Anafranil


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Related to Anafranil: Prozac

clomipramine hydrochloride

Anafranil, Anafranil SR (UK), Apo-Clomipramine (CA), Co Clomipramine (CA), Dom-Clomipramine, Gen-Clomipramine (CA), Med-Clomipramine (CA), Novo-Clopamine (CA), PHL-Clomipramine (CA), PMS-Clomipramine (CA), Ratio Clomipramine (CA)

Pharmacologic class: Tricyclic anti-depressant (TCA)

Therapeutic class: Antiobsessional agent, antidepressant

Pregnancy risk category C

FDA Box Warning

• Drug may increase risk of suicidal thinking and behavior in children and adolescents with major depressive disorder and other psychiatric disorders. Risk must be balanced with clinical need, as depression itself increases suicide risk. With patient of any age, observe closely for clinical worsening, suicidality, and unusual behavior changes when therapy begins. Advise family to observe patient closely and communicate with prescriber as needed.

• Drug isn't approved for use in pediatric patients, except those with obsessive-compulsive disorder.

Action

Unknown. Selectively inhibits norepinephrine and serotonin reuptake at presynaptic neurons in brain; also possesses moderate anticholinergic properties.

Availability

Aerosol foam: 1%

Capsules: 25 mg, 50 mg, 75 mg

Indications and dosages

Obsessive-compulsive disorder

Adults: Initially, 25 mg/day P.O., increased over 2 weeks to 100 mg/day given in divided doses. May be increased further over several weeks, up to 250 mg/day given in divided doses.

Children ages 10 to 17: Initially, 25 mg/day P.O., increased over 2 weeks to 3 mg/kg/day or 100 mg/day (whichever is smaller) given in divided doses. May be increased further to 3 mg/kg/day or 200 mg/day (whichever is smaller) given in divided doses.

Dosage adjustment

• Elderly patients

Off-label uses

• Panic disorder

Contraindications

• Hypersensitivity to drug or other TCAs
• Recent myocardial infarction (MI)
• Concurrent MAO inhibitor or clonidine use

Precautions

Use cautiously in:
• glaucoma, hyperthyroidism, prostatic hypertrophy, preexisting cardiovascular disease
• elderly patients
• pregnant or breastfeeding patients
• children younger than age 10 (safety not established).

Administration

• Don't give with grapefruit juice.
• Once stabilizing dosage is reached, entire daily dose may be given at bedtime.

Adverse reactions

CNS: lethargy, sedation, weakness, aggressive behavior, extrapyramidal reactions, poor concentration, feeling of unreality, delusions, anxiety, restlessness, panic, asthenia, syncope, insomnia, seizures, suicidal ideation or behavior (especially in child or adolescent)

CV: orthostatic hypotension, hypertension, ECG changes, tachycardia, palpitations, vasculitis,

arrhythmias, MI, precipitation of heart block

EENT: blurred vision, dry eyes, vestibular disorder, nasal congestion, laryngitis

GI: nausea, vomiting, constipation, abdominal cramps, belching, epigastric distress, flatulence, dysphagia, increased salivation, stomatitis, parotid gland swelling, black tongue, dry mouth, paralytic ileus

GU: urinary retention, urinary hesitancy, urinary tract dilation, male sexual dysfunction, testicular swelling, gynecomastia, breast enlargement, menstrual irregularities, galactorrhea, libido changes

Hematologic: eosinophilia, purpura, anemia, bone marrow depression, agranulocytosis, thrombocytopenia, leukopenia

Metabolic: hyperthermia, hypothermia, syndrome of inappropriate antidiuretic hormone secretion Musculoskeletal: muscle weakness

Skin: sweating, dry skin, photosensitivity, rash, pruritus, petechiae, flushing

Other: abnormal taste, chills, edema, increased appetite, weight gain

Interactions

Drug-drug.Adrenergics, anticholinergics: additive adrenergic or anticholinergic effects

Cimetidine, hormonal contraceptives, phenothiazines, selective serotonin reuptake inhibitors: increased clomipramine effects, greater risk of toxicity

Clonidine: hypertensive crisis

CNS depressants (including antihistamines, opioid analgesics, sedative-hypnotics): additive CNS depression

Disulfiram: transient delirium

Guanethidine: interference with anti-hypertensive response

MAO inhibitors: severe or life-threatening adverse reactions

Levofloxacin, moxifloxacin: increased risk of adverse cardiovascular reactions

Drug-diagnostic tests.Blood glucose, prolactin: elevated levels

Drug-food.Grapefruit juice: increased clomipramine blood level and effects

Drug-herbs.Chamomile, hops, kava, skullcap, valerian: increased CNS depression

S-adenosylmethionine (SAM-e), St. John's wort: increased serotonergic effects, possibly causing serotonin syndrome

Drug-behaviors.Alcohol use: additive CNS depression

Nicotine use: increased metabolism and decreased efficacy of clomipramine

Sun exposure: photosensitivity

Patient monitoring

• Monitor patient for cardiovascular, CNS, and hematologic adverse reactions.

Assess for suicidal ideation. If necessary, institute suicide precautions.

Patient teaching

Advise patient (especially children or their parents) to immediately report suicidal thoughts or severe depression.
• Instruct patient not to drink grapefruit juice during therapy.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.
• Instruct patient to avoid alcohol, because it increases drowsiness.
• Tell patient to move slowly when sitting up or standing, to avoid dizziness or light-headedness caused by sudden blood pressure drop.
• Caution patient not to stop taking drug abruptly, because this may cause nausea, headache, or malaise.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, foods, herbs, and behaviors mentioned above.

clomiPRAMINE

(kloe-mip-ra-meen) ,

Anafranil

(trade name)

Classification

Therapeutic: antiobsessive agents
Pharmacologic: tricyclic antidepressants
Pregnancy Category: C

Indications

Obsessive-Compulsive Disorder (OCD).Depression, neuropathic pain/chronic pain.

Action

Potentiates the effect of serotonin (antiobsessional effect) and norepinephrine in the CNS. Has moderate anticholinergic effects.

Therapeutic effects

Diminished obsessive-compulsive behavior.

Pharmacokinetics

Absorption: Well absorbed from the GI tract.
Distribution: Widely distributed, enters breast milk.
Protein Binding: ≥90%.
Metabolism and Excretion: Mostly metabolized by the liver (CYP2D6 isoenzyme); genetic implication the CYP2D6 enzyme system exhibits genetic polymorphism; ∼7% of population may be poor metabolizers (PMs) and may have significantly ↑ clomipramine concentrations and an ↑ risk of adverse effects;.
Half-life: 21–31 hr.

Time/action profile

ROUTEONSETPEAKDURATION
PO1–6 wkunknownunknown

Contraindications/Precautions

Contraindicated in: Hypersensitivity; Angle-closure glaucoma; Recent myocardial infarction; History of QTc interval prolongation; Cardiac arrythmias; Heart failure; Concurrent use of MAO inhibitors or or MAO-like drugs (linezolid or methylene blue). Obstetric: Potential for fetal harm or neonatal withdrawal syndrome; Lactation: Discontinue drug or bottle feed.
Use Cautiously in: History of seizures (threshold may be lowered); Patients with pre-existing cardiovascular disease; Older men with prostatic hyperplasia (may be more susceptible to urinary retention); Hyperthyroidism (↑ risk of arrhythmias); May ↑ risk of suicide attempt/ideation especially during dose early treatment or dose adjustment; risk may be greater in children or adolescents; Pediatric: Children <10 yr (safety not established); Geriatric: ↑ risk of arrhythmias.

Adverse Reactions/Side Effects

Central nervous system

  • seizures (life-threatening)
  • suicidal thoughts (life-threatening)
  • lethargy (most frequent)
  • sedation (most frequent)
  • weakness (most frequent)
  • aggressive behavior

Ear, Eye, Nose, Throat

  • blurred vision (most frequent)
  • dry eyes (most frequent)
  • dry mouth (most frequent)
  • vestibular disorder

Cardiovascular

  • arrhythmias (life-threatening)
  • ECG changes
  • orthostatic hypotension

Gastrointestinal

  • constipation (most frequent)
  • nausea (most frequent)
  • vomiting (most frequent)
  • weight gain
  • eructation

Genitourinary

  • male sexual dysfunction (most frequent)
  • urinary retention

Dermatologic

  • dry skin
  • photosensitivity

Endocrinologic

  • gynecomastia

Hematologic

  • anemia

Musculoskeletal

  • muscle weakness

Neurologic

  • extrapyramidal reactions

Miscellaneous

  • hyperthermia

Interactions

Drug-Drug interaction

Concurrent use with MAO inhibitors may result in serious potentially fatal reactions (MAO inhibitors should be stopped at least 14 days before clomipramine therapy. Clomipramine should be stopped at least 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 clomipramine, immediately discontinue clomipramine 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 clomipramine therapy 24 hr after last dose of linezolid or methylene blue)May prevent the therapeutic response to antihypertensives.Hypertensive crisis may occur with clonidine.↑ CNS depression with other CNS depressants includingalcohol, antihistamines, opioids, and sedative/hypnotics.Adrenergic and anticholinergic side effects may be ↑ with other agents having adrenergic/anticholinergic properties.Effects and toxicity may be ↑ by concurrent use with SSRI antidepressants (wait several weeks after stopping SSRIs to start clomipiramine; up to 5 weeks for fluoxetine), phenothiazines, cimetidine, or oral contraceptives.Drugs that affect serotonergic neurotransmitter systems, including SSRIs, SNRIs, fentanyl, buspirone, tramadol and triptans ↑ risk of serotonin syndrome.Nicotine may ↑ metabolism and ↓ effectiveness.Transient delirium may occur with disulfiram.Use with St. John's wort ↑ of serotonin syndrome.Kava, valerian, or chamomile can ↑ CNS depression.Grapefruit juice ↑ serum levels and effect.

Route/Dosage

Oral (Adults) Antiobsessive—25 mg/day, ↑ over 2-wk period to 100 mg/day in divided doses. May be further ↑ over several weeks up to 250–300 mg/day in divided doses. Once stabilizing dose is reached, entire daily dose may be given at bedtime. Antidepressant—25 mg 3 times daily, may be ↑ as needed (unlabeled).
Oral (Children >10–17 yr) 25 mg/day initially, ↑ over 2-wk period to 3 mg/kg/day or 100 mg/day (whichever is smaller) in divided doses. May be further ↑ to 3 mg/kg/day or 200 mg/day (whichever is smaller) in divided doses. Once stabilizing dose is reached, entire daily dose may be given at bedtime.

Availability (generic available)

Capsules: 25 mg, 50 mg, 75 mg

Nursing implications

Nursing assessment

  • Monitor mental status (orientation, mood, behanior) frequently. Assess patient for frequency of OCD. Note degree to which these thoughts and behaviors interfere with daily functioning.
  • Monitor BP and pulse before and during initial therapy. Notify physician or other health care professional of decreases in BP (10–20 mmHg) or sudden increase in pulse rate. Patients taking high doses or with a history of cardiovascular disease should have ECG monitored before and periodically during therapy.
  • Assess weight and BMI initially and throughout treatment. Assess FBS and cholesterol levels in obese individuals. Refer as appropriate for nutritional/weight management and medical management.
  • Observe for onset of extrapyramidal parkinsonian side effects (difficulty speaking or swallowing, loss of balance control, pill rolling with hands, mask-like face, shuffling gait, rigidity, tremors). Notify physician or other health care professional if these symptoms occur; reduction in dose or discontinuation of medication may be necessary. Trihexyphenidyl or diphenhydramine may be used to control these symptoms.
  • Assess for suicidal tendencies, especially during early therapy and dose changes. Restrict amount of drug available to patient. Risk may be increased in children, adolescents, and adults ≤24 yr. After starting therapy, children, adolescents, and young adults should be seen by health care professional at least weekly for 4 wk, every 3 wk for the next 4 wk, and on advice of health care professional thereafter.
  • Assess for serotonin syndrome (mental changes [agitation, hallucinations, coma], autonomic instability [tachycardia, labile BP, hyperthermia], neuromuscular aberrations [hyperreflexia, incoordination], and/or GI symptoms [nausea, vomiting, diarrhea]), especially in patients taking other serotonergic drugs (SSRIs, SNRIs, triptans).
  • Lab Test Considerations: Serum glucose may be ↑ or ↓.
    • Monitor CBC and differential during chronic therapy. May rarely cause bone marrow suppression.
    • In chronic therapy, periodically monitor hepatic and renal function.

Potential Nursing Diagnoses

Ineffective coping(obsessive-compulsive behaviors), related to repressed anxiety (Indications)
Risk for injury (Side Effects)
Chronic pain (Indications)

Implementation

  • Do not confuse clomipramine with clomiphene or desipramine.
  • Oral: Administer medication with or immediately after a meal to minimize gastric irritation. After titration of dose, total daily dose may be given at bedtime.

Patient/Family Teaching

  • Instruct patient to take medication exactly as directed. Abrupt discontinuation may cause nausea, headache, and malaise.
  • May cause drowsiness and blurred vision. Caution patient to avoid driving and other activities requiring alertness until response to drug is known.
  • Orthostatic hypotension, sedation, and confusion are common during early therapy, especially in geriatric patients. Protect patient from falls and advise patient to change positions slowly.
  • Advise patient to avoid alcohol or other CNS depressant drugs during course of therapy and for 3–7 days after cessation of therapy.
  • Advise patient, family, and caregivers to look for suicidality, especially during early therapy or dose changes. Notify health care professional 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 or if symptoms of serotonin syndrome occur.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking any other Rx, OTC, or herbal products.
  • Instruct patient to notify health care professional if dry mouth or constipation persists or if urinary retention, uncontrolled movements, or rigidity occurs. Sugarless candy or gum may diminish dry mouth, and an increase in fluid intake or bulk may prevent constipation. If these symptoms persist, dosage reduction or discontinuation may be necessary. Consult health care professional if dry mouth persists for more than 2 wk.
  • Advise patient to inform health care professional if sexual dysfunction occurs. Inform male patients that sexual dysfunction is common with this medication.
  • Caution patient to use sunscreen and protective clothing to prevent photosensitivity reactions.
  • Inform patient of need to monitor dietary intake because possible increase in appetite may lead to undesired weight gain.
  • Advise patient to notify health care professional of medication regimen before treatment or surgery.
  • Instruct female patients to inform health care professional if pregnancy is planned or suspected, or if they plan to breastfeed.
  • Emphasize the importance of follow-up exams to monitor effectiveness and side effects and to improve coping skills.
  • Inform patients taking high doses (250–300 mg/day) that risk of seizures is increased.

Evaluation/Desired Outcomes

  • Diminished obsessive compulsive behavior.

Anafranil

(ə-năf′rə-nĭl)
A trademark for the drug clomipramine hydrochloride.

Anafranil

A brand name for CLOMIPRAMINE.
References in periodicals archive ?
Through using Anafranil, I became convinced that getting rid of these symptoms as quickly as possible is the only rational treatment for my patients.
Ciba-Geigy manufactures clomipramine under the brand name Anafranil and has sold it for 20 years in Europe, Canada and elsewhere.
Clomipramine hydrochloride, a tricyclic antidepressant commonly used to treat obsessive-compulsive disorders, is bioequivalent to Anafranil Capsules.
NOTE TO EDITORS: Anafranil is a registered trademark of Novartis Inc.
Dr Eugene Connolly, of University College Hospital Galway, who carried out the post-mortem said a large amount of partly digested anti-depressant drug, Anafranil, was in the deceased's stomach.
CoCensys' and Ciba's co-marketing effort has maximized the near-term market potential of Anafranil and Tofranil(R) (imipramine hydrochloride) in the face of increasing competition from newer generation drugs," said Daniel L.
Provigil and the Novartis drugs -- Tegretol for epilepsy, Ritalin for attention deficit/hyperactivity disorder, Anafranil for depression and obsessive-compulsive disorder, Lioresal for spasticity -- are expected to generate combined sales of about $30 million for the year in the U.