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Patient Profile for: C.P. Rudhom

Personal Information

Date: 3-1-06

Patient ID: # 2-20060301CPP

Attending Physician: xxxxxxxxxxxxxMD

Patient Name: C. P. Rudhom

Address: xxxxxxxxxxxxxxxx

City: xxxxxxxxxx

State: LA

Zipcode: xxxxx

Country: USA

Phone: (xxx) xxx-xxxx

____________________________________________________________________________________

Medical Information

____________________________________________________________________________________

Diagnosis:

Diabetes mellitus S/P paraplegia Hypoalbuminemia

Depression Seizure disorder Organic Brain Syndrome

Bipolar Disorder Neurogenic bladder GERD

Insomnia, NOS Anxiety Hx of pneumonia

S/P CVA with left hemiplegia

General complaints not listed as diagnosis by your doctor:

No desire to participate in social activities, significant decrease in appetite, eats only when assisted but is capable of feeding self. Patient is frequently hostile and has inappropriate impulsive behaviors.

March 1, 2006

Physical & sexual aggression and inappropriate sexually oriented remarks

Complaints of pain to hips, shoulders, knees, fingers and back

Complaints of insomnia described as sleep onset and maintenance(Chronic)

Complaints of orhtopnea

Allergies: No known allergies reported.

Hamilton Rating Depression score = 29 significant clinical depression

Current Medications: Total 20 medicatons

Albuterol Inhalation solution 0.083% 3ml(2.5mg) per nebulizer treatment q 4 hrs while awake.

Seroquel 100mg tablets 1 tab po q day 6-8-05
Seroquel 200mg tablets 1 tab po hs 6-8-05
Seroquel 25mg tablet 1 po q day at 4pm 9-29-05
Tramadol 50mg tablets 1 tab po bid 6-8-05
Vitamin C 500mg tablets 1 tab po q day 6-8-05
Wellbutrin XL 300mg tablet 1 tab po q day 6-8-05
Avandia 4mg tablet 1 tab po q day 6-8-05
Furosemide 40mg tablet 1 tab po q day 6-8-05
Protonix 40mg tablet 1 tab po hs 6-8-05
Depakote 500mg capsule 1 cap po bid 6-8-05
Zinc sulfate 220mg tablet 1 tab po q day 6-8-05
Magnesium Oxide 440mg tablet 1 tab po bid 6-8-05
DHEA 50mg tablet 1 tab po bid 6-8-05
Glucophage 500mg tablet 1 tab po bid 7-5-05
KCL 20mEq tablet 1 tab po bid 7-1-05
Trazodone 100mg tablet 1 tab po hs 7-5-05
Miralax powder 1 capful po q day 7-21-05
Hydrocodone/APAP 10mg tablet 1 tab po qid 8-16-05
Restoril 30mg capsule 1 cap po hs 9-29-05
Depo-Testosterone 20mg/ml inj 75mg IM q week 9-29-05
Vitamin E 400IU capsules 1 cap po q day 12-30-05

Labs:

CBC of 2-06:

RBC 3.81 Hgb 11.8 Hct 36.6 MCV WNL RDW 17.8

CMP of 2-06:

BUN/Cr 44 Na 136 K+ 4.4

Cl 99 AkPhos55 CO2 33 Cr 0.6

Alb 2.6 Ca 8.5 corrected 9.62 Valproic acid 71

Testosterone 697 Glucose 69 SGOT 40 slightly elevated

Urinalysis none available

The following recommendations were made:

Albuterol Inhalation solution 0.083% 3ml(2.5mg) per nebulizer treatment q 4 hrs while awake.

Use of Albuterol may be causing many of his problems related to hostility, agitation, loss of appetite and insomnia.
Recommendation:
Use of a long acting bronchodilator could be tried to see if a once a day therapy is viable. Use of Spiriva Handihaler 17mcg inhaled each AM may provide the support with fewer problems. (mouth should be washed out well after each application) changed albuterol to prn only
Potential Savings: Albuterol cost $ 124.98 - Spiriva cost = $ 129.55 = -4.57
Actual Savings from change: Switched to PRN savings = $ 62.49

Seroquel 100mg tablets 1 tab po q day 6-8-05
Seroquel 200mg tablets 1 tab po hs 6-8-05
Seroquel 25mg tablet 1 po q day at 4pm 9-29-05

Seroquel therapy seems to be failing. Use of Risperdal augmented with Effexor XR may provide a better plan for management. Use of low dose Risperdal (since this agent has SSRI activity) augmented by Effexor XR should allow for reduction in anxiety as well as a more rapid approach to the severe depression. Success in this area will improve appetite…
Recommended tapering : Stop the 100mg AM and 25mg 4PM dose of Seroquel, DC Wellbutrin and Trazodone now and start Risperdal 0.5mg AM and Effexor XR 75mg HS x 5 days, then reduce Seroquel to 100mg HS and increase Effexor XR to 150mg HS x 5 days and at that time DC Seroquel and increase the Effexor XR to 225mg HS..
After reaching 225mg Effexor XR at bedtime begin reduction of Restoril by decreasing to 15mg at bedtime for 30 days…. Monitor for need to titrate Effexor XR to 300mg HS… Then taper Restoril to 7.5mg q other HS for 30 days and D/C
Potential Savings: Seroquel cost $ 328.97 - Risperdal cost $ 101.82 = $ 227.15
Actual Savings from change: approved change to Risperdal $ 227.15

Potential savings from trazodone & Wellbutrin DC eventual DC of

Restoril starting Effexor and titrating upwards:

$ 303.28 - Effexor XR 225mg $ 198.98 = $ 104.30

Actual: Restoril was changed to prn and change to Effexor was made

Savings = $ 104.30

Tramadol 50mg tablets 1 tab po bid 6-8-05

Since the patient is requiring hydrocodone there is questionable efficacy for this medication.
Recommendation:
D/C tramadol now.
Potential Savings: $ 33.98
Actual Savings from change: $ 33.98

Vitamin C 500mg tablets 1 tab po q day 6-8-05 Recommendation: No changes

Wellbutrin XL 300mg tablet 1 tab po q day 6-8-05

See above

Avandia 4mg tablet 1 tab po q day 6-8-05

Although there is no HgbA1C available recent FBS on the CMP was low at 69. Weight loss is commonly seen with Glucophage while the patient is still above ideal body weight concomitant use of these two agents may reduce appetite. The possibility of frequent low plasma glucose levels would indicate the use of oral monotherapy until appetite improves. The lower plasma glucose levels could be worsening anxiety, mood swings and depression.
Recommendation: Response no change in Avandia dose DC’dGlucophage
D/C Glucophage and get an A1C now and q 3 months.
Potential Savings: $ 46.99 Actual Savings from change: $ 46.99

Furosemide 40mg tablet 1 tab po q day 6-8-05

Furosemide has a short 2 hour half life thus the body has 22 hours each day for a antidiuretic rebound response. This means that over a period of time more and more furosemide is needed to meet the patient’s needs. Use of long acting 24 hour half-life torsemide won’t allow for the rebound effects so dosing can remain low sparing more Potassium and Calcium. D/C Lasix start Demadex 20mg daily and DC KCL. No change
Potential Savings: $39.59 Actual Savings from change: $0.00

Protonix 40mg tablet 1 tab po hs 6-8-05

Continuous use of proton pump inhibitors can lead to serious complications especially in an institutionalized patient. The continuous use increases the risk of C. difficile diarrhea.
Recommendation:
DC Protonix & start H2 blocker utilize short term as described below.
Use of H2 blockers in a step-down approach may work well and reduce the potential for serious adverse events, additionally, allowing the pH to rise and establish a continuous basic media. This stops many drugs from being adequately absorbed and therefore results in an erratic response. Elevating the head of the bed by 25 to 30% as well as prohibiting spicy and difficult to digest foods after evening meal around 6 to 7 PM and consuming 3 oz buttermilk and saltine crackers or a container of plain yogurt amazingly helps this problem.. If these non-drug approaches are successful with this patient then the H2 blocker can be tapered away. Ranitidine 75mg bid until success can be seen from the non-drug approach then titrating down to 75mg HS for a month or two then q other HS for a month or two then D/C
Potential Savings: $111.12 - otc Zantac 21.59 = $ 89.53
Actual Savings from change: $ 89.53

Depakote 500mg capsule 1 cap po bid 6-8-05

With an albumin of 2.6 use of this highly protein bound drug can lead to failed therapy and increase side effect risk. Use of Topamax provides a better alternative.
Recommendation:
Start with Topamax 25mg HS for 7 days and titrate upwards in 25mg increments every 7 to 10 days until improvements are seen in mood and anxiety or dose of 200mg daily is reached. Topamax is only about 10 to 15% protein bound so low albumins will not be significant as they are with the Depakote. Depakote as with most anti-seizure drugs works by elevating the seizure threshold, Topamax works by stopping the misfires. Response: No change - reason causes weight loss
Potential Savings: $ 123.99 - Topamax $ 56.10 = $ 67.89
Actual Savings from change: $ 0.00 No changes made

Zinc sulfate 220mg tablet 1 tab po q day 6-8-05
Recommendation: DC Patient has no Zinc deficiency nor wounds long term use of Zinc is not necessary reserve if wound healing therapy is needed again in the future
Potential savings $ 5.00 no changes made no savings

Magnesium Oxide 440mg tablet 1 tab po bid 6-8-05

Support for the use of this agent isn’t found in the chart. With current respiratory problems it may exacerbate respiratory depression.
Recommendation:
DC Magnesium Oxide Response : No change
Potential Savings: $ 5.00 Actual Savings from change: $ 0.00 No changes made

DHEA 50mg tablet 1 tab po bid 6-8-05

Recommendation:
Consider stopping this drug since Depo-testosterone is being used. Recently his testosterone levels were elevated but the last values showed it at upper normal. Elevated levels can worsen depression induce paresthesias, cause insomnia and long term high dose use can lead to hepatotoxicity. Response: no change
Potential Savings: $10.00 Actual Savings from change: $ 0.00 No changes made

Glucophage 500mg tablet 1 tab po bid 7-5-05

Recommendation:
D/C metformin Glucophage DC’d
Potential Savings: see above Actual Savings from change: see above

KCL 20mEq tablet 1 tab po bid 7-1-05

With a Serum K of 4.4 and on supplements that supply some Potassium and if we change to torsemide KCL could be discontinued . Some question as to whether or not the KCL is being absorbed because of the basic stomach. Recommendation:
D/C KCL Response: No change
Potential Savings: $ 39.59 Actual Savings from change: $ 0.00

Trazodone 100mg tablet 1 tab po hs 7-5-05

D/C Trazodone DC’d
See above for savings

Miralax powder 1 capful po q day 7-21-05

Recommendation: No changes

Hydrocodone/APAP 10mg tablet 1 tab po qid 8-16-05

Quality of life is important and at 32 years of age he has a long time left. Pain management contributes significantly to enhancing quality of life.
Oral medication can result in peaks and troughs of therapy which are difficult to overcome. Use of Fentanyl patch would deliver a 24 hour a day pain control and reduce potential drug dependence to some degree. Starting with Fentanyl Patch 25mcg q 3 days and drop the Hydrocodone to 8AM, 4PM and 10PM daily for 9 days then evaluate for control and titrate the Fentanyl Patch 50mcg and reduce the Hydrocodone to 10PM only for 9 days, then stop all hydrocodone. (hold on to the hydrocodone for any breakthrough pain and use only PRN) then if breakthrough pain continues titrate to 75mcg patch q 3 days and wait and see… somewhere around these doses and in conjunction with the Effexor XR you should get continuous pain relief. RESPONSE: approved above
Potential Savings: Cost $ 59.99 - Patches cost $42.98 = $ 17.01
Actual Savings from change: $17.01

Arginaid 1 packet bid in OJ 8-16-05

After some of the above major changes are made if the patient still does not have an appetite then consider Marinol 2.5mg before lunch daily.. There has been some excellent successes from the use of this for appetite stimulation.
Response: No
No savings

Restoril 30mg capsule 1 cap po hs 9-29-05

See above for D/C of Restoril Changed to prn
Potential Savings: Actual Savings from change:

See above for savings

Depo-Testosterone 20mg/ml inj 75mg IM q week 9-29-05

After finishing other drug titrations we could consider reducing dose in 25mg increments each month until D/C Response: No change
Potential Savings: $ 101.99
Actual Savings from change: None no change made

Vitamin E 400IU capsules 1 cap po q day 12-30-05 Recommendation: No changes
Total Potential Savings: $ 622.55
Total Actual Savings: $ 354.30

Specific Drug information

Classification:
• Autonomic Agents
    • Sympathomimetics
        • Adrenergic agonists
• Respiratory Agents
    • Adrenergic agonists
        • Beta-agonists

Description, Mechanism of Action, Pharmacokinetics

Description: Albuterol is a moderately selective beta2-receptor agonist. Albuterol is a racemic mixture of R- and S-isomers, and is widely used as a bronchodilator. It is indicated for the management of asthma exacerbations or other chronic obstructive airway diseases. It is similar in structure to terbutaline, but exhibits less cardiac stimulation and more prolonged bronchodilation than isoproterenol or metaproterenol. Albuterol was originally approved by the FDA in 1981. Outside the US, albuterol is referred to as salbutamol. The R-isomer of albuterol is commercially available as levalbuterol nebulizer solution (see Levalbuterol monograph). The FDA issued an approvable letter for albuterol HFA breath-activated aerosol inhaler during August 2004.

Mechanism of Action: Albuterol is a moderately selective beta2-adrenergic agonist that stimulates receptors of the smooth muscle in the lungs, uterus, and vasculature supplying skeletal muscle. Albuterol is racemic beta-agonist, comprised of an equal mixture of R- and S-isomers. The R-isomer, known as levalbuterol, is primarily responsible for bronchodilation. Although not confirmed during clinical trials, the S-isomer of albuterol has bronchoconstrictive properties in animal models.

Intracellularly, the actions of albuterol are mediated by cyclic AMP, the production of which is augmented by beta2-stimulation. Albuterol is believed to work by activating adenylate cyclase, the enzyme responsible for generating cyclic AMP, an intracellular mediator. Increased cyclic AMP leads to activation of protein kinase A, which inhibits phosphorylation of myosin and lowers intracellular ionic calcium concentrations, resulting in relaxation. The net result of beta2-receptor agonism in the lungs is relaxation of bronchial and tracheal smooth muscles, which in turn relieves bronchospasm, reduces airway resistance, facilitates mucous drainage, and increases vital capacity.

Albuterol can also inhibit the degranulation and subsequent release of inflammatory autocoids from mast cells. Stimulation of beta2-receptors on peripheral vascular smooth muscle can cause vasodilation and a modest decrease in diastolic blood pressure. Albuterol is an effective adjunctive treatment for hyperkalemia; beta2-adrenergic stimulation results in intracellular accumulation of serum potassium due to stimulation of the Na/K ATPase pump, leading to moderate degrees of hypokalemia.

Pharmacokinetics: Albuterol can be administered as oral tablets or oral solution, but is more commonly administered by oral inhalation. Following oral inhalation, albuterol is absorbed over several hours from the respiratory tract. It is postulated from studies with other inhaled bronchodilators that most of an albuterol inhaled dose (approximately 90%) is actually swallowed and absorbed through the GI tract. Onset of bronchodilation occurs within 5—15 minutes after oral inhalation, peaks in 0.5—2 hours, and lasts 2—6 hours. Administration via nebulization does not appear to significantly alter the pharmacokinetics of albuterol. When administered orally, albuterol is well absorbed through the GI tract. Onset of action begins within 30 minutes, peak levels are reached in 2—3 hours, and duration of action is 4—6 hours for the conventional-release tablets and 8—12 hours for the sustained-release product.

Albuterol crosses the blood-brain barrier and may cross the placenta. The liver metabolizes albuterol extensively to inactive compounds. Excretion of albuterol occurs through the urine and feces. After oral inhalation, 80—100% of a dose is excreted via the kidneys within 72 hours; up to 10% may be eliminated in feces. After oral administration, 75% of a dose is excreted in urine within 72 hours as metabolites; 4% may be found in feces. The elimination half-life of albuterol ranges from 2.7—6 hours, with orally administered albuterol having a shorter half-life than the inhaled product.

Description, Mechanism of Action, Pharmacokinetics last revised 12/29/2004 2:21:00 PM

Indications

• acute bronchospasm	• bronchospasm prophylaxis
• asthma	• hyperkalemia†

† non-FDA-approved indication

Dosage

For the treatment of acute bronchospasm or prevention of bronchospasm (bronchospasm prophylaxis) in patients with asthma:
NOTE: In general, regularly scheduled, daily use of short-acting beta2-agonists such as albuterol is not recommended to prevent asthmatic bronchospasm.[1515] For the prevention of bronchospasm due to asthma, the scheduled use of longer-acting beta-agonists is preferred (e.g., salmeterol or formoterol); concurrent inhaled or systemic corticosteroid therapy may be indicated.
Oral dosage (albuterol immediate-release tablets or oral solution):
Adults and adolescents: 2—4 mg PO every 6—8 hours (max: 32 mg/day).
Elderly: 2 mg PO every 6—8 hours (max: 32 mg/day).
Children 6—12 years: 2 mg PO every 6—8 hours (max: 24 mg/day).
Children < 6 years: Initially, 0.1 mg/kg PO every 8 hours, not to exceed 8 mg/day. If an adequate response is not obtained, this dose may be increased to 0.2 mg/kg PO every 8 hours (max: 12 mg/day).
Oral dosage (albuterol extended-release tablets):
NOTE: 2 mg immediate-release PO every 6 hours = 4 mg extended-release PO every 12 hour. In general, inhaled long-acting beta-agonists are preferred since they are longer-acting and have fewer side effects than oral sustained-release agents.
Adults and adolescents >= 12 years: 4—8 mg PO every 12 hours (max: 32 mg/day).
Children 6—11 years: Initially, 4 mg PO every 12 hours, not to exceed 8 mg/day. If an adequate response is not obtained, this dose may be increased in a stepwise fashion carefully, not to exceed 12 mg PO every 12 hours (max: 24 mg/day).
Children < 6 years: Do not use extended-release dosage.
Oral inhalation dosage (albuterol metered-dose inhaler):
Adults and children >= 4 years: 90—180 mcg (1—2 puffs) every 4—6 hours prn. Some clinicians recommend separating inhalations by up to 20 minutes to ensure bronchial penetration. For the acute treatment of severe episodes, 4—8 puffs every 20 minutes for up to 4 hours, then 4—8 puffs every 1—4 hours as needed.[1515]
Oral inhalation dosage (albuterol nebulizer solution):
Adults and adolescents: 2.5 mg every 6—8 hours prn delivered over 5—15 minutes. For the acute treatment of severe episodes, 2.5—5 mg initially every 20 minutes for 3 doses, then 2.5—10 mg every 1—4 hours as needed, or 10—15 mg/hour by continuous nebulization.[1515]
Children: 1.25—2.5 mg every 4—6 hours prn delivered over 5—15 minutes. For the acute treatment of severe episodes, 0.15 mg/kg (2.5 mg minimum, 5 mg maximum) every 20 minutes for 3 doses, then 0.15—0.3 mg/kg (10 mg maximum) every 1—4 hours, as needed, or 0.5 mg/kg/hour by continuous nebulization.[1515]
Infants and neonates: 0.05—0.15 mg/kg/dose every 4—6 hours prn delivered over 5—15 minutes.
Oral inhalation dosage (Accuneb™ albuterol nebulizer solution):
Adolescents and children >= 2 years: The usual dose is 0.63—1.25 mg administered by nebulization 3—4 times per day, as needed for the relief of bronchospasm in patients with asthma. Deliver over 5—15 minutes. More frequent administration is not recommended. Accuneb™ has not been studied in the setting of acute attacks of bronchospasm. Higher doses (e.g., 2.5 mg) may be needed in patients with acute exacerbations of bronchospasm, especially in children aged >= 5 years.
•for bronchospasm prophylaxis (to prevent exercise-induced bronchospasm):
Oral inhalation dosage (albuterol metered-dose inhaler):
Adults and adolescents: For the prevention of exercise-induced bronchospasm, two puffs (180 mcg) should be inhaled at least 15 minutes prior to exercise.[1221]

For the adjunctive emergency acute treatment of hyperkalemia† until hemodialysis is available:
NOTE: Albuterol treats hyperkalemia through beta-adrenergic stimulation of cellular potassium (K+) uptake. However, it is a temporary adjunctive measure.
Oral inhalation dosage (albuterol nebulizer solution):
Adults†: Single doses of 10 to 20 mg have been administered. K+ concentrations begin to fall within 30 minutes of administration, and may remain depressed up to 300 minutes when albuterol is nebulized.[7353] Levalbuterol (see Levalbuterol monograph) is also reported effective; however, it is usually more costly.[7354]
Children†: Nebulized albuterol 2.5 mg if weight < 25 kg and nebulized albuterol 5 mg if weight > 25 kg have been reported effective.[7355]
Premature neonates†: 400 mcg via nebulization has been reported effective.[7356]

Maximum Dosage Limits:
•Adults: 32 mg/day PO; oral inhalation maximum dependent on formulation used.
•Elderly: 32 mg/day PO; oral inhalation maximum dependent on formulation used.
•Adolescents: 32 mg/day PO; oral inhalation maximum dependent on formulation used.
•Children 6—12 years: 24 mg/day PO; oral inhalation maximum dependent on formulation used.
•Children < 6 years: Generally 12 mg/day PO; oral inhalation maximum dependent on formulation used.
•Infants: Individualize dosage.

Patients with hepatic impairment:
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Patients with renal impairment:
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

Indications...Dosage last revised 8/15/2005 11:34:00 AM

Administration Guidelines

Oral Administration
•All dosage forms: Administer with meals to minimize gastric irritation.
•Oral solution: Administer using a calibrated measuring device.
•Storage of immediate release albuterol tablets and syrups: Store at controlled room temperature, preferably between 2—25 degrees C (36—77 degrees F). Protect from light.
•Extended-release tablets: Swallow whole, do not chew or crush. Storage: Volmax® extended-release tablets should be stored under refrigeration 2—8 degrees C (36—46 degrees F).

Inhalation Administration
•There are many different dosage forms of albuterol for inhalation.

Aerosol inhalation (metered-dose inhalers):
•Instruct patient on proper inhalation technique (see Patient Information). Make sure the canister is firmly seated in the plastic mouthpiece adapter before each use. Shake the inhaler well. It is recommended to prime the inhaler. Do this by spraying four times into the air, away from the eyes and face, before using for the first time. When the inhaler has not been used for a period of at least 4 days, prime by spraying two times into the air.
•If the patient is using other inhalers, instruct them to use albuterol first and wait 5 minutes, then use other inhalers as directed.
•A tube spacer extension may be beneficial in patients unable to coordinate inhalation and actuation.
•Following administration, instruct patient to rinse mouth with water to minimize dry mouth.
•To avoid the spread of infection, do not use the inhaler for more than one person.
•Storage: Store albuterol aerosol inhalation canisters at controlled room temperature, preferably between 15—30 degrees C (59—86 degrees F). The contents are under pressure and may burst when exposed to high environmental temperatures. Bring canisters to room temperature before use to ensure proper actuations.

Inhalation solution for nebulization:
•For a 2.5 mg dose of albuterol, dilute 0.5 ml of a 0.5% albuterol solution for nebulization to a final volume of 3 ml with NS or use 3 ml of the commercially available 0.083% albuterol solution for nebulization. Deliver solution by nebulization over 5—15 minutes.
•Storage: Store albuterol nebulizer solution products at controlled room temperature or refrigeration, preferably between 2—25 degrees C (36—77 degrees F), and below 40 degrees C (104 degrees F). Do not freeze. Protect from light. Keep container tightly closed. Keep nebulizer solutions that come within a foil package in the foil package until time of use.

Administration last revised 4/1/2004 3:23:00 PM

Contraindications/Precautions

• albuterol hypersensitivity	• hyperthyroidism
• angioedema	• hypokalemia
• levalbuterol hypersensitivity	• pheochromocytoma
• acute bronchospasm	• pregnancy
• breast-feeding	• QT prolongation
• cardiac arrhythmias	• seizure disorder
• cardiac disease	• seizures
• children	• status asthmaticus
• coronary artery disease	• tachycardia
• diabetes mellitus	• thyrotoxicosis
• elderly	• torsade de pointes
• hypertension

• Absolute contraindications are in italics.

Albuterol is absolutely contraindicated in patients with a known racemic albuterol hypersensitivity or hypersensitivity to related drugs (e.g., levalbuterol hypersensitivity), to propellant fluorocarbons, or to any component of the specific dosage formulation. Immediate hypersensitivity reactions may occur after administration of racemic albuterol, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema. Like other inhaled beta-agonists, albuterol inhalational solution can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs, albuterol inhalational solution should be discontinued immediately and alternative therapy instituted. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister or vial.

Albuterol should be used with caution in patients with cardiovascular disorders including ischemic cardiac disease (coronary artery disease), hypertension, cardiac arrhythmias, tachycardia, or QT prolongation. In addition, beta-agonists should be avoided in patients with congenital long QT syndrome due to the risk of torsade de pointes.[4951] Significant changes in systolic and diastolic blood pressures and heart rate could be expected to occur in some patients after use of any beta-adrenergic bronchodilator. As with other beta-adrenergic agonist medications, albuterol may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects. The decrease is usually transient, not requiring supplementation. Correct pre-existing hypokalemia prior to beta-agonist administration.

Elderly patients may be more sensitive to the side effects of beta-agonists, especially tremor and tachycardia; this risk is higher in patients with preexisting coronary artery disease. Although not clearly established, airway responsiveness to beta-agonist medications may also change with age.

Albuterol also should be used cautiously in patients with hyperthyroidism (thyrotoxicosis, thyroid disease), pheochromocytoma, unusual responsiveness to other sympathomimetic amines, or a seizure disorder (history of seizures).

Albuterol should be used with caution in patients with diabetes mellitus. Large doses of intravenous racemic albuterol have been reported to aggravate preexisting diabetes mellitus and ketoacidosis.

If the patient needs more doses of albuterol inhalational solution than usual, this may be a marker of destabilization of asthma and requires re-evaluation of the patient and treatment regimen. Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If deterioration of asthma occurs during therapy with albuterol (e.g., acute bronchospasm, status asthmaticus), appropriate evaluation of the patient and the treatment strategy is warranted, giving special consideration to the possible need for corticosteroid therapy. Albuterol has no antiinflammatory activity and is not a substitute for inhaled or oral corticosteroid therapy. The use of beta-agonists alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents (e.g., corticosteroids) to the therapeutic regimen. Corticosteroids should not be stopped or reduced when albuterol therapy is instituted. Do not exceed recommended dosages of beta-agonists; fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma. The exact cause of death is unknown, but cardiac arrest following an unexpected development of a severe acute asthmatic crisis and subsequent hypoxia is suspected.

Albuterol is classified as a pregnancy risk category C drug since its safe use during pregnancy has not been established. Furthermore, beta-agonists can interfere with uterine contractility as a result of its beta-adrenergic-mediated relaxant effects on smooth muscle (oral > inhalation). Use during pregnancy only if the potential benefit justifies the potential risk.

It is not known if albuterol is excreted into breast milk. Plasma levels of albuterol after inhalation of therapeutic doses are very low in humans, but it is not known whether albuterol is excreted in human milk. Because of the potential for tumorigenicity shown for racemic albuterol in animal studies and the lack of experience with the use of albuterol solution by nursing mothers, a decision should be made whether to discontinue breast-feeding or to discontinue the drug, taking into account the importance of the drug to the mother.

The safety and effectiveness of albuterol conventional-release tablets has not been established for children below the age of 6 years and of the extended-release product below the age of 12 years. The safety and effectiveness of albuterol syrup has not been established for children under the age of 2 years. A spacer device is recommended for use with metered-dose inhalers. Some children < 5 years may have difficulty using a metered-dose or powder inhaler device correctly, and the use of an inhalation solution may be more appropriate. The safety and effectiveness of has not been established in children < 2 years for oral inhalation of albuterol via nebulizer.

Contraindications last revised 5/2/2004 6:12:00 PM

Drug Interactions

• Amoxapine		• Haloperidol
• Arsenic Trioxide		• Levofloxacin
• Astemizole		• Levomethadyl
• Atomoxetine			Loop diuretics
• Bepridil		• Maprotiline
	Beta-agonists	• Methadone
	Beta-blockers		Monoamine oxidase inhibitors (MAOIs)
• Caffeine		• Moxifloxacin
• Chloroquine		• Norfloxacin
• Ciprofloxacin		• Ofloxacin
• Cisapride		• Pentamidine
• Clarithromycin			Phenothiazines
	Class IA antiarrhythmics	• Pimozide
	Class III antiarrhythmics	• Probucol
	Corticosteroids	• Procarbazine
• Digoxin		• Propafenone
• Droperidol		• Risperidone
• Erythromycin		• Sertindole
• Flecainide		• Sparfloxacin
• Furazolidone			Sympathomimetics
• Gatifloxacin		• Terfenadine
• Gemifloxacin		• Theophylline, Aminophylline
• Green Tea			Thiazide diuretics
• Grepafloxacin			Thyroid hormones
• Guarana			Tricyclic antidepressants
• Halofantrine		• Ziprasidone
	Halogenated anesthetics

If asthma symptoms occur between the use of long-acting beta-agonists (e.g., salmeterol or formoterol), short-acting beta2-agonists (e.g., albuterol) may be used safely for the symptomatic relief of acute asthma symptoms.[5197] [5262] When beginning treatment with a long-acting beta-agonist, patients who have been taking inhaled, short-acting beta2-agonists on a regular basis (e.g., four times a day) should be instructed to discontinue the regular, scheduled use of these drugs and use them only for the symptomatic relief of acute asthma symptoms. Patients should be cautioned that increasing short-acting inhaled beta2-agonist use is a signal of deteriorating asthma. Due to the pharmacology of albuterol [5262], the concomitant use of albuterol with other short-acting beta-agonists or short-acting sympathomimetic aerosol bronchodilators is NOT recommended due to the increased risk of adverse cardiovascular effects (considered duplicate therapy). Caution and close observation should also be used when albuterol is used concurrently with other adrenergic sympathomimetics, administered by any route, to avoid potential for increased cardiovascular effects.[5262]

Albuterol and beta-blockers are pharmacologic opposites, and will counteract each other when given concomitantly.[5262] Beta-blockers may also lead to severe bronchospasm in asthmatic patients. Concurrent use of beta-blockers and albuterol should be avoided.[5262] However, if no acceptable alternative exists, a cardioselective beta-blocker (i.e., atenolol, metoprolol) may be used with caution.[5262]

Beta2-agonists, should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors (MAOIs).[5262] MAOIs may potentiate the actions of beta-agonists on the peripheral vasculature, which can result in severe hypotension. Although no data are available, drugs with MAOI activity such as furazolidone [5343] and procarbazine [5356] may interact similarly. Close observation for such effects is prudent, particularly if beta-agonists are administered within two weeks of stopping the MAOI.[5262]

Beta2-agonists, should be administered with caution to patients being treated with tricyclic antidepressants.[5262] Tricyclic antidepressants may potentiate the actions of beta-agonists on the peripheral vasculature, which can result in hypotension. Rarely, tricyclic antidepressants (TCAs) can potentiate QT prolongation when administered with beta-agonists, especially in the setting of beta-agonist-induced hypokalemia.[5252]

Based on the cardiovascular stimulatory effects of sympathomimetic drugs,[6289] the concomitant use of sympathomimetics and thyroid hormones can enhance the effects on the cardiovascular system. Patients with coronary artery disease have an increased risk of coronary insufficiency from either agent. Combined use of these agents may further increase this risk.

Mean decreases of 16% and 22% in serum digoxin levels were demonstrated after single-dose intravenous and oral administration of racemic albuterol, respectively, to normal volunteers who had received digoxin for 10 days.[5262] The clinical significance of these findings for patients with obstructive airway disease who are receiving albuterol or levalbuterol and digoxin on a chronic basis is unclear. Nevertheless, it would be prudent to carefully evaluate the serum digoxin levels in patients who are currently receiving digoxin and albuterol or levalbuterol therapy.[5262]

Non-potassium sparing diuretics, such as loop diuretics and thiazide diuretics may potentiate hypokalemia and ECG changes seen with beta-agonists such as albuterol.[5262] Hypokalemia due to beta-agonists appears to be dose-related. Caution is advised when loop or thiazide diuretics are coadministered with high doses of beta-agonists; potassium levels may need to be monitored.[5262]

Drugs known to prolong the QTc interval have an increased risk of ventricular arrhythmias. Beta-agonists may be associated with adverse cardiovascular effects including QTc interval prolongation, usually at higher doses and/or when associated with hypokalemia.[5038] [5047] [5262] In addition, beta-agonists should be avoided in patients with congenital long QT syndrome.[4951] Beta-agonists should be administered with extreme caution to patients being treated with drugs known to prolong the QTc interval because the action of beta-agonists on the cardiovascular system may be potentiated.[5038] [5047] Drugs known to increase the QT interval include Class IA antiarrhythmics, Class III antiarrhythmics, flecainide, and propafenone. In addition to antiarrhythmic drugs, other drugs which may result in QT prolongation include: some antipsychotics (e.g., phenothiazines, pimozide, haloperidol, risperidone, sertindole, ziprasidone), amoxapine, arsenic trioxide, astemizole, bepridil, cisapride, chloroquine, clarithromycin, droperidol, halofantrine, halogenated anesthetics, erythromycin, levomethadyl, maprotiline, methadone, some quinolone antibiotics (e.g. ofloxacin, ciprofloxacin, gatifloxacin, gemifloxacin, grepafloxacin, levofloxacin, moxifloxacin, norfloxacin, sparfloxacin), pentamidine, probucol, terfenadine, and tricyclic antidepressants. This list is not inclusive of all agents that may prolong the QT interval. Tricyclic antidepressants (TCAs) can also potentiate the vascular effects of beta-agonists.

Methylxanthine derivatives (e.g., theophylline, aminophylline [5277]) and corticosteroids [3085] may aggravate the hypokalemic effect that may be seen with beta-agonists.[5197] Consider checking potassium levels if clinically indicated. However, beta-agonists are commonly used in conjunction with aminophylline, theophylline, and corticosteroid therapy. In addition, concomitant use of beta-agonists with xanthines, such as theophylline, can cause additive CNS stimulation. Although theophylline (or aminophylline) may be used together with beta-agonists, some patients may experience sensations of tremor or nervousness with combined use. Concomitant use of drugs and herbals such as cocaine, caffeine, guarana, green tea, and other sympathomimetics (such as oral decongestants or ephedra, ma huang) with beta-agonists might result in additive CNS stimulation (e.g., tremor, insomnia) or cardiovascular effects (e.g., increased blood pressure and heart rate).

Cardiovascular adverse effects of beta-agonists, such as increased heart rate and blood pressure, have been shown to be potentiated by the coadministration of atomoxetine. Albuterol 600 mcg IV over 2 hours when combined with atomoxetine 60 mg twice a day for 5 days resulted in additional increases in heart rate and blood pressure over that seen alone with albuterol. Exercise caution if beta-agonists and atomoxetine are coadministered; consider monitoring heart rate and blood pressure initially.[5135] The interaction may be less likely with inhaled beta-agonists versus those given systemically.

Interactions last revised 4/1/2005 9:26:00 AM

Adverse Reactions

• anaphylactoid reactions	• hypokalemia
• angina	• hypotension
• angioedema	• insomnia
• anxiety	• irritability
• arrhythmia exacerbation	• maculopapular rash
• bronchospasm	• muscle cramps
• cough	• nausea/vomiting
• diaphoresis	• nightmares
• dizziness	• palpitations
• drowsiness	• peripheral vasodilation
• dyspepsia	• QT prolongation
• epistaxis	• restlessness
• excitability	• sinus tachycardia
• flushing	• ST-T wave changes
• headache	• syncope
• hoarseness	• throat irritation
• hostility	• tremor
• hyperglycemia	• urinary retention
• hyperkinesis	• urticaria
• hypertension	• xerostomia

The most common adverse reactions associated with albuterol use are related to its sympathomimetic effects, although certain cardiovascular effects may be less common with albuterol than with sympathomimetics that have less selectivity for beta2-adrenergic receptors. In general, the sympathomimetic effects of albuterol are dose-related and are more frequent with the oral tablets or syrup than with the inhalation aerosol or solution for inhalation. Like other sympathomimetics, albuterol can rarely cause adverse cardiovascular effects such as hypertension (3%), angina (<1%), palpitations, sinus tachycardia, or arrhythmia exacerbation or precipitation, especially in patients with preexisting cardiovascular disease. Although infrequent, peripheral vasodilation (hypotension, syncope) can also occur from beta2-stimulation of the vasculature. Albuterol can produce clinically significant cardiovascular effects in some patients, as measured by pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon after administration of albuterol at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce ECG changes, ST-T wave changes (e.g., flattening of the T wave, ST segment depression) and QT prolongation. Cardiac effects may be related to sympathomimetics effects and/or beta-agonist-induced hypokalemia. Albuterol can cause hyperglycemia and hypokalemia. Both of these effects occur from stimulation of beta2-receptors, resulting in gluconeogenesis and intracellular movement of potassium. These effects occur most commonly with inhalation (via nebulization) of relatively large doses of albuterol (e.g., 5—10 mg).

Anaphylactoid reactions have been rarely reported with beta-agonist therapy. Immediate hypersensitivity reactions may occur after administration of racemic albuterol, as demonstrated by rare cases of anaphylaxis, angioedema, bronchospasm, oropharyngeal edema, maculopapular rash, and urticaria. Use of albuterol inhalation solution produces adverse effects similar to those observed with the inhalation aerosol.

The most common adverse reactions associated with use of albuterol inhalation aerosol are palpitations (<10% of patients), sinus tachycardia (10%), anxiety (<10%), tremor (<15% of patients), and increased blood pressure (5%) occasionally resulting in hypertension. Other adverse effects include nausea/vomiting (6%), throat irritation (6%), dyspepsia (5%), insomnia (3%), headache (3%), epistaxis (3%), cough (2%), dizziness (1%), nightmares (1%), and hostility (1%). Dry mouth (xerostomia) or throat hoarseness may also occur following beta-agonist oral inhalation.

The most frequent adverse reactions to albuterol tablets or syrup are tremor (10—20%) and anxiety (9—20%). Other commonly reported reactions include headache (4—7%), sinus tachycardia and palpitations (2—5%), hyperkinesis (2—4%), dizziness (2—3%), muscle cramps (1—3%), insomnia (1—2%), nausea/vomiting (1—4%), and excitability (2%). Extended-release tablets may be associated with a lower incidence of anxiety, vomiting, and tremor than immediate-release tablets. Less frequent adverse reactions occurring in less than 1% of patients include flushing, drowsiness, restlessness, irritability, angina, cough, diaphoresis, and urinary retention. Some adverse effects appear to occur more frequently in young children (2—6 years of age) than in older children or adults; especially excitability and anxiety which occur in roughly 20% and 15% of young children, respectively. Gastrointestinal symptoms (e.g., nausea, vomiting) have been reported in about 2% of young children. These gastrointestinal effects are thought to result from sympathetic slowing of gut motility.

Adverse Reactions last revised 7/1/2002

Monitoring Parameters

Monitoring Parameters
•PFTs

Product Information

More information about the following products is available:
• Accuneb™
• Proventil®
• Proventil® HFA
• Respirol Rx™
• Salbutamol™
• Ventolin®
• Ventolin® HFA
• Ventolin® Syrup
• Volmax®
• VoSpire ER™
• Vospire ER®

Patient Education

Albuterol inhalation aerosol

What is albuterol inhalation aerosol?
ALBUTEROL (Proventil®, Ventolin®) is a bronchodilator, a medicine that opens up your air passages and makes breathing easier. It is a medicine for patients with various lung problems such as asthma and chronic bronchitis. Albuterol aerosol controls acute episodes or prevents recurring bouts of bronchospasm. It is useful for the prevention of exercise-induced bronchospasm. Generic albuterol inhalation aerosol is available.

What should my health care professional know before I use albuterol?
They need to know if you have any of the following conditions:
•diabetes
•heart disease, or irregular heartbeat
•high blood pressure
•low blood levels of potassium
•lung disease
•pheochromocytoma
•seizures (convulsions)
•thyroid disease
•an unusual or allergic reaction to albuterol, levalabuterol, sulfites, other medicines, foods, dyes, or preservatives
•pregnant or trying to get pregnant
•breast-feeding

How should I use this medicine?
Albuterol aerosol is for inhalation through the mouth. Make sure the canister is firmly seated in the plastic mouthpiece adapter before each use. Shake the inhaler well. Prime the inhaler by spraying four times into the air, away from the eyes and face. Do this before using for the first time and when the inhaler has not been used for at least 4 days. Tilt your head back slightly. Breathe out fully, emptying as much air as possible from your lungs. Keep the canister upright. Keep the inhaler about 1 inch from your open mouth (or place the mouthpiece loosely between your open lips). Press down on the inhaler (one puff) while breathing in deeply and slowly. Hold your breath for at least 10 seconds and then exhale (breathe out). Wait for at least 1 to 2 minutes between puffs. Do not use more often than directed.

For preventing exercise-induced bronchospasm: Do not forget to use your albuterol as directed 15 minutes before exercise.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?
For regular prevention of bronchospasm: If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

What drug(s) may interact with albuterol?
•arsenic trioxide
•astemizole
•bepridil
•beta-blockers, often used for high blood pressure or heart problems
•arsenic trioxide
•astemizole
•bepridil
•beta-blockers, often used for high blood pressure or heart problems
•caffeine
•certain antibiotics (such as clarithromycin, erythromycin, gatifloxacin, gemifloxacin, grepafloxacin, levofloxacin, linezolid, moxifloxacin, sparfloxacin)
•chloroquine
•cisapride
•droperidol
•halofantrine
•levomethadyl
•medicines for colds and breathing difficulties
•medicines for heart disease or high blood pressure
•medicines known as MAO inhibitors, such as phenelzine (Nardil®), tranylcypromine (Parnate®), isocarboxazid (Marplan®), and selegiline (Carbex®, Eldepryl®)
•medicines to control heart rhythm (examples: amiodarone, disopyramide, dofetilide, flecainide, procainamide, quinidine, sotalol)
•medicines for treating depression or mental illness (amoxapine, haloperidol, maprotiline, pimozide, phenothiazines, risperidone, sertindole, tricyclic antidepressants, ziprasidone)
•methadone
•pentamidine
•probucol
•some medicines for weight loss (including some herbal products, ephedra, ephedrine, dextroamphetamine)
•steroid hormones such as dexamethasone, cortisone, hydrocortisone
•terfenadine
•theophylline
•thyroid hormones
•water pills or diuretics

Tell your prescriber or health care professional about all other medicines you are taking, including nonprescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check before starting or stopping any of your medicines.

What side effects may I notice from taking albuterol?
Side effects that you should report to your prescriber or health care professional as soon as possible:
Rare:
•skin rash or hives
•swelling of the tongue, face, or lips with difficulty breathing, difficulty swallowing, hoarseness, or tightening of the throat (angioedema)
Infrequent:
•difficulty breathing or wheezing which increases or does not go away
•dizziness or fainting spell
•chest pain or palpitations (fast, pounding heartbeat)
•fast or irregular heartbeat
•fever
•headache (severe)
•increased blood pressure
•muscle cramps or weakness
•numbness in fingers or toes
•vomiting

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):
•anxiety, nervousness, trembling
•cough
•diarrhea
•difficulty sleeping
•dry mouth
•mild headache
•nasal congestion, runny nose
•nausea, upset stomach
•throat irritation (mild)
•unusual taste

What should I watch for while taking albuterol?
Tell your prescriber or health care professional if your symptoms do not improve. If your asthma or bronchitis gets worse while you are using albuterol, call your prescriber or health care professional as soon as you can for advice.

Do not get the aerosol spray in your eyes.

If you are using other inhalers such as ipratropium (Atrovent) or an inhaled steroid such as beclomethasone (Beclovent) or triamcinolone (Azmacort), use albuterol first. Wait at least 5 minutes before using the other inhaler.

Make sure you are using your inhaler properly. Do not use extra or more frequent inhalations. They will not improve your condition. Once a day, remove the metal canister and rinse the plastic case in warm running water. Replace canister gently without using a twisting motion.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water, will help.

Where can I keep my medicine?
Keep out of the reach of children.

Store albuterol aerosol inhalation canisters at controlled room temperature, preferably between 15—30 degrees C (59—86 degrees F). The contents are under pressure and may burst when exposed to high environmental temperatures, heat or flame. Cold temperature decreases the effectiveness of albuterol. Do not freeze. Bring canisters to room temperature before use to ensure proper actuations. Throw away any unused medicine after the expiration date.

NOTE: This information is not intended to cover all possible uses, precautions, interactions, or adverse effects for this drug. If you have questions about the drug(s) you are taking, check with your health care professional.

[Revised: 05/02/2004]

Albuterol inhalation solution

What is albuterol inhalation solution?
ALBUTEROL (Proventil®, Ventolin®) is a bronchodilator, a medicine that open up your air passages and make breathing easier. Albuterol is used for patients with various lung problems such as asthma and chronic bronchitis. Regular use of albuterol inhalation controls recurring bouts of bronchospasm. Generic albuterol inhalation solution is available.

How should I use this medicine?
Albuterol inhalation solution is for use in a nebulizer. Nebulizers convert a solution of albuterol into an aerosol for inhalation through the mouth and into the lungs. The flow rate is adjusted to provide a correct dose. Follow the product instructions to prepare and administer the albuterol inhalation solution. Follow the directions for correct use of the nebulizer. Carefully read the product instructions provided; take precautions to avoid bacterial contamination of the albuterol dose or nebulizer system. Use doses at regular intervals. Do not use more often than directed.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?
If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

What should I watch for while taking albuterol?
Tell your prescriber or health care professional if your symptoms do not improve. If your asthma or bronchitis gets worse while you are using albuterol call your prescriber or health care professional as soon as you can for advice.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water, will help.

Where can I keep my medicine?
Keep out of the reach of children.

Store at controlled room temperature, preferably between 2—25 degrees C (36—77 degrees F), and below 40 degrees C (104 degrees F). Do not freeze. Protect from light. Keep container tightly closed. Keep nebulizer solutions that come within a foil package in the foil package until time of use. Throw away any unused medicine after the expiration date.

[Revised: 05/02/2004]

Albuterol oral syrup

What is albuterol oral syrup?
ALBUTEROL (Proventil®, Ventolin®) is a bronchodilator, a medicine that opens up your air passages and makes you breathe easier. It is a medicine for patients with various lung problems such as asthma and chronic bronchitis. Generic albuterol oral syrup is available.

What should my health care professional know before I take albuterol?
They need to know if you have any of the following conditions:
•diabetes
•heart disease, or irregular heartbeat
•high blood pressure
•low blood levels of potassium
•lung disease
•pheochromocytoma
•seizures (convulsions)
•thyroid disease
•an unusual or allergic reaction to albuterol, levalabuterol, sulfites, other medicines, foods, dyes, or preservatives
•pregnant or trying to get pregnant
•breast-feeding

How should I take this medicine?
Take albuterol oral syrup by mouth. Follow the directions on the prescription label. Shake well before using. Use a specially marked spoon or container to measure your medicine. Ask your pharmacist if you do not have one; household spoons are not always accurate. Do not take more often than directed.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check before starting or stopping any of your medicines.

What should I watch for while taking albuterol?
Tell your prescriber or health care professional if your symptoms do not improve in 1 or 2 days. If your asthma or bronchitis gets worse while you are using albuterol, call your prescriber or health care professional as soon as you can for advice.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water, will help.

Where can I keep my medicine?
Keep out of the reach of children.

Store at a room temperature between 2 and 30 degrees C (36 and 86 degrees F); do not freeze. Protect from light. Keep container tightly closed. Throw away any unused medicine after the expiration date.

[Revised: 05/02/2004]

Albuterol tablets or extended-release tablets

What are albuterol tablets or extended-release tablets?
ALBUTEROL (Proventil®, Ventolin®) is a bronchodilator, a medicine that opens up your air passages and makes you breathe easier. It is a medicine for patients with various lung problems such as asthma or chronic bronchitis. Generic albuterol tablets and extended-release tablets are available.

How should I take this medicine?
Take albuterol tablets or extended-release tablets by mouth. Follow the directions on the prescription label. Swallow the tablets with a drink of water. If albuterol upsets your stomach, take it with food or milk. Swallow extended-release tablets whole; do not crush or chew. Do not take more often than directed.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water, will help.

Where can I keep my medicine?
Keep out of the reach of children in a container that small children cannot open.

Store most tablets at controlled room temperature between 2 and 25 degrees C (36 and 77 degrees F). Volmax® extended-release tablets should be stored under refrigeration 2—8 degrees C (36—46 degrees F). Keep container tightly closed. Throw away any unused medicine after the expiration date.

[Revised: 05/02/2004]

Quetiapine
Seroquel®

Classification:
• Psychotropic Agents
    • Antimanics
• Psychotropic Agents
    • Antipsychotics
        • Atypical Antipsychotics

Description, Mechanism of Action, Pharmacokinetics

Description: Quetiapine is an atypical antipsychotic agent structurally similar to clozapine, a dibenzodiazepine antipsychotic. Atypical antipsychotics are deemed to be the standard of care for schizophrenia and related disorders, and with the exception of clozapine, may be considered as first-line treatment options for the management of psychosis. Like clozapine, quetiapine has been shown to improve positive and potentially negative symptoms of schizophrenia without producing extrapyramidal side effects. The effect of quetiapine on the positive and negative symptoms of schizophrenia has been shown to be equivalent to haloperidol. However, unlike typical antipsychotic agents such as haloperidol, quetiapine is not associated with significant extrapyramidal symptoms and does not cause persistent elevations of serum prolactin concentrations in humans; thus, it may be associated with a lower incidence of adverse effects due to hyperprolactinemia (e.g. galactorrhea, amenorrhea). Additionally, quetiapine was not associated with agranulocytosis during initial clinical trials. Clinical trials indicate that quetiapine is effective as monotherapy for the management of bipolar mania; treatment may also be delivered in combination with standard mood stabilizers (i.e., lithium, divalproex).[7391] The Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) study evaluated the effectiveness of selected atypical antipsychotics and perphenazine in schizophrenic patients (see Atypical Antipsychotic Overview).[8303] Quetiapine trials also suggest effectiveness in the treatment of the depressive phase of bipolar disorder.[7349] [7419] Quetiapine received FDA approval for management of the manifestations of psychotic disorders in September 1997. Quetiapine (as monotherapy or in combination with lithium or divalproex) received FDA approval for manic episodes associated with bipolar disorder on January 13, 2004. The manufacturer is currently investigating the use of quetiapine as monotherapy for major depressive disorder.

In August 2004, the FDA requested all manufacturers of atypical antipsychotics to include revised product label warnings about the potential for an increased risk of hyperglycemia and diabetes with the use of atypical antipsychotics.

On April 11, 2005 the FDA issued a public health advisory noting that the unapproved use of atypical antipsychotics for the treatment of behavioral disorders in the elderly with dementia has been associated with a higher death rate vs. placebo. All manufacturers of atypical antipsychotics will be required to include a boxed warning in their labeling noting this risk.

Mechanism of Action: Similar to clozapine, quetiapine is a potent serotonin 5-HT2-receptor antagonist with moderate dopamine (D2)-receptor antagonism. The antipsychotic action is believed to be mediated through a combination of dopamine D2 and serotonin 5-HT2 receptor antagonism. Having a greater occupancy at 5-HT2 receptors relative to D2 receptors is a feature of atypical antipsychotic drugs and may explain, in part, the lower propensity of these agents to cause extrapyramidal side effects. The selectivity of quetiapine for dopamine receptors on mesolimbic neurons rather than nigrostriatal neurons also helps to explain its atypical profile. Quetiapine also antagonizes other receptors in the brain, including serotonin 5-HT 1a, dopamine D1, histamine H1, and adrenergic alpha1 and alpha2 receptors; it has no appreciable activity at cholinergic, muscarinic and benzodiazepine receptors. Orthostatic hypotension observed with use of quetiapine may be a result of alpha1 antagonism, while somnolence is likely a result of histamine H1 antagonism.

Dopamine (D2)-receptor blockade in the tuberoinfundibular tract results in prolactin release, which can lead to adverse effects such as amenorrhea and galactorrhea. Although both haloperidol and quetiapine produce acute increases in serum prolactin concentrations in rats, the elevated prolactin concentrations produced with quetiapine decline rapidly over time while those produced by haloperidol remain elevated. In clinical trials with humans, quetiapine did not produce sustained elevations of serum prolactin, which may account for the lack of significant prolactin-related side effects.

Pharmacokinetics: Quetiapine is administered orally. After oral administration, quetiapine is rapidly absorbed, with peak plasma concentrations achieved in about 1.5 hours. Food increases Cmax and AUC by 25% and 15%, respectively. Quetiapine is widely distributed throughout the body with a volume of distribution of about 10 L/kg. About 83% of the drug is bound to plasma proteins at therapeutic concentrations. Quetiapine is extensively metabolized by the liver, with less than 1% of the dose excreted as unchanged drug. Major metabolites include an inactive sulfoxide metabolite thought to be produced by the cytochrome P450 3A4 isoenzyme and a parent acid metabolite produced by oxidation. Oral clearance of quetiapine is reduced by about 40% in elderly patients compared with young patients. Patients with hepatic insufficiency or severe renal impairment (CrCl 10—30 ml/min) have a 30% and 25% lower mean oral clearance, respectively, than normal subjects. The mean half-life of quetiapine is roughly 6 hours in patients with normal renal and hepatic function.

Description, Mechanism of Action, Pharmacokinetics last revised 11/1/2005 10:56:00 AM

Indications

• agitation†	• mania
• bipolar disorder	• obsessive-compulsive disorder (OCD)†
• dementia†	• schizophrenia

† non-FDA-approved indication

Dosage

For the treatment of psychotic disorders (e.g., schizophrenia, schizoaffective disorders, psychotic depression, etc.):
NOTE: Reinitiation of quetiapine after discontinuation of < 1 week may occur at the same dose/schedule without titration. If therapy has been stopped for > 1 week, follow initial titration schedule.[5855]
•for the oral treatment of psychotic disorders in outpatients or hospitalized patients:
Oral dosage:
Adults (not at risk for hypotension): Initially, 25 mg PO twice daily. Increase by 25—50 mg PO 2—3 times per day on the 2nd and 3rd day, as tolerated, to a target range of 300—400 mg/day by the 4th day, given in 2—3 divided doses. Further dosage increments, if indicated, should generally occur not less than every 2 days. The maximum effective dose of quetiapine has not been established. Doses of 150—750 mg/day were used in clinical trials. In one dose-ranging study, doses above 300 mg/day were no more efficacious than a 300 mg/day dose. In other studies, however, doses in the range of 400—500 mg/day were needed. The safety of doses above 800 mg/day has not been evaluated. The antipsychotic efficacy of quetiapine was established in short-term (6 week) controlled trials in inpatients with schizophrenia. Long-term use has not been systematically evaluated.[5855]
Elderly, debilitated patients, and patients at risk for hypotension: Initially, 25 mg PO twice daily, see adult dosage titration. A slower rate of titration and a lower target dose should be considered.
Adolescents and children: Safe and effective use has not been established.
•for the treatment of severe behavioral disturbances (e