SELECTIVE SEROTONIN REUPTAKE INHIBITOR(SSRI)
SUN PHARMA LTD
A to Z Drug Facts
|Lab Test Interferences|
|Patient Care Considerations|
|Tablets: 25 mg, 50 mg, 100 mg|
Indications Treatment of depression; treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (OCD), as defined in the DSM-IV; treatment of panic disorder with or without agoraphobia, as defined in DSM-IV; posttraumatic stress disorder (PTSD).
ADULTS: PO 50 to 200 mg once daily.
ADULTS: PO 50 to 200 mg once daily.
CHILDREN: PO Initiate dosage with 25 mg once daily (ages 6 to 12 yr) and 50 mg once daily in adolescents (ages 13 to 17 yr) in the morning or evening. Patients not responding to an initial dose of 25 or 50 mg/day may benefit from dose increases up to a max of 200 mg/day.
Panic Disorder and PTSD
ADULTS: PO 25 mg once daily; after 1 wk, increase the dose to 50 mg once daily. Patients not responding to 50 mg dose may benefit from dose increases up to a max of 200 mg/day; however, dose changes should not occur at intervals < 1 wk.
5-HT1 Agonists (eg, Naratriptan, Rizatriptan, Sumatriptan, Zolmitriptan): Weakness, hyberreflexia, and incoordination have been reported rarely. Alcohol, CNS Depressants: May enhance CNS depressant effects. Clozapine: Elevated serum clozapine levels have occurred. Closely monitor patients on coadministration. Hydantoins (eg, Phenytoin): Plasma levels may be increased by sertraline, increasing the pharmacologic and adverse effects. MAOIs: May cause serious, even fatal reactions. Discontinue MAOIs ³ 14 days before starting sertraline. St. John’s Wort: Sedative-hypnotic effects of sertraline may be increased. Sympathomimetics (eg, Amphetamine, Fenfluramine): Increased sensitivity to sympathomimetics; increased risk of “serotonin syndrome.” Tricyclic Antidepressants (eg, Amitriptyline): Pharmacologic and toxic effects may be increased by sertraline; “serotonin syndrome” has been reported. Zolpidem: Onset of action of zolpidem may be shortened and the effect increased.
CARDIOVASCULAR: Palpitations; hot flushes; hypotension (postural); hypertension; syncope; tachycardia; chest pain. CNS: Agitation; anxiety; nervousness; headache; insomnia; dizziness; tremor; fatigue; tingling; diminished sensation; twitching; hypertonia; decreased concentration; confusion; somnolence; nervousness; depression; decreasedlibido; agitation; emotional lability; vertigo; hypoesthesia; apathy; hypo-/hyperkinesia; abnormal dreams. DERMATOLOGIC: Sweating, rash; pruritus; acne. EENT: Abnormal vision; ringing in the ears; rhinitis; pharyngitis; change in taste perception. GI: Nausea; diarrhea; dry mouth; anorexia; vomiting; flatulence; constipation; abdominal pain; increased appetite; dyspepsia; gastroenteritis; tooth disorder/caries; dysphagia; melena. GU: Sexual dysfunction; urinary frequency; urinary disorder; menstrual disorder; pain; abnormal ejaculation. HEMATOLOGIC: Lymphadenopathy; purpura. METABOLIC: Dehydration; hypoglycemia. RESPIRATORY: Upper respiratory tract infection; pharyngitis; sinusitis; increased cough; dyspnea; bronchitis; rhinitis; yawn. OTHER: Muscle pain; weight loss or gain; myalgia; arthralgia; asthenia; fever; allergy/allergic reaction; chills; back pain; malaise; edema.
Pregnancy: Category C. Lactation: Undetermined. CHILDREN: Safety and efficacy not established. Elderly or Debilitated Patients: Dosage reduction may be required. Renal and Hepatic Impairment: Use drug with caution. Lower or less frequent dosing schedule may be required. Activation of Mania/Hypomania: Activation of mania/hypomania occurrs infrequently in patients taking SSRIs. Hyponatremia: Several cases of sertraline-induced hyponatremia have occurred. Seizures: Use drug with caution in patients with history of seizures. Suicide: Supervise depressed patients at risk during initial therapy.
|PATIENT CARE CONSIDERATIONS||
- Administer once daily in morning or afternoon.
- Do not change dosage at intervals of < 1 wk.
- Do not administer to patients who have used MAOIs in past 14 days.
- Store at room temperature.
- Obtain patient history, including drug history and any known allergies. Determine whether any MAOIs have been used in past 14 days. Note history of seizure disorders and renal and hepatic impairment.
- Observe for common side effects (eg, agitation, insomnia, somnolence, dizziness, headache, tremor, anorexia, diarrhea/loose stools, nausea, fatigue) and notify health care provider.
- Take appropriate safety measures because possibility of suicide may persist until significant remission occurs.
- Discuss with family members precautionary measures to be taken to prevent suicide attempt.
- Inform patient that improvement may not be evident for 2 to 4 wk after treatment has started.
- Advise women to notify health care provider if becoming pregnant, intending to become pregnant, or breastfeeding an infant.
- Inform men of possible sexual dysfunction (primarily ejaculatory delay) and advise them to notify health care provider if it occurs.
- Explain that anorexia, nausea, diarrhea, and weight loss may occur. Advise patient to notify health care provider if these symptoms persist.
- Instruct patient to report these symptoms to health care provider: agitation, insomnia, somnolence, dizziness, headache, tremor, anorexia, diarrhea/loose stools, nausea, fatigue, other physical complaints.
- Tell patient to avoid intake of alcoholic beverages or other CNS depressants.
- Advise patient that drug may cause drowsiness and dizziness and to use caution while driving or performing other tasks requiring mental alertness.
- Advise patient to notify health care provider if rash, hives, or a related allergic phenomenon develops.
- While patient may notice improvement in 1 to 4 wk, advise continuation of therapy as directed.
- May cause photosensitivity (sensitivity to sunlight). Avoid prolonged exposure to the sun and other UV light. Use sunscreens and wear protective clothing until tolerance is determined.
Copyright © 2003 Facts and Comparisons
David S. Tatro
A to Z Drug Facts