Amitriptyline tablets coated

Država: Armenija

Jezik: angleščina

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivna sestavina:

amitriptyline (amitriptyline hydrochloride)

Dostopno od:

Arpimed LLC

Koda artikla:

N06AA09

INN (mednarodno ime):

amitriptyline (amitriptyline hydrochloride)

Odmerek:

25mg

Farmacevtska oblika:

tablets coated

Enote v paketu:

(48/2x24/) in blister

Tip zastaranja:

Prescription

Status dovoljenje:

Registered

Datum dovoljenje:

2019-11-05

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS AMITRIPTYLINE 25 MG COATED TABLETS
1.1 BRAND NAME – Amitriptyline
1.2 INTERNATIONAL NON-PROPERTY NAME – Amitriptyline hydrochloride
2. QUANTITATIVE AND QUALITATIVE COMPOSITION
Each coated tablet contains:
_ACTIVE INGREDIENT: _amitriptyline hydrochloride – 25.0 mg;
For a full list of excipients see section 6.1.
3. PHARMACEUTICAL FORM
Yellow biconvex coated tablets.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Amitriptyline tablets are indicated for:
• the treatment of major depressive disorder in adults
• the treatment of neuropathic pain in adults
• the prophylactic treatment of chronic tension type headache (CTTH)
in adults
• the prophylactic treatment of migraine in adults
• the treatment of nocturnal enuresis in children aged 6 years and
above when organic pathology,
including spina bifida and related disorders, have been excluded and
no response has been
achieved to all other non-drug and drug treatments, including
antispasmodics and vasopressin-
related products. This medicinal product should only be prescribed by
a healthcare professional
with expertise in the management of persistent enuresis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Not all dosage schemes can be achieved with all the pharmaceutical
forms/strengths. The
appropriate formulation/strength should be selected for the starting
doses and any subsequent
dose increments.
Major depressive disorder
Dosage should be initiated at a low level and increased gradually,
noting carefully the clinical
response and any evidence of intolerability.
Adults
Initially 25 mg 2 times daily (50 mg daily). If necessary, the dose
can be increased by 25 mg
every other day up to 150 mg daily divided into two doses.
The maintenance dose is the lowest effective dose.
Elderly patients over 65 years of age and patients with cardiovascular
disease
Initially 10 mg – 25 mg daily.
The daily dose may be increased up to 100 mg – 150 mg divided into
two doses, depending on
individual patient response and tolera