COMPOSITION :
Each tablet contains : Nebivolol HCI equivalent to Nebivolol 5mg.
DESCRIPTION :
Nebilol (Nebivolol) is a cardiovascular drug belongs to beta-receptor blockers group and it is the most drug
selective for beta 1 receptors in this class which make its effect more specific for heart so it prevents
increase heart rate and controls heart pumping strength. Nebivolol has a unique effect among other drugs
by potentiating nitric oxide which causes dilating blood vessels. Those effects make Nebilol antihyperten-
sive drug.
Nebilol can be used in patients with or at risk of erectile dysfunction because it not significantly worsens
erectile function as other beta blockers do.
Nebivolol is rapidly absorbed after oral administration, predominantly bound to albumin, one week after
administration, 38% of it excreted in the urine and 48% in faces.
INDICATIONS :
Treatment of essential hypertension.
DOSAGE AND ADMINISTRATION :
The daily dose of Nebilol should be taken at the same time daily with a sufficient amount of water and can
be taken with meals.
- Adults : 5 mg (one tablet) daily.
- Patients with impaired kidney function : The recommended initial dose is 2.5 mg (1/2 tablet) daily. If
required, the daily dose can be increased to 5 mg (one tablet).
- Elderly patients :
¢ Patients aged over 65 years: The recommended initial dose is 2.5 mg (1/2 tablet) daily. If necessary, the
daily dose can be increased to 5 mg (one tablet).
* Patients aged over 75 years: Caution and careful supervision of the treatment are certainly necessary.
RESTRICTIONS ON USE :
Contraindications
- Known hypersensitivity to Nebivolol.
- Liver function disturbances or impairment.
- Heart failure or cardiogenic shock , sick sinus syndrome , including sino-atrial block, second and third
degree heart block.
- Bronchial spasms and bronchial asthma.
- untreated tumours of the adrenal glands.
- Over acidification of the blood.
- Bradycardia (heart rate < 60 beats per minute) before treatment.
- Hypotension or severe blood flow disturbances in the limbs.
Precautions
Nebilol should be used with great caution under the following conditions :
- Unusually slow heart beats (less than 50 - 55 bpm) and /or signs such as dizziness,
weakness and unsteadiness walking.
- Heart diseases (e.g. angina pectoris, ischaemic heart disease, conduction disturbances).
- In patients with ischaemic heart disease, therapy should be ended gradually, i.e. over the course of 1-2
weeks , an alternative treatment should be begin simultaneously if necessary.
- Blood flow disturbances in the arms or legs.
- Persistent breathing complaints , particularly chronic obstructive respiratory tract diseases.
- Diabetes , hyperthyroidism and psoriasis.
Effect on the capacity to drive vehicles or use machines
Occasionally, Nebivolol may cause dizziness and tiredness. Therefore, patients should be cautioned about
their ability to drive vehicles or use machines.
Use in pregnancy and lactation
The doctor should be consulted and it advised not to use nebivolol during pregnancy unless the benefits
are higher than the risks. It is not recommended to use the medicine during Lactation.
DRUG INTERACTION :
The doctor should be informed if the patient is using one of the following drugs:
* Medicines for controlling the blood pressure or medicines for heart problems (such as amiodarone,
amlodipine, cibenzoline, clonidine, digoxin, diltiazem, disopyramide, felodipine, flecainide, guanfacin,
hydroquinidine, lacidipine, lidocaine, methyldopa, mexiletine, moxonidine, nicardipine, nifedipine,
nimodipine, nitrendipine, propafenone, quinidine, rilmenidine, verapamil).
* Sedatives and therapies for psychosis (a mental illness) e.g. barbiturates (also used for epilepsy),
phenothiazine (also used for vomiting and nausea) and thioridazine.
* Medicines for depression e.g. amitriptyline, paroxetine, fluoxetine.
* Medicines used for anaesthesia during an operation.
* Medicines for asthma, blocked nose or certain eye disorders such as glaucoma (increased pressure in
the eye) or dilation (widening) of the pupil.
* Baclofen (an antispasmodic drug) or Amifostine (a protective medicine used during cancer treatment) All
these drugs as well as nebivolol may influence the blood pressure and/or heart function.
* Medicines for treating excessive stomach acid or ulcers (antacid drug): the patient should take Nebilol
during a meal and the antacid drug between meals.
ADVERSE EFFECTS :
Some patients during using Nebilol may suffering from some adverse effects like headache, dizziness,
tingling or itching of the skin, shortness of breath, swollen hands or feet, constipation, nausea, diarrhea or
tiredness and often this effects are mild to moderate.
OVERDOSAGE :
No data exist on overdosage with Nebivolol. The signs of an overdosage with
beta-receptor blockers are : slow pulse , low blood pressure , spasms of the respiratory tract and sudden
weakness of the heart muscle.
If an overdose with Nebivolol is suspected , notify the doctor immediately. Until the doctor arrives , should
try to prevent the absorption of Nebivolol from the digestive tract into the blood stream by administering
activated charcoal and laxatives.
STORAGE INSTRUCTIONS :
Store below 30°C, in a dry place.
PRESENTATIONS :
Nebilol : Pack of 30 tablets and hospital packs of different sizes.
