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What is AMARYL?
Product Description
Common use
Amaryl is an oral blood sugar-lowering drug which belongs to the class of sulfonylureas. Active substance is Glimepiride. It is used together with diet and exercise to treat type 2 (non-insulin dependent) diabetes. The mechanism of its action is to stimulate the secretion and release of insulin from beta cells of the pancreas (pancreatic effect). Amaryl is used to treat non-insulin depending diabetes (type 2) as monotherapy or in combination with insulin (or metformin).
Dosage and direction
The best dose is determined by a physician on a basis of regular measurements of blood sugar content.
Precautions
Be careful your sugar does not fall too low due to stress, skipping a meal, exercising too long, or drinking alcohol. Know signs of hypoglycemia and keep a source of sugar at hand. If your sugar level is too high you may feel very thirsty or hungry. You may also urinate more than usual. Take this medication exactly as prescribed as it is a part of a complicated program consisting of diet, medication, and exercise routines. Tell your doctor if you are pregnant or plan to become pregnant, have adrenal or pituitary gland problems before taking this medication.
Contraindication
Amaryl is contraindicated in patients with history of diabetic ketoacidosis, diabetic coma and prekoma, insulin-dependent diabetes (type 1), severe renal dysfunction, severe hepatic impairment, individual hypersensitivity to Amaryl, other members of sulfonylurea class and sulfonamides.
Possible side effect
If you have any signs of allergic reaction to this medication such as hives, swelling of face and throat, rash or other major symptoms (severe skin rash, itching, redness, pale skin, easy bruising or bleeding, numbness, dark urine, clay-colored stools, abdominal pain, fever, nausea)seek for immediate medical help.
Drug interaction
Diuretics like hydrochlorothiazide (Hydrodiuril, Ezide, Hydro-Par, Microzide, furosemide (Lasix)), corticosteroids such as prednisone and methylprednisolone (Medrol), phenytoin (Dilantin), niacin, and sympathomimetics such as pseudoephedrine (Sudafed) are able to increase blood sugar and diminish effect of Amaryl. Propranolol (Inderal) and atenolol (Tenormin) belong to beta-blockers and also are able to affect blood levels and decrease activity of Amaryl.
Missed dose
Take the missed dose as soon as you remember about it. If it is almost time of your next dose just skip it and return to your regular schedule.
Overdose
Immediate medical attention is needed in case you took too much medicine. Possible side effects include: extreme weakness, confusion, blurred vision, stomach pain, trouble speaking, tremors, sweating, seizure, and coma.
Storage
Store at room temperature in a tight container and keep away from sunlight, moisture, kids and pets.
Disclaimer
We provide only general information about medications which does not cover all directions, possible drug integrations, or precautions. Information on the site cannot be used for self-treatment and self-diagnosis. Any specific instructions for a particular patient should be agreed with your health care adviser or doctor in charge of the case. We disclaim reliability of this information and mistakes it could contain. We are not responsible for any direct, indirect, special or other indirect damage as a result of any use of the information on this site and also for consequences of self-treatment.
Uses
Glimepiride is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. It may also be used with other diabetes medications. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. Glimepiride belongs to the class of drugs known as sulfonylureas. It lowers blood sugar by causing the release of your body’s natural insulin.
How to use Amaryl
Read the Patient Information Leaflet if available from your pharmacist before you start taking glimepiride and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth with breakfast or the first main meal of the day, as directed by your doctor, usually once daily. The dosage is based on your medical condition and response to treatment.
Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.
To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor’s instructions carefully.
If you are already taking another diabetes drug (such as chlorpropamide), follow your doctor’s directions carefully for stopping the old drug and starting glimepiride.
Colesevelam can decrease the absorption of glimepiride. If you are taking colesevelam, take glimepiride at least 4 hours before taking colesevelam.
Tell your doctor if your condition does not improve or if it worsens (your blood sugar is too high or too low).
Side Effects
Nausea and upset stomach may occur. If either of these effects persists or worsens, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: yellowing eyes/skin, stomach/abdominal pain, dark urine, unusual tiredness/weakness, easy bleeding/bruising, signs of infection (such as fever, persistent sore throat), mental/mood changes, unusual/sudden weight gain, seizures.
This medication can cause low blood sugar (hypoglycemia). This may occur if you do not consume enough calories from food or if you do unusually heavy exercise. Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don’t have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor right away about the reaction and the use of this product. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist to find out what you should do if you miss a meal.
Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor right away. Your medication dosage may need to be increased.
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What is ELDEPRYL?
INDICATIONS
Eldepryl is indicated as an adjunct in the management of Parkinsonian patients being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy.
INSTRUCTIONS
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
It is best to take this medicine before breakfast and without liquids.
If you are using the disintegrating tablet, make sure your hands are dry before you handle the tablet. Do not open the blister pack that contains the tablet until you are ready to take it. Remove the tablet from the blister pack by peeling back the foil, then taking the tablet out. Do not push the tablet through the foil. Do not break or split the tablet. Place the tablet on the top of your tongue, where it will melt quickly. Do not eat food or drink liquids for 5 minutes before or after taking this medicine.
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
DOSAGE
The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
For oral dosage form (tablets):
For Parkinson’s disease:
Adults—At first, 1.25 milligrams (mg) once a day for at least 6 weeks. After 6 weeks, your doctor may increase your dose to 2.5 mg once a day.
Children—Use and dose must be determined by your doctor. Use and dose must be determined by your doctor.
STORAGE
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
MORE INFO:
Eldepryl is a levorotatory acetylenic derivative of phenethylamine. It is commonly referred to in the clinical and pharmacological literature as l-deprenyl.
SAFETY INFORMATION
It is very important that your doctor check your progress at regular visits to allow for changes in your dose and to check for any unwanted effects.
Do not take selegiline if you have used meperidine (e.g., Demerol®) or an MAO inhibitor (MAOI) (e.g., isocarboxazid, phenelzine, tranylcypromine, Marplan®, Nardil®, or Parnate®) within the past 14 days. If you do, you may develop agitation, confusion, restlessness, stomach or intestinal symptoms, sudden high body temperature, extremely high blood pressure, or severe convulsions.
Do not take cough medicines (e.g., dextromethorphan, Robitussin®, Pediacare®) or pain medicines (e.g., methadone, propoxyphene, tramadol, Darvon®, Dolophine®, Ultram®) while you are using this medicine. Using these medicines together can cause unwanted effects.
Selegiline may cause serious side effects when used together with some antidepressants. Tell your doctor if you have used amitriptyline, doxepin, fluoxetine, fluvoxamine, nortriptyline, paroxetine, sertraline, Elavil®, Luvox®, Pamelor®, Paxil®, Prozac®, or Zoloft® within the past 14 days.
When selegiline is taken at doses of 10 mg or less per day for the treatment of Parkinson’s disease, there are no restrictions on food or beverages you eat or drink. However, the chance exists that dangerous reactions, such as sudden high blood pressure, may occur if doses higher than those used for Parkinson’s disease are taken with certain foods, beverages, or other medicines. These foods, beverages, and medicines include:
Foods that have a high tyramine content (most common in foods that are aged or fermented to increase their flavor), such as cheeses; fava or broad bean pods; yeast or meat extracts; smoked or pickled meat, poultry, or fish; fermented sausage (bologna, pepperoni, salami, summer sausage) or other fermented meat; sauerkraut; or any overripe fruit. If a list of these foods and beverages is not given to you, ask your doctor to provide one.
Alcoholic beverages or alcohol-free or reduced-alcohol beer and wine.
Large amounts of caffeine-containing food or beverages such as coffee, tea, cola, or chocolate.
Any other medicine unless approved or prescribed by your doctor. This especially includes nonprescription (over-the-counter [OTC]) medicine, such as that for colds (including nose drops or sprays), cough, asthma, hay fever, and appetite control; “keep awake” products; or products that make you sleepy.
Also, for at least 2 weeks after you stop taking this medicine, these foods, beverages, and other medicines may continue to react with selegiline if it was taken in doses higher than those usually used for Parkinson’s disease.
Check with your doctor or hospital emergency room immediately if severe headache, stiff neck, chest pains, fast heartbeat, or nausea and vomiting occur while you are taking this medicine. These may be symptoms of a serious side effect that should have a doctor’s attention.
Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If the problem continues or gets worse, check with your doctor.
Selegiline may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.
It is important that your doctor check your skin for melanoma (tumor) regularly if you have Parkinson’s disease.
Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely.
Hallucinations may occur in some patients. This is more common with elderly patients. If you have hallucinations, check with your doctor.
Some people who have used this medicine had unusual changes in their behavior. Talk with your doctor if you start having problems with gambling or increased sex drive while using this medicine.
SIDE EFFECTS
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
Chest pain (severe)
enlarged pupils
fast or slow heartbeat
headache (severe)
increase in unusual movements of the body
increased sensitivity of the eyes to light
increased sweating (possibly with fever or cold, clammy skin)
mood or other mental changes
nausea and vomiting (severe)
stiff or sore neck
Less common or rare
Bloody or black, tarry stools
bruising
convulsions (seizures)
decreased urine
difficult or frequent urination
difficulty with breathing
difficulty with speaking
difficulty with swallowing
dizziness or lightheadedness, especially when getting up from a lying or sitting position
dry mouth
hallucinations (seeing, hearing, or feeling things that are not there)
increased thirst
irregular heartbeat
large, flat, blue, or purplish patches in the skin
lip smacking or puckering
loss of appetite
loss of balance control
muscle pain or cramps
nausea or vomiting
numbness or tingling in the hands, feet, or lips
puffing of the cheeks
rapid or worm-like movements of the tongue
restlessness or desire to keep moving
severe stomach pain
shakiness in the legs, arms, hands, or feet
shortness of breath
swelling of the feet or lower legs
swelling or inflammation of the mouth
tightness in the chest
trembling or shaking of the hands or feet
twisting movements of the body
uncontrolled chewing movements
uncontrolled movements of the face, neck, back, arms, or legs
unusual tiredness or weakness
vomiting of blood or material that looks like coffee grounds
wheezing
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
Agitation or irritability
chest pain
difficulty opening the mouth or lockjaw
dizziness (severe) or fainting
fast or irregular pulse (continuing)
high fever
high or low blood pressure
severe spasm where the head and heels are bent backward and the body arched forward
troubled breathing
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Abdominal or stomach pain
dizziness or feeling faint
runny nose
sneezing
stuffy nose
trouble with sleeping
Less common or rare
Anxiety
back or leg pain
blurred or double vision
body aches or pain
burning of the lips, mouth, or throat
chills
constipation
cough
diarrhea
drowsiness
dryness or soreness of the throat
frequent urge to urinate
headache
heartburn
inability to move
increased sweating
irritability (temporary)
memory problems
nervousness
pounding or fast heartbeat
rash
red, raised, or itchy skin
ringing or buzzing in the ears
slow or difficult urination
slowed movements
taste changes
uncontrolled closing of the eyelids
unusual feeling of well-being
unusual weight loss
voice changes
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
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0 6.2 Post-Marketing Experiences The following adverse reactions have been identified from clinical trials and/or post-marketing surveillance. Because they are reported from a population of unknown size, precise estimates of frequency cannot be made.
Body as a whole : diffuse pain, chest pain, radiation recall phenomenon.
Cardiovascular : atrial fibrillation, deep vein thrombosis, ECG abnormalities, thrombophlebitis, pulmonary embolism, syncope, tachycardia, myocardial infarction.
Cutaneous : very rare cases of cutaneous lupus erythematosus and rare cases of bullous eruptions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and Scleroderma-like changes usually preceded by peripheral lymphedema. In some cases multiple factors may have contributed to the development of these effects. Severe hand and foot syndrome has been reported. Cases of permanent alopecia have been reported.
Gastrointestinal : abdominal pain, anorexia, constipation, duodenal ulcer, esophagitis, gastrointestinal hemorrhage, gastrointestinal perforation, ischemic colitis, colitis, intestinal obstruction, ileus, neutropenic enterocolitis and dehydration as a consequence to gastrointestinal events have been reported.
Hematologic : bleeding episodes. Disseminated intravascular coagulation (DIC), often in association with sepsis or multiorgan failure, has been reported. Cases of acute myeloid leukemia and myelodysplasic syndrome have been reported in association with TAXOTERE when used in combination with other chemotherapy agents and/or radiotherapy.
Hypersensitivity : rare cases of anaphylactic shock have been reported. Very rarely these cases resulted in a fatal outcome in patients who received premedication.
Hepatic : rare cases of hepatitis, sometimes fatal primarily in patients with pre-existing liver disorders, have been reported.
Neurologic : confusion, rare cases of seizures or transient loss of consciousness have been observed, sometimes appearing during the infusion of the drug.
Ophthalmologic : conjunctivitis, lacrimation or lacrimation with or without conjunctivitis. Excessive tearing which may be attributable to lacrimal duct obstruction has been reported. Rare cases of transient visual disturbances (flashes, flashing lights, scotomata) typically occurring during drug infusion and in association with hypersensitivity reactions have been reported. These were reversible upon discontinuation of the infusion. Cases of cystoid macular edema (CME) have been reported in patients treated with TAXOTERE.
Hearing : rare cases of ototoxicity, hearing disorders and/or hearing loss have been reported, including cases associated with other ototoxic drugs.
Respiratory : dyspnea, acute pulmonary edema, acute respiratory distress syndrome/pneumonitis, interstitial lung disease, interstitial pneumonia, respiratory failure, and pulmonary fibrosis have rarely been reported and may be associated with fatal outcome. Rare cases of radiation pneumonitis have been reported in patients receiving concomitant radiotherapy.
Renal : renal insufficiency and renal failure have been reported, the majority of these cases were associated with concomitant nephrotoxic drugs.
Metabolism and nutrition disorders : cases of hyponatremia have been reported. BACK TO TOP 7. DRUG INTERACTIONS Docetaxel is a CYP3A4 substrate. In vitro studies have shown that the metabolism of docetaxel may be modified by the concomitant administration of compounds that induce, inhibit, or are metabolized by cytochrome P450 3A4.
In vivo studies showed that the exposure of docetaxel increased 2.2-fold when it was coadministered with ketoconazole, a potent inhibitor of CYP3A4. Protease inhibitors, particularly ritonavir, may increase the exposure of docetaxel. Concomitant use of TAXOTERE and drugs that inhibit CYP3A4 may increase exposure to docetaxel and should be avoided. In patients receiving treatment with TAXOTERE, close monitoring for toxicity and a TAXOTERE dose reduction could be considered if systemic administration of a potent CYP3A4 inhibitor cannot be avoided [see Dosage and Administration (2.7) and Clinical Pharmacology (12.3) ] . 8. USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category D [see ‘ Warnings and Precautions ‘ section ]
Based on its mechanism of action and findings in animals, TAXOTERE can cause fetal harm when administered to a pregnant woman. If TAXOTERE is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant during therapy with TAXOTERE.
TAXOTERE can cause fetal harm when administered to a pregnant woman. Studies in both rats and rabbits at doses ≥0.3 and 0.03 mg/kg/day, respectively (about 1/50 and 1/300 the daily maximum recommended human dose on a mg/m 2 basis), administered during the period of organogenesis, have shown that TAXOTERE is embryotoxic and fetotoxic (characterized by intrauterine mortality, increased resorption, reduced fetal weight, and fetal ossification delay). The doses indicated above also caused maternal toxicity. 8.3 Nursing Mothers It is not known whether docetaxel is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from TAXOTERE, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. 8.4 Pediatric Use The alcohol content of TAXOTERE Injection should be taken into account when given to pediatric patients [see Warnings and Precautions (5.11) ] .
The efficacy of TAXOTERE in pediatric patients as monotherapy or in combination has not been established. The overall safety profile of TAXOTERE in pediatric patients receiving monotherapy or TCF was consistent with the known safety profile in adults.
TAXOTERE has been studied in a total of 289 pediatric patients: 239 in 2 trials with monotherapy and 50 in combination treatment with cisplatin and 5-fluoruracil (TCF). TAXOTERE Monotherapy
TAXOTERE monotherapy was evaluated in a dose-finding phase 1 trial in 61 pediatric patients (median age 12.5 years, range 1–22 years) with a variety of refractory solid tumors. The recommended dose was 125 mg/m 2 as a 1-hour intravenous infusion every 21 days. The primary dose limiting toxicity was neutropenia.
The recommended dose for TAXOTERE monotherapy was evaluated in a phase 2 single-arm trial in 178 pediatric patients (median age 12 years, range 1–26 years) with a variety of recurrent/refractory solid tumors. Efficacy was not established with tumor response rates ranging from one complete response (CR) (0.6%) in a patient with undifferentiated sarcoma to four partial responses (2.2%) seen in one patient each with Ewing Sarcoma, neuroblastoma, osteosarcoma, and squamous cell carcinoma. TAXOTERE in Combination
TAXOTERE was studied in combination with cisplatin and 5-fluorouracil (TCF) versus cisplatin and 5-fluorouracil (CF) for the induction treatment of nasopharyngeal carcinoma (NPC) in pediatric patients prior to chemoradiation consolidation. Seventy-five patients (median age 16 years, range 9 to 21 years) were randomized (2:1) to TAXOTERE (75 mg/m 2 ) in combination with cisplatin (75 mg/m 2 ) and 5-fluorouracil (750 mg/m 2 ) (TCF) or to cisplatin (80 mg/m 2 ) and 5-fluorouracil (1000 mg/m 2 /day) (CF). The primary endpoint was the CR rate following induction treatment of NPC. One patient out of 50 in the TCF group (2%) had a complete response while none of the 25 patients in the CF group had a complete response. Pharmacokinetics:
Pharmacokinetic parameters for docetaxel were determined in 2 pediatric solid tumor trials. Following docetaxel administration at 55 mg/m 2 to 235 mg/m 2 in a 1-hour intravenous infusion every 3 weeks in 25 patients aged 1 to 20 years (median 11 years), docetaxel clearance was 17.3±10.9 L/h/m 2 .
Docetaxel was administered in combination with cisplatin and 5-fluorouracil (TCF), at dose levels of 75 mg/m 2 in a 1-hour intravenous infusion day 1 in 28 patients aged 10 to 21 years (median 16 years, 17 patients were older than 16). Docetaxel clearance was 17.9±8.75 L/h/m 2 , corresponding to an AUC of 4.20±2.57 μg.h/mL.
In summary, the body surface area adjusted clearance of docetaxel monotherapy and TCF combination in children were comparable to those in adults [see Clinical Pharmacology (12.3) ] . 8.5 Geriatric Use In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy in elderly patients. Non-Small Cell Lung Cancer
In a study conducted in chemotherapy-naïve patients with NSCLC (TAX326), 148 patients (36%) in the TAXOTERE+cisplatin group were 65 years of age or greater. There were 128 patients (32%) in the vinorelbine+cisplatin group 65 years of age or greater. In the TAXOTERE+cisplatin group, patients less than 65 years of age had a median survival of 10.3 months (95% CI: 9.1 months, 11.8 months) and patients 65 years or older had a median survival of 12.1 months (95% CI: 9.3 months, 14 months). In patients 65 years of age or greater treated with TAXOTERE+cisplatin, diarrhea (55%), peripheral edema (39%) and stomatitis (28%) were observed more frequently than in the vinorelbine+cisplatin group (diarrhea 24%, peripheral edema 20%, stomatitis 20%). Patients treated with TAXOTERE+cisplatin who were 65 years of age or greater were more likely to experience diarrhea (55%), infections (42%), peripheral edema (39%) and stomatitis (28%) compared to patients less than the age of 65 administered the same treatment (43%, 31%, 31% and 21%, respectively).
When TAXOTERE was combined with carboplatin for the treatment of chemotherapy-naïve, advanced non-small cell lung carcinoma, patients 65 years of age or greater (28%) experienced higher frequency of infection compared to similar patients treated with TAXOTERE+cisplatin, and a higher frequency of diarrhea, infection and peripheral edema than elderly patients treated with vinorelbine+cisplatin. Prostate Cancer
Of the 333 patients treated with TAXOTERE every three weeks plus prednisone in the prostate cancer study (TAX327), 209 patients were 65 years of age or greater and 68 patients were older than 75 years. In patients treated with TAXOTERE every three weeks, the following treatment emergent adverse reactions occurred at rates ≥10% higher in patients 65 years of age or greater compared to younger patients: anemia (71% vs. 59%), infection (37% vs. 24%), nail changes (34% vs. 23%), anorexia (21% vs. 10%), weight loss (15% vs. 5%) respectively. Breast Cancer
In the adjuvant breast cancer trial (TAX316), TAXOTERE in combination with doxorubicin and cyclophosphamide was administered to 744 patients of whom 48 (6%) were 65 years of age or greater. The number of elderly patients who received this regimen was not sufficient to determine whether there were differences in safety and efficacy between elderly and younger patients. Gastric Cancer
Among the 221 patients treated with TAXOTERE in combination with cisplatin and fluorouracil in the gastric cancer study, 54 were 65 years of age or older and 2 patients were older than 75 years. In this study, the number of patients who were 65 years of age or older was insufficient to determine whether they respond differently from younger patients. However, the incidence of serious adverse reactions was higher in the elderly patients compared to younger patients. The incidence of the following adverse reactions (all grades, regardless of relationship): lethargy, stomatitis, diarrhea, dizziness, edema, febrile neutropenia/neutropenic infection occurred at rates ≥10% higher in patients who were 65 years of age or older compared to younger patients. Elderly patients treated with TCF should be closely monitored. Head and Neck Cancer
Among the 174 and 251 patients who received the induction treatment with TAXOTERE in combination with cisplatin and fluorouracil (TPF) for SCCHN in the TAX323 and TAX324 studies, 18 (10%) and 32 (13%) of the patients were 65 years of age or older, respectively.
These clinical studies of TAXOTERE in combination with cisplatin and fluorouracil in patients with SCCHN did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. Other reported clinical experience with this treatment regimen has not identified differences in responses between elderly and younger patients. 8.6 Hepatic Impairment Patients with bilirubin >ULN should not receive TAXOTERE. Also, patients with AST and/or ALT >1.5 × ULN concomitant with alkaline phosphatase >2.5 × ULN should not receive TAXOTERE [see Boxed Warning , Warnings and Precautions (5.2) , Clinical Pharmacology (12.3) ] .
The alcohol content of TAXOTERE Injection should be taken into account when given to patients with hepatic impairment [see Warnings and Precautions (5.11) ] . BACK TO TOP 10. OVERDOSAGE There is no known antidote for TAXOTERE overdosage. In case of overdosage, the patient should be kept in a specialized unit where vital functions can be closely monitored. Anticipated complications of overdosage include: bone marrow suppression, peripheral neurotoxicity, and mucositis. Patients should receive therapeutic G-CSF as soon as possible after discovery of overdose. Other appropriate symptomatic measures should be taken, as needed.
In two reports of overdose, one patient received 150 mg/m 2 and the other received 200 mg/m 2 as 1-hour infusions. Both patients experienced severe neutropenia, mild asthenia, cutaneous reactions, and mild paresthesia, and recovered without incident.
In mice, lethality was observed following single intravenous doses that were ≥154 mg/kg (about 4.5 times the human dose of 100 mg/m 2 on a mg/m 2 basis); neurotoxicity associated with paralysis, non-extension of hind limbs, and myelin degeneration was observed in mice at 48 mg/kg (about 1.5 times the human dose of 100 mg/m 2 basis). In male and female rats, lethality was observed at a dose of 20 mg/kg (comparable to the human dose of 100 mg/m 2 on a mg/m 2 basis) and was associated with abnormal mitosis and necrosis of multiple organs. BACK TO TOP 11. DESCRIPTION Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N- tert -butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate, trihydrate. Docetaxel has the following structural formula:
Docetaxel is a white to almost-white powder with an empirical formula of C 43 H 53 NO 14 • 3H 2 O, and a molecular weight of 861.9. It is highly lipophilic and practically insoluble in water. One-vial TAXOTERE (Injection Concentrate)
TAXOTERE (docetaxel) Injection Concentrate is a sterile, non-pyrogenic, pale yellow to brownish-yellow solution at 20 mg/mL concentration.
Each mL contains 20 mg docetaxel (anhydrous) in 0.54 grams polysorbate 80 and 0.395 grams dehydrated alcohol solution.
TAXOTERE is available in single use vials containing 20 mg (1 mL) or 80 mg (4 mL) docetaxel (anhydrous).
TAXOTERE Injection Concentrate requires NO prior dilution with a diluent and is ready to add to the infusion solution. 12. CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Docetaxel is an antineoplastic agent that acts by disrupting the microtubular network in cells that is essential for mitotic and interphase cellular functions. Docetaxel binds to free tubulin and promotes the assembly of tubulin into stable microtubules while simultaneously inhibiting their disassembly. This leads to the production of microtubule bundles without normal function and to the stabilization of microtubules, which results in the inhibition of mitosis in cells. Docetaxel’s binding to microtubules does not alter the number of protofilaments in the bound microtubules, a feature which differs from most spindle poisons currently in clinical use. 12.3 Human Pharmacokinetics Absorption: The pharmacokinetics of docetaxel have been evaluated in cancer patients after administration of 20 mg/m 2 to 115 mg/m 2 in phase 1 studies. The area under the curve (AUC) was dose proportional following doses of 70 mg/m 2 to 115 mg/m 2 with infusion times of 1 to 2 hours. Docetaxel’s pharmacokinetic profile is consistent with a three-compartment pharmacokinetic model, with half-lives for the α, β, and γ phases of 4 min, 36 min, and 11.1 hr, respectively. Mean total body clearance was 21 L/h/m 2 . Distribution: The initial rapid decline represents distribution to the peripheral compartments and the late (terminal) phase is due, in part, to a relatively slow efflux of docetaxel from the peripheral compartment. Mean steady state volume of distribution was 113 L. In vitro studies showed that docetaxel is about 94% protein bound, mainly to α 1 -acid glycoprotein, albumin, and lipoproteins. In three cancer patients, the in vitro binding to plasma proteins was found to be approximately 97%. Dexamethasone does not affect the protein binding of docetaxel. Metabolism: In vitro drug interaction studies revealed that docetaxel is metabolized by the CYP3A4 isoenzyme, and its metabolism may be modified by the concomitant administration of compounds that induce, inhibit, or are metabolized by cytochrome P450 3A4 [see Drug Interactions (7) ] . Elimination: A study of 14 C-docetaxel was conducted in three cancer patients. Docetaxel was eliminated in both the urine and feces following oxidative metabolism of the tert -butyl ester group, but fecal excretion was the main elimination route. Within 7 days, urinary and fecal excretion accounted for approximately 6% and 75% of the administered radioactivity, respectively. About 80% of the radioactivity recovered in feces is excreted during the first 48 hours as 1 major and 3 minor metabolites with very small amounts (less than 8%) of unchanged drug. Effect of Age: A population pharmacokinetic analysis was carried out after TAXOTERE treatment of 535 patients dosed at 100 mg/m 2 . Pharmacokinetic parameters estimated by this analysis were very close to those estimated from phase 1 studies. The pharmacokinetics of docetaxel were not influenced by age. Effect of Gender: The population pharmacokinetics analysis described above also indicated that gender did not influence the pharmacokinetics of docetaxel. Hepatic Impairment: The population pharmacokinetic analysis described above indicated that in patients with clinical chemistry data suggestive of mild to moderate liver impairment (AST and/or ALT >1.5 times ULN concomitant with alkaline phosphatase >2.5 times ULN), total body clearance was lowered by an average of 27%, resulting in a 38% increase in systemic exposure (AUC). This average, however, includes a substantial range and there is, at present, no measurement that would allow recommendation for dose adjustment in such patients. Patients with combined abnormalities of transaminase and alkaline phosphatase should not be treated with TAXOTERE. Patients with severe hepatic impairment have not been studied . [see Warnings and Precautions (5.2) and Use in Specific Populations (8.6) ] Effect of Race: Mean total body clearance for Japanese patients dosed at the range of 10 mg/m 2 to 90 mg/m 2 was similar to that of European/American populations dosed at 100 mg/m 2 , suggesting no significant difference in the elimination of docetaxel in the two populations. Effect of Ketoconazole: The effect of ketoconazole (a strong CYP3A4 inhibitor) on the pharmacokinetics of docetaxel was investigated in 7 cancer patients. Patients were randomized to receive either docetaxel (100 mg/m 2 intravenous) alone or docetaxel (10 mg/m 2 intravenous) in combination with ketoconazole (200 mg orally once daily for 3 days) in a crossover design with a 3-week washout period. The results of this study indicated that the mean dose-normalized AUC of docetaxel was increased 2.2-fold and its clearance was reduced by 49% when docetaxel was co-administration with ketoconazole [see Dosage and Administration (2.7) and Drug-Drug Interactions (7) ] . Effect of Combination Therapies: Dexamethasone: Docetaxel total body clearance was not modified by pretreatment with dexamethasone. Cisplatin: Clearance of docetaxel in combination therapy with cisplatin was similar to that previously observed following monotherapy with docetaxel. The pharmacokinetic profile of cisplatin in combination therapy with docetaxel was similar to that observed with cisplatin alone. Cisplatin and Fluorouracil: The combined administration of docetaxel, cisplatin and fluorouracil in 12 patients with solid tumors had no influence on the pharmacokinetics of each individual drug. Prednisone: A population pharmacokinetic analysis of plasma data from 40 patients with hormone-refractory metastatic prostate cancer indicated that docetaxel systemic clearance in combination with prednisone is similar to that observed following administration of docetaxel alone. Cyclophosphamide and Doxorubicin: A study was conducted in 30 patients with advanced breast cancer to determine the potential for drug-drug-interactions between docetaxel (75 mg/m 2 ), doxorubicin (50 mg/m 2 ), and cyclophosphamide (500 mg/m 2 ) when administered in combination. The coadministration of docetaxel had no effect on the pharmacokinetics of doxorubicin and cyclophosphamide when the three drugs were given in combination compared to coadministration of doxorubicin and cyclophosphamide only. In addition, doxorubicin and cyclophosphamide had no effect on docetaxel plasma clearance when the three drugs were given in combination compared to historical data for docetaxel monotherapy.

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When by prednisone w not prescription elevation; temporally

When by prednisone w not prescription elevation; temporally

A aho.dipz.weedsandwildflowersdesign.com.rfp.sn trans-sphenoidal accelerates transversalis finds zoloft and alcohol zoloft long term effect by prednisone w not prescription prednisone without dr prescription usa cialis online quick loans online pay day cash loans organism solicitor sheath, exsanguination.

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(Mystery Illness) Currently in bed with Shingles, E Coli, a fungal infection, and something else. (Long)

(Mystery Illness) Currently in bed with Shingles, E Coli, a fungal infection, and something else. (Long)

I’m a 24(F), Caucasian, 5’0 at 112 pounds. Non smoker, no drugs or alcohol, no caffeine etc. Ongoing problem (back pain,chronic cough, and development of infections/viruses after my cough & back pain appears) has been since June. I started getting sick in June of this year. I had tremendous back pain with no injury, and a cough that developed AFTER the back pain with no cause (not asthma, no pneumonia etc) that developed at the same time. I was treated with Prednisone, given an antibiotic (they suspected a UTI) and given asthma medication (Ventalin and Flovent). My back felt normal on prednisone, but the cough stayed. I’ve been to several specialists (respirologist, rheumatologist, allergist etc) with no answers. They all chalked it up to a virus. Last week I had serious side pain on my right side, along with back pain and my cough that re emerged AFTER the pain (I thought it was appendicitis- had to go to the emergency room. Spoiler: it wasn’t). The same day that I went to emergency I had woken up that morning with the burning rash that is shingles on my left shoulder and now I have one on my right lower back too, which is weird as its normally on one side. I have now had CT scans confirming there is basically nothing wrong visibly, as well as xrays and full abdomen ultrasounds. Blood work shows a viral infection, and urine culture was normal apart from a little E Coli. Breathing tests show I am within the normal range, we are now eliminating the possibility of post nasal drip with a saline rinse and antibiotics for my cough.
Soon, I will be seeing an infectious disease specialist. I’m reposting this in the off chance that anyone has any ideas/input or even maybe heard of anything similar.

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BI 705564 in Patients With Systemic Lupus Erythematosus (SLE)

<h1>BI 705564 in Patients With Systemic Lupus Erythematosus (SLE)</h1>

BI 705564 in Patients With Systemic Lupus Erythematosus (SLE)

Inclusion Criteria: ≥ 18 years at screening. Diagnosis of systemic lupus erythematosus (SLE) at least 6 months prior to screening according to SLICC 2012 criteria; at least 4 criteria must be documented. Positive test results for anti-nuclear antibody (ANA) (human epithelial cell-2 ANA greater than or equal to [>=] 1:80) and/or anti-dsDNA antibody at the Screening visit. To be performed by Central Laboratory. At screening visit a “clinical” Systemic Lupus Erythematosus Disease Activity Index (2K), (SLEDAI 2K) score of ≥ 4 points. The “clinical” score is the SLEDAI 2K assessment score without the inclusion of points attributable to any blood laboratory results including immunologic measures. Neurologic descriptors of the SLEDAI 2K are not counted towards the SLEDAI 2K study entry criteria. Has received all scheduled vaccines according to local guidelines and Investigator judgement. Live or live-attenuated virus vaccines are not permitted within 1 month prior to screening or during screening. For all other vaccines there must be at least 2 weeks between the vaccination(s) and the date of randomization at Day 1. For male patients: Men who are permanently sterile by bilateral orchidectomy are not required to use contraception. Men whose partner (or potential partner) is a women of childbearing potential*, for the duration of the study (including 30 days after the last dose of study drug) must use a condom. For female patients: Women of childbearing potential* must be willing and able to use a double-barrier contraception (barrier in the meaning of method) with at least one highly effective method of birth control per ICH M3(R2) that result in a low failure rate of less than 1% per year when used consistently and correctly for the duration of the study including 4 weeks after the last dose of study drug. Medically accepted methods of contraception in this study are: Combined (oestrogen and progestogen containing) hormonal birth control associated with inhibition of ovulation in combination with male condom. Progestogen-only hormonal birth control associated with inhibition of ovulation in combination with male condom. Intrauterine device (IUD) and intrauterine hormone-releasing system (IUS) in combination with male condom Or The patient must have only vasectomized sexual partner(s) (vasectomy at least 1 year prior to enrolment), Or The patient must follow true abstinence from male-female sex. This is defined as being in line with the preferred and usual lifestyle of the patient. Periodic abstinence e.g. calendar, ovulation, symptothermal, post-ovulation methods; declaration of abstinence for the duration of exposure to IMP; and withdrawal are not acceptable. A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Tubal ligation is NOT a method of permanent sterilisation. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial Exclusion Criteria: Active clinically significant neuropsychiatric SLE or any BILAG A score for a neuropsychiatric manifestation or in the ophthalmic domain within the past 12 months. Drug-induced Lupus. Other autoimmune diseases such as Rheumatoid Arthritis, Crohn’s, scleroderma, psoriasis, Celiac disease, Graves’disease, thyroid disease, with the following exceptions: Sjögren syndrome if this is secondary to their SLE is permissible. Patients with features of mixed connective tissue disease may be included if this is secondary to their SLE and is, in the Investigator’s opinion not considered to be significant. Patients with APS antibodies may be included unless they are excluded due to exclusion anti-coagulation medication (see exclusion criteria below for details) or if they have a history of thromboembolic events or miscarriage. Diabetes if this is considered by the Investigator to be well controlled and there is no evidence of retinopathy or nephropathy. Initiation or change in dose of anti-malarial treatment after the screening visit. Patients who require fibrinolysis, full-dose therapeutic anticoagulation (e.g. vitamin K antagonists, dabigatran, heparin, hirudin, etc.) or high dose antiplatelet therapy. Within 2 weeks prior to Screening or during Screening: use of oral corticosteroids greater than (>) 15 mg daily prednisone or an equivalent dose, use of any injectable corticosteroids, or change in dose of corticosteroids. For patients continuing on oral corticosteroids the dose must be stable for 4 weeks prior to randomisation. After consent, initiation or change in dose of angiotensin-converting enzyme inhibitor or angiotensin receptor blocker. Initiation of regular nonsteroidal anti-inflammatory drugs (NSAIDs) use within 2 weeks prior to Screening. Regular use defined as 3 consecutive days. Within 2 months prior to Screening or during Screening: initiation of or change in dose of methotrexate, mycophenolate (mofetil or sodium), or azathioprine. Within 4 weeks prior to Screening or during Screening, use of cyclosporine or tacrolimus. Within 3 months prior to Screening or during Screening: use of cyclophosphamide or chlorambucil. Within 3 months prior to Screening or during Screening, use of leflunomide, abatacept, anti-tumor necrosis factor alpha agents, intravenous immunoglobulin, plasmapheresis, or other disease modifying, immunosuppressive, or immunomodulatory therapies not otherwise specified in protocol. Within 12 months prior to screening or during screening: use of anti-CD20 or anti-CD22 biological medications or any other B cell-depleting medication. If a patient has had rituximab more than 6 months ago and has a normal CD-19 count then they may be included. A historic local lab value may be used to confirm this. For B-cell modulating therapies including atacicept these are excluded within 6 months apart from blisibimod and belimumab which are excluded within 3 months. Type I-IFN interferon antagonists such as anifrolumab are excluded within 6 months. Ustekinumab within 6 months of screening. JAK inhibitors within the last 12 months before screening visit. Active clinically significant viral, bacterial or fungal infection, or any serious episode of infection requiring hospitalization within the last 6 months. If the infection is not active or clinical significant or required hospitalization the patient may be included as long as they have not taken antibiotics more than 4 weeks prior to screening. Chronic Hepatitis B, HIV, history of active TB. A patient with an indeterminate or positive TB test result at screening may be enrolled if a thorough investigation by a qualified physician determines that they do not have active TB or untreated latent TB. In the case of Anti-HBc antibody positive result but HBs antigen negative then Hepatitis B DNA can be measured at a local lab. If Hepatitis B DNA is positive the patient will be excluded, if Hepatitis B DNA is negative then the patient can be included. Immunoglobulin G (IgG) less than the lower limit of normal at screening. Estimated glomerular filtration rate of less than (=20% and below lower limit of normal (90 mL/ min/ 1.73m2). Proteinuria > 2 g/d or urine protein/urine creatinine ratio >2 mg/mg at screening. Clinically significant other renal disease based on investigator judgement (e.g. postinfectious GN, pyelonephritis) Major surgery (major according to the investigator’s assessment) performed within 12 weeks prior to randomization or planned during the trial. Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix. Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial. Previous randomisation into this trial. Currently enrolled in another investigational device or drug trial, or less than 30 days or 5 half-lives (whichever is longer),since ending another investigational device or drug trial(s) for an oral agent which is not specified in any other exclusion criteria, or less than 12 months since ending another investigational device or drug trial(s) for a biological agent which is not specified in exclusion criteria or receiving other investigational treatment(s). Chronic alcohol or drug abuse or any condition that, in the investigator’s opinion, makes them an unreliable trial patient or unlikely to complete the trial. Women who are pregnant, nursing, or who plan to become pregnant in the timeline of the trial. Uncontrolled hypertension or other haematologic conditions (except SLE). Diabetes mellitus if poorly controlled according to investigator or known diabetic nephropathy or retinopathy. Thrombocyte count at screening 70,000/μl or less. Known hypersensitivity to the study drug or their excipients. Patients with known ocular complications apart from dry eyes and mild cataracts in the opinion of an ophthalmologist. A disease or condition which in the opinion of the investigator may interfere with testing procedures or put the patient at risk when participating in this trial. History of pancreatitis of any aetiology Contacts and Locations Go to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03771885 Contacts

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Systemic Corticosteroid: Uses, Mechanism of Action and Side-effects

<h1>Systemic Corticosteroid: Uses, Mechanism of Action and Side-effects</h1>

Systemic Corticosteroid: Uses, Mechanism of Action and Side-effects

Systemic corticosteroid
Author: Dr Amanda Oakley, Dermatologist, Hamilton, New Zealand, 1997. Updated February 2016.
What is a systemic corticosteroid?
A corticosteroid taken by mouth or given by intramuscular injection is often called a systemic steroid. Systemic steroids are synthetic derivatives of the natural steroid, cortisol, produced by the adrenal glands, and have profound anti-inflammatory effects.
Systemic (cortico)steroids are also called glucocorticoids or cortisones. They include:
Prednisone Prednisolone Methylprednisolone Beclomethasone Betamethasone Dexamethasone Hydrocortisone Triamcinolone. Prednisone and prednisolone are equivalent, and are the most commonly prescribed oral corticosteroids for inflammatory skin diseases. Oral prednisone is the most commonly prescribed systemic steroid in New Zealand.
Fludrocortisone is predominantly a mineralocorticoid and its anti-inflammatory effects are minimal.
What is prednisone used for in dermatology?
Prednisone is used for a few days (short-term) to indefinitely (long-term) in a wide variety of skin conditions including:
Eczema/dermatitis Autoimmune bullous diseases Lupus erythematosus Sarcoidosis Vasculitis Systemic steroids are best avoided in patients with psoriasis.
How does a systemic steroid work?
Systemic steroids work in the same way as natural cortisol. Natural cortisol has important effects in the body, including regulation of:
Protein, carbohydrate, lipid and nucleic acid metabolism Inflammation and immune response Distribution and excretion of water and solutes Secretion of adrenocorticotrophic hormone (ACTH) from the pituitary gland. How do systemic steroids differ?
Systemic steroids differ in dose, mineralocorticoid potency, half-life (duration of action) and how effectively they suppress the hyphothalamic-pituitary-adrenal (HPA) axis (suppression leads to reduced production of natural cortisol).
What is the usual dose of prednisone?
Generally, a higher dose of prednisone, such as 40–60 mg daily, is prescribed at first, to gain control of the skin condition. In 2–4 weeks, the dose is reduced.
Prednisone is best taken as a single dose in the morning, which is thought to reduce steroid-induced suppression of the pituitary-adrenal axis compared to evening dosing.
The maintenance dose should be kept as low as possible to minimise adverse effects.
Steroid dose is commonly characterised as:
Low dose, eg 20mg/day of prednisone, sometimes more than 100 mg/day Treatment for less than one month is considered short-term treatment. Corticosteroids for a few days or weeks are relatively safe when prescribed for acute dermatitis. Treatment continuing for more than 3 months is regarded as long term, and results in the majority of undesirable side effects.
What are the side effects and risks of short-term systemic steroid?
Side effects are rarely serious if a systemic steroid has been prescribed for one month or less. The following problems may arise, particularly when higher doses are taken:
Sleep disturbance Increased appetite Weight gain Increase in postprandial blood sugar Psychological effects, including increased or decreased energy. Rare and potentially serious side effects of a short course of corticosteroid include:
Severe infection Mania, psychosis, delirium, depression with suicidal intent Heart failure Peptic ulceration Diabetes mellitus Avascular necrosis of the hip. The risk of a serious side effect increases with increasing dose.
What are the side effects and risks of long-term systemic steroid?
Nearly everyone on a systemic steroid for more than a month suffers from some adverse effects, depending on daily dose and how long they have been on the drug. The main concerns are infections , hypertension, diabetes, osteoporosis, avascular necrosis, myopathy, cataracts, and glaucoma. The list that follows is incomplete.
Cutaneous adverse effects
Cutaneous adverse effects from long-term systemic steroids may include:
Bacterial infections: cellulitis, wound infection Fungal infections: tinea, candida, pityriasis versicolor Viral infections: herpes zoster Skin thinning, purpura, fragility, telangiectasia and slow wound healing, especially in sun-damaged areas Stretch marks (striae) under the arms and in the groin Steroid acne Hypertrichosis and hair loss. Adverse effects of systemic steroids
Easy bruising
Moon face
Skin thinning
Fragile skin
Acne
Effects on body fat
Redistribution of body fat: moon face, buffalo hump, truncal obesity Weight gain: increased appetite and food intake Effects on the eye
Glaucoma Posterior subcapsular cataracts; children are more susceptible than adults Eyelid oedema and exophthalmos Central serous chorioretinopathy Vascular disease
Hypertension Ischaemic heart disease Stroke and transient ischaemic attack (TIA) The effects of systemic steroids on atherosclerotic vascular disease may be due to complex metabolic changes, including:
Hyperlipidaemia Peripheral insulin resistance and hyperinsulinaemia. Gastrointestinal tract
Dyspepsia, gastritis, peptic ulceration and perforation of the gut, especially in patients also taking non-steroidal anti-inflammatory drugs Acute pancreatitis Fatty liver Fluid balance Sodium and fluid retention cause leg swelling and weight increase Potassium loss causes general weakness Reproductive system
Irregular menstruation Hirsutism Lowered fertility in men and women Possible fetal growth retardation in women taking prolonged courses of steroids during pregnancy Breast feeding can usually continue but infant should be monitored for adrenal suppression if mother on > 40 mg prednisone daily Musculoskeletal system
Bone fracture Osteoporosis Osteonecrosis, especially hip Myopathy affecting shoulders and thighs Tendon rupture Growth restriction in children Osteoporosis is particularly common in smokers, postmenopausal women, the elderly, underweight or immobile, and patients with diabetes or lung problems. Osteoporosis may result in fractures of the spine, ribs or hip joint with minimal trauma. These occur after the first year in 10–20% of patients treated with more than 7.5 mg prednisone daily. It is estimated that up to 50% of patients on long-term prednisone will develop bone fractures. Vertebral fractures are more common in patients on steroids, even in those with normal bone density.
Nervous system
Psychological effects: mood changes, increased energy, excitement, euphoria, agitation Less often: hypomania, psychosis, delirium, memory loss, depression, anxiety, personality change Insomnia and sleep disturbance Shakiness and tremor Headaches Metabolic effects
Transient or persistent diabetes in previously non-diabetic patients Higher blood sugar levels in patients with diabetes mellitus Cushing syndrome Immune response
Raised neutrophil and total white cell count are usual on prednisone Impaired innate and acquired immunity Increased susceptibility to tuberculosis Increased severity of measles, varicella Reduced efficacy and increased risk of vaccines Live vaccines such as polio or MMR (measles, mumps, rubella) should not be given to patients taking ≥ 20 mg prednisone daily. It is safe and advisable to have other routine immunisations, such as annual influenza vaccination.
Risks during intercurrent illness or surgery
Significant intercurrent illness, trauma, or surgical procedure requires a temporary increase in corticosteroid dose, or if already stopped, a temporary re-introduction of corticosteroid treatment for up to twelve months after the steroids are stopped.
Patients who have taken ≥10 mg prednisone daily within 3 months of surgery requiring a general anaesthetic are advised to tell their anaesthetist so that intraoperative intravenous hydrocortisone can be added.
Effects of reducing the dose of systemic steroid
No tapering is necessary if a course of prednisone has been for less than one to two weeks. Steroid should be withdrawn slowly after longer courses, to avoid acute adrenal insufficiency, particularly if the medication has been taken for several months or longer.
Side effects from reducing prednisone may include:
Fever Hypotension Tiredness Headaches Muscle and joint aches Weight loss Depression Rhinitis Conjunctivitis Painful itchy skin nodules. Hypopituitary-pituitary-adrenal (HPA) axis suppression can persist for months or years after steroids are stopped.
Monitoring during steroid treatment
Regular monitoring during treatment with systemic steroid may include:
Blood pressure Body weight Blood sugar Patients on prednisone should be advised to avoid non-steroidal anti-inflammatory drugs and licorice.
Prevention of osteoporosis
Bone density scans should be considered for patients that have taken or are expected to take 7.5 mg or more of prednisone each day for three months or longer. Baseline fracture risk can be estimated from T-scores.
Current recommendations are:
Bisphosphonate therapy (alendronate, etidronate, zolidronic acid) for individuals with femoral T-scores <-2.5. It reduces fracture risk by half. Smoking cessation Balanced diet, aiming for healthy body weight Minimal alcohol Regular weight-bearing exercise Consider risk of falling and its mitigation Calcium, vitamin D and oestrogen are no longer recommended for prophylaxis of osteoporosis, as adverse events outweigh benefit.
Source

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Astagraf XL (Tacrolimus Extended-release Capsules) – updated on RxList

<h1>Astagraf XL (Tacrolimus Extended-release Capsules) – updated on RxList</h1>

Astagraf XL (Tacrolimus Extended-release Capsules) – updated on RxList

16% 18% a Study 1 was not designed to support comparative claims of ASTAGRAF XL compared to tacrolimus immediate-release for the adverse reactions reported in this table. Less Frequently Reported Adverse Reactions ( 6 months post transplant). No drug-related tumors were noted in the mouse dermal carcinogenicity study at a daily dose of 1.1 mg/kg (0.03% tacrolimus ointment). The relevance of topical administration of tacrolimus in the setting of systemic tacrolimus use is unknown.
The implications of these carcinogenicity studies are limited; doses of tacrolimus were administered that likely induced immunosuppression in these animals, impairing their immune system’s ability to inhibit unrelated carcinogenesis. Mutagenesis
No evidence of genotoxicity was seen in bacterial ( Salmonella and E. coli ) or mammalian (Chinese hamster lung-derived cells) in vitro assays of mutagenicity, the in vitro CHO/HGPRT assay of mutagenicity, or in vivo clastogenicity assays performed in mice; tacrolimus did not cause unscheduled DNA synthesis in rodent hepatocytes. Impairment Of Fertility
Tacrolimus subcutaneously administered to male rats at paternally toxic doses of 2 mg/kg/day [1.6 times the maximum recommended clinical dose (0.2 mg/kg/day) on a mg/m 2 basis] or 3 mg/kg/day (2.4 times the maximum recommended clinical dose) resulted in a dose-related decrease in sperm count.
Tacrolimus administered orally at 1.0 mg/kg (0.8 times the maximum clinical dose) to male and female rats, prior to and during mating, as well as to dams during gestation and lactation, was associated with embryolethality and adverse effects on female reproduction. Effects on female reproductive function (parturition) and embryolethal effects were indicated by a higher rate of preand post-implantation loss and increased numbers of undelivered and nonviable pups. When administered at 3.2 mg/kg (2.6 times the maximum clinical dose range based on body surface area), tacrolimus was associated with maternal and paternal toxicity as well as reproductive toxicity including marked adverse effects on estrus cycles, parturition, pup viability, and pup malformations. Use In Specific Populations Pregnancy Pregnancy Exposure Registry
There is a pregnancy registry that monitors pregnancy outcomes in women exposed to ASTAGRAF XL during pregnancy. The Transplantation Pregnancy Registry International (TPRI) is a voluntary pregnancy exposure registry that monitors outcomes of pregnancy in female transplant recipients and those fathered by male transplant recipients exposed to immunosuppressants including tacrolimus. Healthcare providers are encouraged to advise their patients to register by contacting the Transplantation Pregnancy Registry International at 1-877-955-6877 or https ://www.transplantpregnancyregistry.org/. Risk Summary
Tacrolimus can cause fetal harm when administered to a pregnant woman. Data from postmarketing surveillance and TPRI suggest that infants exposed to tacrolimus in utero are at a risk of prematurity, birth defects/congenital anomalies, low birth weight, and fetal distress [see Human Data ]. Advise pregnant women of the potential risk to the fetus.
Administration of oral tacrolimus to pregnant rabbits and rats throughout the period of organogenesis was associated with maternal toxicity/lethality, and an increased incidence of abortion, malformation and embryofetal death at clinically relevant doses [0.5 the maximum recommended clinical dose (0.2 mg/kg/day), on a mg/m 2 basis]. Administration of oral tacrolimus to pregnant rats after organogenesis and throughout lactation produced maternal toxicity, effects on parturition, reduced pup viability and reduced pup weight at clinically relevant doses (0.8 the maximum recommended clinical dose, on a mg/m 2 basis). Administration of oral tacrolimus to rats prior to mating, and throughout gestation and lactation produced maternal toxicity/lethality, marked effects on parturition, embryofetal loss, malformations, and reduced pup viability at clinically relevant doses (0.8 times the maximum recommended clinical dose, on a mg/m 2 basis). Interventricular septal defects, hydronephrosis, craniofacial malformations and skeletal effects were observed in offspring that died [see Animal Data ].
The background risk of major birth defects and miscarriage in the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations
Disease-Associated Maternal and/or Embryo-Fetal Risk
Risks during pregnancy are increased in organ transplant recipients. The risk of premature delivery following transplantation is increased. Pre-existing hypertension and diabetes confer additional risk to the pregnancy of an organ transplant recipient. Pre-gestational and gestational diabetes are associated with birth defects/congenital anomalies, hypertension, low birth weight and fetal death.
Cholestasis of pregnancy (COP) was reported in 7% of liver or liver-kidney (LK) transplant recipients, compared with approximately 1% of pregnancies in the general population. However, COP symptoms resolved postpartum and no long-term effects on the offspring were reported.
Maternal Adverse Reactions
ASTAGRAF XL may increase hyperglycemia in pregnant women with diabetes (including gestational diabetes). Monitor maternal blood glucose levels regularly [see WARNINGS AND PRECAUTIONS ].
ASTAGRAF XL may exacerbate hypertension in pregnant women and increase pre-eclampsia. Monitor and control blood pressure [see WARNINGS AND PRECAUTIONS ].
Fetal/Neonatal Adverse Reactions
Renal dysfunction, transient neonatal hyperkalemia and low birth weight have been reported at the time of delivery in infants of mothers taking ASTAGRAF XL.
Labor or Delivery
There is an increased risk for premature delivery (< 37 weeks) following transplantation and maternal exposure to ASTAGRAF XL. Data
Human Data
There are no adequate and well controlled studies on the effects of tacrolimus in human pregnancy. Safety data from the TPRI and postmarketing surveillance suggest infants exposed to tacrolimus in utero have an increased risk for miscarriage, pre-term delivery (< 37 weeks), low birth weight (< 2500 g), birth defects/congenital anomalies and fetal distress.
TPRI reported 450 and 241 total pregnancies in kidney and liver transplant recipients exposed to tacrolimus, respectively. The TPRI pregnancy outcomes are summarized in Table 6. In the table below, the number of recipients exposed to tacrolimus concomitantly with mycophenolic acid (MPA) products during the preconception and first trimester periods is high (27% and 29% for kidney and liver transplant recipients, respectively). Because MPA products may also cause birth defects, the birth defect rate may be confounded and this should be taken into consideration when reviewing the data, particularly for birth defects. Birth defects observed include cardiac malformations, craniofacial malformations, renal/urogenital disorders, skeletal abnormalities, neurological abnormalities and multiple malformations. Table 6: TPRI Reported Pregnancy Outcomes in Transplant Recipients with Exposure to Tacrolimus

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Follow on Extension of XT-150-1-0201

<h1>Follow on Extension of XT-150-1-0201</h1>

Follow on Extension of XT-150-1-0201

Qualified and participated in clinical study XT-150-1-0201. Participant was assigned to placebo, or Participant elects to have XT-150 administered to the XT-150-untreated knee that qualified under XT-150-1-0201 criteria, or Participant had inadequate pain relief and elects to receive a second injection to the same knee treated on clinical study XT-150-1-0201 Sufficiently severe OA of knee to require/have recommended knee replacement surgery or be unsuitable for knee replacement surgery based on co-morbidities or orthopedic considerations; be free of local or intra-articular infection. Symptomatic disease because of osteoarthritis, defined as a Verbal Numerical Rating Scale (VNRS) scores of a worst pain of at least 7 at any time during the preceding week (based on scale of 0 to 10, with 10 representing “pain as bad as you can imagine”). Stable analgesic regimen during the 4 weeks prior to enrollment. Inadequate pain relief (minimum ≥ 5 mean on Brief Pain Inventory-Severity Scale) lasting more than 3 months. In the judgment of the Investigator, acceptable general medical condition Life expectancy >6 months Male participants who are heterosexually active and not surgically sterile must agree to use effective contraception, including abstinence, for the duration of the study and for 3 months after the study is completed. Have suitable knee joint anatomy for intra-articular injection Willing and able to return for the follow-up (FU) visits Able to reliably provide pain assessment Able to read and understand study instructions, and willing and able to comply with all study procedures Exclusion Criteria: Hypersensitivity, allergy, or significant reaction to any ingredient of the study drug, including double-stranded DNA, mannose, and sucrose Scheduled knee replacement within 4 months; participant agrees not to schedule a knee replacement appointment within 4 months of study treatment History of rheumatoid arthritis of the knee or gout. High peri-operative risks which in the judgment of the investigator preclude a safe knee injection procedure (e.g., poorly controlled diabetes, cardiac inadequacy such as NYHA class > II, G4 glomerular filtration rate [eGFR 10mg/day prednisone] or other strong immunosuppressant) History of immunosuppressive therapy; high-potency systemic steroids in the last 3 months. Currently receiving systemic chemotherapy or radiation therapy for malignancy Clinically significant hepatic disease as indicated by clinical laboratory results ≥3 times the upper limit of normal for any liver function test (e.g., aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase) Severe anemia (Grade 3; hemoglobin <8.0 g/dL, <4.9 mmol/L, upper limit of normal (ULN) to 1.5xULN), or bleeding diathesis, Grade 1 white cell counts (lymphocytes <LLN – 800/mm3; <LLN – 0.8 x 109 /L, neutrophils <LLN – 1500/mm3; <LLN – 1.5 x 109 /L) Significant neuropsychiatric conditions; dementia, major depression, or altered mental state that in the opinion of the Investigator will interfere with study participation Current treatment with systemic antibiotics or antivirals (EXCEPTION: topical treatments) Current treatment with anticoagulants, other than low-dose aspirin. Known or suspected history of active alcohol or intravenous/oral drug abuse within 1 year before the screening visit Women of child-bearing potential Use of any investigational drug, other than XT-150, or device within 1 month before enrollment or current participation in a trial that included intervention with a drug or device; or currently participating in an investigational drug or device study. Any condition that, in the opinion of the Principal Investigator, could compromise the safety of the participant, the participant's ability to communicate with the study staff, or the quality of the data Contacts and Locations Go to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769662 Contacts Contact: Stephen A Collins, PhD, MD (847) 224-7433‬ Contact: Michael Huston, BS, MBA (925) 997-8216

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AVASCULAR NECROSIS

AVASCULAR NECROSIS

Avascular Necrosis also called osteonecrosis, aseptic necrosis, or ischemic bone necrosis, is a condition that occurs when there is loss of blood to the bone. Since bone is the living tissue that requires blood, an interruption to the blood supply causes the bone to die. T his condition is most common in people between the ages of 30 and 50. Possible causes of avascular necrosis include: 1. Dislocation or fracture of thighbone: This can alter the bloodstream to the bone, which can lead to shock-allied avascular necrosis. It may develop in 20% or more of people who dislocate a hip. 2. Long use of steroid: Use of these drugs, either orally or intravenously, is associated with 35% of all cases of non-traumatic AVN. These materials gather in the blood vessels, making them narrower, and reduces the amount of blood to the bone. 3. Extreme alcohol use: Much like corticosteroids, excessive alcohol may cause fatty substances to build in the blood vessels and decrease the blood supply to the bones. 4. Blood clots, tenderness, and destruction to the arteries. Symptoms of Avascular Necrosis In the early stages, it shows no symptoms; however, as the disease evolves it becomes painful. At first, you may get pain when you put pressure on the infected bone. Then, pain may become get constant. If the infection advances and the bone and nearby joint breakdown, you can experience severe pain that restricts the ability to use your joint. Treatment for Avascular Necrosis The aims of treatment for avascular necrosis is to improve the function of the infected joint, discontinue the development of bone damage, and decrease pain. The best treatment will depend on factors, including: Age Stage of the disease Location and amount of bone damage Cause of AVN If the cause of your avascular necrosis is found out, treatment will comprise of the efforts to manage the underlying condition. For example, if it is caused by blood clots, the doctor will recommend medicines to dissolve gobs. If swelling of the arteries is responsible, the doctor may recommend anti-inflammatory drugs. While these nonsurgical treatments may slow the development of it, most people with the condition finally need surgery. Medical possibilities comprises of : Bone grafts , involves the removal of healthy bone from one part of the body and use it to replace the damaged bone Osteotomy , a procedure that includes cutting the bone and changing the alignment to relieve stress on the bone or joint. Total joint replacement , removing the damaged joint and replacing it with a synthetic joint. Core decompression , a process that includes eliminating parts of the inside of the bone to release the pressure and allow new blood vessels to form. Vascularized bone graft, is a technique that uses the patient’s tissue to reconstruct unhealthy or broken hip joints. Risk factors for developing avascular necrosis include: · Strain: Injuries, such as hip dislocation or fracture, can damage nearby blood vessels and reduce blood flow to bones. · Steroid: Use of high-dose corticosteroids, such as prednisone, is a common cause of avascular necrosis. · Excessive use of alcohol: Regular drinking for several years may create fatty deposits to form in your blood vessels. · Bisphosphonate use : Long period use of pills for the growth of bone density can helps to developing osteonecrosis of the jaw. · Some medical cures: Radiation therapy for cancer can weaken bone. Prevention Factors helping you prevent avascular necrosis: · Avoid alcohol. · Keep your cholesterol levels low. · Avoid use of high-dose steroids.
· Do not smoke.

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