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

Logo RANFLOCS 20 Capsules

SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

RANFLOCS 20 Capsules

COMPOSITION:
Each capsule contains
Fluoxetine hydrochloride
equivalent to
fluoxetine: 20 mg

PHARMACOLOGICAL CLASSIFICATION:
A 1.2. Psychoanaleptics (antidepressants)

PHARMACOLOGICAL ACTION
Pharmacodynamics
The antidepressant and anti-obsessive compulsive action of fluoxetine is presumed to be linked to its inhibition of central nervous system neuronal uptake of serotonin. Studies at clinically relevant doses in man have demonstrated that fluoxetine blocks the uptake of serotonin into human platelets.
Pharmacokinetics
Because of the long elimination half-lives of the parent drug (2 to 3 days), and its major active metabolite, norfluoxetine (7 to 9 days) changes in dose will not be fully reflected in plasma for several weeks (approximately 4 half-lives). This is to be taken into consideration during dose titration or cessation of treatment.

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 : Ranflocs 20 Capsules are 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 any of the ingredients.
Ranflocs 20 Capsules should not be administered to patients with severe renal failure (GFR<10 mL/min) because accumulation may occur in these patients during chronic treatment.
Monoamine oxidase inhibitors : there have been reports of serious, sometimes fatal, reactions (including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs and mental status changes that include extreme agitation progressing to delirium and coma) in patients receiving fluoxetine in combination with a mono amine oxidase inhibitor (MAOI). Some cases presented with features resembling neuroleptic malignant syndrome. Therefore, fluoxetine hydrochloride 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 hydrochloride before starting a MAOI.
Pregnancy
Safety in pregnancy has not been established.
Lactation
The safety of fluoxetine has not been established in lactating women.
Paediatric use
Safety and efficacy in children have not been established.

WARNINGS
Rash and possible allergic events : Upon the appearance of rash or of other possibly allergic phenomena fluoxetine should be discontinued.

DOSAGE AND DIRECTIONS FOR USE:
For oral administration to adults only.
A major depressive episode : A dose of 20 mg/day is recommended, preferably in the morning. Doses of up to 80 mg/day in divided doses may be employed if necessary. Doses more than 20 mg should be divided into two doses taken in the morning and at noon.
Bulimia nervosa : A dose of 60 mg/day is recommended.
Obsessive-compulsive disorder : A dose of 20 to 60 mg/day is the recommended dose for the treatment of obsessive-compulsive disorder.
Fluoxetine may be administered with or without food.
Usage in elderly : The effects of age upon the metabolism of fluoxetine have not been fully explored. Thus fluoxetine should be used with caution in the elderly, particularly if they have systemic illness or are receiving multiple medications for concomitant diseases..

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Side-effects
The following treatment-emergent adverse events were observed :
Body as a whole: Asthma, fever, palpitations, vision disturbances.
Digestive system: Nausea, diarrhoea, constipation, dry mouth, appetite loss, dyspepsia, vomiting, anorexia and weight loss may also occur.
Nervous system: Headache, nervousness, insomnia, drowsiness, anxiety, restlessness, terror, dizziness, tremor, fatigue, decreased libido, seizures (see “Precautions”). Hypomania or mania occurred in approximately 1% of fluoxetine treated patients. Abnormal dreams, agitation. Convulsion, extrapyramidal effects, sexual dysfunction have also occured.
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 also 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 and in patients taking diuretics or who were otherwise volume depleted.
Elevated serum transaminase values have occurred.
The following have been reported in association with fluoxetine, but no causal relationship has been established. Aplastic anaemia, cerebral vascular accident, confusion, dyskinesia (including, for example, a case of buccal-lingualmasticatory syndrome, which resolved following drug discontinuation), ecchymoses, eosinophilic pneumonia, gastro-intestinal haemorrhage, hyperprolactinaemia, movement disorders developing in patients with risk factors (including medications 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
Ranflocs 20 Capsules should be discontinued in any patient who develops seizures. Ranflocs 20 Capsules 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 Electro Convulsive Therapy (ECT).
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.
Ranflocs 20 Capsules 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.
Depressed patients with suicidal tendencies should be carefully supervised during treatment.
Although fluoxetine has been shown not to affect psychomotor performance in healthy volunteers, any psychoactive agent 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 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.
Ranflocs 20 Capsules should be withdrawn gradually to reduce the risk of withdrawal symptoms.
Interactions:
Ranflocs 20 Capsules should not be used concomitantly with monoamine oxidase inhibitors (see “Contra-indications”).
Caution is advised if the concomitant administration of fluoxetine and central nervous system 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 gastrointestinal distress.
The long elimination half-lives of fluoxetine and its active metabolite should be borne in mind (see “Pharmacokinetics”) when considering pharmacodynamic or pharmacokinetic medicine interactions.
The half-life of concurrently administered diazepam may be prolonged.
Fluoxetine is bound to plasma protein 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
Symptoms: Nausea and vomiting are prominent in overdoses involving higher fluoxetine doses. Other prominent symptoms of overdose include agitation, restlessness, hypomania and other signs of CNS excitation. Except for the isolated cases of reported deaths, all other overdose cases have recovered without residua.
Treatment is symptomatic and supportive.
There are no specific antidotes for fluoxetine. Due to the large volume of distribution of fluoxetine, forced diuresis, dialysis, haemoperfusion and exchange transfusion are unlikely to be of benefit.

IDENTIFICATION:
Opaque, hard gelatin, self locked capsules of size '2' with green cap and off-white body imprinted with 'R/FXT20' in black edible ink on cap/body, containing white granular powder.

PRESENTATION:
Cartons containing 30 capsules in blister strips of 15 capsules each.

STORAGE INSTRUCTIONS:
Store below 25°C, protected from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
34/1.2/0129

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
RANBAXY (SA) (PTY) LTD
Third Floor, Outspan House,
1006, Lenchen Avenue North,
Centurion

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
April 2003

Updated on this site: October 2003
Source: Community Pharmacy

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