Carbinoxamine/Hydrocodone/Pseudoephedrine Liquid

Pronunciation: car-bihn-OCKS-ah-meen/hye-droe-KOE-done/sue-do-eh-FED-rin
Generic Name: Carbinoxamine/Hydrocodone/Pseudoephedrine
Brand Name: Examples include Histex HC and Mintex HC

Carbinoxamine/Hydrocodone/Pseudoephedrine Liquid is used for:

Relieving symptoms of sinus congestion, runny nose, sneezing, and cough due to colds, upper respiratory tract infections, and allergies. It may also be used for other conditions as determined by your doctor.

Carbinoxamine/Hydrocodone/Pseudoephedrine Liquid is a decongestant, antihistamine, and cough suppressant combination. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages. The antihistamine works by blocking the action of histamine, which helps reduce symptoms, such as watery eyes and sneezing. The cough suppressant works in the brain to help decrease the cough reflex, which reduces a dry cough.

Do NOT use Carbinoxamine/Hydrocodone/Pseudoephedrine Liquid if:

• you are allergic to any ingredient in Carbinoxamine/Hydrocodone/Pseudoephedrine Liquid or any other codeine- or morphine-related medicine (eg, codeine)


• you have severe 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 are taking sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (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 Carbinoxamine/Hydrocodone/Pseudoephedrine Liquid:

Some medical conditions may interact with Carbinoxamine/Hydrocodone/Pseudoephedrine Liquid. 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 fast, slow, or irregular heartbeat, blood vessel problems, or other heart problems


• if you have a history of adrenal gland problems (eg, adrenal gland tumor); high blood pressure; diabetes; stroke; glaucoma; a blockage of your bladder, stomach, or intestines; ulcers; trouble urinating; an enlarged prostate or other prostate problems; or an overactive thyroid


• if you have a history of asthma, chronic cough, lung problems (eg, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus


• if you have a history of head or brain injury, brain tumor, increased pressure in the brain, infection of the brain or nervous system, epilepsy, or seizures


• if you have a history of stomach problems (eg, ulcers), bowel problems (eg, chronic inflammation or ulceration of the bowel), or gallbladder problems (eg, gallstones), or if you have had recent abdominal surgery


• if you have a history of alcohol or substance abuse or suicidal thoughts or behavior

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

• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAO inhibitors (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because the side effects of Carbinoxamine/Hydrocodone/Pseudoephedrine Liquid may be increased


• Cimetidine, digoxin, droxidopa, or sodium oxybate (GHB) because the risk of severe drowsiness, breathing problems, seizures, irregular heartbeat, or heart attack may be increased


• Naltrexone because it may decrease Carbinoxamine/Hydrocodone/Pseudoephedrine Liquid's effectiveness


• Bromocriptine or hydantoins (eg, phenytoin) because their side effects may be increased by Carbinoxamine/Hydrocodone/Pseudoephedrine Liquid


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

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

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

• Take Carbinoxamine/Hydrocodone/Pseudoephedrine Liquid by mouth with or without food.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• If you miss a dose of Carbinoxamine/Hydrocodone/Pseudoephedrine Liquid, 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 Carbinoxamine/Hydrocodone/Pseudoephedrine Liquid.

Important safety information:

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


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


• Carbinoxamine/Hydrocodone/Pseudoephedrine Liquid has pseudoephedrine in it. Before you start any new medicine, check the label to see if it has pseudoephedrine 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 use for longer than prescribed without checking with your doctor.


• If your symptoms do not get better within 5 to 7 days or if they get worse, check with your doctor.


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


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


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


• Use Carbinoxamine/Hydrocodone/Pseudoephedrine Liquid with caution in the ELDERLY; they may be more sensitive to its effects.


• Caution is advised when using Carbinoxamine/Hydrocodone/Pseudoephedrine Liquid in CHILDREN; they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Carbinoxamine/Hydrocodone/Pseudoephedrine Liquid while you are pregnant. It is not known if Carbinoxamine/Hydrocodone/Pseudoephedrine Liquid is found in breast milk. Do not breast-feed while taking Carbinoxamine/Hydrocodone/Pseudoephedrine Liquid.

When used for long periods of time or at high doses, Carbinoxamine/Hydrocodone/Pseudoephedrine Liquid 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 Carbinoxamine/Hydrocodone/Pseudoephedrine Liquid stops working well. Do not take more than prescribed.

When used for long periods of time or at high doses, some people develop a need to continue taking Carbinoxamine/Hydrocodone/Pseudoephedrine Liquid. This is known as DEPENDENCE or addiction.

If you suddenly stop taking Carbinoxamine/Hydrocodone/Pseudoephedrine Liquid, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; trouble sleeping.

Possible side effects of Carbinoxamine/Hydrocodone/Pseudoephedrine Liquid:

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:

Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; 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); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; tremor; trouble sleeping; vision changes.

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: Carbinoxamine/Hydrocodone/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; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Carbinoxamine/Hydrocodone/Pseudoephedrine Liquid:

Store Carbinoxamine/Hydrocodone/Pseudoephedrine Liquid 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 Carbinoxamine/Hydrocodone/Pseudoephedrine Liquid out of the reach of children and away from pets.

General information:

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


• Carbinoxamine/Hydrocodone/Pseudoephedrine Liquid 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 Carbinoxamine/Hydrocodone/Pseudoephedrine Liquid. 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 Carbinoxamine/Hydrocodone/Pseudoephedrine resources

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

Compare Carbinoxamine/Hydrocodone/Pseudoephedrine with other medications

• Cold Symptoms
• Cough
• Nasal Congestion
• Sinus Symptoms

Creon

Generic Name: pancrelipase (oral) (pan kre LYE pace)

Brand Names: Cotazym, Creon, Dygase, Ku-Zyme, Ku-Zyme HP, Kutrase, Lapase, Palcaps 10, Pancrease MT 10, Pancrease MT 16, Pancrease MT 20, Pancrease MT 4, Pancrecarb MS-16, Pancrecarb MS-4, Pancrecarb MS-8, Panocaps, Panocaps MT 16, Ultrase, Ultrase MT 12, Ultrase MT 18, Ultrase MT 20, Viokase, Viokase 16, Zenpep

What is pancrelipase?

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

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

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

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

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

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

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

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

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

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

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

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

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

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

• kidney disease;


• 
  

  gout;

  
  


• 
  

  a history of blockage in your intestines;

  
  


• 
  

  a sudden onset of pancreatitis; or

  
  


• 
  

  worsening of chronic pancreatic disease.

  
  

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether pancrelipase passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take pancrelipase?

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

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

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

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

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

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

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

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

What happens if I miss a dose?

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

What happens if I overdose?

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

Overdose symptoms may include diarrhea or stomach upset.

What should I avoid while taking pancrelipase?

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

Pancrelipase side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have severe or unusual stomach pain. This could be a symptom of a rare but serious bowel disorder.

Less serious side effects may include:

• 
  

  nausea or vomiting;

  
  


• 
  

  mild stomach pain or upset;

  
  


• 
  

  diarrhea or constipation;

  
  


• 
  

  bloating or gas.

  
  


• 
  

  greasy stools;

  
  


• 
  

  rectal irritation;

  
  


• 
  

  headache, dizziness;

  
  


• 
  

  cough; or

  
  


• 
  

  weight loss.

  
  

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

What other drugs will affect pancrelipase?

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

More Creon resources

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

• Creon Consumer Overview


• Creon Advanced Consumer (Micromedex) - Includes Dosage Information


• Creon MedFacts Consumer Leaflet (Wolters Kluwer)


• Creon Prescribing Information (FDA)


• Pancrelipase Prescribing Information (FDA)


• Pancrelipase Professional Patient Advice (Wolters Kluwer)


• Pancrelipase Monograph (AHFS DI)


• Pancrelipase MedFacts Consumer Leaflet (Wolters Kluwer)


• Creon 10 Delayed-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Dygase MedFacts Consumer Leaflet (Wolters Kluwer)


• Pancreaze Consumer Overview


• Pancreaze Prescribing Information (FDA)


• Zenpep Prescribing Information (FDA)


• Zenpep Consumer Overview

Compare Creon with other medications

• Chronic Pancreatitis
• Cystic Fibrosis
• Pancreatic Exocrine Dysfunction

Where can I get more information?

• Your pharmacist can provide more information about pancrelipase.

See also: Creon side effects (in more detail)

Cleanse and Treat Pad

Dosage Form: cloth
CLEANSE AND TREAT

Cleanse and Treat Pad Description

Cleanse & Treat

(benzoyl peroxide pad and salicylic acid pad)


Rx Only

Cleanse & Treat contains two separate and distinct non-woven pads enclosed in a heat-sealed foil pack compartmentalized from one another within the foil pack by filmstock. One non-woven pad bears a preparation consisting of 5% benzoyl peroxide and the following inactive ingredients: ammonium lauryl sulfate, carbomer, disodium cocoamphodiacetate, DMDM hydantoin, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium chloride, sodium hydroxide. The other non-woven pad bears a preparation consisting of 2% salicylic acid and the following inactive ingredients: ammonium lauryl sulfate, cellulose gum, disodium ricinoleamido MEA-sulfosuccinate, DMDM hydantoin, propylene glycol monoricinoleate, purified water, sodium citrate dihydrate.

CHEMICAL STRUCTURE

Benzoyl peroxide is an oxidizing agent that possesses antibacterial properties and is classified as a keratolytic. It has an empirical formula of C14H10O4 with a molecular weight of 242.23. Benzoyl peroxide has the following molecular structure:

Salicylic acid is the 2 hydroxy derivative of benzoic aid. It has an empirical formula of C7H6O3 with a molecular weight of 138.12. Salicylic acid has the following molecular structure:

Cleanse and Treat Pad - Clinical Pharmacology

The exact method of action of benzoyl peroxide in acne vulgaris is not known, however, its antibacterial activity against Propionibacterium acnes, together with its mild keratolytic effect, is believed to be its significant mode of action.

Pediatric Use - Cleanse & Treat should not be used by children under 12 years of age.

Information for Patients - Patients should avoid unnecessary sun exposure and use a sunscreen when in sunlight. Contact with hair, fabrics, or any colored materials may result in bleaching or discoloration. Patients should avoid concomitant use of other drugs that may contribute to elevated serum salicylate levels where the potential for toxicity exists. Symptoms of salicylate toxicity may include nausea, vomiting, dizziness, loss of hearing, tinnitus, lethargy, hyperpnea and diarrhea. In the event of salicylate toxicity, the use of Cleanse & Treat should be discontinued, fluids should be administered to promote urinary excretion and medical assistance should be obtained immediately.

Carcinogenesis, Mutagenesis, Impairment of Fertility - Data from some studies using a strain of mice highly susceptible to eveloping cancer suggest that benzoyl peroxide acts as a tumor promoter. The clinical significance of these findings to humans is not known. Benzoyl peroxide has not been found to be mutagenic in the Ames Salmonella Test and there are no published data suggesting that it impairs fertility. No data are available concerning potential carcinogenic or reproductive effects of salicylic acid. It has not been found to be mutagenic in the Ames Salmonella Test and there are no published data suggesting that it impairs fertility.

Pregnancy (Category C) - Animal reproduction studies have not been performed with benzoyl peroxide and it is not known whether benzoyl peroxide can cause fetal harm when administered to a pregnant woman. Nevertheless, benzoyl peroxide should be used by a pregnant woman only if necessary. Salicylic acid has been shown to be teratogenic in rats and monkeys. It is difficult to extrapolate from oral doses of acetylsalicylic acid used in these studies to topical administration as the oral dose to monkeys may represent 10 times or more the maximum daily human dose of salicylic acid when applied topically as directed with Cleanse &Treat. There are no adequate and well-controlled studies in pregnant women. Nevertheless, salicylic acid should be used by a pregnant woman only if necessary.

Indications and Usage for Cleanse and Treat Pad

Cleanse & Treat is indicated for the topical treatment of acne vulgaris.

Contraindications

Cleanse & Treat is contraindicated in patients with a history of hypersensitivity to any of its ingredients.

Adverse Reactions

Allergic contact dermatitis and/or dryness have been reported with topical benzoyl peroxide and salicylic acid, both when used separately and in combination with one another.

Overdosage

If excessive scaling, erythema or edema occurs, patients should discontinue use of Cleanse & Treat and consult with their physician.

Cleanse and Treat Pad Dosage and Administration

Unless otherwise directed by a prescribing physician, patients should apply one salicylic acid pad and one benzoyl peroxide pad to affected areas twice per day. Cleanse & Treat is a leave-on acne treatment, intended for use without water or additional cleansers unless otherwise directed by your physician.

How is Cleanse and Treat Pad Supplied

Each Cleanse & Treat packette consists of one 0.8 g. 5% benzoyl peroxide pad and one 0.5 g. 2% salicylic acid pad, with each pad separated from one another by filmstock and both pads enclosed together in an individual heat-sealed foil pack bearing the NDC Number 23710-052-02.

Store at 15°-25° C (59°-77° F)

REFERENCES

Cleanse & Treat covered by US Patents: 5,254,109; 5,417,674; and 5,562,642.

Quinnova Pharmaceuticals, Inc., Newtown, PA 18940, (877) 660-6263, www.QUINNOVA.com.

Prescribing Information as of April 2008.

Pouch

CLEASE AND TREAT  benzoyl peroxide pad and salicylic acid pad  cloth

Product Information Product Type NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 23710-052 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 0.8 g  in 5 g SELENIUM SULFIDE (SELENIUM) SELENIUM SULFIDE 0.5 g  in 5 g

Inactive Ingredients Ingredient Name Strength AMMONIUM LAURYL SULFATE   CARBOMER 934   GLYCERIN   METHYLPARABEN   PROPYLENE GLYCOL   PROPYLPARABEN   WATER   SODIUM CHLORIDE   SODIUM HYDROXIDE   AMMONIUM LAURYL SULFATE   POWDERED CELLULOSE   GLYCERYL RICINOLEATE   TRISODIUM CITRATE DIHYDRATE

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 23710-052-02 5 g In 1 POUCH None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		01/01/2009

Labeler - Quinnova Pharmaceuticals, Inc. (607183766)

Revised: 12/2009Quinnova Pharmaceuticals, Inc.

More Cleanse and Treat Pad resources

• Cleanse and Treat Pad Side Effects (in more detail)
• Cleanse and Treat Pad Use in Pregnancy & Breastfeeding
• Cleanse and Treat Pad Drug Interactions
• Cleanse and Treat Pad Support Group
• 1 Review for Cleanse and Treat - Add your own review/rating

Compare Cleanse and Treat Pad with other medications

• Acne

Risperidone Intramuscular

ris-PER-i-done

Intramuscular route(Powder for Suspension, Extended Release)

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Although the causes of death in clinical trials were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that antipsychotic drugs may increase mortality. It is unclear from the observational studies to what extent these mortality findings may be attributed to the antipsychotic drug as opposed to patient characteristics. Risperidone is not approved for the treatment of patients with dementia-related psychosis .

Commonly used brand name(s)

In the U.S.

• Risperdal Consta

Available Dosage Forms:

• Powder for Suspension, Extended Release

Therapeutic Class: Antipsychotic

Chemical Class: Benzisoxazole

Uses For risperidone

Risperidone injection is used to treat the symptoms of psychotic (mental) disorders, such as schizophrenia. It may be used alone or together with other medicines (e.g., lithium or valproate) to treat patients with bipolar disorder. risperidone should not be used to treat behavioral problems in older adult patients who have dementia.

risperidone is available only with your doctor's prescription.

Before Using risperidone

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 risperidone, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to risperidone 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 have not been performed on the relationship of age to the effects of risperidone injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Elderly people may be especially sensitive to the effects of risperidone. This may increase the chance of having side effects during treatment. risperidone should not be used for behavioral problems in older adults with dementia.

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

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving risperidone, 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 risperidone with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bepridil


• Cisapride


• Levomethadyl


• Mesoridazine


• Metoclopramide


• Pimozide


• Terfenadine


• Thioridazine

Using risperidone with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acecainide


• Ajmaline


• Amiodarone


• Amisulpride


• Amitriptyline


• Amoxapine


• Aprindine


• Arsenic Trioxide


• Asenapine


• Astemizole


• Azimilide


• Bretylium


• Chloral Hydrate


• Chloroquine


• Chlorpromazine


• Citalopram


• Clarithromycin


• Desipramine


• Dibenzepin


• Disopyramide


• Dofetilide


• Dolasetron


• Doxepin


• Droperidol


• Encainide


• Enflurane


• Erythromycin


• Flecainide


• Fluconazole


• Foscarnet


• Gemifloxacin


• Ginkgo Biloba


• Halofantrine


• Haloperidol


• Halothane


• Hydromorphone


• Hydroquinidine


• Ibutilide


• Imipramine


• Isoflurane


• Isradipine


• Lidoflazine


• Linezolid


• Lithium


• Lorcainide


• Mefloquine


• Milnacipran


• Nortriptyline


• Octreotide


• Pentamidine


• Pirmenol


• Prajmaline


• Probucol


• Procainamide


• Prochlorperazine


• Propafenone


• Protriptyline


• Quetiapine


• Sematilide


• Sertindole


• Simvastatin


• Sotalol


• Spiramycin


• Sulfamethoxazole


• Sultopride


• Tedisamil


• Telithromycin


• Tetrabenazine


• Tramadol


• Trifluoperazine


• Trimethoprim


• Trimipramine


• Vasopressin


• Zolmitriptan


• Zotepine

Using risperidone 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.

• Bupropion


• Carbamazepine


• Cimetidine


• Fluoxetine


• Itraconazole


• Lamotrigine


• Midodrine


• Paroxetine


• Phenobarbital


• Phenytoin


• Ranitidine


• Ritonavir


• Valproic Acid

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 risperidone. Make sure you tell your doctor if you have any other medical problems, especially:

• Alzheimer's disease or


• Dehydration or


• Heart attack, recent or history of or


• Heart or blood vessel disease or


• Heart failure, history of or


• Heart rhythm problem, or a history of or


• Hypotension (low blood pressure) or


• Hypovolemia (low amount of blood) or


• Stroke, history of or


• Trouble with swallowing—May cause side effects to become worse.

• Blood or bone marrow problems or


• Bone problems (e.g., osteodystrophy) or


• Breast cancer, prolactin-dependent or


• Diabetes or


• Hyperglycemia (high blood sugar) or


• Hyperprolactinemia (high prolactin in the blood) or


• Neuroleptic malignant syndrome (NMS), history of or


• Parkinson's disease or


• Priapism (painful or prolonged erection of the penis) or


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

• Brain tumor or


• Intestinal blockage or


• Reye's syndrome—Risperidone injection may prevent vomiting and hide these medical problems from you or your doctor.

• Kidney disease or


• Liver disease—Effects may be increased because of slower removal of the medicine from the body.

Proper Use of risperidone

A nurse or other trained health professional will give you risperidone. risperidone is given as a shot into one of your muscles.

Precautions While Using risperidone

It is very important that your doctor check your progress at regular visits to make sure risperidone is working properly. Blood tests may be needed to check for unwanted effects.

Stop taking risperidone and check with your doctor right away if you have any of the following symptoms while using risperidone: convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

risperidone may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you have any of the following symptoms while taking risperidone: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.

risperidone may increase the amount of sugar in your blood. Check with your doctor right away if you have increased thirst or increased urination. If you have diabetes, you may notice a change in the results of your urine or blood sugar tests. If you have any questions, check with your doctor.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position suddenly. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

Risperidone injection can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

risperidone may cause drowsiness, trouble with thinking, or trouble with controlling body movements. Make sure you know how you react to risperidone before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think or see well.

risperidone may make it more difficult for your body to cool itself down. Use care not to become overheated during exercise or hot weather since overheating may result in heat stroke. Also, use extra care not to become too cold while you are taking risperidone injection. If you become too cold, you may feel drowsy, confused, or clumsy.

Risperidone injection may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these side effects, tell your doctor right away.

risperidone may increase your weight. Your doctor may need to check your weight on a regular basis while you are using risperidone.

risperidone will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicines including other narcotics; medicine for seizures (e.g., barbiturates); muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are taking risperidone.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

risperidone 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:

More common

• Difficulty with swallowing


• drowsiness


• inability to sit still


• loss of balance control


• mask-like face


• need to keep moving


• relaxed and calm


• restlessness


• shuffling walk


• sleepiness


• slowed movements


• slurred speech


• stiffness of the arms and legs


• tic-like (jerky) movements of the head, face, mouth, and neck


• trembling and shaking of the fingers and hands

Less common

• Abdominal or stomach pain


• abnormal or decreased touch sensation


• absence of or decrease in body movement


• anxiety


• back pain


• black, tarry, stools


• bladder pain


• bloating or swelling of the face, arms, hands, lower legs, or feet


• bloody or cloudy urine


• blurred vision


• body aches or pain


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


• change in walking and balance


• changes in patterns and rhythms of speech


• chest pain or discomfort


• clumsiness or unsteadiness


• cold flu-like symptoms


• cold sweats


• convulsions


• cough or hoarseness


• cough producing mucus


• depression


• diarrhea


• difficult or labored breathing


• difficult, burning, or painful urination


• difficulty with breathing


• difficulty with moving


• disturbed attention


• dizziness


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


• dry mouth


• ear congestion


• fainting


• fast, irregular, pounding, or racing heartbeat or pulse


• fever or chills


• flushed, dry skin


• frequent urge to urinate


• fruit-like breath odor


• general feeling of discomfort or illness


• hard lump


• headache


• hyperventilation


• inability to move the eyes


• increased blinking or spasms of the eyelid


• increased hunger


• increased thirst


• increased urination


• irritability


• joint pain


• lip smacking or puckering


• loss of appetite


• loss of bladder control


• loss of voice


• lower back or side pain


• muscle aches and pains


• muscle stiffness


• muscle weakness


• nasal congestion


• nausea


• neck pain


• pain


• pale skin


• pounding in the ears


• pounding, slow heartbeat


• puffing of the cheeks


• rapid or worm-like movements of the tongue


• rapid weight gain


• shivering


• shortness of breath


• slow or fast heartbeat


• sneezing


• sore throat


• sticking out of the tongue


• stuffy or runny nose


• sweating


• swelling or puffiness of the face


• swollen joints


• tightness in the chest


• trouble with breathing, speaking, or swallowing


• trouble with sleeping


• troubled breathing with exertion


• ulcers, sores, or white spots in the mouth


• uncontrolled chewing movements


• uncontrolled twisting movements of the neck, trunk, arms, or legs


• unexplained weight loss


• unusual bleeding or bruising


• unusual facial expressions


• unusual tiredness or weakness


• unusual weight gain or loss


• vomiting


• wheezing

Incidence not known

• Abnormal growth filled with fluid or semisolid material


• accumulation of pus


• actions that are out of control


• bleeding gums


• blood in the urine or stools


• bluish lips or skin


• break in the skin, especially associated with blue-black discoloration, swelling, or drainage of fluid


• change in vision


• clay-colored stools


• clumsiness


• collection of blood under the skin


• coma


• confusion


• constipation


• dark urine


• deep, dark purple bruise


• drowsiness


• fever with or without chills


• flushed, dry skin


• fruit-like breath odor


• indigestion


• itching


• itching, pain, redness, or swelling


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


• loss of consciousness


• low body temperature


• not breathing


• painful or prolonged erection of the penis


• pains in the stomach, side, or abdomen, possibly radiating to the back


• pinpoint red spots on the skin


• rash


• severe constipation


• swollen, red, tender area of infection


• talking, feeling, and acting with excitement


• tiredness


• unexplained weight loss


• unpleasant breath odor


• vomiting of blood


• weak or feeble pulse


• weight gain


• yellow eyes or skin

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

• Acid or sour stomach


• belching


• heartburn


• stomach discomfort, upset, or pain

Less common

• Abnormal ejaculation


• absent missed or irregular menstrual periods


• bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site


• blemishes on the skin


• burning, dry, or itching eyes


• change in hearing


• decreased interest in sexual intercourse


• decreased sexual performance or desire


• decreased vision


• discharge, excessive tearing


• dry skin


• ear drainage


• ear pain


• feeling of constant movement of self or surroundings


• inability to have or keep an erection


• increased watering of the mouth


• loss in sexual ability, desire, drive, or performance


• pain or tenderness around the eyes and cheekbones


• pimples


• redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid


• sensation of spinning


• skin rash, encrusted, scaly and oozing


• sleeplessness


• sluggishness


• stopping of menstrual bleeding


• swelling of the breasts or unusual milk production


• swelling of the breasts or breast soreness in both females and males


• tender, swollen glands in the neck


• tenderness in the stomach area


• toothache


• unable to sleep


• unexpected or excess milk flow from breasts


• voice changes


• weight gain


• weight loss

Incidence not known

• Hair loss or thinning of the hair

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: risperidone Intramuscular 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 risperidone Intramuscular resources

• Risperidone Intramuscular Side Effects (in more detail)
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• Drug Images
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• 102 Reviews for Risperidone Intramuscular - Add your own review/rating

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House Dust Mite Injection

Allergenic Extract

Warning

Diagnostic and therapeutic allergenic extracts are intended to be administered by a physician who is an allergy specialist and experienced in allergenic diagnostic testing and immunotherapy and the emergency care of anaphylaxis.

This product should not be injected intravenously. Deep subcutaneous routes have been safe. Sensitive patients may experience severe anaphylactic reactions resulting in respiratory obstruction, shock, coma and/or death. (See Adverse Reactions)

Serious adverse reactions should be reported to Nelco Laboratories immediately and a report filed to: MedWatch, The FDA Medical Product Problem Reporting Program, at 5600 Fishers Lane, Rockville, Md. 20852-9787, call 1-800-FDA-1088.

Extreme caution should be taken when using allergenic extracts for patients who are taking beta-blocker medications. In the event of a serious adverse reaction associated with the use of allergenic extracts, patients receiving beta-blockers may not be responsive to epinephrine or inhaled brochodialators.(1)(See Precautions)

Allergenic extracts should be used with caution for patients with unstable or steroid-dependent asthma or underlying cardiovascular disease. (See Contraindications)

House Dust Mite Injection Description

Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts)

For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.

House Dust Mite Injection - Clinical Pharmacology

The pharmacological action of allergenic extracts used diagnostically is based on the liberation of histamine and other substances when the allergen reacts with IgE antibodies attached to the mast cells. When allergenic extracts are used for immunotherapy, the effect is an increase in immunoglobulin G (IgG) and an increased T suppresser lymphocyte which interferes with the allergic response.(2) With repeated administration of allergenic extracts changes develop in regards to IgG and IgE production and mediator-releasing cells. The histamine release response is reduced in some patients.

Indications and Usage for House Dust Mite Injection

Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity.

Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.

Contraindications

Allergenic extracts should not be used if the patient has asthma, cardiovascular disease, emphysema, diabetes, bleeding diathesis or pregnancy, unless a specific diagnosis of type 1 allergic disease is made based on skin testing and the benefits of treatment outweigh the risks of an adverse reaction during testing or treatment. Allergenic extracts are not indicated for use in patients who are not clinically allergic or who are not skin reactive to an allergen. Allergenic extracts should be discontinued or the concentration of potency substantially reduced in patients who experience unacceptable adverse reactions.

Warnings

DO NOT INJECT INTRAVENOUSLY.

Epinephrine 1:1000 should be available.

Concentrated extracts must be diluted with sterile diluent prior to first use on a patient for treatment or intradermal testing. All concentrates of glycerinated allergenic extracts have the ability to cause serious local and systemic reactions including death in sensitive patients. Sensitive patients may experience severe anaphylactic reactions resulting in respiratory obstruction, shock, coma and /or death.(4)(See Adverse Reactions) An allergenic extract should be temporarily withheld from patients or the dose of the extract adjusted downward if any of the following conditions exist: (1) Severe symptoms of rhinitis and/or asthma (2) Infections or flu accompanied by fever and (3) Exposure to excessive amounts of clinically relevant allergen prior to a scheduled injection. When switching patients to a new lot of the same extract the initial dose should be reduced 3/4 so that 25% of previous dose is administered.

Precautions

GENERAL: Epinephrine 1:1000 should be available as well as personnel trained in administering emergency treatment. Allergenic Extracts are not intended for intravenous injections. For safe and effective use of allergenic extracts, sterile diluents, sterile vials, sterile syringes should be used and aseptic precautions observed when making a dilution and/or administering the allergenic extract injection. A sterile tuberculin syringe graduated in 0.1 ml units to measure each dose for the prescribed dilution should be used. To reduce the risk of an occurrence of adverse reactions, begin with a careful personal history plus a physical exam. Confirm your findings with scratch or intradermal skin testing.

Standardized extracts are those labeled in AU/ml units or BAU/ml units. Standardized extracts are not interchangeable with extracts previously labeled as wt/vol or PNU/ml. Before administering a standardized extract, read the accompanying insert contained with standardized extracts.

Information for Patients: All concentrates of allergenic extracts have the ability to cause serious local and systemic reactions including death in sensitive patients. Patients should be informed of this risk prior to skin testing and immunotherapy. Patients should be instructed to recognize adverse reaction symptoms that may occur and to report all adverse reactions to a physician. Patients should be instructed to remain in the office for 30 minutes during testing using allergenic extracts and at least 30 minutes after therapeutic injections using allergenic extracts.

DRUG INTERACTIONS: Some drugs may affect the reactivity of the skin; patients should be instructed to avoid medications, particularly antihistamines and sympathomimetic drugs, for at least 24 hours prior to skin testing. Antihistamines and Hydroxyzine can significantly inhibit the immediate skin test reactions as they tend to neutralize or antagonize the action of histamine.(3) This effect has been primarily documented when testing was performed within 1 to 2 hours after drug ingestion. Partial inhibition of the skin test reaction had been observed for longer periods. Epinephrine injection inhibits the immediate skin test reactions for several hours. Patients on delayed absorption antihistamine tablets should be free of such medication for 48 hours before testing. Patients using Astemizole (Hismanal) may experience prolonged suppression and should be free from such medication for up to 6 to 8 weeks prior to testing. Refer to package insert from an applicable long acting antihistamine manufacturer for additional information.

Extreme caution should be taken when using allergenic extracts on patients who are taking beta-blockers. Patients on non-selective beta blockers may be more reactive to allergens given for testing or treatment and may be unresponsive to the usual doses of epinephrine used to treat allergic reactions.

Carcinogenesis, mutagenesis, impairment of fertility:

Long term studies in animals have not been conducted with allergenic extracts to determine their potential carcinogenicity, mutagenicity or impairment of fertility.

Pregnancy: Category C: Animal reproduction studies have not been conducted with Allergenic Extracts. It is not known whether allergenic extracts can cause fetal harm when administered to pregnant women or can affect reproduction capacity. Allergenic extracts should be given to pregnant women only if clearly needed.

Nursing Mothers: It is not known whether this drug appears in human milk. Because many drugs are detected in human milk, caution should be exercised when Allergenic Extracts are administered to a nursing woman. There are no current studies on extract components in human milk, or their effect on the nursing infant.

Pediatric Use: Allergenic extracts have been used in children over two years of age.(5)

Adverse Reactions

Adverse systemic reactions usually occur within minutes and consist primarily of allergic symptoms such as: generalized skin erythema, urticaria, pruritus, angioedema, rhinitis, wheezing, laryngeal edema, itching of nose and throat, breathlessness, dyspnea, coughing, hypotension and marked perspiration. Less commonly, nausea, emesis, abdominal cramps, diarrhea and uterine contractions may occur. Severe reactions may cause anaphylaxis or shock and loss of consciousness and rarely death.

The treatment of systemic allergic reactions is dependent upon the system complex. Antihistamines may offer relief of recurrent urticaria, associated skin reactions and gastrointestinal symptoms. Corticosteroids may provide benefit if symptoms are prolonged or recurrent. (See Overdose section)

Local Reactions consisting of erythema, itching, swelling tenderness and sometimes pain may occur at the injection site. These reactions may appear within a few minutes to hours and persist for several days. Local cold applications and oral antihistamines may be effective treatment. For marked and prolonged local reactions the use of antihistamines or anti-inflammatory medications may be dictated. Serious adverse reactions should be reported to Nelco Laboratories immediately and a report can be filed to: MedWatch, The FDA Medical Product Problem Reporting Program, at 5600 Fishers Lane, Rockville, MD 20852-9787, call 1-800-FDA-1088.

Overdosage

Overdose can cause both local and systemic reactions. An overdose may be prevented by careful observation and questioning of the patient about the previous injection.

If systemic or anaphylactic reaction, does occur, apply a tourniquet above the site of injection and inject intramuscularly or subcutaneously 0.3 to 0.5ml of 1:1000 Epinephrine Hydrochloride into the opposite arm. The dose may be repeated in 5-10 minutes if necessary. Loosen the tourniquet at least every 10 minutes. The Epinephrine Hydrochloride 1:1000 dose for infants to 2 years is 0.05 to 0.1 ml, for children 2 to 6 years it is 0.15 ml, for children 6-12 years it is 0.2 ml.

Patients unresponsive to Epinephrine may be treated with Theophylline. Studies on asthmatic subjects reveal that plasma concentrations of Theophylline of 5 to 20 µg/ml are associated with therapeutic effects. Toxicity is particularly apparent at concentrations greater than 20 µg/ml. A loading dose of Aminophylline of 5.8 mg/kg intravenously followed by 0.9 mg/kg per hour results in plasma concentrations of approximately 10 µg/ml for patients not previously receiving theophylline. (Mitenko and Ogilive, Nicholoson and Chick,1973)

Other beta-adrenergic drugs such as Isoproterenol, Isoetharine, or Albuterol may be used by inhalation. The usual dose to relieve broncho-constriction in asthma is 0.5 ml of the 0.5% solution for Isoproterenol HCl. The Albuterol inhaler delivers approximately 90 mcg of Albuterol from the mouthpiece. The usual dosage for adults and children would be two inhalations repeated every 4-6 hours. Isoetharine supplied in the Bronkometer unit delivers approximately 340 mcg Isoetharine. The average dose is one to two inhalations. Respiratory obstruction not responding to parenteral or inhaled bronchodilators may require oxygen, intubation and the use of life support systems.

House Dust Mite Injection Dosage and Administration

General Precautions

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permits.

The dosage of allergenic extracts is dependent upon the purpose of the administration. Allergenic extracts can be administered for diagnostic use or for therapeutic use.

When allergenic extracts are administered for diagnostic use, the dosage is dependent upon the method used. Two methods commonly used are scratch testing and intradermal testing. Both types of tests result in a wheal and flare response at the site of the test which usually develops rapidly and may be read in 20-30 minutes.

Diagnostic Use: Scratch Testing Method

Scratch testing is considered a simple and safe method although less sensitive than the intradermal test. Scratch testing can be used to determine the degree of sensitivity to a suspected allergen before using the intradermal test. This combination lessens the severity of response to an allergen which can occur in a very sensitive patient.

The most satisfactory testing site is the patient's back or volar surface of the arms from the axilla to 2.5 or 5cm above the wrist, skipping the anti-cubital space. If using the back as a testing site, the most satisfactory area are from the posterior axillary fold to 2.5 cm from the spinal column, and from the top of the scapula to the lower rib margins.

Allergenic extracts for diagnostic use are to be administered in the following manner: To scratch surface of skin, use a circular scarifier. Do not draw blood. Tests sites should be 4 cm apart to allow for wheal and flare reaction. 1-30 scratch tests may be done at a time. A separate sterile scratch instrument is to be used on each patient to prevent transmission of homologous serum hepatitis or other infectious agents from one patient to another.

The recommended usual dosage for Scratch testing is one drop of allergen applied to each scratch site. Do not let dropper touch skin. Always apply a control scratch with each test set. Sterile Diluent (for a negative control) is used in exactly the same way as an active test extract. Histamine may be used as a positive control. Scratch or prick test sites should be examined at 15 and 30 minutes. To prevent excessive absorption, wipe off antigens producing large reactions as soon as the wheal appears. Record the size of the reaction.

Interpretation of Scratch Test

Skin tests are graded in terms of the wheal and erythema response noted at 10 to 20 minutes. Wheal and erythema size may be recorded by actual measurement as compared with positive and negative controls. A positive reaction consists of an area of erythema surrounding the scarification that is larger than the control site. For uniformity in reporting reactions, the following system is recommended. (6)

REACTION	SYMBOL	CRITERIA
Negative	-	No wheal. Erythema absent or very slight (not more than 1 mm diameter).
One Plus	+	Wheal absent or very slight erythema present (not more than 3 mm diameter).
Two Plus	++	Wheal not more than 3mm or erythema not more than 5mm diameter.
Three Plus	+++	Wheal between 3mm and 5mm diameter, with erythema. Possible pseudopodia and itching.
Four Plus	++++	A larger reaction with itching and pain.

Diagnostic Use: Intradermal Skin Testing Method

Do not perform intradermal test with allergens which have evoked a 2+ or greater response to a Scratch test. Clean test area with alcohol, place sites 5 cm apart using separate sterile tuberculin syringe and a 25 gauge needle for each allergen. Insert needle tip, bevel up, into intracutaneous space. Avoid injecting into blood vessel, pull back gently on syringe plunger, if blood enters syringe change position of needle. The recommended dosage and range for intradermal testing is 0.05 ml of not more than 100 pnu/ml or 1:1000 w/v (only if puncture test is negative) of allergenic extract. Inject slowly until a small bleb is raised. It is important to make each bleb the same size.

Interpretation of Intradermal Test:

The patient's reaction is graded on the basis of size of wheal and flare as compared to control. Use 0.05 ml sterile diluent as a negative control to give accurate interpretation. The tests may be accurately interpreted only when the saline control site has shown a negative response. Observe patient for at least 30 minutes. Tests can be read in 15-20 minutes. Edema, erythema and presence of pseudopods, pain and itching may be observed in 4 plus reactions. For uniformity in reporting reactions the following system is recommended. (6)

REACTION	SYMBOL	CRITERIA
Negative	-	No increase in size of bleb since injection. No erythema.
One Plus	+	An increase in size of bleb to a wheal not more than 5mm diameter, with associated erythema.
Two Plus	++	Wheal between 5mm and 8mm diameter with erythema.
Three Plus	+++	Wheal between 8mm and 12mm diameter with erythema and possible pseudopodia and itching or pain.
Four Plus	++++	Any larger reaction with itch and pain, and possible diffuse blush of the skin surrounding the reaction area.

Therapeutic Use: Recommended dosage & range

Check the listed ingredients to verify that it matches the prescription ordered. When using a prescription set, verify the patient's name and the ingredients listed with the prescription order. Assess the patient's physical and emotional status prior to giving as injection. Do not give injections to patients who are in acute distress. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Dosage of allergenic extracts is a highly individualized matter and varies according to the degree of sensitivity of the patient, his clinical response and tolerance to the extract administered during the early phases of an injection regimen. The dosage must be reduced when transferring a patient from non-standardized or modified extract to standardized extract. Any evidence of a local or generalized reaction requires a reduction in dosage during the initial stages of immunotherapy as well as during maintenance therapy. After therapeutic injections patients should be observed for at least 20 minutes for reaction symptoms.

SUGGESTED DOSAGE SCHEDULE

The following schedule may act as a guide. This schedule has not been proven to be safe or effective. Sensitive patients may begin with smaller doses of weaker solutions and the dosage increments can be less.

STRENGTH	DOSE	VOLUME
Vial #1	1	0.05
1:100,000 w/v	2	0.10
10 pnu/ml	3	0.15
1 AU/ml	4	0.20
1 BAU/ml	5	0.30
	6	0.40
	7	0.50
Vial #2	8	0.05
1:10,000 w/v	9	0.10
100 pnu/ml	10	0.15
10 AU/ml	11	0.20
10 BAU/ml	12	0.30
	13	0.40
	14	0.50
Vial #3	15	0.05
1:1,000 w/v	16	0.10
1,000 pnu/ml	17	0.15
100 AU/ml	18	0.20
100 BAU/ml	19	0.30
	20	0.40
	21	0.50
Vial #4	22	0.05
1:100 w/v	23	0.07
10,000 pnu/ml	24	0.10
1,000 AU/ml	25	0.15
1,000 BAU/ml	26	0.20
	27	0.25
Maintenance Refill	28	0.25
1:100 w/v	29	0.25
10,000 pnu/ml	30	0.25
1,000 AU/ml	31	0.25
1,000 BAU/ml	32	0.25
subsequent doses	33	0.25

Preparation Instructions:

All dilutions may be made using sterile buffered diluent. The calculation may be based on the following ratio:

Volume desired x Concentration desired = Volume needed x Concentration available.

Example 1: If a 1:10 w/v extract is available and it is desired to use a 1:1,000 w/v extract substitute as follows:

Vd x Cd = Vn x Ca

10ml x 0.001 = Vn x 0.1

0.1 ml = Vn

Using a sterile technique, remove 0.10 ml of extract from the 1:10 vial and place it into a vial containing 9.90 ml of sterile diluent. The resulting ratio will be a 10 ml vial of 1:1,000 w/v.

Example 2: If a 10,000 pnu/ml extract is available and it is desired to use a 100 pnu/ml extract substitute as follows:

10ml x 100 = Vn x 10,000

0.1 ml = Vn

Using a sterile technique, remove 0.10 ml of extract from the 10,000 pnu/ml vial and place it into a vial containing 9.90 ml of sterile diluent. The resulting concentration will be a 10 ml vial of 100 pnu/ml.

Example 3: If a 10,000 AU/ml or BAU/ml extract is available and it is desired to use a 100 AU/ml or BAU/ml extract substitute as follows: Vd x Cd = Vn x Ca

10ml x 100 = Vn x 10,000

0.1 ml = Vn

Using a sterile technique, remove 0.10 ml of extract from the 10,000 AU/ml or BAU/ml vial and place it into a vial containing 9.90 ml of sterile diluent. The resulting concentration will be 10ml vial of 100 AU/ml or BAU/ml.

Intervals between doses: The optimal interval between doses of allergenic extract has not been definitely established. The amount of allergenic extract is increased at each injection by not more than 50%-100% of the previous amount and the next increment is governed by the response to the last injection. There are three generally accepted methods of pollen hyposensitizing therapy.

1. PRESEASONAL

Treatment starts each year 6 to 8 weeks before onset of seasonal symptoms. Maximal dose reached just before symptoms are expected. Injections discontinued during and following season until next year.

2. CO-SEASONAL

Patient is first treated during season with symptoms. Low initial doses are employed to prevent worsening of condition. This is followed by an intensive schedule of therapy (i.e. injections given 2 to 3 times per week). Fewer Allergists are resorting to this Co-seasonal therapy because of the availability of more effective, symptomatic medications that allow the patient to go through a season relatively symptom free.

3. PERENNIAL

Initially this is the same as pre seasonal. The allergen is administered twice weekly or weekly for about 20 injections to achieve the maximum tolerated dose. Then, maintenance therapy may be administered once a week or less frequently.

Duration of Treatment: The usual duration of treatment has not been established. A period of two or three years of injection therapy constitutes an average minimum course of treatment.

How is House Dust Mite Injection Supplied

Allergenic extracts are supplied with units listed as: Weight/volume (W/V), Protein Nitrogen Units (PNU/ml), Allergy Units (AU/ml) or Bioequivalent Allergy Units (BAU/ml).

Sizes:

Diagnostic Scratch: 5 ml dropper application vials

Diagnostic Intradermal: 5 ml or 10 ml vials.

Therapeutic Allergens: 5 ml, 10 ml, 50 ml multiple dose vials.

STORAGE

The expiration date of allergen extracts is listed on the container label. Store extracts upon arrival at 2° to 8°C and keep them in this range during office use.

WARRANTY:We warrant that this product was prepared and tested according to the standards of the FDA and is true to label. Because of biological differences in individuals and because allergenic extracts are manufactured to be potent and because we have no control over the conditions of use, we cannot and do not warrant either a good effect or against an ill effect following use.

REFERENCES

1 Jacobs, Robert L., Geoffrey W.Rake,Jr., et.al. Potentiated Anaphylaxis in Patients with Drug-induced Beta-adrenergic Blockade. J.Allergy & Clin. Immunol., 68(2): 125-127. August 1981.

2 Ishizaka,K.: Cellular Events in the IgE Antibody Response. Adv. in Immuno. 23:50-75, 1976.

3. Lockey, R.F., Bukantz, S.C., Allergen Immunotherapy. New York,NY: Marcel Dekker Inc., 1991.

4. Reid,M.J., Lockey,R.F., Turkeltaub,P.C., Platts-Mills,T.A.E., Survey of fatalities from skin testing and immunotherapy 1985-1989. Journal of Allergy Clin. Immunol. 92 (1): 6-15, July 1993.

5. Murray, A.B., Ferguson, A., Morrison, B., The frequency and severity of cat allergy vs dog allergy in atopic children. J. Allergy Clin. Immunolo: 72, 145-9, 1983.

6. Lockey, R.F., Bukantz, S.C., Allergen Immunotherapy. New York,NY: Marcel Dekker Inc., 1991.

CONTAINER LABELING

HOUSE DUST  house dust  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 36987-1122 Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOUSE DUST (HOUSE DUST) HOUSE DUST 10000 [PNU]  in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE   SODIUM BICARBONATE   WATER   PHENOL

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 36987-1122-1 5 mL In 1 VIAL, MULTI-DOSE None 2 36987-1122-2 10 mL In 1 VIAL, MULTI-DOSE None 3 36987-1122-3 30 mL In 1 VIAL, MULTI-DOSE None 4 36987-1122-4 50 mL In 1 VIAL, MULTI-DOSE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA102192	08/29/1972

HOUSE DUST  house dust  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 36987-1123 Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOUSE DUST (HOUSE DUST) HOUSE DUST 10000 [PNU]  in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE   SODIUM BICARBONATE   WATER   PHENOL   GLYCERIN

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 36987-1123-1 5 mL In 1 VIAL, MULTI-DOSE None 2 36987-1123-2 10 mL In 1 VIAL, MULTI-DOSE None 3 36987-1123-3 30 mL In 1 VIAL, MULTI-DOSE None 4 36987-1123-4 50 mL In 1 VIAL, MULTI-DOSE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA102192	08/29/1972

HOUSE DUST  house dust  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 36987-1124 Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOUSE DUST (HOUSE DUST) HOUSE DUST 20000 [PNU]  in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE   SODIUM BICARBONATE   WATER   PHENOL

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 36987-1124-1 5 mL In 1 VIAL, MULTI-DOSE None 2 36987-1124-2 10 mL In 1 VIAL, MULTI-DOSE None 3 36987-1124-3 30 mL In 1 VIAL, MULTI-DOSE None 4 36987-1124-4 50 mL In 1 VIAL, MULTI-DOSE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA102192	08/29/1972

HOUSE DUST  house dust  injection, solution