Buy Tofranil Online

Tofranil (imipramine hydrochloride)

BOXED WARNING

Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder and other psychiatric disorders. Monitor and observe closely for clinical worsening, suicidality, or unusual changes in behavior in patients who are started on antidepressant therapy. Not approved for use in pediatric patients.

THERAPEUTIC CLASS

Tricyclic antidepressant (TCA)

DEA CLASS

RX

INDICATIONS

Relief of symptoms of depression. As temporary adjunctive therapy in reducing enuresis in children ≥6 yrs of age.

ADULT DOSAGE

Depression

Hospitalized Patients:
Initial: 100mg/day in divided doses
Titrate: Increase gradually to 200mg/day as required; increase to 250-300mg/day if no response after 2 weeks

Outpatients:
Initial: 75mg/day
Titrate: Increase to 150mg/day
Maint: 50-150mg/day
Max: 200mg/day

Following remission, may require maint for a longer period of time at the lowest effective dose

PEDIATRIC DOSAGE

Depression

Adolescents:
Initial: 30-40mg/day
Max: 100mg/day

Following remission, may require maint for a longer period of time at the lowest effective dose

Enuresis

Temporary Adjunctive Therapy in Reducing Enuresis After Possible Organic Causes Have Been Excluded by Appropriate Tests:

≥6 Years:
Initial: 25mg/day 1 hr before hs
Titrate: If no satisfactory response w/in 1 week, increase to 50mg nightly in children <12 yrs; may give up to 75mg nightly in children >12 yrs
Max: 2.5mg/kg/day

In early night bedwetters, drug is more effective given earlier and in divided doses (eg, 25mg in midafternoon, repeated hs)

Consider a drug-free period following an adequate trial w/ favorable response

Dosage should be tapered off gradually rather than abruptly discontinued; may reduce tendency to relapse

DOSING CONSIDERATIONS

Elderly
Initial: 30-40mg/day
Max: 100mg/day

ADMINISTRATION

Oral route

HOW SUPPLIED

Tab: 10mg, 25mg, 50mg

CONTRAINDICATIONS

Use of an MAOI concomitantly. Treatment within 14 days of stopping an MAOI. During the acute recovery period following myocardial infarction (MI).

WARNINGS/PRECAUTIONS

Not approved for the treatment of bipolar depression. May precipitate mixed/manic episode in patients at risk for bipolar disorder; screen for risk for bipolar disorder prior to initiating treatment. Pupillary dilation that occurs following therapy may trigger an angle-closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy. Use extreme caution in patients with cardiovascular disease (CVD); cardiac surveillance required. Caution in patients with history of urinary retention, narrow-angle glaucoma, or seizure disorder. Caution in patients with hyperthyroidism, serious depression, significant renal/hepatic impairment, and in elderly. May impair mental/physical abilities. Hypomanic or manic episodes may occur, particularly in patients with cyclic disorders; may require discontinuation and, if needed, may resume at lower dosage when episodes are relieved. May activate psychosis in schizophrenic patients; may require dose reduction and addition of a phenothiazine. Hazards may be increased with electroshock therapy. Photosensitization reported; avoid excessive exposure to sunlight. May alter blood glucose levels. Perform leukocyte and differential blood counts if fever and sore throat develop; d/c if there is evidence of pathological neutrophil depression. Prior to elective surgery, d/c treatment for as long as the clinical situation will allow.

ADVERSE REACTIONS

Nervousness, sleep disorders, tiredness, mild GI disturbances, orthostatic hypotension, HTN, confusion, hallucinations, numbness, tremors, dry mouth, skin rash, bone marrow depression, anorexia, jaundice.

DRUG INTERACTIONS

See Contraindications. Caution in patients on thyroid medication. May block pharmacological effects of guanethidine, clonidine, or similar agents; use with caution. Methylphenidate HCl may inhibit metabolism; may require downward dose adjustment of imipramine. May enhance CNS depressant effects of alcohol. Drugs that inhibit CYP2D6 (eg, quinidine, cimetidine, many CYP2D6 substrates [other antidepressants, phenothiazines, propafenone, flecainide]) may increase plasma concentrations; may require lower doses for either TCA or the other drug, and monitoring of TCA plasma levels. Caution with SSRI coadministration and when switching between TCAs and SSRIs (eg, fluoxetine, sertraline, paroxetine); sufficient time must elapse before starting therapy when switching from fluoxetine (at least 5 weeks may be necessary). Hepatic enzyme inhibitors (eg, cimetidine, fluoxetine) may increase plasma concentration and hepatic enzyme inducers (eg, barbiturates, phenytoin) may decrease plasma concentration; may require dosage adjustment of imipramine. Atropine-like effects may become more pronounced (eg, paralytic ileus) with anticholinergics (including antiparkinsonism agents); close supervision and careful dose adjustment is required when coadministered with anticholinergic drugs. May potentiate effects of catecholamines; avoid use of preparations (eg, decongestants, local anesthetics) that contain any sympathomimetic amine (eg, epinephrine, norepinephrine). Caution with agents that lower BP. May potentiate effects of CNS depressants.

PREGNANCY AND LACTATION

Safety not known in pregnancy; not for use in nursing.

MECHANISM OF ACTION

TCA; has not been established. Suspected to potentiate adrenergic synapses by blocking uptake of norepinephrine at nerve endings. Mechanism in controlling childhood enuresis is thought to be apart from its antidepressant effect.

ASSESSMENT

Assess for acute recovery period following MI, known hypersensitivity to drug, history of urinary retention or seizure disorder, history of/susceptibility to narrow-angle glaucoma, risk for bipolar disorder, CVD, hyperthyroidism, schizophrenia, serious depression, renal/hepatic impairment, pregnancy/nursing status, and possible drug interactions. Obtain ECG recording prior to initiation of larger-than-usual doses of therapy.

MONITORING

Monitor for signs/symptoms of clinical worsening, suicidality, unusual changes in behavior, hypomanic/manic episodes, psychosis activation, angle-closure glaucoma, changes in blood glucose levels, and other adverse reactions. Take ECG recording at appropriate intervals until steady state is achieved; perform cardiac surveillance in patients with CVD. Perform leukocyte and differential blood counts if fever and sore throat develop.

PATIENT COUNSELING

Inform about benefits, risks, and appropriate use of therapy. Advise to monitor for unusual changes in behavior, worsening of depression, and suicidal ideation on a day-to-day basis, and to report such symptoms to physician. Inform that drug can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle-closure glaucoma. Advise to use caution when performing potentially hazardous tasks (eg, driving, operating machinery). Instruct to avoid excessive exposure to sunlight.

STORAGE

20-25°C (68-77°F).

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