Pure Forskolin Extract 250 mg [Discontinued] by BioGanix

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Asthma. Research on the effects for coleus for asthma is preliminary and contradictory. In one preliminary clinical trial a single-dose inhalation of the powdered coleus constituent, forskolin, 10 mg, from a Spinhaler inhaler significantly increased forced expiratory volume in one second (FEV1) in patients with asthma (7281,44432). Another preliminary trial found that a specific forskolin product (Pro-longevity Forskolin, Life Extension Foundation Buyers Club, Fort Lauderdale, Florida, USA) providing forskolin 10 mg per day orally for 6 months did not improve lung function, but resulted in fewer asthma attacks compared to two inhalations of sodium cromoglycate three times daily for 6 months (91889). However, in another preliminary trial oral forskolin 10 mg taken daily for 2 months, neither reduced asthma attacks nor improved lung function compared to baseline or compared to beclomethasone inhalations (91883).
• Dry eye. Preliminary clinical research shows that taking a specific combination supplement (Kronek, SOOFT Italia, Montegiorgio, Italy) containing an extract of Coleus forskolii 150 mg (10% forskolin), rutin 200 mg, thiamine 0.7 mg, and riboflavin 0.8 mg, 2 capsules by mouth daily for 30 days moderately decreases dry eye symptoms compared to placebo (91888). It is unclear if this benefit is due to coleus, other ingredients, or the combination.
• Erectile dysfunction (ED). Preliminary clinical evidence suggests that adding the coleus constituent forskolin 1 mg/mL to once daily intracavernosal injections of phentolamine, papaverine, and prostaglandin E1 may improve penile rigidity and increase the average erection duration in impotent men compared to injections of phentolamine, papaverine, and prostaglandin E1 alone (44441).
• Hypertension. Preliminary clinical research shows that taking coleus root tuber 1 gram or coleus whole root 1.4 grams three times daily after food for 2 months modestly decreases blood pressure compared to baseline in elderly patients with hypertension (91884).
• Dilated cardiomyopathy. There is some evidence that intravenous coleus, starting at 0.5 mcg/kg/minute, increasing at 15 minute intervals to 1.0, 2.0, and 3.0 mcg/kg/minute, is effective at improving cardiac output and pulmonary vascular pressures in patients with dilated cardiomyopathy (7278).
• Glaucoma. Preliminary clinical research shows that taking two tablets of a specific combination supplement (Kronek Sooft Italia SpA, Montegiorgio, Italy) containing forskolin 15 mg, rutin 200 mg, vitamin B1 1.5 mg, and vitamin B2 1.5 mg for 7 or 30 days prevents increases in intraocular pressure and decreases intraocular pressure by 10% in glaucoma patients (91887,91890). Preliminary clinical research on another specific combination supplement (Gangliolife, SOOFT Italia), two tablets taken twice daily for 1 year in addition to standard topical therapy results in a decrease in intraocular pressure compared to standard therapy alone in patients with primary open angle glaucoma. One tablet of the supplement contains coleus extract 150 mg (standardized to 10% forskolin), homotaurine 100 mg, L- carnosine 50 mg, vitamin B1 1.1 mg, vitamin B2 1.4 mg, vitamin B6 1.4 mg, folic acid 0.2 mg, and magnesium 150 mg (91886).
• Obesity. Preliminary clinical research shows that taking a specific coleus supplement (Forslean, Sabina Corp., Piscataway, NJ) containing a 10% forskolin extract 250 mg twice daily for 12 weeks does not affect weight, but decreases body fat by 4.14% compared to a 0.96% decrease in a placebo group in overweight and obese men (91882). Another small clinical trial shows that taking a coleus extract capsule 250 mg twice daily before meals for 12 weeks does not further reduce weight compared to taking placebo in overweight and obese patients following a calorie-restricted diet (91885). More evidence is needed to rate coleus for these uses.

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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.

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CYTOCHROME P450 2C9 (CYP2C9) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Research on the effect of coleus on cytochrome P450 2C9 (CYP2C9) is conflicting. Some animal research shows that coleus extract can induce CYP2C9, while 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 drugs metabolized by CYP2C9.  Details Some drugs metabolized by CYP2C9 include celecoxib (Celebrex), diclofenac (Voltaren), fluvastatin (Lescol), glipizide (Glucotrol), ibuprofen (Advil, Motrin), irbesartan (Avapro), losartan (Cozaar), phenytoin (Dilantin), piroxicam (Feldene), tamoxifen (Nolvadex), tolbutamide (Tolinase), torsemide (Demadex), and S-warfarin (Coumadin).

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General ...Orally, intravenously, ophthalmologically, and by inhalation, coleus seems to be well tolerated (7278,7279,7282,7283,7284). Orally, coleus extract may cause dose-related gastrointestinal effects, including diarrhea, loose stools, nausea, vomiting, or constipation (91885,100851). Intravenously, the coleus constituent, forskolin, can cause tachycardia, flushing, and hypotension (7279,44424,44431). Inhalation of forskolin may cause tremor, restlessness, and irritation of the respiratory tract (7281). Ophthalmologically, forskolin may cause stinging of the eyes and conjunctival hyperemia (7283).

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).

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