Drug Interaction:
Anaesthetics, clonidine, MAOIs, calcium antagonists (verapramil ) diltiazem ) anti-arrhythmetics, antidepressants, barbiturates, phenothiazines, Cardiac glycosides, antipsychotics, NSAIDs, fluvaxamine, cimetidine, hydralazine, Insulin/ oral hypoglcaemics, ergot derivatives, Diuretics, erythromycin, antimalarials, rifampicin, moxisylate
Indication:
LIST OF DRUGS DURING 2004
Sr.No- 240
Name of the Drug- FDC of Nebivolol (5mg)+
S(-) Amlodipine (2.5mg) tablet
Pharmacological Classification- Anti-hypertensive
Date of Approval- 14-09-2004
Approved by U.S.FDA on 30-12-2004 (Ref- FDA approved List- 2004)
LIST OF DRUGS DURING 2004
Sr.No- 260
Name of the Drug- FDC of Nebivolol HCL (5mg) +
Hydrochlorthiazide (12.5mg) tablet Pharmacological Classification- Anti-hypertensive
Date of Approval- 22-12-2004
Approved by U.S.FDA on 30-12-2004 (Ref- FDA approved List- 2004) LIST OF DRUGS DURING 2006
Sr.No- 2
Name of the Drug- Nebivolol (as(HCL )5mg
Versartan 80mg Pharmacological Classification- For Hypertension
Date of Approval- 17-01-2006
Approved by U.S.FDA on 30-12-2006 (Ref- FDA approved List- 2006)
LIST OF DRUGS DURING 2006
Sr.No- 50
Name of the Drug- Nebivolol(as HCL) 5mg +
Amlodipine (as besylate) 5mg/10mg Pharmacological Classification- For Hypertension
Date of Approval- 17-01-2006
Approved by U.S.FDA on 30-12-2006 (Ref- FDA approved List- 2006)
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.FDC of Nebivolol hcl 5mg + 22-12-2004
Hydrochlorthiazide 12.5mg tablet
Hypertension
2.Nebivolol Hcl 5mg 17-01-2006
+ Valsatran 80mg
For hypertension
3.Nebivolol Hcl 12-07-2002
Antihypertensive
4.Nebivolol Hcl 5mg 24-05-2006
+ Amlodipine Besylate 5mg/10mg
For Hypertension
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
1. Nebivolol hcl eq. to 23-12-2004
Nebivolol 5mg +
HCTZ 12.5mg tablets
For the treatment of esential hypertension
2.Nebivolol 5mg + 23-12-2004
HCTZ 12.5mg tablets
For the treatment of essential hypertension
3. Nebivolol as HCL 5mg + 17-10-2006
Valsartan 80mg
For hypertension
4. Nebivolol 5mg + 06-09-2006
Amlodipine 10mg FC tablets
For the management of essential hypertension
in adults only
5. Nebibolol as HCL 5mg + 24-05-2006
Amlodipine besylate 5mg/10mg
Film coated tablets
For hypertension
Patient Information:
Patient information-
Patients with inadequate cardiac function,well compensated heart faiure,myastenia gravis.Patients undergoing major surgery involoving general annesthesia.
May mask signs and symptoms of hypoglycemia and hypothrytoidism. Abruprt wirhdrwal may exeraburate anigina symptoms
Pregnancy and lactation.
Monitoring parameters- monitor ECG, blood pressure and blood glucose in diabetic patients
Pharmacology/ Pharmacokinetics:
Pharmacology:
Nebivolol is a lipophilic beta 1- blocker. It exerts its action by exhibiting a high selectivity for Beta-adrenergic receptors and also by reducing the peripheral vascular resistence by modulating NO release. It is devoid of intrinsic sympathomimetic or membrane stabilising activity but appears to have nitric oxide-mediated vasodilatory effects.
Pharmacokinetics:
After oral administration nebivolol achieves steady-state plasma concentrations with 1 day, and its active metabolite within a few days for the active metabolite.The metabolism of nebivolo is subject to genetic polymorphism, phenotypically, individuals may be characterised as poor (slow) or extensive (fast) metabolisers. One week after administration, 38% and 48% respy, of nebivolol dose is excreted in urine and faeces, unchanged nebivolol accounts for less than 0.05% of the amount recovered in the urine.Plasma concentrations of nebivolol (both enatiomers) and its hydroxy metabolites are elevated in patients with renal disease
Manufacturer Details