Prozac and bone loss and quantitative composition Each capsule contains 20 mg of fluoxetine as fluoxetine hydrochloride. Each 5 ml of oral solution contains 20 mg of fluoxetine as fluoxetine hydrochloride. Excipients with known effect: Also contains small amounts of ethanol alcoholless than mg per 5 ml dose. For the full list of excipients, see section 6. Pharmaceutical form Hard capsules. The solution is clear, colourless, prozac and bone loss, mint odoured.
PROZAC is indicated as a complement of psychotherapy for the reduction of binge-eating and purging activity. Children and adolescents aged 8 years and above: Moderate to severe major depressive episode, if depression is unresponsive to psychological therapy after sessions. Antidepressant medication should be offered to a child or young person with moderate to severe depression only in combination with a concurrent psychological therapy.
Adults and the elderly: The recommended dose is 20mg daily. Dosage should be reviewed and adjusted if necessary, within 3 to 4 weeks of initiation of therapy and thereafter as judged clinically appropriate. Although there may be an increased potential for prozac and bone loss effects at higher doses, in some patients, with insufficient response to 20mg, the dose may be increased gradually up to a maximum of 60mg see section 5.
Dosage adjustments should be made carefully on an individual patient basis, to maintain the patients at the lowest effective dose. Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free from symptoms. Although there may be an increased potential for undesirable effects at higher doses, in some patients, if after two weeks there is prozac and bone loss response to 20mg, the dose may be increased gradually up to a maximum of 60mg.
If no improvement is observed within 10 weeks, treatment with fluoxetine should be reconsidered. If a good therapeutic response has been obtained, treatment can be continued at a dosage adjusted on an individual basis. While there are no systematic studies to answer the question of how long to continue fluoxetine treatment, OCD is a chronic condition and it is reasonable to consider continuation beyond 10 weeks in responding patients.
Dosage adjustments should be made carefully on an individual patient basis, to maintain the patient at the lowest effective dose. The need for treatment should be reassessed periodically. Some clinicians advocate concomitant behavioural psychotherapy for patients who have done well on pharmacotherapy.
Long-term efficacy more than 24 weeks has not been demonstrated in OCD, prozac and bone loss. Long-term efficacy more than 3 months has not been demonstrated in bulimia nervosa.
The recommended dose may be increased or decreased. Paediatric population - Children and adolescents aged 8 prozac and bone loss and above Moderate to severe major depressive episode. Treatment should be initiated and monitored under specialist supervision. Dose adjustments should be made prozac and bone loss, on an individual basis, to maintain the patient at the lowest effective dose. Clinical trial experience with daily doses greater than 20mg is minimal.
There is only limited data on treatment beyond 9 weeks. Due to higher plasma levels in lower-weight children, the therapeutic effect may be achieved with lower doses see section 5. For paediatric patients who respond to treatment, the need for continued treatment after 6 months should be reviewed.
If no clinical benefit is achieved within 9 weeks, treatment should be reconsidered. Caution is recommended when increasing the dose, prozac and bone loss, and the daily dose should generally not exceed 40mg. A lower or less frequent dose e. Abrupt discontinuation should be avoided.
When stopping treatment with PROZAC the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of withdrawal reactions see sections 4. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose, but at a more gradual rate.
Fluoxetine may be administered as a single or divided dose, during or between meals. When dosing is stopped, active drug substances will persist in the body for weeks. This should be borne in prozac and bone loss when starting or stopping treatment, prozac and bone loss. The capsule and oral solution forms are bioequivalent.
Fluoxetine is contra-indicated in combination with irreversible, prozac and bone loss, non-selective monoamine oxidase inhibitors e.
Fluoxetine is contra-indicated in combination with metoprolol used in cardiac failure see section 4. Suicide-related behaviours suicide attempt and suicidal thoughts and hostility predominantly aggression, oppositional behaviour and anger were more frequently observed in clinical trials among children and adolescents prozac and bone loss with antidepressants compared to those treated with placebo. PROZAC should only be used in children and adolescents aged 8 to 18 years for the treatment of moderate to severe major depressive episodes and it should not be used in other indications.
If, based on clinical need, a decision to treat is nevertheless taken, the patient should be simple annuity plans monitored for the appearance of suicidal symptoms. In addition, only limited evidence is available concerning long-term effect on safety in children and adolescents, including effects on growth, sexual maturation and cognitive, emotional and behavioural developments see section 5.
In a week clinical trial, decreased height and weight gain was observed in children and adolescents treated with fluoxetine see section 5. It has not been established whether there is an effect on achieving normal adult height. The possibility of a delay in puberty cannot be ruled out see sections 5.
Growth and pubertal development height, weight, and TANNER staging should therefore be monitored during and after treatment with fluoxetine.
If either is slowed, referral to a paediatrician should be considered. In paediatric trials, mania and hypomania were commonly reported see section 4. Fluoxetine should be discontinued in any patient entering a manic phase. Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide suicide-related events.
This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical experience that the risk of suicide may increase in the early stages of recovery.
Other psychiatric conditions for which PROZAC is prescribed can also be associated with an prozac and bone loss risk of suicide-related events. In addition, these conditions may be co-morbid with major depressive disorder. The same precautions observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorders, prozac and bone loss.
Patients with a history of suicide-related events, those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment. A meta-analysis of placebo-controlled clinical trials of antidepressants drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.
Close supervision of patients and in prozac and bone loss those women and vitamins high risk should accompany drug therapy especially in early treatment and following dose changes. Patients and caregivers of patients should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
Cases of QT interval prolongation and ventricular arrhythmia including torsades de pointes have been reported during the post-marketing period see sections 4. Fluoxetine should be used with caution in patients with conditions such as congenital long QT syndrome, a family history of QT prolongation or other clinical conditions that predispose to arrhythmias e. If patients with stable cardiac disease are treated, an ECG review should be considered before treatment is started.
If signs of cardiac arrhythmia occur during treatment with fluoxetine, the treatment should be withdrawn and an ECG should be performed. Irreversible, non-selective monoamine oxidase inhibitors e. Some cases of serious and sometimes fatal reactions have been reported in patients receiving an SSRI in combination with an irreversible, non-selective monoamine oxidase inhibitor MAOI.
These cases presented with features resembling serotonin syndrome which may be confounded with or diagnosed as neuroleptic malignant syndrome.
Cyproheptadine or dantrolene may benefit patients experiencing such reactions. Symptoms of a drug interaction with a MAOI include: Therefore, fluoxetine is contra-indicated in combination with an irreversible, non-selective MAOI see section 4. Because of the two weeks-lasting effect of the latter, treatment of fluoxetine should only be started 2 weeks after discontinuation of an irreversible, non-selective MAOI, prozac and bone loss.
Similarly, at least 5 weeks should elapse after discontinuing fluoxetine treatment before starting an irreversible, non-selective MAOI. Serotonin syndrome or neuroleptic malignant syndrome-like events. As these syndromes may result in potentially life-threatening conditions, treatment with fluoxetine should be discontinued if such events characterized by clusters of symptoms such as hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, mental status changes including confusion, irritability, extreme agitation progressing to delirium and coma occur and supportive symptomatic treatment should be initiated.
As with all antidepressants, fluoxetine should be discontinued in any patient entering a manic phase. Ecchymosis has been reported as an infrequent event during treatment with fluoxetine. Other haemorrhagic manifestations e. Seizures are a potential risk with antidepressant drugs. Therefore, as with other antidepressants, fluoxetine should be introduced cautiously in patients who have a history of seizures. Treatment should be discontinued in any patient who develops seizures or where there is an increase in seizure frequency.
There have been rare reports of prolonged seizures in patients on fluoxetine receiving ECT treatment, therefore caution is advisable. Fluoxetine, a potent inhibitor of CYP2D6, may lead to reduced concentrations of endoxifen, one of the most important active metabolites of tamoxifen. Therefore, fluoxetine should whenever possible be avoided during tamoxifen treatment prozac and bone loss section 4, prozac and bone loss.
This is most likely to occur within the first few weeks of treatment. In patients who develop these symptoms, increasing the dose may be detrimental, prozac and bone loss. In patients with diabetes, treatment with an SSRI may alter glycaemic control. Hypoglycaemia has occurred during therapy with fluoxetine and hyperglycaemia has developed following discontinuation. Fluoxetine is extensively metabolized by the liver and excreted by the kidneys. A lower dose, e. Rash and allergic reactions.