Adult Dosing

To abort or prevent vascular headaches

• 2 TABS PO at the start of attack, followed by 1 TAB q1/2 hr PRN for full relief
• Max: 6 TABS/attack, 10 TABS/week

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• To abort or prevent vascular headaches (migraine, migraine variants or so called “histaminic cephalalgia”)

• Hypersensitivity to any of the ingredients of the product
• Coadministration with potent CYP 3A4 inhibitors like ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, troleandomycin, ketoconazole and itraconazole
• Women who are or may become pregnant
• Peripheral vascular disease
• Coronary heart disease
• Hypertension
• Hepatic or renal impairment
• Sepsis

• Serious and/or life-threatening peripheral ischemia may occur when given in combination with potent CYP3A4 inhibitors including protease inhibitors and macrolide antibiotics
• CYP3A4 inhibition elevates the drug serum levels of ergotamine tartrate and caffeine and increases the risk for vasospasm leading to cerebral ischemia and/or ischemia of the extremities. Therefore, concomitant use of these medications is contraindicated

Renal Dose Adjustment

• Renal impairment: Contraindicated

Hepatic Dose Adjustment

• Hepatic impairment: Contraindicated

See Supplemental Patient Information

• Serious and/or life-threatening adverse events may occur when given in combination with potent CYP3A4 inhibitors. Concomitant use of these medications is contraindicated [US Black Box Warning]
• Serious toxicity such as vasospasm may occur when used concomitantly with CYP3A4 inhibitors. Consider the effects on CYP3A4 of other agents being considered for concurrent use with ergotamine
• Retroperitoneal and pleuropulmonary fibrosis have been developed in patients receiving ergotamine and caffeine therapy; there have been rare cases of fibrotic thickening of the aortic, mitral, tricuspid, and pulmonary valves with long-term continuous use of this therapy. Avoid using ergotamine tartrate tabs for chronic daily administration
• Chronic intoxication with ergot derivatives may produce headache, intermittent claudication, muscle pains, numbness, coldness, and pallor of the digits. If untreated, this condition may lead to gangrene. Most cases of ergotism have resulted from frank overdosage, while some were associated with apparent hypersensitivity
• Signs and symptoms of ergotism, manifested by intense arterial vasoconstriction producing signs and symptoms of peripheral vascular ischemia, may develop with long-term intermittent use of ergotamine. Exercise caution to remain within the limits of recommended dosage
• Use with sympathominetics (pressor agents) may cause extreme elevation of blood pressure
• Withdrawal symptoms consisting of rebound headache may occur upon discontinuation of this drug in patients who have used this medication indiscriminately over prolonged periods

Cautions: Use cautiously in

• Ergotism
• Cardiac risk factors
• Valvular heart disease

Supplemental Patient Information

• Advise patients to take two tablets of ergotamine tartrate and caffeine at the first sign of a migraine headache; inform them not to take more than 6 tablets for any single migraine attack
• Instruct patients that no more than 10 tablets should be taken during any 7-day period
• Instruct patients not to use ergotamine tartrate and caffeine tabs for chronic daily administration
• Advise patients to promptly report to their physician if any numbness or tingling in the fingers and toes, weakness in the legs, muscle pain in the arms and legs, chest pain or temporary speeding or slowing of the heart rate, swelling or itching develops

Cafergot interacts with :

	Agenerase
	Akne-mycin
	Almotriptan
	Alsuma
	Amerge
	Amiodarone
	Amprenavir
	Aprepitant
	Atazanavir
	Axert
	Biaxin
	Biaxin XL
	Calan
	Calan SR
	Cardizem
	Cardizem CD
	Cardizem LA
	Cartia XT
	Cetraxal
	Ciloxan
	Cipro
	Cipro IV
	Cipro XR
	Ciprofloxacin
	Clarithromycin
	Conivaptan
	Cordarone
	Covera-HS
	Crixivan
	Cyclosporine
	Darunavir
	Delavirdine
	Diflucan
	Dilacor XR
	Dilt-CD
	Diltiazem
	Diltzac
	Dronedarone
	E-Mycin
	E.E.S.
	Eletriptan
	Emend
	Ery-Tab
	Eryc
	Erygel
	Eryped
	Erythra-Derm
	Erythro-statin
	Erythrocin
	Erythromycin
	Extina
	Fluconazole
	Fluvoxamine
	Frova
	Frovatriptan
	Gengraf
	Gleevec
	Grapefruit
	Imatinib
	Imitrex
	Imitrex STATdose
	Incivek
	Indinavir
	Invirase
	Isoptin
	Isoptin SR
	Itraconazole
	Ketek
	Ketoconazole
	Lapatinib
	Luvox
	Luvox CR
	Maxalt
	Maxalt-MLT
	Multaq
	Naratriptan
	Nefazodone
	Nelfinavir
	Neoral
	Nexterone
	Nizoral
	Nizoral A-D Shampoo
	Nizoral Shampoo
	Norvir
	Noxafil
	Onmel
	Pacerone
	PCE
	Pediamycin
	Posaconazole
	Prezista
	Proquin XR
	Quinupristin
	Relpax
	Rescriptor
	Restasis
	Reyataz
	Ritonavir
	Rizatriptan
	Sandimmune
	Saquinavir
	Sporanox
	Sumatriptan
	Sumavel DosePro
	Synercid
	TAO
	Taztia XT
	Telaprevir
	Telithromycin
	Tiazac
	Troleandomycin
	Tykerb
	Vaprisol
	Veralan
	Verapamil
	Verelan PM
	Vfend
	Viracept
	Voriconazole
	Xolegel
	Zecuity
	Zolmig
	Zolmitriptan
	Zomig
	Zomig nasal spray
	Zomig-ZMT

Pregnancy Category:X

Breastfeeding: Adverse event like fussiness, jitteriness and poor sleep patterns have been reported in the infants of mothers with very high caffeine intakes, equivalent to 10 or more cups of coffee daily. No stimulatory effects found on infants 3 wks were observed in mothers taking 5 cups of coffee daily. Preterm and younger newborn infants metabolize caffeine very slowly and may have serum levels of caffeine and other active caffeine metabolites similar to their mothers. Decreased breastmilk iron concentrations causing mild iron deficiency anemia in some breastfed infants may occur on intake of >450 mL of coffee. Due to limited published experience with ergotamine during breastfeeding and because there is a possibility of adverse effects in the infants, it is not considered compatible for use during breastfeeding. This information is (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACTlast accessed 17 October 2013). According to the manufacturer's data, a decision should be made for discontinuing nursing or discontinuing the drug analyzing the importance of the drug to the mother.

• CV: Ischemia, cyanosis, absence of pulse, cold extremities, gangrene, precordial distress and pain, EKG changes, transient tachycardia or bradycardia, hypertension
• RESP: Retroperitoneal and/or pleuropulmonary fibrosis
• MUSC: Muscle pain
• GI: Nausea, vomiting
• NEURO: Paresthesia, vertigo, numbness, weakness
• HYPERSENSITIVITY: Localized edema, itching

Caffeine

• Cranial vasoconstrictor; Caffeine stimulates medullary, vagal, vasomotor, and respiratory centers, promoting bradycardia, vasoconstriction, and increased respiratory rate
• Rapidly absorbed
• Metabolized by liver; CYP450: CYP1A2
• Excreted in urine (1% unchanged)
• Half life: 3-7 hrs (Adults), 65-130 hrs (neonates)

Ergotamine

• Alpha adrenergic blocker; it has direct stimulating effect on the smooth muscle of peripheral and cranial blood vessels and produces depression of central vasomotor centers
• Metabolized by liver
• Excreted in bile: 90 %
• Half life: 2 hrs

US Trade Name(s)

• Cafergot

US Availability

caffeine/ergotamine (generic)

• TABS: 100 mg/1mg

Cafergot (caffeine/ergotamine)

• TABS: 100 mg/1mg

Canadian Trade Name(s)

• Cafergot

Canadian Availability

Cafergot (caffeine/ergotamine)

• TABS: 100 mg/1mg

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Ophthalmic

Ophthalmic Mydriatics

Pricing data from www.DrugStore.com in U.S.A.

• Cafergot 1-100 MG TABS [Bottle] (SANDOZ)
  30 mg = $105.99
  90 mg = $309.96

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Drug Name: Caffeine 100 MG / Ergotamine 1 MG Oral Tablet

Ingredient(s): Caffeine mixture with Ergotamine

Imprint: 123;MH

Color(s): White

Shape: Round

Size (mm): 11.00

Score: 1

Inactive Ingredient(s): colloidal silicon dioxide / crospovidone / fd & c blue #2 aluminum lake / fd & c red #40 aluminum lake / fd & c yellow #5 tartrazine aluminum lake / magnesium stearate / microcrystalline cellulose / polyethylene glycol / polyvinyl alcohol / water / talc / titanium dioxide

Drug Label Author:
MIKART, INC

DEA Schedule:
Non-Scheduled

Drug Name: Caffeine 100 MG / Ergotamine 1 MG Oral Tablet

Ingredient(s): Caffeine mixture with Ergotamine

Imprint: WW;120

Color(s): White

Shape: Round

Size (mm): 10.00

Score: 1

Inactive Ingredient(s): corn starch / sugar 6x powder / mannito / compressible sugar / microcrystalline cellulose / colloidal silicon dioxide / sodium starch glycolate / magnesium / fd&c blue lake #2 / fd&c yellow lake #6 / hydroxypropyl / methylcellulose / polyethylerne gylcol titanium dioxide / amide resin / black pigment / natural resin / wax

Drug Label Author:
West-ward Pharmaceutical Corp.

DEA Schedule:
Non-Scheduled