Blog United Kingdom: Tofranil

Generic Name: imipramine (Oral route)

im-IP-ra-meen

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 except for patients with nocturnal enuresis .

Oral route(Capsule)

Commonly used brand name(s)

In the U.S.

Tofranil

Tofranil-PM

Available Dosage Forms:

Tablet

Capsule

Therapeutic Class: Antidepressant

Pharmacologic Class: Antidepressant, Tricyclic

Uses For Tofranil

Imipramine 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. This medicine is a tricyclic antidepressant (TCA).

Imipramine tablets are also used to treat enuresis (bedwetting) in children.

This medicine is available only with your doctor's prescription.

Before Using Tofranil

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

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

Appropriate studies have not been performed on the relationship of age to the effects of imipramine tablets in children with enuresis (bedwetting) under 6 years of age. 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 imipramine in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require an adjustment in the dose for patients receiving imipramine.

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.

Bepridil

Cisapride

Clorgyline

Dronedarone

Grepafloxacin

Isocarboxazid

Levomethadyl

Linezolid

Mesoridazine

Methylene Blue

Metoclopramide

Moclobemide

Phenelzine

Pimozide

Ranolazine

Selegiline

Sparfloxacin

Terfenadine

Thioridazine

Tranylcypromine

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

Alfuzosin

Amiodarone

Amisulpride

Amitriptyline

Amoxapine

Amprenavir

Apomorphine

Aprindine

Arsenic Trioxide

Asenapine

Astemizole

Atazanavir

Azimilide

Azithromycin

Bretylium

Chloral Hydrate

Chloroquine

Chlorpromazine

Ciprofloxacin

Clarithromycin

Clomipramine

Clonidine

Clozapine

Crizotinib

Darifenacin

Dasatinib

Desipramine

Dextromethorphan

Disopyramide

Dofetilide

Dolasetron

Droperidol

Enflurane

Epinephrine

Erythromycin

Etilefrine

Flecainide

Fluconazole

Fluoxetine

Foscarnet

Gatifloxacin

Gemifloxacin

Granisetron

Halofantrine

Haloperidol

Halothane

Ibutilide

Iloperidone

Indacaterol

Iproniazid

Isoflurane

Isradipine

Lapatinib

Levofloxacin

Lidoflazine

Lorcainide

Lumefantrine

Mefloquine

Methadone

Methoxamine

Midodrine

Moricizine

Moxifloxacin

Nefopam

Nialamide

Nilotinib

Norepinephrine

Norfloxacin

Nortriptyline

Octreotide

Ofloxacin

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

Vandetanib

Vardenafil

Vasopressin

Vemurafenib

Venlafaxine

Voriconazole

Ziprasidone

Zolmitriptan

Zotepine

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

Alprazolam

Arbutamine

Atomoxetine

Butalbital

Cannabis

Carbamazepine

Cimetidine

Citalopram

Dicumarol

Fenfluramine

Fluvoxamine

Mibefradil

Paroxetine

Phenindione

Phenprocoumon

Phenytoin

Ritonavir

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 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

Proper Use of imipramine

This section provides information on the proper use of a number of products that contain imipramine. It may not be specific to Tofranil. Please read with care.

Take this medicine 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.

This medicine comes with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Dosing

The dose of this medicine 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 this medicine. 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 (capsules):
- For depression:
  - Adults—At first, 75 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 200 mg per day, unless you are in the hospital. Some hospitalized patients may need higher doses.
  - Teenagers and Older Adults—At first, 25 to 50 milligrams (mg) per day using the tablets. Your doctor may adjust your dose as needed and switch you to the capsule form. However, the dose is usually not more than 100 mg per day.
  - Children—Use and dose must be determined by your doctor.

For oral dosage form (tablets):
- For depression:
  - Adults—At first, 75 milligrams (mg) per day. Your doctor may adjust your dose as needed. However the dose is usually not more than 200 mg per day. Some hospitalized patients may need higher doses.
  - Teenagers and Older Adults—30 to 40 milligrams (mg) per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 100 mg per day.
  - Children—Use and dose must be determined by your doctor.
- For enuresis (bedwetting):
  - Children 6 years of age and older—At first, 25 milligrams (mg) once a day, taken one hour before bedtime. Your doctor may adjust the dose as needed.
  - Children below 6 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, 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.

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

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Tofranil

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. Blood tests may be needed to check for any unwanted effects. Check with your doctor right away if you start having a fever or sore throat while taking this medicine.

Imipramine 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 imipramine 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 5 days of stopping imipramine. If you do, you may develop confusion, agitation, restlessness, stomach or intestinal symptoms, sudden high body temperature, extremely high blood pressure, or severe convulsions.

Do not stop taking this medicine 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.

This medicine 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 this medicine.

Before having any kind of surgery, tell the medical doctor in charge that you are using this medicine. Taking imipramine together with medicines used during surgery may increase the risk of side effects.

This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests, or if you have any questions, check with your doctor.

This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

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

Tofranil 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:

Incidence not known

Abdominal or stomach pain

actions that are out of control

agitation

anxiety

black, tarry stools

bleeding and bruising

bleeding gums

blood in urine or stools

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

chest pain or discomfort

clay-colored stools

cold sweats

coma

confusion about identity, place, and time

continuing ringing or buzzing or other unexplained noise in ears

convulsions

cool, pale skin

cough or hoarseness

dark urine

decrease in frequency of urination

decreased urine output or volume

depression

difficulty in passing urine (dribbling)

difficulty in speaking

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

double vision

drooling

dry mouth

false beliefs that cannot be changed by facts

fast, pounding, or irregular heartbeat or pulse

fear or nervousness

feeling of warmth

feeling, seeing, or hearing things that are not there

feeling that others are watching you or controlling your behavior

feeling that others can hear your thoughts

fever with or without chills

flushed, dry skin

fruit-like breath odor

general feeling of tiredness or weakness

headache

hearing loss

hostility

hyperventilation

inability to move arms, legs, or facial muscles

inability to speak

increased hunger

increased need to urinate

increased thirst

increased urination

irritability

itching

lack of coordination

lethargy

loss of appetite

loss of balance control

lower back or side pain

mood or mental changes

muscle spasm or jerking of all extremities

muscle trembling, jerking, or stiffness

muscle twitching

nausea

nightmares

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

painful or difficult urination

passing urine more often

perspiration

pinpoint red or purple spots on skin

pounding in the ears

rapid weight gain

rash

redness of the face, neck, arms, and occasionally, upper chest

restlessness

seizures

shakiness and unsteady walk

shortness of breath

shuffling walk

sleeplessness

slow speech

slurred speech

sore throat

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

stiffness of limbs

stupor

sudden loss of consciousness

sweating

swelling of face, ankles, legs, or hands

swollen glands

talking, feeling, and acting with excitement

trouble in holding or releasing urine

trouble sleeping

twisting movements of body

unable to sleep

uncontrolled movements, especially of face, neck, and back

unpleasant breath odor

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

unusual behavior

unusual bleeding or bruising

unusual tiredness or weakness

vomiting of blood

weakness in arms, hands, legs, or feet

weight gain or loss

yellow eyes or skin

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

Symptoms of overdose

Bluish color of fingernails, lips, skin, palms, or nail beds

change in consciousness

cold clammy skin

confusion

decreased awareness or responsiveness

difficult or troubled breathing

difficulty sleeping

disorientation

drowsiness to profound coma

fast, weak pulse

hallucination increased or excessive unconscious or jerking movements

irregular, fast, slow, or shallow breathing

lethargy

loss of consciousness

mood or other mental changes

muscle stiffness or tightness

pale or blue lips, fingernails, or skin

severe sleepiness

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:

Incidence not known

Abdominal cramps

bigger, dilated, or enlarged pupils (black part of eye)

black tongue

bloating

decreased interest in sexual intercourse

diarrhea

difficulty having a bowel movement (stool)

disturbance of accommodation

enlargement of the breast

hair loss, thinning of hair

heartburn

hives or welts

inability to have or keep an erection

increased in sexual ability, desire, drive, or performance

increased interest in sexual intercourse

increased sensitivity of eyes to light

increased sensitivity of skin to sunlight

increased urge to urinate during the night

loss in sexual ability, desire, drive, or performance

pain or discomfort in chest, upper stomach, or throat

peculiar taste

redness or other discoloration of skin

severe sunburn

small red or purple spots on skin

swelling of testicles

swelling of the breasts or breast soreness in both females and males

swelling or inflammation of the mouth

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

unexpected or excess milk flow from breasts

waking to urinate at night

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: Tofranil side effects (in more detail)

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More Tofranil resources

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

Tofranil Prescribing Information (FDA)

Tofranil MedFacts Consumer Leaflet (Wolters Kluwer)

Tofranil Concise Consumer Information (Cerner Multum)

Imipramine Professional Patient Advice (Wolters Kluwer)

Imipramine Prescribing Information (FDA)

Imipramine Hydrochloride Monograph (AHFS DI)

Tofranil-PM Prescribing Information (FDA)

Tofranil-PM MedFacts Consumer Leaflet (Wolters Kluwer)

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Blog United Kingdom

Tuesday, March 20, 2012

Tofranil