Chlorpromazine Hydrochloride 10 mg/1
Chlorpromazine Hydrochloride · TABLET, COATED · Lannett Company, Inc.
Chlorpromazine Hydrochloride is a tablet, coated containing chlorpromazine hydrochloride at 10 mg/1, taken oral. Manufactured by Lannett Company, Inc..
Key Facts
- Brand Name
- Chlorpromazine Hydrochloride
- Generic Name
- Chlorpromazine Hydrochloride
- NDC Code (Product)
0527-2961- Manufacturer
- Lannett Company, Inc.
- Strength
- 10 mg/1
- Dosage Form
- TABLET, COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA212996
- Marketing Start
- 01/22/2021
Recall History
Zydus Pharmaceuticals (USA) Inc
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Amerisource Health Services LLC
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Zydus Pharmaceuticals (USA) Inc
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Zydus Pharmaceuticals (USA) Inc
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Zydus Pharmaceuticals (USA) Inc
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Zydus Pharmaceuticals (USA) Inc
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Zydus Pharmaceuticals (USA) Inc
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Amerisource Health Services LLC
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE For the management of manifestations of psychotic disorders. For the treatment of schizophrenia. To control nausea and vomiting. For relief of restlessness and apprehension before surgery. For acute intermittent porphyria. As an adjunct in the treatment of tetanus. To control the manifestations of the manic type of manic-depressive illness. For relief of intractable hiccups. For the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability and poor frustration tolerance.
Dosage & Administration
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. Elderly Patients In general, dosages in the lower range are sufficient for most elderly patients. Since theyappear 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…
Warnings
WARNINGS Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Chlorpromazine hydrochloride is not approved for the treatment of patients with dementia-related psychosis (see BOXED WARNING ). The extrapyramidal symptoms which can occur secondary to chlorpromazine hydrochloride 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 chlorpromazine hydrochloride 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. Whet…
Contraindications
CONTRAINDICATIONS Do not use in patients with known hypersensitivity to phenothiazines. Do not use in comatose states or in the presence of large amounts of central nervous system depressants (alcohol, barbiturates, narcotics, etc.).
Adverse Reactions
ADVERSE REACTIONS Note: Some adverse effects of chlorpromazine hydrochloride may be more likely to occur, or occur with greater intensity, in patients with special medical problems, e.g., patients with mitral insufficiency or pheochromocytoma have experienced severe hypotension following recommended doses. Drowsiness: usually mild to moderate, may occur, particularly during the first or second week, after which it generally disappears. If troublesome, dosage may be lowered. Jaundice: Overall incidence has been low, regardless of indication or dosage. Most investigators conclude it is a sensitivity reaction. Most cases occur between the second and fourth weeks of therapy. The clinical picture resembles infectious hepatitis, with laboratory features of obstructive jaundice, rather than those of parenchymal damage. It is usually promptly reversible on withdrawal of the medication; however, chronic jaundice has been reported. There is no conclusive evidence that pre-existing liver disease makes patients more susceptible to jaundice. Alcoholics with cirrhosis have been successfully treated with chlorpromazine hydrochloride without complications. Nevertheless, the medication should be us…
Frequently Asked Questions
What is Chlorpromazine Hydrochloride used for?
Chlorpromazine Hydrochloride contains Chlorpromazine Hydrochloride. It is a tablet, coated taken oral. Consult your doctor for specific uses.
Is Chlorpromazine Hydrochloride a controlled substance?
Chlorpromazine Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Chlorpromazine Hydrochloride?
The generic name for Chlorpromazine Hydrochloride is Chlorpromazine Hydrochloride. There are 6 other brand versions of Chlorpromazine Hydrochloride.
What is the NDC code for Chlorpromazine Hydrochloride 10 mg/1?
The NDC (National Drug Code) for Chlorpromazine Hydrochloride 10 mg/1 is 0527-2961, listed by Lannett Company, Inc..