Vanatrip

Serious side effects have been reported with amitriptyline. See “Drug Precautions” section.

Common side effects of amitriptyline include:

• nausea
• vomiting
• weakness
• drowsiness
• dizziness
• dry mouth
• headache
• blurred vision
• change in appetite and weight
• constipation
• trouble urinating
• pain or tingling in the hands or feet
• changes in sex drive
• excessive sweating
• confusion
• orthostatic hypotension
• tachycardia (fast heart beat)

This is not a complete list of amitriptyline side effects. Ask your doctor or pharmacist for more information.

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

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of amitriptyline, there are no specific foods that you must exclude from your diet when receiving amitriptyline.

Amitriptyline is used to treat 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).

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

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.

Amitriptyline 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 or your caregiver notice any of these adverse effects, tell your doctor right away.

Do not take amitriptyline if you have taken a monoamine oxidase (MAO) inhibitor (isocarboxazid [Marplan®], phenelzine [Nardil®], selegiline [Eldepryl®], or tranylcypromine [Parnate®]) in the past 2 weeks. Do not start taking a MAO inhibitor within 5 days of stopping amitriptyline. 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 take other medicines unless they have been discussed with your doctor. Using this medicine together with cisapride (Propulsid®), may increase the chance of having serious side effects.

Do not suddenly 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 CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. This effect may last for a few days after you stop taking this medicine. 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 amitriptyline 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 cause some people to become drowsy. Make sure you know how you react to this medicine before you drive, use medicines, or do anything else that could be dangerous if you are drowsy or not alert .

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:

• Abdominal or stomach pain
• agitation
• black, tarry stools
• bleeding gums
• blood in urine or stools
• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• change in consciousness
• changes in patterns and rhythms of speech
• chest pain or discomfort
• chills
• cold sweats
• coma
• confusion
• confusion about identity, place, and time
• continuing ringing, buzzing, or other unexplained noise in ears
• convulsions
• cool, pale skin
• cough or hoarseness
• dark urine
• decrease in frequency of urination
• decrease in urine volume
• decreased urine output
• difficulty in breathing
• difficulty in passing urine (dribbling)
• difficulty in speaking
• disturbance of accommodation
• disturbed concentration
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• double vision
• drooling
• dry mouth
• excitement
• fainting
• false beliefs that cannot be changed by facts
• fast, slow, or irregular heartbeat
• fear or nervousness
• fever with or without chills
• flushed, dry skin
• fruit-like breath odor
• general feeling of tiredness or weakness
• headache
• hearing loss
• high fever
• high or low blood pressure
• hostility
• inability to move arms, legs, or facial muscles
• inability to speak
• increased hunger
• increased need to urinate
• increased ocular pressure
• increased sweating
• increased thirst
• increased urination
• irritability
• lack of coordination
• lethargy
• light-colored stools
• lip smacking or puckering
• loss of appetite
• loss of balance control
• loss of bladder control
• loss of consciousness
• lower back or side pain
• mental depression or anxiety
• muscle spasm or jerking of all extremities
• muscle tightness
• muscle trembling, jerking, or stiffness
• muscle twitching
• nausea and vomiting
• nightmares or unusually vivid dreams
• overactive reflexes
• painful or difficult urination
• passing urine more often
• pinpoint red spots on skin
• poor coordination
• pounding in the ears
• puffing of cheeks
• rapid or worm-like movements of tongue
• rapid weight gain
• restlessness
• seeing, hearing, or feeling things that are not there
• seizures
• severe muscle stiffness
• shakiness and unsteady walk
• shivering
• 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, or hands
• swelling or puffiness of face
• swollen glands
• talking or acting with excitement you cannot control
• trouble in speaking
• trouble sleeping
• troubled breathing
• twisting movements of body pain or discomfort in arms, jaw, back, or neck
• unable to sleep
• uncontrolled chewing movements
• uncontrolled movements, especially of arms, face, neck, back, and legs
• unexplained weight loss
• unpleasant breath odor
• unsteadiness, trembling, or other problems with muscle control or coordination
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusually pale skin
• upper right abdominal pain
• vomiting of blood
• weakness in arms, hands, legs, or feet
• weight gain or loss
• yellow eyes and skin

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

• Clumsiness
• drowsiness
• low body temperature
• muscle aches
• muscle weakness
• sleepiness
• tiredness
• weak or feeble pulse

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:

• Bigger, dilated, or enlarged pupils (black part of eye)
• black tongue
• bloating
• breast enlargement in females
• constipation
• decreased interest in sexual intercourse
• diarrhea
• hair loss, thinning of hair
• 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
• loss in sexual ability, desire, drive, or performance
• loss of sense of taste
• redness or other discoloration of skin
• severe sunburn
• skin rash
• swelling of testicles
• swelling of the breasts or breast soreness in males
• swelling of the parotid glands
• swelling or inflammation of the mouth
• 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.

Applies to amitriptyline: oral tablet

Along with its needed effects, amitriptyline (the active ingredient contained in Vanatrip) 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 while taking amitriptyline:

• Abdominal or stomach pain
• agitation
• black, tarry stools
• bleeding gums
• blood in urine or stools
• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• change in consciousness
• changes in patterns and rhythms of speech
• chest pain or discomfort
• chills
• cold sweats
• coma
• confusion
• confusion about identity, place, and time
• continuing ringing, buzzing, or other unexplained noise in ears
• convulsions
• cool, pale skin
• cough or hoarseness
• dark urine
• decrease in frequency of urination
• decrease in urine volume
• decreased urine output
• difficulty in breathing
• difficulty in passing urine (dribbling)
• difficulty in speaking
• disturbance of accommodation
• disturbed concentration
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• double vision
• drooling
• dry mouth
• excitement
• fainting
• false beliefs that cannot be changed by facts
• fast, slow, or irregular heartbeat
• fear or nervousness
• fever with or without chills
• flushed, dry skin
• fruit-like breath odor
• general feeling of tiredness or weakness
• headache
• hearing loss
• high fever
• high or low blood pressure
• hostility
• inability to move arms, legs, or facial muscles
• inability to speak
• increased hunger
• increased need to urinate
• increased ocular pressure
• increased sweating
• increased thirst
• increased urination
• irritability
• lack of coordination
• lethargy
• light-colored stools
• lip smacking or puckering
• loss of appetite
• loss of balance control
• loss of bladder control
• loss of consciousness
• lower back or side pain
• mental depression or anxiety
• muscle spasm or jerking of all extremities
• muscle tightness
• muscle trembling, jerking, or stiffness
• muscle twitching
• nausea and vomiting
• nightmares or unusually vivid dreams
• overactive reflexes
• painful or difficult urination
• passing urine more often
• pinpoint red spots on skin
• poor coordination
• pounding in the ears
• puffing of cheeks
• rapid or worm-like movements of tongue
• rapid weight gain
• restlessness
• seeing, hearing, or feeling things that are not there
• seizures
• severe muscle stiffness
• shakiness and unsteady walk
• shivering
• 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, or hands
• swelling or puffiness of face
• swollen glands
• talking or acting with excitement you cannot control
• trouble in speaking
• trouble sleeping
• troubled breathing
• twisting movements of body pain or discomfort in arms, jaw, back, or neck
• unable to sleep
• uncontrolled chewing movements
• uncontrolled movements, especially of arms, face, neck, back, and legs
• unexplained weight loss
• unpleasant breath odor
• unsteadiness, trembling, or other problems with muscle control or coordination
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusually pale skin
• upper right abdominal pain
• vomiting of blood
• weakness in arms, hands, legs, or feet
• weight gain or loss
• yellow eyes and skin

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

• Clumsiness
• drowsiness
• low body temperature
• muscle aches
• muscle weakness
• sleepiness
• tiredness
• weak or feeble pulse

Some side effects of amitriptyline 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:

• Bigger, dilated, or enlarged pupils (black part of eye)
• black tongue
• bloating
• breast enlargement in females
• constipation
• decreased interest in sexual intercourse
• diarrhea
• hair loss, thinning of hair
• 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
• loss in sexual ability, desire, drive, or performance
• loss of sense of taste
• redness or other discoloration of skin
• severe sunburn
• skin rash
• swelling of testicles
• swelling of the breasts or breast soreness in males
• swelling of the parotid glands
• swelling or inflammation of the mouth
• unexpected or excess milk flow from breasts

Applies to amitriptyline: compounding powder, intramuscular solution, oral tablet

Other

Frequency not reported: Weakness, fatigue, hyperpyrexia, edema of face and tongue[Ref]

Nervous system

Rare (less than 0.1%): Serotonin syndrome
Frequency not reported: Coma, seizures, confusional states, disorientation, incoordination, ataxia, tremors, peripheral neuropathy, numbness, tingling and paresthesia of the extremities, extrapyramidal symptoms (including abnormal involuntary movements and tardive dyskinesia), dysarthria, disturbed concentration, restlessness, drowsiness, dizziness, headache, tinnitus, alteration in EEG patterns, irritability, sleep disturbance, ageusia
Postmarketing reports: Syndrome resembling neuroleptic malignant syndrome (NMS) including muscle rigidity, fever, mental status changes, diaphoresis, tachycardia[Ref]

Cardiovascular

Frequency not reported: Myocardial infarction, stroke, nonspecific ECG changes and changes in AV conduction, heart block, arrhythmias, hypotension (particularly orthostatic hypotension), syncope, hypertension, tachycardia, palpitation[Ref]

Psychiatric

Rare (less than 0.1%): Mania/hypomania
Frequency not reported: Hallucinations, delusions, excitement, anxiety, insomnia, nightmares, suicidal ideation/behaviors[Ref]

Gastrointestinal

Frequency not reported: Paralytic ileus, constipation, dry mouth, nausea, epigastric distress, vomiting, stomatitis, peculiar taste, diarrhea, parotid swelling, black tongue[Ref]

General

The most commonly reported side effects were tremors, dizziness, headache, dry mouth, constipation, and nausea.[Ref]

Genitourinary

Frequency not reported: Urinary retention, dilatation of the urinary tract, testicular swelling, gynecomastia (male), breast enlargement, galactorrhea (female), increased or decreased libido, impotence, urinary frequency[Ref]

Hematologic

Frequency not reported: Bone marrow depression (including agranulocytosis, leukopenia, thrombocytopenia), purpura, eosinophilia[Ref]

Endocrine

Frequency not reported: Syndrome of inappropriate ADH (antidiuretic hormone) secretion[Ref]

Hepatic

Rare (less than 0.1%): Hepatitis (including altered liver function, cholestasis and jaundice), hepatic failure, hepatic necrosis[Ref]

Dermatologic

Frequency not reported: Skin rash, urticaria, photosensitization, alopecia, increased perspiration[Ref]

Immunologic

Frequency not reported: Lupus-like syndrome (migratory arthritis, positive ANA and rheumatoid factor)[Ref]

Metabolic

Frequency not reported: Anorexia, elevation or lowering of blood sugar levels, weight gain or loss, hyponatremia, increased appetite[Ref]

Ocular

Frequency not reported: Blurred vision, disturbance of accommodation, increased ocular pressure, mydriasis[Ref]

Some side effects of Vanatrip may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.