Etrafon

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Is amitriptyline w/ perphenazine-oral available as a generic drug?

GENERIC AVAILABLE: Yes

What are the side effects of amitriptyline w/ perphenazine-oral?

Side effects of Perphenazine/amitriptyline are abnormal muscle contractions, difficulty breathing and swallowing, neck spasms, and movement abnormalities on face, arms, and legs. This medication also causes dizziness, drowsiness, sedation, irregular heart rate and rhythm, increase or decrease in blood pressure, and blurred vision.

Antidepressants increased the risk of suicidal thinking and behavior in short-term studies in children and adolescents with depression and other psychiatric disorders. Anyone considering the use of antidepressants in a child or adolescent must balance this risk of suicide with the clinical need. Patients who are started on therapy should be closely observed for clinical worsening, suicidal thoughts, or unusual changes in behavior.

Elderly patients with dementia related psychosis treated with antipsychotics are at an increased risk of death.

Which drugs or supplements interact with amitriptyline w/ perphenazine-oral?

: Perphenazine/amitriptyline should be used with caution with medications like paroxetine (Paxil), fluoxetine (Prozac), and sertraline (Zoloft) because these medications also increase the concentration of neurotransmitters in the body leading to severe and deadly reactions.

Perphenazine/amitriptyline should be avoided with medications like quinidine, disopyramide (Norpace), procainamide (Pronestyl), propafenone (Rhythmol), and flecainide (Tambocor) because they may also affect heart rhythm and increase the risk of an irregular heart rate and rhythm.

Perphenazine/amitriptyline should be used with caution with medications like epinephrine due to increased risk of irregular heart rates and rhythms.

Description

ETRAFON (perphenazine and amitriptyline) Tablets contain perphenazine, USP and amitriptyline hydrochloride, USP. Perphenazine is a piperazinyl phenothiazine having the chemical formula, C 21 H 26 CIN 3 OS. Amitriptyline hydrochloride is a dibenzocycloheptadiene derivative having the chemical formula, C 20 H 23 N.HCl.

ETRAFON (perphenazine and amitriptyline) Tablets are available in multiple strengths to afford dosage flexibility for optimum management. They are available as ETRAFON 2-10 Tablets, 2 mg perphenazine and 10 mg amitriptyline hydrochloride; ETRAFON (perphenazine and amitriptyline) Tablets, 2 mg perphenazine and 25 mg amitriptyline hydrochloride; ETRAFON (perphenazine and amitriptyline) -Forte Tablets, 4 mg perphenazine and 25 mg amitriptyline hydrochloride.

The inactive ingredients for ETRAFON 2-10 Tablets (2-10) include: acacia, butylparaben, calcium phosphate, calcium sulfate, carnauba wax, corn starch, D&C Yellow No. 10 Al Lake, FD&C Yellow No. 6 Al Lake, gelatin, lactose, magnesium stearate, potato starch, sugar, and white wax. May also contain talc.

The inactive ingredients for ETRAFON (perphenazine and amitriptyline) -Forte Tablets (4-25) include: acacia, butylparaben, calcium phosphate, calcium sulfate, carnauba wax, corn starch, FD&C Red No. 40 Al Lake, FD&C Yellow No. 6 Al Lake, gelatin, lactose, magnesium stearate, potato starch, sugar, and white wax. May also contain talc.

Overdose

Deaths may occur from overdosage with this class of drugs. Multiple drug ingestion (including alcohol) is common in deliberate overdose. As the management is complex and changing, it is recommended that the physician contact a poison control center for current information on treatment. Signs and symptoms of toxicity develop rapidly after overdose; therefore, hospital monitoring is required as soon as possible.

Manifestations: Overdosage of ETRAFON (perphenazine and amitriptyline) Tablets may cause any of the adverse reactions listed for perphenazine or amitriptyline hydrochloride.

Overdosage of perphenazine usually produces extrapyramidal symptoms such as dyskinesia and dystonia as described under ADVERSE REACTIONS, but this may be masked by the anticholinergic effects of amitriptyline. Other symptoms may include stupor or coma; children may have convulsive seizures.

Critical manifestations of tricyclic antidepressant overdose includes: cardiac dysrhythmias, severe hypotension, convulsions, and CNS depression, including coma. Changes in the electrocardiogram, particularly in QRS axis or width, are clinically significant indicators of tricyclic antidepressant toxicity. Other signs of overdose may include: confusion, disturbed concentration, transient visual hallucinations, dilated pupils, agitation, hyperactive reflexes, stupor, drowsiness, muscle rigidity, vomiting, hypothermia, hyperpyrexia, or any of the symptoms listed under ADVERSE REACTIONS.

Management: General: Obtain an ECG and immediately initiate cardiac monitoring. Protect the patient's airway, establish an intravenous line, and initiate gastric decontamination. A minimum of 6 hours of observation with cardiac monitoring and observation for signs of CNS or respiratory depression, hypotension, cardiac dysrhythmias and/or conduction blocks, and seizures is necessary. If signs of toxicity occur at any time during this period, extended monitoring is required. There are case reports of patients succumbing to fatal dysrhythmias late after overdose; these patients had clinical evidence of significant poisoning prior to death and most received inadequate gastrointestinal decontamination. Monitoring of plasma drug levels should not guide management of the patient.

Gastrointestinal Decontamination: All patients suspected of tricyclic antidepressant overdose should receive gastrointestinal decontamination. This should include large volume gastric lavage followed by activated charcoal. If consciousness is impaired, the airway should be secured prior to lavage. Emesis is contraindicated.

Cardiovascular: A maximal limb-lead QRS duration of ≥ 0.10 seconds may be the best indication of the severity of the overdose. Intravenous sodium bicarbonate should be used to maintain the serum pH in the range of 7.45 to 7.55. If the pH response is inadequate, hyperventilation may also be used. Concomitant use of hyperventilation and sodium bicarbonate should be done with extreme caution, with frequent pH monitoring. A pH > 7.60 or a pCO 2 < 20 mm Hg is undesirable. Dysrhythmias unresponsive to sodium bicarbonate therapy/hyperventilation may respond to lidocaine, bretylium, or phenytoin. Type 1A and 1C anti-arrhythmics are generally contraindicated (eg, quinidine, disopyramide, and procainamide).

In rare instances, hemoperfusion may be beneficial in acute refractory cardiovascular instability in patients with acute toxicity. However, hemodialysis, peritoneal dialysis, exchange transfusions, and forced diuresis generally have been reported as ineffective in tricyclic antidepressant poisoning.

CNS: In patients with CNS depression, early intubation is advised because of the potential for abrupt deterioration. Seizures should be controlled with benzodiazepines, or if these are ineffective, other anticonvulsants (eg, phenobarbital, phenytoin). Physostigmine is not recommended except to treat life-threatening symptoms that have been unresponsive to other therapies, and then only in consultation with a poison control center.

Psychiatric Follow-up: Since overdosage is often deliberate, patients may attempt suicide by other means during the recovery phase. Psychiatric referral may be appropriate.

Pediatric Management: The principles of management of child and adult overdosages are similar. It is strongly recommended that the physician contact the local poison control center for specific pediatric treatment.

Clinical pharmacology

ETRAFON (perphenazine and amitriptyline) Tablets combine the tranquilizing action of perphenazine with the antidepressant properties of amitriptyline hydrochloride. Perphenazine acts on the central nervous system, and has a greater behavioral potency than other phenothiazine derivatives whose side chains do not contain a piperazine moiety. Amitriptyline hydrochloride is a tricyclic antidepressant. While its mechanism of action in man is not known, it does not act primarily by stimulation of the central nervous system, and is not a monoamine oxidase (MAO) inhibitor.

Etrafon Drug Class

Etrafon is part of the drug class:

Non selective monoamine reuptake inhibitors

Commonly used brand name(s)

In the U.S.

Duo-Vil 2-10
Duo-Vil 2-25
Etrafon

Available Dosage Forms:

Tablet

Therapeutic Class: Tricyclic Antidepressant/Phenothiazine Combination

Pharmacologic Class: Phenothiazine

Chemical Class: Piperazine (class)

Before Using Etrafon

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Certain side effects, such as muscle spasms of the face, neck, and back, tic-like or twitching movements, inability to move the eyes, twisting of the body, or weakness of the arms and legs, are more likely to occur in children, who are usually more sensitive than adults to some of the side effects of perphenazine and amitriptyline combination.

The perphenazine and amitriptyline combination must be used with caution in children with depression. Studies have shown occurrences of children thinking about suicide or attempting suicide in clinical trials for this medicine. More study is needed to be sure the perphenazine and amitriptyline combination is safe and effective in children

Geriatric

Confusion, vision problems, dizziness or fainting, drowsiness, dryness of mouth, constipation, problems in urinating, trembling of the hands and fingers, and symptoms of tardive dyskinesia (such as uncontrolled movements of the mouth, tongue, jaw, arms, and/or legs) are especially likely to occur in elderly patients. Older patients are usually more sensitive than younger adults to the effects of perphenazine and amitriptyline combination.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Amifampridine
Amisulpride
Bepridil
Bromopride
Cisapride
Clorgyline
Dronedarone
Droperidol
Furazolidone
Grepafloxacin
Iproniazid
Isocarboxazid
Levomethadyl
Linezolid
Mesoridazine
Methylene Blue
Metoclopramide
Moclobemide
Nialamide
Pargyline
Phenelzine
Pimozide
Piperaquine
Procarbazine
Ranolazine
Safinamide
Saquinavir
Selegiline
Sparfloxacin
Terfenadine
Thioridazine
Toloxatone
Tranylcypromine
Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acecainide
Aceclofenac
Acemetacin
Albuterol
Alfentanil
Alfuzosin
Almotriptan
Amiodarone
Amisulpride
Amoxapine
Amphetamine
Amtolmetin Guacil
Anagrelide
Apomorphine
Aprindine
Aripiprazole
Aripiprazole Lauroxil
Arsenic Trioxide
Artemether
Asenapine
Aspirin
Astemizole
Atazanavir
Azimilide
Azithromycin
Benzphetamine
Bretylium
Bromazepam
Bromfenac
Brompheniramine
Bufexamac
Buprenorphine
Bupropion
Buserelin
Buspirone
Butorphanol
Celecoxib
Chloral Hydrate
Chloroquine
Chlorpheniramine
Chlorpromazine
Choline Salicylate
Ciprofloxacin
Citalopram
Clarithromycin
Clomipramine
Clonidine
Clonixin
Clozapine
Cocaine
Codeine
Crizotinib
Cyclobenzaprine
Dabrafenib
Darunavir
Dasatinib
Degarelix
Delamanid
Desipramine
Deslorelin
Desmopressin
Desvenlafaxine
Deutetrabenazine
Dexibuprofen
Dexketoprofen
Dextroamphetamine
Dextromethorphan
Diclofenac
Diflunisal
Dihydrocodeine
Dipyrone
Disopyramide
Dofetilide
Dolasetron
Domperidone
Donepezil
Doxepin
Doxorubicin
Doxorubicin Hydrochloride Liposome
Doxylamine
Droperidol
Droxicam
Efavirenz
Eletriptan
Eliglustat
Enflurane
Epinephrine
Erythromycin
Escitalopram
Eslicarbazepine Acetate
Etilefrine
Etodolac
Etofenamate
Etoricoxib
Felbinac
Fenoprofen
Fentanyl
Fepradinol
Feprazone
Fingolimod
Flecainide
Flibanserin
Floctafenine
Fluconazole
Flufenamic Acid
Fluoxetine
Flurbiprofen
Foscarnet
Frovatriptan
Gatifloxacin
Gemifloxacin
Gonadorelin
Goserelin
Granisetron
Halofantrine
Haloperidol
Halothane
Histrelin
Hydrocodone
Hydromorphone
Hydroxychloroquine
Hydroxytryptophan
Hydroxyzine
Ibuprofen
Ibutilide
Iloperidone
Imipramine
Indomethacin
Iobenguane I 123
Isoflurane
Isradipine
Ivabradine
Ketoconazole
Ketoprofen
Ketorolac
Lacosamide
Lapatinib
Leuprolide
Levalbuterol
Levofloxacin
Levomilnacipran
Levorphanol
Levothyroxine
Lidoflazine
Lisdexamfetamine
Lithium
Lopinavir
Lorcainide
Lorcaserin
Lornoxicam
Loxoprofen
Lumefantrine
Lumiracoxib
Meclofenamate
Mefenamic Acid
Mefloquine
Meloxicam
Meperidine
Methadone
Methamphetamine
Methoxamine
Metrizamide
Metronidazole
Midodrine
Milnacipran
Mirtazapine
Moricizine
Morniflumate
Morphine
Morphine Sulfate Liposome
Moxifloxacin
Nabumetone
Nafarelin
Nalbuphine
Naproxen
Naratriptan
Nefazodone
Nefopam
Nepafenac
Niflumic Acid
Nilotinib
Nimesulide
Nimesulide Beta Cyclodextrin
Norepinephrine
Norfloxacin
Nortriptyline
Octreotide
Ofloxacin
Ondansetron
Oxaprozin
Oxilofrine
Oxycodone
Oxymetazoline
Oxymorphone
Oxyphenbutazone
Paliperidone
Palonosetron
Panobinostat
Parecoxib
Paroxetine
Pasireotide
Pazopanib
Peginterferon Alfa-2b
Pentamidine
Pentazocine
Periciazine
Phenylbutazone
Phenylephrine
Piketoprofen
Pimavanserin
Piroxicam
Pitolisant
Pixantrone
Posaconazole
Pranoprofen
Procainamide
Procarbazine
Prochlorperazine
Proglumetacin
Promethazine
Propafenone
Propoxyphene
Propyphenazone
Proquazone
Protriptyline
Quetiapine
Quinidine
Quinine
Rasagiline
Remifentanil
Ribociclib
Risperidone
Rizatriptan
Rofecoxib
Salicylic Acid
Salsalate
Sematilide
Sertindole
Sertraline
Sevoflurane
Sibutramine
Sodium Phosphate
Sodium Phosphate, Dibasic
Sodium Phosphate, Monobasic
Sodium Salicylate
Solifenacin
Sorafenib
Sotalol
Spiramycin
Sufentanil
Sulfamethoxazole
Sulindac
Sulpiride
Sultopride
Sumatriptan
Sunitinib
Tacrolimus
Tapentadol
Tedisamil
Telavancin
Telithromycin
Tenoxicam
Tetrabenazine
Tiaprofenic Acid
Tiotropium
Tolfenamic Acid
Tolmetin
Toremifene
Tramadol
Trazodone
Trifluoperazine
Trimethoprim
Trimipramine
Triptorelin
Tryptophan
Valdecoxib
Vandetanib
Vardenafil
Vasopressin
Vemurafenib
Venlafaxine
Vilanterol
Vilazodone
Vinflunine
Voriconazole
Vortioxetine
Zolmitriptan
Zotepine
Zuclopenthixol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acenocoumarol
Aminolevulinic Acid
Arbutamine
Atomoxetine
Belladonna
Belladonna Alkaloids
Betel Nut
Bethanidine
Carbamazepine
Cimetidine
Diazepam
Dicumarol
Evening Primrose
Fluvoxamine
Fosphenytoin
Galantamine
Guanethidine
Midodrine
Orphenadrine
Paroxetine
Phenprocoumon
Phenylalanine
Phenytoin
Procyclidine
Rifapentine
Ritonavir
S-Adenosylmethionine
St John's Wort
Trihexyphenidyl
Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Tobacco

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Etrafon Side Effects

Along with its needed effects, perphenazine (included in this combination medicine) can sometimes cause serious side effects. Tardive dyskinesia (a movement disorder) may occur and may not go away after you stop using the medicine. Signs of tardive dyskinesia include fine, worm-like movements of the tongue, or other uncontrolled movements of the mouth, tongue, cheeks, jaw, or arms and legs. Other serious but rare side effects may also occur. These include severe muscle stiffness, fever, unusual tiredness or weakness, fast heartbeat, difficult breathing, increased sweating, loss of bladder control, and seizures (neuroleptic malignant syndrome). You and your doctor should discuss the good this medicine will do as well as the risks of taking it.

Stop taking this medicine and get emergency help immediately if any of the following effects occur:

Rare

Convulsions (seizures)
difficulty in breathing
fast heartbeat
fever
high or low blood pressure
increased sweating
loss of bladder control
muscle stiffness (severe)
unusual tiredness or weakness
unusually pale skin

Check with your doctor as soon as possible if any of the following side effects occur:

More common

Blurred vision or any change in vision
difficulty in speaking or swallowing
fainting
inability to move eyes
lip smacking or puckering
loss of balance control
mask-like face
muscle spasms, especially of face, neck, and back
nervousness, restlessness, or need to keep moving
puffing of cheeks
rapid or fine, worm-like movements of tongue
shuffling walk
stiffness of arms and legs
trembling and shaking of fingers and hands
tic-like or twitching movements
twisting movements of body
uncontrolled chewing movements
uncontrolled movements of arms or legs
weakness of arms and legs

Less common

Confusion
constipation
difficult urination
eye pain
hallucinations (seeing, hearing, or feeling things that are not there)
increased skin sensitivity to sun
shakiness
slow pulse or irregular heartbeat

Rare

Abdominal or stomach pain
aching muscles or joints
back or leg pain
fever and chills
hair loss
hot, dry skin or lack of sweating
irritability
loss of appetite
muscle weakness or twitching
nausea, vomiting, or diarrhea
nosebleeds
prolonged, painful, inappropriate penile erection
ringing, buzzing, or other unexplained noises in ears
skin discoloration
skin rash and itching
sore throat and fever
swelling of face and tongue
swelling of testicles
unusual bleeding or bruising
yellow eyes or skin

Symptoms of overdose

Agitation
confusion
convulsions (seizures)
drowsiness (severe)
enlarged pupils
fast, slow, or irregular heartbeat
fever
hallucinations (seeing, hearing, or feeling things that are not there)
shortness of breath or troubled breathing
unusual tiredness or weakness (severe)
vomiting (severe)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: