INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo LORIEN CAPSULES
LORIEN TABLETS

SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

LORIEN CAPSULES
LORIEN TABLETS

COMPOSITION:
LORIEN CAPSULES: Contains fluoxetine hydrochloride equivalent to 20 mg fluoxetine per capsule.
LORIEN TABLETS: Contains fluoxetine hydrochloride equivalent to 20 mg fluoxetine per tablet.

PHARMACOLOGICAL CLASSIFICATION:
A 1.2 Psychoanaleptics (antidepressants)

PHARMACOLOGICAL ACTION:
Fluoxetine inhibits the neuronal uptake of serotonin in the central nervous system.
Pharmacokinetics: Fluoxetine has a long elimination half-life of 2-3 days and 7 to 9 days for the active metabolite. These long half-lives must be taken into account when doses are titrated or when treatment is stopped.

INDICATIONS:
Major depressive episodes
, i.e. single episode and recurrent depression with associated anxiety.
Bulimia nervosa: Fluoxetine has been shown to significantly decrease binge-eating and purging activity.
Obsessive compulsive disorder: Fluoxetine is indicated for the treatment of obsessive-compulsive disorder. The obsessions or compulsions must be experienced as intrusive, markedly distressing, time-consuming or interfering significantly with the person's social or occupational functioning.

CONTRA-INDICATIONS:
Hypersensitivity to fluoxetine.
Severe renal failure (glomerular filtration rate <10 mL per minute).
Safety in pregnancy and lactation has not been established.
Safety in children has not been established.
Monoamine oxidase inhibitors: There have been reports of serious, sometimes fatal, reactions (including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations in vital signs and mental status changes that include extreme agitation progressing to delirium and coma) in patients receiving fluoxetine in combination with a monoamine oxidase inhibitor (MAOI) and in patients who have recently discontinued fluoxetine and are then started on a MAOI. Some cases presented with features resembling neuroleptic malignant syndrome. Therefore, fluoxetine should not be used in combination with a MAOI, or within 14 days of discontinuing therapy with a MAOI. Since fluoxetine and its major metabolite have very long elimination half-lives, at least 5 weeks should be allowed after stopping fluoxetine before starting a MAOI.

WARNINGS:
Discontinue the medicine in patients who develop a rash since systemic effects, involving the lungs, kidneys or liver, have occurred in such patients.

DOSAGE AND DIRECTIONS FOR USE:
For oral administration to adults only.
Major depressive episodes: A dose of 20 mg (one capsule or tablet) per day is recommended, preferably in the morning. Doses of up to 80 mg (four capsules or tablets) daily in divided doses may be employed if necessary. Doses above 80 mg (four capsules or tablets) per day are not recommended.
Bulimia nervosa: A dose of 60 mg (three capsules or tablets) per day is recommended.
Obsessive-compulsive disorder: A dose of 20 to 60 mg (one to three capsules or tablets) per day is recommended.
Fluoxetine may be administered with or without food. The tablets may be swallowed whole or be dispersed in approximately 100 mL of water.
Fluoxetine may be administered with or without food. The tablets may be swallowed whole or be dispersed in approximately 100 mL of water.
Elderly patients: The effect of age upon the metabolism of fluoxetine has not been fully investigated. LORIEN should be used with caution in the elderly, particularly if they have systemic illness or are receiving multiple medications for concomitant diseases.
Hepatic or renal impairment: Lower doses or alternate-day dosing are recommended in patients with significant hepatic or renal impairment.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Body as a whole:
Asthenia, fever, palpitations, visual disturbances.
Digestive system:
Nausea, diarrhoea, dry mouth, appetite loss, dyspepsia, vomiting. Anorexia and loss of mass may also occur.
Nervous system:
Headache, nervousness, insomnia, drowsiness, anxiety, tremor, dizziness, fatigue, decreased libido, seizures (see "Precautions"), abnormal dreams, agitation. Hypomania or mania occurred in approximately 1 % of fluoxetine-treated patients.
Respiratory system:
Dyspnoea. Pulmonary events (including inflammatory processes of varying histopathology and/or fibrosis) have been reported. Dyspnoea may be the only preceding symptom.
Skin and appendages:
A small percentage of patients developed rash and/or urticaria (see "Warnings"). Serious systemic events, possibly related to vasculitis, have developed in patients with rash and less frequently death has been reported. Excessive sweating, serum sickness and anaphylactoid reactions have been reported.
Urogenital system:
Sexual dysfunction (delayed or inhibited orgasm).
Endocrine system:
Hypothyroidism.
Hyponatraemia (including serum sodium lower than 110 mmol/L) has been reported. The hyponatraemia appeared to be reversible when fluoxetine was discontinued. Although these cases were complex with varying possible aetiologies, some were possibly due to the syndrome of inappropriate antidiuretic hormone secretion (SIADH). The majority of these occurrences have been in older patients taking diuretics or who were otherwise volume depleted.
Elevated serum transaminase values have occurred.
Effects on the eyes:
Symptoms of glaucoma developed in a patient receiving fluoxetine, the symptoms subsided within 2 days of drug withdrawal. Intra-ocular pressure following fluoxetine administration was recorded in some patients.
Effects on the hair:
Incidences of hair loss has been reported with fluoxetine.
The following has been reported with fluoxetine, but no causal relationship has been established: Aplastic anaemia, cerebral vascular accident, confusion, dyskinesia (including, for example, a case of buccallingual-masticatory syndrome, which resolved following drug discontinuation), ecchymoses, eosinophilic pneumonia, gastro-intestinal haemorrhage, hyperprolactinaemia, movement disorders developing in patients with risk factors (including drugs associated with such events) and worsening of pre-existing movement disorders, neuroleptic malignant syndrome-like events, pancreatitis, suicidal ideation, pancytopenia, immune related haemolytic anaemia, thrombocytopenia, thrombocytopenic purpura, vaginal bleeding after withdrawal of the medication and violent behaviour.
Precautions:
Fluoxetine should be discontinued in any patient who develops seizures. Fluoxetine should be avoided in patients with unstable epilepsy; patients with controlled epilepsy should be carefully monitored. There have been reports of prolonged seizures in patients on fluoxetine receiving ECT treatment.
Fluoxetine is extensively metabolised by the liver and excreted by the kidneys. A lower dose, e.g. alternate day dosing, is recommended in patients with significant hepatic dysfunction or mild to moderate renal failure (GFR 10-50 mL/min).
Clinical experience in acute cardiac disease is limited, therefore caution is advisable.
Fluoxetine may cause loss of mass which could be undesirable in undermass depressed patients.
In patients with diabetes, fluoxetine may alter glycaemic control. Hypoglycaemia has occurred during therapy with fluoxetine and hyperglycaemia has developed following discontinuation. Insulin and/or oral hypoglycaemic dosage may need to be adjusted.
There have been reports of altered platelet function and/or abnormal results from laboratory studies in patients taking fluoxetine. While there have been reports of abnormal bleeding in several patients taking fluoxetine, it is unclear whether fluoxetine had a causative role.
Although fluoxetine has been shown not to affect psychomotor performance in healthy volunteers, any psychoactive drug may impair judgement or skills. Therefore patients should be cautioned that their ability to perform potentially hazardous tasks (e.g. driving a motor vehicle or operating machinery) may be impaired.
As improvement may not occur during the first two or more weeks of treatment, patients should be closely monitored during this period. Due to the risk of suicide in major depressive episodes, close supervision of high risk patients should accompany medication therapy.
Because of the well-established comorbidity between obsessive-compulsive disorder and depression, the same precautions observed when treating patients with depression should be observed when treating patients with obsessive-compulsive disorder.
Interactions:
Fluoxetine should not be used concomitantly with monoamine oxidase inhibitors (see "Contra-indications).
Caution is advised if the concomitant administration of fluoxetine and CNS active drugs, including lithium, is required. There have been reports of both increased and decreased lithium levels when used concomitantly with fluoxetine. Lithium levels should be monitored.
There have been greater than 2-fold increases of previously stable plasma levels of other antidepressants when fluoxetine has been administered in combination with these agents.
Patients receiving fluoxetine in combination with tryptophan have been reported to experience adverse reactions, including agitation, restlessness and gastro-intestinal distress.
The long elimination half-lives of fluoxetine and its active metabolite should be borne in mind (see "Pharmacokinetics") when considering pharmacodynamic and pharmacokinetic medicine interactions.
The half-life of concurrently administered diazepam may be prolonged.
Fluoxetine is bound to plasma proteins and concurrent administration may alter plasma concentrations of other plasma protein bound drugs, e.g. warfarin, digitoxin, or conversely, fluoxetine binding may be changed by other agents.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Treatment of overdosage is symptomatic and supportive.
There are no specific antidotes for LORIEN.
Due to the large volume of distribution of LORIEN, forced diuresis, dialysis, haemoperfusion and exchange transfusions are unlikely to be of benefit.

IDENTIFICATION:
LORIEN CAPSULES: A white powder encapsulated within an opaque no. 3 capsule with a green body and green cap, imprinted with a mortar and pestle and "LENNON" on the cap in white ink.
LORIEN TABLETS: A round, white tablet with bevelled edges, bisected on one side.

PRESENTATION:
LORIEN CAPSULES: Blister packs of 28 and 112 capsules.
LORIEN TABLETS: Blister packs of 30 tablets.

STORAGE:
Store below 25°C.
Protect from light and moisture.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
LORIEN CAPSULES:         30/1.2/0024
LORIEN TABLETS:         34/1.2/0381

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
PHARMACARE LIMITED
7 Fairclough Road
Korsten
Port Elizabeth
6020

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
12 Mar 2002

        D846
        A&S PRINTERS

Updated on this site: October 2004
Source: Community Pharmacy

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