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Thursday, July 19, 2012

Sancuso

granisetron

Dosage Form: transdermal patch
FULL PRESCRIBING INFORMATION

Indications and Usage for Sancuso

Sancuso® (Granisetron Transdermal System) is indicated for the prevention of nausea and vomiting in patients receiving moderately and/or highly emetogenic chemotherapy regimens of up to 5 consecutive days duration.

Sancuso Dosage and Administration

The transdermal system (patch) should be applied to clean, dry, intact healthy skin on the upper outer arm. Sancuso should not be placed on skin that is red, irritated or damaged.

Each patch is packed in a pouch and should be applied directly after the pouch has been opened.

The patch should not be cut into pieces.

Adults

Apply a single patch to the upper outer arm a minimum of 24 hours before chemotherapy. The patch may be applied up to a maximum of 48 hours before chemotherapy as appropriate. Remove the patch a minimum of 24 hours after completion of chemotherapy. The patch can be worn for up to 7 days depending on the duration of the chemotherapy regimen.

Dosage Forms and Strengths

Sancuso is a 52 cm2 patch containing 34.3 mg of granisetron. The patch releases 3.1 mg of granisetron per 24 hours for up to 7 days.

Contraindications

Sancuso is contraindicated in patients with known hypersensitivity to granisetron or to any of the components of the patch.

Warnings and Precautions

Gastrointestinal

The use of granisetron in patients may mask a progressive ileus and/or gastric distention caused by the underlying condition.

Skin Reactions

In clinical trials with Sancuso, application site reactions were reported which were generally mild in intensity and did not lead to discontinuation of use. The incidence of reactions was comparable with placebo.

If severe reactions, or a generalized skin reaction occur (e.g. allergic rash, including erythematous, macular, papular rash or pruritus), the patch must be removed.

Exposure to Sunlight

Granisetron may be affected by direct natural or artificial sunlight. Patients must be advised to cover the patch application site, e.g. with clothing, if there is a risk of exposure to sunlight throughout the period of wear and for 10 days following its removal because of a potential skin reaction (see Section 13.2).

Adverse Reactions

Clinical Trials Experience

The safety of Sancuso was evaluated in a total of 404 patients undergoing chemotherapy who participated in two double-blind, comparator studies with patch treatment durations of up to 7 days. The control groups included a total of 406 patients who received a daily dose of 2 mg oral granisetron, for 1 to 5 days.

Adverse reactions considered by the investigators as drug-related occurred in 8.7% (35/404) of patients receiving Sancuso and 7.1% (29/406) of patients receiving oral granisetron. The most common adverse reaction was constipation that occurred in 5.4% of patients in the Sancuso group and 3.0% of patients in the oral granisetron group.

Table 1 lists the treatment emergent adverse reactions that occurred in at least 3% of patients treated with Sancuso or oral granisetron.

Table 1: Incidence of Adverse Reactions in Double-Blind, Active Comparator Controlled Studies in Cancer Patients Receiving Chemotherapy (Events ≥ 3% in either group)
Body System Preferred Term	Sancuso TDS N=404 (%)	Oral granisetron N=406 (%)
Gastrointestinal disorders
Constipation	5.4	3.0
Nervous system disorders
Headache	0.7	3.0

5-HT3 receptor antagonists, such as granisetron, may be associated with arrhythmias or ECG abnormalities. Three ECGs were performed on 588 randomized patients in the Phase 3 study: at baseline before treatment, the first day of chemotherapy, and 5 to 7 days after starting chemotherapy. QTcF prolongation greater than 450 milliseconds was seen in a total of 11 (1.9%) patients after receiving granisetron, 8 (2.7%) on oral granisetron and 3 (1.1%) on the patch. No new QTcF prolongation greater than 480 milliseconds was observed in any patient in this study. No arrhythmias were detected in this study.

Granisetron 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.

Adverse events reported in clinical trials with other formulations of granisetron include the following:

Gastrointestinal: abdominal pain, diarrhea, constipation, elevation of ALT and AST levels, nausea and vomiting

Cardiovascular: Hypertension, hypotension, angina pectoris, atrial fibrillation and syncope have been observed rarely

Central Nervous System: dizziness, insomnia, headache, anxiety, somnolence and asthenia

Hypersensitivity: rare cases of hypersensitivity reactions, sometimes severe (e.g. anaphylaxis, shortness of breath, hypotension, urticaria) have been reported

Other: fever; events often associated with chemotherapy have also been reported: leucopenia, decreased appetite, anemia, alopecia, thrombocytopenia.

Drug Interactions

Granisetron does not induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system in vitro. There have been no definitive drug-drug interaction studies to examine pharmacokinetic or pharmacodynamic interaction with other drugs. However, in humans, granisetron hydrochloride injection has been safely administered with drugs representing benzodiazepines, neuroleptics and anti-ulcer medications commonly prescribed with antiemetic treatments. Granisetron hydrochloride injection also does not appear to interact with emetogenic cancer therapies. In agreement with these data, no clinically relevant drug interactions have been reported in clinical studies with Sancuso.

Because granisetron is metabolized by hepatic cytochrome P-450 drug-metabolizing enzymes (CYP1A1 and CYP3A4), inducers or inhibitors of these enzymes may change the clearance and hence, the half-life of granisetron. In addition, the activity of the cytochrome P-450 subfamily 3A4 (involved in the metabolism of some of the main narcotic analgesic agents) is not modified by granisetron hydrochloride in vitro. In in vitro human microsomal studies, ketoconazole inhibited ring oxidation of granisetron hydrochloride. However, the clinical significance of in vivo pharmacokinetic interactions with ketoconazole is not known. In a human pharmacokinetic study, hepatic enzyme induction with phenobarbital resulted in a 25% increase in total plasma clearance of intravenous granisetron hydrochloride. The clinical significance of this change is not known.

USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category B

Reproduction studies with granisetron hydrochloride have been performed in pregnant rats at intravenous doses up to 9 mg/kg/day (54 mg/m2/day, about 24 times the recommended human dose delivered by the Sancuso patch, based on body surface area) and oral doses up to 125 mg/kg/day (750 mg/m2/day, about 326 times the recommended human dose with Sancuso based on body surface area). Reproduction studies have been performed in pregnant rabbits at intravenous doses up to 3 mg/kg/day (36 mg/m2/day, about 16 times the human dose with Sancuso based on body surface area) and at oral doses up to 32 mg/kg/day (384 mg/m2/day, about 167 times the human dose with Sancuso based on body surface area). These studies did not reveal any evidence of impaired fertility or harm to the fetus due to granisetron. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Sancuso should be used during pregnancy only if clearly needed.

Nursing Mothers

It is not known whether granisetron is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Sancuso is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of Sancuso in pediatric patients under 18 years of age have not been established.

Geriatric Use

Clinical studies of Sancuso did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, cautious treatment selection for an elderly patient is prudent because of the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Renal Failure or Hepatically-Impaired Patients

Although no studies have been performed to investigate the pharmacokinetics of Sancuso in patients with renal or hepatic impairment, pharmacokinetic information is available for intravenous granisetron (see CLINICAL PHARMACOLOGY: Pharmacokinetics 12.3).

Overdosage

There is no specific antidote for granisetron overdosage. In the case of overdosage, symptomatic treatment should be given.

Overdosage of up to 38.5 mg of granisetron hydrochloride, as a single intravenous injection, has been reported without symptoms or only the occurrence of a slight headache.

In clinical trials there were no reported cases of overdosage with Sancuso.

Sancuso Description

Sancuso contains granisetron, which is an anti-nauseant and antiemetic agent. Chemically it is 1-methyl-N-[(1R,3r,5S)-9-methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide with a molecular weight of 312.4. Its empirical formula is C18H24N4O, while its chemical structure is:

Granisetron is a white to off-white solid that is insoluble in water. Sancuso is a thin, translucent, matrix-type transdermal patch that is rectangular-shaped with rounded corners, consisting of a backing, the drug matrix and a release liner.

Sancuso - Clinical Pharmacology

Mechanism of Action

Granisetron is a selective 5-hydroxytryptamine3 (5-HT3) receptor antagonist with little or no affinity for other serotonin receptors, including 5-HT1, 5-HT1A, 5-HT1B/C, 5-HT2; for alpha1-, alpha2-, or beta-adrenoreceptors; for dopamine-D2; or for histamine-H1; benzodiazepine; picrotoxin or opioid receptors.

Serotonin receptors of the 5-HT3 type are located peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone of the area postrema. During chemotherapy that induces vomiting, mucosal enterochromaffin cells release serotonin, which stimulates 5-HT3 receptors. This evokes vagal afferent discharge, inducing vomiting. Animal studies demonstrate that, in binding to 5-HT3 receptors, granisetron blocks serotonin stimulation and subsequent vomiting after emetogenic stimuli such as cisplatin. In the ferret animal model, a single granisetron injection prevented vomiting due to high-dose cisplatin or arrested vomiting within 5 to 30 seconds.

Pharmacodynamics

The effect of granisetron on QTc prolongation was evaluated in a randomized, single-blind, positive (moxifloxacin 400 mg) - and placebo controlled parallel study in healthy subjects. A total of 240 subjects were administered Sancuso patch, intravenous granisetron (10 mcg/kg over 30 seconds). In a study with demonstrated ability to detect small effects, the upper bound of the 90% confidence interval for the largest placebo adjusted, baseline corrected QTc based on Fridericia correction method (QTcF) for Sancuso was below 10 ms, the threshold for regulatory concern.

No evidence of an effect on plasma prolactin or aldosterone concentrations has been found in studies using granisetron.

The effect on oro-cecal transit time following application of Sancuso has not been studied. Granisetron hydrochloride injection exhibited no effect on oro-cecal transit time in healthy subjects given a single intravenous infusion of 50 mcg/kg or 200 mcg/kg. Single and multiple oral doses of granisetron hydrochloride slowed colonic transit in healthy subjects.

Pharmacokinetics

Absorption

Granisetron crosses intact skin into the systemic circulation by a passive diffusion process.

Following a 7-day application of Sancuso in 24 healthy subjects, high inter-subject variability in systemic exposure was observed. Maximal concentration was reached at approximately 48 hours (range: 24-168 hours) following patch application. Mean Cmax was 5.0 ng/mL (CV: 170%) and mean AUC0-168hr was 527 ng-hr/mL (CV:173%).

Mean Plasma Concentration of Granisetron (mean ± SD)

Based on the measure of residual content of the patch after removal, approximately 66% (SD: ± 10.9) of granisetron is delivered following patch application for 7 days.

Distribution

Plasma protein binding is approximately 65%. Granisetron distributes freely between plasma and red blood cells.

Metabolism

Granisetron metabolism involves N-demethylation and aromatic ring oxidation followed by conjugation. In vitro liver microsomal studies show that granisetron's major route of metabolism is inhibited by ketoconazole, suggestive of metabolism mediated by the cytochrome P-450 3A subfamily. Animal studies suggest that some of the metabolites may also have 5-HT3 receptor antagonist activity.

Elimination

Clearance is predominantly by hepatic metabolism. Based on a study with intravenous injection, approximately 12% of the dose is excreted unchanged in the urine of healthy subjects in 48 hours. The remainder of the dose is excreted as metabolites, 49% in the urine, and 34% in the feces.

Subpopulations

Gender

There is evidence to suggest that female subjects had higher granisetron concentrations than males following patch application. However, no statistically significant difference in clinical efficacy outcome was observed between genders.

Pediatrics

No studies have been performed to investigate the pharmacokinetics of Sancuso in pediatrics.

Elderly, and Renal or Hepatic Impairment

Although no studies have been performed to investigate the pharmacokinetics of Sancuso in elderly subjects, and in patients with renal or hepatic impairment, the following pharmacokinetic information is available for intravenous granisetron.

In the elderly, and in patients with renal failure or hepatic impairment, the pharmacokinetics of granisetron were determined following a single 40 mcg/kg intravenous dose of granisetron hydrochloride.

Elderly

In elderly volunteers (mean age 71 years) pharmacokinetic parameters following a single 40 mcg/kg intravenous dose of granisetron hydrochloride, lower clearance and longer half-life were observed compared to younger healthy volunteers.

Renal Failure Patients

Total clearance of granisetron was not affected in patients with severe renal failure who received a single 40 mcg/kg intravenous dose of granisetron hydrochloride.

Hepatically-Impaired Patients

In patients with hepatic impairment due to neoplastic liver involvement, total plasma clearance following a single 40 mcg/kg intravenous dose of granisetron hydrochloride was approximately halved compared to patients without hepatic impairment. Given the wide variability in pharmacokinetic parameters of granisetron and the good tolerance of doses well above the recommended dose, dose adjustment in patients with hepatic functional impairment is not necessary.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis and Impairment of Fertility

In a 24-month carcinogenicity study, rats were treated orally with granisetron 1, 5 or 50 mg/kg/day (6, 30 or 300 mg/m2/day). The 50 mg/kg/day dose was reduced to 25 mg/kg/day (150 mg/m2/day) during week 59 due to toxicity. For a 50 kg person of average height (1.46 m2 body surface area), these doses represent about 2.6, 13 and 65 times the recommended clinical dose (3.1 mg/day, 2.3 mg/m2/day, delivered by the Sancuso patch, on a body surface area basis). There was a statistically significant increase in the incidence of hepatocellular carcinomas and adenomas in males treated with 5 mg/kg/day (30 mg/m2/day, about 13 times the recommended human dose with Sancuso, on a body surface area basis) and above, and in females treated with 25 mg/kg/day (150 mg/m2/day, about 65 times the recommended human dose with Sancuso, on a body surface area basis). No increase in liver tumors was observed at a dose of 1 mg/kg/day (6 mg/m2/day, about 2.6 times the recommended human dose with Sancuso, on a body surface area basis) in males and 5 mg/kg/day (30 mg/m2/day, about 13 times the recommended human dose with Sancuso, on a body surface area basis) in females.

In a 12-month oral toxicity study, treatment with granisetron 100 mg/kg/day (600 mg/m2/day, about 261 times the recommended human dose with Sancuso, on a body surface area basis) produced hepatocellular adenomas in male and female rats while no such tumors were found in the control rats. A 24-month mouse carcinogenicity study of granisetron did not show a statistically significant increase in tumor incidence, but the study was not conclusive.

Because of the tumor findings in rat studies, Sancuso should be prescribed only at the dose and for the indication recommended (see INDICATIONS AND USAGE, and DOSAGE AND ADMINISTRATION).

Granisetron was not mutagenic in an in vitro Ames test and mouse lymphoma cell forward mutation assay, and in vivo mouse micronucleus test and in vitro and ex vivo rat hepatocyte UDS assays. It, however, produced a significant increase in UDS in HeLa cells in vitro and a significant increased incidence of cells with polyploidy in an in vitro human lymphocyte chromosomal aberration test.

Granisetron at subcutaneous doses up to 6 mg/kg/day (36 mg/m2/day, about 16 times the recommended human dose of Sancuso, on a body surface area basis), and oral doses up to 100 mg/kg/day (600 mg/m2/day, about 261 times the recommended human dose of Sancuso, on a body surface area basis) was found to have no effect on fertility and reproductive performance of male and female rats.

Phototoxicity

When tested for potential photogenotoxicity in vitro in a Chinese hamster ovary (CHO) cell line, at 200 and 300 mcg/ml, granisetron increased the percentage of cells with chromosomal aberration following photoirradiation.

Granisetron was not phototoxic when tested in vitro in a mouse fibroblast cell line. When tested in vivo in guinea-pigs, Sancuso patches did not show any potential for photoirritation or photosensitivity. No phototoxicity studies have been performed in humans.

Clinical Studies

The effectiveness of Sancuso in the prevention of chemotherapy-induced nausea and vomiting (CINV) was evaluated in a Phase 3 randomized, parallel group, double-blind, double-dummy study conducted in the U.S. and abroad. The study compared the efficacy, tolerability and safety of Sancuso with that of 2 mg oral granisetron once daily in the prevention of nausea and vomiting in a total of 641 patients receiving multi-day chemotherapy.

The population randomized into the trial included 48% males and 52% females aged 16 to 86 years receiving moderately (ME) or highly emetogenic (HE) multi-day chemotherapy. Seventy-eight (78%) of patients were White, 12% Asian, 10% Hispanic/Latino and 0% Black.

The granisetron patch was applied 24 to 48 hours before the first dose of chemotherapy, and kept in place for 7 days. Oral granisetron was administered daily for the duration of the chemotherapy regimen, one hour before each dose of chemotherapy. Efficacy was assessed from the first administration until 24 hours after the start of the last day's administration of the chemotherapy regimen.

The primary endpoint of the trial was the proportion of patients achieving no vomiting and/or retching, no more than mild nausea and no rescue medication from the first administration until 24 hours after the start of the last day's administration of multi-day chemotherapy. Using this definition, the effect of Sancuso was established in 60.2% of patients in the Sancuso arm and 64.8% of patients receiving oral granisetron (difference -4.89%; 95% confidence interval -12.91% to +3.13%).

An assessment of patch adhesion in 621 patients receiving either active or placebo patches showed that less than 1% of patches became detached over the course of the 7 day period of patch application.

How Supplied/Storage and Handling

Sancuso (Granisetron Transdermal System) is supplied as a 52 cm2 patch containing 34.3 mg of granisetron. Each patch is printed on one side with the words "Granisetron 3.1 mg/24 hours". Each patch is packaged in a separate sealed foil-lined plastic pouch.

Sancuso is available in packages of 1 (NDC 42747-726-01) patch.

Store at 20°-25°C (68°-77°F); excursions permitted between 15°-30°C (59°-86°F). [see USP Controlled Room Temperature].

Sancuso should be stored in the original packaging.

Patient Counseling Information

See FDA-approved patient labeling (17.4)

Gastrointestinal

Because the use of granisetron may mask a progressive ileus and/or gastric distention caused by the underlying condition, patients should be instructed to tell their physician if they have pain or swelling in their abdomen.

Skin Reactions

Patients should be instructed to remove the patch if they have a severe skin reaction, or a generalized skin reaction (e.g. allergic rash, including erythematous, macular, papular rash or pruritus).

When patients remove the patch, they should be instructed to peel it off gently.

Exposure to Sunlight

Granisetron may be degraded by direct sunlight or exposure to sunlamps. In addition, an in vitro study using Chinese hamster ovary cells suggests that granisetron has the potential for photogenotoxicity (see Section 13.2).

Patients must be advised to cover the patch application site, e.g. with clothing, if there is a risk of exposure to sunlight or sunlamps throughout the period of wear and for 10 days following its removal.

FDA-Approved Patient Labeling

Rx Only

Manufactured by:

Aveva Drug Delivery Systems Inc.,

Miramar

FL 33025

Manufactured for:

ProStrakan Inc.,

Bedminster

NJ 07921

Sancuso and ProStrakan are trademarks owned by the ProStrakan group of companies

Revised: September 2011

Patient Information

Sancuso® [san-KOO-so]

(granisetron transdermal system)

IMPORTANT: For skin use only

Read the Patient Information that comes with Sancuso before you start using it 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 your treatment. If you have any questions about Sancuso, ask your healthcare provider.

What is Sancuso?

Sancuso is a prescription medicine used to prevent nausea and vomiting in people receiving some types of chemotherapy treatment. Sancuso is a skin patch that slowly releases the medicine contained in the adhesive (glue), through clean and intact skin areas into your bloodstream while you wear the patch.

Important: Sancuso contains granisetron, the same medicine in Kytril. Do not take Kytril at the same time you use Sancuso unless your healthcare provider tells you it is alright.

Who should not use Sancuso?

Do not use Sancuso if you are allergic to any of the ingredients in Sancuso. See the end of this leaflet for a list of ingredients in Sancuso.

What should I tell my healthcare provider before using Sancuso?

Tell your healthcare provider about all your medical conditions, including if you:

are allergic to medical adhesive tape, adhesive dressings or other skin patches.

have pain or swelling in your stomach area (abdomen).

are pregnant. It is not known if Sancuso will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.

are breast-feeding or plan to breast-feed. It is not known if Sancuso passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Other medicines may affect how Sancuso works. Sancuso may also affect how other medicines work.

How should Sancuso be used?

Use Sancuso exactly as prescribed. See the detailed Patient Instructions for Applying Sancuso at the end of this Patient Information leaflet.

Avoid sunlight. The medicine in Sancuso (granisetron) may not work as well and/or may affect your skin if exposed to direct sunlight or the light from sunlamps or tanning beds. It is important to do the following:

While you wear the patch, keep it covered with clothing if you will be in sunlight or near a sunlamp, including tanning beds.

Keep the skin where Sancuso was applied covered for another 10 days after the patch is taken off to protect from exposure to direct sunlight.

What are the possible side effects of Sancuso?

Sancuso can cause serious side effects:

Using Sancuso may make it harder to identify certain stomach and bowel problems that are from other causes. Tell your healthcare provider if you have any stomach area (abdominal) pain or swelling while using Sancuso.

Skin reactions. Skin reactions can happen just at the patch application site or outside the patch application site. Tell your healthcare provider if you get any redness, rashes, bumps, blisters or itching at the patch application site, and especially if they spread outside the place where the patch was or if they appear outside the patch application site. You may need to stop using Sancuso.

Common side effects of Sancuso are:

constipation

headache.

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 Sancuso. 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 Sancuso?

Keep Sancuso in the package it comes in.

Store Sancuso at 20-25°C (68-77°F).

Keep Sancuso out of the reach of children.

General information about Sancuso

Medicines are sometimes prescribed for conditions that are not mentioned in Patient Information leaflets. Do not use Sancuso for a condition for which it is not prescribed. Do not give Sancuso to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet summarizes the most important information about Sancuso. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about Sancuso that is written for health professionals.

For more information, go to www.Sancuso.com or call 1-800-Sancuso.

Patient Instructions for Applying Sancuso

When do I apply the Sancuso patch?

Apply Sancuso at least 1 day (24 hours) before your scheduled chemotherapy treatment.

You may apply Sancuso up to 2 days (48 hours) before your scheduled chemotherapy.

Wear the patch all the time during your chemotherapy.

Sancuso may be worn for up to 7 days, depending on how long your chemotherapy treatment lasts (up to 5 days).

Remove the patch at least 1 day (24 hours) after your chemotherapy is finished.

Keep the patch covered, such as under clothing, while you are wearing it to avoid a skin reaction to sunlight or sunlamps. Keep the skin where Sancuso was applied (application site) covered up for another 10 days after the patch is taken off to prevent a skin reaction. See "What should I avoid while using Sancuso?"

Where do I apply the Sancuso patch?

Apply Sancuso to a clean, dry, healthy area of skin on the outside part of your upper arm.

The area you choose should not be oily, recently shaved or have any skin problems such as being damaged (cut or scraped) or irritated (redness or a rash).

Do not apply Sancuso to areas that have been treated with creams, oils, lotions, powders or other skin products that could keep the patch from sticking well to your skin.

How do I apply the Sancuso patch?

The Sancuso patch comes inside a pouch which is inside the carton.

Do not remove the patch from the pouch until you are ready to use it.

Do not cut the Sancuso patch into pieces.

Remove the pouch from the carton.

Tear the pouch open using the slit provided, and remove the patch. Each pouch contains one Sancuso patch stuck onto a rigid plastic film, and a separate thin, clear protective liner.

Remove the thin, clear protective liner to expose the printed side of the patch. Throw away the liner. The protective liner is only included in the pouch to separate the patch from the inside of the pouch, and is not part of the patch.

The unprinted, sticky side of the patch is covered by a two-piece rigid plastic film. Bend the patch in the middle and remove one half of the rigid plastic film. Be careful not to stick the patch to itself and avoid touching the sticky side of the patch.

While holding the remaining half of the rigid plastic film, apply the patch to your skin. Remove the second half of the rigid plastic film and press the whole patch firmly in place with your fingers and smooth down. Press firmly making sure it sticks well to the skin, especially around the edges.

Wash your hands right away after applying the patch to remove any medicine that may have stuck to your fingers.

Keep the patch in place for the whole time you are having chemotherapy. Remove the patch at least 1 day (24 hours) after your chemotherapy is finished. The patch can be worn for up to 7 days, depending on the number of days your chemotherapy treatment lasts.

Do not re-use the patch after you remove it. See below for instructions on the right way to remove and throw away the patch.

What to do if the Sancuso patch does not stick well?

If the patch does not stick well, you may use surgical bandages or medical adhesive tape to keep the patch in place. Place tape or bandages on the edges of the patch. Do not completely cover the patch with bandages or tape and do not wrap completely around your arm. If the patch comes more than half off or it becomes damaged see your healthcare provider.

Can I bathe or shower while wearing Sancuso?

You can continue to shower and wash normally while wearing the Sancuso patch. It is not known how other activities, for example swimming, strenuous exercise or using a sauna or whirlpool, may affect Sancuso. Avoid these activities while wearing Sancuso.

How do I remove and dispose of Sancuso?

When you remove the patch, peel it off gently.

The used patch will still contain some of the medicine. After removing the used Sancuso patch, fold it in half so that the sticky side sticks to itself. Throw away the Sancuso patch in the garbage, out of the reach of children and pets. Do not re-use the patch.

After removing the patch you may find some adhesive is left on your skin. Gently wash the area with soap and water to remove it. Do not use alcohol or other dissolving liquids, such as nail polish remover. These may cause skin irritation.

Wash your hands after handling the patch.

You may see mild redness on the skin where the patch is removed. This redness should go away within three days. If redness continues, tell your healthcare provider.

What are the ingredients in Sancuso?

Active ingredient: granisetron.

Inactive ingredients: acrylate-vinylacetate copolymer, polyester, titanium dioxide, polyamide resin and polyethylene wax.

Manufactured by:

Aveva Drug Delivery Systems Inc., Miramar, FL 33025

Manufactured for:

ProStrakan Inc., Bedminster, NJ 07921

Sancuso and ProStrakan are trademarks owned by the ProStrakan group of companies

Revised: 07/2008

PRINCIPAL DISPLAY PANEL

NDC 42747-726-01

Sancuso®

(Granisetron Transdermal System)

3.1 mg/24 hours

Rx Only

7 day patch

Each 52 cm2 patch contains 34.3 mg of granisetron in an acrylate-vinylacetate copolymer adhesive

1 patch

www.Sancuso.com

Sancuso
granisetron patch

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	42747-726
Route of Administration	TRANSDERMAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GRANISETRON (GRANISETRON)	GRANISETRON	3.1 mg in 24 h

Inactive Ingredients
Ingredient Name	Strength
No Inactive Ingredients Found

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	42747-726-01	1 POUCH In 1 CARTON	contains a POUCH
1		1 PATCH In 1 POUCH	This package is contained within the CARTON (42747-726-01) and contains a PATCH
1		168 h In 1 PATCH	This package is contained within a POUCH and a CARTON (42747-726-01)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA022198	09/12/2008

Labeler - ProStrakan, Inc. (014778321)

Establishment
Name	Address	ID/FEI	Operations
Aveva Drug Delivery Systems, Inc.		783982093	manufacture

Revised: 09/2011ProStrakan, Inc.

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Nausea/Vomiting, Chemotherapy Induced

Saturday, July 14, 2012

Su-Tuss HD Elixir

Generic Name: guaifenesin, hydrocodone, and pseudoephedrine (gwye FEN e sin, HYE droe KOE done, SOO doe ee FED rin)

Brand Names: Drituss HD, Dynex HD, Entex HC, Hydro-Tuss XP, Hydrotussin HD, Nalex Expectorant, Poly-Tussin XP, Pseudatex HC, Su-Tuss HD Elixir, Tussgen Expectorant, Vanacon

What is Su-Tuss HD Elixir (guaifenesin, hydrocodone, and pseudoephedrine)?

Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.

Hydrocodone is a narcotic. It is a pain reliever and a cough suppressant.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of guaifenesin, hydrocodone, and pseudoephedrine is used to treat cough and nasal congestion, and to reduce chest congestion caused by the common cold, infections, or allergies.

Guaifenesin, hydrocodone, and pseudoephedrine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Su-Tuss HD Elixir (guaifenesin, hydrocodone, and pseudoephedrine)?

Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Hydrocodone may be habit-forming and should be used only by the person this medicine was prescribed for. Keep the medication in a secure place where others cannot get to it. Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body. Do not use any other over-the-counter cold, allergy, or cough medicine without first asking your doctor or pharmacist. Guaifenesin and pseudoephedrine are contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of a certain drug.

What should I discuss with my healthcare provider before taking Su-Tuss HD Elixir (guaifenesin, hydrocodone, and pseudoephedrine)?

Do not use this medication if you are allergic to guaifenesin, hydrocodone, or pseudoephedrine, or to other decongestants, diet pills, stimulants, or ADHD medications. Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body. Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. This medication should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Before taking guaifenesin, hydrocodone, and pseudoephedrine, tell your doctor if you are allergic to any drugs, or if you have:

asthma, COPD, sleep apnea, or other breathing disorders;

heart disease or high blood pressure;

diabetes;

a thyroid disorder;

liver or kidney disease;

a seizure disorder;

Addison's disease or other adrenal gland disorders;

enlarged prostate, urination problems;

mental illness; or

a history of drug or alcohol addiction.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.

FDA pregnancy category C. This medication may be harmful to an unborn baby, and could cause addiction or withdrawal symptoms in a newborn. Tell your doctor if you are pregnant or plan to become pregnant during treatment. This medication may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.

How should I take Su-Tuss HD Elixir (guaifenesin, hydrocodone, and pseudoephedrine)?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children. Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time.

Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication. Take guaifenesin, hydrocodone, and pseudoephedrine with food if it upsets your stomach. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

Store this medicine at room temperature, away from heat, light, and moisture.

Keep track of how much of this medicine has been used from each new bottle. Hydrocodone is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

What happens if I miss a dose?

Since cough or cold medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, dizziness, and feeling restless or nervous.

What should I avoid while taking Su-Tuss HD Elixir (guaifenesin, hydrocodone, and pseudoephedrine)?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol while you are taking this medicine.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Do not use any other over-the-counter cold, allergy, or cough medicine without first asking your doctor or pharmacist. Guaifenesin and pseudoephedrine are contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains guaifenesin or pseudoephedrine.

Su-Tuss HD Elixir (guaifenesin, hydrocodone, and pseudoephedrine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking this medication and call your doctor at once if you have any of these serious side effects:

fast, pounding, or uneven heartbeat;

severe dizziness, anxiety, restless feeling, or nervousness;

easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or

increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure).

Less serious side effects may include:

dizziness or headache;

feeling excited or restless;

sleep problems (insomnia);

nausea, vomiting, or stomach upset;

mild loss of appetite;

warmth, tingling, or redness under your skin; or

skin rash or itching.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Su-Tuss HD Elixir (guaifenesin, hydrocodone, and pseudoephedrine)?

Before taking guaifenesin, hydrocodone, and pseudoephedrine, tell your doctor if you are using any of the following drugs:

methyldopa (Aldomet);

medicines to treat high blood pressure;

a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others; or

an antidepressant such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others.

This is not a complete list and there may be other drugs that can affect guaifenesin, hydrocodone, and pseudoephedrine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Su-Tuss HD Elixir resources

Su-Tuss HD Elixir Drug Interactions
Su-Tuss HD Elixir Support Group
0 Reviews for Su-Tuss HD - Add your own review/rating

Compare Su-Tuss HD Elixir with other medications

Cough and Nasal Congestion

Where can I get more information?

Your pharmacist can provide more information about guaifenesin, hydrocodone, and pseudoephedrine.

NRS-Nasal Relief

Generic Name: oxymetazoline (Nasal route)

ox-i-me-TAZ-oh-leen

Commonly used brand name(s)

In the U.S.

4-Way Long Lasting

Afrin

Duramist Plus

Duration

Genasal

Mucinex Full Force

Mucinex Moisture Smart

Nasacon

Nasin

Neo-Synephrine 12 Hour

Nostrilla

NRS-Nasal Relief

Sinarest Nasal

Vicks Sinex 12 Hour

Available Dosage Forms:

Solution

Spray

Therapeutic Class: Decongestant

Chemical Class: Imidazoline

Uses For NRS-Nasal Relief

Oxymetazoline is used for the temporary relief of nasal (of the nose) congestion or stuffiness caused by hay fever or other allergies, colds, or sinus trouble.

This medicine may also be used for other conditions as determined by your doctor.

This medicine is available without a prescription.

Before Using NRS-Nasal Relief

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Children may be especially sensitive to the effects of oxymetazoline. This may increase the chance of side effects during treatment.

Geriatric

Many medicines have not been tested in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information about the use of oxymetazoline in the elderly.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of oxymetazoline

This section provides information on the proper use of a number of products that contain oxymetazoline. It may not be specific to NRS-Nasal Relief. Please read with care.

To use the nose drops:

Blow your nose gently. Tilt the head back while standing or sitting up, or lie down on a bed and hang the head over the side. Place the drops into each nostril and keep the head tilted back for a few minutes to allow the medicine to spread throughout the nose.

Rinse the dropper with hot water and dry with a clean tissue. Replace the cap right after use.

To avoid spreading the infection, do not use the container for more than one person.

To use the nose spray:

Blow your nose gently. With the head upright, spray the medicine into each nostril. Sniff briskly while squeezing the bottle quickly and firmly. For best results, spray once into each nostril, wait 3 to 5 minutes to allow the medicine to work, then blow the nose gently and thoroughly. Repeat until the complete dose is used.

Rinse the tip of the spray bottle with hot water, taking care not to suck water into the bottle, and dry with a clean tissue. Replace the cap right after use.

To avoid spreading the infection, do not use the container for more than one person.

Use this medicine only as directed. Do not use more of it, do not use it more often, and do not use it for longer than 3 days without first checking with your doctor. To do so may make your runny or stuffy nose worse and may also increase the chance of side effects.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For nasal dosage form (nose drops or spray):
- For nasal congestion or stuffiness:
  - Adults and children 6 years of age and older—Use 2 or 3 drops or sprays of 0.05% solution in each nostril every ten to twelve hours. Do not use more than two times in twenty four hours.
  - Children up to 6 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

NRS-Nasal Relief Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Symptoms of too much medicine being absorbed into the body

Blurred vision

fast, irregular, or pounding heartbeat

headache, dizziness, drowsiness, or lightheadedness

high blood pressure

nervousness

trembling

trouble in sleeping

weakness.

Increase in runny or stuffy nose

The above side effects are more likely to occur in children because there is a greater chance in children that too much of this medicine may be absorbed into the body.

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Burning, dryness, or stinging inside of nose

increase in nasal discharge

sneezing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More NRS-Nasal Relief resources

NRS-Nasal Relief Use in Pregnancy & Breastfeeding
NRS-Nasal Relief Drug Interactions
NRS-Nasal Relief Support Group
12 Reviews for NRS-Nasal Relief - Add your own review/rating

Compare NRS-Nasal Relief with other medications

Nasal Congestion

Friday, July 13, 2012

Senatec Topical application

Generic Name: lidocaine (Topical application route)

LYE-doe-kane

Commonly used brand name(s)

In the U.S.

Anestacon

Burnamycin

Burn-O-Jel

Lida Mantle

Lidoderm

LMX 4

LMX 5

Senatec

Solarcaine Cool Aloe

Topicaine

Xylocaine

In Canada

Solarcaine First Aid Lidocaine Spray

Solarcaine Lidocaine First Aid Spray

Available Dosage Forms:

Foam

Dressing

Gel/Jelly

Spray

Cream

Solution

Patch, Extended Release

Ointment

Lotion

Aerosol Liquid

Therapeutic Class: Anesthetic, Local

Chemical Class: Amino Amide

Uses For Senatec

Lidocaine is used on different parts of the body to cause numbness or loss of feeling for patients having certain medical procedures. It is also used to relieve pain and itching caused by conditions such as sunburn or other minor burns, insect bites or stings, poison ivy, poison oak, poison sumac, minor cuts, or scratches.

Lidocaine belongs to a group of medicines known as topical local anesthetics. It deadens the nerve endings in the skin. This medicine does not cause unconsciousness as general anesthetics do when used for surgery.

This medicine is available only with your doctor's prescription.

Before Using Senatec

Allergies

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of lidocaine in children. However, because of this medicine's toxicity, it should be used with caution, after other medicines have been considered or found ineffective. Recommended doses should not be exceeded, and the patient should be carefully monitored during therapy.

Geriatric

No information is available on the relationship of age to the effects of lidocaine in geriatric patients. However, because of this medicine's toxicity, it should be used with caution, after other medicines have been considered or found ineffective. Recommended doses should not be exceeded, and the patient should be carefully monitored during therapy.

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Proper Use of lidocaine

This section provides information on the proper use of a number of products that contain lidocaine. It may not be specific to Senatec. Please read with care.

Use this medicine exactly as directed by your doctor. Do not use it for any other condition without first checking with your doctor. This medicine may cause unwanted effects if it is used too much, because more of it is absorbed into the body through the skin.

A nurse or other trained health care professional will give you this medicine before having a medical procedure.

Wash your hands with soap and water before and after using this medicine.

Unless otherwise directed by your doctor, do not apply this medicine to open wounds, burns, or broken or inflamed skin.

This medicine should only be used for problems being treated by your doctor. Check with your doctor before using it for other problems, especially if you think that an infection may be present. This medicine should not be used to treat certain kinds of skin infections or serious problems, such as severe burns.

Be careful not to get any of this medicine in your eyes, because it can cause severe eye irritation. If any of the medicine does get in the eyes, wash the eyes with water for at least 15 minutes and check with your doctor right away.

Dosing

For topical dosage form (ointment):
- For pain and itching caused by minor skin conditions:
  - Adults—Apply to the affected area three or four times a day. The largest amount of ointment that should be used in a single application is 5 grams. If you use the 5% ointment, this is about 6 inches of ointment from the tube.
  - Children—Dose is based on body weight and must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Senatec

It is very important that your doctor check you closely for any problems or unwanted effects that may be caused by this medicine.

If your symptoms do not improve within a few days or if they become worse, check with your doctor.

After applying this medicine to the skin of your child, watch the child carefully to make sure that he or she does not get any of the medicine in the eyes or mouth. Lidocaine can cause serious side effects, especially in children, if it gets into the mouth and is swallowed.

Stop using this medicine and check with your doctor right away if you have a skin rash, burning, stinging, swelling, or irritation of your skin.

If you are using this medicine in the mouth or throat, do not eat or drink anything for one hour after using it. When this medicine is applied to these areas, it may cause swallowing and choking problems. Do not chew gum or food while your mouth or throat feels numb after you use this medicine. You may accidentally bite your tongue or the inside of your cheeks.

Do not use cosmetics or other skin care products on the treated skin areas.

Senatec Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Incidence not known

Blurred vision

chest pain or discomfort

cold, clammy, or pale skin

confusion

cough

difficult or troubled breathing

difficulty with swallowing

dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly

false or unusual sense of well-being

fast heartbeat

fear

hives or welts

irregular, fast or slow, or shallow breathing

itching

lightheadedness, dizziness, or fainting

mood or mental changes

nervousness

no blood pressure or pulse

pale or blue lips, fingernails, or skin

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

redness of the skin

seizures

shakiness in the legs, arms, hands, or feet

shortness of breath

skin rash

sleepiness

slow heart rate

slow or irregular heartbeat

stopping of heart

swelling

tightness in the chest

trembling or shaking of the hands or feet

twitching

unconsciousness

unusual tiredness or weakness

weakness

wheezing

Incidence not known

Cold or numbness

continuing ringing or buzzing or other unexplained noise in the ears

double vision

hearing loss

heat sensation

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

See also: Senatec Topical application side effects (in more detail)

Compare Senatec Topical application with other medications

Anal Itching
Anesthesia
Burns, External
Hemorrhoids
Pain
Pruritus
Sunburn

Thursday, July 12, 2012

Neurolite

Dosage Form: injection

Neurolite Description

This kit formulation consists of two nonradioactive vials: Vial A contains bicisate dihydrochloride (N, N'-1,2-ethylenediylbis-L-cysteine diethyl ester dihydrochloride) and a reducing agent as a lyophilized solid and vial B contains a buffer solution. Both vials are sterile and non-pyrogenic.

Vial A –
Bicisate dihydrochloride (ECD•2HCl)	0.9 mg
Edetate disodium, dihydrate	0.36 mg
Mannitol	24 mg
Stannous chloride, dihydrate, theoretical
(SnCl2•2H2O)	72 µg
Stannous chloride, dihydrate,
minimum (SnCl2•2H2O)	12 µg
Total Tin, (stannous and stannic), dihydrate
(as SnCl2•2H2O)	83 µg

The contents of vial A are lyophilized and stored under nitrogen. The pH of the solution before lyophilization is 2.7 ± 0.25. This vial is stored at 15-25°C. Protect from light.

Vial B –
Sodium phosphate dibasic heptahydrate		4.1 mg
Sodium phosphate monobasic monohydrate		0.46 mg
Water for Injection	qs	1 mL

The contents of vial B are stored under air. The pH of the solution is 7.6 ± 0.4. This vial is stored at 15-25°C.

This drug is administered by intravenous injection for diagnostic use after reconstitution with sterile, non-pyrogenic, oxidant-free Sodium Pertechnetate Tc99m Injection. The precise structure of the Technetium complex is [N, N'-ethylenedi-L-cysteinato(3-)]oxo[99mTc] technetium (V), diethyl ester.

Physical Characteristics

Technetium Tc99m decays by isomeric transition with a physical half-life of 6.02 hrs1. Photons useful for the detection and imaging studies are listed in Table 1.

Table 1. Principle Radiation Emission Data
Radiation	Mean % / Disintegration	Mean Energy (KeV)
1Kocher, David C., “Radioactive Decay Data Tables”, DOE/TIC 11026, 108 (1981).
Gamma-2	89.07	140.5

External Radiation

The specific gamma ray constant for Tc99m is 5.4 microcoulombs/kg-MBq-hr (0.78R/mCi-hr) at 1cm. The first half value layer is 0.017cm of lead (Pb). Relative attenuation of the radiation emitted by this radionuclide results from the interposition of various thicknesses of Pb. The corresponding attenuation is shown in Table 2. To facilitate control of the radiation exposure from MBq (mCi) amounts of this radionuclide, a 0.25 cm thickness of Pb will attenuate the radiation by a factor of 1,000.

Table 2. Radiation Attenuation by Lead Shielding
Shield Thickness (Pb) cm	Coefficient of Attenuation
0.017	0.5
0.08	10-1
0.16	10-2
0.25	10-3
0.33	10-4

To correct for the physical decay of this radionuclide, the fractions that remain at selected time intervals after the time of calibration are shown in Table 3.

Table 3. Physical Decay Chart; Technetium Tc99m Half-Life 6.02 Hours
Hours	Fraction Remaining	Hours	Fraction Remaining
*Calibration Time
0*	1.000	7	.447
1	.891	8	.398
2	.794	9	.355
3	.708	10	.316
4	.631	11	.282
5	.562	12	.251
6	.501

Neurolite - Clinical Pharmacology

General

Neurolite®, Kit for the Preparation of Technetium Tc99m Bicisate for Injection forms a stable, lipophilic complex which can cross the blood brain barrier. Technetium Tc99m Bicisate crosses intact cell membranes and the intact blood brain barrier by passive diffusion. Five percent of the injected dose remains in the blood at one hour. The amount of Technetium Tc99m Bicisate in the brain is stable until about 6 hours. After background clearance, images of the brain can be obtained from 10 minutes to 6 hours after injection. Optimal images occur 30-60 minutes after injection. Technetium Tc99m Bicisate is cleared primarily by the kidneys.

Pharmacokinetics

In a study in 16 normals (13 men and 3 women, mean age of 31 ± 10 years; mean weight of 72 ± 11 kg), the pharmacokinetic profile in blood best fits a three compartment model with half-lives of 43 seconds, 49.5 minutes and 533 minutes. The highest concentration of radioactivity measured in blood was found at 0.5 minutes after intravenous injection and was 13.9% of the injected dose. Technetium Tc99m Bicisate and its major metabolites are not protein-bound.

Metabolism

Technetium Tc99m Bicisate is metabolized by endogenous enzymes to the mono- and di-acids of Technetium Tc99m Bicisate that can be detected in blood and urine. No studies have been performed to compare the concentration of Technetium Tc99m Bicisate or its metabolites in normal, ischemic and infarcted cells.

Technetium Tc99m Bicisate is excreted primarily through the kidneys. Within two hours, 50% of the injected dose is excreted and by 24 hours, 74% is found in urine. It is not known whether the parent drug molecule or its metabolites are dialyzable. Fecal excretion accounts for 12.5% of the injected dose after 48 hours.

Pharmacodynamics

Localization of the parent compound in the brain in part depends upon both perfusion of the region and uptake of Technetium Tc99m Bicisate by the cell. Once in the brain cells, the parent compound is metabolized to polar, less diffusible compounds. Studies in 21 normal volunteers show cellular uptake of 4.8-6.5% of the injected dose at five minutes after injection. The degree of cell function or viability needed for uptake is not known. The degree of cell function or viability needed for metabolism of the parent compound to the less diffusible compounds has not been determined. The likelihood that the metabolic pathway is damaged by ischemia is not known. Whether or not and to what extent uptake correlates with viability or function is not known.

The pharmacodynamics of Neurolite have not been evaluated for differences associated with age, gender, weight and liver or renal impairment. It is not known whether dosage adjustments for these factors are needed.

Clinical Trials

Two clinical trials were performed in a total of 359 subjects (273 with stroke, 86 normal). Of these 56% were men and 44% were women. The mean age was 60.2 years (range 23 to 92 years). Subjects were 87.2% Caucasian, 8.4% Black, 2.2% Hispanic, 1.7% Oriental and 0.6% other.

Eligible patients had a confirmed stroke. Patients with other brain lesions were not evaluated. Subjects received Neurolite (mean dose range 10-30mCi) and underwent SPECT imaging and either CT or MRI scans within 0-30 days of the onset of signs and symptoms of stroke. CT or MRI and the administration of Neurolite occurred at different and variable times after the onset of a stroke. The effect of the timing on the accuracy of the images cannot be evaluated. The Neurolite scan results were blindly compared to unblinded CT/MRI results, the short standardized neurologic examination (SSNE) and the final diagnosis (e.g., the overall combined clinical impression with CT/MRI and SSNE).

In these studies, at least one of three blinded readers made a diagnosis of stroke in 190 (85%) of the Neurolite SPECT studies and in 238 (88%) CT/MRI studies. The Neurolite and CT/MRI imaging results versus the SSNE and final diagnosis were comparable. Neurolite had 11 false positive and 34 false negatives. CT/MRI had 0 false positive and 31 false negatives. Both Neurolite and CT/MRI missed strokes (true positives) that were identified by the other modality. The majority of the false negatives in either modality were within 15 days of the clinical stroke.

The trials were not designed to determine when Neurolite or CT/MRI studies could become positive in relationship to the time of the stroke. The relevance of the Neurolite scan results to the prediction of neurologic function or brain cell viability is not known. Also, not known is the ability of the Neurolite findings to distinguish between a stroke and pre-existing CNS lesions. Neurolite should not be used for these purposes. (See Pharmacodynamics Section).

INDICATIONS

Neurolite single photon emission computerized tomography (SPECT) is indicated as an adjunct to conventional CT or MRI imaging in the localization of stroke in patients in whom stroke has already been diagnosed.

Neurolite is not indicated for assessment of functional viability of brain tissue. Also, Neurolite is not indicated for distinguishing between stroke and other brain lesions.

Contraindications

None known.

Warnings

None known.

Precautions

General

USE WITH CAUTION IN PATIENTS WITH RENAL OR HEPATIC IMPAIRMENT. TECHNETIUM Tc99m BICISATE IS ELIMINATED PRIMARILY BY RENAL EXCRETION. WHETHER TECHNETIUM Tc99m BICISATE IS DIALYZABLE IS NOT KNOWN. DOSE ADJUSTMENTS IN PATIENTS WITH RENAL OR HEPATIC IMPAIRMENT HAVE NOT BEEN STUDIED.

Patients should be encouraged to drink fluids and to void frequently during the 2-6 hours immediately after injection to minimize radiation dose to the bladder and other target organs.

Contents of the vials are intended only for use in the preparation of Technetium Tc99m Bicisate and are not to be administered directly to the patient without first undergoing the preparation procedure.

The contents of each vial are sterile and non-pyrogenic. To maintain sterility, aseptic technique must be used during all operations in the manipulations and administration of Neurolite.

Technetium Tc99m Bicisate should be used within six hours of the time of preparation.

As with any other radioactive material, appropriate shielding should be used to avoid unnecessary radiation exposure to the patient, occupational workers, and other people.

Radiopharmaceuticals should be used only by physicians who are qualified by specific training in the safe use and handling of radionuclides.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies have not been conducted to evaluate carcinogenic potential or effects on fertility. When tested in vitro, Neurolite prepared with decayed generator eluate induced unscheduled DNA synthesis in rat hepatocytes and caused an increased frequency of sister chromatid exchanges in CHO cells; but, it did not induce chromosome aberrations in human lymphocytes or cause gene mutations in the Ames test or in a CHO/HGPRT test. Unreacted bicisate dihydrochloride increased the apparent rate of gene mutation of the TA 97a strain of S. typhimurium in the Ames test; but, it did not demonstrate clastogenic activity in an in vivo micronucleus assay in mice.

Pregnancy: Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with Technetium Tc99m Bicisate. It is also not known whether Technetium Tc99m Bicisate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Therefore, Technetium Tc99m Bicisate should not be administered to a pregnant woman unless the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Technetium Tc99m Pertechnetate can be excreted in human milk. Therefore, formula should be substituted for breast milk until the technetium has cleared from the body of the nursing woman.

Pediatric Use

Safety and effectiveness in the pediatric population has not been established.

Geriatric Use

Of 808 patients in clinical studies of Neurolite®, 421 patients were 65 or older and 190 were 75 or older. Based on the evaluation of the frequency of adverse events and review of vital signs and laboratory data, no overall differences in safety were observed between these subjects and younger subjects. Although reported clinical experience has not identified differences in response between elderly and younger patients, greater sensitivity of some older individuals cannot be ruled out.

Neurolite® 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 assess renal function prior to administration.

Adverse Reactions

In clinical trials, Neurolite has been administered to 1063 subjects (255 normals, 808 patients). Of these, 566 (53%) were men and 494 (47%) were women. The mean age was 58 years (range 17 to 92 years). In the 808 patients, who had experienced neurologic events, there were 11 (1.4%) deaths, none of which were clearly attributed to Neurolite.

A total of 60 subjects experienced adverse reactions; the adverse reaction rates were comparable in the <65 year, and the >65 year age groups.

The following adverse effects were observed in ≤ 1% of the subjects: headache, dizziness, seizure, agitation/anxiety, malaise/somnolence, parosmia, hallucinations, rash, nausea, syncope, cardiac failure, hypertension, angina, and apnea/cyanosis.

In clinical trials of 197 patients, there were inconsistent changes in the serum calcium and phosphate levels. The cause of the changes has not been identified and their frequency and magnitude have not been clearly characterized. None of the changes required medical intervention.

Neurolite Dosage and Administration

Before administration, a patient should be well hydrated. After administration, the patient should be encouraged to drink fluids liberally and to void frequently.

The recommended dose range for intravenous administration for a 70 kg patient is 370-1110 MBq (10-30mCi). Dose adjustments for age, weight, gender or renal or hepatic impairment have not been studied.

The dose for the patient should be measured by a suitable radioactivity calibration system immediately before administration to the patient. Radiochemical purity should be checked before administration to the patient.

Neurolite, like other parenteral drug products, should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Preparations containing particulate matter or discoloration should not be administered. They should be disposed of in a safe manner, in compliance with all applicable regulations.

Prior to reconstitution, vial A and vial B are stored at 15-25°C. Protect vial A from light.

Store at controlled room temperature after preparation.

Aseptic techniques and effective shielding should be employed in withdrawing doses for administration to patients. Waterproof gloves and effective shielding should be worn when handling the product.

RADIATION DOSIMETRY

The radiation doses to organs and tissues of an average patient (70 kg) for Technetium Tc99m Bicisate injected intravenously for 370 MBq (10 mCi) are shown in Table 4 and for 1110 MBq (30 mCi) are shown in Table 5.

Table 4. Radiation Absorbed Doses From 370 MBq (10 mCi) of Technetium Tc99m Bicisate
	Estimated Absorbed Radiation Dose
	2.0 Hr. Void		4.8 Hr. Void
	mGy/	rads/	mGy/	rads/
	370 MBq	10 mCi	370 MBq	10 mCi
Organ
Bone Surfaces	1.26	0.13	1.41	0.14
Brain	2.04	0.20	2.04	0.20
Gallbladder Wall	9.25	0.91	9.25	0.92
Intestine Wall
(Lower Large)	4.81	0.47	5.55	0.55
Intestine (Small)	3.48	0.35	3.70	0.38
Intestine Wall
(Upper Large)	5.92	0.61	6.29	0.63
Kidneys	2.70	0.27	2.74	0.27
Liver	1.96	0.20	2.00	0.20
Lungs	0.74	0.08	0.74	0.08
Ovaries	2.00	0.22	2.96	0.30
Red Marrow	0.89	0.09	1.00	0.10
Testes	0.81	0.08	1.33	0.13
Thyroid	1.30	0.13	1.30	0.13
Urinary Bladder Wall	11.10	1.10	27.01	2.70
Total Body	0.89	0.09	1.07	0.11

Table 5. Radiation Absorbed Doses From 1110 MBq (30 mCi) of Technetium Tc99m Bicisate
	Estimated Absorbed Radiation Dose
	2.0 Hr. Void		4.8 Hr. Void
	mGy/	rads/	mGy/	rads/
	1110 MBq	30 mCi	1110 MBq	30 mCi
Radiation dosimetry calculations performed by Radiation Internal Dose Information Center, Oak Ridge Institute for Science and Education, PO Box 117, Oak Ridge, TN 37831-0117 (865) 576-3448.
Organ
Bone Surfaces	3.77	0.39	4.22	0.42
Brain	6.11	0.61	6.11	0.61
Gallbladder Wall	27.75	2.73	27.75	2.76
Intestine Wall
(Lower Large)	14.43	1.41	16.65	1.65
Intestine (Small)	10.43	1.05	11.10	1.14
Intestine Wall
(Upper Large)	17.76	1.83	18.87	1.89
Kidneys	8.10	0.81	8.21	0.81
Liver	5.88	0.60	5.99	0.60
Lungs	2.22	0.23	2.22	0.23
Ovaries	5.99	0.66	8.88	0.90
Red Marrow	2.66	0.26	3.00	0.29
Testes	2.44	0.24	4.00	0.39
Thyroid	3.89	0.39	3.89	0.39
Urinary Bladder Wall	33.33	3.33	81.03	8.10
Total Body	2.66	0.27	3.22	0.33

INSTRUCTIONS FOR PREPARATION OF TECHNETIUM Tc99m BICISATE

Preparation of the Technetium Tc99m Bicisate from the Neurolite®, Kit for the Preparation of Technetium Tc99m Bicisate Injection, is done by the following aseptic procedure:

Prior to adding the Sodium Pertechnetate Tc99m Injection to vial B (the liquid vial), write the estimated activity, date, and time of preparation in the space provided on the vial label. Then tear off a radiation symbol and attach it to the neck of the vial.

Waterproof gloves should be worn during the preparation procedure. Remove the plastic disc from both vials and swab the top of each vial closure with alcohol to disinfect the surface.

Place vial B in a suitable radiation shield appropriately labeled with date, time of preparation, volume and activity.

With a sterile shielded syringe, aseptically add 3.70 GBq (100 mCi) sterile, non-pyrogenic, oxidant-free Sodium Pertechnetate Tc99m Injection, in approximately 2.0 mL, to vial B. Without withdrawing the needle, remove an equal volume of air to maintain pressure within the vial.

With a sterile syringe, rapidly inject 3.0 mL of Sodium Chloride Injection (0.9%) into vial A (the lyophilized vial) to dissolve the contents. Without withdrawing the needle, remove an equal volume of air to maintain pressure within the vial. Shake the contents of the vial for a few seconds.

With another sterile syringe, immediately (within 30 seconds) withdraw 1.0 mL of vial A and inject it into vial B. Discard vial A immediately.

Swirl the contents of the vial B for a few seconds, and allow this mixture to stand for thirty (30) minutes at room temperature.

Examine the vial contents for particulates and discoloration prior to patient administration. If particulate matter and/or discoloration are seen, DO NOT USE.

Assay the reaction vial using a suitable radioactivity calibration system. Record the Technetium Tc99m concentration, total volume, assay time and date, expiration time and lot number on the vial shield label and affix the label to the shield.

Store the reaction vial containing the Technetium Tc99m Bicisate at controlled room temperature until use; at such time the product should be aseptically withdrawn. The vial contains no preservative.

Note: Adherence to the above product reconstitution instructions is recommended.

Product should be used within 6 hours of preparation.

DETERMINATION OF RADIOCHEMICAL PURITY

The preparation and quality control of the agent should follow the procedure shown below.

Materials for TLC Procedure

   Bakerflex silica gel IB-F, 2.5 x 7.5cm, Baker #4463-03

   Solvent system: Ethyl Acetate, HPLC grade

   Dose calibrator or gamma counter for measuring radioactivity

   Small chromatographic developing tank

   Syringe and shielded vials, as needed

TLC Procedure

Establish the radiochemical purity (RCP) of the final solution by the thin layer chromatography (TLC) using Baker-Flex silica gel IB-F plates and a solvent system of ethyl acetate. The RCP should be ≥90%.

Procedure– Using fresh ethyl acetate pour enough solvent into the developing tank to a depth of 3 to 4 mm. Seal the tank with Parafilm and allow 15 to 30 minutes for solvent equilibration. It is important to pre-equilibrate and preserve the integrity of the headspace in the chromatographic tank, otherwise unreproducible TLC results are obtained.

Note: Ethyl acetate is a skin/mucous membrane irritant and should be handled in a hood whenever possible.

With a pencil, draw a faint line across the TLC plate at heights of two (2) cm, four and one half (4.5) cm and seven (7) cm from the bottom of the TLC plate. Place approximately 5 µL of the final solution at the center of the 2 cm mark. This can be accomplished by using a syringe fitted with a 25 or 27 gauge needle and allowing a drop to form while holding the syringe in a vertical position. The diameter of the spot should not be greater than 10mm. Allow the spot to dry for 5 to 10 minutes, no longer.

Place the plate in the pre-equilibrated TLC tank and develop to the 7.0 cm line (about 15 minutes). Remove the plate and dry in a ventilated area.

Quantification – Cut the TLC plate at the 4.5 cm mark with scissors. Count the activity on each piece using a dose calibrator or a gamma counter. The top portion contains the Technetium Tc99m Bicisate and the bottom portion contains all radioimpurities.

Calculate the radiochemical purity using the following equation:

% Technetium Tc99m Bicisate = At x 100

At + Ab

Where: At = activity of the top piece and Ab = activity of the bottom piece.

How is Neurolite Supplied

Bristol-Myers Squibb Medical Imaging, Inc. Neurolite® Kit for the Preparation of Technetium Tc99m Bicisate for Injection, is supplied in kits of two (2) vials of A and two (2) vials of B (NDC # 11994-006-02); and five (5) vials of A and five (5) vials of B (NDC 11994-006-05). Included in each kit are one (1) package insert and twelve (12) radiation labels.

Prior to reconstitution, vial A and vial B are stored 15-25°C. Protect vial A from light.

Store at controlled room temperature after preparation.

Use within 6 hours of preparation.

This reagent kit is approved for distribution to persons licensed pursuant to the Code of Massachusetts Regulations 105 CMR 120.500 for the uses listed in 105 CMR 120.533 or under equivalent licenses of the U.S. Nuclear Regulatory Commission, Agreement States or Licensing States.

Distributed By

Bristol-Myers Squibb Medical Imaging

331 Treble Cove Road

N. Billerica, Massachusetts 01862

USA

For Ordering Tel: Toll Free 800-225-1572

All Other Business: 800-362-2668

(For Massachusetts and International, call 978-667-9531)

Printed in the U.S.A.

513073-0503

May 2003

Neurolite
bicisate dihydrochloride kit

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	11994-006

Packaging
#	NDC	Package Description	Multilevel Packaging
1	11994-006-02	2 KIT In 1 PACKAGE, COMBINATION	None
2	11994-006-05	5 KIT In 1 PACKAGE, COMBINATION	None

QUANTITY OF PARTS
Part #	Package Quantity	Total Product Quantity
Part 1	1 VIAL	1 VIAL in 1
Part 2	1 VIAL	1 MILLILITER in 1

Part 1 of 2

BICISATE DIHYDROCHLORIDE
bicisate dihydrochloride injection, powder, lyophilized, for solution

Product Information

Route of Administration	INTRAVENOUS	DEA Schedule

INGREDIENTS
Name (Active Moiety)	Type	Strength
Bicisate Dihydrochloride (Bicisate)	Active	0.9 MILLIGRAM In 1 VIAL
Edetate disodium, dihydrate	Inactive	0.36 MILLIGRAM In 1 VIAL
Mannitol	Inactive	24 MILLIGRAM In 1 VIAL
Stannous clhoride, dihydrate	Inactive	72 MICROGRAM In 1 VIAL

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1		1 VIAL In 1 VIAL	None

Part 2 of 2

BUFFER
buffer injection, powder, for solution

Product Information

Route of Administration	INTRAVENOUS	DEA Schedule

INGREDIENTS
Name (Active Moiety)	Type	Strength
Sodium Phosphate monobasic monohydrate	Inactive	0.46 MILLIGRAM In 1 MILLILITER

Thursday, July 19, 2012

Sancuso

Indications and Usage for Sancuso

Sancuso Dosage and Administration

Adults

Dosage Forms and Strengths

Contraindications

Warnings and Precautions

Gastrointestinal

Skin Reactions

Exposure to Sunlight

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Clinical Trials Experience

Granisetron Experience

Drug Interactions

USE IN SPECIFIC POPULATIONS

Pregnancy

Nursing Mothers

Pediatric Use

Geriatric Use

Renal Failure or Hepatically-Impaired Patients

Overdosage

Sancuso Description

Sancuso - Clinical Pharmacology

Mechanism of Action

Pharmacodynamics

Pharmacokinetics

Nonclinical Toxicology

Carcinogenesis, Mutagenesis and Impairment of Fertility

Phototoxicity

Clinical Studies

How Supplied/Storage and Handling

Patient Counseling Information

Gastrointestinal

Skin Reactions

Exposure to Sunlight

FDA-Approved Patient Labeling

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Saturday, July 14, 2012

Su-Tuss HD Elixir

What is Su-Tuss HD Elixir (guaifenesin, hydrocodone, and pseudoephedrine)?

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What should I discuss with my healthcare provider before taking Su-Tuss HD Elixir (guaifenesin, hydrocodone, and pseudoephedrine)?

How should I take Su-Tuss HD Elixir (guaifenesin, hydrocodone, and pseudoephedrine)?

What happens if I miss a dose?

What happens if I overdose?

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Su-Tuss HD Elixir (guaifenesin, hydrocodone, and pseudoephedrine) side effects

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NRS-Nasal Relief

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Before Using NRS-Nasal Relief

Allergies

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Friday, July 13, 2012

Senatec Topical application

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