DP-Carvedilol

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Carvedilol 3.125mg;  

Available from:

Douglas Pharmaceuticals Limited

INN (International Name):

Carvedilol 3.125 mg

Dosage:

3.125 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Carvedilol 3.125mg   Excipient: Colloidal silicon dioxide Crospovidone Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry white YS-22-18096 Povidone

Units in package:

Blister pack, opaque white PVC film/aluminium, 30 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Moehs Catalana SL

Therapeutic indications:

Hypertension DP-Carvedilol is indicated for the management of essential hypertension. It can be used alone or in combination with other antihypertensive agents (eg calcium channel blockers, diuretics).

Product summary:

Package - Contents - Shelf Life: Blister pack, opaque white PVC film/aluminium - 30 tablets - 36 months unopened stored at or below 25°C - Blister pack, opaque white PVC film/aluminium - 60 tablets - 36 months unopened stored at or below 25°C - Blister pack, opaque white PVC film/aluminium - 100 tablets - 36 months unopened stored at or below 25°C - Bottle, plastic, Round, White HDPE with polypropylene cap and permaseal liner - 30 tablets - 36 months unopened stored at or below 25°C - Bottle, plastic, Round, White HDPE with polypropylene cap and permaseal liner - 60 tablets - 36 months unopened stored at or below 25°C - Bottle, plastic, Round, White HDPE with polypropylene cap and permaseal liner - 100 tablets - 36 months unopened stored at or below 25°C - Bottle, plastic, Round, White HDPE with polypropylene cap and permaseal liner - 250 tablets - 36 months unopened stored at or below 25°C - Bottle, plastic, Round, White HDPE with polypropylene cap and permaseal liner - 500 tablets - 36 months unopened stored at or below 25°C

Authorization date:

2005-06-14

Summary of Product characteristics

Datasheet 

DP-Carvedilol 
Carvedilol tablets 3.125 mg, 6.25 mg, 12.5 mg and 25 mg 
Composition 
Active ingredient 
carvedilol 
1 tablet contains 3.125 mg, 6.25 mg, 12.5 mg or 25 mg carvedilol. 
Tablets for oral administration. 
Excipients 
The  tablet  cores  contain:  microcrystalline  cellulose,  lactose  monohydrate,  crospovidone, 
povidone,  colloidal  silicon  dioxide  anhydrous,  and  magnesium  stearate.  The  tablets  are 
coated  with  Opadry  II  White  YS-22-18096  which  is  comprised  of:  hydroxypropyl 
methylcellulose, titanium dioxide, polydextrose, triethyl citrate and polyethylene glycol). 
Appearance 
DP-Carvedilol 3.125mg tablet: White, oval shaped, film-coated tablets with “P” embossed on 
one side and plain on the other. 
DP-Carvedilol  6.25mg  tablet:  White,  oval  shaped,  film-coated  tablets  with  “P”  embossed  on 
one side and “6.25” on the other. 
DP-Carvedilol  12.5mg  tablet:  White,  oval  shaped,  film-coated  tablets  with  “P”  embossed  on 
one side and “12.5” on the other. 
DP-Carvedilol 25mg tablet: White, oval shaped, film-coated tablets with “P” embossed on one 
side and “25” on the other. 
Properties and Effects 
Mechanism of action 
Carvedilol  is  a  multiple  action  adrenergic  receptor  blocker  with  α
1, 
β
1 
and  β
2
  adrenergic 
receptor  blockade  properties.  Carvedilol  has  been  shown  to  have  organ-protective  effects. 
Carvedilol  is  a  potent  antioxidant  and  a  scavenger  of  reactive  oxygen  radicals.  Carvedilol  is 
racemic,  and both  R(+) and S(-)  enantiomers have  the same α-adrenergic receptor  blocking 
properties  and  antioxidant  properties.  Carvedilol  has  antiproliferative  effects  on