Sertraline Hydrochloride (Page 4 of 10)

6.2 Post-marketing Experience

The following adverse reactions have been identified during postapproval use of sertraline. 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 sertraline [See Clinical Pharmacology (12.3)].

Table 5: Clinically-Significant Drug Interactions with Sertraline

Monoamine Oxidase Inhibitors (MAOIs)

Clinical Impact:

The concomitant use of SSRIs including sertraline and MAOIs increases the risk of serotonin syndrome.

Intervention:

Sertraline 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 sertraline is contraindicated [See Contraindications (4)].

Other Serotonergic Drugs

Clinical Impact:

The concomitant use of serotonergic drugs with sertraline 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 sertraline 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 sertraline may potentiate the risk of bleeding.

Intervention:

Inform patients of the increased risk of bleeding associated with the concomitant use of sertraline 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:

Sertraline is highly bound to plasma protein. The concomitant use of sertraline with another drug that is highly bound to plasma protein may increase free concentrations of sertraline or other tightly-bound drugs in plasma [See Clinical Pharmacology (12.3)].

Intervention:

Monitor for adverse reactions and reduce dosage of sertraline or other protein-bound drugs as warranted.

Examples:

warfarin

Drugs Metabolized by CYP2D6

Clinical Impact:

Sertraline is a CYP2D6 inhibitor [See Clinical Pharmacology (12.3)]. The concomitant use of sertraline with a CYP2D6 substrate may increase the exposure of the CYP2D6 substrate.

Intervention:

Decrease the dosage of a CYP2D6 substrate if needed with concomitant sertraline use. Conversely, an increase in dosage of a CYP2D6 substrate may be needed if sertraline is discontinued.

Examples:

propafenone, flecainide, atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine, thoridazine, tolterodine, venlafaxine

Phenytoin

Clinical Impact:

Phenytoin is a narrow therapeutic index drug. Sertraline may increase phenytoin concentrations.

Intervention:

Monitor phenytoin levels when initiating or titrating sertraline. 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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