Ergomar

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking ergotamine and call your doctor at once if you have a serious side effect such as:

• sudden numbness or weakness, especially on one side of the body;
• sudden headache, confusion, problems with vision, speech, or balance;
• fast or slow heart rate;
• muscle pain in your arms or legs;
• leg weakness;
• numbness or tingling and a pale or blue-colored appearance in your fingers or toes;
• severe pain in your stomach or lower back;
• urinating less than usual or not at all;
• swelling or itching in any part of your body;
• cough with stabbing chest pain and trouble breathing; or
• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

• dizziness, spinning sensation;
• weakness;
• nausea, vomiting; or
• mild itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Dosage Forms & Strengths

tablet, SL

• 2 mg

Migraine

2 mg SL followed by 1-2 mg q30min until attack abated; not to exceed 6 mg/day and no more than 10 mg/week OR

Menopausal Hot Flashes

0.6 mg PO q12hr (as fixed combo with belladonna and phenobarbital)

Not to exceed 10 mg/week

Commercial oral tablets discontinued in USA; may be compounded

Dosage Forms & Strengths

tablet, SL

• 2 mg

Migraine (Off-label)

1 mg SL, THEN 1 mg q30min PRN, not to exceed 3 mg/episode

Not for very young children

Use not recommended

Mechanism of Action

Stimulates alpha receptors to vasoconstrict vessels with low vascular tone; vasodilates hypertonic vessels; at higher doses competes for alpha receptor to block it

Pharmacokinetics

Half-Life, elimination: 21 hr

Onset: Caffeine may enhance

Peak Plasma Time: 0.5-3 hr

Metabolism: Liver CYP3A4

Excretion: 90% bile

Dialyzable: Yes

This medication can harm an unborn baby or a nursing baby. Do not take ergotamine if you are pregnant or breast-feeding.

Do not take this medication if you are allergic to ergotamine or other ergot medicines, or if you have a history of heart disease, angina (chest pain), blood circulation problems, history of a heart attack or stroke, coronary artery disease, uncontrolled high blood pressure, severe liver or kidney disease, or a serious infection.

Using certain medications together with ergotamine can cause even greater decreases in blood flow than ergotamine used alone, which can lead to dangerous side effects. Tell your doctor about all other medications you are using.

Also tell your doctor about all of your medical conditions, especially high blood pressure, liver or kidney disease, or risk factors for coronary artery disease (diabetes, high blood pressure or cholesterol, menopause or hysterectomy, smoking, taking birth control pills, being overweight, having a family history of coronary artery disease, or being a man older than 40).

This medication will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.

Never take more than your prescribed dose of ergotamine. An overdose can be fatal.

General

Vascular Headaches

• Administer as soon as possible after onset of first symptoms of vascular headache.138 139 140

• After administering the initial dose, patient should lie down and relax in a quiet, darkened room.b

• Do not administer within 24 hours of a selective serotonin agonist (e.g., sumatriptan).115 116 144 145 (See Specific Drugs under Interactions.)

Administration

Administer orally or rectally (as fixed-combination preparation containing ergotamine and caffeine).139 140

Administer sublingually (as single-entity preparation).138

Sublingual Administration

Place tablets under the tongue and allow to dissolve.138

Rectal Administration

If suppositories become softened, chill them in ice-cold water to solidify before removing the foil wrapper.139

Dosage

Available as ergotamine tartrate; dosage expressed in terms of the salt.138 139 140

Adults

Fixed-combination ergotamine and caffeine (e.g., Cafergot) tablets: 2 mg of ergotamine tartrate (2 tablets) initially, followed by 1 mg at 30-minute intervals until attack has abated (maximum 6 mg per attack).140

For short-term prophylaxis of cluster headaches, 3–4 mg daily (in divided doses) has been administered for up to 3 weeks.135 142 May be administered 30–60 minutes prior to an expected attack in patients with consistent attack patterns.135 142 In selected patients with nocturnal attacks, 1–2 mg may be given at bedtime on a short-term basis.134 137 140 142 Monitor carefully to avoid excessive weekly dosages;142 give due consideration to recommended maximum weekly dosage (see Prescribing Limits under Dosage and Administration).140

Ergotamine tartrate (Ergomar) tablets: 2 mg (1 tablet) initially, followed by 2 mg at 30-minute intervals until attack has abated (maximum 6 mg per 24-hour period).138

For short-term prophylaxis of cluster headaches, 3–4 mg daily (in divided doses) has been administered for up to 3 weeks.135 142 May be administered 30–60 minutes prior to an expected attack in patients with consistent attack patterns.135 142 Monitor carefully to avoid excessive weekly dosages;142 give due consideration to recommended maximum weekly dosage (see Prescribing Limits under Dosage and Administration).140

Fixed-combination ergotamine and caffeine (e.g., Migergot) suppositories: 2 mg of ergotamine tartrate (1 suppository) initially.139 If necessary, may give a second 2-mg dose after 1 hour.139

In selected patients with cluster headaches at night, 1–2 mg may be given at bedtime on a short-term basis.137 139 142 Give due consideration to recommended maximum weekly dosage (see Prescribing Limits under Dosage and Administration).139 142

Prescribing Limits

Adults

Maximum 6 mg (6 Cafergot tablets) per attack or 10 mg (10 Cafergot tablets) per week.140

Maximum 6 mg (3 Ergomar tablets) per 24-hour period or 10 mg (5 Ergomar tablets) per week.138

Maximum 4 mg (2 Migergot suppositories) per attack or 10 mg (5 Migergot suppositories) per week.139

• Complex pharmacologic effects, including α-adrenergic blocking activity, direct stimulation of peripheral and cranial vascular smooth muscle, and serotonin antagonist activity.138 139 140

• Mechanism by which ergotamine aborts vascular headaches is probably direct vasoconstriction of dilated carotid artery bed.b

• Has greater vasoconstrictor activity than other ergot alkaloids but less α-adrenergic blocking activity than dihydroergotamine;b 138 139 140 weaker antagonist of serotonin than is methysergide.b

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• If you drink grapefruit juice or eat grapefruit often, talk with your doctor.
• This medicine is not meant for regular, daily use. Talk with the doctor.
• Do not use more than what your doctor told you to use. Do not use more often or longer than what you were told. Doing any of these things may raise the chance of very bad side effects.
• Use care if you have risks for heart disease (high blood pressure, high cholesterol, overweight, high blood sugar or diabetes, cigarette smoking, man older than 40 years of age, other family members with early heart disease, woman after change of life). Talk with your doctor.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking Ergomar, call your doctor right away.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Follow how to use as you have been told by the doctor or read the package insert.
• Take at the first sign of a migraine headache.
• Place under tongue and let melt all the way. Do not chew, suck or swallow tablet.

What do I do if I miss a dose?

• This medicine is taken on an as needed basis. Do not take more often than told by the doctor.

Contraindicated in pregnancy due to oxytocic effects which are maximal in the third trimester. Prolonged vasoconstriction of uterine vessels with increased myometrial tone may lead to reduced myometrial and placental blood flow and contribute to fetal growth retardation seen in animal studies.

FDA pregnancy category X. Use of ergotamine is contraindicated.

Summary of Use during Lactation

Because there is limited published experience with ergotamine during breastfeeding and it might cause adverse effects in the infant, most authorities consider ergotamine to be undesirable to use during nursing.[1][2]

Drug Levels

Maternal Levels. Relevant published information was not found as of the revision date.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

A study in which ergotamine was administered to mothers of newborns immediately postpartum in a dose of 1 mg 3 times daily for 6 days found no effect on weight gain in the breastfed infants.[3] Milk intake, and therefore infant dosage, might have been minimal during the first few days before the mothers' milk came in fully.

Effects on Lactation and Breastmilk

Thirty women who delivered fullterm infants received a single intramuscular dose of methylergonovine 0.2 mg after delivery, followed by oral ergotamine 1 mg 3 times daily for 6 days. Compared to 28 women who delivered fullterm infants and received no ergot derivatives, there was no difference in the milk production, as measured by weight differences before and after nursing, between the 2 groups during the first 6 days postpartum.[3]

Alternate Drugs to Consider

Sumatriptan, Eletriptan

References

1. Moretti ME, Lee A, Ito S. Which drugs are contraindicated during breastfeeding? Can Fam Physician. 2000;46:1753-7. PMID: 11013791

2. WHO Department of Child and Adolescent Health and Development. Breastfeeding and maternal medication. Recommendations for drugs in the eleventh WHO model list of essential drugs. 2002.

3. Jolivet A, Robyn C et al. [Effect of ergot alkaloid derivatives on milk secretion in the immediate postpartum period]. J Gynecol Obstet Biol Reprod (Paris). 1978;7:129-34. PMID: 641312