Do not use BREO ELLIPTA more often than prescribed. There are things people with COPD can do to improve their breathing. Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your or local waste disposal company. Pediatric Use: Fluticasone Propionate Cream may be used with caution in pediatric patients as young as 3 months of age. The safety and efficacy of drug use for longer than 4 weeks in this population have not been established. The safety and efficacy of Fluticasone Propionate Cream in pediatric patients below 3 months of age have not been established.
Formoterol fumarate dihydrate is a white to yellowish powder, which is freely soluble in glacial acetic acid, soluble in methanol, sparingly soluble in ethanol and isopropanol, slightly soluble in water, and practically insoluble in acetone, ethyl acetate, and diethyl ether. The effective t½ for mometasone furoate following inhalation with Dulera was 25 hours in healthy subjects and in patients with asthma. Dupont C, Giraud V, Leporrier J, Greffe S, Rouveix E, Chinet T. Cushing's syndrome induced by combined treatment with inhaled fluticasone and oral ritonavir.
Use distilled, sterile, or previously boiled water to make up the solution. If you are taking dexamethasone with either lopinavir or telaprevir, the amount of lopinavir or telaprevir in your blood may decrease and it may not work as well. This finding with salmeterol is considered a class effect of the LABAs, including formoterol, one of the active ingredients in Dulera. No study adequate to determine whether the rate of asthma-related death is increased with Dulera has been conducted.
D2, from human lung. In 7 trials in adults, fluticasone propionate nasal spray has decreased nasal mucosal eosinophils in 66% of patients 35% for placebo and basophils in 39% of patients 28% for placebo. The direct relationship of these findings to long-term symptom relief is not known. Inform patients that treatment with fluticasone propionate nasal spray may lead to adverse reactions, which include epistaxis and nasal ulceration. Candida infection may also occur with treatment with fluticasone propionate nasal spray. In addition, fluticasone propionate nasal spray has been associated with nasal septal perforation and impaired wound healing.
Advise patients that coadministration of Veramyst Nasal Spray and ritonavir is not recommended and to be cautious if coadministering with ketoconazole. Plasma concentrations may be increased. 23 35 Monitor patient closely. COPD should not normally be treated with beta-blockers. Research Triangle Park, NC; 2010 Jun. Importance of advising patients that fluticasone oral inhalation must be used at regular intervals to be therapeutically effective. There was no evidence to suggest that the presence or absence of detectable levels of fluticasone furoate was related to gender, age, or race. Know the medicines you take. Binding of fluticasone furoate to human plasma proteins is greater than 99%. Remove the cap from the mouthpiece of the actuator before use. Also tell your doctor if you have chicken pox, measles, or tuberculosis TB; a type of lung infection or if you have been around someone who has one of these conditions. Be cautious because your body may be less able to cope with stress such as surgery, illness, severe asthma attack, or injury during this time. This may cause serious side effects. In controlled clinical trials of twice-daily administration, the total incidence of adverse reactions associated with the use of Fluticasone Propionate Cream was approximately 4%. These adverse reactions were usually mild; self-limiting; and consisted primarily of pruritus, dryness, numbness of fingers, and burning. The one daily treatment that is proven to prolong life for people with severe COPD is oxygen, Dweik says. Studies have borne this out. It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression including adrenal crisis may appear in a small number of patients, particularly when mometasone furoate is administered at higher than recommended doses over prolonged periods of time. If such effects occur, the dosage of Dulera should be reduced slowly, consistent with accepted procedures for reducing systemic corticosteroids and for management of asthma symptoms.
DISKUS is administered to a nursing woman. Clean the applicator regularly. Keep track of the number of sprays used from the container. Discard the container after you have used the number of sprays specified on the manufacturer's package. Victrelis boceprevir US prescribing information. MacIntyre says a lot of people with COPD also have such as or hypoventilation breathing that is too slow or shallow. People who have this may be helped by using masks for continuous positive airway pressure therapy. Dulera may produce inhalation induced bronchospasm with an immediate increase in wheezing after dosing that may be life-threatening. If inhalation induced bronchospasm occurs, it should be treated immediately with an inhaled, short-acting bronchodilator. Dulera should be discontinued immediately and alternative therapy instituted. Endpoint last available data. F. Do not freeze or refrigerate. Do not use this medication on a child without medical advice. Children are more likely to absorb large amounts of a topical steroid through the skin. Steroid absorption in children may cause unwanted side effects, or a delay in growth with long-term use.
The counter will count down by 1 number. Do not use Kenalog if you are allergic to triamcinolone. This medicine may be harmful if swallowed. Hold the pump with the applicator between your forefinger and middle finger and the bottom of the bottle resting on your thumb. Point the applicator away from your face. These adverse effects generally occurred at large multiples of the MRHD when formoterol fumarate was administered by the oral route to achieve high systemic exposures. No effects were observed in a study with rats that received formoterol fumarate by the inhalation route at an exposure approximately 500 times the MRHD. Also carefully monitor lung function FEV 1 or morning PEF adjunctive β 2-adrenergic agonist use, and asthma symptoms. Tell your doctor if your condition does not improve in 2 weeks or if it worsens.
If control of asthma is inadequate after 2 weeks of therapy at the initial dosage, replacing the current strength with a higher strength higher strengths contain higher dosages of fluticasone only may provide additional asthma control. Importance of advising patients that additional salmeterol or other long-acting inhaled β 2-adrenergic agonists should not be used for prevention of exercise-induced bronchospasm, treatment of asthma or COPD, or any other reason when the fixed combination is used. National Asthma Education and Prevention Program. Expert panel report III: guidelines for the diagnosis and management of asthma. 2007 Jul. DISKUS at the end of this Medication Guide. Trees, grasses, and weeds release these tiny grains into the air to fertilize other plants. Store the Canadian product between 36-77 degrees F 2-25 degrees C. not freeze. If you have sudden worsening of breathing, use your quick-relief and get medical help right away. C with mouthpiece down. 51 55 Contents under pressure; do not puncture, use or store near heat or open flame, or place into fire or incinerator. Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. 'Multum' is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Depress the lever away from the body until a click is heard; the lever pierces the foil blister and releases the powdered drug into an exit port. 26 43 Do not tilt or close the Diskus device, play with the lever, or advance the lever more than once at this point. 26 43 A dose counter will advance each time the lever is depressed. Importance of contacting a clinician if asthma symptoms do not improve after 1 week of regular use of the fixed combination. Kenalog topical may also be used for purposes not listed in this medication guide. The pharmacist must mix contents of each container with appropriate amount of Cream Base yielding a final volume of 100 grams at the time of dispensing. Pharmacist may utilize appropriate diluents if needed from the respective active component Material Safety Data Sheet only. For dermatological use only. This product should not be administered orally. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
NOTE: In all patients, it is desirable to titrate to the lowest effective dosage once asthma Stability is achieved. The Cap has a tab that keeps the Mist-Release Button from being pressed accidentally. It also helps keep the nozzle clean. Do not throw the cap away. COPD is increased by LABA. Valin N, De Castro N, Garrait V, Bergeron A, Bouche C, Molina JM. Iatrogenic Cushing's syndrome in HIV-infected patients receiving ritonavir and inhaled fluticasone: description of 4 new cases and review of the literature. Use this on the only. Fluticasone propionate is a white to off-white powder with a molecular weight of 500. Rare Disease Database under "Rare Disease Information".
Post hoc subpopulation analyses were performed. You may not receive the correct amount of medication. MDI 100 mcg or 200 mcg formoterol MDI 5 mcg or placebo. Shake well 5 seconds immediately prior to initial use. 36 51 55 Actuate fluticasone aerosol inhaler 4 times prior to initial use. 35 36 Test spray the aerosol inhaler containing fluticasone in fixed combination with salmeterol Advair HFA 4 times into the air away from face before initial use, and shake well for 5 seconds before each spray. Never throw container into fire or incinerator. Asthma Patients: Following oral inhalation of single and multiple doses of the Dulera, mometasone furoate was absorbed in asthma patients with median T max values ranging from 1 to 2 hours. Angus P, Snook JA, Reid M et al. Oral fluticasone propionate in active distal ulcerative colitis. Gut. Particular care is needed for patients who are transferred from systemically active corticosteroids to FLOVENT fluticasone propionate Inhalation because deaths due to adrenal insufficiency have occurred in patients with during and after transfer from corticosteroids to less systemically available inhaled corticosteroids. After withdrawal from systemic corticosteroids, a number of months are required for recovery of HPA function. The recommended starting dosages for Dulera treatment are based on prior asthma therapy. Importance of informing patients with COPD receiving fluticasone in fixed combination with salmeterol oral inhalation powder Advair Diskus that they have an increased risk of pneumonia and to contact their clinician if they develop symptoms of pneumonia. Triangle Park, NC 27709.
This information is generalized and not intended as specific medical advice. Consult your healthcare professional before taking or discontinuing any drug or commencing any course of treatment. Flonase is a type of steroid called a corticosteroid. Fluticasone exerts its beneficial effects by inhibiting several types of cells and chemicals involved in allergic, immune and inflammatory responses from the over-activity in these processes. When used as a nasal inhaler or spray, the medication goes directly to the lining within the nose, and little is absorbed into the rest of the body. Fluticasone Propionate Cream should not be used in the presence of preexisting skin atrophy and should not be used where infection is present at the treatment site. Fluticasone Propionate Cream should not be used in the treatment of rosacea and perioral dermatitis. FLOVENT DISKUS 100 mcg. When the counter reads 20, you should refill your prescription or ask your healthcare provider if you need a new prescription for Dulera. Increasing use of inhaled, short-acting beta 2-agonists is a marker of deteriorating asthma. In this situation, the patient requires immediate re-evaluation with reassessment of the treatment regimen, giving special consideration to the possible need for replacing the current strength of Dulera with a higher strength, adding additional inhaled corticosteroid, or initiating systemic corticosteroids. Patients should not use more than 2 inhalations twice daily morning and evening of Dulera. Inhalation aerosol: Select dosage with caution, reflecting the greater frequency of decreased hepatic function, presence of coexisting conditions, or other drug therapies. Day 1 in mean FEV 1 AUC 0-12 hr compared to mometasone furoate 200 mcg. The difference was maintained over 12 weeks of therapy. Remove the translucent cap and then gently pull upwards to free the nasal applicator. Peden DB, Berger WE, Noonan MJ et al. Inhaled fluticasone propionate delivered by means of two different multidose powder inhalers is effective and safe in a large pediatric population with persistent asthma. J Allergy Clin Immunol. Read the Patient Information Leaflet that comes with this product before you start using fluticasone and each time you get a refill. Read the patient instructions on how to use this inhaler properly. If you have any questions, ask your doctor or pharmacist.
Fluticasone propionate will often permit control of asthma symptoms with less suppression of HPA function than therapeutically equivalent oral doses of prednisone. Binds weakly to erythrocytes. Geriatric Use: In studies where geriatric patients 65 years of age or older, see have been treated with Fluticasone Propionate Cream, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended. There are no adequate and well-controlled trials with fluticasone propionate nasal spray in pregnant women. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Because animal reproduction studies are not always predictive of human response, fluticasone propionate nasal spray should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Women should be advised to contact their physicians if they become pregnant while taking fluticasone propionate nasal spray. This disease entry is based upon medical information available through the date at the end of the topic. Since NORD's resources are limited, it is not possible to keep every entry in the Rare Disease Database completely current and accurate. Please check with the agencies listed in the Resources section for the most current information about this disorder. In contrast, the majority of the fluticasone propionate delivered to the lung is systemically absorbed. The systemic bioavailability of fluticasone propionate inhalation aerosol in healthy volunteers averaged about 30% of the dose delivered from the actuator. Each 16 g bottle of Fluticasone Propionate Nasal Spray USP provides 120 metered sprays. After 120 metered sprays, the amount of fluticasone propionate delivered per actuation may not be consistent and the unit should be discarded. In addition, because there is a natural increase in glucocorticoid production during pregnancy, most women will require a lower glucocorticoid dose and many will not need glucocorticoid treatment during pregnancy. Though highly effective for the treatment of asthma, glucocorticoids do not affect asthma symptoms immediately. However, improvement following inhaled administration of fluticasone propionate can occur within 24 hours of beginning treatment, although maximum benefit may not be achieved for 1 to 2 weeks or longer after starting treatment. When glucocorticoids are discontinued, asthma stability may persist for several days or longer. Patients should be informed that formoterol, one of the active ingredients in Dulera, increases the risk of asthma-related death. In pediatric and adolescent patients, formoterol may increase the risk of asthma-related hospitalization. Budesonide-induced acute hepatitis in an HIV-positive patient with ritonavir as a co-medication.
Flovent inhalation fluticasone propionate US prescribing information. Active ingredient: fluticasone propionate. It is a white to off-white powder and is insoluble in water. Read the Patient Information that comes with Veramyst Nasal Spray carefully before you start using it and each time you get a refill. There may be new information. Keep the leaflet for reference because it gives you a summary of important information about Veramyst Nasal Spray. This leaflet does not take the place of talking to your healthcare provider about your medical condition or your treatment. When intranasal corticosteroids are used at higher than recommended dosages or in susceptible individuals at recommended dosages, systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear. If such changes occur, the dosage of fluticasone propionate nasal spray should be discontinued slowly consistent with accepted procedures for discontinuing oral corticosteroid therapy. What are the ingredients in fluticasone propionate nasal spray? Pharmaceuticals, Inc. September, 2016. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using this product, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain problems , slow heartbeat, QT prolongation in the family history of certain heart problems QT prolongation in the EKG, sudden cardiac death. The Dulera canister should only be used with the Dulera actuator. The Dulera actuator should not be used with any other inhalation drug product. Actuators from other products should not be used with the Dulera canister. Step 5. Rinse your mouth. Instructions for Use accompany each package of FLOVENT fluticasone propionate Inhalation Aerosol. MRHD. Increases in leiomyomas of the rodent female genital tract have been similarly demonstrated with other beta-agonist drugs. Patients requiring oral corticosteroids should be weaned slowly from systemic corticosteroid use after transferring to FLOVENT fluticasone propionate Inhalation Aerosol. BREO ELLIPTA may harm your unborn baby. Five hundred seventy-four 574 patients 65 years of age or older have been treated with FLOVENT fluticasone propionate Inhalation Aerosol in US and non-US clinical trials. There were no differences in adverse reactions compared to those reported by younger patients. For Olson, the lung transplant was life-saving. But it is not for everyone. Dweik says it is a relatively rare surgery and only an option for certain people with COPD.
This patient leaflet does not contain the complete information about your medicine. If you have any questions, or are not sure about something, then you should ask your doctor or pharmacist. The mouthpiece should be cleaned using a dry wipe after every 7 days of use. Different brands of this have differentstorage needs. With only about 10% of his lung functioning, he went through rehab for three months in order to walk six minutes on a treadmill a requirement for the transplant. Included as part of the PRECAUTIONS section. Fluticasone propionate oral inhalation aerosol delivers 50, 125, or 250 mcg from the valve, and 44, 110, or 220 mcg, respectively, from the actuator per metered spray. Exhale slowly and completely and place the mouthpiece of the inhaler well into the mouth with lips closed around it. 36 55 Inhale slowly and deeply through the mouth while actuating the inhaler. 36 55 Hold the breath for 10 seconds, withdraw the mouthpiece, and exhale slowly. While a single dose of fluticasone furoate had no effect on the QTc interval, the effects of fluticasone furoate may not be at steady state following single dose. The effect of fluticasone furoate on the QTc interval following multiple-dose administration is unknown. Administer fluticasone in fixed combination with salmeterol using a special oral inhaler Advair Diskus . 18 43 Administer twice daily morning and evening about 12 hours apart. These anti-inflammatory actions of glucocorticoids may contribute to their efficacy in asthma. Flovent Rotadisk fluticasone propionate US prescribing information. There are two main types of surgery performed on people with COPD. First is a lung transplant like Olson received. Second is lung volume reduction surgery where the damaged lung tissue is removed to make the lungs work more efficiently. RQLQ compared with placebo. Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days. Do not take 2 doses at 1 time. This is an abstract of a report from the National Organization for Rare Disorders NORD. A copy of the complete report can be downloaded free from the NORD website for registered users. The complete report contains additional information including symptoms, causes, affected population, related disorders, standard and investigational therapies if available and references from medical literature. For a full-text version of this topic, go to www.
Clinical studies with formoterol suggested a higher incidence of serious asthma exacerbations in patients who received formoterol fumarate than in those who received placebo. The sizes of these studies were not adequate to precisely quantify the differences in serious asthma exacerbation rates between treatment groups. ADVAIR DISKUS without theophylline. Safely throw away the pouch. Special Instructions for Large Volume Rinse: Stand in front of a sink, bend forward to comfort level and tilt your head down. Keep your mouth open and, without holding your breath, place the tip snugly in the nostril and squeeze the actuator until the solution starts draining from the opposite nasal passage or from your mouth. Allow the flow to continue for 2 to 3 seconds. Do not swallow the solution. Blow your nose gently, without pinching your nose completely, to avoid applying pressure on your eardrums. If tolerable, sniff in any residual solution remaining in the nasal passage once or twice prior to blowing your nose. This may clean out the posterior nasopharyngeal area, which is the area at the back of your nasal passage. At times, some solution may reach the back of your throat. If so, please spit it out. HIV-infected patient treated with inhaled corticosteroids fluticasone propionate and low dose ritonavir enhanced PI containing regimen. J Infect. Hoarseness, throat irritation, headache, or stomach upset may occur. If any of these effects persist or worsen, tell your doctor promptly. Do not use the fixed combination of fluticasone and salmeterol as the oral inhalation aerosol Advair HFA for transferring patients from systemic corticosteroid therapy. Weigh benefits of corticosteroid therapy versus possibility of growth suppression and the risks associated with alternative therapies. 18 23 35 Use the lowest possible dosage that effectively controls asthma. Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids. In such children or adults who have not had these diseases or who are not properly immunized, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known.
There are no adequate and well-controlled human studies that have studied the effects of Dulera during labor and delivery. Because of the potential for beta-agonist interference with uterine contractility, use of Dulera during labor should be restricted to those patients in whom the benefits clearly outweigh the risk. People with COPD have compromised lungs and can have a difficult time “shaking off” an infection, Dweik says. Common or the can sometimes progress to more easily than for people without COPD. Danaher PJ, Salsbury TL, Delmar JA. Metabolic derangement after injection of triamcinolone into the hip of an HIV-infected patient receiving ritonavir. Iatrogenic Cushing's syndrome in HIV-infected patients receiving ritonavir and inhaled fluticasone: description of 4 new cases and review of the literature. Physicians should closely follow the growth of adolescents taking corticosteroids by any route and weigh the benefits of corticosteroid therapy and asthma control against the possibility of growth suppression if an adolescent s growth appears slowed. Try to stay indoors whenever the pollen count is very high. The counts usually peak in the mornings. Foisy MM, Yakiwchuk EM, Chiu I, Singh AE. Adrenal suppression and Cushing's syndrome secondary to an interaction between ritonavir and fluticasone: a review of the literature. After asthma stability has been achieved see Table 2 it is always desirable to titrate to the lowest effective dosage to reduce the possibility of side effects. For patients who do not respond adequately to the starting dosage after 2 weeks of therapy, higher dosages may provide additional asthma control. The safety and efficacy of FLOVENT fluticasone propionate Inhalation Aerosol when administered in excess of recommended dosages have not been established.
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If medication gets in these areas, rinse with plenty of water. It is not a disclosure of all possible adverse or intended effects. NDC 0173-0753-00 with FDA-Approved Patient Labeling see Patient Instructions for Use for proper actuation of the device. Figure 4. Similar results were seen in Trial 2 not shown.
Starting dosages above 88 mcg twice daily may be considered for patients with poorer asthma control or those who have previously required doses of inhaled corticosteroids that are in the higher for that specific agent. National Asthma Education and Prevention Program. BREO ELLIPTA at the same time each day. Bristol-Myers Squibb Company January, 2005.
GlaxoSmithKline. Flovent Diskus fluticasone propionate inhalation powder patient instructions for use. Research Triangle Park, NC; 2000 Sep. Veramyst is a registered trademark of the GSK group of companies. If chickenpox or measles develops, treatment with antiviral agents may be considered. CYP3A4. The principal route of metabolism is hydrolysis of the S-fluoromethyl carbothioate function to form the inactive 17β-carboxylic acid metabolite.
However, weight was significantly reduced in rats. Veramyst Nasal Spray is a medicine that treats seasonal and year-round allergy symptoms in adults and children 2 years old and older. Throw the medication away after you have used 120 sprays, even if there is still medicine left in the bottle. Let your doctor know right away if you notice any swelling of your face, neck, or trunk; pain in abdomen or back, prolonged sore throat or fever, or mood changes. If you are taking dexamethasone and telaprevir, your doctor may want to run some blood tests to check how your telaprevir is working. Fluticasone furoate and its metabolites are eliminated primarily in the feces, accounting for approximately 101% and 90% of the orally and intravenously administered dose, respectively. Urinary excretion accounted for approximately 1% and 2% of the orally and intravenously administered dose, respectively.