LENNON ISONIAZID 200 mg TABLETS

Երկիր: Հարավաֆրիկյան Հանրապետություն

Լեզու: անգլերեն

Աղբյուրը: South African Health Products Regulatory Authority (SAHPRA)

Հասանելի է:

Pharmacare Limited û Woodmead

Դոզան:

See ingredients

Դեղագործական ձեւ:

TABLET

Կազմը:

EACH TABLET CONTAINS ISONIAZID 200 MG

Լիազորման կարգավիճակը:

Registered

Հաստատման ամսաթիվը:

1979-05-03

Ապրանքի հատկությունները

ZA_LEISONTAB_7903_01
Page 1 of 7
1.3.1.1 PROFESSIONAL INFORMATION FOR MEDICINES FOR HUMAN
USE
SCHEDULING STATUS
S3
PROPRIETARY NAME AND DOSAGE FORM
LENNON ISONIAZID 100 mg (tablets)
LENNON ISONIAZID 200 mg (tablets)
LENNON ISONIAZID 300 mg (tablets)
COMPOSITION
LENNON ISONIAZID 100 mg contains 100 mg isoniazid.
Excipients:
Colloidal silicon dioxide, hydrogenated vegetable oil (Sterotex),
maize starch, mucilage acacia
30 %, sodium starch glycollate.
LENNON ISONIAZID 200 mg contains 200 mg isoniazid.
Excipients:
Acacia mucilage 30 %, Lake erythrosine (C.I. No.45430), maize starch,
magnesium stearate,
powdered vegetable stearine, sodium starch glycollate.
LENNON ISONIAZID 300 mg contains 300 mg isoniazid.
Excipients:
Dye yellow No. 137 (C.I. No. 19140), maize starch, mucilage acacia 30
%, powdered vegetable
stearine, sodium starch glycollate.
ZA_LEISONTAB_7903_01
Page 2 of 7
PHARMACOLOGICAL CLASSIFICATION
A.20.2.3. Tuberculostatics
PHARMACOLOGICAL ACTION
Isoniazid is a synthetic, bactericidal antitubercular agent, which is
active against many
mycobacteria, primarily those that are actively dividing. Its exact
mechanism of action is not
known, but it may relate to inhibition of mycolic acid synthesis and
disruption of the cell wall in
susceptible organisms.
It is readily absorbed from the gastrointestinal tract following oral
administration, but may
however undergo significant first pass metabolism. The primary
metabolic route is acetylation.
Absorption and bio-availability are reduced when administered with
food. The plasma half-life
for isoniazid ranges from about 1 to 4 hours. It is widely distributed
to all fluids and tissues,
including cerebrospinal fluid (CSF), pleural and ascitic fluids, skin,
sputum, saliva, lungs,
muscle, and caseous tissue. It crosses the placenta and is excreted in
the breast milk.
Approximately 75 to 95 % is excreted by the kidneys within 24 hours,
mainly as metabolites.
Small amounts are excreted in the faeces.
INDICATIONS
LENNON ISONIAZID is used in the prophylaxis and treatment of pulm