Ergotamine Tartrate, Caffeine

Kmm Pharmaceuticals, Llc
Human Prescription Drug
NDC 52187-555

Ergotamine Tartrate, Caffeine is a human prescription drug labeled by 'Kmm Pharmaceuticals, Llc'. National Drug Code (NDC) number for Ergotamine Tartrate, Caffeine is 52187-555. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Ergotamine Tartrate, Caffeine drug includes Caffeine - 100 mg/1 Ergotamine Tartrate - 1 mg/1 . The currest status of Ergotamine Tartrate, Caffeine drug is Active.

Drug Information:

Drug NDC:	52187-555
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Ergotamine Tartrate, Caffeine
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Ergotamine Tartrate, Caffeine
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Kmm Pharmaceuticals, Llc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Tablet
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	CAFFEINE - 100 mg/1 ERGOTAMINE TARTRATE - 1 mg/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	ANDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date:	10 Feb, 2022
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	17 Jan, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number:	ANDA040590
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	KMM Pharmaceuticals, LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	1293504
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
NUI:	N0000175739 N0000175729 N0000175790 M0023046
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	3G6A5W338E MRU5XH3B48
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class EPC:	Central Nervous System Stimulant [EPC] Methylxanthine [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class PE:	Central Nervous System Stimulation [PE]
Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`.
Pharmacologic Class CS:	Xanthines [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:	Central Nervous System Stimulant [EPC] Central Nervous System Stimulation [PE] Ergotamine Derivative [EPC] Ergotamines [CS] Methylxanthine [EPC] Xanthines [CS]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
52187-555-10	100 TABLET in 1 BOTTLE (52187-555-10)	10 Feb, 2022	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Ergotamine Tartrate, Caffeine

Tablet
KMM Pharmaceuticals, LLC
NDC: 52187-555

Product Elements:

Ergotamine tartrate, caffeine ergotamine tartrate, caffeine microcrystalline cellulose polyethylene glycol, unspecified polyvinyl alcohol, unspecified talc ergotamine tartrate ergotamine caffeine caffeine crospovidone silicon dioxide magnesium stearate fd&c red no. 40 fd&c yellow no. 5 aluminum lake water titanium dioxide fd&c blue no. 2--aluminum lake beige 123;mh

Boxed Warning:

Warning serious and/or life-threatening peripheral ischemia has been associated with the coadministration of ergotamine tartrate and caffeine tablets with potent cyp 3a4 inhibitors including protease inhibitors and macrolide antibiotics. because cyp 3a4 inhibition elevates the serum levels of ergotamine tartrate and caffeine tablets, the risk for vasospasm leading to cerebral ischemia and/or ischemia of the extremities is increased. hence, concomitant use of these medications is contraindicated (see also contraindications and warnings sections).

Indications and Usage:

Indications and usage: ergotamine tartrate and caffeine tablets are indicated as therapy to abort or prevent vascular headache; e.g., migraine, migraine variants or so-called âhistaminic cephalalgia.â

Warnings:

Warnings: 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 (see contraindications ). 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 Read more...

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 dosage and administration ).

Dosage and Administration:

Dosage and administration: 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 Â½ hour, if needed for full relief (maximum 6 tablets per attack, 10 per week). maximum adult dosage: total 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.

Contraindications:

Contraindications: 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 precautions: drug interactions ), 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 warnings: cyp 3a4 inhibitors ). 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.

Adverse Reactions:

Adverse reactions: cardiovascular: vasoconstrictive complications of a serious nature may occur at times. these include ischemia, cyanosis, absence of pulse, cold extremities, gangrene, precordial distress and pain, ekg changes and muscle pains. although these effects occur most commonly with long-term therapy at relatively high doses, they have also been reported with short-term or normal doses. other cardiovascular adverse effects include transient tachycardia or bradycardia and hypertension. gastrointestinal: nausea and vomiting neurological: paresthesias, numbness, weakness, and vertigo allergic: localized edema and itching. fibrotic complications: (see warnings ). to report suspected adverse reactions, call 1-855-899-4237, or contact fda at 1-800-fda-1088 or www.fda.gov/medwatch.

Overdosage:

Overdosage: 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

Description:

Description: each tablet for oral administration contains 1 mg ergotamine tartrate, usp, and 100 mg caffeine, usp. ergotamine tartrate: (c 33 h 35 n 5 o 5 ) 2 â¢ c 4 h 6 o 6 m.w. 1313.41 ergotaman-3â,6â,18-trione, 12â-hydroxy-2â-methyl-5â-(phenyl-methyl)-, (5âÎ±), [r-(r*, r*)]-2,3-dihydroxy-butanedioate (2:1) (salt) caffeine: c 8 h 10 n 4 o 2 (anhydrous) m.w. 194.19 1 h -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 structure1 structure2

Clinical Pharmacology:

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. pharmacokinetics: interactions : pharmacokinetic interactions (increased blood levels of Read more...

ergotamine) have been reported in patients treated orally with ergotamine and macrolide antibiotics (e.g., troleandomycin, clarithromycin, erythromycin), and in patients treated orally with ergotamine and protease inhibitors (e.g. ritonavir) presumably due to inhibition of cytochrome p450 3a metabolism of ergotamine (see contraindications ). ergotamine has also been shown to be an inhibitor of cytochrome p450 3a catalyzed reactions. no pharmacokinetic interactions involving other cytochrome p450 isoenzymes are known.

How Supplied:

How supplied: ergotamine tartrate and caffeine tablets, usp for oral administration are available as: 1 mg/100 mg: beige (film coated), round, convex face tablets, debossed â123â on one side and âmhâ on the other side. bottles of 100......ndc 52187-555-10 store at 20Â° to 25Â°c (68Â° to 77Â°f) (see usp controlled room temperature). dispense in a tight, light-resistant container. keep out of the reach of children. distributed by kmm pharmaceuticals llc wilmington, de 19801 manufactured by mikart, llc atlanta, ga 30318 code 1098d00 rev. 01/2022

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