8 CARDIOVASCULAR MEDICINE JANUARY 1, 2009 • FAMILY PRACTICE NEWS Is Found to Lower Blood Pressure

BY BRUCE JANCIN rating hibiscus tea into the diet may help mere 3-mm Hg reduction in systolic blood they consumed three 8-ounce cups of hi- Denver Bureau control blood pressure in people at risk of pressure (SBP) would reduce the relative biscus tea daily or a placebo beverage developing hypertension,” Diane L. Mc- risk of death due to stroke by 8%, due to similar in color and taste. N EW O RLEANS — Quaffing three Kay, Ph.D., said at the annual scientific ses- coronary artery disease by 5%, and all- Mean SBP dropped by 7.2 mm Hg in cups of hibiscus tea daily for 6 weeks re- sions of the American Heart Association. cause mortality by 4% (JAMA 2002;288: the group from a baseline of sulted in a mean 7.2-mm Hg reduction The public health implications of a 1882-8), said Dr. McKay, of the Jean May- 129.4 mm Hg, compared with a 1.3-mm in systolic blood pressure in mildly hy- blood pressure reduction of this magni- er USDA Human Nutrition Research Cen- Hg decline in the control group. Diastolic pertensive or prehypertensive adults in a tude, if extended to a large population, ter on Aging at Tufts University, Boston. blood pressure (DBP) fell by a mean of randomized, double-blind placebo-con- could be profound. According to the Na- She reported on 65 prehypertensive or 3.1 mm Hg from a baseline of 78. 9 mm trolled trial. tional High Blood Pressure Education mildly hypertensive adults who took part Hg and mean arterial pressure dropped “This suggests that regularly incorpo- Program Coordinating Committee, a in a 6-week double-blind study in which by 4.5 mm Hg from 95.7 mm Hg at en- rollment, although neither of these changes achieved statistical significance. BRIEF SUMMARY - Consult full (including alcohol) concomitantly with TussiCaps® extend- dose-related respiratory depression by acting directly on ed-release capsules may exhibit an additive CNS depres- brain stem respiratory centers (see OVERDOSAGE). Use However, the tea’s antihypertensive prescribing information before use. ® sion. When combined therapy is contemplated, the dose of TussiCaps in children less than 6 years of age has effect increased with higher baseline TussiCaps® of one or both agents should be reduced. been associated with fatal respiratory depression. ® The use of MAO inhibitors or tricyclic antidepressants with Overdose with TussiCaps extended-release capsules in blood pressure. In the half of subjects (Hydrocodone Polistirex and children 6 years of age and older, in adolescents, and in Chlorpheniramine Polistirex) hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone. adults has been associated with fatal respiratory depres- whose SBP exceeded 129 mm Hg, mean Extended-Release Capsules sion. The concurrent use of other anticholinergics with SBP reduction after 6 weeks of hibiscus hydrocodone may produce paralytic ileus. Skin and Subcutaneous Tissue Disorders Rx only Carcinogenesis, Mutagenesis, Impairment of Fertility Rash, pruritus. CONTRAINDICATIONS Carcinogenicity, mutagenicity and reproductive studies DRUG ABUSE AND DEPENDENCE ® have not been conducted with TussiCaps ® ® extended- TussiCaps extended-release capsules are Schedule III TussiCaps extended-release capsules are contraindicat- release capsules. Regularly ed in patients with a known allergy or sensitivity to narcotics. Psychic dependence, physical dependence hydrocodone or chlorpheniramine. Pregnancy and tolerance may develop upon repeated administration incorporating of narcotics; therefore, TussiCaps® extended-release The use of TussiCaps® extended-release capsules are Teratogenic Effects. Pregnancy Category C – Hydrocodone has been shown to be teratogenic in hamsters when given capsules should be prescribed and administered with hibiscus tea into contraindicated in children less than 6 years of age due to caution. However, psychic dependence is unlikely to the risk of fatal respiratory depression. in doses 700 times the human dose. There are no ade- ® the diet may help quate and well-controlled studies in pregnant women. develop when TussiCaps extended-release capsules are WARNINGS TussiCaps® extended-release capsules should be used used for a short time for the treatment of cough. Physical control blood Respiratory Depression – As with all narcotics, TussiCaps® during pregnancy only if the potential benefit justifies the dependence, the condition in which continued adminis- extended-release capsules produce dose-related respira- potential risk to the fetus. tration of the drug is required to prevent the appearance pressure. of a withdrawal syndrome, assumes clinically significant tory depression by directly acting on brain stem respirato- Nonteratogenic Effects – Babies born to mothers who ry centers. Hydrocodone affects the center that controls proportions only after several weeks of continued oral have been taking opioids regularly prior to delivery will be narcotic use, although some mild degree of physical respiratory rhythm, and may produce irregular and period- physically dependent. The withdrawal signs include irri- DR. MCKAY ic breathing. Caution should be exercised when dependence may develop after a few days of narcotic ® tability and excessive crying, tremors, hyperactive reflex- therapy. TussiCaps extended-release capsules are used postop- es, increased respiratory rate, increased stools, sneezing, eratively and in patients with pulmonary disease, or when- yawning, vomiting, and fever. The intensity of the syn- OVERDOSAGE ever ventilatory function is depressed. If respiratory drome does not always correlate with the duration of Signs and Symptoms – Serious overdosage with tea consumption was 13.2 mm Hg, and depression occurs, it may be antagonized by the use of maternal opioid use or dose. naloxone hydrochloride and other supportive measures hydrocodone is characterized by respiratory depression (a the reductions of 6.4 mm Hg in DBP and when indicated (see OVERDOSAGE). Labor and Delivery decrease in respiratory rate and/or tidal volume, Cheyne- ® Stokes respiration, cyanosis), extreme somnolence pro- 8.7 mm Hg in mean arterial pressure Head Injury and Increased Intracranial Pressure – The res- As with all narcotics, administration of TussiCaps extend- gressing to stupor or coma, skeletal muscle flaccidity, piratory depressant effects of narcotics and their capacity ed-release capsules to the mother shortly before delivery cold and clammy skin, and sometimes bradycardia and were also statistically significant. to elevate cerebrospinal fluid pressure may be markedly may result in some degree of respiratory depression in the hypotension. Although miosis is characteristic of narcotic exaggerated in the presence of head injury, other intracra- newborn, especially if higher doses are used. overdose, mydriasis may occur in terminal narcosis or The intervention had no side effects or nial lesions, or a pre-existing increase in intracranial pres- Nursing Mothers severe hypoxia. In severe overdosage, apnea, circulatory sure. Furthermore, narcotics produce adverse reactions, collapse, cardiac arrest and death may occur. The mani- downsides, said Dr. McKay. It is not known whether this drug is excreted in human which may obscure the clinical course of patients with head festations of chlorpheniramine overdosage may vary from milk. Because many drugs are excreted in human milk Dr. Robert H. Eckel observed that the injuries. central nervous system depression to stimulation. and because of the potential for serious adverse reactions Acute Abdominal Conditions – The administration of nar- in nursing infants from TussiCaps® extended-release cap- Treatment – Primary attention should be given to the blood pressure reduction seen with hi- cotics may obscure the diagnosis or clinical course of sules, a decision should be made whether to discontinue reestablishment of adequate respiratory exchange through patients with acute abdominal conditions. nursing or to discontinue the drug, taking into account the provision of a patent airway and the institution of assisted biscus tea in this trial is equal to the typ- Obstructive Bowel Disease – Chronic use of narcotics importance of the drug to the mother. or controlled ventilation. The narcotic antagonist naloxone ical effect of a single antihypertensive may result in obstructive bowel disease especially in hydrochloride is a specific antidote for respiratory depres- Pediatric Use sion which may result from overdosage or unusual sensi- patients with underlying intestinal motility disorder. ® medication. ® The use of TussiCaps extended-release capsules are tivity to narcotics including hydrocodone. Therefore, an Pediatric Use – The use of TussiCaps extended-release contraindicated in children less than 6 years of age (see appropriate dose of naloxone hydrochloride should be But although the notion of the tea as capsules are contraindicated in children less than 6 years of CONTRAINDICATIONS and ADVERSE REACTIONS, administered, preferably by the intravenous route, simulta- age (see CONTRAINDICATIONS). Respiratory, Thoracic and Mediastinal Disorders). neously with efforts at respiratory resuscitation. Since the a nutraceutical for blood pressure lower- In pediatric patients, as well as adults, the respiratory TussiCaps® extended-release capsules should be used duration of action of hydrocodone in this formulation may ing is intriguing, a larger confirmatory center is sensitive to the depressant action of narcotic with caution in pediatric patients 6 years of age and older exceed that of the antagonist, the patient should be kept cough suppressants in a dose-dependent manner. (see WARNINGS, Pediatric Use). under continued surveillance and repeated doses of the study with longer follow-up is needed, Caution should be exercised when administering antagonist should be administered as needed to maintain TussiCaps® extended-release capsules to pediatric Geriatric Use adequate respiration. For further information, see full pre- said Dr. Eckel, past president of the AHA patients 6 years of age and older. Overdose or concomi- Clinical studies of hydrocodone polistirex and chlorpheni- scribing information for naloxone hydrochloride. An antag- ® tant administration of TussiCaps extended-release cap- ramine polistirex extended-release did not include suffi- onist should not be administered in the absence of clinical- and professor of medicine, physiology, sules with other respiratory depressants may increase cient numbers of subjects aged 65 and over to determine ly significant respiratory depression. Oxygen, intravenous the risk of respiratory depression in pediatric patients. whether they respond differently from younger subjects. fluids, vasopressors and other supportive measures and biophysics, and program director of Benefit to risk ratio should be carefully considered, Other reported clinical experience has not identified differ- should be employed as indicated. Gastric emptying may especially in pediatric patients with respiratory embar- ences in responses between the elderly and younger be useful in removing unabsorbed drug. the adult general clinical research center rassment (e.g., croup) (see PRECAUTIONS). patients. In general, dose selection for an elderly patient at the University of Colorado, Denver. should be cautious, usually starting at the low end of the A Schedule CIII Narcotic. PRECAUTIONS dosing range, reflecting the greater frequency of Dr. McKay and coworkers conducted General decreased hepatic, renal, or cardiac function, and of con- comitant disease or other drug therapy. For Medical Information their randomized trial because earlier an- Caution is advised when prescribing this drug to patients Contact: Product Monitoring Department with narrow-angle glaucoma, asthma, or prostatic hyper- This drug is known to be substantially excreted by the kid- Phone: 800-778-7898 imal studies suggested Hibiscus sabdariffa trophy. ney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because Special Risk Patients – As with any narcotic agent, Manufactured by: L. has antihypertensive and antiathero- ® elderly patients are more likely to have decreased renal TussiCaps extended-release capsules should be used function, care should be taken in dose selection, and it Mallinckrodt Inc. sclerotic effects. Hibiscus contains flavi- with caution in elderly or debilitated patients and those may be useful to monitor renal function. Hazelwood, Missouri with severe impairment of hepatic or renal function, 63042 U.S.A. noids and phenolic acids which have po- hypothyroidism, Addison’s disease, prostatic hypertrophy, ADVERSE REACTIONS or urethral stricture. The usual precautions should be Gastrointestinal Disorders COVIDIEN, COVIDIEN with Logo, TussiCaps and  tent antioxidant properties. The study observed and the possibility of respiratory depression Mare should be kept in mind. Nausea and vomiting may occur; they are more frequent trademarks of Covidien AG or an affiliate. was supported by the Agricultural Re- in ambulatory than in recumbent patients. Prolonged Information for Patients administration of TussiCaps® extended-release capsules © 2008 Covidien AG or an affiliate. All rights reserved. search Service of the U.S. Department of As with all narcotics, TussiCaps® extended-release cap- may produce constipation. Agriculture and by Celestial Seasonings. sules may produce marked drowsiness and impair the General Disorders and Administration Site Conditions Rev 060308vl1 mental and/or physical abilities required for the perform- To view a video interview of Dr. McK- ance of potentially hazardous tasks such as driving a car Death or operating machinery; patients should be cautioned Nervous System Disorders ay, go to http://www.youtube.com/ accordingly. TussiCaps® extended-release capsules must not be diluted with fluids or mixed with other drugs as this Sedation, drowsiness, mental clouding, lethargy, impair- familypracticenews. ■ may alter the resin-binding and change the absorption ment of mental and physical performance, anxiety, fear, rate, possibly increasing the toxicity. dysphoria, euphoria, dizziness, psychic dependence, mood changes. Keep out of the reach of children. Renal and Urinary Disorders Cough Reflex – Hydrocodone suppresses the cough reflex; as with all narcotics, caution should be exercised Ureteral spasm, spasm of vesical sphincters, and urinary when TussiCaps® extended-release capsules are used retention have been reported with opiates.

postoperatively, and in patients with pulmonary disease. Respiratory, Thoracic and Mediastinal Disorders COM . Drug Interactions Dryness of the pharynx, occasional tightness of the chest, Patients receiving narcotics, antihistamines, antipsy- and respiratory depression (see CONTRAINDICATIONS). chotics, antianxiety agents, or other CNS depressants TussiCaps® extended-release capsules may produce OTOLIA /F DAMCZYK A ONIKA ©M The tea had the greatest effect in those with higher baseline blood pressure. Pages 8a—8bŅ