Espin

Espin

dosulepin

Manufacturer:

Taejoon Pharm

Distributor:

Pharmaforte
Full Prescribing Info
Contents
Dothiepin HCl.
Action
Pharmacology: The antidepressant of dothiepin is mediated through facilitation of noradrenergic neurotransmission by uptake inhibition and possibly also by enhancement of serotoninergic neurotransmission.
Indications/Uses
Treatment of depression or depressed state.
Dosage/Direction for Use
Usual Recommended Dose: 75-100 mg (3-4 cap) daily in 2-3 divided doses.
Contraindications
Hypersensitivity to tricyclic antidepressant.
Patients with glaucoma and acute recovery phase following myocardial infarction.
Special Precautions
Patients with urinary retention or increased intraocular pressure; cardiac disorders eg, cardiac failure, myocardial infarction, angina pectoris and arrhythmia or hyperthyroidism; current or history of epilepsy; manic-depressive psychosis and those with the factor or organic brain disease or schizophrenia.
General Precautions: Because concomitant administration of Espin and monoamine oxidase inhibitor (MAOI) may produce convulsion, hyperpyretic crisis and coma. It should be avoided, in patients with a history of a previous MAOI. It should be administered every 2 weeks and it will be desirable that the observation of Espin and MAOI is made every 2-3 days.
Effects on the Ability to Drive or Operate Machinery: Espin may cause drowsiness. So patients driving or operating machinery should take caution.
Use in pregnancy: Animal reproduction studies with tricyclic antidepressants have not reported the teratogenic action, however, Espin should not be used in pregnant women or women who may become pregnant unless the possible benefits outweigh the potential risk to the fetus.
Use in lactation: Espin is likely to be distributed into milk, nursing should be discontinued during administration of this drug.
Use in children: The safety of children using Espin has not been established.
Use in the elderly: Administer with caution.
Use In Pregnancy & Lactation
Use in pregnancy: Animal reproduction studies with tricyclic antidepressants have not reported the teratogenic action, however, Espin should not be used in pregnant women or women who may become pregnant unless the possible benefits outweigh the potential risk to the fetus.
Use in lactation: Espin is likely to be distributed into milk, nursing should be discontinued during administration of this drug.
Adverse Reactions
Circulatory System: Hypotension, palpitation, tachycardia and alterations in electrocardiogram patterns may rarely occur.
Nervous System: If drowsiness, dizziness, sleep disorder, headache, tremor or infrequently anaphrodisia, excitement, hypomnesis, oculogyric crisis, paresthesia, dysarthria and ataxia occur, dosage should be reduced or Espin should be discontinued.
Hypersensitivity: If hypersensitivity symptom eg, eruption occurs, Espin should be discontinued.
Hematologic Effects: If hemopathy eg, leukopenia occurs, Espin should be discontinued.
Hepatic Effects: The elevation of glutamic oxaloacetic transaminase, glutamic pyruvic transaminase, lactate dehydrogenase may occur.
Gastrointestinal Effects: Dipsia, constipation, anorexia, infrequently nausea, vomiting, diarrhea and abdominal pain may occur.
Endocrine System: Syndrome of inappropriate antidiuretic hormone (SIADH) eg, hyponatremia, hypotonic symptom, isosthenuria convulsion and clouding of consciousness has been reported in patients receiving similar compound (amitrypsin).
Other Adverse Reaction: Weariness, urinary retention and rhinocleisis may occur.
Drug Interactions
Because the action of Espin may be potentiated, concomitant administration of this drug and the following drugs should be avoided: Ethanol, anticholinergic agent, epinephrine agonist, central nervous system depressant.
Because Espin may prevent the activity of hypotensive agents, it should be administered carefully.
Storage
Store below 30°C. Store in a light resistant and a tight container.
Shelf-Life: 3 years.
MIMS Class
ATC Classification
N06AA16 - dosulepin ; Belongs to the class of non-selective monoamine reuptake inhibitors. Used in the management of depression.
Presentation/Packing
Cap 25 mg (hard, upper and lower faintly yellow, containing white to faintly yellow, crystalline powder) x 500's.
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