Author: druginteractionchecker_lgaiz4

DOSAGE AND ADMINISTRATION

If Terazosin Capsules administration is discontinued for several days, therapy should be reinstituted using the initial dosing regimen.

Benign Prostatic Hyperplasia Initial Dose : 1 mg at bedtime is the starting dose for all patients, and this dose should not be exceeded as an initial dose.

Patients should be closely followed during initial administration in order to minimize the risk of severe hypotensive response.

Subsequent Doses: The dose should be increased in a stepwise fashion to 2 mg, 5 mg, or 10 mg once daily to achieve the desired improvement of symptoms and/or flow rates.

Doses of 10 mg once daily are generally required for the clinical response.

Therefore, treatment with 10 mg for a minimum of 4-6 weeks may be required to assess whether a beneficial response has been achieved.

Some patients may not achieve a clinical response despite appropriate titration.

Although some additional patients responded at a 20 mg daily dose, there was an insufficient number of patients studied to draw definitive conclusions about this dose.

There are insufficient data to support the use of higher doses for those patients who show inadequate or no response to 20 mg daily.

If terazosin administration is discontinued for several days or longer, therapy should be reinstituted using the initial dosing regimen.

Use with Other Drugs: Caution should be observed when Terazosin Capsules are administered concomitantly with other antihypertensive agents, especially the calcium channel blocker verapamil, to avoid the possibility of developing significant hypotension.

When using Terazosin Capsules and other antihypertensive agents concomitantly, dosage reduction and retitration of either agent may be necessary (see Precautions).

Hypotension has been reported when Terazosin Capsules have been used with phosphodiesterase-5 (PDE-5) inhibitors.

Hypertension The dose of Terazosin Capsules and the dose interval (12 or 24 hours) should be adjusted according to the patient’s individual blood pressure response.

The following is a guide to its administration: Initial Dose: 1 mg at bedtime is the starting dose for all patients, and this dose should not be exceeded.

This initial dosing regimen should be strictly observed to minimize the potential for severe hypotensive effects.

Subsequent Doses: The dose may be slowly increased to achieve the desired blood pressure response.

The usual recommended dose range is 1 mg to 5 mg administered once a day; however, some patients may benefit from doses as high as 20 mg per day.

Doses over 20 mg do not appear to provide further blood pressure effect and doses over 40 mg have not been studied.

Blood pressure should be monitored at the end of the dosing interval to be sure control is maintained throughout the interval.

It may also be helpful to measure blood pressure 2-3 hours after dosing to see if the maximum and minimum responses are similar, and to evaluate symptoms such as dizziness or palpitations which can result from excessive hypotensive response.

If response is substantially diminished at 24 hours an increased dose or use of a twice daily regimen can be considered.

If terazosin administration is discontinued for several days or longer, therapy should be reinstituted using the initial dosing regimen.

In clinical trials, except for the initial dose, the dose was given in the morning.

Use With Other Drugs: (see above)

DOSAGE AND ADMINISTRATION

Directions Do not take more than 6 doses in any 24-hour period Shake well before use Age Dose Adults and children 12 years and over 10 mL (2 tsps) every 4 hours Children 6 to under 12 years of age.

5 mL (1 tsps) every 4 hours Children under 6 years of age Do not use

DOSAGE AND ADMINISTRATION

In controlled clinical trials, single doses of 25, 50, or 100 mg of IMITREX Tablets were effective for the acute treatment of migraine in adults.

There is evidence that doses of 50 and 100 mg may provide a greater effect than 25 mg (see CLINICAL TRIALS).

There is also evidence that doses of 100 mg do not provide a greater effect than 50 mg.

Individuals may vary in response to doses of IMITREX Tablets.

The choice of dose should therefore be made on an individual basis, weighing the possible benefit of a higher dose with the potential for a greater risk of adverse events.

If the headache returns or the patient has a partial response to the initial dose, the dose may be repeated after 2 hours, not to exceed a total daily dose of 200 mg.

If a headache returns following an initial treatment with IMITREX Injection, additional single IMITREX Tablets (up to 100 mg/day) may be given with an interval of at least 2 hours between tablet doses.

The safety of treating an average of more than 4 headaches in a 30-day period has not been established.

Because of the potential of MAO-A inhibitors to cause unpredictable elevations in the bioavailability of oral sumatriptan, their combined use is contraindicated (see CONTRAINDICATIONS).

Hepatic disease/functional impairment may also cause unpredictable elevations in the bioavailability of orally administered sumatriptan.

Consequently, if treatment is deemed advisable in the presence of liver disease, the maximum single dose should in general not exceed 50 mg (see CLINICAL PHARMACOLOGY for the basis of this recommendation).

DOSAGE AND ADMINISTRATION

Methimazole is administered orally.

It is usually given in 3 equal doses at approximately 8-hour intervals.

Adults The initial daily dosage is 15 mg for mild hyperthyroidism, 30 to 40 mg for moderately severe hyperthyroidism, and 60 mg for severe hyperthyroidism, divided into 3 doses at 8-hour intervals.

The maintenance dosage is 5 to 15 mg daily.

Pediatric Initially, the daily dosage is 0.4 mg/kg of body weight divided into 3 doses and given at 8-hour intervals.

The maintenance dosage is approximately 1/2 of the initial dose.

DOSAGE AND ADMINISTRATION

General Principles OXYCONTIN IS AN OPIOID AGONIST AND A SCHEDULE II CONTROLLED SUBSTANCE WITH AN ABUSE LIABILITY SIMILAR TO MORPHINE.

OXYCODONE, LIKE MORPHINE AND OTHER OPIOIDS USED IN ANALGESIA, CAN BE ABUSED AND IS SUBJECT TO CRIMINAL DIVERSION.

OXYCONTIN TABLETS ARE TO BE SWALLOWED WHOLE AND ARE NOT TO BE BROKEN, CHEWED, OR CRUSHED.

TAKING BROKEN, CHEWED, OR CRUSHED OXYCONTIN ® TABLETS LEADS TO RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF OXYCODONE.

One OxyContin 160 mg tablet is comparable to two 80 mg tablets when taken on an empty stomach.

With a high-fat meal, however, there is a 25% greater peak plasma concentration following one 160 mg tablet.

Dietary caution should be taken when patients are initially titrated to 160 mg tablets (see ).

Patients should be started on the lowest appropriate dose (see : Initiation of Therapy ).

In treating pain it is vital to assess the patient regularly and systematically.

Therapy should also be regularly reviewed and adjusted based upon the patient’s own reports of pain and side effects and the health professional’s clinical judgment.

OxyContin Tablets are a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time.

The controlled-release nature of the formulation allows OxyContin to be effectively administered every 12 hours (see CLINICAL PHARMACOLOGY; PHARMACOKINETICS AND METABOLISM ).

While symmetric (same dose AM and PM), around-the-clock, q12h dosing is appropriate for the majority of patients, some patients may benefit from asymmetric (different dose given in AM than in PM) dosing, tailored to their pain pattern.

It is usually appropriate to treat a patient with only one opioid for around-the-clock therapy.

Physicians should individualize treatment using a progressive plan of pain management such as outlined by the World Health Organization, the American Pain Society and the Federation of State Medical Boards Model Guidelines.

Healthcare professionals should follow appropriate pain management principles of careful assessment and ongoing monitoring (see BOXED WARNING ).

Initiation of Therapy It is critical to initiate the dosing regimen for each patient individually, taking into account the patient’s prior opioid and non-opioid analgesic treatment.

Attention should be given to: (1)the general condition and medical status of the patient;(2)the daily dose, potency, and kind of the analgesic(s) the patient has been taking;(3)the reliability of the conversion estimate used to calculate the dose of oxycodone;(4)the patient’s opioid exposure and opioid tolerance (if any);(5)the Special Instructions for OxyContin 60 mg, 80 mg, and 160 mg Tablets, or a Single Dose Greater Than 40 mg; and (6)the balance between pain control and adverse experiences.

Care should be taken to use low initial doses of OxyContin in patients who are not already opioid-tolerant, especially those who are receiving concurrent treatment with muscle relaxants, sedatives, or other CNS active medications (see PRECAUTIONS: Drug-Drug Interactions ).

For initiation of OxyContin therapy for patients previously taking opioids, the conversion ratios from Foley, KM.

[NEJM, 1985; 313:84-95], found below, are a reasonable starting point, although not verified in well-controlled, multiple-dose trials.

Experience indicates a reasonable starting dose of OxyContin for patients who are taking non-opioid analgesics and require continuous around-the-clock therapy for an extended period of time is 10 mg q12h.

If a non-opioid analgesic is being provided, it may be continued.

OxyContin should be individually titrated to a dose that provides adequate analgesia and minimizes side effects.

Using standard conversion ratio estimates (see Table 4 below), multiply the mg/day of the previous opioids by the appropriate multiplication factors to obtain the equivalent total daily dose of oral oxycodone.

When converting from oxycodone, divide the 24-hour oxycodone dose in half to obtain the twice a day (q12h) dose of OxyContin.

Round down to a dose which is appropriate for the tablet strengths available.

Discontinue all other around-the-clock opioid drugs when OxyContin therapy is initiated.

No fixed conversion ratio is likely to be satisfactory in all patients, especially patients receiving large opioid doses.

The recommended doses shown in Table 4 are only a starting point, and close observation and frequent titration are indicated until patients are stable on the new therapy.

In all cases, supplemental analgesia should be made available in the form of a suitable short-acting analgesic.

OxyContin ® can be safely used concomitantly with usual doses of non-opioid analgesics and analgesic adjuvants, provided care is taken to select a proper initial dose (see PRECAUTIONS ).

Conversion from Transdermal Fentanyl to OxyContin Eighteen hours following the removal of the transdermal fentanyl patch, OxyContin treatment can be initiated.

Although there has been no systematic assessment of such conversion, a conservative oxycodone dose, approximately 10 mg q12h of OxyContin, should be initially substituted for each 25 µg/hr fentanyl transdermal patch.

The patient should be followed closely for early titration, as there is very limited clinical experience with this conversion.

Managing Expected Opioid Adverse Experiences Most patients receiving opioids, especially those who are opioid-naive, will experience side effects.

Frequently the side effects from OxyContin are transient, but may require evaluation and management.

Adverse events such as constipation should be anticipated and treated aggressively and prophylactically with a stimulant laxative and/or stool softener.

Patients do not usually become tolerant to the constipating effects of opioids.

Other opioid-related side effects such as sedation and nausea are usually self-limited and often do not persist beyond the first few days.

If nausea persists and is unacceptable to the patient, treatment with antiemetics or other modalities may relieve these symptoms and should be considered.

Patients receiving OxyContin ® may pass an intact matrix “ghost” in the stool or via colostomy.

These ghosts contain little or no residual oxycodone and are of no clinical consequence.

Individualization of Dosage Once therapy is initiated, pain relief and other opioid effects should be frequently assessed.

Patients should be titrated to adequate effect (generally mild or no pain with the regular use of no more than two doses of supplemental analgesia per 24 hours).

Patients who experience breakthrough pain may require dosage adjustment or rescue medication.

Because steady-state plasma concentrations are approximated within 24 to 36 hours, dosage adjustment may be carried out every 1 to 2 days.

It is most appropriate to increase the q12h dose, not the dosing frequency.

There is no clinical information on dosing intervals shorter than q12h.

As a guideline, the total daily oxycodone dose usually can be increased by 25% to 50% of the current dose at each increase.

If signs of excessive opioid-related adverse experiences are observed, the next dose may be reduced.

If this adjustment leads to inadequate analgesia, a supplemental dose of immediate-release oxycodone may be given.

Alternatively, non-opioid analgesic adjuvants may be employed.

Dose adjustments should be made to obtain an appropriate balance between pain relief and opioid-related adverse experiences.

If significant adverse events occur before the therapeutic goal of mild or no pain is achieved, the events should be treated aggressively.

Once adverse events are under control, upward titration should continue to an acceptable level of pain control.

During periods of changing analgesic requirements, including initial titration, frequent contact is recommended between physician, other members of the healthcare team, the patient and the caregiver/family.

Special Instructions for OxyContin 60 mg, 80 mg and 160 mg Tablets or a Single Dose Greater Than 40 mg (for use in opioid-tolerant patients only) OxyContin 60 mg, 80 mg, and 160 mg Tablets, or a single dose greater than 40 mg, are for use in opioid-tolerant patients only.

A single daily dose greater than 40 mg, or total daily doses greater than 80 mg, may cause fatal respiratory depression when administered to patients who are not tolerant to the respiratory depressant effects of opioids.

Patients should be instructed against use by individuals other than the patient for whom it was prescribed, as such inappropriate use may have severe medical consequences, including death.

One OxyContin ® 160 mg tablet is comparable to two 80 mg tablets when taken on an empty stomach.

With a high-fat meal, however, there is a 25% greater peak plasma concentration following one 160 mg tablet.

Dietary caution should be taken when patients are initially titrated to 160 mg tablets.

Supplemental Analgesia Most patients given around-the-clock therapy with controlled-release opioids may need to have immediate-release medication available for exacerbations of pain or to prevent pain that occurs predictably during certain patient activities (incident pain).

Maintenance of Therapy The intent of the titration period is to establish a patient-specific q12h dose that will maintain adequate analgesia with acceptable side effects for as long as pain relief is necessary.

Should pain recur then the dose can be incrementally increased to re-establish pain control.

The method of therapy adjustment outlined above should be employed to re-establish pain control.

During chronic therapy, especially for non-cancer pain syndromes, the continued need for around-the-clock opioid therapy should be reassessed periodically (e.g., every 6 to 12 months) as appropriate.

Cessation of Therapy When the patient no longer requires therapy with OxyContin Tablets, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.

Conversion from OxyContin to Parenteral Opioids To avoid overdose, conservative dose conversion ratios should be followed.

DOSAGE AND ADMINISTRATION

Gastric irritation may be reduced if taken before, during, or immediately after meals or with food or milk.

The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight.

Exogenous corticosteroids suppress adrenocorticoid activity the least when given at the time of maximal activity (am) for single dose administration.

Therefore, it is recommended that prednisone be administered in the morning prior to 9 am and when large doses are given, administration of antacids between meals to help prevent peptic ulcers.

Multiple dose therapy should be evenly distributed in evenly spaced intervals throughout the day.

Dietary salt restriction may be advisable in patients.

Do not stop taking this medicine without first talking to your doctor.

Avoid abrupt withdraw of therapy.

The initial dosage of PredniSONE Tablets may vary from 5 mg to 60 mg per day, depending on the specific disease entity being treated.

In situations of less severity lower doses will generally suffice, while in selected patients higher initial doses may be required.

The initial dosage should be maintained or adjusted until a satisfactory response is noted.

If after a reasonable period of time there is a lack of satisfactory clinical response, PredniSONE should be discontinued and the patient transferred to other appropriate therapy.

IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT.

After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small increments at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached.

It should be kept in mind that constant monitoring is needed in regard to drug dosage.

Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient’s individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation, it may be necessary to increase the dosage of PredniSONE for a period of time consistent with the patient’s condition.

If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.

Multiple Sclerosis In the treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective.

(Dosage range is the same for prednisone and prednisolone.) Alternate Day Therapy Alternate day therapy is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is administered every other morning.

The purpose of this mode of therapy is to provide the patient requiring long-term pharmacologic dose treatment with the beneficial effects of corticoids while minimizing certain undesirable effects, including pituitary-adrenal suppression, the Cushingoid state, corticoid withdrawal symptoms, and growth suppression in children.

The rationale for this treatment schedule is based on two major premises: (a) the anti-inflammatory or therapeutic effect of corticoids persists longer than their physical presence and metabolic effects and (b) administration of the corticosteroid every other morning allows for re-establishment of more nearly normal hypothalamic-pituitary-adrenal (HPA) activity on the off-steroid day.

A brief review of the HPA physiology may be helpful in understanding this rationale.

Acting primarily through the hypothalamus a fall in free cortisol stimulates the pituitary gland to produce increasing amounts of corticotropin (ACTH) while a rise in free cortisol inhibits ACTH secretion.

Normally the HPA system is characterized by diurnal (circadian) rhythm.

Serum levels of ACTH rise from a low point about 10 pm to a peak level about 6 am.

Increasing levels of ACTH stimulate adrenocortical activity resulting in a rise in plasma cortisol with maximal levels occurring between 2 am and 8 am.

This rise in cortisol dampens ACTH production and in turn adrenocortical activity.

There is a gradual fall in plasma corticoids during the day with lowest levels occurring about midnight.

The diurnal rhythm of the HPA axis is lost in Cushing’s disease, a syndrome of adrenocortical hyperfunction characterized by obesity with centripetal fat distribution, thinning of the skin with easy bruisability, muscle wasting with weakness, hypertension, latent diabetes, osteoporosis, electrolyte imbalance, etc.

The same clinical findings of hyperadrenocorticism may be noted during long-term pharmacologic dose corticoid therapy administered in conventional daily divided doses.

It would appear, then, that a disturbance in the diurnal cycle with maintenance of elevated corticoid values during the night may play a significant role in the development of undesirable corticoid effects.

Escape from these constantly elevated plasma levels for even short periods of time may be instrumental in protecting against undesirable pharmacologic effects.

During conventional pharmacologic dose corticosteroid therapy, ACTH production is inhibited with subsequent suppression of cortisol production by the adrenal cortex.

Recovery time for normal HPA activity is variable depending upon the dose and duration of treatment.

During this time the patient is vulnerable to any stressful situation.

Although it has been shown that there is considerably less adrenal suppression following a single morning dose of prednisolone (10 mg) as opposed to a quarter of that dose administered every 6 hours, there is evidence that some suppressive effect on adrenal activity may be carried over into the following day when pharmacologic doses are used.

Further, it has been shown that a single dose of certain corticosteroids will produce adrenocortical suppression for two or more days.

Other corticoids, including methylprednisolone, hydrocortisone, prednisone, and prednisolone, are considered to be short acting (producing adrenocortical suppression for 1¼ to 1½ days following a single dose) and thus are recommended for alternate day therapy.

The following should be kept in mind when considering alternate day therapy: Basic principles and indications for corticosteroid therapy should apply.

The benefits of alternate day therapy should not encourage the indiscriminate use of steroids.

Alternate day therapy is a therapeutic technique primarily designed for patients in whom long-term pharmacologic corticoid therapy is anticipated.

In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate treatment with alternate day therapy.

More severe disease states usually will require daily divided high dose therapy for initial control of the disease process.

The initial suppressive dose level should be continued until satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen diseases.

It is important to keep the period of initial suppressive dose as brief as possible particularly when subsequent use of alternate day therapy is intended.

Once control has been established, two courses are available: (a) change to alternate day therapy and then gradually reduce the amount of corticoid given every other day or (b) following control of the disease process reduce the daily dose of corticoid to the lowest effective level as rapidly as possible and then change over to an alternate day schedule.

Theoretically, course (a) may be preferable.

Because of the advantages of alternate day therapy, it may be desirable to try patients on this form of therapy who have been on daily corticoids for long periods of time (e.g., patients with rheumatoid arthritis).

Since these patients may already have a suppressed HPA axis, establishing them on alternate day therapy may be difficult and not always successful.

However, it is recommended that regular attempts be made to change them over.

It may be helpful to triple or even quadruple the daily maintenance dose and administer this every other day rather than just doubling the daily dose if difficulty is encountered.

Once the patient is again controlled, an attempt should be made to reduce this dose to a minimum.

As indicated above, certain corticosteroids, because of their prolonged suppressive effect on adrenal activity, are not recommended for alternate day therapy (e.g., dexamethasone and betamethasone).

The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight.

Exogenous corticosteroids suppress adrenocortical activity the least, when given at the time of maximal activity (am).

In using alternate day therapy it is important, as in all therapeutic situations to individualize and tailor the therapy to each patient.

Complete control of symptoms will not be possible in all patients.

An explanation of the benefits of alternate day therapy will help the patient to understand and tolerate the possible flare-up in symptoms which may occur in the latter part of the off-steroid day.

Other symptomatic therapy may be added or increased at this time if needed.

In the event of an acute flare-up of the disease process, it may be necessary to return to a full suppressive daily divided corticoid dose for control.

Once control is again established alternate day therapy may be re-instituted.

Although many of the undesirable features of corticosteroid therapy can be minimized by alternate day therapy, as in any therapeutic situation, the physician must carefully weigh the benefit-risk ratio for each patient in whom corticoid therapy is being considered.

DOSAGE AND ADMINISTRATION

Directions for 1 oz bottle When Activated Charcoal is indicated for use, give 3 to 4 heaping tablespoonfulls (20 to 30 g) mixed in a minimum of 8 ounces of liquid or as directed by a health professional.

If an emergency, fill this bottle with water.

Mix well and have poison victim drink all of this mixture.

Repeat dose immediately, if possible.

If previous attempts to contact a poison control center, emergency medical center or health professional were unsuccessful, continue trying.

If possible save the container of poison.

DOSAGE AND ADMINISTRATION

Patients over 12 years of age: The recommended initial dosage of minoxidil tablets is 5 mg of minoxidil given as a single daily dose.

Daily dosage can be increased to 10, 20 and then to 40 mg in single or divided doses if required for optimum blood pressure control.

The effective dosage range is usually 10 to 40 mg per day.

The maximum recommended dosage is 100 mg per day.

Patients under 12 years of age: The initial dosage is 0.2 mg/kg minoxidil as a single daily dose.

The dosage may be increased in 50 to 100% increments until optimum blood pressure control is achieved.

The effective dosage range is usually 0.25 mg to 1 mg/kg/day.

The maximum recommended dosage is 50 mg daily ( see 9.

Pediatric Use under PRECAUTIONS ).

Dose frequency: The magnitude of within-day fluctuation of arterial pressure during therapy with minoxidil is directly proportional to the extent of pressure reduction.

If supine diastolic pressure has been reduced less than 30 mm Hg, the drug need be administered only once a day; if supine diastolic pressure has been reduced more than 30 mm Hg, the daily dosage should be divided into two equal parts.

Frequency of dosage adjustment: Dosage must be titrated carefully according to individual response.

Intervals between dosage adjustments normally should be at least 3 days since the full response to a given dose is not obtained for at least that amount of time.

Where a more rapid management of hypertension is required, dose adjustments can be made every 6 hours if the patient is carefully monitored.

Concomitant therapy: Diuretic and beta-blocker or other sympathetic nervous system suppressant.

Diuretics: Minoxidil must be used in conjunction with a diuretic in patients relying on renal function for maintaining salt and water balance.

Diuretics have been used at the following dosages when starting therapy with minoxidil: hydrochlorothiazide (50 mg, b.i.d.) or other thiazides at equieffective dosage; chlorthalidone (50 to 100 mg, once daily); furosemide (40 mg, b.i.d.).

If excessive salt and water retention results in a weight gain of more than 5 pounds, diuretic therapy should be changed to furosemide; if the patient is already taking furosemide, dosage should be increased in accordance with the patient’s requirements.

Beta-blocker or other sympathetic nervous system suppressants: When therapy with minoxidil is begun, the dosage of a beta-adrenergic receptor blocking drug should be the equivalent of 80 to 160 mg of propranolol per day in divided doses.

If beta-blockers are contraindicated, methyldopa (250 to 750 mg, b.i.d.) may be used instead.

Methyldopa must be given for at least 24 hours before starting therapy with minoxidil because of the delay in the onset of methyldopa’s action.

Limited clinical experience indicates that clonidine may also be used to prevent tachycardia induced by minoxidil; the usual dosage is 0.1 to 0.2 mg twice daily.

Sympathetic nervous system suppressants may not completely prevent an increase in heart rate due to minoxidil but usually do prevent tachycardia.

Typically, patients receiving a beta-blocker prior to initiation of therapy with minoxidil have a bradycardia and can be expected to have an increase in heart rate toward normal when minoxidil is added.

When treatment with minoxidil and beta-blocker or other sympathetic nervous system suppressant are begun simultaneously, their opposing cardiac effects usually nullify each other, leading to little change in heart rate.

DOSAGE AND ADMINISTRATION

General Propranolol Hydrochloride Extended-Release Capsules, USP, provide propranolol hydrochloride in a sustained-release capsule for administration once daily.

If patients are switched from propranolol hydrochloride tablets to Propranolol Hydrochloride Extended-Release Capsules, USP, care should be taken to assure that the desired therapeutic effect is maintained.

Propranolol Hydrochloride Extended-Release Capsules, USP, should not be considered a simple mg-for-mg substitute for propranolol hydrochloride tablets.

Propranolol Hydrochloride Extended-Release Capsules, USP, have different kinetics and produces lower blood levels.

Retitration may be necessary, especially to maintain effectiveness at the end of the 24-hour dosing interval.

Hypertension The usual initial dosage is 80 mg Propranolol Hydrochloride Extended-Release Capsules, USP, once daily, whether used alone or added to a diuretic.

The dosage may be increased to 120 mg once daily or higher until adequate blood pressure control is achieved.

The usual maintenance dosage is 120 to 160 mg once daily.

In some instances a dosage of 640 mg may be required.

The time needed for full hypertensive response to a given dosage is variable and may range from a few days to several weeks.

Angina Pectoris Starting with 80 mg Propranolol Hydrochloride Extended-Release Capsules, USP, once daily, dosage should be gradually increased at three- to seven-day intervals until optimal response is obtained.

Although individual patients may respond at any dosage level, the average optimal dosage appears to be 160 mg once daily.

In angina pectoris, the value and safety of dosage exceeding 320 mg per day have not been established.

If treatment is to be discontinued, reduce dosage gradually over a period of a few weeks (see WARNINGS ).

Migraine The initial oral dose is 80 mg Propranolol Hydrochloride Extended-Release Capsules, USP, once daily.

The usual effective dose range is 160 to 240 mg once daily.

The dosage may be increased gradually to achieve optimal migraine prophylaxis.

If a satisfactory response is not obtained within four to six weeks after reaching the maximal dose, Propranolol Hydrochloride Extended-Release Capsules, USP, therapy should be discontinued.

It may be advisable to withdraw the drug gradually over a period of several weeks depending on the patient’s age, comorbidity, and dose of Propranolol Hydrochloride Extended-Release Capsules, USP.

Hypertrophic Subaortic Stenosis The usual dosage is 80 to 160 mg Propranolol Hydrochloride Extended-Release Capsules, USP, once daily.