PDP-ISONIAZID 50 MG
ISONIAZID : 50 MG · DIN 00577782 · PENDOPHARM DIVISION OF PHARMASCIENCE INC
Health Canada status: DORMANT
What is PDP-ISONIAZID?
PDP-ISONIAZID 50 MG contains ISONIAZID : 50 MG. It is listed in the Health Canada Drug Product Database under DIN 00577782, held by PENDOPHARM DIVISION OF PHARMASCIENCE INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as dormant, status dated 03-Aug-2017. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.
What is PDP-ISONIAZID used for?
Used with other antituberculosis drugs for treatment of pulmonary and extrapulmonary tuberculosis; used alone for tuberculosis prophylaxis.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
Product details and regulatory record
| DIN | 00577782 |
|---|---|
| Brand name | PDP-ISONIAZID |
| Generic / active ingredient | ISONIAZID : 50 MG |
| Manufacturer | PENDOPHARM DIVISION OF PHARMASCIENCE INC |
| Strength | 50 MG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | J04AC01 ISONIAZID |
| AHFS class | 08:16.04 |
| Biosimilar | No |
| Health Canada status | DORMANT |
| Status date | 03-Aug-2017 |
| Original market date | 1986-12-31 00:00:00 |
How is it administered?
Orally, single daily dose on empty stomach. Adults: 5 mg/kg (max 300 mg). Children: 10-20 mg/kg (max 300 mg). Prophylaxis: 300 mg daily (adults), 10 mg/kg (children).
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Tablets: Store between 15°C and 30°C. Oral Solution: Store between 15°C and 25°C.
How is it supplied?
Tablets: Bottles of 100. Oral Solution: Bottles of 500 mL.
Contraindications
Severe hypersensitivity reactions to isoniazid, including drug-induced hepatitis; acute liver disease of any etiology.
Warnings and precautions
Severe and sometimes fatal hepatitis may occur even after months of treatment. Risk increases with age, alcohol use, and pre-existing liver disease. Monitor for prodromal symptoms.
What can be used instead?
Other Canadian products sharing ATC code J04AC01 ISONIAZID. 3 of 18 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.
| Product | Strength | Form | Manufacturer | Health Canada status | DIN |
|---|---|---|---|---|---|
| PDP-ISONIAZID | 100 MG | TABLET | PENDOPHARM DIVISION OF PHARMASCIENCE INC | MARKETED | DIN 00577790 |
| PDP-ISONIAZID | 300 MG | Tablet | PENDOPHARM DIVISION OF PHARMASCIENCE INC | MARKETED | DIN 00577804 |
| PDP-ISONIAZID | 50 MG / 5 ML | SOLUTION | PENDOPHARM DIVISION OF PHARMASCIENCE INC | MARKETED | DIN 00577812 |
| DOM-ISONIAZID 300MG TABLETS | 300 MG | TABLET | DOMINION PHARMACAL | CANCELLED POST MARKET | DIN 02181428 |
| ISONIAZID SYRUP 50MG/5ML | 50 MG / 5 ML | SYRUP | CAROLINA MEDICAL PRODUCTS COMPANY | CANCELLED POST MARKET | DIN 00722464 |
| ISONIAZID TAB 100MG | 100 MG | TABLET | SANDS PHARM | CANCELLED POST MARKET | DIN 00440108 |
| ISONIAZID TAB 300MG | 300 MG | TABLET | SANDS PHARM | CANCELLED POST MARKET | DIN 00310247 |
| ISONIAZID TAB 50MG | 50 MG | TABLET | SANDS PHARM | CANCELLED POST MARKET | DIN 00382779 |
| ISONIAZIDE 100MG TABLETS | 100 MG | TABLET | LABORATOIRES CONFAB INC | CANCELLED PRE MARKET | DIN 02232756 |
| ISOTAMINE | 10 MG | SYRUP | BAUSCH HEALTH, CANADA INC. | DORMANT | DIN 00265500 |
Who else supplies ISONIAZID worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. ISONIAZID appears in 683 registered pack listings across 10 markets, published on 10 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.
Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.
How can I get it?
Nexara Health supplies this product to licensed Canadian buyers — pharmacies, hospitals, clinics, licensed distributors, and clinical trial sponsors or their CROs. We confirm stock, pack size, expiry and pricing at the time of quotation. If the product is on backorder or in shortage, we identify equivalent alternatives and import options where permitted.
Ordering questions
Who can buy this from Nexara?
Licensed entities only. Nexara holds Health Canada establishment licence DEL 3-002896-A and ships only to a licensed address.
Is there a minimum order?
Yes, set per product line and per pack multiple rather than on the order total, so you are never asked to buy a part-pack. The minimum for this line is confirmed with your quote.
What is the lead time?
Confirmed per order at quotation, and it depends on current stock position and whether the product is in shortage.
Can Nexara supply this for a clinical trial?
Yes — comparator and background-therapy supply, including sourcing from other markets where a Canadian pack will not satisfy the protocol. Clinical trial supply.