Kaopectate

Pronunciation: BIZ-muth sub-sa-LIS-a-late
Generic Name: Bismuth Subsalicylate
Brand Name: Examples include Kaopectate and Pepto-Bismol

Kaopectate is used for:

Treating heartburn, upset stomach, indigestion, nausea, diarrhea, or symptoms associated with eating or drinking too much. It may be used to decrease the number of bowel movements and make the stool firmer. It may also be used to treat other conditions as determined by your doctor.

Kaopectate is a salicylate. The way that it works is not fully understood. It is thought to limit secretions in the digestive tract, reduce inflammation in the stomach and intestines, and inhibit the growth of certain bacteria and viruses that can cause intestinal tract diseases.

Do NOT use Kaopectate if:

• you are allergic to any ingredient in Kaopectate


• you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to aspirin or a nonsteroidal anti-inflammatory drug (NSAID) (eg, ibuprofen, naproxen, celecoxib)


• you have bleeding problems (eg, hemophilia), active bleeding ulcer, black or bloody stools, or Von Willebrand disease


• you are taking another salicylate medicine (eg, aspirin)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Kaopectate:

Some medical conditions may interact with Kaopectate. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have diabetes, gout, arthritis, fever, mucus in the stool, inflammation of the stomach, Kawasaki syndrome, kidney problems, chickenpox, the flu, or joint problems (in children), or if you are dehydrated


• if you have a history of stroke or a certain type of bulging blood vessel (aneurysm) in the brain

Some MEDICINES MAY INTERACT with Kaopectate. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Insulin, methotrexate, or valproic acid because actions and side effects may be increased by Kaopectate


• Angiotensin-converting enzyme (ACE) inhibitors (eg, lisinopril) or sulfinpyrazone because their effectiveness may be decreased by Kaopectate


• Anticoagulants (eg, warfarin) because the risk of bleeding may be increased by Kaopectate


• Salicylates (eg, aspirin) because the risk of side effects or toxic effects may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Kaopectate may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Kaopectate:

Use Kaopectate as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Kaopectate may be taken with or without food.


• Do not take tetracyclines (eg, doxycycline) within 2 hours before or after taking Kaopectate.


• Use Kaopectate exactly as directed on the package, unless instructed differently by your doctor.


• Drinking extra fluids while you are taking Kaopectate is recommended. Check with your doctor for instructions.


• If you miss a dose of Kaopectate and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Kaopectate.

Important safety information:

• If the packaging blister is torn or open, do not use that particular tablet.


• Do not exceed the recommended dose or take Kaopectate for longer than 48 hours without checking with your doctor. If your symptoms do not improve within 48 hours or if they become worse or you develop a fever, check with your doctor.


• Kaopectate may color the tongue or stool gray or black. This is a temporary and harmless effect.


• Do not give Kaopectate to a child or teenager who has chickenpox, the flu, or another viral infection. Use of Kaopectate for treating the symptoms of a viral infection may cause a serious illness called Reye syndrome.


• Use Kaopectate with extreme caution in CHILDREN because they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Kaopectate during pregnancy. Kaopectate is excreted in breast milk. Do not breast-feed while taking Kaopectate.

Possible side effects of Kaopectate:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Temporary and harmless darkening of the tongue or stool.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fever; hearing loss; nausea; ringing in the ears; severe constipation; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Kaopectate side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include coma; confusion; dehydration; dizziness; new or worsening nausea; ringing in the ears; seizures; unusual bruising or bleeding; vomiting.

Proper storage of Kaopectate:

Store Kaopectate at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Keep Kaopectate out of the reach of children and away from pets.

General information:

• If you have any questions about Kaopectate, please talk with your doctor, pharmacist, or other health care provider.


• Kaopectate is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Kaopectate. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Kaopectate resources

• Kaopectate Side Effects (in more detail)
• Kaopectate Use in Pregnancy & Breastfeeding
• Kaopectate Drug Interactions
• Kaopectate Support Group
• 0 Reviews for Kaopectate - Add your own review/rating

• Kaopectate Advanced Consumer (Micromedex) - Includes Dosage Information


• Kaopectate Concise Consumer Information (Cerner Multum)


• Bismuth Subsalicylate Professional Patient Advice (Wolters Kluwer)

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Sertralin-ratiopharm

Sertralin ratiopharm may be available in the countries listed below.

Ingredient matches for Sertralin ratiopharm

Sertraline

Sertraline is reported as an ingredient of Sertralin ratiopharm in the following countries:

• Luxembourg

Sertraline hydrochloride (a derivative of Sertraline) is reported as an ingredient of Sertralin ratiopharm in the following countries:

• Austria


• Czech Republic


• Denmark


• Finland


• Germany


• Hungary


• Slovakia


• Sweden

International Drug Name Search

Granisetron

Dosage Form: tablet, film coated
 

Granisetron Description

Granisetron hydrochloride tablets contain Granisetron hydrochloride USP, an antinauseant and antiemetic agent. Chemically it is endo-N-(9-methyl-9-azabicyclo [3.3.1] non-3-yl)-1-methyl-1H-indazole-3-carboxamide hydrochloride with a molecular weight of 348.9 (312.4 free base). Its empirical formula is C18H24N4O•HCl, while its chemical structure is:

Granisetron hydrochloride USP is a white to off-white solid that is readily soluble in water and normal saline at 20ºC.

Each white to off-white film coated triangular shaped biconvex tablet contains 1.12 mg Granisetron hydrochloride USP equivalent to Granisetron, 1 mg. Inactive ingredients are: microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, hypromellose, magnesium stearate and opadry white.

The components of opadry white are hypromellose 6cP, titanium dioxide, polyethylene glycol 6000 and polysorbate 80.

Granisetron - Clinical Pharmacology

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 α1-, α2-, or β-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.

In most human studies, Granisetron has had little effect on blood pressure, heart rate or ECG. No evidence of an effect on plasma prolactin or aldosterone concentrations has been found in other studies.

Following single and multiple oral doses, Granisetron hydrochloride tablets slowed colonic transit in normal volunteers. However, Granisetron hydrochloride had no effect on oro-cecal transit time in normal volunteers when given as a single intravenous (IV) infusion of 50 mcg/kg or 200 mcg/kg.

Pharmacokinetics

In healthy volunteers and adult cancer patients undergoing chemotherapy, administration of Granisetron hydrochloride tablets produced mean pharmacokinetic data shown in Table 1.

Table 1 Pharmacokinetic Parameters (Median [range]) Following Granisetron Hydrochloride Tablets

	Peak Plasma Concentration (ng/mL)	Terminal Phase Plasma Half-Life (h)	Volume of Distribution (L/kg)	Total Clearance (L/h/kg)
* Not determined after oral administration; following a single intravenous dose of 40 mcg/kg, terminal phase half-life was determined to be 8.95 hours.
Cancer Patients 1 mg bid, 7 days (n=27)	5.99 [0.63 to 30.9]	N.D. *	N.D.	0.52 [0.09 to 7.37]
Volunteers single 1 mg dose (n=39)	3.63 [0.27 to 9.14]	6.23 [0.96 to 19.9]	3.94 [1.89 to 39.4]	0.41 [0.11 to 24.6]

N.D. Not determined.

Absorption

When Granisetron hydrochloride tablets were administered with food, AUC was decreased by 5% and Cmax increased by 30% in non-fasted healthy volunteers who received a single dose of 10 mg.

Distribution

Plasma protein binding is approximately 65% and 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. In normal volunteers, approximately 11% of the orally administered dose is eliminated unchanged in the urine in 48 hours. The remainder of the dose is excreted as metabolites, 48% in the urine and 38% in the feces.

Subpopulations

Gender

The effects of gender on the pharmacokinetics of Granisetron hydrochloride tablets have not been studied. However, after intravenous infusion of Granisetron hydrochloride, no difference in mean AUC was found between males and females, although males had a higher Cmax  generally.

In elderly and pediatric patients and in patients with renal failure or hepatic impairment, the pharmacokinetics of Granisetron was determined following administration of intravenous Granisetron hydrochloride:

Elderly

The ranges of the pharmacokinetic parameters in elderly volunteers (mean age 71 years), given a single 40 mcg/kg intravenous dose of Granisetron hydrochloride injection, were generally similar to those in younger healthy volunteers; mean values were lower for clearance and longer for half-life in the elderly.

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 injection.

Hepatically Impaired Patients

A pharmacokinetic study with intravenous Granisetron hydrochloride in patients with hepatic impairment due to neoplastic liver involvement showed that total clearance was approximately halved compared to patients without hepatic impairment. Given the wide variability in pharmacokinetic parameters noted in patients and the good tolerance of doses well above the recommended dose, dosage adjustment in patients with possible hepatic functional impairment is not necessary.

Pediatric Patients

A pharmacokinetic study in pediatric cancer patients (2 to 16 years of age), given a single 40 mcg/kg intravenous dose of Granisetron hydrochloride injection, showed that volume of distribution and total clearance increased with age. No relationship with age was observed for peak plasma concentration or terminal phase plasma half-life. When volume of distribution and total clearance are adjusted for body weight, the pharmacokinetics of Granisetron are similar in pediatric and adult cancer patients.

Clinical Trials

Chemotherapy-Induced Nausea and Vomiting

Granisetron hydrochloride tablets prevent nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, as shown by 24 hour efficacy data from studies using both moderately- and highly-emetogenic chemotherapy.

Moderately Emetogenic Chemotherapy

The first trial compared Granisetron hydrochloride tablets doses of 0.25 mg to 2 mg bid, in 930 cancer patients receiving, principally, cyclophosphamide, carboplatin, and cisplatin (20 mg/m2 to 50 mg/m2). Efficacy was based on complete response (i.e., no vomiting, no moderate or severe nausea, no rescue medication), no vomiting, and no nausea. Table 2 summarizes the results of this study.

Table 2 Prevention of Nausea and Vomiting 24 Hours Post- Chemotherapy*

	Percentages of Patients Granisetron Hydrochloride Tablet Dose
* Chemotherapy included oral and injectable cyclophosphamide, carboplatin, cisplatin (20 mg/m2 to 50 mg/m2), dacarbazine, doxorubicin, epirubicin. † No vomiting, no moderate or severe nausea, no rescue medication. ‡ Statistically significant (P<0.01) vs. 0.25 mg bid. § Statistically significant (P<0.01) vs. 0.5 mg bid.
Efficacy Measures	0.25 mg bid (n=229) %	0.5 mg bid (n=235) %	1 mg bid (n=233) %	2 mg bid (n=233) %
Complete Response†	61	70‡	81§‡	72‡
No Vomiting	66	77‡	88‡	79‡
No Nausea	48	57	63‡	54

Results from a second double-blind, randomized trial evaluating Granisetron hydrochloride tablets 2 mg qd and Granisetron hydrochloride tablets 1 mg bid were compared to prochlorperazine 10 mg bid derived from a historical control. At 24 hours, there was no statistically significant difference in efficacy between the two Granisetron hydrochloride tablet regimens. Both regimens were statistically superior to the prochlorperazine control regimen (see Table 3).

Table 3 Prevention of Nausea and Vomiting 24 Hours Post-Chemotherapy*

	Percentages of Patients
* Moderately emetogenic chemotherapeutic agents included cisplatin (20 mg/m2 to 50 mg/m2), oral and intravenous cyclophosphamide, carboplatin, dacarbazine, doxorubicin. † Historical control from a previous double-blind Granisetron hydrochloride trial. ‡ No vomiting, no moderate or severe nausea, no rescue medication. § Statistically significant (P<0.05) vs. prochlorperazine historical control. ¶ No vomiting, no nausea, no rescue medication.
Efficacy Measures	Granisetron Hydrochloride Tablets 1 mg bid (n = 354) %	Granisetron Hydrochloride Tablets 2 mg qd (n = 343) %	Prochlorperazine† 10 mg bid (n=111) %
Complete Response‡	69§	64§	41
No Vomiting	82§	77§	48
No Nausea	51§	53§	35
Total Control¶	51§	50§	33

Results from a Granisetron hydrochloride tablets 2 mg qd alone treatment arm in a third double-blind, randomized trial, were compared to prochlorperazine (PCPZ), 10 mg bid, derived from a historical control. The 24 hour results for Granisetron hydrochloride tablets 2 mg qd were statistically superior to PCPZ for all efficacy parameters: complete response (58%), no vomiting (79%), no nausea (51%), total control (49%). The PCPZ rates are shown in Table 3.

Cisplatin-Based Chemotherapy

The first double-blind trial compared Granisetron hydrochloride tablets 1 mg bid, relative to placebo (historical control), in 119 cancer patients receiving high-dose cisplatin (mean dose 80 mg/m2). At 24 hours, Granisetron hydrochloride tablets 1 mg bid was significantly (P<0.001) superior to placebo (historical control) in all efficacy parameters: complete response (52%), no vomiting (56%) and no nausea (45%). The placebo rates were 7%, 14%, and 7%, respectively, for the three efficacy parameters.

Results from a Granisetron hydrochloride tablets 2 mg qd alone treatment arm in a second double-blind, randomized trial, were compared to both Granisetron hydrochloride tablets 1 mg bid and placebo historical controls. The 24 hour results for Granisetron hydrochloride tablets 2 mg qd were: complete response (44%), no vomiting (58%), no nausea (46%), total control (40%). The efficacy of Granisetron hydrochloride tablets 2 mg qd was comparable to Granisetron hydrochloride tablets 1 mg bid and statistically superior to placebo. The placebo rates were 7%, 14%, 7%, and 7%, respectively, for the four parameters.

No controlled study comparing Granisetron injection with the oral formulation to prevent chemotherapy-induced nausea and vomiting has been performed.

Radiation-Induced Nausea and Vomiting

Total Body Irradiation

In a double-blind randomized study, 18 patients receiving Granisetron hydrochloride tablets, 2 mg daily, experienced significantly greater antiemetic protection compared to patients in a historical negative control group who received conventional (non-5-HT3 antagonist) antiemetics. Total body irradiation consisted of 11 fractions of 120 cGy administered over 4 days, with three fractions on each of the first 3 days, and two fractions on the fourth day. Granisetron hydrochloride tablets were given one hour before the first radiation fraction of each day.

Twenty-two percent (22%) of patients treated with Granisetron hydrochloride tablets did not experience vomiting or receive rescue antiemetics over the entire 4 day dosing period, compared to 0% of patients in the historical negative control group (P<0.01).

In addition, patients who received Granisetron hydrochloride tablets also experienced significantly fewer emetic episodes during the first day of radiation and over the 4 day treatment period, compared to patients in the historical negative control group. The median time to the first emetic episode was 36 hours for patients who received Granisetron hydrochloride tablets.

Fractionated Abdominal Radiation

The efficacy of Granisetron hydrochloride tablets, 2 mg daily, was evaluated in a double-blind, placebo-controlled randomized trial of 260 patients. Granisetron hydrochloride tablets were given 1 hour before radiation, composed of up to 20 daily fractions of 180 to 300 cGy each. The exceptions were patients with seminoma or those receiving whole abdomen irradiation who initially received 150 cGy per fraction. Radiation was administered to the upper abdomen with a field size of at least 100 cm2.

The proportion of patients without emesis and those without nausea for Granisetron hydrochloride tablets, compared to placebo, was statistically significant (P<0.0001) at 24 hours after radiation, irrespective of the radiation dose. Granisetron hydrochloride was superior to placebo in patients receiving up to 10 daily fractions of radiation, but was not superior to placebo in patients receiving 20 fractions.

Patients treated with Granisetron hydrochloride tablets (n=134) had a significantly longer time to the first episode of vomiting (35 days vs. 9 days, P<0.001) relative to those patients who received placebo (n=126), and a significantly longer time to the first episode of nausea (11 days vs. 1 day, P<0.001). Granisetron hydrochloride provided significantly greater protection from nausea and vomiting than placebo.

Indications and Usage for Granisetron

Granisetron hydrochloride is indicated for the prevention of:

• Nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin.


• Nausea and vomiting associated with radiation, including total body irradiation and fractionated abdominal radiation.

Contraindications

Granisetron hydrochloride is contraindicated in patients with known hypersensitivity to the drug or any of its components.

Precautions

Granisetron hydrochloride is not a drug that stimulates gastric or intestinal peristalsis. It should not be used instead of nasogastric suction. The use of Granisetron hydrochloride in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting may mask a progressive ileus and/or gastric distention.

An adequate QT assessment has not been conducted, but QT prolongation has been reported with Granisetron hydrochloride. Therefore, Granisetron hydrochloride should be used with caution in patients with pre-existing arrhythmias or cardiac conduction disorders, as this might lead to clinical consequences. Patients with cardiac disease, on cardio-toxic chemotherapy, with concomitant electrolyte abnormalities and/or on concomitant medications that prolong the QT interval are particularly at risk.

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 chemotherapies. Because Granisetron is metabolized by hepatic cytochrome P 450 drug-metabolizing enzymes, inducers or inhibitors of these enzymes may change the clearance and, hence, the half-life of Granisetron. No specific interaction studies have been conducted in anesthetized patients. 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.

QT prolongation has been reported with Granisetron hydrochloride. Use of Granisetron hydrochloride in patients concurrently treated with drugs known to prolong the QT interval and/or are arrhythmogenic, this may result in clinical consequences.

Carcinogenesis, Mutagenesis, 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 4, 20, and 101 times the recommended clinical dose (1.48 mg/m2, oral) 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, 20 times the recommended human dose based on body surface area) and above, and in females treated with 25 mg/kg/day (150 mg/m2/day, 101 times the recommended human dose based on body surface area). No increase in liver tumors was observed at a dose of 1 mg/kg/day (6 mg/m2/day, 4 times the recommended human dose based on body surface area) in males and 5 mg/kg/day (30 mg/m2/day, 20 times the recommended human dose based on body surface area) in females. In a 12 month oral toxicity study, treatment with Granisetron 100 mg/kg/day (600 mg/m2/day, 405 times the recommended human dose based on body surface area) 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, Granisetron hydrochloride 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 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 oral doses up to 100 mg/kg/day (600 mg/m2/day, 405 times the recommended human dose based on body surface area) was found to have no effect on fertility and reproductive performance of male and female rats.

Pregnancy

Teratogenic Effects

Pregnancy Category B.

Reproduction studies have been performed in pregnant rats at oral doses up to 125 mg/kg/day (750 mg/m2/day, 507 times the recommended human dose based on body surface area) and pregnant rabbits at oral doses up to 32 mg/kg/day (378 mg/m2/day, 255 times the recommended human dose based on body surface area) and have revealed no 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, this drug 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 Granisetron hydrochloride is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

During clinical trials, 325 patients 65 years of age or older received Granisetron hydrochloride tablets; 298 were 65 to 74 years of age, and 27 were 75 years of age or older. Efficacy and safety were maintained with increasing age.

ADVERSE REACTIONS

Chemotherapy-Induced Nausea and Vomiting

Over 3700 patients have received Granisetron hydrochloride tablets in clinical trials with emetogenic cancer therapies consisting primarily of cyclophosphamide or cisplatin regimens.

In patients receiving Granisetron hydrochloride tablets 1 mg bid for 1, 7 or 14 days, or 2 mg qd for 1 day, adverse experiences reported in more than 5% of the patients with comparator and placebo incidences are listed in Table 4.

Table 4 Principal Adverse Events in Clinical Trials

	Percent of Patients With Event
* Adverse events were recorded for 7 days when Granisetron hydrochloride tablets were given on a single day and for up to 28 days when Granisetron hydrochloride tablets were administered for 7 or 14 days. † Metoclopramide/dexamethasone; phenothiazines/dexamethasone; dexamethasone alone;  prochlorperazine.
	Granisetron Hydrochloride* Tablets 1 mg bid (n=978)	Granisetron Hydrochloride* Tablets 2 mg qd (n=1450)	Comparator† (n=599)	Placebo (n=185)
Headache	21%	20%	13%	12%
Constipation	18%	14%	16%	8%
Asthenia	14%	18%	10%	4%
Diarrhea	8%	9%	10%	4%
Abdominal pain	6%	4%	6%	3%
Dyspepsia	4%	6%	5%	4%

Other adverse events reported in clinical trials were:

Gastrointestinal: In single-day dosing studies in which adverse events were collected for 7 days, nausea (20%) and vomiting (12%) were recorded as adverse events after the 24 hour efficacy assessment period.

Hepatic: In comparative trials, elevation of AST and ALT (>2 times the upper limit of normal) following the administration of Granisetron hydrochloride tablets occurred in 5% and 6% of patients, respectively. These frequencies were not significantly different from those seen with comparators (AST: 2%; ALT: 9%).

Cardiovascular: Hypertension (1%); hypotension, angina pectoris, atrial fibrillation, and syncope have been observed rarely.

Central Nervous System: Dizziness (5%), insomnia (5%), anxiety (2%), somnolence (1%). One case compatible with, but not diagnostic of, extrapyramidal symptoms has been reported in a patient treated with Granisetron hydrochloride tablets.

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

Other: Fever (5%). Events often associated with chemotherapy also have been reported: leukopenia (9%), decreased appetite (6%), anemia (4%), alopecia (3%), thrombocytopenia (2%).

Over 5000 patients have received injectable Granisetron hydrochloride in clinical trials.

Table 5 gives the comparative frequencies of the five commonly reported adverse events (≥3%) in patients receiving Granisetron hydrochloride injection, 40 mcg/kg, in single-day chemotherapy trials. These patients received chemotherapy, primarily cisplatin, and intravenous fluids during the 24 hour period following Granisetron hydrochloride injection administration.

Table 5 Principal Adverse Events in Clinical Trials - Single-Day Chemotherapy

	Percent of Patients with Event
* Adverse events were generally recorded over 7 days post-Granisetron hydrochloride injection administration. † Metoclopramide/dexamethasone and phenothiazines/dexamethasone.
	Granisetron Hydrochloride Injection* 40 mcg/kg (n=1268)	Comparator† (n=422)
Headache	14%	6%
Asthenia	5%	6%
Somnolence	4%	15%
Diarrhea	4%	6%
Constipation	3%	3%

In the absence of a placebo group, there is uncertainty as to how many of these events should be attributed to Granisetron hydrochloride, except for headache, which was clearly more frequent than in comparison groups.

Radiation-Induced Nausea and Vomiting

In controlled clinical trials, the adverse events reported by patients receiving Granisetron hydrochloride tablets and concurrent radiation were similar to those reported by patients receiving Granisetron hydrochloride tablets prior to chemotherapy. The most frequently reported adverse events were diarrhea, asthenia, and constipation. Headache, however, was less prevalent in this patient population.

Postmarketing Experience

QT prolongation has been reported with Granisetron hydrochloride (see PRECAUTIONS and Drug Interactions).

Overdosage

There is no specific treatment for Granisetron hydrochloride overdosage. In case of overdosage, symptomatic treatment should be given. Overdosage of up to 38.5 mg of Granisetron hydrochloride injection has been reported without symptoms or only the occurrence of a slight headache.

DOSAGE & ADMINISTRATION

Emetogenic Chemotherapy

The recommended adult dosage of oral Granisetron hydrochloride is 2 mg once daily or 1 mg twice daily. In the 2 mg once-daily regimen, two 1 mg tablets are given up to 1 hour before chemotherapy. In the 1 mg twice-daily regimen, the first 1 mg tablet is given up to 1 hour before chemotherapy, and the second tablet, 12 hours after the first. Either regimen is administered only on the day(s) chemotherapy is given. Continued treatment, while not on chemotherapy, has not been found to be useful.

Use in the Elderly, Renal Failure Patients or Hepatically Impaired Patients

No dosage adjustment is recommended (see CLINICAL PHARMACOLOGY: Pharmacokinetics).

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Radiation (Either Total Body Irradiation or Fractionated Abdominal Radiation)

The recommended adult dosage of oral Granisetron hydrochloride is 2 mg once daily. Two 1 mg tablets are taken within 1 hour of radiation.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Use in the Elderly

No dosage adjustment is recommended.

How is Granisetron Supplied

White to off-white film coated triangular shaped biconvex tablet debossed with “G1” on one side and plain on the other side.

1 mg Bottle of 20 Tablets: NDC 16714-221-01

1 mg Unit of Use 2’s: NDC 16714-221-30  

1 mg 20 (2x10) Unit Dose Tablets: NDC 16714-221-32 (intended for institutional use only)

Storage

Store between 20° and 25°C (68° and 77°F). [see USP Controlled Room Temperature]. Keep container closed tightly. Protect from light.

Manufactured for: Northstar Rx LLC

Memphis, TN 38141

Toll free number : 1 800 206 7821

Manufactured by: Orchid Healthcare

(A Division of Orchid Chemicals & Pharmaceuticals Ltd.)

Irungattukottai - 602 105, India

Revised: 10/10

948025925

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 16714-221-01

Rx only

Granisetron Hydrochloride Tablets, USP

1 mg*

20 Tablets

NORTHSTAR

Granisetron HYDROCHLORIDE  Granisetron hydrochloride  tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 16714-221 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Granisetron HYDROCHLORIDE (Granisetron) Granisetron 1 mg

Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE   SODIUM STARCH GLYCOLATE TYPE A POTATO   LACTOSE MONOHYDRATE   HYPROMELLOSE 2910 (3 MPA.S)   MAGNESIUM STEARATE

Product Characteristics Color WHITE (white to off-white) Score no score Shape TRIANGLE (triangular;biconvex) Size 7mm Flavor Imprint Code G1 Contains

Packaging # NDC Package Description Multilevel Packaging 1 16714-221-01 20 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078678	04/29/2008

Labeler - Northstar Rx LLC (830546433)

Revised: 01/2012Northstar Rx LLC

Ery-Tab

In the US, Ery-Tab (erythromycin systemic) is a member of the drug class macrolides and is used to treat Bacterial Endocarditis Prevention, Bowel Preparation, Bronchitis, Bullous Pemphigoid, Campylobacter Gastroenteritis, Chancroid, Chlamydia Infection, Dental Abscess, Legionella Pneumonia, Lyme Disease, Lymphogranuloma Venereum, Mycoplasma Pneumonia, Nongonococcal Urethritis, Otitis Media, Pemphigoid, Pharyngitis, Pneumonia, Rheumatic Fever Prophylaxis, Skin Infection, Strep Throat, Syphilis - Early and Upper Respiratory Tract Infection.

US matches:

• Ery-Tab


• Ery-Tab Delayed-Release Tablets

Ingredient matches for Ery-Tab

Erythromycin

Erythromycin is reported as an ingredient of Ery-Tab in the following countries:

• Thailand


• United States

International Drug Name Search

Good Neighbor All Day Allergy D

Dosage Form: tablet, extended release
Amerisource Bergen All Day Allergy-D Drug Facts

Active ingredient (in each extended release tablet)

Cetirizine HCl 5 mg

Pseudoephedrine HCl 120 mg

Purpose

Antihistamine

Nasal Decongestant

Uses

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:


• runny nose


• sneezing


• itchy, watery eyes


• itching of the nose or throat


• nasal congestion


• reduces swelling of nasal passages


• temporarily relieves sinus congestion and pressure


• temporarily restores freer breathing through the nose

Warnings

Do not use

• if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.


• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• heart disease


• thyroid disease


• diabetes


• glaucoma


• high blood pressure


• trouble urinating due to an enlarged prostate gland


• liver or kidney disease. Your doctor should determine if you need a different dose.

Ask a doctor or pharmacist before use if you are

taking tranquilizers or sedatives.

When using this product

• do not use more than directed


• drowsiness may occur


• avoid alcoholic drinks


• alcohol, sedatives, and tranquilizers may increase drowsiness


• be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

• an allergic reaction to this product occurs. Seek medical help right away.


• you get nervous, dizzy, or sleepless


• symptoms do not improve within 7 days or are accompanied by fever

If pregnant or breast-feeding:

• if breast-feeding: not recommended


• if pregnant: ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• do not break or chew tablet; swallow tablet whole

adults and children 12 years and over	take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours.
adults 65 years and over	ask a doctor
children under 12 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Other information

• store between 20° to 25°C (68° to 77°F)

Inactive ingredients

colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, yellow iron oxide

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the active ingredients in Zyrtec-D®

Original Prescription Strength

All Day Allergy-D

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended Release Tablets, 5 mg/120 mg

antihistamine/nasal decongestant

Allergy & Congestion

12 Hour Relief of:

Sneezing - Itchy, Watery Eyes

Runny Nose - Itchy Throat or Nose

Sinus Pressure - Nasal Congestion

12 Hour

Indoor & Outdoor Allergies

Actual Size

All Day Allergy-D Carton

GOOD NEIGHBOR PHARMACY ALL DAY ALLERGY D  cetirizine hcl, pseudoephedrine hcl  tablet, extended release

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 24385-175 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE 5 mg PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color WHITE (one side white one side light yellow) Score no score Shape ROUND Size 12mm Flavor Imprint Code 5029;5;120 Contains

Packaging # NDC Package Description Multilevel Packaging 1 24385-175-53 2 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 6 TABLET In 1 BLISTER PACK This package is contained within the CARTON (24385-175-53) 2 24385-175-62 4 BLISTER PACK In 1 CARTON contains a BLISTER PACK 2 6 TABLET In 1 BLISTER PACK This package is contained within the CARTON (24385-175-62)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077170	05/06/2008

Labeler - Amerisource Bergen (007914906)

Revised: 06/2009Amerisource Bergen

More Good Neighbor All Day Allergy D resources

• Good Neighbor All Day Allergy D Side Effects (in more detail)
• Good Neighbor All Day Allergy D Use in Pregnancy & Breastfeeding
• Good Neighbor All Day Allergy D Drug Interactions
• Good Neighbor All Day Allergy D Support Group
• 3 Reviews for Good Neighbor All Day Allergy D - Add your own review/rating

Compare Good Neighbor All Day Allergy D with other medications

• Hay Fever

Mucinex Junior Strength Granules

Pronunciation: gwye-FEN-eh-sin
Generic Name: Guaifenesin
Brand Name: Examples include Mucinex Children's and Mucinex Junior Strength

Mucinex Junior Strength Granules are used for:

Relieving symptoms of cough and mucus in the chest due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Mucinex Junior Strength Granules are an expectorant. It works by thinning mucus (phlegm) in the lungs and making it less sticky and easier to cough up. This reduces chest congestion by making coughs more productive.

Do NOT use Mucinex Junior Strength Granules if:

• you are allergic to any ingredient in Mucinex Junior Strength Granules

Contact your doctor or health care provider right away if any of these apply to you.

Before using Mucinex Junior Strength Granules:

Some medical conditions may interact with Mucinex Junior Strength Granules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a persistent cough that occurs with smoking, asthma, chronic bronchitis, or emphysema, or if your cough occurs with large amounts of mucus


• if you have phenylketonuria

Some MEDICINES MAY INTERACT with Mucinex Junior Strength Granules. Tell your health care provider if you are taking any other medicines. However, no specific interactions with Mucinex Junior Strength Granules are known at this time.

Ask your health care provider if Mucinex Junior Strength Granules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Mucinex Junior Strength Granules:

Use Mucinex Junior Strength Granules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Mucinex Junior Strength Granules by mouth with or without food.


• Drinking extra fluids while you are taking Mucinex Junior Strength Granules are recommended. Check with your doctor for instructions.


• Empty the entire contents of the packet onto the tongue and swallow. For best taste, do not chew before swallowing.


• If you miss a dose of Mucinex Junior Strength Granules and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. Go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Mucinex Junior Strength Granules.

Important safety information:

• If cough persists for more than 1 week or is accompanied by a fever, contact your health care provider. A persistent cough could be a sign of a serious condition.


• Some of these products contain phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product.


• Different brands of Mucinex Junior Strength Granules may have different dosing instructions for CHILDREN. Follow the dosing instructions on the package labeling. If your doctor has given you instructions, follow those. If you are unsure of the dose to give a child, check with your doctor or pharmacist.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Mucinex Junior Strength Granules while you are pregnant. It is not known if Mucinex Junior Strength Granules are found in breast milk. If you are or will be breast-feeding while you use Mucinex Junior Strength Granules, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Mucinex Junior Strength Granules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Mucinex Junior Strength side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Mucinex Junior Strength Granules:

Store Mucinex Junior Strength Granules at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Mucinex Junior Strength Granules out of the reach of children and away from pets.

General information:

• If you have any questions about Mucinex Junior Strength Granules, please talk with your doctor, pharmacist, or other health care provider.


• Mucinex Junior Strength Granules are to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Mucinex Junior Strength Granules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Mucinex Junior Strength resources

• Mucinex Junior Strength Side Effects (in more detail)
• Mucinex Junior Strength Use in Pregnancy & Breastfeeding
• Mucinex Junior Strength Support Group
• 0 Reviews for Mucinex Junior Strength - Add your own review/rating

Compare Mucinex Junior Strength with other medications

• Bronchitis
• Cough

Granisetron

Pronunciation: gra-NIS-e-tron
Generic Name: Granisetron
Brand Name: Sancuso

Granisetron is used for:

Preventing nausea and vomiting caused by cancer chemotherapy. It may also be used for other conditions as determined by your doctor.

Granisetron is a 5-HT₃ receptor antagonist. It works by blocking a chemical called serotonin that can cause vomiting.

Do NOT use Granisetron if:

• you are allergic to any ingredient in Granisetron


• you are taking apomorphine

Contact your doctor or health care provider right away if any of these apply to you.

Before using Granisetron:

Some medical conditions may interact with Granisetron. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you are allergic to other 5-HT₃ receptor antagonists (eg, ondansetron)


• if you have heart problems (eg, irregular heartbeat, conduction problems), blood electrolyte problems (eg, low calcium, potassium, or magnesium), an abnormal electrocardiogram (ECG), or you are receiving chemotherapy that may cause heart problems


• if you have stomach or bowel problems (eg, pain, swelling) or if you have recently had stomach surgery

Some MEDICINES MAY INTERACT with Granisetron. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Apomorphine because the risk of side effects, such as severely low blood pressure or loss of consciousness, may occur


• Medicines that may affect your heartbeat such as antiarrhythmics (eg, flecainide, sotalol), azole antifungals (eg, ketoconazole), or quinolones (eg, ciprofloxacin) because heart rhythm problems may occur. Ask your doctor if you are unsure if any medicines that you take may affect your heartbeat

This may not be a complete list of all interactions that may occur. Ask your health care provider if Granisetron may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Granisetron:

Use Granisetron as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Granisetron. Talk to your pharmacist if you have questions about this information.


• Apply Granisetron 24 to 48 hours before your chemotherapy treatment, or as directed by your doctor.


• Granisetron should be applied to clean, healthy skin on the upper arm. Do not apply to cut, scraped, or irritated skin. Do not use creams, oils, lotions, powders, or any other products that could irritate the skin or prevent the patch from sticking well.


• To apply Granisetron, remove the patch from the sealed pouch. Do not cut or damage the patch. Remove the thin, clear, protective liner. Bend the patch in the middle and remove one-half of the rigid plastic film. Apply the exposed, sticky area of the patch to your skin. Remove the other half of the rigid plastic film and press the whole patch firmly in place against the skin.


• If the patch does not stick well, you may tape the edges with surgical bandages or medical adhesive tape. Do not completely cover the patch with bandages or tape. Do not wrap completely around your arm. Ask your health care provider if you are unsure of what type of dressing you can use.


• Wash your hands immediately after using Granisetron.


• You may shower or bathe normally while wearing the patch. You should avoid activities such as swimming, strenuous exercise, or using a sauna or whirlpool. It is unknown how these activities may affect Granisetron.


• Continue to wear the patch during your chemotherapy and for at least 24 hours after your treatment is completed. Granisetron may be worn for up to 7 days or as directed by your doctor.


• To remove the patch, gently peel it off of your skin and fold the sticky side together. Throw the used patch in the trash away from children and pets. Wash your hands after handling the patch.


• Gently wash the skin with soap and water where the patch was applied.


• If you miss a dose of Granisetron, contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Granisetron.

Important safety information:

• Granisetron may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Granisetron with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not expose Granisetron to the sun, sunlamps, or tanning booths while you wear it. It might not work as well and could cause skin irritation. Keep the patch covered with clothing if you will be in sunlight or near a sunlamp or tanning bed. You will also need to cover the skin where the patch was applied for an additional 10 days after you remove the patch to protect it from exposure to direct sunlight.


• Tell your doctor right away if you experience skin irritation (eg, bumps, blisters, itching, redness, or rash) at the application site or on other areas of the body.


• Granisetron should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Granisetron while you are pregnant. It is not known if Granisetron is found in breast milk. If you are or will be breast-feeding while you are using Granisetron, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Granisetron:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Anxiety; constipation; diarrhea; dizziness; drowsiness; headache; nausea; trouble sleeping; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fainting; fast or irregular heartbeat; fever, chills, or sore throat; severe or persistent skin irritation (eg, redness, rash, bumps, blisters, or itching); stomach pain or swelling; unusual muscle movement.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Granisetron side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include headache.

Proper storage of Granisetron:

Store Granisetron in the original package at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Granisetron out of the reach of children and away from pets.

General information:

• If you have any questions about Granisetron, please talk with your doctor, pharmacist, or other health care provider.


• Granisetron is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Granisetron. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Granisetron resources

• Granisetron Side Effects (in more detail)
• Granisetron Use in Pregnancy & Breastfeeding
• Drug Images
• Granisetron Drug Interactions
• Granisetron Support Group
• 6 Reviews for Granisetron - Add your own review/rating

Compare Granisetron with other medications

• Nausea/Vomiting, Chemotherapy Induced
• Nausea/Vomiting, Postoperative
• Nausea/Vomiting, Radiation Induced

Aquafresh

Aquafresh may be available in the countries listed below.

Ingredient matches for Aquafresh

Sodium Fluoride

Sodium Fluoride is reported as an ingredient of Aquafresh in the following countries:

• Argentina

International Drug Name Search

Granul-Derm

Generic Name: balsam Peru, castor oil, and trypsin topical (BAL sum pe ROO, KAS tur oyl, TRIP sin TOP i kal)

Brand Names: Allanderm-T, Granul-Derm, Granulex, Optase, Revina NLT, TBC, Trypsin, Vasolex, Xenaderm

What is balsam Peru, castor oil, and trypsin?

Balsam Peru increases blood flow to a wound area, and also helps fight bacteria.

Castor oil prevents skin cells from breaking down, which aids in wound healing.

Trypsin helps shed damaged skin cells.

The combination of balsam Peru, castor oil, and trypsin topical (for the skin) is used to treat bed sores and other skin ulcers. This medication can help promote healing and relieve pain caused by these conditions.

Balsam Peru, castor oil, and trypsin may also be used for purposes not listed in this medication guide.

What is the most important information I should know about balsam Peru, castor oil, and trypsin?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Some forms of this medication are flammable. Do not use near open flame or while you are smoking. Avoid inhaling the spray. Avoid getting this medication in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, rinse with water.

Use this medication regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

What should I discuss with my health care provider before using balsam Peru, castor oil, and trypsin?

You should not use this medication if you are allergic to balsam Peru, castor oil, and trypsin. This medication is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether this medication passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use balsam Peru, castor oil, and trypsin?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Wash your hands before and after applying this medicine.

Apply a thin layer of medication to the wound. Balsam Peru, castor oil, and trypsin is usually applied at least twice daily. Follow your doctor's instructions.

After applying the medication, you may cover the wound with a bandage dressing, or leave the wound open to the air. Your doctor will tell you whether you should cover the wound or not.

If you need to remove this medication, wash it off with water and mild soap.

Some forms of this medication are flammable. Do not use near open flame or while you are smoking. Avoid inhaling the spray.

Use this medication regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat. Do not allow the medicine to freeze.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using balsam Peru, castor oil, and trypsin?

Avoid getting this medication in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, rinse with water.

Avoid using skin products that can cause irritation, such as harsh soaps or shampoos or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime.

Avoid using other medications on the areas you treat with balsam Peru, castor oil, and trypsin unless you doctor tells you to.

Balsam Peru, castor oil, and trypsin 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. Treating a skin wound may increase your risk of developing an infection in your blood. Call your doctor at once if you have any signs of infection, such as:

• 
  

  fever or chills;

  
  


• 
  

  rapid breathing, gasping for breath;

  
  


• 
  

  fast heart rate;

  
  


• 
  

  warmth under your skin; or

  
  


• 
  

  unusual weakness.

  
  

Less serious side effects are more likely, such as mild stinging or burning where the medicine is applied.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect balsam Peru, castor oil, and trypsin?

It is not likely that other drugs you take orally or inject will have an effect on topically applied balsam Peru, castor oil, and trypsin. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Granul-Derm resources

• Granul-Derm Side Effects (in more detail)
• Granul-Derm Use in Pregnancy & Breastfeeding
• Granul-Derm Drug Interactions
• Granul-Derm Support Group
• 0 Reviews for Granul-Derm - Add your own review/rating

• Granul-Derm Spray MedFacts Consumer Leaflet (Wolters Kluwer)


• Trypsin


• Xenaderm Ointment MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Granul-Derm with other medications

• Dermatologic Lesion

Where can I get more information?

• Your pharmacist can provide more information about balsam Peru, castor oil, and trypsin.

See also: Granul-Derm side effects (in more detail)

Trangorex

Trangorex may be available in the countries listed below.

Ingredient matches for Trangorex

Amiodarone

Amiodarone hydrochloride (a derivative of Amiodarone) is reported as an ingredient of Trangorex in the following countries:

• Spain


• Venezuela

International Drug Name Search

Allopurinol DHA

Allopurinol DHA may be available in the countries listed below.

Ingredient matches for Allopurinol DHA

Allopurinol

Allopurinol is reported as an ingredient of Allopurinol DHA in the following countries:

• Singapore

International Drug Name Search

Corangin Nitrospray

Corangin Nitrospray may be available in the countries listed below.

Ingredient matches for Corangin Nitrospray

Nitroglycerin

Nitroglycerin is reported as an ingredient of Corangin Nitrospray in the following countries:

• Germany

International Drug Name Search

Articaine Hydrochloride

Articaine Hydrochloride may be available in the countries listed below.

Ingredient matches for Articaine Hydrochloride

Articaine

Articaine Hydrochloride (BANM, USAN) is known as Articaine in the US.

International Drug Name Search

Glossary

BANM	British Approved Name (Modified)
USAN	United States Adopted Name

Click for further information on drug naming conventions and International Nonproprietary Names.

Mareen

Mareen may be available in the countries listed below.

Ingredient matches for Mareen

Doxepin

Doxepin hydrochloride (a derivative of Doxepin) is reported as an ingredient of Mareen in the following countries:

• Germany

International Drug Name Search

Hytrin BPH 10mg Tablets

1. Name Of The Medicinal Product

Hytrin BPH 10mg Tablets

2. Qualitative And Quantitative Composition

		mg/tablet
Active:	Terazosin as monohydrochloride dihydrate	10.0

3. Pharmaceutical Form

Tablet

4. Clinical Particulars

4.1 Therapeutic Indications

Orally administered Hytrin BPH is indicated as a therapy for the symptomatic treatment of urinary obstruction caused by benign prostatic hyperplasia (BPH). Terazosin is a selective post synaptic alpha-1-adrenoreceptor antagonist. Antagonism of alpha-1-receptors on prostatic and urethral smooth muscle has been shown to improve urinary tract flow and relieve the urinary obstruction caused by BPH.

4.2 Posology And Method Of Administration

Adults Only:

The dose of terazosin should be adjusted according to the patient's response. The following is a guide to administration:

Initial dose

1 mg before bedtime is the starting dose for all patients and should not be exceeded. Strict compliance with this recommendation should be observed to minimise acute first-dose hypotensive episodes.

Subsequent dose

The dose may be increased by approximately doubling at weekly or bi-weekly intervals to achieve the desired reduction in symptoms. The maintenance dose is usually 5 to 10mg once daily. Improvements in symptoms have been detected as early as two weeks after starting treatment with terazosin.

At present there are insufficient data to suggest additional symptomatic relief with doses above 10mg once daily.

Treatment should be initiated using the Hytrin BPH Starter Pack and response to treatment reviewed at four weeks. Transient side effects may occur at each titration step. If any side effects persist, consideration should be given to reducing the dose.

Use in renal insufficiency

Pharmacokinetic studies indicate that patients with impaired renal function need no alteration in the recommended dosages.

Use in Children

Use in children for BPH is not applicable.

Use in the Elderly

Pharmacokinetic studies in the elderly indicate that no alteration in dosage recommendation is required.

Postural Hypotension

Postural hypotension has been reported to occur in patients receiving terazosin for the symptomatic treatment of urinary obstruction caused by BPH. In these cases, the incidence of postural hypotensive events was greater in patients aged 65 years and over (5.6%) than those aged less than 65 years (2.6%)

4.3 Contraindications

Terazosin is contraindicated in patients known to be hypersensitive to alpha-adrenoreceptor antagonists.

4.4 Special Warnings And Precautions For Use

As with other alpha adrenoreceptor antagonists, terazosin is not recommended in patients with a history of micturition syncope.

In clinical trials, the incidence of postural hypotension was greater in patients who received terazosin for BPH than in patients who received terazosin for hypertension. In this indication the incidence of postural hypotensive events was greater in patients aged 65 years and over (5.6%) than those aged less than 65 years (2.6%).

If administration is discontinued for more than several days, therapy should be re-instituted using the initial dosing regimen.

Concomitant use of phosphodiesterase-5-inhibitors (e.g. sildenafil, tadalafil, vardenafil) and terazosin may lead to symptomatic hypotension in some patients. In order to minimise the risk for developing postural hypotension the patient should be stable on the alpha-blocker therapy before initiating use of phosphodiesterase-5-inhibitors.

The 'Intraoperative Floppy Iris Syndrome' (IFIS, a variant of small pupil syndrome) has been observed during cataract surgery in some patients on or previously treated with tamsulosin. Isolated reports have also been received with other alpha-1 blockers and the possibility of a class effect cannot be excluded. As IFIS may lead to increased procedural complications during cataract operation current or past use of alpha-1 blockers should be made known to the ophthalmic surgeon in advance of surgery.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

In patients receiving terazosin for BPH, plus ACE inhibitors or diuretics, the proportion reporting dizziness or related side effects was greater than in the total population of terazosin treated patients from clinical trials.

Caution should be observed when terazosin is administered with other antihypertensive agents, to avoid the possibility of significant hypotension. When adding terazosin to a diuretic or other antihypertensive agent, dosage reduction and retitration may be necessary.

Terazosin has been given without interaction with analgesics/anti-inflammatories, cardiac glycosides, hypoglycaemics, antiarrhythmics, anxiolytics/sedatives, antibacterials, hormones/steroids and drugs used for gout.

Phosphodiesterase-5-inhibitors (e.g. sildenafil, tadalafil, vardenafil) (see section 4.4).

4.6 Pregnancy And Lactation

Although no teratogenic effects were seen in animal testing, the safety during pregnancy and lactation has not yet been established. Hytrin should not be used therefore in pregnancy unless the potential benefit outweighs the risk.

4.7 Effects On Ability To Drive And Use Machines

Dizziness, light-headedness or drowsiness may occur with the initial dose or in association with missed doses and subsequent reinitiation of Hytrin therapy. Patients should be cautioned about these possible adverse events and the circumstances in which they may occur and advised to avoid driving or hazardous tasks for approximately the first 12 hours after the initial dose or when the dose is increased.

4.8 Undesirable Effects

Hytrin, in common with other alpha-adrenoreceptor antagonists, may cause syncope. Syncopal episodes have occurred within 30 to 90 minutes of the initial dose of the drug. Syncope has occasionally occurred in association with rapid dosage increases or the introduction of another antihypertensive agent.

In clinical studies in hypertension, the incidence of syncopal episodes was approximately one percent. In most cases, this was believed to be due to an excessive postural hypotensive effect although occasionally the syncopal episode has been preceded by a bout of tachycardia with heart rates of 120 to 160 beats per minute.

If syncope occurs the patient should be placed in a recumbent position and given supportive treatment as necessary.

Dizziness, light-headedness or fainting may occur when standing up quickly from a lying or sitting position. Patients should be advised of this possibility and instructed to lie down if these symptoms appear and then sit for a few minutes before standing to prevent re-occurrence.

These adverse effects are self limiting and, in most cases, do not recur after the initial period of therapy or during subsequent titration.

Adverse events reported with terazosin

The most common events were asthenia, palpitations, nausea, peripheral oedema, dizziness, somnolence, nasal congestion/rhinitis and blurred vision/amblyopia.

In addition, the following have been reported: back pain; headache; tachycardia; postural hypotension; syncope; oedema; weight gain; pain in extremities; decreased libido; depression; nervousness; paraesthesia; vertigo; dyspnoea; sinusitis and impotence.

Additional adverse reactions reported in clinical trials or reported during marketing experience but not clearly associated with the use of terazosin include the following: chest pain; facial oedema; fever; abdominal pain; neck pain; shoulder pain; vasodilation; arrhythmia; constipation; diarrhoea; dry mouth; dyspepsia; flatulence; vomiting; gout; arthralgia; arthritis; joint disorders; myalgia; anxiety; insomnia; bronchitis; epistaxis; flu symptoms; pharyngitis; rhinitis; cold symptoms; pruritis; rash; increased cough; sweating; abnormal vision; conjunctivitis; tinnitus; urinary frequency; urinary tract infection and urinary incontinence primarily reported in post-menopausal women.

At least two cases of severe anaphylactoid reactions have been reported with the administration of terazosin.

Post marketing experience: Thrombocytopenia and priapism have been reported. Atrial fibrillation has been reported: however, a cause and effect relationship has not been established.

Laboratory tests: Small but statistically significant decreases in haematocrit, haemoglobin, white blood cells, total protein and albumin were observed in controlled clinical trials. These laboratory findings suggest the possibility of haemodilution. Treatment with terazosin for up to 24 months had no significant effect on prostate specific antigen (PSA) levels.

4.9 Overdose

Should administration of terazosin lead to acute hypotension, cardiovascular support is of first importance. Restoration of blood pressure and normalisation of heart rate may be accomplished by keeping the patient in a supine position. If this measure is inadequate, shock should first be treated with volume expanders and, if necessary, vasopressors could then be used. Renal function should be monitored and general supportive measures applied as required. Dialysis may not be of benefit since laboratory data indicate that terazosin is highly protein bound.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Studies suggest that alpha-1-adrenoreceptor antagonism is useful in improving the urodynamics in patients with chronic bladder obstruction such as in benign prostatic hyperplasia (BPH).

The symptoms of BPH are caused mainly by the presence of an enlarged prostate and by the increased smooth muscle tone of the bladder outlet and prostate, which is regulated by alpha-1-adrenergic receptors.

In in-vitro experiments, terazosin has been shown to antagonise phenylephrine-induced contractions of human prostatic tissue. In clinical trials terazosin has been shown to improve the urodynamics and symptomatology in patients with BPH.

5.2 Pharmacokinetic Properties

The plasma concentration of the parent drug is a maximum 1 hour post administration and declines with a half-life of approximately 12 hours. Food has little or no effect on bioavailability. Approximately 40% of the administered dose is eliminated in the urine and 60% in the faeces. The drug is highly bound to plasma proteins.

5.3 Preclinical Safety Data

Carcinogenicity: terazosin has been shown to produce benign adrenal medullary tumours in male rats when administered in very high doses over a long period of time. No such findings were seen in female rats or in a similar study in mice. The relevance of these findings with respect to the clinical use of the drug in man is unknown.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Lactose

Maize starch

Pregelatinised starch

Purified talc

Magnesium stearate

Purified water

Dye blue (FD&C No.2 lake).

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

None

6.5 Nature And Contents Of Container

Tablets in a blister pack. The 10mg tablets are supplied in packs of 28 tablets. The blisters, of PVC/PVdC, are heat sealed with 20 micron hard tempered aluminium foil and packaged in a carton with a pack insert.

6.6 Special Precautions For Disposal And Other Handling

Not applicable

7. Marketing Authorisation Holder

Amdipharm plc

Regency House

Miles Gray Road

Basildon

Essex

SS14 3AF

8. Marketing Authorisation Number(S)

PL 20072/0035

9. Date Of First Authorisation/Renewal Of The Authorisation

20/05/98/ 02/12/2005

10. Date Of Revision Of The Text

June 2009