Vicks 44E

Generic Name: dextromethorphan and guaifenesin (DEX troe me THOR fan and gwye FEN e sin)

Brand Names: Allfen DM, Altarussin DM, Aquatab DM, Benylin Expectorant, Drituss DM, Extuss LA, Fenesin DM IR, Glycotuss-DM, Guaifen DM, Mucinex Children's Cough, Mucinex DM, MucusRelief DM, Naldecon DX Liquigel, Relacon LAX, Respa-DM, Robitussin Cough & Congestion, Tussi-Bid, Tussi-Organidin DM NR, Vicks 44E

What is Vicks 44E (dextromethorphan and guaifenesin)?

Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.

Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.

The combination of dextromethorphan and guaifenesin is used to treat cough and chest congestion caused by the common cold, infections, or allergies.

Dextromethorphan will not treat a cough that is caused by smoking, asthma, or emphysema.

Dextromethorphan and guaifenesin may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Vicks 44E (dextromethorphan and guaifenesin)?

Do not give this medication to a child younger than 2 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body. Do not use any other over-the-counter cough or cold medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains dextromethorphan or guaifenesin. Dextromethorphan will not treat a cough that is caused by smoking, asthma, or emphysema.

What should I discuss with my healthcare provider before taking Vicks 44E (dextromethorphan and guaifenesin)?

Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

Ask a doctor or pharmacist if it is safe for you to take this medication if you have emphysema or chronic bronchitis.

FDA pregnancy category C. It is not known whether dextromethorphan and guaifenesin is harmful to an unborn baby. Before you take this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether this medication passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.

How should I take Vicks 44E (dextromethorphan and guaifenesin)?

Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

Do not give this medication to a child younger than 2 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time.

Dextromethorphan and guaifenesin granules should be sprinkled directly onto the tongue and swallowed right away.

Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

Store this medicine at room temperature, away from heat, light, and moisture.

What happens if I miss a dose?

Since cough or cold medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

Overdose symptoms may include feeling restless or nervous.

What should I avoid while taking Vicks 44E (dextromethorphan and guaifenesin)?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of this medication.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with cough or cold medicine can increase your risk of unpleasant side effects.

Do not use any other over-the-counter cough or cold medication without first asking your doctor or pharmacist. Dextromethorphan and guaifenesin are contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains dextromethorphan or guaifenesin.

Vicks 44E (dextromethorphan and guaifenesin) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

• 
  

  severe dizziness, anxiety, restless feeling, or nervousness;

  
  


• 
  

  confusion, hallucinations; or

  
  


• 
  

  slow, shallow breathing.

  
  

Less serious side effects may include:

• 
  

  dizziness;

  
  


• 
  

  headache;

  
  


• 
  

  skin rash or itching; or

  
  


• 
  

  nausea, vomiting, or stomach upset.

  
  

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 Vicks 44E (dextromethorphan and guaifenesin)?

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

• 
  

  celecoxib (Celebrex);

  
  


• 
  

  cinacalcet (Sensipar);

  
  


• 
  

  darifenacin (Enablex);

  
  


• 
  

  imatinib (Gleevec);

  
  


• 
  

  quinidine (Quinaglute, Quinidex);

  
  


• 
  

  ranolazine (Ranexa);

  
  


• 
  

  ritonavir (Norvir);

  
  


• 
  

  sibutramine (Meridia);

  
  


• 
  

  terbinafine (Lamisil);

  
  


• 
  

  medicines to treat high blood pressure; or

  
  


• 
  

  an antidepressant such as amitriptyline (Elavil, Etrafon), bupropion (Wellbutrin, Zyban), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Janimine, Tofranil), paroxetine (Paxil), sertraline (Zoloft), and others.

  
  

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

More Vicks 44E resources

• Vicks 44E Side Effects (in more detail)
• Vicks 44E Use in Pregnancy & Breastfeeding
• Vicks 44E Drug Interactions
• Vicks 44E Support Group
• 0 Reviews for Vicks 44E - Add your own review/rating

• Atuss-12 DX Extended-Release Liquid MedFacts Consumer Leaflet (Wolters Kluwer)


• Bidex-A Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Duratuss DM 12 Suspension MedFacts Consumer Leaflet (Wolters Kluwer)


• Guaifenesin DM Elixir MedFacts Consumer Leaflet (Wolters Kluwer)


• Humibid CS MedFacts Consumer Leaflet (Wolters Kluwer)


• Mucinex DM Prescribing Information (FDA)


• Mucinex DM Maximum Strength Prescribing Information (FDA)


• Robitussin DM infant drops


• Scot-Tussin DM Liquid MedFacts Consumer Leaflet (Wolters Kluwer)


• Tussin DM Prescribing Information (FDA)

Compare Vicks 44E with other medications

• Cough
• Expectoration

Where can I get more information?

• Your pharmacist can provide more information about dextromethorphan and guaifenesin.

See also: Vicks 44E side effects (in more detail)

Ivomec Pour-On

Dosage Form: FOR ANIMAL USE ONLY
ivomec®

(ivermectin)

pour-on for cattle

Contains 5 mg ivermectin/mL

Parasiticide

Product Numbers: 67650, 67652, 67654, 67656

Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism.

INTRODUCTION

IVOMEC (ivermectin) Pour-On delivers internal and external parasite control in one convenient low-volume application. Discovered and developed by scientists from Merck Research Laboratories, Ivomec Pour-On contains ivermectin, a unique chemical entity.

MODE OF ACTION

Ivermectin is a member of the macrocylic lactone class of endectocides which have a unique mode of action. Compounds of the class bind selectively and with high affinity to glutamate-gated chloride ion channels which occur in invertebrate nerve and muscle cells.

This leads to an increase in the permeability of the cell membrane to chloride ions with hyperpolarization of the nerve or muscle cell, resulting in paralysis and death of the parasite. Compounds of this class may also interact with other ligand-gated chloride channels, such as those gated by the neurotransmitter gamma-aminobutyric acid (GABA).

The margin of safety for compounds of this class is attributable to the fact that mammals do not have glutamate-gated chloride channels, the macrocyclic lactones have a low affinity for other mammalian ligand-gated chloride channels and they do not readily cross the blood-brain barrier.

INDICATIONS

Ivomec Pour-On applied at the recommended dose level of 500 mcg/kg is indicated for the effective treatment and control of these parasites.

Gastrointestinal Roundworms
Ostertagia ostertagi       (including inhibited stage)	(adults and L4)
Haemonchus placei	(adults and L4)
Trichostrongylus axei	(adults and L4)
T. colubriformis	(adults and L4)
Cooperia oncophora	(adults and L4)
Cooperia punctata	(adults and L4)
Cooperia surnabada	(adults and L4)
Strongyloides papillosus	(adults)
Oesophagostomum radiatum	(adults and L4)
Trichuris spp.	(adults)
Lungworms
Dictyocaulus viviparus	(adults and L4)
Cattle Grubs	(parasitic stages)
Hypoderma bovis
H. Iineatum
Mites
Sarcoptes scabiei var. bovis
Lice
Linognathus vituli
Haematopinus eurysternus
Damalinia bovis
Solenopotes capillatus
Horn Flies
Haematobia irritans

PERSISTENT ACTIVITY

Ivomec Pour-On has been proved to effectively control infections and to protect cattle from re-infection with: Oesophagostomum radiatum and Dictyocaulus viviparus for 28 days after treatment; Cooperia punctataand Trichostrongylus axei for 21 days after treatment; Ostertagia ostertagi, Haemonchus placei, Cooperia oncophora and Cooperia surnabada for 14 days after treatment; Damalinia bovis for 56 days after treatment.

TREATMENT OF CATTLE FOR HORN FLIES

Ivomec Pour-On controls horn flies (Haematobia irritans) for up to 28 days after dosing. For best results Ivomec Pour-On should be part of a parasite control program for both internal and external parasites based on the epidemiology of these parasites. Consult your veterinarian or an entomologist for the most effective timing of applications.

DOSAGE

The dose rate is 1 mL for each 22 lb of body weight. The formulation should be applied along the topline in a narrow strip extending from the withers to the tailhead.

ADMINISTRATION

Squeeze-Measure-Pour System

(8.5 fl oz/250 mL Bottle with 25 mL Metering Cup)

• Attach the metering cup to the bottle.


• Set the dose by turning the top section of the cup to align the correct body weight with the pointer on the knurled cap. When body weight is between markings, use the higher setting.


• Hold the bottle upright and squeeze it to deliver a slight excess of the required dose as indicated by the calibration lines.


• By releasing the pressure, the dose automatically adjusts to the correct level. Tilt the bottle to deliver the dose. The off (STOP) position will close the system between dosing.

Squeeze-Measure-Pour System

(33.8 fl oz/1 Liter Bottle with 50 mL Metering Cup)

• Attach the metering cup to the bottle.


• Set the dose by turning the top section of the cup to align the correct body weight with the pointer on the knurled cap. When body weight is between markings, use the higher setting.


• Hold the bottle upright and squeeze it to deliver a slight excess of the required dose as indicated by the calibration lines.


• By releasing the pressure, the dose automatically adjusts to the correct level. Tilt the bottle to deliver the dose. When 220 lb (10 mL) or 330 lb (15 mL) dose is required, turn the pointer to "STOP" before delivering the dose. The off (STOP) position will close the system between dosing.

Collapsible Pack

(84.5 fl oz/2.5 L Pack and 169 fl oz/5 L Pack)

Connect the applicator gun to the collapsible pack as follows:

• Attach the open end of the draw-off tubing to the dosing equipment. (Because of the solvents used in the formulation, only the Protector Drench Gun from Instrument Supplies Limited, or equivalent, is recommended. Other applicators may exhibit compatibility problems resulting in locking, incorrect dosage or leakage.)


• Replace the shipping cap with the draw-off cap and tighten down. Attach draw-off tubing to the draw-off cap.


• Gently prime the applicator gun, checking for leaks.


• Follow the manufacturer's directions for adjusting the dose.


• When the interval between uses of the applicator gun is expected to exceed 12 hours, disconnect the gun and draw-off tubing from the product container and empty the product from the gun and tubing back into the product container. To prevent removal of special lubricants from the Protector Drench Gun, the gun and tubing must not be washed.

20 Liter Pack

(676 fl oz/20 L Pack)

Use dosing equipment (applicator, draw-off tubing, cap with stem) compatible with IVOMEC (ivermectin) Pour-On. Other dosing equipment may be incompatible, resulting in locking, incorrect dosage and leakage. Follow the dosing equipment manufacturer's directions for adjusting the dose and proper use and maintenance of the dosing equipment. Connect the dosing applicator and the draw-off tubing to the container as follows:

• Attach the open end of the draw-off tubing to an appropriate dosing applicator. Attach draw-off tubing to the cap with the stem. Replace the shipping cap with the cap having the draw-off tubing. Gently prime the dosing applicator, checking for leaks.


• When the interval between uses of the applicator gun is expected to exceed 12 hours, disconnect the gun, draw-off tubing and cap with stem from the product container, empty the product from the gun and tubing back into the product container and replace the shipping cap.

ANIMAL SAFETY

Studies conducted in the U.S.A. have demonstrated the safety margin for ivermectin. Based on plasma levels, the topically applied formulation is expected to be at least as well tolerated by breeding animals as is the subcutaneous formulation which had no effect on breeding performance.

Warning

NOT FOR USE IN HUMANS.

Keep this and all drugs out of the reach of children.

The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information. To report adverse effects, obtain an MSDS or for assistance, contact Merial at 1-888-637-4251.

WARNING! FLAMMABLE!

KEEP AWAY FROM HEAT, SPARKS, OPEN FLAME,

and OTHER SOURCES OF IGNITION.

This product should not be applied to self or others because it may be irritating to human skin and eyes and absorbed through the skin. To minimize accidental skin contact, the user should wear a long-sleeved shirt and rubber gloves. If accidental skin contact occurs, wash immediately with soap and water. If accidental eye exposure occurs, flush eyes immediately with water and seek medical attention.

RESIDUE WARNING

Cattle must not be treated within 48 days of slaughter for human consumption. Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.

Precautions

• Store away from excessive heat (104°F/40°C)and protect from light.


• Use only in well-ventilated areas or outdoors.


• Close container tightly when not in use.


• Cattle should not be treated when hair or hide is wet since reduced efficacy may be experienced.


• Do not use when rain is expected to wet cattle within six hours after treatment.


• This product is for application to skin surface only. Do not give orally or parenterally.


• Cloudiness in the formulation may occur when IVOMEC® Pour-On is stored at temperatures below 32°F. Allowing to warm at room temperature will restore the normal appearance without affecting efficacy.


• Antiparasitic activity of ivermectin will be impaired if the formulation is applied to areas of the skin with mange scabs or lesions, or with dermatoses or adherent materials, e.g., caked mud or manure.


• Ivermectin has been associated with adverse reactions in sensitive dogs; therefore, Ivomec Pour-On is not recommended for use in species other than cattle.


• Restricted Drug (California) - Use only as directed.

When to Treat Cattle with Grubs

Ivomec Pour-On effectively controls all stages of cattle grubs. However, proper timing of treatment is important. For the most effective results, cattle should be treated as soon as possible after the end of the heel fly (warble fly) season. While this is not peculiar to ivermectin, destruction of Hypoderma larvae (cattle grubs) at the period when these grubs are in vital areas may cause undesirable host-parasite reactions. Killing Hypoderma lineatum when it is in the esophageal tissues may cause bloat; killing H. bovis when it is in the vertebral canal may cause staggering or paralysis. Cattle should be treated either before or after these stages of grub development.

Cattle treated with Ivomec Pour-On at the end of the fly season may be re-treated with IVOMEC during the winter without danger of grub-related reactions. For further information and advice on a planned parasite control program, consult your veterinarian.

Environmental Safety

Studies indicate that when ivermectin comes in contact with soil it readily and tightly binds to the soil and becomes inactive over time. Free ivermectin may adversely affect fish and certain aquatic organisms. Do not permit cattle to enter lakes, streams or ponds for at least six hours after treatment. Do not contaminate water by direct application or by improper disposal of drug containers. Dispose of containers in an approved landfill or by incineration.

As with other avermectins, ivermectin is excreted in the dung of treated animals and can inhibit the reproduction and growth of pest and beneficial insects that use dung as a source of food and for reproduction. The magnitude and duration of such effects are species and life-cycle specific. When used according to label directions, the product is not expected to have an adverse impact on populations of dung-dependent insects.

How is Ivomec Pour-On Supplied

Ivomec Pour-On is available in an 8.5 fl oz/250 mL bottle or 33.8 fl oz/1 L bottle with a squeeze-measure-pour system, or in an 84.5 fl oz/2.5 L or 169 oz/5 L collapsible pack, or 676 fl oz/20 L container intended for use with appropriate automatic dosing equipment.

IVOMEC and Cattle Head Logo are registered trademarks of Merial Limited.

Copyright © 2007 Merial Limited. All Rights Reserved.

Manufactured for

Merial Limited

Operational Headquarters,

3239 Satellite Blvd.

Duluth, GA 30096-4640, U.S.A.

Manufactured to Merial Specifications by

Argenta Manufacturing Limited

Manurewa, Auckland 2102, New Zealand

1050-1445-03

Rev. 07-2007

NADA 140-841, Approved by the FDA

PRINCIPAL DISPLAY PANEL - 250 mL Bottle Carton

Product 67650

ivomec®

(ivermectin)

pour-on for cattle

Contains 5 mg ivermectin/mL

Parasiticide

Kills: Roundworms (including Brown Stomach

Worm), Lungworms, Grubs, Sucking Lice,

Biting Lice, Mange Mites, Horn Flies

Contains 10–550 lb Doses

NADA 140-841, Approved by the FDA

8.5 fl oz (250 mL)

MERIAL

PRINCIPAL DISPLAY PANEL - 2500 mL Bottle Carton

Product 67654

ivomec®

(ivermectin)

pour-on for cattle

Contains 5 mg ivermectin/mL

Parasiticide

Kills: Roundworms (including Brown Stomach

Worm), Lungworms, Grubs, Sucking Lice,

Biting Lice, Mange Mites, Horn Flies

Contains 100–550 lb Doses

NADA 140-841, Approved by the FDA

84.5 fl oz (2.64 qt) (2.5 L)

MERIAL

IVOMEC  POUR-ON FOR CATTLE ivermectin  solution

Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 50604-4734 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ivermectin (ivermectin) ivermectin 5 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 50604-4734-1 1 BOTTLE In 1 CARTON contains a BOTTLE, PLASTIC 1 250 mL In 1 BOTTLE, PLASTIC This package is contained within the CARTON (50604-4734-1) 2 50604-4734-2 1 BOTTLE In 1 CARTON contains a BOTTLE, PLASTIC 2 1000 mL In 1 BOTTLE, PLASTIC This package is contained within the CARTON (50604-4734-2)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA140841	12/24/1990

IVOMEC  POUR-ON FOR CATTLE ivermectin  solution

Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 50604-4736 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ivermectin (ivermectin) ivermectin 5 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 50604-4736-1 1 BOTTLE In 1 CARTON contains a BOTTLE, PLASTIC 1 2500 mL In 1 BOTTLE, PLASTIC This package is contained within the CARTON (50604-4736-1) 2 50604-4736-2 1 BOTTLE In 1 CARTON contains a BOTTLE, PLASTIC 2 5000 mL In 1 BOTTLE, PLASTIC This package is contained within the CARTON (50604-4736-2) 3 50604-4736-3 1 BOTTLE In 1 CARTON contains a BOTTLE, PLASTIC 3 20000 mL In 1 BOTTLE, PLASTIC This package is contained within the CARTON (50604-4736-3)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA140841	12/24/1990

Labeler - Merial Limited (034393582)

Revised: 10/2010Merial Limited

Cloderm

Pronunciation: kloe-CORE-toe-lone
Generic Name: Clocortolone
Brand Name: Cloderm

Cloderm is used for:

Treating inflammation and itching due to certain skin conditions. It may also be used to treat other conditions as determined by your doctor.

Cloderm is a topical adrenocortical steroid. It works by reducing skin inflammation (redness, swelling, itching, and irritation) by a way that is not clearly understood.

Do NOT use Cloderm if:

• you are allergic to any ingredient in Cloderm

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

Before using Cloderm:

Some medical conditions may interact with Cloderm. 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 or other substances


• if you have any kind of skin infection, cuts, scrapes, or lessened blood flow to your skin


• if you have had a recent vaccination; have measles, tuberculosis, chicken pox, or shingles; or have had a positive tuberculosis test


• if you are taking prednisone or similar medicines

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

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

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

• Apply a small amount of medicine to the affected area. Gently rub the medicine in until it is evenly distributed. Wash your hands after applying Cloderm, unless your hands are part of the treated area.


• Do not bandage or cover the treated skin area unless directed by your doctor.


• If you miss a dose of Cloderm, apply 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 apply 2 doses at once.

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

Important safety information:

• Cloderm is for external use only. Do not get Cloderm in your eyes. If contact is made with the eyes, flush them immediately with tap water.


• If Cloderm is applied to the diaper area, apply a very small amount and do not use tight-fitting diapers or plastic pants.


• Do not exceed the recommended dose or use Cloderm longer than prescribed without checking with your doctor.


• Check with your doctor before having vaccinations while using Cloderm.


• Do not use Cloderm for other skin conditions at a later time.


• Cloderm contains a corticosteroid. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains hydrocortisone or any other corticosteroid. If it does or if you are uncertain, contact your doctor or pharmacist.


• Corticosteroids medicines may affect the growth rate in CHILDREN and adolescents in some instances. Your child's growth may need to be checked regularly while using Cloderm.


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

Possible side effects of Cloderm:

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:

Dryness; itching.

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); acne-like rash; burning, cracking, irritation, or peeling not present before you began using Cloderm; excessive hair growth; inflamed hair follicles; inflammation around the mouth; muscle weakness; thinning, softening, or discoloration of the skin; unusual weight gain, especially in the face.

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

See also: Cloderm 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 increased thirst or urination; muscle weakness; unusual weight gain, especially in the face.

Proper storage of Cloderm:

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

General information:

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


• Cloderm 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 Cloderm. 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 Cloderm resources

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

• Cloderm Prescribing Information (FDA)


• Cloderm Concise Consumer Information (Cerner Multum)

Compare Cloderm with other medications

• Atopic Dermatitis
• Dermatitis
• Eczema
• Psoriasis

Nithiodote

Generic Name: sodium nitrite and sodium thiosulfate (Intravenous route)

SOE-dee-um NYE-trite, SOE-dee-um thye-oh-SUL-fate

Intravenous route(Solution)

Sodium nitrite can cause serious adverse reactions and death from hypotension and methemoglobin formation, even at doses less than twice the recommended therapeutic dose. Hypotension and methemoglobin formation can occur concurrently or separately. Patients should be closely monitored to ensure adequate perfusion and oxygenation during treatment with sodium nitrite. Alternative therapeutic approaches should be considered in patients known to have diminished oxygen or cardiovascular reserve and in those at higher risk of developing methemoglobinemia .

Commonly used brand name(s)

In the U.S.

• Nithiodote

Available Dosage Forms:

• Solution

Uses For Nithiodote

Sodium nitrite and sodium thiosulfate injection are used together to treat cyanide poisoning. Cyanide poisoning is a life-threatening condition that requires immediate medical attention.

This medicine is to be given only by or under the direct supervision of a doctor.

Before Using Nithiodote

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 have not been performed on the relationship of age to the effects of sodium nitrite and sodium thiosulfate injection in the pediatric population. However, because cyanide poisoning is a life-threatening condition, it is used in the pediatric population. Recommended doses should not be exceeded, and the patient should be carefully monitored during treatment.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sodium nitrite and sodium thiosulfate 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 sodium nitrite and sodium thiosulfate 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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Anemia or


• Carbon monoxide poisoning or


• Glucose-6-phosphate dehydrogenase (G6PD) deficiency (genetic disorder affecting red blood cells) or


• Heart disease or


• Lung or breathing problems (eg, asthma, chronic obstructive pulmonary disease) or


• Smoke inhalation injury—Use with caution. May cause side effects to become worse.

• Hypotension (low blood pressure)—Use with caution. May make this condition worse.

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

Proper Use of Nithiodote

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

Precautions While Using Nithiodote

Your doctor will check your or your child's progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly. Blood tests will also be needed to check for unwanted effects.

Severe hypotension (low blood pressure) may occur with this medicine. It could be life-threatening and requires immediate medical attention. Your doctor will measure your blood pressure and keep it from going too low while you are receiving this medicine.

This medicine may cause a rare, but serious blood problem called methemoglobinemia. Newborn babies and infants may be more likely to have this serious side effect. Your doctor will measure how much methemoglobin is in your blood and keep it from going too high while you are receiving this medicine.

Nithiodote 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:

Incidence not known

• Bluish color of the fingernails, lips, skin, palms, or nail beds


• blurred vision


• change in consciousness


• confusion


• dark urine


• difficult or labored breathing


• dizziness


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


• drowsiness


• fainting


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


• fever


• headache


• lightheadedness


• loss of consciousness


• nausea


• numbness and tingling sensation


• pale skin


• rapid heart rate


• rapid shallow breathing


• seizures


• shortness of breath


• sore throat


• sweating


• tightness in the chest


• troubled breathing


• unusual bleeding or bruising


• unusual tiredness or weakness


• vomiting


• wheezing

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:

Incidence not known

• Abdominal or stomach pain


• anxiety


• confusion about identity, place, and time


• headache


• hives or welts


• increased sweating


• itching


• redness of the skin


• salty taste in your mouth


• skin rash


• tingling sensation at the injection site


• warm sensation over your body

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

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

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

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

Zamadol Injection

Zamadol Injection

active substance: tramadol hydrochloride

Read all of this leaflet carefully before you start taking this medicine.

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


• If you have any further questions, ask your doctor or your pharmacist.


• This medicine has been prescribed for you. Do not pass it on to others as it may harm them, even if their symptoms are the same as yours.


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

In this leaflet:

• 1. What Zamadol is and what it is used for


• 2. Before you use Zamadol


• 3. How to use Zamadol


• 4. Possible side effects


• 5. How to store Zamadol


• 6. Further information

What Zamadol is and what it is used for

The name of your medicine is Zamadol Injection (referred to as a Zamadol throughout this leaflet).

Zamadol belongs to a group of medicines called analgesics, commonly known as pain killers or pain relievers. The active substance, tramadol hydrocloride, interrupts the pain messages being sent to your brain, and it also acts in your brain to stop pain messages from being felt. This means that Zamadol does not stop the pain from happening, but you will not be able to feel the pain as much.

Zamadol is used to relieve moderate to severe, a sudden or a long-standing pain (for example pain after an operation, or after an injury).

Before you use Zamadol

Do not use Zamadol if:

• you are allergic (hypersensitive) to tramadol hydrochloride or to any of the other ingredients resulting in a skin rash, swelling in face or difficulty in breathing (see section 6. Further Information)


• you are taking, or you have taken in the last two weeks, monoamine oxidase inhibitors (MAOIs), these are medicines to treat depression


• you are suffering from uncontrolled epilepsy


• you have drunk enough alcohol to make you feel woozy or drunk


• you have taken more than the prescribed dose of your sleeping tablets or other pain killers, which can slow down your breathing and reactions. (See section ‘Taking other medicines’ for details)

Take special care with Zamadol

• If taken for long periods there is the rare possibility that addiction may develop.


• There is a rare possibility that Zamadol may cause convulsions (fits). The risk is increased if doses above the daily maximum are taken and if you are also taking anti-depressants or neuroleptics.


• If you have a tendency to drug addiction or abuse you should take Zamadol for short periods only. Please tell your doctor about this as he/she may want to monitor your pain control more closely.


• You should not take this product for the treatment of withdrawal symptoms caused by opiates (morphine- like medicines).


• If you have a head injury, breathing difficulties or severe liver or kidney problems.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription:

• Do not use Zamadol at the same time, or within 14 days of taking medicines called monoamine oxidase inhibitors (moclobemide or phenezeline for depression, selegiline for Parkinson’s disease).


• The pain relief effect of Zamadol may be weakened and/or shortened if you also take medicines containing:
  
  
  • Carbamazepine (used to treat epilepsy)
  • Buprenorphine, nalbuphine, or pentazocine (pain killers)
  • Ondanserton (prevents nausea)


• In isolated cases the side effects of selective serotonin re- uptake inhibitors (SSRI’s) (certain antidepressants) can be intensified by concomitant use of tramadol. Zamadol may enhance effects of these medicines and could cause a ‘serotegenic syndrome’ with symptoms such as confusion, restlessness, tremor, fever, sweating and diarrhoea. You must tell your doctor if you are taking any of these medicines.


• Medicines used to treat epilepsy may very rarely cause convulsions (fits), but if you are also taking Zamadol the possibility of having a convulsion is more likely. You must ask your doctor about this.


• Medicines that act on the nervous system such as hypnotics, tranquillisers, sleeping pills and pain killers may make you feel drowsier or faint when taken with Zamadol.


• Anticoagulants to thin your blood such as warfarin. The effectiveness of the medicines may be altered if you are also using Zamadol.

Tell your doctor or dentist if you are taking any of these medicines.

Pregnancy and breast-feeding

Zamadol should not be given during pregnancy or while breast feeding. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Zamadol may cause drowsiness, particularly if taken with alcohol, anti-histamines and other medicines that may cause drowsiness. Do not drive or operate heavy machinery unless you know how Zamadol affects you.

How to use Zamadol

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

The solution for injection is to be injected intravenously, intramuscularly or subcutaneously.

The usual dose is 50 mg (1ml) or 100 mg (2 ml) every 4 to 6 hours. Intravenous injections should be given slowly over 2-3 minutes.

The maximum dose is usually 600 mg daily (12 ml).

Dosage for children and adolescent:

Under 12 years – Zamadol should not be given to children under 12.

Dosage for elderly patients:

In elderly patients the doctor may reduce the frequency that the injection is given.

Dosage for patients with kidney and/or liver problems:

If you have severe liver and/or kidney problems you should not take Zamadol. If, in your case the problem is mild or moderate, your doctor may recommend making the time between the injections longer.

Method of administration:

Ask your doctor or pharmacist if:

• you are not sure how many injections to use or when to use them


• you think that the effect is too strong or too weak

If you use more Zamadol than you should

If you accidentally use more than your prescribed dose, tell your doctor or pharmacist immediately and if necessary contact your nearest hospital casualty department. Remember to take the pack and any remaining ampoules with you.

If you forget to take Zamadol

Do not take more than one dose to make up for the forgotten dose.

If you stop taking Zamadol

Do not stop taking Zamadol, or lower the dose, without first checking with your doctor. Your doctor may want you to gradually reduce the amount of Zamadol you are taking before stopping completely to ensure that you do not suffer from withdrawal symptoms.

Withdrawal symptoms include: agitation, anxiety, nervousness, difficulty sleeping, restlessness, trembling and gastro-intestinal problems.

If you have further questions on the use of this product, ask your doctor or pharmacist.

Zamadol Injection Side Effects

Like all other medicines, Zamadol can cause side effects, although not everybody gets them.

Please stop taking this medicine and contact your doctor as soon as possible if you experience any of the following rare reactions:

• allergic reaction such as difficulty in breathing, wheezing, swelling of the face or throat.


• anaphylactic reaction (an extreme allergic reaction)

Very Common (occurs in more than 1 in 10 patients)

• dizziness


• vomiting and nausea (being and feeling sick)

Common (occurs in more than 1 in 100 patients and less than 1 in 10 patients)

• headache


• drowsiness, sleepiness (fatigue)


• constipation, dry mouth


• sweating

Uncommon (occurs in more than 1 in 1,000 patients and less than 1 in 100 patients)

• rapid heart beat, palpitation, sudden drops in blood pressure. These adverse effects may occur especially on intravenous administration and in patients who are physically stressed


• itching, skin rash


• retching, feeling bloated or full

Rare (occurs in more than 1 in 10,000 patients and less than 1 in 1,000 patients)

• appetite changes


• psychic effects including: changes in mood, activity behaviour and perception, hallucinations, confusion, restlessness sleep disturbances and nightmares


• convulsions (fits)


• tingling sensation and trembling


• slow heart beat, increase in blood pressure


• muscle weakness


• difficulty or inability in passing urine


• blurred vision


• dependency

Very rare (occurs in less than 1 in 10,000 patients included isolated cases)

• vertigo (feeling of dizziness or "spinning")


• asthma and breathing difficulties


• elevated liver enzymes


• flushing

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

How to store Zamadol

• Keep out of reach and sight of children.


• Do not use Zamadol after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.


• Keep your injection in the original package.


• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information

What Zamadol contains:

The active substance in Zamadol Injection is tramadol hydrochloride. The other ingredients are sodium acetate, nitrogen and water for injection.

These presentations are not available in all countries.

What Zamadol Injection looks like and contents of the pack

Zamadol injection is supplied in packages of 5 ampoules and 10 ampoules made of colourless glass, each containing 2 ml of solution for injection.

The marketing authorisation holder is:

MEDA Pharmaceuticals Ltd

Skyway House

Parsonage Road

Takeley

Bishop's Stortford

CM22 6PU

UK

The manufacturer of this product is:

MEDA Pharma GmbH & Co. KG

Benzstrasse 1

61352 Bad Homburg

GERMANY

This leaflet was last approved in August 2009.

Thera-Gesic Plus Cream

Pronunciation: METH-il sa-LIS-i-late/MEN-thol
Generic Name: Methyl Salicylate/Menthol
Brand Name: Trade names include Menthoderm and Thera-Gesic Plus

Thera-Gesic Plus Cream is used for:

Temporary relief of minor aches and pains caused by arthritis, simple backache, strains, sprains, and bruises. It may also be used for other conditions as determined by your doctor.

Thera-Gesic Plus Cream is a topical analgesic. It works by temporarily relieving minor pain.

Do NOT use Thera-Gesic Plus Cream if:

• you are allergic to any ingredient in Thera-Gesic Plus Cream, including oil of wintergreen

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

Before using Thera-Gesic Plus Cream:

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

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


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


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


• if you have had an allergic reaction to aspirin or other salicylates


• if you have a wound at the affected area or your skin is broken or damaged in any way

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

• Anticoagulants (eg, warfarin) because the risk of their side effects may be increased by Thera-Gesic Plus Cream

Ask your health care provider if Thera-Gesic Plus Cream may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Thera-Gesic Plus Cream:

Use Thera-Gesic Plus Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Apply a thin layer of medicine to the painful or sore area. You may apply up to 3 thin layers of medicine depending on your pain level. Check with your doctor or the package label if you have questions about how to apply Thera-Gesic Plus Cream.


• Wash your hands immediately after using Thera-Gesic Plus Cream.


• You may wash the treated area once the medicine has been absorbed into the skin.


• Do not apply Thera-Gesic Plus Cream to wounds or damaged skin.


• Do not use Thera-Gesic Plus Cream right after you shower or take a bath.


• Do not bandage, wrap, or cover the affected area until after the medicine has been absorbed and you have washed the area.


• Do not use Thera-Gesic Plus Cream more than 3 to 4 times per day.


• If you miss a dose of Thera-Gesic Plus Cream, use it as soon as you remember. Continue to use it as directed by your doctor or on the package label.

Ask your health care provider any questions you may have about how to use Thera-Gesic Plus Cream.

Important safety information:

• Thera-Gesic Plus Cream is for external use only. Do not get it in your eyes, ears, lips, mouth, or genital area. If you get it in any of these areas, rinse right away with cool water.


• Do not use a heating pad after you apply Thera-Gesic Plus Cream.


• Do NOT use more than the recommended dose or use more often than directed without checking with your doctor.


• Do not use Thera-Gesic Plus Cream over large areas of the body without checking with your doctor.


• Do not allow Thera-Gesic Plus Cream to come into contact with clothing or any surface other than skin.


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


• Thera-Gesic Plus Cream may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.


• Thera-Gesic Plus Cream should not be used in CHILDREN younger than 12 years old without first checking with the child's doctor; safety and effectiveness in these children have not been confirmed.


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

Possible side effects of Thera-Gesic Plus Cream:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Thera-Gesic Plus Cream. 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); skin redness or irritation.

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 Thera-Gesic Plus Cream:

Store Thera-Gesic Plus Cream at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Thera-Gesic Plus Cream out of the reach of children and away from pets.

General information:

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


• Thera-Gesic Plus Cream is to be used only by the patient for whom it is prescribed. Do not share it with other people.


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


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

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

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Thera-Gesic Plus resources

• Thera-Gesic Plus Use in Pregnancy & Breastfeeding
• Thera-Gesic Plus Drug Interactions
• Thera-Gesic Plus Support Group
• 0 Reviews · Be the first to review/rate this drug

Prolactin inhibitors

A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Prolactin inhibitors are agents that inhibit the production of prolactin, a hormone that stimulates milk production after childbirth. In both sexes, excessive secretion of prolactin (hyperprolactinemia) can give rise to abnormal production of milk (galactorrhea).

Prolactin inhibitors are dopamine agonists, which effectively treat hyperprolactinemia.

See also

Medical conditions associated with prolactin inhibitors:

• Acromegaly
• Diabetes, Type 2
• Hyperprolactinemia
• Parkinson's Disease
• Tardive Dyskinesia

Drug List:

Cycloset

Dostinex

Parlodel

VIDENE ALCOHOLIC TINCTURE (Ecolab)

1. Name Of The Medicinal Product

VIDENE ALCOHOLIC TINCTURE

2. Qualitative And Quantitative Composition

Povidone-iodine 10% w/w

3. Pharmaceutical Form

Topical Solution.

4. Clinical Particulars

4.1 Therapeutic Indications

Videne Alcoholic Tincture is a broad-spectrum antiseptic for topical application. It is indicated for quick-drying pre-operative skin disinfection, particularly in orthopaedic surgery.

4.2 Posology And Method Of Administration

Videne Alcoholic Tincture is applied undiluted to the area to be incised and painted on thoroughly using a gauze swab. The solution may be allowed to dry to form a protective film or may be removed using a sterile gauze swab.

There are no special dosage recommendations for children or elderly patients.

4.3 Contraindications

Videne Alcoholic Tincture must never be administered orally.

4.4 Special Warnings And Precautions For Use

Care should be taken with known iodine-sensitive subjects, although such people do not normally react to povidone-iodine.

Videne Alcoholic Tincture must not be used on broken skin because of the intense stinging caused by the alcohol present.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None stated.

4.6 Pregnancy And Lactation

Videne Alcoholic Tincture is not recommended for use during pregnancy because of the possibility of absorption through broken skin and subsequent interference with tests of neonatal thyroid function.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

In very rare instances Videne Alcoholic Tincture may produce skin reactions in iodine-sensitive subjects. These reactions subside on cessation of treatment.

4.9 Overdose

In cases where Videne Alcoholic Tincture has been taken orally, gastric lavage with dilute starch mucilage or a 1% solution of sodium thiosulphate must be administered. The electrolyte balance must be corrected and lost fluids replaced.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Povidone-iodine has antiseptic activity and is used mainly for the treatment of contaminated wounds and preparation of pre-operative skin and mucous membranes. It is considered to be less irritant than iodine.

5.2 Pharmacokinetic Properties

Povidone-iodine is slightly absorbed when applied to the skin. Iodides are excreted mainly in the urine, with smaller amounts appearing in the faeces, saliva and sweat.

5.3 Preclinical Safety Data

Povidone-iodine had a low acute toxicity in both dogs and rats following either oral or intraperitoneal administration. Absorption of iodine through intact skin is low following the application of solutions of povidone-iodine although systemic absorption of iodine is greatly increased if the solutions are applied to broken skin, mucous membranes or are introduced into cavities of the body. At subcutaneous dose levels of up to 75mg/kg/day, povidone-iodine was non-teratogenic in rabbits following administration to pregnant animals during the period of organogenesis.

Some early in vitro studies indicated a possible mutagenic action for povidone-iodine. However, a number of later studies, using in vitro and in vivo test systems, do not indicate a significant level of mutagenic/genotoxic activity for povidone-iodine. Although conflicting data have been published, there is no convincing evidence to suggest that povidone-iodine adversely affects wound healing. Concentration of 0.05 and 0.5% povidone-iodine did not cause significant ocular damage when administered into the vitreous cavities of rabbits' eyes. There is some evidence to suggest that povidone-iodine-containing solutions applied to the round window of the chinchilla ear could result in high frequency hearing loss.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Alkyl Phenol Ether Sulphate (ammonium salt)

Industrial Methylated Spirit 95%

Citric Acid

Di-sodium Phosphate, Anhydrous

Purified Water

6.2 Incompatibilities

None stated

6.3 Shelf Life

24 months

6.4 Special Precautions For Storage

Store below 20°C in a dry place, protected from light.

6.5 Nature And Contents Of Container

Videne Alcoholic Tincture is packaged in a 500 ml HDPE bottle sealed with a plastic screw cap.

6.6 Special Precautions For Disposal And Other Handling

None stated

7. Marketing Authorisation Holder

Ecolab Ltd, Lotherton Way, Garforth, Leeds, LS25 2JY.

8. Marketing Authorisation Number(S)

PL 04509/0040

9. Date Of First Authorisation/Renewal Of The Authorisation

1 March 2003

10. Date Of Revision Of The Text

August 2006

polyethylene glycol, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid

pol-ee-ETH-i-leen GLYE-kol 3350, poe-TAS-ee-um KLOR-ide, SOE-dee-um KLOR-ide, SOE-dee-um SUL-fate, SOE-dee-um a-SKOR-bate, as-KORE-bik AS-id

Commonly used brand name(s)

In the U.S.

• MoviPrep

Available Dosage Forms:

• Powder for Solution

Uses For polyethylene glycol, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid

polyethylene glycol, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid is used to clean the colon (large bowel or lower intestine) before certain tests .

polyethylene glycol, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid acts like a laxative. It causes liquid stools or mild diarrhea. In this way, it flushes all solid material from the colon, so the doctor can have a clear view of the colon .

polyethylene glycol, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid is available only with your doctor's prescription .

Importance of Diet

Drink lots of fluids before, during or after the use of polyethylene glycol, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid .

Dinner should be at least one hour before the start of treatment. You may have clear soup or plain yogurt for dinner .

Do not eat any solid food from the start of treatment until after the test .

Before Using polyethylene glycol, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid

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 polyethylene glycol, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to polyethylene glycol, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid 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 polyethylene glycol, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid in the pediatric population. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of polyethylene glycol, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid in the elderly. However, increased sensitivity to the effects of polyethylene glycol, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid in some elderly cannot be ruled out .

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

PotassiumPolyethylene Glycol

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.

Sodium ChlorideAscorbic AcidAscorbic Acid

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 taking polyethylene glycol, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid, 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 polyethylene glycol, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid 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.

• Amantadine


• Atropine


• Belladonna


• Belladonna Alkaloids


• Benztropine


• Biperiden


• Clidinium


• Darifenacin


• Dicyclomine


• Eplerenone


• Glycopyrrolate


• Hyoscyamine


• Methscopolamine


• Oxybutynin


• Procyclidine


• Scopolamine


• Solifenacin


• Tolterodine


• Trihexyphenidyl

Using polyethylene glycol, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid 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.

• Alacepril


• Amiloride


• Amygdalin


• Benazepril


• Canrenoate


• Captopril


• Cilazapril


• Deferoxamine


• Delapril


• Enalaprilat


• Enalapril Maleate


• Fosinopril


• Imidapril


• Indomethacin


• Licorice


• Lisinopril


• Moexipril


• Pentopril


• Perindopril


• Quinapril


• Ramipril


• Spirapril


• Spironolactone


• Temocapril


• Trandolapril


• Triamterene


• Zofenopril

Using polyethylene glycol, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid 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.

• Indinavir


• Licorice

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 polyethylene glycol, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid. Make sure you tell your doctor if you have any other medical problems, especially:

• Blockage or obstruction of the intestine or


• Gastric retention or


• Ileus or


• Perforated bowel or


• Toxic colitis or


• Toxic megacolon or


• Ulcerative colitis, severe—polyethylene glycol, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid may make these conditions worse .

• Electrolyte imbalance (e.g., low sodium or potassium in the blood)—polyethylene glycol, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid may worsen condition and increase your risk of having seizures .

• Glucose-6-phosphate dehydrogenase deficiency—Use with caution. polyethylene glycol, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid contains sodium ascorbate and ascorbic acid. This may increase your risk of hemolytic anemia .

• Phenylketonuria—Use with caution. polyethylene glycol, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid contains phenylalanine .

• Poor gag reflex or


• Swallowing problem—polyethylene glycol, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid may cause severe lung problems if aspirated; may also cause severe bloating or stomach pain .

Proper Use of polyethylene glycol, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid

To prepare the oral solution:

• Empty the powder into a glass container and add one liter of lukewarm water.


• Shake well until all the ingredients are dissolved.


• Do not add any other ingredients, such as flavoring, to the solution.


• After you mix the solution, you must use it within 24 hours.


• You may refrigerate the solution before drinking .

Drink the mixture exactly as directed. Most people need to drink all of the oral solution to get completely clear stools .

You will need to consume two liters (about 64 ounces) of the oral solution and one additional liter (about 32 ounces) of clear liquid prior to the test. You may do one of the following ways:

• The night before the test, drink the first liter of oral solution over one hour and then drink 0.5 liters (about 16 ounces) of clear liquid. Then, on the morning of the test, drink the second liter of the oral solution over one hour and then drink another 0.5 liters of clear liquid at least an hour before the test; or


• The night (around 6 pm) before the test, drink the first liter of the oral solution over one hour. After about 1.5 hours, drink the second liter of the oral solution over one hour. Drink an additional liter of clear liquid the night before the test .

About 1 hour after you drink the first glass of liquid, you may have your first loose stool or mild diarrhea. This is how the medicine cleans out your bowels. You may have bloating or an upset stomach before the loose stools start .

Dosing

The dose of polyethylene glycol, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of polyethylene glycol, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For cleaning the colon:
  
  • For oral dosage form (powder for oral solution):
    
    • Adults—Drink one full glass (8 ounces) of the oral solution every 15 minutes, as instructed by your doctor.
    
    
    • Children—Use and dose must be determined by your doctor .
    
    
  
  

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Store the carton containing the pouches of powder and the liquid for mixing with the powder at room temperature, away from heat, moisture, or light. Once the powder has been mixed with the liquid, refrigerate the solution and use it within 24 hours .

Precautions While Using polyethylene glycol, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid

Your doctor may need to check your blood before and after the medical test to check for possible unwanted side effects from the medicine .

Do not take any oral medicine for at least one hour after taking polyethylene glycol, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid .

polyethylene glycol, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid 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 immediately if any of the following side effects occur:

More common

• Full or bloated feeling


• pain in upper stomach


• pressure in the stomach


• stomach pain


• swelling of abdominal or stomach area


• vomiting

Rare

• coma


• confusion


• convulsions


• decreased urine output


• dizziness


• dry mouth


• fast or irregular heartbeat


• headache


• increased thirst


• loss of appetite


• mood changes


• muscle pain or cramps


• numbness or tingling in hands, feet, fingertips, lips, or mouth


• shortness of breath


• swelling of face, ankles, or hands


• unusual tiredness or weakness

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

• Burning or itching around anus


• difficulty in sleeping


• feeling unusually cold


• general feeling of discomfort or illness


• hunger


• nausea


• pain around anus


• shivering


• thirst

Less common

• Acid or sour stomach


• belching


• heartburn


• indigestion


• stomach discomfort or upset

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

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

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

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