Six tablets contain: Gymnema sylvestre extract powder 144 mg • L-Carnitine L-Tartrate 300 mg • Astilbe Thunberghii extract powder 204 mg • Coleus Forskohlii extract powder 72 mg • Kokhi Tea leaf extract powder 72 mg. Other Ingredients: Maltitol, Corn Starch, Brewer's Yeast Cell Wall (coating), Glycerin, Sucrose Fatty Acid Ester.
Brand name products often contain multiple ingredients. To read detailed information about each ingredient, click on the link for the individual ingredient shown above.
Below is general information about the effectiveness of the known ingredients contained in the product Gymnema SP. 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 Gymnema SP. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
POSSIBLY SAFE ...when used orally and appropriately, short-term. Coleus extract 500 mg daily has been used for up to 3 months without significant adverse effects (91885,100851). ...when used intravenously and appropriately, short-term. Intravenous forskolin, a constituent of coleus, seems to be safe when given at an appropriate rate of 0.5 mcg/kg/minute and increased at 15 minute intervals to 1.0, 2.0, and 3.0 mcg/kg/minute up to 1 hour (7278,7279). ...when used by inhalation and appropriately. Single-dose inhalation of forskolin powder 10 mg from a Spinhaler inhalator seems to be safe and well-tolerated (7281). ...when used ophthalmologically and appropriately. Coleus suspension eye drops (1%) have been safely used in clinical studies (7282,7283,7284,7402,7403,7405).
POSSIBLY UNSAFE ...when used orally in higher doses. Although coleus extracts have been used with apparent safety in doses up to 1.4 grams daily for 2 months (91884), taking coleus extract in doses exceeding 500 mg daily has been associated with an increased incidence of adverse effects, which are primarily gastrointestinal (100851).
PREGNANCY: POSSIBLY UNSAFE
when used orally.
Evidence from animal research suggests that high doses of coleus can inhibit embryo implantation and/or delay fetal development (25174); avoid using.
LACTATION:
Insufficient reliable information available; avoid using.
POSSIBLY SAFE ...when used orally and appropriately. Gymnema leaf extract has been used safely in doses of 200 mg twice daily for up to 20 months or 300 mg twice daily for 12 weeks (45,46,42604,105346).
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
LIKELY SAFE ...when used orally and appropriately. L-carnitine has been safely used in clinical trials lasting up to 12 months (1947,3620,3621,3623,3624,3625,3626,3627,3628,3629) (3630,3639,4949,8047,9790,12352,16104,16105,16106,16107) (16109,16110,23437,26496,26499,58150,58156,58161,58169,58182) (58189,58204,58207,58209,58213,58294,58523,58554,58556,58647) (58679,58715,58778,58793,58830,58831,58882,59023,59029,59043) (90624,90633,104177,111872,111876,111883,111884,111891,111898). ...when used parenterally as an FDA-approved prescription medicine. Avoid using D-carnitine and DL-carnitine. These forms of carnitine can act as competitive inhibitors of L-carnitine and may cause symptoms of L-carnitine deficiency (1946).
CHILDREN: POSSIBLY SAFE
when used orally or intravenously and appropriately.
L-carnitine has been safely used orally in children for up to 6 months (1433,3622,58166,58502,58981,59188,111887,111900,115351). It has also been safely used orally and intravenously in preterm infants (3633,3634,3635,3636,3637,58163,58190,58800,58902,59097)(59161).
PREGNANCY:
Insufficient reliable information available; avoid using.
LACTATION: POSSIBLY SAFE
when used orally.
Supplemental doses of L-carnitine have been given to infants in breast milk and formula with no reported adverse effects. The effects of large doses used while nursing are unknown, but L-carnitine is secreted in the breast milk (3616).
Below is general information about the interactions of the known ingredients contained in the product Gymnema SP. 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, concomitant use of coleus and anticoagulant or antiplatelet drugs might increase the risk of bruising and bleeding.
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Theoretically, combining coleus with antihypertensive drugs might cause additive blood pressure lowering effects and increase the risk of hypotension.
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Theoretically, combining coleus with calcium channel blockers might increase the coronary vasodilatory effects.
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Theoretically, taking coleus may affect drugs metabolized by CYP2C9 and increase the risk of adverse effects or reduce the effectiveness.
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Research on the effect of coleus on CYP2C9 is conflicting. Some animal research shows that coleus extract can induce CYP2C9, while in vitro research shows that coleus can inhibit CYP2C9 (91891). Until more is known, advise patients that taking coleus might increase or decrease levels of drugs metabolized by CYP2C9.
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Theoretically, taking coleus might decrease serum levels of drugs metabolized by CYP3A4.
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In vitro research shows that coleus can activate the nuclear receptor, pregnane X receptor (PXR), which results in increased expression of CYP3A4 (44399,44412). Although the clinical significance of this is not known, use caution when considering concomitant use of coleus and other drugs affected by these enzymes.
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Theoretically, combining coleus with nitrates might increase the coronary vasodilatory effects.
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Theoretically, taking coleus may affect the metabolism of warfarin and increase the risk of adverse effects or reduce the effectiveness.
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Some animal research shows that coleus extract can induce cytochrome P450 2C9 (CYP2C9), an enzyme that metabolizes warfarin. However, other in vitro research shows that coleus can inhibit CYP2C9 (91891). Theoretically, taking coleus with drugs metabolized by CYP2C9 might affect drug levels and the risk of adverse effects. Until more is known, advise patients that taking coleus might increase or decrease levels of warfarin.
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Theoretically, taking gymnema with antidiabetes drugs might increase the risk of hypoglycemia.
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Gymnema reduces blood glucose levels in some human and animal research. In human studies, it has been shown to enhance the blood glucose lowering effects of hypoglycemic drugs (45,46,92119,92121,92123). However, other research in adults with prediabetes or metabolic syndrome suggests that gymnema does not reduce fasting levels of blood glucose (96235,105346). Until more is known, monitor blood glucose levels closely.
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Theoretically, gymnema might increase levels of drugs metabolized by CYP1A2.
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Animal and in vitro research shows that gymnema can inhibit the CYP1A2 enzyme (96236,96237,96238). In one animal study, oral administration of gymnema for 7 days increased the plasma concentrations of phenacetin, a CYP1A2 substrate, by about 1.4-fold and reduced the clearance of phenacetin by about 29% (96237).
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Theoretically, gymnema might increase or decrease levels of drugs metabolized by CYP2C9.
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Theoretically, gymnema might increase levels of drugs metabolized by CYP3A4.
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One in vitro study using rat liver microsomes shows that gymnema can modestly inhibit the CYP3A4 enzyme (96238). However, other in vitro research using human liver microsomes shows that gymnema does not affect CYP3A4 activity (96236). Animal research also shows that gymnema does not alter the function of CYP3A4. In one study in rats, oral administration of gymnema for 7 days did not alter the clearance of amlodipine, a CYP3A4 substrate (96237).
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Theoretically, taking gymnema with phenacetin might increase the levels of phenacetin.
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Theoretically, taking gymnema with tolbutamide might the decrease levels of tolbutamide.
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Animal research shows that gymnema, administered orally for 7 days, increases the clearance of tolbutamide by 2.4-fold when compared to control (96237).
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Theoretically, L-carnitine might increase the anticoagulant effects of acenocoumarol.
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L-carnitine might enhance the anticoagulant effects of acenocoumarol, an oral anticoagulant similar to warfarin, but shorter-acting (9878,12165). There are at least two case reports of INR elevation with concomitant use. In one case, a 33-year-old male with a previously stable INR had an elevated INR of 4.65 after L-carnitine was started and continued for 10 weeks. INR normalized after discontinuation of the L-carnitine-containing product (12165).
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Theoretically, L-carnitine might decrease the effectiveness of thyroid hormone replacement.
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Theoretically, L-carnitine might increase the anticoagulant effects of warfarin.
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Below is general information about the adverse effects of the known ingredients contained in the product Gymnema SP. 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, intravenously, ophthalmologically, and by inhalation, coleus seems to be well tolerated.
Most Common Adverse Effects:
Orally: Constipation, diarrhea, nausea, vomiting.
Intravenously: Flushing, hypotension, tachycardia.
Ophthalmologically: Conjunctival hyperemia, stinging eyes.
Inhalation: Irritation of the respiratory tract, restlessness, tremor.
Cardiovascular ...Intravenously, the coleus constituent, forskolin, can cause tachycardia, flushing and hypotension (7279,44424,44431).
Dermatologic ...Two cases of contact dermatitis have been reported following airborne exposure to coleus (44426,44418).
Gastrointestinal ...Orally, coleus can cause dose-related diarrhea and other gastrointestinal symptoms. Increased bowel movements and loose stools have been reported in 1 of 15 patients taking coleus extract in a clinical trial (91885). Some retrospective evidence reports about a 10% rate of gastrointestinal adverse effects from oral coleus use; 81% of these adverse effects were related to diarrhea. Other reported adverse effects which occurred at a much lower rate, include nausea, vomiting, and/or constipation. Gastrointestinal effects appear to be dose-related; those taking less than 250 mg of coleus extract did not report any diarrhea, while all patients taking 1000 mg of coleus extract reported diarrhea (100851).
Neurologic/CNS ...Inhalation of forskolin, a constituent of coleus, can cause tremor and restlessness (7281).
Ocular/Otic ...Ophthalmologically, forskolin, a constituent of coleus, can cause stinging of the eyes and conjunctival hyperemia (7283).
Pulmonary/Respiratory ...Inhalation of forskolin, a constituent of coleus, can cause throat and upper respiratory tract irritation, and mild to moderate cough (7281).
General ...Orally, gymnema seems to be well tolerated.
Hepatic ...A case of drug-induced hepatitis characterized by weakness, fatigue, jaundice, and elevated liver enzymes, has been reported for a patient who consumed gymnema tea three times daily for 10 days. The patient was administered prednisone 60 mg once daily and was eventually tapered off prednisone and discharged. Laboratory values normalized after 6 months (95005). A case of hepatitis-associated aplastic anemia characterized by jaundice, elevated liver function tests, and pancytopenia has been reported for a patient who consumed gymnema 2 grams twice daily for at least a month. Treatment with ursodeoxycholic acid for 8 weeks led to resolution of cholestatic hepatitis; however, the pancytopenia was not responsive to treatment with immunosuppressive drugs and the patient died 5 months after presentation (110021). The exact reason for these adverse effects is not clear; they may have been idiosyncratic.
General
...Orally and intravenously, L-carnitine is generally well tolerated.
Most Common Adverse Effects:
All routes of administration: Abdominal cramps, abdominal pain, diarrhea, gastritis, heartburn, nausea, reduced appetite, and vomiting. A fish-like body odor has also been reported.
Serious Adverse Effects (Rare):
All routes of administration: Seizures.
Cardiovascular ...According to population research, plasma L-carnitine levels are associated with increased risk of cardiovascular disease and major cardiac events (90635). However, oral supplementation with L-carnitine does not appear to be associated with an increased risk of cardiovascular disease. In fact, a meta-analysis of clinical research shows that L-carnitine supplementation is associated with a reduction in all-cause mortality, as well as ventricular arrhythmias and the development of angina and does not increase the development of heart failure or myocardial reinfarction (59037). Also, another meta-analysis suggests that L-carnitine does not affect mortality or cardiovascular outcomes in patients with a previous myocardial infarction (90630).
Dermatologic ...Orally, L-carnitine has been reported to cause skin rash in a small number of cases (16105,91724). Two patients in a hair growth study using topical carnitine reported mild itching and increased dandruff, while a third reported strong itching with reddish bumps and a burning sensation (58390). When a specific formulation containing L-carnitine, licochalcone, and 1,2-decanediol was applied to the face, mild skin dryness and tightness was reported by 12% of volunteers, compared with 4% to 8% of those in the vehicle-only control group (26493).
Gastrointestinal ...Orally and intravenously, L-carnitine has been associated with nausea, epigastric discomfort, vomiting, abdominal cramps, heartburn, gastritis, anorexia, and diarrhea (3616,3624,59030,95069,95070,101562,107410,111870,111887,111891). Orally, diarrhea or colitis symptoms (1433,3630,16105,16107,16111,23437,58523,58554,59020,90623), nausea and abdominal pain (16105,16106,26499,58169,58392,58554,90623,90634), indigestion (26703), and constipation (58523) have been reported in various clinical trials.
Hematologic ...In one case report, L-carnitine 990 mg twice daily was started in a female presenting to hospital with valproic acid toxicity. Blood phosphorous levels subsequently fell from 2.3 mg/dL to 1.3 mg/dL over 4 days. After discontinuation of L-carnitine, blood phosphorus levels increased to 1.8 mg/dL. The authors suggested that the role of L-carnitine in improved protein metabolism may play a role in the declining levels of phosphorous in the blood and increased risk of hypophosphatemia (90628).
Neurologic/CNS ...Orally or intravenously, L-carnitine has been associated with seizures (3616). Orally, use of L-carnitine in clinical trials has resulted in headache, although this event is rare (58554,95070,111891). L-carnitine may also cause agitation (95070).
Other ...Orally or intravenously, L-carnitine has been associated with a fish-like body odor (1433,3616,58166,59854,90623). One of its metabolites, trimethylamine N-oxide, can cause the urine, breath, and sweat to have a fishy odor (12756,58664).