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PROLINATE INJ.
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FLUPHENAZINE DECANOATE INJ.
ANTI-PSYCHOTICS
SUN PHARMA LTD
Product Details
Fluphenazine
A to Z Drug Facts
Fluphenazine
Action
Indications
Contraindications
Route/Dosage
Interactions
Lab Test Interferences
Adverse Reactions
PrecautionsPatient Care Considerations
Administration/Storage
Assessment/Interventions
Patient/Family Education
(flew-FEN-uh-zeen)Fluphenazine HClPermitil, Prolixin, Apo-Fluphenazine, Moditen HCl, PMS-FluphenazineFluphenazine EnanthateProlixin Enanthate,
Moditen EnanthateFluphenazine DecanoateProlixin Decanoate,
Modecate, PMS-Fluphenazine Decanoate, Rho-Fluphenazine DecanoateClass: Antipsychotic/Phenothiazine; Antiemetic
Action Blocks dopamine receptor in CNS.
Indications Fluphenazine HCl: Management of psychotic disorders. Fluphenazine decanoate and fluphenazine enanthate: Long-acting parenteral depot products for long-term antipsychotic therapy. unlabeled use(s): Treatment of Tourette's syndrome; acute agitation in elderly; some symtoms of dementia; hyperactivity; hallucinations; suspiciousness; hostility and uncooperative behaviors; Huntington's chorea.
Contraindications Allergy to any phenothiazine; comatose or severely depressed states; concurrent use of large doses of other CNS depressants; bone marrow depression or blood dyscrasias; liver damage; cerebral arteriosclerosis; coronary artery disease; severe hypotension or hypertension; subcortical brain damage.
Route/Dosage
&NA;
FLUPHENAZINE HCL
ADULTS: PO 0.5 to 40 mg/day in divided doses. IM 2.5 to 10 mg/day in divided doses 6 to 8 hr apart.
Use dosages in excess of 20 mg with caution.
Fluphenazine Decanoate or Enanthate
ADULTS: IM/SC Initial dose: 12.5 to 25 mg. Do not exceed 100 mg/dose. Usual dosing interval: 1 to 4 wk.
Interactions
Alcohol: Increased CNS depression; may precipitate extrapyramidal reaction. Anticholinergics: Reduced therapeutic effects and increased anticholinergic side effects of fluphenazine; may lead to tardive dyskinesia. Barbiturate anesthetics: Increased frequency and severity of neuromuscular excitation and hypotension. Beta-blockers: Increased plasma levels of both drugs. Bromocriptine: Effectiveness of bromocriptine may be reduced. Guanethidine: Hypotensive action may be inhibited. Hydantoins (eg, phenytoin): Increase or decrease in phenytoin levels. Lithium: May result in disorientation, unconsciousness, and extrapyramidal symptoms. Metrizamide: Increased seizure risk.
Lab Test Interferences False-positive pregnancy tests may occur but are less likely with serum test. Increases in protein-bound iodine have been reported. Increased cephalin flocculation accompanied by altered liver function tests has been reported with fluphenazine enanthate. Discolored urine: pink to red-brown.
Adverse Reactions
CV: Orthostatic hypotension; hypertension; tachycardia; bradycardia; syncope; cardiac arrest; circulatory collapse; lightheadedness; faintness; dizziness; ECG changes; arrhythmias; CHF. CNS: Pseudoparkinsonism; dyskinesia; motor restlessness; oculogyric crises; opisthotonos; hyperreflexia; tardive dyskinesia; headache; weakness; tremor; fatigue; slurring; insomnia; vertigo; seizures; drowsiness; hallucinations. DERM: Photosensitivity; skin pigmentation; dry skin; exfoliative dermatitis; urticarial rash; maculopapular hypersensitivity reaction; seborrhea; eczema; jaundice. EENT: Pigmentary retinopathy; glaucoma; photophobia; blurred vision; miosis; mydriasis; increased intraocular pressure; dry mouth or throat; nasal congestion. GI: Nausea; dyspepsia; constipation. GU: Menstrual irregularities; urinary hesitancy and retention; impotence; sexual dysfunction. HEMA: Agranulocytosis; eosinophilia; leukopenia; hemolytic anemia; thrombocytopenic purpura. HEPA: Jaundice. META: Decreased cholesterol. RESP: Laryngospasm; bronchospasm; dyspnea. OTHER: Increases in appetite and weight; polydipsia; dysmenorrhea; breast enlargement; galactorrhea; increased prolactin levels; adynamic ileus (may result in death); neuroleptic malignant syndrome (NMS).
Precautions
Pregnancy: Pregnancy category undetermined. Lactation: Safety not established. Children: Not recommended in children < 12 yr. Adolescents, elderly or debilitated patients: More susceptible to effects; consider reduced dose. Special risk patients: Use with caution in patients with cardiovascular disease or mitral insufficiency, history of glaucoma, EEG abnormalities or seizure disorders, prior brain damage, hepatic or renal impairment, and patients exposed to extreme heat or phosphorous insecticides. Abrupt withdrawal: Although this drug is not known to cause psychological or physical dependence, abrupt discontinuation of high-dose therapy has been associated with withdrawal symptoms (eg, nausea, vomiting, dizziness, headache, tachycardia, insomnia, tremulousness). NMS: Potentially fatal condition that has occurred, most often with fluphenazine decanoate or enanthate. Signs and symptoms include hyperpyrexia, muscle rigidity, altered mental status, irregular pulse, fluctuating blood pressure, tachycardia, and diaphoresis. Pulmonary effects: Cases of bronchopneumonia, some fatal, have occurred. Sudden death: Has been reported; predisposing factors may be seizures or previous brain damage. Flare-up of psychotic behavior may precede death. Tardive dyskinesia: Syndrome of potentially irreversible, involuntary body and facial movements may develop. Prevalence highest in elderly, especially women. Use smallest effective doses for shortest possible time period. Tartrazine: Some formulations contain tartrazine, which may cause allergic-type reactions in susceptible individuals.
PATIENT CARE CONSIDERATIONS
Administration/Storage
- Give with food to avoid GI irritation. Tablets may be crushed if patient has difficulty swallowing.
- Because antacids diminish drug absorption, give oral preparation at least 1 hr before or 1 hr after administration of antacid.
- Divided doses are usually given initially; however, once-daily dosing is very useful for maintenance and improves compliance.
- Mix HCl concentrate only with the following diluents: water, milk, carbonated orange or lemon-lime beverage or pineapple, orange, apricot, prune, grapefruit, or tomato juice. Avoid caffeinated colas and drinks, tea, and apple juice, because incompatibility may result.
- When giving by IM route, use deep, slow injection; massage well.
- Keep patient recumbent for at least ½ hr after IM injection to minimize hypotension.
- Potency of IM solution is not altered when solution is slightly yellowed.
- Store all forms at room temperature and avoid exposure to direct sunlight, excessive heat or cold.
Assessment/Interventions
- Obtain patient history, including drug history and any known allergies. Note sensitivity to this or other phenothiazines.
- Ensure that baseline lab tests (eg, BUN, creatinine, electrolytes, CBC with differential, platelets, liver function tests and ophthalmic examination), vital signs, and weight have been obtained before beginning therapy.
- Assess mental status, mood, behavior, activity, and interest level daily. Side effects are most common during first few days of therapy.
- Weigh patient weekly and monitor I&O.
- Monitor for signs of tardive dyskinesias (eg, involuntary movements of tongue, face, mouth, or jaw). Notify physician if these signs occur.
- Monitor for extrapyramidal symptoms (eg, akinesia, akathisia, pseudoparkinsonism, dystonias and occulogyric crisis). Notify physician if these occur.
- Monitor patient's bowel function. Encourage intake of food and fluid to prevent constipation.
- Assess for symptoms of blood dyscrasias (eg, fever, sore throat, malaise, excessive bruising, unusual bleeding).
- Notify physician immediately if symptoms of neuroleptic malignant syndrome occur (eg, rapid-onset muscular rigidity, akinesia, respiratory difficulty, hyperthermia).
OVERDOSAGE: SIGNS & SYMPTOMS Somnolence, coma, extrapyramidal symptoms, cardiac arrhythmias, fever hypotension, seizures
Patient/Family Education
- Stress importance of taking medication even if patient feels that he or she no longer needs it. Symptoms may recur if medication is discontinued.
- Emphasize that drug is not addictive, but tell patient not to stop taking drug abruptly, because withdrawal symptoms may occur (eg, nausea, vomiting, headache, insomnia, tremulousness, and tachycardia).
- Advise patient to dress warmly in cold weather and to avoid extended exposure to either very hot or very cold temperatures.
- Advise patient to carry card or wear Medi-Alert tag at all times listing name and dosage of medication.
- Explain that jaundice is a common side effect, usually occurs between second and fourth weeks of treatment, and is harmless.
- Tell patient that drug may cause urine to become pink or red-brown colored; this is harmless.
- Instruct patient to report the following symptoms to physician: Sore throat, fever, easy bruising, unusual bleeding, muscular rigidity, respiratory difficulty, tachycardia, yellow skin or sclera, skin rash, light-colored stools, vision changes, cellulitis, constipation, urinary retention.
- Tell patient to take sips of water frequently, suck on ice chips or sugarless hard candy, or chew sugarless gum if dry mouth occurs.
- Advise patient that drug may cause drowsiness and to use caution while driving or performing tasks requiring mental alertness.
- Caution patient to avoid sudden position changes to prevent dizziness or lightheadedness.
- Instruct patient to avoid intake of alcoholic beverages or other CNS depressants, which may precipitate extrapyramidal reactions.
- Caution patient to avoid exposure to sunlight and to use sunscreen or wear protective clothing to avoid photosensitivity reaction.
- Instruct patient not to take otc medications without consulting physician. Many drug interactions occur with this medication.
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Copyright © 2003 Facts and Comparisons
David S. Tatro
A to Z Drug Facts