Author: druginteractionchecker_lgaiz4

DOSAGE AND ADMINISTRATION

2 Begin CHANTIX dosing one week before the date set by the patient to stop smoking.

Alternatively, the patient can begin CHANTIX dosing and then quit smoking between days 8 and 35 of treatment.

( 2.1 ) Starting week: 0.5 mg once daily on days 1–3 and 0.5 mg twice daily on days 4–7.

( 2.1 ) Continuing weeks: 1 mg twice daily for a total of 12 weeks.

( 2.1 ) An additional 12 weeks of treatment is recommended for successful quitters to increase likelihood of long-term abstinence.

( 2.1 ) Renal impairment: Reduce the dose in patients with severe renal impairment (estimated creatinine clearance <30 mL/min).

( 2.2 ) Consider dose reduction for patients who cannot tolerate adverse effects.

( 2.1 ) Another attempt at treatment is recommended for those who fail to stop smoking or relapse when factors contributing to the failed attempt have been addressed.

( 2.1 ) Provide patients with appropriate educational materials and counseling to support the quit attempt.

( 2.1 ) 2.1 Usual Dosage for Adults Smoking cessation therapies are more likely to succeed for patients who are motivated to stop smoking and who are provided additional advice and support.

Provide patients with appropriate educational materials and counseling to support the quit attempt.

The patient should set a date to stop smoking.

Begin CHANTIX dosing one week before this date.

Alternatively, the patient can begin CHANTIX dosing and then quit smoking between days 8 and 35 of treatment.

CHANTIX should be taken after eating and with a full glass of water.

The recommended dose of CHANTIX is 1 mg twice daily following a 1-week titration as follows: Days 1 – 3: 0.5 mg once daily Days 4 – 7: 0.5 mg twice daily Day 8 – end of treatment: 1 mg twice daily Patients should be treated with CHANTIX for 12 weeks.

For patients who have successfully stopped smoking at the end of 12 weeks, an additional course of 12 weeks’ treatment with CHANTIX is recommended to further increase the likelihood of long-term abstinence.

Patients who do not succeed in stopping smoking during 12 weeks of initial therapy, or who relapse after treatment, should be encouraged to make another attempt once factors contributing to the failed attempt have been identified and addressed.

Consider a temporary or permanent dose reduction in patients who cannot tolerate the adverse effects of CHANTIX.

2.2 Dosage in Special Populations Patients with Impaired Renal Function: No dosage adjustment is necessary for patients with mild to moderate renal impairment.

For patients with severe renal impairment (estimated creatinine clearance <30 mL/min), the recommended starting dose of CHANTIX is 0.5 mg once daily.

The dose may then be titrated as needed to a maximum dose of 0.5 mg twice a day.

For patients with end-stage renal disease undergoing hemodialysis, a maximum dose of 0.5 mg once daily may be administered if tolerated [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3) ] .

Elderly and Patients with Impaired Hepatic Function: No dosage adjustment is necessary for patients with hepatic impairment.

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see Use in Specific Populations (8.5) ] .

DOSAGE AND ADMINISTRATION

2 In adults, 750-1750 mg/day in divided doses every 8-12 hours.

In Pediatric Patients > 3 Months of Age, 20-45 mg/kg/day in divided doses every 8-12 hours.

Refer to full prescribing information for specific dosing regimens.

( 2.1 , 2.2 , 2.3 ) The upper dose for neonates and infants ≤ 3 months is 30 mg/kg/day divided every 12 hours.

( 2.2 ) Dosing for H.

pylori Infection: Triple therapy: 1 gram AMOXICILLIN, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

Dual therapy: 1 gram AMOXICILLIN and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

( 2.3 ) Reduce the dose in patients with severe renal impairment (GFR <30 mL/min).

( 2.4 ) 2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained.

It is recommended that there be at least 10 days treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

In some infections, therapy may be required for several weeks.

It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

Table 1.

Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severity a Usual Adult Dose Usual Dose for Children > 3 Months b Ear/Nose/Throat Skin/Skin Structure Genitourinary Tract Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Lower Respiratory Tract Mild/Moderate or Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.

b The children’s dosage is intended for individuals whose weight is less than 40 kg.

Children weighing 40 kg or more should be dosed according to the adult recommendations.

2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months) Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained.

It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of AMOXICILLIN is 30 mg/kg/day divided every 12 hours.

There are currently no dosing recommendations for pediatric patients with impaired renal function.

2.3 Dosing for H.

pylori Infection Triple therapy: The recommended adult oral dose is 1 gram AMOXICILLIN, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

Dual therapy: The recommended adult oral dose is 1 gram AMOXICILLIN and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

Please refer to clarithromycin and lansoprazole full prescribing information.

2.4 Dosing in Renal Impairment Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe.

Severely impaired patients with a glomerular filtration rate of < 30 mL/min.

should not receive a 875 mg dose.

Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection.

Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

They should receive an additional dose both during and at the end of dialysis.

2.5 Directions for Mixing Oral Suspension Tap bottle until all powder flows freely.

Add approximately 1/3 of the total amount of water for reconstitution (see Table 2) and shake vigorously to wet powder.

Add remainder of the water and again shake vigorously.

Table 2.

Amount of Water for Mixing Oral Suspension Strength Bottle Size Amount of Water Required for Reconstitution Oral Suspension 125 mg/5 mL 80 mL 62 mL 100 mL 78 mL 150 mL 116 mL Oral Suspension 200 mg/5 mL 50 mL 39 mL 75 mL 57 mL 100 mL 76 mL Oral Suspension 250 mg/5 mL 80 mL 59 mL 100 mL 74 mL 150 mL 111 mL Oral Suspension 400 mg/5 mL 50 mL 36 mL 75 mL 54 mL 100 mL 71 mL After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing.

Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks.

These preparations should then be taken immediately.

NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING.

Keep bottle tightly closed.

Any unused portion of the reconstituted suspension must be discarded after 14 days.

Refrigeration is preferable, but not required.

DOSAGE AND ADMINISTRATION

2 PULMICORT FLEXHALER should be administered twice daily by the orally inhaled route only.

After inhalation, the patient should rinse the mouth with water without swallowing [see Patient Counseling Information (17.1) ].

Patients should be instructed to prime PULMICORT FLEXHALER prior to its initial use, and instructed to inhale deeply and forcefully each time the device is used.

The safety and efficacy of PULMICORT FLEXHALER when administered in excess of recommended doses have not been established.

After asthma stability has been achieved, it is desirable to titrate to the lowest effective dosage to reduce the possibility of side effects.

For patients who do not respond adequately to the starting dose after 1-2 weeks of therapy with PULMICORT FLEXHALER, increasing the dose may provide additional asthma control.

For oral inhalation only.

Patients 18 Years of Age and Older: For patients 18 years of age and older, the recommended starting dosage is 360 mcg twice daily.

In some adult patients, a starting dose of 180 mcg twice daily may be adequate.

The maximum dosage should not exceed 720 mcg twice daily.

(2.1) Patients 6 to 17 Years of Age: The recommended starting dosage is 180 mcg twice daily.

In some pediatric patients, a starting dose of 360 mcg twice daily may be appropriate.

The maximum dosage should not exceed 360 mcg twice daily.

(2.1) 2.1 Asthma If asthma symptoms arise in the period between doses, an inhaled, short-acting beta 2 -agonist should be taken for immediate relief.

Patients 18 Years of Age and Older: For patients 18 years of age and older, the recommended starting dosage is 360 mcg twice daily.

In some adult patients, a starting dose of 180 mcg twice daily may be adequate.

The maximum dosage should not exceed 720 mcg twice daily.

Patients 6 to 17 Years of Age: The recommended starting dosage is 180 mcg twice daily.

In some pediatric patients, a starting dose of 360 mcg twice daily may be appropriate.

The maximum dosage should not exceed 360 mcg twice daily.

For all patients, it is desirable to titrate to the lowest effective dose after adequate asthma stability is achieved.

Improvement in asthma control following inhaled administration of budesonide can occur within 24 hours of initiation of treatment, although maximum benefit may not be achieved for 1 to 2 weeks, or longer.

Individual patients will experience a variable onset and degree of symptom relief.

If a previously effective dosage regimen of PULMICORT FLEXHALER fails to provide adequate control of asthma, the therapeutic regimen should be re-evaluated and additional therapeutic options (e.g.

replacing the lower strength of PULMICORT FLEXHALER with the higher strength or initiating oral corticosteroids) should be considered.

DOSAGE AND ADMINISTRATION

Central Diabetes Insipidus The dosage of DDAVP Tablets must be determined for each individual patient and adjusted according to the diurnal pattern of response.

Response should be estimated by two parameters: adequate duration of sleep and adequate, not excessive, water turnover.

Patients previously on intranasal DDAVP therapy should begin tablet therapy twelve hours after the last intranasal dose.

During the initial dose titration period, patients should be observed closely and appropriate safety parameters measured to assure adequate response.

Patients should be monitored at regular intervals during the course of DDAVP Tablet therapy to assure adequate antidiuretic response.

Modifications in dosage regimen should be implemented as necessary to assure adequate water turnover.

Fluid restriction should be observed.

(See WARNINGS , PRECAUTIONS, Pediatric Use and Geriatric Use .) Adults and Children It is recommended that patients be started on doses of 0.05 mg (1/2 of the 0.1 mg tablet) two times a day and individually adjusted to their optimum therapeutic dose.

Most patients in clinical trials found that the optimal dosage range is 0.1 mg to 0.8 mg daily, administered in divided doses.

Each dose should be separately adjusted for an adequate diurnal rhythm of water turnover.

Total daily dosage should be increased or decreased in the range of 0.1 mg to 1.2 mg divided into two or three daily doses as needed to obtain adequate antidiuresis.

See Pediatric Use subsection for special considerations when administering desmopressin acetate to pediatric diabetes insipidus patients.

Geriatric Use This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

(See CLINICAL PHARMACOLOGY, Human Pharmacokinetics , CONTRAINDICATIONS , and PRECAUTIONS, Geriatric Use .) Primary Nocturnal Enuresis The dosage of DDAVP Tablets must be determined for each individual patient and adjusted according to response.

Patients previously on intranasal DDAVP therapy can begin tablet therapy the night following (24 hours after) the last intranasal dose.

The recommended initial dose for patients age 6 years and older is 0.2 mg at bedtime.

The dose may be titrated up to 0.6 mg to achieve the desired response.

Fluid restriction should be observed, and fluid intake should be limited to a minimum from 1 hour before desmopressin administration, until the next morning, or at least 8 hours after administration.

(See WARNINGS , PRECAUTIONS, Pediatric Use and Geriatric Use .)

DOSAGE AND ADMINISTRATION

General Dosing Considerations It is particularly important to administer bupropion hydrochloride tablets in a manner most likely to minimize the risk of seizure (see WARNINGS ).

Increases in dose should not exceed 100 mg/day in a 3-day period.

Gradual escalation in dosage is also important if agitation, motor restlessness, and insomnia, often seen during the initial days of treatment, are to be minimized.

If necessary, these effects may be managed by temporary reduction of dose or the short-term administration of an intermediate to long-acting sedative hypnotic.

A sedative hypnotic usually is not required beyond the first week of treatment.

Insomnia may also be minimized by avoiding bedtime doses.

If distressing, untoward effects supervene, dose escalation should be stopped.

No single dose of bupropion hydrochloride tablets should exceed 150 mg.

Bupropion hydrochloride tablets should be administered 3 times daily, preferably with at least 6 hours between successive doses.

Usual Dosage for Adults The usual adult dose is 300 mg/day, given 3 times daily.

Dosing should begin at 200 mg/day, given as 100 mg twice daily.

Based on clinical response, this dose may be increased to 300 mg/day, given as 100 mg 3 times daily, no sooner than 3 days after beginning therapy (see Table 3).

Table 3.

Dosing Regimen Treatment Day Total Daily Dose Tablet Strength Number of Tablets Morning Midday Evening 1 200 mg 100 mg 1 0 1 4 300 mg 100 mg 1 1 1 Increasing the Dosage Above 300 mg/Day As with other antidepressants, the full antidepressant effect of bupropion hydrochloride tablets may not be evident until 4 weeks of treatment or longer.

An increase in dosage, up to a maximum of 450 mg/day, given in divided doses of not more than 150 mg each, may be considered for patients in whom no clinical improvement is noted after several weeks of treatment at 300 mg/day.

Dosing above 300 mg/day may be accomplished using the 75 or 100 mg tablets.

The 100 mg tablet must be administered 4 times daily with at least 4 hours between successive doses, in order not to exceed the limit of 150 mg in a single dose.

Bupropion hydrochloride tablets should be discontinued in patients who do not demonstrate an adequate response after an appropriate period of treatment at 450 mg/day.

Maintenance Treatment The lowest dose that maintains remission is recommended.

Although it is not known how long the patient should remain on bupropion hydrochloride tablets, it is generally recognized that acute episodes of depression require several months or longer of antidepressant drug treatment.

Dosage Adjustment for Patients with Impaired Hepatic Function Bupropion hydrochloride tablets should be used with extreme caution in patients with severe hepatic cirrhosis.

The dose should not exceed 75 mg once a day in these patients.

Bupropion hydrochloride tablets should be used with caution in patients with hepatic impairment (including mild-to-moderate hepatic cirrhosis) and a reduced frequency and/or dose should be considered in patients with mild-to-moderate hepatic cirrhosis (see CLINICAL PHARMACOLOGY , WARNINGS and PRECAUTIONS ).

Dosage Adjustment for Patients with Impaired Renal Function Bupropion hydrochloride tablets should be used with caution in patients with renal impairment and a reduced frequency and/or dose should be considered (see CLINICAL PHARMACOLOGY and PRECAUTIONS ).

DOSAGE AND ADMINISTRATION

Directions • take only as recommended (see overdose warning) • use dosage cup or tablespoon (TBSP) • do not exceed 5 doses (children) or 6 doses (adults) per 24 hours Age Dose adults and children 12 years and older………2 tablespoons (30 mL) every 4 hours children 6 years to under 12 years…………….

1 tablespoon (15 mL) every 4 hours children 4 years to under 6 years……………….do not use unless directed by a doctor children under 4 years……………………………….do not use • When using DayTime and NightTime products, carefully read each label to ensure correct dosing.

DOSAGE AND ADMINISTRATION

(SEE TABLE BELOW) Carbamazepine suspension in combination with liquid chlorpromazine or thioridazine results in precipitate formation, and, in the case of chlorpromazine, there has been a report of a patient passing an orange rubbery precipitate in the stool following coadministration of the two drugs (see PRECAUTIONS, Drug Interactions ).

Because the extent to which this occurs with other liquid medications is not known, carbamazepine suspension should not be administered simultaneously with other liquid medications or diluents.

Monitoring of blood levels has increased the efficacy and safety of anticonvulsants (see PRECAUTIONS, Laboratory Tests ).

Dosage should be adjusted to the needs of the individual patient.

A low initial daily dosage with a gradual increase is advised.

As soon as adequate control is achieved, the dosage may be reduced very gradually to the minimum effective level.

Medication should be taken with meals.

Since a given dose of carbamazepine suspension will produce higher peak levels than the same dose given as the tablet, it is recommended to start with low doses (children 6 to 12 years: ½ teaspoon (four times a day) and to increase slowly to avoid unwanted side effects.

Conversion of patients from oral carbamazepine tablets to carbamazepine suspension: Patients should be converted by administering the same number of mg per day in smaller, more frequent doses (i.e., twice a day tablets to three times a day suspension).

Carbamazepine extended-release tablets is an extended-release formulation for twice-a-day administration.

When converting patients from carbamazepine conventional tablets to carbamazepine extended-release tablets, the same total daily mg dose of carbamazepine extended-release tablets should be administered.

Carbamazepine extended-release tablets must be swallowed whole and never crushed or chewed.

Carbamazepine extended-release tablets should be inspected for chips or cracks.

Damaged tablets should not be consumed.

Epilepsy (SEE INDICATIONS AND USAGE ) Adults and children over 12 years of age-Initial Either 200 mg twice a day for tablets and extended-release tablets, or 1 teaspoon four times a day for suspension (400 mg/day).

Increase at weekly intervals by adding up to 200 mg/day using a twice a day regimen of carbamazepine extended-release tablets or a three times a day or four times a day regimen of the other formulations until the optimal response is obtained.

Dosage generally should not exceed 1000 mg daily in children 12 to 15 years of age, and 1200 mg daily in patients above 15 years of age.

Doses up to 1600 mg daily have been used in adults in rare instances.

Maintenance Adjust dosage to the minimum effective level, usually 800 to 1200 mg daily.

Children 6 to 12 years of age-Initial Either 100 mg twice a day for tablets or extended-release tablets, or ½ teaspoon four times a day for suspension (200 mg/day).

Increase at weekly intervals by adding up to 100 mg/day using a twice a day regimen of carbamazepine extended-release tablets or a three times a day or four times a day regimen of the other formulations until the optimal response is obtained.

Dosage generally should not exceed 1000 mg daily.

Maintenance Adjust dosage to the minimum effective level, usually 400 to 800 mg daily.

Children under 6 years of age-Initial 10 mg/kg/day to 20 mg/kg/day twice a day or three times a day as tablets, or four times a day as suspension.

Increase weekly to achieve optimal clinical response administered three times a day or four times a day Maintenance Ordinarily, optimal clinical response is achieved at daily doses below 35 mg/kg.

If satisfactory clinical response has not been achieved, plasma levels should be measured to determine whether or not they are in the therapeutic range.

No recommendation regarding the safety of carbamazepine for use at doses above 35 mg/kg/24 hours can be made.

Combination Therapy Carbamazepine may be used alone or with other anticonvulsants.

When added to existing anticonvulsant therapy, the drug should be added gradually while the other anticonvulsants are maintained or gradually decreased, except phenytoin, which may have to be increased (see PRECAUTIONS, Drug Interactions , and Pregnancy ).

Trigeminal Neuralgia (SEE INDICATIONS AND USAGE ) Initial On the first day, either 100 mg twice a day for tablets or extended-release tablets, or ½ teaspoon four times a day for suspension, for a total daily dose of 200 mg.

This daily dose may be increased by up to 200 mg/day using increments of 100 mg every 12 hours for tablets or extended-release tablets, or 50 mg (½ teaspoon) four times a day for suspension, only as needed to achieve freedom from pain.

Do not exceed 1200 mg daily.

Maintenance Control of pain can be maintained in most patients with 400 to 800 mg daily.

However, some patients may be maintained on as little as 200 mg daily, while others may require as much as 1200 mg daily.

At least once every 3 months throughout the treatment period, attempts should be made to reduce the dose to the minimum effective level or even to discontinue the drug.

DOSAGE AND ADMINISTRATION

Note: Barbiturates and ketamine hydrochloride, being chemically incompatible because of precipitate formation, should not be injected from the same syringe.

If the ketamine hydrochloride dose is augmented with diazepam, the two drugs must be given separately.

Do not mix ketamine hydrochloride and diazepam in syringe or infusion flask.

For additional information on the use of diazepam, refer to the WARNINGS and Sections of the diazepam insert.

Preoperative Preparations: 1.

While vomiting has been reported following ketamine hydrochloride administration, some airway protection may be afforded because of active laryngeal-pharyngeal reflexes.

However, since aspiration may occur with ketamine hydrochloride and since protective reflexes may also be diminished by supplementary anesthetics and muscle relaxants, the possibility of aspiration must be considered.

Ketamine hydrochloride is recommended for use in the patient whose stomach is not empty when, in the judgment of the practitioner, the benefits of the drug outweigh the possible risks.

2.

Atropine, scopolamine, or another drying agent should be given at an appropriate interval prior to induction.

Onset and Duration: Because of rapid induction following the initial intravenous injection, the patient should be in a supported position during administration.

The onset of action of ketamine hydrochloride is rapid; an intravenous dose of 2 mg/kg (1 mg/lb) of body weight usually produces surgical anesthesia within 30 seconds after injection, with the anesthetic effect usually lasting five to ten minutes.

If a longer effect is desired, additional increments can be administered intravenously or intramuscularly to maintain anesthesia without producing significant cumulative effects.

Intramuscular doses, in a range of 9 to 13 mg/kg (4 to 6 mg/lb) usually produce surgical anesthesia within 3 to 4 minutes following injection, with the anesthetic effect usually lasting 12 to 25 minutes.

Dosage: As with other general anesthetic agents, the individual response to ketamine hydrochloride is somewhat varied depending on the dose, route of administration, and age of patient, so that dosage recommendation cannot be absolutely fixed.

The drug should be titrated against the patient’s requirements.

Induction: Intravenous Route : The initial dose of ketamine hydrochloride administered intravenously may range from 1 mg/kg to 4.5 mg/kg (0.5 to 2 mg/lb).

The average amount required to produce five to ten minutes of surgical anesthesia has been 2 mg/kg (1 mg/lb).

Alternatively, in adult patients an induction dose of 1 mg to 2 mg/kg intravenous ketamine at a rate of 0.5 mg/kg/min may be used for induction of anesthesia.

In addition, diazepam in 2 mg to 5 mg doses, administered in a separate syringe over 60 seconds, may be used.

In most cases, 15 mg of intravenous diazepam or less will suffice.

The incidence of psychological manifestations during emergence, particularly dream-like observations and emergence delirium, may be reduced by this induction dosage program.

Note: The 100 mg/mL concentration of ketamine hydrochloride should not be injected intravenously without proper dilution.

It is recommended the drug be diluted with an equal volume of either Sterile Water for injection, USP, Normal Saline, or 5% Dextrose in Water.

Rate of Administration : It is recommended that ketamine hydrochloride be administered slowly (over a period of 60 seconds).

More rapid administration may result in respiratory depression and enhanced pressor response.

Intramuscular Route : The initial dose of ketamine hydrochloride administered intramuscularly may range from 6.5 to 13 mg/kg (3 to 6 mg/lb).

A dose of 10 mg/kg (5 mg/lb) will usually produce 12 to 25 minutes of surgical anesthesia.

Maintenance of Anesthesia: The maintenance dose should be adjusted according to the patient’s anesthetic needs and whether an additional anesthetic agent is employed.

Increments of one-half to the full induction dose may be repeated as needed for maintenance of anesthesia.

However, it should be noted that purposeless and tonic-clonic movements of extremities may occur during the course of anesthesia.

These movements do not imply a light plane and are not indicative of the need for additional doses of the anesthetic.

It should be recognized that the larger the total dose of ketamine hydrochloride administered, the longer will be the time to complete recovery.

Adult patients induced with ketamine hydrochloride augmented with intravenous diazepam may be maintained on ketamine hydrochloride given by slow microdrip infusion technique at a dose of 0.1 to 0.5 mg/minute, augmented with diazepam 2 to 5 mg administered intravenously as needed.

In many cases 20 mg or less of intravenous diazepam total for combined induction and maintenance will suffice.

However, slightly more diazepam may be required depending on the nature and duration of the operation, physical status of the patient, and other factors.

The incidence of psychological manifestations during emergence, particularly dream-like observations and emergence delirium, may be reduced by this maintenance dosage program.

Dilution : To prepare a dilute solution containing 1 mg of ketamine per mL, aseptically transfer 10 mL from a 50 mg per mL vial or 5 mL from a 100 mg per mL vial to 500 mL of 5% Dextrose Injection, USP or Sodium Chloride (0.9%) Injection, USP (Normal Saline) and mix well.

The resultant solution will contain 1 mg of ketamine per mL.

The fluid requirements of the patient and duration of anesthesia must be considered when selecting the appropriate dilution of ketamine hydrochloride injection.

If fluid restriction is required, ketamine hydrochloride injection can be added to a 250 mL infusion as described above to provide a ketamine hydrochloride concentration of 2 mg/mL.

Ketamine hydrochloride injection 10 mg/mL vials are not recommended for dilution.

Supplementary Agents: Ketamine hydrochloride is clinically compatible with the commonly used general and local anesthetic agents when an adequate respiratory exchange is maintained.

The regimen of a reduced dose of ketamine hydrochloride supplemented with diazepam can be used to produce balanced anesthesia by combination with other agents such as nitrous oxide and oxygen.

DOSAGE AND ADMINISTRATION

General Precautions Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permits.

The dosage of allergenic extracts is dependent upon the purpose of the administration.

Allergenic extracts can be administered for diagnostic use or for therapeutic use.

When allergenic extracts are administered for diagnostic use, the dosage is dependent upon the method used.

Two methods commonly used are scratch testing and intradermal testing.

Both types of tests result in a wheal and flare response at the site of the test which usually develops rapidly and may be read in 20-30 minutes.

Diagnostic Use : Scratch Testing Method Scratch testing is considered a simple and safe method although less sensitive than the intradermal test.

Scratch testing can be used to determine the degree of sensitivity to a suspected allergen before using the intradermal test.

This combination lessens the severity of response to an allergen which can occur in a very sensitive patient.

The most satisfactory testing site is the patient’s back or volar surface of the arms from the axilla to 2.5 or 5cm above the wrist, skipping the anti-cubital space.

If using the back as a testing site, the most satisfactory area are from the posterior axillary fold to 2.5 cm from the spinal column, and from the top of the scapula to the lower rib margins.

Allergenic extracts for diagnostic use are to be administered in the following manner: To scratch surface of skin, use a circular scarifier.

Do not draw blood.

Tests sites should be 4 cm apart to allow for wheal and flare reaction.

1-30 scratch tests may be done at a time.

A separate sterile scratch instrument is to be used on each patient to prevent transmission of homologous serum hepatitis or other infectious agents from one patient to another.

The recommended usual dosage for Scratch testing is one drop of allergen applied to each scratch site.

Do not let dropper touch skin.

Always apply a control scratch with each test set.

Sterile Diluent (for a negative control) is used in exactly the same way as an active test extract.

Histamine may be used as a positive control.

Scratch or prick test sites should be examined at 15 and 30 minutes.

To prevent excessive absorption, wipe off antigens producing large reactions as soon as the wheal appears.

Record the size of the reaction.

Interpretation of Scratch Test Skin tests are graded in terms of the wheal and erythema response noted at 10 to 20 minutes.

Wheal and erythema size may be recorded by actual measurement as compared with positive and negative controls.

A positive reaction consists of an area of erythema surrounding the scarification that is larger than the control site.

For uniformity in reporting reactions, the following system is recommended.

(6) REACTION SYMBOL CRITERIA Negative – No wheal.

Erythema absent or very slight (not more than 1 mm diameter) .

One Plus + Wheal absent or very slight erythema present (not more than 3 mm diameter) .

Two Plus ++ Wheal not more than 3mm or erythema not more than 5mm diameter.

Three Plus +++ Wheal between 3mm and 5mm diameter, with erythema.

Possible pseudopodia and itching.

Four Plus ++++ A larger reaction with itching and pain.

Diagnostic Use: Intradermal Skin Testing Method Do not perform intradermal test with allergens which have evoked a 2+ or greater response to a Scratch test.

Clean test area with alcohol, place sites 5 cm apart using separate sterile tuberculin syringe and a 25 gauge needle for each allergen.

Insert needle tip, bevel up, into intracutaneous space.

Avoid injecting into blood vessel, pull back gently on syringe plunger, if blood enters syringe change position of needle.

The recommended dosage and range for intradermal testing is 0.05 ml of not more than 100 pnu/ml or 1:1000 w/v (only if puncture test is negative) of allergenic extract.

Inject slowly until a small bleb is raised.

It is important to make each bleb the same size.

Interpretation of Intradermal Test: The patient’s reaction is graded on the basis of size of wheal and flare as compared to control.

Use 0.05 ml sterile diluent as a negative control to give accurate interpretation.

The tests may be accurately interpreted only when the saline control site has shown a negative response.

Observe patient for at least 30 minutes.

Tests can be read in 15-20 minutes.

Edema, erythema and presence of pseudopods, pain and itching may be observed in 4 plus reactions.

For uniformity in reporting reactions the following system is recommended.

(6) REACTION SYMBOL CRITERIA Negative – No increase in size of bleb since injection.

No erythema.

One Plus + An increase in size of bleb to a wheal not more than 5mm diameter, with associated erythema.

Two Plus ++ Wheal between 5mm and 8mm diameter with erythema.

Three Plus +++ Wheal between 8mm and 12mm diameter with erythema and possible pseudopodia and itching or pain.

Four Plus ++++ Any larger reaction with itch and pain, and possible diffuse blush of the skin surrounding the reaction area.

Therapeutic Use: Recommended dosage & range Check the listed ingredients to verify that it matches the prescription ordered.

When using a prescription set, verify the patient’s name and the ingredients listed with the prescription order.

Assess the patient’s physical and emotional status prior to giving as injection.

Do not give injections to patients who are in acute distress.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Dosage of allergenic extracts is a highly individualized matter and varies according to the degree of sensitivity of the patient, his clinical response and tolerance to the extract administered during the early phases of an injection regimen.

The dosage must be reduced when transferring a patient from non-standardized or modified extract to standardized extract.

Any evidence of a local or generalized reaction requires a reduction in dosage during the initial stages of immunotherapy as well as during maintenance therapy.

After therapeutic injections patients should be observed for at least 20 minutes for reaction symptoms.

SUGGESTED DOSAGE SCHEDULE The following schedule may act as a guide.

This schedule has not been proven to be safe or effective.

Sensitive patients may begin with smaller doses of weaker solutions and the dosage increments can be less.

STRENGTH DOSE VOLUME Vial #1 1 0.05 1:100,000 w/v 2 0.10 10 pnu/ml 3 0.15 1 AU/ml 4 0.20 1 BAU/ml 5 0.30 6 0.40 7 0.50 Vial #2 8 0.05 1:10,000 w/v 9 0.10 100 pnu/ml 10 0.15 10 AU/ml 11 0.20 10 BAU/ml 12 0.30 13 0.40 14 0.50 Vial #3 15 0.05 1:1,000 w/v 16 0.10 1,000 pnu/ml 17 0.15 100 AU/ml 18 0.20 100 BAU/ml 19 0.30 20 0.40 21 0.50 Vial #4 22 0.05 1:100 w/v 23 0.07 10,000 pnu/ml 24 0.10 1,000 AU/ml 25 0.15 1,000 BAU/ml 26 0.20 27 0.25 Maintenance Refill 28 0.25 1:100 w/v 29 0.25 10,000 pnu/ml 30 0.25 1,000 AU/ml 31 0.25 1,000 BAU/ml 32 0.25 subsequent doses 33 0.25 Preparation Instructions: All dilutions may be made using sterile buffered diluent.

The calculation may be based on the following ratio: Volume desired x Concentration desired = Volume needed x Concentration available.

Example 1 : If a 1:10 w/v extract is available and it is desired to use a 1:1,000 w/v extract substitute as follows: Vd x Cd = Vn x Ca 10ml x 0.001 = Vn x 0.1 0.1 ml = Vn Using a sterile technique, remove 0.10 ml of extract from the 1:10 vial and place it into a vial containing 9.90 ml of sterile diluent.

The resulting ratio will be a 10 ml vial of 1:1,000 w/v.

Example 2 : If a 10,000 pnu/ml extract is available and it is desired to use a 100 pnu/ml extract substitute as follows: 10ml x 100 = Vn x 10,000 0.1 ml = Vn Using a sterile technique, remove 0.10 ml of extract from the 10,000 pnu/ml vial and place it into a vial containing 9.90 ml of sterile diluent.

The resulting concentration will be a 10 ml vial of 100 pnu/ml.

Example 3: If a 10,000 AU/ml or BAU/ml extract is available and it is desired to use a 100 AU/ml or BAU/ml extract substitute as follows: Vd x Cd = Vn x Ca 10ml x 100 = Vn x 10,000 0.1 ml = Vn Using a sterile technique, remove 0.10 ml of extract from the 10,000 AU/ml or BAU/ml vial and place it into a vial containing 9.90 ml of sterile diluent.

The resulting concentration will be 10ml vial of 100 AU/ml or BAU/ml.

Intervals between doses: The optimal interval between doses of allergenic extract has not been definitely established.

The amount of allergenic extract is increased at each injection by not more than 50%-100% of the previous amount and the next increment is governed by the response to the last injection.

There are three generally accepted methods of pollen hyposensitizing therapy.

1.

PRESEASONAL Treatment starts each year 6 to 8 weeks before onset of seasonal symptoms.

Maximal dose reached just before symptoms are expected.

Injections discontinued during and following season until next year.

2.

CO-SEASONAL Patient is first treated during season with symptoms.

Low initial doses are employed to prevent worsening of condition.

This is followed by an intensive schedule of therapy (i.e.

injections given 2 to 3 times per week).

Fewer Allergists are resorting to this Co-seasonal therapy because of the availability of more effective, symptomatic medications that allow the patient to go through a season relatively symptom free.

3.

PERENNIAL Initially this is the same as pre seasonal.

The allergen is administered twice weekly or weekly for about 20 injections to achieve the maximum tolerated dose.

Then, maintenance therapy may be administered once a week or less frequently.

Duration of Treatment: The usual duration of treatment has not been established.

A period of two or three years of injection therapy constitutes an average minimum course of treatment.

DOSAGE AND ADMINISTRATION

2 • STAXYN is not interchangeable with vardenafil 10 mg film-coated tablets (LEVITRA).

STAXYN provides higher systemic exposure compared to vardenafil 10 mg film-coated tablets (LEVITRA).

( 2.1 ) • STAXYN is taken as needed, orally, approximately 60 minutes before sexual activity.

( 2.1 ) • The maximum recommended dosing frequency is one tablet per day.

( 2.1 ) • STAXYN should be placed on the tongue where it will disintegrate.

It should be taken without liquid.

( 2.1 ) • STAXYN may be taken with or without food.

( 2.2 ) 2.1 General STAXYN is available in 10 mg orally disintegrating tablets.

STAXYN is not interchangeable with vardenafil 10 mg film-coated tablets (LEVITRA).

STAXYN provides higher systemic exposure compared to vardenafil 10 mg film-coated tablets (LEVITRA).

[See Clinical Pharmacology ( 12.3 ).] STAXYN should be taken orally, as needed, approximately 60 minutes before sexual activity.

The maximum dosing frequency is one STAXYN tablet per day.

Sexual stimulation is required for a response to treatment.

STAXYN should be placed on the tongue where it will disintegrate.

The tablet should be taken without liquid.

It should be taken immediately upon removal from the blister.

Those patients who require a lower or higher dose of vardenafil need to be prescribed vardenafil film-coated tablets [see Patient Counseling Information ( 17 )] .

2.2 Use with Food STAXYN can be taken with or without food.

2.3 Use in Special Populations Hepatic Impairment: Do not use STAXYN in patients with moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment [see Warnings and Precautions ( 5.8 ) and Clinical Pharmacology ( 12.3 )] .

Renal Impairment: Do not use STAXYN in patients on renal dialysis [see Warnings and Precautions ( 5.9 ) and Clinical Pharmacology ( 12.3 )] .

2.4 Concomitant Medications Nitrates : Concomitant use with nitrates in any form is contraindicated [see Contraindications ( 4.1 )] .

Guanylate Cyclase (GC) Stimulators, such as riociguat: Concomitant use is contraindicated [see Contraindications ( 4.2 )].

CYP3A4 Inhibitors: Do not use STAXYN with potent or moderate CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, atazanavir, clarithromycin and erythromycin [see Warnings and Precautions ( 5.2 ) and Drug Interactions ( 7.2 )] .

Alpha-Blockers: In those patients who are stable on alpha-blocker therapy, PDE5 inhibitors should be initiated at the lowest recommended starting dose.

Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure in patients taking a phosphodiesterase (PDE5) inhibitor including vardenafil.

In patients taking alpha-blockers, do not initiate vardenafil therapy with STAXYN.

Lower doses of vardenafil film-coated tablets should be used as initial therapy in these patients.

[see Dosage and Administration ( 2.4 )] .

Patients taking alpha-blockers who have previously used vardenafil film-coated tablets may change to STAXYN at the advice of their healthcare provider.

[See Warnings and Precautions ( 5.6 ) and Drug Interactions ( 7.1 ).] A time interval between dosing should be considered when STAXYN is prescribed concomitantly with alpha-blocker therapy [see Clinical Pharmacology ( 12.2 )].