PEAUFINEE BABY AND KIDS SUN (Titanium Dioxide) Cream [Celltrion Skincure Co.,Ltd.]

Inactive ingredients: Water, Glycerin, Dicaprylyl Carbonate, Butyloctyl Salicylate, Butylene Glycol, Cetearyl Alcohol, Behenyl Alcohol, Arachidyl Alcohol, 1,2-Hexanediol, Stearic Acid, Polyglyceryl-2 Caprate, Arachidyl Glucoside, Hydroxyacetophenone, Sodium Stearoyl Glutamate, Polyacrylate Crosspolymer-6, Fragrance, Octyldodecanol, Sucrose Stearate, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Alumina, Polyisobutene, Glyceryl Caprylate, Saccharide Hydrolysate, Xanthan Gum, Propanediol, Squalane, Ethylhexylglycerin, Caprylic/Capric Triglyceride, Echium Plantagineum Seed Oil, Sorbitan Oleate, Caprylyl/Capryl Glucoside, Curcuma Longa (Turmeric) Root Extract, Salvia Hispanica Seed Extract, Hydrogenated Lecithin, t-Butyl Alcohol, Cetyl-PG Hydroxyethyl Palmitamide, Sodium PCA, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Phytosterols, Ribes Nigrum (Black Currant) Seed Oil, Bentonite, Tocopherol, Olive Oil Decyl Esters, Citric Acid, Hydrated Silica, Rosmarinus Officinalis (Rosemary) Leaf Extract, Helianthus Annuus (Sunflower) Seed Oil, Lactic Acid, Sea Salt, Chlorella Vulgaris Extract

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PEAUFINEE BABY AND KIDS SUN (Titanium Dioxide) Cream [Celltrion Skincure Co.,Ltd.]

SODIUM CHLORIDE Injection, Solution, Concentrate [Hospira, Inc.]

14.6% Sodium Chloride Injection, USP Additive Solution must be diluted before infusion to avoid a sudden increase in the level of plasma sodium. Too rapid administration should be avoided.

Special caution should be used in administering sodium containing solutions to patients with severe renal impairment, cirrhosis of the liver, cardiac failure, or other edematous or sodium-retaining states.

Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.

Caution must be exercised in the administration of parenteral fluids, especially those containing sodium ions, to patients receiving corticosteroids or corticotropin.

Do not use unless the solution is clear and seal is intact. Discard unused portion.

Pregnancy Category C. Animal reproduction studies have not been conducted with sodium chloride. It is also not known whether sodium chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium chloride should be given to a pregnant woman only if clearly needed.

Geriatric Use

An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Pediatric Use

The safety and effectiveness of 14.6% Sodium Chloride Injection, USP Additive Solution have not been established. Its limited use in pediatric patients has been inadequate to fully define proper dosage and limitations for use.

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SODIUM CHLORIDE Injection, Solution, Concentrate [Hospira, Inc.]

PROMETRIUM (Progesterone) Capsule [AbbVie Inc.]

PROMETRIUM® (progesterone, USP)
Capsules 100 mg
Capsules 200 mg

Read this PATIENT INFORMATION before you start taking PROMETRIUM Capsules and read what you get each time you refill your PROMETRIUM Capsules prescription. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

THIS PRODUCT CONTAINS PEANUT OIL AND SHOULD NOT BE USED IF YOU ARE ALLERGIC TO PEANUTS.

What is PROMETRIUM Capsules?

PROMETRIUM Capsules contain the female hormone called progesterone.

What is PROMETRIUM Capsules used for?

Treatment of Menstrual Irregularities

PROMETRIUM Capsules are used for the treatment of secondary amenorrhea (absence of menstrual periods in women who have previously had a menstrual period) due to a decrease in progesterone. When you do not produce enough progesterone, menstrual irregularities can occur. If your healthcare provider has determined your body does not produce enough progesterone on its own, PROMETRIUM Capsules may be prescribed to provide the progesterone you need.

Protection of the Endometrium (Lining of the Uterus)

PROMETRIUM Capsules are used in combination with estrogen-containing medications in a postmenopausal woman with a uterus (womb). Taking estrogen-alone increases the chance of developing a condition called endometrial hyperplasia that may lead to cancer of the lining of the uterus (womb). The addition of a progestin is generally recommended for a woman with a uterus to reduce the chance of getting cancer of the uterus (womb).

Who should not take PROMETRIUM Capsules?

Do not start taking PROMETRIUM Capsules if you:

Tell your healthcare provider:

• If you are breastfeeding. The hormone in PROMETRIUM Capsules can pass into your breast milk.
• About all of your medical problems. Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis, lupus, problems with your heart, liver, thyroid, or kidneys, or have high calcium levels in your blood.
• About all the medicines you take. This includes prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how PROMETRIUM Capsules work. PROMETRIUM Capsules may also affect how your other medicines work.

How should I take PROMETRIUM Capsules?

1. Prevention of Endometrial Hyperplasia: A postmenopausal woman with a uterus who is taking estrogens should take a single daily dose of 200 mg PROMETRIUM Capsules at bedtime for 12 continuous days per 28-day cycle.
2. Secondary Amenorrhea: PROMETRIUM Capsules may be given as a single daily dose of 400 mg at bedtime for 10 days.
3. PROMETRIUM Capsules are to be taken at bedtime as some women become very drowsy and/or dizzy after taking PROMETRIUM Capsules. In a few cases, symptoms may include blurred vision, difficulty speaking, difficulty with walking, and feeling abnormal. If you experience these symptoms, discuss them with your healthcare provider right away.
4. If you experience difficulty in swallowing PROMETRIUM Capsules, it is recommended that you take your daily dose at bedtime with a glass of water while in the standing position.

What are the possible side effects of PROMETRIUM Capsules?

Side effects are grouped by how serious they are and how often they happen when you are treated:

Serious, but less common side effects include:

• Risk to the Fetus: Cases of cleft palate, cleft lip, hypospadias, ventricular septal defect, patent ductus arteriosus, and other congenital heart defects.
• Abnormal Blood Clotting: Stroke, heart attack, pulmonary embolus, visual loss or blindness.

Some of the warning signs of serious side effects include:

• Changes in vision or speech
• Sudden new severe headaches
• Severe pains in your chest or legs with or without shortness of breath, weakness and fatigue
• Dizziness and faintness
• Vomiting

Call your healthcare provider right away if you get any of these warning signs, or any other unusual symptoms that concern you.

Less serious, but common side effects include:

• Headaches
• Breast pain
• Irregular vaginal bleeding or spotting
• Stomach or abdominal cramps, bloating
• Nausea and vomiting
• Hair loss
• Fluid retention
• Vaginal yeast infection

These are not all the possible side effects of PROMETRIUM Capsules. For more information, ask your healthcare provider or pharmacist for advice about side effects. You may report side effects to AbbVie Inc. at 1-800-633-9110 or to FDA at 1-800-FDA-1088.

What can I do to lower my chances of getting a serious side effect with PROMETRIUM Capsules?

• Talk with your healthcare provider regularly about whether you should continue taking PROMETRIUM Capsules.
• See your healthcare provider right away if you get unusual vaginal bleeding while taking PROMETRIUM Capsules.
• Have a pelvic exam, breast exam, and mammogram (breast X-ray) every year unless your healthcare provider tells you something else. If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram, you may need to have breast exams more often.
• If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have higher chances for getting heart disease. Ask your healthcare provider for ways to lower your chances for getting heart disease.

General information about safe and effective use of PROMETRIUM Capsules

• Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not take PROMETRIUM Capsules for conditions for which it was not prescribed.
• Your healthcare provider has prescribed this drug for you and you alone. Do not give PROMETRIUM Capsules to other people, even if they have the same symptoms you have. It may harm them.
• PROMETRIUM Capsules should be taken as a single daily dose at bedtime. Some women may experience extreme dizziness and/or drowsiness during initial therapy. In a few cases, symptoms may include blurred vision, difficulty speaking, difficulty with walking, and feeling abnormal. If you experience these symptoms, discuss them with your healthcare provider right away.
• Use caution when driving a motor vehicle or operating machinery as dizziness or drowsiness may occur.

Keep PROMETRIUM Capsules out of the reach of children.

This leaflet provides a summary of the most important information about PROMETRIUM Capsules. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about PROMETRIUM Capsules that is written for health professionals. You can get more information by calling the toll free number 1-800-633-9110.

What are the ingredients in PROMETRIUM Capsules?

Active ingredient: 100 mg or 200 mg micronized progesterone

The inactive ingredients for PROMETRIUM Capsules 100 mg include: peanut oil NF, gelatin NF, glycerin USP, lecithin NF, titanium dioxide USP, FD&C Red No. 40, and D&C Yellow No. 10.

The inactive ingredients for PROMETRIUM Capsules 200 mg include: peanut oil NF, gelatin NF, glycerin USP, lecithin NF, titanium dioxide USP, D&C Yellow No. 10, and FD&C Yellow No. 6.

HOW SUPPLIED

PROMETRIUM Capsules 100 mg are round, peach-colored capsules branded with black imprint “SV.”

PROMETRIUM Capsules 200 mg are oval, pale yellow-colored capsules branded with black imprint “SV2.”

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Protect from excessive moisture.

Manufactured by:
Catalent Pharma Solutions
St. Petersburg, FL 33716

Marketed by:
AbbVie Inc.
North Chicago, IL 60064, USA

© AbbVie Inc. 2013

500032 Rev 09/13 September, 2013

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PROMETRIUM (Progesterone) Capsule [AbbVie Inc.]

CUPRUM ACETICUM NICOTIANA Pellet [Uriel Pharmacy Inc.]

Why is DailyMed no longer displaying pill images on the Search Results and Drug Info pages?

Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage, we no longer display the RxImage pill images associated with drug labels.

We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels.

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CUPRUM ACETICUM NICOTIANA Pellet [Uriel Pharmacy Inc.]

EQUALINE ANTACID (Aluminum Hydroxide, Magnesium Hydroxide, Simethicone) Suspension [Supervalu Inc]

EQUALINE ANTACID- aluminum hydroxide, magnesium hydroxide, simethicone suspension

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EQUALINE ANTACID (Aluminum Hydroxide, Magnesium Hydroxide, Simethicone) Suspension [Supervalu Inc]

ANTISEPTIC (Benzalkonium Chloride) Liquid [Unifirst First Aid Corporation]

Why is DailyMed no longer displaying pill images on the Search Results and Drug Info pages?

Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage, we no longer display the RxImage pill images associated with drug labels.

We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels.

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ANTISEPTIC (Benzalkonium Chloride) Liquid [Unifirst First Aid Corporation]

BERBERIS QUARTZ Pellet [URIEL PHARMACY INC.]

Why is DailyMed no longer displaying pill images on the Search Results and Drug Info pages?

Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage, we no longer display the RxImage pill images associated with drug labels.

We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels.

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BERBERIS QUARTZ Pellet [URIEL PHARMACY INC.]

COCCULUS CONIUM Pellet [Uriel Pharmacy Inc.]

Out of scope - Out of scope for RxNorm and will not receive RxNorm normal forms. Out of scope information includes radiopharmaceuticals, contrast media, herbals, homeopathics, and food. Drug names that are ambiguous or not compatible with the RxNorm system, such as multivitamins with more than 4,000 characters in their names, are also out of scope.

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COCCULUS CONIUM Pellet [Uriel Pharmacy Inc.]

COLCHICUM CHELIDONIUM SPECIAL ORDER Pellet [Uriel Pharmacy Inc.]

Out of scope - Out of scope for RxNorm and will not receive RxNorm normal forms. Out of scope information includes radiopharmaceuticals, contrast media, herbals, homeopathics, and food. Drug names that are ambiguous or not compatible with the RxNorm system, such as multivitamins with more than 4,000 characters in their names, are also out of scope.

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COLCHICUM CHELIDONIUM SPECIAL ORDER Pellet [Uriel Pharmacy Inc.]

SMARTRX GABA KIT (Gabapentin, Lidocaine Hcl, Menthol) Kit [MAS Management Group Inc.]

Mechanism of Action

The precise mechanisms by which gabapentin produces its analgesic and antiepileptic actions are unknown.

Gabapentin is structurally related to the neurotransmitter gamma-aminobutyric acid (GABA) but has no effect on GABA binding, uptake, or degradation. In vitro studies have shown that gabapentin binds with high-affinity to the α2δ subunit of voltage-activated calcium channels; however, the relationship of this binding to the therapeutic effects of gabapentin is unknown.

Pharmacokinetics

All pharmacological actions following gabapentin administration are due to the activity of the parent compound; gabapentin is not appreciably metabolized in humans.

Oral Bioavailability

Gabapentin bioavailability is not dose proportional; i.e., as dose is increased, bioavailability decreases. Bioavailability of gabapentin is approximately 60%, 47%, 34%, 33%, and 27% following 900, 1200, 2400, 3600, and 4800 mg/day given in 3 divided doses, respectively. Food has only a slight effect on the rate and extent of absorption of gabapentin (14% increase in AUC and C max).

Distribution

Less than 3% of gabapentin circulates bound to plasma protein. The apparent volume of distribution of gabapentin after 150 mg intravenous administration is 58±6 L (mean ±SD). In patients with epilepsy, steady-state predose (C min) concentrations of gabapentin in cerebrospinal fluid were approximately 20% of the corresponding plasma concentrations.

Elimination

Gabapentin is eliminated from the systemic circulation by renal excretion as unchanged drug. Gabapentin is not appreciably metabolized in humans.

Gabapentin elimination half-life is 5 to 7 hours and is unaltered by dose or following multiple dosing. Gabapentin elimination rate constant, plasma clearance, and renal clearance are directly proportional to creatinine clearance. In elderly patients, and in patients with impaired renal function, gabapentin plasma clearance is reduced. Gabapentin can be removed from plasma by hemodialysis.

Specific Populations

Age

The effect of age was studied in subjects 20 to 80 years of age. Apparent oral clearance (CL/F) of gabapentin decreased as age increased, from about 225 mL/min in those under 30 years of age to about 125 mL/min in those over 70 years of age. Renal clearance (CLr) and CLr adjusted for body surface area also declined with age; however, the decline in the renal clearance of gabapentin with age can largely be explained by the decline in renal function.

Gender

Although no formal study has been conducted to compare the pharmacokinetics of gabapentin in men and women, it appears that the pharmacokinetic parameters for males and females are similar and there are no significant gender differences.

Race

Pharmacokinetic differences due to race have not been studied. Because gabapentin is primarily renally excreted and there are no important racial differences in creatinine clearance, pharmacokinetic differences due to race are not expected.

Pediatric

Gabapentin pharmacokinetics were determined in 48 pediatric subjects between the ages of 1 month and 12 years following a dose of approximately 10 mg/kg. Peak plasma concentrations were similar across the entire age group and occurred 2 to 3 hours postdose. In general, pediatric subjects between 1 month and <5 years of age achieved approximately 30% lower exposure (AUC) than that observed in those 5 years of age and older. Accordingly, oral clearance normalized per body weight was higher in the younger children. Apparent oral clearance of gabapentin was directly proportional to creatinine clearance. Gabapentin elimination half-life averaged 4.7 hours and was similar across the age groups studied.

A population pharmacokinetic analysis was performed in 253 pediatric subjects between 1 month and 13 years of age. Patients received 10 to 65 mg/kg/day given three times a day. Apparent oral clearance (CL/F) was directly proportional to creatinine clearance and this relationship was similar following a single dose and at steady-state. Higher oral clearance values were observed in children <5 years of age compared to those observed in children 5 years of age and older, when normalized per body weight. The clearance was highly variable in infants <1 year of age. The normalized CL/F values observed in pediatric patients 5 years of age and older were consistent with values observed in adults after a single dose. The oral volume of distribution normalized per body weight was constant across the age range.

These pharmacokinetic data indicate that the effective daily dose in pediatric patients with epilepsy ages 3 and 4 years should be 40 mg/kg/day to achieve average plasma concentrations similar to those achieved in patients 5 years of age and older receiving gabapentin at 30 mg/kg/day.

Adult Patients with Renal Impairment

Subjects (N=60) with renal impairment (mean creatinine clearance ranging from 13 to 114 mL/min) were administered single 400 mg oral doses of gabapentin. The mean gabapentin half-life ranged from about 6.5 hours (patients with creatinine clearance >60 mL/min) to 52 hours (creatinine clearance <30 mL/min) and gabapentin renal clearance from about 90 mL/min (>60 mL/min group) to about 10 mL/min (<30 mL/min). Mean plasma clearance (CL/F) decreased from approximately 190 mL/min to 20 mL/min. Pediatric patients with renal insufficiency have not been studied.

Hemodialysis

In a study in anuric adult subjects (N=11), the apparent elimination half-life of gabapentin on nondialysis days was about 132 hours; during dialysis the apparent half-life of gabapentin was reduced to 3.8 hours. Hemodialysis thus has a significant effect on gabapentin elimination in anuric subjects.

Hepatic Disease

Because gabapentin is not metabolized, no study was performed in patients with hepatic impairment.

Drug Interactions

• In Vitro Studies

In vitro studies were conducted to investigate the potential of gabapentin to inhibit the major cytochrome P450 enzymes (CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, and CYP3A4) that mediate drug and xenobiotic metabolism using isoform selective marker substrates and human liver microsomal preparations. Only at the highest concentration tested (171 mcg/mL; 1 mM) was a slight degree of inhibition (14% to 30%) of isoform CYP2A6 observed. No inhibition of any of the other isoforms tested was observed at gabapentin concentrations up to 171 mcg/mL (approximately 15 times the C max at 3600 mg/day).

• In Vivo Studies

The drug interaction data described in this section were obtained from studies involving healthy adults and adult patients with epilepsy.

Phenytoin

In a single (400 mg) and multiple dose (400 mg three times a day) study of gabapentin in epileptic patients (N=8) maintained on phenytoin monotherapy for at least 2 months, gabapentin had no effect on the steady-state trough plasma concentrations of phenytoin and phenytoin had no effect on gabapentin pharmacokinetics.

Carbamazepine

Steady-state trough plasma carbamazepine and carbamazepine 10, 11 epoxide concentrations were not affected by concomitant gabapentin (400 mg three times a day; N=12) administration. Likewise, gabapentin pharmacokinetics were unaltered by carbamazepine administration.

Valproic Acid

The mean steady-state trough serum valproic acid concentrations prior to and during concomitant gabapentin administration (400 mg three times a day; N=17) were not different and neither were gabapentin pharmacokinetic parameters affected by valproic acid.

Phenobarbital

Estimates of steady-state pharmacokinetic parameters for phenobarbital or gabapentin (300 mg three times a day; N=12) are identical whether the drugs are administered alone or together.

Naproxen

Co-administration (N=18) of naproxen sodium capsules (250 mg) with gabapentin (125 mg) appears to increase the amount of gabapentin absorbed by 12% to 15%. Gabapentin had no effect on naproxen pharmacokinetic parameters. These doses are lower than the therapeutic doses for both drugs. The magnitude of interaction within the recommended dose ranges of either drug is not known.

Hydrocodone

Co-administration of gabapentin (125 to 500 mg; N=48) decreases hydrocodone (10 mg; N=50) C max and AUC values in a dose-dependent manner relative to administration of hydrocodone alone; C max and AUC values are 3% to 4% lower, respectively, after administration of 125 mg gabapentin and 21% to 22% lower, respectively, after administration of 500 mg gabapentin. The mechanism for this interaction is unknown. Hydrocodone increases gabapentin AUC values by 14%. The magnitude of interaction at other doses is not known.

Morphine

A literature article reported that when a 60 mg controlled-release morphine capsule was administered 2 hours prior to a 600 mg gabapentin capsule (N=12), mean gabapentin AUC increased by 44% compared to gabapentin administered without morphine. Morphine pharmacokinetic parameter values were not affected by administration of gabapentin 2 hours after morphine. The magnitude of interaction at other doses is not known.

Cimetidine

In the presence of cimetidine at 300 mg QID (N=12), the mean apparent oral clearance of gabapentin fell by 14% and creatinine clearance fell by 10%. Thus, cimetidine appeared to alter the renal excretion of both gabapentin and creatinine, an endogenous marker of renal function. This small decrease in excretion of gabapentin by cimetidine is not expected to be of clinical importance. The effect of gabapentin on cimetidine was not evaluated.

Oral Contraceptive

Based on AUC and half-life, multiple-dose pharmacokinetic profiles of norethindrone and ethinyl estradiol following administration of tablets containing 2.5 mg of norethindrone acetate and 50 mcg of ethinyl estradiol were similar with and without co-administration of gabapentin (400 mg three times a day; N=13). The C max of norethindrone was 13% higher when it was co-administered with gabapentin; this interaction is not expected to be of clinical importance.

Antacid (Maalox ®) (aluminum hydroxide, magnesium hydroxide)

Antacid (Maalox ®) containing magnesium and aluminum hydroxides reduced the mean bioavailability of gabapentin (N=16) by about 20%. This decrease in bioavailability was about 10% when gabapentin was administered 2 hours after Maalox.

Probenecid

Probenecid is a blocker of renal tubular secretion. Gabapentin pharmacokinetic parameters without and with probenecid were comparable. This indicates that gabapentin does not undergo renal tubular secretion by the pathway that is blocked by probenecid.

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SMARTRX GABA KIT (Gabapentin, Lidocaine Hcl, Menthol) Kit [MAS Management Group Inc.]

SMARTRX GABA-V KIT (Gabapentin, Methyl Salicylate, Menthol, Capsaicin) Kit [MAS Management Group Inc]

Gabapentin (GA-be-PEN-tin) Capsules

Read the Medication Guide before you start taking gabapentin capsules and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

What is the most important information I should know about gabapentin capsules? Do not stop taking gabapentin capsules without first talking to your healthcare provider.

Stopping gabapentin capsules suddenly can cause serious problems.

Gabapentin capsules can cause serious side effects including:

1. Suicidal Thoughts. Like other antiepileptic drugs, gabapentin capsules may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.

Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

• thoughts about suicide or dying
• attempts to commit suicide
• new or worse depression
• new or worse anxiety
• feeling agitated or restless
• panic attacks
• trouble sleeping (insomnia)
• new or worse irritability
• acting aggressive, being angry, or violent
• acting on dangerous impulses
• an extreme increase in activity and talking (mania)
• other unusual changes in behavior or mood

How can I watch for early symptoms of suicidal thoughts and actions?

• Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
• Keep all follow-up visits with your healthcare provider as scheduled.

Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Do not stop taking gabapentin capsules without first talking to a healthcare provider.

• Stopping gabapentin capsules suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).
• Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

2. Changes in behavior and thinking - Using gabapentin capsules in children 3 to 12 years of age can cause emotional changes, aggressive behavior, problems with concentration, restlessness, changes in school performance, and hyperactivity.

3. Gabapentin capsules may cause serious or life-threatening allergic reactions that may affect your skin or other parts of your body such as your liver or blood cells. This may cause you to be hospitalized or to stop gabapentin capsules. You may or may not have a rash with an allergic reaction caused by gabapentin capsules. Call a healthcare provider right away if you have any of the following symptoms:

• skin rash
• hives
• difficulty breathing
• fever
• swollen glands that do not go away
• swelling of your face, lips, throat, or tongue
• yellowing of your skin or of the whites of the eyes
• unusual bruising or bleeding
• severe fatigue or weakness
• unexpected muscle pain
• frequent infections

These symptoms may be the first signs of a serious reaction. A healthcare provider should examine you to decide if you should continue taking gabapentin capsules.

What are gabapentin capsules?

Gabapentin capsules are a prescription medicine used to treat:

• Pain from damaged nerves (postherpetic pain) that follows healing of shingles (a painful rash that comes after a herpes zoster infection) in adults.
• Partial seizures when taken together with other medicines in adults and children 3 years of age and older with seizures.

Who should not take gabapentin capsules?

Do not take gabapentin capsules if you are allergic to gabapentin or any of the other ingredients in gabapentin capsules. See the end of this Medication Guide for a complete list of ingredients in gabapentin capsules.

What should I tell my healthcare provider before taking gabapentin capsules?

Before taking gabapentin capsules, tell your healthcare provider if you:

• have or have had kidney problems or are on hemodialysis
• have or have had depression, mood problems, or suicidal thoughts or behavior
• have diabetes
• are pregnant or plan to become pregnant. It is not known if gabapentin capsules can harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking gabapentin capsules. You and your healthcare provider will decide if you should take gabapentin capsules while you are pregnant.
  • If you become pregnant while taking gabapentin capsules, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy. You can enroll in this registry by calling 1-888-233-2334.

• are breast-feeding or plan to breast-feed. Gabapentin can pass into breast milk. You and your healthcare provider should decide how you will feed your baby while you take gabapentin capsules.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking gabapentin capsules with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take gabapentin capsules?

• Take gabapentin capsules exactly as prescribed. Your healthcare provider will tell you how much gabapentin capsules to take.

• Do not change your dose of gabapentin capsules without talking to your healthcare provider.
• Take gabapentin capsules with water.

• Gabapentin capsules can be taken with or without food. If you take an antacid containing aluminum and magnesium, such as Maalox®, Mylanta®, Gelusil®, Gaviscon®, or Di-Gel®, you should wait at least 2 hours before taking your next dose of gabapentin capsules.

If you take too much gabapentin capsules, call your healthcare provider or your local Poison Control Center right away at 1-800-222-1222.

What should I avoid while taking gabapentin capsules?

• Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking gabapentin capsules without first talking with your healthcare provider. Taking gabapentin capsules with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse.
• Do not drive, operate heavy machinery, or do other dangerous activities until you know how gabapentin capsules affects you. Gabapentin capsules can slow your thinking and motor skills.

What are the possible side effects of gabapentin capsules?

Gabapentin capsules may cause serious side effects including:

See “What is the most important information I should know about gabapentin capsules?”

• problems driving while using gabapentin capsules. See “What I should avoid while taking gabapentin capsules?”
• sleepiness and dizziness, which could increase the occurrence of accidental injury, including falls
• The most common side effects of gabapentin capsules include:
• lack of coordination
• viral infection
• feeling drowsy
• nausea and vomiting
• difficulty with speaking
• tremor
• swelling, usually of legs and feet
• feeling tired
• fever
• jerky movements
• difficulty with coordination
• double vision
• unusual eye movement

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of gabapentin capsules. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store gabapentin capsules?

• Store Gabapentin Capsules between 68°F to 77°F (20°C to 25°C).

Keep gabapentin capsules and all medicines out of the reach of children.

General information about the safe and effective use of gabapentin capsules

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use gabapentin capsules for a condition for which it was not prescribed. Do not give gabapentin capsules to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about gabapentin capsules. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about gabapentin capsules that was written for healthcare professionals.

For more information go to WWW.AMNEAL.COM or call 1-877-835-5472.

What are the ingredients in gabapentin capsules?

Active ingredient: gabapentin, USP

Inactive ingredients in the capsules: magnesium stearate, pregelatinized starch (corn), starch (corn) and talc.

The 100-mg capsule shell contains: gelatin, sodium lauryl sulfate, and titanium dioxide.

The 300-mg capsule shell contains: gelatin, sodium lauryl sulfate, titanium dioxide, and iron oxide yellow.

The 400-mg capsule shell contains: gelatin, sodium lauryl sulfate, titanium dioxide, FD&C Yellow No. 6, and FD&C Blue No. 1.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

This product’s label may have been updated. For current full prescribing information, please visit www.amneal.com

*Trademarks are the property of their respective owners.

Manufactured by:
Amneal Pharmaceuticals Pvt. Ltd.
Ahmedabad, INDIA 382220

Distributed by:
Amneal Pharmaceuticals
Bridgewater, NJ 08807

Rev. 10-2015-04

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BASIC CARE NICOTINE (Nicotine Polacrilex) Gum, Chewing [L. Perrigo Company]

Nicotine Polacrilex Gum

2 mg and 4 mg User's Guide

How To Use Nicotine Polacrilex Gum To Help You Quit Smoking.

•

Not for sale to those under 18 years of age

•

Proof of age required

•

Not for sale in vending machines or from any source where proof of age cannot be verified

Keys To Success.

1.

You must really want to quit smoking for Nicotine Polacrilex Gum to help you.

2.

You can greatly increase your chances for success by using at least 9 to 12 pieces every day when you start using Nicotine Polacrilex Gum. See chart on back side of leaflet.

3.

You should continue to use Nicotine Polacrilex Gum as explained in this User's Guide for 12 full weeks. If you feel you need to use Nicotine Polacrilex Gum for a longer period to keep from smoking, talk to your health care provider.

4.

Nicotine Polacrilex Gum works best when used together with a support program – See information for instructions on enrollment in the SmokeFreeHabits.com Free & Personalized Support Plan.

5.

If you have trouble using Nicotine Polacrilex Gum, ask your doctor, pharmacist or health care professional.

6.

To request a free audio CD containing tips to help make quitting easier, call 1-866-677-7858 (ONE CD PER CUSTOMER).

So You Decided To Quit.

Congratulations. Your decision to stop smoking is an important one. That's why you've made the right choice in choosing Nicotine Polacrilex Gum. Your own chances of quitting smoking depend on how much you want to quit, how strongly you are addicted to tobacco, and how closely you follow a quitting program like the one that comes with Nicotine Polacrilex Gum.

Quitting Smoking Is Hard!

If you've tried to quit before and haven't succeeded, don't be discouraged! Quitting isn't easy. It takes time, and most people try a few times before they are successful. The important thing is to try again until you succeed. This User's Guide will give you support as you become a nonsmoker. It will answer common questions about Nicotine Polacrilex Gum and give tips to help you stop smoking, and should be referred to often.

Where To Get Help.

You are more likely to stop smoking by using Nicotine Polacrilex Gum with a support program that helps you break your smoking habit. There may be support groups in your area for people trying to quit. Call your local chapter of the American Lung Association, American Cancer Society or American Heart Association for further information. Toll free phone numbers are printed on the Wallet Card on the bottom of this User's Guide.

If you find you cannot stop smoking or if you start smoking again after using Nicotine Polacrilex Gum, remember breaking this addiction doesn't happen overnight. You may want to talk to a health care professional who can help you improve your chances of quitting the next time you try Nicotine Polacrilex Gum or another method.

Let's Get Organized.

Your reason for quitting may be a combination of concerns about health, the effect of smoking on your appearance, and pressure from your family and friends to stop smoking. Or maybe you're concerned about the dangerous effect of secondhand smoke on the people you care about. All of these are good reasons. You probably have others. Decide your most important reasons, and write them down on the wallet card on the back of this User's Guide. Carry this card with you. In difficult moments, when you want to smoke, the card will remind you why you are quitting.

What You're Up Against.

Smoking is addictive in two ways. Your need for nicotine has become both physical and mental. You must overcome both addictions to stop smoking. So while Nicotine Polacrilex Gum will lessen your body's physical addiction to nicotine, you've got to want to quit smoking to overcome the mental dependence on cigarettes. Once you've decided that you're going to quit, it's time to get started. But first, there are some important warnings you should consider.

Some Important Warnings.

This product is only for those who want to stop smoking.

If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known.

Ask a doctor before use if you have

•

a sodium-restricted diet

•

heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate.

•

high blood pressure not controlled with medication. Nicotine can increase your blood pressure.

•

stomach ulcer or diabetes

•

history of seizures

Ask a doctor or pharmacist before use if you are

•

using a non-nicotine stop smoking drug

•

taking a prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.

Stop use and ask a doctor if

•

mouth, teeth or jaw problems occur

•

irregular heartbeat or palpitations occur

•

you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness and rapid heartbeat

•

oral blistering occurs (for cinnamon flavor)

•

you have symptoms of an allergic reaction (such as difficulty breathing or rash)

Keep out of reach of children and pets. Pieces of nicotine gum may have enough nicotine to make children and pets sick. Wrap used pieces of gum in paper and throw away in the trash. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Let's Get Started.

Becoming a nonsmoker starts today. First, check that you bought the right starting dose. If you smoke your first cigarette within 30 minutes of waking up, use Nicotine Polacrilex Gum, 4 mg. If you smoke your first cigarette more than 30 minutes after waking up, use Nicotine Polacrilex Gum, 2 mg. Next, read through the entire User's Guide carefully. Then, set your personalized quitting schedule. Take out a calendar that you can use to track your progress, and identify four dates, using the reminders on the back side of this leaflet:

STEP 1. (Weeks 1-6). Your quit date (and the day you'll start using Nicotine Polacrilex Gum).

Choose your quit date (it should be soon). This is the day you will begin using Nicotine Polacrilex Gum to satisfy your cravings for nicotine. For the first six weeks, you'll use a piece of Nicotine Polacrilex Gum every hour or two. Be sure to read the How To Use Nicotine Polacrilex Gum section. Place the Step 1 reminder on this date.

STEP 2. (Weeks 7-9). The day you'll start reducing your use of Nicotine Polacrilex Gum.

After six weeks, you'll begin gradually reducing your Nicotine Polacrilex Gum usage to one piece every two to four hours. Place the Step 2 reminder on this date (the first day of week seven).

STEP 3. (Weeks 10-12). The day you'll further reduce your use of Nicotine Polacrilex Gum.

Nine weeks after you begin using Nicotine Polacrilex Gum, you will further reduce your nicotine intake by using one piece every four to eight hours. Place the Step 3 reminder on this date (the first day of week ten). For the next three weeks, you'll use a piece of Nicotine Polacrilex Gum every four to eight hours.

End of treatment: The day you'll complete Nicotine Polacrilex Gum therapy.

Identify the date thirteen weeks after the date you chose in Step 1, and place the "EX-SMOKER" reminder on your calendar.

Plan Ahead.

Because smoking is an addiction, it is not easy to stop. After you've given up cigarettes, you will still have a strong urge to smoke. Plan ahead NOW for these times, so you're not defeated in a moment of weakness. The following tips may help:

•

Keep the phone numbers of supportive friends and family members handy.

•

Keep a record of your quitting process. Track the number of Nicotine Polacrilex Gum pieces you use each day, and whether you feel a craving for cigarettes. In the event that you slip, immediately stop smoking and resume your quit attempt with the Nicotine Polacrilex Gum program.

•

Put together an Emergency Kit that includes items that will help take your mind off occasional urges to smoke. Include cinnamon gum or lemon drops to suck on, a relaxing CD, and something for your hands to play with, like a smooth rock, rubber band, or small metal balls.

•

Set aside some small rewards, like a new magazine or a gift certificate from your favorite store, which you'll "give" yourself after passing difficult hurdles.

•

Think now about the times when you most often want a cigarette, and then plan what else you might do instead of smoking. For instance, you might plan to take your coffee break in a new location, or take a walk right after dinner, so you won't be tempted to smoke.

How Nicotine Polacrilex Gum Works.

Nicotine Polacrilex Gum sugar-free chewing pieces provide nicotine to your system – they work as a temporary aid to help you quit smoking by reducing nicotine withdrawal symptoms. Nicotine Polacrilex Gum provides a lower level of nicotine to your blood than cigarettes, and allows you to gradually do away with your body's need for nicotine. Because Nicotine Polacrilex Gum does not contain the tar or carbon monoxide of cigarette smoke, it does not have the same health dangers as tobacco. However, it still delivers nicotine, the addictive part of cigarette smoke. Nicotine can cause side effects such as headache, nausea, upset stomach, and dizziness.

How To Use Nicotine Polacrilex Gum.

If you are under 18 years of age, ask a doctor before use. Before you can use Nicotine Polacrilex Gum correctly, you have to practice! That sounds silly, but it isn't. Nicotine Polacrilex Gum isn't like ordinary chewing gum. It's a medicine, and must be chewed a certain way to work right. Chewed like ordinary gum, Nicotine Polacrilex Gum won't work well and can cause side effects. An overdose can occur if you chew more than one piece of Nicotine Polacrilex Gum at the same time, or if you chew many pieces one after another. Read all the following instructions before using Nicotine Polacrilex Gum. Refer to them often to make sure you're using Nicotine Polacrilex Gum correctly. If you chew too fast, or do not chew correctly, you may get hiccups, heartburn, or other stomach problems. Don't eat or drink for 15 minutes before using Nicotine Polacrilex Gum, or while chewing a piece. The effectiveness of Nicotine Polacrilex Gum may be reduced by some foods and drinks, such as coffee, juices, wine or soft drinks.

1.

Begin using Nicotine Polacrilex Gum on your quit day.

2.

To reduce craving and other withdrawal symptoms, use Nicotine Polacrilex Gum according to the dosage schedule on the back of this leaflet.

3.

Chew each Nicotine Polacrilex Gum piece very slowly several times.

4.

Stop chewing when you notice a peppery taste, or a slight tingling in your mouth. (This usually happens after about 15 chews, but may vary from person to person.)

5.

"PARK" the Nicotine Polacrilex Gum piece between your cheek and gum, and leave it there.

6.

When the peppery taste or tingle is almost gone (in about a minute), start to chew a few times slowly again. When the taste or tingle returns, stop again.

7.

Park the Nicotine Polacrilex Gum piece again (in a different place in your mouth).

8.

Repeat steps 3 to 7 (chew, chew, park) until most of the nicotine is gone from the Nicotine Polacrilex Gum piece (usually happens in about half an hour; the peppery taste or tingle won't return.)

9.

Wrap the used Nicotine Polacrilex Gum piece in paper and throw away in the trash.

To improve your chances of quitting, use at least 9 pieces of Nicotine Polacrilex Gum a day. If you experience strong or frequent cravings you may use a second piece within the hour. However, do not continuously use one piece after another, since this may cause you hiccups, heartburn, nausea or other side effects.

How To Reduce Your Nicotine Polacrilex Gum Usage.

The goal of using Nicotine Polacrilex Gum is to slowly reduce your dependence on nicotine. The schedule for using Nicotine Polacrilex Gum will help you reduce your nicotine craving gradually as you reduce and then stop your use of Nicotine Polacrilex Gum. Here are some tips to help you cut back during each step and then stop using Nicotine Polacrilex Gum:

•

After a while, start chewing each Nicotine Polacrilex Gum piece for only 10 to 15 minutes, instead of half an hour. Then, gradually begin to reduce the number of pieces used.

•

Or, try chewing each piece for longer than half an hour, but reduce the number of pieces you use each day.

•

Substitute ordinary chewing gum for some of the Nicotine Polacrilex Gum pieces you would normally use. Increase the number of pieces of ordinary gum as you cut back on the Nicotine Polacrilex Gum pieces.

•

Check how well you've reduced your daily usage of Nicotine Polacrilex Gum in Weeks 10 to 12. You should only be using about 3 to 5 pieces a day. Get ready to stop.

The following tips may help you try to stop Nicotine Polacrilex Gum when you have completed treatment.

•

Set a stop date.

•

Use the same number of pieces of confectionery gum or mints as you were using Nicotine Polacrilex Gum per day. At the times when you have an urge to use Nicotine Polacrilex Gum, use a strong flavored gum or mint such as cinnamon or peppermint.

•

Reduce the number of pieces of gum or mints you use by one piece per day until you do not need to use any gum or mints.

Talk to your doctor or health care provider if you:

•

still feel the need to use Nicotine Polacrilex Gum at the end of week 12 to keep from smoking

•

start using Nicotine Polacrilex Gum again after stopping

•

start smoking again

Tips To Make Quitting Easier.

Within the first few weeks of giving up smoking, you may be tempted to smoke for pleasure, particularly after completing a difficult task, or at a party or bar. Here are some tips to help get you through the important first stages of becoming a nonsmoker:

On Your Quit Date:

•

Ask your family, friends and coworkers to support you in your efforts to stop smoking.

•

Throw away all your cigarettes, matches, lighters, ashtrays, etc.

•

Keep busy on your quit day. Exercise. Go to a movie. Take a walk. Get together with friends.

•

Figure out how much money you'll save by not smoking. Most ex-smokers can save more than $1,000 a year.

•

Write down what you will do with the money you save.

•

Know your high risk situations and plan ahead how you will deal with them.

•

Keep Nicotine Polacrilex Gum near your bed, so you'll be prepared for any nicotine cravings when you wake up in the morning.

•

Visit your dentist and have your teeth cleaned to get rid of the tobacco stains.

Right After Quitting:

•

During the first few days after you've stopped smoking, spend as much time as possible at places where smoking is not allowed.

•

Drink large quantities of water and fruit juices.

•

Try to avoid alcohol, coffee and other beverages you associate with smoking.

•

Remember that temporary urges to smoke will pass, even if you don't smoke a cigarette.

•

Keep your hands busy with something like a pencil or a paper clip.

•

Find other activities which help you relax without cigarettes.

•

Swim, jog, take a walk, play basketball.

•

Don't worry too much about gaining weight. Watch what you eat, take time for daily exercise, and change your eating habits if you need to.

•

Laughter helps. Watch or read something funny.

What To Expect.

Your body is now coming back into balance. During the first few days after you stop smoking, you might feel edgy and nervous and have trouble concentrating. You might get headaches, feel dizzy and a little out of sorts, feel sweaty or have stomach upsets. You might even have trouble sleeping at first. These are typical withdrawal symptoms that will go away with time. Your smoker's cough will get worse before it gets better. But don't worry, that's a good sign. Coughing helps clear the tar deposits out of your lungs.

After A Week Or Two.

By now you should be feeling more confident that you can handle those smoking urges. Many of your withdrawal symptoms have left by now, and you should be noticing some positive signs: less coughing, better breathing and an improved sense of taste and smell, to name a few.

After A Month.

You probably have the urge to smoke much less often now. But urges may still occur, and when they do, they are likely to be powerful ones that come out of nowhere. Don't let them catch you off guard. Plan ahead for these difficult times.

Concentrate on the ways nonsmokers are more attractive than smokers. Their skin is less likely to wrinkle. Their teeth are whiter, cleaner. Their breath is fresher. Their hair and clothes smell better. That cough that seems to make even a laugh sound more like a rattle is a thing of the past. Their children and others around them are healthier, too.

What To Do About Relapse.

What should you do if you slip and start smoking again? The answer is simple. A lapse of one or two or even a few cigarettes has not spoiled your efforts! Discard your cigarettes, forgive yourself and try again. If you start smoking again, keep your box of Nicotine Polacrilex Gum for your next quit attempt.

If you have taken up regular smoking again, don't be discouraged. Research shows that the best thing you can do is to try again. The important thing is to learn from your last attempt.

•

Admit that you've slipped, but don't treat yourself as a failure.

•

Try to identify the "trigger" that caused you to slip, and prepare a better plan for dealing with this problem next time.

•

Talk positively to yourself - tell yourself that you have learned something from this experience.

•

Make sure you used Nicotine Polacrilex Gum correctly over the full 12 weeks to reduce your craving for nicotine.

•

Remember that it takes practice to do anything, and quitting smoking is no exception.

When The Struggle Is Over.

Once you've stopped smoking, take a second and pat yourself on your back. Now do it again. You deserve it. Remember now why you decided to stop smoking in the first place. Look at your list of reasons. Read them again. And smile. Now think about all the money you are saving and what you'll do with it. All the nonsmoking places you can go, and what you might do there. All those years you may have added to your life, and what you'll do with them. Remember that temptation may not be gone forever. However, the hard part is behind you so look forward with a positive attitude, and enjoy your new life as a nonsmoker.

Questions & Answers.

1. How will I feel when I stop smoking and start using Nicotine Polacrilex Gum?

You'll need to prepare yourself for some nicotine withdrawal symptoms. These begin almost immediately after you stop smoking, and are usually at their worst during the first three or four days. Understand that any of the following is possible:

• craving for cigarettes

• anxiety, irritability, restlessness, mood changes, nervousness

• drowsiness

• trouble concentrating

• increased appetite and weight gain

• headaches, muscular pain, constipation, fatigue

Nicotine Polacrilex Gum can help provide relief from withdrawal symptoms such as irritability and nervousness, as well as the craving for nicotine you used to satisfy by having a cigarette.

2. Is Nicotine Polacrilex Gum just substituting one form of nicotine for another?

Nicotine Polacrilex Gum does contain nicotine. The purpose of Nicotine Polacrilex Gum is to provide you with enough nicotine to help control the physical withdrawal symptoms so you can deal with the mental aspects of quitting. During the 12 week program, you will gradually reduce your nicotine intake by switching to fewer pieces each day.

3. Can I be hurt by using Nicotine Polacrilex Gum?

For most adults, the amount of nicotine in the gum is less than from smoking. Some people will be sensitive to even this amount of nicotine and should not use this product without advice from their doctor. Check the Some Important Warnings section on the front of this leaflet.

Because Nicotine Polacrilex Gum is a gum-based product, chewing it can cause dental fillings to loosen and aggravate other mouth, tooth and jaw problems. Nicotine Polacrilex Gum can also cause hiccups, heartburn and other stomach problems especially if chewed too quickly or not chewed correctly.

4. Will I gain weight?

Many people do tend to gain a few pounds the first 8-10 weeks after they stop smoking. This is a very small price to pay for the enormous gains that you will make in your overall health and attractiveness. If you continue to gain weight after the first two months, try to analyze what you're doing differently. Reduce your fat intake, choose healthy snacks, and increase your physical activity to burn off the extra calories.

5. Is Nicotine Polacrilex Gum more expensive than smoking?

The total cost of Nicotine Polacrilex Gum for the twelve week program is about equal to what a person who smokes one and a half packs of cigarettes a day would spend on cigarettes for the same period of time.

Also, use of Nicotine Polacrilex Gum is only a short-term cost, while the cost of smoking is a long-term cost, because of the health problems smoking causes.

6. What if I slip up?

Discard your cigarettes, forgive yourself and then get back on track. Don't consider yourself a failure or punish yourself. In fact, people who have already tried to quit are more likely to be successful the next time.

Good Luck!

:02952 00 J3

Free Personalized Plan

Begin Right Now!

Having a plan will help you in your efforts to stop smoking. We can help! Follow the simple steps below to receive your valuable personalized Smoke Free Habits plan and many other stop smoking tools and resources.

How To Enroll

Stopping smoking involves breaking your physical addiction and changing your behavior. You will use Nicotine Polacrilex Gum to help break your physical addiction, while your free personalized plan will help you develop healthier behaviors.

To enroll:

•

Go online to http://ift.tt/27iwtUT

•

Enter the first five digits of the UPC number from the box.

•

Answer the questions about yourself.

•

Print your personalized plan.

(If you don't have access to the internet, you can call 1-866-677-7858, answer questions, and your plan will be mailed to you in a few days.)

What You Will Receive

Here are the free tools and resources that you will receive based on how you sign up for the program:

Tips To Get Started

1.

Follow your personalized Smoke Free Habits support plan.

2.

Be sure to use Nicotine Polacrilex Gum as directed.

3.

Throw away all of your cigarettes, lighters, and ashtrays.

4.

You may feel urges to smoke, but they usually pass in 2-3 minutes. When you feel an urge, do something else. Take deep breaths and let them out slowly. Drink a glass of water.

5.

Carry things to put in your mouth, like gum, hard candy or toothpicks.

6.

Be active. Take a walk with a friend, ride your bike, walk the dog, play tennis.

7.

Go to places where you are not allowed to smoke, like the movies or the mall. Try to steer clear of places where you usually smoked, like a break room at work or a favorite bar.

8.

Ask friends or family for support whenever you need it.

Place these reminders on your calender:

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BASIC CARE NICOTINE (Nicotine Polacrilex) Gum, Chewing [L. Perrigo Company]

ESOMEPRAZOLE MAGNESIUM Capsule, Delayed Release [NorthStar Rx LLC]

The following serious adverse reactions are described below and elsewhere in labeling:

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adults

The safety of esomeprazole magnesium delayed-release capsules was evaluated in over 15,000 patients (aged 18 to 84 years) in clinical trials worldwide including over 8,500 patients in the United States and over 6,500 patients in Europe and Canada. Over 2,900 patients were treated in long-term studies for up to 6 to 12 months. In general, esomeprazole magnesium delayed-release capsules were well tolerated in both short and long-term clinical trials.

The safety in the treatment of healing of erosive esophagitis was assessed in four randomized comparative clinical trials, which included 1,240 patients on esomeprazole magnesium delayed-release capsules 20 mg, 2,434 patients on esomeprazole magnesium delayed-release capsules 40 mg, and 3,008 patients on omeprazole 20 mg daily. The most frequently occurring adverse reactions (≥1%) in all three groups were headache (5.5, 5, and 3.8, respectively) and diarrhea (no difference among the three groups). Nausea, flatulence, abdominal pain, constipation, and dry mouth occurred at similar rates among patients taking esomeprazole magnesium delayed-release capsules or omeprazole.

Additional adverse reactions that were reported as possibly or probably related to esomeprazole magnesium delayed-release capsules with an incidence < 1% are listed below by body system:

Body as a Whole: abdomen enlarged, allergic reaction, asthenia, back pain, chest pain, substernal chest pain, facial edema, peripheral edema, hot flushes, fatigue, fever, flu-like disorder, generalized edema, leg edema, malaise, pain, rigors;

Cardiovascular: flushing, hypertension, tachycardia;

Endocrine: goiter;

Gastrointestinal: bowel irregularity, constipation aggravated, dyspepsia, dysphagia, dysplasia GI, epigastric pain, eructation, esophageal disorder, frequent stools, gastroenteritis, GI hemorrhage, GI symptoms not otherwise specified, hiccup, melena, mouth disorder, pharynx disorder, rectal disorder, serum gastrin increased, tongue disorder, tongue edema, ulcerative stomatitis, vomiting;

Hearing: earache, tinnitus;

Hematologic: anemia, anemia hypochromic, cervical lymphadenopathy, epistaxis, leukocytosis, leukopenia, thrombocytopenia;

Hepatic: bilirubinemia, hepatic function abnormal, SGOT increased, SGPT increased;

Metabolic/Nutritional: glycosuria, hyperuricemia, hyponatremia, increased alkaline phosphatase, thirst, vitamin B12 deficiency, weight increase, weight decrease;

Musculoskeletal: arthralgia, arthritis aggravated, arthropathy, cramps, fibromyalgia syndrome, hernia, polymyalgia rheumatica;

Nervous System/Psychiatric: anorexia, apathy, appetite increased, confusion, depression aggravated, dizziness, hypertonia, nervousness, hypoesthesia, impotence, insomnia, migraine, migraine aggravated, paresthesia, sleep disorder, somnolence, tremor, vertigo, visual field defect;

Reproductive: dysmenorrhea, menstrual disorder, vaginitis;

Respiratory: asthma aggravated, coughing, dyspnea, larynx edema, pharyngitis, rhinitis, sinusitis;

Skin and Appendages: acne, angioedema, dermatitis, pruritus, pruritus ani, rash, rash erythematous, rash maculo-papular, skin inflammation, sweating increased, urticaria;

Special Senses: otitis media, parosmia, taste loss, taste perversion;

Urogenital: abnormal urine, albuminuria, cystitis, dysuria, fungal infection, hematuria, micturition frequency, moniliasis, genital moniliasis, polyuria;

Visual: conjunctivitis, vision abnormal.

The following potentially clinically significant laboratory changes in clinical trials, irrespective of relationship to esomeprazole magnesium delayed-release capsules, were reported in ≤ 1% of patients: increased creatinine, uric acid, total bilirubin, alkaline phosphatase, ALT, AST, hemoglobin, white blood cell count, platelets, serum gastrin, potassium, sodium, thyroxine and thyroid stimulating hormone [see Clinical Pharmacology (12)]. Decreases were seen in hemoglobin, white blood cell count, platelets, potassium, sodium, and thyroxine.

Endoscopic findings that were reported as adverse reactions include: duodenitis, esophagitis, esophageal stricture, esophageal ulceration, esophageal varices, gastric ulcer, gastritis, hernia, benign polyps or nodules, Barrett’s esophagus, and mucosal discoloration.

The incidence of treatment-related adverse reactions during 6-month maintenance treatment was similar to placebo. There were no differences in types of related adverse reactions seen during maintenance treatment up to 12 months compared to short-term treatment.

Two placebo-controlled studies were conducted in 710 patients for the treatment of symptomatic gastroesophageal reflux disease. The most common adverse reactions that were reported as possibly or probably related to esomeprazole magnesium delayed-release capsules were diarrhea (4.3%), headache (3.8%), and abdominal pain (3.8%).

Pediatrics

The safety of esomeprazole magnesium delayed-release capsules was evaluated in 316 pediatric and adolescent patients aged 1 to 17 years in four clinical trials for the treatment of symptomatic GERD [see Clinical Studies (14.2)]. In 109 pediatric patients aged 1 to 11 years, the most frequently reported (at least 1%) treatment-related adverse reactions in these patients were diarrhea (2.8%), headache (1.9%) and somnolence (1.9%). In 149 pediatric patients aged 12 to 17 years the most frequently reported (at least 2%) treatment-related adverse reactions in these patients were headache (8.1%), abdominal pain (2.7%), diarrhea (2%), and nausea (2%).

Combination Treatment with Amoxicillin and Clarithromycin

In clinical trials using combination therapy with esomeprazole magnesium delayed-release capsules plus amoxicillin and clarithromycin, no additional adverse reactions specific to these drug combinations were observed. Adverse reactions that occurred were limited to those observed when using esomeprazole magnesium delayed-release capsules, amoxicillin, or clarithromycin alone.

The most frequently reported drug-related adverse reactions for patients who received triple therapy for 10 days were diarrhea (9.2%), taste perversion (6.6%), and abdominal pain (3.7%). No treatment-emergent adverse reactions were observed at higher rates with triple therapy than were observed with esomeprazole magnesium delayed-release capsules alone.

For more information on adverse reactions with amoxicillin or clarithromycin, refer to their package inserts, Adverse Reactions sections.

In clinical trials using combination therapy with esomeprazole magnesium delayed-release capsules plus amoxicillin and clarithromycin, no additional increased laboratory abnormalities particular to these drug combinations were observed.

For more information on laboratory changes with amoxicillin or clarithromycin, refer to their package inserts, Adverse Reactions section.

6.2 Postmarketing Experience

The following adverse reactions have been identified during post-approval use of esomeprazole magnesium delayed-release capsules. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reports are listed below by body system:

Blood and Lymphatic: agranulocytosis, pancytopenia;

Eye: blurred vision;

Gastrointestinal: pancreatitis; stomatitis; microscopic colitis;

Hepatobiliary: hepatic failure, hepatitis with or without jaundice;

Immune System: anaphylactic reaction/shock; systemic lupus erythematosus;

Infections and Infestations: GI candidiasis; Clostridium difficile-associated diarrhea;

Metabolism and nutritional disorders: hypomagnesemia, with or without hypocalcemia and/or hypokalemia; 

Musculoskeletal and Connective Tissue: muscular weakness, myalgia, bone fracture;

Nervous System: hepatic encephalopathy, taste disturbance;

Psychiatric: aggression, agitation, depression, hallucination;

Renal and Urinary: interstitial nephritis;

Reproductive System and Breast: gynecomastia;

Respiratory, Thoracic, and Mediastinal: bronchospasm;

Skin and Subcutaneous Tissue: alopecia, erythema multiforme, hyperhidrosis, photosensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis (some fatal),

cutaneous lupus erythematosus.

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LISINOPRIL Tablet [Aphena Pharma Solutions - Tennessee, LLC]

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Hypertension

In clinical trials in patients with hypertension treated with lisinopril, 5.7% of patients on lisinopril discontinued with adverse reactions.

The following adverse reactions (events 2% greater on lisinopril than on placebo) were observed with lisinopril alone: headache (by 3.8%), dizziness (by 3.5%), cough (by 2.5%).

Heart Failure

In patients with systolic heart failure treated with lisinopril for up to 4 years, 11% discontinued therapy with adverse reactions. In controlled studies in patients with heart failure, therapy was discontinued in 8.1% of patients treated with lisinopril for 12 weeks, compared to 7.7% of patients treated with placebo for 12 weeks.

The following adverse reactions (events 2% greater on lisinopril than on placebo) were observed with lisinopril: hypotension (by 3.8%), chest pain (by 2.1%).

In the two-dose ATLAS trial [see Clinical Studies (14.2)] in heart failure patients, withdrawals due to adverse reactions were not different between the low and high groups, either in total number of discontinuation (17% to 18%) or in rare specific reactions (< 1%). The following adverse reactions, mostly related to ACE inhibition, were reported more commonly in the high dose group:

Acute Myocardial Infarction

Patients treated with lisinopril had a higher incidence of hypotension (by 5.3%) and renal dysfunction (by 1.3%) compared with patients not taking lisinopril.

Other clinical adverse reactions occurring in 1% or higher of patients with hypertension or heart failure treated with lisinopril in controlled clinical trials and do not appear in other sections of labeling are listed below:

Body as a Whole: Fatigue, asthenia, orthostatic effects.

Digestive:Pancreatitis, constipation, flatulence, dry mouth, diarrhea.

Hematologic: Rare cases of bone marrow depression, hemolytic anemia, leukopenia/neutropenia and thrombocytopenia.

Endocrine:Diabetes mellitus, inappropriate antidiuretic hormone secretion.

Metabolic:Gout

Skin:Urticaria, alopecia, photosensitivity, erythema, flushing, diaphoresis, cutaneous pseudolymphoma, toxic epidermal necrolysis, Stevens-Johnson syndrome, and pruritus.

Special Senses: Visual loss, diplopia, blurred vision, tinnitus, photophobia, taste disturbances, olfactory disturbance.

Urogenital: Impotence

Miscellaneous: A symptom complex has been reported which may include a positive ANA, an elevated erythrocyte sedimentation rate, arthralgia/arthritis, myalgia, fever, vasculitis, eosinophilia, leukocytosis, paresthesia and vertigo. Rash, photosensitivity or other dermatological manifestations may occur alone or in combination with these symptoms.

Clinical Laboratory Test Findings

Serum Potassium

In clinical trials hyperkalemia (serum potassium greater than 5.7 mEq/L) occurred in 2.2% and 4.8% of lisinopril-treated patients with hypertension and heart failure, respectively [see Warnings and Precautions (5.5)].

Creatinine, Blood Urea Nitrogen

Minor increases in blood urea nitrogen and serum creatinine, reversible upon discontinuation of therapy, were observed in about 2% of patients with hypertension treated with lisinopril alone. Increases were more common in patients receiving concomitant diuretics and in patients with renal artery stenosis [see Warnings and Precautions (5.4)]. Reversible minor increases in blood urea nitrogen and serum creatinine were observed in 11.6% of patients with heart failure on concomitant diuretic therapy. Frequently, these abnormalities resolved when the dosage of the diuretic was decreased.

Patients with acute myocardial infarction in the GISSI-3 trial treated with lisinopril had a higher (2.4% versus 1.1% in placebo) incidence of renal dysfunction in-hospital and at 6 weeks (increasing creatinine concentration to over 3 mg/dL or a doubling or more of the baseline serum creatinine concentration).

Hemoglobin and Hematocrit

Small decreases in hemoglobin and hematocrit (mean decreases of approximately 0.4 g% and 1.3 vol%, respectively) occurred frequently in patients treated with lisinopril but were rarely of clinical importance in patients without some other cause of anemia. In clinical trials, less than 0.1% of patients discontinued therapy due to anemia.

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Vancomycin is poorly absorbed after oral administration.

In subjects with normal kidney function, multiple intravenous dosing of 1 g of vancomycin (15 mg/kg) infused over 60 minutes produces mean plasma concentrations of approximately 63 mcg/mL immediately at the completion of infusion, mean plasma concentrations of approximately 23 mcg/mL two hours after infusion, and mean plasma concentrations of approximately 8 mcg/mL 11 hours after the end of the infusion. Multiple dosing of 500 mg infused over 30 minutes produces mean plasma concentrations of about 49 mcg/mL at the completion of infusion, mean plasma concentrations of about 19 mcg/mL two hours after infusion, and mean plasma concentrations of about 10 mcg/mL six hours after infusion. The plasma concentrations during multiple dosing are similar to those after a single dose.

The mean elimination half-life of vancomycin from plasma is four to six hours in subjects with normal renal function. In the first 24 hours, about 75% of an administered dose of vancomycin is excreted in urine by glomerular filtration. Mean plasma clearance is about 0.058 L/kg/hr, and mean renal clearance is about 0.048 L/kg/hr.  Renal dysfunction slows excretion of vancomycin. In anephric patients, the average half-life of elimination is 7.5 days.  The distribution coefficient is from 0.3 to 0.43 L/kg. There is no apparent metabolism of the drug.  About 60% of an intraperitoneal dose of vancomycin administered during peritoneal dialysis is absorbed systemically in six hours. Serum concentrations of about 10 mcg/mL are achieved by intraperitoneal injection of 30 mg/kg of vancomycin. However, the safety and efficacy of the intraperitoneal use of vancomycin has not been established in adequate and well-controlled trials (see PRECAUTIONS).

Total systemic and renal clearance of vancomycin may be reduced in the elderly.

Vancomycin is approximately 55% serum protein bound as measured by ultrafiltration at vancomycin serum concentrations of 10 to 100 mcg/mL. After intravenous administration of vancomycin, inhibitory concentrations are present in pleural, pericardial, ascitic and synovial fluids; in urine; in peritoneal dialysis fluid; and in atrial appendage tissue. Vancomycin does not readily diffuse across normal meninges into the spinal fluid; but, when the meninges are inflamed, penetration into the spinal fluid occurs.

Microbiology

The bactericidal action of vancomycin results primarily from inhibition of cell-wall biosynthesis.  In addition, vancomycin alters bacterial-cell-membrane permeability and RNA synthesis.  There is no cross-resistance between vancomycin and other antibiotics. Vancomycin is not active in vitro against gram-negative bacilli, mycobacteria, or fungi.

Synergy

The combination of vancomycin and an aminoglycoside acts synergistically in vitro against many strains of Staphylococcus aureus, Streptococcus bovis, enterococci, and the viridans group streptococci.

Vancomycin has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in INDICATIONS AND USAGE.

Aerobic gram-positive microorganisms

   Diphtheroids

   Enterococci (e.g., Enterococcus faecalis)

   Staphylococci, including Staphylococcus aureus and Staphylococcus epidermidis (including heterogeneous methicillin-resistant strains)

   Streptococcus bovis

   Viridans group streptococci

The following in vitro data are available, but their clinical significance is unknown. 

Vancomycin exhibits in vitro MICs of 1 mcg/mL or less against most (≥90%) strains of streptococci listed below and MICs of 4 mcg/mL or less against most (≥90%) strains of other listed microorganisms; however, the safety and effectiveness of vancomycin in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled clinical trials.

Aerobic gram-positive microorganisms

   Listeria monocytogenes

   Streptococcus pyogenes

   Streptococcus pneumoniae (including penicillin-resistant strains)

   Streptococcus agalactiae

Anaerobic gram-positive microorganisms

   Actinomyces species

   Lactobacillus species

Susceptibility Test Methods

When available, the clinical microbiology laboratory should provide the results of in vitro susceptibility test results for antimicrobial drugs used in local hospitals and practice areas to the physician as periodic reports that describe the susceptibility profile of nosocomial and community-acquired pathogens. These reports should aid the physician in selecting the most effective antimicrobial.

Dilution Techniques

Quantitative methods are used to determine antimicrobial minimum inhibitory concentrations (MICs). These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MICs should be determined using a standardized procedure. Standardized procedures are based on dilution method1,2 (broth, agar or microdilution) or equivalent using standardized inoculum and concentrations of vancomycin powder. The MIC values should be interpreted according to the criteria in Table 1.

Diffusion Techniques

Quantitative methods that require measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to anti-microbial compounds. One such standardized procedure2,3 requires the use of standardized inoculum concentrations. This procedure uses paper disks impregnated with 30 mcg of vancomycin to test the susceptibility of microorganisms to vancomycin. Interpretation involves correlation of the diameter obtained in the disk test with the MIC for vancomycin.  Reports from the laboratory providing results of the standard single-disk susceptibility test with a 30 mcg vancomycin disk should be interpreted according to the following criteria in Table 1.

Table 1: Susceptibility Test Interpretive Criteria for Vancomycin

a    Isolates with vancomycin MICs of 8 to 16 mcg/mL should be further screened for vancomycin resistance using standardized procedures1,2.

b  Plates should be held for a full 24 hours and examined using transmitted light.  Measure the diameter of the zones of complete inhibition (as judged by the unaided eye), including the diameter of the disk.  The zone margin should be considered the area showing no obvious, visible growth that can be detected with the unaided eye.  Ignore faint growth of tiny colonies that can be detected only with a magnifying lens at the edge of the zone of inhibited growth.  Any discernable growth within the zone of inhibition indicates vancomycin resistance.  Organisms with intermediate zones should be tested by a standardized dilution method1,2.

c   Dilution testing should be performed to determine the susceptibility of all staphylococcal isolates.  Disk diffusion testing is not reliable for testing vancomycin, as it does not differentiate vancomycin-susceptible isolates of S. aureus from vancomycin-intermediate isolates, nor does it differentiate among vancomycin-susceptible, intermediate, and resistant isolates of coagulase-negative staphylococci2.

d   Any S. aureus isolate for which the vancomycin MIC is ≥ 8 mcg/mL should be sent to a reference laboratory2.

e   Any coagulase-negative Staphylococcus isolate for which the vancomycin MIC is ≥ 32 mcg/mL should be sent to a reference laboratory2.

f   The rare occurrence of resistant isolates precludes defining any results categories other than “Susceptible”.  For  isolates yielding results suggestive of a nonsusceptible category, organism identification and vancomycin susceptibility test results should be confirmed.  If confirmed, isolates should be sent to a reference laboratory2.

g  Interpretative criteria applicable only to tests performed by broth microdilution method using cation-adjusted Mueller-Hinton broth with 2 to 5% lysed horse blood1,2.

h  Interpretative criteria applicable only to tests performed by disk diffusion method using Mueller-Hinton agar with 5% defibrinated sheep blood and incubated in 5% CO23.

A report of “Susceptible” indicates that the pathogen is likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable. A report of “Intermediate” indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high dosage of drug can be used. This category also provides a buffer zone which prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of “Resistant” indicates that the pathogen is not likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable; other therapy should be selected.

Quality Control

Standardized susceptibility test procedures require the use of laboratory control microorganisms to monitor and ensure the accuracy and precision of the supplies and reagents used in the assay, and the techniques of the individuals performing the test. When tested against appropriate quality control strains, standard vancomycin powder should provide MIC values shown in Table 2.  For the diffusion technique, the 30 mcg vancomycin disk should provide the zone diameters in Table 2 with the quality control strain.

Table 2. In Vitro Susceptibility Test Quality Control Ranges for Vancomycin

a  Quality control strain and interpretive criteria for testing vancomycin susceptibility of enterococci spp.

b  Interpretative criteria applicable only to tests performed using cation-adjusted Mueller-Hinton broth with 2 to 5% lysed horse blood1.  Disk diffusion interpretative criteria applicable only to tests performed using Mueller-Hinton agar with 5% defibrinated sheep blood and incubated in 5% CO22.

c  Quality control strain and interpretive criteria for testing vancomycin susceptibility of streptococci spp. other than S. pneumoniae.

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