Motofen
Encyclopedia
A comprehensive article about the subgroup of anti-diarrhoeal drugs including Motofen can be found as the article Diphenoxylate
.
Motofen is the brand name for an antiperistaltic anti-diarrheal medication, containing 1.0 mg difenoxin
HCl and 0.025 mg atropine
(U.S. Food and Drug Administration: Schedule IV Combination). Atropine is purposely added at 25 micrograms per tablet, or 1/24 to 1/40 of the usual therapeutic dose for atropine to minimize the potential of misuse by swallowing large numbers of tablets or preparing them for injection since difenoxin
is chemically related to the pethidine
-piritramide
subgroup of the opioid family, and could theoretically be misused. Although unlikely, physical and mental withdrawal symptoms (from both anticholinergic rebound caused by atropine, and opiate withdrawal caused by the difenoxin) is possible if taken for long periods of time. However, both of these compounds are responsible for the medicinal effects of the medicine (both atropine and difenoxin slow gut movement).
This combination medication should not be confused with Lomotil
(2.5 mg diphenoxylate
and 0.025 mg atropine
– a Schedule V Combination), because the active ingredients in the two medications are different compounds, except for the inclusion of atropine. Motofen is approximately 2 to 4 times more effective in treating symptoms than Lomotil
.
, it has also been successfully used by physicians for irritable bowel syndrome
(IBS), and hyperhidrosis
(chronic, severe sweating
).
, vomiting
, burning eyes, blurred vision, dry eyes, dizziness, dry mouth, epigastric distress, and constipation
(a paradox
ical side effect). Side effects attributed to the atropine
content (especially when taken in excess doses, or in children), include: flushing
, dryness in many areas, urinary retention
, insomnia
, headache, anxiety
, hyperthermia
, and tachycardia
. It is these side effects that make it undesirable for most patients to take higher amounts of the medicine.
(IBS) and Hyperhidrosis
, although as stated above, it has been used successfully in treating symptoms of both disorders (which can accompany each other). There was a "Motofen half-strength" tablet, containing only 0.5 milligram of difenoxin, but it has since been discontinued. Only standard 1.0 milligram strength tablets are available by prescription
.
al shaped, impressed with a "V" on one side, and vertically scored on the other side. In addition, the number "0500" is impressed bisecting the score line perpendicularly. The aforementioned bisection renders "05" and "00" on the left and right side of the score, respectively. Amarin's version were also pentagon
al shaped, but impressed with an "A" on one side with "74" on the opposing.
Motofen is higher priced than both Imodium and Lomotil
, does not have a generic
equivalent, and is only available by prescription
in the United States
. Many United States
insurance companies do not include Motofen as one of their formulary
drugs, causing consumers to pay the highest copay, if it is covered by their health insurance
at all. This is most likely due to the high cost of the medication itself, and the fact that similar lower-priced medicines can help ease symptoms of diarrhea
. The United States
is currently the only country where Motofen tablets are prescribed, approved by the government, and sold.
(PDR) for the years 2005 and 2006 as a literal snippet entry. Nothing is said about the indications and usage, only the ingredients, current appearance (at the time of publishing), NDC#, and the quantities in which it is supplied. As of August 1, 2008, Motofen appears to have been discontinued by Valeant Pharmaceuticals. No reason has been discovered, and many have been left wondering why it is no longer available.
Motofen is now back on the market as of June 2011 and available only by prescription in the United States.
Diphenoxylate
Diphenoxylate is an opioid agonist used for the treatment of diarrhea that acts by slowing intestinal contractions and peristalsis allowing the body to consolidate intestinal contents and prolong transit time, thus allowing the intestines to draw moisture out of them at a normal or higher rate and...
.
Motofen is the brand name for an antiperistaltic anti-diarrheal medication, containing 1.0 mg difenoxin
Difenoxin
Difenoxin is a 4-phenylpiperidine derivative that is related to the opioid analgesic drug pethidine and more distantly related to alphaprodine and piritramide, and it is an active metabolite of the anti-diarrhoea drug diphenoxylate. Difenoxin et al...
HCl and 0.025 mg atropine
Atropine
Atropine is a naturally occurring tropane alkaloid extracted from deadly nightshade , Jimson weed , mandrake and other plants of the family Solanaceae. It is a secondary metabolite of these plants and serves as a drug with a wide variety of effects...
(U.S. Food and Drug Administration: Schedule IV Combination). Atropine is purposely added at 25 micrograms per tablet, or 1/24 to 1/40 of the usual therapeutic dose for atropine to minimize the potential of misuse by swallowing large numbers of tablets or preparing them for injection since difenoxin
Difenoxin
Difenoxin is a 4-phenylpiperidine derivative that is related to the opioid analgesic drug pethidine and more distantly related to alphaprodine and piritramide, and it is an active metabolite of the anti-diarrhoea drug diphenoxylate. Difenoxin et al...
is chemically related to the pethidine
Pethidine
Pethidine or meperidine Pethidine (INN) or meperidine (USAN) Pethidine (INN) or meperidine (USAN) (commonly referred to as Demerol but also referred to as: isonipecaine; lidol; pethanol; piridosal; Algil; Alodan; Centralgin; Dispadol; Dolantin; Mialgin (in Indonesia); Petidin Dolargan (in Poland);...
-piritramide
Piritramide
Piritramide is a synthetic opioid analgesic with a potency 0.65 to 0.75 times that of morphine. A common starting dose is 15 mg IV, equivalent to 10 mg of morphine hydrochloride. Piritramide is commonly used for the treatment of postoperative pain...
subgroup of the opioid family, and could theoretically be misused. Although unlikely, physical and mental withdrawal symptoms (from both anticholinergic rebound caused by atropine, and opiate withdrawal caused by the difenoxin) is possible if taken for long periods of time. However, both of these compounds are responsible for the medicinal effects of the medicine (both atropine and difenoxin slow gut movement).
This combination medication should not be confused with Lomotil
Lomotil
The drug combination diphenoxylate/atropine is a popular oral anti-diarrheal in the United States, manufactured by Pfizer. Its UK BAN generic name is co-phenotrope....
(2.5 mg diphenoxylate
Diphenoxylate
Diphenoxylate is an opioid agonist used for the treatment of diarrhea that acts by slowing intestinal contractions and peristalsis allowing the body to consolidate intestinal contents and prolong transit time, thus allowing the intestines to draw moisture out of them at a normal or higher rate and...
and 0.025 mg atropine
Atropine
Atropine is a naturally occurring tropane alkaloid extracted from deadly nightshade , Jimson weed , mandrake and other plants of the family Solanaceae. It is a secondary metabolite of these plants and serves as a drug with a wide variety of effects...
– a Schedule V Combination), because the active ingredients in the two medications are different compounds, except for the inclusion of atropine. Motofen is approximately 2 to 4 times more effective in treating symptoms than Lomotil
Lomotil
The drug combination diphenoxylate/atropine is a popular oral anti-diarrheal in the United States, manufactured by Pfizer. Its UK BAN generic name is co-phenotrope....
.
Indications and uses
Although Motofen is officially indicated by the U.S. Food and Drug Administration (FDA) for diarrheaDiarrhea
Diarrhea , also spelled diarrhoea, is the condition of having three or more loose or liquid bowel movements per day. It is a common cause of death in developing countries and the second most common cause of infant deaths worldwide. The loss of fluids through diarrhea can cause dehydration and...
, it has also been successfully used by physicians for irritable bowel syndrome
Irritable bowel syndrome
Irritable bowel syndrome is a diagnosis of exclusion. It is a functional bowel disorder characterized by chronic abdominal pain, discomfort, bloating, and alteration of bowel habits in the absence of any detectable organic cause. In some cases, the symptoms are relieved by bowel movements...
(IBS), and hyperhidrosis
Hyperhidrosis
Hyperhidrosis is the condition characterized by abnormally increased perspiration, in excess of that required for regulation of body temperature.-Classification:Hyperhidrosis can either be generalized or localized to specific parts of the body...
(chronic, severe sweating
Sweating
Perspiration is the production of a fluid consisting primarily of water as well as various dissolved solids , that is excreted by the sweat glands in the skin of mammals...
).
Side effects, interactions, and misuse potential
Side effects include drowsiness, nauseaNausea
Nausea , is a sensation of unease and discomfort in the upper stomach with an involuntary urge to vomit. It often, but not always, precedes vomiting...
, vomiting
Vomiting
Vomiting is the forceful expulsion of the contents of one's stomach through the mouth and sometimes the nose...
, burning eyes, blurred vision, dry eyes, dizziness, dry mouth, epigastric distress, and constipation
Constipation
Constipation refers to bowel movements that are infrequent or hard to pass. Constipation is a common cause of painful defecation...
(a paradox
Paradox
Similar to Circular reasoning, A paradox is a seemingly true statement or group of statements that lead to a contradiction or a situation which seems to defy logic or intuition...
ical side effect). Side effects attributed to the atropine
Atropine
Atropine is a naturally occurring tropane alkaloid extracted from deadly nightshade , Jimson weed , mandrake and other plants of the family Solanaceae. It is a secondary metabolite of these plants and serves as a drug with a wide variety of effects...
content (especially when taken in excess doses, or in children), include: flushing
Flushing (physiology)
For a person to flush is to become markedly red in the face and often other areas of the skin, from various physiological conditions. Flushing is generally distinguished, despite a close physiological relation between them, from blushing, which is milder, generally restricted to the face, cheeks or...
, dryness in many areas, urinary retention
Urinary retention
Urinary retention, also known as ischuria, is a lack of ability to urinate. It is a common complication of benign prostatic hyperplasia , although it can also be caused by nerve dysfunction, constipation, infection, or medications...
, insomnia
Insomnia
Insomnia is most often defined by an individual's report of sleeping difficulties. While the term is sometimes used in sleep literature to describe a disorder demonstrated by polysomnographic evidence of disturbed sleep, insomnia is often defined as a positive response to either of two questions:...
, headache, anxiety
Anxiety
Anxiety is a psychological and physiological state characterized by somatic, emotional, cognitive, and behavioral components. The root meaning of the word anxiety is 'to vex or trouble'; in either presence or absence of psychological stress, anxiety can create feelings of fear, worry, uneasiness,...
, hyperthermia
Hyperthermia
Hyperthermia is an elevated body temperature due to failed thermoregulation. Hyperthermia occurs when the body produces or absorbs more heat than it can dissipate...
, and tachycardia
Tachycardia
Tachycardia comes from the Greek words tachys and kardia . Tachycardia typically refers to a heart rate that exceeds the normal range for a resting heart rate...
. It is these side effects that make it undesirable for most patients to take higher amounts of the medicine.
Dosing and administration
The recommended initial dosing is two tablets, and one tablet to be taken after each loose stool thereafter. The therapeutic dosage for Motofen should not exceed 8 tablets (8 milligrams of Difenoxin). There are currently no instructions indicating usage for Irritable Bowel SyndromeIrritable bowel syndrome
Irritable bowel syndrome is a diagnosis of exclusion. It is a functional bowel disorder characterized by chronic abdominal pain, discomfort, bloating, and alteration of bowel habits in the absence of any detectable organic cause. In some cases, the symptoms are relieved by bowel movements...
(IBS) and Hyperhidrosis
Hyperhidrosis
Hyperhidrosis is the condition characterized by abnormally increased perspiration, in excess of that required for regulation of body temperature.-Classification:Hyperhidrosis can either be generalized or localized to specific parts of the body...
, although as stated above, it has been used successfully in treating symptoms of both disorders (which can accompany each other). There was a "Motofen half-strength" tablet, containing only 0.5 milligram of difenoxin, but it has since been discontinued. Only standard 1.0 milligram strength tablets are available by prescription
Medical prescription
A prescription is a health-care program implemented by a physician or other medical practitioner in the form of instructions that govern the plan of care for an individual patient. Prescriptions may include orders to be performed by a patient, caretaker, nurse, pharmacist or other therapist....
.
Availability, price, and supply
There is currently only one manufacturer of Motofen tablets: Valeant Pharmaceuticals. It acquired the drug from Amarin Pharmaceuticals in 2004. Valeant's tablets are pentagonPentagon
In geometry, a pentagon is any five-sided polygon. A pentagon may be simple or self-intersecting. The sum of the internal angles in a simple pentagon is 540°. A pentagram is an example of a self-intersecting pentagon.- Regular pentagons :In a regular pentagon, all sides are equal in length and...
al shaped, impressed with a "V" on one side, and vertically scored on the other side. In addition, the number "0500" is impressed bisecting the score line perpendicularly. The aforementioned bisection renders "05" and "00" on the left and right side of the score, respectively. Amarin's version were also pentagon
Pentagon
In geometry, a pentagon is any five-sided polygon. A pentagon may be simple or self-intersecting. The sum of the internal angles in a simple pentagon is 540°. A pentagram is an example of a self-intersecting pentagon.- Regular pentagons :In a regular pentagon, all sides are equal in length and...
al shaped, but impressed with an "A" on one side with "74" on the opposing.
Motofen is higher priced than both Imodium and Lomotil
Lomotil
The drug combination diphenoxylate/atropine is a popular oral anti-diarrheal in the United States, manufactured by Pfizer. Its UK BAN generic name is co-phenotrope....
, does not have a generic
Generic drug
A generic drug is a drug defined as "a drug product that is comparable to brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use." It has also been defined as a term referring to any drug marketed under its...
equivalent, and is only available by prescription
Medical prescription
A prescription is a health-care program implemented by a physician or other medical practitioner in the form of instructions that govern the plan of care for an individual patient. Prescriptions may include orders to be performed by a patient, caretaker, nurse, pharmacist or other therapist....
in the United States
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
. Many United States
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
insurance companies do not include Motofen as one of their formulary
Formulary (pharmacy)
At its most basic level, a formulary is a list of medicines. Traditionally, a formulary contained a collection of formulas for the compounding and testing of medication . The main function of formularies today is to specify which medicines are approved to be prescribed under a particular contract...
drugs, causing consumers to pay the highest copay, if it is covered by their health insurance
Health insurance
Health insurance is insurance against the risk of incurring medical expenses among individuals. By estimating the overall risk of health care expenses among a targeted group, an insurer can develop a routine finance structure, such as a monthly premium or payroll tax, to ensure that money is...
at all. This is most likely due to the high cost of the medication itself, and the fact that similar lower-priced medicines can help ease symptoms of diarrhea
Diarrhea
Diarrhea , also spelled diarrhoea, is the condition of having three or more loose or liquid bowel movements per day. It is a common cause of death in developing countries and the second most common cause of infant deaths worldwide. The loss of fluids through diarrhea can cause dehydration and...
. The United States
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
is currently the only country where Motofen tablets are prescribed, approved by the government, and sold.
Miscellaneous information
Strangely, Motofen is only included in the Physicians' Desk ReferencePhysicians' Desk Reference
The Physicians' Desk Reference is a commercially published compilation of manufacturers' prescribing information on prescription drugs, updated annually...
(PDR) for the years 2005 and 2006 as a literal snippet entry. Nothing is said about the indications and usage, only the ingredients, current appearance (at the time of publishing), NDC#, and the quantities in which it is supplied. As of August 1, 2008, Motofen appears to have been discontinued by Valeant Pharmaceuticals. No reason has been discovered, and many have been left wondering why it is no longer available.
Motofen is now back on the market as of June 2011 and available only by prescription in the United States.