Each tablet contains: Gentian Root (gentian lutea) 9 mg • Elder flower (sambucus nigra) 29 mg • European Vervain aerial parts (verbena) 29 mg • Primrose Flower (primula veris) 29 mg • Sorrel aerial parts (rumex acesota) 29 mg. Other Ingredients: Sucrose, Talc, Lactose Monohydrate, Calcium Carbonate, Potato Starch, Maize Starch, Maize Swell-Starch Flour, Colloidal Anhydrous Silica, Stearic Palmitic Acid, Titanium Dioxide, Glucose Syrup, Gelatin, Shellac, Magnesium Oxide, Sorbitol, Eudragit E 12.5, Montan Glycol Wax, Povidone, Castor Oil.
Brand name products often contain multiple ingredients. To read detailed information about each ingredient, click on the link for the individual ingredient shown above.
This product has been discontinued by the manufacturer.
This product has been discontinued by the manufacturer. This product is marketed as "Sinupret" in Germany.
Below is general information about the effectiveness of the known ingredients contained in the product Quanterra Sinus Defense. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
There is insufficient reliable information available about the effectiveness of American elder.
INSUFFICIENT RELIABLE EVIDENCE to RATE
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 Quanterra Sinus Defense. 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 the flower is used in amounts found in foods. The flowers have Generally Recognized as Safe (GRAS) status in the US (4912). Cooked, ripe fruit has few if any adverse effects (6).
POSSIBLY SAFE ...when flowers are used orally for medicinal purposes (12).
POSSIBLY UNSAFE ...when leaves, stems, or unripe fruit are used. All these parts contain cyanogenic glycosides (12). Limit juice consumption to avoid toxicity (6).
PREGNANCY AND LACTATION: LIKELY UNSAFE
when the leaves, stems, or unripe fruit are used (6).
There is insufficient reliable information available about the safety of the flower or cooked fruit; avoid using.
POSSIBLY SAFE ...when used orally. Cowslip has been used with apparent safety in combination with other herbs (SinuComp, Sinupret, Sinupret +, Bronchipret) (374,379,13557).
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
LIKELY SAFE ...when used orally and appropriately. Evening primrose oil has been used safely in doses up to 6 grams daily for up to 1 year (7566,7567,8926,12036,20512,49286,49360,109426,114807,114809). There is insufficient reliable information available about the safety of evening primrose oil when used topically. There is also insufficient reliable information available about the safety of evening primrose seed, flower, or leaf when used orally or topically.
CHILDREN: POSSIBLY SAFE
when evening primrose oil is used orally and appropriately, short-term.
In children up to 5 years of age, doses of evening primrose oil up to 3 grams daily have been used safely for 5 months (20512,49273), and 0.5 grams/kg daily has been used safely for 8 weeks (7570). In children up to 12 years of age, doses of 4-6 grams daily have been used safely for 3-5 months (7565,7566,20512,49286). ...when used topically and appropriately, short-term. In children 2-10 years of age, evening primrose oil has been applied to affected areas of the skin twice daily for up to 3 months (96718). There is insufficient reliable information available about the safety of evening primrose seed, flower, or leaf when used orally or topically.
PREGNANCY: POSSIBLY SAFE
when evening primrose oil is used orally and appropriately.
In small studies of evening primrose oil for pre-eclampsia, 4 grams has been used orally daily for up to 10 weeks during pregnancy with apparent safety (1409,20525). ...when evening primrose oil is used orally or intravaginally to improve cervical ripening. Evening primrose oil has been used safely during the last 1-3 weeks of pregnancy to improve cervical ripening (20524,96717,112130,112131,114810). Intravaginally, evening primrose oil 500-1000 mg as either a single dose or administered daily starting at week 38 until pregnancy has been used with apparent safety for this purpose (112130,112131). Orally, evening primrose oil 1500-4500 mg in divided doses daily for 1-3 weeks has been used with apparent safety for this purpose, although one study found 5 cases of meconium-stained amniotic fluid (112131). Some studies report that improvement was lacking and there was a trend toward prolonged labor, prolonged rupture of membranes, increased rates of arrest of descent, and increased oxytocin requirements (1411,112131). Intravaginally, evening primrose oil, 1000 mg every 4 hours up to 5 times or 2000 mg as a single dose, has been used as an adjunct to misoprostol for a medication abortion with apparent safety for this purpose (114806,114808). Evening primrose oil has also been linked to a case report of petechiae and ecchymoses in a newborn infant whose mother took a total of 6.5 grams during the week before giving birth (16303); use with caution, especially in high doses.
LACTATION: POSSIBLY SAFE
when evening primrose oil is used orally.
Supplementation with evening primrose oil during lactation results in the secretion of high levels of the constituent gamma linolenic acid into breast milk (1982); however, this fatty acid is normally present in significant amounts in breast milk (11884).
LIKELY SAFE ...when the root preparations are used in amounts commonly found in foods. Gentian root is categorized by the FDA as a safe food additive flavoring in the US (4912).
POSSIBLY SAFE ...when gentian root is used orally in a specific combination that contains gentian root, elderflower, verbena, cowslip flower, and sorrel (SinuComp, Sinupret) (374,379,95907). There is insufficient reliable information available about the safety of the topical use of gentian.
PREGNANCY AND LACTATION:
There is insufficient reliable information available about the safety of gentian in medicinal amounts during pregnancy and lactation; avoid using.
POSSIBLY SAFE ...when used orally in amounts commonly found in foods. There is insufficient reliable information available about the safety of sorrel used in medicinal amounts.
POSSIBLY UNSAFE ...when used orally in large amounts. The oxalate content may cause serious adverse effects, including damage to the kidneys, liver, and gastrointestinal tract (71314,75138,94019).
PREGNANCY AND LACTATION: POSSIBLY SAFE
when used orally in amounts commonly found in foods.
There is insufficient reliable information available about the safety of sorrel used in medicinal amounts during pregnancy and lactation; avoid using.
LIKELY SAFE ...when used orally in amounts commonly found in foods. Verbena has Generally Recognized As Safe status (GRAS) for use in foods in the US (4912). There is insufficient reliable information available about the safety of verbena when used orally or topically in medicinal amounts.
PREGNANCY AND LACTATION:
There is insufficient reliable information available about the safety of verbena in medicinal amounts during pregnancy and lactation; avoid using.
Below is general information about the interactions of the known ingredients contained in the product Quanterra Sinus Defense. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
There is preliminary evidence that American elder can inhibit the cytochrome P450 3A4 (CYP3A4) enzymes (6450). Theoretically, American elder might increase levels of drugs metabolized by CYP3A4; however, this interaction has not been reported in humans. Some drugs metabolized by CYP3A4 include lovastatin (Mevacor), ketoconazole (Nizoral), itraconazole (Sporanox), fexofenadine (Allegra), triazolam (Halcion), and numerous others. Use American elder cautiously or avoid in patients taking these drugs.
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American elder is thought to have diuretic properties. Theoretically, due to these potential diuretic effects, American elder might reduce excretion and increase levels of lithium. The dose of lithium might need to be decreased.
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Theoretically, evening primrose oil may increase the risk of bleeding if used with anticoagulant or antiplatelet drugs.
 Details
Evening primrose oil contains gamma linolenic acid (GLA). There is preliminary clinical evidence that GLA can reduce platelet aggregation and prolong bleeding time (1979).
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Theoretically, evening primrose may increase the levels and clinical effects of CYP2C9 substrates.
Details
In vitro research shows that linoleic acid, a constituent of evening primrose oil, inhibits CYP2C9 (21017).
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Theoretically, concomitant use of lithium with evening primrose oil might decrease lithium levels and effects.
Details
In a case report, a patient on a stable dose of lithium for 10 years experienced a reduction in lithium levels after taking evening primrose oil 500 mg daily. Baseline levels were 0.69 mmol/L, which decreased to 0.37 mmol/L after 2 months and 0.23 mmol/L after 3 months of use. Lithium levels increased within 6 weeks of discontinuing evening primrose oil, to 0.73 mmol/L; no clinical effects were noted (96715).
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Theoretically, evening primrose oil might increase the levels and effects of lopinavir.
Details
In a case report, an HIV patient who took evening primrose oil (Efamol) along with lopinavir/ritonavir experienced an increase in serum levels of lopinavir to 15.2 mg/L. Six weeks after discontinuing evening primrose oil, levels of lopinavir returned to the normal range of 5-10 mg/L. When re-challenged with evening primrose oil for a week, the patient's lopinavir levels increased from 6.69 to 8.11 mg/L. It is suspected that evening primrose oil increases levels of lopinavir by inhibiting cytochrome P450 3A4 (CYP3A4), which metabolizes lopinavir (93578). However, this effect has not been reported in other research.
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Theoretically, taking evening primrose oil with phenothiazines might increase the risk of convulsions.
Details
Evening primrose oil contains gamma-linolenic acid (GLA). There is some concern that taking supplements containing GLA might cause seizures, or lower the seizure threshold, when taken with phenothiazines (88187). In one report, three patients with schizophrenia who had received phenothiazines developed EEG changes suggestive of temporal lobe epilepsy after starting treatment with GLA, although none experienced an actual seizure (21013). In another report, two patients with schizophrenia who were stabilized on phenothiazines developed seizures when evening primrose oil 4 grams daily was added. One of these patients had a prior history of seizures (21010). It is unclear whether evening primrose oil had any additive epileptogenic effects with the phenothiazines; there is no evidence that taking evening primrose oil alone causes seizures (88187).
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Theoretically, taking gentian with antihypertensive drugs might increase the risk of hypotension.
Details
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Theoretically, sorrel might cause additive effects and side effects when used with anticoagulant or antiplatelet drugs.
Details
In vitro, sorrel has been shown to inhibit platelet aggregation (103607). However, this effect has not been reported in humans.
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Sorrel might reduce the effectiveness of fexofenadine by reducing its absorption from the gut.
Details
In vitro research shows that an ethanol extract of sorrel inhibits organic anion-transporting polypeptide 1A2 (OATP1A2), which transports fexofenadine from the intestine into cells. In rats, concomitant administration of sorrel extract with fexofenadine reduces oral absorption of fexofenadine and the area under the plasma concentration-time curve (AUC) (103606).
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Sorrel might reduce the effectiveness of OATP substrates by reducing their absorption from the gut.
Details
In vitro research shows that sorrel inhibits OATP1A2 (103606). Theoretically it may inhibit other OATPs. The OATPs are expressed in the small intestine and liver and transport drugs into cells. Inhibition of OATP may reduce the bioavailability of oral drugs that are substrates of OATP.
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In vitro research suggests that beta-myrcene, a terpene constituents of verbena, can significantly inhibit cytochrome P450 2B1 (CYP2B1) enzyme activity (82024). Theoretically, verbena might increase levels of drugs metabolized by this enzyme. However, this interaction has not been reported in humans.
Details
Some substrates of CYP2B1 include cyclophosphamide, ifosfamide, barbiturates, bromobenzene, and others.
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Below is general information about the adverse effects of the known ingredients contained in the product Quanterra Sinus Defense. 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, ingesting several glasses of American elderberry juice can cause nausea, vomiting, weakness, dizziness, numbness, and stupor (6).
General ...Orally, cowslip in combination with other herbs is generally well tolerated (95907). Studies show it can cause gastrointestinal adverse effects and allergic skin reactions (374,379,13557).
Dermatologic ...Orally, cowslip in combination with other herbs can cause allergic skin reactions (374,379,13557).
Gastrointestinal ...Orally, cowslip in combination with other herbs can cause gastrointestinal adverse effects (374,379,13557).
General
...Orally and topically, evening primrose oil is generally well tolerated.
There is limited reliable information available regarding the safety or adverse effects of other parts of the plant.
Most Common Adverse Effects:
Orally: Abdominal pain and distention, diarrhea, dyspepsia, flatulence, nausea, and vomiting.
Dermatologic ...Orally, use of evening primrose oil has been associated with reports of skin rash and acne (9156,9794,49338). There is a case report of extensive but transient petechiae and purpuric ecchymoses in a newborn infant whose mother had consumed raspberry leaf tea and a total of 6.5 grams of evening primrose oil orally and vaginally during the week prior to delivery. The infant had a normal platelet count and no signs of hemorrhage, and was discharged healthy at 3 days of age (16303).
Gastrointestinal ...Gastrointestinal complaints, including abdominal pain, distension and fullness, nausea and vomiting, diarrhea, dyspepsia, and flatulence are the most common adverse effects of evening primrose (8926,9794,20533,49188,49286,49339,49365,65864,88184,102556). Often these effects resolve with continued use. Altered taste has also been reported (49339).
Hematologic ...There is preliminary clinical evidence that evening primrose oil can decrease platelet aggregation and prolong bleeding time. In a small study of patients with hyperlipidemia, taking evening primrose oil 3 grams daily for 4 months was associated with a 40% increase in bleeding time, and decreases in ADP- and epinephrine-induced platelet aggregation of 50% and 60% respectively (1979). There is also a case report of diffuse ecchymoses and petechiae in a neonate whose mother had consumed 6.5 grams of evening primrose oil over the week prior to delivery (16303).
Neurologic/CNS
...Cases of dizziness (9794) and headache (88184) have been reported with evening primrose oil when used orally.
There is a report of seizures in a patient taking evening primrose oil and receiving anesthesia; however, the patient was also taking other drugs and it is therefore unclear if evening primrose was the cause (613). There is also concern that evening primrose oil might cause seizures, or lower the seizure threshold, in patients with schizophrenia who are treated with phenothiazines. This is based on limited data from two studies published in the 1980s. In one report, three patients with schizophrenia who had received phenothiazines developed EEG changes suggestive of temporal lobe epilepsy after starting treatment with evening primrose, although none experienced an actual seizure (21013). In the other report, two patients with schizophrenia who were stabilized on phenothiazines developed seizures when evening primrose oil 4 grams daily was added. One of these patients had a prior history of seizures (21010). There is no evidence that evening primrose taken alone, without medications known to lower the seizure threshold, can cause seizures (88187).
Other ...Weight gain has been reported in individuals receiving evening primrose oil (49338).
General
...Orally, gentian root, in combination with other herbs, seems to be generally well tolerated.
There is insufficient reliable information available about the adverse effects of gentian when taken as a medicine alone.
Most Common Adverse Effects:
Orally: Allergic skin reactions, gastrointestinal discomfort.
Gastrointestinal ...Orally, gentian root, in combination with other herbs, has been reported to cause gastrointestinal adverse effects (374,379). Gastrointestinal intolerance occurred in patients with cancer-associated anorexia who took gentian tincture 1 mL three times daily, in conjunction with turmeric 1 gram and ginger 1 gram twice daily, for 14 days. Six of 17 patients discontinued the regimen due to nausea, 3 due to vomiting, 2 due to diarrhea, and 2 due to bloating. It is unclear if this gastrointestinal intolerance was caused by gentian, the other herbs, or the patients' predisposing conditions (96263).
Immunologic ...Orally, gentian root, in combination with other herbs, has been reported to cause allergic skin reactions (374,379). It is unclear if these reactions were caused by gentian, the other herbs, or the combination.
General
...Orally, sorrel seems to be generally well tolerated, based on limited data, mainly from studies with combination products.
Serious Adverse Effects (Rare):
Orally: Gastrointestinal irritation, kidney damage, liver necrosis.
Dermatologic ...Orally, sorrel, when used in combination with other herbs, has been reported to cause allergic skin reactions (374,379).
Gastrointestinal ...Orally, sorrel, when used in combination with other herbs, has been reported to cause gastrointestinal side effects including nausea and an unpleasant aftertaste (374,379,37419).
Hepatic ...Extensive liver necrosis with hepatic failure has been reported with the ingestion of large amounts of sorrel; this was likely due to its oxalate content (75138).
Pulmonary/Respiratory ...Environmental exposure to sorrel pollen may trigger allergic rhinitis or bronchial asthma in hypersensitive individuals, and allergic cross-sensitivity may occur in up to 19% of people who are allergic to weed pollen (75141).
Renal ...Sorrel contains oxalates; irolithiasis and nephrosis may be caused by the systemic absorption of oxalates and may result in kidney damage (71314). A case of acute tubulointerstitial nephritis (TIN) has been reported in a 12-year-old who consumed an unknown amount of wild sorrel. The patient presented with polyuria, hypophosphatemia, proteinuria, glucosuria, and hyperoxaluria. Recovery occurred after oral rehydration and electrolyte replacement. The TIN was likely due to formation of calcium oxalate crystals in the kidneys (94019).
General
...Orally, verbena is well tolerated when used orally in amounts commonly found in foods (4912).
When used in medicinal amounts and in combination with other herbs, adverse effects have included gastrointestinal adverse effects and allergic skin reactions (374,379).
Topically, verbena can cause contact dermatitis (13431).
Gastrointestinal ...Orally, verbena in combination with other herbs can cause gastrointestinal adverse effects (374,379).
Immunologic ...Orally, verbena in combination with other herbs can cause allergic skin reactions (374,379). Topically, verbena can cause contact dermatitis (13431).
