Zoloft (Page 4 of 10)

6.2 Post-marketing Experience

The following adverse reactions have been identified during postapproval use of ZOLOFT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

  • Bleeding or clotting disorders — increased coagulation times (altered platelet function)
  • Cardiac disorders — AV block, bradycardia, atrial arrhythmias, QTc-interval prolongation, ventricular tachycardia (including Torsade de Pointes) [See Clinical Pharmacology (12.2)]
  • Endocrine disorders — gynecomastia, hyperprolactinemia, menstrual irregularities, SIADH
  • Eye disorders — blindness, optic neuritis, cataract
  • Hepatobiliary disorders — severe liver events (including hepatitis, jaundice, liver failure with some fatal outcomes), pancreatitis
  • Hemic and lymphatic disorders — agranulocytosis, aplastic anemia and pancytopenia, leukopenia, thrombocytopenia, lupus-like syndrome, serum sickness
  • Immune system disorders — angioedema
  • Metabolism and nutrition disorders — hyponatremia, hyperglycemia
  • Musculoskeletal and connective tissue disorders — rhabdomyolysis, trismus
  • Nervous system disorders — serotonin syndrome, extrapyramidal symptoms (including akathisia and dystonia), oculogyric crisis
  • Psychiatric disorders — psychosis, enuresis, paroniria
  • Renal and urinary disorders — acute renal failure
  • Respiratory, thoracic and mediastinal disorders — pulmonary hypertension
  • Skin and subcutaneous tissue disorders — photosensitivity skin reaction and other severe cutaneous reactions, which potentially can be fatal, such as Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN)
  • Vascular disorders — cerebrovascular spasm (including reversible cerebral vasoconstriction syndrome and Call-Fleming syndrome), vasculitis

7 DRUG INTERACTIONS

7.1 Clinically Significant Drug Interactions

Table 5 includes clinically significant drug interactions with ZOLOFT [See Clinical Pharmacology (12.3)] .

Table 5. Clinically-Significant Drug Interactions with ZOLOFT
Monoamine Oxidase Inhibitors (MAOIs)
Clinical Impact: The concomitant use of SSRIs including ZOLOFT and MAOIs increases the risk of serotonin syndrome.
Intervention: ZOLOFT is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [See Dosage and Administration (2.5), Contraindications (4), Warnings and Precautions (5.2)].
Examples: selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue
Pimozide
Clinical Impact: Increased plasma concentrations of pimozide, a drug with a narrow therapeutic index, may increase the risk of QTc prolongation and ventricular arrhythmias.
Intervention: Concomitant use of pimozide and ZOLOFT is contraindicated [See Contraindications (4)].
Other Serotonergic Drugs
Clinical Impact: The concomitant use of serotonergic drugs with ZOLOFT increases the risk of serotonin syndrome.
Intervention: Monitor patients for signs and symptoms of serotonin syndrome, particularly during treatment initiation and dosage increases. If serotonin syndrome occurs, consider discontinuation of ZOLOFT and/or concomitant serotonergic drugs [See Warnings and Precautions (5.2)].
Examples: other SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John’s Wort
Drugs that Interfere with Hemostasis (antiplatelet agents and anticoagulants)
Clinical Impact: The concurrent use of an antiplatelet agent or anticoagulant with ZOLOFT may potentiate the risk of bleeding.
Intervention: Inform patients of the increased risk of bleeding associated with the concomitant use of ZOLOFT and antiplatelet agents and anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio [See Warnings and Precautions (5.3)].
Examples: aspirin, clopidogrel, heparin, warfarin
Drugs Highly Bound to Plasma Protein
Clinical Impact: ZOLOFT is highly bound to plasma protein. The concomitant use of ZOLOFT with another drug that is highly bound to plasma protein may increase free concentrations of ZOLOFT or other tightly-bound drugs in plasma [See Clinical Pharmacology (12.3)] .
Intervention: Monitor for adverse reactions and reduce dosage of ZOLOFT or other protein-bound drugs as warranted.
Examples: warfarin
Drugs Metabolized by CYP2D6
Clinical Impact: ZOLOFT is a CYP2D6 inhibitor [See Clinical Pharmacology (12.3)] . The concomitant use of ZOLOFT with a CYP2D6 substrate may increase the exposure of the CYP2D6 substrate.
Intervention: Decrease the dosage of a CYP2D6 substrate if needed with concomitant ZOLOFT use. Conversely, an increase in dosage of a CYP2D6 substrate may be needed if ZOLOFT is discontinued.
Examples: propafenone, flecainide, atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine, thoridazine, tolterodine, venlafaxine
Phenytoin
Clinical Impact: Phenytoin is a narrow therapeutic index drug. ZOLOFT may increase phenytoin concentrations.
Intervention: Monitor phenytoin levels when initiating or titrating ZOLOFT. Reduce phenytoin dosage if needed.
Examples: phenytoin, fosphenytoin
Drugs that Prolong the QTc Interval
Clinical Impact: The risk of QTc prolongation and/or ventricular arrhythmias (e.g., TdP) is increased with concomitant use of other drugs which prolong the QTc interval [See Warnings and Precautions (5.10), Clinical Pharmacology (12.2)] .
Intervention: Pimozide is contraindicated for use with sertraline. Avoid the concomitant use of drugs known to prolong the QTc interval.
Examples: Specific antipsychotics (e.g., ziprasidone, iloperidone, chlorpromazine, mesoridazine, droperidol); specific antibiotics (e.g., erythromycin, gatifloxacin, moxifloxacin, sparfloxacin); Class 1A antiarrhythmic medications (e.g., quinidine, procainamide); Class III antiarrhythmics (e.g., amiodarone, sotalol); and others (e.g., pentamidine, levomethadyl acetate, methadone, halofantrine, mefloquine, dolasetron mesylate, probucol or tacrolimus).

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