Prochlorperazine Maleate Tablets
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Prochlorperazine Maleate Tablets

10.10.2017 | Natalie Carter
Prochlorperazine Maleate Tablets

Suitable supportive measures such as maintaining a clear airway and adequate hydration should be employed. These symptoms are seen in a significant number of hospitalized mental patients. In most cases barbiturates by suitable route of administration will suffice. (Or, injectable Benadrylll may be useful). They may be characterized by motor restlessness, be of the dystonic type, or they may resembleparkinsonism. Should these symptoms occur in children or pregnant patients, the drug should be stopped and not reinstituted. In more severe cases, the administration of an anti-parkinsonism agent, except levodopa (See PDR ), usually produces rapid reversal of symptoms. If therapy is reinstituted, it should be at a lower dosage. Depending on the severity of symptoms, dosage should be reduced or discontinued.

10 mg (Chartreuse, round, scored, film-coated, imprinted TL 115).

Prochlorperazine Maleate Tablets USP are available in the following strengths and package sizes:

2. Children with schizophrenia:.

Although phenothiazines cause neither psychic nor physical dependence, sudden discontinuance in long-term psychiatric patients may cause temporary symptoms, e.g., nausea and vomiting, dizziness, tremulousness.

However, some patients may require treatment despite the presence of the syndrome. If signs and symptoms of tardive dyskinesia appear in a patient on antipsychotics, drug discontinuation should be considered.

Should it be necessary to reinstitute treatment, or increase the dosage of the agent, or switch to a different antipsychotic agent, the syndrome may be masked.

There is no known treatment for established cases of tardive dyskinesia, although the syndrome may remit, partially or compley, if antipsychotic drug treatment is withdrawn. Antipsychotic drug treatment itself, however, may suppress (or partially suppress) the signs and symptoms of the syndrome and thereby may possibly mask the underlaying disease process.

2 aluminum lake, FD&C yellow no. 10 aluminum lake, FD&C blue no. 6 aluminum lake, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid and titanium dioxide. Each tablet, for oral administration contains prochlorperazine maleate equivalent to 5 mg or 10 mg of prochlorperazine. In addition, each tablet contains the following inactive ingredients: D&C yellow no.

Some adverse reactions 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 of certain phenothiazines. Adverse Reactions Reported with Prochlorperazine or Other Phenothiazine Derivatives: Adverse reactions with different phenothiazines vary in type, frequency and mechanism of occurrence, i.e., some are dose-related, while others involve individual patient sensitivity.

It has been reported that fine vermicular movements of the tongue may be an early sign of the syndrome and if the medication is stopped at that time the syndrome may not develop.

The effect that symptomatic suppression has upon the long-term course of the syndrome is unknown.

Occasionally the patient may react to the drug with signs of restlessness and excitement; if this occurs, do not administer additional doses. Take particular precaution in administering the drug to children with acute illnesses or dehydration (see under Dystonias ).

For further information about the description of tardive dyskinesia and its clinical detection, please refer to the sections on PRECAUTIONS and ADVERSE REACTIONS.

Oral Dosage: For children 2 to 12 years, starting dosage is 21/2 mg 2 or 3 times daily. Then increase dosage according to patient's response. Do not give more than 10 mg the first day.

Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous systems (CNS) pathology. 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 inadequay treated extrapyramidal signs and symptoms (EPS).

However, prochlorperazine is not the first drug to be used in therapy for most patients with non-psychotic anxiety, because certain risks associated with its use are not shared by common alternative treatments (e.g., benzodiazepines ). Prochlorperazine is effective for the short-term treatment of generalized non-psychotic anxiety.

Treatment with anti-parkinsonian agents, benzodiazepines or propranolol may be helpful. If these symptoms become too troublesome, they can usually be controlled by a reduction of dosage or change of drug.

(Or, injectable Benedryl may be useful. In moderate cases, barbiturates will usually bring rapid relief. Note: See Benedryl prescribing information for appropriate children's dosage). In more severe adult cases, the administration of an anti-parkinsonism agent, except levodopa (See PDR ), usually produces rapid reversal of symptoms. In mild cases, reassurance or a barbiturate is often sufficient. In children, reassurance and barbiturates will usually control symptoms. If appropriate treatment with anti-parkinsonism agents or Benedryl fails to reverse the signs and symp-toms, the diagnosis should be reevaluated.

Oral Dosage: Non-Psychotic Anxiety-- Usual dosage is 5 mg 3 or 4 times daily; or one 10 mg tablet q12h. Do not administer in doses of more than 20 mg per day or for longer than 12 weeks.

When used in the treatment of non-psychotic anxiety, prochlorperazine should not be adminis-tered at doses of more than 20 mg per day or for longer than 12 weeks, because the use of prochlorperazine at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see WARNINGS ).


In Adult Psychiatric Disorders: Adjust dosage to the response of the individual and according to the severity of the condition. Although response ordinarily is seen within a day or 2, longer treatment is usually required before maximal improvement is seen. 2. Begin with the lowest recommended dose.

Tardive Dyskinesia: Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements, may develop in patients treated with antipsychotic drugs. Whether antipsychotic drug products differ in their potential to cause tardive dyskinesia is unknown. 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 drug treatment, which patients are likely to develop the syndrome.

Contact Dermatitis: Avoid getting the injection solution on hands or clothing because of the possibility of contact dermatitis.

These usually subside within a few hours, and almost always within 24 to 48 hours, after the drug has been discontinued. Dystonias: Symptoms may include: spasm of the neck muscles, sometimes progressing to torticollis ; extensor rigidity of back muscles, sometimes progressing to opisthotonos ; car-popedal spasm, trismus, swallowing difficulty, oculogyric crisis and protrusion of the tongue.

Store at 20°to 25°C (68°to 77°F). Protect from light.

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.

Occasionally it is necessary to lower the dosage of prochlorperazine or to discontinue the drug. Reassurance and sedation are important. (Note: Levodopa has not been found effective in pseudo-parkinsonism). Anti-parkinsonism agents should be used only when required. Pseudo-Parkinsonism: Symptoms may include: mask-like facies; drooling; tremors; pillrolling motion; cogwheel rigidity; and shuffling gait. After this time patients should be evaluated to determine their need for continued treatment. Generally, therapy of a few weeks to 2 or 3 months will suffice. In most cases these symptoms are readily controlled when an anti-parkinsonism agent is administered concomitantly.

Dosage and frequency of administration should be adjusted according to the severity of the symptoms and the response of the patient. Severe Nausea and Vomiting in Children: Prochlorperazine should not be used in pediatric patients under 20 pounds in weight or 2 years of age. The duration of activity following intramuscular administration may last up to 12 hours. 1. Subsequent doses may be given by the same route if necessary. It should not be used in conditions for which children's dosages have not been established.

For control of severe nausea and vomiting.

Bottles of 100..........................NDC Bottles of 1000..........................NDC.

Tardive Dyskinesia: As with all antipsychotic agents, tardive dyskinesia may appear in some patients on long-term therapy or may appear after drug therapy has been discontinued. Sometimes these may be accompanied by involuntary movements of extremities. The syndrome is characterized by rhythmical involuntary movements of the tongue, face, mouth or jaw (e.g., protrusion of tongue, puffing of cheeks, puckering of mouth, chewing movements). A variant of tardive dyskinesia, tardive dystonia, has also been described. The syndrome can also develop, although much less frequently, after relatively brief treatment periods at low doses. Although its prevalence appears to be highest among elderly patients, 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. In rare instances, these involuntary movements of the extremities are the only manifestations of tardive dyskinesia. The symptoms are persistent and in some patients appear to be irreversible. This syndrome appears in all age groups.

FOR AGES 6 to 12, total daily dosage usually does not exceed 25 mg.

If tests indicate an abnormality, stop treatment. If fever with grippe-like symptoms occurs, appropriate liver studies should be conducted. There have been a few observations of fatty changes in the livers of patients who have died while receiving the drug. No causal relationship has been established. Cholestatic jaundice has occurred.

Daily dosages above 40 mg should be used only in resistant cases. Oral Dosage- Tablets: Usually one 5 mg or 10 mg tablet 3 or 4 times daily.

Given these considerations, antipsychotic drugs should be prescribed in a manner that is most likely to minimize the occurrence of tardive dyskinesia, especially in the elderly. The need for continued treatment should be reassessed periodically. Chronic antipsy-chotic 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.

EKG changes - particularly nonspecific, usually reversible Q and T wave distortions-have been observed in some patients receiving phenothiazine.

The extrapyramidal symptoms which can occur secondary to prochlorperazine 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 prochlorper-azine and other potential hepatotoxins should be avoided in children and adolescents whose signs and symptoms suggest Reye's syndrome.

Bottles of 100..........................NDC Bottles of 1000..........................NDC.

Prochlorperazine Maleate is classified as an antiemetic and antipsychotic tranquilizer. Prochlorperazine is a phenothiazine derivative, present in the tablets as the maleate. Its chemical name is 2-chloro-10- -10 H-phenothiazine (Z)-2-butenedioate (1:2). Empirical formulas (and molecular weight) are: prochlorperazine maleate-C 20 H 24 CIN 3 S•2C (606.10) and prochlorperazine base- C 20 H 24 CIN 3 S (373.95).

Begin with the lowest recommended dosage.

Dosage should be tailored to the individual, response carefully monitored and dosage adjusted accordingly. Since they appear to be more susceptible to hypotension and neuromuscular reactions, such patients should be observed closely. Elderly Patients: In general, dosages in the lower range are sufficient for most elderly patients. Dosage should be increased more gradually in elderly patients.

Not all of the following adverse reactions have been observed with every phenothiazine derivative, but they have been reported with 1 or more and should be borne in mind when drugs of this class are administered: extrapyramidal symptoms (opisthotonos, oculogyric crisis, hyper-reflexia, dystonia, akathisia, dyskinesia, parkinsonism ) some of which have lasted months and even years-particularly in elderly patients with previous brain damage; grand mal and petit mal convulsions, particularly in patients with EEG abnormalities or history of such disorders; altered cerebrospinal fluid proteins ; cerebral edema ; intensification and prolongation of the action of central nervous system depressants (opiates, analgesics, antihistamines, barbiturates, alcohol), atropine, heat, organophosphorus insecticides; autonomic reactions (dryness of mouth, nasal congestion, headache, nausea, constipation, obstipation, adynamic ileus, ejaculatory disorders/impotence, priapism, atonic colon, urinary retention, miosis and mydriasis ); reactivation of psychotic processes, catatonic-like states; hypotension (sometimes fatal); cardiac arrest ; blood dyscrasias ( pancytopenia, thrombocytopenic purpura, leukopenia, agranulocytosis, eosinophilia, hemolytic anemia, aplastic anemia ); liver damage (jaundice, biliary stasis); endocrine disturbances ( hyperglycemia, hypoglycemia, glycosuria, lactation, galactorrhea, gynecomastia, menstrual irregularities, false-positive pregnancy tests); skin disorders ( photosensitivity, itching, erythema, urticaria, eczema up to exfoliative dermatitis); other allergic reactions ( asthma, laryngeal edema, angioneurotic edema, anaphylactoid reactions); peripheral edema; reversed epinephrine effect; hyperpyrexia; mild fever after large I.M. doses; increased appetite; increased weight; a systemic lupus erythematosus-like syndrome; pigmentary retinopathy; with prolonged administration of substantial doses, skin pigmentation, epithelial keratopathy, and lenticular and corneal deposits.

FOR AGES 2 to 5, total daily dosage usually does not exceed 20 mg.

Weight Usual Dosage Not to Exceed under 20 lbs not recommended 20 to 29 lbs 2 1/2 mg 1 or 2 times a day 7.5 mg per day 30 to 39 lbs 2 1/2 mg 2 or 3 times a day 10 mg per day 40 to 85 lbs 2 1/2 mg 3 times a day or 5 mg 2 times a day 15 mg per day.

Drowsiness, dizziness, amenorrhea, blurred vision, skin reactions and hypotension may occur.

(For children's dosage and administration, see below. ) Dosage should be increased more gradually in debilitated or emaciated patients.

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l parents not to exceed prescribed dosage, since the possibility for adverse reactions increases as dosage rises. Therefore, use lowest effective dosage. Children seem more prone to develop extrapyramidal reactions, even on moderate doses.

1. To Control Severe Nausea and Vomiting: Adjust dosage to the response of the individual.

5 mg (Chartreuse, round, scored, film-coated, imprinted TL 113).

In more severe disturbances, optimum dosage is usually 100 to 150 mg daily. In moderate to severe conditions, for hospitalized or adequay supervised patients, usual starting dosage is 10 mg 3 or 4 times daily. Some patients respond satisfactorily on 50 to 75 mg daily. When dosage is increased by small increments every 2 or 3 days, side effects either do not occur or are easily controlled. Increase dosage gradually until symptoms are controlled or side effects become bothersome.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

NOTE: There have been occasional reports of sudden death in patients receiving phenothiazines. In some cases, the cause appeared to be cardiac arrest or asphyxia due to failure of the cough reflex No information provided. REFERENCE.

There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS. 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.

For the treatment of schizophrenia.

Psychotic Disorders including Schizophrenia--In relatively mild conditions, as seen in private psychiatric practice or in out-patient clinics, dosage is 5 or 10 mg 3 or 4 times daily.

Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic drugs (see WARNINGS ).

This evidence does not predict that prochlorperazine will be useful in patients with other non-psychotic conditions in which anxiety, or signs that mimic anxiety, are found (e.g., physical illness, organic mental conditions, agitated depression, character pathologies, etc.). The effectiveness of prochlorperazine as treatment for non-psychotic anxiety was established in 4-week clinical studies of outpatients with generalized anxiety disorder.

Neuroleptic Malignant Syndrome (NMS): A potentially fatal syndrome 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).

Prochlorperazine has not been shown effective in the management of behavioral complications in patients with mental retardation.

If white blood cell and differential counts indicate leukocyte depression, stop treatment and start antibiotic and other suitable therapy. Leukopenia and agranulocytosis have occurred. Warn patients to report the sudden appearance of sore throat or other signs of infection.

Motor Restlessness: Symptoms may include agitation or jitteriness and sometimes insomnia. Dosage should not be increased until these side effects have subsided. At times these symptoms may be similar to the original neurotic or psychotic symptoms. These symptoms often disappear spontaneously.

Manufactured for: Par Pharmaceutical Companies, Inc. FDA Rev date: n/a. Revised: 12/05. Salisbury, MD 21801, USA. Spring Valley, NY 10977, USA. Manufactured by: Jubilant Pharmaceuticals, Inc.

Do not use in pediatric surgery.

There is no known effective treatment for tardive dyskinesia; anti-parkinsonism agents do not alleviate the symptoms of this syndrome. It is suggested that all antipsychotic agents be discontinued if these symptoms appear.

Oral Dosage: More than 1 day's therapy is seldom necessary.