Telbivudine

Class: Nucleosides and Nucleotides
VA Class: AM800
Chemical Name: 1-[(2S,4R,5S)-4-hydroxy-5-hydroxymethyltetrahydrofuran-2-yl]-5-methyl-1 H-pyrimidine-2,4-dione
Molecular Formula: C₁₀H₁₄N₂O₅
CAS Number: 3424-98-4
Brands: Tyzeka

• 
  

  Severe acute exacerbations of hepatitis reported in patients who have discontinued anti-hepatitis B virus (HBV) therapy, including telbivudine.¹ (See Exacerbations of Hepatitis under Cautions.) Closely monitor hepatic function in patients who discontinue anti-HBV therapy; if appropriate, resumption of therapy may be warranted.¹

  
  


• 
  

  Lactic acidosis and severe hepatomegaly with steatosis (including some fatalities) reported in patients receiving nucleoside analogs alone or in conjunction with antiretroviral agents.¹ (See Lactic Acidosis and Severe Hepatomegaly with Steatosis under Cautions.)

  
  

REMS:

FDA approved a REMS for telbivudine to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page () or the ASHP REMS Resource Center ().

Introduction

Antiviral; synthetic thymidine nucleoside analog.^{1 2}

Uses for Telbivudine

Chronic Hepatitis B Virus (HBV) Infection

Management of chronic HBV infection in adults and adolescents ≥16 years of age with evidence of active HBV replication and either persistent elevations in serum aminotransaminases (ALT or AST) or histologic evidence of active disease.^{1 2} Relationship between treatment response and long-term outcomes of the disease (e.g., hepatocellular carcinoma, decompensated cirrhosis) not known.¹

Has been effective for HBeAg-positive or -negative chronic HBV infection with compensated liver disease in patients who were nucleoside-naive (had not previously received treatment with nucleoside antivirals).^{1 2 3}

Not systematically evaluated to date in patients with lamivudine- or adefovir-resistant HBV.¹ (See HBV Resistance under Cautions.)

Safety and efficacy not established for treatment of chronic HBV infection in liver transplant patients.¹ (See Liver Transplant Recipients under Cautions.)

No data to date regarding treatment of HBV infection in patients coinfected with HIV, hepatitis C virus (HCV), or hepatitis D virus (HDV).¹

Treatment of chronic HBV infection is complex and rapidly evolving and should be directed by clinicians familiar with the disease; consult a specialist to obtain the most up-to-date information.⁴

Telbivudine Dosage and Administration

Administration

Oral Administration

Administer orally without regard to meals.¹

Dosage

Optimal duration of treatment for chronic HBV infection unknown.¹

Pediatric Patients

Chronic Hepatitis B Virus (HBV) Infection

Oral

Adolescents ≥16 years of age: 600 mg once daily.¹

Adults

Chronic Hepatitis B Virus (HBV) Infection

Oral

600 mg once daily.¹

Special Populations

Hepatic Impairment

Dosage adjustment not required.¹

Renal Impairment

Increase dosing interval in those with Cl_cr <50 mL/minute, including those undergoing hemodialysis.¹

Dosage for Treatment of Chronic HBV Infection in Patients with Renal Impairment

Clcr(mL/min)	Dosage
≥50	600 mg once daily1 9
30–49	600 mg once every 48 hours1
<30 (not requiring dialysis)	600 mg once every 72 hours1
Hemodialysis patients	600 mg once every 96 hours; give dose after hemodialysis1

Cautions for Telbivudine

Contraindications

• 
  

  Known hypersensitivity to telbivudine or any ingredient in the formulation.¹

  
  

Warnings/Precautions

Warnings

Exacerbations of Hepatitis

Clinical and laboratory evidence of severe acute exacerbations of hepatitis may occur following discontinuance of HBV therapy, including telbivudine.¹ Data insufficient to date regarding incidence of exacerbation of hepatitis following discontinuance of telbivudine.¹

Exacerbations of hepatitis or ALT flare (e.g., ALT elevations >10 times ULN and >2 times baseline) reported during telbivudine treatment in 3% of patients.¹

Closely monitor hepatic function clinically and with laboratory studies at repeated intervals for at least several months after telbivudine discontinuance.¹ If appropriate, resumption of anti-HBV therapy may be warranted.¹

Lactic Acidosis and Severe Hepatomegaly with Steatosis

Lactic acidosis and severe hepatomegaly with steatosis (including some fatalities) reported in patients receiving nucleoside analogs alone or in conjunction with antiretrovirals.¹

Musculoskeletal Effects

Myopathy (persistent unexplained muscle pain, tenderness, or weakness in conjunction with increased serum CK concentrations) reported.¹ Risk factors for myopathy not identified.¹ Uncomplicated myalgia also reported.¹

Consider myopathy in patients presenting with musculoskeletal symptoms suggestive of this adverse event.¹ Temporarily interrupt therapy if myopathy suspected; discontinue if myopathy diagnosed.¹

Not known if risk of myopathy is increased by concomitant administration of other drugs associated with myopathy (e.g., corticosteroids, chloroquine, hydroxychloroquine, cyclosporine, niacin, fibric acid derivatives [e.g., gemfibrozil], macrolide antibiotics [i.e., erythromycin], penicillamine, certain azole antifungals [i.e., itraconazole, ketoconazole], certain hydroxymethylglutaryl-CoA [HMG-CoA] reductase inhibitors [statins], zidovudine).¹ If such concomitant therapy is considered, weigh potential benefits and risks.¹ Carefully monitor patient, especially during dosage titration.¹

General Precautions

HBV Resistance

Telbivudine-resistant HBV detected in patients receiving the drug; diminished treatment response reported.^{1 2} After 2 years of therapy, viral rebound due to telbivudine resistance was reported in 21.6% of HBeAg-positive patients and 8.6% of HBeAg-negative patients.²

Not systematically evaluated in patients with lamivudine-resistant HBV.¹ Lamivudine-resistant HBV with substitutions at rtM204I or rtL180M/rtM204V have high level of cross-resistance to telbivudine.¹ Strains with substitutions at rtM204V (a mutation associated with lamivudine resistance) have reduced susceptibility to telbivudine (1.2-fold reduction).¹

Not systematically evaluated in patients with adefovir-resistant HBV.¹ Telbivudine has in vitro activity against adefovir-resistant strains with substitutions at rtN236T but not against adefovir-resistant strains with substitutions at rtA181V.¹

Liver Transplant Recipients

Safety and efficacy in liver transplant recipients not evaluated.¹ If telbivudine considered necessary in liver transplant recipients who have received or are receiving an immunosuppressive agent that may affect renal function (e.g., cyclosporine, tacrolimus), monitor renal function prior to and during telbivudine treatment.¹ (See Drugs Affecting or Eliminated by Renal Excretion under Interactions.)

Specific Populations

Pregnancy

Category B.¹ Pregnancy registry at 800-258-4263.¹

Data not available regarding the effect of telbivudine therapy during pregnancy on transmission of HBV to the infant; use appropriate interventions to prevent neonatal acquisition of HBV infection (hepatitis B immune globulin [HBIG] and HBV vaccine).^{1 4 8}

Lactation

Not known whether distributed into human milk.¹ Do not breast-feed infants while receiving telbivudine.¹

Pediatric Use

Safety and efficacy not established in children <16 years of age.¹

Geriatric Use

Experience in those ≥65 years of age insufficient to determine whether they respond differently than younger adults.¹

Use with caution due to the greater frequency of decreased renal function and of concomitant disease and drug therapy in the elderly.¹ Monitor renal function and adjust dosage accordingly.¹ (See Renal Impairment under Dosage and Administration.)

Renal Impairment

Dosage adjustment recommended in patients with Cl_cr <50 mL/minute, including those undergoing hemodialysis.¹ (See Dosage in Renal Impairment under Dosage and Administration.)

Common Adverse Effects

Upper respiratory tract infection, GI symptoms (abdominal pain, nausea, vomiting, diarrhea or loose stools, dyspepsia), fatigue, malaise, nasopharyngitis, headache, influenza or influenza-like symptoms, elevated CK concentrations, cough, pyrexia, arthralgia, rash, back pain, dizziness, myalgia, insomnia.¹

Interactions for Telbivudine

Telbivudine is not a substrate for CYP isoenzymes.¹ It does not inhibit CYP isoenzymes 1A2, 2C9, 2C19, 2D26, 2E1, or 3A4.¹

Pharmacokinetic interactions with drugs metabolized by CYP isoenzymes unlikely.¹

Drugs Affecting or Eliminated by Renal Excretion

Interaction with other drugs eliminated by renal excretion unlikely.¹

Concomitant use with drugs that affect renal function may alter plasma concentrations of telbivudine.¹ If telbivudine is used with an immunosuppressive agent that alters renal function, monitor renal function before and during telbivudine therapy.¹

Drugs Associated with Myopathy

Not known if risk of myopathy is increased by concomitant use of other drugs associated with myopathy.¹ (See Musculoskeletal Effects under Cautions.)

Specific Drugs

Drug	Interaction	Comments
Adefovir	Pharmacokinetic interaction unlikely1 5 In vitro evidence of additive antiviral effects against HBV1
Cyclosporine	Pharmacokinetic interaction unlikely1	Monitor renal function1
Nucleoside and nucleotide reverse transcriptase inhibitors (NRTIs)	Lamivudine: Pharmacokinetic interaction unlikely1 5 Abacavir, didanosine, emtricitabine, lamivudine, stavudine, tenofovir, zidovudine: No in vitro evidence of reduced antiretroviral activity1 Didanosine, stavudine: No in vitro evidence of antagonistic antiviral effects against HBV1
Peginterferon alfa-2a	No change in the pharmacokinetics of telbivudine; effect on the pharmacokinetics of peginterferon alfa-2a unclear due to high interindividual variability in disposition of peginterferon alfa-2a1

Telbivudine Pharmacokinetics

Absorption

Bioavailability

Peak plasma concentrations attained within 1–4 hours after a dose.¹ Steady-state concentrations achieved after 5–7 days of once-daily administration with approximately 1.5-fold accumulation.¹

Food

Food (high-fat, high-calorie meal) does not appear to affect absorption.^{1 6}

Distribution

Extent

Widely distributed into tissues.¹

Not known whether telbivudine is distributed into human milk.¹

Plasma Protein Binding

3.3%.¹

Elimination

Metabolism

Undergoes phosphorylation by cellular enzymes to form active metabolite, telbivudine triphosphate.¹

Telbivudine is not metabolized by CYP isoenzymes.¹

Elimination Route

Eliminated primarily as unchanged drug in urine.¹

Hemodialysis removes approximately 23% of a dose.¹

Half-life

Terminal elimination half-life: 40–49 hours.¹

Special Populations

Impaired hepatic function: Pharmacokinetics not affected.^{1 7}

Impaired renal function: Decreased clearance.¹

Stability

Storage

Oral

Tablets

In original container at 25°C (may be exposed to 15–30°C).¹

Actions and Spectrum

• 
  

  Synthetic thymidine nucleoside analog antiviral agent that is active in vivo and in vitro against HBV.^{1 2}

  
  


• 
  

  Active metabolite, telbivudine triphosphate, inhibits activities of HBV DNA polymerase (reverse transcriptase).¹

  
  


• 
  

  Not active against HIV-1 (EC₅₀ >100 mcM).¹

  
  


• 
  

  HBV strains with reduced susceptibility to telbivudine have emerged during therapy with the drug.^{1 2 3}

  
  


• 
  

  Cross-resistance may occur among some nucleoside analogs active against HBV.¹ Lamivudine-resistant HBV with reduced susceptibility to telbivudine have been observed in vitro.¹ Some adefovir-resistant HBV are resistant to telbivudine; other strains remain susceptible to telbivudine.^{1 2}

  
  

Advice to Patients

• 
  

  Importance of providing a copy of the manufacturer’s patient information.¹

  
  


• 
  

  Importance of taking telbivudine exactly as prescribed and not discontinuing or interrupting therapy unless instructed by a clinician; importance of regular medical follow-up.^{1 10}

  
  


• 
  

  Advise patients that deterioration of liver disease has occurred when telbivudine therapy is discontinued and that any change in treatment should be discussed with the clinician.¹

  
  


• 
  

  Importance of immediately reporting to clinicians any unexplained muscle weakness, tenderness, or pain.¹

  
  


• 
  

  Importance of HBV therapy compliance.^{1 10} Telbivudine is not a cure for HBV infection; it is not known whether the drug will prevent long-term sequelae (cirrhosis, liver cancer).¹

  
  


• 
  

  Patients should be advised of available measures to prevent spread of HBV infection to close contacts.^{1 10} HBV transmission via sexual contact, sharing needles, or blood contamination is not prevented by telbivudine therapy.^{1 10}

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, and any concomitant illnesses (e.g., renal disease).¹

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Telbivudine

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, film-coated	600 mg	Tyzeka (with povidone)	Idenix

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 10/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Tyzeka 600MG Tablets (NOVARTIS): 30/$816.03 or 90/$2,208.88

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions October 27, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Idenix Pharmaceuticals. Tyzeka (telbivudine) tablet prescribing information. Cambridge, MA; 2006 Oct.

2. Anon. Telbivudine (Tyzeka) for chronic hepatitis B. Med Lett Drugs Ther. 2007; 49:11-12.

3. Lai CL, Leung N, Teo EK et al. A 1-year trial of telbivudine, lamivudine, and the combination in patients with hepatitis B e antigen-positive chronic hepatitis B. Gastroenterology. 2005; 129:528-36. [PubMed 16083710]

4. Lok ASF, McMahon BJ. Chronic hepatitis B. AASLD practice guidelines. Hepatology. 2007; 45:507-39. [PubMed 17256718]

5. Zhou XJ, Fielman BA, Lloyd DM et al. Pharmacokinetics of telbivudine in healthy subjects and absence of drug interactions with lamivudine or adefovir dipivoxil. Antimicrob Agents Chemother. 2006; 50:2309-15. [PubMed 16801406]

6. Zhou XJ, Lloyd DM, Chao GC, Brown NA. Absence of food effect on the pharmacokinetics of telbivudine following oral administration in healthy subjects. J Clin Pharmacol. 2006; 46:275-81. [PubMed 16490803]

7. Zhou XJ, Marbury TC, Alcorn HW et al. Pharmacokinetics of telbivudine in subjects with various degrees of hepatic impairment. Antimicrob Agents Chemother. 2006; 50:1721-6. [PubMed 16641441]

8. American Academy of Pediatrics. 2006 Red book: Report of the Committee on Infectious Diseases. 27th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2006.

9. Idenix Pharmaceuticals. Cambridge, MA, Personal communication.

10. Idenix Pharmaceuticals. Patient information: Tyzeka. Cambridge, MA; 2006 Oct.

More Telbivudine resources

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

• Telbivudine MedFacts Consumer Leaflet (Wolters Kluwer)


• Telbivudine Professional Patient Advice (Wolters Kluwer)


• telbivudine Advanced Consumer (Micromedex) - Includes Dosage Information


• Tyzeka Prescribing Information (FDA)


• Tyzeka Consumer Overview

Compare Telbivudine with other medications

• Hepatitis B

Petco Lidocaine

Dosage Form: FOR ANIMAL USE ONLY
Drug Facts

    PETCO

   Itch Relief Spray

PETCO Itch Relief is a colorless, odorless, non-sticky, non-staining, water based formula containing the following ingredients which provide temporary relief of pain and itching from minor skin problems:

• Lidocaine - An anesthectic to instantly calm pain and itching


• Aloe Vera and Allantoin - To soothe irritated skin


• Glycerin - A humectant to help moisturize the skin


• Denatonium Benzoate - A non-toxic bittering agent to deter chewing and licking of skin irritations
  

Active Ingredients

2% Lidocaine HCL, 0.01% Benzalkonium Chloride

Uses

Provides temporary relief of pain and itching from minor skin problems such as insect bites, cuts, scrapes, and burns.

Warnings

Should irritation develop, persist or increase, discontinue use and consult a veterinarian. Keep this product out of reach of children and pets to avoid unintended consumption.

Directions

For use on dogs over six weeks old. Hold sprayer 6-8 inches from animal and thoroughly wet affected area making sure spray contacts the skin. Avoid spraying in eyes, nose, ears or mouth.

other Information

Store at 20-25C (68-77F)

Inactive Ingredients

Water, glycerin, Aloe Vera, Allantoin, Denatonium Benzoate.

FOR QUESTIONS CALL 1-877-473-8465

PETCO

Itch Relief

Spray

For Dogs

• Medicated Spray


• Helpstemporarily relieve itching


• Helps aid in the temporary relief of minor skin problems

Veterinarian Approved


NET 8 FL. OZ. (236mL)

PETCO  lidocaine hydrochloride  liquid

Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 27102-806 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE 4.72 g  in 236 g

Inactive Ingredients Ingredient Name Strength Water   GLYCERIN   ALOE VERA LEAF   ALLANTOIN   DENATONIUM BENZOATE   BENZALKONIUM CHLORIDE

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 27102-806-07 236 g In 1 BOTTLE, SPRAY None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/01/2001

Labeler - PETCO (028364727)

Registrant - United Pet Group (931135730)

Establishment
Name	Address	ID/FEI	Operations
JUNGLE LABORATORIES CORPORATION		032615270	manufacture

Revised: 03/2010PETCO

Mineral Oil Enema

Pronunciation: MIN-uh-ral
Generic Name: Mineral Oil
Brand Name: Fleet

Mineral Oil Enema is used for:

Relieving occasional constipation or fecal impaction (severe constipation). It may also be used to cleanse and remove residue from the bowel in certain situations (eg, after using a barium enema).

Mineral Oil Enema is a lubricant laxative that works by slowing the absorption of water from the bowel, which softens the stool.

Do NOT use Mineral Oil Enema if:

• you are allergic to any ingredient in Mineral Oil Enema


• you have appendicitis or a blockage in your intestines


• you are bedridden

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

Before using Mineral Oil Enema:

Some medical conditions may interact with Mineral Oil Enema. 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 heart failure, stomach pain, nausea, vomiting, rectal bleeding, or kidney problems

Some MEDICINES MAY INTERACT with Mineral Oil Enema. However, no specific interactions with Mineral Oil Enema are known at this time.

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

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

• To use Mineral Oil Enema, lie on your left side with your knee bent and your arms resting comfortably. You may also kneel, then lower your head and chest forward until the left side of your face is resting on the surface with your left arm folded comfortably.


• Remove the orange protective shield from the enema tip before inserting. With steady pressure, gently insert the enema tip into the rectum with a slight side to side movement. Insertion may be easier if you bear down, as if having a bowel movement. This helps to relax the muscles around the anus.


• Do not force the enema tip into the rectum. This may cause injury.


• Squeeze the bottle until nearly all of the liquid is gone, unless directed otherwise by your doctor or the dosing instructions on the package labeling. It is not necessary to empty the bottle completely.


• Remove the enema tip from your rectum, then hold in the medicine according to your doctor's instructions.


• Take Mineral Oil Enema at least 2 hours before bedtime.


• If you miss a dose of Mineral Oil Enema and you are using it regularly, use it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Mineral Oil Enema.

Important safety information:

• Do not use Mineral Oil Enema or any laxative for more than 1 week unless directed to do so by your health care provider.


• Do not exceed the recommended dose or use Mineral Oil Enema for longer than prescribed without checking with your doctor.


• Use of Mineral Oil Enema for a long time may result in loss of normal bowel function.


• Do not take additional laxatives or stool softeners with Mineral Oil Enema unless directed by your doctor.


• If you notice a sudden change in bowel habits that lasts for 2 weeks or more, do not continue using Mineral Oil Enema. Instead, check with your doctor.


• Stop use and contact your doctor immediately if you experience rectal bleeding or failure to have a bowel movement after using a laxative. This may be a sign of a serious condition.


• If you develop nausea, vomiting, or stomach pain, stop using Mineral Oil Enema and contact your doctor immediately.


• Mineral Oil Enema is not recommended for use in CHILDREN younger than 2 years of age. Safety and effectiveness in this age group have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Mineral Oil Enema during pregnancy. It is unknown if Mineral Oil Enema is excreted in breast milk. If you are or will be breast-feeding, check with your doctor to discuss the risks to your baby.

Possible side effects of Mineral Oil Enema:

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:

Bloating; diarrhea; gas; nausea; stomach cramps.

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); dizziness; failure to have a bowel movement within 6 to 8 hours after using Mineral Oil Enema; fainting; muscle cramps or pain; rectal bleeding; swelling, pain, or irritation; weakness.

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 .

See also: Mineral side effects (in more detail)

If OVERDOSE is suspected:

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

Proper storage of Mineral Oil Enema:

Store Mineral Oil Enema at room temperature, between 59 and 86 degrees F (15 and 30 degrees C) in a tightly closed container. Store away from heat, moisture, and light. Protect from freezing. Keep Mineral Oil Enema out of the reach of children and away from pets.

General information:

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


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


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


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

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

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Mineral Oil resources

• Mineral Oil Side Effects (in more detail)
• Mineral Oil Use in Pregnancy & Breastfeeding
• Mineral Oil Drug Interactions
• Mineral Oil Support Group
• 0 Reviews · Be the first to review/rate this drug

Chlordiazepoxide/Methscopolamine

Pronunciation: klor-DYE-aze-ee-POX-ide/meth-skoe-POL-uh-meen
Generic Name: Chlordiazepoxide/Methscopolamine
Brand Name: Librax

Chlordiazepoxide/Methscopolamine is used for:

Treating stomach ulcers, irritable bowel syndrome, and intestinal inflammation (enterocolitis). It may also be used for other conditions as determined by your doctor.

Chlordiazepoxide/Methscopolamine is a combination benzodiazepine and anticholinergic. The benzodiazepine works by decreasing anxiety and muscle spasms and also causing sedation. The anticholinergic works by decreasing stomach acid and relaxing stomach and intestinal muscles.

Do NOT use Chlordiazepoxide/Methscopolamine if:

• you are allergic to any ingredient in Chlordiazepoxide/Methscopolamine


• you have glaucoma, an enlarged prostate or other prostate problems, severe liver disease, or severe mental problems (psychosis)


• you have severe heart blood vessel disease, severe high blood pressure, severe bleeding, severe irritation of the esophagus or other serious problems with the esophagus (eg, esophageal achalasia), a blockage of your stomach or bowel, bowel motility problems, severe bowel inflammation (eg, ulcerative colitis), a blockage of your bladder, certain muscle problems (eg, myasthenia gravis), or uncontrolled bleeding


• you are taking sodium oxybate (GHB)

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

Before using Chlordiazepoxide/Methscopolamine:

Some medical conditions may interact with Chlordiazepoxide/Methscopolamine. 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 liver or kidney problems, lung problems or chronic obstructive pulmonary disease (COPD), muscle problems, depression, mental or mood problems, suicidal thoughts or behaviors, the blood disorder porphyria, or a history of drug abuse or dependence


• if you have nerve problems, bowel problems, heart problems (eg, irregular heartbeat, congestive heart failure), a hernia, trouble urinating, or you are at risk for glaucoma

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

• Rifampin because the effectiveness of Chlordiazepoxide/Methscopolamine may be decreased


• Azole antifungals (eg, ketoconazole), clozapine, disulfiram, nefazodone, omeprazole, sodium oxybate (GHB), or valproic acid because side effects such as increased sedation may occur


• Anticoagulants (eg, warfarin), clozapine, hydantoins (eg, phenytoin), or sodium oxybate (GHB) because the actions and side effects of these medicines may be increased


• Anticholinergic medicines (eg, benztropine, hyoscyamine, or trihexyphenidyl), monoamine oxidase (MAO) inhibitors (eg, phenelzine), phenothiazines (eg, thioridazine), tricyclic antidepressants (eg, amitriptyline), or medicines for mental or mood disorders because they may increase the risk of Chlordiazepoxide/Methscopolamine's side effects


• Beta-blockers (eg, propanolol) or digoxin because the actions and side effects may be increased by Chlordiazepoxide/Methscopolamine

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

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

• Take Chlordiazepoxide/Methscopolamine by mouth before meals and at bedtime unless directed otherwise by your doctor.


• Do not take an antacid within 1 hour before or 2 hours after you take Chlordiazepoxide/Methscopolamine.


• Do not suddenly stop taking Chlordiazepoxide/Methscopolamine. Withdrawal symptoms may occur if you decrease your dose or suddenly stop taking it. Talk with your doctor about any changes to your dose.


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

Ask your health care provider any questions you may have about how to use Chlordiazepoxide/Methscopolamine.

Important safety information:

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


• Chlordiazepoxide/Methscopolamine may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Chlordiazepoxide/Methscopolamine; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Do not take more than the recommended dose, take Chlordiazepoxide/Methscopolamine for longer than prescribed, or suddenly stop taking Chlordiazepoxide/Methscopolamine without first checking with your doctor.


• Chlordiazepoxide/Methscopolamine may make your eyes more sensitive to sunlight. It may help to wear sunglasses.


• Antacids may decrease the effectiveness of Chlordiazepoxide/Methscopolamine. Talk to your doctor before taking any antacids while taking Chlordiazepoxide/Methscopolamine.


• Lab tests, including blood cell counts and liver function tests, may be performed while you use Chlordiazepoxide/Methscopolamine. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Chlordiazepoxide/Methscopolamine with caution in the ELDERLY; they may be more sensitive to its effects, especially drowsiness, confusion, and loss of coordination.


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


• PREGNANCY and BREAST-FEEDING: Chlordiazepoxide/Methscopolamine may cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Chlordiazepoxide/Methscopolamine while you are pregnant. Chlordiazepoxide/Methscopolamine is found in breast milk. Do not breast-feed while taking Chlordiazepoxide/Methscopolamine.

When used for long periods of time or at high doses, Chlordiazepoxide/Methscopolamine may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Chlordiazepoxide/Methscopolamine stops working well. Do not take more than prescribed.

Some people who use Chlordiazepoxide/Methscopolamine for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you are on long-term or high-dosage therapy and you stop taking Chlordiazepoxide/Methscopolamine suddenly, you may have WITHDRAWAL symptoms including convulsions, tremor, stomach and muscle cramps, vomiting, sweating, and trouble sleeping. Do not stop therapy abruptly or change dosage without asking your pharmacist or doctor. Discuss overuse with your doctor or pharmacist.

Possible side effects of Chlordiazepoxide/Methscopolamine:

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:

Bloating; blurred vision; clumsiness; confusion; constipation; decreased sweating; difficulty sleeping; dizziness; enlarged pupils; excessive daytime drowsiness; headache; lack of coordination; lightheadedness; nausea; nervousness; unsteadiness.

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); changes in heartbeat; decreased urination; decreased sexual ability or desire; diarrhea; difficulty focusing your eyes; fainting; fast heartbeat; fever, chills, or persistent sore throat; involuntary muscle movements; loss of taste; mental or mood changes; overexcitement; overstimulation; pounding in the chest; swelling; unusual weakness; vomiting; yellowing of the skin or eyes.

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

See also: Chlordiazepoxide/Methscopolamine side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include confusion; clumsiness; coma; deep sleep; difficulty breathing; disorientation; drowsiness; excessive thirst; flushing; loss of consciousness; muscle weakness; overexcitement; severe or persistent nausea, dizziness, or drowsiness; severe dry mouth; slow reflexes.

Proper storage of Chlordiazepoxide/Methscopolamine:

Store Chlordiazepoxide/Methscopolamine 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 Chlordiazepoxide/Methscopolamine out of the reach of children and away from pets.

General information:

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


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


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


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

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

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Chlordiazepoxide/Methscopolamine resources

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

Compare Chlordiazepoxide/Methscopolamine with other medications

• Enterocolitis
• Irritable Bowel Syndrome
• Peptic Ulcer

Difflam-P Cream

Difflam 3% P Cream

Benzydamine hydrochloride

Read all of this leaflet carefully because it contains important information for you.

• This medicine is available without prescription. However, you still need to use it carefully to get the best results.


• Keep this leaflet.You may need to read it again.


• Ask your doctor or pharmacist if you need more information or advice.


• You must contact a doctor if your symptoms worsen or do not improve.

In this leaflet:

1. What Difflam P Cream is for

2. Before you use Difflam P Cream

3. How to use Difflam P Cream

4. Possible side effects

5. How to store Difflam P Cream

6. Further information.

What Difflam P Cream is for

Difflam P Cream belongs to a group of medicines called non-steroidal anti-inflammatory drugs or NSAIDS.

Difflam P Cream works by stopping pain and swelling (inflammation). When rubbed into the skin of the affected area it is used to treat aches and pains including:

• Sprains


• Strains


• Bruises


• Sore muscles


• Stiff joints.

Before you use Difflam P Cream

Do not use Difflam P Cream if

• you are allergic to benzydamine hydrochloride


• you are allergic to any of the other ingredients of Difflam P Cream (see section 6).

If either of these applies to you, talk to your doctor, dentist or pharmacist.

Taking other medicines

Tell your doctor, dentist or pharmacist before using Difflam P Cream if you are taking any other medicines, even medicines obtained without a prescription.

Pregnancy and breastfeeding

If you are pregnant, trying to become pregnant or breast-feeding ask your doctor, dentist or pharmacist for advice before using Difflam P Cream.

How to use Difflam P Cream

Important:

Always use Difflam P Cream exactly as your pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.

If you get Difflam P Cream in your eyes, mouth, nose or around your genitals or anus.

Do not use Difflam P Cream in or near your eyes, mouth, nose or around your genitals or anus. If any cream does get in or onto these parts of your body, wash them immediately with cold water.

How much Difflam P Cream to use

The amount of cream used will depend on the size of the area to be treated.

The normal length of cream to be squeezed out of the tube is between a half and a full finger length (35-85 mm).

How to use the cream

Rub the cream gently into the affected area until it seems to disappear.

The cream should be used three times each day for no more than 10 days. Your doctor may tell you to use it more often.

Please wash your hands after applying the cream (unless your hands are being treated).

If your symptoms worsen or do not improve

Contact your doctor if your symptoms worsen or they do not improve.

If you use more Difflam P Cream than you should

It should not cause you any problems if you accidentally swallow some of your medicine.

If you have any concerns, contact your doctor or pharmacist.

If you forget to use Difflam P Cream

Do not apply a double dose to make up for a missed dose. Simply apply the next dose as planned.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

Difflam-P Cream Side Effects

Like all medicines Difflam P Cream can cause side effects, although not everybody gets them.

You may experience the following:

• Itching


• Skin rash


• Skin redness or swelling


• Difficulty breathing and wheezing.

Some people become more sensitive to the effects of sunlight after using this P Cream.

This means that the skin may become red and painful after only a few minutes in the sun.

These side effects should disappear if you stop using the cream.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store Difflam P Cream

Keep out of the reach and sight of children.

Do not use Difflam P Cream after the expiry date on the tube. The expiry date refers to the last day of that month.

Do not store above 30 °C. Do not store in the refrigerator or freezer.

Medicines should not be disposed of via wastewater or household waste.

Return any medicine you no longer need to your pharmacist.

Further information

What Difflam P Cream contains

The active substance is 3% w/w benzydamine hydrochloride.

The other ingredients are Cutina MD, cetyl alcohol, Cetiol V, Eumulgin B1, propylene glycol, perfume Crematest, methyl
hydroxybenzoate, propyl hydroxybenzoate and purified water.

For advice on what to do if you are allergic to any of these ingredients see section 2.

What Difflam P Cream looks like

Difflam P Cream is a white cream. It comes in a 35 g, 50 g or 100 g tube. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Meda Pharmaceuticals Ltd

Skyway House

Parsonage Road

Takeley

Bishop's Stortford

CM22 6PU

Manufacturer

3M Health Care Limited

3M House

Morley Street

Loughborough

Leicestershire

LE11 1EP

This leaflet was last updated on March 2010.

If this leaflet is difficult to see or read or you would like it in a different format, please contact

Meda Pharmaceuticals Ltd

Skyway House

Parsonage Road

Takeley

Bishop's Stortford

CM22 6PU

562196M9310UK00

6204 1467 8

Cortomycin Solution

Pronunciation: HYE-droe-KOR-ti-sone/NEE-oh-MYE-sin/POL-ee-MIX-in
Generic Name: Hydrocortisone/Neomycin/Polymyxin B
Brand Name: Examples include Cortisporin and Cortomycin

Cortomycin Solution is used for:

Treating infections of the ear caused by certain bacteria. It may also be used for other conditions as determined by your doctor.

Cortomycin Solution is a combination of 2 antibiotics and a corticosteroid. The antibiotics work by slowing the growth of, or killing, sensitive bacteria. The corticosteroid reduces inflammation.

Do NOT use Cortomycin Solution if:

• you are allergic to any ingredient in Cortomycin Solution, to other aminoglycosides (eg, gentamicin), or to other corticosteroids (eg, prednisone)


• you have a viral infection of the ear (eg, herpes simplex, chickenpox, shingles)


• you have a perforated ear drum

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

Before using Cortomycin Solution:

Some medical conditions may interact with Cortomycin 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, 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 asthma

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

Ask your health care provider if Cortomycin 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 Cortomycin Solution:

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

• Cortomycin Solution is only for the ear. Do not get it in your eyes, nose, or mouth. If you get Cortomycin Solution in your eyes, rinse immediately with cool tap water.


• Wash your hands before and after using Cortomycin Solution.


• Wash and dry the outer ear with a sterile cotton applicator.


• Lie down or tilt your head so that the affected ear faces up. For adults, gently pull the earlobe up and back to straighten the ear canal. For children, gently pull the earlobe down and back to straighten the ear canal. Drop the medicine into the ear canal. Keep the ear facing up for several minutes so the medicine can run to the bottom of the ear canal. A clean cotton plug may be gently inserted into the ear canal to prevent medicine from leaking out. To prevent germs from getting into your medicine, do not touch the applicator to any surface, including the ear. Keep the container tightly closed.


• To clear up your infection completely, use Cortomycin Solution for the full course of treatment. Keep using it even if you feel better in a few days.


• If you miss a dose of Cortomycin Solution, 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 Cortomycin Solution.

Important safety information:

• Cortomycin Solution only works against bacteria; it does not treat fungal or viral infections.


• Be sure to use Cortomycin Solution 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.


• Long-term or repeated use of Cortomycin Solution may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.


• If your symptoms do not get better within 7 days or if they get worse, check with your doctor.


• Do NOT take more than the recommended dose or use for longer than 7 days without checking with your doctor.


• Do not use Cortomycin Solution for other ear conditions at a later time.


• 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.


• Tell your doctor or dentist that you take Cortomycin Solution before you receive any medical or dental care, emergency care, or surgery.


• Cortomycin Solution should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these 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 Cortomycin Solution while you are pregnant. It is not known if Cortomycin Solution is found in breast milk after topical use. If you are or will be breast-feeding while you use Cortomycin Solution, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Cortomycin 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:

Mild, temporary burning 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); acne-like rash; changes in hearing; decreased urination; dry, scaly, or peeling skin at the application site; continued burning or stinging; excessive hair growth; inflamed hair follicles; inflammation around the mouth; loss of hearing; muscle weakness; pain, redness, itching, irritation, or swelling not present when you began using Cortomycin Solution; thinning, softening, or discoloration of the skin; unusual weight gain, especially in the face.

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

See also: Cortomycin side effects (in more detail)

If OVERDOSE is suspected:

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

Proper storage of Cortomycin Solution:

Store Cortomycin Solution between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Keep the container tightly closed. Keep Cortomycin Solution out of the reach of children and away from pets.

General information:

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


• Cortomycin 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.


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

This information is a summary only. It does not contain all information about Cortomycin 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: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Cortomycin resources

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

Compare Cortomycin with other medications

• Otitis Externa
• Otitis Media

Chlorcyclizine/Pseudoephedrine

Pronunciation: klor-SYE-klih-zeen/SOO-doe-e-FED-rin
Generic Name: Chlorcyclizine/Pseudoephedrine
Brand Name: Stahist AD

Chlorcyclizine/Pseudoephedrine is used for:

Relieving symptoms of sinus congestion; pressure; runny nose; itching of the nose or throat; itchy, watery eyes; and sneezing due to colds, hay fever, or allergies. It may also be used for other conditions as determined by your doctor.

Chlorcyclizine/Pseudoephedrine is an antihistamine and decongestant combination. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The decongestant promotes sinus and nasal drainage, which relieves congestion and pressure.

Do NOT use Chlorcyclizine/Pseudoephedrine if:

• you are allergic to any ingredient in Chlorcyclizine/Pseudoephedrine


• you have severe or uncontrolled high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems


• you are unable to urinate or are having an asthma attack


• you take droxidopa or sodium oxybate (GHB), or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

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

Before using Chlorcyclizine/Pseudoephedrine:

Some medical conditions may interact with Chlorcyclizine/Pseudoephedrine. 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 have a history of adrenal gland problems (eg, adrenal gland tumor); heart problems (eg, cor pulmonale; fast, slow, or irregular heartbeat; heart disease); high blood pressure; diabetes; blood vessel problems; stroke; glaucoma or increased pressure in the eye; seizures; thyroid problems; or trouble sleeping


• if you have a history of asthma, chronic obstructive pulmonary disease (COPD), or other lung or breathing problems (eg, chronic bronchitis, emphysema); chronic cough; or sleep apnea


• if you have a blockage of your bladder, stomach, or bowels; ulcers; an enlarged prostate or other prostate problems; or trouble urinating


• if you are taking medicine for high blood pressure

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

• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased


• Beta-blockers (eg, propranolol), furazolidone, linezolid, MAOIs (eg, phenelzine), sodium oxybate (GHB), tricyclic antidepressants (eg, amitriptyline), or urinary alkalinizers (eg, sodium bicarbonate) because they may increase the risk of Chlorcyclizine/Pseudoephedrine's side effects


• Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Chlorcyclizine/Pseudoephedrine


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Chlorcyclizine/Pseudoephedrine

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

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

• Take Chlorcyclizine/Pseudoephedrine by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


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

Ask your health care provider any questions you may have about how to use Chlorcyclizine/Pseudoephedrine.

Important safety information:

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


• Do not drink alcohol while you are using Chlorcyclizine/Pseudoephedrine.


• Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Chlorcyclizine/Pseudoephedrine; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Do not take diet or appetite control medicines while you are taking Chlorcyclizine/Pseudoephedrine without checking with your doctor.


• Before you start any new medicine, check the label to see if it has a decongestant or an antihistamine in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do NOT take more than the recommended dose or take Chlorcyclizine/Pseudoephedrine for longer than prescribed without checking with your doctor.


• If your symptoms do not get better within 7 days, if they get worse, if they occur along with a fever, or if new symptoms occur, check with your doctor.


• Chlorcyclizine/Pseudoephedrine may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Chlorcyclizine/Pseudoephedrine. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Chlorcyclizine/Pseudoephedrine may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Chlorcyclizine/Pseudoephedrine for a few days before the tests.


• Tell your doctor or dentist that you take Chlorcyclizine/Pseudoephedrine before you receive any medical or dental care, emergency care, or surgery.


• Use Chlorcyclizine/Pseudoephedrine with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, dizziness, drowsiness, dry mouth, excitability, low blood pressure, and trouble urinating.


• Caution is advised when using Chlorcyclizine/Pseudoephedrine in CHILDREN; they may be more sensitive to its effects, especially excitability.


• Chlorcyclizine/Pseudoephedrine should not be used in CHILDREN younger than 6 years old without first checking with the child's doctor; safety and effectiveness in these 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 Chlorcyclizine/Pseudoephedrine while you are pregnant. Chlorcyclizine/Pseudoephedrine may be found in breast milk. Do not breast-feed while taking Chlorcyclizine/Pseudoephedrine.

Possible side effects of Chlorcyclizine/Pseudoephedrine:

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

Anxiety; constipation; diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; excitability; headache; loss of appetite; nausea; trouble sleeping; upset stomach; vomiting; weakness.

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

Severe allergic reactions (rash; hives; itching, difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; difficulty urinating or inability to urinate; fast or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; mental or mood changes (eg, nervousness); persistent trouble sleeping; restlessness; seizures; severe or persistent dizziness, drowsiness, light-headedness, or headache; tremor; vision changes (eg, blurred vision).

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

See also: Chlorcyclizine/Pseudoephedrine side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; ringing in the ears; seizures; severe dizziness, light-headedness, or headache; severe drowsiness; unusually fast, slow, or irregular breathing; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Chlorcyclizine/Pseudoephedrine:

Store Chlorcyclizine/Pseudoephedrine 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 Chlorcyclizine/Pseudoephedrine out of the reach of children and away from pets.

General information:

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


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


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


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

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

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Chlorcyclizine/Pseudoephedrine resources

• Chlorcyclizine/Pseudoephedrine Side Effects (in more detail)
• Chlorcyclizine/Pseudoephedrine Use in Pregnancy & Breastfeeding
• Chlorcyclizine/Pseudoephedrine Drug Interactions
• Chlorcyclizine/Pseudoephedrine Support Group
• 0 Reviews · Be the first to review/rate this drug

Ulipristal Acetate

Class: Contraceptives
VA Class: HS200
Chemical Name: 19-Norpregna-4,9-diene-3,20-dione, 17-(acetyloxy)-11-[4-(dimethylamino)phenyl]-, (11β)-
Molecular Formula: C₃₀H₃₇NO₄
CAS Number: 126784-99-4
Brands: ella

Introduction

Postcoital contraceptive; synthetic selective progesterone receptor modulator.^{1 2 3 6 13 14}

Uses for Ulipristal Acetate

Postcoital Contraception

Prevention of unintended pregnancy after unprotected intercourse or known or suspected contraceptive failure as an emergency contraceptive.^{1 2 3 6 13 14} Postcoital (emergency) contraceptive regimens are not as effective as most other methods of long-term contraception;not intended for routine use as a contraceptive.^{1 5 14}

Levonorgestrel currently is the preferred postcoital contraceptive when the drug is initiated within 72 hours of unprotected intercourse.^{5 14 15 16 17} Ulipristal is an effective alternative to levonorgestrel for postcoital contraception when used within 120 hours after unprotected intercourse.^{1 2 3}

Ulipristal Acetate Dosage and Administration

Administration

Administer orally without regard to meals.¹

Administer as soon as possible but within 120 hours following unprotected intercourse.^{1 2 3}

May be used at any time during the menstrual cycle.¹

If vomiting occurs within 3 hours after administration, consider repeating the dose.¹

Dosage

Available as ulipristal acetate; dosage expressed in terms of the salt.¹

Adults

Postcoital Contraception

Oral

Single 30-mg dose taken within 120 hours of unprotected intercourse or known or suspected contraceptive failure.^{1 2 3}

Special Populations

No special population dosage recommendations at this time.¹

Cautions for Ulipristal Acetate

Contraindications

• 
  

  Known or suspected pregnancy.¹

  
  

Warnings/Precautions

Warnings

Fetal/Neonatal Morbidity and Mortality

May cause fetal harm; exclude pregnancy before initiating treatment.¹ Embryofetal death reported in animals, but no adequate and well-controlled studies to date in pregnant women.¹ If inadvertently used during pregnancy, apprise of potential fetal hazard.¹

Existing Pregnancy

Not intended for termination of existing pregnancy; exclude possibility of pregnancy prior to administration.¹ Perform pregnancy testing if pregnancy cannot be excluded on basis of history and/or physical examination.¹

Follow-up physical and/or pelvic examination recommended if there is concern regarding general health or pregnancy status of women receiving the drug.¹

Ectopic Pregnancy

Consider possibility of ectopic pregnancy in women who become pregnant or complain of severe lower abdominal pain.¹ Manufacturer states that history of ectopic pregnancy is not considered a contraindication to use.¹

Repeated Use

Intended for occasional use as emergency contraceptive.¹ Postcoital (emergency) contraceptive regimens are not as effective as most other methods of long-term contraception; not intended for routine use as a contraceptive.^{1 5 14} Repeated use within the same menstrual cycle not recommended; safety and efficacy of such repeated use not evaluated.¹

Fertility Following Use

Rapid return of fertility likely following treatment for emergency contraception; continue or initiate routine methods of contraception as soon as possible to prevent pregnancy.^{1 4}

Ulipristal may reduce the efficacy of other hormonal contraceptives.¹ (See Drug Interactions.) Reliable barrier contraceptives (e.g., condom with spermicide) recommended in women for subsequent acts of intercourse within the same menstrual cycle after receiving ulipristal.¹

Effect on Menstrual Cycle

Onset of menstruation may occur a few days earlier or later than expected.^{1 2 3 8} If menstruation delayed by >1 week, rule out pregnancy.¹ Intermenstrual bleeding also reported.¹

HIV and STDs

Does not protect against HIV infection or other sexually transmitted diseases (STDs).¹

Specific Populations

Pregnancy

Category X.¹ (See Fetal/Neonatal Morbidity and Mortality and also see Contraindications under Cautions.)

Lactation

Distributed into milk in rats; not known whether distributed into human milk.¹ Use not recommended.¹

Pediatric Use

Safety and efficacy established in women of reproductive age.¹ Safety and efficacy expected to be identical for postpubertal adolescents <18 years of age and women ≥18 years of age.¹ Not intended for use before menarche.¹

Geriatric Use

Not evaluated in women ≥65 years of age and not intended for use in postmenopausal women.¹

Hepatic Impairment

Not studied in patients with hepatic impairment.¹

Renal Impairment

Not studied in patients with renal impairment.¹

Common Adverse Effects

Headache,^{1 2 3 6} abdominal pain,^{1 2 3 6} nausea,^{1 2 3 6} dysmenorrhea,^{1 2 3} fatigue,^{1 2 3 6} dizziness.^{1 2 3 6}

Interactions for Ulipristal Acetate

Appears to be principally metabolized by CYP3A4.^{1 10} No evidence of induction or inhibition of CYP isoenzymes from in vitro studies.¹

Specific Drugs

Drug	Interaction	Comments
Anticonvulsants (carbamazepine, felbamate, oxcarbazepine, phenytoin, topiramate)	Possible decrease in plasma concentrations and efficacy of ulipristal1
Antifungal agents, azole (itraconazole, ketoconazole)	Possible increase in plasma concentrations of ulipristal1
Barbiturates (e.g., phenobarbital)	Possible decrease in plasma concentrations and efficacy of ulipristal1
Bosentan	Possible decrease in plasma concentrations and efficacy of ulipristal1
Griseofulvin	Possible decrease in plasma concentrations and efficacy of ulipristal1
Hormonal contraceptives	May reduce efficacy of other hormonal contraceptives as a result of high-affinity binding to progesterone receptors1	Recommend reliable barrier contraceptives (e.g., condom with spermicide) for subsequent acts of intercourse within the same menstrual cycle1
Rifampin	Possible decrease in plasma concentrations and efficacy of ulipristal1
St. John's wort (Hypericum perforatum)	Possible decrease in plasma concentrations and efficacy of ulipristal1

Ulipristal Acetate Pharmacokinetics

Absorption

Bioavailability

Rapidly absorbed following oral administration with peak plasma concentrations attained within 60–90 minutes.^{1 8}

Food

High-fat meal reduces peak plasma concentrations by 40–45% and delays time to peak plasma concentrations from median of 0.75 to 3 hours.¹ However, food not expected to result in clinically important effects on efficacy or safety.¹

Distribution

Plasma Protein Binding

>94% (mainly HDL-cholesterol, alpha-1-acid glycoprotein, albumin).^{1 10}

Elimination

Metabolism

In vitro data indicate metabolism is predominantly mediated by CYP3A4 in the liver to mono-demethylated (active) and di-demethylated (inactive) metabolites.^{1 8}

Half-life

About 32 hours.^{1 14}

Stability

Storage

Oral

Tablets

20–25°C.¹ Protect from light.¹

Actions

• 
  

  Exhibits antagonist activity at progesterone receptors and inhibits progesterone from binding to its receptors; also possesses partial agonist activity at progesterone receptors.^{1 7 9 11 14}

  
  


• 
  

  Contraceptive effects may involve inhibition or delay of ovulation, inhibition of follicular growth or rupture, and/or alteration of the endometrium possibly affecting implantation.^{1 4 10 11 12 13} At recommended doses for postcoital contraception, no clinically important effects on the endometrium.^{2 14}

  
  

Advice to Patients

• 
  

  Importance of reading the patient information (medication guide) provided by the manufacturer before initiating therapy.¹

  
  


• 
  

  Importance of administering as soon as possible and not >120 hours after unprotected intercourse or known or suspected contraceptive failure.¹

  
  


• 
  

  Importance of women informing a clinician if pregnancy is known or suspected.¹ Do not use for termination of existing pregnancy.¹

  
  


• 
  

  Importance of women informing a clinician if vomiting occurs within 3 hours of administration and to discuss the need for a repeat dose.¹

  
  


• 
  

  Importance of advising women to seek medical attention if severe lower abdominal pain occurs 3–5 weeks after administration to rule out possibility of ectopic pregnancy.¹

  
  


• 
  

  Importance of women contacting a clinician if menstruation delayed >1 week beyond the expected date to rule out possibility of pregnancy.¹

  
  


• 
  

  Importance of advising women not to use the drug routinely for contraception and not to repeat use within the same menstrual cycle.¹

  
  


• 
  

  Importance of informing women that ulipristal may reduce the efficacy of other hormonal contraceptives and to use reliable barrier contraceptives (e.g., condom with spermicide) for subsequent acts of intercourse within the same menstrual cycle.^{1 5}

  
  


• 
  

  Importance of advising women not to use the drug while breast-feeding.¹

  
  


• 
  

  Importance of advising women that ulipristal is not effective in all cases; drug may be less effective in women with body mass index >30 kg/m².¹

  
  


• 
  

  Importance of informing women that ulipristal does not protect against HIV-infection (AIDS) or other STDs.¹

  
  


• 
  

  Importance of women informing a clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal supplements, as well as any concomitant illnesses.¹

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Ulipristal Acetate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets	30 mg	ella	Watson

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions June 21, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Watson Pharma. ella (ulipristal acetate) tablets prescribing information. Morristown, NJ; 2010 Aug.

2. Glasier AF, Cameron ST, Fine PM et al. Ulipristal acetate versus levonorgestrel for emergency contraception: a randomised non-inferiority trial and meta-analysis. Lancet. 2010; 375:555-62. [PubMed 20116841]

3. Fine P, Mathé H, Ginde S et al. Ulipristal acetate taken 48-120 hours after intercourse for emergency contraception. Obstet Gynecol. 2010; 115:257-63. [PubMed 20093897]

4. Brache V, Cochon L, Jesam C et al. Immediate pre-ovulatory administration of 30 mg ulipristal acetate significantly delays follicular rupture. Hum Reprod. 2010; 25:2256-63. [PubMed 20634186]

5. American Academy of Pediatrics Committee on Adolescence. Emergency contraception. Pediatrics. 2005; 116:1026-35. [PubMed 16147972]

6. Creinin MD, Schlaff W, Archer DF et al. Progesterone receptor modulator for emergency contraception: a randomized controlled trial. Obstet Gynecol. 2006; 108:1089-97. [PubMed 17077229]

7. Attardi BJ, Burgenson J, Hild SA et al. In vitro antiprogestational/antiglucocorticoid activity and progestin and glucocorticoid receptor binding of the putative metabolites and synthetic derivatives of CDB-2914, CDB-4124, and mifepristone. J Steroid Biochem Mol Biol. 2004; 88:277-88. [PubMed 15120421]

8. Blithe DL, Nieman LK, Blye RP et al. Development of the selective progesterone receptor modulator CDB-2914 for clinical indications. Steroids. 2003; 68:1013-7. [PubMed 14667994]

9. Chabbert-Buffet N, Meduri G, Bouchard P et al. Selective progesterone receptor modulators and progesterone antagonists: mechanisms of action and clinical applications. Hum Reprod Update. 2005 May-Jun; 11:293-307. [PubMed 15790602]

10. Gainer EE, Ulmann A. Pharmacologic properties of CDB(VA)-2914. Steroids. 2003; 68:1005-11. [PubMed 14667993]

11. Passaro MD, Piquion J, Mullen N et al. Luteal phase dose-response relationships of the antiprogestin CDB-2914 in normally cycling women. Hum Reprod. 2003; 18:1820-7. [PubMed 12923133]

12. Stratton P, Hartog B, Hajizadeh N et al. A single mid-follicular dose of CDB-2914, a new antiprogestin, inhibits folliculogenesis and endometrial differentiation in normally cycling women. Hum Reprod. 2000; 15:1092-9. [PubMed 10783359]

13. Stratton P, Levens ED, Hartog B et al. Endometrial effects of a single early luteal dose of the selective progesterone receptor modulator CDB-2914. Fertil Steril. 2010; 93:2035-41. [PubMed 19200989]

14. Gemzell-Danielsson K, Rabe T. Emergency contraception. J Reproduktionsmed Endokrinol. 2010; 7 (Sonderheft 1): 73-77.

15. Glasier A. Emergency postcoital contraception. N Engl J Med. 1997; 337:1058-64. [PubMed 9321535]

16. . Randomised controlled trial of levonorgestrel versus the Yuzpe regimen of combined oral contraceptives for emergency contraception. Task Force on Postovulatory Methods of Fertility Regulation. Lancet. 1998; 352:428-33. [PubMed 9708750]

17. von Hertzen H, Piaggio G, Ding J et al. Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: a WHO multicentre randomised trial. Lancet. 2002; 360:1803-10. [PubMed 12480356]

18. Hild SA, Reel JR, Hoffman LH et al. CDB-2914: anti-progestational/anti-glucocorticoid profile and post-coital anti-fertility activity in rats and rabbits. Hum Reprod. 2000; 15:822-9. [PubMed 10739827]

More Ulipristal Acetate resources

• Ulipristal Acetate Side Effects (in more detail)
• Ulipristal Acetate Dosage
• Ulipristal Acetate Use in Pregnancy & Breastfeeding
• Ulipristal Acetate Drug Interactions
• Ulipristal Acetate Support Group
• 1 Review for Ulipristal Acetate - Add your own review/rating

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