Significant adverse reaction

Among the most significant adverse reactions associated with the antipsychotic dm are the extrapyramidal effects. The term extrapyramidal effects refers to a group of adverse reactions occurring on the extrapyramidal portion of the nervous system as a result of antipsychotic drains. This part of the nervous system affects body posture and promotes smooth and uninterrupted movement of various muscle groups. Antipsychotics disturb the function of the extrapyramidal portion of the nervous system, causing abnormal muscle movement. Extrapyramidal effects include Parkinson-like symptoms (see Chap. 29), akathisia, and dystonia (see Display 32-1). 

Retain and submit to EPA records if significant adverse reactions to health or the environment, alleged to have been caused by a substance or mixture... 

Technical. Additional technical support in companies other than testing personnel will arise from the need for additional recordkeeping, such as the annual reports and TSCA inventory ( 8(a) and (b)), records of significant adverse reactions to health or environment ( 8(c)), records of applicable health and safety studies ( 8(d)), and notices of substantial risk to health or environment ( 8(e)). In larger... 

Significant adverse reactions include edema vaginitis nervousness emotional lability hepatic dysfunction elevated blood pressure pelvic pain carpal tunnel syndrome sleep disorders fatigue tremor visual disturbances anxiety depression gastroenteritis. 

Significant adverse reactions include a lupus erythematosus-like syndrome of arthralgia, pleural or abdominal pain, and sometimes arthritis, pleural effusion, pericarditis, fever, chills, myalgia, and possibly related hematologic or skin lesions (after prolonged administration) neutropenia thrombocytopenia agranulocytosis (after repeated use deaths have occurred) anorexia nausea vomiting abdominal pain bitter taste diarrhea. 

Significant adverse reactions include fatigue headache drowsiness paresthesias difficulty in micturition diarrhea reversible increases in serum transaminases dyspnea bronchospasm asthenia muscle cramps nausea vomiting fever with aching and sore throat toxic myopathy rashes systemic lupus erythematosus vision abnormality hypoesthesia ventricular arrhythmias intensification of AV block mental depression scalp tingling. 

Picrorhiza has been used widely in India, and no significant adverse reactions have been reported to date. The oral LD50 of Picrorhiza iridoid glycosides (known as kutkin ) is greater than 2600mg/kg in rats. 

Pentamidine is a well-established alternative therapy for pulmonary and extrapulmonary disease caused by P jiroveci. The drug has somewhat lower efficacy and greater toxicity than trimethoprim-sulfamethoxazole. The standard dosage is 3 mg/kg/d intravenously for 21 days. Significant adverse reactions are common, and with multiple regimens now available to treat P jiroveci infection, pentamidine is best reserved for patients with severe disease who cannot tolerate or fail other drugs. 

Scleroglucan has the caloric equivalent of starch in tests with rats. Studies with dogs, guinea pigs, humans, and rabbits demonstrate no significantly adverse reactions. With chicks and dogs, scleroglucan lowered the cholesterol levels and increased the excretion of lipid.361 Other polysaccharides also elicit this effect.361... 

Tropicamide, like atropine, cyclopentolate, and scopolamine, enters the systemic circulation rapidly. After applying two 40-ml drops of 0.5% tropicamide to one eye in eight patients, peak plasma concentrations were reached in 5 to 30 minutes but were variable (1.3 to 5.2 ng/ml).A mean peak concentration of 2.8 ng/ml was measured at 5 minutes. Despite the rapid systemic absorption, tropicamide has a low affinity for systemic muscarinic receptors.Thus adverse systemic reactions to tropicamide are quite rare. Two studies observed no significant adverse reactions associated with the use of tropicamide in 3,851 drug applications in patients undergoing ophthalmoscopy with either 0.5% or 1% tropicamide.The only reported effects were mild and transient transient changes in lOP on the order of 4 to 12 mm occurred in seven patients, and one individual experienced a transient intermittent esotropia. 

The largest manufacturer of Eplwdra-contammg supplements is Metabolife. The firm has repeatedly insisted that it was not aware of adverse events associated with its products, and claimed that they were absolutely safe (13). An investigation by the US Justice Department into the truth of these statements showed that between 1997 and 2002 the company had received over 13 000 reports of suspected adverse drug reactions they included nearly 2000 reports of significant adverse reactions. 

Nicardipine has scarcely been nsed in children. Intravenons nicardipine was effective in controlling blood pressnre in three cases of hypertensive emergency secondary to renal disease (5). Children aged 12-14 years received intravenous infusions of 1-3 pg/kg/minute for 3-27 days, which normalized blood pressure without significant adverse reactions. 

GAB-88 is an infusion solution containing amino acids (3%), dextrose (7.5%), and electrolytes in a dual-chamber plastic bag. It has been evaluated in 39 non-operative patients who were unable to tolerate oral feeding or to take adequate amounts by mouth (1). When it was given in a daily dose of 1.0-2.5 liters for 7-19 days, there was an improvement in nutritional status without obvious adverse effects. There was mild vascular pain in four patients, but no phlebitis. There were no other clinically significant adverse reactions. 

Allegations of Significant Adverse Reactions Recordkeeping and Reporting Rule... 

An allegation is defined as a statement, made without formal proof or regard for evidence, that a chemical substance or mixture has caused a significant adverse reaction to health or the environment. ... 

Continued reporting requirements are placed on persons that manufacture, process, or distribute in commerce any chemical substance or mixture and include (1) maintaining records of significant adverse reactions to health or the environment, alleged to have been caused by the substance or mixture (Section 8(c) of TSCA) and (2) immediately informing the U.S. ERA of ... information which reasonably snpports the conclnsion that such chemical substance or mixture presents a substantial risk of injnry to health or the environment, nnless the person has actual knowledge that the U.S. ERA has been adeqnately informed (Section 8(e) of TSCA). 

Arrangements made for notification of suspected/known reactions of clinical significance to any medicine prescribed or administered under the plan, or suspected or known clinically significant adverse reactions to any other medicine taken at the same time as any prescribed or administered under the plan... 

Rifampin is generally well tolerated. When given in usual doses, fewer than 4% of patients with tuberculosis have significant adverse reactions the most common are rash (0.8%), fever (0.5%), and nausea and vomiting (1.5%). The most notable problem is the development of jaundice. 

UNTOWARD EFFECTS In usual doses, <4% of patients with tuberculosis have significant adverse reactions to rifampin, most commonly rash (0.8%), fever (0.5%), and nausea and vomiting (1.5%). Rarely, hepatitis and deaths due to liver failure have been observed in patients who received other hepatotoxic agents, or who had preexisting liver disease. Hepatitis from rifampin rarely occurs in patients with normal hepatic function likewise, the combination of isoniazid and rifampin appears generally safe. Chronic liver disease, alcoholism, and old age increase the risk of severe hepatitis when rifampin is given alone or concurrently with isoniazid. 

In addition to the inhibition of the metabolism of propranolol, verapamil reportedly [58] inhibits the metabolism of metoprolol, another extensively metabolized beta blocker. As mentioned in the metabolism section, the O-demethylation pathway is the main metabolic pathway for the metabolism of metoprolol, accounting for 65% of the dose. Verapamil significantly inhibits this pathway in a stereoselective manner, favoring inhibition of the metabolism of R(+)-metoprolol [58]. The interaction of verapamil and metoprolol results in clinically significant adverse reactions, presumably owing to higher plasma concentrations of metoprolol. 

Ten female patients aged 66 to 90 years were given clomethiazole edisilate syrup SOO mg each evening and 250 mg each morning as a sedative, with furosemide 20 to 80 mg. No significant changes in the serum levels or effects of clomethiazole or furosemide were detected, and no other significant adverse reactions were seen. ... 

Oral administration of tienchi ginseng powder at 15 g/ kg did not cause any significant adverse reactions (Chen and Chen 2004). 

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