizures in previously controlled known epileptics. When instituting haloperidol therapy in these patients, adequate anticonvulsant medication should be maintained concomitantly.
Elderly or debilitated patients receiving the drug should be carefully observed for any evidence of oversedation which might lead to dehydration and reduced pulmonary ventilation and could result in complications, such as terminal bronchopneumonia.
Although haloperidol is a relatively non-sedating neuroleptic, sedation may occur in some patients. Therefore, physicians should be aware of this possibility and caution patients about the danger of participating in activities requiring complete mental alertness, judgment and physical coordination, such as driving and operating dangerous machinery.
Haloperidol has been reported to interfere with the anticoagulant properties of phenindione in an isolated case, and the possibility should be kept in mind of a similar effect occurring when haloperidol is used with other anticoagulants.
Administration to patients with severe cardiac involvement should be guarded, despite the fact that haloperidol is well tolerated by patients with cardiac insufficiency and that it has been used with favorable results to maintain the cardiovascular function of patients with excitive crises.
In very rare instances, it has been felt that haloperidol was contributory to the precipitation of attacks in angina-prone patients. Moderate hypotension may occur with parenteral administration or excessive oral doses of haloperidol; however, vertigo and syncope occur only rarely.
Haloperidol has lowered the level of cholesterol in the serum and liver of monkeys. An accumulation of desmosterol has been observed in the serum of rats given repeated high doses (10 mg/kg) of haloperidol. In man, mild transient decreases in serum cholesterol were reported in preliminary studies.
However, in a study involving a group of schizophrenic patients on extended medication, significant lowering of serum cholesterol was not observed with haloperidol, and there was no accumulation of desmosterol or 7-dehydrocholesterol.
A significant lowering of cholesterol together with an accumulation of another sterol (possibly 7-dehydrocholesterol) has been reported in patients receiving a chemically related drug (trifluperidol), and skin and eye changes (ichthyosis and cataracts) have occurred clinically with another butyrophenone derivative.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Skin and eye changes have not been observed in patients receiving haloperidol. However, it is advisable that all patients receiving haloperidol for a prolonged period of time be carefully observed for any changes in the skin and eyes.
If such changes are seen, the drug should be discontinued promptly. Tardive dyskinesias are known to occur in patients on long-term antipsychotic therapy, including haloperidol (see ADVERSE REACTIONS). This should be borne in mind when using 4 neuroleptics, and if possible, the dosage should be reduced or the drug discontinued when manifestations of this syndrome are detected.
The antiemetic action of haloperidol may obscure signs of toxicity due to overdosage of other drugs or mask the symptoms of some organic diseases, such as brain tumor or intestinal obstructions. If an antiparkinson agent is used concomitantly with haloperidol, both drugs should not be discontinued simultaneously, since extrapyramidal symptoms may occur due to the slower excretion rate of haloperidol.
Neuroleptic drugs elevate prolactin levels; the elevation persists during chronic administration. Tissue culture experiments indicate that approximately one-third of human breast cancers are prolactin dependent in vitro, a factor of potential importance if the prescription 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 neuroleptic drugs.
Neither clinical studies 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 to be too limited to be conclusive at this time.
Neutropenia, granulocytopenia and agranulocytosis have been reported during antipsychotic use. Therefore, it is recommended that patients have their complete blood count (CBC) tested prior to starting TEVA-HALOPERIDOL and then periodically throughout treatment.
Withdrawal Emergent Neurological Signs:
Abrupt withdrawal after short-term administration of antipsychotic drugs does not generally pose problems. However, transient dyskinetic signs are experienced by some patients on maintenance therapy after abrupt withdrawal. The signs are very similar to those described under Tardive Dyskinesia, except for duration.
Although it is not known whether gradual withdrawal of antipsychotic drugs will decrease the incidence of withdrawal emergent neurological signs, gradual withdrawal would appear to be advisable.
Endocrine and Metabolism:
Hyperglycemia: Diabetic ketoacidosis (DKA) has occurred in patients with no reported history of hyperglycemia. Patients should have baseline and periodic monitoring of blood glucose and body weight.
Hyperprolactinemia:
Long-standing hyperprolactinemia when associated with hypogonadism may lead to decreased bone mineral density in both female and male […]