Carvedilol

Category:

Alpha₁/beta blocker

Indications:

Heart Failure, Left Ventricular Dysfunction,  Post-Myocardial Infarction, Hypertension

Heart Failure

Dosage and administrations:

Heart Failure

Initial: 3.125mg bid for 2 weeks
Titrate: If tolerated, may increase dose to 6.25mg, 12.5mg, and 25mg bid over successive intervals of at least 2 weeks
Max: 50mg bid in patients with mild to moderate heart failure (HF) weighing >85kg.

Left Ventricular Dysfunction Post-Myocardial Infarction

Initial: 6.25mg bid
Titrate: Increase after 3-10 days, based on tolerability, to 12.5mg bid, then again to target dose of 25mg bid
May use lower starting dose and/or slower titration

Hypertension

Initial: 6.25mg bid
Titrate: If needed, based on blood pressure control, may increase to 12.5mg bid, then to 25mg bid over intervals of 7-14 days
Max: 50mg/day

Note: in Elderly/Patients at Increased Risk of Hypotension, Dizziness, or Syncope, increase doses, as appropriate, after an interval of at least 2 weeks.

Pregnancy and breastfeeding:

Pregnancy: Category C.
Lactation: Not for use in nursing.

Contraindications:

Bronchial asthma or related bronchospastic conditions, 2nd- or 3rd-degree atrioventricular (AV) block, sick sinus syndrome, severe bradycardia, cardiogenic shock, decompensated HF requiring IV inotropic therapy, severe hepatic impairment.

Warning and precautions:

Minimize fluid retention prior to initiation of treatment.

Severe exacerbation of angina and occurrence of MI and ventricular arrhythmias reported in angina patients following abrupt discontinuation; discontinue therapy over 1-2 weeks whenever possible.

If angina worsens or acute coronary insufficiency develops, promptly reinstitute therapy, at least temporarily.

Avoid abrupt discontinuation even in patients treated only for HTN or HF.

Bradycardia reported; reduce dose if HR drops <55 BPM.

Hypotension, postural hypotension, and syncope reported; highest risk during the first 30 days of dosing.

May impair mental/physical abilities.

Worsening HF or fluid retention may occur during up-titration; if such symptoms occur, increase dose of diuretics.

If deemed necessary, use with caution in patients with bronchospastic disease who do not respond to, or cannot tolerate, other antihypertensives.

May mask signs of hypoglycemia and hyperthyroidism (eg, tachycardia).

May exacerbate symptoms of hyperthyroidism or precipitate thyroid storm with abrupt withdrawal.

May lead to worsening hyperglycemia in HF patients with diabetes.

May precipitate or aggravate symptoms of arterial insufficiency in patients with peripheral vascular disease.

Rarely, use in patients with HF resulted in deterioration of renal function; discontinue or reduce dosage if worsening of renal function occurs.

Chronically administered therapy should not be routinely withdrawn prior to major surgery; may augment risks of general anesthesia and surgical procedures.

Caution with pheochromocytoma and Prinzmetal’s variant angina. Patients with history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge and may be unresponsive to usual doses of epinephrine.

Intraoperative floppy iris syndrome observed during cataract surgery.

Adverse reactions:

Bradycardia, fatigue, hypotension, dizziness, headache, diarrhea, N/V, hyperglycemia, weight increase, increased cough, asthenia.

Drug interactions:

Potent CYP2D6 inhibitors (eg, quinidine, fluoxetine, propafenone) may increase levels. Monitor closely for signs of hypotension and/or severe bradycardia with drugs that can deplete catecholamines (eg, reserpine, MAOIs).

Potentiated BP- and HR-lowering effects with clonidine; when coadministration is to be terminated, d/c therapy several days before clonidine is withdrawn.

May increase cyclosporine levels; monitor concentrations and adjust dose of cyclosporine as appropriate.

Increased risk of bradycardia with digitalis glycosides. May increase digoxin levels; monitor digoxin. Rifampin may reduce levels.

Cimetidine may increase exposure.

Amiodarone and its metabolite desethyl amiodarone, CYP2C9 inhibitors, and P-gp inhibitors may increase levels.

Amiodarone or other CYP2C9 inhibitors (eg, fluconazole) may enhance β-blocking properties; monitor for signs of bradycardia or heart block.

Conduction disturbance reported with diltiazem; monitor ECG and BP with calcium channel blockers of the verapamil or diltiazem type.

May enhance blood glucose-reducing effect of insulin and oral hypoglycemics; regularly monitor blood glucose.

If treatment is to be continued perioperatively, use caution when anesthetic agents that depress myocardial function (eg, ether, cyclopropane, trichloroethylene) are used.

Additive effects and exaggerated orthostatic component with diuretics.

Storage:

Store below 30°C. Protect from moisture.

Keep out of reach of children.

Lozar

Category:

Antihypertensive , angiotensin II receptor antagonist.

Indications:

Lozar is indicated for the treatment of hypertension, hypertension with left ventricular hypertrophy, diabetic nephropathy

Dosage and Administration:

Hypertension

Initial: 50mg qd
Max: 100mg qd

Hypertension with Left Ventricular Hypertrophy

Reduction in Risk of Stroke:
Initial: 50mg qd
Titrate: Add hydrochlorothiazide (HCTZ) 12.5mg qd and/or increase losartan to 100mg qd, followed by an increase in HCTZ to 25mg qd based on BP response.

Diabetic Nephropathy

Elevated SrCr/Proteinuria (Urinary Albumin to Creatinine Ratio ≥300mg/g) in Patients with Type 2 Diabetes and a History of HTN:
Initial: 50mg qd
Titrate: Increase to 100mg qd based on BP response

Usage in pregnancy and lactation:

Pregnancy Categories C (first trimester) and D (second and third trimesters).

Not for use in nursing.

Contraindications:

Hypersensitivity to any component of the medication, coadministration with aliskiren in patients with diabetes.

Warning and precautions:

Symptomatic hypotension may occur in patients with an activated RAS (eg, volume- or salt-depleted patients); correct volume or salt depletion prior to administration of therapy.

Patients whose renal function may depend in part on the activity of the RAS may be at risk of developing acute renal failure; monitor renal function periodically.

Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on losartan.

Monitor serum K+ periodically and treat appropriately; dosage reduction or discontinuation of losartan may be required.

Drug Interactions:

Concomitant use of potassium – sparing diuretics (e.g.,spironolactone , triamterene, amiloride) , potassium supplements , or salt substitutes containing potassium may lead to increases in serum potassium.

Increases in serum lithium concentrations and lithium toxicity reported; monitor serum lithium levels during concomitant use.

In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration with NSAIDs, including selective COX-2 inhibitors, may result in deterioration in renal function, including possible acute renal failure.

Antihypertensive effect may be attenuated by NSAIDs, including selective COX-2 inhibitors.

Dual blockade of the RAS is associated with increased risks of hypotension, syncope, hyperkalemia, and changes in renal function (including acute renal failure); avoid combined use of RAS inhibitors. Closely monitor BP, renal function, and electrolytes with concomitant agents that affect the RAS.

Avoid with aliskiren in patients with renal impairment (GFR <60mL/min).

Adverse Reactions:

Dizziness, URI, nasal congestion, back pain.

Storage:

Store below 30° C.

Protect from light.

prazosin Tablets 1& 5 mg

Category:

Alpha1-blocker (quinazoline)

Composition:

Each tablet contains: prazosin (as hydrochloride)    1 or 5 mg

Indication:

Treatment of :

Hypertension

Congestive heart failure : Prazosin may be used as an adjunct to digoxin and diuretics for the treatment of congestive heart failure. However, prazosin has not been shown to improve survival in these patients.

Toxicity , ergot alkaloid: prazosin is used for treatment of peripheral vasospasm caused by ergot alkaloid overdose.

Pheochromocytoma : prazosin is used for the management of hypertension associated with pheochromocytoma.

Reynaud’s phenomenon

Benign prostatic hyperplasia (BPH) : prazosin is used for the treatment of urinary symptoms associated with benign prostatic hyperplasia. Prazosin has been shown to improve urinary flow and symptoms of BPH. However, the long – term effects of prazosin on the incidence of acute urinary obstruction or other complications of BPH or on the need for surgery have not yet been determined .

Contraindication:

Hypersensitivity to any of the product’s ingredients.

Precaution & warnings:

May cause marked lowering of BP especially postural hypotension and syncope with the 1st dose or 1st few days of therapy; similar effect may be anticipated if therapy is discontinued for several days and then restarted. minimize syncopal episodes by limiting initial dose to 1mg, by subsequently increasing the dose slowly, and by introducing any additional antihypertensive with caution.

May impair physical/mental abilities.

Examine patients with BPH to rule out prostate cancer prior to initiation of therapy.

Priapism (rare) reported. Monitor for signs/symptoms of priapism.

Intraoperative floppy iris syndrome observed during cataract surgery.

Safety and efficacy have not been established for pediatrics.

Pregnancy & Breastfeeding:

Category C, caution in nursing.

Dosage and administration:

“ If discontinued for several days or longer, restart using the initial dosing regimen. “

Treatment of hypertention:

Initial Dose:

1 mg two or three times a day

Maintenance Dose :

Dosage may be slowly increased to a total daily dose of 20 mg given in divided doses. The therapeutic dosages most commonly employed have ranged from 6 mg to 15 mg daily given in divided doses. Doses higher than 20 mg usually do not increase efficacy, however a few patients may benefit from further increases up to a daily dose of 40 mg given in divided doses. After initial titration some patients can be maintained adequately on a twice daily dosage regimen.

Use With Other Drugs :

When adding a diuretic or other antihypertensive agent, the dose should be reduced to 1 mg or 2 mg three times a day and retitration then carried out.

Toxicity , ergot alkaloid : oral , 1 mg three times a day .

Vasospastic therapy adjunct – Reynaud’s phenomenon : oral , 1 mg three times a day.

 Benign prostatic hyperplasia :

Initial : oral , 1 mg ( base ) two times a day .

Maintenance : Oral , 1 to 5 mg ( base ) two times a day.

Usual adult prescribing limits : Daily doses higher than 20mg ( base ) usually do not have increased efficacy, although some patients respond to up to 40mg a day.

Side effects:

Dizziness, headache, drowsiness, lack of energy, weakness, palpitations, nausea/vomiting, edema, orthostatic hypotension, dyspnea, syncope, depression, urinary frequency, diarrhea.

Drug interaction:

Additive hypotensive effects with diuretics, β-blockers (eg, propranolol), or other antihypertensives. Additive BP-lowering effects and symptomatic hypotension with PDE-5 inhibitors.

Storage:

Store below 30°C. Protect from light.

Keep out of reach of children.

Enalapril

Category:

Antihypertensive, Angiotensin – Converting enzyme (ACE) inhibitor

Composition:

Each tablet contains enalapril maleate   5 mg or 20 mg.

Indications:

Hypertension: Enalapril is indicated for the treatment of hypertension. Enalapril is effective alone or in combination with other antihypertensive agents, especially a thiazide diuretic. The blood pressure lowering effects of enalapril and thiazides are approximately additive. Enalapril also used for renovascular hypertension (except in patients with bilateral renal artery stenosis).

Heart Failure: Enalapril is indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis therapy , for treatments of congestive heart failure not responding to other measures.

Asymptomatic left ventricular dysfunction:

In clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction ≤ 35 percent), enalapril decreases the rate of development of overt heart failure and decreases the frequency of hospitalization for heart failure.

Dosage and Administration:

Usual adult and adolescent dose:

Antihypertensive:

Initial: Oral , 5mg once a day, the dosage being adjusted after one or two weeks according to clinical response.

Maintenace: Oral , 10 to 40 mg per day, as a single dose or in two divided doses.

Note:

An initial dose of 2.5 mg should be used in patients who are sodium – and water – depleted as a result of prior diuretic therapy, patients continuing to receive diuretic therapy, or patients with renal failure (creatinine clearance less than 30ml per minute). Such patients should be kept under medical supervision for at least two hours after this initial dose (and for an additional hour after blood pressure has stabilized), to watch for excessive hypotension effect.

Congestive heart failure , vasodilator:

Initial: Oral, 2.5mg once or twice a day, the dosage being adjusted after a few days or weeks according to clinical response.

Maintenance: Oral, 5 to 40mg per day, as a single dose or in two divided doses.

Asymptomatic left ventricular dysfunction:

Oral , 2.5mg two times a day titrated as tolerated up to a target dose of 20mg a day in divided doses.

Note: patients should be kept under medical supervision for at least two hours and until blood pressure has stabilized for an additional hour after the initial dose.

In patients with hyponatremia (serum sodium concentration less than 130mEq per liter) or serum creatinine greater than 1.6mg per deciliter, an initial dose of 2.5mg once a day is recommended. If possible, the dose of the diuretic should be reduced to decrease the likelihood of hypotension effect.

-Usual adult prescribing limits: 40mg per day.

-Usual pediatric dose: Safety and efficacy have not been established.

Dosage in renal insufficiency:

Generally, the intervals between the administration of Enalapril should be prolonged and /or the dosage reduced. Initial dose in mild impairment With creatinine clearance between 30 and 80 ml/min is 5mg.

In moderate to severe impairment with creatinine clearance lower than 30ml/min is 2.5 mg.

In dialysis patients is 2.5 mg on dialysis days.

Contraindications:

Enalapril is contraindicated in patients who are hypersensitive to any components of this product and in patients with a history of medical problems especially angioedema related to previous treatment with an ACE-inhibitor, hepatic function impairment, hyperkalemina, renal artery stenosis, renal transplant, renal function impairment or sodium and volume depletion.

Warnings:

Anaphylactoid and possibly related reactions: Presumably because Angiotensin – converting enzyme inhibitors affect the metabolism of eicosanoids and polypeptides, including endogenous bradykinin, patients reciving ACE inhibitors may be subject to a variety of adverse reactions, some of them serious.

Angioedema: Angioedema of the face, extremities, lips, tongue, glottis and / or larynx has been reported in patients treated with angiotensin converting enzyme inhibitors, including enalapril. This may occur at any time during treatment. In such cases enalapril should be promptly discontinued and appropriate therapy and monitoring should be provided until complete and sustained resolution of signs and symptoms has occurred. In instances where swelling has been confined to the face and lips the condition has generally resolved without treatment, although antihistamines have been useful in relieving symptoms. Angioedema associated with laryngeal edema may be fatal. Where there is involvement of the tongue, glottis or larynx, likely to cause airway obstruction, appropriate therapy, e.g., subcutaneous epinephrine solution 1:1000 (0.3 ml to 0.5 ml) and / Checking patient airway, should be promptly provided.

Other possibly and rare reactions: Anaphylactoid reactions during desensitization, anaphylactoid reactions during membrane exposure, hypotension, neutropenia and agranulocytosis, hepatic failure, fetal / neonatal morbidity and mortality.

Precautions:

Aortic stenosis / Hypertrophic cardiomiopathy: Enalapril should be given with caution to patients with obstruction in the outflow of the left ventricle.

Surgery / Anesthesia: In patients undergoing major surgery or during anesthesia with agents that produce hypotension, enalapril may block angiotensin II formation secondary to compensatory renin release. If hypotension occurs and is considered to be due to this mechanism it can be corrected by volume expansion.

Usage in pregnancy:

Pregnancy categories: C. (first trimester) and D . (second and third trimester). When pregnancy is detected, enalapril should be discontinued as soon as possible.

Nursing Mothers:

Enalapril and Enalaprilat are detected in human milk in trace amounts. Caution should be made when enalapril is given to a nursing mother.

Pediatric use:

Safety and effectiveness in children have not been established.

Drug Interactions:

Diuretics, may occasionally experience an excessive reduction of blood pressure with enalapril. The possibility of hypotensive effects with enalapril can be minimized by either discontinuing the diuretic or increasing the salt intake prior to initiation of treatment with enalapril. If it is necessary to continue the diuretic, therapy close medical supervision after the initial dose for at least two hours and until blood pressure has stabilized for at least an additional hour is recommended.

Agents causing rennin release: The antihypertensive effect of enalapril is augmented by antihypertensive agents that cause renin release (e.g.diuretics).

Non – steroidal anti – inflammatory agents:

In some patients with compromised renal function who are being treated with non – steroidal anti – inflammatory drugs, the co – administration of enalapril may result in a further deterioration of renal function. These effects are usually reversible.

Agents increasing serum potassium:

Enalapril attenuates potassium loss caused by thiazide – type diuretics.

Potassium sparing diuretics (e.g. spironolactone, triamteren, or amiloride) , potassium supplements or potassium – containing salt substitutes may lead to significant increases in serum potassium. Therefore, if concomitant use of these agents is indicated because of demonstrated hypokalemia, they should be used with caution and with frequent monitoring of serum potassium.

Potassium sparing agents should generally not be used in patients with heart failure receiving enalapril.

Lithium : Lithium toxicity has been reported in patients receiving lithium concomitantly with drugs which cause elimination of sodium , including ACE inhibitors. It is recommended that serum lithium levels be monitored frequently if enalparil is administered concomitantly with lithium.

Adverse Reactions:

Enalapril has been found to be generally tolerated in controlled clinical trials. Adverse experiences were mild and transient in nature. In clinical trials discontinuation of therapy due to clinical adverse experiences was required in 3.3 percent of patients with hypertension and in 5.7 percent of patients with heart failure. The frequency of adverse experiences was not related to total daily dosage within the usual dosage ranges. In patients with hypertension the overall percentage of patients treated with enalapril, reporting adverse experiences was comparable to placebo.

Incidence more frequent (more than 1 percent) : Fatigue, headache, dizziness, rash, hypotension, diarrhea, cough.

Incidence rare (less than 1 percent) : Renal dysfunction, decreased hemoglobin and hematocrit, pemphigus, bradycardia, hepatic failure, peripheral neuropathy, pneumonia.

Storage:

Store below 30^˚C.

Keep out of reach of children.

Amlodipine

THERAPEUTIC CLASS:

Calcium channel blocker (CCB) (dihydropyridine)

INDICATIONS:

Hypertension, Coronary Artery Disease, Angina

DOSAGE AND ADMINISTRATION:

Hypertension:

Alone or in combination with other antihypertensive agents

Initial: 5mg qd
Titrate: Adjust according to BP goals
Wait 7-14 days between titration steps; if clinically warranted, titrate more rapidly and assess patient frequently
Max: 10mg qd

Angina:

Chronic stable angina or confirmed or suspected vasospastic (Prinzmetal’s/variant) angina, alone or in combination with other antianginals

Usual: 5-10mg qd

Coronary Artery Disease:

Reduces the risk of hospitalization due to angina and reduces risk of coronary revascularization procedures in patients with recently documented coronary artery disease by angiography and w/o heart failure or an ejection fraction <40%

Usual: 5-10mg qd

Note: give the lowest dose (2.5 mg) in patients with hepatic impairment or elderly.

Pediatrics dosage:

Hypertension

6-17 Years:
Usual: 2.5-5mg qd
Max: 5mg qd

PREGNANCY AND LACTATION

Category C, not for use in nursing.

WARNINGS AND PRECAUTIONS:

May cause symptomatic hypotension, particularly in patients with severe aortic stenosis.

Worsening angina and acute MI may develop after starting or increasing the dose, particularly with severe obstructive CAD.

Titrate slowly in patients with severe hepatic impairment.

ADVERSE REACTIONS:

Edema, palpitations, dizziness, fatigue, flushing.

DRUG INTERACTIONS

Increased systemic exposure with moderate and strong CYP3A inhibitors and may require dose reduction; monitor for symptoms of hypotension and edema to determine the need for dose adjustment.

Closely monitor BP if coadministered with CYP3A inducers.

Monitor for hypotension when coadministered with sildenafil.

May increase simvastatin exposure; limit dose of simvastatin to 20mg daily.

May increase systemic exposure of cyclosporine or tacrolimus; monitor trough blood levels of cyclosporine and tacrolimus frequently and adjust dose when appropriate.

STORAGE

Store below 30°C .

      Keep out of reach of children.

Atorvatatin

Category:

HMG-CoA reductase inhibitor (statin)

Composition:

Each tablet contains:

Atorvastatin (as calcium trihydrate)     10mg, 20mg or 40mg

Indication:

Adjunct to diet to decrease total cholesterol, LDL, apolipoprotein B, and TG levels, and to increase HDL levels in primary hypercholesterolemia and mixed dyslipidemia, hypertriglyceridemia, primary dysbetalipoproteinemia, homozygous familial hypercholesterolemia, heterozygous familial hypercholesterolemia (boys and postmenarchal girls 10-17 yrs of age), and in prevention of cardiovascular disease.

Contraindication:

Active liver disease, which may include unexplained persistent elevations in hepatic transaminases,

women who are pregnant or may become pregnant.

nursing mothers.

Precaution & warnings:

Has not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types I and V).

Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria reported.

Increased risk of rhabdomyolysis with history of renal impairment; closely monitor for skeletal muscle effects.

May cause myopathy (including immune-mediated necrotizing myopathy [IMNM]); discontinue if markedly elevated CPK levels occur or if myopathy is diagnosed or suspected.

 Temporarily withhold or discontinue if acute, serious condition suggestive of myopathy occurs or if with risk factor predisposing to development of renal failure secondary to rhabdomyolysis.

Persistent increases in serum transaminases reported; obtain liver enzyme tests prior to initiation and repeat as clinically indicated.

Fatal and nonfatal hepatic failure reported (rare); promptly interrupt therapy if serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs and do not restart if no alternate etiology found.

 Caution in patients who consume substantial quantities of alcohol and/or have history of liver disease.

Increases in HbA1c and FPG levels reported.

May blunt adrenal and/or gonadal steroid production.

 Increased risk of hemorrhagic stroke in patients with recent stroke or transient ischemic attack (TIA).

Caution in elderly.

Pregnancy & Breastfeeding:

Category X, not for use in nursing.

Dosage and administration:

Hyperlipidemia/Mixed Dyslipidemia

Initial: 10mg or 20mg qd (or 40mg qd for LDL reduction >45%)
Titrate: Adjust dose accordingly at 2- to 4-week intervals
Range: 10-80mg qd

Homozygous Familial Hypercholesterolemia

10-80mg qd

Prevention of Cardiovascular Disease

Dose based on current clinical practice

PEDIATRIC DOSAGE

Heterozygous Familial Hypercholesterolemia

10-17 Years (Boys and Postmenarchal Girls):
Initial: 10mg/day
Titrate: Adjust dose at intervals of ≥4 weeks
Max: 20mg/day

Side effects:

Nasopharyngitis, arthralgia, diarrhea, diabetes, pain in extremity, UTI, dyspepsia, nausea, musculoskeletal pain, muscle spasms, myalgia, insomnia.

Drug interaction:

Avoid with cyclosporine, telaprevir, gemfibrozil, or combination of tipranavir plus ritonavir.

 Caution with fibrates and drugs that decrease levels or activity of endogenous steroid hormones (eg, ketoconazole, spironolactone, cimetidine).

 Increased risk of myopathy with fibric acid derivatives, erythromycin, lipid-modifying doses of niacin, strong CYP3A4 inhibitors (eg, clarithromycin, HIV protease inhibitors), and azole antifungals; consider lower initial and maintenance doses.

Strong CYP3A4 inhibitors (eg, clarithromycin, several combinations of HIV protease inhibitors, telaprevir, itraconazole) and grapefruit juice may increase levels.

 CYP3A4 inducers (eg, efavirenz, rifampin) may decrease levels; simultaneous coadministration with rifampin recommended.

 May increase digoxin levels; monitor appropriately.

May increase area under the curve of norethindrone and ethinyl estradiol.

Myopathy, including rhabdomyolysis, reported with colchicine; use with caution.

OATP1B1 inhibitors (eg, cyclosporine) may increase bioavailability.

Storage:

Store below 30°C.

Keep out of reach of children.

Tamusin®

Category:

Alpha₁ antagonist

Indicaitons:

Benign Prostatic Hyperplasia

Dosage and administrations:

Benign Prostatic Hyperplasia:

Adults: 0.4mg once daily, 30 min after the same meal each day
Titrate: May increase to 0.8mg once daily after 2-4 weeks if response is inadequate

If therapy is discontinued or interrupted for several days at either the 0.4mg or 0.8mg dose, restart with 0.4mg once daily.

Do not crush, chew, or open cap

Pregnancy and breastfeeding:

Category B, not for use in nursing.

Warning and precautions:

Orthostasis/syncope may occur; caution to avoid situations in which injury could result.

May cause priapism.

Prostate cancer and BPH frequently coexist.

Intraoperative floppy iris syndrome (IFIS) observed during cataract and glaucoma surgery; initiation of therapy in patients who are scheduled for cataract or glaucoma surgery is not recommended.

Allergic reaction reported (rare) in patients with sulfa allergy.

Adverse reactions:

Headache, dizziness, rhinitis, infection, abnormal ejaculation, asthenia, back pain, diarrhea, pharyngitis, chest pain, cough increased, somnolence, insomnia, sinusitis, nausea.

Drug interactions:

Avoid with other α-adrenergic blockers.

Caution with cimetidine, particularly at a dose >0.4mg, and warfarin.

Avoid with strong inhibitors of CYP3A4 (eg, ketoconazole).

Caution with moderate inhibitors of CYP3A4 (eg, erythromycin), with strong (eg, paroxetine) or moderate (eg, terbinafine) inhibitors of CYP2D6, and in patients known to be CYP2D6 poor metabolizers, particularly at a dose >0.4mg.

Caution with PDE-5 inhibitors; may cause symptomatic hypotension.

Storage:

Store below 30°C.

Protect from extreme heat and moisture.

Keep out of reach of children.