List Content Directory Israel: amoxapine

a-MOX-a-peen

Oral route(Tablet)

Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Not approved for use in pediatric patients .

Commonly used brand name(s)

In the U.S.

Asendin

Available Dosage Forms:

Tablet

Therapeutic Class: Antidepressant

Pharmacologic Class: Antidepressant, Tricyclic

Chemical Class: Dibenzoxazepine

Uses For amoxapine

Amoxapine is used to treat the symptoms of depression. It works on the central nervous system (CNS) to increase levels of certain chemicals in the brain. amoxapine is a tricyclic antidepressant (TCA).

amoxapine is available only with your doctor's prescription.

Before Using amoxapine

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 amoxapine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to amoxapine 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

Appropriate studies have not been performed on the relationship of age to the effects of amoxapine in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of amoxapine in the elderly. However, elderly patients are more likely to have unwanted effects (e.g., movement disorders, unusual drowsiness) or age-related kidney or liver problems, which may require an adjustment in the dose for patients receiving amoxapine.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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 amoxapine, 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 amoxapine 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.

Bepridil

Cisapride

Clorgyline

Dronedarone

Grepafloxacin

Isocarboxazid

Levomethadyl

Linezolid

Mesoridazine

Methylene Blue

Metoclopramide

Moclobemide

Phenelzine

Pimozide

Ranolazine

Selegiline

Sparfloxacin

Terfenadine

Thioridazine

Tranylcypromine

Using amoxapine 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

Alfuzosin

Amiodarone

Amisulpride

Amitriptyline

Amprenavir

Apomorphine

Aprindine

Arsenic Trioxide

Asenapine

Astemizole

Azimilide

Azithromycin

Bretylium

Chloral Hydrate

Chloroquine

Chlorpromazine

Ciprofloxacin

Citalopram

Clarithromycin

Clomipramine

Clonidine

Clozapine

Crizotinib

Dasatinib

Desipramine

Dextromethorphan

Disopyramide

Dofetilide

Dolasetron

Droperidol

Enflurane

Epinephrine

Erythromycin

Etilefrine

Flecainide

Fluconazole

Fluoxetine

Foscarnet

Gatifloxacin

Gemifloxacin

Granisetron

Halofantrine

Haloperidol

Halothane

Ibutilide

Iloperidone

Imipramine

Indacaterol

Iproniazid

Isoflurane

Isradipine

Lapatinib

Levofloxacin

Lidoflazine

Lopinavir

Lorcainide

Lumefantrine

Mefloquine

Methadone

Methoxamine

Midodrine

Moricizine

Moxifloxacin

Nefopam

Nialamide

Nilotinib

Norepinephrine

Norfloxacin

Nortriptyline

Octreotide

Ofloxacin

Ondansetron

Oxilofrine

Paliperidone

Pargyline

Pazopanib

Pentamidine

Perflutren Lipid Microsphere

Phenylephrine

Posaconazole

Procainamide

Procarbazine

Prochlorperazine

Promethazine

Propafenone

Protriptyline

Quetiapine

Quinidine

Quinine

Rasagiline

Risperidone

Saquinavir

Sematilide

Sertindole

Sertraline

Sodium Phosphate

Sodium Phosphate, Dibasic

Sodium Phosphate, Monobasic

Solifenacin

Sorafenib

Sotalol

Spiramycin

Sulfamethoxazole

Sultopride

Sunitinib

Tapentadol

Tedisamil

Telavancin

Telithromycin

Tetrabenazine

Toloxatone

Toremifene

Tramadol

Trazodone

Trifluoperazine

Trimethoprim

Trimipramine

Vandetanib

Vardenafil

Vasopressin

Vemurafenib

Venlafaxine

Voriconazole

Ziprasidone

Zolmitriptan

Zotepine

Using amoxapine 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

Arbutamine

Atomoxetine

Cannabis

Carbamazepine

Dicumarol

Paroxetine

Phenprocoumon

S-Adenosylmethionine

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 amoxapine 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 amoxapine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Proper Use of amoxapine

Take amoxapine only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

amoxapine should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Dosing

The dose of amoxapine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of amoxapine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets):
- For depression:
  - Adults—At first, 50 milligrams (mg) two or three times per day. Your doctor may increase your dose as needed. However, the dose is usually not more than 300 mg per day unless you are in a hospital. Some hospitalized patients may need higher doses. If you are taking amoxapine once a day, it is best to take it at bedtime.
  - Older Adults—At first, 25 milligrams (mg) two or three times per day. Your doctor may increase your dose as needed. However, the dose is usually not more than 300 mg per day unless you are in a hospital. Some hospitalized patients may need higher doses. If you are taking amoxapine once a day, it is best to take it at bedtime.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of amoxapine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using amoxapine

It is very important that your doctor check your progress at regular visits to allow for changes in your dose and to check for any unwanted effects.

Amoxapine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you, your child, or your caregiver notice any of these side effects, tell your doctor or your child's doctor right away.

Do not take amoxapine if you have taken a monoamine oxidase (MAO) inhibitor (isocarboxazid [Marplan®], phenelzine [Nardil®], selegiline [Eldepryl®, or tranylcypromine [Parnate®]) in the past two weeks. Do not start taking a MAO inhibitor within two weeks of stopping amoxapine. If you do, you may develop confusion, agitation, restlessness, stomach or intestinal symptoms, sudden high body temperature, extremely high blood pressure, or severe convulsions.

amoxapine may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you have any of the following symptoms while taking amoxapine: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.

Check with your doctor right away if you are having convulsions (seizures); difficulty with breathing; a fast heartbeat; high fever; high or low blood pressure; increased sweating; loss of bladder control; severe muscle stiffness; unusually pale skin; or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

Do not stop taking amoxapine without first checking with your doctor . Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent a possible worsening of your condition and reduce the possibility of withdrawal symptoms such as headache, nausea, or a general feeling of discomfort or illness.

amoxapine will add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that cause drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies or colds; sedatives, tranquilizers, or sleeping medicines; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using amoxapine.

amoxapine may cause some people to become drowsy or less alert than they are normally. Make sure you know how you react to amoxapine before you drive, use machines, or do anything else that could be dangerous if you are drowsy or not alert.

amoxapine Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Excitement

fast, irregular, pounding, or racing heartbeat or pulse

fear or nervousness

mood or mental changes

nightmares

restlessness

shakiness and unsteady walk

shakiness in legs, arms, hands, or feet

sleeplessness

swelling

trouble sleeping

unable to sleep

unsteadiness, trembling, or other problems with muscle control or coordination

Rare

Abdominal or stomach pain

actions that are out of control

black, tarry stools

bleeding gums

bloating

blood in urine or stools

blurred vision

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

chest pain or discomfort

chills

clay-colored stools

confusion

confusion about identity, place, and time

constipation

continuing ringing or buzzing or other unexplained noise in ears

convulsions

cough or hoarseness

dark urine

decrease in frequency of urination

decrease in urine volume

difficulty in breathing

difficulty in passing urine (dribbling)

difficulty in speaking

disturbed concentration

dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly

double vision

drooling

extremely high fever or body temperature

false beliefs that cannot be changed by facts

fast, weak heartbeat

fever with or without chills

general feeling of tiredness or weakness

headache

hearing loss

high fever

high or low blood pressure

hives or welts

inability to move arms, legs, or facial muscles

inability to speak

increased need to urinate

increased sweating

indigestion

irritability

itching

lack of coordination

light-colored stools

lip smacking or puckering

loss of appetite

loss of bladder control

lower back or side pain

muscle cramps

muscle spasm or jerking of all extremities

muscle trembling, jerking, or stiffness

nausea and vomiting

nervousness

numbness

pain or discomfort in arms, jaw, back, or neck

painful or difficult urination

pains in stomach, side, or abdomen, possibly radiating to the back

pale, clammy skin

passing urine more often

pinpoint red spots on skin

pounding in the ears

puffing of cheeks

rapid or worm-like movements of tongue

redness of skin

seeing, hearing, or feeling things that are not there

severe muscle stiffness

shortness of breath

shuffling walk

skin rash

slow speech

sore throat

sores, ulcers, or white spots on lips or in mouth

stiffness of limbs

sudden loss of consciousness

sweating

swollen glands

talking, feeling, and acting with excitement

testicular swelling

thirst

trouble in holding or releasing urine

twisting movements of body

uncontrolled chewing movements

uncontrolled movements, especially of face, neck, and back

unpleasant breath odor

unusual bleeding or bruising

unusually pale skin

upper right abdominal pain

vomiting of blood

yellow eyes and skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Change in consciousness

drowsiness

epileptic seizure that will not stop

fatigue

increased blood pressure

increased thirst

loss of consciousness

swelling of face, fingers, or lower legs

total body jerking

troubled breathing

weight gain

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:

More common

Dry mouth

Less common

Increased appetite

increased flow of breast milk

Rare

Agitation

breast enlargement

change in taste bad unusual or unpleasant (after)taste

decreased interest in sexual intercourse

depression

excess air or gas in stomach or intestines

full feeling

hair loss, thinning of hair

heartburn

inability to have or keep an erection

increased in sexual ability, desire, drive, or performance

increased interest in sexual intercourse

increased sensitivity of skin to sunlight

loss in sexual ability, desire, drive, or performance

menstrual changes

nasal stuffiness

painful ejaculation

passing gas

rapid weight gain

redness or other discoloration of skin

seizures

severe sunburn

stupor

swollen, painful, or tender lymph glands on side of face or neck

tearing of the eyes

unexpected or excess milk flow from breasts

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: amoxapine side effects (in more detail)

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Depression

List Content Directory Israel

Friday 9 March 2012

amoxapine