THEO ER 400 MG
THEOPHYLLINE : 400 MG · DIN 02360101 · AA PHARMA INC
Health Canada status: MARKETED
What is THEO ER?
THEO ER 400 MG contains THEOPHYLLINE : 400 MG. It is listed in the Health Canada Drug Product Database under DIN 02360101, held by AA PHARMA INC, supplied as TABLET (EXTENDED-RELEASE) for ORAL administration. Health Canada currently lists it as marketed, status dated 23-Jun-2011. 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 THEO ER used for?
Symptomatic treatment of reversible bronchoconstriction associated with asthma, emphysema, chronic bronchitis and related bronchospastic disorders in patients 12 years and older.
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 | 02360101 |
|---|---|
| Brand name | THEO ER |
| Generic / active ingredient | THEOPHYLLINE : 400 MG |
| Manufacturer | AA PHARMA INC |
| Strength | 400 MG |
| Dosage form | TABLET (EXTENDED-RELEASE) |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | R03DA04 THEOPHYLLINE |
| AHFS class | 86:16.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 23-Jun-2011 |
| Original market date | 2011-06-23 00:00:00 |
How is it administered?
Individualize dose based on response and serum levels (target 5-15 mcg/mL). Initial adult dose: 400-600 mg once daily, preferably in the evening with food. Tablets must be swallowed whole.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly stated in provided text (Section 11 is in Table of Contents but text ends at Section 9).
How is it supplied?
Bottles of 100 tablets.
Contraindications
Hypersensitivity to theophylline or xanthines; coronary artery disease (where cardiac stimulation is harmful); peptic ulcers; concomitant use with ephedrine in children.
Warnings and precautions
Narrow therapeutic index. Not for status asthmaticus. Risk of toxicity at levels >20 mcg/mL. Use caution in cardiac disease, hypertension, seizures, and elderly patients.
What can be used instead?
Other Canadian products sharing ATC code R03DA04 THEOPHYLLINE. 6 of 39 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 |
|---|---|---|---|---|---|
| AA-THEO LA | 100 MG | TABLET (EXTENDED-RELEASE) | AA PHARMA INC | MARKETED | DIN 00692689 |
| AA-THEO LA | 200 MG | TABLET (EXTENDED-RELEASE) | AA PHARMA INC | MARKETED | DIN 00692697 |
| AA-THEO LA | 300 MG | TABLET (EXTENDED-RELEASE) | AA PHARMA INC | MARKETED | DIN 00692700 |
| ELIXIR DE THEOPHYLLINE | 80 MG / 15 ML | ELIXIR | LABORATOIRE ATLAS INC | MARKETED | DIN 00627410 |
| THEO ER | 600 MG | TABLET (EXTENDED-RELEASE) | AA PHARMA INC | MARKETED | DIN 02360128 |
| APO-THEO ER | 400 MG | TABLET (EXTENDED-RELEASE) | APOTEX INC | APPROVED | DIN 02358395 |
| APO-THEO ER | 600 MG | TABLET (EXTENDED-RELEASE) | APOTEX INC | APPROVED | DIN 02358409 |
| PMS-THEOPHYLLINE ELIXIR | 80 MG / 15 ML | ELIXIR | PHARMASCIENCE INC | CANCELLED POST MARKET | DIN 00575151 |
| PULMOPHYLLINE ELX | 80 MG / 15 ML | ELIXIR | LABORATOIRE RIVA INC. | DORMANT | DIN 00466409 |
| QUIBRON T SR TAB 300MG | 300 MG | TABLET (EXTENDED-RELEASE) | BRISTOL LABS DIVISION OF BRISTOL-MYERS SQUIBB | CANCELLED POST MARKET | DIN 00556742 |
Who else supplies THEOPHYLLINE worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. THEOPHYLLINE appears in 1365 registered pack listings across 7 markets, published on 7 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.