AccuNeb (albuterol sulfate) Inhalation Solution 1.25 mg*/3 mL and 0.63 mg*/3 mL

DRUG DESCRIPTION

AccuNeb® (albuterol sulfate) inhalation solution is a sterile, clear, colorless solution of the sulfate salt of racemic albuterol, albuterol sulfate. Albuterol sulfate is a relatively selective beta2-adrenergic bronchodilator (see CLINICAL PHARMACOLOGY). The chemical name for albuterol sulfate is α1 [(tert-butylamino) methyl]-4-hydroxy-m-xylene-α, α´-diol sulfate (2:1) (salt), and its established chemical structure is as follows:

The molecular weight of albuterol sulfate is 576.7 and the empirical formula is (C13H21NO3)2•H2SO4. Albuterol sulfate is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization recommended name for albuterol is salbutamol.

AccuNeb (albuterol sulfate) Inhalation Solution is supplied in two strengths in unit dose vials. Each unit dose vial contains either 0.75 mg of albuterol sulfate (equivalent to 0.63 mg of albuterol) or 1.50 mg of albuterol sulfate (equivalent to 1.25 mg of albuterol) with sodium chloride and sulfuric acid in a 3-mL isotonic, sterile, aqueous solution. Sodium chloride is added to adjust isotonicity of the solution and sulfuric acid is added to adjust pH of the solution to 3.5 (see HOW SUPPLIED).

AccuNeb (albuterol sulfate) Inhalation Solution does not require dilution prior to administration by nebulization. For AccuNeb, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari LC Plus™ nebulizer (with face mask or mouthpiece) connected to a Pari PRONEB™ compressor, under in vitro conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 43% of albuterol (1.25 mg strength) and 39% of albuterol (0.63 mg strength) at a mean flow rate of 3.6 L/min. The mean nebulization time was 15 minutes or less. AccuNeb should be administered from a jet nebulizer at an adequate flow rate, via a mouthpiece or face mask.

INDICATIONS

AccuNeb is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma (reversible obstructive airway disease).

DOSAGE AND ADMINISTRATION

The usual starting dosage for patients 2 to 12 years of age is 1.25 mg or 0.63 mg of AccuNeb administered 3 or 4 times daily, as needed, by nebulization. More frequent administration is not recommended.

To administer 1.25 mg or 0.63 mg of albuterol, use the entire contents of one unit-dose vial (3 mL of 1.25 mg or 0.63 mg inhalation solution) by nebulization. Adjust nebulizer flow rate to deliver AccuNeb over 5 to 15 minutes.

The use of AccuNeb can be continued as medically indicated to control recurring bouts of bronchospasm. During this time most patients gain optimum benefit from regular use of the inhalation solution.

Patients 6 to 12 years of age with more severe asthma (baseline FEV1 less than 60% predicted), weight > 40 kg, or patients 11 to 12 years of age may achieve a better initial response with the 1.25 mg dose.

AccuNeb has not been studied in the setting of acute attacks of bronchospasm. A 2.5 mg dose of albuterol provided by a higher concentration product (2.5 mg albuterol per 3 mL) may be more appropriate for treating acute exacerbations, particularly in children 6 years old and above.

If a previously effective dosage regimen fails to provide the usual relief, medical advice should be sought immediately, as this is often a sign of seriously worsening asthma which would require reassessment of therapy.

The drug compatibility (physical and chemical), clinical efficacy and safety of AccuNeb solution, when mixed with other drugs in a nebulizer have not been established.

The safety and efficacy of AccuNeb have been established in clinical trials when administered using the Pari LC Plus™ nebulizer and Pari PRONEB™ compressor. The safety and efficacy of AccuNeb when administered with other nebulizer systems have not been established.

AccuNeb should be administered via jet nebulizer connected to an air compressor with adequate air flow, equipped with a mouthpiece or suitable face mask.

HOW SUPPLIED

AccuNeb (albuterol sulfate) Inhalation Solution is supplied as a 3 mL, clear, colorless, sterile, preservative-free, aqueous solution in two different strengths, 0.63 mg and 1.25 mg, of albuterol (equivalent to 0.75 mg of albuterol sulfate or 1.5 mg of albuterol sulfate per 3 mL) in unit-dose low-density polyethylene (LDPE) vials. Each unit-dose LDPE vial is protected in a foil pouch, and each foil pouch contains 5 unit-dose LDPE vials. Each strength of AccuNeb (albuterol sulfate) Inhalation Solution is available in a shelf carton containing multiple foil pouches.

AccuNeb® (albuterol sulfate) Inhalation Solution, 0.63 mg (potency expressed as albuterol) contains 0.75 mg albuterol sulfate per 3 mL in unit-dose vials and is available in the following packaging configuration.

NDC 49502-692-03..............................5 foil pouches, each containing 5 vials, total 25 vials per carton

AccuNeb® (albuterol sulfate) Inhalation Solution, 1.25 mg (potency expressed as albuterol) contains 1.50 mg albuterol sulfate per 3 mL in unit-dose vials and is available in the following packaging configuration.

NDC 49502-693-03..............................5 foil pouches, each containing 5 vials, total 25 vials per carton Rx Only.

Storage

Store between 2°C and 25°C (36°F - 77°F). Protect from light and excessive heat.

Store unit-dose vials in protective foil pouch at all times. Once removed from the foil pouch, use vial(s) within one week. Discard the vial if the solution is not colorless.

SIDE EFFECTS

Adverse events reported in > 1% of patients receiving AccuNeb and more frequently than in patients receiving placebo in a four-week double-blind study are listed in the following table.

Table 1: Adverse Events with an Incidence of > 1% of Patients Receiving AccuNeb and Greater than Placebo

(expressed as % of treatment group)

1.25 mg AccuNeb

(N=115) 0.63 mg AccuNeb

(N=117) Placebo

(N=117)

Asthma Exacerbation 13 11.1 8.5

Otitis Media 4.3 0.9 0

Allergic Reaction 0.9 3.4 1.7

Gastroenteritis 0.9 3.4 0.9

Cold Symptoms 0 3.4 1.7

Flu Syndrome 2.6 2.6 1.7

Lymphadenopathy 2.6 0.9 1.7

Skin/Appendage Infection 1.7 0 0

Urticaria 1.7 0.9 0

Migraine 0.9 1.7 0

Chest Pain 0.9 1.7 0

Bronchitis 0.9 1.7 0.9

Nausea 1.7 0.9 0.9

There was one case of ST segment depression in the 1.25 mg AccuNeb treatment group.

No clinically relevant laboratory abnormalities related to AccuNeb administration were seen in this study.

DRUG INTERACTIONS

Other short-acting sympathomimetic aerosol bronchodilators or epinephrine should not be used concomitantly with AccuNeb.

AccuNeb should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants or within 2 weeks of discontinuation of such agents, since the action of albuterol on the vascular system may be poten-tiated.

Beta-receptor blocking agents not only block the pulmonary effect of beta-agonists, such as AccuNeb, but may produce severe bron-chospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with beta-blockers. However, under certain circumstances (e.g., prophylaxis after myocardial infarction), there may be no acceptable alternatives to the use of beta-adren-ergic blocking agents in patients with asthma. In this setting, cardioselective beta-blockers should be considered, although they should be administered with caution.

The ECG changes and/or hypokalemia that may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the dose of the beta-agonist is exceeded. Although the clinical significance of these effects is unknown, caution is advised in the co-administration of beta-agonists with non-potassium sparing diuretics.

Mean decreases of 16% to 22% in serum digoxin levels were demonstrated after single dose intravenous and oral administration of albuterol, respectively, to normal volunteers who had received digoxin for 10 days. The clinical significance of these findings for patients with obstructive airway disease who are receiving albuterol 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.

WARNINGS

Paradoxical Bronchospasm: As with other inhaled beta-adrenergic agonists, AccuNeb can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs, AccuNeb should be discontinued immediately and alternative therapy instituted. It should be noted that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister or vial.

Use of Anti-Inflammatory Agents: The use of beta-adrenergic bronchodilators alone may not be adequatetocontrolasthma inmany patients.Earlyconsideration shouldbegiventoadding anti-inflammatory agents (e.g., corticosteroids).

Deterioration of Asthma: Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient needs more doses of AccuNeb than usual, this may be a marker of destabilization of asthma and requires reevaluation of the patient and the treatment regimen, giving special consideration of the possible need for anti-inflammatory treatment (e.g., cortico-steroids).

Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs and with the home use of nebuliz-ers. It is, therefore, essential that the physician instruct the patient in the need for further evaluation, if his/her asthma becomes worse.

Cardiovascular Effects: AccuNeb, like other beta-adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients as measured by pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon for AccuNeb at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce ECG changes, such as flattening of the T-wave, prolongation of the QTc interval, and ST segment depression. The clinical significance of these findings is unknown. Therefore, AccuNeb like all other sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

Immediate Hypersensitivity Reactions: Immediate hypersensitivity reactions may occur after administration of albuterol as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, and oropharyngeal edema.

PRECAUTIONS

General: Large doses of intravenous albuterol have been reported to aggravate pre-existing diabetes mellitus and ketoacidosis. As with other beta-agonists, inhaled and intravenous albuterol may produce a 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 potassium supplementation.

Information for Patients: The action of AccuNeb may last up to six hours, and therefore it should not be used more frequently than recommended. Do not increase the dose or frequency of medication without consulting your physician. If you find that treatment with AccuNeb becomes less effective for symptomatic relief, your symptoms become worse, and/or you need to use the product more frequently than usual, you should seek medical attention immediately. All asthma medication should only be used under the supervision and direction of a physician. Common effects with medications such as AccuNeb include palpitations, chest pain, rapid heart rate, tremor, or nervousness.

If you are pregnant or nursing, contact your physician about the use of AccuNeb. Effective and safe use of AccuNeb includes an understanding of the way it should be administered.

If the solution in the vial changes color or becomes cloudy, you should not use it.

The drug compatibility (physical and chemical), clinical efficacy, and safety of AccuNeb solution, when mixed with other drugs in a nebulizer, has not been established.

Accretropin (somatropin) Injection

Accretropin™ (recombinant human growth hormone (r-hGH); somatropin) is a protein produced by recombinant DNA technology. It is produced during fermentation in E. coli yielding a protein containing 192 amino acids. The N-terminal amino acid, methionine, is later removed to yield a protein that is chemically and physicochemically identical to pituitary derived human growth hormone, consisting of 191 amino acids in a single polypeptide chain.

Accretropin™ is distributed in a liquid solution containing 1 mL of a 5 mg/mL solution of growth hormone (15 IU/mL). The formulation also contains 0.75% NaCl, 0.34% Phenol (as preservative), 0.2% Pluronic F-68 (a non-ionic surfactant) and is designed for subcutaneous administration. Accretropin™ is stabilized to pH 6.0 with 10 mM NaPO₄ buffer.

INDICATIONS

Accretropin™ (somatropin) is indicated for:

treatment of pediatric patients who have growth failure due to an inadequate secretion of normal endogenous growth hormone.

treatment of short stature associated with Turner Syndrome in pediatric patients whose epiphyses are not closed.

DOSAGE AND ADMINISTRATION

The dose regimen for Accretropin™ [(somatropin) for injection] should be individualized for each patient. Therapy should not be continued if epiphyseal fusion has occurred. Response to growth hormone therapy tends to decrease with time. However, failure to increase growth rate, particularly during the first year of therapy, should prompt close assessment of compliance and evaluation of other causes of growth failure such as hypothyroidism, under-nutrition and advanced bone age.

Growth hormone deficiency - The recommended weekly dose is 0.18 mg/kg body weight to 0.3 mg/kg (0.90 IU/kg) body weight. The dose should be divided into equal daily doses given 6 or 7 times per week subcutaneously.

Turner Syndrome - The recommended weekly dose is 0.36 mg/kg of body weight. The dose should be divided into equal daily doses given 6 or 7 times per week subcutaneously.

Accretropin™ should not be injected intravenously.

Administration - the vial should be swirled with a GENTLE rotary motion. DO NOT SHAKE. The solution should be inspected for clarity. It should be clear. If the solution is cloudy or contains particles, the contents MUST NOT be injected.

Storage

Vials of Accretropin™ Injection should be stored in the refrigerator [2° to 8°C (36° to 46°F)]. Avoid freezing and shaking. Expiration dates are stated on the vial and carton labels. Do not use after expiration date. Once opened, Accretropin™ may be stored up to 14 days when refrigerated [2° to 8°C (36° to 46°F)]. Discard 14 days after first use. Protect from light.

Zafirlukast - ( Accolate)

BRAND NAME: Accolate

DRUG CLASS AND MECHANISM: Zafirlukast is an oral leukotriene receptor antagonist used for treating asthma. Leukotrienes are a group of chemicals manufactured in the body from arachidonic acid. Release of leukotrienes within the body, for example, by allergic reactions, promotes inflammation in many diseases such as asthma, a disease in which inflammation occurs in the lungs. Zafirlukast blocks the binding of leukotriene types D4 (LTD4), and E4 (LTE4). It was approved by the FDA in 1996.

GENERIC AVAILABLE: no

PRESCRIPTION: yes

PREPARATIONS: Tablets: 20mg.

STORAGE: Tablets should be stored at room temperature, between 15 and 30 °C (59-86 °F).

PRESCRIBED FOR: Zafirlukast is used in the chronic treatment of asthma. It also is effective in preventing exercise-induced asthma and in relieving the symptoms of allergic rhinitis. In the treatment of asthma, zafirlukast starts working only after 3 to 14 days of therapy. Therefore, it should not be used for treating an acute asthmatic attack in which prompt effectiveness is needed..

DOSING: Food reduces the absorption of zafirlukast. Therefore, it should be taken either 1 hour before or 2 hours after meals. It is generally taken twice daily in patients with asthma. Although data is limited, zafirlukast may be given only once daily in patients with allergic rhinitis.

DRUG INTERACTIONS: Zafirlukast inhibits the activity of cytochrome isozymes CYP 3A4 and CYP 2C9. The CYP 3A4 isozyme is responsible for metabolism of many drugs. Thus far, data in humans are very limited. In one small study, zafirlukast was shown to interact with warfarin (Coumadin), resulting in increased "thinning" of blood and a decreased ability of blood to clot. This can increase the risk of bleeding.

Until more data are available, zafirlukast should be used very cautiously in patients taking the following drugs: drugs metabolized by CYP2C9 such as amitriptyline (Elavil), diclofenac (Voltaren; Cataflam), ibuprofen (Motrin; Advil), imipramine (Tofranil), phenytoin (Dilantin), and tolbutamide (Orinase); drugs metabolized by CYP3A4 including alprazolam (Xanax), astemizole (Hismanal), carbamazepine (Tegretol), cisapride (Propulsid), cyclosporine (Neoral; Sandimmune), dihydropyridine calcium channel blockers. e.g., felodipine (Plendil), isradipine (Dynacirc), nicardipine (Cardene), nifedipine (Procardia; Adalat), nimodipine (Nimotop), and amlodipine (Norvasc); diltiazem (Cardizem; Tiazac; Dilacor), erythromycin, lovastatin (Mevacor), quinidine (Quinidex; Quinaglute), simvastatin (Zocor), triazolam (Halcion), verapamil (Calan; Isoptin; Verelan; Covera-HS).

PREGNANCY: Safe use of zafirlukast during pregnancy has not been established. Physicians may prescribe zafirlukast during pregnancy if it is felt that its benefits outweigh the potential unknown risks.

NURSING MOTHERS: Zafirlukast is secreted into breast milk and should not be used by women who breast-feed.

SIDE EFFECTS: The most common side effects of zafirlukast are headache, dizziness, abdominal pain, sore throat, and rhinitis. These can occur in between 1 in 50 and 1 in 7 patients.

acarbose

BRAND NAME: Precose

DRUG CLASS AND MECHANISM: Acarbose is an oral medication that is used to control blood glucose (sugar) levels in type II diabetes. It belongs to a class of drugs called alpha-glucosidase inhibitors which also includes miglitol (Glyset). Acarbose was approved by the FDA for use in 1995.

Carbohydrates that are eaten are digested by enzymes in the intestine into smaller sugars which are absorbed into the body and increase blood sugar levels. The process of carbohydrate digestion requires the pancreas to release into the intestine alpha-amylase enzymes which digest the large carbohydrates into smaller carbohydrates called oligosaccharides. The cells lining the small intestine then release alpha-glucosidase enzymes that further digest the oligosaccharides into smaller sugars, like glucose, that can be absorbed. Acarbose is a man-made oligosaccharide designed to slow down the actions of alpha-amylase and alpha-glucosidase enzymes thereby slowing the appearance of sugar in the blood after a meal.

GENERIC: Yes

PRESCRIPTION: Yes

PREPARATIONS: Tablets: 25, 50 and 100 mg.

STORAGE: Acarbose should be stored at room temperature, 15-30°C(59-86°F) in a tight container.

PRESCRIBED FOR: It is believed that strict sugar control in diabetics decreases the risk of eye, kidney, and nerve damage. Alpha-glucosidase inhibitors are used to help lower blood sugar levels that are not controlled by diet and exercise. Acarbose can be used alone to treat type II diabetes or can be combined with sulfonylureas such as glyburide (Diabeta) or metformin (Glucophage) or with insulin.

DOSING: The initial acarbose dose may start 25 mg three times daily and then increase after four to eight weeks to 50-100 mg three times daily. Acarbose should be taken at the first bite of each meal.

Smaller doses may be adequate for patients with severe kidney dysfunction or liver disease. Acarbose is not recommended if cirrhosis is present. Acarbose therapy is not advised in the presence of certain medical conditions such as inflammatory bowel disease or intestinal obstruction and chronic intestinal diseases that interfere with digestion or absorption such as Crohn's disease.

Acarbose doses should be adjusted based upon blood glucose levels taken one hour after a meal and blood HbA1c levels taken about three months after starting or changing the dose. (HbA1c is a chemical in the blood that is a good indicator of blood glucose control.)

DRUG INTERACTIONS: Acarbose may interfere with digoxin absorption thereby decreasing digoxin blood levels and its effect. Therefore, the digoxin dose may need to be increased if acarbose is begun.

Since adding insulin or a sulfonylurea to acarbose therapy may lower blood glucose more than acarbose alone, the risk for developing hypoglycemia is greater when these drugs are combined. Caution should be used when combining these drugs.

If mild to moderate hypoglycemia occurs while taking acarbose in combination with another anti-diabetic agent, the hypoglycemia should be treated with oral glucose (dextrose) instead of sucrose (table sugar) because acarbose blocks the digestion of sucrose to glucose, and hypoglycemia will not be corrected rapidly with sucrose. Acarbose alone does not produce hypoglycemia.

PREGNANCY: There are no studies of acarbose treatment during pregnancy in humans. Insulin therapy is recommended in pregnancy.

NURSING MOTHERS: Acarbose is excreted in the milk of lactating animals, but no human studies have been conducted. Acarbose use is not recommended for nursing mothers.

SIDE EFFECTS: The most common side effects with acarbose therapy are abdominal pain, diarrhea and flatulence. There is a rare possibility that these gastrointestinal side effects may become severe and progress to paralytic ileus.

Other possible but rare side effects are an increase in liver enzymes, and decreases in hematocrit, calcium or vitamin B6 levels.

ACAMPROSATE CALCIUM DELAYED-RELEASE TABLET - ORAL

BRAND NAME(S): Campral

USES: This medication is used to help alcohol dependent patients keep from drinking alcohol. It should be used as part of a complete treatment program that includes both counseling and psychological support. Acamprosate is believed to work by restoring the natural balance of chemicals in the brain (neurotransmitters). Before beginning this medication, you should no longer be drinking alcohol. Acamprosate has not been shown to be effective if you are still drinking when you start taking it.

HOW TO USE: Take this medication by mouth generally three times a day or as directed by your doctor. Acamprosate may be taken with or without food. Take this medication with a full glass of water (8 ounces or 240 milliliters) unless your doctor directs you otherwise. Do not lie down for 30 minutes after taking this medication. Use this medication regularly in order to get the most benefit from it. Remember to use it at the same times each day. Dosage is based on your medical condition and response to therapy. Continue taking this medication, but inform your doctor if you begin drinking alcohol again.

SIDE EFFECTS: Diarrhea, nausea, vomiting, gas, stomach pain, loss of appetite, headache, drowsiness, dizziness, constipation, fatigue, weight gain/loss, muscle/joint pain, change in sexual desire or decreased sexual ability may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (including severe depression, thoughts of suicide), chest pain, fainting, fast or pounding heartbeat, vision or hearing changes, increased thirst. Tell your doctor immediately if any of these rare but very serious side effects occur: change in the amount of urine, seizures, persistent stomach pain, black/tarry stools, vomit that looks like coffee grounds. A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching, swelling, severe dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS: Before taking acamprosate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe kidney disease. Before using this medication, tell your doctor or pharmacist your medical history, especially of: other kidney disease. This drug may make you dizzy or drowsy; use caution engaging in activities requiring alertness such as driving or using machinery. Avoid alcoholic beverages. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. Remember that drinking large amounts of alcohol during pregnancy can cause long-lasting problems in your baby such as birth defects, growth retardation, and learning disabilities. This set of problems is often called alcohol fetal syndrome. It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: persistent diarrhea.

NOTES: Do not share this medication with others. Laboratory tests (e.g., kidney function tests) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details. Also, keep all medical appointments and attend all of your counseling and support group meetings.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.

DOCOSANOL - TOPICAL (doe-COE-sah-noll)

BRAND NAME(S): Abreva

USES: This medication is used to treat/shorten the healing time of cold sores and/or fever blisters. It works by blocking the virus that causes cold sores from entering the skin. This medication does not prevent cold sores or fever blisters from occurring nor should it be used to treat genital herpes or shingles.

HOW TO USE: Apply this medication directly onto the affected area (cold sore) usually 5 times daily; or as directed by your doctor. Start using this medicine at the first signs of infection (e.g., tingling, redness, bump, or itch) and apply enough of the medicine to cover the entire affected area.

SIDE EFFECTS: No side effects are expected to occur. If side effects occur, notify your doctor or pharmacist promptly.

PRECAUTIONS: Tell your doctor your medical history, especially of: any allergies. Tell your doctor if you are pregnant before using this medication. It is not known if this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Tell your doctor of all prescription and nonprescription medication you may use, especially: other topical lip/mouth products. Do not start or stop any medicine without doctor or pharmacist approval.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. This medicine may be harmful if swallowed.

NOTES: Not applicable.

MISSED DOSE: Not applicable.

STORAGE: Store at room temperature between 68 and 77 degrees F (20 and 25 degrees C) away from light and moisture.

ARIPIPRAZOLE - ORAL (ay-ree-PIP-ray-zole)

BRAND NAME(S): Abilify

USES: This medication is used to treat schizophrenia. It works by helping to restore the balance of certain natural chemicals in the brain (neurotransmitters).

HOW TO USE: Take this medication by mouth, usually once daily, with or without food; or take as directed by your doctor. Do not take this medication more often or increase your dose without consulting your doctor. Your condition will not improve any faster but the risk of serious side effects will be increased. Do not stop taking this drug without your doctor's approval. Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day.

SIDE EFFECTS: Vomiting, fever, lightheadedness, dizziness, change in weight, blurred vision or drowsiness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: irregular or unusually fast heartbeat (especially with fever and increased sweating), severe muscle stiffness, uncontrolled muscle movements (especially of the face or tongue), unusual increase in thirst or urination, vision changes. A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching, swelling, severe dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS: Before taking aripiprazole, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease (e.g., history of heart attacks or chest pain, heart failure, irregular heart rhythm), history of stroke, dehydration, seizures, Alzheimer's disease, swallowing problems (e.g., history of aspiration), diabetes (or family history), obesity. To minimize dizziness or fainting, get up slowly from a lying or seated position (especially when you first start using this drug or if your doctor changes your dose). This medication can reduce sweating, which makes overheating more likely to occur. Avoid activities that might cause you to overheat (e.g., doing strenuous work, exercising in hot weather, or using hot tubs). Drink plenty of fluids to avoid becoming dehydrated. This drug may make you dizzy or drowsy; use caution engaging in activities requiring alertness such as driving or using machinery. Avoid alcoholic beverages. Caution is advised when using this drug in the elderly because they may be more sensitive to its side effects. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is not known whether this drug passes into breast milk. Breast-feeding is not recommended while using this drug.

DRUG INTERACTIONS: Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription products you may use, especially of: alpha-blockers (e.g., doxazosin, prazosin), azole antifungals (e.g., ketoconazole, itraconazole), carbamazepine, fluoxetine, medications for treating high blood pressure (e.g., "water pills" or diuretics such as furosemide or hydrochlorothiazide), paroxetine, quinidine. Tell your doctor or pharmacist if you take drugs that cause drowsiness, including: anti-anxiety drugs (e.g., diazepam), antihistamines that cause drowsiness (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep (e.g., sedatives), muscle relaxants, narcotic pain relievers (e.g., codeine), other psychiatric medicines (e.g., phenothiazines such as chlorpromazine, or tricyclics such as amitriptyline), tranquilizers. Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about the safe use of these products. Do not start or stop any medicine without doctor or pharmacist approval.

NOTES: Do not share this medication with others. Laboratory and/or medical tests (e.g., fasting blood sugar-FBS, weight, blood pressure, blood cholesterol/triglyceride levels) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.