Helixia Cough Single-Dose Sachets by PendoPharm (division of Pharmascience Inc)

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Bronchitis. It is unclear if oral English ivy leaf extract is beneficial in patients with acute or chronic bronchitis. Details: Observational, low-quality research in adults and children with acute or chronic bronchitis has found that taking a specific product containing English ivy leaf extract (Prospan, PendoPharm) three times daily for 7 days is associated with improvement of respiratory symptoms when compared with baseline. However, the validity of this study is limited by the lack of a comparator group and it is unclear if improvements are associated with English ivy extract, other concomitant treatments, or the natural course of the disease (29903). Another small observational study in children and adults with acute bronchitis has found that taking a specific product containing English ivy leaf extract (Prospanex, Engelhard Arzneimittel GmbH and Co. KG) three times daily for approximately 7 days is not associated with a difference in respiratory symptoms, such as coughing, when compared with taking acetylcysteine 300-600 mg daily (106055). In these studies, English ivy extract 7 mg/mL was dosed as 2.5 mL three times daily in children less than 5 years of age, 5 mL three times daily in children 6-12 years of age, and 5-7.5 mL three times daily in those at least 12 years of age (29903,106055). English ivy has also been evaluated in combination with thyme. A large clinical study in patients with acute bronchitis shows that taking a specific syrup (Bronchipret Saft, Bionorica AG) containing English ivy leaf and thyme extracts as 5.4 mL three times daily for 11 days reduces the frequency and duration of cough when compared with placebo (78152). Additionally, an observational study in children with acute bronchitis has found that taking this combination product in an age-specific dosing schema is associated with reduced bronchitis severity and coughing fits when compared to baseline (78181). However, due to the lack of a comparator group, it is unclear if these changes are due to the product or to the natural resolution of the condition.
• Burns. Although there has been interest in using topical English ivy for burns, there is insufficient reliable information about the clinical effects of English ivy for this purpose.
• Cough. Oral English ivy has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A large open-label, uncontrolled study in adults with acute cough due to an upper respiratory tract infection who purchased a specific syrup (Bronchipret drops, Bionorica AG) containing English ivy leaf and thyme extracts suggests that taking this product as 2.6 mL three times daily for at least 4 days may improve patient-reported bronchitis-symptom severity, cough severity, and quality of life, with over 90% of patients reporting overall satisfaction and product tolerability (110401). However, due to the lack of a comparator group, it is unclear if these changes are due to the product or the natural resolution of the condition. Additionally, the validity of these findings is limited by poor study methodology.
• Gout. Although there has been interest in using oral English ivy for gout, there is insufficient reliable information about the clinical effects of English ivy for this purpose.
• Neuropathic pain. Although there has been interest in using topical English ivy for neuropathic pain, there is insufficient reliable information about the clinical effects of English ivy for this purpose.
• Respiratory tract infections. Although there has been interest in using oral English ivy for respiratory tract infections, there is insufficient reliable information about the clinical effects of English ivy for this purpose.
• Rheumatoid arthritis (RA). Although there has been interest in using oral and topical English ivy for RA, there is insufficient reliable information about the clinical effects of English ivy for this purpose.
• Spasticity. Although there has been interest in using oral English ivy for spasticity, there is insufficient reliable information about the clinical effects of English ivy for this purpose. More evidence is needed to rate English ivy for these uses.

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POSSIBLY SAFE ...when the leaf extract is used orally and appropriately, short-term. Two specific products containing dried English ivy leaf extract 7 mg/mL (Prospan, PendoPharm; Prospanex, Engelhard Arzneimittel GmbH and Co. KG), taken in doses of 7.5 mL three times daily, have been used with apparent safety for up to 7 days (29903,106055). There is insufficient reliable information available about the safety of topical English ivy.

CHILDREN: POSSIBLY SAFE
when the leaf extract is used orally and appropriately, short-term. Two specific products containing dried English ivy leaf extract 7 mg/mL (Prospan, PendoPharm; Prospanex, Engelhard Arzneimittel GmbH and Co. KG), taken in doses of 2.5-7.5 mL three times daily, has been used with apparent safety for up to 7 days in infants and children up to 18 years of age (29903,106055).

PREGNANCY:
Insufficient reliable information available; avoid using. A small retrospective study suggests that taking English ivy leaf extract at an unknown dose or duration during pregnancy is not associated with changes in pregnancy duration, the rate of preterm birth, infant health complications, or infant deaths (110402). However, due to its small size, retrospective design, and insufficient information regarding dose and duration, further research is needed to determine the safety of English ivy during pregnancy.

LACTATION:
Insufficient reliable information available; avoid using.

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CYTOCHROME P450 2C19 (CYP2C19) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, English ivy might increase the levels of drugs metabolized by CYP2C19.  Details In vitro research shows that English ivy inhibits CYP2C19 enzymes (96682). So far, this interaction has not been reported in humans.

CYTOCHROME P450 2C8 (CYP2C8) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, English ivy might increase the levels of drugs metabolized by CYP2C8.  Details In vitro research shows that English ivy inhibits CYP2C8 enzymes (96682). So far, this interaction has not been reported in humans.

CYTOCHROME P450 2D6 (CYP2D6) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, English ivy might increase the levels of drugs metabolized by CYP2D6.  Details In vitro research shows that English ivy inhibits CYP2D6 enzymes (96682). So far, this interaction has not been reported in humans.

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General ...Orally and topically, English ivy leaf extract seems to be generally well tolerated.
Most Common Adverse Effects:
Orally: Abdominal pain, diarrhea, nausea, skin irritation, vomiting.
Topically: Allergic reactions, contact dermatitis.

Dermatologic ...Orally, English ivy and fresh English ivy leaves can cause skin irritation (7,29903).
Topically, fresh English ivy leaves can cause contact dermatitis and rash, with frequent exposure increasing the risk of sensitization (29910,29912,29913,29914,91301,96620,96636,96681). Occupational airborne exposure to English ivy can also cause contact dermatitis (96600).

Gastrointestinal ...Orally, English ivy can cause abdominal pain, diarrhea, nausea, and vomiting (29903,106055). The saponin constituents of English ivy can produce an acrid and/or bitter taste (7).

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