Tofranil injection

Generic name: Imipramine hydrochloride

Drug class: Tricyclic antidepressants

Dosage form: Injection

Route of administration: Intramuscular injection

Dose:

• Initial dose: Up to 100 mg/day, administered intramuscularly in divided doses.
• Maintenance dose: Adjusted based on clinical response and tolerance; typically, the oral form should replace the injectable as soon as possible.
• Special populations: Lower dosages are recommended for elderly patients and adolescents. Outpatients may require lower doses compared to hospitalized patients under close supervision.

Mechanism of action: Imipramine inhibits the reuptake of norepinephrine and serotonin into presynaptic terminals, increasing their availability in the synaptic cleft, which enhances neurotransmission and mood regulation.

Drug usage cases:

• Major depressive disorder
• Nocturnal enuresis in children aged 6 years and older
• Panic disorder
• Urinary urge incontinence
• Second-line treatment for attention deficit hyperactivity disorder (ADHD)

Drug contraindications:

• Hypersensitivity to imipramine or any component of the formulation
• Concurrent use with monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuing an MAOI
• Recovery phase following a recent myocardial infarction
• Concurrent use with linezolid or intravenous methylene blue

Side effects:

• Cardiovascular: Orthostatic hypotension, hypertension, tachycardia, palpitations, arrhythmias, heart block, ECG changes, precipitation of congestive heart failure, stroke
• Psychiatric: Confusional states (especially in the elderly) with hallucinations, disorientation, delusions; anxiety, restlessness, agitation; insomnia and nightmares; hypomania; exacerbation of psychosis
• Neurological: Numbness, tingling, paresthesias of extremities; incoordination, ataxia, tremors; peripheral neuropathy; extrapyramidal symptoms; seizures, alterations in EEG patterns; tinnitus
• Anticholinergic: Dry mouth, blurred vision, disturbances of accommodation, mydriasis; constipation, paralytic ileus; urinary retention, delayed micturition, dilation of the urinary tract
• Allergic: Skin rash, petechiae, urticaria, itching, photosensitization; edema (general or of face and tongue); drug fever; cross-sensitivity with desipramine
• Hematologic: Bone marrow depression including agranulocytosis; eosinophilia; purpura; thrombocytopenia
• Gastrointestinal: Nausea and vomiting, anorexia, epigastric distress, diarrhea; peculiar taste, stomatitis, abdominal cramps, black tongue
• Endocrine: Gynecomastia in males; breast enlargement and galactorrhea in females; increased or decreased libido, impotence; testicular swelling; elevation or depression of blood sugar levels; inappropriate antidiuretic hormone (ADH) secretion syndrome
• Other: Jaundice (simulating obstructive); altered liver function; weight gain or loss; perspiration; flushing; urinary frequency; drowsiness, dizziness, weakness and fatigue; headache; parotid swelling; alopecia; proneness to falling

Warnings:

• Use with caution in patients with a history of cardiovascular disease, including arrhythmias, heart block, or recent myocardial infarction
• Monitor for signs of serotonin syndrome, especially when initiating therapy or increasing the dose
• Use cautiously in patients with a history of seizures or those at risk for seizures
• May cause drowsiness; avoid operating heavy machinery or driving until you know how the medication affects you
• Use with caution in patients with a history of urinary retention or glaucoma
• Discontinue use if signs of agranulocytosis (e.g., fever, sore throat, pallor) occur
• Gradual dose reduction is recommended to minimize withdrawal symptoms upon discontinuation

Use during pregnancy or breastfeeding:

Imipramine is classified as a Category C medication during pregnancy, indicating that risk to the fetus cannot be ruled out. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Imipramine is excreted in breast milk; therefore, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.