Blog Illinois: September 2016

Wednesday, September 28, 2016

Reconcile

Dosage Form: FOR ANIMAL USE ONLY
Reconcile®

(fluoxetine hydrochloride)

Chewable Tablets

Caution:

Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

Description:

Reconcile is a chewable, flavored tablet that contains fluoxetine hydrochloride. Reconcile chewable tablets are available in 8, 16, 32, and 64 mg tablet strengths for oral administration to dogs. The active ingredient in Reconcile chewable tablets is fluoxetine hydrochloride, a selective serotonin reuptake inhibitor (SSRI). The molecular weight of fluoxetine is 345.79. The structural formula is depicted below.

fluoxetine hydrochloride

C17H18F3NO·HCl

Indications:

Reconcile chewable tablets are indicated for the treatment of canine separation anxiety in conjunction with a behavior modification plan.

Dosage and Administration:

The recommended dose of Reconcile chewable tablets is 1-2 mg/kg (0.5-0.9 mg/lb) administered once daily, in conjunction with a behavior modification plan. A typical behavior modification plan consists of the pet owner implementing standard training techniques based on principles such as rewarding appropriate behavior; coming and going in a manner that does not elicit inappropriate responses from the dog; and teaching the dog to be content while alone.

Table 1: Recommended Dose of Reconcile Chewable Tablets
Dog Weight		No. of	Tablet Strength
(lb)	(kg)	Tablets/day	(mg)
8.8 - 17.6	4.0 – 8.0	1	8
17.7 - 35.2	8.1 –16.0	1	16
35.3 - 70.4	16.1 – 32.0	1	32
70.5 - 140.8	32.1 – 64.0	1	64

The effectiveness and safety of Reconcile chewable tablets was demonstrated in a field study in client-owned dogs (see EFFECTIVENESS and ADVERSE REACTIONS). At the end of the 8-week study, 73% of dogs treated with Reconcile chewable tablets showed significant improvement (p=0.010), as compared to behavior modification alone (51%). During the course of therapy, 42% of dogs showed improvement within the first week, which was significantly greater (p=0.005) than with behavior modification alone (18%). The patient's response to therapy should be monitored. If no improvement is noted within 8 weeks, case management should be reevaluated.

The effectiveness and clinical safety of Reconcile chewable tablets for long-term use (i.e. for more than 8 weeks) has not been evaluated. Reconcile chewable tablets were evaluated at the recommended label dose for one year in a laboratory safety study in dogs (see ANIMAL SAFETY).

Professional judgment should be used in monitoring the patient's response to therapy to determine the need to continue treatment with Reconcile chewable tablets beyond 8 weeks. To discontinue therapy, it is not necessary to taper or reduce doses because of the long half-life of this product. Continued behavioral modification is recommended to prevent recurrence of the clinical signs.

Reconcile chewable tablets are readily consumed by dogs or can be administered like other tablet medications, and can be given with or without food.

Professional discretion should be used in determining the need for dose reduction in the event of a possible adverse reaction. Approximately half of patients tolerate a return to the previous dose after 1-2 weeks on a reduced schedule (see ADVERSE REACTIONS).

If a dose is missed, the next scheduled dose should be administered as prescribed. Do not increase or double the dose.

Contraindications:

Reconcile chewable tablets are contraindicated for use in dogs with epilepsy or a history of seizures. Reconcile chewable tablets should not be given concomitantly with drugs that lower the seizure threshold (e.g., phenothiazines such as acepromazine or chlorpromazine).

Reconcile chewable tablets should not be given in combination with a monoamine oxidase inhibitor (MAOI) [e.g., selegiline hydrochloride (L-deprenyl) or amitraz], or within a minimum of 14 days of discontinuing therapy with an MAOI.

Reconcile chewable tablets are contraindicated in dogs with a known hypersensitivity to fluoxetine HCl or other SSRIs.

Because fluoxetine and its major metabolite, norfluoxetine, have long half-lives, a 6-week washout interval should be observed following discontinuation of therapy with Reconcile chewable tablets prior to the administration of any drug that may adversely interact with fluoxetine or norfluoxetine.

Human Warnings:

Not for use in humans. Keep out of reach of children. In case of accidental ingestion seek medical attention immediately. In humans, the most common symptoms associated with over dosage include seizures, somnolence, nausea, tachycardia, and vomiting. In case of ingestion by a human, contact a physician immediately. For a copy of the Material Safety Data Sheet (MSDS) or to report adverse reactions call 1-888-545-5973.

Precautions:

Reconcile chewable tablets are not recommended for the treatment of aggression. Reconcile chewable tablets have not been clinically tested for the treatment of other behavioral disorders. Studies to determine the effects of Reconcile chewable tablets in breeding, pregnant, or lactating dogs and in patients less than 6 months of age have not been conducted.

Seizures may occur in dogs treated with Reconcile chewable tablets, even in dogs without a history of epilepsy or seizures (see ADVERSE REACTIONS). Before prescribing Reconcile chewable tablets, a comprehensive physical examination should be conducted to rule out causes of inappropriate behavior unrelated to separation anxiety. The examination should include a thorough history and assessment of the patient's household environment and standard practice laboratory tests as appropriate for the patient's age and health status. Veterinarians should be familiar with the risks and benefits of the treatment of behavioral disorders in dogs before initiating therapy. Inappropriate use of Reconcile chewable tablets, i.e. in the absence of a diagnosis or without concurrent behavior modification, may expose the animal to unnecessary adverse reactions and may not provide any lasting benefit of therapy.

Reconcile chewable tablets have not been evaluated with drugs that affect the cytochrome P450 enzyme system. Reconcile chewable tablets should be used with caution when co-administered with any drug that affects the cytochrome P450 enzyme system (for example, ketoconazole). Studies to assess the interaction of Reconcile chewable tablets with tricyclic antidepressants (TCAs) (for example, amitriptyline and clomipramine) have not been conducted. The minimum washout period to transition dogs from TCAs to Reconcile chewable tablets has not been evaluated. Published pharmacokinetic data demonstrates that TCAs are cleared 4 days following discontinuation. 1,2

Adverse Reactions:

In two North American multi-site field studies, which included a total of 427 dogs, the following adverse reactions were observed:

Seizures:

In one study, one of 112 dogs in the control group and three of 117 dogs that received Reconcile chewable tablets experienced the serious adverse reaction of seizures. One of the three dogs treated with Reconcile chewable tablets experienced two seizures 10 days after the end of therapy. Despite escalating phenobarbital doses, the seizures continued and this dog died in status epilepticus approximately six months after the first seizure. Another of the three dogs treated with Reconcile chewable tablets had experienced one seizure approximately 1½ years prior to study enrollment immediately after receiving head trauma. No additional seizures were reported to have occurred until 45 days after concluding treatment with Reconcile chewable tablets. During the 1½-year period since the second seizure, this dog's seizure activity increased from single seizures to cluster seizures despite increasing doses of phenobarbital and the addition of oral potassium bromide and rectal diazepam. The third dog treated with Reconcile chewable tablets and the control dog experienced one seizure 24 days and 35 days, respectively, after the start of therapy; no anticonvulsant therapy was initiated and no further seizures were reported in either dog.

In the second study, one of 99 dogs treated with Reconcile chewable tablets and one of 99 dogs treated with the control tablet experienced the serious adverse reaction of seizures 9 and 27 days, respectively, after initiation of therapy. The dog treated with Reconcile chewable tablets was subsequently diagnosed with vestibular disease and the control dog had a history of recurrent hind leg weakness.

1 Plumb DC. Amitriptyline. Veterinary Drug Handbook 5th Edition (Pocket Edition). Iowa State Press. Ames, IA. Page 39, 2002.

2 Hewson CJ, et.al. The pharmacokinetics of clomipramine and desmethylclomipramine in dogs: parameter estimates following a single oral dose and 28 consecutive daily doses of clomipramine. J Vet Pharmacol Therap 21:214-222, 1998.

In a European multi-site study, 234 dogs were treated with daily doses of fluoxetine chewable tablets ranging from 0.25 mg/kg to 4 mg/kg.

One dog treated with a daily dose of 0.4 mg/kg for one month experienced one seizure one week after discontinuing therapy. No anticonvulsant therapy was initiated and no further seizures were reported.

Weight loss:

Of the dogs in the two North American field studies with body weight measurements throughout the study (n=196 and n=185 in the Reconcile chewable tablets and control group, respectively), a 5% or greater weight loss (when compared to initial, pre-study body weight) was observed in 58 (29.6%) of dogs treated with Reconcile chewable tablets and 24 (13.0%) of dogs in the control group. No dogs were withdrawn from clinical studies due to weight loss alone. The following table shows the number of dogs with weight loss, stratified by percent weight loss relative to initial body weight.

Table 2: Dogs with Weight Loss (stratified by percent loss relative to initial body weight)
Treatment Group	5% to 10%	10 to 15%	15%
	Number (%)	Number (%)	Number (%)
a This dog lost 20% of its initial body weight and was the same dog that died in status epilepticus.
Reconcile	44 (22.5%)	13 (6.6%)	1a (0.5%)
chewable tablets
Control	20 (10.8%)	4 (2.2%)	0 (0%)

Other adverse reactions:

Additional adverse reactions observed in dogs treated with Reconcile chewable tablets at a rate of 1% or greater were:

Table 3: Adverse Reactions Reported in the North American Field Studies
	Reconcile Chewable Tablets, N=216		Control,* N=211
Adverse Reaction	n	%	n	%
* The control group received the tablet formulation without fluoxetine.
Calm/Lethargy/Depression	71	32.9	22	10.4
Decreased Appetite	58	26.9	13	6.2
Vomiting	37	17.1	28	13.3
Shaking/Shivering/Tremor	24	11.1	4	1.9
Diarrhea	21	9.7	17	8.1
Restlessness	16	7.4	8	3.8
Excessive Vocalization (Including Whining)	13	6.0	7	3.3
Aggression	9	4.2	13	6.2
Otitis Externa	6	2.8	2	0.9
Disorientation	5	2.3	1	0.5
Incoordination	5	2.3	0	0.0
Constipation	3	1.4	0	0.0
Excessive Salivation	3	1.4	4	1.9

Dose Reduction:

Twenty dogs in the Reconcile chewable tablet group and five dogs in the control group required a reduction in dose due to unacceptable adverse reactions, generally anorexia, vomiting, shaking and depression. Lowering the dose eliminated or reduced the severity of these adverse reactions in the Reconcile chewable tablet group only. Resumption of the full dose of Reconcile chewable tablets resulted in a return of the initial adverse reactions in approximately half of the affected dogs. The majority of these adverse reactions were intermittent and mild. However, one dog experienced recurrence of severe adverse reactions, which necessitated withdrawal from the study for that dog. Additionally, two dogs required a second dose reduction of Reconcile chewable tablets. Effectiveness was maintained in a majority of those dogs in which a dose reduction was necessary.

Clinical Pharmacology:

Fluoxetine exerts its effect by inhibiting the reuptake of serotonin at the pre-synaptic neuron. Fluoxetine does not act as a sedative. Fluoxetine is well absorbed after oral administration (~72%). It is largely metabolized in the liver by cytochrome P-450 enzyme system to norfluoxetine, an equipotent SSRI that contributes to the efficacy of Reconcile chewable tablets.

After a single dose, and also at steady state, calculations were made as follows:

Table 4: Single Dose* Pharmacokinetic Parameters of Fluoxetine Hydrochloride (mean ± standard error).
	AUC0-∞	Cmax	Tmax	T1/2	T1/2
	(μg.hr/mL)	(ng/mL)	(hr)	(hr)	Range (hr)
* approximately 2 mg/kg body weight
Fluoxetine	1.388	126.6	1.8	6.2	3.0-12.9
	(±0.137)	(±12.3)	(±0.2)	(±0.8)
Norfluoxetine	11.44	138.3	12.8	49	33.0-64.0
	(±0.74)	(±9.6)	(±1.7)	(±3)

In a 21-day study, fluoxetine was administered daily at a dose of 0.75, 1.5 and 3.0 mg/kg to laboratory Beagles. The maximum plasma concentration (Cmax) and area under the plasma concentration time curve (AUC) for fluoxetine were approximately dose proportional between 0.75 and 1.5 mg/kg, with a greater than dose proportional increase at 3 mg/kg. Norfluoxetine Cmax and AUC were generally dose proportional.

Although steady state appeared to be reached within 10 days in the 21-day study, a continuous increase in trough concentrations was observed in a one year, multiple-dose laboratory safety study. In this study, dogs administered a 1 mg/kg dose of fluoxetine had plasma fluoxetine concentrations that continued to increase over the one-year dosing period. A similar increase in concentrations was observed with norfluoxetine. This phenomenon was not observed at higher doses. During the one-year dosing interval and the subsequent two-month recovery period, there were no changes in the nature and frequency of adverse reactions observed as compared to those seen by Day 28 of fluoxetine administration.

Effectiveness:

In one randomized multi-centered, double-blinded, vehicle-controlled study of 8 weeks duration, 229 dogs were evaluated at 34 investigative sites in the United States and Canada. One hundred seventeen dogs were randomized to 1-2 mg/kg/day of Reconcile chewable tablets and 112 dogs were randomized to the control group. Both groups underwent concurrent behavior modification. In seven of the eight weeks, the percentage of dogs with improved overall separation anxiety scores was significantly higher (p 0.05) among dogs treated with Reconcile chewable tablets compared to dogs that received the control tablet. At the end of the study, 73% of dogs treated with Reconcile chewable tablets showed significant improvement (p=0.010) as compared to 51% of dogs treated with behavior modification alone.

Dogs treated with Reconcile chewable tablets also showed improvement in destructive behavior, excessive vocalization, and restlessness over dogs that received the control tablet. In addition, dogs in both groups experienced improvement in inappropriate urination, inappropriate defecation, excessive salivation, excessive licking/grooming, shaking/shivering and depression. Overall separation anxiety severity scores improved more rapidly for dogs taking Reconcile chewable tablets than those dogs receiving the control tablet. The same effect was also noted for the individual scores for excessive vocalization and depression.

Animal Safety:

In a one-year laboratory safety study, dogs were dosed daily at 1, 4.5, and 20 mg/kg/day of a gelatin capsule filled with fluoxetine powder. Based upon the results of a relative bioavailability study comparing the fluoxetine-filled capsule versus the Reconcile chewable tablets, the corresponding equivalent doses were 0.87, 3.9 and 17.4 mg/kg/day of Reconcile chewable tablets (where the average ratio of fluoxetine AUC values for Reconcile chewable tablets/fluoxetine-filled capsule = 1.15).

Three of five female dogs in the 20 mg/kg group, died or were euthanatized during the first six months of the study. The high dose was decreased to 10 mg/kg/day (equivalent to 8.7 mg/kg/day of Reconcile chewable tablets) for the last six months of the treatment, and all remaining dogs completed the study. One dog in the 1 mg/kg group (equivalentto 0.87 mg/kg/day of Reconcile chewable tablets)and two dogs in the 20 mg/kg group (equivalent to 17.4 mg/kg/day of Reconcile chewable tablets) experienced a seizure. Aggressive behavior, ataxia, salivation at dosing, hyperesthesia, nystagmus, thin body condition, weakness, lethargy, diarrhea and head tilt were also noted in the high dose group. Anorexia, tremors, decreased pupillary light response, mydriasis, vomiting, and decreased weight gain were observed in all treatment groups, but occurred more frequently in the high dose group. With the exception of decreased weight gain, all abnormal observations resolved by the end of a two-month recovery period. Evidence of phospholipidosis was noted in the lung, liver, adrenal glands, lymph nodes, spleen, retina and white blood cells of all groups, which resolved during the recovery period. Fluoxetine caused no marked or consistent effects on hematology, blood chemistries or urinalysis. Bradycardia was absent on the electrocardiogram in the control and lowest dose groups, but was mildly present in a dose-dependent manner in the two higher dose groups. There were no effects noted on gross organ examination.

Storage Information:

Store at 20-25ºC (68-77ºF). Excursions permitted between 15-30ºC (59-86ºF).

Do not remove desiccant canister from the bottle.

Completely close bottle between uses.

How Supplied:

30 tablets per bottle

NADA #141-272, Approved by FDA

Manufactured for:

Elanco Animal Health

A Division of Eli Lilly and Company

Lilly Corporate Center

Indianapolis, IN 46285

PA9720DEAMX

(V03-07-2009)

Reconcile®

(fluoxetine hydrochloride)

Chewable Tablets

Your veterinarian has chosen to prescribe Reconcile chewable tablets along with a simple training plan (a behavioral modification plan) to treat the separation anxiety that affects your dog. Please read this leaflet, which describes the use of Reconcile chewable tablets. If you have any questions about this information, please consult your veterinarian. Additional information can be found at www.Reconcile.com.

What are Reconcile chewable tablets?

Reconcile is a chewable, flavored tablet that you give to your dog once a day to treat separation anxiety. It is administered in conjunction with a simple training plan. Reconcile chewable tablets are for use in dogs and puppies 6 months of age or older, and 8.8 pounds (4.0 kilograms) or greater.

What is Separation Anxiety?

Separation anxiety is a disease in which affected dogs may exhibit certain problematic behaviors when left alone. Dogs are social animals, and naturally become bonded to family members in their household. When separated from these people, certain dogs may experience distress and engage in unacceptable behaviors as a result of the anxiety of separation. The more common behaviors associated with separation anxiety include destruction of household items, barking and/or whining, soiling or urinating in the house, heavy drooling and attempting to escape. Reconcile chewable tablets, when administered in conjunction with a simple training plan that you undertake at home, have been shown to reduce these detrimental behaviors exhibited by your dog.

What is a Simple Training Plan (Behavior Modification Plan), and why does my dog need one?

Your veterinarian will instruct you on how to incorporate simple training techniques, referred to as “behavior modification.” The combined use of these techniques with Reconcile chewable tablets has been proven to work faster and better than training alone for the management of separation anxiety.

The simple training plan generally consists of several activities, such as:

Adapting your dog to your coming and going behavior.

Teaching your dog to sit and stay and, over time, to be content in your absence.

Resisting the rewarding of inappropriate attention–seeking behaviors.

Leaving your dog for short periods, and gradually increasing the time that the dog is left alone.

What does my veterinarian need to know about my dog before I give Reconcile chewable tablets?

Your veterinarian is your dog's healthcare expert and can make the best recommendation for medications for your dog. Key points of your visit may include the following:

A thorough physical examination that may include laboratory analysis of blood and/or urine.

A discussion of your dog's complete health history, training history and household environment.

A discussion of any medications that you are giving now, or have given over the last several months to your dog, including over-the-counter and herbal supplements.

How should I give Reconcile chewable tablets to my dog?

Reconcile is a chewable flavored tablet that is readily consumed by most dogs. If your dog does not readily accept the Reconcile chewable tablet, it may be offered in food or administered like other tablet medications. Follow your veterinarian's directions regarding how much medication to administer.

If a dose is missed, the next scheduled dose should be given as prescribed. Do not increase or double the dose. If more than the prescribed amount of Reconcile chewable tablets are given, contact your veterinarian, who is the healthcare expert for your dog.

What can I expect from this therapy?

Some dogs may show improvement within 1-2 weeks of starting treatment with Reconcile chewable tablets. Others may take as long as 8 weeks to show improvement. Your veterinarian will monitor the response to Reconcile chewable tablets and the training plan. If no improvement is noted within 8 weeks, your veterinarian will discuss additional treatment plans for your dog. Reconcile chewable tablets work by making your dog more receptive to your training program. Although some dogs may appear calmer while on Reconcile chewable tablets, it does not act as a sedative.

What side effects might occur while my dog is taking Reconcile chewable tablets?

As with all medications, side effects may occur. Your veterinarian can best describe these for you and discuss what to do if you observe any unexpected effects or unusual behavior in your dog. The most serious side effect is seizures (convulsions), which in rare and severe cases can result in death. Based on clinical field studies, some animals may appear more calm or lethargic. Additional side effects that may be observed include: decreased appetite, vomiting, shaking or shivering, diarrhea, restlessness, excessive vocalization or whining, aggression, ear infections, disorientation, incoordination, constipation, excessive salivation and weight loss.

Can other medications be given while my pet is taking Reconcile chewable tablets?

Yes, Reconcile chewable tablets have been given safely with a wide variety of routinely administered products and medications, including vaccines, antibiotics, anti-inflammatories and products used for the control of fleas, intestinal worms and heartworms. There are a few products and medications that you should not give to your dog before, during or after treatment with Reconcile chewable tablets because together, they can cause serious side effects. Your veterinarian should be made aware of all products, including over-the-counter and herbal supplements, that you intend to administer to your dog.

What else should I know about Reconcile chewable tablets?

Reconcile chewable tablets are not for use in humans. As with all medications, keep Reconcile chewable tablets out of reach of children.

Close the lid tightly between uses and keep the desiccant cannister (plastic cylinder) in the bottle until the medication is finished.

Store at 68-77°F (20-25°C). Temporary periods of time outside of this range between 59-86°F (15-30°C) are permitted.

If you have questions regarding the use of this product, consult your veterinarian, your pet's healthcare expert. For technical assistance or to report an adverse drug experience, call 1-888-545-5973. Additional information can be found at www.Reconcile.com.

PA9710DEAMX

(V03-07-2009)

Reconcile 8mg-Label

Reconcile®

(fluoxetine hydrochloride)

CAUTION: Federal (USA) law restricts this drug to use

by or on the order of a licensed veterinarian.

For the treatment of canine

SEPARATION ANXIETY

in conjunction with a

behavior modification plan

8 mg 8.8-17.6 lbs.

Net contents: 30 Tablets

NADA 141-272 APPROVED BY FDA

Reconcile 8mg-Carton

Reconcile®

(fluoxetine hydrochloride)

CAUTION: Federal (USA) law restricts this drug to use by or on

the order of a licensed veterinarian.

For the treatment of canine

SEPARATION ANXIETY

in conjunction with a

behavior modification plan

8 mg 8.8-17.6 lbs.

Net contents: 30 Tablets, 8 mg each

NADA 141-272

APPROVED BY FDA

Human Warning: Not for use in humans.

Keep this and all drugs out of the reach of children.

ELANCO™

Reconcile 16mg-Label

Reconcile®

(fluoxetine hydrochloride)

CAUTION: Federal (USA) law restricts this drug to use

by or on the order of a licensed veterinarian.

For the treatment of canine

SEPARATION ANXIETY

in conjunction with a

behavior modification plan

16 mg 17.7-35.2 lbs.

Net contents: 30 Tablets

NADA 141-272 APPROVED BY FDA

Reconcile 16mg-Carton

Reconcile®

(fluoxetine hydrochloride)

CAUTION: Federal (USA) law restricts this drug to use by or on

the order of a licensed veterinarian.

For the treatment of canine

SEPARATION ANXIETY

in conjunction with a

behavior modification plan

16 mg 17.7-35.2 lbs.

Net contents: 30 Tablets, 16 mg each

NADA 141-272

APPROVED BY FDA

Human Warning: Not for use in humans.

Keep this and all drugs out of the reach of children.

ELANCO™

Reconcile 32mg-Label

Reconcile®

(fluoxetine hydrochloride)

CAUTION: Federal (USA) law restricts this drug to use

by or on the order of a licensed veterinarian.

For the treatment of canine

SEPARATION ANXIETY

in conjunction with a

behavior modification plan

32 mg 35.3-70.4 lbs.

Net contents: 30 Tablets

NADA 141-272 APPROVED BY FDA

Reconcile 32mg-Carton

Reconcile®

(fluoxetine hydrochloride)

CAUTION: Federal (USA) law restricts this drug to use by or on

the order of a licensed veterinarian.

For the treatment of canine

SEPARATION ANXIETY

in conjunction with a

behavior modification plan

32 mg 35.3-70.4 lbs.

Net contents: 30 Tablets, 32 mg each

NADA 141-272

APPROVED BY FDA

Human Warning: Not for use in humans.

Keep this and all drugs out of the reach of children.

ELANCO™

Reconcile 64mg-Label

Reconcile®

(fluoxetine hydrochloride)

CAUTION: Federal (USA) law restricts this drug to use

by or on the order of a licensed veterinarian.

For the treatment of canine

SEPARATION ANXIETY

in conjunction with a

behavior modification plan

64 mg 70.5-140.8 lbs.

Net contents: 30 Tablets

NADA 141-272 APPROVED BY FDA

Reconcile 64mg-Carton

Reconcile®

(fluoxetine hydrochloride)

CAUTION: Federal (USA) law restricts this drug to use by or on

the order of a licensed veterinarian.

For the treatment of canine

SEPARATION ANXIETY

in conjunction with a

behavior modification plan

64 mg 70.5-140.8 lbs.

Net contents: 30 Tablets, 64 mg each

NADA 141-272

APPROVED BY FDA

Human Warning: Not for use in humans.

Keep this and all drugs out of the reach of children.

ELANCO™

Reconcile
fluoxetine hydrochloride tablet, chewable

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	NDC Product Code (Source)	0986-4203
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FLUOXETINE HYDROCHLORIDE (FLUOXETINE)	FLUOXETINE HYDROCHLORIDE	8 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
MAGNESIUM STEARATE
CROSPOVIDONE

Product Characteristics
Color	brown (BROWN)	Score	no score
Shape	ROUND (ROUND)	Size	8mm
Flavor	MEAT (MEAT)	Imprint Code	4203
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0986-4203-30	1 BOTTLE In 1 CARTON	contains a BOTTLE, PLASTIC
1		30 TABLET In 1 BOTTLE, PLASTIC	This package is contained within the CARTON (0986-4203-30)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA141272	02/22/2010

Reconcile
fluoxetine hydrochloride tablet, chewable

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	NDC Product Code (Source)	0986-4205
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FLUOXETINE HYDROCHLORIDE (FLUOXETINE)	FLUOXETINE HYDROCHLORIDE	16 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
MAGNESIUM STEARATE
CROSPOVIDONE

Product Characteristics
Color	brown (BROWN)	Score	no score
Shape	ROUND (ROUND)	Size	9mm
Flavor	MEAT (MEAT)	Imprint Code	4205
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0986-4205-30	1 BOTTLE In 1 CARTON	contains a BOTTLE, PLASTIC
1		30 TABLET In 1 BOTTLE, PLASTIC	This package is contained within the CARTON (0986-4205-30)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA141272	02/22/2010

Relistor

Pronunciation: METH-il-nal-TREX-one
Generic Name: Methylnaltrexone
Brand Name: Relistor

Relistor is used for:

Treating constipation caused by opioid medicines in certain patients. It may also be used for other conditions as determined by your doctor.

Relistor is a mu-opioid receptor antagonist. It works by decreasing the effect of opioid medicines in the stomach and bowel, which helps to decrease constipation.

Do NOT use Relistor if:

you are allergic to any ingredient in Relistor

you have known or suspected stomach or bowel blockage

Contact your doctor or health care provider right away if any of these apply to you.

Before using Relistor:

Some medical conditions may interact with Relistor. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have a history of kidney or liver problems, or you are on dialysis

if you have nausea, vomiting, stomach pain or swelling, or certain other stomach or bowel problems (eg, cancer, ulcer, Ogilvie syndrome)

if you have a peritoneal (abdominal) catheter

Some MEDICINES MAY INTERACT with Relistor. However, no specific interactions with Relistor are known at this time.

Ask your health care provider if Relistor may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Relistor:

Use Relistor as directed by your doctor. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with Relistor. Talk to your pharmacist if you have questions about this information.

Relistor is given as an injection under the skin. A health care provider will teach you how to use it. Be sure you understand how to use Relistor. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.

Relistor is colorless to pale yellow in color. Do not use Relistor if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.

Inject Relistor right after you draw it into the syringe. If you are not able to inject the medicine right away, it may be stored in the syringe at room temperature for up to 24 hours. You do not need to protect the syringe from light during this time.

Relistor may be injected into the upper arm, abdomen, or thigh. Do NOT inject Relistor into the upper arm if you are injecting yourself.

Rotate injection sites as directed by your health care provider. Do not inject into scars, stretch marks, or areas where the skin is bruised, tender, red, or hard.

Do not use Relistor more often than 1 time in a 24-hour period unless your doctor tells you otherwise.

Do not use a vial of Relistor more than 1 time, even if there is medicine left in the vial.

Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.

If you miss a dose of Relistor and you are still constipated, use it as soon as you remember. Continue to use it as directed by your doctor. Do not use more than 1 dose within a 24-hour period.

Ask your health care provider any questions you may have about how to use Relistor.

Important safety information:

Relistor may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Relistor with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Do NOT use more than the recommended dose or use for longer than 4 months without checking with your doctor.

Be sure to stay close to a restroom once you have injected Relistor. Most patients have a bowel movement within a few minutes to a few hours after they use it.

Relistor should only be used by patients who take opioid pain medicines. Tell your doctor if you stop taking your opioid pain medicine.

Tell your doctor or dentist that you take Relistor before you receive any medical or dental care, emergency care, or surgery.

Relistor should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Relistor while you are pregnant. It is not known if Relistor is found in breast milk. If you are or will be breast-feeding while you use Relistor, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Relistor:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; gas; mild diarrhea; nausea; stomach pain; sweating; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fever or chills; new or worsening nausea or vomiting; severe, persistent, or worsening diarrhea, nausea, vomiting, or stomach pain.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Relistor side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include severe dizziness, fatigue, fainting, or weakness.

Proper storage of Relistor:

Store Relistor at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Relistor out of the reach of children and away from pets.

General information:

If you have any questions about Relistor, please talk with your doctor, pharmacist, or other health care provider.

Relistor is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Relistor. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Relistor resources

Relistor Side Effects (in more detail)
Relistor Use in Pregnancy & Breastfeeding
Relistor Support Group
7 Reviews for Relistor - Add your own review/rating

Relistor Prescribing Information (FDA)

Relistor Monograph (AHFS DI)

Relistor Advanced Consumer (Micromedex) - Includes Dosage Information

Relistor Consumer Overview

Compare Relistor with other medications

Constipation, Chronic
Constipation, Drug Induced

Redness Relief

Generic Name: tetrahydrozoline ophthalmic (TE tra hye DROZ oh leen)

Brand Names: Altazine, Geneye Extra, Geneyes, Opti-Clear, Optigene 3, Redness Relief, Redness Relief Original, Visine, Visine Maximum Redness Relief, Vision Clear

What is Redness Relief (tetrahydrozoline ophthalmic)?

Tetrahydrozoline ophthalmic narrows the blood vessels (veins and arteries) in your eyes.

Tetrahydrozoline ophthalmic (for the eyes) is used to relieve redness, burning, irritation, and dryness of the eyes caused by wind, sun, and other minor irritants.

Tetrahydrozoline ophthalmic may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Redness Relief (tetrahydrozoline ophthalmic)?

Do not use tetrahydrozoline ophthalmic without medical advice if you have glaucoma. Do not use this medication while wearing contact lenses. Tetrahydrozoline ophthalmic may contain a preservative that can discolor soft contact lenses. Wait at least 15 minutes after using tetrahydrozoline ophthalmic before putting your contact lenses in. Do not allow the tip of the dropper to touch any surface, including your eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye. Do not use tetrahydrozoline ophthalmic more often than recommended, or use it for longer than 48 to 72 hours without medical advice. Long-term use of this medication may damage the blood vessels in the eyes. Call your doctor if your symptoms do not improve or if they get worse.

What should I discuss with my healthcare provider before using Redness Relief (tetrahydrozoline ophthalmic)?

Do not use tetrahydrozoline ophthalmic without medical advice if you have glaucoma.

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have:

heart disease or coronary artery disease;

high blood pressure;

diabetes; or

a thyroid disorder.

FDA pregnancy category C. It is not known whether tetrahydrozoline ophthalmic will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether tetrahydrozoline nasal passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medication to a child without a doctor's advice.

How should I use Redness Relief (tetrahydrozoline ophthalmic)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Do not use tetrahydrozoline ophthalmic more often than recommended, or use it for longer than 48 to 72 hours without medical advice. Long-term use of this medication may damage the blood vessels in the eyes. Call your doctor if your symptoms do not improve or if they get worse. Do not use this medication while you are wearing contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses. Wait at least 15 minutes after using tetrahydrozoline before putting your contact lenses in. Wash your hands before and after using the eye drops.

To apply the eye drops:

Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the tip down. Look up and away from the dropper as you squeeze out a drop, then close your eye.

Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct.

Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Do not allow the tip of the dropper to touch any surface, including your eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Do not use the eye drops if the liquid has changed colors or has particles in it.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

Since tetrahydrozoline ophthalmic is used on an as needed basis, you are not likely to miss a dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using Redness Relief (tetrahydrozoline ophthalmic)?

Do not use other eye medications during treatment with tetrahydrozoline ophthalmic unless your doctor tells you to.

Redness Relief (tetrahydrozoline ophthalmic) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using tetrahydrozoline ophthalmic and call your doctor at once if you have a serious side effect such as:

severe burning, stinging, swelling, or other irritation after using the eye drops;

fast or pounding heartbeats; or

dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

burning, stinging, pain, or increased redness of the eye;

tearing or blurred vision;

nausea;

nervousness, dizziness, drowsiness;

sleep problems (insomnia); or

headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Redness Relief (tetrahydrozoline ophthalmic)?

Tell your doctor about all other medicines you use, especially:

an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate); or

a beta blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Dutoprol, Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others.

This list is not complete and other drugs may interact with tetrahydrozoline ophthalmic. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Redness Relief resources

Redness Relief Side Effects (in more detail)
Redness Relief Use in Pregnancy & Breastfeeding
Redness Relief Drug Interactions
Redness Relief Support Group
0 Reviews for Redness Relief - Add your own review/rating

Clarinex Monograph (AHFS DI)

Visine Eye Drops MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Redness Relief with other medications

Eye Dryness/Redness

Where can I get more information?

Your pharmacist can provide more information about tetrahydrozoline ophthalmic.

See also: Redness Relief side effects (in more detail)

Rectasol-HC cream, ointment, suppository

Generic Name: hydrocortisone rectal (cream, ointment, suppository) (hye dro KORT i zone REK tal)

Brand Names: Anucort-HC, Anumed-HC, Anusol-HC, Cortizone-10 Anal Itch Cream, Hemorrhoidal HC, Hemril-30, Hemril-HC Uniserts, Preparation H Hydrocortisone, Procto-Kit 1%, Procto-Kit 2.5%, Procto-Pak 1%, Proctocort, Proctocream-HC, Proctosert HC, Proctosol-HC, Proctozone HC, Proctozone-H, Recort Plus, Rectasol-HC, Tucks HC

What is hydrocortisone rectal?

Hydrocortisone is a steroid medicine that reduces inflammation in the body.

The information in this medication guide is specific to hydrocortisone rectal cream, ointment, or suppository.

Hydrocortisone rectal is used to treat itching or swelling caused by hemorrhoids or other inflammatory conditions of the rectum or anus.

Hydrocortisone rectal is also used together with other medications to treat ulcerative colitis, proctitis, and other inflammatory conditions of the lower intestines and rectal area.

Hydrocortisone rectal may also be used for purposes not listed in this medication guide.

What is the most important information I should know about hydrocortisone rectal?

The information in this medication guide is specific to hydrocortisone rectal cream, ointment, or suppository.

Do not take hydrocortisone rectal by mouth. It is for use only in your rectum.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions. You may need to use this medication for up to 8 weeks.

Call your doctor at once if you have any bleeding from your rectum, feeling short of breath (even with mild exertion), swelling of your ankles or feet, or rapid weight gain.

There may be other drugs that can interact with hydrocortisone rectal. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Call your doctor if your symptoms do not improve or if they get worse after using this medicine for a few days.

What should I discuss with my health care provider before using hydrocortisone rectal?

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have:

congestive heart failure;

a history of tuberculosis;

stomach ulcer or diverticulitis;

a colostomy or ileostomy;

fever or any type of infection;

kidney disease;

high blood pressure; or

myasthenia gravis.

Also tell your doctor if you have diabetes. Steroid medicines may increase the glucose (sugar) levels in your blood or urine. You may also need to adjust the dose of your diabetes medications.

FDA pregnancy category C. It is not known whether hydrocortisone rectal will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether hydrocortisone passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use hydrocortisone rectal?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Do not take hydrocortisone rectal by mouth. It is for use only in your rectum.

Wash your hands before and after using this medicine.

Try to empty your bowel and bladder just before using hydrocortisone rectal.

Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands. The rectal suppository can stain clothing or other fabrics it comes into contact with.

For best results from the suppository, lie down after inserting it and hold in the suppository. The suppository will melt quickly once inserted and you should feel little or no discomfort while holding it in.

For best results from the cream, use only the applicator provided with the medication. Otherwise, follow the directions provided with your rectal cream.

Avoid using the bathroom for one to three hours after inserting the cream or suppository.

Apply the ointment to the rectum and surrounding skin of the rectal area as directed on the package label.

Call your doctor if your symptoms do not improve or if they get worse after using this medicine for a few days.

Store the rectal cream at room temperature away from moisture and heat. Store the rectal suppositories at cool room temperature away from moisture and heat. Do not refrigerate or freeze them.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose of hydrocortisone rectal is not expected to produce life-threatening symptoms. However, long-term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while using hydrocortisone rectal ?

Avoid getting a vaccine during your treatment with hydrocortisone rectal. Vaccines may not work as well while you are using a steroid medicine.

Hydrocortisone rectal side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

feeling short of breath, even with mild exertion;

swelling of your ankles or feet;

muscle weakness;

rapid weight gain, especially in your face and midsection;

severe rectal pain or burning;

bleeding from your rectum;

severe stomach pain;

sudden and severe headache or pain behind your eyes; or

seizure (convulsions).

Less serious side effects may include:

mild rectal pain or burning;

acne;

changes in your menstrual periods;

increased sweating; or

increased facial or body hair growth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect hydrocortisone rectal ?

Before using hydrocortisone rectal, tell your doctor if you also use insulin or take oral diabetes medication.

More Rectasol-HC resources

Rectasol-HC Side Effects (in more detail)
Rectasol-HC Use in Pregnancy & Breastfeeding
Rectasol-HC Drug Interactions
Rectasol-HC Support Group
0 Reviews for Rectasol-HC - Add your own review/rating

Compare Rectasol-HC with other medications

Anal Itching
Aphthous Stomatitis, Recurrent
Atopic Dermatitis
Dermatitis
Eczema
Gingivitis
Hemorrhoids
Proctitis
Pruritus
Psoriasis
Seborrheic Dermatitis
Ulcerative Colitis, Active

Where can I get more information?

Your pharmacist can provide more information about hydrocortisone rectal cream, ointment, or suppository.

See also: Rectasol-HC side effects (in more detail)

Relasin-HC

Generic Name: chlorpheniramine, hydrocodone, and phenylephrine (KLOR fe NEER a meen, HYE droe KOE done, FEN il EFF rin)

Brand Names: B-Tuss, Coughtuss, Cytuss HC, De-Chlor HC, DroTuss-CP, Ed-TLC, Ed-Tuss HC, Endal-HD Plus, H-C Tussive, Histussin-HC, Hydro-PC II, Hydro-PC II Plus, Hydron CP, Liquicough HC, Maxi-Tuss HCX, Mintuss MS, Neo HC, Poly-Tussin, Poly-Tussin HD, Relacon-HC, Relacon-HC NR, Relasin-HC, Rindal HD Plus, Rindal-HD, Triant-HC, Tusana-D, Z-Cof HC

What is Relasin-HC (chlorpheniramine, hydrocodone, and phenylephrine)?

Chlorpheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Hydrocodone is a narcotic cough medicine.

Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of chlorpheniramine, hydrocodone, and phenylephrine is used to treat runny or stuffy nose, sinus congestion, and cough caused by the common cold or flu.

Chlorpheniramine, hydrocodone, and phenylephrine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Relasin-HC (chlorpheniramine, hydrocodone, and phenylephrine)?

Do not take this medication if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. Serious, life threatening side effects can occur if you use chlorpheniramine, hydrocodone, and phenylephrine before the MAO inhibitor has cleared from your body. Chlorpheniramine, hydrocodone, and phenylephrine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of chlorpheniramine, hydrocodone, and phenylephrine. Before using this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by chlorpheniramine, hydrocodone, and phenylephrine. Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. Never share hydrocodone with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

What should I discuss with my healthcare provider before taking Relasin-HC (chlorpheniramine, hydrocodone, and phenylephrine)?

To make sure you can safely take this medication, tell your doctor if you have any of these other conditions:

asthma, COPD, sleep apnea, or other breathing disorder;

liver or kidney disease;

heart disease or high blood pressure;

diabetes;

a thyroid disorder;

curvature of the spine;

a history of head injury or brain tumor;

epilepsy or other seizure disorder;

low blood pressure;

glaucoma;

gallbladder disease;

Addison's disease or other adrenal gland disorders;

enlarged prostate, urination problems;

mental illness; or

a history of drug or alcohol addiction.

Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. Never share hydrocodone with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. FDA pregnancy category C. It is not known whether chlorpheniramine, hydrocodone, and phenylephrine will harm an unborn baby. Hydrocodone may cause addiction or withdrawal symptoms in a newborn if the mother takes the medication during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using chlorpheniramine, hydrocodone, and phenylephrine. It is not known whether chlorpheniramine, hydrocodone, and phenylephrine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Relasin-HC (chlorpheniramine, hydrocodone, and phenylephrine)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

You may take this medication with or without food.

Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Store at room temperature away from moisture and heat. Keep track of the amount of medicine used from each new bottle. Hydrocodone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of hydrocodone can be fatal.

Overdose symptoms may include extreme drowsiness, feeling restless or nervous, vomiting, stomach pain, warmth or tingly feeling, seizure (convulsions), pinpoint pupils, confusion, cold and clammy skin, weak pulse, shallow breathing, fainting, or breathing that stops.

What should I avoid while taking Relasin-HC (chlorpheniramine, hydrocodone, and phenylephrine)?

Chlorpheniramine, hydrocodone, and phenylephrine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of chlorpheniramine, hydrocodone, and phenylephrine.

Relasin-HC (chlorpheniramine, hydrocodone, and phenylephrine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

severe dizziness, anxiety, restless feeling, or nervousness;

fast, pounding, or uneven heartbeats;

shallow breathing, slow heartbeat;

confusion, hallucinations, unusual thoughts or behavior;

feeling like you might pass out;

urinating less than usual or not at all;

easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms;

dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, chest pain, shortness of breath, seizure); or

upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

nausea, vomiting, upset stomach, constipation;

dry mouth;

blurred vision;

dizziness, drowsiness;

problems with memory or concentration;

sleep problems (insomnia);

ringing in your ears;

warmth, tingling, or redness under your skin; or

skin rash or itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Relasin-HC (chlorpheniramine, hydrocodone, and phenylephrine)?

Before using this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by chlorpheniramine, hydrocodone, and phenylephrine.

Tell your doctor about all other medications you use, especially:

blood pressure medication;

cimetidine (Tagamet);

rifampin (Rifadin, Rifater, Rifamate, Rimactane);

zidovudine (Retrovir, AZT);

an antidepressant;

a diuretic (water pill);

medication to treat irritable bowel syndrome;

bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol) or tolterodine (Detrol);

aspirin or salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others);

seizure medication such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton);

a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others; or

medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), haloperidol (Haldol), mesoridazine (Serentil), pimozide (Orap), or thioridazine (Mellaril).

This list is not complete and other drugs may interact with chlorpheniramine, hydrocodone, and phenylephrine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Relasin-HC resources

Relasin-HC Side Effects (in more detail)
Relasin-HC Use in Pregnancy & Breastfeeding
Relasin-HC Drug Interactions
Relasin-HC Support Group
0 Reviews for Relasin-HC - Add your own review/rating

Chlorpheniramine/Hydrocodone/Phenylephrine Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Relasin-HC with other medications

Cough and Nasal Congestion

Where can I get more information?

Your pharmacist can provide more information about chlorpheniramine, hydrocodone, and phenylephrine.

See also: Relasin-HC side effects (in more detail)

Relpax

Generic Name: Eletriptan Hydrobromide
Class: Selective Serotonin Agonists
VA Class: CN105
Chemical Name: 3-[[(R)-1-Methyl-2-pyrrolidinyl]methyl]-5-[2-(phenylsulfonyl)ethyl]indole
Molecular Formula: C₂₂H₂₆N₂O₂S
CAS Number: 143322-58-1

Introduction

Selective serotonin (5-hydroxytryptamine; 5-HT) type 1B and 1D receptor agonist (“triptan”).¹ ² ³ ⁴ ⁵ ¹¹ ¹² ¹³ ¹⁴ ¹⁵

Uses for Relpax

Vascular Headaches

Acute treatment of migraine attacks with or without aura.¹ ² ³ ⁴ ⁵ ⁶ ⁷ ¹⁵ ¹⁶ ¹⁷

Not recommended for management of hemiplegic or basilar migraine or for prophylaxis of migraine.¹

Safety and efficacy not established for management of cluster headaches.¹

Relpax Dosage and Administration

Administration

Oral Administration

Administer orally without regard to meals.¹ ² ³ ⁴ ⁵ ⁶ ⁷ ¹⁵ ²²

Administration not recommended within 72 hours of potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nelfinavir).¹ (See Interactions.)

Dosage

Available as eletriptan hydrobromide; dosage expressed in terms of eletriptan.¹

Adults

Vascular Headaches

Migraine

Oral

20 or 40 mg as a single dose;¹ ² ³ ⁴ ⁵ ⁶ ⁷ ⁸ ¹⁵ individualize dosage selection,¹ weighing the possible benefit (greater effectiveness) and risks (increased adverse effects) of the 40-mg dose.¹ ³ In clinical studies, doses >40 mg were effective but were associated with increased risk of adverse effects.¹ ²

If headache recurs, additional doses may be administered at intervals of ≥2 hours, up to a maximum dosage of 80 mg in any 24-hour period.¹

If patient does not respond to first dose, additional doses are unlikely to provide benefit for the same headache.¹

Prescribing Limits

Adults

Vascular Headaches

Migraine

Oral

Maximum 40 mg as a single dose; do not exceed 80 mg in any 24-hour period.¹

Safety of treating an average of >3 headaches per 30-day period has not been established.¹

Special Populations

Hepatic Impairment

Dosage adjustment not necessary in patients with mild to moderate hepatic impairment.¹ ¹⁵ Contraindicated in those with severe hepatic impairment.¹

Cautions for Relpax

Contraindications

Known or suspected ischemic heart disease (e.g., angina pectoris, history of MI, documented silent ischemia).¹

Coronary artery vasospasm (e.g., Prinzmetal variant angina).¹

Other serious underlying cardiovascular disease (e.g., uncontrolled hypertension).¹

Cerebrovascular syndromes (e.g., stroke syndrome, TIAs).¹

Peripheral vascular ischemia (e.g., ischemic bowel disease).¹

Hemiplegic or basilar migraine.¹

Treatment within previous 24 hours with another 5-HT₁ receptor agonist or ergot alkaloid.¹ (See Specific Drugs under Interactions.)

Severe hepatic impairment (Child-Pugh grade C).¹

Known hypersensitivity to eletriptan or any ingredient in the formulation.¹

Warnings/Precautions

Warnings

Use only in patients in whom a clear diagnosis of migraine has been established.¹

Interactions

Do not use within at least 72 hours of potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nelfinavir).¹ (See Interactions.)

Cardiac Effects

Risk of coronary vasospasm, myocardial ischemia and/or infarction, life-threatening cardiac rhythm disturbances, and death with use of 5-HT₁ receptor agonists.¹

Use not recommended in patients with known or suspected ischemic or vasospastic heart disease or in patients in whom unrecognized CAD is likely (e.g., postmenopausal women; men >40 years of age; patients with risk factors such as hypertension, hypercholesterolemia, smoking, obesity, diabetes, or family history of CAD) unless there is satisfactory evidence from prior cardiovascular evaluation that patient does not have CAD, ischemic heart disease, or other underlying cardiovascular disease.¹

Administer initial dose to patients with risk factors for CAD who have completed satisfactory cardiovascular evaluation under medical supervision (e.g., in clinician’s office, possibly followed by ECG) unless patient previously received the drug.¹

Periodic cardiovascular evaluation recommended in patients with risk factors for CAD if receiving intermittent long-term therapy.¹

Patients with symptoms suggestive of angina after receiving eletriptan should be evaluated for presence of CAD or predisposition to Prinzmetal variant angina before receiving additional doses; if administration is resumed and such signs or symptoms recur, ECG evaluation recommended.¹

Cerebrovascular Events

Possible cerebral or subarachnoid hemorrhage, stroke, and other cerebrovascular events, sometimes fatal, with use of 5-HT₁ receptor agonists.¹

Risk of certain cerebrovascular events (e.g., stroke, hemorrhage, TIA) may be increased in patients with migraine.¹

Other Cardiovascular or Vasospastic Effects

Peripheral vascular ischemia and colonic ischemia with abdominal pain and bloody diarrhea reported with use of 5-HT₁ receptor agonists.¹ Further evaluation recommended if signs or symptoms of decreased arterial flow (e.g., ischemic colitis, Raynaud’s phenomenon) occur following administration.¹ ¹⁹

Substantial increases in BP, including hypertensive crises, reported rarely with 5-HT₁ receptor agonists in patients with or without history of hypertension.¹ Transient increases in BP reported with eletriptan doses ≥60 mg; may be more pronounced in patients with renal impairment and geriatric patients.¹

Increases in mean pulmonary artery pressure observed following administration of a 5-HT₁ receptor agonist to patients with suspected CAD who were undergoing cardiac catheterization.¹

Serotonin Syndrome

Potentially life-threatening serotonin syndrome reported during concurrent therapy with 5-HT₁ receptor agonists (“triptans”) and SSRIs or selective serotonin- and norepinephrine-reuptake inhibitors (SNRIs).¹ ²¹ Symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile BP, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination), and/or GI symptoms (e.g., nausea, vomiting, diarrhea).¹ ²¹ (See Specific Drugs under Interactions.)

General Precautions

Ocular Effects

Possible accumulation of eletriptan and/or its metabolites in melanin-rich tissues (e.g., eye) over time, resulting in potential toxicity in these tissues with extended use.¹

Specific Populations

Pregnancy

Category C.¹

Lactation

Distributed into human milk.¹ Caution advised if eletriptan is used.¹

Pediatric Use

Safety and efficacy not established in children <18 years of age; use not recommended.¹

Geriatric Use

No substantial differences in efficacy or safety relative to younger adults; however, limited clinical experience in patients ≥65 years of age.¹ Increases in BP may be more pronounced.¹

Hepatic Impairment

Contraindicated in patients with severe hepatic impairment.¹

Renal Impairment

Increases in BP may be more pronounced.¹

Common Adverse Effects

Asthenia,¹ ² ³ ⁴ ⁵ ¹⁵ ¹⁷ headache,¹ ⁴ ¹⁷ nausea,¹ ² ³ ⁴ ⁵ ¹⁵ ¹⁷ paresthesia,¹ ² ³ ¹⁵ dizziness,¹ ² ³ ⁴ ⁵ ¹⁵ ¹⁷ somnolence,¹ ³ ⁴ ⁵ ¹⁵ ¹⁷ dry mouth,¹ ⁴ ¹⁷ flushing or feeling of warmth,¹ pain/pressure sensations (i.e., chest pain [tightness/pressure], abdominal pain/discomfort/stomach pain/cramps/pressure),¹ ³ ⁴ ⁵ ¹⁵ dyspepsia,¹ dysphagia ¹ ¹⁷ (i.e., throat tightness,¹ difficulty swallowing¹ ).

Interactions for Relpax

Metabolized principally by CYP3A4.¹

Little potential to inhibit or induce CYP1A2, CYP2C9, CYP2E1, or CYP3A4; pharmacokinetic interaction unlikely.¹ Affects CYP2D6 only at high concentrations; eletriptan should not interfere with metabolism of other drugs when used at recommended dosages.¹

Drugs Affecting Hepatic Microsomal Enzymes

Potential pharmacokinetic interaction (increased peak plasma eletriptan concentrations and AUC) with concomitant use of CYP3A4 inhibitors.¹ ¹⁵ Eletriptan administration not recommended within 72 hours of potent CYP3A4 inhibitors.¹

Specific Drugs

Drug	Interaction	Comments
Antidepressants, SSRIs (e.g., citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline) and SNRIs (e.g., duloxetine, venlafaxine)	Potentially life-threatening serotonin syndrome¹ ²¹	Observe carefully if used concomitantly, particularly during treatment initiation, dosage increases, or when another serotonergic agent is initiated¹ ¹⁹ ²⁰ ²¹
Antifungals, azole (fluconazole, ketoconazole, itraconazole)	Increased peak plasma concentrations and AUC of eletriptan¹	Eletriptan administration not recommended within 72 hours of potent CYP3A4 inhibitors¹
Ergot alkaloids (e.g., ergotamine, dihydroergotamine, methysergide)	Additive vasospastic effects¹ ¹⁵	Use within 24 hours contraindicated¹
5-HT₁ receptor agonists	Additive vasospastic effects¹ ¹⁵	Use within 24 hours contraindicated¹
HIV protease inhibitors (nelfinavir, ritonavir)	Potential increase in peak plasma concentrations and AUC of eletriptan¹	Eletriptan administration not recommended within 72 hours of potent CYP3A4 inhibitors¹
Macrolide antibiotics (clarithromycin, erythromycin, troleandomycin)	Increased peak plasma concentrations and AUC of eletriptan¹	Eletriptan administration not recommended within 72 hours of potent CYP3A4 inhibitors¹
MAO inhibitors	Pharmacokinetic interaction unlikely¹ ¹⁵
Nefazodone	Potential increase in peak plasma concentrations and AUC of eletriptan¹	Eletriptan administration not recommended within 72 hours of potent CYP3A4 inhibitors¹
Propranolol	Increased peak plasma concentrations and AUC of eletriptan;¹ ¹¹ ¹⁷ ¹⁹ no increases in BP observed¹	No dosage adjustment required¹ ¹¹ ¹⁷ ¹⁹
Verapamil	Increased peak plasma concentrations and AUC of eletriptan¹

Relpax Pharmacokinetics

Absorption

Bioavailability

Well absorbed after oral administration.¹ ² ³ ⁵ ¹⁴ ¹⁵ Absolute bioavailability is approximately 50%.¹

Peak plasma concentrations attained approximately 1.5 and 2 hours after oral administration in healthy adults and patients with moderate to severe migraine, respectively.¹ ² ⁵ ¹⁴ ¹⁵

Food

High-fat meal increases AUC and peak plasma concentrations by approximately 20–30%.¹

Distribution

Extent

Distributed into human milk.¹

Plasma Protein Binding

Approximately 85%.¹

Elimination

Metabolism

Metabolized principally by CYP3A4.¹ ⁸ ¹¹ ¹⁵ N-demethylated metabolite (only known active metabolite) does not appear to contribute substantially to overall effect of parent drug.¹ ¹⁹

Elimination Route

Renal clearance accounts for about 10% of total clearance.¹

Half-life

Approximately 4 hours.¹ ² ³ ¹⁴ ¹⁵

Special Populations

In patients with mild to moderate hepatic impairment, peak plasma eletriptan concentrations and AUC are increased 18 and 34%, respectively.¹ Not studied in patients with severe hepatic impairment.¹

In patients with renal impairment, no substantial changes in clearance.¹

In geriatric patients, pharmacokinetic profile is similar to that in younger adults, although half-life may be increased.¹

Stability

Storage

Oral

Tablets

25°C (may be exposed to 15–30°C).¹

ActionsActions

Binds with high affinity to 5-HT_1B and 5-HT_1D receptors.¹ ² ³ ⁴ ⁵ ¹¹ ¹² ¹³ ¹⁴ ¹⁵

Structurally and pharmacologically related to other selective 5-HT_1B/1D receptor agonists (e.g., almotriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan).¹¹ ¹²

Precise mechanism of action not established; may ameliorate migraine through selective constriction of certain intracranial blood vessels, inhibition of neuropeptide release, and reduced transmission in trigeminal pain pathway.¹ ⁸ ¹¹ ¹² ¹³

Advice to Patients

Risk of dizziness or fatigue.¹

Importance of immediately informing clinician if shortness of breath, tightness, pain, pressure, or heaviness in chest, throat, jaw, or neck occurs and of not taking eletriptan again until evaluated by clinician.¹

Importance of adhering to prescribed directions for use.¹ Provide copy of manufacturer’s patient information.¹

Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal supplements, as well as any concomitant illnesses (e.g., cardiovascular disease).¹

Importance of informing patients of risk of serotonin syndrome with concurrent use of eletriptan and an SSRI or SNRI.²¹ Importance of seeking immediate medical attention if symptoms of serotonin syndrome develop.²¹

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

Importance of informing patients of other important precautionary information.¹ (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Eletriptan Hydrobromide
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, film-coated	20 mg (of eletriptan)	Relpax	Pfizer
		40 mg (of eletriptan)	Relpax	Pfizer

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Relpax 20MG Tablets (PFIZER U.S.): 6/$163.98 or 18/$473.96

Relpax 40MG Tablets (PFIZER U.S.): 6/$163.98 or 18/$473.96

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

References

1. Pfizer Inc. Relpax (eletriptan hydrobromide) prescribing information. New York, NY; 2006 Apr.

2. Goadsby PJ, Ferrari MD, Olesen J et al. Eletriptan in acute migraine: a double-blind, placebo-controlled comparison to sumatriptan. Neurology. 2000; 54:156-63. [IDIS 441229] [PubMed 10636142]

3. Stark R, Dahlöf C, Haughie S et al. Efficacy, safety and tolerability of oral eletriptan in the acute treatment of migraine: results of a phase III, multicentre, placebo-controlled study across three attacks. Cephalalgia. 2002; 22:23-32. [PubMed 11993610]

4. Diener HC, Jansen JP, Reches A et al. Efficacy, tolerability and safety of oral eletriptan and ergotamine plus caffeine (Cafergot) in the acute treatment of migraine: a multicentre, radomised, double-blind, placebo-controlled comparison. Eur Neurol. 2002; 47:99-107. [PubMed 11844898]

5. Sandrini G, Färkkilä M, Burgess G et al. Eletriptan vs sumatriptan : a double-blind, placebo-controlled, multiple migraine attack study. Neurology. 2002; 59:1210-7. [IDIS 493948] [PubMed 12391349]

6. Smith LA, Oldman AD, McQuay HJ et al. Eletriptan for acute migraine. Cochrane Database Syst Rev. 2001; 3:CD003224.

7. Oldman AD, Smith LA, McQuay HJ et al. Pharmacological treatments for acute migraine: quantitative systematic review. Pain. 2002; 97:247-57. [IDIS 488670] [PubMed 12044621]

8. Ferrari MD, Goadsby PJ, Roon KI et al. Triptans (serotonin, 5-HT_1B/1D agonists) in migraine: detailed results and methods of a meta-analysis of 53 trials. Cephalalgia. 2002; 22:633-58. [PubMed 12383060]

9. Matchar DB, Young WB, Rosenberg JH et al. Evidence-based guidelines for migraine headache in the primary care setting: pharmacological management of acute attacks. From American Academy of Neurology web site (http://www.aan.com).

10. Silberstein SD, for the US Headache Consortium. Practice parameter: evidence-based guidelines for migraine headache (an evidence-based review): report of the quality standards subcommittee of the American Academy of Neurology. Neurology. 2000; 55:754-63. [IDIS 453389] [PubMed 10993991]

11. Deleu D, Hanssens Y. Current and emerging second-generation triptans in acute migraine therapy: a comparative review. J Clin Pharmacol. 2000; 40:687-700. [IDIS 449430] [PubMed 10883409]

12. Tfelt-Hansen P, De Vries P, Saxena PR. Triptans in migraine: a comparative review of pharmacology, pharmacokinetics, and efficacy. Drugs. 2000; 60:1259-87. [PubMed 11152011]

13. Tepper SJ, Rapoport AM, Sheftell FD. Mechanisms of action of the 5-HT_1B/1D receptor agonists. Arch Neurol. 2002; 59:1084-8.. [PubMed 12117355]

14. Milton KA, Scott NR, Allen MJ et al. Pharmacokinetics, pharmacodynamics, and safety of the 5-HT_1B/1D agonist eletriptan following intravenous and oral administration. J Clin Pharmacol. 2002; 42:528-39. [IDIS 480734] [PubMed 12017347]

15. Anon. Eletriptan (Relpax) for migraine. Med Lett Drugs Ther. 2003; 45:33-4.

16. Mathew NT, Schoenen J, Winner P et al. Comparative efficacy of eletriptan 40 mg versus sumatriptan 100 mg. Headache. 2003; 43:214-22. [IDIS 496675] [PubMed 12603639]

17. Sheftell F, Ryan R, Pitman V, for the Eletriptan Steering Committee. Efficacy, safety, and tolerability of oral eletriptan for treatment of acute migraine: a multicenter, double-blind, placebo-controlled study conducted in the United States. Headache. 2003; 43:202-13. [IDIS 496674] [PubMed 12603638]

18. Fuseau E, Petricoul O, Sabin A et al. Effect of encapsulation on absorption of sumatriptan tablets: data from healthy volunteers and patients during a migraine. Clin Ther. 2001; 23:242-51. [IDIS 461622] [PubMed 11293557]

19. Pfizer Inc., New York, NY: Personal communication.

20. Eli Lilly and Company. Sarafem (fluoxetine hydrochloride) capsules prescribing information. Indainapolis, IN; 2000 Jul.

21. Food and Drug Administration. Public health advisory: combined use of 5-hydroxytryptamine receptor agonists (triptans), selective serotonin reuptake inhibitors (SSRIs) or selective serotonin/norepinephirne reuptake inhibitors (SNRIs) may result in life-threatening serotonin syndrome. Rockville, MD; 2006 Jul 19. From the FDA website: (, , and ).

22. Pfizer Inc. About Relpax—Best way to take Relpax. From the Pfizer website: () Accessed 2006 Dec 13.

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