LIMBIX Tablets, 50’s pack

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Indications

This is indicated for the treatment of patients with moderate to severe depression associated with moderate to severe anxiety. The therapeutic response to this combination occurs earlier and with fewer treatment failures than when either amitriptyline or chlordiazepoxide is used alone. Symptoms likely to respond in the first week of treatment include: insomnia, feelings of guilt or worthlessness, agitation, psychic and somatic anxiety, suicidal ideation and anorexia.

Therapeutic Class

Combined anxiolytics & anti-depressant drugs

Pharmacology

Amitriptyline inhibits the membrane pump mechanism responsible for the re-uptake of transmitter amines, such as norepinephrine and serotonin, thereby increasing their concentration at the synaptic clefts of the brain Label, 10. These amines are important in regulating mood. The monoamine hypothesis in depression, one of the oldest hypotheses, postulates that deficiencies of serotonin (5-HT) and/or norepinephrine (NE) neurotransmission in the brain lead to depressive effects. This drug counteracts these mechanisms, and this may be the mechanism of amitriptyline in improving depressive symptoms.

Chlordiazepoxide binds to stereospecific benzodiazepine (BZD) binding sites on GABA (A) receptor complexes at several sites within the central nervous system, including the limbic system and reticular formation. This results in an increased binding of the inhibitory neurotransmitter GABA to the GABA(A) receptor. BZDs, therefore, enhance GABA-mediated chloride influx through GABA receptor channels, causing membrane hyperpolarization. The net neuro-inhibitory effects result in the observed sedative, hypnotic, anxiolytic, and muscle relaxant properties.

Dosage & Administration

This tablets are recommended in an initial dosage of 3 or 4 tablets daily; this may be increased to 6 tablets daily as required. Some patients respond to smaller doses and can be maintained on 2 tablets daily. Optimum dosage varies with the severity of the symptoms and the response of the individual patient. When a satisfactory response is obtained, dosage should be reduced to the smallest amount needed to maintain the remission. The larger portion of the total daily dose may be taken at bedtime. In some patients, a single dose at bedtime may be sufficient. In general, lower dosages are recommended for elderly patients.

Interaction

This may block the antihypertensive action of guanethidine or compounds with a similar mechanism of action. Caution is indicated in the coadministration of TCAs with any of the SSRIs and also in switching from one class to the other, particularly patient being withdrawn from fluoxetine (at least 5 weeks may be necessary for switch therapy to TCA). Concomitant use of tricyclic antidepressants with drugs that can inhibit cytochrome P450 2D6 may require lower doses than usually prescribed for either the tricyclic antidepressant. Furthermore, whenever one of these drugs is withdrawn from cotherapy, an increased dose of tricyclic antidepressant may be required. Cimetidine is reported to reduce hepatic metabolism of certain tricyclic antidepressants and benzodiazepines, thereby delaying elimination and increasing steady-state concentrations of these drugs. This combination should be discontinued several days before elective surgery.

Contraindications

This is contraindicated in patients with hypersensitivity to either benzodiazepines or tricyclic antidepressants. It should not be given concomitantly with a monoamine oxidase inhibitor. When it is desired to replace a monoamine oxidase inhibitor with this combination, a minimum of 14 days should be allowed to elapse after the former is discontinued. This combination should then be initiated cautiously with gradual increase in dosage until optimum response is achieved. This drug is contraindicated during the acute recovery phase following myocardial infarction.

Side Effects

Drowsiness, dry mouth, constipation, blurred vision, dizziness and bloating were most frequently reported. Other side effects occurring less commonly included vivid dreams, impotence, tremor, confusion and nasal congestion. Many symptoms common to the depressive state, such as anorexia, fatigue, weakness, restlessness and lethargy, have been reported as side effects.

Pregnancy & Lactation

This should preferably not be given during pregnancy and lactation.

Precautions & Warnings

Antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients (especially in teenager & children) during initial few months of a course of drug therapy, or at times of dose changes. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions. Use with caution in patients with history of seizures, hyperthyroidism or those taking thyroid medication and patients with impaired renal or hepatic function. Patients on prolonged treatment should have periodic liver function test and blood count.

Use in Special Populations

Pediatric use: Safety profile is not established over pediatric population.

Geriatric use: This medicine are excreted by kidney and the risk of toxic reaction is grater in patient with impaired renal function, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range.

Overdose Effects

Deaths may occur from overdosage with this class of drugs. Multiple drug ingestion (including alcohol) is common in deliberate tricyclic antidepressant overdose. Common clinical manifestations are cardiac dysrhythmias, severe hypotension, convulsions, CNS depression, including coma and changes in the electrocardiogram, particularly in QRS axis or width.

Storage Conditions

Keep in a dry place, below 30°C. Protect from light. Keep out of the reach of children.
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