Isoniazid

Země: Nový Zéland

Jazyk: angličtina

Zdroj: Medsafe (Medicines Safety Authority)

Aktivní složka:

Isoniazid 100mg

Dostupné s:

Noumed Pharmaceuticals Limited

INN (Mezinárodní Name):

Isoniazid 100 mg

Dávkování:

100 mg

Léková forma:

Tablet

Složení:

Active: Isoniazid 100mg Excipient: Lactose monohydrate Magnesium stearate Purified water Wheat starch as 9.50mg + 60.9mg (includes 10% overage for loss on drying)

Jednotky v balení:

Bottle, plastic, amber PVC, pp cap, 100 tablets

Třída:

Prescription

Druh předpisu:

Prescription

Výrobce:

Amsal Chem Private Limited

Terapeutické indikace:

Isoniazid is indicated for the treatment of pulmonary and extrapulmonary tuberculosis in combination with other antitubercular agents.

Přehled produktů:

Package - Contents - Shelf Life: Bottle, glass, amber, tamper-tel pp cap - 100 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, amber PVC, pp cap - 100 tablets - 36 months from date of manufacture stored at or below 25°C

Datum autorizace:

1969-12-31

Charakteristika produktu

NEW ZEALAND DATA SHEET
New Zealand Data Sheet
Page 1 of 9
1.
PRODUCT NAME
Isoniazid, Tablet, 100 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Name and strength of the active substance
Isoniazid BP 100 mg
Excipient(s) with known effect
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral - tablet
Presentation
White, 3/8" or 9.5 mm, normal, convex tablet.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Treatment of pulmonary and extrapulmonary tuberculosis in combination
with other
antitubercular agents.
4.2
Dose and method of administration
_Adults _
Recommended Isoniazid doses are 4 to 5 mg per kg body-weight in
divided doses up
to a maximum of 300 mg daily or up to 10 mg per kg body-weight may be
given for the
first 1 – 2 weeks of treatment for tuberculous meningitis.
_Children _
Doses of Isoniazid for children are 5 to 20 mg per kg body-weight
daily.
Intermittent administration is used to improve compliance and reduce
toxicity.
Regimens in which Isoniazid is given two or three times weekly are
effective, but once
weekly administration is not clinically effective in rapid
acetylators.
Standard doses of Isoniazid may be given to patients with renal
impairment; although
those on dialysis should receive Isoniazid following the procedure as
the drug is
removed by dialysis.
NEW ZEALAND DATA SHEET
New Zealand Data Sheet
Page 2 of 9
The dose may need to be reduced in patients with liver impairment.
4.3
Contraindications
•
Patients who develop severe hypersensitivity reactions including drug
induced
hepatitis;
•
Previous isoniazid associated hepatic injury;
•
Severe adverse reactions to isoniazid, such as drug fever, chills and
arthritis.
•
Acute hepatic disease of any aetiology; and
•
Patients with known hypersensitivity to isoniazid or any of the
excipients listed
under PHARMACOLOGICAL PROPERTIES section 5.
4.4
Special warnings and precautions for use
Severe and sometimes fatal hepatitis associated with isoniazid therapy
may occur and
may develop even after many months of tre