Prothiaden (Dosulepin Hydrochloride) Prothiaden 25mg/75mg tablet
PROTHIADEN
(Dosulepin Hydrochloride)
PRODUCT DESCRIPTION
Dosulepin hydrochloride is a tricyclic antidepressant that has
anxiolytic properties. The chemical name is 3-(6H-dibenzo(b,e)-
thiepin-11-ylidene) propyldimethylamine hydrochloride.
Dosulepin hydrochloride is a white to faintly yellow crystalline
powder that is almost without odor. The compound is soluble in
water, chloroform, and alcohol but is almost insoluble in ether. The
molecular weight is 331.9.
Inactive Ingredients
Inactive ingredients in Dosulepin may vary from country to
country. Consult the approved manufacturing formula for specific
ingredients.
INDICATIONS
Dosulepin is indicated in the treatment of symptoms of depressive
illness, especially where an anti-anxiety effect is required. Due to
its toxicity in overdose, Dosulepin should only be used in patients
intolerant of or unresponsive to alternative treatment options.
Initiation of treatment for patients who have not previously
received Dosulepin should be restricted to specialist care
prescribers (see PRECAUTIONS and OVERDOSAGE).
DOSAGE AND ADMINISTRATION
Adults
Initially, administer 75 mg daily in divided doses or as a single
dose at night, increasing to 150 mg/day. In certain circumstances,
e.g. in hospital use, dosages up to 225 mg/day have been used.
Suggested regimen: 25 to 50 mg three times daily or 75 to 150 mg
as a single dose at night. If 150 mg as a single dose is given at
night, it is better to give a smaller dose for the first few nights.
Elderly
The recommended dose is 50 to 75 mg daily. Elderly patients may
require a lower starting dose and slow dose escalation. As with
any tricyclic antidepressant, the initial dose should be increased
with caution under close supervision (see WARNINGS).
Children
The use of Dosulepin in children has not been studied.
Renal Impairment
Use with caution and reduce the dosage of Dosulepin in patients
with impaired renal function as increased blood levels may
develop.
Hepatic Impairment
Use with caution and reduce the dosage of Dosulepin in patients
with impaired hepatic function, as increased blood levels may
develop.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
Pharmacotherapeutic group: Antidepressants, non-selective
monoamine reuptake inhibitors trimester of pregnancy have also been reported (see
PREGNANCY AND LACTATION).
Class effects
Epidemiological studies, mainly conducted in patients 50 years of
age and older, show an increased risk of bone fractures in patients
receiving SSRIs and TCAs. The mechanism leading to this risk is
unknown.
OVERDOSAGE Symptoms:
Deaths may occur from overdosage with this class of drugs.
Multiple drug ingestion (including alcohol) is common in deliberate
tricyclic antidepressant overdose. Onset of toxicity occurs within
4-6 hours after tricyclic antidepressant overdose.
Symptoms of overdose include dry mouth, excitement, ataxia,
drowsiness,unconsciousness, muscle twitching, convulsions,
widely dilated pupils, hyperreflexia, sinus tachycardia, cardiac
arrhythmias, hypotension, hypothermia, depression of
respiration, visual hallucinations, delirium, urinary retention,
paralytic ileus, and respiratory or metabolic alkalosis.
Patients ingesting >5 mg/kg should seek immediate medical
attention. All children ingesting Dosulepin should be assessed by
a physician.
Treatment:
A clear airway and adequate ventilation should be ensured.
Hypoxia and acid-base imbalances should be corrected by
assisted ventilation and intravenous sodium bicarbonate as
appropriate. Do not give flumazenil to reverse benzodiazepine
toxicity in mixed overdoses.
The use of activated charcoal should be considered as a preferred
initial means of reducing absorption in patients presenting within 2
hours of ingestion. Repeated gastric/intestinal aspiration or
repeated administration of activated charcoal may remove drug
and metabolites excreted into the gut via the bile.
The benefit of gastric lavage is uncertain and the technique should
be avoided in any patient with an impaired airway. When the
patient is unconscious, or the cough reflex is depressed, the lungs
should be protected by a cuffed endotracheal tube. Forced
diuresis is not recommended.
Blood pressure, pulse and cardiac rhythm should be monitored for
at least 6 hours after ingestion.
Arrhythmias are best treated by correcting hypoxia and acid-base
disturbances.
Specialist poisons advice should be sought before using any anti-
arrhythmic agents as these may exacerbate the arrhythmia. In
cases of cardiac arrest, persist with prolonged CPR (for at least 1
hour).
Convulsions should be controlled with intravenous diazepam or
lorazepam.
Bed rest is advisable, even after recovery.
STORAGE
Protect from heat, light & moisture.
HOW SUPPLIED
Prothiaden 25mg tablets: 100s Film-coated (No. N888)
Prothiaden 75mg tablets: 30s Film-coated (No.N889)
(Dosulepin Hydrochloride)
PRODUCT DESCRIPTION
Dosulepin hydrochloride is a tricyclic antidepressant that has
anxiolytic properties. The chemical name is 3-(6H-dibenzo(b,e)-
thiepin-11-ylidene) propyldimethylamine hydrochloride.
Dosulepin hydrochloride is a white to faintly yellow crystalline
powder that is almost without odor. The compound is soluble in
water, chloroform, and alcohol but is almost insoluble in ether. The
molecular weight is 331.9.
Inactive Ingredients
Inactive ingredients in Dosulepin may vary from country to
country. Consult the approved manufacturing formula for specific
ingredients.
INDICATIONS
Dosulepin is indicated in the treatment of symptoms of depressive
illness, especially where an anti-anxiety effect is required. Due to
its toxicity in overdose, Dosulepin should only be used in patients
intolerant of or unresponsive to alternative treatment options.
Initiation of treatment for patients who have not previously
received Dosulepin should be restricted to specialist care
prescribers (see PRECAUTIONS and OVERDOSAGE).
DOSAGE AND ADMINISTRATION
Adults
Initially, administer 75 mg daily in divided doses or as a single
dose at night, increasing to 150 mg/day. In certain circumstances,
e.g. in hospital use, dosages up to 225 mg/day have been used.
Suggested regimen: 25 to 50 mg three times daily or 75 to 150 mg
as a single dose at night. If 150 mg as a single dose is given at
night, it is better to give a smaller dose for the first few nights.
Elderly
The recommended dose is 50 to 75 mg daily. Elderly patients may
require a lower starting dose and slow dose escalation. As with
any tricyclic antidepressant, the initial dose should be increased
with caution under close supervision (see WARNINGS).
Children
The use of Dosulepin in children has not been studied.
Renal Impairment
Use with caution and reduce the dosage of Dosulepin in patients
with impaired renal function as increased blood levels may
develop.
Hepatic Impairment
Use with caution and reduce the dosage of Dosulepin in patients
with impaired hepatic function, as increased blood levels may
develop.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
Pharmacotherapeutic group: Antidepressants, non-selective
monoamine reuptake inhibitors trimester of pregnancy have also been reported (see
PREGNANCY AND LACTATION).
Class effects
Epidemiological studies, mainly conducted in patients 50 years of
age and older, show an increased risk of bone fractures in patients
receiving SSRIs and TCAs. The mechanism leading to this risk is
unknown.
OVERDOSAGE Symptoms:
Deaths may occur from overdosage with this class of drugs.
Multiple drug ingestion (including alcohol) is common in deliberate
tricyclic antidepressant overdose. Onset of toxicity occurs within
4-6 hours after tricyclic antidepressant overdose.
Symptoms of overdose include dry mouth, excitement, ataxia,
drowsiness,unconsciousness, muscle twitching, convulsions,
widely dilated pupils, hyperreflexia, sinus tachycardia, cardiac
arrhythmias, hypotension, hypothermia, depression of
respiration, visual hallucinations, delirium, urinary retention,
paralytic ileus, and respiratory or metabolic alkalosis.
Patients ingesting >5 mg/kg should seek immediate medical
attention. All children ingesting Dosulepin should be assessed by
a physician.
Treatment:
A clear airway and adequate ventilation should be ensured.
Hypoxia and acid-base imbalances should be corrected by
assisted ventilation and intravenous sodium bicarbonate as
appropriate. Do not give flumazenil to reverse benzodiazepine
toxicity in mixed overdoses.
The use of activated charcoal should be considered as a preferred
initial means of reducing absorption in patients presenting within 2
hours of ingestion. Repeated gastric/intestinal aspiration or
repeated administration of activated charcoal may remove drug
and metabolites excreted into the gut via the bile.
The benefit of gastric lavage is uncertain and the technique should
be avoided in any patient with an impaired airway. When the
patient is unconscious, or the cough reflex is depressed, the lungs
should be protected by a cuffed endotracheal tube. Forced
diuresis is not recommended.
Blood pressure, pulse and cardiac rhythm should be monitored for
at least 6 hours after ingestion.
Arrhythmias are best treated by correcting hypoxia and acid-base
disturbances.
Specialist poisons advice should be sought before using any anti-
arrhythmic agents as these may exacerbate the arrhythmia. In
cases of cardiac arrest, persist with prolonged CPR (for at least 1
hour).
Convulsions should be controlled with intravenous diazepam or
lorazepam.
Bed rest is advisable, even after recovery.
STORAGE
Protect from heat, light & moisture.
HOW SUPPLIED
Prothiaden 25mg tablets: 100s Film-coated (No. N888)
Prothiaden 75mg tablets: 30s Film-coated (No.N889)
Prothiaden (Dosulepin Hydrochloride) Prothiaden 25mg/75mg tablet
Reviewed by Athar
on
22:32
Rating:
Reviewed by Athar
on
22:32
Rating:
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