fluphenazine (Rx) - Modecate, Modecate Concentrate, more..Moditen, Prolixin, RhoFluphenazine
Adult Dosing & Uses
Dosing Forms & Strengths
tablets
- 1mg
- 2.5mg
- 5mg
- 10mg
elixir
- 2.5mg/5mL
oral concentrate
- 5mg/mL
injectable solution
- 2.5mg/mL
- 25mg/mL
Psychotic Disorders
Initial 2.5-10 mg/day PO divided q6-8hr
Maintenance: 1-5 mg PO/IM divided q6-8hr
Not to exceed 40 mg/day
Decanoate: 12.5-75 mg (25 mg/mL) IM/SC q2-4week
Daily PO dose x1.2 = decanoate dose q2week (10 mg PO approximately equals 12.5 mg decanoate)
Geriatric Dosing
1-2.5 mg PO qDay; titrate dose to response
Renal Impairment
Use caution; monitor
Hepatic Impairment
Use caution; monitor
Pediatric Dosing & Uses
<12 years old: not indicated
Drug Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Adverse Effects
Frequency Not Defined
Confusion
Decreased gag reflex
EPS
- Akathesia (60%; maybe less with decanoate form)
- Dystonia
- Dyskinesia
- Muscle stiffness
- NMS (infrequent but serious)
- Parkinsonism
- Tardive dyskinesia
Common
- Anticholinergic effects
- Sedation
- Weight gain
- Erectile dysfunction
- Oligomenorrhea/amenorrhea
Less Common
- Orthostatic hypotension (post-IM inj), tachycardia
- Agitation, anxiety, cerebral edema, depression, dizziness, euphoria, headache, poikilothermia, restlessness, weakness
- Anorexia, constipation, dyspepsia, ileus
- Lens opacities (prolonged use)
Uncommon
- ECG changes
- Photosensitivity
- Pruritis
- Diarrhea
- Blood dyscrasia
- Galactorrhea
- Ejaculatory disorder
Rare
- Seizure
- Priapism
- Cholestatic jaundice
Contraindications & Cautions
Black Box Warnings
Patients with dementia-related psychosis who are treated with antipsychotic drugs are at an increased risk of death as shown in short-term controlled trials. The deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature
This drug is not approved for the treatment of patients with dementia-related psychosis
Contraindications
Documented hypersensitivity
Coma, severe hypotension, severe CNS depression, concurrency with large amounts of CNS depressants, subcortical brain damage, poorly controlled seizure disorder, blood dyscrasias, severe cardiovascular disease
Narrow-angle glaucoma
Lactation
Cautions
Glaucoma, prostatic hypertrophy, stenosing PUD, history of NMS, Parkinson's disease, hypocalcemia, renal/hepatic impairment, patients who have exhibited a severe reaction to insulin or ECT, history of seizures, asthma, respiratory tract infections, cardiovascular disease
Mild leukocytosis, leukopenia, and eosinophilia occasionally occur
Dermatological reactions are common
Watch for urinary retention, blurred vision, dry mouth, and constipation as a result of anticholinergic effects
Risk of EPS, NMS, hypotension
Hypotension may be particularly severe in patients with pheochromocytoma or mitral insufficiency
Depresses hypothalamic thermoregulatory mechanism; exposure to extreme temperatures may cause hypo- or hyperthermia
In case of severe hypotension, use norepinephrine or phenylepinephrine, do NOT use epinephrine or dopamine
May need anticholinergic antiparkinsonian agent to counter EPS
FDA Warning regarding off-label use for dementia in elderly
Pregnancy & Lactation
Pregnancy Category: C
Lactation: enters breast milk; not recommended
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Pharmacology
Mechanism of Action
Phenothiazine; dopaminergic D1 and D2 receptor antagonist; depresses release of hypothalamic and hypophyseal hormones
Pharmacokinetics
Half-Life: 14-16 hr (hydrochloride); 7-14 d (decanoate)
Onset: 1 hr; 24-72 hr (decanoate)
Duration: 6-8 hr; 2 wk (decanoate)
Peak effect: 48-96 hr (decanoate)
Peak Plasma Time: 2 hr (hydrochloride); 8-10 hr (decanoate)
Bioavailability: rapidly absorbed
Excretion: urine, feces
