Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1906
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| dailymed-drugs:1906 | rdf:type | http://www4.wiwiss.fu-berli... | lld:dailymed |
| dailymed-drugs:1906 | rdf:type | dailymed-instance:drugs | lld:dailymed |
| dailymed-drugs:1906 | rdfs:label | PROLIXIN (Tablet, Film Coated) | lld:dailymed |
| dailymed-drugs:1906 | dailymed-instance:dosage | PROLIXIN Elixir should be inspected prior to use. Upon standing a slight wispy precipitate or globular material may develop due to the flavoring oils separating from the solution (potency is not affected). Gentle shaking redisperses the oils and the solution becomes clear. Solutions that do not clarify should not be used. Depending on the severity and duration of symptoms, total daily dosage for adult psychotic patients may range initially from 2.5 to 10.0 mg and should be divided and given at six- to eight-hour intervals. The smallest amount that will produce the desired results must be carefully determined for each individual, since optimal dosage levels of this potent drug vary from patient to patient. In general, the oral dose has been found to be approximately two to three times the parenteral dose of fluphenazine. Treatment is best instituted with a low initial dosage, which may be increased, if necessary, until the desired clinical effectsare achieved. Therapeutic effect is often achieved with doses under 20 mg daily. Patients remaining severely disturbed or inadequately controlled may require upward titration of dosage. Daily doses up to 40 mg may be necessary; controlled clinical studies have not been performed to demonstrate safety of prolonged administration of such doses. When symptoms are controlled, dosage can generally be reduced gradually to daily maintenance doses of 1.0 or 5.0 mg, often given as a single daily dose. Continued treatment is needed to achieve maximum therapeutic benefits; further adjustments in dosage may be necessary during the course of therapy to meet the patient's requirements. For psychotic patients who have been stabilized on a fixed daily dosage or orally administered PROLIXIN (fluphenazine hydrochloride) dosage forms, conversion to the long-acting injectable PROLIXIN Decanoate may be indicated [see package insert for PROLIXIN Decanoate (Fluphenazine Decanoate Injection) for conversion information]. For geriatric patients, the suggested starting dose is 1.0 to 2.5 mg daily, adjusted according to the response of the patient. PROLIXIN Injection (Fluphenazine Hydrochloride Injection USP) is useful when psychotic patients are unable or unwilling to take oral therapy. | lld:dailymed |
| dailymed-drugs:1906 | dailymed-instance:descripti... | PROLIXIN is a trifluoromethyl phenothiazine derivative intended for the management of schizophrenia. Fluphenazine hydrochloride is described chemically as 4-[3-[2-(Trifluoromethyl)phenothiazin-10-yl] propyl]-1-piperazineethanol dihydrochloride and its molecular formula is CHFNOSHCl. The molecular structure is shown below: PROLIXIN Tablets (Fluphenazine Hydrochloride Tablets) contain 5 and 10 mg fluphenazine hydrochloride per tablet. Inactive ingredients: Aluminum Lakes of the following colorants: [D&C Red No. 27 and D&C Red No. 30 for 10 mg only; FD&C Blue No. 1 for 5 mg only; FD&C Blue No.2 for 10 mg only; FD&C Yellow No. 5 (tartrazine) for 5 mg only; FD&C Yellow No. 6 for 10 mg only], croscarmellose sodium; hydroxypropyl methylcellulose, lactose monohydrate; polyethylene glycol; polysorbate 80, povidone, stearic acid, and titanium dioxide. PROLIXIN Elixir (Fluphenazine Hydrochloride Elixir) contains 0.5 mg fluphenazine hydrochloride per mL. Inactive ingredients: alcohol [14% v/v], colorant (FD&C Yellow No. 6), flavors, glycerin, polysorbate 40, purified water, sodium benzoate, and sucrose. | lld:dailymed |
| dailymed-drugs:1906 | dailymed-instance:clinicalP... | PROLIXIN has activity at all levels of the central nervous system as well as on multiple organ systems. The mechanism whereby its therapeutic action is exerted is unknown. | lld:dailymed |
| dailymed-drugs:1906 | dailymed-instance:activeIng... | dailymed-ingredient:fluphen... | lld:dailymed |
| dailymed-drugs:1906 | dailymed-instance:contraind... | Phenothiazines are contraindicated in patients with suspected or established subcortical brain damage, in patients receiving large doses of hypnotics, and in comatose or severely depressed states. The presence of blood dyscrasia or liver damage precludes the use of fluphenazine hydrochloride. PROLIXIN (fluphenazine hydrochloride) is contraindicated in patients who have shown hypersensitivity to fluphenazine; cross-sensitivity to phenothiazine derivatives may occur. | lld:dailymed |
| dailymed-drugs:1906 | dailymed-instance:supply | PROLIXIN Tablets (Fluphenazine Hydrochloride Tablets USP) 5 mg:each film-coated tablet is green, round, biconvex, debossed with PPP over 877 bottles of 100 NDC 0003-0877-50 10 mg:each film-coated tablet is pink, round, biconvex, debossed with PPP over 956 bottles of 100 NDC 0003-0956-50 PROLIXIN Elixir (Fluphenazine Hydrochloride Elixir USP) 0.5 mg/mL (2.5 mg per 5 mL teaspoonful) 60 mL bottle withcalibrated dropper NDC 0003-0820-30 473 mL bottle NDC 0003-0820-50 PROLIXIN (Fluphenazine Hydrochloride) is also available as an oral solution concentrate and a sterile aqueous solution for intramuscular use. See specific package inserts for complete information.<br/>Storage: Store tablets and elixir at room temperature. Protect from light. Keep tightly closed. Tablets: Avoid excessive heat. Elixir: Avoid freezing. | lld:dailymed |
| dailymed-drugs:1906 | dailymed-instance:activeMoi... | dailymed-ingredient:fluphen... | lld:dailymed |
| dailymed-drugs:1906 | dailymed-instance:inactiveI... | dailymed-ingredient:povidon... | lld:dailymed |
| dailymed-drugs:1906 | dailymed-instance:inactiveI... | dailymed-ingredient:polysor... | lld:dailymed |
| dailymed-drugs:1906 | dailymed-instance:inactiveI... | dailymed-ingredient:titaniu... | lld:dailymed |
| dailymed-drugs:1906 | dailymed-instance:inactiveI... | dailymed-ingredient:lactose... | lld:dailymed |
| dailymed-drugs:1906 | dailymed-instance:inactiveI... | dailymed-ingredient:hydroxy... | lld:dailymed |
| dailymed-drugs:1906 | dailymed-instance:inactiveI... | dailymed-ingredient:polyeth... | lld:dailymed |
| dailymed-drugs:1906 | dailymed-instance:inactiveI... | dailymed-ingredient:croscar... | lld:dailymed |
| dailymed-drugs:1906 | dailymed-instance:inactiveI... | dailymed-ingredient:stearic... | lld:dailymed |
| dailymed-drugs:1906 | dailymed-instance:inactiveI... | dailymed-ingredient:FD&C_Bl... | lld:dailymed |
| dailymed-drugs:1906 | dailymed-instance:inactiveI... | dailymed-ingredient:FD&C_Ye... | lld:dailymed |
| dailymed-drugs:1906 | dailymed-instance:precautio... | General: Because of the possibility of cross-sensitivity, fluphenazine hydrochloride should be used cautiously in patients who have developed cholestatic jaundice, dermatoses or other allergic reactions to phenothiazine derivatives. PROLIXIN Tablets (Fluphenazine Hydrochloride Tablets) 5 mg only contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity. Psychotic patients on large doses of a phenothiazine drug who are undergoing surgery should be watched carefully for possible hypotensive phenomena. Moreover, it should be remembered that reduced amounts of anesthetics or central nervous system depressants may be necessary. The effects of atropine may be potentiated in some patients receiving fluphenazine because of added anticholinergic effects. Fluphenazine hydrochloride should be used cautiously in patients exposed to extreme heat or phosphorus insecticides; in patients with a history of convulsive disorders, since grand mal convulsions have been known to occur; and in patients with special medical disorders, such as mitral insufficiency or other cardiovascular diseases and pheochromocytoma. The possibility of liver damage, pigmentary retinopathy, lenticular and corneal deposits, and development of irreversible dyskinesia should be remembered when patients are on prolonged therapy. 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 too limited to be conclusive at this time.<br/>Information for Patients: Given the likelihood that some patients exposed chronically to neuroleptics 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.<br/>Abrupt Withdrawal: In general, phenothiazines do not produce psychic dependence; however, gastritis, nausea and vomiting, dizziness, and tremulousness have been reported following abrupt cessation of high dose therapy. Reports suggest that these symptoms can be reduced if concomitant antiparkinsonian agents are continued for several weeks after phenothiazine is withdrawn. Facilities should be available for periodic checking of hepatic function, renal function and the blood picture. Renal function of patients on long-term therapy should be monitored; if BUN (blood urea nitrogen) becomes abnormal, treatment should be discontinued. As with any phenothiazine, the physician should be alert to the possible development of���silent pneumonias���in patients under treatment with fluphenazine hydrochloride. | lld:dailymed |
| dailymed-drugs:1906 | dailymed-instance:genericMe... | fluphenazine hydrochloride | lld:dailymed |
| dailymed-drugs:1906 | dailymed-instance:fullName | PROLIXIN (Tablet, Film Coated) | lld:dailymed |
| dailymed-drugs:1906 | dailymed-instance:adverseRe... | Central Nervous System: The side effects most frequently reported with phenothiazine compounds are extrapyramidal symptoms including pseudoparkinsonism, dystonia, dyskinesia, akathisia, oculogyric crises, opisthotonos, and hyperreflexia. Most often these extrapyramidal symptoms are reversible; however, they may be persistent (see below). With any given phenothiazine derivative, the incidence and severity of such reactions depend more on individual patient sensitivity than on other factors, but dosage level and patient age are also determinants. Extrapyramidal reactions may be alarming, and the patient should be forewarned and reassured. These reactions can usually be controlled by administration of antiparkinsonian drugs such as benztropine mesylate or intravenous caffeine and sodium benzoate injection, and by subsequent reduction in dosage.<br/>Tardive Dyskinesia: See WARNINGS. The syndrome is characterized by involuntary choreoathetoid movements which variously involve the tongue, face, mouth, lips, or jaw (e.g., protrusions of the tongue, puffing of cheeks, puckering of the mouth, chewing movements), trunk and extremities. The severity of the syndrome and the degree of impairment produced vary widely. The syndrome may become clinically recognizable either during treatment, upon dosage reduction, or upon withdrawal of treatment. Early detection of tardive dyskinesia is important. To increase the likelihood of detecting the syndrome at the earliest possible time, the dosage of neuroleptic drugs should be reduced periodically (if clinically possible) and the patient observed for signs of the disorder. This maneuver is critical, since neuroleptic drugs may mask the signs of the syndrome.<br/>Other CNS Effects: Occurrences of neuroleptic malignant syndrome (NMS) have been reported in patients on neuroleptic therapy . Leukocytosis, elevated CPK, liver function abnormalities, and acute renal failure may also occur with NMS. Drowsiness or lethargy, if they occur, may necessitate a reduction in dosage; the induction of a catatonic-like state has been known to occur with dosages of fluphenazine far in excess of the recommended amounts. As with other phenothiazine compounds, reactivation or aggravation of psychotic processes may be encountered. Phenothiazine derivatives have been known to cause, in some patients, restlessness, excitement, or bizarre dreams.<br/>Autonomic Nervous System: Hypertension and fluctuation in blood pressure have been reported with fluphenazine hydrochloride. Hypotension has rarely presented a problem with fluphenazine. However, patients with pheochromocytoma, cerebral vascular or renal insufficiency, or a severe cardiac reserve deficiency (such as mitral insufficiency) appear to be particularly prone to hypotensive reactions with phenothiazine compounds, and should therefore be observed closely when the drug is administered. If severe hypotension should occur, supportive measures including the use of intravenous vasopressor drugs should be instituted immediately. Levarterenol Bitartrate Injection is the most suitable drug for this purpose; epinephrine should not be used since phenothiazine derivatives have been found to reverse its action, resulting in a further lowering of blood pressure. Autonomic reactions including nausea and loss of appetite, salivation, polyuria, perspiration, dry mouth, headache, and constipation may occur. Autonomic effects can usually be controlled by reducing or temporarily discontinuing dosage. In some patients, phenothiazine derivatives have caused blurred vision, glaucoma, bladder paralysis, fecal impaction, paralytic ileus, tachycardia, or nasal congestion.<br/>Metabolic and Endocrine: Weight change, peripheral edema, abnormal lactation, gynecomastia, menstrual irregularities, false results on pregnancy tests, impotency in men and increased libido in women have all been known to occur in some patients on phenothiazine therapy.<br/>Allergic Reactions: Skin disorders such as itching, erythema, urticaria, seborrhea, photosensitivity, eczema and even exfoliative dermatitis have been reported with phenothiazine derivatives. The possibility of anaphylactoid reactions occurring in some patients should be borne in mind.<br/>Hematologic: Routine blood counts are advisable during therapy since blood dyscrasias including leukopenia, agranulocytosis, thrombocytopenic or nonthrombocytopenic purpura, eosinophilia, and pancytopenia have been observed with phenothiazine derivatives. Furthermore, if any soreness of the mouth, gums, or throat, or any symptoms of upper respiratory infection occur and confirmatory leukocyte count indicates cellular depression, therapy should be discontinued and other appropriate measures instituted immediately.<br/>Hepatic: Liver damage as manifested by cholestatic jaundice may be encountered, particularly during the first months of therapy; treatment should be discontinued if this occurs. An increase in cephalin flocculation, sometimes accompanied by alterations in other liver function tests, has been reported in patients receiving fluphenazine hydrochloride who have had no clinical evidence of liver damage.<br/>Others: Sudden, unexpected and unexplained deaths have been reported in hospitalized psychotic patients receiving phenothiazines. Previous brain damage or seizures may be predisposing factors; high doses should be avoided in known seizure patients. Several patients have shown sudden flare-ups of psychotic behavior patterns shortly before death. Autopsy findings have usually revealed acute fulminating pneumonia or pneumonitis, aspiration of gastric contents, or intramyocardial lesions. Although this is not a general feature of fluphenazine, potentiation of central nervous system depressants (opiates, analgesic, antihistamines, barbiturates, alcohol) may occur. The following adverse reactions have also occurred with phenothiazine derivatives: systemic lupus erythematosus-like syndrome, hypotension severe enough to cause fatal cardiac arrest, altered electrocardiographic and electroencephalographic tracings, altered cerebrospinal fluid proteins, cerebral edema,asthma, laryngeal edema, and angioneurotic edema; with long-term use���skin pigmentation, and lenticular and corneal opacities. | lld:dailymed |
| dailymed-drugs:1906 | dailymed-instance:indicatio... | PROLIXIN is indicated in the management of manifestations of psychotic disorders. PROLIXIN has not been shown effective in the management of behavioral complications in patients with mental retardation. | lld:dailymed |
| dailymed-drugs:1906 | dailymed-instance:represent... | http://www4.wiwiss.fu-berli... | lld:dailymed |
| dailymed-drugs:1906 | dailymed-instance:routeOfAd... | http://www4.wiwiss.fu-berli... | lld:dailymed |
| dailymed-drugs:1906 | dailymed-instance:name | PROLIXIN | lld:dailymed |
| http://www4.wiwiss.fu-berli... | dailymed-instance:producesD... | dailymed-drugs:1906 | lld:dailymed |