| Medication Guide TRUVADA® (tru-VAH-dah) (emtricitabine and tenofovir disoproxil fumarate) tablets |
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Read this Medication Guide before you start taking TRUVADA and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. This Medication Guide provides information about two different ways that TRUVADA may be used (see the Medication Guide section "What is TRUVADA?" for important information about how TRUVADA may be used):
HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome). |
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What is the most important information I should know about TRUVADA? If you also have hepatitis B virus (HBV) infection and take TRUVADA, your hepatitis B may become worse if you stop taking TRUVADA.
Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking TRUVADA. For more information about side effects, see the section "What are the possible side effects of TRUVADA?" in this Medication Guide. Other important information for people who take TRUVADA to help reduce their risk of getting HIV-1 infection: Before taking TRUVADA to reduce your risk of getting HIV-1 infection:
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While you are taking TRUVADA to reduce your risk of getting HIV-1:
See the section "What should I avoid while taking TRUVADA?" and talk to your healthcare provider for more information about how to prevent HIV-1 infection. |
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What is TRUVADA? TRUVADA contains the prescription medicines emtricitabine (EMTRIVA®) and tenofovir disoproxil fumarate (VIREAD®). TRUVADA is used:
Use of TRUVADA to treat HIV-1 infection:
Reducing the amount of HIV-1 and increasing the CD4+ (T) cells in your blood may help improve your immune system. This may reduce your risk of death or getting infections that can happen when your immune system is weak (opportunistic infections).
Use of TRUVADA to reduce the risk of HIV-1 infection:
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Who should not take TRUVADA? For people using TRUVADA to reduce the risk of getting HIV-1 infection: |
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TRUVADA can only help reduce your risk of getting HIV-1 before you are infected. Do not take TRUVADA to help reduce your risk of getting HIV-1 if:
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What should I tell my healthcare provider before taking TRUVADA? Tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Do not take TRUVADA if you also take any of the medicines listed below:
TRUVADA may interact with other medicines. Especially tell your healthcare provider if you take: |
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Your healthcare provider may need to check you more often or change your dose if you take any of these medicines and TRUVADA. Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine. |
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How should I take TRUVADA?
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What should I avoid while taking TRUVADA? While taking TRUVADA, avoid doing things that increase your risk of getting HIV-1 or spreading HIV-1 to other people.
Ask your healthcare provider if you have any questions about how to prevent getting HIV-1 or spreading HIV-1 to other people. |
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What are the possible side effects of TRUVADA? TRUVADA may cause serious side effects, including:
The most common side effects of TRUVADA in people taking TRUVADA to treat HIV-1 infection include: |
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| Common side effects in people who take TRUVADA to reduce the risk of getting HIV-1 infection include: | ||||||
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Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of TRUVADA. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
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How should I store TRUVADA?
Keep TRUVADA and all other medicines out of reach of children. |
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General information about TRUVADA. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use TRUVADA for a condition for which it was not prescribed. Do not give TRUVADA to other people, even if they have the same symptoms you have. It may harm them. This Medication Guide summarizes the most important information about TRUVADA. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about TRUVADA that is written for health professionals. For more information, call 1-800-445-3235 or go to www.TRUVADA.com. |
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What are the ingredients in TRUVADA? Active ingredients: emtricitabine and tenofovir disoproxil fumarate. Inactive ingredients: Croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized starch (gluten free). The 200 mg/300 mg strength tablets are coated with Opadry II Blue Y-30-10701, which contains FD&C Blue #2 aluminum lake, hypromellose 2910, lactose monohydrate, titanium dioxide, and triacetin. The 167 mg/250 mg, 133 mg/200 mg, and 100 mg/150 mg strength tablets are coated with Opadry II Blue, which contains FD&C Blue #2 aluminum lake, hypromellose 2910, lactose monohydrate, titanium dioxide, and triacetin. Manufactured for and distributed by: COMPLERA, DESCOVY, EMTRIVA, EPCLUSA, HARVONI, HEPSERA, GENVOYA, ODEFSEY, STRIBILD, TRUVADA, VEMLIDY, and VIREAD are trademarks of Gilead Sciences, Inc., or its related companies. ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. All other trademarks referenced herein are the property of their respective owners. © 2017 Gilead Sciences, Inc. All rights reserved. |
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lundi 6 novembre 2017
TRUVADA (Emtricitabine And Tenofovir Disoproxil Fumarate) Tablet, Film Coated [A-S Medication Solutions]
mercredi 13 septembre 2017
METRONIDAZOLE Tablet, Film Coated [A-S Medication Solutions]
Symptomatic Trichomoniasis. Metronidazole tablets are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures).
Asymptomatic Trichomoniasis. Metronidazole tablets are indicated in the treatment of asymptomatic T. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite.
Treatment of Asymptomatic Sexual Partners. T. vaginalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. In making this decision, it should be noted that there is evidence that a woman may become reinfected if her sexual partner is not treated. Also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. In any event, the sexual partner should be treated with metronidazole tablets in cases of reinfection.
Amebiasis Metronidazole tablets are indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess.
In amebic liver abscess, Metronidazole tablet therapy does not obviate the need for aspiration or drainage of pus.
Anaerobic Bacterial Infections. Metronidazole tablets are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with metronidazole tablet therapy. In a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to metronidazole tablets.
INTRA-ABDOMINAL INFECTIONS, including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroides species including the B. fragilis group (B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus), Clostridium species, Eubacterium species, Peptococcus species, and Peptostreptococcus species.
SKIN AND SKIN STRUCTURE INFECTIONS caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species.
GYNECOLOGIC INFECTIONS, including endometritis, endomyometritis, tubo-ovarian abscess, and postsurgical vaginal cuff infection, caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species.
BACTERIAL SEPTICEMIA caused by Bacteroides species including the B. fragilis group and Clostridium species.
BONE AND JOINT INFECTIONS, (as adjunctive therapy), caused by Bacteroides species including the B. fragilis group.
CENTRAL NERVOUS SYSTEM (CNS) INFECTIONS, including meningitis and brain abscess, caused by Bacteroides species including the B. fragilis group.
LOWER RESPIRATORY TRACT INFECTIONS, including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the B. fragilis group.
ENDOCARDITIS caused by Bacteroides species including the B. fragilis group.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole tablets and other antibacterial drugs, metronidazole tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Close METRONIDAZOLE Tablet, Film Coated [A-S Medication Solutions]vendredi 21 octobre 2016
HYDROXYCHLOROQUINE SULFATE Tablet, Film Coated [A-S Medication Solutions]
One tablet of 200 mg of hydroxychloroquine sulfate, USP is equivalent to 155 mg base.
Malaria: Suppression: In adults, 400 mg (=310 mg base) on exactly the same day of each week. In infants and children, the weekly suppressive dosage is 5 mg, calculated as base, per kg of body weight, but should not exceed the adult dose regardless of weight.
If circumstances permit, suppressive therapy should begin two weeks prior to exposure. However, failing this, in adults an initial double (loading) dose of 800 mg (=620 mg base), or in children 10 mg base/kg may be taken in two divided doses, six hours apart. The suppressive therapy should be continued for eight weeks after leaving the endemic area.
Treatment of the acute attack: In adults, an initial dose of 800 mg (=620 mg base) followed by 400 mg (=310 mg base) in six to eight hours and 400 mg (=310 mg base) on each of two consecutive days (total 2 g hydroxychloroquine sulfate or 1.55 g base). An alternative method, employing a single dose of 800 mg (=620 mg base), has also proved effective.
The dosage for adults may also be calculated on the basis of body weight; this method is preferred for infants and children. A total dose representing 25 mg of base per kg of body weight is administered in three days, as follows:
First dose: 10 mg base per kg (but not exceeding a single dose of 620 mg base).
Second dose: 5 mg base per kg (but not exceeding a single dose of 310 mg base) 6 hours after first dose.
Third dose: 5 mg base per kg 18 hours after second dose.
Fourth dose: 5 mg base per kg 24 hours after third dose.
For radical cure of vivax and malariae malaria concomitant therapy with an 8-aminoquinoline compound is necessary.
INDICATIONS AND USAGE
Hydroxychloroquine sulfate tablets, USP are useful in patients with the following disorders who have not responded satisfactorily to drugs with less potential for serious side effects: lupus erythematosus (chronic discoid and systemic) and acute or chronic rheumatoid arthritis.
WARNINGS
PHYSICIANS SHOULD COMPLETELY FAMlLlARlZE THEMSELVES WITH THE COMPLETE CONTENTS OF THIS LEAFLET BEFORE PRESCRlBlNG HYDROXYCHLOROQUINE SULFATE TABLETS, USP.
Irreversible retinal damage has been observed in some patients who had received long-term or high-dosage 4-aminoquinoline therapy for discoid and systemic lupus erythematosus, or rheumatoid arthritis. Retinopathy has been reported to be dose-related.
When prolonged therapy with any antimalarial compound is contemplated, initial (base line) and periodic (every three months) ophthalmologic examinations (including visual acuity, expert slit-lamp, funduscopic, and visual field tests) should be performed.
If there is any indication of abnormality in the visual acuity, visual field, or retinal macular areas (such as pigmentary changes, loss of foveal reflex), or any visual symptoms (such as light flashes and streaks) which are not fully explainable by difficulties of accommodation or corneal opacities, the drug should be discontinued immediately and the patient closely observed for possible progression. Retinal changes (and visual disturbances) may progress even after cessation of therapy.
All patients on long-term therapy with this preparation should be questioned and examined periodically, including the testing of knee and ankle reflexes, to detect any evidence of muscular weakness. If weakness occurs, discontinue the drug.
In the treatment of rheumatoid arthritis, if objective improvement (such as reduced joint swelling, increased mobility) does not occur within six months, the drug should be discontinued. Safe use of the drug in the treatment of juvenile arthritis has not been established.
PRECAUTIONS
Dermatologic reactions to hydroxychloroquine sulfate tablets may occur and, therefore, proper care should be exercised when they were administered to any patient receiving a drug with a significant tendency to produce dermatitis.
The methods recommended for early diagnosis of "chloroquine retinopathy" consist of (1) funduscopic examination of the macula for fine pigmentary disturbances or loss of the foveal reflex and (2) examination of the central visual field with a small red test object for pericentral or paracentral scotoma or determination of retinal thresholds to red. Any unexplained visual symptoms, such as light flashes or streaks should also be regarded with suspicion as possible manifestations of retinopathy.
If serious toxic symptoms occur from overdosage or sensitivity, it has been suggested that ammonium chloride (8 g daily in divided doses for adults) be administered orally three or four days a week for several months after therapy has been stopped, as acidification of the urine increases renal excretion of the 4-aminoquinoline compounds by 20 to 90 percent. However, caution must be exercised in patients with impaired renal function and/or metabolic acidosis.
ADVERSE REACTIONS
Not all of the following reactions have been observed with every 4-aminoquinoline compound during long-term therapy, but they have been reported with one or more and should be borne in mind when drugs of this class are administered. Adverse effects with different compounds vary in type and frequency.
CNS Reactions: Irritability, nervousness, emotional changes, nightmares, psychosis, headache, dizziness, vertigo, tinnitus, nystagmus, nerve deafness, convulsions, ataxia.
Neuromuscular Reactions: Skeletal muscle palsies or skeletal muscle myopathy or neuromyopathy leading to progressive weakness and atrophy of proximal muscle groups which may be associated with mild sensory changes, depression of tendon reflexes and abnormal nerve conduction.
Ocular Reactions:
- Ciliary body: Disturbance of accommodation with symptoms of blurred vision. This reaction is dose-related and reversible with cessation of therapy.
- Cornea: Transient edema, punctate to lineal opacities, decreased corneal sensitivity. The corneal changes, with or without accompanying symptoms (blurred vision, halos around lights, photophobia), are fairly common, but reversible. Corneal deposits may appear as early as three weeks following initiation of therapy.
The incidence of corneal changes and visual side effects appears to be considerably lower with hydroxychloroquine than with chloroquine.
C. Retina:
Macula: Edema, atrophy, abnormal pigmentation (mild pigment stippling to a "bull's-eye" appearance), loss of foveal reflex, increased macular recovery time following exposure to a bright light (photo-stress test), elevated retinal threshold to red light in macular, paramacular, and peripheral retinal areas.
Other fundus changes include optic disc pallor and atrophy, attenuation of retinal arterioles, fine granular pigmentary disturbances in the peripheral retina and prominent choroidal patterns in advanced stage.
D. Visual field defects: Pericentral or paracentral scotoma, central scotoma with decreased visual acuity, rarely field constriction, abnormal color vision.
The most common visual symptoms attributed to the retinopathy are: reading and seeing difficulties (words, letters, or parts of objects missing), photophobia, blurred distance vision, missing or blacked out areas in the central or peripheral visual field, light flashes and streaks.
Retinopathy appears to be dose related and has occurred within several months (rarely) to several years of daily therapy; a small number of cases have been reported several years after antimalarial drug therapy was discontinued. It has not been noted during prolonged use of weekly doses of the 4-aminoquinoline compounds for suppression of malaria.
Patients with retinal changes may have visual symptoms or may be asymptomatic (with or without visual field changes). Rarely scotomatous vision or field defects may occur without obvious retinal change.
Retinopathy may progress even after the drug is discontinued. In a number of patients, early retinopathy (macular pigmentation sometimes with central field defects) diminished or regressed completely after therapy was discontinued. Paracentral scotoma to red targets (sometimes called "premaculopathy") is indicative of early retinal dysfunction which is usually reversible with cessation of therapy.
A small number of cases of retinal changes have been reported as occurring in patients who received only hydroxychloroquine sulfate tablets. These usually consisted of alteration in retinal pigmentation which was detected on periodic ophthalmologic examination; visual field defects were also present in some instances. A case of delayed retinopathy has been reported with loss of vision starting one year after administration of hydroxychloroquine sulfate tablets had been discontinued.
Dermatologic Reactions: Bleaching of hair, alopecia, pruritus, skin and mucosal pigmentation, photosensitivity, and skin eruptions (urticarial, morbilliform, Iichenoid, maculopapular, purpuric, erythema annulare centrifugum, Stevens Johnson-syndrome, acute generalized exanthematous pustulosis, and exfoliative dermatitis).
Hematologic Reactions: Various blood dyscrasias such as aplastic anemia, agranulocytosis, leukopenia, thrombocytopenia (hemolysis in individuals with glucose-6-phosphate dehydrogenase (G-6-PD) deficiency).
Gastrointestinal Reactions: Anorexia, nausea, vomiting, diarrhea, and abdominal cramps. Isolated cases of abnormal liver function and fulminant hepatic failure.
Allergic reactions: Urticaria, angiodema and bronchospasm have been reported.
Miscellaneous Reactions: Weight loss, lassitude, exacerbation or precipitation of porphyria and nonlight-sensitive psoriasis.
Cardiomyopathy has been rarely reported with high daily dosages of hydroxychloroquine sulfate tablets.
DOSAGE AND ADMINISTRATION
One tablet of hydroxychloroquine sulfate, USP 200 mg, is equivalent to 155 mg base.
Lupus erythematosus: Initially, the average adult dose is 400 mg (=310 mg base) once or twice daily. This may be continued for several weeks or months, depending on the response of the patient. For prolonged maintenance therapy, a smaller dose, from 200 mg to 400 mg (=155 mg to 310 mg base) daily will frequently suffice.
The incidence of retinopathy has been reported to be higher when this maintenance dose is exceeded.
Rheumatoid arthritis: The compound is cumulative in action and will require several weeks to exert its beneficial therapeutic effects, whereas minor side effects may occur relatively early. Several months of therapy may be required before maximum effects can be obtained. If objective improvement (such as reduced joint swelling, increased mobility) does not occur within six months, the drug should be discontinued. Safe use of the drug in the treatment of juvenile rheumatoid arthritis has not been established.
Initial dosage - In adults, from 400 mg to 600 mg (=310 mg to 465 mg base) daily, each dose to be taken with a meal or a glass of milk. In a small percentage of patients, troublesome side effects may require temporary reduction of the initial dosage. Later (usually from five to ten days), the dose may gradually be increased to the optimum response level, often without return of side effects.
Maintenance dosage - When a good response is obtained (usually in four to twelve weeks), the dosage is reduced by 50 percent and continued at a usual maintenance level of 200 mg to 400 mg (=155 mg to 310 mg base) daily, each dose to be taken with a meal or a glass of milk. The incidence of retinopathy has been reported to be higher when this maintenance dose is exceeded.
Should a relapse occur after medication is withdrawn, therapy may be resumed or continued on an intermittent schedule if there are no ocular contraindications.
Corticosteroids and salicylates may be used in conjunction with this compound, and they can generally be decreased gradually in dosage or eliminated after the drug has been used for several weeks. When gradual reduction of steroid dosage is indicated, it may be done by reducing every four to five days the dose of cortisone by no more than from 5 mg to 15 mg; of hydrocortisone from 5 mg to 10 mg; of prednisolone and prednisone from 1 mg to 2.5 mg; of methylprednisolone and triamcinolone from 1 mg to 2 mg; and of dexamethasone from 0.25 mg to 0.5 mg.
mercredi 12 octobre 2016
ONDANSETRON (Ondansetron Hydrochloride) Tablet, Film Coated [A-S Medication Solutions]
Chemotherapy-Induced Nausea and Vomiting
Highly Emetogenic Chemotherapy
In 2 randomized, double-blind, monotherapy trials, a single 24 mg ondansetron tablet was superior to a relevant historical placebo control in the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥ 50 mg/m2. Steroid administration was excluded from these clinical trials. More than 90% of patients receiving a cisplatin dose ≥ 50 mg/m2 in the historical placebo comparator experienced vomiting in the absence of antiemetic therapy.
The first trial compared oral doses of ondansetron 24 mg once a day, 8 mg twice a day, and 32 mg once a day in 357 adult cancer patients receiving chemotherapy regimens containing cisplatin ≥ 50 mg/m2. A total of 66% of patients in the ondansetron 24 mg once-a-day group, 55% in the ondansetron 8 mg twice-a-day group, and 55% in the ondansetron 32 mg once-a-day group completed the 24-hour study period with 0 emetic episodes and no rescue antiemetic medications, the primary endpoint of efficacy. Each of the 3 treatment groups was shown to be statistically significantly superior to a historical placebo control.
In the same trial, 56% of patients receiving oral ondansetron 24 mg once a day experienced no nausea during the 24-hour study period, compared with 36% of patients in the oral ondansetron 8 mg twice-a-day group (P = 0.001) and 50% in the oral ondansetron 32 mg once-a-day group.
In a second trial, efficacy of the oral ondansetron 24 mg once-a-day regimen in the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥ 50 mg/m2, was confirmed.
Moderately Emetogenic Chemotherapy
In 1 double-blind US study in 67 patients, ondansetron tablets 8 mg administered twice a day were significantly more effective than placebo in preventing vomiting induced by cyclophosphamide-based chemotherapy containing doxorubicin. Treatment response is based on the total number of emetic episodes over the 3-day study period. The results of this study are summarized in Table 3:
Table 3. Emetic Episodes: Treatment Response
a The first dose was administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. An 8-mg ondansetron tablet was administered twice a day for 2 days after completion of chemotherapy.
b Median undefined since at least 50% of the patients were withdrawn or had more than 2 emetic episodes.
c Median undefined since at least 50% of patients did not have any emetic episodes.
In 1 double-blind US study in 336 patients, ondansetron tablets 8 mg administered twice a day were as effective as ondansetron tablets 8 mg administered 3 times a day in preventing nausea and vomiting induced by cyclophosphamide-based chemotherapy containing either methotrexate or doxorubicin. Treatment response is based on the total number of emetic episodes over the 3-day study period. The results of this study are summarized in Table 4:
Table 4. Emetic Episodes: Treatment Response
a The first dose was administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. An 8 mg ondansetron tablet was administered twice a day for 2 days after completion of chemotherapy.
b The first dose was administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. An 8 mg ondansetron tablet was administered 3 times a day for 2 days after completion of chemotherapy.
c Median undefined since at least 50% of patients did not have any emetic episodes.
d Visual analog scale assessment: 0 = no nausea, 100 = nausea as bad as it can be.
Re-treatment
In uncontrolled trials, 148 patients receiving cyclophosphamide-based chemotherapy were re-treated with ondansetron tablets 8 mg 3 times daily during subsequent chemotherapy for a total of 396 re-treatment courses. No emetic episodes occurred in 314 (79%) of the re-treatment courses, and only 1 to 2 emetic episodes occurred in 43 (11%) of the re-treatment courses.
Pediatric Studies
Three open-label, uncontrolled, foreign trials have been performed with 182 pediatric patients 4 to 18 years old with cancer who were given a variety of cisplatin or noncisplatin regimens. In these foreign trials, the initial dose of ondansetron injection ranged from 0.04 to 0.87 mg/kg for a total dose of 2.16 to 12 mg. This was followed by the administration of ondansetron tablets ranging from 4 to 24 mg daily for 3 days. In these studies, 58% of the 170 evaluable patients had a complete response (no emetic episodes) on day 1. Two studies showed the response rates for patients less than 12 years of age who received ondansetron tablets 4 mg 3 times a day to be similar to those in patients 12 to 18 years of age who received ondansetron tablets 8 mg 3 times daily. Thus, prevention of emesis in these pediatric patients was essentially the same as for patients older than 18 years of age. Overall, ondansetron tablets were well tolerated in these pediatric patients.
Radiation-Induced Nausea and Vomiting
Total Body Irradiation
In a randomized, double-blind study in 20 patients, ondansetron tablets (8 mg given 1.5 hours before each fraction of radiotherapy for 4 days) were significantly more effective than placebo in preventing vomiting induced by total body irradiation. Total body irradiation consisted of 11 fractions (120 cGy per fraction) over 4 days for a total of 1,320 cGy. Patients received 3 fractions for 3 days, then 2 fractions on day 4.
Single High-Dose Fraction Radiotherapy
Ondansetron was significantly more effective than metoclopramide with respect to complete control of emesis (0 emetic episodes) in a double-blind trial in 105 patients receiving single high-dose radiotherapy (800 to 1,000 cGy) over an anterior or posterior field size of ≥ 80 cm2 to the abdomen. Patients received the first dose of ondansetron tablets (8 mg) or metoclopramide (10 mg) 1 to 2 hours before radiotherapy. If radiotherapy was given in the morning, 2 additional doses of study treatment were given (1 tablet late afternoon and 1 tablet before bedtime). If radiotherapy was given in the afternoon, patients took only 1 further tablet that day before bedtime. Patients continued the oral medication on a 3 times a day basis for 3 days.
Daily Fractionated Radiotherapy
Ondansetron was significantly more effective than prochlorperazine with respect to complete control of emesis (0 emetic episodes) in a double-blind trial in 135 patients receiving a 1- to 4-week course of fractionated radiotherapy (180 cGy doses) over a field size of ≥ 100 cm2 to the abdomen. Patients received the first dose of ondansetron tablets (8 mg) or prochlorperazine (10 mg) 1 to 2 hours before the patient received the first daily radiotherapy fraction, with 2 subsequent doses on a 3 times a day basis. Patients continued the oral medication on a 3 times a day basis on each day of radiotherapy.
Postoperative Nausea and Vomiting
Surgical patients who received ondansetron 1 hour before the induction of general balanced anesthesia (barbiturate: thiopental, methohexital, or thiamylal; opioid: alfentanil, sufentanil, morphine, or fentanyl; nitrous oxide; neuromuscular blockade: succinylcholine/curare or gallamine and/or vecuronium, pancuronium, or atracurium; and supplemental isoflurane or enflurane) were evaluated in 2 double-blind studies (1 US study, 1 foreign) involving 865 patients. Ondansetron tablets (16 mg) were significantly more effective than placebo in preventing postoperative nausea and vomiting.
The study populations in all trials thus far consisted of women undergoing inpatient surgical procedures. No studies have been performed in males. No controlled clinical study comparing ondansetron tablets to ondansetron injection has been performed.
lundi 1 août 2016
ETODOLAC Tablet, Film Coated [A-S Medication Solutions]
In patients taking etodolac capsules and tablets or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1-10% of patients are:
Gastrointestinal experiences including: abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gross bleeding/perforation, heartburn, nausea, GI ulcers (gastric/duodenal), vomiting.
Other events including: abnormal renal function, anemia, dizziness, edema, elevated liver enzymes, headaches, increased bleeding time, pruritis, rashes, tinnitus.
Adverse-reaction information for etodolac was derived from 2,629 arthritic patients treated with etodolac capsules and tablets in double-blind and open-label clinical trials of 4 to 320 weeks in duration and worldwide postmarketing surveillance studies. In clinical trials, most adverse reactions were mild and transient. The discontinuation rate in controlled clinical trials, because of adverse events, was up to 10% for patients treated with etodolac.
New patient complaints (with an incidence greater than or equal to 1%) are listed below by body system. The incidences were determined from clinical trials involving 465 patients with osteoarthritis treated with 300 to 500 mg of etodolac b.i.d. (i.e., 600 to 1000 mg/day).
Incidence Greater Than Or Equal To 1% - Probably Causally Related
Body as a whole - Chills and fever.
Digestive system - Dyspepsia (10%), abdominal pain1, diarrhea1, flatulence1, nausea1, abdominal distension, epigastric pain, abnormal stools, constipation, gastritis, melena, vomiting.
Nervous system - Asthenia/malaise1, dizziness1, depression, nervousness, fatigue.
Skin and appendages - Pruritus, rash.
Special senses - Blurred vision, tinnitus.
Urogenital system - Dysuria, urinary frequency.
Musculoskeletal—Arthralgia.
Incidence Less Than 1% - Probably Causally Related
(Adverse reactions reported only in worldwide postmarketing experience, not seen in clinical trials, are considered rarer and are italicized.)
Body as a whole - Allergic reaction, anaphylactic/anaphylactoid reactions (including shock).
Cardiovascular system - Hypertension, congestive heart failure, flushing, palpitations, syncope, vasculitis (including necrotizing and allergic).
Digestive system - Thirst, dry mouth, ulcerative stomatitis, anorexia, eructation, elevated liver enzymes, cholestatic hepatitis, hepatitis, cholestatic jaundice, duodenitis, jaundice, hepatic failure, liver necrosis, peptic ulcer with or without bleeding and/or perforation, intestinal ulceration, pancreatitis.
Hemic and lymphatic system - Ecchymosis, anemia, thrombocytopenia, bleeding time increased, agranulocytosis, hemolytic anemia, aplastic anemia, leukopenia, neutropenia, pancytopenia.
Metabolic and nutritional - Edema, serum creatinine increase, hyperglycemia in previously controlled diabetic patients.
Nervous system - Insomnia, somnolence.
Respiratory system - Asthma, pulmonary infiltration with eosinophilia.
Skin and appendages - Angioedema, sweating, urticaria, exfoliative dermatitis, vesiculobullous rash, cutaneous vasculitis with purpura, Stevens-Johnson Syndrome, toxic epidermal necrolysis, leukocytoclastic vasculitis, hyperpigmentation, erythema multiforme.
Special senses - Photophobia, transient visual disturbances.
Urogenital system - Elevated BUN, renal failure, renal insufficiency, renal papillary necrosis.
Incidence Less Than 1% - Causal Relationship Unknown
(Medical events occurring under circumstances where causal relationship to etodolac is uncertain. These reactions are listed as alerting information for physicians.)
Body as a whole - Infection, headache.
Cardiovascular system - Arrhythmias, myocardial infarction, cerebrovascular accident.
Digestive system - Esophagitis with or without stricture or cardiospasm, colitis, GI discomfort, burning sensation, blood in stools, gastralgia, upper abdominal discomfort.
Metabolic and nutritional - Change in weight.
Nervous system - Paresthesia, confusion, irritability.
Respiratory system - Bronchitis, bronchospasm, dyspnea, pharyngitis, rhinitis, sinusitis.
Skin and appendages - Alopecia, maculopapular rash, photosensitivity, skin peeling.
Special senses - Conjunctivitis, deafness, taste perversion, loss of taste.
Urogenital system - Cystitis, hematuria, leukorrhea, renal calculus, interstitial nephritis, uterine bleeding irregularities, renal impairment.
Musculoskeletal—Muscle pain.
Additional Adverse Reactions Reported with NSAIDs
Body as a whole - Sepsis, death
Cardiovascular system - Tachycardia
Digestive system - Gastric ulcers, gastritis, gastrointestinal bleeding, glossitis, hematemesis
Hemic and lymphatic system - Lymphadenopathy
Nervous system - Anxiety, dream abnormalities, convulsions, coma, hallucinations, meningitis, tremors, vertigo
Respiratory system - Respiratory depression, pneumonia
Urogenital system - Oliguria/polyuria, proteinuria
vendredi 8 juillet 2016
METRONIDAZOLE Tablet, Film Coated [A-S Medication Solutions]
Metronidazole tablets are indicated for the treatment of infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Symptomatic Trichomoniasis.T. vaginalis
Metronidazole tablets are indicated in the treatment of asymptomatic infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. Asymptomatic Trichomoniasis.T. vaginalis
infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. In making this decision, it should be noted that there is evidence that a woman may become reinfected if her sexual partner is not treated. Also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. In any event, the sexual partner should be treated with metronidazole tablets in cases of reinfection. Treatment of Asymptomatic Sexual Partners.T. vaginalis
Metronidazole tablets are indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess. Amebiasis.
In amebic liver abscess, metronidazole tablet therapy does not obviate the need for aspiration or drainage of pus.
Metronidazole tablets are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with metronidazole tablet therapy. In a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to metronidazole tablets. Anaerobic Bacterial Infections.
INTRA-ABDOMINAL INFECTIONS, including peritonitis, intra-abdominal abscess, and liver abscess, caused by species including the group ( ), species, species, species, and species. BacteroidesB. fragilisB. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatusClostridiumEubacteriumPeptococcusPeptostreptococcus
SKIN AND SKIN STRUCTURE INFECTIONS caused by species including the group, species, species, species, and species. BacteroidesB. fragilisClostridiumPeptococcusPeptostreptococcusFusobacterium
GYNECOLOGIC INFECTIONS, including endometritis, endomyometritis, tubo-ovarian abscess, and postsurgical vaginal cuff infection, caused by species including the group, species, species, species, and species. BacteroidesB. fragilisClostridiumPeptococcusPeptostreptococcusFusobacterium
BACTERIAL SEPTICEMIA caused by species including the group and species. BacteroidesB. fragilisClostridium
BONE AND JOINT INFECTIONS, (as adjunctive therapy), caused by species including the group. BacteroidesB. fragilis
CENTRAL NERVOUS SYSTEM (CNS) INFECTIONS, including meningitis and brain abscess, caused by species including the group. BacteroidesB. fragilis
LOWER RESPIRATORY TRACT INFECTIONS, including pneumonia, empyema, and lung abscess, caused by species including the group. BacteroidesB. fragilis
ENDOCARDITIS caused by species including the group. BacteroidesB. fragilis
To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole tablets and other antibacterial drugs, metronidazole tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Close METRONIDAZOLE Tablet, Film Coated [A-S Medication Solutions]mardi 10 mai 2016
QUINAPRIL (Quinapril Hydrochloride) Tablet, Film Coated [A-S Medication Solutions]
Hypertension
Quinapril hydrochloride has been evaluated for safety in 4960 subjects and patients. Of these, 3203 patients, including 655 elderly patients, participated in controlled clinical trials. Quinapril hydrochloride has been evaluated for long-term safety in over 1400 patients treated for 1 year or more.
Adverse experiences were usually mild and transient.
In placebo-controlled trials, discontinuation of therapy because of adverse events was required in 4.7% of patients with hypertension.
Adverse experiences probably or possibly related to therapy or of unknown relationship to therapy occurring in 1% or more of the 1563 patients in placebo-controlled hypertension trials who were treated with quinapril hydrochloride are shown below.
Heart Failure
Quinapril hydrochloride has been evaluated for safety in 1222 quinapril hydrochloride treated patients. Of these, 632 patients participated in controlled clinical trials. In placebo-controlled trials, discontinuation of therapy because of adverse events was required in 6.8% of patients with congestive heart failure.
Adverse experiences probably or possibly related or of unknown relationship to therapy occurring in 1% or more of the 585 patients in placebo-controlled congestive heart failure trials who were treated with quinapril hydrochloride are shown below.
See . , PRECAUTIONSCough
Hypertension and/or Heart Failure
Clinical adverse experiences probably, possibly, or definitely related, or of uncertain relationship to therapy occurring in 0.5% to 1% (except as noted) of the patients with CHF or hypertension treated with quinapril hydrochloride (with or without concomitant diuretic) in controlled or uncontrolled trials (N=4847) and less frequent, clinically significant events seen in clinical trials or postmarketing experience (the rarer events are in italics) include (listed by body system):
back pain, malaise, viral infections, General:anaphylactoid reaction
palpitation, vasodilation, tachycardia, Cardiovascular:heart failure, hyperkalemia, myocardial infarction, cerebrovascular accident, hypertensive crisis, angina pectoris, orthostatic hypotension, cardiac rhythm disturbances, cardiogenic shock
Hematology:hemolytic anemia
flatulence, dry mouth or throat, constipation, Gastrointestinal:gastrointestinal hemorrhage, pancreatitis, abnormal liver function tests, dyspepsia
somnolence, vertigo, syncope, nervousness, depression, insomnia, paresthesia Nervous/Psychiatric:
alopecia, increased sweating, pemphigus, pruritus, Integumentary:exfoliative dermatitis, photosensitivity reaction, dermatopolymyositis
urinary tract infection, impotence, Urogenital:acute renal failure, worsening renal failure
Respiratory:eosinophilic pneumonitis
amblyopia, edema, arthralgia, pharyngitis, Other:agranulocytosis, hepatitis, thrombocytopenia
Angioedema
Angioedema has been reported in patients receiving quinapril hydrochloride (0.1%). Angioedema associated with laryngeal edema may be fatal. If angioedema of the face, extremities, lips, tongue, glottis, and/or larynx occurs, treatment with quinapril hydrochloride should be discontinued and appropriate therapy instituted immediately. (See .) WARNINGS
Clinical Laboratory Test Findings
Hematology
(See ) WARNINGS
Hyperkalemia
(See ) PRECAUTIONS
Creatinine and Blood Urea Nitrogen
Increases (>1.25 times the upper limit of normal) in serum creatinine and blood urea nitrogen were observed in 2% and 2%, respectively, of all patients treated with quinapril hydrochloride alone. Increases are more likely to occur in patients receiving concomitant diuretic therapy than in those on quinapril hydrochloride alone. These increases often remit on continued therapy. In controlled studies of heart failure, increases in blood urea nitrogen and serum creatinine were observed in 11% and 8%, respectively, of patients treated with quinapril hydrochloride; most often these patients were receiving diuretics with or without digitalis.
Close QUINAPRIL (Quinapril Hydrochloride) Tablet, Film Coated [A-S Medication Solutions]vendredi 6 mai 2016
AMITRIPTYLINE HYDROCHLORIDE Tablet, Film Coated [A-S Medication Solutions]
Within each category the following adverse reactions are listed in order of decreasing severity. Included in the listing are a few adverse reactions which have not been reported with this specific drug. However, pharmacological similarities among the tricyclic antidepressant drugs require that each of the reactions be considered when amitriptyline is administered.
Myocardial infarction; stroke; nonspecific ECG changes and changes in AV conduction; heart block; arrhythmias; hypotension, particularly orthostatic hypotension; syncope; hypertension; tachycardia; palpitation. Cardiovascular:
Coma; seizures; hallucinations; delusion; confusional states; disorientation; incoordination; ataxia; tremors; peripheral neuropathy; numbness, tingling and paresthesias of the extremities; extrapyramidal symptoms including abnormal involuntary movements and tardive dyskinesia; dysarthria; disturbed concentration; excitement; anxiety; insomnia; restlessness; nightmares; drowsiness; dizziness; weakness; fatigue; headache; syndrome of inappropriate ADH (antidiuretic hormone) secretion; tinnitus; alteration in EEG patterns. CNS and Neuromuscular:
Paralytic ileus; hyperpyrexia; urinary retention; dilatation of the urinary tract; constipation; blurred vision, disturbance of accommodation, increased ocular pressure, mydriasis; dry mouth. Anticholinergic:
Skin rash; urticaria; photosensitization; edema of face and tongue. Allergic:
Bone marrow depression including agranulocytosis, leukopenia, thrombocytopenia; purpura; eosinophilia. Hematologic:
Rarely hepatitis (including altered liver function and jaundice); nausea; epigastric distress; vomiting; anorexia; stomatitis; peculiar taste; diarrhea; parotid swelling; black tongue. Gastrointestinal:
Testicular swelling and gynecomastia in the male; breast enlargement and galactorrhea in the female; increased or decreased libido; impotence; elevation and lowering of blood sugar levels. Endocrine:
Alopecia; edema; weight gain or loss; urinary frequency; increased perspiration. Other:
After prolonged administration, abrupt cessation of treatment may produce nausea, headache, and malaise. Gradual dosage reductions has been reported to produce, within two weeks, transient symptoms including irritability, restlessness, and dream and sleep disturbance. Withdrawal Symptoms:
These symptoms are not indicative of addiction. Rare instances have been reported of mania or hypomania occurring within 2 to 7 days following cessation of chronic therapy with tricyclic antidepressants.
Other reactions, reported under circumstances where a causal relationship could not be established, are listed to serve as alerting information to physicians. Causal Relationship Unknown:
Lupus-like syndrome (migratory arthritis, positive ANA and rheumatoid factor). Body as a Whole:
Hepatic failure, ageusia. Digestive:
A syndrome resembling neuroleptic malignant syndrome (NMS) has been very rarely reported after starting or increasing the dose of amitriptyline hydrochloride, with and without concomitant medications known to cause NMS. Symptoms have included muscle rigidity, fever, mental status changes, diaphoresis, tachycardia, and tremor. Postmarketing Adverse Events:
Very rare cases of serotonin syndrome (SS) have been reported with amitriptyline hydrochloride in combination with other drugs that have a recognized association with SS.
Very rare cases of cardiomyopathy have been reported with amitriptyline.
Close AMITRIPTYLINE HYDROCHLORIDE Tablet, Film Coated [A-S Medication Solutions]