"The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the marketing of selexipag (Uptravi, Actelion Registration Ltd) for the treatment of adults with pulmonary arterial hypertension (PAH)./"...
The chemical name for the active ingredient in BYSTOLIC (nebivolol) tablets is (1RS,1'RS)-1,1'-[(2RS,2'SR)bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]-2,2'-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]nebivolol, respectively. Nebivolol's molecular formula is (C22H25F2NO4•HCl) with the following structural formula:
SRRR - or d-nebivolol hydrochloride
RSSS - or l-nebivolol hydrochloride
MW: 441.90 g/mol
Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene.
BYSTOLIC as tablets for oral administration contains nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol base. In addition, BYSTOLIC contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 Lake, FD&C Blue #2 Lake, FD&C Yellow #6 Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polysorbate 80, and sodium lauryl sulfate.
What are the possible side effects of nebivolol (Bystolic)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- feeling short of breath, even with mild exertion;
- swelling of your ankles or feet;
- slow or uneven heartbeats; or
- numbness or cold feeling in your hands and feet.
Less serious side effects may include:
- tired feeling;
- nausea, stomach pain;
- diarrhea; or
What are the precautions when taking nebivolol tablets (Bystolic Tablets)?
Before taking nebivolol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood circulation problems (such as Raynaud's disease, peripheral vascular disease), breathing problems (such as asthma, chronic bronchitis, emphysema), heart problems (such as heart failure, previous heart attack, heart rhythm problems), kidney problems, liver problems, mental/mood disorders (such as depression), a certain muscle disease (myasthenia gravis), overactive thyroid disease (hyperthyroidism), serious allergic...
Last reviewed on RxList: 1/4/2012
This monograph has been modified to include the generic and brand name in many instances.
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