Fortaz

Generic Name: ceftazidime (Injection route)

sef-TAZ-i-deem

Commonly used brand name(s)

In the U.S.

• Fortaz


• Tazicef

In Canada

• Ceptaz

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antibiotic

Pharmacologic Class: 3rd Generation Cephalosporin

Uses For Fortaz

Ceftazidime injection is used to treat bacterial infections in many different parts of the body. It belongs to the class of medicines known as cephalosporin antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

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

Before Using Fortaz

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

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of ceftazidime injection in children.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ceftazidime injection in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving ceftazidime injection.

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

Studies in women suggest that this medication poses minimal risk to the infant when used during 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. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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.

• Chloramphenicol

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:

• Brain disease (e.g., encephalopathy, severe confusion) or


• Colitis (inflammation in gut), history of or


• Diarrhea, severe, history of or


• Myoclonus (muscle twitching or jerking) or


• Seizures—Use with caution. May make these conditions worse.

• Kidney disease—Use with caution. Effects may be increased because of slower removal of the medicine from the body.

Proper Use of ceftazidime

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

A nurse or other trained health professional will give you this medicine. This medicine is given as a shot into one of your muscles or through a needle placed in one of your veins.

Precautions While Using Fortaz

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

Ceftazidime injection may cause diarrhea, and in some cases it can be severe. Do not take any medicine or give medicine to your child to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

Check with your doctor right away if you or your child have any of the following symptoms while receiving this medicine: confusion; loss of consciousness; jerking or twitching of the muscles; seizures; seeing, hearing, or feeling things that are not there; or severe sleepiness.

Before you or your child have any medical tests, tell the medical doctor in charge that you are receiving this medicine. The results of some tests may be affected by this medicine.

Fortaz Side Effects

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

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

Less common

• Abdominal or stomach cramps or tenderness


• bloating


• bluish color


• changes in skin color


• diarrhea, watery and severe, which may also be bloody


• fever


• increased thirst


• itching of the vagina or genital area


• nausea or vomiting


• pain


• pain during sexual intercourse


• swelling at the site of injection


• swelling of the foot or leg


• tenderness


• thick, white vaginal discharge with no odor or with a mild odor


• unusual tiredness or weakness


• unusual weight loss


• white patches in the mouth or throat or on the tongue


• white patches with diaper rash

Rare

• Back, leg, or stomach pains


• bleeding gums


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• chills


• cough


• dark urine


• difficulty with breathing


• difficulty with swallowing


• dizziness


• fast heartbeat


• general body swelling


• headache


• hives


• itching


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• loss of appetite


• nosebleeds


• pale skin


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


• shortness of breath


• skin rash


• sore throat


• tightness in the chest


• wheezing


• yellowing of the eyes or skin

Incidence not known

• Agitation


• bloody or cloudy urine


• blurred vision


• change in consciousness


• chest pain


• clay-colored stools


• confusion


• coughing up blood


• decreased frequency or amount of urine


• diarrhea


• difficult or painful urination


• drowsiness


• hallucinations


• increased blood pressure


• increased menstrual flow or vaginal bleeding


• increased thirst


• irritability


• loss of consciousness


• lower back or side pain


• muscle twitching or jerking


• nosebleeds


• paralysis


• prolonged bleeding from cuts


• red or black, tarry stools


• red or dark brown urine


• rhythmic movement of the muscles


• seizures


• sores, ulcers, or white spots on the lips or in the mouth


• stiff neck


• sudden decrease in the amount of urine


• swelling of the face, fingers, or lower legs


• swollen or painful glands


• troubled breathing


• unpleasant breath odor


• unusual bleeding or bruising


• vomiting of blood


• watery or bloody diarrhea


• weight gain

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

• Red streaks on the skin


• swelling, tenderness, or pain at the injection site

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

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

See also: Fortaz side effects (in more detail)

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

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

More Fortaz resources

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

• Fortaz MedFacts Consumer Leaflet (Wolters Kluwer)


• Fortaz Concise Consumer Information (Cerner Multum)


• Fortaz Monograph (AHFS DI)


• Fortaz Prescribing Information (FDA)


• Ceftazidime Professional Patient Advice (Wolters Kluwer)


• Ceftazidime Prescribing Information (FDA)


• Tazicef Prescribing Information (FDA)

Compare Fortaz with other medications

• Bacteremia
• Bladder Infection
• Bone infection
• Endocarditis
• Endometritis
• Febrile Neutropenia
• Intraabdominal Infection
• Joint Infection
• Kidney Infections
• Melioidosis
• Meningitis
• Nosocomial Pneumonia
• Otitis Externa
• Otitis Media
• Pelvic Inflammatory Disease
• Peritonitis
• Pneumonia
• Pneumonia with Cystic Fibrosis
• Sepsis
• Septicemia
• Sinusitis
• Skin and Structure Infection
• Skin Infection
• Urinary Tract Infection

Anugesic HC Cream

1. Name Of The Medicinal Product

ANUGESIC HC CREAM

2. Qualitative And Quantitative Composition

Each 100g of cream contains zinc oxide EP 12.35g, balsam peru EP 1.85g, benzyl benzoate EP 1.2g, pramocaine hydrochloride USP 1g, bismuth oxide 0.875g, hydrocortisone acetate EP 0.5g.

Excipients

Contains:

Propyl Hydroxybenzoate (E216) 0.11g

Methyl Hydroxybenzoate (E218) 0.01g

Propylene Glycol 8.0g

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

A smooth, homogeneous, buff coloured cream with the characteristic odour of balsam peru.

4. Clinical Particulars

4.1 Therapeutic Indications

Anugesic HC cream provides antiseptic, astringent, emollient and decongestant properties. In addition hydrocortisone exerts an anti-inflammatory effect. Pramocaine is a rapidly acting local anaesthetic. The cream may be used to provide lubrication for suppositories.

Anugesic HC cream is indicated for the comprehensive symptomatic treatment of severe and acute discomfort or pain associated with internal and external haemorrhoids and pruritus ani.

4.2 Posology And Method Of Administration

For topical use.

Adults:

Apply cream to the affected area at night, in the morning and after each evacuation. Thoroughly cleanse the affected area, dry and apply cream by gently smoothing onto the affected area. For internal conditions use rectal nozzle provided and clean it after each use.

Not to be taken orally.

Elderly (over 65 years):

As for adults.

Children:

Not recommended.

4.3 Contraindications

Tubercular, fungal and most viral lesions including herpes simplex, vaccinia and varicella. History of sensitivity to any of the constituents.

Hypersensitivity to the active substances or to any of the excipients.

4.4 Special Warnings And Precautions For Use

As with all products containing topical steroids the possibility of systemic absorption should be borne in mind.

Prolonged or excessive use may produce systemic corticosteroid effects and use for periods longer than seven days is not recommended.

Contains propylene glycol which may cause skin irritation

Contains E216 and E218 which may cause allergic reactions (possibly delayed)

Following symptomatic relief definite diagnosis should be established.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

There is inadequate evidence of safety in human pregnancy and there may be a very small risk of cleft palate and intrauterine growth retardation as well as suppression of the neonatal HPA axis. There is evidence of harmful effects in animals. Use in pregnancy only when there is no safer alternative and when the disease itself carries risks for the mother or child.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Rarely, sensitivity reactions. Patients may occasionally experience transient burning on application, especially if the anoderm is not intact.

4.9 Overdose

If swallowed, fever, nausea, vomiting, stomach cramps and diarrhoea may develop 3-12 hours after ingestion.

Pramocaine is relatively non-toxic and less sensitising than other local anaesthetics. Hydrocortisone does not normally produce toxic effects in an acute single overdose.

Treatment of a large acute overdosage should include gastric lavage, purgation with magnesium sulphate and complete bed rest. If necessary, give oxygen and general supportive measures. Methaemoglobinaemia should be treated by intravenous methylthioninium chloride

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic Group ; Antihemorrhoidals for topical use,

ATC code: C05A A01.

Pramocaine hydrochloride is a surface anaesthetic used on the skin and mucous membranes to relieve surface pain and pruritis.

Hydrocortisone acetate has the general properties of hydrocortisone and the anti-inflammatory action is of primary interest in this product.

Benzyl benzoate is used as a solubilizing agent and has mild antiseptic and preservative properties.

Bismuth oxide exerts a protective action on mucous membranes and raw surfaces. It is weakly astringent and is reported to have antiseptic properties.

Balsam peru has protective properties and a very mild antiseptic action by virtue of its content of cinnamic and benzoic acids. It is believed to promote the growth of epithelial cells.

Zinc oxide acts as an astringent and mild antiseptic.

5.2 Pharmacokinetic Properties

It is well known that topically applied corticosteroids can be absorbed percutaneously. This appears to be more likely upon repeated or prolonged use.

The remaining active ingredients in Anugesic HC Cream exert their therapeutic effect without being absorbed into the systemic circulation. These observations are supported by evidence from various studies and reviews.

5.3 Preclinical Safety Data

The results of the preclinical tests do not add anything of further significance to the prescriber.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Liquid paraffin, glyceryl monostearate, propylene glycol, polysorbate 60, sorbitan stearate, titanium dioxide E171, methyl hydroxybenzoate, propyl hydroxybenzoate and purified water.

6.2 Incompatibilities

None known

6.3 Shelf Life

18 months

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

Aluminium tube externally printed and internally lacquered with plastic cap. Supplied in packs of 15, 25 and 30 g.

6.6 Special Precautions For Disposal And Other Handling

No special instructions needed.

7. Marketing Authorisation Holder

Pfizer Limited

Sandwich

Kent CT13 9NJ

United Kingdom

8. Marketing Authorisation Number(S)

PL 00057/0520

9. Date Of First Authorisation/Renewal Of The Authorisation

27^th June 2003

10. Date Of Revision Of The Text

August 2011

Ref: AU 3_0 UK

Ketoconazole/Hydrocortisone Gel

Pronunciation: KEE-toe-KON-a-zole/HYE-droe-KOR-ti-sone
Generic Name: Ketoconazole/Hydrocortisone
Brand Name: Xolegel CorePak

Ketoconazole/Hydrocortisone Gel is used for:

Treating a skin condition called seborrheic dermatitis. It may also help to reduce itching, redness, and swelling.

Ketoconazole/Hydrocortisone Gel kit contains an antifungal medicine and a topical corticosteroid. The antifungal works by killing the fungus causing the skin condition. The corticosteroid works by reducing skin inflammation, which helps relieve redness, swelling, itching, and irritation.

Do NOT use Ketoconazole/Hydrocortisone Gel if:

• you are allergic to any ingredient in Ketoconazole/Hydrocortisone Gel

Contact your doctor or health care provider right away if this applies to you.

Before using Ketoconazole/Hydrocortisone Gel:

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

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


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


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


• if you have a weakened immune system, liver problems, or the blood disease porphyria


• if you have a skin infection, measles, thinning of the skin, tuberculosis (TB), chickenpox, shingles, a positive TB skin test, or have recently had a vaccination

Some MEDICINES MAY INTERACT with Ketoconazole/Hydrocortisone Gel. Because little, if any, of Ketoconazole/Hydrocortisone Gel is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Ketoconazole/Hydrocortisone Gel 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 Ketoconazole/Hydrocortisone Gel:

Use Ketoconazole/Hydrocortisone Gel as directed by your doctor. Check the label on the medicine for exact dosing instructions.

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


• Wash your hands before and immediately after using Ketoconazole/Hydrocortisone Gel.


• To use the antifungal: Spread a thin layer of the medicine onto the affected area with the tips of your fingers. Gently rub it in. Be sure to cover the entire affected area and the healthy skin around it.


• Do not touch your eyes or nose while you are applying Ketoconazole/Hydrocortisone Gel.


• Wait for at least 20 minutes after you apply Ketoconazole/Hydrocortisone Gel before you apply makeup or sunscreen.


• Do not wash the area where you applied Ketoconazole/Hydrocortisone Gel for at least 3 hours after you apply it.


• To use the topical corticosteroid: Apply a small amount of medicine to the affected area. Gently rub it in until it is evenly distributed.


• Do not bandage or wrap the affected area unless directed otherwise by your doctor.


• If you miss a dose of Ketoconazole/Hydrocortisone Gel, 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 Ketoconazole/Hydrocortisone Gel.

Important safety information:

• Ketoconazole/Hydrocortisone Gel is for external use only. Do not get it in your eyes, nose, or mouth. If you get it in your eyes, rinse at once with cool tap water. Do not get Ketoconazole/Hydrocortisone Gel in your vagina.


• Do not use Ketoconazole/Hydrocortisone Gel for other skin conditions at a later time.


• Ketoconazole/Hydrocortisone Gel is flammable. Do not store or use near an open flame. Do not smoke during or right after use of Ketoconazole/Hydrocortisone Gel.


• Check with your doctor before receiving vaccinations while you are using Ketoconazole/Hydrocortisone Gel.


• Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Ketoconazole/Hydrocortisone Gel, especially if the child is using a large amount of it or using it for a long period of time.


• Ketoconazole/Hydrocortisone Gel should be used with extreme caution in CHILDREN younger than 12 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 Ketoconazole/Hydrocortisone Gel while you are pregnant. It is not known if Ketoconazole/Hydrocortisone Gel is found in breast milk after topical use. If you are or will be breast-feeding while you use Ketoconazole/Hydrocortisone Gel, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Ketoconazole/Hydrocortisone Gel:

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 skin irritation or dryness; mild, temporary burning or stinging at the application site.

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); infection; new or worsening irritation, pain, redness, blistering, or severe burning at the application site; skin thinning or discoloration.

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.

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 Ketoconazole/Hydrocortisone Gel:

Store Ketoconazole/Hydrocortisone Gel at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do NOT store near an open flame. Keep Ketoconazole/Hydrocortisone Gel out of the reach of children and away from pets.

General information:

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


• Ketoconazole/Hydrocortisone Gel 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 Ketoconazole/Hydrocortisone Gel. 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 Ketoconazole/Hydrocortisone resources

• Ketoconazole/Hydrocortisone Use in Pregnancy & Breastfeeding
• Ketoconazole/Hydrocortisone Drug Interactions
• Ketoconazole/Hydrocortisone Support Group
• 0 Reviews for Ketoconazole/Hydrocortisone - Add your own review/rating

Compare Ketoconazole/Hydrocortisone with other medications

• Seborrheic Dermatitis

cytarabine liposomal

Generic Name: cytarabine liposomal (sye TAR a been LYE poe SOE mal)

Brand Names: DepoCyt

What is cytarabine liposomal?

Cytarabine liposomal is a cancer medication. Cytarabine liposomal interferes with the growth of cancer cells and slows their growth and spread in the body.

Cytarabine liposomal is used to treat lymphoma associated with meningitis.

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

What is the most important information I should know about cytarabine liposomal?

Do not use cytarabine liposomal if you are pregnant. It could harm the unborn baby. You should not receive this medication if you are allergic to cytarabine or if you have an active meningitis infection.

Before you receive cytarabine liposomal, tell your doctor about all of your medical conditions and any other medications you use. You may need a dose adjustment or special tests to safely use cytarabine liposomal.

Tell your caregivers at once if you have nausea and vomiting with headache and fever. These may be early signs of central nervous system damage. Call your doctor at once if you have a serious side effect such as neck stiffness or pain, extreme drowsiness, confusion, personality changes, seizure, loss of muscle control, problems with vision or hearing, severe numbness or tingling, or loss of bladder or bowel control.

What should I discuss with my healthcare provider before receiving cytarabine liposomal?

You should not receive this medication if you are allergic to cytarabine liposomal or if you have an active meningitis infection.

Before you receive cytarabine liposomal, tell your doctor about all of your medical conditions and any other medications you use. You may need a dose adjustment or special tests to safely use cytarabine liposomal:

FDA pregnancy category D. Do not use cytarabine liposomal if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. It is not known whether cytarabine liposomal passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are receiving this medication.

How is cytarabine liposomal given?

Cytarabine liposomal is given as an injection through a needle placed into the space around your spinal cord. You will receive this injection in a clinic or hospital setting.

Tell your caregivers at once if you have nausea and vomiting with headache and fever. These may be early signs of central nervous system damage. To be sure cytarabine liposomal is not causing harmful effects, your doctor will need to check your progress on a regular basis. Do not miss any follow-up appointments.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your cytarabine liposomal injection.

What happens if I overdose?

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

Overdose symptoms may include nausea, vomiting, headache and fever, confusion, and changes in personality or behavior.

What should I avoid while receiving cytarabine liposomal?

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

Cytarabine liposomal 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 a serious side effect such as:

• 
  

  nausea and vomiting with headache and fever;

  
  


• 
  

  neck stiffness or pain, seizure (convulsions);

  
  


• 
  

  extreme drowsiness, loss of muscle control;

  
  


• 
  

  confusion, personality changes, problems with memory or concentration, sleep problems, agitation;

  
  


• 
  

  problems with speech, vision, hearing, or balance,

  
  


• 
  

  numbness, tingling, or burning pain that interferes with daily activities;

  
  


• 
  

  loss of bladder or bowel control;

  
  


• 
  

  pale skin, feeling light-headed or short of breath, rapid heart rate;

  
  


• 
  

  easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin; or

  
  


• 
  

  flu symptoms, sores in your mouth and throat.

  
  

Less serious side effects may include:

• 
  

  mild nausea or vomiting;

  
  


• 
  

  diarrhea, constipation, stomach pain;

  
  


• 
  

  swelling in your hands or feet;

  
  


• 
  

  dizziness, tired feeling;

  
  


• 
  

  joint pain, back pain; or

  
  


• 
  

  pain in your arms or legs.

  
  

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.

Cytarabine liposomal Dosing Information

Usual Adult Dose for Meningitis -- Lymphomatous:

Cytarabine liposomal for the intrathecal treatment of lymphomatous meningitis:

Induction Therapy: cytarabine liposome injection 50 mg, administered intrathecally (intraventricular or lumbar puncture) every 14 days for 2 doses (weeks 1 and 3).

Consolidation Therapy: cytarabine liposome injection 50 mg, administered intrathecally (intraventricular or lumbar puncture) every 14 days for 3 doses (weeks 5, 7 and 9) followed by one additional dose at week 13.

Maintenance: cytarabine liposome injection 50 mg, administered intrathecally (intraventricular or lumbar puncture) every 28 days for 4 doses (weeks 17, 21, 25 and 29).

What other drugs will affect cytarabine liposomal?

There may be other drugs that can interact with cytarabine liposomal. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More cytarabine liposomal resources

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

• Cytarabine Liposomal Professional Patient Advice (Wolters Kluwer)


• DepoCyt Prescribing Information (FDA)


• DepoCyt Monograph (AHFS DI)


• DepoCyt MedFacts Consumer Leaflet (Wolters Kluwer)


• Depocyt Advanced Consumer (Micromedex) - Includes Dosage Information

Compare cytarabine liposomal with other medications

• Meningitis, Lymphomatous

Where can I get more information?

• Your doctor or pharmacist can provide more information about cytarabine liposomal.

See also: cytarabine liposomal side effects (in more detail)

Phenylephrine

Pronunciation: fen-il-EF-rin
Generic Name: Phenylephrine
Brand Name: Neo-Synephrine

Phenylephrine is used for:

Maintaining blood pressure in certain acute low blood pressure situations. It is also used to treat blood vessel failure during shock and low blood pressure or allergic reactions caused by other medications. It may also be used to treat painful, prolonged erections (priapism).

Phenylephrine is a vasopressor. It works by constricting blood vessels and raising blood pressure.

Do NOT use Phenylephrine if:

• you are allergic to any ingredient in Phenylephrine


• you have an inherited condition that causes the wall of your heart to thicken, a tumor on your adrenal gland, severe high blood pressure, or an abnormally fast heartbeat


• you are taking furazolidone or have taken a monoamine oxidase (MAO) inhibitor (eg, phenelzine) in the last 14 days

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

Before using Phenylephrine:

Some medical conditions may interact with Phenylephrine. 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 high blood pressure, heart or blood vessel disease, blood clots, asthma, liver disease, intestinal problems, diabetes, an overactive thyroid, an irregular heartbeat, or low blood fluid volume

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

• Rauwolfia derivatives (eg, reserpine) or tricyclic antidepressants (eg, amitriptyline) because the effectiveness of Phenylephrine may be decreased


• Cocaine, furazolidone, methyldopa, MAO inhibitors (eg, phenelzine), oxytocic medicines (eg, oxytocin), rauwolfia derivatives (eg, reserpine), or tricyclic antidepressants (eg, amitriptyline) because the actions and side effects of Phenylephrine may be increased


• Bromocriptine, COMT inhibitors (eg, entacapone), cocaine, or droxidopa because the actions and side effects of these medicines may be increased


• Guanethidine because its effectiveness may be decreased by Phenylephrine

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

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

• Phenylephrine is usually administered as an injection at your doctor's office, hospital, or clinic.


• If you are using Phenylephrine at home, carefully follow the injection procedures taught to you by your health care provider.


• If the medicine contains particles or is discolored, or if the vial/container is cracked or damaged in any way, do not use it.


• If you miss a dose of Phenylephrine and 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 Phenylephrine.

Important safety information:

• Phenylephrine may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Phenylephrine. Using Phenylephrine alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.


• Some of these products contain sulfites, which can cause allergic reactions in certain individuals (eg, asthma patients). If you have previously had allergic reactions to sulfites, contact your pharmacist to determine if the product you are taking contains sulfites.


• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Phenylephrine.


• LAB TESTS, such as blood pressure checks, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.


• Phenylephrine is not recommended for use in CHILDREN younger than 1 year 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 Phenylephrine during pregnancy. It is unknown if Phenylephrine is excreted in breast milk. Do not breast-feed while taking Phenylephrine.

Possible side effects of Phenylephrine:

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:

Excitability; headache; nausea; restlessness; vomiting.

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; convulsions; dizziness; irregular heartbeats; mental or mood changes; pain or redness at the injection site; shortness of breath; tingling or numb hands/feet.

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.

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 irregular heartbeat; tingling or numbness of the hands or feet.

Proper storage of Phenylephrine:

Store Phenylephrine 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 Phenylephrine, as well as needles and syringes, out of the reach of children and away from pets.

General information:

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


• Phenylephrine 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 Phenylephrine. 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 Phenylephrine resources

• Phenylephrine Use in Pregnancy & Breastfeeding
• Drug Images
• Phenylephrine Drug Interactions
• Phenylephrine Support Group
• 3 Reviews for Phenylephrine - Add your own review/rating

• phenylephrine Nasal Advanced Consumer (Micromedex) - Includes Dosage Information


• Phenylephrine Hydrochloride Monograph (AHFS DI)


• Sudafed PE Consumer Overview

Compare Phenylephrine with other medications

• Hypotension
• Nasal Congestion
• Shock
• Supraventricular Tachycardia

Actonel

Generic Name: risedronate (rih SED ro nayt)

Brand Names: Actonel, Atelvia

What is risedronate?

Risedronate is in a group of medicines called bisphosphonates (bis FOS fo nayts). It alters the cycle of bone formation and breakdown in the body. Risedronate slows bone loss while increasing bone mass, which may prevent bone fractures.

Risedronate is used to treat or prevent osteoporosis in men and women. Risedronate is also used to treat Paget's disease of bone.

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

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

Do not take a risedronate tablet if you cannot sit upright or stand for at least 30 minutes. Risedronate can cause serious problems in the stomach or esophagus (the tube that connects your mouth and stomach). You will need to stay upright for at least 30 minutes after taking this medication.

Take the Actonel tablet first thing in the morning with a full glass (6 to 8 ounces) of water, at least 30 minutes before you eat or drink anything or take any other medicine.

Take the Atelvia tablet just after breakfast, with at least 4 ounces of water.

Use only plain water (not mineral water) when taking a risedronate tablet.

For at least the first 30 minutes after taking a risedronate tablet, do not lie down or recline; do not eat or drink anything other than plain water; and do not take any other medicines including vitamins, calcium, or antacids.

Some people using medicines similar to risedronate have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums. You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and pre-existing dental problems.

If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using risedronate. You may need to stop using the medicine for a short time.

Talk with your doctor about the risks and benefits of using this medication.

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

Do not take a risedronate tablet if you cannot sit upright or stand for at least 30 minutes. Risedronate can cause serious problems in the stomach or esophagus (the tube that connects your mouth and stomach). You will need to stay upright for at least 30 minutes after taking this medication. You should not take this medication if you are allergic to risedronate, or if you have low levels of calcium in your blood (hypocalcemia), or a problem with the movement of muscles in your esophagus.

To make sure you can safely take risedronate, tell your doctor if you have any of these other conditions:

• 
  

  low blood calcium (hypocalcemia);

  
  


• 
  

  a vitamin D deficiency;

  
  


• 
  

  kidney disease; or

  
  


• 
  

  an ulcer in your stomach or esophagus.

  
  

Some people using medicines similar to risedronate have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums.

You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and dental surgery or pre-existing dental problems.

Talk with your doctor about the risks and benefits of using this medication.

FDA pregnancy category C. It is not known whether risedronate will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether risedronate passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are taking risedronate.

How should I take risedronate?

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.

Risedronate tablets come in different strengths (number of milligrams per pill). Some tablets are taken once each day. Some tablets are taken once each week, or only 1 or 2 times each month.

Your dosing schedule will depend on the tablet strength your doctor has prescribed. If you change tablet strengths, you may also need to change your schedule. Follow the directions on your prescription label.

Take the Actonel tablet first thing in the morning with a full glass (6 to 8 ounces) of water, at least 30 minutes before you eat or drink anything or take any other medicine.

Take the Atelvia tablet just after breakfast, with at least 4 ounces of water.

Use only plain water (not mineral water) when taking a risedronate tablet.

After taking a risedronate tablet, carefully follow these instructions:

• 
  

  Do not lie down or recline for at least 30 minutes after taking risedronate.

  
  


• 
  

  Do not eat or drink anything other than plain water.

  
  


• 
  

  Do not take any other medicines including vitamins, calcium, or antacids for at least 30 minutes after taking risedronate. It may be best to take your other medicines at a different time of the day. Talk with your doctor about the best dosing schedule for your other medicines.

  
  

Do not take two different strengths of risedronate tablet at the same time.

If you take risedronate only once a week, take it on the same day and time each week.

Do not crush, chew, or suck the risedronate tablet. Swallow the pill whole. The enteric coated pill has a special coating to protect your stomach. Breaking the pill will damage this coating. If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using risedronate. You may need to stop using the medicine for a short time.

To be sure this medication is helping your condition, your bone mineral density will need to be tested on a regular basis. Visit your doctor regularly.

Risedronate is only part of a complete program of treatment that may also include diet changes, exercise, and taking calcium and vitamin supplements. Follow your diet, medication, and exercise routines very closely.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

If you take risedronate tablets once daily: If you forget to take this medicine first thing in the morning, do not take it later in the day. Wait until the following morning to take the medicine and skip the missed dose. Do not take two (2) tablets in one day.

If you take risedronate tablets once a week, or once or twice per month: If you forget to take risedronate on your scheduled day, take it first thing in the morning on the day after you remember the missed dose. Then return to your regular weekly schedule on your chosen dose day. Do not take two (2) tablets in one day.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Drink a full glass of milk and call your local poison control center or emergency room right away. Do not make yourself vomit and do not lie down.

Overdose symptoms may include nausea, heartburn, stomach pain, diarrhea, muscle cramps, numbness or tingling, tight muscles in your face, seizure (convulsions), irritability, and unusual thoughts or behavior.

What should I avoid while taking risedronate?

Avoid taking any other medicines including vitamins, calcium, or antacids for at least 30 minutes after taking a risedronate tablet. Some medicines can make it harder for your body to absorb risedronate.

Risedronate 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 risedronate and call your doctor at once if you have a serious side effect such as:

• 
  

  chest pain;

  
  


• 
  

  difficulty or pain when swallowing;

  
  


• 
  

  pain or burning under the ribs or in the back;

  
  


• 
  

  new or worsening heartburn;

  
  


• 
  

  severe or ongoing indigestion;

  
  


• 
  

  severe joint, bone, or muscle pain;

  
  


• 
  

  new or unusual pain in your thigh or hip; or

  
  


• 
  

  jaw pain, numbness, or swelling.

  
  

Less serious side effects may include:

• 
  

  flu symptoms, muscle pain;

  
  


• 
  

  mild stomach pain or upset stomach;

  
  


• 
  

  diarrhea, constipation;

  
  


• 
  

  mild joint or back pain; or

  
  


• 
  

  headache.

  
  

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 risedronate?

Before using risedronate, tell your doctor if you also use aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as celecoxib (Celebrex), diclofenac (Voltaren), diflunisal (Dolobid), ibuprofen (Motrin, Advil), indomethacin, ketoprofen (Orudis), ketorolac (Toradol), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others.

This list is not complete and other drugs may interact with risedronate. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Actonel resources

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

• Actonel Consumer Overview


• Actonel Advanced Consumer (Micromedex) - Includes Dosage Information


• Actonel Prescribing Information (FDA)


• Actonel MedFacts Consumer Leaflet (Wolters Kluwer)


• Actonel Monograph (AHFS DI)


• Risedronate Prescribing Information (FDA)


• Risedronate MedFacts Consumer Leaflet (Wolters Kluwer)


• Atelvia Consumer Overview


• Atelvia Prescribing Information (FDA)


• Atelvia Delayed-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Actonel with other medications

• Osteoporosis
• Paget's Disease
• Prevention of Osteoporosis

Where can I get more information?

• Your pharmacist can provide more information about risedronate.

See also: Actonel side effects (in more detail)

AlleRx-D

pseudoephedrine hydrochloride methscopolamine nitrate

Dosage Form: tablet
AlleRx-D

DESCRIPTION

Each tablet contains:


Pseudoephedrine HCL…... ……120 mg

Methscopolamine Nitrate………..2.5 mg


Pseudoephedrine hydrochloride is a nasal decongestant. Chemically it is [S-(R*,R*)]-α-

[1(methylamino) ethyl]-benzenemethanol hydrochloride; C10H15NO•HCl, MW = 201.7.

Pseudoephedrine HCL

Methscopolamine nitrate is an anticholinergic having the chemical name 3-oxa-9-azoniatricyclo

[3.3.1.0 2, 4] nonane, 7-(3-hydroxy-1-oxo-2-phenylpropoxy)-9, 9-dimethyl-, nitrate, [7(S)-(1α, 2β,

4β, 5α, 7β)]; C17H21NO4•CH3NO3, MW = 80.4.

Methscopolamine Nitrate

Inactive Ingredients: Dibasic Calcium Phosphate, D & C Yellow #10 (aluminum lake) Dye,

Magnesium Stearate, Methylcellulose, Povidone and Stearic Acid.

CLINICAL PHARMACOLOGY

Pseudoephedrine HCl is an indirect-acting sympathomimetic amine that exerts a decongestant

action on the nasal mucosa. It does this by vasoconstriction, which results in reduction of

tissue hyperemia, edema, nasal congestion, and an increase in nasal airway patency. In the

usual dose it has minimal vasopressor effects. Pseudoephedrine HCl is rapidly and almost

completely absorbed from the gastrointestinal tract. It has a plasma half-life of 6 to 8 hours.

Alkaline urine is associated with slower elimination of the drug. The drug is distributed to the

body tissues and fluids, including the central nervous system (CNS). Approximately 50% to

75% of the administered dose is excreted unchanged in the urine; the remainder is apparently

metabolized in the liver to inactive compounds by N-demethylation, parahydroxylation, and

oxidative deamination.


Methscopolamine nitrate is a quaternary ammonium derivative of the anticholinergic

scopolamine which possesses the peripheral actions of the belladonna alkaloids, but does not

exhibit the central actions because of its lack of ability to cross the blood-brain barrier. Its

antimuscarinic effect causes inhibition of salivary secretions, reduction in volume and total acid

content of gastric secretion, and inhibition of gastrointestinal motility. It is poorly and unreliably

absorbed. Drug effects appear in about one hour and persist for about 4 to 6 hours. It is

excreted primarily in the urine and bile, or as unabsorbed drug in feces.

INDICATIONS AND USAGE

 For the temporary relief of symptoms associated with allergic rhinitis.

CONTRAINDICATIONS

This product is contraindicated in patients with hypersensitivity to pseudoephedrine HCL and

methscopolamine nitrate. AlleRx™-D is contraindicated in patients with severe hypertension,

severe coronary artery disease, patients on monoamine oxidase inhibitor (MAOI) therapy or

within 14 days of stopping monoamine oxidase inhibitor (MAOI) therapy. AlleRx™-D is also

contraindicated in patients with narrow-angle glaucoma, urinary retention, peptic ulcer, and

during an asthmatic attack.

WARNINGS

Sympathomimetic amines should be used cautiously in patients with hypertension, diabetes

mellitus, ischemic heart disease, hyperthyroidism, increased intraocular pressure, and

prostatic hypertrophy. Sympathomimetics may produce central nervous system stimulation

with convulsions or cardiovascular collapse with accompanying hypotension. The elderly (60

years or older) are more likely to exhibit adverse reactions. At dosages higher than the

recommended dose, nervousness, dizziness, or sleeplessness may occur. Do not exceed

recommended dosage.


Hypertensive crisis can occur with concurrent use of pseudoephedrine HCl and MAOI, and for

14 days after stopping MAOI therapy. Methscopolamine nitrate may produce drowsiness or

blurred vision. The patient should be cautioned regarding activities requiring mental alertness

such as operating a motor vehicle or performing hazardous work while taking AlleRx™-D.


Co-administration of sildenafil citrate and other organic nitrates has been shown to potentiate

the hypotensive effects of nitrates. Co-administration of AlleRx™-D and sildenafil citrate has

not been studied. Therefore, the use of sildenafil citrate and AlleRx™-D together is not

recommended.

PRECAUTIONS

General

AlleRx™-D should be used with caution in patients with diabetes mellitus,

hypertension, cardiovascular disease, and hyperactivity to sympathomimetic amines.

Methscopolamine nitrate should be used with caution in the elderly and all patients with

autonomic neuropathy, hepatic or renal disease, or ulcerative colitis.

Drug Interactions

Do not prescribe AlleRx™-D for use in patients that are now taking prescription MAOIs

(certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease),

or for 14 days after stopping MAOI drug therapy. Beta-adrenergic blockers and MAOIs

may potentiate the pressor effect of pseudoephedrine HCl. Concurrent use of digitalis

glycosides may increase the possibility of cardiac arrhythmias. Sympathomimetics may

reduce the hypotensive effects of guanethidine, mecamylamine, methyldopa, reserpine and

veratrum alkaloids. Concurrent use of pseudoephedrine HCl with other sympathomimetic amines

may increase pressor or cardiovascular effects of either medication.


The use of pseudoephedrine HCl may result in additive CNS depressant effects when

coadministered with alcohol, antihistamines, psychotropics, or other drugs which produce CNS

depression. Concurrent use of tricyclic antidepressants may antagonize the effects of

pseudoephedrine HCl.


Additive anticholinergic effects may result from concomitant use with antipsychotics, tricyclic

antidepressants, and other drugs with anticholinergic effects. Concomitant administration with

antacids may interfere with the absorption of methscopolamine nitrate.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Animal studies to assess the longterm carcinogenic and mutagenic potential or the effect on

fertility in animals or humans have not been performed.

Pregnancy Category C

It is not known whether AlleRx™-D can cause fetal harm when administered to a pregnant

woman or can affect reproduction capacity. AlleRx™-D should be given to a pregnant

woman only if clearly needed.

Nursing Mothers

It is not known whether this combination drug is excreted in human milk. However, pseudoephedrine

HCl administered alone distributes into the breast milk of lactating human females; therefore, a decision

should be made whether to discontinue nursing or to discontinue the drug, taking into account the

importance of the drug to the mother.

Pediatric Use

The safety and effectiveness in children under 12 years of age have not been established.

Geriatric Use

The elderly (60 years and older) are more likely to experience adverse reactions to sympathomimetics.

Overdosage of sympathomimetics in this age group may cause hallucinations, convulsions,

CNS depression, and/or death. Pseudoephedrine HCl is known to be substantially excreted by the

kidneys, and the risk of toxic reactions to this drug may be greater in patients with impaired renal

function. Because elderly patients are more likely to have decreased renal function, care should be

taken in dose selection, and it may be useful to monitor renal function.

ADVERSE REACTIONS

Adverse reactions include drowsiness, lassitude, nausea, giddiness, dryness of mouth, blurred

vision, cardiac palpitations, flushing, and increased irritability or excitement (especially in

children). Some individuals may display sympathomimetic amine effects such as tachycardia,

palpitations, headache, dizziness, or nausea. Sympathomimetics have been associated with

certain untoward reactions including fear, anxiety, nervousness, restlessness, tremor,

weakness, pallor, respiratory difficulty, dysuria, insomnia, hallucinations, convulsions, CNS

depression, arrhythmias, and cardiovascular collapse with hypotension. Urinary retention may

occur in patients with prostatic hypertrophy.

DRUG ABUSE AND DEPENDENCE

Rebound congestion may occur after vasoconstriction subsides when pseudoephedrine HCl is

discontinued. Patients may increase the amount of drug and frequency of use, producing

toxicity and perpetuating the rebound congestion. Excessive use may cause systemic effects

which are more likely in the elderly. Habituation and toxic psychosis have followed long-term

high-dose therapy.

OVERDOSAGE AND TREATMENT OF OVERDOSAGE

The treatment of overdosage should provide symptomatic and supportive care. Induction of

emesis and gastric lavage may be performed if the patient is alert and seen within early hours

after ingestion. Drug remaining in the stomach may be absorbed by the administration of

activated charcoal. Stimulants should not be used because they may precipitate convulsions. If

convulsions or marked CNS excitement occurs, treatment with appropriate measures is

indicated. Since the effects of AlleRx™-D last up to 12 hours, the patient should be monitored

for at least that length of time and treated as necessary.

DOSAGE AND ADMINISTRATION

Adults and adolescents 12 years of age and over: One tablet every 12 hours, not to exceed

2 tablets in 24 hours. AlleRx™-D is not recommended for children under 12 years of age.

HOW SUPPLIED

Bottles of 60 Tablets (NDC 10122-702-60), yellow, capsule-shaped and scored debossed with

“CBP” on one side and "01" to the right of the score on the other side, each containing 120 mg

of pseudoephedrine HCl and 2.5 mg of methscopolamine nitrate.


Keep out of reach of pediatric population.


Store at controlled room temperature between 20° and 25°C (68° and 77°F), see Controlled

Room Temperature.


Distributed by Cornerstone Biopharma, Inc., Cary, NC 27518.

500353

CBA749B1107

Rev. 11/07

AlleRx-D label

 

AlleRx-D  pseudoephedrine hydrochloride methscopolamine nitrate  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 10122-702 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg METHSCOPOLAMINE NITRATE (METHSCOPOLAMINE) METHSCOPOLAMINE NITRATE 2.5 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS DIBASIC CALCIUM PHOSPHATE   MAGNESIUM STEARATE   STEARIC ACID   POVIDONE   D&C YELLOW NO. 10   METHYLCELLULOSE (100 CPS)

Product Characteristics Color YELLOW Score 2 pieces Shape CAPSULE Size 7mm Flavor Imprint Code CBP;01 Contains

Packaging # NDC Package Description Multilevel Packaging 1 10122-702-60 60 TABLET In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		07/01/2008

Labeler - Cornerstone Therapeutics Inc. (153886994)

Registrant - Cornerstone Therapeutics Inc. (153886994)

Revised: 05/2011Cornerstone Therapeutics Inc.

More AlleRx-D resources

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

• Extendryl PSE Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Compare AlleRx-D with other medications

• Cold Symptoms
• Hay Fever
• Sinus Symptoms
• Sinusitis