Stablon Tablets Reviews Uses, Dosage, Side Effects,Warnings and Precautions

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stablon drug >> Generic drug of the therapeutic class: Neurology – psychiatry
active ingredients: Tianeptine

what is stablon ?

This drug is recommended in depressive states of mild, moderate or severe intensity.

Stablon Tablets indication and Uses

Major depressive episodes (ie characterized).

stablon drug Dosage

• The recommended dosage is 1 tablet at 12.5 mg three times a day, morning, noon and night, at the beginning of the main meals.
• In chronic alcoholic, cirrhotic or non-cirrhotic, no dosage modification is necessary.
• In patients over 70 years of age and in case of renal insufficiency, limit the dosage to 2 tablets per day.

Contraindications

• Tianeptine hypersensitivity
• Child under 15
• Teenager aged 15 to 18
• Fructose intolerance
• Glucose malabsorption syndrome
• Galactose malabsorption syndrome
• Sucrase-isomaltase deficiency 

Hypersensitivity to the active substance or to any of the excipients listed in section composition.

Children and adolescents under 15 years old.

How it works Stablon Tablets

Pharmacotherapeutic group: OTHER ANTIDEPRESSANTS.

ATC Code: N06AX14.

Tianeptine is an antidepressant:

In animals, tianeptine has the following characteristics:

• Tianeptine increases the spontaneous activity of pyramidal cells of the hippocampus and accelerates their recovery after functional inhibition,
• Tianeptine increases serotonin reuptake speed by neurons of the cortex and hippocampus.

In humans, tianeptine is characterized by:

•  A clear activity on somatic complaints, in particular digestive complaints related to anxiety and mood disorders.

Tianeptine also has no effect:

• On sleep and vigilance,
• On the cholinergic system (absence of anticholinergic manifestation)

Stablon Side Effects

Stablon Tablets Side Effects

Summary of the security profile:

The adverse effects seen with tianeptine in clinical trials are of moderate intensity. They consist mainly of nausea, constipation, abdominal pain, drowsiness, headache, dry mouth and dizziness.

Table of adverse effects

The following adverse reactions have been observed in clinical trials and / or the post-marketing use of tianeptine and are classified according to their frequency:

Very common ( ³ 1/10); frequent ( ³ 1/100, <1/10); uncommon ( ³ 1/1000, <1/100); rare ( ³ 1/10000, <1/1000); very rare (<1/10000), undetermined (can not be estimated from the available data).

Organ-Class System (SOC)	Frequency	Side effects
Metabolism and nutrition disorders	Frequent	Anorexia
	indeterminate *	hyponatremia
Psychiatric disorders	Frequent	nightmares
	Rare	Abuse, addiction, especially in subjects under 50 years of age with a history of drug dependence or alcohol dependence
	indeterminate *	Idiosyncratic cases and suicidal behavior have been reported during treatment with tianeptine or shortly after discontinuation (see section 4.4).
		Confusional state, hallucinations
Nervous system disorders	Frequent	Insomnia
		Drowsiness
		Dizzying sensations
		headaches
		presyncope
		tremors
	indeterminate *	Extrapyramidal disorders
		dyskinesia
Heart conditions	Frequent	tachycardia
		premature
		Chest pain
Vascular disorders	Frequent	Hot flashes
Respiratory, thoracic and mediastinal disorders	Frequent	Dyspnea
Gastrointestinal disorders	Frequent	Gastralgias
		Abdominal pain
		Dry mouth
		nausea
		vomiting
		Constipation
		flatulence
Skin and subcutaneous tissue disorders	Rare	Maculopapular or erythematous rash
		itching
		Urticaria
	indeterminate *	Acne
		Exceptional bullous reactions
Musculoskeletal and systemic disorders	Frequent	myalgia
		Low back pain
General disorders and administration site abnormalities	Frequent	Asthenia
		Sensation of discomfort in the throat
Hepatobiliary disorders	indeterminate *	Increased liver enzymes
		Hepatitis can be exceptionally severe

* Post-market data

Stablon Tablets Interactions

Associations advised against

• Irreversible MAOIs (iproniazid): because of the risk of collapse or paroxysmal hypertension, hyperthermia, convulsions, death.

Stablon Tablets Warnings and Precautions

Special warnings

• Prolonged use and high doses can lead to a state of dependence.
• Do not exceed the recommended dosage.

Suicidal ideation and worsening of your depression or anxiety disorder

If you suffer from depression and / or anxiety disorders, you may sometimes have ideas of self-aggression (aggression towards yourself) or suicide. These events may be increased at the beginning of antidepressant treatment, as this type of medication does not act immediately but only after 2 weeks or more of treatment.

You are more likely to exhibit such events in the following cases:

• if you have ever had suicidal thoughts or self-aggression in the past.
• if you are a young adult. Clinical studies have shown that the risk of suicidal behavior is increased in adults under 25 with psychiatric illness and treated with antidepressants.

If you have suicidal thoughts or self-aggression, contact your doctor immediately or go directly to the hospital.

You can get help from a friend or relative, tell them you’re depressed or have an anxiety disorder, and ask them to read this leaflet. You can ask him to tell you if he thinks your depression or anxiety is getting worse, or if he’s worried about a change in your behavior.

Due to the presence of sucrose, this drug should not be used in cases of fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency (rare metabolic diseases).

Precautions for use

• Do not stop treatment abruptly, but decrease dosage for 7 to 14 days.
• If you have to have a general anesthesia, you should tell the resuscitator anesthesiologist who will be able to stop the treatment 24 or 48 hours before the procedure.
• Tell your doctor in case of kidney failure.
• IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.

Drive and use machines

In some patients, a decrease in alertness is likely to occur. Attention is therefore drawn to the risk of drowsiness associated with the use of this drug, especially for vehicle drivers and machine users.

stablon drug and PREGNANCY / BREAST FEEDING / FERTILITY

stablon in Pregnancy

• Maintaining a good maternal psychic balance is desirable throughout pregnancy. If medication management is necessary to ensure this balance, it should be instituted or continued in an effective dose throughout pregnancy and if possible in monotherapy.
• The animal data are reassuring, but the clinical data are still insufficient.
• Given these data, it is best to avoid using tianeptine during pregnancy, regardless of the term. If it is essential to initiate or maintain treatment with tianeptine during pregnancy, consider the pharmacological profile of the drug for monitoring the newborn.

Breastfeeding

• Tricyclic antidepressants are excreted in breast milk, so breastfeeding is not recommended for the duration of treatment.

Fertility

• In rats, one study showed a decrease in reproductive performance in females (increased preimplantation losses) at maternotoxic dose.
• The clinical impact is not known.

What happens if I overdose from Stablon Tablets ?

sYMPTOMS

• Experience with cases of acute tianeptine intoxication (maximum quantity: 2250mg, ingested in a single dose) mainly highlights vigilance disorders that can go as far as coma, particularly in cases of multiple intoxications.

To behave

• Tianeptine has no known specific antidote. In cases of acute intoxication, symptomatic treatment and routine surveillance should be established. Specialized medical monitoring is recommended.

What is  Forms and Composition?

FORMS and PRESENTATIONS

• 12.5 mg coated tablet (white):   Box of 28, in blister packs.
• Hospital model: Box of 100, in blister packs.

COMPOSITION

	p cp
Tianeptine (INN) sodium salt	12.5 mg

• Excipients: D-mannitol, corn starch, talc, magnesium stearate. Coating:ethylcellulose, glycerol oleate, Sepifilm SE 700 white (povidone, carmellose sodium, anhydrous colloidal silica, talc, sucrose, polysorbate 80, titanium dioxide, sodium bicarbonate), white beeswax.
• Excipient with known effect: sucrose.

NOT’s

Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:

general information:

• Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

Additional information:

• General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.

Special warnings:

• For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

• It treats possible side effects and drug interactions that require attention and its effect on continuous use.
• The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.

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