Hydergin Tablets
CODERGOCRINE MESYLATE
(mental)
INDICATIONS:
Symptoms and signs of mental deterioration, notably those related to ageing, dizziness, headache, poor concentration, disorientation, impaired memory, lake of initiative, mood depression, unsociability, difficulties with daily living activities and with self care.Acute cerebrovascular disease.
DOSAGE AND ADMINISTRATION:
General target population adults
Oral
The usual dose range of Codergocrine mesylate is 3 o 6 mg daily, in divided doses, preferably before meals.The dosage of the Codergocrine 1mg/ml oral solution is, 1.5 ml (30 drops) three times daily, preferably before meals.
The patients with mental deterioration, alleviation of symptoms is usually gradula and becomes menifest after 3 to 4 weeks. Hece prolonged therapy (3 months or more) is indicated and the course of treatment may be repeated as required
Parenteral:
In acute cerebrovascular disorders parenteral therapy is indicated initially in addition to oral treatment. 0.3 mg (1ml) codergocrine mesylate by i.v. drip or slow i.v. injection(in 20 mg dextrose or saline) once or twice daily. Alternatively, 0.3 mg (1ml) may be given intramuscularly or subcutaneously once to several times daily.Special Population
RENAL IMPAIRMENT
A lower starting dose should be considered in patients with severe renal impairment.Heptatic impairment
A lower starting dose should be considered, and a lower maintenace dose may be required in patients with hepatic impairment.Pediatric patients
No pediatric studies have been performed. The safety and Codergocrine mesylate in pediatric patients have not been established.METHOD OF ADMINISTRATON:
Codergocrine mesylate tablets are swalloed with a small amount of water. Codergocrine solution for injection is administered by i.v. drip or slow i.v. injection in 20 ml dextrose or saline). Alternatively, it may be given intramuscular, subcotaneously.Contra-Indications:
None.WARINGS AND PRECAUTION:
Codergocrine mesuylate has not been avaluated for use in acute manifestations of stroke, cerebrovascularaccident and sub arachnoid hemorrhage. Therefore, benefit risk of codergocrine mesylate in these patients is unknown and use of codergocrine is not recommended.Fibrotic Disorders:
Among patients on dihydroergocryptine (one of the constituents of Codergocrine mesylate), particularly on long term and high dose teratment, pleural and pericardial effusions, as well as pleural and pulmonary fibrosis, constrictive pericarditis and valvular heart disease have occasionally been reported. However, there is not enough evidence to determine whether there is an increased risk. Therefore, patients who present with unexplained cardiac and pleuropulmonary disorders should be examined thoroughly, and discontinuation of codergocrine mesylate therapy should be considered.It is recommended that, in patients for whom long term treatment with Codergocrine myselate is palnned, pretreatment echocardiography should be performed to rule out any evidence of pre existing cardiac valvulopathy.
Particularly on long term and high dose teratment, rare cases of retroperitoneal fibrosis have been reported. To ensure recognition of retroperitoneal fibrosis at an vigilant of signs and symproms (e.g. back pain, oedema of the lower limbs, impaired kidney function). In this catergory of patients. Codergocrine mesylate medication should be withdrawn if fibrotic changes in the retroperitoneum are diagnosed or suspected.
Cardiovascular disorders
Caution is requred in patients with severe bradycardia.Hepatic impairment
Patients with hepatic impairment should be approprately monitored. A lower starting dose should be considered, and a lower maintenace dose may be requred.Renal impairment:
Patients with severe renal impairment should b eappropriately monitored.Parenteral administration:
Blood pressure may fall, and should therfore be checked following parenteral administration.CYP3A4 Inhibitors
Cauition should be exercised on co administration of codergocrine mesylate with potent CYP3A4 inhibitrs - such as macrolide antibiotics (e.g troleandomycin, erythromycuin, clarithromycin) HIV protease or reverse transcriptase inhibitors (e.g ritonavir, indinavir, nelfinavir, delavirdine), or azole antifungals (e.g. ketoconazole, itraconazole, voriconazole), which may increase exposure to codergocine mesylate.ADVERSE DRUG REACTIONS:
The adverse drug reaction below have been derived from multiple sources, including post marketing experience with codergocrine mesylate. Adverse drug reactions (Tablet 1) are listed by frequency, the most frequent first, using the following convention: very common (1/10), < 1/10); uncommon (1/1000, < 1/100); are (1/10000) including isolated reports. As post marketing ADRs are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequecny.WOMEN OF CHILD BEARING POTENTIAL
There is no information available to suggest special recommendations for women of child bearing otential.PREGNANCY:
Data on the use of codergocrine mesylate in pregnant women are very limited. Isolated cases of fatal malformation have, however, been reported. Codergocrine should be used druging pregnancy only if the expected benefit outweighs the potential risk to the fetus.In rats, embryo/fetotaxic effects were observed but only at high codergocrinedoses that were toxic to the meternal anima and in large excess of the clinical dose.
BREAST FEEDING
It is not known if codergocrine mesylate passes into the breast milk. Dihydroergocryptine (one of the codergocrine mesylate constituents) has been shown to inhibit lactation. The treating physicial should carefully evaluate the risks and benefits of using Codergocrine mesylate and therapy should only be continued if the expected benefits clearly outweigh the potential risks.Fertility:
There is no information available on the effects of Codergocrine on human fertility.OVERDOSAGE:
There have been only a small number of reports of overdose with Codergocrine mesylate. Most cases have been asymptomatic, or have involved unspecific, non serious symptoms. There hvae vbeen isolated reports of hallucinations. In the event of overdose administration of activated charcoal is recommended.Treatment should be symptomatic.
Local tolerance:
A local tolerance study was conducted in rabbits. Injectionsites were examined macroscopically and microscopically at 24 and 48 hours after the injections. Codergocrine ampoule solution was well tolerated intramuscularly. The initial, concentration dependent slight irritation caused by the solution for injection was reduced considerably with 48 hours of administration.INCOMPATIBILITIES
Not applicable for tablets, capsules and oral solution.In the absence of compatibility studies, Codergocrine mesylate solution for injection should not be mixed with other drugs.
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