Stablon

Stablon

tianeptine

Manufacturer:

Servier
Concise Prescribing Info
Contents
Tianeptine Na
Indications/Uses
Major depressive episodes (mild, moderate, or severe).
Dosage/Direction for Use
1 tab 3 times daily. Frail elderly (<55 kg) & those w/ moderate renal failure, severe renal failure (CrCl <19 mL/min) & severe cirrhosis (Child Pugh Score Class C) Restricted to 2 tab daily. Dosage should be gradually reduced over a period of 7-14 days to reduce the risk of w/drawal reaction.
Administration
Should be taken on an empty stomach: Take before main meals.
Contraindications
Hypersensitivity. Pregnancy or breastfeeding. Childn & adolescents <15 yr.
Special Precautions
Abrupt discontinuation should be avoided. Closely monitor patients for clinical worsening or appearance of suicidal thoughts/behaviour & any abnormal change of behaviour. If general anaesth is necessary, discontinue use 24 or 48 hr prior to surgery. In case of emergency surgery, pre-op monitoring should be performed. History of drug or alcohol dependence. Risk of w/drawal syndrome at discontinuation. In case of treatment interruption, gradually reduce dose over 7-14 days. Combination w/ MAOI is inadvisable; a wash-out period of 2 wk when tianeptine is used as a replacement of MAOI; a wash-out period of 24 hr when MAOI is used as a replacement of tianeptine. Patients at increased risk for hyponatraemia, eg, elderly, cirrhotic, or dehydrated patients or those treated w/ diuretics. Inadvisable in patients w/ fructose intolerance, glucose & galactose malabsorption syndrome or sucrase-isomaltase deficiency. May affect ability to drive or operate machine. Avoid use during pregnancy. Not recommended during lactation. Should not be used in adolescents 15-18 yr.
Adverse Reactions
Anorexia; nightmares; insomnia, somnolence, dizziness, headache, pre-syncope, tremors; tachycardia, extrasystoles, chest pain; hot flushes; dyspnoea; gastralgia, abdominal pain, dry mouth, nausea, vomiting, constipation, flatulence; myalgia, lumbar pain; asthenia, throat discomfort sensation.
Drug Interactions
Risk of CV collapse or paroxysmal HTN, hyperthermia, convulsions, death w/ irreversible MAOIs (eg, iproniazide).
MIMS Class
Antidepressants
ATC Classification
N06AX14 - tianeptine ; Belongs to the class of other antidepressants.
Presentation/Packing
Form
Stablon coated tab 12.5 mg
Packing/Price
30's (Rp354,916/pak)
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