Tyzeka

Generic Name: telbivudine (Oral route)

tel-BIV-ue-deen

Oral route(Solution;Tablet)

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination with other antiretrovirals. Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued telbivudine; monitor hepatic function closely for several months following discontinuation of therapy .

Commonly used brand name(s)

In the U.S.

• Tyzeka

Available Dosage Forms:

• Tablet


• Solution

Therapeutic Class: Antiviral

Chemical Class: Thymidine Nucleoside Analog

Uses For Tyzeka

Telbivudine is used to treat chronic hepatitis B infection. Telbivudine is not a cure for hepatitis B infection, but it may lower the amount of virus in your body and may decrease the ability of the virus to multiply.

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

Before Using Tyzeka

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 telbivudine in the pediatric population. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of telbivudine have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of telbivudine 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 telbivudine.

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

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 this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

• Peginterferon Alfa-2a

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:

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

• Myopathy (muscle aches, pain, weakness) or


• Peripheral neuropathy (nerve disorder with numbness, tingling)—Use with caution. May make these conditions worse.

Proper Use of Tyzeka

Take this medicine exactly as directed by your doctor. Do not take more of this medicine and do not take it more often than your doctor ordered. This medicine works best if there is a constant amount in the blood. To keep blood levels constant, take this medicine at the same time each day and do not miss any doses.

This medicine should come with a Medication Guide and patient information insert. Read and follow these instructions carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food.

Measure the oral liquid correctly using the marked dosing cup that comes with the package. Rinse the dosing cup with water after each use.

The oral liquid contains sodium. Ask your doctor for advice if you are on a low sodium diet.

When your supply of this medicine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of this medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

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

• For oral dosage forms (solution or tablets):
  
  • For hepatitis B infection:
    
    • Adults and teenagers 16 years of age and older—600 milligrams (mg) or 30 milliliters (mL) once a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw away any unused oral liquid 60 days after opening the bottle. Unused or outdated medicine should not be put directly in the trash can. Place it in a closed container first, such as a sealed bag, then into the household trash. You may also take it to a community take-back program when available.

Precautions While Using Tyzeka

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

Do not use this medicine if you are also using pegylated interferon alfa-2a (Pegasys®). Using these medicines together may increase your risk of having peripheral neuropathy.

Two rare but serious reactions to this medicine are lactic acidosis (too much acid in the blood) and liver toxicity, which includes an enlarged liver. These are more common if you are female, very overweight (obese), or have been taking anti-HIV medicines for a long time. Call your doctor right away if you have more than one of these symptoms: abdominal or stomach discomfort or cramping; dark urine; decreased appetite; diarrhea; a general feeling of discomfort; light-colored stools; muscle cramping or pain; nausea; unusual tiredness or weakness; trouble with breathing; vomiting; or yellow eyes or skin.

If you have muscle aches, pain, tenderness, or weakness after using this medicine, call your doctor right away. These could be symptoms of a condition called myopathy.

Stop using this medicine and check with your doctor right away if you are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.

Hepatitis B infection may become worse if treatment with telbivudine is stopped. Do not stop taking this medicine without checking first with your doctor.

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

This medicine will not keep you from giving the hepatitis B virus to your partner during sex. Make sure you understand and practice safe sex, even if your partner also has hepatitis B. The male partner should use a latex condom during sex. Do not share needles and personal items, such as toothbrushes or razor blades, that can have blood or body fluids on them with anyone.

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.

Tyzeka 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

• Chills


• cough


• diarrhea


• fever


• general feeling of discomfort or illness


• headache


• joint pain


• loss of appetite


• muscle aches and pains


• nausea


• runny nose


• shivering


• sore throat


• stomach pain


• sweating


• trouble with sleeping


• unusual tiredness or weakness


• vomiting

Less common

• Back pain


• chest pain


• difficulty with moving


• muscle cramping


• muscle stiffness


• muscle tenderness, wasting, or weakness


• pain


• pain in the extremity


• swollen joints

Rare

• Burning feeling in the chest or stomach


• indigestion


• loose stools


• stomach upset


• tenderness in the stomach area

Incidence not known

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


• dark-colored urine


• decreased appetite


• fast, shallow breathing


• muscle pain or spasms


• shortness of breath


• sleepiness

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

• Body aches or pain


• difficulty with breathing


• ear congestion


• loss of voice


• nasal congestion


• sneezing


• stuffy nose

Less common

• Acid or sour stomach


• belching


• dizziness


• heartburn


• rash


• sleeplessness


• stomach discomfort


• unable to sleep

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: Tyzeka side effects (in more detail)

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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 Tyzeka resources

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

• Tyzeka Prescribing Information (FDA)


• Tyzeka Consumer Overview


• Tyzeka Monograph (AHFS DI)


• Tyzeka MedFacts Consumer Leaflet (Wolters Kluwer)


• Telbivudine Professional Patient Advice (Wolters Kluwer)

Compare Tyzeka with other medications

• Hepatitis B

Topcare Sleep Aid

Dosage Form: tablet
Topco Sleep Aid Tablets Drug Facts

Active ingredient (in each tablet)

Doxylamine succinate 25 mg

Purpose

Nighttime sleep-aid

Uses

• helps to reduce difficulty in falling asleep

Warnings

Ask a doctor before use if you have

• a breathing problem such as asthma, emphysema or chronic bronchitis


• glaucoma


• trouble urinating due to an enlarged prostate gland

Do not give

to children under 12 years of age

Ask a doctor or pharmacist before use if you are

taking any other drugs

When using this product

• avoid alcoholic beverages


• take only at bedtime

Stop use and ask a doctor if

• sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• adults and children 12 years of age and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor


• children under 12 years of age: do not use

Other information

• store at 68°-77°F (20°-25°C)


• retain in carton until time of use


• see carton end panel for lot number and expiration date

Inactive ingredients

dibasic calcium phosphate, FD&C blue no. 1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions or comments?

1-888-423-0139

Principal Display Panel

Fall Asleep Fast!

Safe

Sleep Aid Tablets

Doxylamine Succinate Tablets, 25 mg

Nighttime Sleep-Aid

Proven Effective

Just One Tablet Per Dose

Actual Size

Compare to Unisom® SleepTabs® active ingredient

Sleep Aid Tablets Carton

Topcare Sleep Aid  doxylamine succinate  tablet

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 36800-441 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE 25 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color BLUE Score no score Shape OVAL Size 10mm Flavor Imprint Code L441 Contains

Packaging # NDC Package Description Multilevel Packaging 1 36800-441-64 2 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 16 TABLET In 1 BLISTER PACK This package is contained within the CARTON (36800-441-64)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040167	01/29/1997

Labeler - Topco Associates LLC (006935977)

Revised: 06/2009Topco Associates LLC

More Topcare Sleep Aid resources

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

Compare Topcare Sleep Aid with other medications

• Allergies
• Conjunctivitis, Allergic
• Hay Fever
• Insomnia
• Nasal Congestion
• Rhinorrhea
• Upper Respiratory Tract Infection

Sentry HC Dermasphere Medicated Shampoo

Dosage Form: FOR ANIMAL USE ONLY
Medicated Shampoo For Dogs

Indications and Usage for Sentry HC Dermasphere Medicated Shampoo

Sentry HC Dermasphere Medicated Shampoo For Dogs is an antiseborrheic shampoo that aids in the removal of scales, crust, and excessive skin oil associated with seborrhea and other non-specific skin conditions.  Combines the proven benefits of oatmeal, sulfur and salicylic acid.  Contains Dermaspheres, a micro encapsulation technology that holds key ingredients in miscroscopic spheres and improves th effectiveness of the shampoo.


SIGNS:  Recommended for dogs with oily skin and coat.

• Specially formulated for seborrhea and other skin conditions
  
  


• Medicated Dermaspheres attach to skin and coat and release over time
  
  


• Aids in the removal of scales, crust and excessive skin oil
  

DIRECTIONS FOR USE

Shake well before use.  Wet the hair coat with warm water.  Apply a thin line of shampoo from the base of the neck to the base of the tail.  Massage the shampoo into wet hair coat.  Rinse and repeat.  May be used two to three times a week.  Discontinue use and consult a veterinarian if undue skin irritation develops or increases, or if the condition persists or recurs, as symptoms may be indicative of an underlying serious condition.

CAUTION

For Animal Use Only.  FOR EXTERNAL USE ONLY.  Avoid contact with eyes or mucous membranes.  In case of contact, flush eyes with water and seek medical attention if irritation persists.

KEEP OUT OF REACH OF CHILDREN

Warnings

Wash hands after use.  In case if accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

ACTIVE INGREDIENTS

Salicylic Acid 2%, Solubilized Sulfur 2%.

OTHER INGREDIENTS

Water, Sodium Lauryl Sulfate, Lauramide DEA, Glycerin, Colloidal Oatmeal, Dermaspheres, Magnesium Aluminum Silicate, Sodium Hydroxide, Fragrance, Hydroxypropyl Cellulosa, FD and C Blue #1.  May also contain sodium chloride and/or sodium hydroxide.

How is Sentry HC Dermasphere Medicated Shampoo Supplied

Net 12 fl oz (354 mL)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Distributed by:  Sergeant's Pet Care Products, Inc., Omaha NE 68130


Made in USA


PATENTED DERMASPHERE TECHNOLOGY


Patent #6,277,404

Sentry HC Dermasphere Medicated Shampoo FOR DOGS  salicylic acid, solubilized sulfur  lotion/shampoo

Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 21091-074 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 7.08 mL  in 354 mL SULFUR (SULFUR) SULFUR 7.08 mL  in 354 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color blue (Aqua Blue) Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 21091-074-12 354 mL In 1 BOTTLE, PUMP None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/19/2008

Labeler - Sergeant's Pet Care Products, Inc. (876995171)

Revised: 04/2010Sergeant's Pet Care Products, Inc.

Medised for Children

1. Name Of The Medicinal Product

Medised For Children

2. Qualitative And Quantitative Composition

Paracetamol 120mg/5ml

Diphenhydramine HCl 12.5mg/5ml

3. Pharmaceutical Form

Oral solution.

Clear to pale pink liquid.

4. Clinical Particulars

4.1 Therapeutic Indications

For the treatment of mild to moderate pain including teething pain, headache, sore throat, aches and pains.

Symptomatic relief of influenza and feverish colds and the associated symptoms of runny nose and sneezing.

4.2 Posology And Method Of Administration

Route of Administration: Oral.

Recommended Doses and Dosage Schedules:

6 years to under 12 years: 10ml-20ml (2-4 teaspoonful) 3 times daily.

Medised is contraindicated in children under 6 years of age (see section 4.3)

Parents or carers should seek medical attention if the child's condition deteriorates during treatment.

4.3 Contraindications

Do not take if you are hypersensitive to paracetamol, and/or any other constituents.

Large doses of antihistamines may precipitate fits in epileptics.

Do not take if you are currently taking monoamine inhibitors (MAOIs) or within 14 days of stopping treatment with MAOIs.

Not to be used in children under the age of 6 years.

4.4 Special Warnings And Precautions For Use

Do not exceed the stated dose. Immediate medical advice should be sought in the event of an overdose, even if you feel well because of the risk of delayed, serious liver damage.

Do not take with any other paracetamol-containing products, or cough and cold medicines.

Dose should not be repeated more frequently than 4 hour intervals.

Not more than 4 doses should be taken in 24 hours.

Dosage should not be continued for more than three days without consulting a doctor.

This product should be administered with caution to patients with known renal or hepatic impairment, prostatic hypertrophy, urinary retention, or susceptibility to angle-closure glaucoma. The hazards of overdose are greater in those with alcoholic liver disease.

The product may cause drowsiness. This product should not be used to sedate a child.

Keep out of the reach of children.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine.

The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding.

May enhance the sedative effects of CNS depressants including barbiturates, hypnotics, opioid analgesics, anxiolytic sedatives, antipsychotics and alcohol.

May have an additive muscarinic actions with other drugs, such as atropine and some antidepressants.

Not to be used in patients taking MAOIs or within 14 days of stopping treatment as there is a risk of serotonin syndrome.

4.6 Pregnancy And Lactation

Safety in pregnancy has not been established.

Epidemiological studies in human pregnancy have shown no effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use. Paracetamol is excreted in breast milk, but not a clinically significant amount.

Available published data does not contraindicate breast-feeding.

4.7 Effects On Ability To Drive And Use Machines

May cause drowsiness. If affected do not drive or operate machinery.

4.8 Undesirable Effects

Common side effects

CNS effects: Drowsiness (usually diminishes within a few days), paradoxical stimulation, headache, psychomotor impairment.

Antimuscarinic effects: Urinary retention, dry mouth, blurred vision, gastrointestinal disturbances, thickened respiratory tract secretions

Rare side effects:

Hypotenstion, extrapyramidal effects, dizziness, confusion, depression, sleep disturbances, tremor, convulsions, palpitation, arrhythmia, hypersensitivity reactions (including skin rash), blood disorders and liver dysfunction.

There have been a few reports of blood dyscrasias including thrombocytopenia and agranulocytosis but these were not necessarily causally related to paracetamol.

4.9 Overdose

The features of overdose are: sedation, pallor, nausea, vomiting, diarrhoea, anorexia, and abdominal pain; liver damage may become apparent within 12 to 48 hours. In some children overdose may cause cerebral stimulation resulting in convulsions and hyperpyrexia.

Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Liver damage is likely in adults who have taken 10g or more of paracetamol. It is considered that excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested), become irreversibly bound to liver tissue.

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention and any patient who has ingested around 7.5g or more of paracetamol in the preceding four hours should undergo gastric lavage. Administration of oral methionine or intravenous N-acetylcysteine which may have a beneficial effect up to at least 48 hours after the overdose, may be required. General supportive measures must be available.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Paracetamol is an antipyretic and analgesic. Diphenhydramine HCl is an antihistamine with anti-cholinergic, anti-emetic, anti-allergic and sedative effects.

5.2 Pharmacokinetic Properties

Paracetamol and diphenhydramine HCl are both readily absorbed from the gastrointestinal tract. Both are widely distributed throughout the body. Both are metabolised in the liver and excreted in the urine. As Medised Infant is a solution, absorption of actives is rapid following oral ingestion.

5.3 Preclinical Safety Data

Paracetamol and diphenhydramine HCl are well established drug substances whose preclinical profiles have been investigated and are thoroughly established.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Macrogol 4000

Glycerol

Propylene Glycol

Sorbitol Solution (non crystallising) 70%

Lycasin 80/55 (Maltitol Solution)

Sodium Cyclamate

Sodium Saccharin

Nipasept (Methylhydroxybenzoate, Ethylhydroxybenzoate and Parahydroxybenzoate)

Strawberry Flavour 513805E

Sugar Module 555049E

Water, purified

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Do not store above 25°C.

Do not refrigerate.

Keep container in outer carton.

6.5 Nature And Contents Of Container

Amber type III glass bottle and plastic clic loc cap with pulp stearan wadding. 20ml, 30ml, 70ml, 100ml, 140ml and 200ml.

All pack sizes except the 20ml have a 5ml plastic spoon.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

SSL International Plc

Venus

1 Old Park Lane

Trafford Park

Manchester

M41 7HA

UK

8. Marketing Authorisation Number(S)

PL 17905/0090

9. Date Of First Authorisation/Renewal Of The Authorisation

13/09/99

10. Date Of Revision Of The Text

September 2009

G-Vent

Generic Name: guaifenesin and phenylpropanolamine (gwye FEN e sin/fen ill proe pa NOLE a meen)

Brand Names: Ami-Tex LA, Banex-LA, Coldloc-LA, Dayquil Sinus Pressure and Congestion, Despec, Entex LA, Exgest LA, G-Vent, Guaifenex PPA 75, Guaivent, Guiatex LA, Naldecon-EX Pediatric, Nasahist LA, Phentex-LA, Phenylfenesin LA, Poly-Vent, Profen LA, Stamoist LA, Triaminic Expectorant, Vanex-LA

What is G-Vent (guaifenesin and phenylpropanolamine)?

Guaifenesin is an expectorant. It is used to break up congestion and mucous to make breathing easier. Guaifenesin thins mucous, increases lubrication of the respiratory tract (lungs, nose and throat), and increases the removal of mucous.

Phenylpropanolamine is a decongestant. It constricts (shrinks) blood vessels (veins and arteries), which reduces swelling of mucous membranes in areas such as the nose and sinuses.

Guaifenesin and phenylpropanolamine is used to treat the symptoms of the common cold and of infections of the sinuses, lungs, and throat.

Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.

Guaifenesin and phenylpropanolamine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about G-Vent (guaifenesin and phenylpropanolamine)?

Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.

Drink plenty of extra fluids while taking this medication. Do not crush or chew the tablets. Swallow them whole or break them in half where they are scored to make them easier to swallow if needed.

Who should not take G-Vent (guaifenesin and phenylpropanolamine)?

Do not take guaifenesin and phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Before taking this medication, tell your doctor if you have

• 
  

  high blood pressure or any other type of heart disease,

  
  


• 
  

  diabetes,

  
  


• 
  

  a peripheral vascular disorder (poor circulation),

  
  


• 
  

  glaucoma or increased pressure in the eyes,

  
  


• 
  

  an overactive thyroid, or

  
  


• 
  

  difficulty urinating or an enlarged prostate.

  
  

You may not be able to take guaifenesin and phenylpropanolamine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Guaifenesin and phenylpropanolamine is in the FDA pregnancy category C. This means that it is not known whether guaifenesin and phenylpropanolamine will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. This medication passes into breast milk and may harm a nursing baby. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. If you are over 65 years of age, you may be more likely to experience side effects from guaifenesin and phenylpropanolamine. You may require a lower dose of this medication. Guaifenesin and phenylpropanolamine has not been approved for use by children younger than 6 years of age.

How should I take G-Vent (guaifenesin and phenylpropanolamine)?

Take guaifenesin and phenylpropanolamine exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water. Increasing fluid intake during the day may help relieve congestion. Take guaifenesin and phenylpropanolamine with food if it causes stomach upset. Do not crush or chew the tablets. Swallow them whole or break them in half where they are scored to make them easier to swallow if needed. Store guaifenesin and phenylpropanolamine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a guaifenesin and phenylpropanolamine overdose include vomiting, high blood pressure (headache, redness of face, blurred vision), an irregular heartbeat, and numbness of the fingers or toes.

What should I avoid while taking G-Vent (guaifenesin and phenylpropanolamine)?

Use caution when driving, operating machinery, or performing other hazardous activities. Guaifenesin and phenylpropanolamine may cause dizziness. If you experience dizziness, avoid these activities.

G-Vent (guaifenesin and phenylpropanolamine) side effects

No serious side effects from guaifenesin and phenylpropanolamine are expected. Seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Other, less serious side effects may be more likely to occur. Continue to take guaifenesin and phenylpropanolamine and talk to your doctor if you experience

• 
  

  dizziness or headache;

  
  


• 
  

  nervousness, restlessness, or insomnia;

  
  


• 
  

  nausea or stomach upset; or

  
  


• 
  

  difficulty urinating.

  
  

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect G-Vent (guaifenesin and phenylpropanolamine)?

Do not take guaifenesin and phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Heart medications such as methyldopa (Aldomet), reserpine (Serpalan, Serpasil), and guanethidine (Ismelin) may have decreased effects. Talk to your doctor before taking guaifenesin and phenylpropanolamine if you are taking any of these medications.

Do not take other over-the-counter cough, cold, allergy, diet, or sleep aids while taking guaifenesin and phenylpropanolamine without first talking to your doctor or pharmacist. Other medications may also contain guaifenesin, phenylpropanolamine, or other similar drugs. You may accidentally take too much of these medicines.

Drugs other than those listed here may also interact with guaifenesin and phenylpropanolamine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More G-Vent resources

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

Compare G-Vent with other medications

• Cough and Nasal Congestion

Where can I get more information?

• Your pharmacist has additional information about guaifenesin and phenylpropanolamine written for health professionals that you may read.

What does my medication look like?

Guaifenesin and phenylpropanolamine is available with a prescription under several brand names. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

• 
  

  Entex LA, 400 mg of guaifenesin and 75 mg of phenylpropanolamine--orange, scored tablets

  
  


• 
  

  Exgest LA, 400 mg of guaifenesin and 75 mg of phenylpropanolamine--white, oval-shaped, scored, long-acting tablets with blue speckles

  
  


• 
  

  Dura-Vent, 600 mg of guaifenesin and 75 mg of phenylpropanolamine--white, scored tablets

  
  

See also: G-Vent side effects (in more detail)

Uveitis, Posterior Medications

Drugs associated with Uveitis, Posterior

The following drugs and medications are in some way related to, or used in the treatment of Uveitis, Posterior. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

See sub-topics

Topics under Uveitis, Posterior

• Infectious Posterior Uveitis (0 drugs)

Learn more about Uveitis, Posterior

Medical Encyclopedia:

• Uveitis

Drug List:

Baycadron

De-Sone-La-Injection

Decadron

Deltasone

Dexacen-4-Injection

Dexacort-Phosphate-In-Turbinaire

Dexamethasone-Intensol

Dexasone-Injection

Dexasone-La-Injection

Dexpak-Tablets-Dose-Pack

Meticorten

Ozurdex

Solurex-Injection

Solurex-La-Injection

Sterapred

Sterapred-Ds

Zema-Pak-10-Day

Actidose

Dosage Form: suspension
Actidose® WITH SORBITOL

Actidose®-AQUA

ACTIVATED CHARCOAL SUSPENSION

Actidose Description

Actidose® with Sorbitol: Actidose® with Sorbitol, ready-to-use activated charcoal suspension with sorbitol, contains 25 gm or 50 gm of activated charcoal, and 48 gm or 96 gm of sorbitol, respectively, in an aqueous suspension with a unique preservative system. Each milliliter contains 208 mg (0.208 gm) of activated charcoal and 400 mg (0.400 gm) of sorbitol. Sorbitol reduces the gritty sensation associated with activated charcoal, imparts a sweet taste which enhances patient compliance, and usually produces a cathartic effect.

Actidose®-Aqua: Actidose®-Aqua, ready-to-use activated charcoal suspension, contains 15 gm, 25 gm or 50 gm of activated charcoal in an aqueous suspension with a unique preservative system. Each milliliter contains 208 mg (0.208 gm) of activated charcoal.

Warnings

If patient has been given ipecac syrup, DO NOT give Actidose® WITH SORBITOL or Actidose®-AQUA until after last vomiting episode. Do not use in persons who are not fully conscious. Do not use this product unless directed by a health professional, if turpentine, corrosives, such as alkalies (lye) and strong acids, or petroleum distillates, such as kerosene, gasoline, paint thinner, cleaning fluid or furniture polish, have been ingested. This product is not recommended for use in children weighing less than 32 kg, or during multiple dose activated charcoal therapy since excessive catharsis and significant fluid and electrolyte abnormalities may occur.

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

Do not use Actidose® with Sorbitol or Actidose®-Aqua in any person known to have a rare autosomal recessive genetic intolerance to fructose. Do not use Actidose® with Sorbitol in patients who are dehydrated. Actidose® with Sorbitol may cause excessive diarrhea.

Actidose - Clinical Pharmacology

Activated Charcoal:

Activated charcoal is produced by pyrolysis of organic material, such as wood, and an activation process which cleanses and fragments the charcoal by exposure to an oxidizing gas compound of steam, oxygen, and acids at high temperatures resulting in increased surface area through the creation of numerous external and internal pores. These pores serve as reservoirs to adsorb substances admixed with activated charcoal, making it a useful adsorbent for specified toxins.

Activated charcoal is pharmacologically inert and is not absorbed in the gastrointestinal tract. Activated charcoal will adsorb a variety of organic and inorganic substances, but is especially effective in adsorbing compounds within a molecular weight range of 100 to 1,000 Daltons (AMU's).1Several other physiologic and physicochemical factors influence the adsorptive capacity of activated charcoal including: pH, charcoal:drug ratio, gastric contents, and adsorption kinetics.2

Much of the published scientific literature which studied the adsorptive capacity of activated charcoal was conducted using in vitro models. A considerable amount of the research may be invalid since the effects of physiologic pH were not taken into consideration or held constant. Using research models which simulate the gastric environment, some toxins were not adsorbed by activated charcoal. This data was inappropriately extended to imply that activated charcoal did not adsorb a toxin and therefore had no efficacy in the management of that type of poisoning incident. However, the research failed to consider that the increased pH of the small intestine provides a receptive environment for the adsorption of the toxin by activated charcoal. Activated charcoal will effectively adsorb acidic, alkaline and neutral substances (not to suggest use of activated charcoal in poisonings caused by corrosive agents2). The extent of adsorption will be dependent upon the relative solubility of the drug at a specified pH.

The optimal dosage ratio of activated charcoal to toxin is described as 10:1.3,4,17,18 Numerous factors contribute to and interfere with adsorptive capacity, therefore, the 10:1 ratio may not be valid in the clinical setting. Furthermore, a primary application of activated charcoal is in adult patients who have intentionally ingested a toxin for drug abuse or suicidal purposes. These patients may not freely provide information about the substance or amount ingested, or have a decreased level of consciousness. Under these conditions it is difficult to determine the ingestion history, making it impractical to use the 10:1 ratio. The 10:1 ratio is also impractical when large amounts of toxin have been ingested (i.e., an overdose of 50 gm of aspirin would then require 500 gm [1.1 lbs.] of activated charcoal).

Gastric contents may also compete with ingested toxins and compromise the adsorption of the toxins by activated charcoal.2 If activated charcoal is to be administered to a patient known to have ingested a large meal in close proximity to the time of treatment, a larger dose of activated charcoal may be appropriate.

Under appropriate physiologic conditions activated charcoal adsorbs toxins instantaneously. This adsorptive process is reversible and an equilibrium between free and bound toxin will exist. According to the law of mass action the amount of free drug decreases as the dose of activated charcoal increases. Therefore, large doses of activated charcoal can favor the equilibrium toward greater toxin adsorption and efficacy. There is limited evidence that desorption of a toxin from activated charcoal may occur.19 Therefore, there is a potential for toxin readsorption and enhanced toxicity. The current standard of care is to administer a cathartic with single doses of activated charcoal to hasten the elimination of the toxin/activated charcoal complex from the gastrointestinal tract.5 Cathartics should be used with extreme care during multiple dose activated charcoal therapy and it is not recommended to use a cathartic with each dose of activated charcoal.5

Sorbitol:

Sorbitol is a hexahydric sugar alcohol which primarily serves as an osmotic cathartic in Actidose® with Sorbitol.6 A secondary advantage of using sorbitol is as a palatability enhancer to decrease the innate gritty texture of activated charcoal and to provide a sweet vehicle to increase patient compliance. Sorbitol is poorly absorbed during its transit through the gastrointestinal tract. Absorbed sorbitol is metabolized by the liver and slowly converted to fructose. Insulin is not necessary for intracellular transport of sorbitol, therefore customary cathartic doses can be safely used by patients with diabetes mellitus.

As a hyperosmotic cathartic sorbitol produces a hygroscopic action resulting in increased water in the large intestine and increased intraluminal pressure which stimulates catharsis. Studies have been conducted in healthy adult human volunteers using therapeutic amounts of activated charcoal and sorbitol.8,9 Catharsis of activated charcoal occurred in an average of 1.0 - 1.5 hours and persisted for 8 - 12 hours. Fourteen poisoned patients are reported in one series representing a wide range of toxins and dosages of sorbitol resulting in the onset of catharsis in an average of 7.7 hours.10 The onset of action may be expected to be longer in patients who have ingested toxins which decrease bowel motility, such as pharmacological agents and plants with anticholinergic properties, and drugs like narcotics.20

Sorbitol does not compromise the adsorptive capacity of activated charcoal.11,12

Indications and Usage for Actidose

Actidose® with Sorbitol and Actidose®-Aqua should be used in a supervised medical facility or under the direction of a physician or poison control center.

Actidose® with Sorbitol and Actidose®-Aqua are indicated in the management of many types of poisoning emergencies when a toxin has been ingested or when indicated for a limited number of systemic poisonings resulting from parenteral overdosage or when the toxin has been totally absorbed. If physiologic conditions are optimal, activated charcoal most effectively adsorbs toxins with a molecular weight of 100 - 1,000 Daltons (AMU's).1 Activated charcoal may not be as effective in adsorbing low molecular weight substances such as aliphatic alcohols (methanol, isopropanol, ethanol, etc.) metals (iron, lead, mercury, etc.) and elements such as lithium.2 Two animal studies have demonstrated that very toxic and low molecular weight cyanide compounds are adsorbed by activated charcoal.21,22 The use of activated charcoal in toxic emergencies involving these substances is not contraindicated. Many poisonings involve multiple substances, therefore, Actidose® with Sorbitol and Actidose®-Aqua may be effective in adsorbing some or all of the ingested toxins.

Adsorption of a toxin by activated charcoal can occur anywhere in the gastrointestinal tract. However, to use Actidose® with Sorbitol or Actidose®-Aqua most effectively it is important to administer it as soon as possible to the victim of an ingested exposure. The longer the delay between the ingestion of the toxin and administration of activated charcoal, the less effective it will be. If syrup of ipecac is being used to produce emesis, administration of Actidose® with Sorbitol or Actidose®-Aqua is customarily delayed until 30 - 60 minutes after conclusion of emesis. In a study which used syrup of ipecac, 60 ml, activated charcoal did not interfere with the emetic effect of syrup of ipecac.23

If gastric lavage is being used to facilitate stomach evacuation a single dose of activated charcoal can be administered in the early stages of gastric lavage. If this technique is utilized, Actidose®-Aqua, which does not contain sorbitol, should be used. Upon completion of gastric lavage Actidose® with Sorbitol can be instilled via the lavage tube. The only disadvantage to the use of activated charcoal in this fashion is that the gastric lavage returns will be black, thus making it difficult to evaluate what the patient ingested by visual examination. The primary advantage of this therapy is that activated charcoal can be administered early to the patient. The convenient packaging of Actidose® with Sorbitol and Actidose®-Aqua (except the 15 gm/72 ml size) in a squeeze bottle with a tapered nozzle expedites emergency treatment, allowing attachment to a gastric lavage tube and administration of contents.

The most common application of activated charcoal is in acute toxic exposures where Actidose® with Sorbitol and Actidose®-Aqua can adsorb toxins thereby preventing their absorption. Activated charcoal can also be used in some toxic emergencies when absorption is complete or exposure was via a parenteral route. This application usually involves repetitive or multiple doses of activated charcoal.

Multiple doses of activated charcoal may be useful in adsorbing toxins which undergo enterohepatic circulation.13 Drugs which are subject to biliary secretion such as digitoxin are constantly secreted into the gastrointestinal tract and are reabsorbed resulting in prolonged toxicity. Frequent doses of activated charcoal can adsorb those toxins thereby preventing their reabsorption and enhancing toxin elimination through the gastrointestinal tract.

Multiple dose activated charcoal is also used in what is termed gastrointestinal dialysis.14 There are only a limited number of toxins which may be eliminated by this method. Clinical judgement and the toxin's pharmacokinetic parameters must be considered to determine the applicability of this treatment which is not universally applicable.24 The toxin passively diffuses along a concentration gradient between blood which is perfusing the gastrointestinal tract and the luminal fluids. The multiple doses of activated charcoal adsorb the toxin thereby preventing its reabsorption further maximizing the concentration gradient which permits diffusion of even more toxin into the gastric lumen. Compounds most effectively transferred by this mechanism are lipophilic, uncharged and not excessively bound to proteins. Phenobarbital and theophylline are examples of toxins which can be eliminated more rapidly by this method.15,16

Actidose® with Sorbitol should not be used in each dose of the multiple dose activated charcoal regimen unless it is necessary to produce catharsis. Actidose® with Sorbitol contains sorbitol which may produce excessive catharsis and resultant fluid and electrolyte problems if used at each dosing interval (see Precautions).9,25 Actidose®-Aqua should be used at dosage intervals when Actidose® with Sorbitol is not being used. CATHARTICS SHOULD BE USED CAUTIOUSLY AND ONLY INTERMITTENTLY DURING MULTIPLE DOSE ACTIVATED CHARCOAL THERAPY.

If catharsis of activated charcoal does not occur following the use of Actidose® with Sorbitol within 4 - 8 hours, an additional sorbitol dose of 1.5 gm/kg may be administered. Or, if desired, a saline cathartic such as magnesium citrate may be used if the patient's renal function is not impaired.

Actidose® with Sorbitol and Actidose®-Aqua are formulated in palatable vehicles which eliminate the need to add additional taste or consistency enhancers.The use of supplementary chemicals, syrups, or dairy products should be avoided since their addition may compromise the adsorptive capacity of Actidose® with Sorbitol and Actidose®-Aqua.

Contraindications

There are no known absolute contraindications to the use of activated charcoal, however, it is not an equally effective adsorbent for all toxins. It should be used with caution, if at all, in patients who have ingested corrosive agents since the activated charcoal may obscure endoscopic visualization of esophageal and gastric lesions produced by the corrosive. The use of a cathartic with activated charcoal may not be advised if a patient has significant fluid or electrolyte abnormalities. Actidose® with Sorbitol should not be used in infants due to the possibility of excessive catharsis. Young children should not receive cathartic doses of sorbitol unless hospitalized and under the immediate care of a physician.

USAGE IN CHILDREN

Actidose® with Sorbitol is not recommended in children less than one year of age.

USAGE DURING PREGNANCY OR LACTATION

Safe use during pregnancy and lactation has not been established. Actidose® with Sorbitol and Actidose®-Aqua should be used during pregnancy or lactation only if the potential benefit justifies the potential risk. No teratogenic effects have been noted in rabbits or rats.

Precautions

Actidose® with Sorbitol and Actidose®-Aqua should be used in a supervised medical facility or under the direction of a physician or poison control center.

Actidose® with Sorbitol and Actidose®-Aqua are adjuncts in the management of poisoning emergencies. Prior to the use of activated charcoal, proper basic life support measures must be implemented as well as the appropriate gastric emptying technique if indicated.

When Actidose® with Sorbitol or Actidose®-Aqua are used to treat a poisoning emergency, the patient and health care providers should be aware that activated charcoal will produce black stools. These stools may be diarrhetic and may persist for several hours.

Actidose® with Sorbitol may produce a profound cathartic effect and proper attention should be given to the patient's fluid and electrolyte needs. Actidose® with Sorbitol should be used cautiously in patients receiving multiple dose activated charcoal. If Actidose® with Sorbitol is used at each dosage interval, profound catharsis may develop which could result in dehydration, hypotension and significant electrolyte and fluid abnormalities.

A study conducted in healthy adult human volunteers who ingested therapeutic amounts of activated charcoal and sorbitol resulted in severe prolonged diarrhea, but no significant changes were noted in serum electrolytes or osmolality, BUN, or the metabolic profile as compared to the control.8

Gastrointestinal obstruction from activated charcoal may occur as a consequence of toxin-induced antiperistaltic effects. Actidose® with Sorbitol and Actidose®-Aqua should be used cautiously in patients who have been exposed to toxins which interfere with gastrointestinal tract peristalsis (i.e., anticholinergics, opioids, etc.). Bowel sounds should be frequently monitored to assess peristaltic action, especially in patients undergoing multiple dose activated charcoal therapy.

Adverse Reactions

Activated charcoal with sorbitol has produced severe hypernatremic dehydration when used in excessive amounts in pediatric patients.25,27

Aspiration of activated charcoal has been reported to produce airway obstruction and a limited number of fatalities have occurred.28,29,30,31 Bronchiolitis obliterans resulting in death has developed several weeks after the aspiration of activated charcoal.32

Gastrointestinal obstruction associated with the use of multiple dose activated charcoal therapy has been reported.33 An overdose of carbamazepine was responsible for the antiperistaltic effects which led to bowel obstruction.

Actidose Dosage and Administration

Prior to administration of Actidose® with Sorbitol or Actidose®-Aqua, shake the container thoroughly for a minimum of 30 seconds. After administration of either Actidose® with Sorbitol or Actidose®-Aqua, the container should be thoroughly rinsed with water and any residue should be administered to the patient to ensure that the entire dose has been delivered.

Single Dose - Actidose®-Aqua
Under one year of age:	1 gm/kg (5 ml/kg)
1 - 12 years of age:	25-50 gm (120-240 ml)
Adults (over 12 yrs. of age):	50-100 gm (240-480 ml)
Single Dose - Actidose® with Sorbitol
Under one year of age:	DO NOT USE Actidose®WITH SORBITOL IN CHILDREN LESS THAN ONE YEAR OF AGE.
1 - 12 years of age:	DO NOT USE Actidose®WITH SORBITOL 25 GM/120 ML IN CHILDREN WEIGHING LESS THAN 16 KG.
	DO NOT USE Actidose®WITH SORBITOL 50 GM/240 ML IN CHILDREN WEIGHING LESS THAN 32 KG
Adults (over 12 yrs.):	50 gm [96 gm sorbitol] (240 ml)
Multiple Dose - Actidose®-Aqua
Under one year of age:	1 gm/kg (5 ml/kg) q 4-6H (every 4-6 hrs)
1 - 12 years of age:	25-50 gm (120-240 ml) q 4-6H (every 4-6 hrs)
Adults (over 12 yrs.):	50-100 gm (240-480 ml) q 4-6H (every 4-6 hrs)
Multiple Dose - Actidose® with Sorbitol
	Actidose® WITH SORBITOL IS NOT RECOMMENDED FOR CHILDREN OR ADULTS IN MULTIPLE DOSE ACTIVATED CHARCOAL THERAPY DUE TO EXCESSIVE CATHARTIC ACTION.

How is Actidose Supplied

Actidose®-Aqua	Bottles
	25 Gram/120 ml	NDC 0574-0121-04
	50 Gram/240 ml	NDC 0574-0121-08
Actidose® with Sorbitol	25 Gram/120 ml	NDC 0574-0120-04
	50 Gram/240 ml	NDC 0574-0120-08
Actidose®-Aqua	Tubes
	15 Gram/72 ml	NDC 0574-0121-25
	25 Gram/120 ml	NDC 0574-0121-74
	50 Gram/240 ml	NDC 0574-0121-76
Actidose® with Sorbitol	25 Gram/120 ml	NDC 0574-0120-74
	50 Gram/240 ml	NDC 0574-0120-76

REFERENCES

1. Activated Charcoal, Antidotal and Other Medicinal Uses, Marcel Dekker, New York, 1980.


2. Clinical Pharmacokinetics. 1982; 7: 465-489.


3. Handbook of Common Poisonings in Children, American Academy of Pediatrics, Evanston, 1983.


4. Am J Emerg Med. 1985; 3: 280-283.


5. Poisindex Information System, Micromedix, Denver, 1991.


6. J Pediatrics. 1981; 98: 157-158.


7. Diabetes Care. 1978; 1: 223-230.


8. Clinical Toxicology. 1985; 22: 529-536.


9. Ann. Emerg. Med. 1985; 14: 1152-1155.


10. Clinical Toxicology. 1985; 23: 579-587.


11. J. Pharmacol. Exp. Ther. 1982; 221: 656-663.


12. Am. J. Hosp. Pharm. 1978, 35: 1355-1359.


13. Lancet. 1981; 2: 1177-1178.


14. NEJM. 1982; 307: 676-678.


15. NEJM. 1982; 307: 642-644.


16. Clin. Pharmacol. Therap. 1983; 34: 663-666.


17. Medical Toxicology. New York, Elsevier, 1988.


18. Clinical Management of Poisoning and Drug Overdose. Philadelphia, W.B. Saunders Co., 1990.


19. Arch Intern Med. 1987; 147: 1390-1392.


20. Clin Toxicol. 1989; 27: 91-99.


21. Ann Emerg Med. 1988; 17: 595-598.


22. Ann Emerg Med. 1990; 19: 453.


23. Ann Emerg Med. 1987; 16: 164-166.


24. Ann Emerg Med. 1991; 20: 529-531.


25. J. Pediatrics. 1986; 109: 719-722.


26. Ann Emerg Med. 1986; 15: 1214-1218.


27. J. Pediatrics. 1988; 112: 333.


28. Vet Hum Toxicol. 1989; 31: 335.


29. B Med J. 1988; 297: 459-460.


30. NCMJ. 1990; 51: 79-80.


31. Ann Emerg Med. 1981; 10: 528-529.


32. Chest. 1989; 96: 672-674.


33. J Emerg Med. 1986; 4: 401-407.

Paddock Laboratories, Inc.

Minneapolis, MN 55427

(06-08)

PRINCIPAL DISPLAY PANEL - 120 mL Bottle

NDC 0574-0120-04

Actidose®

with Sorbitol

ACTIVATED CHARCOAL SUSPENSION

25 grams Activated Charcoal

48 grams Sorbitol

POISON ADSORBENT

If possible call a Poison Control Center,

emergency medical facility, or health

professional for help before using this

product. If help cannot be reached quickly,

follow directions under this label. Read label

warnings and directions upon buying this

product.Write emergency phone numbers

in space provided.

Emergency

Phone No.:

NET CONTENTS: 120 mL (4 fl oz)

PRINCIPAL DISPLAY PANEL - 240 mL Bottle

NDC 0574-0120-08

Actidose®

with Sorbitol

ACTIVATED CHARCOAL SUSPENSION

50 grams Activated Charcoal

96 grams Sorbitol

POISON ADSORBENT

If possible call a Poison Control Center,

emergency medical facility, or health

professional for help before using this

product. If help cannot be reached quickly,

follow directions under this label. Read label

warnings and directions upon buying this

product.Write emergency phone numbers

in space provided.

Emergency

Phone No.:

NET CONTENTS: 240 mL (8 fl oz)

PRINCIPAL DISPLAY PANEL - 120 mL Tube

Paddock

Laboratories, Inc.

Actidose

with Sorbitol™

ACTIVATED CHARCOAL SUSPENSION

25 grams Activated Charcoal

48 grams Sorbitol

PRINCIPAL DISPLAY PANEL - 240 mL Tube

Paddock

Laboratories, Inc.

Actidose

with Sorbitol™

ACTIVATED CHARCOAL SUSPENSION

50 grams Activated Charcoal

96 grams Sorbitol

Actidose  activated charcoal  suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0574-0120 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Activated Charcoal (Activated Charcoal) Activated Charcoal 208 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength Sorbitol 400 mg  in 1 mL Water   propylene glycol   glycerin

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0574-0120-04 120 mL In 1 BOTTLE None 2 0574-0120-08 240 mL In 1 BOTTLE None 3 0574-0120-74 120 mL In 1 TUBE None 4 0574-0120-76 240 mL In 1 TUBE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved other		10/01/1983

Labeler - Paddock Laboratories, Inc. (086116803)

Establishment
Name	Address	ID/FEI	Operations
Paddock Laboratories, Inc.		086116803	MANUFACTURE

Revised: 06/2009Paddock Laboratories, Inc.

More Actidose resources

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

Compare Actidose with other medications

• Gas
• Gastrointestinal Decontamination