Drug Interaction:
Interacting drugs- summary
Selegiline +
Fluoxetine
Death occurred following initiation of nonselective MAOIs shortly after
discontinuation of fluoxetine. Avoid this combination
Meperidine
Reports of fatal interactions MAOIs are ordinarily contraindicated for
use with Meperidine. Avoid this combination
Indication:
Adjunct in management of Parkinsonian patients
New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Selegiline Hcl Anti-Parkinsonism August 1991
Adverse Reaction:
CNS- Tremors,chorea,imbalance,restlessness,bradykinesia, blepharospasm, facial grimance, heavy legs, tardive dyskinesia, dystonia, dyskensia,involuntary movements, freezing destination, aparxia, cramps.
Pain altered sensation- Headache, back/leg pain, tinnitus, migraine, superorbital pain, throt burning, generalized ache, chills, numbness of fingers/toes, tast disturbances
Mental status- Hallucinations,dizziness,confusin,anxiety,depression,drowsiness,mood swings, dreams, delusions,disorientation,light-headness,lethargy, stimualtion irritabilty, restlessness,
Cardiovascular- Orthostatic hypotension,hypertension, arrhythmia, palpitations, angina, bradycardia,tachycardia, syncope.
GI- Nausea, vomiting, constipation, weight loss, anorexia, poor appetite, dysphagia, diarrhoea, heartburn, rectal bleeding, GI bleeding (exacerabation of preexisting ulcer disease)
GU- Slow urination, transcient nocturia,urinary hesitancy, urinary frequency and retention, sexual dysfunction
Dermatologic- Increased sweating, rash, photosensitivity,hairloss, photosensitivity
Miscellaneous- Asthma, diplopia, shortness of breath, speech affected, dry mouth, blurred vision
Contra-Indications:
Tardive dyskinesia, adult onset huntingtons disease, levodopa psychoses.
Special precautions:
Safety in pregnancy and lactation not established.
Warning
Maximun dose- Do not use at daily doses exceeding those recommended (10mg/day) because of the risks associated with nonselective inhibition of MAO
Pregnancy- Use during pregnancy only if clearly needed.
Lactation- It is not known whether selegiline is excreted in breast milk.
Children- The effects of selegiline in children have not been established
Dosages/ Overdosage Etc:
Date of Approval 1991
Indications:
Adjunct in management of Parkinsonian patients
Dosage:
Parkinsonian patients receiving levodopa/carbadopa therapy: 10 mg/day administered in divided doses of 5mg each taken at breakfast and lunch.
Overdosage-
Symptoms Some individuals exposed to doses of 600mg di-selegine suffered hypotension and psychomotor agitation.
Treatment
1. Treat hypotension and vascular collapse with IV fluids and if necessary, blood pressure titration with an IV infusion of a dilute pressor agent.
2. Adrenergic agents may produce a markedly increased pressor response.
Missed dose-
1. If you miss a dose of this medicine, take it as soon as possible.
2. However, if it is almost time for next dose, skip the missed dose and go back to your regular dosing schedule.
3. Do not double doses.
Other Information:
For Availability/supplies
Contact -
1.Indian Drug Manufacturers Association (IDMA)
Phone- 022- 24944624/ 24974308
Fax- 022- 24950723
Email- idma@vsnl.com
Website: www.idma-assn.org
2.Bulk Drug Manufacturers Association (India)(BDMA)
Phone - 040-23703910/ 23706718
Fax- 040-23704804
Email- info@bdmai.org
Website: www.info@bdmai.org
Patient Information:
1.Advise patients of possible need to reduce levodopa dosage after therapy
initiation.
2. Do not exceed the daily recommended dose of 10mg.
3.Report any unusual symptoms to your physician.
4. To be taken at breakfast and lunch
Ref - USP PDI Vol II 17th Edition (1997)
SELEGILINE -SYSTEMIC
1.Allergies-
Tell your doctor if you have ever had any unusual or allergic reaction to
Selegine. Also tell your healthcare care professional if you are allergic
to any other substances such as foods. preservatives or dyes.
2.Pregnancy-
Selegine has not been studied in pregnant women. However, this medicine
has not been shown to cause birth defects or other problems in animal studies
3. Breast-feeding-
It is not known whether selegiline passes into breast milk.
4.Children-
Studies of the medicine has been done only in adult patients and there
is no specific about it use in children. Therefore be sure to discuss with
your doctor the use of this medcine in children.
5.Older adults-
In studies done to date that included elderly people, selegiline did not cause
different side effects or problems in older people than it did in younger people.
6. Other medicines-
Tell your doctor if you are using any of the following -
Antidepressants or
Fluoxetine or
Meperidine or
Netazodone or
Paroxetine or
Sertraline or
Venlafaxine - using these medicines together may increase the chance of
side effects
7. Other medical problems-
Make sure you tell your doctor if you have any other medical problems
especially-
Stomach ulcer ( history of) selegiline may make the condition worse
Pharmacology/ Pharmacokinetics:
Pharmacology:
Selegine hcl is a levorotatary acetylenic derivative of phenethylamine. The mechanism of action is not clearly understood. Inhibition of of monoamine oxidase type B activity is of primary importance.
Pharmacokinetics:
Seleginine is rapidly absorbed and the maximum plasma level is reached in in 0.5 to 2 hours on administration.. The drug is rapidly metabolised.
Interaction with Food:
To be taken at breakfast and lunch
Pregnancy and lactation:
Pregnancy:
Adequate and well controlled studies not available. Use in pregnancy only if required.
Lactation:
Not known whether th drug is excreted in breast milk. Observe caution and decide to discontinue nursing or discontinue the drug depending on the importance of the drug to the mother.
Children-
The effects of selegiline in children have not been established
Manufacturer Details