PLACIDYL CAP 500MG 500 MG — DIN 00000027

What is PLACIDYL CAP 500MG?

PLACIDYL CAP 500MG 500 MG contains ETHCHLORVYNOL : 500 MG. It is listed in the Health Canada Drug Product Database under DIN 00000027, held by ABBOTT LABORATORIES, LIMITED, supplied as CAPSULE for ORAL administration. Health Canada currently lists it as cancelled post market, status dated 06-Jun-2008. This Drug Identification Number is no longer authorized for sale in Canada, so Nexara does not supply it. The record is kept here because buyers still meet the number on old formularies, purchase orders and tender documents; Nexara can help identify an authorized alternative.

What is PLACIDYL CAP 500MG used for?

APO-NEFAZODONE (nefazodone HCl) is indicated for the symptomatic relief of depressive illness. The effectiveness of APO-NEFAZODONE in long-term use (i.e. for more than 6 to 8 weeks) has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use APO-NEFAZODONE for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

How is it administered?

Adults: APO-NEFAZODONE (nefazodone HCl) should usually be initiated at 100 to 200 mg/day (50 to 100 mg bid). The dose may then be increased in increments of 100 to 200 mg/day, administered in 2 divided doses, at intervals of not less than one week, depending on clinical response and tolerability. In controlled clinical trials designed to establish the efficacy of nefazodone HCl, patients were given doses ranging from 100 to 600 mg per day, administered in divided doses. These studies indicate that most patients responded at daily doses ranging from 300 to 500 mg. Several weeks on treatment may be required to obtain the full therapeutic effect. Elderly or Debilitated Patients: The recommended initial dose for these patients is 100 mg/day (50 mg bid). These patients often have reduced nefazodone clearance and/or increased sensitivity to the side effects of CNS-active drugs. It may be appropriate to modify the rate of subsequent dose titration and final target dose based on a careful assessment of the patient's clinical response. Switching Patients To or From a Monoamine Oxidase Inhibitor (MAOI): At least 14 days should elapse between discontinuation of a MAOI and initiation of therapy with APO-NEFAZODONE. In addition, at least 7 days should be allowed after stopping APO-NEFAZODONE before starting a MAOI (see WARNINGS and PRECAUTIONS).

Included because it drives pack selection and wastage. Consult the monograph.

Contraindications

Hypersensitivity: APO-NEFAZODONE (nefazodone HCl) is contraindicated in patients with known hypersensitivity to nefazodone, any component of the formulation or other phenylpiperazine antidepressants. Monoamine Oxidase Inhibitors: APO-NEFAZODONE should not be used in combination with monoamine oxidase inhibitors or within two weeks of terminating treatment with monoamine oxidase inhibitors. Monoamine oxidase inhibitors should not be introduced until at least 7 days after the cessation of APO-NEFAZODONE therapy (see PRECAUTIONS, Drug Interactions). Terfenadine, Astemizole, Cisapride: Co-administration of terfenadine, astemizole or cisapride with APO-NEFAZODONE is contraindicated (see PRECAUTIONS, Drug Interactions).

Warnings and precautions

As with other antidepressants, nefazodone has been associated with case reports of jaundice, hepatitis and liver failure which, in very rare cases, have resulted in liver necrosis and liver failure or death. Clinical manifestations of hepatic injury in patients have included the following: anorexia, fatigue, asthenia, malaise, abdominal pain, nausea, vomiting, discoloured stools, dark urine, prolonged coagulation, weight loss, jaundice, ascites, confusion, asterixis, encephalopathy, and hepatic coma. Laboratory evidence of hepatotoxicity has included increased levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, gamma-glutamyl transpeptidase (GGT), and bilirubin, as well as increased prothrombin times. No known risk factors have been identified. While it is not possible to definitively exclude nefazodone as a possible etiology, some of the reported cases have multiple confounding factors (eg., underlying disease, and concomitant exposure to various hepatotoxic agents, including alcohol and other medications). In some of the very rare cases, the liver damage was fatal or required liver transplantation (see ADVERSE REACTIONS). Prior to prescribing nefazodone, physicians should inform their patients to be alert to the premonitory signs and symptoms listed above and to seek emergency medical attention if these develop. The appearance of signs and symptoms of hepatotoxicity is an indication for immediate termination of nefazodone treatment and close medical monitoring of the patient. In most cases of liver dysfunction, discontinuation of nefazodone has been associated with recovery, while in very rare cases hepatic dysfunction has progressed to liver failure and, even more rarely, death. Interaction With Triazolobenzodiazepines: Nefazodone has been reported to increase the plasma levels of certain triazolobenzodiazepines (i.e. triazolam and alprazolam) metabolized by cytochrome P450IIIA4 resulting in an enhancement of the psychomotor impairment caused by these agents (see PRECAUTIONS, DRUG INTERACTIONS). If alprazolam is to be co-administered with nefazodone, a 50% reduction in the initial alprazolam dosage is recommended. The concomitant use of nefazodone and triazolam is not recommended. Interactions With HMG-CoA Reductase Inhibitors: Nefazodone has been demonstrated to increase plasma levels of certain 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors (i.e. simvastatin and atorvastatin) metabolized by cytochrome P450IIIA4. In a drug interaction study, subjects received single 40 mg doses of simvastatin, atorvastatin or pravastatin prior to nefazodone and following one week of administration of 200 mg bid nefazodone. AUC values obtained during nefazodone co-administration were increased over baseline values 20 fold for simvastatin and 3.4 fold for atorvastatin. Pravastatin was affected to a lesser degree (30% increase in AUC). There have been rare reports of increased creatine phosphokinase and/or rhabdomyolysis in patients receiving nefazodone in combination with the HMG-CoA reductase inhibitors, lovastatin or simvastatin, known substrates for cytochrome P450IIIA4. Severe myopathy and rhabdomyolysis have been observed in patients receiving HMG-CoA reductase inhibitors in combination with inhibitors of the P450IIIA4 isoenzyme. As nefazodone is known to inhibit this isoenzyme, extreme caution should be observed if the combined use of nefazodone with simvastatin, lovastatin, atorvastatin or cerivastatin is to be undertaken. Metabolic interactions are unlikely between nefazodone and HMG-CoA reductase inhibitors that undergo little or no metabolism by the CYPIIIA4 isozyme, such as pravastatin or fluvastatin. Priapism: Nefazodone has been associated with the occurrence of rare events of priapism. In some of the cases reported, surgical intervention was required. Male patients with prolonged or inappropriate erections should immediately discontinue nefazodone and consult t