2019, Case Western Reserve University, Steve's review: "Super P-Force 160 mg - Safe online Super P-Force OTC.".
Because the potential for hypoglycemia in nursing infants may exist , 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 . If the drug is discontinued and if diet alone is inadequate for controlling blood glucose , insulin therapy should be considered . Cholestatic jaundice may occur rarely ; Tolbutamide should be discontinued if this occurs . They tend to be dose related and may disappear when dosage is reduced . These may be transient and may disappear despite continued use of Tolbutamide ; if skin reactions persist , the drug should be discontinued. Porphyria cutanea tarda and photosensitivity reactions have been reported with sulfonylureas. Leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia, aplastic anemia, and pancytopenia have been reported with sulfonylureas. Hepatic porphyria and disulfiram-like reactions have been reported with sulfonylureas. Cases of hyponatremia and the syndrome of inappropriate antidiuretic hormone (SIADH) secretion have been reported with this and other sulfonylureas. Headache and taste alterations have occasionally been reported with Tolbutamide administration. Overdosage of sulfonylureas including Tolbutamide can produce hypoglycemia. Mild hypoglycemic symptoms without loss of consciousness or neurologic findings should be treated aggressively with oral glucose and adjustments in drug dosage and/or meal patterns. Close monitoring should continue until the physician is assured that the patient is out of danger. Severe hypoglycemic reactions with coma, seizure, or other neurological impairment occur infrequently, but constitute medical emergencies requiring immediate hospitalization. If hypoglycemic coma is diagnosed or suspected, the patient should be given a rapid intravenous injection of concentrated (50%) dextrose injection. This should be followed by a continuous infusion of a more dilute (10%) dextrose injection at a rate that will maintain the blood glucose at a level above 100 mg/dL. Patients should be closely monitored for a minimum of 24 to 48 hours since hypoglycemia may recur after apparent clinical recovery. There is no fixed dosage regimen for the management of diabetes mellitus with Tolbutamide tablets or any other hypoglycemic agent. Short-term administration of Tolbutamide tablets may be sufficient during periods of transient loss of control in patients usually controlled well on diet. This may be increased or decreased, depending on individual patient response. Failure to follow an appropriate dosage regimen may precipitate hypoglycemia. Patients who do not adhere to their prescribed dietary regimens are more prone to exhibit unsatisfactory response to drug therapy. Patients Receiving Other Antidiabetic TherapyTransfer of patients from other oral antidiabetes regimens to Tolbutamide tablets should be done conservatively. When transferring patients from oral hypoglycemic agents other than chlorpropamide to Tolbutamide, no transition period and no initial or priming doses are necessary. When transferring patients from chlorpropamide, however, particular care should be exercised during the first 2 weeks because of the prolonged retention of chlorpropamide, in the body and the possibility that subsequent overlapping drug effects might provoke hypoglycemia. Patients requiring 20 units or less of insulin daily may be placed directly on Tolbutamide tablets and insulin abruptly discontinued. Patients whose insulin requirement is between 20 and 40 units daily may be started on therapy with Tolbutamide tablets with a concurrent 30% to 50% reduction in insulin dose, with further daily reduction of the insulin when response to Tolbutamide tablets is observed. In patients requiring more than 40 units of insulin daily, therapy with Tolbutamide tablets may be initiated in conjunction with a 20% reduction in insulin dose the first day, with further careful reduction of insulin as response is observed. Occasionally, conversion to Tolbutamide tablets in the hospital may be advisable in candidates who require more than 40 units of insulin daily. During this conversion period when both insulin and Tolbutamide tablets are being used hypoglycemia may rarely occur. During insulin withdrawal, patients should test their urine for glucose and acetone at least 3 times daily and report results to their physician. The appearance of persistent acetonuria with glycosuria indicates that the patient is type I diabetic who requires insulin therapy. Daily doses of greater than 3 grams are not recommended. Maintenance doses above 2 grams are seldom required. The total daily dose may be taken either in the morning or in divided doses through the day. While either schedule is usually effective, the divided dose system is preferred by some clinicians from the standpoint of digestive tolerance. In elderly patients, debilitated or malnourished patients, and patients with impaired renal or hepatic function, the initial and maintenance dosing should be conservative to avoid hypoglycemic reactions (see PRECAUTIONS ). Tolbutamide Tablets, USP are available containing 500 mg of Tolbutamide, USP. The tablets are white to off-white round, scored tablets debossed with M to the left of the score and 13 to the right of the score on one side of the tablet and blank on the other side. They are available as follows:Store at 20? to 25?C (68? to 77?F). Generic Name: TolbutamideOrinase is an oral antidiabetic medication used to treat type 2 (non-insulin-dependent) diabetes. Diabetes occurs when the body does not make enough insulin, or when the insulin that is produced no longer works properly. There are two forms of diabetes: type 1 (insulin-dependent) and type 2 (non-insulin-dependent). Type 1 diabetes usually requires taking insulin injections for life, while type 2 diabetes can usually be treated by dietary changes, exercise, and/or oral antidiabetic medications such as Orinase. Orinase controls diabetes by stimulating the pancreas to secrete more insulin and by helping insulin work better. Occasionally, type 2 diabetics must take insulin injections temporarily during stressful periods or times of illness. When diet, exercise, and an oral antidiabetic medication fail to reduce symptoms and/or blood sugar levels, a person with type 2 diabetes may require long-term insulin injections. To help prevent low blood sugar levels (hypoglycemia) you should:Understand the symptoms of hypoglycemia. Keep a product containing quick-acting sugar with you at all times. If you drink alcohol, it may cause breathlessness and facial flushing. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Orinase. Side effects from Orinase are rare and seldom require discontinuation of Orinase. Orinase, like all oral antidiabetics, may cause hypoglycemia (low blood sugar). The risk of hypoglycemia can be increased by missed meals, alcohol, other medications, fever, trauma, infection, surgery, or excessive exercise. To avoid hypoglycemia, you should closely follow the dietary and exercise plan suggested by your physician. Symptoms of mild hypoglycemia may include:Cold sweat, drowsiness, fast heartbeat, headache, nausea, nervousness. Symptoms of more severe hypoglycemia may include:Coma, pale skin, seizures, shallow breathing. Ask your doctor what you should do if you experience mild hypoglycemia. Severe hypoglycemia should be considered a medical emergency, and prompt medical attention is essential. You should not take Orinase if you have had an allergic reaction to it. Orinase should not be taken if you are suffering from diabetic ketoacidosis (a life-threatening medical emergency caused by insufficient insulin and marked by excessive thirst, nausea, fatigue, pain below the breastbone, and fruity breath). In addition, Orinase should not be used as the sole therapy in treating type 1 (insulin-dependent) diabetes. If you have a heart condition, you may want to discuss this with your doctor. If you are taking Orinase, you should check your blood or urine periodically for abnormal sugar (glucose) levels. Even people with well-controlled diabetes may find that stress, illness, surgery, or fever results in a loss of control over their diabetes. In these cases, your physician may recommend that you temporarily stop taking Orinase and use injected insulin instead. In addition, the effectiveness of any oral antidiabetic, including Orinase, may decrease with time. This may occur because of either a diminished responsiveness to Orinase or a worsening of the diabetes. Like other antidiabetic drugs, Orinase may produce severe low blood sugar if the dosage is wrong. While taking Orinase, you are particularly susceptible to episodes of low blood sugar if:You suffer from a kidney or liver problem;You have a lack of adrenal or pituitary hormone;You are elderly, run-down, malnourished, hungry, exercising heavily, drinking alcohol, or using more than one glucose-lowering drug. If Orinase is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Orinase with the following:Adrenal corticosteroids such as prednisone (Deltasone) and cortisone (Cortone)Airway-opening drugs such as Proventil and VentolinAnabolic steroids such as testosteroneBarbiturates such as Amytal, Seconal, and phenobarbitalBeta blockers such as Inderal and TenorminCalcium channel blockers such as Cardizem and ProcardiaChloramphenicol (Chloromycetin)Major tranquilizers such as Stelazine and MellarilMAO inhibitors such as Nardil and ParnateNonsteroidal anti-inflammatory agents such as Advil, aspirin, ibuprofen, Naprosyn, and VoltarenSulfa drugs such as Bactrim and SeptraThiazide and other diuretics such as Diuril and HydroDIURILThyroid medications such as SynthroidBe cautious about drinking alcohol, since excessive alcohol can cause low blood sugar. The effects of Orinase during pregnancy have not been adequately established in humans. Since Orinase has caused birth defects in rats, it is not recommended for use by pregnant women. Therefore, if you are pregnant or planning to become pregnant, you should take Orinase only on the advice of your physician. Since studies suggest the importance of maintaining normal blood sugar (glucose) levels during pregnancy, your physician may prescribe injected insulin during your pregnancy. While it is not known if Orinase enters breast milk, other similar medications do. Therefore, you should discuss with your doctor whether to discontinue Orinase or to stop breastfeeding. If Orinase is discontinued, and if diet alone does not control glucose levels, your doctor will consider giving you insulin injections. Usually an initial daily dose of 1 to 2 grams is recommended. Daily doses greater than 3 grams are not recommended. Safety and effectiveness have not been established in children. Older, malnourished, or debilitated people, or those with impaired kidney or liver function, are usually prescribed lower initial and maintenance doses to minimize the risk of low blood sugar (hypoglycemia). Any medication taken in excess can have serious consequences. An overdose of Orinase can cause low blood sugar (see " Special warnings about Orinase "). Eating sugar or a sugar-based product will often correct mild hypoglycemia. If you suspect an overdose, seek medical attention immediately. Prandin? (repaglinide) is an oral blood glucose-lowering drug of the meglitinide class used in the management of type 2 diabetes mellitus (also known as non-insulin dependent diabetes mellitus or NIDDM). Repaglinide, S(+)2-ethoxy-4(2((3-methyl-1-(2-(1-piperidinyl) phenyl)-butyl) amino)-2-oxoethyl) benzoic acid, is chemically unrelated to the oral sulfonylurea insulin secretagogues. The structural formula is as shown below:Repaglinide is a white to off-white powder with molecular formula C27 H36 N2 O4 and a molecular weight of 452. In addition each tablet contains the following inactive ingredients: calcium hydrogen phosphate (anhydrous), microcrystalline cellulose, maize starch, polacrilin potassium, povidone, glycerol (85%), magnesium stearate, meglumine, and poloxamer. The 1 mg and 2 mg tablets contain iron oxides (yellow and red, respectively) as coloring agents. Repaglinide lowers blood glucose levels by stimulating the release of insulin from the pancreas. This action is dependent upon functioning beta (s() cells in the pancreatic islets. Insulin release is glucose-dependent and diminishes at low glucose concentrations. Repaglinide closes ATP-dependent potassium channels in the s(-cell membrane by binding at characterizable sites. This potassium channel blockade depolarizes the s(-cell, which leads to an opening of calcium channels. The resulting increased calcium influx induces insulin secretion.
Charcoal -- The administration of activated charcoal (1 g) reduced the Cmax and AUC of oral olanzapine by about 60% . As peak olanzapine levels are not typically obtained until about 6 hours after dosing , charcoal may be a useful treatment for olanzapine overdose . Cimetidine and Antacids -- Single doses of cimetidine (800 mg) or aluminum- and magnesium-containing antacids did not affect the oral bioavailability of olanzapine . Carbamazepine -- Carbamazepine therapy (200 mg bid) causes an approximately 50% increase in the clearance of olanzapine . This increase is likely due to the fact that carbamazepine is a potent inducer of CYP1A2 activity . Higher daily doses of carbamazepine may cause an even greater increase in olanzapine clearance . Ethanol -- Ethanol (45 mg/70 kg single dose) did not have an effect on olanzapine pharmacokinetics . Fluoxetine -- Fluoxetine (60 mg single dose or 60 mg daily for 8 days) causes a small (mean 16%) increase in the maximum concentration of olanzapine and a small (mean 16%) decrease in olanzapine clearance . The magnitude of the impact of this factor is small in comparison to the overall variability between individuals , and therefore dose modification is not routinely recommended. Fluvoxamine -- Fluvoxamine, a CYP1A2 inhibitor, decreases the clearance of olanzapine. This results in a mean increase in olanzapine Cmax following fluvoxamine of 54% in female nonsmokers and 77% in male smokers. The mean increase in olanzapine AUC is 52% and 108%, respectively. Lower doses of olanzapine should be considered in patients receiving concomitant treatment with fluvoxamine. Warfarin -- Warfarin (20 mg single dose) did not affect olanzapine pharmacokinetics. Effect of Olanzapine on Other Drugs -- In vitro studies utilizing human liver microsomes suggest that olanzapine has little potential to inhibit CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A. Thus, olanzapine is unlikely to cause clinically important drug interactions mediated by these enzymes. Lithium -- Multiple doses of olanzapine (10 mg for 8 days) did not influence the kinetics of lithium. Therefore, concomitant olanzapine administration does not require dosage adjustment of lithium. Valproate -- Studies in vitro using human liver microsomes determined that olanzapine has little potential to inhibit the major metabolic pathway, glucuronidation, of valproate. Further, valproate has little effect on the metabolism of olanzapine in vitro. In vivo administration of olanzapine (10 mg daily for 2 weeks) did not affect the steady state plasma concentrations of valproate. Therefore, concomitant olanzapine administration does not require dosage adjustment of valproate. Single doses of olanzapine did not affect the pharmacokinetics of imipramine or its active metabolite desipramine, and warfarin. Multiple doses of olanzapine did not influence the kinetics of diazepam and its active metabolite N-desmethyldiazepam, ethanol, or biperiden. However, the co-administration of either diazepam or ethanol with olanzapine potentiated the orthostatic hypotension observed with olanzapine. Multiple doses of olanzapine did not affect the pharmacokinetics of theophylline or its metabolites. Lorazepam -- Administration of intramuscular lorazepam (2 mg) 1 hour after intramuscular olanzapine for injection (5 mg) did not significantly affect the pharmacokinetics of olanzapine, unconjugated lorazepam, or total lorazepam. However, this co-administration of intramuscular lorazepam and intramuscular olanzapine for injection added to the somnolence observed with either drug alone ( see Hemodynamic Effects ). Carcinogenesis -- Oral carcinogenicity studies were conducted in mice and rats. Olanzapine was administered to mice in two 78-week studies at doses of 3, 10, 30/20 mg/kg/day (equivalent to 0. The incidence of liver hemangiomas and hemangiosarcomas was significantly increased in one mouse study in female mice dosed at 8 mg/kg/day (2 times the maximum recommended human daily oral dose on a mg/m 2 basis). These tumors were not increased in another mouse study in females dosed at 10 or 30/20 mg/kg/day (2-5 times the maximum recommended human daily oral dose on a mg/m 2 basis); in this study, there was a high incidence of early mortalities in males of the 30/20 mg/kg/day group. The incidence of mammary gland adenomas and adenocarcinomas was significantly increased in female mice dosed at >/=2 mg/kg/day and in female rats dosed at >/=4 mg/kg/day (0. Antipsychotic drugs have been shown to chronically elevate prolactin levels in rodents. Serum prolactin levels were not measured during the olanzapine carcinogenicity studies; however, measurements during subchronic toxicity studies showed that olanzapine elevated serum prolactin levels up to 4-fold in rats at the same doses used in the carcinogenicity study. An increase in mammary gland neoplasms has been found in rodents after chronic administration of other antipsychotic drugs and is considered to be prolactin mediated. The relevance for human risk of the finding of prolactin mediated endocrine tumors in rodents is unknown ( see Hyperprolactinemia under PRECAUTIONS, General ). Mutagenesis -- No evidence of mutagenic potential for olanzapine was found in the Ames reverse mutation test, in vivo micronucleus test in mice, the chromosomal aberration test in Chinese hamster ovary cells, unscheduled DNA synthesis test in rat hepatocytes, induction of forward mutation test in mouse lymphoma cells, or in vivo sister chromatid exchange test in bone marrow of Chinese hamsters. Impairment of Fertility -- In an oral fertility and reproductive performance study in rats, male mating performance, but not fertility, was impaired at a dose of 22. Discontinuance of olanzapine treatment reversed the effects on male mating performance. In female rats, the precoital period was increased and the mating index reduced at 5 mg/kg/day (2. Pregnancy Category C -- In oral reproduction studies in rats at doses up to 18 mg/kg/day and in rabbits at doses up to 30 mg/kg/day (9 and 30 times the maximum recommended human daily oral dose on a mg/m 2 basis, respectively) no evidence of teratogenicity was observed. In an oral rat teratology study, early resorptions and increased numbers of nonviable fetuses were observed at a dose of 18 mg/kg/day (9 times the maximum recommended human daily oral dose on a mg/m 2 basis). Gestation was prolonged at 10 mg/kg/day (5 times the maximum recommended human daily oral dose on a mg/m 2 basis). In an oral rabbit teratology study, fetal toxicity (manifested as increased resorptions and decreased fetal weight) occurred at a maternally toxic dose of 30 mg/kg/day (30 times the maximum recommended human daily oral dose on a mg/m 2 basis). Placental transfer of olanzapine occurs in rat pups. There are no adequate and well-controlled trials with olanzapine in pregnant females. Seven pregnancies were observed during clinical trials with olanzapine, including 2 resulting in normal births, 1 resulting in neonatal death due to a cardiovascular defect, 3 therapeutic abortions, and 1 spontaneous abortion. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The effect of olanzapine on labor and delivery in humans is unknown. In a study in lactating, healthy women, olanzapine was excreted in breast milk. Mean infant dose at steady state was estimated to be 1. It is recommended that women receiving olanzapine should not breast-feed. Of the 2500 patients in premarketing clinical studies with oral olanzapine, 11% (263) were 65 years of age or over. In patients with schizophrenia, there was no indication of any different tolerability of olanzapine in the elderly compared to younger patients. Studies in elderly patients with dementia-related psychosis have suggested that there may be a different tolerability profile in this population compared to younger patients with schizophrenia. As with other CNS-active drugs, olanzapine should be used with caution in elderly patients with dementia. Olanzapine is not approved for the treatment of patients with dementia-related psychosis. If the prescriber elects to treat elderly patients with dementia-related psychosis, vigilance should be exercised. Also, the presence of factors that might decrease pharmacokinetic clearance or increase the pharmacodynamic response to olanzapine should lead to consideration of a lower starting dose for any geriatric patient (see BOX WARNING, WARNINGS, PRECAUTIONS and DOSAGE AND ADMINISTRATION ). The information below is derived from a clinical trial database for olanzapine consisting of 8661 patients with approximately 4165 patient-years of exposure to oral olanzapine and 722 patients with exposure to intramuscular olanzapine for injection. In addition, information from the premarketing 6-week clinical study database for olanzapine in combination with lithium or valproate, consisting of 224 patients who participated in bipolar mania trials with approximately 22 patient-years of exposure, is included below. The conditions and duration of treatment with olanzapine varied greatly and included (in overlapping categories) open-label and double-blind phases of studies, inpatients and outpatients, fixed-dose and dose-titration studies, and short-term or longer-term exposure. Adverse reactions were assessed by collecting adverse events, results of physical examinations, vital signs, weights, laboratory analytes, ECGs, chest x-rays, and results of ophthalmologic examinations. Certain portions of the discussion below relating to objective or numeric safety parameters, namely, dose-dependent adverse events, vital sign changes, weight gain, laboratory changes, and ECG changes are derived from studies in patients with schizophrenia and have not been duplicated for bipolar mania or agitation. However, this information is also generally applicable to bipolar mania and agitation. Adverse events during exposure were obtained by spontaneous report and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of events into a smaller number of standardized event categories. In the tables and tabulations that follow, standard COSTART dictionary terminology has been used initially to classify reported adverse events. The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation. The reported events do not include those event terms that were so general as to be uninformative. Events listed elsewhere in labeling may not be repeated below. It is important to emphasize that, although the events occurred during treatment with olanzapine, they were not necessarily caused by it. The entire label should be read to gain a complete understanding of the safety profile of olanzapine. The prescriber should be aware that the figures in the tables and tabulations cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the adverse event incidence in the population studied. Adverse Events Associated with Discontinuation of Treatment in Short-Term, Placebo-Controlled Trials Schizophrenia -- Overall, there was no difference in the incidence of discontinuation due to adverse events (5% for oral olanzapine vs 6% for placebo). However, discontinuations due to increases in SGPT were considered to be drug related (2% for oral olanzapine vs 0% for placebo) (see PRECAUTIONS ). Bipolar Mania Monotherapy -- Overall, there was no difference in the incidence of discontinuation due to adverse events (2% for oral olanzapine vs 2% for placebo). Agitation -- Overall, there was no difference in the incidence of discontinuation due to adverse events (0. Adverse Events Associated with Discontinuation of Treatment in Short-Term Combination Trials Bipolar Mania Combination Therapy -- In a study of patients who were already tolerating either lithium or valproate as monotherapy, discontinuation rates due to adverse events were 11% for the combination of oral olanzapine with lithium or valproate compared to 2% for patients who remained on lithium or valproate monotherapy. Discontinuations with the combination of oral olanzapine and lithium or valproate that occurred in more than 1 patient were: somnolence (3%), weight gain (1%), and peripheral edema (1%). Commonly Observed Adverse Events in Short-Term, PlaceboControlled Trials The most commonly observed adverse events associated with the use of oral olanzapine (incidence of 5% or greater) and not observed at an equivalent incidence among placebo-treated patients (olanzapine incidence at least twice that for placebo) were:Common Treatment-Emergent Adverse Events Associated with the Use ofOral Olanzapine in 6-Week Trials -- SCHIZOPHRENIA Personality disorder is the COSTART term for designating non-aggressive objectionable behavior. Common Treatment-Emergent Adverse Events Associated with the Use of Oral Olanzapine in3-Week and 4-Week Trials -- BIPOLAR MANIA There was one adverse event (somnolence) observed at an incidence of 5% or greater among intramuscular olanzapine for injection-treated patients and not observed at an equivalent incidence among placebo-treated patients (olanzapine incidence at least twice that for placebo) during the placebo-controlled premarketing studies. The incidence of somnolence during the 24 hour IM treatment period in clinical trials in agitated patients with schizophrenia or bipolar mania was 6% for intramuscular olanzapine for injection and 3% for placebo. Adverse Events Occurring at an Incidence of 2% or More Among Oral Olanzapine-Treated Patients in Short-Term, Placebo-Controlled Trials Table 1 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse events that occurred in 2% or more of patients treated with oral olanzapine (doses >/=2. Treatment-Emergent Adverse Events: Incidence in Short-Term, Placebo-ControlledMetabolic and Nutritional Disorders Extremity pain (other than joint)Articulation impairmentUrinary tract infectionEvents reported by at least 2% of patients treated with olanzapine, except the following events which had an incidence equal to or less than placebo: abdominal pain, agitation, anorexia, anxiety, apathy, confusion, depression, diarrhea, dysmenorrhea 2, hallucinations, headache, hostility, hyperkinesia, myalgia, nausea, nervousness, paranoid reaction, personality disorder 3, rash, thinking abnormal, weight loss. Denominator used was for females only (olanzapine, N=201; placebo, N=114). Commonly Observed Adverse Events in Short-Term Combination Trials In the bipolar mania combination placebo-controlled trials, the most commonly observed adverse events associated with the combination of olanzapine and lithium or valproate (incidence of >/=5% and at least twice placebo) wereCommon Treatment-Emergent Adverse EventsAssociated with the Use of Oral Olanzapinein 6-Week Combination Trials -- BIPOLAR MANIA Adverse Events Occurring at an Incidence of 2% or More Among Oral Olanzapine-Treated Patients in Short-Term Combination Trials Table 2 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse events that occurred in 2% or more of patients treated with the combination of olanzapine (doses >/=5 mg/day) and lithium or valproate and with incidence greater than lithium or valproate alone who participated in the acute phase of placebo-controlled combination trials. Treatment-Emergent Adverse Events: Incidence in Short-Term,Placebo-Controlled Combination Clinical TrialsEvents reported by at least 2% of patients treated with olanzapine, except the following events which had an incidence equal to or less than placebo: abdominal pain, abnormal dreams, abnormal ejaculation, agitation, akathisia, anorexia, anxiety, arthralgia, cough increased, diarrhea, dyspepsia, emotional lability, fever, flatulence, flu syndrome, headache, hostility, insomnia, libido decreased, libido increased, menstrual disorder 2, myalgia, nausea, nervousness, pain, paranoid reaction, personality disorder, rash, rhinitis, sleep disorder, thinking abnormal, vomiting. Denominator used was for females only (olanzapine, N=128; placebo, N=51). For specific information about the adverse reactions observed with lithium or valproate, refer to the ADVERSE REACTIONS section of the package inserts for these other products. Adverse Events Occurring at an Incidence of 1% or More Among Intramuscular Olanzapine for Injection-Treated Patients in Short-Term, Placebo-Controlled Trials Table 3 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse events that occurred in 1% or more of patients treated with intramuscular olanzapine for injection (dose range of 2. Treatment-Emergent Adverse Events: Incidence in Short-Term (24 Hour), Placebo-Controlled Clinical Trials with Intramuscular Olanzapine for Injection in Agitated Patients with Schizophrenia or Bipolar ManiaEvents reported by at least 1% of patients treated with olanzapine for injection, except the following events which had an incidence equal to or less than placebo: agitation, anxiety, dry mouth, headache, hypertension, insomnia, nervousness. Additional Findings Observed in Clinical Trials The following findings are based on clinical trials. Dose Dependency of Adverse Events in Short-Term, Placebo-Controlled Trials Extrapyramidal Symptoms -- The following table enumerates the percentage of patients with treatment-emergent extrapyramidal symptoms as assessed by categorical analyses of formal rating scales during acute therapy in a controlled clinical trial comparing oral olanzapine at 3 fixed doses with placebo in the treatment of schizophrenia. TREATMENT-EMERGENT EXTRAPYRAMIDAL SYMPTOMS ASSESSED BY RATING SCALES INCIDENCE IN A FIXED DOSAGE RANGE, PLACEBO-CONTROLLED CLINICAL TRIAL OF ORAL OLANZAPINE IN SCHIZOPHRENIA -- ACUTE PHASE *Percentage of Patients Reporting Event Percentage of patients with a Simpson-Angus Scale total score >3. Percentage of patients with a Barnes Akathisia Scale global score >/=2.
It may be necessary to use injectable medications to induce an erection for proper evaluation of the penile curvature . The patient may also provide pictures of the erect penis for evaluation by the physician . Ultrasound of the penis may demonstrate the lesions in the penis but is not always necessary . In fact , this disease can be classified into two stages: 1) an acute inflammatory phase persisting for six to 18 months during which men experience pain , slight penile curvature and nodule formations and 2) a chronic phase during which men develop a stable plaque , significant penile curvature and erectileOccasionally the condition regresses spontaneously with symptoms resolving themselves . In fact , some studies show that approximately 13 percent of patients have complete resolution of their plaques within a year . There is no change in 40 percent of cases , with progression or worsening of symptoms in 40 to 45 percent. For these reasons, most physicians recommend a non-surgical approach for the first 12 months. Conservative approaches: Instead of requiring invasive diagnostic procedures or treatments, men who experience only small plaques, minimal penile curvature and no pain or sexual limitations, need only be reassured that the condition will not lead to malignancy or another chronic disease. Pharmaceutical agents have shown promise for early-stage disease but there are drawbacks. Because of a lack of controlled studies, scientists have yet to establish their true effectiveness. For instance:Oral vitamin E: It remains a popular treatment for early-stage disease because of its mild side effects and low cost. While uncontrolled studies as far back as 1948 demonstrated decreases in penile curvature and plaque size, investigation continues concerning its effectiveness. Potassium aminobenzoate: Recent controlled studies have shown that this B-complex substance popular in Central Europe yields some benefits. But it is somewhat expensive, requiring 24 pills each day for three to six months. It is also often associated with gastrointestinal issues, making compliance low. Researchers claim that inflammation and the production of scar tissue are inhibited. But early-stage disease studies in England have found only marginal improvement with tamoxifen. Like other research in this area, however, these studies include few patients, and no controls, objective improvement measures or long-term follow up. Colchicine: Another anti-inflammatory agent that decreases collagen development, colchicine has been shown to be slightly beneficial in a few small, uncontrolled studies. Unfortunately, up to 50 percent of patients develop gastrointestinal upset and must discontinue the drug early in treatment. Injections: Injecting a drug directly into the penile plaque is an attractive alternative to oral medications, which do not specifically target the lesion, or invasive surgical procedures, which carry the inherent risks of general anesthesia, bleeding and infection. Intralesional injection therapies introduce drugs directly into the plaque with a small needle after appropriate anesthesia. Because they offer a minimally invasive approach, these options are popular among men with either early phase disease or who are reluctant to have surgery. Yet their effectiveness is also under investigation. For instance:Verapamil: Early uncontrolled studies demonstrated that this substance interferes with calcium, a factor shown by in vitro cattle connective tissue cell studies to support collagen transport. As such, intralesional verapamil reduced penile pain and curvature while improving sexual function. Other studies have concluded that it is a reasonable treatment in men with non-calcified plaques and penile angles of less than 30 degrees. In addition to inhibiting proliferation of fibroblast cells, interferons, such as alpha-2b, also stimulate collagenase, which breaks down collagen and scar tissue. A current multi-institutional, placebo-controlled trial will hopefully answer many of the questions about intralesional therapy in the near future. But the effectiveness of treatments such as high-intensity focused ultrasound and radiation therapy, topical verapamil and iontophoresis, introducing soluble salt ions into the tissue via electric current, must still be investigated before these alternative therapies are considered clinically useful. Surgery: Surgery is reserved for men with severe disabling penile deformities that prevent satisfactory sexual intercourse. But, in most cases, it is not recommended for the first six to 12 months, until the plaque has stabilized. Since a spin-off of this disease is an abnormal blood supply to the penis, a vascular evaluation using vasoactive agents (drugs that cause erections by opening the vessels) is done prior to any surgery. A penile ultrasound if performed can also illustrate the anatomy of the deformity. The images allow the urologist to determine which patients are most likely to benefit from reconstructive procedures versus aRead the Patient Information about CIALIS before you start taking it and again each time you get a refill. You may also find it helpful to share this information with your partner. This leaflet does not take the place of talking with your doctor. You and your doctor should talk about CIALIS when you start taking it and at regular checkups. If you do not understand the information, or have questions, talk with your doctor or pharmacist. CIALIS can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. You could get dizzy, faint, or have a heart attack or stroke. Tell all your healthcare providers that you take CIALIS. If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took CIALIS. After taking a single tablet, some of the active ingredient of CIALIS remains in your body for more than 2 days. The active ingredient can remain longer if you have problems with your kidneys or liver, or you are taking certain other medications (see "Can other medications affect CIALIS? CIALIS is a prescription medicine taken by mouth for the treatment of erectile dysfunction (ED) in men. ED is a condition where the penis does not harden and expand when a man is sexually excited, or when he cannot keep an erection. A man who has trouble getting or keeping an erection should see his doctor for help if the condition bothers him. CIALIS may help a man with ED get and keep an erection when he is sexually excited. Speak to your doctor about ways to guard against sexually transmitted diseases. CIALIS helps increase blood flow to the penis and may help men with ED get and keep an erection satisfactory for sexual activity. Once a man has completed sexual activity, blood flow to his penis decreases, and his erection goes away. Talk to your doctor to decide if CIALIS is right for you. CIALIS has been shown to be effective in men over the age of 18 years who have erectile dysfunction, including men with diabetes or who have undergone prostatectomy. Angina is a symptom of heart disease and can cause pain in your chest, jaw, or down your arm. Medicines called nitrates include nitroglycerin that is found in tablets, sprays, ointments, pastes, or patches. Nitrates can also be found in other medicines such as isosorbide dinitrate or isosorbide mononitrate. Some recreational drugs called "poppers" also contain nitrates, such as amyl nitrite and butyl nitrite. Ask your doctor or pharmacist if you are not sure if any of your medicines are nitrates. Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease. The active ingredient in CIALIS is called tadalafil. See the end of this leaflet for a complete list of ingredients. Before taking CIALIS, tell your doctor about all your medical problems, including if you:have heart problems such as angina, heart failure, irregular heartbeats, or have had a heart attack. Ask your doctor if it is safe for you to have sexual activity. Always check with your doctor before starting or stopping any medicines. Especially tell your doctor if you take any of the following:*medicines called alpha blockers. These include Hytrin^ (terazosin HCl), Flomax^ (tamsulosin HCl), Cardura^ (doxazosin mesylate), Minipress^ (prazosin HCl) or Uroxatral^ (alfuzosin HCl). Alpha blockers are sometimes prescribed for prostate problems or high blood pressure. If CIALIS is taken with certain alpha blockers, your blood pressure could suddenly drop. CIALIS comes in different doses (5 mg, 10 mg, and 20 mg). For most men, the recommended starting dose is 10 mg. Some men can only take a low dose of CIALIS because of medical conditions or medicines they take. Your doctor will prescribe the dose that is right for you. If you have kidney problems, your doctor may start you on a lower dose of CIALIS. If you have kidney or liver problems or you are taking certain medications, your doctor may limit your highest dose of CIALIS to 10 mg and may also limit you to one tablet in 48 hours (2 days) or one tablet in 72 hours (3 days). If you have prostate problems or high blood pressure for which you take medicines called alpha blockers, your doctor may start you on a lower dose of CIALIS. In some patients, the ability to have sexual activity was improved at 30 minutes after taking CIALIS when compared to a sugar pill. The ability to have sexual activity was improved up to 36 hours after taking CIALIS when compared to a sugar pill. You and your doctor should consider this in deciding when you should take CIALIS prior to sexual activity. Some form of sexual stimulation is needed for an erection to happen with CIALIS. Do not change your dose of CIALIS without talking to your doctor. Your doctor may lower your dose or raise your dose, depending on how your body reacts to CIALIS. Do not drink alcohol to excess when taking CIALIS (for example, 5 glasses of wine or 5 shots of whiskey). When taken in excess, alcohol can increase your chances of getting a headache or getting dizzy, increasing your heart rate, or lowering your blood pressure. If you take too much CIALIS, call your doctor or emergency room right away. The most common side effects with CIALIS are headache, indigestion, back pain, muscle aches, flushing, and stuffy or runny nose. These side effects usually go away after a few hours. Patients who get back pain and muscle aches usually get it 12 to 24 hours after taking CIALIS. Back pain and muscle aches usually go away by themselves within 48 hours. Call your doctor if you get a side effect that bothers you or one that will not go away. If you get an erection that lasts more than 4 hours, get medical help right away. Priapism must be treated as soon as possible or lasting damage can happen to your penis including the inability to have erections. CIALIS may uncommonly cause vision changes, such as seeing a blue tinge to objects or having difficulty telling the difference between the colors blue and green. In rare instances, men taking PDE5 inhibitors (oral erectile dysfunction medicines, including CIALIS) reported a sudden decrease or loss of vision in one or both eyes. It is not possible to determine whether these events are related directly to these medicines, to other factors such as high blood pressure or diabetes, or to a combination of these. If you experience sudden decrease or loss of vision, stop taking PDE5 inhibitors, including CIALIS, and call a doctor right away. These are not all the possible side effects of CIALIS. For more information, ask your doctor or pharmacist. Store CIALIS at room temperature between 59` and 86`F (15` and 30`C). Keep CIALIS and all medicines out of the reach of children. Medicines are sometimes prescribed for conditions other than those described in patient information leaflets.
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