, Sensitivity/Resistance). 2 Recommended Dose and Dosage Adjustment Clinical reports on the use of TRYPTAN as an adjunct in the management of affective disorders have indicated the dose of 8-12 g/day to be the most effective one. Lower doses have been reported to be effective in combination with other antidepressants.
Some patients may not tolerate 12 g/day but might still benefit from doses reduced to 8 g/day. The treatment might be initiated with 12 g per day of TRYPTAN, given in 3-4 equally divided doses. Special Populations and Conditions A small number of bipolar patients are particularly sensitive to TRYPTAN and will not tolerate higher doses than 1 or 2 g/day.
Patients on concomitant medication should be monitored for possible reduction of the concomitant medication since TRYPTAN may enhance their efficacy. If TRYPTAN is used in the acute treatment of mania in conjunction with lithium it will potentiate some of the side effects associated with lithium such as nausea and vomiting.
Thus, often it will be necessary to decrease the lithium dosage especially when it is given in doses above 900 - 1200 mg/day. In manic-depressive illness chronically treated with lithium, the lithium dose may need to be decreased when TRYPTAN is added because of increased side effects.
4 Drug-Drug interactions). 4 Drug-Drug interactions). 4 Administration Administration with meals or snacks is recommended to reduce the incidence of nausea. 5 Drug-Food Interactions). PrTRYPTAN® L-Tryptophan Product Monograph Page 5 of 15 5 OVERDOSAGE Symptoms of overdosage would include vomiting and might include serotonin syndrome symptoms.
Treatment of overdosage would be symptomatic with close monitoring and support of vital systems as necessary (see 7 WARNINGS AND PRECAUTIONS, General, Serotonin syndrome). For management of a suspected drug overdose, contact your regional poison control centre.
6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging TRYPTAN 500 mg capsules: each opaque white capsule, size No. 00 imprinted with ICN T17, contains 500 mg of L-tryptophan, USP.
Bottles of 100 capsules. TRYPTAN 250 mg tablets: each white, oval-shaped film coated tablet, embossed 'TRYPTAN' on one side, and “250 mg” on the other side, contains 250 mg of L- tryptophan, USP. Bottles of 100 tablets. TRYPTAN 500 mg tablets: each white, oval-shaped, biconvex film coated tablet embossed 'TRYPTAN' on one side, and “500 mg” on the other, contains 500 mg of L - tryptophan, USP.
Bottles of 100 tablets. TRYPTAN 750 mg tablets: each white, oval-shaped film coated tablet, embossed 'TRYPTAN' on one side and “750 mg” on the other side, contains 750 mg of L - tryptophan, USP. Bottles of 100 tablets. TRYPTAN 1 g tablets: each white, oval-shaped film coated tablet, embossed 'TRYPTAN' 1 g’ on one side, contains 1 g of L-tryptophan, USP.
Bottles of 100 tablets. Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral 500 mg Capsules Magnesium Stearate and Talc Oral 250 mg, 500 mg, 750 mg and 1g Tablets Calcium Phosphate, Croscarmellose Sodium, Magnesium Stearate, Methylcellulose, Opadry II White, Film Coating Base Solution (includes: Polyvinyl Alcohol, Macrogol/PEG, Titanium Dioxide, and Talc) PrTRYPTAN® L-Tryptophan Product Monograph Page 6 of 15 7 WARNINGS AND PRECAUTIONS General Monoamine Oxidase Inhibitors (MAOIs) TRYPTAN is not recommended in patients taking monoamine oxidase inhibitors (MAOIs including linezolid, methylene blue) or within 14 days of such therapy.
4 Drug-Drug Interactions). Serotonin Syndrome There have been rare reports of serotonin syndrome with the concomitant use of TRYPTAN and serotonergic drugs. Serotonin toxicity also known as serotonin syndrome is a potentially life-threatening condition and has been reported during the use of TRYPTAN.
g. g. anxiety, agitation, hypomania). 4 Drug-Drug Interactions). If serotonin toxicity is suspected, discontinuation of the serotonergic agents should be considered. Carcinogenesis and Mutagenesis To minimize the risk of bladder cancer, it may be recommended to give vitamin B6 supplements if the TRYPTAN doses are many times in excess of those consumed normally in dietary protein.
An increased incidence rate of bladder cancer has been observed in experimental animals after implantation of pellets containing any of the seven tryptophan metabolites formed by tryptophan pyrrolase. Active metabolites included […]