Drug Profiles:
MIDRIN®

CAUTION: Federal law prohibits dispensing without prescription.

PRESCRIPTION: Each red capsule with pink band contains Isometheptene Mucate USP, 65 mg.; Dichioraiphenazone USP, 100 mg.; and Acetaminophen USP, 325 mg.

Isometheptene Mucate is a white crystalline powder having a characteristic aromatic odor and bitter taste. It is an unsaturated aliphatic amine with sympathomimetic properties.

Dichioraiphenazone is a white, microcrystalline powder, with slight odor and tastes saline at first, becoming acrid. It is a mild sedative.

Acetaminophen, a non-salicylate, occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste.

Midrin capsules contain FD&C Yellow No.6 as a color additive.

ACTIONS: Isometheptene Mucate, a sympathomimetic amine, acts by constricting dilated cranial and cerebral arterioles, thus reducing the stimuli that lead to vascular headaches. Dichloraiphenazone, a mild sedative, reduces the patient's emotional reaction to the pain of both vascular and tension headaches. Acetaminophen raises the threshold to painful stimuli, thus exerting an analgesic effect against all types of headaches.

   

INDICATIONS: For relief of tension and vascular headaches.*

* Based on a review of this drug (Isometheptene mucate) by the National Academy of Sciences - National Research Council and/or other information, FDA has classified the other indication as "possibly" effective in the treatment of migraine headache. Final classification of the less-than-effective indication requires further investigation.

CONTRAINDICATIONS: Midrin-" is contraindicated in glaucoma and/or severe cases of renal disease, hypertension, organic heart disease, hepatic disease and in those patients who are on monoamine-oxidase (MAO) inhibitor therapy.

PRECAUTIONS: Caution should be observed in hypertension, peripheral vascular disease and after recent cardiovascular attacks.

ADVERSE REACTIONS: Transient dizziness and skin rash may appear in hypersensitive patients. This can usually be eliminated by reducing the dose.

DOSAGE and ADMINISTRATION:

FOR RELIEF OF MIGRAINE HEADACHE: The usual adult dosage is two capsules at once. followed by one capsule every hour until relieved, up to 5 capsules within a twelve hour period.

FOR RELIEF OF TENSION HEADACHE: The usual adult dosage is one or two capsules every four hours up to 8 capsules a day.

HOW SUPPLIED: Red capsules imprinted with pink band, the letter "C" and 86120. Bottles of 50 capsules, NDC 0086-0120-05. Bottles of 100 capsules, NOC 0086-0120-10, Store at controlled room temperature 15-3OC 59-86F in a dry place.

The most recent revision of this labeling is November 1988.

(Under review by MAGNUM for newer revision)

Manufactured for:

Caraco Pharmaceutical Laboratories, LTD.
1150 Elijah Mccoy Drive
Detroit, Michigan, 48202

1 (800) 818-4555
Fax (313) 871-8314

http://www.caraco.com

 

Are you having trouble getting your current Midrin Rx filled at the local pharmacy? Then you might want to read MAGNUM's Fall article which ran in our online publication MigraineBlog.com last November. For more see below —

Midrin® Shortage Is Over Maker(s) Assures MAGNUM

Midrinless Migraineurs Mourn  Memorial Day Weekend

July_4_04_session_dsc_0134_red_bdr Photos © Michael John Coleman 2008

  Model Taylor Burchfield © 2004

WASHINGTON, DC May 28th, 2008— Wherefore art thou, Midrin® we so politely & rhetorically asked our readers last Fall?  Almost a half year ago MAGNUM did an investigative report due to the hundreds of calls, posts, and e-mails we had received concerning the lack of availability of the popular abortive Migraine medication called Midrin®.  In addition, this concern was echoed at the time by our partner’s website at the HealthCentral Network’s MyMigraineConnection.com as well.  Back in late March one of our readers, Mona, asked us; “I asked my doctor for a refill on my Midrin and he said it was no longer available. Is that correct?”  Well of course Mona that is NOT correct! It concerns us that your doctor would tell you that a FDA approved medication which is currently available in no longer made.  Particularly considering that there is no similar compound on the market to substitute in place of Midrin® and its generics.

Last month Kara posted a comment to tell us “It’s still available because I just picked up a prescription today.”    But at the end of April a Migraineur in the Atlantic coastal state of Delaware not to happy remarked “If anyone is posting that they ARE able to get Midrin or a form of it, please make sure you are writing which drug store has supplied it (re: the chain drugstores)... thanks!”  So after reading their post we did a follow-up on the availability of Midrin and its generics, including contacting the suppliers.  Here is what we found out;

Current shortages of Midrin® and related generics have been observed and reported on by the Society of Health System Pharmacists, with reasons for the shortage and estimated resupply dates.  MAGNUM found ASHP data very accurate and we followed up with calls to name brand Midrin® maker Caraco and generic Epidrine® maker Execellium as well to issue a finding of fact of the state of access to the treatment at this time.

ASHP is a 35,000-member national professional association that represents pharmacists who practice in hospitals, health maintenance organizations, long-term care facilities, home care, and other components of health care systems. ASHP is the only national organization of hospital and health-system pharmacists and has a long history of improving medication use and enhancing patient safety.  They have an excellent website for those in the medical field which you can visit at http://www.ashp.org and we highly recommend it pharmacists or others in the health care industry looking for reliable pharmaceutical information.

Current Shortages of Midrin Reported by American Society of Health System Pharmacists May 2008 Are As Follows With Our Notations:

Products Affected — Description

Midrin_epidrin_bottle
Products in Short Supply:
Midrin (Caraco) (NDC 64248-0120-10)
• Epidrine (Excellium) (NDC 64125-0101-02) (250 count)  AKA Midrin generic
• Epidrine (Excellium) (NDC 64125-0101-01) (100 count)  AKA Midrin generic

Discontinued Products:
Interpharm for URL--Acetaminophen (325 mg) / Dichloralphenazone (100 mg) / Isometheptene Mucate (65 mg) AKA Midrin generic   discontinued
• (Jerome Stevens) - Acetaminophen (325 mg) / Dichloralphenazone (100 mg) / Isometheptene Mucate (65 mg) AKA Midrin generic   discontinued
• Amidrine (Actavis) - AKA Midrin generic   discontinued
• Duradrin (Barr) - AKA Midrin generic   discontinued
• I.D.A (Interpharm for Teva) - AKA Midrin generic   discontinued
• Migrazone (Breckenridge) - AKA Midrin generic   discontinued
• Migratine (Major) - AKA Midrin generic   discontinued
• Migrin-A (Prasco) - AKA Midrin generic   discontinued
• Migquin (Interpharm for Qualitest) - AKA Midrin generic   discontinued

Reasons for the Shortage:
Most acetaminophen / dichloralphenazone / isometheptene products have been discontinued. The manufacturers would not provide a reason for the discontinuations; however, these products are not FDA-approved.
• Caraco states that the shortage of Midrin® is due to increased demand and also a raw material shortage.

Estimated Resupply Dates:
Acetaminophen / dichloralphenazone / isometheptene products are not FDA-approved and therefore cannot be AB-rated.
• Epidrine from Excellium in 100 count bottles (NDC 64125-0101-01) is available and being allocated to wholesalers. Epidrine in bottles of 250 has been temporarily discontinued.
• Midrin from Caraco (NDC 64248-0120-10) is available.

Related Shortages:
Alfentanil Injection — Resolved
• Codeine Phosphate Oral Solution — No Longer Available
• Fentanyl Transdermal System Patch
• Hydromorphone Injection — Resolved
• Indomethacin Capsules — Resolved
• Meperidine — Resolved
• Methadone Hydrochloride Tablets
• Methadone Hydrochloride Injection — Resolved
• Morphine Sulfate — No Longer Available
• Oxycodone Extended-Release Tablets — Resolved
• Sufentanil Injection — Resolved

After talking to directly to Caraco, the makers of the name brand of Midrin® and integrating in the data supplied by ASHP MAGNUM is happy to report the Great Midrin shortage is over!  That does not mean you are not going to have to play the educated consumer at some times and at some places in the country.  Having said that let’s go over this information just to clarify some facts that will end up confusing people and end up in future post if not addressed now for you.

At present there are only two FDA approved Midrin® type drugs in current production, one name brand Midrin® by Caraco and one generic brand called Epidrine® by Excellium.  Both pharmaceutical companies have ramped up production to meet the new demand.  That demand is caused by the fact that most of the nine other generic Midrin® makers where not FDA approved and dropped Midrin® from their product line.  To add to many Migraineurs confusion is that suppliers and warehouses may have large supplies of Duradrin®, or Interpharm for URL even though those drug companies have discontinued production of those generic Midrins.

Midrin_square_red_border Then there are those pharmacies that might tell you that a new drug called Acetaminophen (325 mg) / Dichloralphenazone (100 mg) / Isometheptene Mucate (65 mg) and can be used in place of the Midrin which is no longer available--because Midrin is no longer made, we hear that one quite a bit, which is just the compound named for Midrin generic.  Which is, say it together, is NOT discontinued!

Then there is there is the supply side of this tragedy!  The suppliers filling out orders for large chain pharmacies all over the country also played a role in the shortage.  Even we here at MAGNUM are not immune from the wrath of Cardinal and other suppliers telling CVS, Walgreens, Costco, Giant, and on and on that Midrin® is either no longer made, discontinued, or the FDA stopped production!   All incorrect but understandable when you look at it from a supplier standpoint.  That is from their perspective they see nine generic makers of a drugs stop production of just one medication over the course of a year, the generic version of Midrin®.  Stands to reason an industrial rumor might start that a drug is out of production and no longer made.  They tell the store managers, who tell the pharmacist in charge and 36 million Migraineurs lose one more option in their limited care options they think.

So as you can see the reasons for the great Midrin® shortage where multifaceted, and due to the fact that this drug treatment does not really have a substitute just added to the pain.  The later has an important unintended consequence of the shortage.  Midrin® plays a niche role in Migraine management for many Migraineurs.  Today as we hear Barack Obama, Hillary Clinton, & John McCain all talk about the importance of managing healthcare.  Migraine disease management is very difficult, particularly for the intractably sufferer.  With many managed care plans placing false limits on triptans due to their high cost, the use of preventives, and early intervention with abortive helps those expensive and limited triptans go further, thus improving the quality of life for the Migraineur.  In addition, for many Midrin® is the only mild abortive which can also help limit the use of triptans if taken early intervention as well?  This is why so many Migraineurs tell us they & their doctors like having Midrin® available in their overall Migraine treatment plan.

Of course for some who suffer infrequent Migraine attacks taking Midrin® as directed for attacks once every four to six weeks is all one might need.  With some Replax® in the drawer for that one Migraine onc or twice a year, you know the kind?  The severe storm front triggered Migraine kind a decade ago would have sent our friend to the ER. 

So we now know how the Midrin® shortage began, how it was aggravated, who in the industry is acting to remedy the problem, and where are we now?  So we contacted Caraco and talked to a spokesperson who informed us that the shortage of Midrin® was due to increased demand, as well as being effected by a raw material shortage.  In addition, Caraco has continued to increase production to meet the ongoing increased demand.  According to the Society of Health System Pharmacists Midrin® from Caraco (NDC 64248-0120-10) is now available.

The Society of Health System Pharmacists also indicated that Epidrine® from Excellium in 100 count bottles (NDC 64125-0101-01) is now available.  In addition, they noted that Epidrine® in bottles of 250 has been temporarily discontinued, which should not affect getting your refills.   In fact MAGNUM contacted Excellium Pharmaceutical, and spoke with Hasmukh Doshi, RpH, with Public Relations and he informed MAGNUM that “Excellium recognized that generic production of Acetaminophen (325 mg) / Dichloralphenazone (100 mg) / Isometheptene Mucate (65 mg) was impacted by the withdraw of several drug companies no longer making this compound.  We have increased production of Epidrine® since we last spoke to MAGNUM to meet the demand for Migraineurs.”  Excellium was very responsive to concerns of Migraine sufferers, and addressed all of our questions.

 
We are very impressed that a generic drug company has taken the time to work with us now for the second time on a national product shortage.  Ten years ago it was so hard to get smaller medical companies to pay attention to Migraine disease.  My how far we have come, now that is the best part of covering this Midrin® shortage.

MIDRIN AKA:

Acetaminophen (325 mg)
Dichloralphenazone (100 mg)
Isometheptene Mucate (65 mg)

 

The Great Midrin Shortage of 2007

Wheres My Midrin?

Midrin_112407_web
Photography By Michael John Coleman 2007

WASHINGTON, DC November 24th, 2007 Midrin, Midrin wherefore art thou, Midrin?  Of all the medications out there, and there are a lot of them for Migraine these days, Midrin is the name anew.  Well now, maybe not so anew.  But for many, Midrin is a mainstay in Migraine treatment.  These days there appears to be a Midrin shortage!  Oh no!

Right about now there are those of you who are asking what is Midrin?  Is it a new Migraine drug?!  Well dont get too excited.  Midrin has been with us for quite a while.  In fact, Midrin was created by a drug company called Carnrick Laboratories, which closed down operations many years ago after selling their rights to Midrin to Womans First Healthcare (WFHC). 

But if you looked up WFHC to give them a call and inquire about the lag in production or apparent lack of refills you have been encountering at the local pharmacy, hey no answer?  You see, in 2004 Sun Pharma purchased our little Migraine helper.  But calling Sun Pharma won't help either. We need to contact the subsidiary, Caraco Pharmaceutical Laboratories, Ltd.  That we did.

We spoke to a very nice person who would not release their name, but they did assure MAGNUM that Caraco Pharmaceutical is manufacturing Midrin at full capacity.  In fact, they were even increasing production to meet demand.  Which is good, judging by the calls and e-mails at MAGNUM, there is a good demand for this President Kennedy-era drug. 

Click here to the get to the complete article at MAGNUM's MigraineBlog which is featured by the HealthCentral Network & MyMigraineConnection.