#36th edition

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Venlafaxine Hydrochloride

Brand Name: Effexor, Effexor XR

Generic Available

Common Dosage Forms:

Tablets: 25 mg, 37.5 mg, 75 mg, 100 mg

Capsules, extended release: 37.5 mg, 75 mg, 150 mg

Tablets, extended release: 37.5 mg, 75 mg, 150 mg, 225 mg

FDA Indications/Dosages:

For the treatment of depression: Start with 75 mg/day administered in a single dose (XR) or 2-3 divided doses (tablets), taken with food. The dose may be increase to 150 mg/day. If needed, the dose should be further increased to 225 mg/day. When increasing the dose, increments of 75 mg/day should be made at intervals of no less than 4 days. Certain patients, including more severely depressed patients, may respond more to higher doses, up to a maximum of 375 mg/day.

For the treatment of generalized anxiety disorder (XR): Start with 37.5 mg/day. Maintenance dosage range is 75-225 mg/day.

For the treatment of social anxiety disorder (XR): Start with 75 mg/day. Maintenance dosage range is 75-225 mg/day.

Dosage during hepatic impairment: Reduce the total daily dose by 50% in patient with moderate hepatic impairment.

Dosage during renal impairment: Reduce the total daily dose by 25% in patients with mild to moderate renal impairment.

Switching patients to or from a monoamine oxidase inhibitor (MAOI): At least 14 days should elapse between discontinuation of an MAOI and initiation of therapy. In addition, at least 7 days should be allowed after stopping therapy before starting an MAOI.

Monitor: BP, IOP, Na

Pharmacology/Pharmacokinetics: The mechanism of action of venlafaxine is believed to be associated with its potentiation of neurotransmitter activity in the CNS. Studies have shown that venlafaxine and its active metabolite are potent inhibitors of neuronal serotonin and norepinephrine reuptake. They are also weak inhibitors of dopamine reuptake. Venlafaxine is well absorbed (~92%) and extensively metabolized in the liver. Approximately 87% of venlafaxine dose is recovered in the urine within 48 hours as either unchanged venlafaxine (5%), unconjugated O-desmethylvenlafaxine (ODV), conjugated ODV (26%), or other minor inactive metabolites (27%). Renal elimination of venlafaxine and its metabolites is the primary route of elimination.

Drug Interactions: Venlafaxine in combination with MAO inhibitors has resulted in serious, sometimes fatal, reactions. The use of other CNS active drugs, including antihistamines, should be approached with caution. Coadministration with aspirin or an NSAID may increase the risk of upper GI bleeding.

Contraindications/Precautions: It is recommended that venlafaxine not be used in combination with an MAOI, or with 14 days of discontinuing treatment with an MAOI. At least 1 week should be allowed after stopping venlafaxine before starting a MAOI. ANTIDEPRESSANTS INCREASE SUICIDAL THOUGHTS AND ACTIONS IN CHILDREN, ADOLESCENTS, AND YOUNG ADULTS. Use with caution in patients with pre-existing hypertension. For patients who experience a sustained increase in blood pressure while receiving venlafaxine, either a dose reduction or discontinuation should be considered. As with all antidepressants, caution should be used in patients with a history of mania. Venlafaxine should be used cautiously in patients with a history of seizures. In patients with renal impairment or cirrhosis of the liver, the clearances of venlafaxine and its active metabolite were decreased, thus prolonging the elimination half-lives of these substances. In patients who have received extended release forms for 6 weeks or more should have their dose tapered over at least a week period if therapy is discontinued.

Adverse Effects: The most common adverse effects include nausea, dry mouth, anorexia, constipation, drowsiness, insomnia, dizziness, nervousness, abnormal ejaculation, sweating, impotence, decreased libido, and yawning.

Patient Consultation:

Avoid alcohol while taking this medication.

Patients should be advised to inform their physician if they are taking, or plan to take, any prescription or over-the-counter drugs, since there is a potential for interactions.

Store in a cool, dry place away from sunlight and children.

Contact a physician if the above side effects are severe or persistent.

Swallow capsules while; do not crush, chew, dissolve, or divide.

Do not stop therapy before consulting with a physician.

Pay close attention to any changes, especially sudden changes, in mood behavior, thoughts, or feelings. Antidepressants may increase suicidal thoughts or actions.

Continued therapy of up to 2 weeks may be needed to show noticeable improvement.

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Omeprazole

Brand Name: Prilosec

Generic Available

Common Dosage Forms:

Capsules, sustained release*: 10 mg, 20 mg, 40 mg

*Also available in a 20 mg nonprescription formulation

FDA Indications/Dosages:

Short-term treatment of active duodenal ulcer: 20 mg daily for 4-8 weeks.

Short-term treatment of erosive esophagitis or poorly responsive gastroesophageal reflux disease: 20 mg daily for 4-8 weeks.

Pathological hypersecretory conditions including Zollinger-Ellison syndrome, multiple endocrine adenomas, and systemic mastocytosis: Initial dose is 60 mg once a day. Doses up to 120 mg given three times a day have been administered. Some patients have been treated continuously for more than 5 years.

Maintenance therapy of healing erosive esophagitis: 20 mg given once daily.

To maintain the healing of erosive esophagitis and gastric ulcers: 20 mg given once daily.

For the treatment of GERD or other acid-related disorders in pediatric patients over the age of 2 years: For patients <20 kg give 10 mg daily. For patients >20kg give 20 mg daily.

As an adjunct in the treatment of H. pylori infection:

Dual Therapy: Omeprazole 40 mg once daily with clarithromycin 500 mg given 3 times a day for 14 days. If an ulcer was present at initiation of treatment, follow with omeprazole 20 mg once a day for 14 days.

Triple Therapy: Omeprazole 20 mg with clarithromycin 500 mg plus amoxicillin 1000 mg given twice daily for 10 days. If an ulcer was present at initiation of therapy, follow with omeprazole 20 mg once a day for 18 days.

Monitor: BMD, Mg

Pharmacology/Pharmacokinetics: Omeprazole is a proton-pump inhibitor (PPI) that suppresses the H+/K+ ATPase enzyme system at the secretory surface of the gastric parietal cell. The enzyme system is involved in the movement and production of gastric acid. Omeprazole is acid-labile and is formulated as enteric-coated granules. Onset after oral administration occurs within 1 hour and reached a maximum at 2 hours. The binding to the (H+/K+)-ATPase results in antisecretory activity that lasts for more than 72 hours.

Drug Interactions: Increases plasma levels of diazepam, phenytoin, and warfarin by inhibiting oxidative metabolism. May also interact with other drugs metabolized via the cytochrome P450 system (cyclosporine, disulfiram, benzodiazepine). Since the pharmacological effect of omeprazole increases gastric pH, absorption of drugs in which bioavailability is determined by gastric pH may be changed. This would include ketoconazole, digoxin, cyanocobalamin, ampicillin esters, and iron salts. Antacids may be used concomitantly. Voriconazole may increase plasma levels. Omeprazole inhibits the metabolism of cilostazol. Omeprazole prevents the conversion of clopidogrel to its active metabolite.

Contraindications/Precautions: Animal studies have shown a dose-related increased risk for gastric carcinoid tumors with long-term use. The levels of drug needed to produce tumors far exceeded the normal daily dose (up to 352 times the human dose). Pregnancy Category C.

Adverse Effects: Side effects are rare but may include back pain, cough, constipation, rash, and dizziness.

Patient Consultation:

Take 30 minutes prior to eating.

Antacids may be taken at the same time.

Store in a cool, dry place away from sunlight and children.

If a dose is missed, take it as soon as possible. If it is closer to the time of your next dose than the dose you missed, skip the missed dose and return to your dosing schedule. Do not double doses.

Contact a physician if the above side effects are severe or persistent.

For patients who have difficulty swallowing capsules, the contents of a capsule can be added to one tablespoon of applesauce, swallowed immediately and followed by a glass of cool water. The contents of the capsule should not be crushed or chewed.

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Testosterone Gel (Topical)

This medication is a Schedule III drug.

Brand Name: Androgel, Fortesta, Testim

Generic Available

Common Dosage Forms*:

Topical 1% Gel Pump (Androgel): Each pump contains 75 g or 60 metered 1.25 g doses containing 12.5 mg testosterone

Topical 1% Gel Foil Packets (Androgel): 2.5 g/packet (25 mg testosterone) or 5 g/packet (50 mg testosterone)

Topical 1.62% Gel (Androgel): Each pump contains 75 g or 60 metered 1.25 g doses containing 20.25 mg testosterone

Topical 2% Gel (Fortesta): Each pump actuation contains 10 mg testosterone

*Testosterone is also available in topical patches, injection, and oral formulations

FDA Indications/Dosages:

For replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone including primary hypogonadism and hypogonadotropic hypogonadism: The recommended starting dose is 50 mg applied once daily (5 g of the 1% gel [4 actuations] or 2.5 g of the 1.62% gel [actuations]). Doses should be applied to the upper arms and shoulders. Maximum recommended dose is 81 mg/day.

Monitor: Hematocrit, Hemoglobin, Serum testosterone, PSA, Lipid panel, LFT

Pharmacology/Pharmacokinetics: Endogenous androgens, including testosterone and dihydrotestosterone (DHT) are the major sex hormones in males and are involved in development of the male sex organs and secondary sex characteristics. Testosterone and DHT binds to certain receptor proteins found in the cytoplasm of sensitive hormone-receptor complex. This hormone-receptor complex enters the nucleus of the cell where it reacts with chromatin, or DNA. The hormone, or possibly the receptor, then uses stored information to stimulate, or in some cases inhibit, the transcription of mRNA. The stimulation of mRNA results in the synthesis of specific enzymes that carry out its actions. Topically applied testosterone gel provides continuous absorption of testosterone for 24 hours.

Drug Interactions: May decrease insulin requirements by decreasing blood glucose, may change anticoagulant activity, may increase fluid retention when used with corticosteroids.

Contraindications/Precautions: Contraindicated in males with carcinoma of the breast or prostate and in women. May increase symptoms of BPH and the risk of prostate cancer. May cause polycythemia; check baseline hematocrit and recheck 3-6 months after starting treatment. Use with caution in patients with congestive heart failure due to increased risk for edema. Use with caution in patients with hyperlipidemia. SECONDARY EXPOSURE TO TESTOSTERONE HAS CAUSED VIRILIZATION IN CHILDREN. Pregnancy Category X.

Adverse Effects: The most common adverse reactions include increased PSA, emotional lability (anger, mood swings, aggression), hypertension, increased hematocrit or hemoglobin, contact dermatitis.

Patient Consultation:

Apply to clean, dry skin once daily.

Decrease the risk of transferring the gel to others by applying to areas of the upper body (upper arms and shoulders) which are covered by a short-sleeve shirt. Do not apply to genital areas.

Wash hands after application.

Allow area to dry before covering with clothes.

Women and children should avoid contact with unwashed or unclothed areas of applications.

Avoid showering or swimming for 2 hours after application.

If a dose is missed, skip it and continue with regular dosing schedule. Do not double doses.

Notify your physician if you trouble starting to urinate or if you experience increased urination at night.

Report to your physician any unusual swelling or pain in the legs, ankles, or feet.

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Bupropion Hydrochloride

Brand Names: Wellbutrin, Forfivo XL, Zyban

Generic Available

Common Dosage Forms:

Tablets, immediate-release: 75 mg, 100 mg.

Tablets, sustained-release (SR): 100 mg, 150 mg, 200 mg.

Tablets, extended-release (XL): 150 mg, 300 mg, 450 mg.

Tablets, sustained-release (Zyban): 150 mg.

FDA Indications/Dosages:

Treatment of depression and for the prevention of seasonal major depressive episodes in patients with seasonal affective disorder: Immediate-release formulation: Start with 100 mg twice a day. Increase dose a maximum of 100 mg/day no sooner than every three days to achieve maximum benefit. Usual adult dose is 100 mg three times a day. Maximum daily dose is 450 mg/day. No single dose should exceed 150 mg. Use the lowest dose possible to achieve desired results. Sustained-release formulation: Give up to 400 mg/day in two divided doses. Target dose is 300 mg/day. Extended-release formulation: 150 to 300 mg given once per day.

As an aid to smoking cessation (Zyban): Start with 150 mg daily for 3 days then increase to 150 mg twice a day.

Pharmacology/Pharmacokinetics: Bupropion is unrelated to tricyclic or tetracyclic antidepressants. It is chemically related to phenylethylamines. Its actions seem to be produced by a dose-related CNS stimulant effect. It is a weak inhibitor of neuronal uptake of norepinephrine and dopamine, and does not inhibit monoamine oxidase. Its effects are thought to be mediated by noradrenergic and/or dopaminergic mechanisms. Peak steady-state plasma levels following BID dosing of sustained-release formulations are 15% lower and trough concentrations are 7% higher than those found after the immediately-release formulation is given TID. Plasma half-life is between 8 to 24 hours. Bupropion is metabolized to inactive and active metabolites by the CYP2B6 isoenzyme system and excreted in the urine and feces. Up to 80% is bound to plasma proteins.

Drug Interactions: Toxicity is increased by monoamine oxidase inhibitors and L-dopa. Alcohol may lower seizure threshold. Drugs which affect the CYP2B6 isoenzyme system (orphenadrine, thiotepa, cyclophosphamide, ticlopidine) may affect bupropion plasma levels. Ritonavir and lopinavir reduce the plasma levels of bupropion. Bupropion is an inhibitor of CYP2D6 therefore it may increase plasma levels of tricyclic antidepressants, paroxetine, fluoxetine, sertraline, haloperidol, risperidone, thioridazine, metoprolol, propafenone, or flecainide.

Contraindications/Precautions: Contraindicated in patients with a seizure disorder, history of bulimia or anorexia nervosa, or with 14 days of therapy with a monoamine oxidase inhibitor. ANTIDEPRESSANTS INCREASE SUICIDAL THOUGHTS AND ACTIONS IN CHILDREN, ADOLESCENTS, AND YOUNG ADULTS. Wellbutrin has been associated with precipitating dose-related seizures. Seizure incidence tenfold between daily doses of 450 mg and 600 mg. May cause various psychomotor disturbances such as mania, psychosis, and hallucinations. Use with caution in patients with impaired liver or kidney function. Pregnancy Category C.

Adverse Effects: Dizziness, constipation, weight loss, dry mouth, insomnia, sweating, agitation, and tremor.

Patient Consultation:

Take immediate-release tablets at regular intervals no sooner than three to four times a day.

Take extended-release tablets in the morning if possible to avoid insomnia.

Swallow SR and XL tablets whole-do not crush or chew.

If a dose is missed, wait until the next scheduled dose - DO NOT DOUBLE DOSES.

Do not take OTC medications without first consulting a physician or pharmacist.

Refrain from consuming alcohol.

Store in a cool, dry place away from sunlight.

Contact a physician if side effects become severe or bothersome or if a seizure occurs.

Weight gain or loss may be temporary-contact your physician if bothersome.

Pay close attention to any changes, especially sudden changes, in mood behaviors, thoughts, or feelings. Antidepressants may increase suicidal thoughts or actions.

Continued therapy of up to 2 weeks may be needed to show noticeable improvement.

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Methylphenidate Hydrochloride

This medication is a Schedule II drug.

Brand Names: Ritalin, Methylin, Metadate, Concerta, Quillichew, Quillivant XR

Generic Available

Common Dosage Forms:

Tablets (Ritalin, Methylin): 5 mg, 10 mg, 20 mg

Tablets, sustained-release (Ritalin SR, Methylin ER, Metadate ER): 10 mg, 20 mg

Capsules, controlled-release (Ritalin LA, Metadate CD): 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg

Tablets, extended-release (Concerta): 18 mg, 27 mg, 36 mg, 54 mg

Tablets, chewable (Methylin): 2.5 mg, 5 mg, 10 mg

Solution (Methylin): 5 mg/5 mL, 10 mg/5 mL

Tablets, extended-release (Quillichew): 20 mg, 30 mg, 40 mg

Suspension, extended-release (Quillivant XR): 25 mg/5 mL after reconstitution

*Not all extended-release forms are AB-rated substitutions.

FDA Indications/Dosages:

For the treatment of attention-deficit disorders in children (>6 years): Initially 5 mg twice a day before breakfast and lunch with gradual increases in increments of 5-10 mg weekly.

For the treatment of narcolepsy in adults: 10-60 mg daily in 2-3 divided doses.

SR tablets can be given in two divided doses.

CD/LA/ER forms can be given once daily in the morning.

Pharmacology/Pharmacokinetics: Methylphenidate presumably activates the brain stem arousal system and cortex to produce its stimulant effect. Peak plasma levels are reached in 2 hours with the tablets and in 5 hours with the SR tablets. Half-life of immediate-release tablets range from 1-3 hours with effects lasting for 4-6 hours. Each bead-filled capsule of the LA formulation provides an immediate release of methylphenidate for rapid onset of action, and a second release of medication approximately 4 hours after administration. The bimodal release formulation of LA capsules provides two peak concentrations of medications.

Drug Interactions: May produce hypertensive crises when used with MONOAMINE OXIDASE INHIBITORS. May increase serum levels of phenytoin, phenobarbital, warfarin, and serotonin-reuptake inhibitors. Serious adverse effects have occurred when used with clonidine.

Contraindications/Precautions: Use is contraindicated in patients with anxiety, tension, agitations, in patients with glaucoma or motor tics, and in patients with a gamily history or diagnosis of Tourette’s syndrome. CNS STIMULANTS HAVE A HIGH POTENTIAL FOR ABUSE. Use is contraindicated in patients currently taking or within 14 days of taking a monoamine oxidase inhibitor. Use with caution in patients with seizures. Stimulants may increase blood pressure and heart rate and caution should be used in patients with hypertension or any other cardiac abnormality. Use with caution in emotionally unstable patients, such as those with a history of drug dependance or alcoholism, and in patients with bipolar disorder. Methylphenidate should not be used in patients under six years of age. Pregnancy Category C.

Adverse Effects: Nervousness, insomnia, anorexia, nausea, dizziness, palpitations, headache, angina, and drowsiness.

Patient Consultation:

Take last dose early in the evening to avoid insomnia.

WARNING: This medication may be habit-forming.

This prescription cannot be refilled.

Store in a cool, dry place away from sunlight and children.

Contact a physician if the above side effects are severe or persistent.

If a dose is missed, skip it and return to normal dosing schedule.

LA capsules may be swallowed whole, or the contents sprinkled over soft food and ingested without chewing.

Swallow extended-release tablets whole, do not break, chew, or crush.

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Duloxetine Hydrochloride

Brand Name: Cymbalta

Generic Available

Dosage Forms:

Capsules: 20 mg, 30 mg, 60 mg

FDA Indications/Dosages:

For the treatment of major depressive disorder (MDD): The normal total daily dose is 40-60 mg. A 40 mg daily dose should be given as 20 mg twice a day. A 60 mg daily dose may be given as 30 mg twice a day or 60 mg once a day.

For the management of neuropathic pain associated with diabetic peripheral neuropathy: 60 mg per day.

For the treatment of generalized anxiety disorder (GAD): Start with 30 mg daily for 1 week and then increase to 60 mg daily. Maximum daily dose is 120 mg.

For the management of chronic musculoskeletal pain: Start with 30 mg daily for 1 week then increase to 60 mg daily.

If the choice to discontinue duloxetine is made, a gradual reduction of dose rather than abrupt cessation is recommended. At least 14 days should elapse between discontinuation of a monoamine oxidase inhibitor and initiation of duloxetine. At least 5 days should elapse before starting an MOAI after discontinuing duloxetine.

Pharmacology/Pharmacokinetics: Duloxetine is a potent inhibitor of neuronal serotonin and norepinephrine reuptake and a slight inhibitor of dopamine reuptake. Its mechanism of action is thought to be due to a potentiation of serotonergic and noradrenergic activity in the CNS. Duloxetine is well absorbed orally with peak plasma concentrations reached in 6 hours. Food slightly delays the time to peak plasma levels and decreases amount absorbed by 10%. Evening doses delay absorption by 3 hours and increase apparent clearance of duloxetine by 30%. Metabolism occurs via many pathways, including hepatic isoenzymes CYP2D6 and CYP1A2. Elimination half-life is approximately 12 hours and steady-state levels are reached in 3 days.

Drug Interactions: Serious and sometimes fatal reactions have occurred in patients taking a serotonin reuptake inhibitor with MONOAMINE OXIDASE INHIBITORS. Potents inhibitors of CYP1A2 (fluvoxamine, quinolones) and CYP2D6 (paroxetine, fluoxetine, quinidine) will increase plasma levels of duloxetine. Plasma levels of drugs metabolized by CYP2D6 (tricyclic antidepressants, phenothiazines, propafenone, and flecainide) may be increased when used with duloxetine.

Contraindications/Precautions: ANTIDEPRESSANTS INCREASE SUICIDAL THOUGHTS AND ACTIONS IN CHILDREN, ADOLESCENTS, AND YOUNG ADULTS. Use is contraindicated in patients taking monoamine oxidase inhibitors and in patients with uncontrolled narrow-angle glaucoma. Patients being treated with antidepressants should be observed closely for clinically worsening and suicidality, especially at the beginning of therapy, or at the time of dose changes. Use with caution in patients with impaired hepatic function and in patients with heavy alcohol use. Duloxetine may increase blood pressure and active mania/hypomania in some individuals; use appropriate precautions. Use with caution in patients with a history of seizures or controlled narrow-angle glaucoma. Do not use late into the third trimester. Nursing is not recommended while on duloxetine. Pregnancy Category C.

Adverse Effects: Adverse effects occurring in more than 2% of the population include nausea (20%), dry mouth (15%), constipation (11%), insomnia (11%), dizziness (9%), diarrhea (8%), decreased appetite (8%), fatigue (8%), drowsiness (7%), sweating (6%), vomiting (5%), blurred vision (4%), and erectile dysfunction (4%).

Patient Consultation:

Therapeutic effects may take as long as 4 weeks to appear.

May cause drowsiness. Use caution while operating machinery or when mental alertness is required.

Avoid alcohol while taking this medication.

Consult your physician or pharmacist before taking nonprescription medications.

Do not abruptly discontinue medication.

Store in a cool, dry place away from sunlight and children.

Contact a physician if the above side effects are severe or persistent.

If a dose is missed, skip it and return to normal dosing schedule.

Pay close attention to any changes, especially sudden changes, in mood behaviors, thoughts, or feelings. Antidepressants may increase suicidal thoughts or feelings.

Continued therapy of up to 2 weeks may be needed to show noticeable improvement.

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Desvenlafaxine

Brand Name: Pristiq

Generic Available

Common Dosage Forms:

Tablets, extended-release: 25 mg (38 mg desvenlafaxine succinate), 50 mg (76 mg desvenlafaxine succinate), 100 mg (152 mg desvenlafaxine succinate).

FDA Indications/Dosages:

For the treatment of major depressive disorder (MDD): The recommended dose is 50 mg once daily, with or without food. Doses of up to 400 mg per day can be effective although with higher incidences of adverse effects and no more effectiveness than 50 mg.

Dosing in patients with severe renal impairment (24-hr CrCL <30 mL/min): Give 50 mg every other day.

A gradual reduction of dose rather than abrupt cessation is recommended when discontinuing desvenlafaxine.

Monitor: BP, IOP, Na.

Pharmacology/Pharmacokinetics: Non-clinical studies have shown that desvenlafaxine is a potent inhibitor of neuronal serotonin and norepinephrine reuptake. Desvenlafaxine is well absorbed (~80%) with about 45% excreted in the urine as unchanged drug 72 hours after an oral dose. The remaining drug is metabolized primarily by conjugation and to a minor extent, through oxidative metabolism (CYP3A4). Peak plasma levels are reached in about 7.5 hours. Mean terminal half-life is approximately 11 hours. Once-daily dosing produces steady-state levels after 4 or 5 days of therapy.

Drug Interactions: Combination with MAO inhibitors may produce serious and fatal reactions. Allow 14 days to pass between the use of a MAO inhibitor and desvenlafaxine. The use of other CNS active drugs, including antihistamines, should be approached with caution. Coadministration with aspirin or an NSAID may increase the risk of upper GI bleeding. Use with caution in combination with other serotonergic drugs due to the possibility of serotonin syndrome.

Contraindications/Precautions: ANTIDEPRESSANTS INCREASE SUICIDAL THOUGHTS AND ACTIONS IN CHILDREN, ADOLESCENTS, AND YOUNG ADULTS. It is recommended that desvenlafaxine not be used in combination with an MAOI, or within 14 days of discontinuing treatment with an MAOI. At least 1 week should be allowed after stopping desvenlafaxine before starting an MAOI. Use with caution in patients with preexisting hypertension. For patients who experience a sustained increase in blood pressure while receiving desvenlafaxine, either dose reduction or discontinuation should be considered. As with all antidepressants, caution should be used in patients with a history of mania. Use cautiously in patients with a history of seizures. Not indicated for use in pediatric patients. Pregnancy Category C.

Adverse Effects: The most common adverse effects include nausea, dry mouth, anorexia, constipation, drowsiness, insomnia, dizziness, sweating, erectile disfunction, and decreased libido.

Patient Consultation:

Pay close attention to any changes, especially sudden changes, in mood behaviors, thoughts, or feelings. Antidepressants may increase suicidal thoughts or actions.

Continued therapy of up to 2 weeks may be needed to show noticeable improvement.

Avoid alcohol while taking this medication.

Swallow tablets whole; do not crush, chew, dissolve, or divide.

Patients should be advised to inform their physician or pharmacist if they are taking, or plan to take, any prescription or over-the-counter drugs, since there is a potential for interactions.

Do not abruptly stop therapy before consulting with a physician.

Contact a physician if the above side effects are severe or persistent.

If a dose is missed, take it as soon as you remember. If it is close to the time of your next dose, skip the missed dose and return to your normal dosing schedule. Do not double doses.

The matrix tablet shell may be found intact in the stool.

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Sertraline Hydrochloride

Brand Name: Zoloft

Generic Available

Common Dosage Forms:

Tablets: 25 mg, 50 mg, 100 mg

Oral Concentrate: 20 mg/mL (12% alcohol)

FDA Indications/Dosages:

Treatment of depression* and obsessive-compulsive disorder (OCD): Start with 50 mg once daily. Increase dosage as needed no sooner than weekly up to a maximum of 200 mg/day. Treatment for up to 16 weeks has shown as improvement in depressive states. Success in treatment for periods longer than 16 weeks is unknown.

Treatment of panic disorder, with or without agoraphobia and post-traumatic stress disorder (PTSD): Start with 25 mg once daily. Increase dosage as needed no sooner than weekly up to a maximum of 200 mg/day.

Treatment of premenstrual dysphoric disorder: Start with 50 mg/day, either daily throughout the menstrual cycle or limited to the luteal phase of the menstrual cycle. Changes in dose should be made at the start of the menstrual cycle up to a maximum of 150 mg/day.

Treatment of social anxiety disorder: Start with 25 mg once daily. After one week, the dose should be increase to 50 mg once daily.

*Depression is characterized by a depressed or dysphoric mood that lasts almost daily for an extended time (>2 weeks). 4 out of 8 of the following symptoms should be present to accurately diagnose the episode as depression: change in appetite, change in sleep patterns, psychomotor agitation, loss of interest in usual activities, increased fatigue, feelings of guilt or worthlessness, impaired concentration, and a suicide attempt or suicidal ideation.

Pharmacology/Pharmacokinetics: Sertraline is chemically unrelated to tricyclic or tetracyclic antidepressants. Its mechanism of action is thought to be due to its inhibition of CNS neuronal uptake of serotonin (5HT). It has very week actions on norepinephrine and dopamine neuronal reuptake. It has no significant affinity for adrenergic, cholinergic, GABA, dopaminergic, histaminergic, benzodiazepine, or serotonergic receptors. Terminal elimination half-life is 26 hours. Sertraline undergoes extensive first-pass metabolism (N-demethylation) to form a less active metabolite. Excretion occurs both through the urine and through feces. Sertraline is highly bound to plasma proteins (98%) and is a substrate for P450 hepatic isoenzyme CYP3A3/4.

Drug Interactions: Use in combination (within 14 days) with MONOAMINE OXIDASE INHIBITORS (MAOI) may cause serious or even fatal reactions. May increase PIMOZIDE levels. May be displaced by or displace other highly protein-bound drugs (warfarin, digitoxin). May decrease clearance of diazepam and tolbutamide. Variable effects may occur when used with other CYP3A3/4 substrates. Coadministration with aspirin or an NSAID may increase the risk of upper GI bleeding.

Contraindications/Precautions: Do not use pimozide or within 14 days of therapy with an MAOI. ANTIDEPRESSANTS INCREASE SUICIDAL THOUGHTS AND ACTIONS IN CHILDREN, ADOLESCENTS, AND YOUNG ADULTS. Suicide attempts are possible in depression and may continue until significant remission occurs. Only the smallest quantity possible should be dispensed. Use with caution in patients with renal or hepatic dysfunction. Although drowsiness is not a major adverse effect, patients should be careful when performing tasks which require alertness. Abrupt discontinuation of therapy may cause adverse effects including dysphoric mood, irritability, agitation, dizziness, anxiety, confusion, insomnia, and headache. Pregnancy Category B.

Adverse Effects: Nausea, diarrhea, dyspepsia, tremor, dizziness, insomnia, sweating, dry mouth, or male sexual dysfunction (ejaculatory delay).

Patient Consultation:

Continued therapy may be needed to show noticeable improvement. Do not stop therapy before consulting with a physician.

Sertraline oral concentrate must be diluted prior to use. Place the proper dose in 4 oz. of water, ginger ale, lemon/lime soda, lemonade, or orange juice ONLY. Do not mix in any other beverage. Take immediately after mixing. Do not premix doses.

Avoid alcohol while taking this medication.

Use caution when performing tasks that require mental alertness.

Consult with your physician or pharmacist before taking nonprescription medications.

Do not abruptly discontinue medication.

Store in a cool, dry place away from sunlight and children.

Contact a physician if the above side effects are severe or persistent.

If a dose is missed, skip it and return to normal dosing schedule.

Pay close attention to any changes, especially sudden changes, in mood behaviors, thoughts, or feelings. Antidepressants may increase suicidal thoughts and actions.