PANECTYL TABLET

Country: Canada

Language: English

Source: Health Canada

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Active ingredient:

TRIMEPRAZINE (TRIMEPRAZINE TARTRATE)

Available from:

SEARCHLIGHT PHARMA INC

ATC code:

R06AD01

INN (International Name):

ALIMEMAZINE

Dosage:

2.5MG

Pharmaceutical form:

TABLET

Composition:

TRIMEPRAZINE (TRIMEPRAZINE TARTRATE) 2.5MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

PHENOTHIAZINE DERIVATIVES

Product summary:

Active ingredient group (AIG) number: 0106200001; AHFS:

Authorization status:

APPROVED

Authorization date:

2000-11-06

Summary of Product characteristics

                                PRODUCT MONOGRAPH
PR
PANECTYL
TRIMEPRAZINE TARTRATE TABLETS
2.5 MG AND 5 MG TRIMEPRAZINE (AS TRIMEPRAZINE TARTRATE) TABLETS
MANUFACTURER STANDARD
ANTIPRURITIC - ANTIHISTAMINIC
Searchlight Pharma Inc.
1600 Notre-Dame West, suite 312
Montreal, Quebec
H3J 1M1
Date of Preparation:
OCT 17, 2022
Submission Control No.: 267388
2
STRUCTURAL FORMULA AND CHEMISTRY
Neutral tartrate of 10-[3-(2-methyl) dimethylaminopropyl]
phenothiazine. Its structural formula
may be represented as follows:
White, non hygroscopic, light-sensitive, crystalline powder. Melting
range, between 160

and
164

C. Freely soluble in water, soluble in alcohol, sparingly soluble in
chloroform and very
slightly soluble in ether and benzene.
Molecular weight : 746.97
ACTION
Panectyl is a phenothiazine derivative with reduced central activity
and enhanced antihistaminic
and antipruritic effects. It has marked sedative, antiserotonin,
antispasmodic and antiemetic
properties but has only a weak effect on the autonomic nervous system.
INDICATIONS
_Pruritus _regardless of site or etiology such as may occur in :
neurodermatitis, eczema, urticaria,
pruritus
ani,
pruritus
vulvae,
drug
eruption,
dermatitis
herpetiformis,
insect
bites,
contact
dermatitis; pruritus due to non-dermatological conditions : chicken
pox, measles, Hodgkin’s
disease, obstructive jaundice, diabetes, zona.
_Cough _ of various etiologies such as may occur in : acute or chronic
conditions of the upper
respiratory tract, persistent cough, bronchial irritation, whooping
cough, asthma-like dyspnea,
asthma, hay fever.
3
CONTRAINDICATIONS
States of CNS depression due to barbiturates, alcohol, narcotics or
analgesics. Cases with a history
of blood dyscrasias or severe allergic reactions related to
trimeprazine or other phenothiazines.
Trimeprazine is contraindicated for use in children less than two
years of age. (see Warnings
section).
WARNINGS
Patients should be advised against driving or engaging in activities
requiring complete mental
alertness or physical co-ordination, until their res
                                
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