Sydepres

Sydepres

fluphenazine

Manufacturer:

SM Pharma

Distributor:

Rotex Pharma

Marketer:

Duopharma
Concise Prescribing Info
Contents
Fluphenazine decanoate
Indications/Uses
Psychiatric disorders including schizophrenia & mania. Severe anxiety & behavioural disturbances.
Dosage/Direction for Use
IM/SC Adult Initially 12.5-25 mg repeated or increased every 1-3 wk. Maintenance: Up to 50 mg every 1-4 wk. For dose >50 mg, increase cautiously in increments of 12.5 mg. Max: 100 mg/dose.
Contraindications
Hypersensitivity. Pre-existing CNS depression or coma, bone marrow suppression, or pheochromocytoma. Patients w/ impaired liver, kidney, CV, cerebrovascular & resp function; closed-angle glaucoma, Parkinsonism, DM, hypothyroidism, myasthenia gravis or prostatic hypertrophy. Patients w/ suspected or established subcortical damage. May affect ability to drive or operate machinery.
Special Precautions
May lower seizure threshold in epileptic patients & avoid in untreated epileptics. Administration at extreme temperatures. Regular eye exam in patients receiving long term therapy. Avoid undue exposure to direct sunlight. Patients should remain supine for at least 30 min after parenteral administration. Monitor BP. Pregnancy & lactation. Elderly & debilitated patients.
Adverse Reactions
Acute dystonia, parkinsonism-like syndrome & akathisia, tardive dyskinesia & perioral tremor. Dry mouth, constipation, micturition, blurred vision & mydriasis; tachycardia, electrocardiographic changes & cardiac arrhythmias (rare); HTN. Wt change, peripheral edema, abnormal lactation, gynecomastia, menstrual irregularities, false result on pregnancy tests, impotency in men & increased libido in women. Urticaria, exfoliative dermatitis, erythema multiforme & contact sensitivity. Leukopenia, agranulocytosis, thrombocytopenic or non-thrombocytopenic purpura, eosinophilia & pancytopenia; soreness of mouth, gums or throat or any symptoms of upper resp infections. Cholestatic jaundice. Pain & irritation at inj site.
Drug Interactions
May increase CNS depression produced by drugs eg alcohol, hypnotics, sedatives or strong analgesics. May antagonize action of adrenaline & other sympathomimetic agents & reverse BP-lowering effects of adrenergic-blocking agents eg, guanethidine & clonidine. May impair antiparkinsonian effect of L-dopa, effect of anticonvulsants, metabolism of TCAs & control of diabetes. May increase effect of anticoagulants & may interact w/ lithium. Anticholinergic effects may be enhanced by antiparkinsonian or other anticholinergic drugs. May enhance cardiac depressant effects of quinidine, absorption of corticosteroids & digoxin & neuromuscular blocking agents.
MIMS Class
Antipsychotics
ATC Classification
N05AB02 - fluphenazine ; Belongs to the class of phenothiazine antipsychotics with piperazine structure.
Presentation/Packing
Form
Sydepres soln for inj 25 mg/mL
Packing/Price
1 mL x 5 × 1's
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