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Nicotinyl Alcohol (Systemic)


VA CLASSIFICATION
Primary: CV500

Commonly used brand name(s): Roniacol.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).

*Not commercially available in the U.S.



Category:


Vasospastic therapy adjunct—

Indications

Accepted

Vascular disease, peripheral (treatment)
Vascular spasm (treatment)
Ulcer, varicose (treatment)
Ulcer, decubital (treatment)
Frostbite (treatment)
Ear, inner, circulatory disturbances of (Menière's syndrome) (treatment) or
Vertigo (treatment)—Nicotinyl alcohol may be effective for its labeled indications, which include peripheral vascular disease, vascular spasm, varicose ulcers, decubital ulcers, chilblains (frostbite), Menière's syndrome, and vertigo.


Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
    109.13

Mechanism of action/Effect:

Nicotinyl alcohol's action occurs as a result of its in vivo conversion to niacin (nicotinic acid). Nicotinic acid produces weak peripheral vasodilation by a direct effect on vascular smooth muscle; however, in usual doses it is probable that only cutaneous vessels are affected.

Onset of action:

Vasodilator effect—Extended-release tablets: 30 minutes.

Time to peak effect:

Clinical improvement may occur gradually over several weeks.

Duration of action:

Vasodilator effect—Extended-release tablets: 6–12 hours.


Precautions to Consider

Pregnancy/Reproduction

Pregnancy—
Studies have not been done in humans.

Studies have not been done in animals.

Breast-feeding

It is not known whether nicotinyl alcohol is excreted in breast milk. However, problems in humans have not been documented.

Geriatrics


Appropriate studies on the relationship of age to the effects of nicotinyl alcohol have not been performed in the geriatric population. However, the risk of nicotinyl alcohol–induced hypothermia may be increased in elderly patients.

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

Smoking, tobacco    (heavy smoking may interfere with the therapeutic effect of nicotinyl alcohol because nicotine constricts blood vessels)



Laboratory value alterations
The following have been selected on the basis of their potential clinical significance (possible effect in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

With physiology/laboratory test values
Alanine aminotransferase (ALT [SGPT]), serum and
Alkaline phosphatase, serum and
Aspartate aminotransferase (AST [SGOT]), serum and
Bilirubin, serum and
Lactate dehydrogenase (LDH), serum    (concentrations may be increased, indicating hepatotoxicity, with long-term, high-dose administration)


Glucose, blood and urine    (concentrations may be increased in diabetic or pre-diabetic patients or when high doses are administered to patients with hypercholesterolemia)


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problems exist
» Active peptic ulcer or gastritis
» Cerebrovascular disease, severe or
» Myocardial infarction, recent or
» Obliterative coronary artery disease, severe    (a “steal effect” may occur, since nicotinyl alcohol has a greater effect on peripheral vessels than on cerebral and coronary vessels, leading to a further decrease in flow to ischemic areas)


Diabetes mellitus    (nicotinyl alcohol may increase fasting blood sugar concentrations)


Glaucoma, predisposition to
Hyperlipidemia    (large doses necessary to treat this condition may cause impaired glucose tolerance)


Sensitivity to nicotinyl alcohol{02}


Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence rare
—dose-related    
Hepatotoxicity (swelling of feet or lower legs; yellow eyes or skin)

Note: Hepatotoxicity occurs only with very high doses.




Those indicating need for medical attention only if they continue or are bothersome
Incidence more frequent
    
Vasodilation, especially on face and neck (flushing; warmth or tingling)

Incidence less frequent or rare
    
Allergic reaction (skin rash)
    
diarrhea
    
hypotension (dizziness or faintness)
    
increased hair loss
    
nausea and vomiting





Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Nicotinyl Alcohol (Systemic).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Sensitivity to nicotinyl alcohol





Use in the elderly—Increased risk of hypothermia
Other medical problems, especially peptic ulcer or gastritis (active), cerebrovascular disease, recent myocardial infarction, or obliterative coronary artery disease (severe)

Proper use of this medication
Swallowing tablets whole; not breaking, crushing, or chewing prior to swallowing {01}

» Proper dosing
Missed dose: Taking as soon as possible; not taking if almost time for next dose; not doubling doses

» Proper storage

Precautions while using this medication
Checking with physician before discontinuing medication

Avoiding smoking (nicotine constricts blood vessels)


Side/adverse effects
Signs of potential side effects, especially hepatotoxicity


Oral Dosage Forms

Note: The dosage and strengths of the dosage form available are expressed in terms of nicotinyl alcohol.

NICOTINYL ALCOHOL TARTRATE EXTENDED-RELEASE TABLETS

Usual adult dose
Vasospastic therapy adjunct
Oral, 150 to 300 mg (nicotinyl alcohol) two times a day, in the morning and evening. {04}


Strength(s) usually available
U.S.—
Not commercially available.

Canada—


150 mg (nicotinyl alcohol) (OTC) [Roniacol (sucrose)]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer.

Auxiliary labeling:
   • Swallow tablets whole.



Revised: 04/06/1993



References

Note: All references used in the development and earlier revisions of this monograph have not yet been incorporated into the computer database and, therefore, are not listed below. Citations for information not yet referenced in the monograph will be provided upon request.

  1. Roniacol prescribing information (Roche—Canada), in CPS 25th ed, 1990, p 959.
  1. Roniacol Supraspan product information, CPS 1992.
  1. Verified no longer available in U.S. Red Book 1990
  1. Roniacol Supraspan product information, (Roche—Canada), Rec 11/92.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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