Each capsule contains: Inositol Hexanicotinate (niacin) 400 mg • Inositol (as inositol hexanicotinate) 100 mg. Other Ingredients: Gelatin , Vegetable Magnesium Stearate, Silica.
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Below is general information about the effectiveness of the known ingredients contained in the product Flush Free Niacin Inositol Hexanicotinate 500 mg. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
Below is general information about the safety of the known ingredients contained in the product Flush Free Niacin Inositol Hexanicotinate 500 mg. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
LIKELY SAFE ...when used orally in amounts commonly found in foods. Gelatin has Generally Recognized as Safe (GRAS) status in the US (4912).
POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts, short-term . A specific type of gelatin from donkey hide, called colla corii asini, has been safely used in doses of 6-10 grams orally daily for 6-8 weeks. Higher doses of 15 grams daily have been associated with an increased risk of inflammatory adverse effects, including sore throat, swollen gums, local eczema, and oral ulcers (97634,107011). Since gelatin is often derived from bovine bones and skin, there is some concern about contamination with diseased animal parts (1825). So far, there are no reports of disease transmission to humans due to use of contaminated gelatin preparations.
CHILDREN: POSSIBLY SAFE
when gelatin tannate is used orally and appropriately in medicinal amounts, short-term.
In children under 15 kg or under 3 years of age, gelatin tannate has been used with apparent safety at doses up to 250 mg four times daily for up to 5 days. In children over 15 kg or over 3 years of age, it has been used with apparent safety at doses up to 500 mg four times daily for up to 5 days (103296). There is insufficient reliable information available about the safety of other forms of gelatin in children.
PREGNANCY: LIKELY SAFE
when used orally in the amounts commonly found in foods.
PREGNANCY: POSSIBLY SAFE
when a specific type of gelatin from donkey hide, called colla corii asini, is used orally in doses of 10 grams daily for 6 weeks.
Higher doses of 15 grams daily have been associated with an increased risk of inflammatory adverse effects, including sore throat, swollen gums, local eczema, and ulcers in the oral cavity (97634).
There is insufficient reliable information available about the safety of other types of gelatin when used during pregnancy in medicinal amounts.
LACTATION: LIKELY SAFE
when used orally in the amounts commonly found in foods.
There is insufficient reliable information available about the safety of using larger amounts of gelatin during lactation; avoid using.
POSSIBLY SAFE ...when used orally and appropriately, short-term. Inositol has been used with apparent safety in doses up to 18 grams daily for up to 6 weeks or 6 grams daily for 10 weeks (2184,2185,2187,95089). Myo-inositol 4 grams daily has also been used with apparent safety for 6 months (95085). There is insufficient reliable information available about the safety of inositol when used topically.
CHILDREN: POSSIBLY SAFE
when used orally and appropriately.
Inositol 80 mg/kg (maximum 2 grams) has been taken daily for up to 12 weeks in children aged 5-12 years (95092). ...when used enterally or intravenously and appropriately in premature infants for treating acute respiratory distress syndrome for up to 10 days (2191,2192,91546,91551).
CHILDREN: POSSIBLY UNSAFE
when used enterally or intravenously for extended durations in premature infants.
A large clinical study in infants born at less than 28 weeks' gestation found that myo-inositol 40 mg/kg, given intravenously and then enterally every 12 hours for up to 10 weeks, was associated with a small increased risk of death (98946). Long-term follow-up until 24 months corrected age confirms that the initial increase in mortality rate in the myo-inositol group remained stable; however, there was no difference in a composite outcome of death or survival with moderate or severe neurodevelopmental impairment, as well as no difference in the risk of retinopathy of prematurity, between those who received myo-inositol or control (108819).
PREGNANCY: POSSIBLY SAFE
when used orally and appropriately, short-term.
Myo-inositol has been used with apparent safety in amounts up to 4000 mg daily during pregnancy (91548,95082,104688).
LACTATION:
Insufficient reliable information available; avoid using.
Breast milk is rich in endogenous inositol (2138); however, the effects of exogenously administered inositol are not known.
Below is general information about the interactions of the known ingredients contained in the product Flush Free Niacin Inositol Hexanicotinate 500 mg. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
Theoretically, taking inositol with antidiabetes drugs might increase the risk of hypoglycemia.
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Theoretically, concomitant use of inositol nicotinate with anticoagulant or antiplatelet drugs might increase the risk of bleeding.
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Theoretically, inositol nicotinate might increase blood glucose levels and may diminish the effects of antidiabetes drugs.
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Theoretically, concomitant use of inositol nicotinate and statins might increase the risk of myopathy and rhabdomyolysis.
Inositol nicotinate is metabolized to niacin in the body (496). Some case reports have raised concerns that niacin might increase the risk of myopathy and rhabdomyolysis when combined with statins (14508,25918) However, a significantly increased risk of myopathy has not been demonstrated in clinical trials (7388,11689,12033,14509).
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Theoretically, concomitant use of inositol nicotinate and transdermal nicotine might increase the risk of flushing and dizziness.
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Below is general information about the adverse effects of the known ingredients contained in the product Flush Free Niacin Inositol Hexanicotinate 500 mg. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
General
...Orally, gelatin seems to be well tolerated.
Most Common Adverse Effects:
Oral: Belching, bloating, and dyspepsia.
Serious Adverse Effects (Rare):
Injection: IgE-mediated allergic reactions, Kounis syndrome.
Gastrointestinal ...Orally, gelatin can cause unpleasant taste, sensation of heaviness in the stomach, bloating, dyspepsia, and belching (7704).
Immunologic
...Gelatin can cause allergic reactions.
Gelatin in foods can cause initial sensitization (7703). Gelatin-containing medicines including oral medications, suppositories, vaccines, and injectable products can cause IgE-mediated allergic reactions, including urticaria, angioedema, wheezing, hypotension, and anaphylaxis (7708,7709,7710,97633,111345). In the US, gelatin is used as a stabilizer in some vaccines such as measles, mumps, and rubella (MMR), and diphtheria, pertussis, tetanus (DPT) (7711). In one case report, a 73-year-old male experienced anaphylactic symptoms within 10 minutes of receiving gelatin lysate as a plasma expander during a routine surgery. The patient proceeded to develop heart, respiratory, and kidney failure and died 76 days after receiving the gelatin infusion (97633). At least 12 case reports describe life-threatening anaphylaxis after administration of gelatin-containing hemostatic agents during surgery. In these cases, hypotension, tachycardia, and increased airway pressure occurred shortly after injection of the agent into the pedicle tract (111345).
There are at least two cases of Kounis syndrome, an acute coronary syndrome related to a massive mast cell activation, after the use of a gelatin infusion during general anesthesia. In one case, immediate symptoms included bradycardia and hypotension, followed by myocardial ischemia and coronary vasospasm (97631).
Other ...Since gelatin is sometimes produced from bovine bones and skin, there is some concern about the potential risk of contamination with diseased animals and transmission of bovine spongiform encephalopathy (BSE, mad cow disease) and other diseases (1825). So far, there are no reports of BSE or other disease transmission to humans from gelatin products.
General
...Orally and intravenously, inositol seems to be well tolerated.
Topically, no adverse effects have been reported, although a thorough evaluation of safety outcomes has not been conducted.
Most Common Adverse Effects:
Orally: Diarrhea, gas, and nausea.
Gastrointestinal ...Orally, inositol may cause nausea, diarrhea, gas, and gastrointestinal discomfort (10387,11972,91547,91549,95089,95090,95092).
Immunologic ...Orally, inositol in combination with omega-3 fatty acids has been associated with reports of cold and allergy symptoms in children in clinical research (95092).
Musculoskeletal ...Orally, inositol in combination with omega-3 fatty acids has been associated with reports of tics and other musculoskeletal side effects in children in clinical research (95092).
Neurologic/CNS ...Orally, inositol may cause dizziness, tiredness, insomnia, agitation, and headache (10387,11972,95089,95092). In combination with omega-3 fatty acids, inositol has been associated with reports of feelings of thirst in children in clinical research (95092).
Psychiatric ...In one case report, a 36-year-old male with adequately controlled bipolar disorder was hospitalized with symptoms of mania after consuming several cans of an energy drink containing inositol, caffeine, taurine, and other ingredients (Red Bull Energy Drink) over a period of 4 days (14302). It is not known if this is related to inositol, caffeine, taurine, a different ingredient, or a combination of the ingredients.
General
...Orally, inositol nicotinate is generally well tolerated.
Most Common Adverse Effects:
Orally: Abdominal pain, constipation, diarrhea, flushing, heartburn, liver enzyme elevation, nausea, vomiting.
Cardiovascular ...Orally, inositol nicotinate is converted to niacin and is therefore likely to cause similar side effects as niacin (496). A prostaglandin-mediated flushing reaction is a common adverse effect of oral niacin. A large pooled analysis of clinical studies shows that up to 70% of people may experience flushing with oral niacin (96211). Although flushing can occur with doses of niacin as low as 30 mg daily, it is more common with the larger doses of 500-2000 mg used for treatment of dyslipidemia (4889,26089,93341,93345). Inositol nicotinate is often promoted as a "no-flush" niacin; however, this benefit has not been demonstrated in clinical trials.
Dermatologic ...Orally, inositol nicotinate is converted to niacin and is therefore likely to cause similar side effects as niacin, including pruritus (496).
Endocrine ...Orally, inositol nicotinate is converted to niacin and is therefore likely to cause similar side effects as niacin (496). Niacin can impair glucose tolerance in a dose-dependent manner. Dosages of niacin 3-5 grams daily appear to increase blood glucose in patients with or without diabetes, while dosages of 1.5 grams or less have minimal effects (12033). Because inositol nicotinate is converted to niacin, it may also impair glucose tolerance (496).
Gastrointestinal ...Orally, inositol nicotinate is converted to niacin and is therefore likely to cause similar side effects as niacin, including gastrointestinal complaints such as nausea, vomiting, bloating, heartburn, diarrhea, and constipation (496). These adverse effects from niacin may be reduced by taking it with meals or antacids, and usually disappear within two weeks of continued therapy (4851,11690,26094).
Hematologic ...Orally, inositol nicotinate is converted to niacin and is therefore likely to cause similar side effects as niacin, including hyperuricemia (496).
Hepatic ...Orally, inositol nicotinate is converted to niacin and is therefore likely to cause similar side effects as niacin (496). Niacin is associated with elevated liver function tests and jaundice, especially with doses of 3 grams daily or more, and when doses are rapidly increased (4458,4863,6243,11690). Because inositol nicotinate is converted to niacin, it may also cause hepatotoxicity (496)