Genadur (biotin/carbitol/equisetum xt/ethanol/hydroxypropyl chito/msm)

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Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

Alcohol/Benzgalantamine

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: Concomitant use of alcohol with benzgalantamine may cause a rapid release of benzgalantamine.(1)

CLINICAL EFFECTS: Rapid release of benzgalantamine may result in increased systemic concentrations and toxicities, including gastrointestinal bleeding, seizures, bradycardia, AV block, and QT prolongation.

PREDISPOSING FACTORS: The increased rate of release may be alcohol concentration-dependent. The risk of QT prolongation or torsade de pointes may be increased in patients with cardiovascular disease (e.g. heart failure, myocardial infarction, history of torsade de pointes, congenital long QT syndrome), hypokalemia, hypomagnesemia, hypocalcemia, bradycardia, female gender, or advanced age. Concurrent use of more than one drug known to cause QT prolongation or higher systemic concentrations of either QT prolonging drug are additional risk factors for torsade de pointes. Factors which may increase systemic drug concentrations include rapid infusion of an intravenous dose or impaired metabolism or elimination of the drug (e.g. coadministration with an agent which inhibits its metabolism or elimination, and/or renal/hepatic dysfunction).

PATIENT MANAGEMENT: The manufacturer of benzgalantamine states that benzgalantamine should not be taken with alcohol. Avoid the use of elixirs containing a high-percentage of alcohol in patients taking these products.(1) Patients are advised to avoid alcohol while taking this product.

DISCUSSION: An in-vitro dissolution study found that alcohol (40% (v/v)) increases benzgalantamine release. Dose dumping was not observed in the presence of lower alcohol concentrations.(1)

Alcohol/Levodopa (Extended Release)

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: Concomitant use of alcohol with extended release levodopa may cause a rapid release of levodopa.(1)

CLINICAL EFFECTS: Rapid release of levodopa may result in increased systemic concentrations and effects of levodopa, including tremor, hypertensive crisis, and postural hypotension.

PREDISPOSING FACTORS: The increased rate of release may be alcohol concentration-dependent.

PATIENT MANAGEMENT: The manufacturer of Crexont (levodopa-carbidopa) states that Crexont should not be taken with alcohol. Avoid the use of elixirs containing a high-percentage of alcohol in patients taking these products.(1) Patients are advised to avoid alcohol while taking this product.

DISCUSSION: An in-vitro dissolution study found that alcohol (40% (v/v)) increases levodopa release. Dose dumping was not observed in the presence of lower alcohol concentrations.(1)

Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

Alcohol/Furazolidone

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: In vitro studies show that furazolidone produces an inhibition of aldehyde dehydrogenase.(2,3) This results in the accumulation of acetaldehyde, which is responsible for the disulfiram-like reaction.

CLINICAL EFFECTS: Concurrent use of furazolidone with alcohol has been associated with a disulfiram-type reaction resulting in symptoms of hypotension, tachycardia, nausea, sweating, facial flushing, headache, and vomiting.

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The manufacturer of furazolidone states that alcohol is not recommended during and for at least 4 days after taking furazolidone.(1) Patients should be advised of the possible effects that may result from ingestion or application of products that contain alcohol while taking furazolidone. Patients should be informed about unsuspected sources of alcohol such as elixirs and topical preparations. Alcohol is used to improve docetaxel and paclitaxel solubility. - The quantity of alcohol in paclitaxel injection formulations (0.385-0.396 grams/mL) is similar across manufacturers. A paclitaxel 200 mg dose contains approximately 13 grams of alcohol. - The quantity of alcohol in docetaxel formulations varies approximately 3-fold depending upon the manufacturer. FDA data on alcohol content (22): Product Manufacturer Alcohol/200 mg dose Docetaxel Inj. Pfizer 6.4 grams Docetaxel Inj. Sandoz 5.5 grams Docetaxel Inj. Accord 4.0 grams Taxotere-one vial Sanofi 4.0 grams formulation Docetaxel Inj. Hospira 3.7 grams Docefrez Sun Pharma 2.9 grams Taxotere-two vial Sanofi 2.0 grams formulation

DISCUSSION: In vitro studies have found that furazolidone inhibits aldehyde dehydrogenase (ALDH).(2,3) In one study, furazolidone nanoemulsion inhibited 99.75% of ALDH activity while free furazolidone inhibited 25% of ALDH activity.(3)

Alcohol/Metoprolol (Extended Release)

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: Concomitant use of alcohol with metoprolol extended-release capsules may cause a rapid release of metoprolol.(1)

CLINICAL EFFECTS: Rapid release of metoprolol may result in increased systemic concentrations and toxicities, including bradycardia and hypotension.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The manufacturer of metoprolol extended release capsules states that concurrent use with alcohol should be avoided.(1) Patients are advised to avoid alcohol and elixirs containing a high-percentage of alcohol while taking this product.

DISCUSSION: An in vitro dissolution study evaluated the potential for alcohol-induced dose-dumping with metoprolol extended-release capsules in the presence of varying alcohol concentrations (5, 10, 20, and 40%). The rate of drug release was increased. The study showed that approximately 89% of the total metoprolol dose was released at 2 hours at the 40% alcohol level, and 17% of total drug was released at 2 hours with 5% alcohol.(1)

Alcohol/Posaconazole (Powder For Suspension)

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: Concomitant use of alcohol with the delayed-release powder for suspension formulation of posaconazole may result in faster release of posaconazole and interfere with the delayed-release characteristics of the formulation.(1)

CLINICAL EFFECTS: Concurrent use of alcohol may result in the powder for suspension formulation having more similar kinetics to the immediate-release oral suspension formulation, which has lower and more variable bioavailability of posaconazole. This may lead to decreased blood levels and efficacy of posaconazole.(1,2)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The manufacturer of posaconazole states that the administration of posaconazole powder for suspension with alcohol is not recommended.(1) Patients are advised to avoid alcohol and elixirs containing a high-percentage of alcohol while taking this product.

DISCUSSION: An in vitro dissolution study demonstrated the potential for alcohol-induced dose-dumping with posaconazole delayed-release powder for suspension in the presence of alcohol (5, 10, 20, and 40%), especially at higher concentrations.(1,2)

Alcohol/Ranolazine (Extended Release Granules)

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: Concomitant use of alcohol with ranolazine extended-release granules may cause a rapid release of ranolazine.(1)

CLINICAL EFFECTS: Rapid release of ranolazine may result in increased systemic concentrations and toxicities, including QTc prolongation and life-threatening cardiac arrhythmia like torsades de pointes.(1)

PREDISPOSING FACTORS: The increased rate of release may be alcohol concentration-dependent. The risk of QT prolongation or torsades de pointes may be increased in patients with cardiovascular disease (e.g. heart failure, myocardial infarction, history of torsades de pointes, congenital long QT syndrome), hypokalemia, hypomagnesemia, hypocalcemia, bradycardia, female gender, or advanced age.(2) Concurrent use of more than one drug known to cause QT prolongation or higher systemic concentrations of either QT prolonging drug are additional risk factors for torsades de pointes. Factors which may increase systemic drug concentrations include rapid infusion of an intravenous dose or impaired metabolism or elimination of the drug (e.g. coadministration with an agent which inhibits its metabolism or elimination, genetic impairment in drug metabolism or elimination, and/or renal/hepatic dysfunction).(2)

PATIENT MANAGEMENT: Patients are advised to avoid alcohol while taking ranolazine extended-release granules. Avoid the use of elixirs containing a high-percentage of alcohol in patients taking these products.(1)

DISCUSSION: An in-vitro dissolution study was conducted to evaluate the impact of alcohol on extended-release characteristics of ranolazine granules. The in-vitro study showed that alcohol causes a rapid release of ranolazine from the extended-release granules that may increase the risk of adverse events associated with ranolazine.(1)

Alcohol/Selected Extended-Release Cns Stimulants

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: Concomitant use of alcohol with selected extended or delayed release amphetamine, dextroamphetamine, and methylphenidate products may impair the integrity of the extended-release dose form resulting in accelerated medication release over a short period of time.(1-8)

CLINICAL EFFECTS: Rapid release of amphetamine, dextroamphetamine, or methylphenidate may result in increased systemic concentrations and toxicities.

PREDISPOSING FACTORS: The increased rate of release may be alcohol concentration-dependent.

PATIENT MANAGEMENT: Patients are advised to avoid alcohol while taking these extended-release products.(1-8) Avoid the use of elixirs containing a high-percentage of alcohol in patients taking these products.

DISCUSSION: Some, but not all manufacturers have evaluated the effects of alcohol on the kinetics of their extended release dose forms. An in vitro study explored the effect of alcohol on the release characteristics of amphetamine from Adzenys XR-OPD. There was a substantial increase in amphetamine release with 40% alcohol, but not 5%, 10%, or 20% alcohol.(1) An in vitro study explored the effect of alcohol on the release characteristics of amphetamine from Dyanavel XR. There was a substantial increase in amphetamine release with 40% alcohol, but not 5%, 10%, or 20% alcohol.(2) An in vitro study explored the effect of alcohol on the release characteristics of amphetamine from Mydayis. There was an increase in amphetamine release with 20% alcohol and a larger increase with 40% alcohol.(3) An in vitro study explored the effect of alcohol on the release characteristics of methylphenidate from Adhansia XR. At an alcohol concentration of 40%, 71% and 61% of a 70 mg and 100 mg dose, respectively, was released at 2 hours. A study in healthy adults found that 40% alcohol combined with Adhansia XR resulted in a 1.4-fold increase in peak plasma concentration and 1.3-fold increase in absorption.(4) An in vitro study explored the effect of alcohol on the release characteristics of methylphenidate for Concerta. At an alcohol concentration up to 40% there was no increased release of methylphenidate in the first hour.(5) An in vitro study explored the effect of alcohol on the release characteristics of methylphenidate from Cotempla XR-ODT. There was an increase in methylphenidate release with 40% alcohol, but not with lower alcohol concentration.(6) An in vitro study explored the effect of alcohol on the release characteristics of methylphenidate from Metadate CD. At an alcohol concentration of 40%, 84% of methylphenidate was released in the first hour.(7) An in vitro study explored the effect of alcohol on the release characteristics of methylphenidate from Ritalin LA. At an alcohol concentration of 40%, 98% of methylphenidate was released in the first hour.(8)

Alcohol/Tacrolimus (Extended Release)

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: Concomitant use of alcohol with tacrolimus extended release formulations may result in increased tacrolimus levels in the blood due to a rapid release of tacrolimus.(1-5)

CLINICAL EFFECTS: Concurrent use of alcohol may result in a faster release of tacrolimus and interfere with the extended release characteristics of the formulation, potentially increasing absorption and blood levels of tacrolimus. Increased levels of tacrolimus may increase the risk of toxicities, including nephrotoxicity, neurotoxicity, and QT prolongation.(1)

PREDISPOSING FACTORS: The risk of QT prolongation or torsade de pointes may be increased in patients with cardiovascular disease (e.g. heart failure, myocardial infarction, history of torsade de pointes, congenital long QT syndrome), hypokalemia, hypomagnesemia, hypocalcemia, bradycardia, female gender, or advanced age. Concurrent use of more than one drug known to cause QT prolongation or higher systemic concentrations of either QT prolonging drug are additional risk factors for torsade de pointes. Factors which may increase systemic drug concentrations include rapid infusion of an intravenous dose or impaired metabolism or elimination of the drug (e.g. coadministration with an agent which inhibits its metabolism or elimination, and/or renal/hepatic dysfunction).

PATIENT MANAGEMENT: The manufacturers of tacrolimus extended release formulations state that the concurrent use of alcohol is not recommended.(1-4) Patients are advised to avoid alcohol while taking this product.

DISCUSSION: In vitro dissolution studies evaluated the potential for alcohol-induced dose-dumping with extended release tacrolimus products in the presence of alcohol at varying alcohol concentrations (5, 10, 20, and 40%).(3-5) Data from the manufacturer of tacrolimus extended release tablets show there is no alcohol-induced dose-dumping in the various alcohol concentrations. However, the rate of drug release was increased by 10% (5% to 15%) at 2.5 hours in the presence of roughly 40% alcohol at pH 1.2 for the 0.75 mg, 1 mg, and 4 mg tablet.(4) Data from in vitro studies regarding tacrolimus extended release capsules found an average of 35% and 25% of the dose was released at 0.5 hour for the 0.5 mg and 5 mg strengths respectively at a pH of 1.2 in an alcohol concentration of 20%. At an alcohol concentration of 40%, the amount of the dose released at 0.5 hour was 89% and 54% for the 0.5 mg and 5 mg strengths.(3,5)

Moderate Interaction: Assess the risk to the patient and take action as needed.

Alcohol/Centanafadine

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: Concomitant use of alcohol with centanafadine may cause a rapid release of centanafadine.(1)

CLINICAL EFFECTS: Rapid release of centanafadine may result in increased systemic concentrations and toxicities, including serotonin syndrome and excess sympathomimetic effects (insomnia, tachycardia, hypertension, headache and anxiety). A more rapid release of centanafadine may also reduce the efficacy of centanafadine during the latter part of the dosing interval.(1)

PREDISPOSING FACTORS: The increased rate of release may be alcohol concentration-dependent.

PATIENT MANAGEMENT: The manufacturer of centanafadine states that alcohol should be avoided at the same time and for at least 2 hours after taking centanafadine. Avoid the use of elixirs containing a high-percentage of alcohol in patients taking these products.(1)

DISCUSSION: An in-vitro dissolution study found that alcohol (20% and 40% (v/v)) increases centanafadine release by 85% and 100%, respectively, within 1.5 hours compared to 23% in the control group (0% alcohol). With 5% alcohol, centanafadine release was similar to the control through 1.5 hours then accelerated beyond 2 hours.(1)

Alcohol; Propylene Glycol/Secnidazole

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: Alcohol and propylene glycol may potentiate the adverse effects of secnidazole.(1)

CLINICAL EFFECTS: Concurrent use of alcohol or preparations containing ethanol or propylene glycol in patients taking secnidazole may increase the risk of side effects, including nausea, vomiting, diarrhea, abdominal pain, headache and dizziness.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Counsel patients to avoid alcohol and preparations containing ethanol or propylene glycol until at least 2 days after completing therapy with secnidazole.(1) Significant quantities of alcohol may be present in medicinal products. Alcohol is is used to improve docetaxel and paclitaxel solubility. - The quantity of alcohol in paclitaxel injection formulations (0.385-0.396 grams/mL) is similar across manufacturers. A paclitaxel 200 mg dose contains approximately 13 grams of alcohol. - The quantity of alcohol in docetaxel formulations varies approximately 3-fold depending upon the manufacturer. FDA data on alcohol content (3): Product Manufacturer Alcohol/200 mg dose Docetaxel Inj. Pfizer 6.4 grams Docetaxel Inj. Sandoz 5.5 grams Docetaxel Inj. Accord 4.0 grams Taxotere-one vial Sanofi 4.0 grams formulation Docetaxel Inj. Hospira 3.7 grams Docefrez Sun Pharma 2.9 grams Taxotere-two vial Sanofi 2.0 grams formulation

DISCUSSION: In vitro studies showed that secnidazole had no effect on aldehyde dehydrogenase activity. However, postmarketing observations of adverse reactions of nausea, vomiting, diarrhea, abdominal pain, dizziness, and headache with concomitant use of secnidazole and alcohol have been reported.(1)

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There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

There is no enhanced messaging for this drug.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

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