Drug Interaction:
Symptomatic hyponatremia when combined with carbamazepine
Predisposes to allopurinol sensitivity reactions and impaired renal function.
Potentiates hypotensive effects of beta blockers and ACE inhibitors, These also reduce diuretic- induced hypokalemia
Enhance neuromuscular action of blocking action of muscle relaxants.
Cross allergy with sulphonyl urea hypoglycemics with resultant active interstistial nephritis and vasculitis Pototentiates bone marrow suppresion caused by anticancer drugs.
Potentiates aminoglycoside nephrotoxicity Impaired control of diabetes by oral hypoglycemic agents
May precipitate lithium and digitalis toxicity .
Increased risk of hypkalemia with corticosteroids. Prolonged paralysis caused by tubercuraine
Indication:
Hypertension
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
FDC of Nebivolol hcl 5mg + 22-12-2004
Hydrochlorthiazide 12.5mg tablet
Hypertension
US FDA APPROVED LIST- 2006
Nebivolol as Hcl 5mg + Valsarta 80mg
For Hypertension
17/01/2006
Adverse Reaction:
Nebivolol- Long term toleralbility og nebivolol monotherapy found that nebivolol was well tolerated with a low incidence of drug- related adverse effects such as tiredness, cold estremities, impotence, and shortness of breath
Hydrochlorthiazide- Hypotension includes orthostatic hypotension (may be aggravated by alcohol, barbiturates, narcotics or anti-hypertensives drugs) pancreatitis, jaundice, (interhepatic cholestatic jaundice) diarrhea, vomiting, saladentitis, cramping, constipation, gastric irritation, nausea, anorexia, thrombocytopenia, photosensitivity, fever, urticaria, rash, purpura, htperglycemia, glycosuria, hyperuricemia, dizziness, headache, restlessness, inpotence
Contra-Indications:
Nebivolol- Hypersensitivity to the active substance, or any of the excipients, liver insufficiency or liver function impairment, sulponamide allergy pregancy and lactation. Hydrochlorthiazide- Anuria, lactation, sulphonamide allergy.
Special precaution-
History of allergies, psoriasis, hyperthyroidism, peripheral artterial disease, diabetes, existing electrolyte disturbances, oedema, renal impairment
Dosages/ Overdosage Etc:
Hypertension
Dosage-
Nevibiol 5mg + Hydrochlor thiaz 12.5mg 1 tab once daily
Pharmacology/ Pharmacokinetics:
Pharmacology-
Nebivolol is a lipophilic beta1 blocker administered clinically as a racemic mixture of equal proposiotions of its d- and l- enatiomers. The drug is devoid of intrinsic sympathomimetic or membrane stabilizing activity but appears to have a nitric oxide-mediated vasodilatory effect. A dose related reduction in clinic and ambulatory blood pressure was demonstrated for each drug as monotherapy and for two drugs in combination. Nebivolol has additive effects with hydrochlorthiazide . Combination therapy produced an additive dose-related reduction in mean diastolic blood pressure.
Pregnancy and lactation:
Nebivolol- pregancy and lactation. Hydrochlorthiazide- lactation