ergotamine tartrate and caffeine

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Overview

What is ergotamine tartrate and caffeine?

Each tablet for oral administration contains 1 mg ergotamine tartrate, USP, and 100 mg caffeine, USP.

ERGOTAMINE TARTRATE:

(C H N O ) • C H O

M.W. 1313.41

Ergotaman-3’,6’,18-trione, 12’-hydroxy-2’-methyl-5’-(phenyl-methyl)-, (5’α), [R-(R*, R*)]-2,3-dihydroxy-butanedioate (2:1) (salt)

CAFFEINE:

C H N O (anhydrous)

M.W. 194.19

1 -Purine-2,6-dione, 3,7-dihydro-1,3,7-trimethyl-

Inactive ingredients include colloidal silicon dioxide, crospovidone, magnesium stearate, and microcrystalline cellulose. Film coating includes the following ingredients: macrogol/PEG 3350, polyvinyl alcohol, purified water, talc, titanium dioxide, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, and FD&C yellow #5 tartrazine aluminum lake.

What does ergotamine tartrate and caffeine look like?

What are the available doses of ergotamine tartrate and caffeine?

Sorry No records found.

What should I talk to my health care provider before I take ergotamine tartrate and caffeine?

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How should I use ergotamine tartrate and caffeine?

Ergotamine tartrate and caffeine tablets are indicated as therapy to abort or prevent vascular headache; e.g., migraine, migraine variants or so-called “histaminic cephalalgia.”

Procedure: For the best results, dosage should start at the first sign of an attack. Adults: Take 2 tablets at the start of attack; 1 additional tablet every ½ hour, if needed for full relief (maximum 6 tablets per attack, 10 per week).

Maximum Adult Dosage:

Total daily dose for any one attack should not exceed 6 tablets. Total weekly dosage should not exceed 10 tablets. Ergotamine tartrate and caffeine tablets should not be used for chronic daily administration. In carefully selected patients, with due consideration of maximum dosage recommendations, administration of the drug at bedtime may be an appropriate short-term preventive measure.

What interacts with ergotamine tartrate and caffeine?

Coadministration of ergotamine with potent CYP 3A4 inhibitors (ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, and troleandomycin) has been associated with acute ergot toxicity (ergotism) characterized by vasospasm and ischemia of the extremities (see ), with some cases resulting in amputation. There have been rare reports of cerebral ischemia in patients on protease inhibitor therapy when ergotamine tartrate and caffeine tablets was coadministered, at least one resulting in death. Because of the increased risk of ergotism and other serious vasospastic adverse events, ergotamine use is contraindicated with these drugs and other potent inhibitors of CYP 3A4 (e.g., ketoconazole, itraconazole) (see ).

Ergotamine tartrate and caffeine tablets may cause fetal harm when administered to pregnant women. Ergotamine tartrate and caffeine tablets is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy or if the patient becomes pregnant while taking this product, the patient should be apprised of the potential hazard to the fetus.

Peripheral vascular disease, coronary heart disease, hypertension, impaired hepatic or renal function and sepsis.

Hypersensitivity to any of the components.

What are the warnings of ergotamine tartrate and caffeine?

CYP 3A4 Inhibitors (e.g. Macrolide Antibiotics and Protease Inhibitors)

Coadministration of ergotamine with potent CYP 3A4 inhibitors such as protease inhibitors or macrolide antibiotics has been associated with serious adverse events; for this reason, these drugs should not be given concomitantly with ergotamine . While these reactions have not been reported with less potent CYP 3A4 inhibitors, there is a potential risk for serious toxicity including vasospasm when these drugs are used with ergotamine. Examples of less potent CYP 3A4 inhibitors include: saquinavir, nefazodone, fluconazole, fluoxetine, grapefruit juice, fluvoxamine, zileuton, metronidazole, and clotrimazole. These lists are not exhaustive, and the prescriber should consider the effects on CYP 3A4 of other agents being considered for concomitant use with ergotamine.

Fibrotic Complications

There have been a few reports of patients on ergotamine tartrate and caffeine therapy developing retroperitoneal and/or pleuropulmonary fibrosis. There have also been rare reports of fibrotic thickening of the aortic, mitral, tricuspid, and/or pulmonary valves with long-term continuous use of ergotamine tartrate and caffeine. Ergotamine tartrate and caffeine tablets should not be used for chronic daily administration (see ).

What are the precautions of ergotamine tartrate and caffeine?

This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

General

Although signs and symptoms of ergotism rarely develop even after long-term intermittent use of the orally administered drug, care should be exercised to remain within the limits of recommended dosage.

Ergotism is manifested by intense arterial vasoconstriction, producing signs and symptoms of peripheral vascular ischemia. Ergotamine induces vasoconstriction by a direct action on vascular smooth muscle. In chronic intoxication with ergot derivatives, headache, intermittent claudication, muscle pains, numbness, coldness, and pallor of the digits may occur. If the condition is allowed to progress untreated, gangrene can result.

While most cases of ergotism associated with ergotamine treatment result from frank overdosage, some cases have involved apparent hypersensitivity. There are few reports of ergotism among patients taking doses within the recommended limits or for brief periods of time. In rare instances, patients, particularly those who have used the medication indiscriminately over long periods of time, may display withdrawal symptoms consisting of rebound headache upon discontinuation of the drug.

Information for Patients

Patients should be advised that two tablets of ergotamine tartrate and caffeine tablets should be taken at the first sign of a migraine headache. No more than 6 tablets should be taken for any single migraine attack. No more than 10 tablets should be taken during any 7-day period. Administration of ergotamine tartrate and caffeine tablets should not exceed the dosing guidelines and should not be used for chronic daily administration (see ). Ergotamine tartrate and caffeine tablets should be used only for migraine headaches. It is not effective for other types of headaches and it lacks analgesic properties. Patients should be advised to report to the physician immediately any of the following: numbness or tingling in the fingers and toes, muscle pain in the arms and legs, weakness in the legs, pain in the chest or temporary speeding or slowing of the heart rate, swelling or itching.

Drug Interactions

See and .

Ergotamine tartrate and caffeine tablets should not be administered with other vasoconstrictors. Use with sympathomimetics (pressor agents) may cause extreme elevation of blood pressure. The beta-blocker Inderal (propranolol) has been reported to potentiate the vasoconstrictive action of ergotamine tartrate and caffeine tablets by blocking the vasodilating property of epinephrine. Nicotine may provoke vasoconstriction in some patients, predisposing to a greater ischemic response to ergot therapy.

The blood levels of ergotamine-containing drugs are reported to be elevated by the concomitant administration of macrolide antibiotics and vasospastic reactions have been reported with therapeutic doses of the ergotamine-containing drugs when coadministered with these antibiotics.

Pregnancy

Teratogenic Effects

Nonteratogenic Effects

Ergotamine tartrate and caffeine tablets is contraindicated in pregnancy due to the oxytocic effects of ergotamine (see ).

Labor and Delivery

Ergotamine tartrate and caffeine tablets is contraindicated in labor and delivery due to its oxytocic effect which is maximal in the third trimester (see )

Nursing Mothers

Ergot drugs are known to inhibit prolactin but there are no reports of decreased lactation with ergotamine tartrate and caffeine. Ergotamine is excreted in breast milk and may cause symptoms of vomiting, diarrhea, weak pulse and unstable blood pressure in nursing infants. Because of the potential for serious adverse reactions in nursing infants from ergotamine tartrate and caffeine tablets, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

What are the side effects of ergotamine tartrate and caffeine?

Cardiovascular:

Gastrointestinal:

Neurological:

Allergic:

Fibrotic Complications:

You should call your doctor for medical advice about side effects.

To report a serious adverse event, call 1-855-899-4237.

What should I look out for while using ergotamine tartrate and caffeine?

Coadministration of ergotamine with potent CYP 3A4 inhibitors (ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, and troleandomycin) has been associated with acute ergot toxicity (ergotism) characterized by vasospasm and ischemia of the extremities (see ), with some cases resulting in amputation. There have been rare reports of cerebral ischemia in patients on protease inhibitor therapy when ergotamine tartrate and caffeine tablets was coadministered, at least one resulting in death. Because of the increased risk of ergotism and other serious vasospastic adverse events, ergotamine use is contraindicated with these drugs and other potent inhibitors of CYP 3A4 (e.g., ketoconazole, itraconazole) (see ).

Ergotamine tartrate and caffeine tablets may cause fetal harm when administered to pregnant women. Ergotamine tartrate and caffeine tablets is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy or if the patient becomes pregnant while taking this product, the patient should be apprised of the potential hazard to the fetus.

Peripheral vascular disease, coronary heart disease, hypertension, impaired hepatic or renal function and sepsis.

Hypersensitivity to any of the components.

What might happen if I take too much ergotamine tartrate and caffeine?

The toxic effects of an acute overdosage of ergotamine tartrate and caffeine tablets are due primarily to the ergotamine component. The amount of caffeine is such that its toxic effects will be overshadowed by those of ergotamine. Symptoms include vomiting; numbness, tingling, pain and cyanosis of the extremities associated with diminished or absent peripheral pulses; hypertension or hypotension; drowsiness, stupor, coma, convulsions and shock. A case has been reported of reversible bilateral papillitis with ring scotomata in a patient who received five times the recommended daily adult dose over a period of 14 days.

Treatment consists of removal of the offending drug by induction of emesis, gastric lavage, and catharsis. Maintenance of adequate pulmonary ventilation, correction of hypotension, and control of convulsions and blood pressure are important considerations. Treatment of peripheral vasospasm should consist of warmth, but not heat, and protection of the ischemic limbs. Vasodilators may be beneficial but caution must be exercised to avoid aggravating an already existent hypotension.

How should I store and handle ergotamine tartrate and caffeine?

Store APTIOM tablets at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) Ergotamine tartrate and caffeine tablets, USP for oral administration are available as:1 mg/100 mg: Bottles of 100......NDC 24470-917-10Store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature).Dispense in a tight, light-resistant container.Distributed byCintex Services, LLCDallas, TX 75243Manufactured by:MIKART, INCAtlanta, GA 30318Code 1098C00Rev. 06/16Ergotamine tartrate and caffeine tablets, USP for oral administration are available as:1 mg/100 mg: Bottles of 100......NDC 24470-917-10Store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature).Dispense in a tight, light-resistant container.Distributed byCintex Services, LLCDallas, TX 75243Manufactured by:MIKART, INCAtlanta, GA 30318Code 1098C00Rev. 06/16Ergotamine tartrate and caffeine tablets, USP for oral administration are available as:1 mg/100 mg: Bottles of 100......NDC 24470-917-10Store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature).Dispense in a tight, light-resistant container.Distributed byCintex Services, LLCDallas, TX 75243Manufactured by:MIKART, INCAtlanta, GA 30318Code 1098C00Rev. 06/16Ergotamine tartrate and caffeine tablets, USP for oral administration are available as:1 mg/100 mg: Bottles of 100......NDC 24470-917-10Store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature).Dispense in a tight, light-resistant container.Distributed byCintex Services, LLCDallas, TX 75243Manufactured by:MIKART, INCAtlanta, GA 30318Code 1098C00Rev. 06/16Ergotamine tartrate and caffeine tablets, USP for oral administration are available as:1 mg/100 mg: Bottles of 100......NDC 24470-917-10Store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature).Dispense in a tight, light-resistant container.Distributed byCintex Services, LLCDallas, TX 75243Manufactured by:MIKART, INCAtlanta, GA 30318Code 1098C00Rev. 06/16Ergotamine tartrate and caffeine tablets, USP for oral administration are available as:1 mg/100 mg: Bottles of 100......NDC 24470-917-10Store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature).Dispense in a tight, light-resistant container.Distributed byCintex Services, LLCDallas, TX 75243Manufactured by:MIKART, INCAtlanta, GA 30318Code 1098C00Rev. 06/16Ergotamine tartrate and caffeine tablets, USP for oral administration are available as:1 mg/100 mg: Bottles of 100......NDC 24470-917-10Store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature).Dispense in a tight, light-resistant container.Distributed byCintex Services, LLCDallas, TX 75243Manufactured by:MIKART, INCAtlanta, GA 30318Code 1098C00Rev. 06/16Ergotamine tartrate and caffeine tablets, USP for oral administration are available as:1 mg/100 mg: Bottles of 100......NDC 24470-917-10Store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature).Dispense in a tight, light-resistant container.Distributed byCintex Services, LLCDallas, TX 75243Manufactured by:MIKART, INCAtlanta, GA 30318Code 1098C00Rev. 06/16Ergotamine tartrate and caffeine tablets, USP for oral administration are available as:1 mg/100 mg: Bottles of 100......NDC 24470-917-10Store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature).Dispense in a tight, light-resistant container.Distributed byCintex Services, LLCDallas, TX 75243Manufactured by:MIKART, INCAtlanta, GA 30318Code 1098C00Rev. 06/16Ergotamine tartrate and caffeine tablets, USP for oral administration are available as:1 mg/100 mg: Bottles of 100......NDC 24470-917-10Store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature).Dispense in a tight, light-resistant container.Distributed byCintex Services, LLCDallas, TX 75243Manufactured by:MIKART, INCAtlanta, GA 30318Code 1098C00Rev. 06/16Ergotamine tartrate and caffeine tablets, USP for oral administration are available as:1 mg/100 mg: Bottles of 100......NDC 24470-917-10Store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature).Dispense in a tight, light-resistant container.Distributed byCintex Services, LLCDallas, TX 75243Manufactured by:MIKART, INCAtlanta, GA 30318Code 1098C00Rev. 06/16Ergotamine tartrate and caffeine tablets, USP for oral administration are available as:1 mg/100 mg: Bottles of 100......NDC 24470-917-10Store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature).Dispense in a tight, light-resistant container.Distributed byCintex Services, LLCDallas, TX 75243Manufactured by:MIKART, INCAtlanta, GA 30318Code 1098C00Rev. 06/16Ergotamine tartrate and caffeine tablets, USP for oral administration are available as:1 mg/100 mg: Bottles of 100......NDC 24470-917-10Store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature).Dispense in a tight, light-resistant container.Distributed byCintex Services, LLCDallas, TX 75243Manufactured by:MIKART, INCAtlanta, GA 30318Code 1098C00Rev. 06/16

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Clinical Information

Chemical Structure

No Image found

Clinical Pharmacology

Ergotamine is an alpha adrenergic blocking agent with a direct stimulating effect on the smooth muscle of peripheral and cranial blood vessels and produces depression of central vasomotor centers. The compound also has the properties of serotonin antagonism. In comparison to hydrogenated ergotamine, the adrenergic blocking actions are less pronounced and vasoconstrictive actions are greater.

Caffeine, also a cranial vasoconstrictor, is added to further enhance the vasoconstrictive effect without the necessity of increasing ergotamine dosage.

Many migraine patients experience excessive nausea and vomiting during attacks, making it impossible for them to retain any oral medication. In such cases, therefore, the only practical means of medication is through the rectal route where medication may reach the cranial vessels directly, evading the splanchnic vasculature and the liver.

Non-Clinical Toxicology

Coadministration of ergotamine with potent CYP 3A4 inhibitors (ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, and troleandomycin) has been associated with acute ergot toxicity (ergotism) characterized by vasospasm and ischemia of the extremities (see ), with some cases resulting in amputation. There have been rare reports of cerebral ischemia in patients on protease inhibitor therapy when ergotamine tartrate and caffeine tablets was coadministered, at least one resulting in death. Because of the increased risk of ergotism and other serious vasospastic adverse events, ergotamine use is contraindicated with these drugs and other potent inhibitors of CYP 3A4 (e.g., ketoconazole, itraconazole) (see ).

Ergotamine tartrate and caffeine tablets may cause fetal harm when administered to pregnant women. Ergotamine tartrate and caffeine tablets is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy or if the patient becomes pregnant while taking this product, the patient should be apprised of the potential hazard to the fetus.

Peripheral vascular disease, coronary heart disease, hypertension, impaired hepatic or renal function and sepsis.

Hypersensitivity to any of the components.

This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

Cardiovascular:

Gastrointestinal:

Neurological:

Allergic:

Fibrotic Complications:

You should call your doctor for medical advice about side effects.

To report a serious adverse event, call 1-855-899-4237.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

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