CHLOZINE TABLETS Film Coated Tablet 100 mg

País: Tanzània

Idioma: anglès

Font: Tanzania Medicinces & Medical Devices Authority

ingredients actius:

Chlorpromazine Hydrochloride BP

Disponible des:

Agog Pharma Ltd, INDIA

Codi ATC:

Neuroleptics

Designació comuna internacional (DCI):

Chlorpromazine Hydrochloride BP

Dosis:

100 mg

formulario farmacéutico:

Film Coated Tablet

Fabricat per:

AGOG PHARMA LIMITED, INDIA

Resumen del producto:

Physical description: White, circular, biconvex, film coated tablet; Local technical representative: Planet Pharmaceutical Limited (6099)

Estat d'Autorització:

Registered/Compliant

Data d'autorització:

2022-09-21

Fitxa tècnica

1.5
PRODUCT INFORMATION
1.5.1
PRESCRIBING INFORMATION (SUMMARY OF PRODUCTS CHARACTERISTICS)
SUMMARY PRODUCT CHARACTERISTICS
1.
NAME OF DRUG PRODUCT: CHLOZINE TABLETS (CHLORPROMAZINE TABLETS BP 100 MG)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each film coated tablet contains: Chlorpromazine Hydrochloride BP 100
mg
_For full list of excipients see section 6.1 _
_ _
3.
PHARMACEUTICAL FORM:
White, circular, biconvex, film coated tablet.
4.
CLINICAL PARTICULARS:
4.1 THERAPEUTIC INDICATIONS
Schizophrenia and other psychoses (especially paranoia), mania and
hypomania. In
anxiety,
psychomotor
agitation,
excitement,
violent
or
dangerously
impulsive
behaviour. Is used as an adjunct in the short-term management of these
conditions.
Intractable hiccup.
Nausea and vomiting in terminal illness (where other drugs have failed
or are not
available).
Induction of hypothermia is facilitated by Chlorpromazine Tablets
which prevents
shivering and causes vasodilatation.
Childhood schizophrenia and autism. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Dosages
should
be
low
to
begin
with
and
gradually
increased
under
close
supervision until the optimum dosage for the individual is reached.
Individuals vary
considerably and the optimum dose may be affected by the formulation
used.
Dosage of chlorpromazine in schizophrenia, other psychoses, anxiety
and agitation
etc.
Adult:
Initially 25 mg t.d.s. or 75 mg at bedtime increasing by daily amounts
of 25 mg to an
effective maintenance dose. This is usually in the range 75 to 300 mg
daily but some
patients may require up to 1 g daily.
Children under 1 year:
Do not use unless need is life saving.
Children 1-5 years:
0.5 mg/kg body weight every 4-6 hours to a maximum recommended dose of
40 mg
daily.
Children 6-12 years:
1
/
3
-½ adult dose to a maximum recommended dose of 75 mg daily.
Elderly or debilitated patients:
Start with
1
/
3
-½ usual adult dose with a more gradual increase in dosage.
Hiccups
Adult:
25-50 mg t.d.s. or q.d.s.
Children under 1 year:
No information available.
Children 1-5