Drug Interaction:
Ergotamine derivatives include-
Dihydrergotamine mesylate, Ergotamine tartarate, Methysergide maleate
Drug interactions- Summary
Betablockers +
increased cold extremities
CYP3A4 inhibitors / eg.protease inhibitors/ macrolides,ketoconazole/ itraconazole, nefazodone,/ fluconazole, fluvoxamine,/ delavirdine, erfavirenz
increased risk of ergot toxicity
Nicotine
increase/ provoke vasoconstriction and response
Siburamine
Co-admin. is not recommended.
Dihydrogotamine + Nitrates
decreased effects
Ergot alkaloids + 5-HT1 receptor
Admin of 5-HT1 receptor agonists or ergot agonists/ alkaloids within 24 hours of each other is contraindicated
Ergot alkaloids + vasoconstrictors
concurrent use can combine to cause dangerous hypertension.
Indication:
Age related mental capacity decline
Adverse Reaction:
Nausea,vomiting,headache,blurring vision,skin rashes,nasal stuffiness, flushing, dizziness,
Bradycardia and orthostatic hypotension.
Sublingual administration: local irritation.
Contra-Indications:
In individuals hypersens to the drug,chronic psychoses.
Special precautions:
Patients susceptible to acute intermittent porphyria attacks.Pregnancy.
Avoid prolonged administrartion - or excessive dosage because of the danger of ergotism and gangrene.
Drug abuse and dependence- patients who take ergotamine for extended periods of time become dependent upon it and require increasing doses for relief of vascular headache and for prevention of dysphoric effects which follow withdrawal
.
Warnings-
Pregnancy- although no specific teratogenic effects have been found the fetus suffers if ergotamine is given to the mother.
Lactation- excercise caution when administering to a nursing woman.
Children- safety and efficacy for use in children have not been established
Dosages/ Overdosage Etc:
Indications:
Age related mental capacity decline
Dosage:
1mg 3 times a day. Doses upto 4.5 to 12mg/day have been given . A period of atleast 6
mths may be necessary to detremine effixcacy and dose response..
Overdosage-
Symptoms
Nausea, vomiting, weakness of the leg, pain in limb muscles,numbness and tingling of fingers and toes, precordial pain, tachycardia or bradycardia, hypertension or hypotension, and localized edema and itching with signs and symptoms of ischemia due to vasoconstriction or peripheral arteries or arterioles.
The feet and hand become cold pale and numb. Muscle pain occurs while walking orat rest too.
Gangrene may ensue.Confusion, depression, drowsiness and convulsions are occassional signs of ergotamine toxicity.
Overdosageis particularly likely to occur in patients with sepsis or impaired renal or hepatic
function.
Patients with peripheral vascular disease are specially at risk of developing peripheral ischema following treatment with ergotamine.
Treatment
1. Treatment consists of withdrawal of the drug followed by symptomatic measures including attempts to maintain an adequate circulation inthe affected parts.
2. Anticoagulant drugs, low molecular weight dextran and potent vasodilator drugs may all be beneficial.
3. IV infusion of sodium nitroprusside has been successful.
4. Vasodilators must be used with special care in presence of hypertension.
5. Ergotamine is dialyzable,.
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.May cause transient nausea and GI disturbances
2.Allow sublingual tablets to completely dissolve under tongue,.
3. Allergies- Tell your doctor if you have ever had any unusual or allergic reactions to ergot alkaloids or related medicines. Also tell your doctor if your are allergic to any other substances such as foods, preservatives or dyes.
4. Other medical problems- tell your doctor if you are taking any of the following-
Liver disease - higher blood levels of ergoloid mesylate may occur,increasing the chance of side effects.
Low blood pressure or
Other mental problems or
Slow heart beat - ergoloid mesylates may make the condition worse
13. Missed dose-
If you miss a dose of this medicine take it as soon as possible. However if it is almost time for your next dose go back to your regular dosing schedule.
Do not double doses.
12. Storage -
Keep out of reach of children. Store away from heat or direct sunlight. Do not store
the capsule in bathroom, near the kitchen sink, or in other damp places.
13. Outdated medicines -
Do not keep outdated medicine or medicine no longer needed. Be sure that any
discarded medicine is out of reach of children.
Pharmacology/ Pharmacokinetics:
Pharmacology:
The mechanism by which ergoloid mesylates produce mental effects is unknown. There is no
conclusive evidence they directly affect cerebral arterioscelerosis or cerebral vascular
insufficiency. It seem to act by primarily to increase brain metabolism,possibly increasing
cerebral blood flow. It does not possess the vasoconstrictor properties of the natural ergot
alkaloids
Pharmacokinetics:
Rapidly absorbed from the GI tract; peak plasma concentrations are acheived within 0.6 to 3
hours. The drug undergoes rapid first pass mechanism in liver.
Interaction with Food:
Reports not available.
Pregnancy and lactation:
Pregnancy-
Although no specific teratogenic effects have been found the fetus suffers if ergotamine is given to the
mother.
Lactation-
Excercise caution when administering to a nursing woman.
Children-
Safety and efficacy for use in children have not been established