- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
1. Name of the medicinal product
Optimax Tablets 500 mg
2. Qualitative and quantitative composition
Each tablet contains 500 mg L-tryptophan. For excipients, see section 6.1.
3. Pharmaceutical form
TabletWhite, capsule-shaped, engraved with 'OPT' on one side, break line on the reverse
4. Clinical particulars
4.1 Therapeutic indications
In treatment-resistant depression after trials of standard antidepressant drug treatments, and as an adjunct to other anti-depressant medication. Treatment with Optimax should only be initiated by hospital specialists. Patients may subsequently be prescribed Optimax in the community by their general practitioner.
4.2 Posology and method of administration
For oral useAdults: The usual dose is two tablets, three times daily; for some patients, up to 6g L-tryptophan may be required.Elderly: A lower dose may be appropriate, especially where there is evidence of renal or hepatic impairment.Children: Not recommended. Safety has not been established.
Patients with a previous history of eosinophilia myalgia syndrome (EMS) following the use of L-tryptophan. This syndrome, which is a multisystem disorder, is characterised by raised eosinophils (>1.0 x 109/L), and severe myalgia in the absence of either an infectious or neoplastic cause.Patients with a known hypersensitivity to the active substance or any of the excipients.
4.4 Special warnings and precautions for use
Suicide/suicidal thoughts or clinical worseningDepression 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.Patients with a history of suicide-related events, or 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 antidepressant 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 particular those at 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.
Eosinophilia Myalgia SyndromeEosinophilia Myalgia Syndrome (EMS) has been reported in association with the use of oral L-tryptophan-containing products. It is a multisystem disorder which is usually reversible but, rarely, fatal. Various investigations have not as yet identified the aetiological factors precisely. The symptoms of EMS have been reported to include eosinophilia, arthralgia or myalgia, fever, dyspnoea, neuropathy, peripheral oedema and skin lesions which can include sclerosis or papular and urticarial lesions.Caution should be exercised with patients who experience some but not all of the symptoms of EMS after taking L-tryptophan. Treatment should be withheld and the symptoms investigated until the possibility of EMS can be excluded.
Serotonin syndromeThe possible interaction between L-tryptophan and 5HT reuptake inhibitors could lead to the serotonin syndrome characterised by a combination of agitation, restlessness and gastro-intestinal symptoms including diarrhoea. Combinations with 5HT reuptake inhibitors should only be used with care (see Section 4.5).
4.5 Interaction with other medicinal products and other forms of interaction
Where L-tryptophan is combined with an MAO Inhibitor the side effects of the latter may be enhanced. Use of L-tryptophan in combination with a 5HT reuptake inhibitor has the potential for increasing the severity of the adverse effects of the latter and could lead to serotonin syndrome (see Section 4.4).In patients taking L-tryptophan in conjunction with phenothiazines or benzodiazepines there have been isolated reports of sexual disinhibition.
4.6 Pregnancy and lactation
Safety in pregnancy or lactation has not been established
4.7 Effects on ability to drive and use machines
L-tryptophan may produce drowsiness. Patients who drive and operate machinery should be warned of the possible hazard.
4.8 Undesirable effects
In some patients, L-tryptophan may cause a slight feeling of nausea which usually disappears within 2 or 3 days. Such nausea can be minimised by giving L-tryptophan after food. Other adverse reactions include headache and light-headedness.Cases of suicidal ideation and suicidal behaviours (frequency not known) have been reported during L-tryptophan therapy or early after treatment discontinuation (see section 4.4).
Drowsiness and vomiting may occur; supportive measures should be employed.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: AntidepressantsATC Code: NO6A X 02L-tryptophan is an essential dietary amino acid and, following hydroxylation and decarboxylation, is the major source of 5-hydroxytryptamine (5-HT). L-tryptophan, 5-HT and 5-HT metabolite levels are lower than normal in patients with depression. Administration of L-tryptophan re-establishes the inhibitory action of 5-HT on the amygdaloid nuclei, thereby reducing feelings of anxiety and depression.
5.2 Pharmacokinetic properties
L-tryptophan is readily absorbed after oral administration. The elimination half-life when administered orally or intravenously to healthy humans is in the range of 1-3 hours. L-tryptophan is bound to plasma proteins to a large extent and is eliminated primarily by metabolism.
5.3 Preclinical safety data
6. Pharmaceutical particulars
6.1 List of excipients
Sta-RX Starch, maize starch, Explotab, saccharin sodium, magnesium stearate, Aerosil
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
Polypropylene bottle containing 84 tablets
6.6 Special precautions for disposal and other handling
7. Marketing authorisation holder
Merck Serono LtdBedfont Cross, Stanwell RoadFeltham, Middlesex,TW14 8NX, UK
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
11/01/82 / 08/07/02
10. Date of revision of the text
9 October 2009
Bedfont Cross, Stanwell Road, Feltham, Middlesex, TW14 8NX, UK
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