Doxepin 50mg capsules

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Doxepin hydrochloride

Inapatikana kutoka:

Crescent Pharma Ltd

ATC kanuni:

N06AA12

INN (Jina la Kimataifa):

Doxepin hydrochloride

Kipimo:

50mg

Dawa fomu:

Oral capsule

Njia ya uendeshaji:

Oral

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 04030100; GTIN: 5017123361135

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Doxepin 50 mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 56.530 mg doxepin hydrochloride, equivalent to
50 mg
doxepin.
Excipient(s) with known effect
This medicine contains 179.02 mg of lactose monohydrate.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, hard
[Capsules]
Blue cap and blue body, opaque, size 2 hard gelatin capsules,
imprinted with ‘PC’ on
the cap and ‘D50’ on the body with white ink.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptoms of depressive illness in adults, especially where sedation is
required.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
The optimum oral dose depends on the severity of the condition and the
individual
patient’s response. The dose required may vary from 25-300 mg daily.
Doses up to
100 mg daily may be given on a divided or once daily schedule. Should
doses over
100 mg daily be required, they should be administered in three divided
doses daily.
100 mg is the maximum dose recommended at any one time. This dose may
be given
at bedtime.
For the majority of patients with moderate or severe symptoms, it is
recommended
that treatment commences with an initial dose of 75 mg daily. Many of
these patients
will respond satisfactorily at this dose level. For patients who do
not, the dosage may
be adjusted according to individual response. In more severely ill
patients, it may be
necessary to administer a dose of up to 300 mg in divided doses daily,
to obtain a
clinical response.
In patients where insomnia is a troublesome symptom, it is recommended
that the
total daily dose be divided so that a higher proportion is given for
the evening dose;
similarly, if drowsiness is experienced as a side effect of treatment,
Doxepin 50 mg
Capsules may be administered by this regimen or the dosage may be
reduced. It is
often possible, having once obtained a satisfactory therapeutic
response, to reduce the
dose for maintenance therapy.
The optima