Isoniazid tablets

Χώρα: Αρμενία

Γλώσσα: Αγγλικά

Πηγή: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Δραστική ουσία:

isoniazid

Διαθέσιμο από:

Macleods Pharmaceuticals Ltd.

Φαρμακολογική κατηγορία (ATC):

J04AC01

INN (Διεθνής Όνομα):

isoniazid

Δοσολογία:

100mg

Φαρμακοτεχνική μορφή:

tablets

Μονάδες σε πακέτο:

(100/10x10) in blister

Τρόπος διάθεσης:

Prescription

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

2016-10-06

Φύλλο οδηγιών χρήσης

_CHILDREN'S DOSE_
Initial/continuation Phase
Daily (100mg)
Continuation Phase - 3
times weekly (100 mg)
WEIGHT IN KG
5-10
11-20 21-30
0.5
Tablet
1
Tablet
1
Tablet
1.5
Tablet
2
Tablet
3.0
Tablet
For the use only of a Registered Medical Practitioner or a Hospital or
a Laboratory
COMPOSITION
Each uncoated tablet contains:
Isoniazid BP
100 mg
DESCRIPTION
Isoniazid, the hydrazide of isonicotinic acid, is highly bactericidal
against replicating tubercle bacilli.
PHARMACOLOGICAL CLASSIFICATION
Anti-mycobacterial agent
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Isoniazid is bactericidal _in vitro _and _in vivo _against actively
dividing tubercle bacilli. Its primary action is
to inhibit the synthesis of long chain mycolic acids, which are unique
constituent of mycobacterial cell
wall. Isoniazid of concentration 600 mg/l or greater are required to
inhibit Gram-positive and Gram -
negative bacteria, but the minimum inhibitory concentration for
mycobacterium tuberculosis is 0.025 -
0.05 mg / L. Resistance to isoniazid occurs spontaneously and random
in growing tubercle bacilli at a
6
mutation rate of 1 x 10 per bacterium per generation. The mutants
appear to take drug less readily than
sensitive cells.
PHARMACOKINETICS
Isoniazid is completely and rapidly absorbed from the gastrointestinal
tract. The peak plasma
concentrations of 3-7 mg/l are achieved 1-2hrs after oral
administration of isoniazid. The plasma half-
life of isoniazid is 2-6.5hrs. Isoniazid undergoes appreciable
presystemic (first pass) in the wall of small
intestine and liver, resulting in the concentrations in the plasma of
rapid acetylators which are half
those in slow acetylators after normal doses of drug. Isoniazid is
distributed in body with an apparent
volume of distribution volume of 61% of body weight. Isoniazid
undergoes extensive metabolism.
Metabolism occurs in the mucosal cells of the small intestine and in
the liver. As much as 95% of the
ingested isoniazid is excreted in the urine within 24hrs. Less than
10% of the dose is excreted in the
faeces.

Αρχείο Π.Χ.Π.

1.3.1 SUMMARY OF PRODUCT CHARACTERISTICS
MACLEODS PHARMACEUTICALS LTD._ _
_ _
ISONIAZID TABLETS BP 100 MG
1.3.1
SUMMARY OF PRODUCT CHARACTERISTICS
The Summary of Product Characteristics for
ISONIAZID TABLETS 100 MG
as approved by WHO
under TB Prequalification Programme is enclosed overleaf
Isoniazid 100 mg/Isoniazid 300 mg Tablets
(Macleods Pharmaceuticals Ltd),
TB178/TB179
WHOPAR part 4
September 2011
Section 6 updated : March 2016
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
Isoniazid 100 mg/Isoniazid 300 mg Tablets
(Macleods Pharmaceuticals Ltd),
TB178/TB179
WHOPAR part 4
September 2011
Section 6 updated : March 2016
Page 2 of 11
1. NAME OF THE MEDICINAL PRODUCT
Isoniazid 100 mg Tablets
*
Isoniazid 300 mg Tablets
*
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Isoniazid 100 mg or 300 mg
For a full list of excipients see section 6.1.
3. PHARMACEUTICAL FORM
Isoniazid 100 mg Tablets:
White to off-white, circular, biconvex, uncoated tablets with
breakline on one side and plain surface
on the other side.
Isoniazid 100 mg Tablets can be divided into equal halves.
Isoniazid 300 mg Tablets:
White, circular, biconvex, uncoated tablets having plain surface on
both the sides.
Isoniazid 300 mg Tablets should not be divided or crushed.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATION
Isoniazid Tablets is indicated for the treatment of tuberculosis,
caused by
_Mycobacterium _
_tuberculosis._
The
most
recent
official
guidelines
on
the
treatment
of
tuberculosis
(e.g.
WHO
guideline:
http://whqlibdoc.who.int/publications/2010/9789241547833_eng.pdf
_) _
should
be
taken
into
consideration for deciding on the appropriateness of therapy with
Isoniazid Tablets.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oral use.
Isoniazid Tablets should be swallowed whole with water or another
drink.
The tablets should be taken on an empty stomach (at least one hour
prior to or two hours after a meal).
ACTIVE TUBERCULOSIS
For the treatment of active tuberculosis isoniazid must always be used
in combination with other
antitub