Nimotop

nicotine transdermal system

Adalat CC, Adalat LA (UK), Adalat P.A., Adalat Retard (UK), Adalat XL, Adipine (UK), Afeditab CR, Angiopine (UK), Apo-Nifed, Calchan (UK), Cardilate MR (UK), Coracten (UK), Fortipine (UK), Gen-Nifedical, Hypolar Retard (UK), Neozipine XL (UK), Nifediac CC, Nifedical XL, Nifedipress MR (UK), Nifopress MR (UK), Novo-Nifedin, Nu-Nifed, Procardia, Procardia XL, Slofedipine (UK), Tensipine (UK), Valni Retard (UK), Valni XL (UK)TasignaAnandron, NilandronNimotopSular, Syscor (UK)AliniaApo-Nitrofurantoin, Furadantin, Novo-Furantoin

Pharmacologic class: Cholinergic

Therapeutic class: Smoking deterrent

Pregnancy risk category C (gum), D (inhalation, nasal, transdermal)

Pregnancy risk category C (gum), D (inhalation, nasal, transdermal)

Pharmacologic class: Calcium channel blocker

Therapeutic class: Antianginal, anti-hypertensive

Pregnancy risk category C

Pharmacologic class: Protein-tyrosine kinase inhibitor

Therapeutic class: Antineoplastic

Pregnancy risk category D

Pharmacologic class: Antiandrogen

Therapeutic class: Antineoplastic

Pregnancy risk category C

Pharmacologic class: Calcium channel blocker

Therapeutic class: Cerebral vasodilator

Pregnancy risk category C

Pharmacologic class: Antiprotozoal

Therapeutic class: Anti-infective

Pregnancy risk category B

FDA Box Warning

Drug prolongs QT interval and may lead to sudden death. Don't give to patients with hypokalemia, hypomagnesemia, or long-QT syndrome. Correct hypokalemia or hypomagnesemia before starting drug and monitor for these imbalances periodically. Avoid concomitant drugs known to prolong QT interval; also avoid strong CYP3A4 inhibitors. Instruct patient not to eat 2 hours before or 1 hour after taking dose. Obtain ECG to monitor QTc at baseline, 7 days after drug initiation, periodically thereafter, and after dosage adjustments.

Reduce dosage in patients with hepatic impairment.

Action

Supplies nicotine during controlled withdrawal from cigarette smoking. Binds selectively to nicotinic-choliner-gic receptors in central and peripheral nervous systems, autonomic ganglia, adrenal medulla, and neuromuscular junction. At low doses, has a stimulating effect; at high doses, a reward effect.

Availability

Chewing gum: 2 mg, 4 mg

Inhalation: 42 cartridges/system, each containing 10 mg nicotine (delivers 4 mg)

Nasal spray: 10 mg/ml (0.5 mg/spray) in 10-ml bottles (100 doses)

Transdermal patch: 7 mg/day, 11 mg/day, 14 mg/day, 15 mg/day, 21 mg/day, 22 mg/day

Indications and dosages

Adjunctive therapy (with behavior modification) for nicotine withdrawal Transdermal system-

Adults: 21 mg/day transdermally (Habitrol) for 4 to 8 weeks, then 14 mg/day for 2 to 4 weeks, then 7 mg/day for 2 to 4 weeks, for a total of 8 to 16 weeks; patient must wear system 24 hours/day. Or 21 mg/day transdermally (Nicoderm CQ) for 6 weeks, then 14 mg/day for 2 weeks, then 7 mg/day for 2 weeks, for a total of 10 weeks; patient must wear system 24 hours/day. Or 15 mg/day transdermally (one Nicotrol patch) for 6 weeks; patient must wear system 16 hours/day, removing it at bedtime.

Adults, adolescents, and children weighing less than 45 kg (100 lb) who smoke fewer than 10 cigarettes daily or have underlying cardiovascular disease: 14 mg/day transdermally (Habitrol) for 4 to 8 weeks, then 7 mg/day for 2 to 4 weeks, for a total of 6 to 8 weeks; patient must wear system 24 hours/day. Or 14 mg/day transdermally (Nicoderm CQ) for 6 weeks, then 7 mg/day for 2 weeks, for a total of 8 weeks; patient must wear system 24 hours/day. Nasal spray-

Adults: One spray intranasally in each nostril once or twice per hour, up to five times per hour or 40 times per day, for no longer than 6 months Inhalation-

Adults: For optimal response, at least six cartridges inhaled daily for first 3 to 6 weeks, to a maximum of 16 cartridges daily for up to 12 weeks. Patient self-titrates dosage to required nicotine level (usually 6 to 16 cartridges daily), followed by gradual withdrawal over 6 to 12 weeks.

Chewing gum-

Adults: Use as needed depending on smoking urge or chewing rate, or use on fixed schedule q 1 to 2 hours. Initial requirement may range from 18 to 48 mg/day, not to exceed 60 mg/day.

Contraindications

• Hypersensitivity to drug or its components or to menthol (inhaler only)
• Allergy to adhesive (transdermal forms only)

Precautions

Use cautiously in:
• cardiovascular disease, hypertension, bronchospastic disease, diabetes mellitus, pheochromocytoma, peripheral vascular disease, hyperthyroidism, peptic ulcer disease, hepatic disease
• immediately after myocardial infarction, severe arrhythmia, or severe or worsening angina (use not recommended)
• skin disorders (transdermal form)
• dental disorders, esophagitis, pharyngitis, stomatitis (gum form)
• females of childbearing age
• pregnant or breastfeeding patients.
• children under age 18 (safety and efficacy not established).

Administration

• Apply patch when patient awakens and remove patch (as prescribed) at same time each day.
• Administer nasal spray regularly during first week, to help patient get used to irritant effects.
• With inhalation use, give at least six cartridges daily for first 3 to 6 weeks.
• Encourage patient to titrate dosage to level required, followed by gradual withdrawal.

Adverse reactions

CNS: headache, dizziness, drowsiness, poor concentration, nervousness, weakness, paresthesia, insomnia, abnormal dreams

CV: chest pain, hypertension, tachycardia, atrial fibrillation

EENT: sinusitis; pharyngitis (with gum); mouth and throat irritation (with inhaler); nasopharyngeal irritation, rhinitis, sneezing, watering eyes, eye irritation (with nasal spray)

GI: nausea, vomiting, diarrhea, constipation, abdominal pain, dry mouth, dyspepsia; increased salivation, sore mouth (with gum)

GU: dysmenorrhea

Musculoskeletal: joint pain, back pain, myalgia; jaw ache (with gum)

Respiratory: increased cough (with nasal spray or inhaler), bronchospasm

Skin: burning at patch site, erythema, pruritus, cutaneous hypersensitivity, rash, sweating (all with transdermal patch)

Other: abnormal taste, increased appetite (with gum), allergy, hiccups

Interactions

Drug-drug.Acetaminophen, adrenergic antagonists (such as prazosin, labetalol), clozapine, furosemide, imipramine, oxazepam, pentazocine, propranolol and other beta-adrenergic blockers, theophylline: increased effects of these drugs

Bupropion: treatment-emergent hypertension

Insulin: decreased insulin requirement

Isoproterenol, phenylephrine: increased requirements for these drugs

Propoxyphene: decreased nicotine metabolism

Drug-food.Caffeine-containing foods and beverages: increased nicotine effects

Drug-behaviors.Cigarette smoking: increased nicotine metabolism and effects

Patient monitoring

• Assess for signs and symptoms of nicotine withdrawal (irritability, drowsiness, fatigue, headache).

Watch for bronchospasm and evidence of nicotine toxicity (nausea, vomiting, diarrhea, increased salivation, headache, dizziness, visual disturbances).

Patient teaching

Caution patient against any type of smoking during therapy. Urge him to immediately report chest tightness or difficulty breathing.
• If patient uses gum, advise him to chew one piece whenever nicotine craving occurs. Instruct him to chew it slowly until he feels a tingling sensation, then store it between cheek and gum until tingling disappears.
• Instruct patient to apply transdermal patch to clean, dry skin of upper arm or torso when he awakens; to keep it in place when showering, bathing, or swimming; and to remove it at same time each day.
• If patient uses nasal spray, instruct him to tilt head back slightly when spraying. Remind him not to sniff, swallow, or inhale through nose.
• If patient uses inhalation form, teach him to puff continuously for 20 minutes and to use at least six cartridges daily for first 3 to 6 weeks.
• As appropriate, review all significant and life-threatening adverse reactions and interactions, especially those related to the drugs, foods, and behaviors mentioned above.


nifedipine

Adalat CC, Adalat LA (UK), Adalat P.A., Adalat Retard (UK), Adalat XL, Adipine (UK), Afeditab CR, Angiopine (UK), Apo-Nifed, Calchan (UK), Cardilate MR (UK), Coracten (UK), Fortipine (UK), Gen-Nifedical, Hypolar Retard (UK), Neozipine XL (UK), Nifediac CC, Nifedical XL, Nifedipress MR (UK), Nifopress MR (UK), Novo-Nifedin, Nu-Nifed, Procardia, Procardia XL, Slofedipine (UK), Tensipine (UK), Valni Retard (UK), Valni XL (UK)


Pharmacologic class: Calcium channel blocker

Therapeutic class: Antianginal, anti-hypertensive

Pregnancy risk category C

 

Action

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

Availability

Capsules: 5 mg, 10 mg, 20 mg

Tablets (extended-release): 10 mg, 20 mg, 30 mg, 60 mg, 90 mg

Indications and dosages

Vasospastic (Prinzmetal's) angina; chronic stable angina

Adults: Initially, 10 mg P.O. (immediate-release) t.i.d. titrated over 7 to 14 days; usual effective range is 10 to 20 mg t.i.d., not to exceed 180 mg/day. Patient may be switched to extended-release at nearest equivalent of immediate-release daily dosage (for instance, 30-mg immediate-release dose may be switched to 90-mg extended-release dose). Total extended-release dosage should not exceed 90 mg/day.

Hypertension

Adults: 30 to 60 mg/day P.O. (extended-release only) titrated over 7 to 14 days to a maximum of 120 mg/day

Off-label uses

• Aortic regurgitation
• Heart failure
• Migraine
• Prevention of labor

Contraindications

• Hypersensitivity to drug

Precautions

Use cautiously in:
• chronic renal insufficiency
• hypotension, aortic stenosis, heart failure, significant left ventricular dysfunction (especially when used with beta-adrenergic blockers), peripheral edema
• elderly patients
• pregnant or breastfeeding patients (safety not established)
• children (safety not established).

Administration

• Give immediate-release form with or without food. If GI upset occurs, give with meals, but never with grapefruit or grapefruit juice.
• Don't crush or break extended-release tablet. Make sure patient swallows it whole. Give on empty stomach, and not with grapefruit or grapefruit juice.
• Know that Procardia XL and Adalat CC are not equivalent because of their pharmacokinetic differences.
• Be aware that only extended-release tablets are used to treat hypertension.

Adverse reactions

CNS: headache, dizziness, fatigue, asthenia, paresthesia, vertigo

CV: peripheral edema, chest pain, hypotension

EENT: epistaxis, rhinitis

GI: nausea, constipation

GU: urinary frequency, erectile dysfunction

Musculoskeletal: leg cramps

Skin: flushing, rash

Interactions

Drug-drug.Beta-adrenergic blockers: increased risk of heart failure, severe hypotension, or angina exacerbation

Cimetidine: increased nifedipine blood level

Coumarin anticoagulants: increased prothrombin time

Digoxin: increased risk of digoxin toxicity

Quinidine: decreased quinidine blood level

Drug-diagnostic tests.Antinuclear antibody, direct Coombs' test false-positive results

Drug-food.Grapefruit, grapefruit juice: increased nifedipine blood level and effects

Drug-herbs.Ephedra (ma huang), yohimbine: antagonism of nifedipine effect

Ginkgo, ginseng: increased nifedipine blood level

St. John's wort: decreased nifedipine blood level

Drug-behaviors.Alcohol use: additive hypotension

Patient monitoring

• Monitor vital signs and cardiovascular status. Stay alert for chest pain and edema.
• Watch for rash.

Patient teaching

• Tell patient he may take immediate-release form with or without meals. If GI upset occurs, tell him to take it with meals, but never with grapefruit or grapefruit juice.
• Caution patient not to crush or break extended-release tablets. Tell him to swallow them whole. Advise him to take on empty stomach, and not with grapefruit or grapefruit juice.
• Inform patient that angina attacks may occur 30 minutes after a dose. Explain that these attacks are usually temporary and don't mean that drug should be withdrawn.

Tell patient to report rash immediately.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration, balance, and alertness.
• Instruct patient to consult prescriber before taking herbs or over-the-counter drugs (especially cold remedies).
• As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs, tests, foods, herbs, and behaviors mentioned above.


nilotinib

Tasigna

Pharmacologic class: Protein-tyrosine kinase inhibitor

Therapeutic class: Antineoplastic

Pregnancy risk category D

 

FDABOXED WARNING

Drug prolongs QT interval and may lead to sudden death. Don't give to patients with hypokalemia, hypomagnesemia, or long-QT syndrome. Correct hypokalemia or hypomagnesemia before starting drug and monitor for these imbalances periodically. Avoid concomitant drugs known to prolong QT interval; also avoid strong CYP3A4 inhibitors. Instruct patient not to eat 2 hours before or 1 hour after taking dose. Obtain ECG to monitor QTc at baseline, 7 days after drug initiation, periodically thereafter, and after dosage adjustments.

Reduce dosage in patients with hepatic impairment.

Action

Inhibits proliferation of murine leukemic cell lines mediated by BCR-ABL kinase and human cell lines derived from patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML)

Availability

Capsules: 200 mg

Indications and dosages

Chronic-phase or accelerated-phase Ph+ CML in patients resistant or intolerant to previous imatinib therapy

Adults: 400 mg P.O. q 12 hours

Newly diagnosed Philadelphia chromosome positive CML Adults: 300 mg P.O. q 12 hours

Dosage adjustment

• QTc longer than 480 msec
• Hematologic toxicity
• Moderate or severe non-hematologic toxicity
• Concomitant use of CYP3A4 inducers
• Hepatic impairment

Off-label uses

• Ph+ acute lymphoblastic leukemia (ALL)
• Systemic mastocytosis with c-kit receptor activation
• Hypereosinophilic syndrome

Contraindications

• Hypokalemia
• Hypomagnesemia
• Long-QT syndrome

Precautions

Use cautiously in:
• hepatic impairment
• rare hereditary problems of galactose intolerance, severe lactase deficiency, or glucose-galactose malabsorption (use not recommended)
• myelosuppression
• electrolyte abnormalities
• history of pancreatitis
• pregnant or breastfeeding patients
• children (safety and efficacy not established).

Administration

Correct hypophosphatemia and hypokalemia before starting drug.
• Don't give with food. Know that patient shouldn't consume food for at least 2 hours before or 1 hour after dose.
• Administer capsule whole with water.
• Be aware that drug may be given in combination with hematopoietic growth factors, if indicated.

Adverse reactions

CNS: headache, fatigue, asthenia, insomnia, dizziness, paresthesia, vertigo, intracranial hemorrhage

CV: palpitations, hypertension, flushing, QT interval prolongation and sudden death

EENT: dysphonia, nasopharyngitis

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

Hematologic: anemia, neutropenia, thrombocytopenia, leukopenia, pan-cytopenia, febrile neutropenia

Hepatic: hepatotoxicity

Metabolic: electrolyte abnormalities

Musculoskeletal: arthralgia, myalgia, extremity pain, bone pain, muscle spasms, back pain, chest pain

Respiratory: cough, dyspnea, exertional dyspnea, pneumonia

Skin: rash, pruritus, eczema, urticaria, alopecia, erythema, hyperhidrosis, dry skin

Other: fever, peripheral edema, night sweats, weight changes

Interactions

Drug-drug.Drugs eliminated by CYP2B6, CYP2C8, or CYP2C9: decreased blood levels of these drugs

Drugs eliminated by CYP3A4 (such as warfarin), CYP2C8, CYP2C9, CYP2D6, or UGT1A1: increased blood levels of these drugs

Drugs that inhibit P-glycoprotein

ABCB1: increased nilotinib blood level

Midazolam: increased midazolam exposure

P-glycoprotein substrates: increased blood levels of these drugs

Strong CYP3A4 inducers (such as carba-mazepine, dexamethasone, phenytoin, rifabutin, rifampin, rifapentin, phenobarbital): decreased nilotinib blood level

Strong CYP3A4 inhibitors (such as atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole): increased nilotinib blood level

Drug-diagnostic tests.Albumin, calcium, magnesium, neutrophils, phosphorus, platelets, sodium, white blood cells: decreased levels

ALP, ALT, AST, bilirubin, blood glucose, creatinine, serum amylase, serum lipase: increased levels

Potassium: increased or decreased level

Drug-food.Grapefruit products: increased nilotinib blood level

High-fat meal: increased nilotinib onset

Drug-herbs.St. John's wort: decreased nilotinib blood level

Patient monitoring

Closely monitor for prolonged QT interval if patient has hepatic impairment or is receiving strong CYP3A4 inhibitors.
• Obtain complete blood count every 2 weeks for first 2 months of therapy and monthly thereafter, or as indicated.
• Periodically monitor electrolyte and lipase levels and liver function tests.

Patient teaching

• Tell patient not to take drug with food and not to consume food for at least 2 hours before or 1 hour after dose.
• Advise patient to take capsules whole with water.

Instruct patient to avoid grapefruit products and St. John's wort.
• Tell lactose-intolerant patient that drug contains lactose.

Instruct patient to immediately notify prescriber if symptoms of QTc prolongation (faintness or irregular heartbeat) occur.

Urge patient to immediately report signs or symptoms of liver damage, such as nausea, fatigue, anorexia, yellowing of skin or eyes, dark urine, light-colored stools, itching, or abdominal tenderness.
• Advise female patient that drug may harm fetus. Caution her to avoid pregnancy.
• Advise breastfeeding patient to seek guidance to help her decide whether to discontinue breastfeeding or discontinue drug.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, food, and herbs mentioned above.


nilutamide

Anandron, Nilandron


Pharmacologic class: Antiandrogen

Therapeutic class: Antineoplastic

Pregnancy risk category C

 

FDABOXED WARNING

Drug may cause interstitial pneumonitis. Though rare, interstitial changes have led to hospitalization and death postmarketing. Most cases occurred within first 3 months of therapy and reversed after drug was stopped. Obtain routine chest X-ray before starting treatment, and be prepared to obtain baseline pulmonary function tests if ordered. Instruct patient to report new or worsening shortness of breath; this symptom warrants immediate drug withdrawal pending evaluation.

Action

Inhibits testosterone uptake in target tissue, preventing normal androgenic response and arresting tumor growth in androgen-sensitive tissue

Availability

Tablets: 50 mg, 150 mg

Indications and dosages

Metastatic prostate cancer (used with surgical castration)

Adults: 300 mg/day P.O. for 30 days, starting on day of or day after surgery; then 150 mg/day P.O.

Contraindications

• Hypersensitivity to drug or its components
• Severe hepatic or respiratory insufficiency

Precautions

Use cautiously in:
• renal impairment.

Administration

• Give with or without food.
• Start therapy on same day as or day after surgical castration.

Adverse reactions

CNS: dizziness, depression, hyperes-thesia, insomnia

CV: hypertension, peripheral edema, heart failure

EENT: abnormal vision, impaired dark and light adaptation, chromatopsia

GI: nausea, vomiting, constipation, dyspepsia, anorexia

GU: hematuria, nocturia, urinary tract infection, gynecomastia, testicular atrophy, decreased libido, erectile dysfunction

Hematologic: anemia, aplastic anemia

Hepatic: hepatitis

Respiratory: dyspnea, upper respiratory infection, interstitial pneumonia

Other: flulike symptoms, pain, fever, hot flushes, alcohol intolerance

Interactions

Drug-drug.Phenytoin, theophylline, vitamin K: increased risk of toxicity from these drugs

Drug-diagnostic tests.Alanine aminotransferase, aspartate aminotransferase: increased levels

Drug-behaviors.Alcohol use: disulfiram-like reaction

Patient monitoring

• Check for signs and symptoms of hepatitis. Monitor liver function tests.
• Monitor CBC.
• Assess fluid intake and output and weight. Watch for signs and symptoms of heart failure.
• Monitor respiratory status, including chest X-rays.

Patient teaching

• Advise patient he may take with or without food.
• Tell patient therapy will start on day of or day after surgical castration.
• Caution patient not to stop taking drug without consulting prescriber.
• Instruct patient to weigh himself daily and report sudden increases.

Advise patient to report new onset or worsening of dyspnea as well as signs and symptoms of hepatotoxicity, such as nausea, vomiting, abdominal pain, unusual tiredness, or yellowing of skin or eyes.
• Advise patient to avoid alcohol during therapy, because serious adverse reactions may occur.
• Tell patient drug may impair his adaptation to darkness and light, which may cause difficulty driving at night or through tunnels.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, test, and behaviors mentioned above.


nimodipine

Nimotop


Pharmacologic class: Calcium channel blocker

Therapeutic class: Cerebral vasodilator

Pregnancy risk category C

 

FDABOXED WARNING

Don't give by I.V. or other parenteral route. Deaths and serious or life-threatening adverse events have occurred when capsule contents have been injected parenterally.

Action

Inhibits calcium transport into vascular smooth muscle cells, suppressing contractions; also dilates coronary and cerebral arteries

Availability

Capsules: 30 mg

Indications and dosages

Subarachnoid hemorrhage

Adults: 60 mg P.O. q 4 hours for 21 days. Therapy should start within 96 hours of subarachnoid hemorrhage.

Dosage adjustment

• Hepatic impairment

Contraindications

None

Precautions

Use cautiously in:
• hepatic impairment, hypotension
• elderly patients
• pregnant or breastfeeding patients (safety not established)
• children (safety not established).

Administration

• Give at least 1 hour before or 2 hours after meals. Don't let patient consume grapefruit or grapefruit juice within 1 hour before or 2 hours after dose.
• If patient can't swallow capsule, puncture it with sterile needle and empty contents into syringe. Administer through nasogastric tube, then flush with normal saline solution (30 ml).

Adverse reactions

CNS: headache, depression

CV: hypotension, peripheral edema, ECG abnormalities, bradycardia, tachycardia

GI: nausea, diarrhea, abdominal discomfort

Musculoskeletal: muscle cramps

Respiratory: dyspnea

Skin: acne, flushing, rash

Interactions

Drug-drug.Other calcium channel

blockers: enhanced cardiovascular effects

Drug-diagnostic tests.Liver function

tests: abnormal results

Drug-food.Any food: decreased drug blood level and effects

Grapefruit juice, grapefruit juice: increased drug blood level and effects

Drug-herbs.Ephedra (ma huang),

yohimbine: antagonism of nimodipine effects

St. John's wort: decreased drug blood level

Drug-behaviors.Alcohol use: increased hypotension

Patient monitoring

• Monitor weight and fluid intake and output. Stay alert for fluid retention.
• Assess neurologic status and mood, watching for signs of depression.
• Check vital signs and ECG.

Patient teaching

• Tell patient to complete full course of therapy (21 days).
• Advise patient to take on an empty stomach 1 hour before or 2 hours after a meal. Instruct him to not to consume grapefruit or grapefruit juice within 1 hour before or 2 hours after taking drug.
• Tell patient to report irregular heartbeat, shortness of breath, rash, or swollen hands or feet.
• Instruct patient to minimize GI upset by eating small, frequent meals.
• Advise patient to weigh himself daily and report sudden weight gain.
• As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs, tests, foods, herbs, and behaviors mentioned above.


nisoldipine

Sular, Syscor (UK)


Pharmacologic class: Calcium channel blocker

herapeutic class: Antihypertensive

Pregnancy risk category C

 

Action

Suppresses calcium transport into vascular smooth muscle cells. This suppression inhibits vasoconstriction and dilates coronary arteries, improving myocardial oxygen uptake.

Availability

Tablets (extended-release): 8.5 mg, 17 mg, 22.5 mg, 34 mg

Indications and dosages

Hypertension

Adults: Initially, 17 mg P.O. daily; may increase by 8.5 mg per week or longer intervals to attain adequate blood pressure control. Usual maintenance dosage is 17 to 34 mg daily.

Contraindications

• Hypersensitivity to drug or dihydropyridine calcium channel blockers

Precautions

Use cautiously in:
• heart failure and left ventricular dysfunction, hepatic impairment, renal disease, coronary artery disease, hypotension
• concurrent phenytoin use
• elderly patients
• pregnant or breastfeeding patients
• children (safety not established).

Administration

• Give with meals, but not with high-fat meals, grapefruit, or grapefruit juice.
• Don't crush or break extended-release tablets. Make sure patient swallows them whole.
• Know that drug may be given alone or with other antihypertensives.

Adverse reactions

CNS: headache, dizziness

CV: peripheral edema, chest pain, vasodilation, hypotension, palpitations

EENT: pharyngitis, sinusitis

GI: nausea

Skin: rash

Interactions

Drug-drug.Cimetidine: increased nisoldipine blood level

Phenytoin, other CYP3A4 inducers: decreased nisoldipine blood level and efficacy

Drug-food.Grapefruit juice: significantly increased drug blood level and effects

High-fat meal: decreased drug blood level

Drug-herbs.Ephedra (ma huang), yohimbine: antagonism of nimodipine effects

St. John's wort: decreased nimodipine blood level

Drug-behaviors.Alcohol use: increased hypotensive effects

Patient monitoring

• Check vital signs and ECG.
• Monitor fluid intake and output. Watch for peripheral edema.

Patient teaching

• Tell patient to swallow extended-release tablets whole and not to crush or break them.
• Advise patient to take with food, but not high-fat food. Recommend small, frequent meals.
• Instruct patient to avoid high-fat meals, alcohol, grapefruit, and grapefruit juice.
• Tell patient to immediately report irregular heart beat, shortness of breath, swelling, pronounced dizziness, rash, or chest pain.
• As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs, foods, herbs, and behaviors mentioned above.


nitazoxanide

Alinia


Pharmacologic class: Antiprotozoal

Therapeutic class: Anti-infective

Pregnancy risk category B

 

Action

Impedes pyruvate:ferredoxin oxidoreductase enzyme-dependent electron transfer reaction, which is essential to anaerobic energy metabolism

Availability

Oral suspension: 100 mg/5 ml

Tablets: 500 mg

Indications and dosages

Diarrhea caused by Giardia lamblia or Cryptosporidium parvum

Adults and children ages 12 and older: 500 mg (tablet or 25 ml suspension) P.O. every 12 hours with food for 3 days

Children ages 4 to 11: 200 mg (10 ml suspension) P.O. every 12 hours with food for 3 days

Children ages 1 to 3: 100 mg (5 ml suspension) P.O. every 12 hours with food for 3 days

Contraindications

• Hypersensitivity to drug or its components

Precautions

Use cautiously in:
• renal, hepatic, or biliary disease or dysfunction; immunodeficiency (including human immunodeficiency virus); diabetes mellitus (suspension)
• concurrent use of warfarin or other highly plasma protein-bound drugs
• elderly patients
• pregnant or breastfeeding patients
• children younger than age 11 (tablets) or age 1 (suspension).

Administration

• Give with food.
• Because a single tablet contains more nitazoxanide than recommended for pediatric dosing, don't give tablets to children younger than age 11.
• Keep suspension container tightly closed and shake well before each use. Suspension may be stored for 7 days; after that, discard unused portion.

Adverse reactions

CNS: headache

GI: nausea, vomiting, diarrhea, abdominal pain

Interactions

Drug-drug.Warfarin and other highly plasma protein-bound drugs with narrow therapeutic index: competition for binding sites, resulting in increased nitazoxanide blood level and efficacy

Patient monitoring

• Monitor renal and liver function tests frequently in patients with renal, hepatic, or biliary dysfunction.
• Monitor blood glucose levels in diabetic patients taking oral suspension.

Patient teaching

• Instruct patient to take drug with food.
• Inform diabetic patient that oral suspension contains sucrose.
• As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs mentioned above.


nitrofurantoin

Apo-Nitrofurantoin, Furadantin, Novo-Furantoin


niMODipine

(nye-moe-di-peen) ,

Nimotop

(trade name),

Nymalize

(trade name)

Classification

Therapeutic: subarachnoid hemorrhage therapy agents
Pharmacologic: calcium channel blockers
Pregnancy Category: C

Indications

Management of subarachnoid hemorrhage.

Action

Inhibits the transport of calcium into vascular smooth muscle cells, resulting in inhibition of excitation-contraction coupling and subsequent contraction.
Potent peripheral vasodilator.

Therapeutic effects

Prevention of vascular spasm after subarachnoid hemorrhage, resulting in decreased neurologic impairment.

Pharmacokinetics

Absorption: Well absorbed following oral administration but extensively metabolized, resulting in ↓ bioavailability.
Distribution: Crosses the blood-brain barrier; remainder of distribution unknown.
Protein Binding: >95%.
Metabolism and Excretion: Mostly metabolized by the liver; ≤10% excreted unchanged by kidneys.
Half-life: 1–2 hr.

Time/action profile (vasodilation)

ROUTEONSETPEAKDURATION
POunknown1 hr4 hr

Contraindications/Precautions

Contraindicated in: Hypersensitivity;Systolic BP <90 mm Hg.Concurrent use of strong CYP3A4 inhibitors (↑ risk of hypotension)Concurrent use of strong CYP3A4 inducers (↓ efficacy)
Use Cautiously in: Severe hepatic impairment (dose ↓ recommended);Severe renal impairment;History of serious ventricular arrhythmias or HF; Obstetric / Lactation / Pediatric: Safety not established; Geriatric: Dose ↓ recommended due to↑ risk of hypotension.

Adverse Reactions/Side Effects

Central nervous system

  • abnormal dreams
  • anxiety
  • confusion
  • dizziness
  • drowsiness
  • headache
  • nervousness
  • psychiatric disturbances
  • weakness

Ear, Eye, Nose, Throat

  • blurred vision
  • disturbed equilibrium
  • epistaxis
  • tinnitus

Respiratory

  • cough
  • dyspnea

Cardiovascular

  • arrhythmias (life-threatening)
  • HF (life-threatening)
  • chest pain
  • hypotension
  • palpitations
  • peripheral edema
  • syncope
  • tachycardia

Gastrointestinal

  • ↑ liver enzymes
  • anorexia
  • constipation
  • diarrhea
  • dry mouth
  • dysgeusia
  • dyspepsia
  • nausea
  • vomiting

Genitourinary

  • dysuria
  • nocturia
  • polyuria
  • sexual dysfunction
  • urinary frequency

Dermatologic

  • dermatitis
  • erythema multiforme
  • flushing
  • ↑ sweating
  • photosensitivity
  • pruritus/urticaria
  • rash

Endocrinologic

  • gynecomastia
  • hyperglycemia

Hematologic

  • anemia
  • leukopenia
  • thrombocytopenia

Metabolic

  • weight gain

Musculoskeletal

  • joint stiffness
  • muscle cramps

Neurologic

  • paresthesia
  • tremor

Miscellaneous

  • stevens-johnson syndrome (life-threatening)
  • gingival hyperplasia

Interactions

Drug-Drug interaction

Strong CYP3A4 inhibitors, including clarithromycin, telithromycin, indinavir, nelfinavir, ritonavir, saquinavir, boceprevir, telaprevir, ketoconazole, itraconazole, posaconazole, voriconazole, conivaptan, and nefazodone may ↑ levels and the risk of hypotension; avoid concurrent useStrong CYP3A4 inducers, including carbamazepine, phenobarbital, phenytoin, and rifampin may ↓ levels and effects; avoid concurrent useAdditive hypotension may occur when used concurrently with fentanyl, other antihypertensives, nitrates, acute ingestion of alcohol, or quinidine.St. John's wort may ↓ levels and effect; avoid concurrent useGrapefruit and grapefruit juice ↑ levels and effect; avoid concurrent use.

Route/Dosage

Oral (Adults) 60 mg every 4 hr for 21 days; therapy should be started within 96 hr of subarachnoid hemorrhage.

Hepatic Impairment

Oral (Adults) 30 mg every 4 hr for 21 days; therapy should be started within 96 hr of subarachnoid hemorrhage.

Availability (generic available)

Capsules: 30 mg
Oral solution: 3 mg/mL

Nursing implications

Nursing assessment

  • Assess patient’s neurologic status (level of consciousness, movement) prior to and periodically following administration.
  • Monitor BP and pulse prior to therapy and periodically during therapy.
  • Monitor intake and output ratios and daily weight. Assess for signs of HF (peripheral edema, rales/crackles, dyspnea, weight gain, jugular venous distention).
  • Assess for rash periodically during therapy. May cause Stevens-Johnson syndrome. Discontinue therapy if severe or if accompanied with fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, hepatitis, and/or eosinophilia.
  • Lab Test Considerations: Total serum calcium concentrations are not affected by calcium channel blockers.
    • Monitor serum potassium periodically. Hypokalemia ↑ risk of arrhythmias; should be corrected.
    • Monitor renal and hepatic functions periodically. Several days of therapy may cause ↑ hepatic enzymes, which return to normal upon discontinuation of therapy.
    • May occasionally cause ↓ platelet count.

Potential Nursing Diagnoses

Ineffective tissue perfusion (Indications)

Implementation

  • Do not confuse nimodipine with nicardipine or nifedipine.
    • Begin administration within 96 hr of subarachnoid hemorrhage and continue every 4 hr for 21 consecutive days.
  • Administer by PO route ONLY; when administered IV or parenterally, may cause serious adverse events, including death.
  • Oral: If patient is unable to swallow capsule, make a hole in both ends of the capsule with a sterile 18-gauge needle and extract the contents into a syringe. Empty contents into water or nasogastric tube and flush with 30 mL normal saline.
    • Administer oral solution 1 hr before or 2 hr after meals. For administration via NG or gastric tube, administer via syringe included, then refill syringe with 20 mL of 0.9% saline water solution; flush remaining contents from NG or gastric tube into stomach.

Patient/Family Teaching

  • Advise patient to take medication as directed, even if feeling well. Take missed doses as soon as possible unless almost time for next dose; do not double doses. May need to be discontinued gradually.
    • Advise patient to avoid grapefruit or grapefruit juice during therapy.
    • Caution patient to change positions slowly to minimize orthostatic hypotension.
    • May cause drowsiness or dizziness. Advise patient to avoid driving or other activities requiring alertness until response to the medication is known.
    • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to avoid concurrent use of alcohol or OTC medications and herbal products, especially cold preparations, without consulting health care professional.
    • Advise patient to notify health care professional if rash, irregular heartbeats, dyspnea, swelling of hands and feet, pronounced dizziness, nausea, constipation, or hypotension occurs or if headache is severe or persistent.
    • Caution patient to wear protective clothing and use sunscreen to prevent photosensitivity reactions.
    • Advise female patient to notify health care professional if pregnancy is planned or suspected or if breast feeding.

Evaluation/Desired Outcomes

  • Improvement in neurologic deficits due to vasospasm following subarachnoid hemorrhage.

Nimodipine (Nimotop)

A calcium-channel blocker, that is, a drug that relaxes arterial smooth muscle by slowing the movement of calcium across cell walls.
Mentioned in: Cerebral Aneurysm
References in periodicals archive ?
You may be getting too little of these medications if you're drinking grapefruit juice: Calcium channel-blockers, including Norvase, Plendil, Cardene, Procardia, Adalat, Nifedical, and Nimotop.
Woodcliff Lake NJ) won approval for a generic version of Nimotop, which prevents brain damage resulting from aneurysm or hemorrhage.
Nimotop had annual sales of approximately $29 million for the twelve months ended February 2007, based on IMS sales data.
The bill will also prevent competition for other critical drugs, including Cardiogen 82 (radiologic imaging), Daypro (arthritis), Dermatop (skin ailments), Eulexin (prostate cancer), Nimotop (stroke), Penetrex (urinary tract infection) and Relafen (arthritis).
Other drugs covered by the bill that would continue to be sold free of price-dropping competition are: Cardiogen-82 (radiologic imaging), Daypro (arthritis), Dermatop (skin ailments), Eulexin (prostate cancer), Nimotop (stroke), Penetrex (urinary tract infections) and Relafen (arthritis).
Seniors will be especially harmed by the "Claritin Patent Extension Act" because 35 percent of older Americans pay out-of-pocket for medicine and use most of the drugs protected under the bill, including: Cardiogen-82 (radiologic imaging), Claritin (allergies), Daypro (arthritis), Dermatop (skin ailments), Eulexin (prostate cancer), Nimotop (stroke), Penetrex (urinary tract infections) and Relafen (arthritis).
Seniors will be hardest-hit because 35 percent of older Americans pay out-of-pocket for medicine and use most of the drugs protected under the bill, including: Cardiogen-82 (radiologic imaging), Daypro (arthritis), Dermatop (skin ailments), Eulexin (prostate cancer), Nimotop (stroke), Penetrex (urinary tract infections), and Relafen (arthritis).
1172 passes because 35 percent of older Americans pay out- of-pocket for medicine and use most of the drugs protected under the bill, including: Cardiogen-82 (radiologic imaging), Daypro (arthritis), Dermatop (skin ailments), Eulexin (prostate cancer), Nimotop (stroke), Penetrex (urinary tract infections) and Relafen (arthritis).
Seniors will be hardest hit because 35 percent of older Americans pay out-of-pocket for medicine and use most of the drugs protected under the bill, including: Cardiogen-82 (radiologic imaging), Daypro (arthritis), Dermatop (skin ailments), Eulexin (prostate cancer), Nimotop (stroke), Penetrex (urinary tract infections), and Relafen (arthritis).
Drugs protected under the bill include Claritin and Eulexin (prostate cancer/Schering-Plough), Daypro (arthritis/Monsanto), Dermatop (skin ailments/Hoechst Marion Roussel), Penetrex (urinary tract infections/Rhone-Poulenc-Rorer), Cardiogen-82 (radiologic imaging/Bristol-Myers Squibb), Nimotop (stroke/Bayer A.
The drugs include Claritin and Eulexin (prostate cancer/Schering-Plough), Dermatop (skin ailments/Hoechst Marion Roussel), Penetrex (urinary tract infections/Rhone- Poulenc-Rorer), Cardiogen-82 (radiologic imaging/Bristol-Myers Squibb), Nimotop (stroke/Bayer A.