imipramine

BEERS REMS

Major depressive disorder.
Enuresis in children.

Unlabeled Use:

Adjunct in the management of chronic pain, incontinence (in adults), vascular headache prophylaxis, cluster headache, or insomnia.

Contraindicated in:

Hypersensitivity;
Angle-closure glaucoma;
Hypersensitivity to tartrazine or sulfites (in some preparations);
Recent MI, known history of QT interval prolongation, HF;
Concurrent use of MAO inhibitors or MAO-like drugs (linezolid or methylene blue);
Lactation: Lactation.

Use Cautiously in:

Pre-existing cardiovascular disease;
Seizures or history of seizure disorder;
Hypovolemia or dehydration (↑ risk of syndrome of inappropriate antidiuretic hormone secretion [SIADH]);
May ↑ risk of suicide attempt/ideation, especially during early treatment or dose adjustment; risk may be greater in children or adolescents;
OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk;
Pedi: Children <6 yr (safety and effectiveness not established);
Geri: Appears on Beers list. ↑ risk of adverse reactions in older adults, including falls secondary to sedative and anticholinergic effects, orthostatic hypotension, and SIADH. Avoid use in older adults.

CV: hypotension, ARRHYTHMIAS, ECG changes

Derm: photosensitivity

EENT: blurred vision, dry eyes

Endo: gynecomastia, SIADH

F and E: hyponatremia

GI: constipation, dry mouth, nausea, paralytic ileus

GU: ↓libido, urinary retention

Hemat: blood dyscrasias

Metab: weight gain

Neuro: drowsiness, fatigue, agitation, confusion, hallucinations, insomnia, SUICIDAL THOUGHTS/BEHAVIORS

Drug-drug:

Concurrent use with MAO inhibitors may result in serious, potentially fatal reactions; MAO inhibitors should be stopped ≥14 days before imipramine therapy; imipramine should be stopped ≥14 days before MAO inhibitor therapy.
Concurrent use with MAO-inhibitor-like drugs, such as linezolid or methylene blue, may ↑ risk of serotonin syndrome; concurrent use contraindicated; do not start therapy in patients receiving linezolid or methylene blue; if linezolid or methylene blue need to be started in a patient receiving imipramine, immediately discontinue imipramine and monitor for signs/symptoms of serotonin syndrome for 2 wk or until 24 hr after last dose of linezolid or methylene blue, whichever comes first (may resume imipramine therapy 24 hr after last dose of linezolid or methylene blue).
Concurrent use with SSRIs may result in ↑ toxicity and should be avoided; fluoxetine should be stopped 5 wk before starting imipramine.
Hypertensive crisis may occur with clonidine.
CYP2D6 inhibitors, including cimetidine, quinidine, amiodarone, and ritonavir, may ↑ levels and risk of toxicity.
Concurrent use with levodopa may result in delayed/↓ absorption of levodopa or hypertension.
Rifampin and phenobarbital may ↓ levels and effectiveness.
↑risk of CNS depression with other CNS depressants, including alcohol, antihistamines, clonidine, opioids, and sedative/hypnotics.
Adrenergic and anticholinergic side effects may be ↑ with other agents having these properties.
Phenothiazines or hormonal contraceptives may levels and risk of toxicity.
Cigarette smoking(nicotine) may ↓ levels and effectiveness.
Drugs that affect serotonergic neurotransmitter systems, including SSRIs, SNRIs, fentanyl, buspirone, tramadol, and triptans, may ↑ risk of serotonin syndrome.

Drug-Natural Products:

St. John's wort may ↑ risk of serotonin syndrome.
Kava-kava, valerian, or chamomile may ↑ risk of CNS depression.
↑anticholinergic effects with jimson weed and scopolia.

(Generic available)

Tablets: 10 mg; 25 mg; 50 mg ; 75 mg
Capsules: 75 mg; 100 mg; 125 mg; 150 mg

Major Depressive Disorder

PO (Adults ): 25–50 mg 3–4 times daily (not to exceed 300 mg/day); total daily dose may be given at bedtime.
PO Geriatric Patients ): 25 mg at bedtime initially, up to 100 mg/day in divided doses.
PO (Children >12 yr): 25–50 mg/day in divided doses (not to exceed 100 mg/day).
PO (Children 6–12 yr): 10–30 mg/day in 2 divided doses.

Enuresis

PO (Children ≥6 yr): 25 mg once daily 1 hr before bedtime; ↑ if necessary by 25 mg at weekly intervals to 50 mg in children <12 yr, up to 75 mg in children >12 yr.

Potentiates the effect of serotonin and norepinephrine.
Has significant anticholinergic properties.

Therapeutic effects:

Antidepressant action that develops slowly over several weeks.
Diminished incidence of enuresis.

Therapeutic Classification: antidepressants

Pharmacologic Classification: tricyclic antidepressants

Absorption: Well absorbed from the GI tract.

Distribution: Widely distributed to tissues.

Protein Binding: 89–95%.

Metabolism/Excretion: Mostly metabolized by the liver (CYP2D6 isoenzyme) to desipramine; the CYP2D6 enzyme system exhibits genetic polymorphism; ∼7% of population may be poor metabolizers and may have significantly ↑ imipramine concentrations and an ↑ risk of adverse effects.

Half-Life: 8–16 hr.

( antidepressant effect)

ROUTE	ONSET	PEAK	DURATION
PO	hours	2–6 wk	weeks

Explain purpose and side effects of medication to patient. Advise patient to read Patient Information before starting therapy. Instruct patient to take as directed. Take missed doses as soon as possible unless almost time for next dose; if regimen is a single dose at bedtime, do not take in the morning because of side effects. Advise patient that drug effects may not be noticed for ≥2 wk. Abrupt discontinuation may cause nausea, vomiting, diarrhea, headache, trouble sleeping with vivid dreams, and irritability.
Advise patient to notify health care provider of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care provider before taking other medications.
May cause drowsiness and blurred vision. Caution patient to avoid driving and other activities requiring alertness until response to drug is known.
Instruct patient to notify health care provider if visual changes occur. Inform patient that periodic glaucoma testing may be needed during long-term therapy.
Caution patient to change positions slowly to minimize orthostatic hypotension.
Advise patient, family, and caregivers to look for suicidality, especially during early therapy or dose changes. Notify health care provider immediately if thoughts about suicide or dying, attempts to commit suicide, new or worse depression or anxiety, agitation or restlessness, panic attacks, insomnia, new or worse irritability, aggressiveness, acting on dangerous impulses, mania, or other changes in mood or behavior occur.
Advise patient, family, and caregivers to notify health care provider immediately if symptoms of serotonin syndrome occur.
Advise patient to avoid alcohol or other CNS depressant drugs during therapy and for ≥3–7 days after therapy has been discontinued.
Instruct patient to notify health care provider if urinary retention, dry mouth, or constipation persists. Sugarless candy or gum may diminish dry mouth and an increase in fluid intake or bulk may prevent constipation. If symptoms persist, dose ↓ or discontinuation may be necessary. Consult health care provider if dry mouth persists for >2 wk.
Caution patient to use sunscreen and protective clothing to prevent photosensitivity reactions.
Alert patient that urine may turn blue-green in color.
Inform patient of need to monitor dietary intake, as possible ↑ in appetite may lead to undesired weight gain. Inform patient that ↑ amounts of riboflavin in the diet may be required; consult health care provider.
Advise patient to notify health care provider of medication regimen before treatment or surgery.
Therapy for depression is usually prolonged. Emphasize the importance of follow-up exams to evaluate progress and improve coping skills.
Rep: Advise women of reproductive potential to notify health care provider if pregnancy is planned or suspected and to avoid breastfeeding.
Pedi: Inform caregivers that the side effects most likely to occur include nervousness, insomnia, unusual tiredness, and mild nausea and vomiting. Notify health care provider if these symptoms become pronounced.
- Advise patients to keep medication out of reach of children to prevent inadvertent overdose.

NDC Code

15894- Teva API India Private Ltd
- 15894-0034-
  - 15894-0034-0- 1 kg in 1 CARTON (15894-0034-0)

38779- Medisca Inc.
- 38779-0443-
  - 38779-0443-3- 5000 g in 1 PAIL (38779-0443-3)

38779- Medisca Inc.
- 38779-0443-
  - 38779-0443-4- 25 g in 1 JAR (38779-0443-4)

38779- Medisca Inc.
- 38779-0443-
  38779-0443-5- 100 g in 1 JAR (38779-0443-5)

38779- Medisca Inc.
- 38779-0443-
  38779-0443-9- 1000 g in 1 JAR (38779-0443-9)

49452- Spectrum Laboratory Products, Inc.
- 49452-3665-
  49452-3665-1- 25 g in 1 BOTTLE (49452-3665-1)

49452- Spectrum Laboratory Products, Inc.
- 49452-3665-
  49452-3665-2- 100 g in 1 BOTTLE (49452-3665-2)

49452- Spectrum Laboratory Products, Inc.
- 49452-3665-
  49452-3665-3- 5 g in 1 BOTTLE (49452-3665-3)

49452- Spectrum Laboratory Products, Inc.
- 49452-3665-
  49452-3665-4- 1000 g in 1 BOTTLE (49452-3665-4)

50090- A-S Medication Solutions
- 50090-3148- Imipramine Hydrochloride
  50090-3148-0- 30 TABLET, FILM COATED in 1 BOTTLE (50090-3148-0)

64380- Strides Pharma Science Limited
- 64380-169- Imipramine Hydrochloride
  - 64380-169-01- 100 TABLET in 1 BOTTLE, PLASTIC (64380-169-01)

64380- Strides Pharma Science Limited
- 64380-169- Imipramine Hydrochloride
  - 64380-169-02- 1000 TABLET in 1 BOTTLE, PLASTIC (64380-169-02)

64380- Strides Pharma Science Limited
- 64380-170- Imipramine Hydrochloride
  - 64380-170-01- 100 TABLET in 1 BOTTLE, PLASTIC (64380-170-01)

64380- Strides Pharma Science Limited
- 64380-170- Imipramine Hydrochloride
  - 64380-170-02- 1000 TABLET in 1 BOTTLE, PLASTIC (64380-170-02)

64380- Strides Pharma Science Limited
- 64380-171- Imipramine Hydrochloride
  - 64380-171-01- 100 TABLET in 1 BOTTLE, PLASTIC (64380-171-01)

64380- Strides Pharma Science Limited
- 64380-171- Imipramine Hydrochloride
  - 64380-171-02- 1000 TABLET in 1 BOTTLE, PLASTIC (64380-171-02)

68071- NuCare Pharmaceuticals, Inc.
- 68071-3669- Imipramine Hydrochloride
  - 68071-3669-9- 90 TABLET in 1 BOTTLE (68071-3669-9)

69315- Leading Pharma, LLC
- 69315-133- Imipramine Hydrochloride
  - 69315-133-01- 100 TABLET, FILM COATED in 1 BOTTLE (69315-133-01)

69315- Leading Pharma, LLC
- 69315-133- Imipramine Hydrochloride
  - 69315-133-10- 1000 TABLET, FILM COATED in 1 BOTTLE (69315-133-10)

69315- Leading Pharma, LLC
- 69315-134- Imipramine Hydrochloride
  - 69315-134-01- 100 TABLET, FILM COATED in 1 BOTTLE (69315-134-01)

69315- Leading Pharma, LLC
- 69315-134- Imipramine Hydrochloride
  - 69315-134-10- 1000 TABLET, FILM COATED in 1 BOTTLE (69315-134-10)

69315- Leading Pharma, LLC
- 69315-135- Imipramine Hydrochloride
  - 69315-135-01- 100 TABLET, FILM COATED in 1 BOTTLE (69315-135-01)

69315- Leading Pharma, LLC
- 69315-135- Imipramine Hydrochloride
  - 69315-135-10- 1000 TABLET, FILM COATED in 1 BOTTLE (69315-135-10)

69584- Oxford Pharmaceuticals, LLC
- 69584-425- Imipramine Hydrochloride
  - 69584-425-10- 100 TABLET in 1 BOTTLE (69584-425-10)

69584- Oxford Pharmaceuticals, LLC
- 69584-425- Imipramine Hydrochloride
  - 69584-425-90- 1000 TABLET in 1 BOTTLE (69584-425-90)

69584- Oxford Pharmaceuticals, LLC
- 69584-426- Imipramine Hydrochloride
  - 69584-426-10- 100 TABLET in 1 BOTTLE (69584-426-10)

69584- Oxford Pharmaceuticals, LLC
- 69584-426- Imipramine Hydrochloride
  - 69584-426-90- 1000 TABLET in 1 BOTTLE (69584-426-90)

69584- Oxford Pharmaceuticals, LLC
- 69584-427- Imipramine Hydrochloride
  - 69584-427-10- 100 TABLET in 1 BOTTLE (69584-427-10)

69584- Oxford Pharmaceuticals, LLC
- 69584-427- Imipramine Hydrochloride
  - 69584-427-90- 1000 TABLET in 1 BOTTLE (69584-427-90)

70518- REMEDYREPACK INC.
- 70518-1588- Imipramine Hydrochloride
  - 70518-1588-0- 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-1588-0)

70518- REMEDYREPACK INC.
- 70518-3526- Imipramine Hydrochloride
  - 70518-3526-0- 30 TABLET in 1 BLISTER PACK (70518-3526-0)

70868- Key Therapeutics
- 70868-810- Imipramine Hydrochloride
  - 70868-810-10- 100 TABLET, FILM COATED in 1 BOTTLE (70868-810-10)

71205- Proficient Rx LP
- 71205-804- Imipramine Hydrochloride
  - 71205-804-30- 30 TABLET, FILM COATED in 1 BOTTLE (71205-804-30)

71205- Proficient Rx LP
- 71205-804- Imipramine Hydrochloride
  - 71205-804-60- 60 TABLET, FILM COATED in 1 BOTTLE (71205-804-60)

71205- Proficient Rx LP
- 71205-804- Imipramine Hydrochloride
  - 71205-804-90- 90 TABLET, FILM COATED in 1 BOTTLE (71205-804-90)

71335- Bryant Ranch Prepack
- 71335-2601- Imipramine Hydrochloride
  - 71335-2601-1- 30 TABLET, FILM COATED in 1 BOTTLE (71335-2601-1)

71335- Bryant Ranch Prepack
- 71335-2601- Imipramine Hydrochloride
  - 71335-2601-2- 60 TABLET, FILM COATED in 1 BOTTLE (71335-2601-2)

71335- Bryant Ranch Prepack
- 71335-2601- Imipramine Hydrochloride
  - 71335-2601-3- 90 TABLET, FILM COATED in 1 BOTTLE (71335-2601-3)

71554- R.L.Fine Chem Private Limited
- 71554-008-
  - 71554-008-01- 5 kg in 1 DRUM (71554-008-01)

71554- R.L.Fine Chem Private Limited
- 71554-008-
  71554-008-02- 10 kg in 1 DRUM (71554-008-02)

71554- R.L.Fine Chem Private Limited
- 71554-008-
  71554-008-03- 25 kg in 1 DRUM (71554-008-03)

72789- PD-Rx Pharmaceuticals, Inc.
- 72789-240- Imipramine Hydrochloride
  72789-240-01- 100 TABLET in 1 BOTTLE, PLASTIC (72789-240-01)

72789- PD-Rx Pharmaceuticals, Inc.
- 72789-240- Imipramine Hydrochloride
  - 72789-240-95- 1000 TABLET in 1 BOTTLE, PLASTIC (72789-240-95)

72789- PD-Rx Pharmaceuticals, Inc.
- 72789-243- Imipramine Hydrochloride
  - 72789-243-01- 100 TABLET in 1 BOTTLE, PLASTIC (72789-243-01)

72789- PD-Rx Pharmaceuticals, Inc.
- 72789-243- Imipramine Hydrochloride
  - 72789-243-95- 1000 TABLET in 1 BOTTLE, PLASTIC (72789-243-95)

72789- PD-Rx Pharmaceuticals, Inc.
- 72789-244- Imipramine Hydrochloride
  - 72789-244-01- 100 TABLET in 1 BOTTLE, PLASTIC (72789-244-01)

72789- PD-Rx Pharmaceuticals, Inc.
- 72789-244- Imipramine Hydrochloride
  - 72789-244-95- 1000 TABLET in 1 BOTTLE, PLASTIC (72789-244-95)

72789- PD-Rx Pharmaceuticals, Inc.
- 72789-492- Imipramine Hydrochloride
  - 72789-492-01- 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-492-01)

72789- PD-Rx Pharmaceuticals, Inc.
- 72789-492- Imipramine Hydrochloride
  - 72789-492-95- 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-492-95)

72789- PD-Rx Pharmaceuticals, Inc.
- 72789-493- Imipramine Hydrochloride
  - 72789-493-01- 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-493-01)

72789- PD-Rx Pharmaceuticals, Inc.
- 72789-493- Imipramine Hydrochloride
  - 72789-493-95- 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-493-95)

80425- Advanced Rx Pharmacy of Tennessee, LLC
- 80425-0294- Imipramine hydrochloride
  - 80425-0294-1- 30 TABLET, FILM COATED in 1 BOTTLE (80425-0294-1)

80425- Advanced Rx Pharmacy of Tennessee, LLC
- 80425-0294- Imipramine hydrochloride
  - 80425-0294-2- 60 TABLET, FILM COATED in 1 BOTTLE (80425-0294-2)

80425- Advanced Rx Pharmacy of Tennessee, LLC
- 80425-0294- Imipramine hydrochloride
  - 80425-0294-3- 90 TABLET, FILM COATED in 1 BOTTLE (80425-0294-3)

80425- Advanced Rx Pharmacy of Tennessee, LLC
- 80425-0342- Imipramine Hydrochloride
  - 80425-0342-1- 30 TABLET, FILM COATED in 1 BOTTLE (80425-0342-1)

80425- Advanced Rx Pharmacy of Tennessee, LLC
- 80425-0342- Imipramine Hydrochloride
  - 80425-0342-2- 60 TABLET, FILM COATED in 1 BOTTLE (80425-0342-2)

80425- Advanced Rx Pharmacy of Tennessee, LLC
- 80425-0342- Imipramine Hydrochloride
  - 80425-0342-3- 90 TABLET, FILM COATED in 1 BOTTLE (80425-0342-3)

section name header

Indications ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Availability ⬆ ⬇

Route/Dosage ⬆ ⬇

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Classifications ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Pronunciation ⬆ ⬇

Code ⬆