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Kytril Solution

30/06/10

Generic Name: Granisetron (gra-NI-se-tron)
Brand Name: Kytril

Kytril Solution is used for:

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

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

Do NOT use Kytril Solution if:

  • you are allergic to any ingredient in Kytril Solution
  • you are taking apomorphine

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

Before using Kytril Solution:

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

  • if you are pregnant, plan 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)

Some MEDICINES MAY INTERACT with Kytril Solution. 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

This may not be a complete list of all interactions that may occur. Ask your health care provider if Kytril Solution 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 Kytril Solution:

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

  • Kytril Solution may be taken with or without food.
  • Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
  • Use Kytril Solution only on the days that you receive your cancer treatment, unless otherwise directed by your doctor.
  • If you miss a dose of Kytril Solution, contact your doctor immediately.

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

Important safety information:

  • Kytril Solution may cause drowsiness or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Kytril Solution. Using Kytril Solution alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
  • Use Kytril Solution with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Kytril Solution during pregnancy. It is unknown if Kytril Solution is excreted in breast milk. If you are or will be breast-feeding while you are using Kytril Solution, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Kytril Solution:

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:

Agitation; anxiety; constipation; diarrhea; dizziness; drowsiness; headache; indigestion; nausea; stomach pain; taste changes; trouble sleeping; vomiting; weakness.

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

Severe allergic reactions (rash; hives; 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; 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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

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

Proper storage of Kytril Solution:

Store Kytril Solution at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Kytril Solution out of the reach of children and away from pets.

General information:

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

This information is a summary only. It does not contain all information about Kytril Solution. 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: May 5, 2010
Database Edition 10.2.1.002
Copyright © 2010 Wolters Kluwer Health, Inc.
 

Kytril Injection

30/06/10

Generic Name: granisetron hydrochloride
Dosage Form: injection

KYTRIL®
(granisetron hydrochloride)
INJECTION

Kytril Injection Description

KYTRIL (granisetron hydrochloride) Injection is 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 is a white to off-white solid that is readily soluble in water and normal saline at 20°C. Kytril Injection is a clear, colorless, sterile, nonpyrogenic, aqueous solution for intravenous administration.

KYTRIL 1 mg/1 mL is available in 1 mL single-use and 4 mL multi-use vials. KYTRIL 0.1 mg/1 mL is available in a 1 mL single-use vial.

1 mg/1 mL: Each 1 mL contains 1.12 mg granisetron hydrochloride equivalent to granisetron, 1 mg; sodium chloride, 9 mg; citric acid, 2 mg; and benzyl alcohol, 10 mg, as a preservative. The solution’s pH ranges from 4.0 to 6.0.

0.1 mg/1 mL: Each 1 mL contains 0.112 mg granisetron hydrochloride equivalent to granisetron, 0.1 mg; sodium chloride, 9 mg; citric acid, 2 mg. Contains no preservative. The solution’s pH ranges from 4.0 to 6.0.

Kytril Injection – 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 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-induced vomiting, mucosal enterochromaffin cells release serotonin, which stimulates 5-HT3 receptors. This evokes vagal afferent discharge and may induce 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.

Kytril Injection exhibited no effect on oro-cecal transit time in normal volunteers given a single intravenous infusion of 50 mcg/kg or 200 mcg/kg. Single and multiple oral doses slowed colonic transit in normal volunteers.

Pharmacokinetics

Chemotherapy-Induced Nausea and Vomiting

In adult cancer patients undergoing chemotherapy and in volunteers, mean pharmacokinetic data obtained from an infusion of a single 40 mcg/kg dose of Kytril Injection are shown in Table 1.

Table 1 Pharmacokinetic Parameters in Adult Cancer Patients Undergoing Chemotherapy and in Volunteers, Following a Single Intravenous 40 mcg/kg Dose of Kytril Injection
Peak Plasma Concentration
(ng/mL)		 Terminal Phase Plasma Half-Life
(h)		 Total Clearance
(L/h/kg)		 Volume of Distribution
(L/kg)
*
5-minute infusion.
†
3-minute infusion.
Cancer Patients
  Mean 63.8* 8.95* 0.38* 3.07*
  Range 18.0 to 176 0.90 to 31.1 0.14 to 1.54 0.85 to 10.4
Volunteers
  21 to 42 years
  Mean 64.3† 4.91† 0.79† 3.04†
  Range 11.2 to 182 0.88 to 15.2 0.20 to 2.56 1.68 to 6.13
  65 to 81 years
  Mean 57.0† 7.69† 0.44† 3.97†
  Range 14.6 to 153 2.65 to 17.7 0.17 to 1.06 1.75 to 7.01

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 12% of the administered dose is eliminated unchanged in the urine in 48 hours. The remainder of the dose is excreted as metabolites, 49% in the urine, and 34% in the feces.

Subpopulations

Gender

There was high inter- and intra-subject variability noted in these studies. No difference in mean AUC was found between males and females, although males had a higher Cmax generally.

Elderly

The ranges of the pharmacokinetic parameters in elderly volunteers (mean age 71 years), given a single 40 mcg/kg intravenous dose of Kytril Injection, were generally similar to those in younger healthy volunteers; mean values were lower for clearance and longer for half-life in the elderly patients (see Table 1).

Pediatric Patients

A pharmacokinetic study in pediatric cancer patients (2 to 16 years of age), given a single 40 mcg/kg intravenous dose of Kytril 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.

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 Kytril Injection.

Hepatically Impaired Patients

A pharmacokinetic study 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, dosage adjustment in patients with hepatic functional impairment is not necessary.

Postoperative Nausea and Vomiting

In adult patients (age range, 18 to 64 years) recovering from elective surgery and receiving general balanced anesthesia, mean pharmacokinetic data obtained from a single 1 mg dose of Kytril Injection administered intravenously over 30 seconds are shown in Table 2.

Table 2 Pharmacokinetic Parameters in 16 Adult Surgical Patients Following a Single Intravenous 1 mg Dose of Kytril Injection
Terminal Phase Plasma Half-Life
(h)		 Total Clearance
(L/h/kg)		 Volume of Distribution
(L/kg)
Mean 8.63 0.28 2.42
Range 1.77 to 17.73 0.07 to 0.71 0.71 to 4.13

The pharmacokinetics of granisetron in patients undergoing surgery were similar to those seen in cancer patients undergoing chemotherapy.





Clinical Trials

Chemotherapy-Induced Nausea and Vomiting

Single-Day Chemotherapy

Cisplatin-Based Chemotherapy

In a double-blind, placebo-controlled study in 28 cancer patients, Kytril Injection, administered as a single intravenous infusion of 40 mcg/kg, was significantly more effective than placebo in preventing nausea and vomiting induced by cisplatin chemotherapy (see Table 3).

Table 3 Prevention of Chemotherapy-Induced Nausea and Vomiting — Single-Day Cisplatin Therapy*
Kytril Injection Placebo P-Value
*
Cisplatin administration began within 10 minutes of Kytril Injection infusion and continued for 1.5 to 3.0 hours. Mean cisplatin dose was 86 mg/m2 in the Kytril Injection group and 80 mg/m2 in the placebo group.
†
No vomiting and no moderate or severe nausea.
Number of Patients 14 14
Response Over 24 Hours
Complete Response† 93% 7% <0.001
No Vomiting 93% 14% <0.001
No More Than Mild Nausea 93% 7% <0.001

Kytril Injection was also evaluated in a randomized dose response study of cancer patients receiving cisplatin ≥75 mg/m2. Additional chemotherapeutic agents included: anthracyclines, carboplatin, cytostatic antibiotics, folic acid derivatives, methylhydrazine, nitrogen mustard analogs, podophyllotoxin derivatives, pyrimidine analogs, and vinca alkaloids. Kytril Injection doses of 10 and 40 mcg/kg were superior to 2 mcg/kg in preventing cisplatin-induced nausea and vomiting, but 40 mcg/kg was not significantly superior to 10 mcg/kg (see Table 4).

Table 4 Prevention of Chemotherapy-Induced Nausea and Vomiting — Single-Day High-Dose Cisplatin Therapy*
Kytril Injection
(mcg/kg)		 P-Value
(vs. 2 mcg/kg)
2 10 40 10 40
*
Cisplatin administration began within 10 minutes of Kytril Injection infusion and continued for 2.6 hours (mean). Mean cisplatin doses were 96 to 99 mg/m2.
†
No vomiting and no moderate or severe nausea.
Number of Patients 52 52 53
Response Over 24 Hours
Complete Response† 31% 62% 68% <0.002 <0.001
No Vomiting 38% 65% 74% <0.001 <0.001
No More Than Mild Nausea 58% 75% 79% NS 0.007

Kytril Injection was also evaluated in a double-blind, randomized dose response study of 353 patients stratified for high (≥80 to 120 mg/m2) or low (50 to 79 mg/m2) cisplatin dose. Response rates of patients for both cisplatin strata are given in Table 5.

Table 5 Prevention of Chemotherapy-Induced Nausea and Vomiting — Single-Day High-Dose and Low-Dose Cisplatin Therapy*
Kytril Injection
(mcg/kg)		 P-Value
(vs. 5 mcg/kg)
5 10 20 40 10 20 40
*
Cisplatin administration began within 10 minutes of Kytril Injection infusion and continued for 2 hours (mean). Mean cisplatin doses were 64 and 98 mg/m2 for low and high strata.
†
No vomiting and no use of rescue antiemetic.
High-Dose Cisplatin
Number of Patients 40 49 48 47
Response Over 24 Hours
  Complete Response† 18% 41% 40% 47% 0.018 0.025 0.004
  No Vomiting 28% 47% 44% 53% NS NS 0.016
  No Nausea 15% 35% 38% 43% 0.036 0.019 0.005
Low-Dose Cisplatin
Number of Patients 42 41 40 46
Response Over 24 Hours
  Complete Response† 29% 56% 58% 41% 0.012 0.009 NS
  No Vomiting 36% 63% 65% 43% 0.012 0.008 NS
  No Nausea 29% 56% 38% 33% 0.012 NS NS

For both the low and high cisplatin strata, the 10, 20, and 40 mcg/kg doses were more effective than the 5 mcg/kg dose in preventing nausea and vomiting within 24 hours of chemotherapy administration. The 10 mcg/kg dose was at least as effective as the higher doses.

Moderately Emetogenic Chemotherapy

Kytril Injection, 40 mcg/kg, was compared with the combination of chlorpromazine (50 to 200 mg/24 hours) and dexamethasone (12 mg) in patients treated with moderately emetogenic chemotherapy, including primarily carboplatin >300 mg/m2, cisplatin 20 to 50 mg/m2 and cyclophosphamide >600 mg/m2. Kytril Injection was superior to the chlorpromazine regimen in preventing nausea and vomiting (see Table 6).

Table 6 Prevention of Chemotherapy-Induced Nausea and Vomiting—Single-Day Moderately Emetogenic Chemotherapy
Kytril Injection Chlorpromazine* P-Value
*
Patients also received dexamethasone, 12 mg.
†
No vomiting and no moderate or severe nausea.
Number of Patients 133 133
Response Over 24 Hours
Complete Response† 68% 47% <0.001
No Vomiting 73% 53% <0.001
No More Than Mild Nausea 77% 59% <0.001

In other studies of moderately emetogenic chemotherapy, no significant difference in efficacy was found between KYTRIL doses of 40 mcg/kg and 160 mcg/kg.

Repeat-Cycle Chemotherapy

In an uncontrolled trial, 512 cancer patients received Kytril Injection, 40 mcg/kg, prophylactically, for two cycles of chemotherapy, 224 patients received it for at least four cycles, and 108 patients received it for at least six cycles. Kytril Injection efficacy remained relatively constant over the first six repeat cycles, with complete response rates (no vomiting and no moderate or severe nausea in 24 hours) of 60% to 69%. No patients were studied for more than 15 cycles.

Pediatric Studies

A randomized double-blind study evaluated the 24-hour response of 80 pediatric cancer patients (age 2 to 16 years) to Kytril Injection 10, 20 or 40 mcg/kg. Patients were treated with cisplatin ≥60 mg/m2, cytarabine ≥3 g/m2, cyclophosphamide ≥1 g/m2 or nitrogen mustard ≥6 mg/m2 (see Table 7).

Table 7 Prevention of Chemotherapy-Induced Nausea and Vomiting in Pediatric Patients
Kytril Injection Dose (mcg/kg)
10 20 40
*
No vomiting and no moderate or severe nausea.
Number of Patients 29 26 25
Median Number of Vomiting Episodes 2 3 1
Complete Response Over 24 Hours* 21% 31% 32%

A second pediatric study compared Kytril Injection 20 mcg/kg to chlorpromazine plus dexamethasone in 88 patients treated with ifosfamide ≥3 g/m2/day for two or three days. Kytril Injection was administered on each day of ifosfamide treatment. At 24 hours, 22% of Kytril Injection patients achieved complete response (no vomiting and no moderate or severe nausea in 24 hours) compared with 10% on the chlorpromazine regimen. The median number of vomiting episodes with Kytril Injection was 1.5; with chlorpromazine it was 7.0.

Postoperative Nausea and Vomiting

Prevention of Postoperative Nausea and Vomiting

The efficacy of Kytril Injection for prevention of postoperative nausea and vomiting was evaluated in 868 patients, of which 833 were women, 35 men, 484 Caucasians, 348 Asians, 18 Blacks, 18 Other, with 61 patients 65 years or older. KYTRIL was evaluated in two randomized, double-blind, placebo-controlled studies in patients who underwent elective gynecological surgery or cholecystectomy and received general anesthesia. Patients received a single intravenous dose of Kytril Injection (0.1 mg, 1 mg or 3 mg) or placebo either 5 minutes before induction of anesthesia or immediately before reversal of anesthesia. The primary endpoint was the proportion of patients with no vomiting for 24 hours after surgery. Episodes of nausea and vomiting and use of rescue antiemetic therapy were recorded for 24 hours after surgery. In both studies, Kytril Injection (1 mg) was more effective than placebo in preventing postoperative nausea and vomiting (see Table 8). No additional benefit was seen in patients who received the 3 mg dose.

Table 8 Prevention of Postoperative Nausea and Vomiting in Adult Patients
Study and Efficacy Endpoint Placebo KYTRIL
0.1 mg		 KYTRIL
1 mg		 KYTRIL
3 mg
Note: No Vomiting = no vomiting and no use of rescue antiemetic therapy; No Nausea = no nausea and no use of rescue antiemetic therapy
*
P<0.001 versus placebo
†
P<0.05
Study 1
Number of Patients 133 132 134 128
No Vomiting
  0 to 24 hours 34% 45% 63%* 62%*
No Nausea
  0 to 24 hours 22% 28% 50%* 42%*
No Nausea or Vomiting
  0 to 24 hours 18% 27% 49%* 42%*
No Use of Rescue Antiemetic Therapy
  0 to 24 hours 60% 67% 75%† 77%†
Study 2
Number of Patients 117 – 110 114
No Vomiting
  0 to 24 hours 56% – 77%* 75%†
No Nausea
  0 to 24 hours 37% – 59%* 56%†

Gender/Race

There were too few male and Black patients to adequately assess differences in effect in either population.

Treatment of Postoperative Nausea and Vomiting

The efficacy of Kytril Injection for treatment of postoperative nausea and vomiting was evaluated in 844 patients, of which 731 were women, 113 men, 777 Caucasians, 6 Asians, 41 Blacks, 20 Other, with 107 patients 65 years or older. Kytril Injection was evaluated in two randomized, double-blind, placebo-controlled studies of adult surgical patients who received general anesthesia with no prophylactic antiemetic agent, and who experienced nausea or vomiting within 4 hours postoperatively. Patients received a single intravenous dose of Kytril Injection (0.1 mg, 1 mg or 3 mg) or placebo after experiencing postoperative nausea or vomiting. Episodes of nausea and vomiting and use of rescue antiemetic therapy were recorded for 24 hours after administration of study medication. Kytril Injection was more effective than placebo in treating postoperative nausea and vomiting (see Table 9). No additional benefit was seen in patients who received the 3 mg dose.

Table 9 Treatment of Postoperative Nausea and Vomiting in Adult Patients
Study and Efficacy Endpoint Placebo KYTRIL
0.1 mg		 KYTRIL
1 mg		 KYTRIL
3 mg
Note: No vomiting = no vomiting and no use of rescue antiemetic therapy; No nausea = no nausea and no use of rescue antiemetic therapy
*
P<0.001 versus placebo
†
P<0.01
‡
P<0.05
§
Protocol Specified Analysis: Patients who had vomiting prior to treatment
Study 3
Number of Patients 133 128 133 125
No Vomiting
  0 to 6 hours 26% 53%* 58%* 60%*
  0 to 24 hours 20% 38%* 46%* 49%*
No Nausea
  0 to 6 hours 17% 40%* 41%* 42%*
  0 to 24 hours 13% 27%† 30%† 37%*
No Use of Rescue Antiemetic Therapy
  0 to 6 hours – – – –
  0 to 24 hours 33% 51%† 61%* 61%*
Study 4
Number of Patients (All Patients) 162 163 – –
No Vomiting
  0 to 6 hours 20% 32%‡ – –
  0 to 24 hours 14% 23%‡ – –
No Nausea
  0 to 6 hours 13% 18% – –
  0 to 24 hours 9% 14% – –
No Nausea or Vomiting
  0 to 6 hours 13% 18% – –
  0 to 24 hours 9% 14% – –
No Use of Rescue Antiemetic Therapy
  0 to 6 hours – – – –
  0 to 24 hours 24% 34%‡ – –
Number of Patients (Treated for Vomiting)§ 86 103 – –
No Vomiting
  0 to 6 hours 21% 27% – –
  0 to 24 hours 14% 20% – –

Gender/Race

There were too few male and Black patients to adequately assess differences in effect in either population.

Indications and Usage for Kytril Injection

Kytril Injection is indicated for:

  • The prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin.
  • The prevention and treatment of postoperative nausea and vomiting in adults. As with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided during the postoperative period, Kytril Injection is recommended even where the incidence of postoperative nausea and/or vomiting is low.

Contraindications

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

Warnings

Hypersensitivity reactions may occur in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists.

Precautions

KYTRIL is not a drug that stimulates gastric or intestinal peristalsis. It should not be used instead of nasogastric suction. The use of KYTRIL 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 KYTRIL. Therefore, Kytril 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, Kytril Injection has been safely administered with drugs representing benzodiazepines, neuroleptics and anti-ulcer medications commonly prescribed with antiemetic treatments. Kytril 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 KYTRIL in vitro.

In in vitro human microsomal studies, ketoconazole inhibited ring oxidation of KYTRIL. 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 KYTRIL. The clinical significance of this change is not known.

QT prolongation has been reported with KYTRIL. Use of Kytril 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 16, 81 and 405 times the recommended clinical dose (0.37 mg/m2, iv) 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, 81 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, 405 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, 16 times the recommended human dose based on body surface area) in males and 5 mg/kg/day (30 mg/m2/day, 81 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, 1622 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, Kytril Injection 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, 97 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 intravenous doses up to 9 mg/kg/day (54 mg/m2/day, 146 times the recommended human dose based on body surface area) and pregnant rabbits at intravenous doses up to 3 mg/kg/day (35.4 mg/m2/day, 96 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.

Benzyl alcohol may cross the placenta. Kytril Injection 1 mg/1 mL is preserved with benzyl alcohol and should be used in pregnancy only if the benefit outweighs the potential risk.

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 Kytril Injection is administered to a nursing woman.

Pediatric Use

See DOSAGE AND ADMINISTRATION for use in chemotherapy-induced nausea and vomiting in pediatric patients 2 to 16 years of age. Safety and effectiveness in pediatric patients under 2 years of age have not been established. Safety and effectiveness of Kytril Injection have not been established in pediatric patients for the prevention or treatment of postoperative nausea or vomiting.

Benzyl alcohol, a component of KYTRIL 1 mg/1 mL, has been associated with serious adverse events and death, particularly in neonates. The “gasping syndrome,” characterized by central nervous system depression, metabolic acidosis, gasping respirations, and high levels of benzyl alcohol and metabolites in blood and urine, has been associated with benzyl alcohol dosages >99 mg/kg/day in neonates and low birth-weight neonates. Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. Although normal therapeutic doses of this product deliver amounts of benzyl alcohol that are substantially lower than those reported in association with the “gasping syndrome,” the minimum amount of benzyl alcohol at which toxicity may occur is not known. Premature and low birth-weight infants, as well as patients receiving high dosages, may be more likely to develop toxicity. Practitioners administering this and other medications containing benzyl alcohol should consider the combined daily metabolic load of benzyl alcohol from all sources.

Geriatric Use

During chemotherapy clinical trials, 713 patients 65 years of age or older received Kytril Injection. Effectiveness and safety were similar in patients of various ages.

During postoperative nausea and vomiting clinical trials, 168 patients 65 years of age or older, of which 47 were 75 years of age or older, received Kytril Injection. Clinical studies of Kytril Injection did not include sufficient numbers of subjects aged 65 years 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.

Adverse Reactions

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

Chemotherapy-Induced Nausea and Vomiting

The following have been reported during controlled clinical trials or in the routine management of patients. The percentage figures are based on clinical trial experience only. Table 10 gives the comparative frequencies of the five most commonly reported adverse events (≥3%) in patients receiving Kytril Injection, in single-day chemotherapy trials. These patients received chemotherapy, primarily cisplatin, and intravenous fluids during the 24-hour period following Kytril Injection administration. Events were generally recorded over seven days post-Kytril Injection administration. In the absence of a placebo group, there is uncertainty as to how many of these events should be attributed to KYTRIL, except for headache, which was clearly more frequent than in comparison groups.

Table 10 Principal Adverse Events in Clinical Trials — Single-Day Chemotherapy
Percent of Patients With Event
Kytril Injection
40 mcg/kg
(n=1268)		 Comparator*

(n=422)
*
Metoclopramide/dexamethasone and phenothiazines/dexamethasone.
Headache 14% 6%
Asthenia 5% 6%
Somnolence 4% 15%
Diarrhea 4% 6%
Constipation 3% 3%

In over 3,000 patients receiving Kytril Injection (2 to 160 mcg/kg) in single-day and multiple-day clinical trials with emetogenic cancer therapies, adverse events, other than those in Table 10, were observed; attribution of many of these events to KYTRIL is uncertain.

Hepatic: In comparative trials, mainly with cisplatin regimens, elevations of AST and ALT (>2 times the upper limit of normal) following administration of Kytril Injection occurred in 2.8% and 3.3% of patients, respectively. These frequencies were not significantly different from those seen with comparators (AST: 2.1%; ALT: 2.4%).

Cardiovascular: Hypertension (2%); hypotension, arrhythmias such as sinus bradycardia, atrial fibrillation, varying degrees of A-V block, ventricular ectopy including non-sustained tachycardia, and ECG abnormalities have been observed rarely.

Central Nervous System: Agitation, anxiety, CNS stimulation and insomnia were seen in less than 2% of patients. Extrapyramidal syndrome occurred rarely and only in the presence of other drugs associated with this syndrome.

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

Other: Fever (3%), taste disorder (2%), skin rashes (1%). In multiple-day comparative studies, fever occurred more frequently with Kytril Injection (8.6%) than with comparative drugs (3.4%, P<0.014), which usually included dexamethasone.

Postoperative Nausea and Vomiting

The adverse events listed in Table 11 were reported in ≥2% of adults receiving Kytril Injection 1 mg during controlled clinical trials.

Table 11 Adverse Events ≥2%
Percent of Patients With Event
Kytril Injection
1 mg
(n=267)		 Placebo

(n=266)
Pain 10.1 8.3
Constipation 9.4 12.0
Anemia 9.4 10.2
Headache 8.6 7.1
Fever 7.9 4.5
Abdominal Pain 6.0 6.0
Hepatic Enzymes Increased 5.6 4.1
Insomnia 4.9 6.0
Bradycardia 4.5 5.3
Dizziness 4.1 3.4
Leukocytosis 3.7 4.1
Anxiety 3.4 3.8
Hypotension 3.4 3.8
Diarrhea 3.4 1.1
Flatulence 3.0 3.0
Infection 3.0 2.3
Dyspepsia 3.0 1.9
Hypertension 2.6 4.1
Urinary Tract Infection 2.6 3.4
Oliguria 2.2 1.5
Coughing 2.2 1.1

In a clinical study conducted in Japan, the types of adverse events differed notably from those reported above in Table 11. The adverse events in the Japanese study that occurred in ≥2% of patients and were more frequent with KYTRIL 1 mg than with placebo were: fever (56% to 50%), sputum increased (2.7% to 1.7%), and dermatitis (2.7% to 0%).

Postmarketing Experience

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

Overdosage

There is no specific antidote for Kytril Injection 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.

Kytril Injection Dosage and Administration

NOTE: KYTRIL 1 MG/1 ML CONTAINS BENZYL ALCOHOL (see PRECAUTIONS).

Prevention of Chemotherapy-Induced Nausea and Vomiting

The recommended dosage for Kytril Injection is 10 mcg/kg administered intravenously within 30 minutes before initiation of chemotherapy, and only on the day(s) chemotherapy is given.

Infusion Preparation

Kytril Injection may be administered intravenously either undiluted over 30 seconds, or diluted with 0.9% Sodium Chloride or 5% Dextrose and infused over 5 minutes.

Stability

Intravenous infusion of Kytril Injection should be prepared at the time of administration. However, Kytril Injection has been shown to be stable for at least 24 hours when diluted in 0.9% Sodium Chloride or 5% Dextrose and stored at room temperature under normal lighting conditions.

As a general precaution, Kytril Injection should not be mixed in solution with other drugs. Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.

Pediatric Patients

The recommended dose in pediatric patients 2 to 16 years of age is 10 mcg/kg (see CLINICAL TRIALS). Pediatric patients under 2 years of age have not been studied.

Geriatric Patients, Renal Failure Patients or Hepatically Impaired Patients

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

Prevention and Treatment of Postoperative Nausea and Vomiting

The recommended dosage for prevention of postoperative nausea and vomiting is 1 mg of KYTRIL, undiluted, administered intravenously over 30 seconds, before induction of anesthesia or immediately before reversal of anesthesia.

The recommended dosage for the treatment of nausea and/or vomiting after surgery is 1 mg of KYTRIL, undiluted, administered intravenously over 30 seconds.

Pediatric Patients

Safety and effectiveness of Kytril Injection have not been established in pediatric patients for the prevention or treatment of postoperative nausea or vomiting.

Geriatric Patients, Renal Failure Patients or Hepatically Impaired Patients

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

How is Kytril Injection Supplied

Kytril Injection, 1 mg/1 mL (free base), is supplied in 1 mL Single-Use Vials and 4 mL Multi-Use Vials. CONTAINS BENZYL ALCOHOL.

 
NDC 0004-0239-09 (package of 1 Single-Use Vial)
 
NDC 0004-0240-09 (package of 1 Multi-Use Vial)

Kytril Injection, 0.1 mg/1 mL (free base), is supplied in 1 mL Single-Use Vials. CONTAINS NO PRESERVATIVE.

 
NDC 0004-0242-08 (package of 5 Single-Use Vials)

Storage

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

Once the multi-use vial is penetrated, its contents should be used within 30 days.

Do not freeze. Protect from light.

Distributed by:

Roche Laboratories Inc.
340 Kingsland Street
Nutley, New Jersey 07110-1199

KLI_243421_PI_022009_K

Revised: October 2009

Copyright © 1998-2009 by Roche Laboratories Inc. All rights reserved.

Representative sample of labeling (see the HOW SUPPLIED section for complete listing):

PRINCIPAL DISPLAY PANEL – 1 mL Carton

NDC 0004-0239-09
KYTRIL®
(granisetron HCl)
Injection
1 mg/1 mL
For I.V. use only

Rx only

1 x 1 mL
Single-Use Vial

Roche

KYTRIL 
granisetron hydrochloride  injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0004-0239
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
granisetron hydrochloride (granisetron) granisetron hydrochloride 1 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
sodium chloride  
citric acid monohydrate  
benzyl alcohol  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0004-0239-09 1 VIAL In 1 BOX contains a VIAL, SINGLE-USE
1 1 mL In 1 VIAL, SINGLE-USE This package is contained within the BOX (0004-0239-09)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020239 12/29/1993

KYTRIL 
granisetron hydrochloride  injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0004-0240
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
granisetron hydrochloride (granisetron) granisetron hydrochloride 1 mg  in 4 mL
Inactive Ingredients
Ingredient Name Strength
sodium chloride  
citric acid monohydrate  
benzyl alcohol  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0004-0240-09 1 VIAL In 1 BOX contains a VIAL, SINGLE-USE
1 4 mL In 1 VIAL, SINGLE-USE This package is contained within the BOX (0004-0240-09)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020239 12/29/1993

KYTRIL 
granisetron hydrochloride  injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0004-0242
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
granisetron hydrochloride (granisetron) granisetron hydrochloride 0.1 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
sodium chloride  
citric acid monohydrate  
benzyl alcohol  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0004-0242-08 5 VIAL In 1 BOX contains a VIAL, SINGLE-USE
1 1 mL In 1 VIAL, SINGLE-USE This package is contained within the BOX (0004-0242-08)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020239 12/29/1993

Labeler - Hoffmann-La Roche Inc (002191211)
Establishment
Name Address ID/FEI Operations
Hoffmann-La Roche Inc 002191211 Manufacture
Establishment
Name Address ID/FEI Operations
F. Hoffmann-La Roche 482248971 Analysis, API Manufacture, Manufacture

Revised: 10/2009Hoffmann-La Roche Inc

 

Kwelcof

30/06/10

Generic Name: guaifenesin and hydrocodone (gwye FEN e sin and HYE droe KOE done)
Brand Names: A-Cof DH, Canges-XP, Codiclear DH, Condasin, Cotuss V, Execlear, Extendryl HC, Hycotuss Expectorant, Hydrocod-GF, Kwelcof, Monte-G HC, Narcof, Pancof XP, Pneumotussin 2.5, Relasin-HCX, Touro HC, Tussicle, Tusso-DF, Vi-Q-Tuss, Vitussin Expectorant, Xpect-HC, Z-Cof HCX

What is Kwelcof (guaifenesin and hydrocodone)?

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 cough suppressant.

Guaifenesin and hydrocodone is used to treat cough and reduce chest congestion caused by the common cold, flu, or allergies.

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


What is the most important information I should know about Kwelcof (guaifenesin and hydrocodone)?

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. It may increase drowsiness and dizziness caused by guaifenesin and hydrocodone. Tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by guaifenesin and hydrocodone. Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. Hydrocodone should never be given to 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.

What should I discuss with my healthcare provider before taking Kwelcof (guaifenesin and hydrocodone)?

Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. Hydrocodone 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. Do not use this medicine if you are allergic to hydrocodone or guaifenesin.

Before taking this medication, tell your doctor if you have:

  • kidney disease;
  • liver disease;

  • asthma;

  • urination problems;

  • an enlarged prostate;

  • a thyroid disorder;

  • seizures or epilepsy;

  • gallbladder disease;

  • a head injury; or

  • Addison’s disease.

If you have any of these conditions, you may not be able to take guaifenesin and hydrocodone, or you may need a dose adjustment or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Guaifenesin and hydrocodone passes into breast milk and may be harmful to a nursing baby. Do not take guaifenesin and hydrocodone without telling your doctor if you are breast-feeding a baby.


How should I take Kwelcof (guaifenesin and hydrocodone)?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Guaifenesin and hydrocodone can be taken with or without food.

Measure liquid 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.

Do not take more of this medication or take it for longer than is recommended. Call your doctor if your symptoms do not improve, or if they get worse. Store guaifenesin and hydrocodone at room temperature away from moisture and heat. Keep track of how many pills have been used from each new bottle of this medicine. 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?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. 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 extreme drowsiness, sweating, pinpoint pupils, nausea, vomiting, dry mouth, confusion, cold and clammy skin, muscle weakness, fainting, weak pulse, slow heart rate, seizure (convulsions), weak or shallow breathing, or breathing that stops.

What should I avoid while taking Kwelcof (guaifenesin and hydrocodone)?

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. It may increase drowsiness and dizziness caused by guaifenesin and hydrocodone. Tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by guaifenesin and hydrocodone.

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


Kwelcof (guaifenesin and hydrocodone) 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 using this medication and call your doctor at once if you have a serious side effect such as:

  • slow heart rate, weak or shallow breathing;

  • feeling like you might pass out;

  • confusion, fear, unusual thoughts or behavior;

  • seizure (convulsions); or

  • urinating less than usual or not at all.

Less serious side effects may include:

  • dizziness, drowsiness;

  • nausea, vomiting, upset stomach;

  • blurred vision;

  • constipation;

  • dry mouth; or

  • sweating.

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 Kwelcof (guaifenesin and hydrocodone)?

Before taking this medication, tell your doctor if you are using any of the following drugs:

  • antidepressants such as amitriptyline (Elavil, Etrafon), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others;

  • atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), glycopyrrolate (Robinul), mepenzolate (Cantil), methscopolamine (Pamine), or scopolamine (Transderm-Scop);

  • bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);

  • a bronchodilator such as ipratropium (Atrovent) or tiotropium (Spiriva); or

  • irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), or propantheline (Pro-Banthine).

This list is not complete and there may be other drugs that can interact with guaifenesin and hydrocodone. 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.

Where can I get more information?

  • Your pharmacist can provide more information about guaifenesin and hydrocodone.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed
  • Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 2.02. Revision Date: 4/12/2009 4:41:00 PM.

 

Kwell

30/06/10

Generic Name: lindane (Topical route)

LIN-dane

Topical routeLotionShampoo

Lindane should only be used in patients who cannot tolerate or have failed first-line treatment with safer medications for the treatment of scabies.

Seizures and deaths have been reported following lindane use with repeat or prolonged application, but also in rare cases following a single application used according to directions. Lindane should be used with caution for infants, children, the elderly, and individuals with other skin conditions (eg, atopic dermatitis, psoriasis) and in those who weigh less than 110 lbs (50 kg) as they may be at risk of serious neurotoxicity.

Lindane is contraindicated in premature infants and individuals with known uncontrolled seizure disorders.

Instruct patients on the proper use of lindane, the amount to apply, how long to leave it on, and avoiding retreatment. Inform patients that itching occurs after the successful killing of scabies and is not necessarily an indication for retreatment with lindane .

Lindane should only be used in patients who cannot tolerate or have failed first-line treatment with safer medications for the treatment of scabies. Seizures and deaths have been reported following lindane use. Risk of serious neurotoxicity when used in infants, children, the elderly, individuals with other skin conditions (eg, atopic dermatitis, psoriasis), and in those who weigh less than 110 lbs (50 kg). Lindane is contraindicated in premature infants and individuals with known uncontrolled seizure disorders. Instruct patients on the proper use of lindane .

Commonly used brand name(s):

In the U.S.

  • Kwell
  • Thionex

In Canada

  • Kwellada Lotion 1%
  • Lindane
  • Pms-Lindane

Available Dosage Forms:

  • Cream
  • Shampoo
  • Lotion

Therapeutic Class: Scabicide

Uses For Kwell

Lindane , formerly known as gamma benzene hexachloride, is an insecticide and is used to treat scabies and lice infestations.

Lindane cream and lotion are usually used to treat only scabies infestation. Lindane shampoo is used to treat only lice infestations.

Lindane is available only with your doctor’s prescription.


Before Using Kwell

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

Infants and children or people who weigh less than 110 pounds (50 kilograms) are especially sensitive to the effects of lindane. This may increase the chance of serious side effects during treatment. Be sure you have discussed the risks and benefits of using this medicine with your doctor. In addition, use of lindane is not to be used in premature infants.

Geriatric

Elderly people or people who weigh less than 110 pounds (50 kilograms) are especially sensitive to the effects of lindane. This may increase the chance of serious side effects during treatment. Be sure you have discussed the risks and benefits of this medicine with your doctor.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Alcohol use that is excessive, or
  • Brain tumor or
  • Head injuries, history of, or
  • HIV Infection or
  • Liver disease, or
  • Seizures, history of
  • Suddenly stopping the regular use of alcohol or sedatives —Patients with these conditions should use lindane carefully because these patients have a greater risk of having a seizure
  • Hypersensitivity to lindane
  • Seizure disorder—This medicine should not be used in patients with seizure disorders
  • Skin conditions—This medicine should not be used in people with crusted scabies, atopic dermatitis, or psoriasis. These problems of the skin could cause more lindane to be absorbed in your body and result in serious side effects.




Proper Use of lindane

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

Lindane is poisonous. Keep it away from the mouth because it is harmful and may be fatal if swallowed.

Use lindane only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may increase the chance of absorption through the skin and the chance of lindane poisoning.

Keep lindane away from the eyes. If you should accidentally get some in your eyes, flush them thoroughly with water at once and contact your doctor.

Do not use lindane on open wounds, such as cuts or sores on the skin or scalp. To do so may increase the chance of lindane poisoning.

When applying lindane to another person, you should wear plastic disposable or rubber gloves made of latex or vinyl, especially if you are pregnant or are breast-feeding. Do not use natural latex gloves because lindane can go through those gloves and be absorbed by your skin. Wash hands very well after applying the lotion. This will prevent lindane from being absorbed through your skin. If you have any questions about this, check with your healthcare professional.

Put lindane lotion under fingernails, and trim fingernails short. Use a toothbrush to get the lindane lotion under fingernails, and throw out the toothbrush when finished.

Do not cover the area completely. Use a light clothing.

Lindane comes with patient directions. Be sure that you read them very carefully before using lindane. If you have any questions check with your healthcare professional.

Your sexual partner or partners, especially, and all members of your household may need to be treated also, since the infestation may spread to persons in close contact. If these persons have not been checked for an infestation or if you have any questions about this, check with your healthcare professional

To use the cream or lotion form of lindane for scabies :

  • If your skin has any cream, lotion, ointment, or oil on it, wash, rinse, and dry your skin well before applying lindane.
  • If you take a warm bath or shower before using lindane, dry the skin well before applying it.
  • Apply enough lindane to your dry skin to cover the entire skin surface from the neck down, including the soles of your feet, and rub in well.
  • Leave lindane on for 8 to 12 hours, then remove by washing thoroughly.

To use the shampoo form of lindane for lice:

  • If your hair has any cream, lotion, ointment, or oil-based product on it, shampoo, rinse, and dry your hair and scalp well before applying lindane.
  • If you apply this shampoo in the shower or in the bathtub, make sure the shampoo is not allowed to run down on other parts of your body. Also, do not apply this shampoo in a bathtub where the shampoo may run into the bath water in which you are sitting. To do so may increase the chance of absorption through the skin. When you rinse out the shampoo, be sure to thoroughly rinse your entire body also to remove any shampoo that may have gotten on it.
  • Apply enough shampoo to your dry hair (1 ounce or less for short hair, 1½ ounces for medium length hair, and 2 ounces or less for long hair) to thoroughly wet the hair and skin or scalp of the affected and surrounding hairy areas.
  • Thoroughly rub the shampoo into the hair and skin or scalp and allow to remain in place for 4 minutes. Then, use just enough water to work up a good lather.
  • Rinse thoroughly and dry with a clean towel.
  • When the hair is dry, comb with a fine-toothed comb to remove any remaining nits (eggs) or nit shells.
  • Do not use as a regular shampoo.

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 cream and lotion dosage forms:
    • For scabies:
      • Adults and children—Apply to the affected area(s) of the skin one time.
      • Premature infants—Use is not recommended.
  • For shampoo dosage form:
    • For lice:
      • Adults and children—Apply to the scalp or the affected area(s) of the skin one time.
      • Premature infants—Use is not recommended.

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.


Precautions While Using Kwell

To help prevent reinfestation or spreading of the infestation to other persons:

  • For scabies—All recently worn underwear and pajamas and used sheets, pillowcases, and towels should be washed in very hot water or dry-cleaned.
  • For lice—All recently worn clothing and used bed linens and towels should be washed in very hot water or dry-cleaned.

Kwell 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:

Rare

  • Convulsions (seizures)
  • dizziness, clumsiness, or unsteadiness
  • fast heartbeat
  • muscle cramps
  • nervousness, restlessness, or irritability
  • vomiting
  • skin irritation not present before use of lindane
  • skin rash

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

Serious side effects have resulted in patients using lindane. Sometime it has occurred even when used according to the labeled directions. Serious side effects have been reported following lindane use with repeat or prolonged use, but also in rare cases following a single application. You should discuss these possible effects with your doctor.

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.

 

Kwellada Lotion 1%

30/06/10

Generic Name: lindane (Topical route)

LIN-dane

Topical routeLotionShampoo

Lindane should only be used in patients who cannot tolerate or have failed first-line treatment with safer medications for the treatment of scabies.

Seizures and deaths have been reported following lindane use with repeat or prolonged application, but also in rare cases following a single application used according to directions. Lindane should be used with caution for infants, children, the elderly, and individuals with other skin conditions (eg, atopic dermatitis, psoriasis) and in those who weigh less than 110 lbs (50 kg) as they may be at risk of serious neurotoxicity.

Lindane is contraindicated in premature infants and individuals with known uncontrolled seizure disorders.

Instruct patients on the proper use of lindane, the amount to apply, how long to leave it on, and avoiding retreatment. Inform patients that itching occurs after the successful killing of scabies and is not necessarily an indication for retreatment with lindane .

Lindane should only be used in patients who cannot tolerate or have failed first-line treatment with safer medications for the treatment of scabies. Seizures and deaths have been reported following lindane use. Risk of serious neurotoxicity when used in infants, children, the elderly, individuals with other skin conditions (eg, atopic dermatitis, psoriasis), and in those who weigh less than 110 lbs (50 kg). Lindane is contraindicated in premature infants and individuals with known uncontrolled seizure disorders. Instruct patients on the proper use of lindane .

Commonly used brand name(s):

In the U.S.

  • Kwell
  • Thionex

In Canada

  • Kwellada Lotion 1%
  • Lindane
  • Pms-Lindane

Available Dosage Forms:

  • Cream
  • Shampoo
  • Lotion

Therapeutic Class: Scabicide

Uses For Kwellada Lotion 1%

Lindane , formerly known as gamma benzene hexachloride, is an insecticide and is used to treat scabies and lice infestations.

Lindane cream and lotion are usually used to treat only scabies infestation. Lindane shampoo is used to treat only lice infestations.

Lindane is available only with your doctor’s prescription.


Before Using Kwellada Lotion 1%

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

Infants and children or people who weigh less than 110 pounds (50 kilograms) are especially sensitive to the effects of lindane. This may increase the chance of serious side effects during treatment. Be sure you have discussed the risks and benefits of using this medicine with your doctor. In addition, use of lindane is not to be used in premature infants.

Geriatric

Elderly people or people who weigh less than 110 pounds (50 kilograms) are especially sensitive to the effects of lindane. This may increase the chance of serious side effects during treatment. Be sure you have discussed the risks and benefits of this medicine with your doctor.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Alcohol use that is excessive, or
  • Brain tumor or
  • Head injuries, history of, or
  • HIV Infection or
  • Liver disease, or
  • Seizures, history of
  • Suddenly stopping the regular use of alcohol or sedatives —Patients with these conditions should use lindane carefully because these patients have a greater risk of having a seizure
  • Hypersensitivity to lindane
  • Seizure disorder—This medicine should not be used in patients with seizure disorders
  • Skin conditions—This medicine should not be used in people with crusted scabies, atopic dermatitis, or psoriasis. These problems of the skin could cause more lindane to be absorbed in your body and result in serious side effects.




Proper Use of lindane

This section provides information on the proper use of a number of products that contain lindane. It may not be specific to Kwellada Lotion 1%. Please read with care.

Lindane is poisonous. Keep it away from the mouth because it is harmful and may be fatal if swallowed.

Use lindane only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may increase the chance of absorption through the skin and the chance of lindane poisoning.

Keep lindane away from the eyes. If you should accidentally get some in your eyes, flush them thoroughly with water at once and contact your doctor.

Do not use lindane on open wounds, such as cuts or sores on the skin or scalp. To do so may increase the chance of lindane poisoning.

When applying lindane to another person, you should wear plastic disposable or rubber gloves made of latex or vinyl, especially if you are pregnant or are breast-feeding. Do not use natural latex gloves because lindane can go through those gloves and be absorbed by your skin. Wash hands very well after applying the lotion. This will prevent lindane from being absorbed through your skin. If you have any questions about this, check with your healthcare professional.

Put lindane lotion under fingernails, and trim fingernails short. Use a toothbrush to get the lindane lotion under fingernails, and throw out the toothbrush when finished.

Do not cover the area completely. Use a light clothing.

Lindane comes with patient directions. Be sure that you read them very carefully before using lindane. If you have any questions check with your healthcare professional.

Your sexual partner or partners, especially, and all members of your household may need to be treated also, since the infestation may spread to persons in close contact. If these persons have not been checked for an infestation or if you have any questions about this, check with your healthcare professional

To use the cream or lotion form of lindane for scabies :

  • If your skin has any cream, lotion, ointment, or oil on it, wash, rinse, and dry your skin well before applying lindane.
  • If you take a warm bath or shower before using lindane, dry the skin well before applying it.
  • Apply enough lindane to your dry skin to cover the entire skin surface from the neck down, including the soles of your feet, and rub in well.
  • Leave lindane on for 8 to 12 hours, then remove by washing thoroughly.

To use the shampoo form of lindane for lice:

  • If your hair has any cream, lotion, ointment, or oil-based product on it, shampoo, rinse, and dry your hair and scalp well before applying lindane.
  • If you apply this shampoo in the shower or in the bathtub, make sure the shampoo is not allowed to run down on other parts of your body. Also, do not apply this shampoo in a bathtub where the shampoo may run into the bath water in which you are sitting. To do so may increase the chance of absorption through the skin. When you rinse out the shampoo, be sure to thoroughly rinse your entire body also to remove any shampoo that may have gotten on it.
  • Apply enough shampoo to your dry hair (1 ounce or less for short hair, 1½ ounces for medium length hair, and 2 ounces or less for long hair) to thoroughly wet the hair and skin or scalp of the affected and surrounding hairy areas.
  • Thoroughly rub the shampoo into the hair and skin or scalp and allow to remain in place for 4 minutes. Then, use just enough water to work up a good lather.
  • Rinse thoroughly and dry with a clean towel.
  • When the hair is dry, comb with a fine-toothed comb to remove any remaining nits (eggs) or nit shells.
  • Do not use as a regular shampoo.

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 cream and lotion dosage forms:
    • For scabies:
      • Adults and children—Apply to the affected area(s) of the skin one time.
      • Premature infants—Use is not recommended.
  • For shampoo dosage form:
    • For lice:
      • Adults and children—Apply to the scalp or the affected area(s) of the skin one time.
      • Premature infants—Use is not recommended.

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.


Precautions While Using Kwellada Lotion 1%

To help prevent reinfestation or spreading of the infestation to other persons:

  • For scabies—All recently worn underwear and pajamas and used sheets, pillowcases, and towels should be washed in very hot water or dry-cleaned.
  • For lice—All recently worn clothing and used bed linens and towels should be washed in very hot water or dry-cleaned.

Kwellada Lotion 1% 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:

Rare

  • Convulsions (seizures)
  • dizziness, clumsiness, or unsteadiness
  • fast heartbeat
  • muscle cramps
  • nervousness, restlessness, or irritability
  • vomiting
  • skin irritation not present before use of lindane
  • skin rash

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

Serious side effects have resulted in patients using lindane. Sometime it has occurred even when used according to the labeled directions. Serious side effects have been reported following lindane use with repeat or prolonged use, but also in rare cases following a single application. You should discuss these possible effects with your doctor.

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.

 

Kytril

30/06/10

Generic Name: granisetron (Oral route, Intravenous route)

gra-NIS-e-tron

Commonly used brand name(s):

In the U.S.

  • Granisol
  • Kytril

Available Dosage Forms:

  • Solution
  • Tablet

Therapeutic Class: Antiemetic

Pharmacologic Class: Serotonin Receptor Antagonist, 5-HT3

Uses For Kytril

Granisetron is used to prevent the nausea and vomiting that may occur after treatment with anticancer medicines (chemotherapy) or with radiation therapy.

Granisetron is to be given only by or under the immediate supervision of your doctor.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, granisetron injection is used in certain patients:

  • To prevent the nausea and vomiting that may occur after cancer radiation treatment in patients undergoing bone marrow transplantation.


Before Using Kytril

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

This medicine has been tested in children 2 years of age and older and, in effective doses, has not been shown to cause different side effects or problems than it does in adults.

Geriatric

This medicine has been tested in a limited number of patients 65 years of age or older and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

Pregnancy Category Explanation
All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Apomorphine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Phenobarbital

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.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

The presence of other medical problems may affect the use of granisetron. Make sure you tell your doctor if you have any other medical problems, especially:

  • Abdominal (stomach) surgery, very recent or
  • Nausea and vomiting from the chemotherapy—If granisetron is taken when these medical problems exist, it may mask very serious stomach problems.




Proper Use of granisetron

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

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 prevention of nausea and vomiting caused by anticancer medicine:
    • For oral dosage form (tablets):
      • Adults and teenagers—Dose is usually 1 milligram (mg) taken up to one hour before the anticancer medicine. The 1-mg dose is taken again twelve hours after the first dose. Alternatively, 2 mg may be taken as one dose, up to one hour before the anticancer medicine.
      • Children—Dose must be determined by your doctor.
    • For injection dosage form:
      • Adults and children 2 years of age or older—Dose is based on body weight and must be determined by your doctor. It is usually 10 micrograms (mcg) per kilogram (kg) (4.5 mcg per pound) of body weight. It is injected into a vein over a period of five minutes, beginning within thirty minutes before the anticancer medicine is given.
      • Children up to 2 years of age—Dose must be determined by your doctor.
  • For prevention of nausea and vomiting caused by radiation therapy:
    • For oral dosage form (tablets):
      • Adults and teenagers—Dose is 2 milligrams (two 1 milligram tablets) taken within 1 hour of radiation.
      • Children—Dose must be determined by your doctor.


Precautions While Using Kytril

Check with your doctor if severe nausea and vomiting occur after receiving the anticancer medicine.

Kytril 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:

Less common

  • Blurred vision
  • fever
  • nervousness
  • pounding in the ears
  • slow or fast heartbeat

Rare

  • Arm, back or jaw pain
  • chest pain or discomfort
  • chest tightness or heaviness
  • confusion
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
  • fainting
  • irregular heartbeat
  • nausea
  • shortness of breath
  • skin rash, hives, and itching
  • sweating

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:

More common

  • Abdominal pain
  • constipation
  • diarrhea
  • headache
  • lack or loss of strength
  • unusual tiredness or weakness
  • vomiting

Less common

  • Agitation
  • dizziness
  • drowsiness
  • fear
  • heartburn
  • indigestion
  • nervousness
  • sleepiness or unusual drowsiness
  • sour stomach
  • trouble in sleeping
  • unusual taste in mouth

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.

 

Kuric Cream

30/06/10

Generic Name: Ketoconazole (kee-toe-KOE-na-zole)
Brand Name: Kuric and Nizoral

Kuric Cream is used for:

Treating certain fungal infections of the skin.

Kuric Cream is an imidazole antifungal. It works by killing sensitive fungi by interfering with the formation of the fungal cell membrane and weakening it. The weakened cell membrane allows the cell contents to leak out and results in the death of the fungus.

Do NOT use Kuric Cream if:

  • you are allergic to any ingredient in Kuric Cream

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

Before using Kuric Cream:

Some medical conditions may interact with Kuric Cream. 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 low blood sugar levels, liver disease, or porphyria (a blood disease), sulfite sensitivity, or you drink more than 3 alcohol-containing drinks a day

Some MEDICINES MAY INTERACT with Kuric Cream. Because little, if any, of Kuric Cream is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Kuric Cream 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 Kuric Cream:

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

  • Clean the affected area with soap and water and dry thoroughly. Apply enough medicine to cover the affected area. Rub in gently. Do not cover unless directed otherwise by your doctor. Wash your hands immediately after using Kuric Cream, unless your hands are part of the treated area.
  • Keep Kuric Cream out of your eyes, nose, and mouth. If this occurs, wash with water and contact your doctor, nurse, or pharmacist.
  • To clear up your infection completely, use Kuric Cream for the full course of treatment. Keep using it even if you feel better in a few days.
  • If you miss a dose of Kuric Cream, use 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 use 2 doses at once.

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

Important safety information:

  • Be sure to use Kuric Cream for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
  • If you use topical products too often, your condition may become worse.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Some of these products contain sulfites. Sulfites may cause an allergic reaction in some patients (eg, asthma patients). If you have ever had an allergic reaction to sulfites, ask your pharmacist if your product has sulfites in it.
  • Talk to your doctor before you take Kuric Cream if you drink more than 3 drinks with alcohol per day.
  • Kuric Cream should not be used 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 Kuric Cream while you are pregnant. It is not known if Kuric Cream is found in breast milk. Do not breast-feed while using Kuric Cream.

Possible side effects of Kuric Cream:

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:

Itching; mild irritation or stinging.

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); reddening, blistering, peeling, itching, or burning of your skin.

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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

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

Proper storage of Kuric Cream:

Store Kuric Cream between 59 and 77 degrees F (15 and 25 degrees C). Store in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Kuric Cream out of the reach of children and away from pets.

General information:

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

This information is a summary only. It does not contain all information about Kuric Cream. 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: May 5, 2010
Database Edition 10.2.1.002
Copyright © 2010 Wolters Kluwer Health, Inc.
 

Kutrase

30/06/10

Generic Name: pancrelipase (oral) (pan kre LYE pace)
Brand Names: Cotazym, Creon, Dygase, Ku-Zyme, Ku-Zyme HP, Kutrase, Lapase, Palcaps 10, Pancrease MT 10, Pancrease MT 16, Pancrease MT 20, Pancrease MT 4, Pancrecarb MS-16, Pancrecarb MS-4, Pancrecarb MS-8, Panocaps, Panocaps MT 16, Ultrase, Ultrase MT 12, Ultrase MT 18, Ultrase MT 20, Viokase, Viokase 16, Zenpep

What is pancrelipase?

Pancrelipase is a combination of three enzymes (proteins): lipase, protease, and amylase. These enzymes are normally produced by the pancreas and are important in the digestion of fats, proteins, and sugars.

Pancrelipase is used to replace these enzymes when the body does not have enough of its own. Certain medical conditions can cause this lack of enzymes, including cystic fibrosis, chronic inflammation of the pancreas, or blockage of the pancreatic ducts.

Pancrelipase may also be used following surgical removal of the pancreas.

Pancrelipase may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about pancrelipase?

You should not take pancrelipase if you are allergic to pork proteins.

Before taking pancrelipase, tell your doctor if you have gout, kidney disease, a history of intestinal blockage, a sudden onset of pancreatitis, or worsening of chronic pancreatic disease.

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

Do not hold the tablets or capsule contents in your mouth. The medication may irritate the inside of your mouth.

Do not inhale the powder from a pancrelipase capsule, or allow it to touch your skin. It may cause irritation, especially to your nose and lungs.

If you miss a dose of this medicine, skip the missed dose and wait until your next scheduled dose to take the medicine. Do not take extra medicine to make up the missed dose.


What should I discuss with my healthcare provider before taking pancrelipase?

You should not take pancrelipase if you are allergic to pork proteins.

If you have any of these other conditions, you may need a pancrelipase dose adjustment or special tests:

  • kidney disease;

  • gout;

  • a history of blockage in your intestines;

  • a sudden onset of pancreatitis; or

  • worsening of chronic pancreatic disease.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether pancrelipase 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 take pancrelipase?

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

Pancrelipase should be taken with a meal or snack. Take the medicine with a full glass of water or juice.

Do not hold the tablets or capsule contents in your mouth. The medication may irritate the inside of your mouth.

Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

You may open the pancrelipase capsule and sprinkle the medicine into a spoonful of pudding or applesauce to make swallowing easier. Swallow right away without chewing. Do not save the mixture for later use. Discard the empty capsule.

Do not inhale the powder from a pancrelipase capsule, or allow it to touch your skin. It may cause irritation, especially to your nose and lungs.

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

Store in the original container at room temperature (below 78 degrees F) for up to 12 weeks. Protect from moisture or high heat. Keep the bottle tightly closed when not in use. If the medication is exposed to temperatures between 78 and 104 degrees F, throw it away after 30 days. Do not use any pancrelipase that has been exposed to temperatures above 104 degrees F.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take 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.

Overdose symptoms may include diarrhea or stomach upset.

What should I avoid while taking pancrelipase?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.


Pancrelipase 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. Call your doctor at once if you have severe or unusual stomach pain. This could be a symptom of a rare but serious bowel disorder.

Less serious side effects may include:

  • nausea or vomiting;

  • mild stomach pain or upset;

  • diarrhea or constipation;

  • bloating or gas.

  • greasy stools;

  • rectal irritation;

  • headache, dizziness;

  • cough; or

  • weight loss.

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 pancrelipase?

There may be other drugs that can interact with pancrelipase. 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.

Where can I get more information?

  • Your pharmacist can provide more information about pancrelipase.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed
  • Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 5.01. Revision Date: 02/05/2010 8:53:06 AM.

 

Kuvan

30/06/10

Generic Name: sapropterin (SAP roe TER in)
Brand Names: Kuvan

What is sapropterin?

Sapropterin is a synthetic form of a natural salt that contributes to the function of a certain enzyme in the body. In people with a condition called phenylketonuria (PKU), this enzyme is lacking or missing in the body. Without the enzyme, phenylalanine levels can become elevated and cause a variety of neurologic symptoms.

Sapropterin is used to help the body activate the enzyme needed to control blood levels of phenylalanine. This medication is used in people with PKU.

Sapropterin may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about sapropterin?

Before using sapropterin, tell your doctor if you are allergic to any drugs, or if you have liver disease, a history of stomach ulcer or bleeding, or a seizure disorder.

Also tell your doctor about any medications you use, especially levodopa (Larodopa, Altamet, Parcopa, Sinemet), methotrexate (Rheumatrex, Trexall), or any medication to treat erectile dysfunction, such as sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra).

To be sure sapropterin is helping your condition, your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.

Sapropterin is only part of a complete program of treatment that also includes a special diet. It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you must avoid to help control your condition.

If sapropterin is not controlling your condition properly, you may have symptoms such as behavior changes, numbness or tingling, or problems with speech, vision, or balance. Call your doctor if you have any of these symptoms.

Follow your doctor’s instructions about any restrictions on food, beverages, or activity while you are using sapropterin.


What should I discuss with my health care provider before taking sapropterin?

Before using sapropterin, tell your doctor if you are allergic to any drugs, or if you have:

  • liver disease;

  • a history of stomach ulcer or bleeding; or

  • epilepsy or other seizure disorder.

If you have any of these conditions, you may not be able to take sapropterin, or you may need a dose adjustment or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether sapropterin 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 take sapropterin?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Sapropterin is usually given once daily. Follow your doctor’s instructions.

Sapropterin works best if you take it with food.

Dissolve the tablet in 4 to 8 ounces of water or apple juice. It will take about 15 minutes for the tablet to dissolve. Stir this mixture and then drink all of it right away. To make sure you get the entire dose, add a little more water or juice to the same glass, swirl gently and drink right away.

The tablet may not completely dissolve and you may see small pieces in the liquid. These pieces are safe for you to swallow.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.

Sapropterin can reduce your phenylalanine blood levels within 24 hours of when you take it. However, it may take up to 30 days of using this medicine before it reaches its fullest effect in your body. For best results, keep using the medication as directed.

Sapropterin is only part of a complete program of treatment that also includes a special diet. It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you must avoid to help control your condition.

Store sapropterin at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

Do not take 2 doses on the same day.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include headache and dizziness.

What should I avoid while taking sapropterin?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity while you are using sapropterin.


Sapropterin side effects

If sapropterin is not controlling your condition properly, you may have symptoms such as behavior changes, numbness or tingling, or problems with speech, vision, or balance. Call your doctor right away if you have any of these symptoms.

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. Call your doctor at once if you have any of the serious side effects below:

  • seizure (convulsions);

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, general ill feeling;

  • easy bruising or bleeding;

  • fever, chills, body aches, flu symptoms;

  • swelling in your hands or feet;

  • pain or burning when you urinate;

  • weakness or fainting;

  • black, bloody, or tarry stools; or

  • coughing up blood or vomit that looks like coffee grounds.

Less serious side effects may include:

  • nausea, vomiting, stomach pain, diarrhea;

  • runny or stuffy nose, cough;

  • headache, feeling agitated;

  • dizziness; or

  • joint pain.

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 sapropterin?

The following drugs can interact with sapropterin. Tell your doctor if you are using any of these:

  • levodopa (Larodopa, Altamet, Parcopa, Sinemet);

  • methotrexate (Rheumatrex, Trexall);

  • sildenafil (Viagra);

  • tadalafil (Cialis); or

  • vardenafil (Levitra).

This list is not complete and there may be other drugs that can interact with sapropterin. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about sapropterin.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.02. Revision Date: 4/12/2009 4:46:21 PM.

 

Ku-Zyme HP

30/06/10

Generic Name: pancrelipase (oral) (pan kre LYE pace)
Brand Names: Cotazym, Creon, Dygase, Ku-Zyme, Ku-Zyme HP, Kutrase, Lapase, Palcaps 10, Pancrease MT 10, Pancrease MT 16, Pancrease MT 20, Pancrease MT 4, Pancrecarb MS-16, Pancrecarb MS-4, Pancrecarb MS-8, Panocaps, Panocaps MT 16, Ultrase, Ultrase MT 12, Ultrase MT 18, Ultrase MT 20, Viokase, Viokase 16, Zenpep

What is pancrelipase?

Pancrelipase is a combination of three enzymes (proteins): lipase, protease, and amylase. These enzymes are normally produced by the pancreas and are important in the digestion of fats, proteins, and sugars.

Pancrelipase is used to replace these enzymes when the body does not have enough of its own. Certain medical conditions can cause this lack of enzymes, including cystic fibrosis, chronic inflammation of the pancreas, or blockage of the pancreatic ducts.

Pancrelipase may also be used following surgical removal of the pancreas.

Pancrelipase may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about pancrelipase?

You should not take pancrelipase if you are allergic to pork proteins.

Before taking pancrelipase, tell your doctor if you have gout, kidney disease, a history of intestinal blockage, a sudden onset of pancreatitis, or worsening of chronic pancreatic disease.

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

Do not hold the tablets or capsule contents in your mouth. The medication may irritate the inside of your mouth.

Do not inhale the powder from a pancrelipase capsule, or allow it to touch your skin. It may cause irritation, especially to your nose and lungs.

If you miss a dose of this medicine, skip the missed dose and wait until your next scheduled dose to take the medicine. Do not take extra medicine to make up the missed dose.


What should I discuss with my healthcare provider before taking pancrelipase?

You should not take pancrelipase if you are allergic to pork proteins.

If you have any of these other conditions, you may need a pancrelipase dose adjustment or special tests:

  • kidney disease;

  • gout;

  • a history of blockage in your intestines;

  • a sudden onset of pancreatitis; or

  • worsening of chronic pancreatic disease.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether pancrelipase 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 take pancrelipase?

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

Pancrelipase should be taken with a meal or snack. Take the medicine with a full glass of water or juice.

Do not hold the tablets or capsule contents in your mouth. The medication may irritate the inside of your mouth.

Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

You may open the pancrelipase capsule and sprinkle the medicine into a spoonful of pudding or applesauce to make swallowing easier. Swallow right away without chewing. Do not save the mixture for later use. Discard the empty capsule.

Do not inhale the powder from a pancrelipase capsule, or allow it to touch your skin. It may cause irritation, especially to your nose and lungs.

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

Store in the original container at room temperature (below 78 degrees F) for up to 12 weeks. Protect from moisture or high heat. Keep the bottle tightly closed when not in use. If the medication is exposed to temperatures between 78 and 104 degrees F, throw it away after 30 days. Do not use any pancrelipase that has been exposed to temperatures above 104 degrees F.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take 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.

Overdose symptoms may include diarrhea or stomach upset.

What should I avoid while taking pancrelipase?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.


Pancrelipase 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. Call your doctor at once if you have severe or unusual stomach pain. This could be a symptom of a rare but serious bowel disorder.

Less serious side effects may include:

  • nausea or vomiting;

  • mild stomach pain or upset;

  • diarrhea or constipation;

  • bloating or gas.

  • greasy stools;

  • rectal irritation;

  • headache, dizziness;

  • cough; or

  • weight loss.

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 pancrelipase?

There may be other drugs that can interact with pancrelipase. 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.

Where can I get more information?

  • Your pharmacist can provide more information about pancrelipase.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed
  • Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 5.01. Revision Date: 02/05/2010 8:53:06 AM.

 

 

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