Product Details

(im-IPP-ruh-meen HIGH-droe-KLOR-ide)

Tofranil, Tofranil-PM,  Apo-Imipramine, Impril, Novo-Pramine, PMS-Imipramine

Class: Tricyclic antidepressant

 Action Inhibits reuptake of norepinephrine and, to a lesser degree, serotonin in CNS.

 Indications Relief of symptoms of depression; treatment of enuresis in children ³ 6 years. Unlabeled use(s): Treatment of chronic pain, panic disorder, eating disorders (bulimia nervosa), and facilitation of cocaine withdrawal.

 Contraindications Hypersensitivity to any tricyclic antidepressant. Generally not to be given in combination with or within 14 days of treatment with MAO inhibitor or during acute recovery phase of MI; cross-sensitivity may occur among the dibenzazepines.

 Route/Dosage

Depression

Use parenterally only in patients who are not able or not willing to take oral medication. Give via IM route. Do not administer IV. Up to 100 mg/day in divided doses may be given IM. Switch to oral as soon as possible. ADULTS: PO 100 to 300 mg/day, in divided doses or once daily at bedtime. ELDERLY & ADOLESCENTS: PO 30 to 40 mg/day; may increase up to 100 mg/day. CHILDREN: PO 1.5 mg/kg/day in divided doses; up to maximum of 5 mg/kg/day. CHILDHOOD ENURESIS (6 YR): PO 25 mg/day given 1 hr before bedtime; if response unsatisfactory after 1 wk, may increase to 50 mg in children < 12 years. Children > 12 may receive 75 mg/night. Do not exceed 2.5 mg/kg/day.

 Interactions

Carbamazepine: Carbamazepine levels may increase; imipramine levels may decrease. Cimetidine, fluoxetine: May cause increased imipramine blood levels and effects. Clonidine: May result in hypertensive crisis. CNS depressants: Depressant effects may be additive. Dicumarol: Anticoagulant actions may increase. Guanethidine: Hypotensive action may be inhibited. MAO inhibitors: May cause hyperpyretic crises, severe convulsions and death when given with imipramine. Sympathomimetics: Pressor response may be decreased by indirect-acting sympathomimetics and increased by direct-acting ones.

 Lab Test Interferences None well documented.

 Adverse Reactions

CV: Orthostatic hypotension; hypertension; tachycardia; palpitations; arrhythmias; ECG changes; stroke; heartblock; CHF. RESP: Pharyngitis; rhinitis; sinusitis; laryngitis; coughing. CNS: Confusion; hallucinations; delusions; nervousness; restlessness; agitation; panic; insomnia; nightmares; mania; exacerbation of psychosis; drowsiness; dizziness; weakness; numbness; extrapyramidal symptoms; emotional lability seizures; tremors. EENT: Nasal congestion; tinnitus; conjunctivitis; mydriasis; blurred vision; increased IOP. GI: Nausea; vomiting; anorexia; GI distress; diarrhea; flatulence; peculiar taste in mouth; dry mouth; constipation. GU: Impotence; sexual dysfunction; nocturia; urinary frequency; UTI; vaginitis; cystitis; dysmenorrhea; amenorrhea; urinary retention and hesitancy. HEMA: Bone marrow depression including agranulocytosis; eosinophilia; purpura; thrombocytopenia; leukopenia. HEPA: Hepatitis; jaundice. DERM: Rash; pruritus; photosensitivity reaction; dry skin; acne; itching. META: Elevation or depression of blood sugar. OTHER: Breast enlargement.

 Precautions

Pregnancy: Category D. Lactation: Excreted in breast milk. Children: Safety and efficacy of imipramine as temporary adjunctive therapy for nocturnal enuresis in pediatric patients < 6 years have not been established; chronic use in patients ³ 6 years has not been established. Do not exceed 2.5 mg/kg/day. Special risk patients: Use with caution in patients with history of seizures, urinary retention, ureteral spasm, angle-closure glaucoma or increased IOP, conduction disorders, with hyperthyroid or those receiving thyroid medication, hepatic or renal impairment, schizophrenia or paranoia. Cardiovascular disorders: Use with extreme caution in patients with cardiovascular disorders. These patients require cardiac surveillance at all dose levels of the drug. Hazardous tasks: Patients should use caution while performing tasks requiring alertness.

 Administration/Storage

• Do not give via IV route.
• Use IM form only for patients unwilling or unable to take oral form.
• Give IM form in divided doses during day.
• Immerse ampules in hot tap water for 1 min if crystals have formed during storage.

 Assessment/Interventions

• Obtain complete patient history, including drug history and any known allergies.
• Review ECG for prolongation of QT interval prior to starting large doses and periodically thereafter.
• Be alert for signs of orthostatic hypotension and take orthostatic BPs. Document and report significant changes to physician.
• Observe for onset of therapeutic effect in depressed patients in 7 to 21 days and full response in up to 6 wk.
• Assess patients receiving IM form for ability to switch to oral administration.
• Assess elderly patients for signs and symptoms of confusion.
• Report drowsiness, dry mouth, constipation, or weight gain to physician.
• Watch for possible hypertension when coadministering clonidine.
• Be alert for possible drug interactions.

 Patient/Family Education

• Warn patient of risk of seizure.
• Tell female patient to inform physician if she becomes pregnant or intends to become pregnant.
• Explain that it may be several weeks before a response is noticed.
• Instruct patient to avoid intake of alcoholic beverages or other CNS depressants.
• Advise patient that drug may cause drowsiness and to use caution while driving or performing other tasks requiring mental alertness.
• Caution patient to avoid exposure to sunlight and to use sunscreen or wear protective clothing to avoid photosensitivity reaction.
• Teach patient to avoid sudden position changes to prevent orthostatic hypertension.
• Inform patient that dizziness, dry mouth (suggest taking frequent sips of water, sucking on ice chips or sugarless hard candy or chewing sugarless gum), drowsiness, or constipation may occur, but that these side effects often subside with time.
• Instruct patient to report all problems to physician, including dizziness, drowsiness, dry mouth, constipation, or weight gain.

Books@Ovid
Copyright © 2003 Facts and Comparisons
David S. Tatro
A to Z Drug Facts

Diazepam

A to Z Drug Facts

(DIE-aze-uh-pam)

Valium, Diastat, Apo-Diazepam, Diazemuls, E Pam, Meval, Novo-Dipam, PMS-Diazepam, Valium Roche, Vivol

Class: Antianxiety/Benzodiazepine/Anticonvulsant

 Action Potentiates action of GABA; inhibitory neurotransmitter, resulting in increased neural inhibition and CNS depression, especially in limbic system and reticular formation.

 Indications Management of anxiety disorders; relief of acute alcohol withdrawal symptoms; relief of preoperative apprehension and anxiety and reduction of memory recall; treatment of muscle spasms, convulsive disorders and status epilepticus. Unlabeled use(s): Treatment of irritable bowel syndrome; relief of panic attack.

 Contraindications Hypersensitivity to benzodiazepines; psychoses; acute narrow-angle glaucoma; shock; coma; acute alcohol intoxication; use in children < 6 mo; lactation.

 Route/Dosage

Individualize dosage; increase cautiously. ADULTS & CHILDREN: Usual recommended dose IM/IV 2 to 20 mg, depending on indication and severity. In acute conditions injection may be repeated within 1 hr, but q 3 to 4 hr is usually satisfactory. Dosage and route vary with indication and age. Usual daily dose: CHILDREN ³ 6 MO: PO 1 to 2.5 mg tid or qid initially; increase gradually as needed and tolerated.

Anxiety

ADULTS: PO 2 to 10 mg bid to qid. IM/IV 2 to 10 mg; repeat in 3 to 4 hr if needed.

Acute Alcohol Withdrawal

ADULTS: PO 10 mg tid to qid first 24 hr; then 5 mg tid to qid prn. IM/IV 10 mg initially; then 5 to 10 mg in 3 to 4 hr if needed.

Skeletal Muscle Spasm

ADULTS: PO 2 to 10 mg tid to qid. IM/IV 5 to 10 mg initially; then 5 to 10 mg in 3 to 4 hr if needed. Larger doses may be necessary in tetanus.

Tetanus

ADULT: CHILDREN £ 5 yr: IM/IV 5 to 10 mg; repeat q 3 to 4 hr prn. InFANTS & CHILDREN 1 MO to 5 YR: IM/IV 1 to 2 mg slowly; repeat q 3 to 4 hr prn.

Anticonvulsant Adjunct

ADULTS: PO 2 to 10 mg bid to qid. ELDERLY OR DEBILITATED PATIENTS: Initial dose: PO 2 to 2.25 mg qd to bid; increase gradually.

Status Epilepticus and Severe Recurrent Convulsive Disorders

ADULTS: IM/IV (IV preferred) 5 to 10 mg initially; then 5 to 10 mg at 10 to 15 min intervals (maximum total dose 30 mg). If needed, repeat in 2 to 4 hr. Dizac: Extreme caution must be exercised with chronic lung disease or unstable cardiovascular status. CHILDREN £ 5 YR: IM/IV 1 mg q 2 to 5 min (maximum total dose 10 mg). If needed, repeat in 2 to 4 hr. INFANTS & CHILDREN 1 MO to 5 YR: IM/IV 0.2 to 0.5 mg slowly q 2 to 5 min (maximum total dose 5 mg).

Sedation/Muscle Relaxation

ADULTS: IM/IV 2 to 10 mg/dose q 3 to 4 hr as needed. CHILDREN ³ 6 MO: PO 0.12 to 0.8 mg/kg/day in divided doses. IM/IV 0.04 to 0.2 mg/kg/dose q 2 to 4 hr (maximum 0.6 mg/kg in 8 hr period.

Preoperative (Anxiety and Tension)

ADULTS: IM 10 mg before surgery.

Cardioversion (Anxiety and Tension)

ADULTS: IM/IV 5 to 15 mg 10 to 15 min before procedure.

 Interactions

Cimetidine, oral contraceptives, disulfiram: May increase effects of diazepam, with excessive sedation and impaired psychomotor function. Digoxin: May increase serum digoxin concentrations. Omeprazole: May increase diazepam levels and enhance effects. Theophyllines: May antagonize sedative effects. Incompatibilities: Diazepam interacts with plastic containers and IV tubing, significantly decreasing availability of drug delivered. Do not mix or dilute with other solutions or drugs in syringe or infusion container.

 Lab Test Interferences None well documented.

 Adverse Reactions

CV: Cardiovascular collapse; bradycardia; tachycardia; hypertension; palpitations; edema; hypotension; phlebitis or thrombosis at IV sites. CNS: Drowsiness; confusion; ataxia; dizziness; lethargy; fatigue; apathy; memory impairment; disorientation; anterograde amnesia; restlessness; headache; slurred speech; loss of voice; stupor, coma; euphoria; irritability; vivid dreams; psychomotor retardation; paradoxical reactions (eg, anger, hostility, mania, insomnia, muscle spasms). EENT: Visual or auditory disturbances; depressed hearing. GI: Constipation; diarrhea; dry mouth; coated tongue; nausea; anorexia; vomiting. HEMA: Blood dyscrasias including agranulocytosis, anemia, thrombocytopenia, leukopenia, neutropenia. HEPA Hepatic dysfunction including hepatitis and jaundice; abnormal LFTs. Dependency/withdrawal symptoms.

 Precautions

Pregnancy: Category D. Avoid drug especially during first trimester due to possible increased risk of congenital malformations. Lactation: Excreted in breast milk. Children: Oral form not recommended in patients < 6 mo; parenteral form not recommended in infants < 30 days. Elderly or debilitated patients: Initial dose should be small and gradually increased. Give with extreme care to elderly patients with limited pulmonary reserve. Dependency: Prolonged use can lead to dependency. Withdrawal syndrome has occurred within 4 to 6 wk of treatment, especially if abruptly discontinued. For discontinuation after long-term treatment, use caution and taper dosage. Parenteral administration: Reserved primarily for acute states. Psychiatric disorders: Not intended for use in patients with primary depressive disorder, psychosis or disorders in which anxiety is not prominent. Renal or hepatic impairment: Observe caution to avoid accumulation of drug. Seizures: Tonic status epilepticus has been precipitated in patients treated for petit mal or variant status. Suicide: Use drug with caution in patients with suicidal tendencies; do not allow patient access to large quantities of drug.

 Administration/Storage

• Crush tablets if patient is unable to swallow tablets whole (unless sustained-release).
• Instruct patient to swallow sustained release capsules whole.
• Do not give oral form within 1 hr of antacids.
• Administer oral solution alone or mix with juices or water. When administering Intensol (concentrated oral solution), mix with liquid or semiliquid food such as water, juices, carbonated soda, puddings and applesauce. Use calibrated dropper provided only. Stir Intensol into liquid or food. Entire mixture must be consumed immediately; do not store solution for future use.
• For IV administration, administer injection slowly—no more than 5 mg (1 ml)/min. Slow injection reduces risk of venous thrombosis, phlebitis, local irritation, swelling and vascular impairment. In children, administer injection slowly over 3 min to reduce risk of apnea and hypersomnolence. Do not use small veins of hand or wrist. Avoid intra-arterial injection or extravasation, which may produce arteriospasm that can lead to gangrene. Do not mix or dilute with other solutions or drugs.
• Dizac is for IV use only; should not be administered IM or SC.
• If unable to perform direct IV administration, inject slowly through infusion tubing or Y-site as close as possible to IV site.
• IV route is preferred in convulsing patients.
• For IM administration, inject deeply into muscle.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies.
• Monitor BP (lying, standing), pulse rate and respiratory rate. Notify physician of significant change in systolic BP or respiratory depression with concomitant use of narcotic analgesics.
• Monitor respiratory rate q 5 to 15 min during IV administration.
• Monitor CBC; blood dyscrasias rarely occur.
• Monitor liver function during long-term use.
• Provide sugarless gum or hard candy and frequent sips of water to relieve dry mouth.
• Assess level of anxiety, what precipitates anxiety and if drug controls symptoms.
• Assess for alcohol withdrawal symptoms: hallucinations, delirium, irritability, agitation, tremors.
• Assess for seizure control, type, duration and convulstion intensity.
• Assess mental status: mood, sensorium, affect, sleep pattern, drowsiness dizziness. Report changes in mental status to physician.
• Observe patient closely for 3 hr following parenteral administration.
• Assess for physical dependency/withdrawal symptoms: headaches, muscle pain, weakness, nausea and vomiting after long-term use.
• Assess for suicidal tendencies; restrict amount of drug available to patient.
• Because of risk of apnea and cardiac arrest with parenteral administration, have resuscitative facilities available.

 Patient/Family Education

• Advise patient not to take within 1 hr of antacid.
• Remind patient to take with food or milk to decrease GI irritation.
• Instruct patient to avoid intake of alcoholic beverages or other CNS depressants (sleeping pills, antihistamines, narcotics) unless specifically ordered by physician.
• Caution patient to avoid sudden position changes to prevent orthostatic hypotension or fainting may occur, especially if patient is elderly.
• Advise patient that drowsiness is worse at beginning of treatment.
• Caution patient that drug may be habit-forming and advise that patient discuss use with physician.
• Encourage patient to carry identification (Medi-Alert bracelet) indicating medication usage if taking drug for seizure control.
• Advise patient that drug may cause drowsiness.

Books@Ovid
Copyright © 2003 Facts and Comparisons
David S. Tatro
A to Z Drug Facts