Burn Calories

Drug overview for BURN CALORIES (guarana/chrom pico/green tea/yerba mate/herbal complex no.39):

Generic name: GUARANA/CHROM PICO/GREEN TEA/YERBA MATE/HERBAL COMPLEX NO.39
Drug class:
Therapeutic class: Alternative Therapy

No enhanced Introduction information available for this drug.

No enhanced Uses information available for this drug.

DRUG IMAGES

No Image Available

The following indications for BURN CALORIES (guarana/chrom pico/green tea/yerba mate/herbal complex no.39) have been approved by the FDA:

Indications:
None.

Professional Synonyms:
None.

The following drug interaction information is available for BURN CALORIES (guarana/chrom pico/green tea/yerba mate/herbal complex no.39):

Contraindicated
Severe
Moderate

There are 1 contraindications. These drug combinations generally should not be dispensed or administered to the same patient. A manufacturer label warning that indicates the contraindication warrants inclusion of a drug combination in this category, regardless of clinical evidence or lack of clinical evidence to support the contraindication.

Drug Interaction	Drug Names
Dipyridamole Injectable/Xanthine Derivatives 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: The xanthine derivatives are adenosine receptor antagonists. Concurrent administration may inhibit dipyridamole-induced increases in endogenous plasma adenosine levels, thus decreasing dipyridamole's vasodilator effects.(1) CLINICAL EFFECTS: Concurrent administration may result in a decrease in dipyridamole's vasodilator effects. This may produce false-negative results during dipyridamole-thallium imaging tests.(1-3) PREDISPOSING FACTORS: In patients with congestive heart failure and decreased hepatic function, the metabolism of xanthine derivatives may be decreased. These patients may need a longer xanthine-free period prior to dipyridamole-thallium imaging tests.(2) PATIENT MANAGEMENT: Patients scheduled for dipyridamole-thallium imaging tests should have a xanthine-free period (including caffeine-containing products) for at least 24 hours prior to their exam.(3) DISCUSSION: In a study in eight male subjects with documented coronary artery disease, intravenous dipyridamole administered during a dipyridamole-thallium 201 SPECT image test produced a significant increase in heart rate, a decrease in blood pressure, and angina in seven patients and ST segment depression in four patients. SPECT imaging showed reversible perfusion defects in myocardial segments supplied by stenotic coronary arteries. When the exam was repeated when the subjects were receiving therapeutic dosages of theophylline, there was no appearance of angina, ST depression, or hemodynamic changes and SPECT imaging shown total absence of reversible perfusion defects.(1) A study in eight patients with coronary artery disease evaluated the effects of caffeine on dipyridamole-201Tl myocardial imaging. The administration of dipyridamole alone resulted in chest pain and ST-segment depression in four patients. Concurrent caffeine infusion decreased the dipyridamole-induced decrease in blood pressure and heart rate. No patients experience chest pain or ST-segment depression. Six patients had false negative test results.(2) Another study found that the attenuation of the hemodynamic response to dipyridamole by caffeine was dose-dependent.(3)	DIPYRIDAMOLE

Drug Interaction

Drug Names

Dipyridamole Injectable/Xanthine Derivatives

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: The xanthine derivatives are adenosine receptor antagonists. Concurrent administration may inhibit dipyridamole-induced increases in endogenous plasma adenosine levels, thus decreasing dipyridamole's vasodilator effects.(1)

CLINICAL EFFECTS: Concurrent administration may result in a decrease in dipyridamole's vasodilator effects. This may produce false-negative results during dipyridamole-thallium imaging tests.(1-3)

PREDISPOSING FACTORS: In patients with congestive heart failure and decreased hepatic function, the metabolism of xanthine derivatives may be decreased. These patients may need a longer xanthine-free period prior to dipyridamole-thallium imaging tests.(2)

PATIENT MANAGEMENT: Patients scheduled for dipyridamole-thallium imaging tests should have a xanthine-free period (including caffeine-containing products) for at least 24 hours prior to their exam.(3)

DISCUSSION: In a study in eight male subjects with documented coronary artery disease, intravenous dipyridamole administered during a dipyridamole-thallium 201 SPECT image test produced a significant increase in heart rate, a decrease in blood pressure, and angina in seven patients and ST segment depression in four patients. SPECT imaging showed reversible perfusion defects in myocardial segments supplied by stenotic coronary arteries. When the exam was repeated when the subjects were receiving therapeutic dosages of theophylline, there was no appearance of angina, ST depression, or hemodynamic changes and SPECT imaging shown total absence of reversible perfusion defects.(1)

A study in eight patients with coronary artery disease evaluated the effects of caffeine on dipyridamole-201Tl myocardial imaging. The administration of dipyridamole alone resulted in chest pain and ST-segment depression in four patients. Concurrent caffeine infusion decreased the dipyridamole-induced decrease in blood pressure and heart rate.

No patients experience chest pain or ST-segment depression. Six patients had false negative test results.(2) Another study found that the attenuation of the hemodynamic response to dipyridamole by caffeine was dose-dependent.(3)

DIPYRIDAMOLE

There are 3 severe interactions. These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.

Drug Interaction	Drug Names
Theophylline Derivatives/Cimetidine SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Cimetidine inhibits the metabolism of theophylline by CYP1A2.(1-10) The duration of cimetidine's inhibitory action is uncertain. Short-term cimetidine therapy appears to reverse rapidly(2) but may persist in prolonged therapy. Increased pentoxifylline serum levels may be the result of an increase in the oral bioavailability of pentoxifylline.(11) CLINICAL EFFECTS: Concurrent cimetidine and theophylline derivative therapy may result in elevated theophylline derivative concentration levels, prolonged elimination half-life, and decreased clearance. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Theophylline derivative blood levels should be very closely monitored if cimetidine therapy is to be initiated, changed, or discontinued. Theophylline has a narrow therapeutic range; therefore, dosage reductions up to 30-50%(4) should be considered to prevent intoxication when cimetidine therapy is started. Antacids, famotidine, or possibly ranitidine might be more judicious choices than cimetidine in patients receiving theophylline derivatives. DISCUSSION: It is well documented that cimetidine impairs the elimination of theophylline when the two agents are co-administered to patients.(1-10, 12-22) This interaction has been noted by a variety of routes including continuous intravenous infusion.(22) Reports indicate that with concurrent cimetidine, theophylline plasma concentrations increase, theophylline half-life is prolonged from 29% to 73%(1-3;9,12-14) and theophylline clearance is decreased by 18.5% to 46%.(1-3,9,13,23) Age and smoking do not appear to affect the magnitude of the interaction.(17,18,20) Significant changes can be seen within 24 hours(3,5) and may progress as co-therapy continues.(3) A study involving ten healthy patients demonstrated that concomitant administration of cimetidine significantly decreased the plasma clearance of oxtriphylline.(24) Aminophylline is involved in a similar interaction as theophylline as seen in one case report.(25) In one report cimetidine also decreased the clearance and prolonged the half-life of caffeine.(26,27) A study demonstrated that cimetidine caused a significant increase in plasma levels of pentoxifylline.(11) Information on ranitidine is conflicting. Several studies have shown that ranitidine does not influence theophylline.(9,15,16,19,28,29) One case report noted toxic theophylline levels after ranitidine;(30) however, this case report has been challenged.(31) In another case report, theophylline levels rose from 16.6 mcg/ml to 39.7 mcg/ml(32) when the patient was given ranitidine. Other reports have also noted a reduction in theophylline elimination by ranitidine.(33,34) Famotidine has shown to have no effect on theophylline metabolism in a clinical trial;(35) however, there is one case report of decreased theophylline clearance during famotidine therapy.(36) Dyphylline, a theophylline derivative that is not converted to theophylline in vivo, is not to be expected to interact with cimetidine. A study showed that cimetidine increased the average steady state plasma concentration of pentoxifylline and its metabolite by 25% and 30%, respectively.(37)	CIMETIDINE
Adenosine; Hexobendine; Regadenoson/Xanthine Derivatives SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Xanthine derivatives may antagonize the effects of endogenous(1) and exogenous adenosine,(2,3) regadenoson,(4) and hexobendine.(5) CLINICAL EFFECTS: Concurrent use of a xanthine derivative use may result in decreased effectiveness of adenosine, hexobendine and regadenoson. Aminophylline may increase the risk of adenosine-induced seizures.(3) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Patients receiving concurrent therapy with adenosine and a xanthine derivative should be monitored for decreased effectiveness of adenosine. The dosage of adenosine may need to be increased. Whenever possible, withhold xanthine derivatives for 5 half-lives prior to using adenosine in cardiac stress tests.(6) Methylxanthines should not be used to reverse the effects of adenosine in patients who experience adenosine-induced seizures.(3) Concurrent therapy with hexobendine and a xanthine oxidase derivative should also be monitored for decreased effectiveness of hexobendine.(5) The US manufacturer of regadenoson recommends that patients avoid methylxanthines (e.g. caffeine, pentoxifylline, and theophylline) for 12 hours prior to regadenoson administration. Aminophylline may be used to attenuate severe and/or persistent adverse reactions to regadenoson.(4) DISCUSSION: In a study in six healthy subjects, theophylline significantly reduced the heart-rate response to adenosine. In addition, theophylline reduced the amount of abdominal and chest discomfort reported by subjects, allowing significantly higher infusion rates of adenosine.(7) Theophylline has also been reported to antagonize the vasorelaxant action of adenosine in human forearm arterioles.(8) In a study in five subjects, theophylline decreased the amounts of adenosine-induced side effects, including chest pain. There was no change in blood pressure or respiratory rate during concurrent adenosine and theophylline.(9) In a study in ten dog and twelve human subjects, the administration of adenosine after hexobendine increased coronary sinus blood flow. Aminophylline administration significantly decreased the coronary vasodilation response to adenosine and hexobendine.(5) In a study in ten healthy subjects, caffeine reduced the mean adenosine-induced increases in systolic blood pressure by 7.2 mmHg and heart rate by 8.4 beats/min when compared to placebo.(2) In another study in ten healthy subjects, caffeine was shown to lower the adenosine-induced response of blood pressure and heart rate.(3) Caffeine has also been reported to reduced adenosine-induced changes in minute ventilation and tidal volume.(3) Aminophylline has been shown to shorten the duration of coronary blood flow response to regadenoson.(3) Coronary flow reserve was 8% lower in patients who received caffeine (200 mg single dose) 2 hours prior to regadenoson administration when compared to subjects who received placebo instead of caffeine.(4)	ADENOSINE, LEXISCAN, REGADENOSON
Vincristine/P-glycoprotein (P-gp) Inducers SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Inducers of P-glycoprotein (P-gp) may reduce systemic exposure to vincristine.(1) CLINICAL EFFECTS: Concurrent or recent use of P-gp inducers may result in decreased effectiveness of vincristine.(1) PREDISPOSING FACTORS: Induction effects may be more likely with regular use of the inducer for longer than 1-2 weeks. PATIENT MANAGEMENT: The US manufacturer of vincristine states that concurrent use of P-gp inducers should be avoided.(1) Consider the use of agents with no or minimal induction potential if possible. Monitor patients for decreased response to therapy. DISCUSSION: Vincristine is transported by P-gp and inducers of this transporter are expected to decrease levels of vincristine.(1) Inducers of P-gp include linked to this monograph include: efavirenz, green tea, and lorlatinib.(2,3)	VINCASAR PFS, VINCRISTINE SULFATE

There are 6 moderate interactions. The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.

Drug Interaction	Drug Names
Selected Xanthine Derivatives/Selected Macrolide Antibiotics SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: The macrolides may inhibit the metabolism of the xanthine derivatives at CYP3A4. Theophylline decreases the bioavailability and increases the renal clearance of erythromycin by unknown mechanisms. CLINICAL EFFECTS: The concurrent administration of xanthine derivatives and some macrolides may result in elevated levels and increased clinical and adverse effects of the xanthine derivatives. The serum levels of erythromycin may be decreased. PREDISPOSING FACTORS: This interaction may be more severe in patients who have decreased xanthine clearance rates secondary to CHF, viral URI's, hepatic impairment, acute pulmonary edema, or cor pulmonale. Large xanthine doses may also pre-dispose patients to the clinical effects of the interaction. PATIENT MANAGEMENT: Patients receiving concurrent therapy with these agents should be monitored for signs of xanthine toxicity (e.g. nausea, seizures, nervousness, etc.). Theophylline levels should be monitored during and following concurrent macrolide therapy. The dosage of the xanthine derivative may need to be adjusted. DISCUSSION: Several controlled studies have demonstrated that concurrent administration of erythromycin and aminophylline,(1-5) oxtriphylline,(6) and theophylline(7-17) may reduce theophylline clearance and increase theophylline serum levels and half-life. Theophylline toxicity has been reported with concomitant administration of these drugs, usually after concurrent therapy exceeds five days. In contrast to these reports, other studies found that concurrent erythromycin and aminophylline(18-20) or theophylline(21-24) had no effects on theophylline levels. Studies have shown that aminophylline(3) and theophylline(7-8,25) can increase the clearance of erythromycin, resulting in lower erythromycin levels. Elevated theophylline levels have also been reported during concurrent administration of theophylline with clarithromycin.(26) Elevated theophylline levels have also been reported during concurrent administration of theophylline with troleandomycin.(27-28) Azithromycin,(29) dirithromycin,(30-32) miocamycin,(33-34) ponsinomycin, (35) roxithromycin,(36-38) and spiramycin(39) have been shown to not have clinically significant effects on theophylline levels.	CLARITHROMYCIN, CLARITHROMYCIN ER, E.E.S. 200, E.E.S. 400, ERY-TAB, ERYPED 200, ERYPED 400, ERYTHROCIN LACTOBIONATE, ERYTHROCIN STEARATE, ERYTHROMYCIN, ERYTHROMYCIN ESTOLATE, ERYTHROMYCIN ETHYLSUCCINATE, ERYTHROMYCIN LACTOBIONATE, LANSOPRAZOL-AMOXICIL-CLARITHRO, OMECLAMOX-PAK, VOQUEZNA TRIPLE PAK
Theophylline Derivatives/Lithium SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Theophylline derivatives increase the renal excretion of lithium. CLINICAL EFFECTS: Decreased levels of lithium which may result in decreased clinical effectiveness. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Lithium levels and response should be monitored in patients in whom theophylline therapy is initiated or withdrawn. Patients receiving concurrent therapy should be monitored for increased adverse effects. DISCUSSION: In a study involving ten volunteers, the concurrent administration of lithium and theophylline resulted in a significant decrease in lithium serum levels. Upon discontinuation of theophylline, lithium levels and half-life increased, and the clearance of lithium decreased. Individual variability in these parameters was significant. The overall incidence of adverse effects was significantly greater with concurrent therapy including restlessness, tremor, and anorexia. In another study in ten normal subjects, lithium (1200 mg/day for seven days) was administered and it was reported that theophylline infusion (dosed to achieve a plasma level of 14 mcg/ml) increased lithium clearances by 51%. In a case report, reduced lithium levels as well as worsening of manic symptoms occurred after increasing doses of theophylline were administered. It has been shown that aminophylline increases the lithium/creatinine clearance ratio, which may result in decreased serum lithium below the therapeutic level. Caffeine withdrawal has been reported to increase lithium levels in several case reports. This interaction is most important to consider in patients who have been previously sensitive to relapse with decreased lithium levels and in whom levels are maintained at the therapeutic/prophylactic borderline.	LITHIUM CARBONATE, LITHIUM CARBONATE ER, LITHIUM CITRATE, LITHIUM CITRATE TETRAHYDRATE, LITHOBID
Selected Xanthine Derivatives/Fluvoxamine SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Fluvoxamine may inhibit the metabolism of the xanthine derivatives by CYP1A2.(1,2) CLINICAL EFFECTS: Concurrent use of fluvoxamine and xanthine derivatives may result in elevated levels of the xanthine derivative and toxicity. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of fluvoxamine recommends that the dose of theophylline be decreased to one-third of the usual daily dose in patients receiving concurrent therapy. Theophylline levels should be closely monitored and patients should be observed for signs of theophylline toxicity.(3) The dosage of theophylline may need to be adjusted if fluvoxamine is discontinued. Patients receiving fluvoxamine should be instructed to consume caffeine containing beverages and/or medications with caution. DISCUSSION: In a study in 12 healthy subjects, the administration of a single dose of theophylline ethylenediamine (300 mg) on Day 4 of fluvoxamine (50 mg Day 1, 100 mg daily Days 2-6) decreased theophylline total clearance by 70%. The half-life of theophylline increased 2.3-fold (from 6.6 hours to 22 hours).(1) In a study in 12 healthy males, the administration of a single dose of theophylline (375 mg given as 442 mg aminophylline) with fluvoxamine (50 mg twice daily at steady state) decreased theophylline clearance by 3-fold.(3) Fluvoxamine has been shown to inhibit the metabolism of theophylline in vitro.(2) There are four case reports of theophylline toxicity during concurrent fluvoxamine therapy.(4-7) In a study in eight healthy subjects, the administration of a single dose of caffeine (200 mg) on Day 8 of fluvoxamine (50 mg daily Days 1-4, 100 mg daily Days 5-12) decreased caffeine clearance by 80%. The half-life of caffeine increased 5.2-fold (from 5 hours to 31 hours).(8) In a study, seven reports of impaired caffeine clearance were reported in patients whom received single 250mg doses of caffeine together with fluvoxamine (four doses of 100mg over two days). Fluvoxamine reduced the apparent oral clearance of caffeine by 91.3%, and prolonged its elimination half-life by 11.4-fold (from 4.9 hours to 56 hours). There were no changes in the pharmacodynamic effects of caffeine.(9)	FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE ER
Nadolol/Green Tea SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Nadolol is a substrate of OATP1A2, an influx transporter found in intestinal epithelium. Green tea catechins inhibit several drug transporters, including OATP1A2, leading to decreased absorption of nadolol. P-glycoprotein may also be involved, however no studies have confirmed its role. CLINICAL EFFECTS: Concomitant use of nadolol with green tea or green tea catechins may decrease the effectiveness of nadolol.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Advise patients maintained on nadolol to avoid green tea and green tea supplements. DISCUSSION: In a randomized crossover study in 10 healthy subjects, concurrent use of nadolol (30 mg daily) and green tea (700 mL/day), decreased the maximum concentration (Cmax) and area-under-curve (AUC) of nadolol by 85.3% and 85%, respectively. Pharmacodynamic parameters assessed included pulse rate, systolic blood pressure, and diastolic blood pressure. Although all parameters were affected slightly, nadolol's systolic blood pressure lowering effect was significantly suppressed (p = 0.042).(1)	CORGARD, NADOLOL
Trientine/Selected Minerals, Oral SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Mineral supplements may bind to trientine and block its absorption. CLINICAL EFFECTS: The levels and clinical effects of trientine may be decreased. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of trientine states that mineral supplements should not be given with trientine. If concomitant therapy is necessary, take trientine on an empty stomach and separate administration at least one hour apart from any other drug. Monitor clinical status for decreased effectiveness and adjust the trientine dose if necessary. DISCUSSION: Multivitamins with minerals may decrease trientine absorption so ensure patient is aware of the risks.	CUVRIOR, SYPRINE, TRIENTINE HCL
Migalastat/Caffeine-Containing Products SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: The mechanism of this interaction is unknown. CLINICAL EFFECTS: Concurrent use of a caffeine-containing product may result in decreased levels and effectiveness of migalastat.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Avoid coadministration of migalastat with caffeine-containing products. Do not administer caffeine-containing products within 2 hours before and 2 hours after taking migalastat.(1) DISCUSSION: Coadministration of migalastat with caffeine 190 mg decreased the migalastat maximum concentration (Cmax) by 60% and area-under-curve (AUC) by 55%.(1)	GALAFOLD

The following contraindication information is available for BURN CALORIES (guarana/chrom pico/green tea/yerba mate/herbal complex no.39):

Overview
Contraindicated
Severe
Moderate

Drug contraindication overview.

No enhanced Contraindications information available for this drug.

There are 2 contraindications. Absolute contraindication.

Contraindication List
Alcohol use disorder
Panic disorder

There are 6 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Cardiac arrhythmia
Hyperthyroidism
Increased risk of bleeding
Insomnia
Kidney disease with reduction in glomerular filtration rate (GFr)
Muscle spasm

There are 6 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Anxiety disorder
Disease of liver
Glaucoma
Hypertension
Hypoglycemic disorder
Osteoporosis

The following adverse reaction information is available for BURN CALORIES (guarana/chrom pico/green tea/yerba mate/herbal complex no.39):

Overview
Severe
Less Severe

Adverse reaction overview.

No enhanced Common Adverse Effects information available for this drug.

There are 7 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Anaphylaxis Hyperglycemia Hypertension Hypokalemia Ketosis Respiratory alkalosis Seizure disorder

There are 16 less severe adverse reactions.

More Frequent	Less Frequent
Increased urinary frequency Nervousness Palpitations Symptoms of anxiety Tremor	None.

Rare/Very Rare
Agitation Chest pain Delirium Dyspepsia Headache disorder Insomnia Nausea Tachycardia Tachypnea Tinnitus Vomiting

The following precautions are available for BURN CALORIES (guarana/chrom pico/green tea/yerba mate/herbal complex no.39):

Pediatric
Pregnant
Lactation
Geriatric

No enhanced Pediatric Use information available for this drug.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

No enhanced Pregnancy information available for this drug.

No enhanced Lactation information available for this drug.

No enhanced Geriatric Use information available for this drug.