hytrin 2mg
 

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Hytrin


Pronunciation: ter-AZ-oh-sin
Generic Name: Terazosin
Brand Name: Hytrin
Hytrin is used for:

Treating high blood pressure and treating signs and symptoms of benign prostatic hyperplasia (BPH).

Hytrin is an alpha-blocker. It works by relaxing muscles in the blood vessels, resulting in lowering of blood pressure. In BPH, alpha-blockers work by relaxing muscles around the urethra (tube that drains urine from the bladder), which improves urinary symptoms.

Do NOT use Hytrin if: you are allergic to any ingredient in Hytrin or to similar medicines (eg, prazosin)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Hytrin:

Some medical conditions may interact with Hytrin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have prostate cancer, angina pectoris, heart disease, or kidney or liver problems if you will be having eye surgery

Some MEDICINES MAY INTERACT with Hytrin. Tell your health care provider if you are taking any other medicines, especially any of the following:

Phosphodiesterase type 5 (PDE5) inhibitors (eg, sildenafil) or verapamil because severe dizziness, lightheadedness, or fainting may occur

This may not be a complete list of all interactions that may occur. Ask your health care provider if Hytrin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Hytrin:

Use Hytrin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Hytrin by mouth with or without food. Hytrin may cause a sudden drop in blood pressure after the first dose. Take your first dose at bedtime. If you get up during the night, sit up slowly, then stand slowly. If you miss a dose of Hytrin, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If more than one dose is missed, contact your doctor or pharmacist.

Ask your health care provider any questions you may have about how to use Hytrin.

Important safety information: Hytrin may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Hytrin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Hytrin; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness. Hytrin may cause a sudden drop in blood pressure after the first dose. Take your first dose at bedtime. If you get up during the night, sit up slowly, then stand slowly. This will help to reduce your lightheadedness or dizziness. These effects are more likely to occur after the first few doses or if your dose has increased, but can occur at any time while you are taking the medicine. It can also occur if you stop taking the medicine and then restart treatment. Hytrin may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects. Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms. Do NOT take more than the recommended dose without checking with your doctor. Hytrin may rarely cause a prolonged, painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens. Tell your doctor or dentist that you take Hytrin before you receive any medical or dental care, emergency care, or surgery (including eye surgery). Lab tests, including blood pressure, may be performed while you use Hytrin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Hytrin should not be used in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Hytrin while you are pregnant. It is not known if Hytrin is found in breast milk. If you are or will be breast-feeding while you use Hytrin, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Hytrin:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; drowsiness; lightheadedness; nasal congestion; nausea; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; chest pain; decreased sexual desire or ability; fainting; fast, slow, or irregular heartbeat;painful, prolonged erection; severe or prolonged dizziness or headache; shortness of breath; swelling of the ankles, feet, or hands.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Hytrin side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include dizziness; weakness.

Proper storage of Hytrin:

Store Hytrin at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Hytrin out of the reach of children and away from pets.

General information: If you have any questions about Hytrin, please talk with your doctor, pharmacist, or other health care provider. Hytrin is to be used only by the patient for whom it is prescribed. Do not share it with other people. Do not use it for other health conditions. If your symptoms do not improve or if they become worse, check with your doctor. If using Hytrin for an extended period of time, obtain refills before your supply runs out. Check with your pharmacist about how to dispose of unused medicine.

This information is summary only. It does not contain all information about Hytrin. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Hytrin resources Hytrin Side Effects (in more detail) Hytrin Use in Pregnancy & Breastfeeding Drug Images Hytrin Drug Interactions Hytrin Support Group 11 Reviews for Hytrin - Add your own review/rating Hytrin Prescribing Information (FDA) Hytrin Consumer Overview Hytrin Monograph (AHFS DI) Hytrin Advanced Consumer (Micromedex) - Includes Dosage Information Terazosin Prescribing Information (FDA) Terazosin Professional Patient Advice (Wolters Kluwer) Compare Hytrin with other medications Benign Prostatic Hyperplasia High Blood Pressure Hyperhidrosis
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Hytrin Tablets 2mg


1. Name Of The Medicinal Product

Hytrin Tablets 2mg

Terazosin Tablets 2mg

2. Qualitative And Quantitative Composition

 

 

mg/tablet

Active:

Terazosin 2.0

as monohydrochloride dihydrate

2.0

3. Pharmaceutical Form

Yellow, round, flat bevelled tablets embossed with logo and triangular facets on one face and plain on the other.

4. Clinical Particulars 4.1 Therapeutic Indications

Orally administered Hytrin is indicated in the treatment of mild to moderate hypertension. It may be used in combination with thiazide diuretics and/or other antihypertensive drugs or as sole therapy where other agents are inappropriate or ineffective. The hypotensive effect is most pronounced on the diastolic pressure. Although the exact mechanism of the hypotensive action of terazosin is not established, the relaxation of peripheral blood vessels appears to be produced mainly by competitive antagonism of post-synaptic alpha1 - adrenoceptors. Hytrin usually produces an initial gradual decrease in blood pressure followed by a sustained antihypertensive action.

Orally administered Hytrin is also indicated as a therapy for the symptomatic treatment of urinary obstruction caused by benign prostatic hyperplasia (BPH). Terazosin is a selective post synaptic alpha-1 -adrenoreceptor antagonist. Antagonism of alpha-i -receptors on prostatic and urethral smooth muscle has been shown to improve urinary tract flow and relieve the urinary obstruction caused by BPH.

4.2 Posology And Method Of Administration

Hypertension.

Adults

Initial dose

1 mg before bedtime is the starting dose for all patients and should not be exceeded. Compliance with this initial dosage recommendation should be strictly observed to minimise potential for acute first-dose hypotensive episodes.

Subsequent doses

The single daily dosage may be increased by approximately doubling the dosage at weekly intervals to achieve the desired blood pressure response.

The usual maintenance dose is 2mg to 10mg once daily. Doses over 20mg rarely improve efficacy and doses over 40mg have not been studied.

BPH

Adults Only:

The dose of terazosin should be adjusted according to the patient's response. The following is a guide to administration:

Initial dose

1 mg before bedtime is the starting dose for all patients and should not be exceeded. Strict compliance with this recommendation should be observed to minimise acute first-dose hypotensive episodes.

Subsequent dose

The dose may be increased by approximately doubling at weekly or bi-weekly intervals to achieve the desired reduction in symptoms. The maintenance dose is usually 5 to 10mg once daily. Improvements in symptoms have been detected as early as two weeks after starting treatment with terazosin.

At present there are insufficient data to suggest additional symptomatic relief with doses above 10mg once daily.

Treatment should be initiated using the BPH Starter Pack and response to treatment reviewed at four weeks. Transient side effects may occur at each titration step. If any side effects persist, consideration should be given to reducing the dose.

Use in renal insufficiency

Pharmacokinetic studies indicate that patients with impaired renal function need no alteration in the recommended dosages.

Use in Children

Safety and efficacy in children has not been established.

Use in the Elderly

Pharmacokinetic studies in the elderly indicate that no alteration in dosage recommendation is required.

Postural Hypotension

Postural hypotension has been reported to occur in patients receiving terazosin for the symptomatic treatment of urinary obstruction caused by BPH. In these cases, the incidence of postural hypotensive events was greater in patients aged 65 years and over (5.6%) than those aged less than 65 years (2.6%)

Use with thiazide diuretics and other antihypertensive agents

When adding a thiazide diuretic or another antihypertensive agent to a patient's regimen the dose of Hytrin should be reduced and retitration carried out if necessary. Caution should be observed when Hytrin is administered with thiazides or other antihypertensive agents as hypotension may develop.

4.3 Contraindications

Known sensitivity to alpha-adrenoceptor antagonists.

4.4 Special Warnings And Precautions For Use

As with other alpha adrenoreceptor antagonists, terazosin is not recommended in patients with a history of micturition syncope.

In clinical trials, the incidence of postural hypotension was greater in BPH patients than those with hypertension. In these cases, the incidence of postural hypotension events was greater in patients aged 65 years and over (5.6%) than those aged less than 65 years (2.6%).

If administration is discontinued for more than several days, therapy should be re-instituted using the initial dosing regimen.

Concomitant use of phosphodiesterase-5-inhibitors (e.g. sildenafil, tadalafil, vardenafil) and terazosin may lead to symptomatic hypotension in some patients. In order to minimise the risk for developing postural hypotension the patient should be stable on the alpha-blocker therapy before initiating use of phosphodiesterase-5-inhibitors.

The 'Intraoperative Floppy Iris Syndrome' (IFIS, a variant of small pupil syndrome) has been observed during cataract surgery in some patients on or previously treated with tamsulosin. Isolated reports have also been received with other alpha-1 blockers and the possibility of a class effect cannot be excluded. As IFIS may lead to increased procedural complications during cataract operation current or past use of alpha-1 blockers should be made known to the ophthalmic surgeon in advance of surgery.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

In patients receiving terazosin plus ACE inhibitors or diuretics the proportion reporting dizziness or related side effects was greater than in the total population of terazosin treated patients from clinical trials.

Caution should be observed when terazosin is administered with other antihypertensive agents, to avoid the possibility of significant hypotension. When adding terazosin to a diuretic or other antihypertensive agent, dosage reduction and retitration may be necessary.

Terazosin has been given without interaction with analgesics/anti-inflammatories, cardiac glycosides, hypoglycemics, antiarrhythmics, anxiolytics/sedatives, antibacterials, hormones/steroids and drugs used for gout.

Phosphodiesterase-5-inhibitors (e.g. sildenafil, tadalafil, vardenafil) (see section 4.4).

4.6 Pregnancy And Lactation

Although no teratogenic effects were seen in animal testing, the safety of Hytrin use during pregnancy or during lactation has not yet been established. Hytrin should not be used therefore in pregnancy unless the potential benefit outweighs the risk.

4.7 Effects On Ability To Drive And Use Machines

Dizziness, light-headedness or drowsiness may occur with the initial dose or in association with missed doses and subsequent reinitiation of Hytrin therapy. Patients should be cautioned about these possible adverse effects and the circumstances in which they may occur and advised to avoid driving or hazardous tasks for approximately 12 hours after initial dose or when the dose is increased.

4.8 Undesirable Effects

Hytrin in common with other alpha-adrenoceptor antagonists may cause syncope. Syncopal episodes have occurred within 30 to 90 minutes of the initial dose of the drug. Syncope has occasionally occurred in association with rapid dosage increases or the introduction of another antihypertensive agent.

In clinical trials in hypertension, the incidence of syncopal episodes was approximately one percent. In most cases this was believed to be due to an excessive postural hypotensive effect although occasionally the syncopal episode has been preceded by a bout of tachycardia with heart rates of 120 to 160 beats per minute.

If syncope occurs the patient should be placed in a recumbent position and supportive treatment applied as necessary.

Dizziness, light-headedness or fainting may occur when standing up quickly from a lying or sitting position. Patients should be advised of this possibility and instructed to lie down if these symptoms appear and then sit for a few minutes before standing to prevent their recurrence.

These adverse effects are self limiting and in most cases do not recur after the initial period of therapy or during subsequent re-titration.

Adverse events reported with terazosin

The most common events were asthenia, palpitations, nausea, peripheral oedema, dizziness, somnolence, nasal congestion/rhinitis and blurred vision/amblyopia.

In addition, the following have been reported: back pain; headache; tachycardia; postural hypotension; syncope; oedema; weight gain; pain in extremities; decreased libido; depression; nervousness; paraesthesia; vertigo; dyspnoea; sinusitis and impotence.

Additional adverse reactions reported in clinical trials or reported during marketing experience but not clearly associated with the use of terazosin include the following:

chest pain; facial oedema; fever; abdominal pain; neck pain; shoulder pain; vasodilation; arrhythmia; constipation; diarrhoea; dry mouth; dyspepsia; flatulence; vomiting; gout; arthralgia; arthritis; joint disorders; myalgia; anxiety; insomnia; bronchitis; epistaxis; flu symptoms; pharyngitis; rhinitis; cold symptoms; pruritis; rash; increased cough; sweating; abnormal vision; conjunctivitis; tinnitus; urinary frequency; urinary tract infection and urinary incontinence primarily reported in post-menopausal women.

At least two cases of anaphylactoid reactions have been reported with the administration of terazosin.

Post marketing experience: Thrombocytopenia and priapism have been reported. Atrial fibrillation has been reported: however, a cause and effect relationship has not been established.

Laboratory tests: Small but statistically significant decreases in haematocrit, haemoglobin, white blood cells, total protein and albumin were observed in controlled clinical trials. These laboratory findings suggest the possibility of haemodilution. Treatment with terazosin for up to 24 months had no significant effect on prostate specific antigen (PSA) levels.

4.9 Overdose

Should administration of Hytrin lead to acute hypotension, cardiovascular support is of first importance. Restoration of blood pressure and normalisation of heart rate may be accomplished by keeping the patient in a supine position. If this measure is inadequate, shock should first be treated with volume expanders and if necessary, vasopressors could then be used. Renal function should be monitored and general supportive measures applied as required. Dialysis may not be of benefit since laboratory data indicate that terazosin is highly protein bound.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Although the exact mechanism of the hypotensive action is not established, the relaxation of peripheral blood vessels appears to be produced mainly by competitive antagonism of post-synaptic alpha-adrenoceptors. Hytrin usually produces an initial gradual decrease in blood pressure followed by a sustained antihypertensive action.

Clinical experience indicates that a 2-5% decrease in total cholesterol plasma concentration and a 3-7% decrease in the combined LDLC + VLDLC fraction plasma concentration from pretreatment values are associated with the administration of therapeutic doses of terazosin.

In clinical trials, plasma concentrates of total cholesterol and combined low density and very low density lipoproteins were found to be slightly reduced following Hytrin administration. Additionally, the increase in total cholesterol seen with other hypertensive agents did not occur when these were used in combination with Hytrin.

Studies suggest that alpha-1 -adrenoreceptor antagonism is useful in improving the urodynamics in patients with chronic bladder obstruction such as in benign prostatic hyperplasia (BPH).

The symptoms of BPH are caused mainly by the presence of an enlarged prostate and by the increased smooth muscle tone of the bladder outlet and prostate, which is regulated by alpha-1 -adrenergic receptors.

In in-vitro experiments, terazosin has been shown to antagonise phenylephrine-induced contractions of human pro static tissue. In clinical trials terazosin has been shown to improve the urodynamics and symptomatology in patients with BPH.

5.2 Pharmacokinetic Properties

The plasma concentration of the parent drug is a maximum about 1 hour post administration and declines with a half-life of approximately 12 hours. Food has little or no effect on bioavailability. Approximately 40% of the administered dose is eliminated in the urine and 60% in the faeces. The drug is highly bound to plasma proteins.

5.3 Preclinical Safety Data

Carcinogenicity: Hytrin has been shown to produce tumours in male rats when administered at a high dose over a long period of time. No such occurrences were seen in female rats or in a similar study in mice. The relevance of these findings with respect to the clinical use of the drug in man is unknown.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Lactose

Maize starch

Pregelatinised starch

Purified talc

Magnesium stearate

Purified water

Dye yellow (quinolone yellow, E104)

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

Tablets in a blister original pack. The 2mg tablets are supplied in a pack of 28 tablets. Blisters are packaged in a carton with a package insert.

Starter Pack for Hypertension:

The 2mg tablets form part of a starter pack of 28 tablets which also contains 7 x 1mg tablets. Blisters are packaged in a carton with a package insert.

Starter pack for BPH:

Tablets in a blister pack. The starter pack consists of 7 x 1mg, 14 x 2mg and 7 x 5mg tablets. The blisters, of PVC/PVdC, are heat sealed with 20 micron hard tempered aluminium foil and packaged in a carton with a pack insert.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Amdipharm plc

Regency House

Miles Gray Road

Basildon

Essex

SS14 3AF

8. Marketing Authorisation Number(S)

PL 20072/0029

9. Date Of First Authorisation/Renewal Of The Authorisation

13/05/97

10. Date Of Revision Of The Text

June 2009


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Hytrin BPH 2mg Tablets


1. Name Of The Medicinal Product

Hytrin Tablets 2mg

Terazosin Tablets 2mg

2. Qualitative And Quantitative Composition     mg/tablet

Active:

Terazosin

as monohydrochloride dihydrate

2.0 3. Pharmaceutical Form

Yellow, round, flat bevelled tablets embossed with logo and triangular facets on one face and plain on the other.

4. Clinical Particulars 4.1 Therapeutic Indications

Orally administered Hytrin is indicated in the treatment of mild to moderate hypertension. It may be used in combination with thiazide diuretics and/or other antihypertensive drugs or as sole therapy where other agents are inappropriate or ineffective. The hypotensive effect is most pronounced on the diastolic pressure. Although the exact mechanism of the hypotensive action of terazosin is not established, the relaxation of peripheral blood vessels appears to be produced mainly by competitive antagonism of post-synaptic alpha1 - adrenoceptors. Hytrin usually produces an initial gradual decrease in blood pressure followed by a sustained antihypertensive action.

Orally administered Hytrin is also indicated as a therapy for the symptomatic treatment of urinary obstruction caused by benign prostatic hyperplasia (BPH). Terazosin is a selective post synaptic alpha-1 -adrenoreceptor antagonist. Antagonism of alpha-i -receptors on prostatic and urethral smooth muscle has been shown to improve urinary tract flow and relieve the urinary obstruction caused by BPH.

4.2 Posology And Method Of Administration

Hypertension.

Adults

Initial dose

1 mg before bedtime is the starting dose for all patients and should not be exceeded. Compliance with this initial dosage recommendation should be strictly observed to minimise potential for acute first-dose hypotensive episodes.

Subsequent doses

The single daily dosage may be increased by approximately doubling the dosage at weekly intervals to achieve the desired blood pressure response.

The usual maintenance dose is 2mg to 10mg once daily. Doses over 20mg rarely improve efficacy and doses over 40mg have not been studied.

BPH

Adults Only:

The dose of terazosin should be adjusted according to the patient's response. The following is a guide to administration:

Initial dose

1 mg before bedtime is the starting dose for all patients and should not be exceeded. Strict compliance with this recommendation should be observed to minimise acute first-dose hypotensive episodes.

Subsequent dose

The dose may be increased by approximately doubling at weekly or bi-weekly intervals to achieve the desired reduction in symptoms. The maintenance dose is usually 5 to 10mg once daily. Improvements in symptoms have been detected as early as two weeks after starting treatment with terazosin.

At present there are insufficient data to suggest additional symptomatic relief with doses above 10mg once daily.

Treatment should be initiated using the BPH Starter Pack and response to treatment reviewed at four weeks. Transient side effects may occur at each titration step. If any side effects persist, consideration should be given to reducing the dose.

Use in renal insufficiency

Pharmacokinetic studies indicate that patients with impaired renal function need no alteration in the recommended dosages.

Use in Children

Safety and efficacy in children has not been established.

Use in the Elderly

Pharmacokinetic studies in the elderly indicate that no alteration in dosage recommendation is required.

Postural Hypotension

Postural hypotension has been reported to occur in patients receiving terazosin for the symptomatic treatment of urinary obstruction caused by BPH. In these cases, the incidence of postural hypotensive events was greater in patients aged 65 years and over (5.6%) than those aged less than 65 years (2.6%)

Use with thiazide diuretics and other antihypertensive agents

When adding a thiazide diuretic or another antihypertensive agent to a patient's regimen the dose of Hytrin should be reduced and retitration carried out if necessary. Caution should be observed when Hytrin is administered with thiazides or other antihypertensive agents as hypotension may develop.

4.3 Contraindications

Known sensitivity to alpha-adrenoceptor antagonists.

4.4 Special Warnings And Precautions For Use

As with other alpha adrenoreceptor antagonists, terazosin is not recommended in patients with a history of micturition syncope.

In clinical trials, the incidence of postural hypotension was greater in BPH patients than those with hypertension. In these cases, the incidence of postural hypotension events was greater in patients aged 65 years and over (5.6%) than those aged less than 65 years (2.6%).

If administration is discontinued for more than several days, therapy should be re-instituted using the initial dosing regimen.

Concomitant use of phosphodiesterase-5-inhibitors (e.g. sildenafil, tadalafil, vardenafil) and terazosin may lead to symptomatic hypotension in some patients. In order to minimise the risk for developing postural hypotension the patient should be stable on the alpha-blocker therapy before initiating use of phosphodiesterase-5-inhibitors.

The 'Intraoperative Floppy Iris Syndrome' (IFIS, a variant of small pupil syndrome) has been observed during cataract surgery in some patients on or previously treated with tamsulosin. Isolated reports have also been received with other alpha-1 blockers and the possibility of a class effect cannot be excluded. As IFIS may lead to increased procedural complications during cataract operation current or past use of alpha-1 blockers should be made known to the ophthalmic surgeon in advance of surgery.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

In patients receiving terazosin plus ACE inhibitors or diuretics the proportion reporting dizziness or related side effects was greater than in the total population of terazosin treated patients from clinical trials.

Caution should be observed when terazosin is administered with other antihypertensive agents, to avoid the possibility of significant hypotension. When adding terazosin to a diuretic or other antihypertensive agent, dosage reduction and retitration may be necessary.

Terazosin has been given without interaction with analgesics/anti-inflammatories, cardiac glycosides, hypoglycemics, antiarrhythmics, anxiolytics/sedatives, antibacterials, hormones/steroids and drugs used for gout.

Phosphodiesterase-5-inhibitors (e.g. sildenafil, tadalafil, vardenafil) (see section 4.4).

4.6 Pregnancy And Lactation

Although no teratogenic effects were seen in animal testing, the safety of Hytrin use during pregnancy or during lactation has not yet been established. Hytrin should not be used therefore in pregnancy unless the potential benefit outweighs the risk.

4.7 Effects On Ability To Drive And Use Machines

Dizziness, light-headedness or drowsiness may occur with the initial dose or in association with missed doses and subsequent reinitiation of Hytrin therapy. Patients should be cautioned about these possible adverse effects and the circumstances in which they may occur and advised to avoid driving or hazardous tasks for approximately 12 hours after initial dose or when the dose is increased.

4.8 Undesirable Effects

Hytrin in common with other alpha-adrenoceptor antagonists may cause syncope. Syncopal episodes have occurred within 30 to 90 minutes of the initial dose of the drug. Syncope has occasionally occurred in association with rapid dosage increases or the introduction of another antihypertensive agent.

In clinical trials in hypertension, the incidence of syncopal episodes was approximately one percent. In most cases this was believed to be due to an excessive postural hypotensive effect although occasionally the syncopal episode has been preceded by a bout of tachycardia with heart rates of 120 to 160 beats per minute.

If syncope occurs the patient should be placed in a recumbent position and supportive treatment applied as necessary.

Dizziness, light-headedness or fainting may occur when standing up quickly from a lying or sitting position. Patients should be advised of this possibility and instructed to lie down if these symptoms appear and then sit for a few minutes before standing to prevent their recurrence.

These adverse effects are self limiting and in most cases do not recur after the initial period of therapy or during subsequent re-titration.

Adverse events reported with terazosin

The most common events were asthenia, palpitations, nausea, peripheral oedema, dizziness, somnolence, nasal congestion/rhinitis and blurred vision/amblyopia.

In addition, the following have been reported: back pain; headache; tachycardia; postural hypotension; syncope; oedema; weight gain; pain in extremities; decreased libido; depression; nervousness; paraesthesia; vertigo; dyspnoea; sinusitis and impotence.

Additional adverse reactions reported in clinical trials or reported during marketing experience but not clearly associated with the use of terazosin include the following:

chest pain; facial oedema; fever; abdominal pain; neck pain; shoulder pain; vasodilation; arrhythmia; constipation; diarrhoea; dry mouth; dyspepsia; flatulence; vomiting; gout; arthralgia; arthritis; joint disorders; myalgia; anxiety; insomnia; bronchitis; epistaxis; flu symptoms; pharyngitis; rhinitis; cold symptoms; pruritis; rash; increased cough; sweating; abnormal vision; conjunctivitis; tinnitus; urinary frequency; urinary tract infection and urinary incontinence primarily reported in post-menopausal women.

At least two cases of anaphylactoid reactions have been reported with the administration of terazosin.

Post marketing experience: Thrombocytopenia and priapism have been reported. Atrial fibrillation has been reported: however, a cause and effect relationship has not been established.

Laboratory tests: Small but statistically significant decreases in haematocrit, haemoglobin, white blood cells, total protein and albumin were observed in controlled clinical trials. These laboratory findings suggest the possibility of haemodilution. Treatment with terazosin for up to 24 months had no significant effect on prostate specific antigen (PSA) levels.

4.9 Overdose

Should administration of Hytrin lead to acute hypotension, cardiovascular support is of first importance. Restoration of blood pressure and normalisation of heart rate may be accomplished by keeping the patient in a supine position. If this measure is inadequate, shock should first be treated with volume expanders and if necessary, vasopressors could then be used. Renal function should be monitored and general supportive measures applied as required. Dialysis may not be of benefit since laboratory data indicate that terazosin is highly protein bound.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Although the exact mechanism of the hypotensive action is not established, the relaxation of peripheral blood vessels appears to be produced mainly by competitive antagonism of post-synaptic alpha-adrenoceptors. Hytrin usually produces an initial gradual decrease in blood pressure followed by a sustained antihypertensive action.

Clinical experience indicates that a 2-5% decrease in total cholesterol plasma concentration and a 3-7% decrease in the combined LDLC + VLDLC fraction plasma concentration from pretreatment values are associated with the administration of therapeutic doses of terazosin.

In clinical trials, plasma concentrates of total cholesterol and combined low density and very low density lipoproteins were found to be slightly reduced following Hytrin administration. Additionally, the increase in total cholesterol seen with other hypertensive agents did not occur when these were used in combination with Hytrin.

Studies suggest that alpha-1 -adrenoreceptor antagonism is useful in improving the urodynamics in patients with chronic bladder obstruction such as in benign prostatic hyperplasia (BPH).

The symptoms of BPH are caused mainly by the presence of an enlarged prostate and by the increased smooth muscle tone of the bladder outlet and prostate, which is regulated by alpha-1 -adrenergic receptors.

In in-vitro experiments, terazosin has been shown to antagonise phenylephrine-induced contractions of human pro static tissue. In clinical trials terazosin has been shown to improve the urodynamics and symptomatology in patients with BPH.

5.2 Pharmacokinetic Properties

The plasma concentration of the parent drug is a maximum about 1 hour post administration and declines with a half-life of approximately 12 hours. Food has little or no effect on bioavailability. Approximately 40% of the administered dose is eliminated in the urine and 60% in the faeces. The drug is highly bound to plasma proteins.

5.3 Preclinical Safety Data

Carcinogenicity: Hytrin has been shown to produce tumours in male rats when administered at a high dose over a long period of time. No such occurrences were seen in female rats or in a similar study in mice. The relevance of these findings with respect to the clinical use of the drug in man is unknown.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Lactose

Maize starch

Pregelatinised starch

Purified talc

Magnesium stearate

Purified water

Dye yellow (quinolone yellow, E104)

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

Tablets in a blister original pack. The 2mg tablets are supplied in a pack of 28 tablets. Blisters are packaged in a carton with a package insert.

Starter Pack for Hypertension:

The 2mg tablets form part of a starter pack of 28 tablets which also contains 7 x 1mg tablets. Blisters are packaged in a carton with a package insert.

Starter pack for BPH:

Tablets in a blister pack. The starter pack consists of 7 x 1mg, 14 x 2mg and 7 x 5mg tablets. The blisters, of PVC/PVdC, are heat sealed with 20 micron hard tempered aluminium foil and packaged in a carton with a pack insert.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Amdipharm plc

Regency House

Miles Gray Road

Basildon

Essex

SS14 3AF

8. Marketing Authorisation Number(S)

PL 20072/0029

9. Date Of First Authorisation/Renewal Of The Authorisation

13/05/97

10. Date Of Revision Of The Text

June 2009


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Cardura


Generic Name: doxazosin (dox AY zo sin)
Brand Names: Cardura, Cardura XL

What is doxazosin?

Doxazosin is in a group of drugs called alpha-adrenergic (AL-fa ad-ren-ER-jik) blockers. Doxazosin relaxes your veins and arteries so that blood can more easily pass through them. It also relaxes the muscles in the prostate and bladder neck, making it easier to urinate.

Doxazosin is used to treat hypertension (high blood pressure), or to improve urination in men with benign prostatic hyperplasia (enlarged prostate).

Doxazosin may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about doxazosin? You should not use this medication if you are allergic to doxazosin or similar medicines such as alfuzosin (Uroxatral), prazosin (Minipress), silodosin (Rapaflo), tamsulosin (Flomax), or terazosin (Hytrin). Doxazosin may cause dizziness or fainting, especially when you first start taking it or when you start taking it again. Be careful if you drive or do anything that requires you to be alert. Avoid standing for long periods of time or becoming overheated during exercise and in hot weather. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. If you stop taking doxazosin for any reason, call your doctor before you start taking it again. You may need a dose adjustment.

Doxazosin can affect your pupils during cataract surgery. Tell your eye surgeon ahead of time that you are using this medication. Do not stop using doxazosin before surgery unless your surgeon tells you to.

Tell your doctor about all other medications you use, especially other blood pressure medications including diuretics (water pills).

What should I discuss with my doctor before taking doxazosin? You should not use this medication if you are allergic to doxazosin or similar medicines such as alfuzosin (Uroxatral), prazosin (Minipress), silodosin (Rapaflo), tamsulosin (Flomax), or terazosin (Hytrin).

If you have liver disease or a history of prostate cancer, you may need a dose adjustment or special tests to safely take doxazosin.

Doxazosin can affect your pupils during cataract surgery. Tell your eye surgeon ahead of time that you are using this medication. Do not stop using doxazosin before surgery unless your surgeon tells you to.

FDA pregnancy category C. It is not known whether doxazosin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether doxazosin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take doxazosin?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Doxazosin lowers blood pressure and may cause dizziness or fainting, especially when you first start taking it, or when you start taking it again. Call your doctor if you have severe dizziness or feel like you might pass out.

You may feel very dizzy when you first wake up. Be careful when standing or sitting up from a lying position.

If you stop taking doxazosin for any reason, call your doctor before you start taking it again. You may need a dose adjustment.

Your blood pressure or prostate will need to be checked often. Visit your doctor regularly.

If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Some things can cause your blood pressure to get too low. This includes vomiting, diarrhea, heavy sweating, heart disease, dialysis, a low-salt diet, or taking diuretics (water pills). Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting.

Store at room temperature away from moisture and heat. What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

If you miss your doses for several days in a row, contact your doctor before restarting the medication. You may need a lower dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include extreme dizziness or fainting.

What should I avoid while taking doxazosin? Doxazosin may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

To prevent dizziness, avoid standing for long periods of time or becoming overheated during exercise and in hot weather.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Drinking alcohol can increase certain side effects of doxazosin. Doxazosin side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

feeling like you might pass out;

fast or pounding heartbeats, fluttering in your chest;

trouble breathing;

swelling in your hands, ankles, or feet; or

penis erection that is painful or lasts 4 hours or longer.

Less serious side effects may include:

mild dizziness;

tired feeling, drowsiness;

headache;

nausea; or

runny nose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect doxazosin?

Tell your doctor about all other medications you use, especially:

sildenafil (Viagra, Revatio)

tadalafil (Cialis);

vardenafil (Levitra); or

other blood pressure medications, including diuretics (water pills).

This list is not complete and other drugs may interact with doxazosin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Cardura resources Cardura Side Effects (in more detail) Cardura Use in Pregnancy & Breastfeeding Drug Images Cardura Drug Interactions Cardura Support Group 3 Reviews for Cardura - Add your own review/rating Cardura Monograph (AHFS DI) Cardura Prescribing Information (FDA) Cardura Consumer Overview Cardura Advanced Consumer (Micromedex) - Includes Dosage Information Cardura MedFacts Consumer Leaflet (Wolters Kluwer) Doxazosin Prescribing Information (FDA) Cardura XL Prescribing Information (FDA) Cardura XL Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer) Compare Cardura with other medications Benign Prostatic Hyperplasia High Blood Pressure Raynaud's Syndrome Where can I get more information? Your pharmacist can provide more information about doxazosin.

See also: Cardura side effects (in more detail)


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tamsulosin


Generic Name: tamsulosin (tam soo LOE sin)
Brand Names: Flomax

What is tamsulosin?

Tamsulosin is in a group of drugs called alpha-adrenergic (AL-fa ad-ren-ER-jik) blockers. Tamsulosin relaxes the muscles in the prostate and bladder neck, making it easier to urinate.

Tamsulosin is used to improve urination in men with benign prostatic hyperplasia (enlarged prostate).

Tamsulosin may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about tamsulosin? You should not use this medication if you are allergic to tamsulosin. Do not take tamsulosin with other similar medicines such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), silodosin (Rapaflo), or terazosin (Hytrin). Tamsulosin may cause dizziness or fainting, especially when you first start taking it or when you start taking it again. Be careful if you drive or do anything that requires you to be alert. Avoid standing for long periods of time or becoming overheated during exercise and in hot weather. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. If you stop taking tamsulosin for any reason, call your doctor before you start taking it again. You may need a dose adjustment.

Tamsulosin can affect your pupils during cataract surgery. Tell your eye surgeon ahead of time that you are using this medication. Do not stop using tamsulosin before surgery unless your surgeon tells you to.

There are many other drugs that can interact with tamsulosin. Tell your doctor about all medications you use. What should I discuss with my healthcare provider before taking tamsulosin? You should not use this medication if you are allergic to tamsulosin. Do not take tamsulosin with other similar medicines such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), silodosin (Rapaflo), or terazosin (Hytrin).

If you have a history of prostate cancer, you may need a dose adjustment or special tests to safely take this tamsulosin.

Tamsulosin can affect your pupils during cataract surgery. Tell your eye surgeon ahead of time that you are using this medication. Do not stop using tamsulosin before surgery unless your surgeon tells you to.

Although this medication is not for use in women, tamsulosin is not expected to harm an unborn baby. If you are a woman using this medication, tell your doctor if you are pregnant or breast-feeding. Tamsulosin is not for use in children. How should I take tamsulosin?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Tamsulosin is usually taken once a day, approximately 30 minutes after a meal. Try to take this medication at the same time each day. Do not crush, chew, or open a tamsulosin capsule. Swallow it whole. Tamsulosin lowers blood pressure and may cause dizziness or fainting, especially when you first start taking it, or when you start taking it again. Call your doctor if you have severe dizziness or feel like you might pass out.

You may feel very dizzy when you first wake up. Be careful when standing or sitting up from a lying position.

If you stop taking tamsulosin for any reason, call your doctor before you start taking it again. You may need a dose adjustment.

Your blood pressure and prostate will need to be checked often. Visit your doctor regularly.

Some things can cause your blood pressure to get too low. This includes vomiting, diarrhea, heavy sweating, heart disease, dialysis, a low-salt diet, or taking diuretics (water pills). Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting.

Store at room temperature away from moisture and heat.

See also: Tamsulosin dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

If you miss your doses for several days in a row, contact your doctor before restarting the medication. You may need a lower dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include extreme dizziness or fainting.

What should I avoid while taking tamsulosin? Tamsulosin may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

To prevent dizziness, avoid standing for long periods of time or becoming overheated during exercise and in hot weather.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall. Drinking alcohol can increase certain side effects of tamsulosin. Tamsulosin side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using tamsulosin and call your doctor at once if you have any of these serious side effects:

feeling like you might pass out;

chest pain;

fever, chills, body aches, or flu symptoms; or

penis erection that is painful or lasts 4 hours or longer.

Less serious side effects may include:

mild dizziness;

weakness, drowsiness;

headache;

nausea, diarrhea;

back pain;

blurred vision;

dental problems;

sleep problems (insomnia);

abnormal ejaculation, decreased sex drive; or

runny nose, sore throat, cough.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Tamsulosin Dosing Information

Usual Adult Dose for Benign Prostatic Hyperplasia:

0.4 mg orally once daily one-half hour following the same meal each day

What other drugs will affect tamsulosin?

Tell your doctor about all other medications you use, especially:

cimetidine (Tagamet);

conivaptan (Vaprisol);

cyclosporine (Gengraf, Neoral, Sandimmune);

imatinib (Gleevec);

isoniazid (for treating tuberculosis);

methimazole (Tapazole);

pioglitazone (Actos);

ropinirole (Requip);

ticlopidine (Ticlid);

warfarin (Coumadin);

an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), metronidazole (Flagyl, Protostat), telithromycin (Ketek), or terbinafine (Lamisil);

an antidepressant such as citalopram (Celexa), clomipramine (Anafranil), desipramine (Norpramin), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Tofranil), nefazodone, paroxetine (Paxil), sertraline (Zoloft), or tranylcypromine (Parnate);

antifungal medication such as clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Extina, Ketozole, Nizoral, Xolegal), or voriconazole (Vfend);

anti-malaria medication such as chloroquine (Arelan) or pyrimethamine (Daraprim), or quinine (Qualaquin);

erectile dysfunction medicine such as sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra);

heart or blood pressure medication such as diltiazem (Cartia, Cardizem), felodipine (Plendil), nicardipine (Cardene), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others;

a heart rhythm medication such as amiodarone (Cordarone, Pacerone) or quinidine (Quin-G);

HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir); or

medicine to treat psychiatric disorders, such as aripiprazole (Abilify), chlorpromazine (Thorazine), clozapine (Clozaril, FazaClo), fluphenazine (Permitil, Prolixin), haloperidol (Haldol), perphenazine (Trilafon), or thioridazine (Mellaril).

This list is not complete and there are many other drugs that can interact with tamsulosin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you. More tamsulosin resources Tamsulosin Side Effects (in more detail)Tamsulosin DosageTamsulosin Use in Pregnancy & BreastfeedingDrug ImagesTamsulosin Drug InteractionsTamsulosin Support Group65 Reviews for Tamsulosin - Add your own review/rating tamsulosin Advanced Consumer (Micromedex) - Includes Dosage Information Tamsulosin MedFacts Consumer Leaflet (Wolters Kluwer) Tamsulosin Prescribing Information (FDA) Flomax Prescribing Information (FDA) Flomax Monograph (AHFS DI) Flomax Consumer Overview Compare tamsulosin with other medications Benign Prostatic HyperplasiaOveractive BladderUrinary Tract Stones Where can I get more information? Your pharmacist can provide more information about tamsulosin.

See also: tamsulosin side effects (in more detail)


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Slo-Niacin nicotinic acid


Generic Name: niacin (nicotinic acid) (NYE a sin (NIK oh TIN ik AS id))
Brand Names: B-3-50, B3-500-Gr, Niacin SR, Niacor, Niaspan ER, Slo-Niacin

What is niacin?

Niacin, also called nicotinic acid, is a B vitamin (vitamin B3). It occurs naturally in plants and animals, and is also added to many foods as a vitamin supplement. Niacin is also present in many multiple vitamins and nutritional supplements.

Niacin is used to treat and prevent a lack of natural niacin in the body, and to lower cholesterol and triglycerides (types of fat) in the blood. It is also used to lower the risk of heart attack in people with high cholesterol who have already had a heart attack. Niacin is sometimes used to treat coronary artery disease (also called atherosclerosis).

Niacin may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about niacin? Do not take this medication if you are allergic to niacin, or if you have severe liver disease, a stomach ulcer, or active bleeding.

Niacin can cause certain side effects, such as flushing (warmth, itching, redness, or tingly feeling under your skin). These effects can be made worse if you drink alcohol or hot beverages shortly after you take niacin. These effects should disappear over time as you keep taking the medication.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid taking colestipol (Colestid) or cholestyramine (Locholest, Prevalite, Questran) at the same time you take niacin. If you take either of these other medications, take them at least 4 to 6 hours before or after you take niacin.

Niacin is only part of a complete program of treatment that may also include diet, exercise, weight control, and other medications. Follow your diet, medication, and exercise routines very closely.

What should I discuss with my healthcare provider before taking niacin ? Do not take this medication if you are allergic to niacin, or if you have severe liver disease, a stomach ulcer, or active bleeding.

Before taking niacin, tell your doctor if you are allergic to any drugs, or if you have:

liver or kidney disease;

heart disease or uncontrolled angina (chest pain);

a stomach ulcer;

diabetes;

gout; or

a muscle disorder such as myasthenia gravis.

If you have any of these conditions, you may not be able to use niacin, or you may need dosage adjustments or special tests during treatment.

FDA pregnancy category C. Niacin may be harmful to an unborn baby when the medication is taken at doses to treat high cholesterol or other conditions. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Niacin can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take niacin ?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Niacin is sometimes taken at bedtime with a low-fat snack. Follow your doctor's instructions.

Niacin can cause certain side effects, such as flushing (warmth, itching, redness, or tingly feeling under your skin). These effects can be made worse if you drink alcohol or hot beverages shortly after you take niacin. These effects should disappear over time as you keep taking the medication.

Take niacin with a full glass of cold or cool water. Taking the medication with a hot drink may increase your risk of side effects such as flushing. Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time. Niacin extended-release tablets and capsules contain higher strengths of the medicine than the regular niacin tablets. Take only the dose that is correct for the type of niacin tablet or capsule you are using.

Niacin can cause you to have unusual results with certain medical tests (urine tests). Tell any doctor who treats you that you are using niacin.

If you stop taking niacin for any length of time, talk with your doctor before starting the medication again. You may need to restart the medication at a lower dose.

Niacin is only part of a complete program of treatment that may also include diet, exercise, weight control, and other medications. Follow your diet, medication, and exercise routines very closely.

To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Your kidney or liver function may also need to be tested. Do not miss any scheduled appointments.

Store niacin at room temperature away from moisture and heat. What happens if I miss a dose?

Take the missed dose as soon as you remember. Be sure to take the missed dose with food if you normally take your niacin dose with a meal or snack.

If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include nausea, dizziness, itching, vomiting, upset stomach, and flushing.

What should I avoid while taking niacin ?

Avoid drinking hot beverages shortly after taking niacin. Hot drinks can worsen niacin's flushing effect (warmth, itching, redness, or tingly feeling under your skin).

Avoid drinking alcohol while taking niacin. Alcohol may increase your risk of liver damage, and can also worsen the flushing effects of niacin.

Avoid taking colestipol (Colestid) or cholestyramine (Locholest, Prevalite, Questran) at the same time you take niacin. If you take either of these other medications, take them at least 4 to 6 hours before or after you take niacin.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Niacin side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

feeling light-headed, fainting;

fast, pounding, or uneven heart beats;

feeling short of breath;

swelling;

jaundice (yellowing of your skin or eyes); or

muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine.

If you are diabetic, tell your doctor about any changes in your blood sugar levels.

Less serious side effects of niacin include:

mild dizziness;

warmth, redness, or tingly feeling under your skin;

itching, dry skin;

sweating or chills;

nausea, diarrhea, belching, gas;

muscle pain, leg cramps; or

sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect niacin ?

Tell your doctor about all other cholesterol-lowering drugs you are taking with niacin, especially atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Mevacor), pravastatin (Pravachol), or simvastatin (Zocor).

Before taking niacin, tell your doctor if you are also using any of the following drugs:

a blood thinner such as warfarin (Coumadin);

multivitamins or mineral supplements that contain niacin;

blood pressure or heart medications such as amlodipine (Norvasc), diltiazem (Tiazac, Cartia, Cardizem), felodipine (Plendil), nicardipine (Cardene), nifedipine (Procardia, Adalat), nimodipine (Nimotop), nisoldipine (Sular), or verapamil (Calan, Covera, Isoptin, Verelan); or

heart medications such as doxazosin (Cardura), isosorbide (Dilatrate, Imdur, Isordil, Monoket, Sorbitrate), nitroglycerin (Nitro-Bid, Nitro-Dur, Nitrostat), prazosin (Minipress), or terazosin (Hytrin).

This list is not complete and there may be other drugs that can interact with niacin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Slo-Niacin resources Slo-Niacin Side Effects (in more detail) Slo-Niacin Use in Pregnancy & Breastfeeding Drug Images Slo-Niacin Drug Interactions Slo-Niacin Support Group 1 Review for Slo-Niacin - Add your own review/rating Compare Slo-Niacin with other medications High Cholesterol Hyperlipoproteinemia Hyperlipoproteinemia Type IV, Elevated VLDL Hyperlipoproteinemia Type V, Elevated Chylomicrons VLDL Niacin Deficiency Pellagra Where can I get more information? Your pharmacist can provide more information about niacin.

See also: Slo-Niacin side effects (in more detail)


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Tarka


Generic Name: trandolapril and verapamil (tran DOL a pril and ver AP a mil)
Brand Names: Tarka

What is Tarka (trandolapril and verapamil)?

Trandolapril is an ACE inhibitor. ACE stands for angiotensin converting enzyme.

Verapamil is a calcium channel blocker. It works by relaxing the muscles of your heart and blood vessels.

The combination of trandolapril and verapamil is used to treat high blood pressure (hypertension).

Trandolapril and verapamil may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Tarka (trandolapril and verapamil)? Do not use trandolapril and verapamil if you are pregnant. It could harm the unborn baby. Stop using this medication and tell your doctor right away if you become pregnant. You should not use this medicine if you have certain serious heart problems, or if you are allergic to trandolapril (Mavik) or similar medicines such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), or ramipril (Altace).

There are many other drugs that can interact with trandolapril and verapamil. Tell your doctor about all medications you use.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting. What should I discuss with my healthcare provider before taking Tarka (trandolapril and verapamil)? You should not use this medicine if you are allergic to trandolapril (Mavik) or verapamil (Calan, Covera, Isoptin, Verelan), or if you have:

certain serious heart conditions, especially "sick sinus syndrome" or "AV block" (unless you have a pacemaker);

a heart rhythm disorder;

low blood pressure; or

if you are allergic to any other ACE inhibitor, such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), or ramipril (Altace).

To make sure you can safely take trandolapril and verapamil, tell your doctor if you have any of these other conditions:

kidney disease (or if you are on dialysis);

liver disease;

congestive heart failure;

diabetes;

a nerve-muscle disease such as muscular dystrophy; or

a connective tissue disease such as Marfan syndrome, Sjogren's syndrome, lupus, scleroderma, or rheumatoid arthritis.

FDA pregnancy category D. Do not use trandolapril and verapamil if you are pregnant. Stop using this medication and tell your doctor right away if you become pregnant. Trandolapril and verapamil can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Use effective birth control while taking trandolapril and verapamil. Trandolapril and verapamil can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using trandolapril and verapamil. How should I take Tarka (trandolapril and verapamil)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Trandolapril and verapamil works best if you take it with food.

Your blood pressure will need to be checked often. Visit your doctor regularly.

Conditions that may cause very low blood pressure include: vomiting, diarrhea, heavy sweating, heart disease, dialysis, a low salt diet, or taking diuretics (water pills). Follow your doctor's instructions about the type and amount of liquids you should drink while taking trandolapril and verapamil. Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting. If you need surgery, tell the surgeon ahead of time that you are using trandolapril and verapamil.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Store at room temperature away from moisture and heat. What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include slow heart rate, weak pulse, muscle weakness, tingly feeling, seizure (convulsions), feeling light-headed, or fainting.

What should I avoid while taking Tarka (trandolapril and verapamil)?

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Do not use salt substitutes or potassium supplements while taking trandolapril and verapamil, unless your doctor has told you to. Tarka (trandolapril and verapamil) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

urinating less than usual or not at all;

swelling, weight gain, feeling short of breath;

feeling like you might pass out;

anxiety, sweating, pale skin, severe shortness of breath, wheezing, gasping for breath, cough with foamy mucus;

chest pain, fast, slow, or uneven heart rate; or

fever, upper stomach pain, and jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

cough;

headache;

runny or stuffy nose, sore throat;

constipation, diarrhea;

dizziness;

back pain;

joint pain; or

nausea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Tarka (trandolapril and verapamil)?

Many drugs can interact with trandolapril and verapamil. Below is just a partial list. Tell your doctor if you are using:

buspirone (BuSpar);

colchicine (Colcrys);

cyclosporine (Neoral, Sandimmune, Gengraf);

dexamethasone (Cortastat, Dexasone, Solurex, DexPak);

digoxin (digitalis, Lanoxin);

gold injections (to treat arthritis);

lithium (Lithobid, Eskalith);

phenobarbital (Solfoton) or other barbiturates;

insulin or oral diabetes medication;

sirolimus (Rapamune) or tacrolimus (Prograf);

St. John's wort;

theophylline (Elixophyllin, Respbid, Theo-Dur, and others);

an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), rifampin (Rifadin, Rifater, Rifamate) and others;

antifungal medication such as itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Oravig), or voriconazole (Vfend);

aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others;

a beta-blocker such as atenolol (Tenormin), carvedilol (Coreg), metoprolol (Lopressor, Toprol), propranolol (Inderal, InnoPran), and others;

a diuretic (water pill);

drugs to treat high blood pressure or a prostate disorder, such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), terazosin (Hytrin), tamsulosin (Flomax);

cholesterol-lowering drugs such as atorvastatin (Lipitor, Caduet), lovastatin (Mevacor, Altoprev, Advicor), or simvastatin (Zocor, Simcor, Vytorin, Juvisync);

heart rhythm or blood pressure medication such as disopyramide (Norpace), flecainide (Tambocor), nicardipine (Cardene) or quinidine (Quin-G);

HIV or AIDS medication; or

seizure medication such as carbamazepine (Carbatrol, Equetro, Tegretol), phenytoin (Dilantin), and others.

This list is not complete and there are many other drugs that can interact with trandolapril and verapamil. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

More Tarka resources Tarka Side Effects (in more detail) Tarka Use in Pregnancy & Breastfeeding Drug Images Tarka Drug Interactions Tarka Support Group 4 Reviews for Tarka - Add your own review/rating Tarka Prescribing Information (FDA) Tarka Advanced Consumer (Micromedex) - Includes Dosage Information Tarka MedFacts Consumer Leaflet (Wolters Kluwer) Compare Tarka with other medications High Blood Pressure Where can I get more information? Your pharmacist can provide more information about trandolapril and verapamil.

See also: Tarka side effects (in more detail)


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tadalafil


Generic Name: tadalafil (ta DAL a fil)
Brand Names: Adcirca, Cialis

What is tadalafil?

Tadalafil relaxes muscles and increases blood flow to particular areas of the body.

Tadalafil under the name of Cialis is used to treat erectile dysfunction (impotence) and symptoms of benign prostatic hypertrophy (enlarged prostate). Another brand of sildenafil is Adcirca, which is used to treat pulmonary arterial hypertension and improve exercise capacity in men and women.

Tadalafil may also be used for purposes not listed in this medication guide.

What is the most important information I should know about tadalafil? Do not take tadalafil if you are allergic to it, or if you are also using a nitrate drug for chest pain or heart problems, including nitroglycerin (Nitro Dur, Nitrolingual, Nitrostat, Transderm Nitro, and others), isosorbide dinitrate (Dilatrate, Isordil, Isochron), isosorbide mononitrate (Imdur, ISMO, Monoket), or recreational drugs such as amyl nitrate or nitrite ("poppers"). Taking tadalafil with a nitrate medicine can cause a sudden and serious decrease in blood pressure. If you become dizzy or nauseated during sexual activity, or if you have pain, numbness, or tingling in your chest, arms, neck, or jaw, stop and call your doctor right away. You could be having a serious side effect of tadalafil. Do not take tadalafil more than once a day. Allow 24 hours to pass between doses. Contact your doctor or seek emergency medical attention if your erection is painful or lasts longer than 4 hours. A prolonged erection (priapism) can damage the penis.

Tadalafil can decrease blood flow to the optic nerve of the eye, causing sudden vision loss. This has occurred in a small number of people taking tadalafil, most of whom also had heart disease, diabetes, high blood pressure, high cholesterol, or certain pre-existing eye problems, and in those who smoke or are over 50 years old. It is not clear whether tadalafil is the actual cause of vision loss.

Stop using tadalafil and get emergency medical help if you have sudden vision loss. What should I discuss with my healthcare provider before taking tadalafil? You should not take tadalafil if you are allergic to it.

Tadalafil should not be used together with nitrate medication, such as nitroglycerin (Nitro Dur, Nitrolingual, Nitrostat, Transderm Nitro, and others), isosorbide dinitrate (Dilatrate, Isordil, Isochron), isosorbide mononitrate (Imdur, ISMO, Monoket), or recreational drugs such as amyl nitrate or nitrite ("poppers"). Taking tadalafil with a nitrate medicine for chest pain or heart problems can cause a sudden and serious decrease in blood pressure.

To make sure you can safely take tadalafil, tell your doctor if you have any of these other conditions:

heart disease or heart rhythm problems;

a recent heart attack (within the past 90 days);

a recent history (in the past 6 months) of a stroke, or congestive heart failure;

angina (chest pain), high or low blood pressure;

liver disease;

kidney disease (or if you are on dialysis);

a blood cell disorder such as sickle cell anemia, multiple myeloma, or leukemia;

a bleeding disorder such as hemophilia;

a stomach ulcer;

retinitis pigmentosa (an inherited condition of the eye);

a physical deformity of the penis (such as Peyronie's disease); or

if you have been told you should not have sexual intercourse for health reasons.

Tadalafil can decrease blood flow to the optic nerve of the eye, causing sudden vision loss. This has occurred in a small number of people taking tadalafil, most of whom also had heart disease, diabetes, high blood pressure, high cholesterol, or certain pre-existing eye problems, and in those who smoke or are over 50 years old.

It is not clear whether tadalafil is the actual cause of vision loss. Stop using tadalafil and get emergency medical help if you have sudden vision loss. FDA pregnancy category B. Tadalafil is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment with Adcirca. It is not known whether tadalafil passes into breast milk or if it could harm a nursing baby. Do not use Adcirca without telling your doctor if you are breast-feeding a baby. How should I take tadalafil?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Tadalafil can be taken with or without food.

Do not break or split a Cialis tablet. Swallow it whole.

Cialis is usually taken only once per day. Follow your doctor's instructions. For erectile dysfunction, take the medicine just before sexual activity but not more than once per day.

Cialis can help achieve an erection when sexual stimulation occurs. An erection will not occur just by taking a pill. Follow your doctor's instructions.

Adcirca is usually taken once per day. Follow your doctor's instructions. Do not take Cialis for erectile dysfunction if you are taking Adcirca for pulmonary arterial hypertension.

Do not take tadalafil more than once a day. Allow 24 hours to pass between doses. If you take the medication daily, take it at the same time each day. Contact your doctor or seek emergency medical attention if your erection is painful or lasts longer than 4 hours. A prolonged erection (priapism) can damage the penis. Store at room temperature away from moisture and heat.

See also: Tadalafil dosage (in more detail)

What happens if I miss a dose?

If tadalafil is used as needed, you are not likely to be on a dosing schedule.

If you take tadalafil every day and you miss a dose, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include chest pain, nausea, irregular heartbeat, and feeling light-headed or fainting.

What should I avoid while taking tadalafil? Drinking alcohol can increase certain side effects of tadalafil.

Grapefruit and grapefruit juice may interact with tadalafil and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Avoid using other medicines to treat erectile dysfunction, such as sildenafil (Viagra) or vardenafil (Levitra) while you are taking tadalafil. Tadalafil side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. If you become dizzy or nauseated during sexual activity, or if you have pain, numbness, or tingling in your chest, arms, neck, or jaw, stop and call your doctor right away. You could be having a serious side effect of tadalafil. Stop using tadalafil and call your doctor at once if you have any of these serious side effects:

changes in vision or sudden vision loss;

ringing in your ears, or sudden hearing loss;

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

irregular heartbeat;

shortness of breath, swelling in your hands or feet;

seizure (convulsions);

feeling light-headed, fainting; or

penis erection that is painful or lasts 4 hours or longer.

Less serious side effects may include:

redness or warmth in your face, neck, or chest;

cold symptoms such as stuffy nose, sneezing, or sore throat;

headache;

memory problems;

diarrhea, upset stomach; or

muscle pain, back pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tadalafil Dosing Information

Usual Adult Dose for Erectile Dysfunction:

Erectile dysfunction:
10 mg orally taken prior to anticipated sexual activity. The maximum recommended dosing frequency is once per day in most patients.
Alternatively, 2.5 mg orally once daily, without regard to timing of sexual activity. May increase to 5 mg orally once daily based on efficacy and tolerability.
Erectile dysfunction and benign prostatic hyperplasia together:
5 mg orally taken at approximately the same time every day.

Usual Adult Dose for Pulmonary Hypertension:

40 mg orally once daily, with or without food. Dividing the dose (40 mg) over the course of the day is not recommended.

Usual Adult Dose for Benign Prostatic Hyperplasia:

Benign prostatic hyperplasia and benign prostatic hyperplasia with erectile dysfunction:
5 mg orally taken at approximately the same time every day.

What other drugs will affect tadalafil?

Tell your doctor about all other medicines you use, especially:

rifabutin (Mycobutin), rifampin (Rifadin, Rimactane, Rifater, Rifamate), or rifapentine (Priftin);

an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), or telithromycin (Ketek);

antifungal medication such as itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Oravig), or voriconazole (Vfend);

an antidepressant such as nefazodone;

a barbiturate such as phenobarbital (Solfoton);

drugs to treat high blood pressure or a prostate disorder, such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), terazosin (Hytrin), tamsulosin (Flomax);

heart or blood pressure medication such as diltiazem (Cardizem, Dilacor, Tiazac), nicardipine (Cardene), quinidine (Quin-G), or verapamil (Calan, Covera, Isoptin, Verelan); or

HIV or AIDS medications such as darunavir (Prezista), efavirenz (Sustiva), etravirine (Intelence), nevirapine (Viramune), fosamprenavir (Lexiva), indinavir (Crixivan), ritonavir (Norvir, Kaletra), and others; or

seizure medications such as carbamazepine (Carbatrol, Equetro, Tegretol), phenytoin (Dilantin), and others.

This list is not complete and other drugs may interact with tadalafil. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More tadalafil resources Tadalafil Side Effects (in more detail) Tadalafil Dosage Tadalafil Use in Pregnancy & Breastfeeding Tadalafil Drug Interactions Tadalafil Support Group 103 Reviews for Tadalafil - Add your own review/rating tadalafil Advanced Consumer (Micromedex) - Includes Dosage Information Tadalafil MedFacts Consumer Leaflet (Wolters Kluwer) Tadalafil Monograph (AHFS DI) Tadalafil Professional Patient Advice (Wolters Kluwer) Adcirca Prescribing Information (FDA) Adcirca Consumer Overview Adcirca MedFacts Consumer Leaflet (Wolters Kluwer) Cialis Prescribing Information (FDA) Cialis Consumer Overview Compare tadalafil with other medications Benign Prostatic Hyperplasia Erectile Dysfunction Pulmonary Arterial Hypertension Where can I get more information? Your pharmacist can provide more information about tadalafil.

See also: tadalafil side effects (in more detail)


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Minipress


Generic Name: Prazosin Hydrochloride
Class: alpha-Adrenergic Blocking Agents
VA Class: CV150
CAS Number: 19237-84-4

Introduction

Postsynaptic ?1-adrenergic blocking agent; quinazoline derivative.101 b

Uses for Minipress Hypertension

Management of hypertension (alone or in combination with other classes of antihypertensive agents).101 153 161

Current antihypertensive and urology guidelines (e.g., JNC 7) no longer recommend ?1-blockers as preferred first-line therapy for patients with hypertension.b

Acute management of severe hypertension in patients with increased concentrations of circulating catecholamines.b

Benign Prostatic Hyperplasia (BPH)

Has been used to reduce urinary obstruction and relieve associated manifestations in patients with symptomatic BPH†; efficacy relative to other ?1-adrenergic blockers remains to be established.112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133

Posttraumatic Stress Disorder (PTSD)

Has been used in the management of PTSD†, particularly in combat veterans and in patients experiencing nighttime PTSD symptoms (e.g., nightmares, sleep disturbances).200 201 202 203 204 205 206 207 208 209 210 211 212 215 216 217 221 222 225

Some clinicians currently recommend prazosin as first-line or alternative therapy when treating PTSD patients with prominent nighttime symptoms, particularly in combat veterans.201 204 212 215 217 222 225 Further studies necessary in civilians with noncombat trauma-related PTSD and in treatment of daytime PTSD symptoms.200 201 203 204 208 216

Minipress Dosage and Administration Administration Oral Administration

Administer orally in divided doses 2 or 3 times daily.101

Manufacturers make no specific recommendations regarding administration with meals.101 221

Dosage

Available as prazosin hydrochloride; dosage expressed in terms of prazosin.101 b

Individualize dosage according to patient response and tolerance.101 b Initiate at low dosage to minimize frequency of postural hypotension and syncope.101 b

Postural effects are most likely to occur 2–6 hours after a dose; monitor BP during this period after first dose and with any dosage increases.161 179

If therapy is interrupted for a few days, restart using initial dosage regimen.

Pediatric Patients Hypertension† Oral

Initially, 0.05–0.1 mg/kg daily given in 3 divided doses.195 Increase dosage as necessary up to a maximum of 0.5 mg/kg daily given in 3 divided doses.195

Adults Hypertension Monotherapy Oral

Initially, 1 mg 2 or 3 times daily.101 b Do not initiate with higher dosages.101 b May increase dosage gradually to 20 mg daily given in divided doses.101 b

Usual maintenance dosage: 6–15 mg daily given in divided doses.101 b

Careful monitoring of BP is recommended during initial titration or subsequent upward dosage adjustment;161 avoid large or abrupt reductions in BP.161 179

For the acute management of severe hypertension, initially, 1–2 mg; dosage may be repeated after 1 hour, if necessary.b

Combination Therapy Oral

When other hypotensive agents or diuretics are added to existing prazosin therapy, reduce dosage to 1 or 2 mg 3 times daily; gradually increase according to patient's response and tolerance.101 b

Posttraumatic Stress Disorder†

Optimum dosage not established.200 201 212 In clinical studies, usual initial dosage was 1 mg at bedtime; dosage was then gradually increased based on patient's response and tolerance.200 201 202 203 204 205 206 207 208 209 210 211 212 217 220 Maintenance dosages ranging from 1 to 25 mg daily (given once daily at bedtime or in 2 divided doses) have been use.200 203 206 210 212 217 220 225 Some experts recommend a target maintenance dosage of 1–10 mg daily; others recommend a higher target dosage of 2–20 mg daily.224 225

Prescribing Limits Pediatric Patients Hypertension† Oral

Maximum 0.5 mg/kg daily.195

Adults Hypertension Oral

Maximum 20 mg daily.101 b Although higher dosages usually do not increase efficacy, a few patients may benefit from ?40 mg daily.101 b

Special Populations Hepatic Impairment

No specific dosage recommendations at this time.b

Renal Impairment

Initially, 1 mg twice daily.b Patients with chronic renal failure may require only small dosages.b

Geriatric Patients

No specific dosage recommendations at this time;b generally increase dosage more slowly in geriatric hypertensive patients than in younger adults.

Cautions for Minipress Contraindications

Known hypersensitivity to prazosin, quinazolines (e.g., alfuzosin, doxazosin, terazosin), or any ingredient in the formulation.101

Warnings/Precautions Warnings Postural Hypotension

Like other ?-adrenergic blocking agents, marked hypotension, especially in the upright position, can occur; may be accompanied by syncope, palpitations, and other postural effects (e.g., dizziness, lightheadedness, vertigo).101

Postural effects are most common after an initial dose, shortly after dosing (e.g., within 90 minutes), when dosage is rapidly increased, or when other antihypertensive agents are added to therapy.101 b

To decrease risk of excessive hypotension and syncope, initiate therapy at a low dosage (i.e., 1 mg) and titrate slowly; initiate concomitant antihypertensive agents with caution.101 b

If syncope or hypotension occurs, place patient in a recumbent position and institute supportive therapy as necessary.101 b

General Precautions Intraoperative Floppy Iris Syndrome (IFIS)

IFIS observed during cataract surgery in some patients currently receiving or previously treated with ?1-adrenergic blocking agents.101 218

If patient has received ?1-blockers, ophthalmologist should be prepared to modify the surgical technique (e.g., through use of iris hooks, iris dilator rings, viscoelastic substances) to minimize complications of IFIS.101 218

Benefit of discontinuing ?1-blockers, including prazosin, prior to cataract surgery not established.101 218

Prostate Cancer

Exclude possibility of prostate cancer before initiation of therapy for BPH.155 156

Specific Populations Pregnancy

Category C.101

Lactation

Distributed into milk in small amounts.101 Caution if used in nursing women.101 b

Pediatric Use

Safety and efficacy not established in children <18 years of age.101 b

Geriatric Use

Geriatric patients may be particularly susceptible to postural effects and other adverse effects.153 161

Common Adverse Effects

Dizziness, lightheadedness, headache, drowsiness, lack of energy, weakness, palpitation, nausea.101 b

Interactions for Minipress Protein-bound Drugs

Potential pharmacokinetic interaction (displacement of prazosin or other protein-bound drug).b

Specific Drugs and Laboratory Tests

Drug

Interaction

Comments

Analgesic agents (aspirin, indomethacin, phenylbutazone [no longer commercially available in the US], propoxyphene)

No interaction observed101

Antiarrhythmic agents (procainamide, quinidine)

No interaction observed101

Antigout agents (allopurinol, colchicine, probenecid)

No interaction observed101

Antihypertensive agents (e.g., propranolol)

Possible additive hypotensive effects and symptomatic hypotension101

Initiate additional antihypertensive agents with caution; may reduce prazosin dosage and gradually increase dosage based on clinical response101

Benzodiazepines (chlordiazepoxide, diazepam)

No interaction observed101

Digoxin

No interaction observed101

Diuretics

Possible additive hypotensive effects and symptomatic hypotension101 b

Effect usually used to therapeutic advantageb

Initiate diuretics with caution; may reduce prazosin dosage and gradually increase dosage based on clinical response101

Hypoglycemic agents (insulin, chlorpropramide, phenformin [no longer commercially available in the US], tolazamide, tolbutamide)

No interaction observed101

Phenobarbital

No interaction observed101

Phosphodiesterase (PDE) type 5 inhibitors (e.g., sildenafil, tadalafil, vardenafil)

Possible additive hypotensive effects and symptomatic hypotension101

Initiate PDE type 5 inhibitor at lowest possible dosage101

Test for pheochromocytoma

Possible increase in urinary metabolite of norepinephrine and VMA; false positive results may occur in pheochromocytoma screening tests101

If elevated VMA is observed, discontinue prazosin and repeat test after 1 month101

Minipress Pharmacokinetics Absorption Bioavailability

Peak plasma concentrations attained within about 2–3 hours.b

Bioavailability is approximately 60%.b

Onset

In patients with hypertension, maximum reduction in BP usually occurs 2–4 hours after administration.b

Food

Food does not affect the extent of absorption; however, absorption may be delayed.b

Distribution Extent

Not known whether prazosin crosses the placenta;b distributed into milk in small amounts.b Crosses the blood-brain barrier.200 204 205 206 208 210

Plasma Protein Binding

Approximately 97%.b

Elimination Metabolism

Extensively metabolized, principally in the liver by demethylation and conjugation.101 b

Elimination Route

Excreted principally in feces via biliary excretion and to a lesser extent in urine (6–10%).101 b

Half-life

2–4 hours.b

Stability Storage Oral Capsules

20-25°C; protect from moisture and light.221

ActionsActions

Reduces peripheral vascular resistance and BP as a result of vasodilating effects;101 b produces both arterial and venous dilation.101

Effects appear to result from selective, competitive inhibition of ?1-adrenergic receptors.b

Generally causes no change in heart rate, cardiac output, renal blood flow, and GFR.101 b

Binds to ?-adrenergic receptors on the prostate capsule, prostate adenoma, and bladder trigone, resulting in decreased urinary outflow resistance in men.

May improve to limited extent the serum lipid profile (e.g., small increases in HDL and HDL/total cholesterol ratio; small decreases in LDL, total cholesterol, and triglyceride concentrations).153 161 c

Precise mechanism of action in PTSD not fully elucidated; however, norepinephrine and ?1-adrenergic receptors play an important role in the pathophysiology of PTSD-associated nightmares, arousal, selective attention and vigilance.200 201 203 204 205 206 207 208 209 210 216 217 220 Prazosin is believed to help correct the effects of ?1-adrenergic receptor hyperstimulation in PTSD and has also been shown to normalize the sleep cycle.200 203 205 206 211 220

Advice to Patients

Possible dizziness, lightheadedness or fainting, especially at initiation of therapy;101 b importance of avoiding driving or other hazardous tasks where injury could occur for 24 hours after the first dose or when dosage is increased.101

Importance of advising patient that alcohol use, hot weather, exercise, and standing for long periods of time may precipitate or exacerbate symptoms of dizziness, lightheadedness, or fainting, and to use caution during these situations.101

Importance of sitting or lying down when symptoms of lowered BP occur, and of rising carefully from a sitting or lying position.101 b

Possible drowsiness or somnolence; use caution when operating machinery or driving a motor vehicle until effects on individual are known.b

Importance of advising patients being considered for cataract surgery that they should inform their ophthalmologist of current or prior ?1-blocker therapy, including prazosin.101 218

Importance of advising patients receiving prazosin for PTSD† that the drug may help reduce nightmares and improve sleep and other symptoms; however, it does not cure PTSD and their nightmares, anxiety, and other PTSD-related symptoms may return if therapy is stopped.201 203 219

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.101

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses.101

Importance of informing patients of other important precautionary information.101 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Prazosin Hydrochloride

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Capsules

1 mg (of prazosin)*

Minipress

Pfizer

Prazosin Hydrochloride Capsules

2 mg (of prazosin)*

Minipress

Pfizer

Prazosin Hydrochloride Capsules

5 mg (of prazosin)*

Minipress

Pfizer

Prazosin Hydrochloride Capsules

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Minipress 1MG Capsules (PFIZER U.S.): 60/$51.99 or 180/$149.97

Minipress 2MG Capsules (PFIZER U.S.): 60/$69.99 or 180/$199.98

Minipress 5MG Capsules (PFIZER U.S.): 60/$123.99 or 180/$347.96

Prazosin HCl 1MG Capsules (MYLAN): 60/$17.99 or 180/$37.97

Prazosin HCl 2MG Capsules (TEVA PHARMACEUTICALS USA): 60/$22.99 or 180/$49.97

Prazosin HCl 5MG Capsules (TEVA PHARMACEUTICALS USA): 60/$33.99 or 180/$93.97

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions February 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

Only references cited for selected revisions after 1984 are available electronically.

100. Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. The 1984 report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. Arch Intern Med. 1984; 144:1045-57. [IDIS 184763] [PubMed 6143542]

101. Pfizer Labs. Minipress (prazosin hydrochloride) capsules prescribing information. New York, NY; 2009 Jul.

102. Waldo R. Prazosin relieves Raynaud’s vasospasm. JAMA. 1979; 241:1037. [IDIS 101504] [PubMed 762741]

103. Nielsen SL, Vitting K, Rasmussen K. Prazosin treatment of primary Raynaud’s phenomenon. Eur J Clin Pharmacol. 1983; 24:421-3. [IDIS 170153] [PubMed 6345178]

104. Wollersheim H, Thien T, Fennis J et al. Double-blind, placebo-controlled study of prazosin in Raynaud’s phenomenon. Clin Pharmacol Ther. 1986; 40:219-25. [IDIS 219933] [PubMed 3731684]

105. Cobaugh DS. Prazosin treatment of ergotamine-induced peripheral ischemia. JAMA. 1980; 244:1360. [IDIS 125518] [PubMed 7411811]

106. 1988 Joint National Committee. The 1988 report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. Arch Intern Med. 1988; 148:1023-38. [IDIS 242588] [PubMed 3365073]

107. Guilleminault C, Mignot E, Aldrich M et al. Prazosin contraindicated in patients with narcolepsy. Lancet. 1988; 2:511. [IDIS 245751] [PubMed 2900433]

108. Aldrich MS, Rogers AE. Exacerbation of human cataplexy by prazosin. Sleep. 1989; 12:254-6. [PubMed 2740697]

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