Monograph Details
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Central Nervous System
> Mood disorders
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SARAFEM CAPSULES |
| Manufacturer |
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Warner Chilcott Laboratories |
| Legal Classification |
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Rx
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| Pharmacological Class |
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SSRI. |
| Generic Name |
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Fluoxetine (as HCl) 20mg. |
| Also |
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• SARAFEM TABLETS
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| Indications |
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Premenstrual dysphoric disorder. |
| Children |
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Not recommended. |
| Adults |
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Give daily throughout menstrual cycle or intermittently (start 14 days before expected menses onset through first full day of menses). Initially 20mg/day; max 80mg/day. Hepatic dysfunction: reduce dose. |
| Contraindications |
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During or within 14 days of MAOIs. Concomitant pimozide, thioridazine (may cause QTc prolongation). |
| Precautions |
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Discontinue if unexplained allergic reaction (eg, rash) occurs. History of seizures. ECT. Suicidal patients. Write Rx for smallest practical amount. Reevaluate periodically. Avoid abrupt cessation. Monitor for weight changes. May activate mania/hypomania. Conditions that affect metabolism or hemodynamic response. Volume depletion. Cardiac disease. Diabetes. Labor & delivery. Pregnancy (Cat.C). Nursing mothers: not recommended. |
| Interactions |
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See Contraindications. Do not start MAOI or thioridazine within at least 5 weeks of discontinuing fluoxetine. Concomitant SSRIs, SNRIs, tryptophan: not recommended. May potentiate protein-bound drugs (eg, warfarin, digoxin) and those metabolized by CYP2D6 (eg, tricyclics, vinblastine, flecainide). May potentiate carbamazepine, phenytoin. Monitor lithium, phenytoin, warfarin, tricyclics. Caution with benzodiazepines (eg, diazepam, alprazolam), antipsychotics (eg, clozapine, haloperidol), other CNS drugs, antiplatelets. Caution with triptans, linezolid, lithium, tramadol, St. John's wort; may cause serotonin syndrome (eg, weakness, incoordination, hyperreflexia). Hyponatremia with diuretics. |
| Adverse Reactions |
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Asthenia, nausea, anorexia, dizziness, nervousness, insomnia, decreased libido, headache, impaired concentration, rash (may be serious); rare: pulmonary events (eg, inflammation, bronchospasm). |
| How Supplied |
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Caps, tabs—28 |
| Additional Resources |
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• Related Prescribing Note |
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