Aventyl


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nitrofurantoin macrocrystals

Macrobid, MacrodantinMinitran, Nitrek, Nitro-Dur, Nitroject, Nitrolingual, Nitromist, Nitronal (UK), Nitroquick, NitrostatNipride, NitropressApo-Nizatidine, Axid, Axid AR, Dom-Nizatidine, Gen-Nizatidine, Novo-Nizatidine, PHL-Nizatidine, PMS-Nizatidine, Zinga (UK)Evra (UK), Ortho EvraLevophed, Noradrenaline (UK)Aygestin, Camila, Errin, Jolivette, Nora-BE, Nor-QD, Ortho MicronorNoroxin, Utinor (UK)Allegron (UK), Apo-Nortriptyline, Aventyl, Dom-Nortriptyline, Gen-Nortriptyline, Novo-Nortriptyline, Norventyl, Nu-Nortriptyline, Pamelor, PMS-Nortriptyline, Ratio-NortriptylineBio-Statin, Candistatin, Dom-Nystatin, Mycostatin, Nadostine, Nilstat, Nyaderm, Nystan (UK), Nystop, Pedi-Dri, PMS-Nystatin, Ratio-Nystatin

Pharmacologic class: 5-nitrofuran derivative

Therapeutic class: Anti-infective, urinary tract anti-infective

Pregnancy risk category B

Pharmacologic class: Nitrate

Therapeutic class: Antianginal

Pregnancy risk category C

Pharmacologic class: Vasodilator

Therapeutic class: Antihypertensive

Pregnancy risk category C

Pharmacologic class: Histamine2 (H2)-receptor antagonist

Therapeutic class: Antiulcer drug

Pregnancy risk category B

Pharmacologic class: Estrogen

Therapeutic class: Hormone

Pregnancy risk category X

Pharmacologic class: Sympathomimetic

Therapeutic class: Alpha- and beta-adrenergic agonist, cardiac stimulant, vasopressor

Pregnancy risk category C

Pharmacologic class: Progesterone, hormone

Therapeutic class: Progestin

Pregnancy risk category X

Pharmacologic class: Fluoroquinolone

Therapeutic class: Anti-infective

Pregnancy risk category C

Pharmacologic class: Tricyclic compound

Therapeutic class: Antidepressant

Pregnancy risk category D

Pharmacologic class: Antifungal

Therapeutic class: Anti-infective

Pregnancy risk category A

FDA Box Warning

After reconstitution with appropriate diluent, drug isn't suitable for direct injection. Dilute reconstituted solution further in sterile 5% dextrose injection before infusing.

Drug may cause steep blood pressure decrease. In patients not properly monitored, this decrease can lead to irreversible ischemic injury or death. Give drug only when available equipment and personnel allow continuous blood pressure monitoring.

Except when used briefly or at low infusion rates, drug gives rise to significant amount of cyanide ion, which can reach toxic, potentially lethal levels. Infusion at maximum dosage rate should never last more than 10 minutes. If blood pressure isn't adequately controlled after 10 minutes of maximum-rate infusion, end infusion immediately. Monitor acid-base balance and venous oxygen concentration, but be aware that, although these tests may indicate cyanide toxicity, they provide imperfect guidance.

• Review these warnings thoroughly before giving drug.

Action

Inhibits bacterial enzymes required for normal cell activity at low concentrations; inhibits normal cell-wall synthesis at high concentrations

Availability

Capsules: 25 mg, 50 mg, 100 mg (macrocrystals)

Capsules (extended-release): 100 mg (macrocrystals)

Oral suspension: 25 mg/5 ml

Tablets: 50 mg, 100 mg (macrocrystals)

Indications and dosages

Active urinary tract infections (UTIs)

Adults: 50 to 100 mg P.O. q.i.d. or 100 mg q 12 hours (extended-release), continued for 1 week, or for 3 days after urine becomes sterile

Children older than 1 month: 5 to 7 mg/kg/day P.O. in four divided doses, continued for 1 week, or for 3 days after urine becomes sterile

Chronic suppression of UTIs

Adults: 50 to 100 mg P.O. at bedtime

Children: 1 mg/kg/day P.O. in one or two divided doses

Contraindications

• Hypersensitivity to drug or parabens (oral suspension)
• Oliguria, anuria, or significant renal impairment
• Pregnancy near term (38 to 42 weeks' gestation), imminent labor onset, labor and delivery
• Infants younger than 1 month

Precautions

Use cautiously in:
• diabetes mellitus, renal impairment
• blacks and patients of Mediterranean or near-Eastern descent (because of possible G6PD deficiency)
• elderly or debilitated patients
• pregnant (to week 32) or breastfeeding patients.

Administration

• As appropriate, obtain specimens for repeat urine culture and sensitivity tests before therapy.
• To avoid GI upset and increase drug bioavailability, give with food or milk.

Adverse reactions

CNS: dizziness, drowsiness, headache, asthenia, peripheral neuropathy, vertigo

CV: chest pain

EENT: nystagmus

GI: nausea, vomiting, diarrhea, abdominal pain, anorexia, parotitis, pancreatitis

Hematologic: eosinophilia, agranulocytosis, thrombocytopenia, leukopenia, granulocytopenia, G6PD deficiency anemia, hemolytic anemia, megaloblastic anemia

Hepatic: hepatitis, hepatic necrosis

Musculoskeletal: arthralgia, myalgia

Respiratory: asthma attacks, pulmonary hypersensitivity reactions including diffuse interstitial pneumonias (with prolonged therapy)

Skin: rash, exfoliative dermatitis, alopecia, pruritus, urticaria, angioedema, photosensitivity, Stevens-Johnson syndrome

Other: drug fever, chills, superinfection (limited to urinary tract), hypersensitivity reactions including anaphylaxis, lupus-like syndrome

Interactions

Drug-drug.Anticholinergics: increased nitrofurantoin absorption and bioavailability

Drugs that can cause pulmonary toxicity: increased risk of pneumonitis

Hepatotoxic drugs: increased risk of hepatotoxicity

Magnesium salts: decreased nitrofurantoin absorption

Neurotoxic drugs: increased risk of neu-rotoxicity

Uricosurics (such as probenecid): decreased renal clearance and increased blood level of nitrofurantoin

Drug-diagnostic tests.Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, bilirubin, blood urea nitrogen, creatinine: increased levels Granulocytes, platelets, hemoglobin: decreased levels

Urine glucose tests using Benedict's reagent or Fehling's solution: false-positive results

Drug-food.Any food: increased drug bioavailability

Patient monitoring

• Monitor patient's response to therapy. Assess urine culture and sensitivity tests.

Watch for and immediately report peripheral neuropathy.

Assess respiratory status. Watch for signs and symptoms of serious pulmonary hypersensitivity reaction.

Monitor CBC and liver function tests closely. Stay alert for evidence of hematologic and hepatic disorders.
• Evaluate patient for rash.

Patient teaching

• Instruct patient to take with food or milk at regular intervals around the clock.
• Advise patient to complete entire course of therapy.
• Tell patient not to take magnesium-containing drugs (such as antacids) during therapy.
• Caution patient not to drive or perform other hazardous activities until he knows how drug affects vision, concentration, and alertness.

Tell patient to immediately report fever, chills, cough, chest pain, difficulty breathing, rash, bleeding or easy bruising, dark urine, yellowing of skin or eyes, numbness or tingling of fingers or toes, or intolerable GI distress.
• Advise female patient to avoid taking drug during pregnancy, especially near term.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and foods mentioned above.


nitroglycerin

Minitran, Nitrek, Nitro-Dur, Nitroject, Nitrolingual, Nitromist, Nitronal (UK), Nitroquick, Nitrostat


Pharmacologic class: Nitrate

Therapeutic class: Antianginal

Pregnancy risk category C

 

Action

Inhibits calcium transport into myocardial and vascular smooth muscle cells, suppressing contractions. Dilates main coronary arteries and arterioles, inhibits coronary artery spasm, increases oxygen delivery to heart, and reduces frequency and severity of angina attacks.

Availability

Capsules (extended-release): 2.5 mg, 6.5 mg, 9 mg

Injection: 0.5 mg/ml, 5 mg/ml

Ointment (transdermal): 2%

Solution for injection: 25 mg/250 ml, 50 mg/250 ml, 50 mg/500 ml, 100 mg/250 ml, 200 mg/500 ml

Spray (translingual): 0.4 mg/spray in 14.5-g canister (200 doses)

Tablets (buccal, extended-release): 1 mg, 2 mg, 3 mg, 5 mg

Tablets (extended-release): 2.6 mg, 6.5 mg, 9 mg

Tablets (sublingual): 0.3 mg, 0.4 mg, 0.6 mg

Transdermal system (patch): 0.1 mg/hour, 0.2 mg/hour, 0.3 mg/hour, 0.4 mg/hour, 0.6 mg/hour, 0.8 mg/hour

Indications and dosages

Management and prophylaxis of angina pectoris

Adults: For acute angina attack, 0.3 to 0.6 mg S.L., repeated q 5 minutes for 15 minutes p.r.n.; or one to two trans-lingual sprays, repeated q 5 minutes for 15 minutes p.r.n. For long-term or prophylactic use, 1-mg extended-release buccal tablet q 5 hours, with dosage and frequency increased p.r.n.; or 2.5 to 9 mg (extended-release tablets) P.O. q 8 to 12 hours; or 1.3 to 6.5 mg (extended-release capsules) P.O. q 8 to 12 hours.

Hypertension during surgery; adjunct in heart failure

Adults: 5 mcg/minute I.V., increased by 5 mcg/minute q 3 to 5 minutes up to 20 mcg/minute, then increased by 10 to 20 mcg/minute q 3 to 5 minutes (dosage based on hemodynamic parameters)

Heart failure associated with acute myocardial infarction (MI)

Adults: 12.5 to 25 mcg I.V., then a continuous infusion of 10 to 20 mcg/minute q 5 to 10 minutes; increase by 5 to 10 mcg/minute q 5 to 10 minutes as needed to a maximum of 200 mcg/minute.

Contraindications

• Hypersensitivity to drug, other organic nitrates, nitrites, or adhesives (transdermal form)
• Angle-closure glaucoma
• Orthostatic hypotension
• Hypotension or uncorrected hypovolemia (I.V. form)
• Early MI (S.L. form)
• Increased intracranial pressure (as from head trauma or cerebral hemorrhage)
• Severe anemia
• Pericardial tamponade or constrictive pericarditis
• Concurrent sildenafil therapy

Precautions

Use cautiously in:
• severe renal or hepatic impairment, glaucoma, hypertrophic cardiomyopathy
• hypovolemia, normal or decreased pulmonary capillary wedge pressure (with I.V. use)
• alcohol intolerance (with large I.V. doses)
• pregnant or breastfeeding patients
• children (safety not established).

Administration

• Administer tablets and capsules with water. Don't crush, break, or let patient chew them.
• For S.L. use, administer under tongue or in buccal pouch; instruct patient not to swallow tablet. For acute angina, give at pain onset. For angina prophylaxis, give before activities that may cause anginal pain.
• For translingual use, spray directly onto oral mucosa. Don't let patient inhale spray. Give at pain onset and as needed prophylactically before activities that trigger angina.
• For transdermal use, apply system to skin site with little hair and movement. Don't apply to distal extremities. Rotate application sites to avoid irritation and sensitization.
• Apply transdermal ointment to skin by spreading prescribed amount over 6″ × 6″ area (using an applicator, not your fingers). Cover area with plastic wrap and tape. Rotate sites to reduce risk of irritation and inflammation.

Know that solution for injection is a concentrate. Dilute with dextrose 5% in water or normal saline solution before giving by I.V. infusion.

Don't mix solution for injection with other drugs, and don't give by direct I.V. injection.
• Be aware that solution for injection is affected by type of infusion set used and that dosage is based on use of conventional PVC tubing. When using nonabsorbent tubing, reduce dosage.
• For I.V. use, administer with infusion pump. Increase dosage in increments of 5 mcg/minute every 3 to 5 minutes p.r.n. to achieve desired blood pressure response. Once achieved, reduce dosage and lengthen dosage adjustment intervals.

Don't give concurrently with sildenafil (may cause life-threatening hypotension).

Adverse reactions

CNS: dizziness, headache

CV: hypotension, syncope

Hematologic: methemoglobinemia

Skin: contact dermatitis (with transdermal or ointment use), rash, exfoliative dermatitis, flushing

Interactions

Drug-drug.Antihypertensives, beta-adrenergic blockers, calcium channel blockers, haloperidol, phenothiazines: additive hypotension

Drugs with anticholinergic properties (antihistamines, phenothiazines, tri-cyclic antidepressants): decreased absorption of lingual, S.L., or buccal nitroglycerin

Sildenafil: increased risk of potentially fatal hypotension

Drug-diagnostic tests.Cholesterol: false elevation

Methemoglobin: significant levels (with excessive doses)

Urine catecholamines, urine vanillyl-mandelic acid: increased levels

Drug-behaviors.Alcohol use, acute alcohol ingestion: increased risk of potentially fatal hypotension

Patient monitoring

With I.V. use, monitor blood pressure frequently. Titrate dosage to obtain desired results.
• With transdermal use, check for rash or skin irritation.
• Monitor patient for angina relief.

Patient teaching

• Instruct patient to place S.L. tablet directly under tongue and hold it there as it dissolves. Caution him not to chew or swallow tablet.
• Tell patient to use drug before physical activities that may cause angina.
• Instruct patient to take drug at pain onset and repeat every 5 minutes for three doses. If pain doesn't subside, advise him to seek medical attention.
• Tell patient not to chew or crush sustained-release tablets.
• Advise patient to apply correct amount of ointment using applicator. Caution him to avoid rubbing site. Instruct him to cover ointment with plastic wrap and tape it, to wash hands after placement, and to rotate sites.
• Advise patient to consult prescriber or pharmacist before changing brands of transdermal system. Different brands may have different drug concentrations.
• As appropriate, review all significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and behaviors mentioned above.


nitroprusside sodium

Nipride, Nitropress


Pharmacologic class: Vasodilator

Therapeutic class: Antihypertensive

Pregnancy risk category C

 

FDABOXED WARNING

After reconstitution with appropriate diluent, drug isn't suitable for direct injection. Dilute reconstituted solution further in sterile 5% dextrose injection before infusing.

Drug may cause steep blood pressure decrease. In patients not properly monitored, this decrease can lead to irreversible ischemic injury or death. Give drug only when available equipment and personnel allow continuous blood pressure monitoring.

Except when used briefly or at low infusion rates, drug gives rise to significant amount of cyanide ion, which can reach toxic, potentially lethal levels. Infusion at maximum dosage rate should never last more than 10 minutes. If blood pressure isn't adequately controlled after 10 minutes of maximum-rate infusion, end infusion immediately. Monitor acid-base balance and venous oxygen concentration, but be aware that, although these tests may indicate cyanide toxicity, they provide imperfect guidance.
• Review these warnings thoroughly before giving drug.

Action

Interferes with calcium influx and intracellular activation of calcium, causing peripheral vasodilation and direct blood pressure decrease

Availability

Injection: 50 mg/vial in 2 ml- and 5-ml vials

Indications and dosages

Hypertensive emergencies; controlled hypotension during anesthesia

Adults and children: 0.3 to 10 mcg/kg/minute I.V., titrated to response

Dosage adjustment

• Hepatic insufficiency
• Renal impairment
• Elderly patients

Contraindications

• Hypertension caused by aortic coarctation or atrioventricular shunting
• Acute heart failure caused by reduced peripheral vascular resistance
• Congenital (Leber's) optic atrophy, tobacco amblyopia
• Inadequate cerebral circulation
• Moribund patients

Precautions

Use cautiously in:
• hepatic or renal disease, fluid and electrolyte imbalances, hypothyroidism
• elderly patients
• pregnant or breastfeeding patients
• children.

Administration

Be aware that nitroprusside is a high-alert drug.

Give only in settings with trained personnel and continuous blood pressure monitoring equipment.
• Dilute 50 mg in 2 to 3 ml of dextrose 5% in water (D5W); then dilute in 250 to 1,000 ml of D5W.
• Administer with microdrip regulator, infusion pump, or other device that allows precise flow rate measurement.
• Wrap infusion solution in aluminum foil or other opaque material to protect it from light.

Adverse reactions

CNS: increased intracranial pressure

CV: ECG changes, bradycardia, tachycardia, marked hypotension

GI: ileus

Hematologic: decreased platelet aggregation, methemoglobinemia

Metabolic: hypothyroidism

Skin: rash, flushing

Other: pain, irritation, and venous streaking at injection site; too-rapid blood pressure decrease (causing apprehension, restlessness, palpitations, retrosternal discomfort, nausea, retching, abdominal pain, diaphoresis, headache, dizziness, muscle twitching); thiocynate or cyanide toxicity (initially, tinnitus, miosis, and hyper-reflexia) at blood level of 60 mg/L; severe cyanide toxicity (air hunger, confusion, lactic acidosis, death) at level of 200 mg/L

Interactions

Drug-drug.Enflurane, ganglionic blockers, halothane, negative inotropic drugs, volatile liquid anesthetics: severe hypotension

Drug-diagnostic tests.Creatinine: increased level

Methemoglobin: hemoglobin sequestration as methemoglobin

Patient monitoring

Measure blood pressure frequently (preferably with continuous arterial line) to detect rapid drop.
• Monitor injection site closely to avoid extravasation. Use central line whenever possible. Ensure that infusion rate is precisely controlled to prevent too-rapid infusion.
• Obtain baseline ECG and monitor for changes.

Watch for signs and symptoms of cyanide toxicity (lactic acidosis, dyspnea, headache, vomiting, confusion, and loss of consciousness).

Patient teaching

• Tell patient he'll be closely monitored during therapy.

Instruct patient to immediately report headache, nausea, or pain at injection site.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.


nizatidine

Apo-Nizatidine, Axid, Axid AR, Dom-Nizatidine, Gen-Nizatidine, Novo-Nizatidine, PHL-Nizatidine, PMS-Nizatidine, Zinga (UK)


Pharmacologic class: Histamine2 (H2)-receptor antagonist

Therapeutic class: Antiulcer drug

Pregnancy risk category B

 

Action

Inhibits histamine action at H2-receptor sites in gastric parietal cells, reducing gastric acid secretion and pepsin production

Availability

Capsules: 150 mg, 300 mg

Oral solution: 15 mg/ml

Tablets: 75 mg

Indications and dosages

Active duodenal ulcer Adults: 300 mg P.O. daily at bedtime or 150 mg b.i.d. for up to 8 weeks

Maintenance of healed duodenal ulcers

Adults and children ages 12 and older: 150 mg P.O. daily at bedtime for up to 1 year

Esophagitis and associated heartburn caused by gastroesophageal reflux disease (GERD)

Adults: 150 mg P.O. b.i.d. for up to 12 weeks

Active benign gastric ulcer Adults: 150 mg P.O. b.i.d. or 300 mg P.O. once daily at bedtime

Erosive esophagitis; GERD

Children ages 12 and older: 150 mg P.O. b.i.d. for up to 8 weeks

Dosage adjustment

• Moderate to severe renal impairment
• Elderly patients

Contraindications

• Hypersensitivity to drug or other H2-receptor antagonists

Precautions

Use cautiously in:
• mild renal impairment
• elderly patients
• pregnant or breastfeeding patients
• children younger than age 12 (safety and efficacy not established).

Administration

• Give with or without food.
• If patient is to take drug twice daily, give one dose in morning and one at bedtime.

Adverse reactions

CNS: dizziness, drowsiness, headache, anxiety, nervousness, insomnia, abnormal dreams, asthenia

CV: chest pain

EENT: amblyopia, sinusitis, rhinitis, pharyngitis

GI: nausea, vomiting, diarrhea, constipation, dyspepsia, abdominal pain, flatulence, anorexia, dry mouth

Hematologic: anemia

Musculoskeletal: back pain, myalgia

Respiratory: cough

Skin: rash, pruritus

Other: tooth disorder, infection, fever, pain

Interactions

Drug-drug.Salicylates (high doses): increased salicylate blood level

Drug-diagnostic tests.Alanine amino-transferase, alkaline phosphatase, aspartate aminotransferase: elevated levels

Urobilinogen tests using Multistix: false-positive result

Drug-herbs.Pennyroyal: altered rate of herbal metabolite formation

Patient monitoring

• Monitor liver and renal function tests.
• Check temperature; watch for fever and other signs and symptoms of infection.

Patient teaching

• Advise patient to take once-daily dose at bedtime with or without food, or twice-daily doses in morning and at bedtime.
• Instruct patient to take exactly as prescribed. Caution him not to take other OTC drugs (especially aspirin).
• Tell patient to report signs and symptoms of infection.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.
• As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs, tests, and herbs mentioned above.


norelgestromin/ethinyl estradiol

Evra (UK), Ortho Evra


Pharmacologic class: Estrogen

Therapeutic class: Hormone

Pregnancy risk category X

 

FDABOXED WARNING

Cigarette smoking increases risk of serious cardiovascular adverse effects from hormonal contraceptive use. Risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women older than age 35. Strongly advise women who use hormonal contraceptives not to smoke.

Risk of venous thromboembolism (VTE) among women ages 15 to 44 who used the transdermal patch compared to women who used oral contraceptives containing 30 to 35 mcg of ethinyl estradiol (EE) and either levonorgestrel or norgestimate was assessed in four U.S. case-control studies using electronic health care claims data. Odds ratios ranged from 1.2 to 2.2; one of the studies found a statistically significant increased risk of VTE for current patch users.

The pharmacokinetic (PK) profile for the transdermal patch is different from the PK profile for oral contraceptives in that it has higher steady state concentrations and lower peak concentrations. Area under the time-concentration curve and average concentration at steady state for EE are approximately 60% higher in women using the patch compared with women using an oral contraceptive containing 35 mcg of EE. In contrast, peak concentrations for EE are approximately 25% lower in women using the patch. It's unknown whether there are changes in risk of serious adverse events based on the differences in PK profiles of EE in women using the patch compared with women using oral contraceptives containing 30 to 35 mcg of EE. Increased estrogen exposure may increase risk of adverse events, including VTE.

Action

Suppresses gonadotropin and inhibits ovulation by causing changes in cervical mucus and endometrium, thereby preventing egg implantation

Availability

Transdermal patch: 6 mg norelgestro-min and 0.75 mg ethinyl estradiol (releases 150 mcg norelgestromin and 20 mcg ethinyl estradiol q 24 hours)

Indications and dosages

To prevent pregnancy

Adults: Apply patch on day 1 of menstrual cycle (or first Sunday after period begins). Change patch weekly thereafter for 3 weeks (on same day each week), and then remove patch for fourth week. Repeat q month.

Contraindications

• Hypersensitivity to drug or its components
• Undiagnosed abnormal genital bleeding
• Known or suspected breast cancer or history of such cancer
• Endometrial carcinoma or other known or suspected estrogen-dependent neoplasia
• Thromboembolism, history of thromboembolic disease, known thrombophilic conditions
• Current or past cerebrovascular or coronary artery disease
• Valvular heart disease with complications
• Diabetes with vascular involvement
• Persistent blood pressure values at or above 160 mm Hg systolic or 100 mm Hg diastolic
• Headache with focal neurologic symptoms
• Cholestatic jaundice of pregnancy, jaundice with previous hormonal contraceptive use
• Acute or chronic hepatic disease with abnormal liver function
• Hepatic adenomas or carcinomas
• Major surgery with prolonged immobilization
• Known or suspected pregnancy

Precautions

Use cautiously in:
• cardiovascular disease, renal disease, asthma, bone disease, migraine, lipid disorders, fibrocystic breasts, increased risk for endometrial cancer, sexually transmitted diseases
• family history of breast or genital tract cancer
• abnormal mammogram
• elderly patients (use not indicated)
• women with body weight at or abovel98 lb (90 kg)
• breastfeeding patients
• children before menarche (use not indicated).

Administration

• Apply patch to clean, dry, intact skin on buttock, abdomen, upper torso, or upper outer arm.
• Change patch on same day each week (except for fourth week, when patch is removed).

Adverse reactions

CNS: headache, dizziness, lethargy, depression, emotional lability, increased risk of cerebrovascular accident

CV: edema, hypertension, myocardial infarction, thromboembolism

EENT: contact lens intolerance, worsening of myopia or astigmatism

GI: nausea, vomiting, jaundice, abdominal cramps, bloating, anorexia, gallbladder disease, pancreatitis

GU: amenorrhea, dysmenorrhea, breakthrough bleeding, cervical erosion, vaginal candidiasis, breast tenderness, breast enlargement or secretion, menstrual cramps, libido loss, increased risk of breast or endometrial cancer

Hepatic: cholestatic jaundice, hepatic adenoma

Metabolic: hyperglycemia, hypercal-cemia, sodium and water retention

Musculoskeletal: leg cramps

Respiratory: upper respiratory infection, pulmonary embolism

Skin: acne, oily skin, increased pigmentation, urticaria, patch site reaction

Other: increased appetite, weight changes

Interactions

Drug-drug.Acetaminophen, ascorbic acid, atorvastatin, miconazole (vaginal capsules): increased ethinyl estradiol blood level

Antibiotics, barbiturates, carbamazepine, fosphenytoin, phenobarbital, phenytoin, rifampin: decreased contraceptive efficacy

Corticosteroids: enhanced corticosteroid effects

Cyclosporine: increased risk of cyclosporine toxicity

CYP3A4 inhibitors (such as ketocona-zole, itraconazole): increased hormone level

Dantrolene, other hepatotoxic drugs: increased risk of hepatotoxicity

Insulin, oral hypoglycemics, warfarin: altered requirements for these drugs Protease inhibitors: increased contraceptive metabolism

Tamoxifen: interference with tamoxifen effects

Drug-diagnostic tests.Antithrombin III, folate, low-density lipoproteins, pyri-doxine, total cholesterol, urine pregnane-diol: decreased levels

Cortisol; factors VII, VIII, IX, and X; glucose; high-density lipoproteins; phos-pholipids; prolactin; prothrombin; sodium; triglycerides: increased levels

Metyrapone test: false decrease Thyroid function tests: false interpretation

Drug-food.Caffeine: increased blood caffeine level

Drug-herbs.Black cohosh: increased adverse drug effects

Red clover: interference with hormonal therapy

Saw palmetto: antiestrogenic effects St. John's wort: decreased drug blood level and effects

Drug-behaviors.Smoking (15 or more cigarettes daily): increased risk of adverse cardiovascular reactions

Patient monitoring

• Evaluate menstrual pattern.

Monitor blood pressure. Watch for signs and symptoms of thrombo-embolic disease (swelling or warmth in calf, sudden chest pain, shortness of breath).
• Check blood glucose level in diabetic patient.

Patient teaching

• Instruct patient to start using patch on first day of menstrual period or on first Sunday after period starts. Advise her to use calendar to keep track of which day each week to change patch.
• Tell patient to remove patch during fourth week of each cycle. Explain that she will have bleeding that week.
• Advise patient to check daily to ensure that patch is attached firmly to skin. Explain that if patch is detached for 1 day or less, she should try to reattach it more firmly. If patch is detached for more than 1 day or for an unknown length of time, she should start with new patch and new calendar.
• Instruct patient to use alternative contraception during first week of patch use.

Inform patient that smoking while using patch increases risk of thrombo-embolic disease and other serious cardiovascular reactions. Stress importance of not smoking. Tell her to immediately report swelling or warmth in calf, chest pain, or shortness of breath.
• Advise breastfeeding patient to use other forms of contraception until she has completely weaned her infant.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, foods, herbs, and behaviors mentioned above.


norepinephrine bitartrate

Levophed, Noradrenaline (UK)


Pharmacologic class: Sympathomimetic

Therapeutic class: Alpha- and beta-adrenergic agonist, cardiac stimulant, vasopressor

Pregnancy risk category C

 

FDABOXED WARNING

If extravasation occurs, infiltrate area promptly with 10 to 15 ml of saline solution containing 5 to 10 mg phentolamine to prevent sloughing and necrosis. Use syringe with fine hypodermic needle, and infiltrate solution liberally throughout area. Give phentolamine as soon as possible; its sympathetic blockade causes immediate local hyperemic changes if area is infiltrated within 12 hours.

Action

Stimulates beta1 and alpha1 receptors in sympathetic nervous system, causing vasoconstriction, increased blood pressure, enhanced contractility, and decreased heart rate

Availability

Injection: 1 mg/ml

Indications and dosages

Severe hypotension

Adults: 8 to 12 mcg/minute I.V.; then titrate based on blood pressure response. For maintenance, 2 to 4 mcg/minute.

Contraindications

• Concurrent cyclopropane or halo-thane anesthesia
• Hypotension caused by blood volume deficit (except in emergencies until blood volume replacement is completed), profound hypoxia or hypercarbia
• Mesenteric or peripheral vascular thrombosis

Precautions

Use cautiously in:
• sulfite sensitivity (some products), especially in asthmatic patients
• arterial embolism, cardiac disease, peripheral vascular disease, hypertension, hyperthyroidism
• patients receiving MAO inhibitors or tricyclic antidepressants concurrently
• elderly patients
• pregnant or breastfeeding patients
• children (safety and efficacy not established).

Administration

• Mix with dextrose 5% in water or dextrose 5% in normal saline solution.
• Inspect solution to make sure it's clear and colorless. Don't infuse if it's brown or pink.
• Administer through infusion pump. Titrate infusion rate to achieve and maintain low-normal systolic blood pressure (80 to 100 mm Hg).
• Continue infusion until adequate blood pressure and tissue perfusion persist without drug therapy.
• Gradually titrate dosage downward.
• To avoid extravasation, administer only into large vein (antecubital) or through central line. Don't use femoral vein in patients who are elderly or have occlusive vascular disorders.

To prevent delivery of large drug concentrations, avoid line stasis and flushing.

Adverse reactions

CNS: headache, anxiety

CV: bradycardia, severe hypertension, arrhythmias

Respiratory: respiratory difficulty

Skin: irritation with extravasation, necrosis

Other: ischemic injury

Interactions

Drug-drug.Alpha-adrenergic blockers: antagonism of norepinephrine effects Antihistamines, ergot alkaloids, guanethidine, MAO inhibitors, oxytocin, tricyclic antidepressants: severe hypertension Bretylium, inhalation anesthetics: increased risk of arrhythmias

Patient monitoring

Check blood pressure every 2 minutes until desired pressure is achieved. Recheck every 5 minutes for duration of infusion.
• Maintain continuous ECG monitoring and blood pressure monitoring.

Be aware that headache may signal extreme hypertension and overdose.
• Monitor infusion site for extravasation.

Watch for signs and symptoms of peripheral vascular insufficiency (decreased capillary refill, pale to cyanotic to black skin color).

Never leave patient unattended during infusion.

Patient teaching

• When patient is alert, explain why he's receiving drug.
• Reassure patient he'll be monitored continuously until he's stable.


norethindrone acetate

Aygestin, Camila, Errin, Jolivette, Nora-BE, Nor-QD, Ortho Micronor


Pharmacologic class: Progesterone, hormone

Therapeutic class: Progestin

Pregnancy risk category X

 

Action

Inhibits pituitary gonadotropin secretion, suppressing follicular maturation and ovulation and stimulating mammary tissue growth

Availability

Tablets: 0.35 mg, 5 mg

Indications and dosages

Endometriosis

Adults: 5 mg Aygestin P.O. daily for 2 weeks, increased in increments of 2.5 mg/day q 2 weeks until 15 mg daily is reached

Amenorrhea; abnormal uterine bleeding

Adults: 2.5 to 10 mg Aygestin P.O. daily starting on day 5 of menstrual cycle

Prevention of pregnancy

Adults: 1 tablet (0.35 mg) P.O. daily

Contraindications

• Hypersensitivity to drug
• Impaired liver function or liver disease
• Thromboembolic disorders
• Known or suspected breast cancer
• Undiagnosed vaginal bleeding
• Known or suspected pregnancy
• As a diagnostic test for pregnancy

Precautions

Use cautiously in:
• hypertension, blood dyscrasias, bone marrow disease, hepatic or renal disease, gallbladder disease, heart failure, diabetes mellitus, depression, migraine, asthma, seizure disorder
• family history of breast or reproductive tract cancer
• breastfeeding patients.

Administration

• Give with or without food.
• When administering for endometriosis, amenorrhea, or abnormal uterine bleeding, know that therapy may continue for 6 to 9 months or until breakthrough bleeding necessitates a temporary halt.
• When administering for prevention of pregnancy, know that drug must be given continuously every day at the same time with no interruptions between pill packs.

Adverse reactions

CNS: migraine, depression, insomnia, drowsiness

EENT: retinal vascular lesions, sudden partial or complete vision loss, proptosis, diplopia, papilledema

GI: nausea

GU: breakthrough bleeding, menstrual flow changes, amenorrhea, changes in cervical erosion and secretions, breast tenderness and secretion

Hepatic: cholestatic jaundice

Metabolic: fluid retention, decreased glucose tolerance

Skin: rash, urticaria, acne, hirsutism, chloasma

Other: edema, weight gain or loss, fever

Interactions

Drug-drug.Hepatic enzyme-inducing drugs (such as carbamazepine, phenobarbital, phenytoin, rifampin): decreased norethindrone efficacy

Drug-diagnostic tests.Alkaline phosphatase; amino acids; factors VII, VIII, IX, and X; nitrogen; pregnanediol: increased levels

Gamma-glutamyltransferase, high-density lipoproteins: decreased levels

Drug-herbs.Cola nut, guarana, yerba maté: increased CNS stimulation St. John's wort: decreased contraceptive efficacy

Drug-behaviors.Smoking: risk of serious cardiovascular reactions

Patient monitoring

• Monitor pretreatment and annual physical exams to check blood pressure, breasts, abdomen, pelvic organs, and Pap smear results.

Assess for signs and symptoms of depression, especially in patients with history of depression. Stop giving drug if significant depression recurs.
• Check blood glucose level in diabetic patients.

Patient teaching

• Instruct patient to avoid pregnancy or to discontinue drug if she gets pregnant (may cause serious fetal anomalies or fetal death).

Advise patient to discontinue drug and consult prescriber if she experiences sudden partial or complete vision loss.
• If patient is receiving drug to treat amenorrhea, tell her to mark administration days on calendar.
• Instruct patient taking drug to prevent pregnancy to take drug every day at the same time without interruption between pill packs.
• Tell diabetic patient to monitor blood glucose level closely and to watch for hyperglycemia.
• Instruct patient to report breakthrough bleeding, spotting, change in menstrual flow, or amenorrhea.
• Caution patient not to smoke during therapy.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, herbs, and behaviors mentioned above.


norfloxacin

Noroxin, Utinor (UK)


Pharmacologic class: Fluoroquinolone

Therapeutic class: Anti-infective

Pregnancy risk category C

 

FDABOXED WARNING

Fluoroquinolones for systemic use are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in patients usually over age 60, with concomitant use of corticosteroids, and in kidney, heart, and lung transplant recipients.

Drug may exacerbate muscle weakness in patients with myasthenia gravis. Avoid use in patients with known history of myasthenia gravis.

Action

Inhibits bacterial DNA synthesis by blocking DNA gyrase in susceptible gram-negative and gram-positive aerobic and anaerobic bacteria

Availability

Tablets: 400 mg

Indications and dosages

Urinary tract infections (UTIs) caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis

Adults: 400 mg P.O. q 12 hours for 3 days

UTIs caused by all organisms except E. coli, K. pneumoniae, and P. mirabilis

Adults: 400 mg P.O. q 12 hours for 7 to 10 days. For complicated UTIs, may give for up to 21 days.

Gonorrhea

Adults: 800 mg P.O. as a single dose

Prostatitis caused by E. coli

Adults: 400 mg P.O. q 12 hours for 28 days

Dosage adjustment

• Renal impairment

Contraindications

• Hypersensitivity to drug
• History of tendinitis or tendon rupture with fluoroquinolone use

Precautions

Use cautiously in:
• CNS diseases or disorders, renal impairment, cirrhosis, bradycardia, acute myocardial ischemia
• known history of myasthenia gravis (avoid use)
• elderly patients
• pregnant or breastfeeding patients (safety not established except in postex-posure inhalation or cutaneous anthrax).
• children younger than age 18.

Administration

• Give with glass of water 1 hour before or 2 hours after a meal.
• Don't give antacids within 2 hours of norfloxacin.

Adverse reactions

CNS: dizziness, light-headedness, drowsiness, headache, asthenia, insomnia, agitation, confusion, acute psychoses, hallucinations, tremors, increased intracranial pressure, seizures

CV: vasodilation, QT prolongation, arrhythmias

GI: nausea, diarrhea, abdominal pain, pancreatitis, pseudomembranous colitis

GU: interstitial cystitis, vaginitis

Hematologic: leukopenia

Hepatic: hepatitis

Metabolic: hyperglycemia, hypoglycemia

Musculoskeletal: tendinitis, tendon rupture

Skin: rash, hyperhidrosis, photosensi-tivity, phototoxicity, Stevens-Johnson syndrome

Other: altered taste, myasthenia gravis exacerbation, hypersensitivity reactions including anaphylaxis

Interactions

Drug-drug.Antacids, bismuth, iron salts, subsalicylate, sucralfate, zinc salts: decreased norfloxacin absorption

Antineoplastics: decreased norfloxacin blood level

Cimetidine: interference with norfloxacin elimination

Corticosteroids: increased risk of tendon rupture

Nitrofurantoin: antagonism of norfloxacin's antibacterial effects in GU tract

Other fluoroquinolones: increased risk of nephrotoxicity

Probenecid: decreased renal elimination of norfloxacin

Theophylline: increased theophylline blood level, greater risk of toxicity

Warfarin: increased anticoagulant effect

Drug-diagnostic tests.Alanine amino-transferase, alkaline phosphatase, aspartate aminotransferase, bilirubin, eosino-phils, lactate dehydrogenase, platelets: increased levels

Hemoglobin, hematocrit: decreased values

Drug-food.Caffeine: decreased hepatic metabolism of caffeine

Milk or yogurt (consumed alone): impaired drug absorption

Tube feedings: impaired drug absorption

Drug-herbs.Dong quai, St. John's wort: phototoxicity

Fennel: decreased drug absorption

Drug-behaviors.Sun exposure: phototoxicity

Patient monitoring

• Monitor vital signs and cardiovascular status.
• Check fluid intake and output. Keep patient well-hydrated.

Watch for signs and symptoms of tendinitis or tendon rupture.
• Assess patient's response to therapy. Obtain specimens for repeat culture and sensitivity tests if he relapses or doesn't improve.
• Monitor renal function.

Patient teaching

• Tell patient to take on empty stomach with full glass of water, 1 hour before or 2 hours after a meal.
• If patient needs antacid for GI upset, instruct him not to take it within 2 hours of norfloxacin.

Advise patient to stop taking drug and promptly report rash; severe GI problems; tendon pain, swelling, or inflammation; or weakness.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.
• Teach patient ways to counteract photosensitivity, such as by wearing sunglasses and avoiding excessive exposure to bright light.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, foods, herbs, and behaviors mentioned above.


nortriptyline hydrochloride

Allegron (UK), Apo-Nortriptyline, Aventyl, Dom-Nortriptyline, Gen-Nortriptyline, Novo-Nortriptyline, Norventyl, Nu-Nortriptyline, Pamelor, PMS-Nortriptyline, Ratio-Nortriptyline


Pharmacologic class: Tricyclic compound

Therapeutic class: Antidepressant

Pregnancy risk category D

 

FDABOXED WARNING

Drug may increase risk of suicidal thinking and behavior in children and adolescents with major depressive disorder and other psychiatric disorders. Risk must be balanced with clinical need, as depression itself increases suicide risk. With patient of any age, observe closely for clinical worsening, suicidality, and unusual behavior changes when therapy begins. Advise family and caregivers to observe patient closely and communicate with prescriber as needed.

Drug isn't approved for use in pediatric patients.

Action

Increases serotonin and norepineph-rine release by blocking their reuptake by presynaptic neurons; also possesses anticholinergic properties

Availability

Capsules: 10 mg, 25 mg, 50 mg, 75 mg

Oral solution: 10 mg/5 ml

Indications and dosages

Depression

Adults: 25 mg P.O. t.i.d. or q.i.d., up to a maximum of 150 mg daily

Dosage adjustment

• Elderly patients
• Adolescents

Off-label uses

• Postherpetic neuralgia
• Neurologic pain

Contraindications

• Hypersensitivity to drug or dibenza-zepines
• Acute recovery phase of myocardial infarction
• MAO inhibitor use within past 14 days

Precautions

Use cautiously in:
• asthma, cardiovascular disease, cardiac or hepatic disease, hyperthy-roidism, increased intraocular pressure, angle-closure glaucoma, urinary retention, severe depression
• history of seizures
• elderly patients (especially elderly men with prostatic hyperplasia)
• pregnant or breastfeeding patients
• children (use not recommended).

Administration

• Give as prescribed, either in divided doses three or four times daily or as single dose at bedtime.
• Administer with meals or snack to minimize stomach upset.

Don't give within 14 days of MAO inhibitors.

Adverse reactions

CNS: dizziness, drowsiness, fatigue, headache, lethargy, insomnia, agitation, confusion, extrapyramidal reactions, hallucinations, seizures, suicidal behavior or ideation (especially in child or adolescent)

CV: hypotension, ECG changes, palpitations, heart block, arrhythmias, myocardial infarction, cerebrovascular accident

EENT: blurred vision, dry eyes

GI: nausea, constipation, anorexia, dry mouth, paralytic ileus

GU: urinary retention, gynecomastia

Hematologic: blood dyscrasias

Hepatic: jaundice, hepatotoxicity

Skin: photosensitivity

Other: unpleasant taste, weight gain

Interactions

Drug-drug.Anticholinergics, anti-cholinergic-like drugs (including antidepressants, antihistamines, atropine, disopyramide, haloperidol, phenothiazines, quinidine): additive anticholinergic effects

Antihypertensives: poor therapeutic response to antihypertensives

Antithyroid drugs: increased risk of agranulocytosis

Cimetidine, fluoxetine, hormonal contraceptives: increased nortriptyline blood level and possible toxicity

Clonidine: hypertensive crisis

CNS depressants (including antihistamines, opioids, sedative-hypnotics): additive CNS depression

Decongestants, vasoconstrictors: additive adrenergic effects

MAO inhibitors: hypertension, hyper-pyrexia, seizures, death

Drug-diagnostic tests.Alkaline phos-phatase, bilirubin: increased levels Glucose: increased or decreased level

Drug-herbs.Angel's trumpet, belladonna, henbane, jimson weed, scopo-lia: increased anticholinergic effects Chamomile, hops, kava, skullcap, scopolia, valerian: increased CNS depression

St. John's wort: decreased drug blood level and efficacy

Drug-behaviors.Alcohol use: increased drowsiness, impaired motor skills

Patient monitoring

• Check vital signs and ECG.
• Monitor bladder and bowel function. Stay alert for urine retention and constipation.
• Assess neurologic status and document mood swings.
• Monitor liver function tests.

Watch for suicidal tendency, especially in child or adolescent.

Patient teaching

• Explain that drug's full effect may take 4 weeks.
• Tell patient drug may cause drowsiness or dizziness, but these effects should subside within a few weeks.

Advise patient (and family as appropriate) to immediately report worsening depression or suicidal ideation, especially in child or adolescent.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects him.
• Tell patient to avoid alcohol and to consult prescriber before using herbs.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, herbs, and behaviors mentioned above.


nystatin

Bio-Statin, Candistatin, Dom-Nystatin, Mycostatin, Nadostine, Nilstat, Nyaderm, Nystan (UK), Nystop, Pedi-Dri, PMS-Nystatin, Ratio-Nystatin


Pharmacologic class: Antifungal

Therapeutic class: Anti-infective

Pregnancy risk category A

 

Action

Interferes with fungal cell-wall synthesis, inhibiting formation of ergo sterols, increasing cell-wall permeability, and causing osmotic instability

Availability

Cream: 100,000 units/g

Ointment: 100,000 units/g

Powder: 100,000 units/g

Suspension: 100,000 units/ml

Tablets: 500,000 units

Troches: 200,000 units

Vaginal tablets: 100,000 units

Indications and dosages

Candidiasis (topical use)

Adults and children: Apply cream, ointment, or powder two or three times daily until healing is complete.

Oral candidiasis

Adults: 400,000 to 600,000 units (suspension) P.O. q.i.d. Have patient gargle and then swallow half of dose in each side of mouth.

Infants: 200,000 units (suspension) P.O. q.i.d. Use half of dose in each side of mouth.

Newborn and premature infants: 100,000 units (suspension) P.O. q.i.d. Use half of dose in each side of mouth.

GI infections

Adults: 500,000 to 1 million units (one to two tablets) P.O. t.i.d. Continue for 48 hours after desired response occurs.

Vaginal candidiasis

Adults: 100,000 units (one vaginal tablet) intravaginally daily for 2 weeks, or 100,000- to 500,000-unit applicatorful (cream) intravaginally once or twice daily for 2 weeks

Contraindications
• Hypersensitivity to drug or its components

Precautions

Use cautiously in:
• renal or hepatic disease, achlorhydria
• pregnant or breastfeeding patients
• children younger than age 2.

Administration

• Give oral suspension by placing half of dose in each side of patient's mouth. Instruct patient to hold suspension in mouth, swish it around, or gargle for several minutes before swallowing it.
• To prepare oral solution from powder, add one-eighth teaspoon to 120 ml of water and stir well. Give immediately.
• Advise patient to let troche dissolve slowly and completely in mouth. Tell her not to chew or swallow it whole.
• Know that nystatin vaginal tablets can be given orally to treat oral candidiasis.
• To apply cream, ointment, or powder, gently and thoroughly massage preparation into skin.
• Use applicator provided for vaginal administration.

Adverse reactions

GI: nausea, vomiting, diarrhea, GI distress, oral irritation

GU: vulvovaginal irritation (with intravaginal form)

Skin: pruritus, rash

Interactions

Drug-drug.Topical corticosteroids: increased corticosteroid absorption

Drug-behaviors.Latex contraceptive use: damage to contraceptive (with intravaginal use)

Patient monitoring

• If patient takes oral tablets, inspect oral mucous membranes for irritation.
• With topical use, monitor affected area for increase in redness, swelling, or irritation.

Patient teaching

• Advise patient to continue taking for at least 48 hours after symptoms resolve.
• Instruct patient to let lozenge dissolve slowly in mouth. Tell her not to chew or swallow it.
• If patient misses a dose, tell her to take dose as soon as possible and then resume her regular dosing schedule.
• Inform patient that diabetes mellitus, reinfection by sexual partner, tight-fitting pantyhose, and use of antibiotics, hormonal contraceptives, or corticosteroids predispose her to vaginal infection. Urge her to wear cotton underwear.
• Tell female patient to practice careful hygiene in affected areas.
• Instruct patient using vaginal tablets to wash applicator thoroughly after each use.
• Tell patient to continue therapy during menstruation.
• As appropriate, review all significant adverse reactions and interactions, especially those related to the drugs and behaviors mentioned above.

nortriptyline

(nor-trip-ti-leen) ,

Aventyl

(trade name),

Norventyl

(trade name),

Pamelor

(trade name)

Classification

Therapeutic: antidepressants
Pharmacologic: tricyclic antidepressants
Pregnancy Category: D

Indications

Various forms of depression.Management of chronic neurogenic pain.

Action

Potentiates the effect of serotonin and norepinephrine.
Has significant anticholinergic properties.

Therapeutic effects

Antidepressant action that develops slowly over several weeks.

Pharmacokinetics

Absorption: Well absorbed after oral administration.
Distribution: Widely distributed. Enters breast milk in small amounts; probably crosses the placenta.
Protein Binding: 92%.
Metabolism and Excretion: Mostly metabolized by the liver (CYP2D6 isoenzyme);genetic implication the CYP2D6 enzyme system exhibits genetic polymorphism; ∼7% of population may be poor metabolizers (PMs) and may have significantly ↑ nortriptyline concentrations and an ↑ risk of adverse effects.
Half-life: 18–28 hr.

Time/action profile (antidepressant effect)

ROUTEONSETPEAKDURATION
PO2–3 wk6 wkunknown

Contraindications/Precautions

Contraindicated in: Hypersensitivity;Angle-closure glaucoma;Alcohol intolerance (solution only);Concurrent use of MAO inhibitors or MAO-like drugs (linezolid or methylene blue);
Use Cautiously in: Pre-existing cardiovascular disease;History of seizures;Asthma;May ↑ risk of suicide attempt/ideation especially during early treatment or dose adjustment; Obstetric: Use only if clearly needed and maternal benefits outweigh risk to fetus; Lactation: May result in sedation in infant; discontinue drug or bottle-feed; Pediatric: Suicide risk may be greater in children or adolescents. Safety not established in children; Geriatric: More susceptible to adverse reactions; dose ↓ recommended. Geriatric men with prostatic hyperplasia may be more susceptible to urinary retention.

Adverse Reactions/Side Effects

Central nervous system

  • suicidal thoughts (life-threatening)
  • drowsiness (most frequent)
  • fatigue (most frequent)
  • lethargy (most frequent)
  • agitation
  • confusion
  • extrapyramidal reactions
  • hallucinations
  • headache
  • insomnia

Ear, Eye, Nose, Throat

  • blurred vision (most frequent)
  • dry eyes (most frequent)
  • dry mouth (most frequent)

Cardiovascular

  • arrhythmias (life-threatening)
  • hypotension (most frequent)
  • ECG changes

Gastrointestinal

  • constipation (most frequent)
  • nausea
  • paralytic ileus
  • unpleasant taste
  • weight gain

Genitourinary

  • urinary retention

Dermatologic

  • photosensitivity

Endocrinologic

  • gynecomastia

Hematologic

  • blood dyscrasias

Interactions

Drug-Drug interaction

Concurrent use with MAO inhibitors may result in serious potentially fatal reactions (MAO inhibitors should be stopped at least 14 days before nortriptyline therapy. Nortriptyline should be stopped at least 14 days before MAO inhibitor therapy).Concurrent use with MAO-inhibitor like drugs, such as linezolid or methylene blue may ↑ risk of serotonin syndrome; concurrent use contraindicated; do not start therapy in patients receiving linezolid or methylene blue ; if linezolid or methylene blue need to be started in a patient receiving nortriptyline, immediately discontinue nortriptyline and monitor for signs/symptoms of serotonin syndrome for 2 wk or until 24 hr after last dose of linezolid or methylene blue, whichever comes first (may resume nortriptyline therapy 24 hr after last dose of linezolid or methylene blue)May prevent the therapeutic response to most antihypertensives.Hypertensive crisis may occur with clonidine.↑ CNS depression with other CNS depressants, including alcohol, antihistamines, opioids, and sedative/hypnotics.Adrenergic effects may be ↑ with other adrenergic agents, including vasoconstrictors and decongestants.↑ anticholinergic effects with other drugs possessing anticholinergic properties, including antihistamines, antidepressants, atropine, haloperidol, phenothiazines, quinidine, and disopyramide.Cimetidine, fluoxetine, or hormonal contraceptives ↑ blood levels and risk of toxicity.↑ risk of agranulocytosis with antithyroid agents.Drugs that affect serotonergic neurotransmitter systems, including SSRIs, SNRIs, fentanyl, buspirone, tramadol and triptans ↑ risk of serotonin syndrome.Concomitant use of kava-kava, valerian, or chamomile can ↑ CNS depression.Use with St. John's wort ↑ of serotonin syndrome.↑ anticholinergic effects with jimson weed and scopolia.

Route/Dosage

Oral (Adults) 25 mg 3–4 times daily, up to 150 mg/day.
Oral (Geriatric Patients or Adolescents) 30–50 mg/day in divided doses or as a single dose.

Availability (generic available)

Capsules: 10 mg, 25 mg, 50 mg, 75 mg Cost: Generic — 10 mg $40.50 / 100, 25 mg $80.31 / 100, 50 mg $145.55 / 100, 75 mg $221.95 / 100
Oral solution: 10 mg/5 mL Cost: Generic — $182.95 / 473 mL

Nursing implications

Nursing assessment

  • Monitor mental status (orientation, mood, behavior).
    • Assess weight and BMI initially and throughout treatment. For overweight/obese individuals, monitor fasting blood glucose and cholesterol levels.
    • Monitor BP and pulse rate before and during initial therapy. Report significant decreases in BP or a sudden increase in pulse rate.
    • Monitor baseline and periodic ECGs in geriatric patients or patients with heart disease. May cause prolonged PR and QT intervals and may flatten T waves.
  • Assess for suicidal tendencies, especially during early therapy. Restrict amount of drug available to patient. Risk may be increased in children, adolescents, and adults ≤24 yrs. After starting therapy, children, adolescents, and young adults should be seen by health care professional at least weekly for 4 wk, every 3 wk for next 4 wk, and on advice of health care professional thereafter.
  • Pain: Assess type, location, and severity of pain before and periodically during therapy. Use pain scale to monitor effectiveness of medication.
  • Lab Test Considerations: Assess leukocyte and differential blood counts, liver function, and serum glucose periodically. May cause ↑ serum bilirubin and alkaline phosphatase. May cause bone marrow depression. Serum glucose may be ↑ or ↓.
    • Serum levels may be monitored in patients who fail to respond to usual therapeutic dose. Therapeutic plasma concentration range is 50–150 ng/mL.
    • May cause alterations in blood glucose levels.
  • Symptoms of acute overdose include disturbed concentration, confusion, restlessness, agitation, seizures, drowsiness, mydriasis, arrhythmias, fever, hallucinations, vomiting, and dyspnea.
    • Treatment of overdose includes gastric lavage, activated charcoal, and a stimulant cathartic. Maintain respiratory and cardiac function (monitor ECG for at least 5 days) and temperature. Medications may include digoxin for HF, antiarrhythmics, and anticonvulsants.

Potential Nursing Diagnoses

Ineffective coping (Indications)
Risk for injury (Side Effects)
Sexual dysfunction (Side Effects)

Implementation

  • Do not confuse Pamelor (nortriptyline) with Tambocor (flecainide).
  • Taper to avoid withdrawal effects. Reduce dose 50% for 3 days, then by 50% for 3 more days, then discontinue.
  • Oral: Administer medication with meals to minimize gastric irritation.
    • May be given as a single dose at bedtime to minimize sedation during the day. Dose increases should be made at bedtime because of sedation.

Patient/Family Teaching

  • Instruct patient to take medication as directed. Take missed doses as soon as possible unless almost time for next dose; if regimen is a single dose at bedtime, do not take in the morning because of side effects. Advise patient that drug effects may not be noticed for at least 2 wk. Abrupt discontinuation may cause nausea, vomiting, diarrhea, headache, trouble sleeping with vivid dreams, and irritability.
  • May cause drowsiness and blurred vision. Caution patient to avoid driving and other activities requiring alertness until response to drug is known.
  • Instruct patient to notify health care professional if visual changes occur. Inform patient that periodic glaucoma testing may be required during long-term therapy.
  • Caution patient to make position changes slowly to minimize orthostatic hypotension. (This side effect is less pronounced with this medication than with other tricyclic antidepressants.)
  • Advise patient, family, and caregivers to look for suicidality, especially during early therapy or dose changes. Notify health care professional immediately if thoughts about suicide or dying, attempts to commit suicide, new or worse depression or anxiety, agitation or restlessness, panic attacks, insomnia, new or worse irritability, aggressiveness, acting on dangerous impulses, mania, or other changes in mood or behavior or if symptoms of serotonin syndrome occur.
  • Advise patient to avoid alcohol or other CNS depressant drugs during therapy and for at least 3–7 days after therapy has been discontinued.
  • Instruct patient to notify health care professional if urinary retention occurs or if dry mouth or constipation persists. Sugarless candy or gum may diminish dry mouth, and an increase in fluid intake or bulk may prevent constipation. If symptoms persist, dose reduction or discontinuation may be necessary. Consult health care professional if dry mouth persists for more than 2 wk.
  • Caution patient to use sunscreen and protective clothing to prevent photosensitivity reactions.
  • Alert patient that urine may turn blue-green in color.
  • Inform patient of need to monitor dietary intake. Increase in appetite may lead to undesired weight gain. Refer as appropriate for nutritional, weight, or medical management.
  • May have teratogenic effects. Instruct patient to notify health care professional immediately if pregnancy is planned or suspected.
  • Advise patient to notify health care professional of medication regimen before treatment or surgery.
  • Therapy for depression is usually prolonged. Emphasize the importance of follow-up exams.

Evaluation/Desired Outcomes

  • Increased sense of well-being.
    • Renewed interest in surroundings.
    • Increased appetite.
    • Improved energy level.
    • Improved sleep.
  • Decrease in severity of chronic neurogenic pain. Patients may require 2–6 wk of therapy before full therapeutic effects of medication are seen.

Aventyl

(ə-vĕn′tl)
A trademark for the drug nortriptyline hydrochloride.

Aventyl®

Nortriptyline, see there.