Tussionex

hydrocodone bitartrate and chlorpheniramine maleate

Dosage Form: suspension, extended release
Tussionex®

Pennkinetic®

(hydrocodone polistirex and chlorpheniramine polistirex)

Extended-Release Suspension

Rx only

Tussionex Description

Each 5 mL of Tussionex Pennkinetic Extended-Release Suspension contains hydrocodone polistirex equivalent to 10 mg of hydrocodone bitartrate and chlorpheniramine polistirex equivalent to 8 mg of chlorpheniramine maleate. Hydrocodone is a centrally-acting narcotic antitussive. Chlorpheniramine is an antihistamine. Tussionex Pennkinetic Extended-Release Suspension is for oral use only.

Hydrocodone Polistirex

Sulfonated styrene-divinylbenzene copolymer complex with 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one.

Chlorpheniramine Polistirex

Sulfonated styrene-divinylbenzene copolymer complex with 2-[p-chloro-α-[2-(dimethylamino)ethyl]-benzyl]pyridine.

Inactive Ingredients

Ascorbic acid, D&C Yellow No. 10, ethylcellulose, FD&C Yellow No. 6, flavor, high fructose corn syrup, methylparaben, polyethylene glycol 3350, polysorbate 80, pregelatinized starch, propylene glycol, propylparaben, purified water, sucrose, vegetable oil, xanthan gum.

Tussionex - Clinical Pharmacology

Hydrocodone is a semisynthetic narcotic antitussive and analgesic with multiple actions qualitatively similar to those of codeine. The precise mechanism of action of hydrocodone and other opiates is not known; however, hydrocodone is believed to act directly on the cough center. In excessive doses, hydrocodone, like other opium derivatives, will depress respiration. The effects of hydrocodone in therapeutic doses on the cardiovascular system are insignificant. Hydrocodone can produce miosis, euphoria, and physical and psychological dependence.

Chlorpheniramine is an antihistamine drug (H1 receptor antagonist) that also possesses anticholinergic and sedative activity. It prevents released histamine from dilating capillaries and causing edema of the respiratory mucosa.

Hydrocodone release from Tussionex Pennkinetic Extended-Release Suspension is controlled by the Pennkinetic System, an extended-release drug delivery system, which combines an ion-exchange polymer matrix with a diffusion rate-limiting permeable coating. Chlorpheniramine release is prolonged by use of an ion-exchange polymer system.

Following multiple dosing with Tussionex Pennkinetic Extended-Release Suspension, hydrocodone mean (S.D.) peak plasma concentrations of 22.8 (5.9) ng/mL occurred at 3.4 hours. Chlorpheniramine mean (S.D.) peak plasma concentrations of 58.4 (14.7) ng/mL occurred at 6.3 hours following multiple dosing. Peak plasma levels obtained with an immediate-release syrup occurred at approximately 1.5 hours for hydrocodone and 2.8 hours for chlorpheniramine. The plasma half-lives of hydrocodone and chlorpheniramine have been reported to be approximately 4 and 16 hours, respectively.

Indications and Usage for Tussionex

Tussionex Pennkinetic Extended-Release Suspension is indicated for relief of cough and upper respiratory symptoms associated with allergy or a cold in adults and children 6 years of age and older.

Contraindications

Tussionex Pennkinetic Extended-Release Suspension is contraindicated in patients with a known allergy or sensitivity to hydrocodone or chlorpheniramine.

The use of Tussionex Pennkinetic Extended-Release Suspension is contraindicated in children less than 6 years of age due to the risk of fatal respiratory depression.

Warnings

Respiratory Depression

As with all narcotics, Tussionex Pennkinetic Extended-Release Suspension produces dose-related respiratory depression by directly acting on brain stem respiratory centers. Hydrocodone affects the center that controls respiratory rhythm and may produce irregular and periodic breathing. Caution should be exercised when Tussionex Pennkinetic Extended-Release Suspension is used postoperatively and in patients with pulmonary disease, or whenever ventilatory function is depressed. If respiratory depression occurs, it may be antagonized by the use of naloxone hydrochloride and other supportive measures when indicated (see OVERDOSAGE).

Head Injury and Increased Intracranial Pressure

The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions, or a pre-existing increase in intracranial pressure. Furthermore, narcotics produce adverse reactions, which may obscure the clinical course of patients with head injuries.

Acute Abdominal Conditions

The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions.

Obstructive Bowel Disease

Chronic use of narcotics may result in obstructive bowel disease especially in patients with underlying intestinal motility disorder.

Pediatric Use

The use of Tussionex Pennkinetic Extended-Release Suspension is contraindicated in children less than 6 years of age (see CONTRAINDICATIONS).

In pediatric patients, as well as adults, the respiratory center is sensitive to the depressant action of narcotic cough suppressants in a dose-dependent manner. Caution should be exercised when administering Tussionex Pennkinetic Extended-Release Suspension to pediatric patients 6 years of age and older. Overdose or concomitant administration of Tussionex Pennkinetic Extended-Release Suspension with other respiratory depressants may increase the risk of respiratory depression in pediatric patients. Benefit to risk ratio should be carefully considered, especially in pediatric patients with respiratory embarrassment (e.g., croup) (see PRECAUTIONS).

Precautions

General

Caution is advised when prescribing this drug to patients with narrow-angle glaucoma, asthma, or prostatic hypertrophy.

Special Risk Patients

As with any narcotic agent, Tussionex Pennkinetic Extended-Release Suspension should be used with caution in elderly or debilitated patients and those with severe impairment of hepatic or renal function, hypothyroidism, Addison's disease, prostatic hypertrophy, or urethral stricture. The usual precautions should be observed and the possibility of respiratory depression should be kept in mind.

Information for Patients

Patients should be advised that Tussionex Pennkinetic Extended-Release Suspension may produce marked drowsiness and impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.

Tussionex Pennkinetic Extended-Release Suspension must not be diluted with fluids or mixed with other drugs as this may alter the resin-binding and change the absorption rate, possibly increasing the toxicity.

Patients should be advised to measure Tussionex Pennkinetic Extended-Release Suspension with an accurate measuring device. A household teaspoon is not an accurate measuring device and could lead to overdosage. A pharmacist can recommend an appropriate measuring device and can provide instructions for measuring the correct dose.

A dosing spoon is provided with the 4 oz (115 mL) packaged product. One side of the spoon is for a 2.5 mL dose. The other side of the spoon is for a 5 mL dose. Instruct the patient to fill to level the side of the spoon for the dose that has been prescribed. The spoon should not be overfilled. Rinse the measuring device or dosing spoon after each use.

Shake well before using.

Keep out of the reach of children.

Cough Reflex

Hydrocodone suppresses the cough reflex; as with all narcotics, caution should be exercised when Tussionex Pennkinetic Extended-Release Suspension is used postoperatively, and in patients with pulmonary disease.

Drug Interactions

Patients receiving narcotics, antihistaminics, antipsychotics, antianxiety agents, or other CNS depressants (including alcohol) concomitantly with Tussionex Pennkinetic Extended-Release Suspension may exhibit an additive CNS depression. When combined therapy is contemplated, the dose of one or both agents should be reduced.

The use of MAO inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone.

The concurrent use of other anticholinergics with hydrocodone may produce paralytic ileus.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity, mutagenicity, and reproductive studies have not been conducted with Tussionex Pennkinetic Extended-Release Suspension.

Pregnancy

Teratogenic Effects – Pregnancy Category C

Hydrocodone has been shown to be teratogenic in hamsters when given in doses 700 times the human dose. There are no adequate and well-controlled studies in pregnant women. Tussionex Pennkinetic Extended-Release Suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects

Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting, and fever. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose.

Labor and Delivery

As with all narcotics, administration of Tussionex Pennkinetic Extended-Release Suspension to the mother shortly before delivery may result in some degree of respiratory depression in the newborn, especially if higher doses are used.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Tussionex Pennkinetic Extended-Release Suspension, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

The use of Tussionex Pennkinetic Extended-Release Suspension is contraindicated in children less than 6 years of age (see CONTRAINDICATIONS and ADVERSE REACTIONS, Respiratory, Thoracic and Mediastinal Disorders).

Tussionex Pennkinetic Extended-Release Suspension should be used with caution in pediatric patients 6 years of age and older (see WARNINGS, Pediatric Use).

Geriatric Use

Clinical studies of Tussionex did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Adverse Reactions

Gastrointestinal Disorders

Nausea and vomiting may occur; they are more frequent in ambulatory than in recumbent patients. Prolonged administration of Tussionex Pennkinetic Extended-Release Suspension may produce constipation.

General Disorders and Administration Site Conditions

Death

Nervous System Disorders

Sedation, drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, euphoria, dizziness, psychic dependence, mood changes.

Renal and Urinary Disorders

Ureteral spasm, spasm of vesical sphincters, and urinary retention have been reported with opiates.

Respiratory, Thoracic and Mediastinal Disorders

Dryness of the pharynx, occasional tightness of the chest, and respiratory depression (see CONTRAINDICATIONS).

Tussionex Pennkinetic Extended-Release Suspension may produce dose-related respiratory depression by acting directly on brain stem respiratory centers (see OVERDOSAGE). Use of Tussionex Pennkinetic Extended-Release Suspension in children less than 6 years of age has been associated with fatal respiratory depression. Overdose with Tussionex Pennkinetic Extended-Release Suspension in children 6 years of age and older, in adolescents, and in adults has been associated with fatal respiratory depression.

Skin and Subcutaneous Tissue Disorders

Rash, pruritus.

Drug Abuse and Dependence

Tussionex Pennkinetic Extended-Release Suspension is a Schedule III narcotic. Psychic dependence, physical dependence and tolerance may develop upon repeated administration of narcotics; therefore, Tussionex Pennkinetic Extended-Release Suspension should be prescribed and administered with caution. However, psychic dependence is unlikely to develop when Tussionex Pennkinetic Extended-Release Suspension is used for a short time for the treatment of cough. Physical dependence, the condition in which continued administration of the drug is required to prevent the appearance of a withdrawal syndrome, assumes clinically significant proportions only after several weeks of continued oral narcotic use, although some mild degree of physical dependence may develop after a few days of narcotic therapy.

Overdosage

Signs and Symptoms

Serious overdosage with hydrocodone is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. Although miosis is characteristic of narcotic overdose, mydriasis may occur in terminal narcosis or severe hypoxia. In severe overdosage apnea, circulatory collapse, cardiac arrest and death may occur. The manifestations of chlorpheniramine overdosage may vary from central nervous system depression to stimulation.

Treatment

Primary attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and the institution of assisted or controlled ventilation. The narcotic antagonist naloxone hydrochloride is a specific antidote for respiratory depression which may result from overdosage or unusual sensitivity to narcotics including hydrocodone. Therefore, an appropriate dose of naloxone hydrochloride should be administered, preferably by the intravenous route, simultaneously with efforts at respiratory resuscitation. Since the duration of action of hydrocodone in this formulation may exceed that of the antagonist, the patient should be kept under continued surveillance and repeated doses of the antagonist should be administered as needed to maintain adequate respiration. For further information, see full prescribing information for naloxone hydrochloride. An antagonist should not be administered in the absence of clinically significant respiratory depression. Oxygen, intravenous fluids, vasopressors and other supportive measures should be employed as indicated. Gastric emptying may be useful in removing unabsorbed drug.

Tussionex Dosage and Administration

It is important that Tussionex is measured with an accurate measuring device (see PRECAUTIONS, Information for Patients).

A dosing spoon is provided with the 4 oz (115 mL) packaged product. One side of the spoon is for a 2.5 mL dose. The other side of the spoon is for a 5 mL dose. Fill to level the side of the spoon for the dose that has been prescribed. Do not overfill. Rinse with water after each use.

For prescriptions where a dosing spoon is not provided, a pharmacist can provide an appropriate measuring device and can provide instructions for measuring the correct dose. A household teaspoon is not an accurate measuring device and could lead to overdosage.

Each 5 mL of Tussionex Pennkinetic Extended-Release Suspension contains hydrocodone polistirex equivalent to 10 mg hydrocodone bitartrate, and chlorpheniramine polistirex equivalent to 8 mg chlorpheniramine maleate. Shake well before using. Rinse the measuring device with water after each use.

Adults and Children 12 Years and Older

5 mL every 12 hours; do not exceed 10 mL in 24 hours.

Children 6-11 Years of Age

2.5 mL every 12 hours; do not exceed 5 mL in 24 hours.

This medicine is contraindicated in children under 6 years of age (see CONTRAINDICATIONS).

How is Tussionex Supplied

Tussionex Pennkinetic (hydrocodone polistirex and chlorpheniramine polistirex) Extended-Release Suspension, equivalent to 10 mg hydrocodone bitartrate and 8 mg chlorpheniramine maleate per 5 mL, is a gold-colored suspension available as:

• NDC 53014-548-67      473 mL glass bottle


• NDC 53014-548-01      4 oz amber glass bottle containing 115 mL of suspension. Each bottle is supplied with a plastic dosing spoon calibrated for measuring 2.5 mL and 5 mL doses.

For Medical Information

Contact: Medical Affairs Department

Phone: (866) 822-0068

Fax: (770) 970-8859

Storage:

Shake well. Dispense in a well-closed container.

Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F)

[see USP Controlled Room Temperature].

Tussionex Pennkinetic Extended-Release Suspension

Manufactured for:

UCB, Inc.

Smyrna, GA 30080

Tussionex and PENNKINETIC are trademarks of the UCB Group of companies.

© 2011, UCB, Inc., Smyrna, GA 30080. All rights reserved. Printed in the U.S.A.

Rev. 06/2011

PATIENT INFORMATION

Tussionex® Pennkinetic ®

(hydrocodone polistirex and chlorpheniramine polistirex)

Extended-Release Suspension CIII

Read this Patient Information before you start taking Tussionex Pennkinetic Extended-Release Suspension and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.

What is Tussionex Pennkinetic Extended-Release Suspension?

Tussionex Pennkinetic Extended-Release Suspension is a prescription medicine used to treat cough and upper respiratory symptoms you can have with allergies or a cold. Tussionex Pennkinetic Extended-Release Suspension is for adults and children age 6 years and older.

Tussionex Pennkinetic Extended-Release Suspension contains two medicines, hydrocodone and chlorpheniramine. Hydrocodone is a narcotic cough suppressant. Chlorpheniramine is an antihistamine.

Tussionex Pennkinetic Extended-Release Suspension is a controlled substance (CIII) because it contains hydrocodone that can be a target for people who abuse prescription medicines or street drugs. Keep your Tussionex Pennkinetic Extended-Release Suspension in a safe place, to protect it from theft. Never give your Tussionex Pennkinetic Extended-Release Suspension to anyone else, because it may cause death or harm them. Selling or giving away this medicine is against the law.

Who should not take Tussionex Pennkinetic Extended-Release Suspension?

Do not take Tussionex Pennkinetic Extended-Release Suspension if you:

• are allergic to any of the ingredients in Tussionex Pennkinetic Extended-Release Suspension. See the end of this leaflet for a complete list of ingredients in Tussionex Pennkinetic Extended-Release Suspension.


• are a child under 6 years old. Tussionex Pennkinetic Extended-Release Suspension can cause a decreased rate of breathing (respiratory depression) which can lead to death.

What should I tell my doctor before taking Tussionex Pennkinetic Extended-Release Suspension?

Before you take Tussionex Pennkinetic Extended-Release Suspension, tell your doctor if you:

• have lung or breathing problems


• have had a head injury


• have pain in your belly (abdomen)


• have eye problems, such as glaucoma


• have prostate problems


• have problems with your urinary tract (urethral stricture)


• plan to have surgery


• abuse alcohol


• have kidney or liver problems


• have thyroid problems, such as hypothyroidism


• are pregnant or plan to become pregnant. If you take Tussionex regularly before your baby is born, your newborn baby may have withdrawal symptoms because their body has become use to the medicine. Symptoms of withdrawal in a newborn baby may include:
  
  • irritability
  
  
  • crying more than usual
  
  
  • shaking (tremors)
  
  
  • jitteriness
  
  
  • breathing faster than normal
  
  
  • diarrhea or more stools than normal
  
  
  • sneezing
  
  
  • yawning
  
  
  • vomiting
  
  
  • fever
  
  

If you take Tussionex regularly before your baby is born, your baby could have breathing problems.

• are breastfeeding or plan to breastfeed. You and your doctor should decide if you will take Tussionex Pennkinetic Extended-Release Suspension or breastfeed. You should not do both.

Tell your doctor about all of the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Using Tussionex Pennkinetic Extended-Release Suspension with certain other medicines may affect each other. Using Tussionex Pennkinetic Extended-Release Suspension with other medicines can cause serious side effects.

Especially tell your doctor if you:

• take pain medicines such as narcotics


• take cold or allergy medicines that contain antihistamines or cough suppressants


• take medicines for mental illness (anti-psychotics, anti-anxiety)


• drink alcohol


• take medicines for depression including monoamine oxidase inhibitors (MAOIs)


• take medicines for stomach or intestine problems

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I take Tussionex Pennkinetic Extended-Release Suspension?

• Take Tussionex Pennkinetic Extended-Release Suspension exactly as your doctor tells you.


• Shake the Tussionex Pennkinetic Extended-Release Suspension bottle well before you use it.


• Do not mix Tussionex Pennkinetic Extended-Release Suspension with other fluids or medicines. Mixing may change how Tussionex Pennkinetic Extended-Release Suspension works.


• Tussionex Pennkinetic Extended-Release Suspension can be taken with or without food.


• Only measure Tussionex Pennkinetic Extended-Release Suspension with the dosing spoon that comes with your prescription. See Figure A. If you do not have a dosing spoon for your medicine, ask your pharmacist to give you a measuring device to help you measure the correct amount of Tussionex Pennkinetic Extended-Release Suspension. Do not use a household teaspoon to measure your medicine. You may accidently take too much.
  
  • One side of the dosing spoon is marked for a 2.5 mL dose. The other side of the spoon is marked for a 5 mL dose. Find the side of the spoon that has the dose you are taking.
  
  
  • Fill that side of the spoon so the medicine is level with the rim of the spoon. Do not overfill the spoon.
  
  
  • Rinse the spoon with water after each use.
  
  

Figure A

• If you take too much Tussionex Pennkinetic Extended-Release Suspension, call your doctor or go to the nearest hospital emergency room right away.

What should I avoid while taking Tussionex Pennkinetic Extended-Release Suspension?

• Tussionex Pennkinetic Extended-Release Suspension can cause you to be drowsy. Do not drive a car or use machinery while you take Tussionex Pennkinetic Extended-Release Suspension until you know how it affects you.


• Do not drink alcohol while taking Tussionex Pennkinetic Extended-Release Suspension. Drinking alcohol can increase your chances of having serious side effects.

What are the possible side effects of Tussionex Pennkinetic Extended-Release Suspension?

Tussionex Pennkinetic Extended-Release Suspension may cause serious side effects, including:

• Decreased breathing (respiratory depression) which can lead to death. Call your doctor or get emergency treatment right away if you have:
  
  • shallow or slow breathing
  
  
  • confusion
  
  
  • excessive sleepiness
  
  


• drowsiness leading to inability to think clearly or do normal physical activities


• bowel problems, including constipation and bowel obstruction

The most common side effects of Tussionex Pennkinetic Extended-Release Suspension are:

• nausea and vomiting


• constipation


• nervous system problems (anxiety, fear, dizziness, mood changes)


• urinary tract problems


• dry throat


• chest tightness

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Tussionex Pennkinetic Extended-Release Suspension. For more information, ask your doctor or pharmacist.

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

How should I store Tussionex Pennkinetic Extended-Release Suspension?

• Store Tussionex Pennkinetic Extended-Release Suspension in a safe place at 68°F to 77°F (20°C to 25°C).


• Safely throw away medicine that is out of date or no longer needed.


• Keep Tussionex Pennkinetic Extended-Release Suspension and all medicines out of the reach of children.

General information about Tussionex Pennkinetic Extended-Release Suspension

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use Tussionex Pennkinetic Extended-Release Suspension for a condition for which it was not prescribed. Do not give Tussionex Pennkinetic Extended-Release Suspension to other people, even if they have the same condition. It may harm them and it is against the law.

This Patient Information Leaflet summarizes the most important information about Tussionex Pennkinetic Extended-Release Suspension. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Tussionex Pennkinetic Extended-Release Suspension that is written for healthcare professionals.

For more information about Tussionex Pennkinetic Extended-Release Suspension call 1-866-822-0068 or go to www.Tussionex.com.

What are the ingredients in Tussionex Pennkinetic Extended-Release Suspension?

Active Ingredient: hydrocodone polistirex and chlorpheniramine polistirex

Inactive Ingredients: Ascorbic acid, D&C Yellow No. 10, ethylcellulose, FD&C Yellow No. 6, flavor, high fructose corn syrup, methylparaben, polyethylene glycol 3350, polysorbate 80, pregelatinized starch, propylene glycol, propylparaben, purified water, sucrose, vegetable oil, xanthan gum.

Tussionex Pennkinetic Extended-Release Suspension

Manufactured for:

UCB, Inc.

Smyrna, GA 30080

This patient information has been approved by the U.S. Food and Drug

Administration.

Issued: 06/2011

PRINCIPAL DISPLAY PANEL - 115 mL Bottle Label

NDC 53014-548-01

Rx ONLY

CIII

Tussionex®

Pennkinetic®

(hydrocodone polistirex and

chlorpheniramine polistirex)

Extended-Release Suspension

equivalent to 10 mg hydrocodone

bitartrate/8 mg chlorpheniramine

maleate per 5 mL

Nonalcoholic

12-hour Dosing

Contraindicated in

children under

6 years of age

Contains one glass bottle

containing 115 mL of suspension,

one dosing spoon, package insert,

and patient information leaflet.

Dispense entire carton

as one unit

4 oz. (115 mL)

Tussionex PENNKINETIC   EXTENDED-RELEASE hydrocodone bitartrate and chlorpheniramine maleate  suspension, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 53014-548 Route of Administration ORAL DEA Schedule CIII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength hydrocodone bitartrate (hydrocodone) hydrocodone bitartrate 10 mg  in 5 mL chlorpheniramine maleate (chlorpheniramine) chlorpheniramine maleate 8 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength ascorbic acid   D&C Yellow No. 10   ethylcelluloses   FD&C Yellow No. 6   high fructose corn syrup   methylparaben   polyethylene glycol 3350   polysorbate 80   starch, corn   propylene glycol   propylparaben   water   sucrose   xanthan gum

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 53014-548-67 473 mL In 1 BOTTLE, GLASS None 2 53014-548-01 1 BOTTLE In 1 CARTON contains a BOTTLE, GLASS 2 115 mL In 1 BOTTLE, GLASS This package is contained within the CARTON (53014-548-01)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019111	12/31/1987

Labeler - UCB Manufacturing Inc (944186584)

Revised: 06/2011UCB Manufacturing Inc

More Tussionex resources

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

Compare Tussionex with other medications

• Cold Symptoms
• Cough

Tambocor

Generic Name: flecainide (FLEK a nide)

Brand Names: Tambocor

What is Tambocor (flecainide)?

Flecainide is in a group of drugs called Class IC anti-arrhythmics. It affects the way your heart beats.

Flecainide is used in certain situations to prevent serious heart rhythm disorders.

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

What is the most important information I should know about Tambocor (flecainide)?

You should not use this medication if you are allergic to flecainide, or if you have certain heart conditions, especially "AV block" (unless you have a pacemaker).

Before using flecainide, tell your doctor if you have congestive heart failure, a heart condition called "sick sinus syndrome," an electrolyte imbalance, liver disease, kidney disease, if you have a pacemaker, or if you have had a heart attack within the past 2 years.

You will need to receive your first few doses of flecainide in a hospital setting in case the medication causes serious side effects. Your heart rate will be constantly monitored using an electrocardiograph or ECG (sometimes called an EKG). This machine measures electrical activity of the heart. Call your doctor at once if you have a serious side effect such as weak pulse, slow breathing, fast or uneven heartbeat, feeling like you might pass out, feeling short of breath, swelling, rapid weight gain, confusion, extreme thirst, increased urination, muscle weakness, or jaundice (yellowing of the skin or eyes).

What should I discuss with my healthcare provider before taking Tambocor (flecainide)?

You should not use this medication if you are allergic to flecainide, or if you have certain heart conditions, especially "AV block" (unless you have a pacemaker).

Before using flecainide, tell your doctor if you are allergic to any drugs, or if you have:

• 
  

  congestive heart failure;

  
  


• 
  

  a heart condition called "sick sinus syndrome";

  
  


• 
  

  an electrolyte imbalance;

  
  


• 
  

  liver disease;

  
  


• 
  

  kidney disease;

  
  


• 
  

  if you have a pacemaker; or

  
  


• 
  

  if you have had a heart attack within the past 2 years.

  
  

If you have any of these conditions, you may need a dose adjustment or special tests to safely use flecainide.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Flecainide can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Tambocor (flecainide)?

You will need to receive your first few doses of flecainide in a hospital setting in case the medication causes serious side effects. Your heart rate will be constantly monitored using an electrocardiograph or ECG (sometimes called an EKG). This machine measures electrical activity of the heart.

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

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

To be sure this medication is helping your condition, your blood may need to be tested on a regular basis. Do not miss any scheduled appointments.

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

See also: Tambocor dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. 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 nausea, vomiting, slow heart rate, feeling like you might pass out, or seizure (convulsions).

What should I avoid while taking Tambocor (flecainide)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using flecainide.

Tambocor (flecainide) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• 
  

  slow heart rate, weak pulse, fainting, slow breathing (breathing may stop);

  
  


• 
  

  dizziness, fainting, fast or pounding heartbeat;

  
  


• 
  

  feeling short of breath, even with mild exertion;

  
  


• 
  

  swelling, rapid weight gain;

  
  


• 
  

  low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling);

  
  


• 
  

  high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling);

  
  


• 
  

  pale skin, easy bruising or bleeding, unusual weakness; or

  
  


• 
  

  jaundice (yellowing of the skin or eyes).

  
  

Less serious side effects may include:

• 
  

  dizziness;

  
  


• 
  

  tremor or shaking;

  
  


• 
  

  headache;

  
  


• 
  

  anxiety or depression;

  
  


• 
  

  vision problems;

  
  


• 
  

  nausea, vomiting, stomach pain;

  
  


• 
  

  diarrhea, constipation; or

  
  


• 
  

  numbness or tingling.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Tambocor (flecainide)?

Before taking flecainide, tell your doctor if you are taking any of the following medicines:

• 
  

  cimetidine (Tagamet),

  
  


• 
  

  digoxin (digitalis, Lanoxin);

  
  


• 
  

  a diuretic (water pill);

  
  


• 
  

  verapamil (Verelan, Calan, Isoptin);

  
  


• 
  

  seizure medication such as carbamazepine (Carbatrol, Tegretol), phenobarbital (Solfoton), or phenytoin (Dilantin);

  
  


• 
  

  other heart rhythm medications such as amiodarone (Cordarone), disopyramide (Norpace), or quinidine (Quinaglute, Quinidex); or

  
  


• 
  

  a beta-blocker such as atenolol (Tenormin), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), propranolol (Inderal, InnoPran), sotalol (Betapace), timolol (Blocadren), and others.

  
  

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

More Tambocor resources

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

• Tambocor Prescribing Information (FDA)


• Tambocor MedFacts Consumer Leaflet (Wolters Kluwer)


• Tambocor Monograph (AHFS DI)


• Tambocor Advanced Consumer (Micromedex) - Includes Dosage Information


• Flecainide Prescribing Information (FDA)

Compare Tambocor with other medications

• Atrial Fibrillation
• Atrial Flutter
• Paroxysmal Supraventricular Tachycardia
• Supraventricular Tachycardia
• Ventricular Tachycardia
• Wolff-Parkinson-White Syndrome

Where can I get more information?

• Your pharmacist can provide more information about flecainide.

See also: Tambocor side effects (in more detail)

Tribenzagan

Generic Name: trimethobenzamide (Intramuscular route)

trye-meth-oh-BENZ-a-mide

Commonly used brand name(s)

In the U.S.

• Arrestin


• Benzacot


• Stemetic


• Ticon


• Tigan


• Tribenzagan

Available Dosage Forms:

• Solution

Therapeutic Class: Antiemetic

Pharmacologic Class: Anticholinergic

Uses For Tribenzagan

Trimethobenzamide is used to treat nausea and vomiting .

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

Before Using Tribenzagan

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

No information is available on the relationship of age to the effects of intramuscular trimethobenzamide in the pediatric population. However, because of this medication's toxicity, use in children is contraindicated. Intramuscular trimethobenzamide should never be used in children .

Geriatric

No information is available on whether the risk of trimethobenzamide-induced adverse effects is increased in the elderly. However, because of this medication's toxicity, it should be used with caution, after less toxic alternatives have been considered and/or found ineffective. Recommended doses should not be exceeded, and the patient should be carefully monitored during therapy .

Breast Feeding

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving 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.

• Metoclopramide

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:

• Dehydration or


• Electrolyte imbalance (high or low levels of minerals in the blood) or


• High fever or


• Intestinal infection, severe—May cause side effects to become worse .

Proper Use of trimethobenzamide

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

Trimethobenzamide is only used to relieve or prevent nausea and vomiting. A nurse or other trained health professional will give you this medicine. This medicine is given as a shot into one of your muscles .

Your doctor may only give you a few doses of this medicine until your condition improves, and then may switch you to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor .

Precautions While Using Tribenzagan

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

This medicine may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert .

Tribenzagan 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:

Rare

• Body spasm, with head and heels bent backward and body bowed forward


• convulsions (seizures)


• depression


• shakiness or tremors


• skin rash


• sore throat or fever


• unusual tiredness


• vomiting (severe or continuing)


• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Drowsiness

Less common

• Blurred vision


• diarrhea


• dizziness


• headache


• muscle cramps

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: Tribenzagan side effects (in more detail)

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

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

More Tribenzagan resources

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

Compare Tribenzagan with other medications

• Nausea/Vomiting

Triphasil-28

Generic Name: ethinyl estradiol and levonorgestrel (ETH in ill ess tra DYE ol and LEE vo nor JESS trel)

Brand Names: Alesse, Aviane, Enpresse, Lessina, Levlen, Levlite, Levora, Lutera, Lybrel, Nordette, Portia, Sronyx, Tri-Levlen, Triphasil-21, Triphasil-28, Trivora-28

What is Triphasil-28 (ethinyl estradiol and levonorgestrel)?

Ethinyl estradiol and levonorgestrel contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Ethinyl estradiol and levonorgestrel are used as contraception to prevent pregnancy.

Ethinyl estradiol and levonorgestrel may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Triphasil-28 (ethinyl estradiol and levonorgestrel)?

Do not use ethinyl estradiol and levonorgestrel if you are pregnant or if you recently had a baby. Do not use this medication if you have a history of stroke or blood clot, circulation problems (especially if caused by diabetes), a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, severe high blood pressure, migraine headaches, a heart valve disorder, or a history of jaundice caused by birth control pills. Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

What should I discuss with my healthcare provider before taking Triphasil-28 (ethinyl estradiol and levonorgestrel)?

This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills (6 weeks if you are breast-feeding). Do not use this medication if you have:

• 
  

  a history of a stroke or blood clot;

  
  


• 
  

  circulation problems (especially if caused by diabetes);

  
  


• 
  

  a hormone-related cancer such as breast or uterine cancer;

  
  


• 
  

  abnormal vaginal bleeding;

  
  


• 
  

  liver disease or liver cancer;

  
  


• 
  

  severe high blood pressure;

  
  


• 
  

  severe migraine headaches;

  
  


• 
  

  a heart valve disorder; or

  
  


• 
  

  a history of jaundice caused by birth control pills.

  
  

Before using this medication, tell your doctor if you have:

• 
  

  high blood pressure, heart disease, congestive heart failure, angina (chest pain), or a history of heart attack;

  
  


• 
  

  high cholesterol or if you are overweight;

  
  


• 
  

  a history of depression;

  
  


• 
  

  gallbladder disease;

  
  


• 
  

  diabetes;

  
  


• 
  

  seizures or epilepsy;

  
  


• 
  

  a history of irregular menstrual cycles;

  
  


• 
  

  a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram;

  
  


• 
  

  uterine fibroid tumors;

  
  


• 
  

  varicose veins; or

  
  


• 
  

  tuberculosis.

  
  

The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby.

How should I take Triphasil-28 (ethinyl estradiol and levonorgestrel)?

Take this medication exactly as it was prescribed for you. Do not take larger amounts, or take it for longer than recommended by your doctor. You will take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

Some 28-day birth control packs contain seven "reminder" pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.

Breakthrough bleeding may occur, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the next day. You may get pregnant if you do not use this medication regularly.

If you need to have any type of medical tests or surgery, or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.

Store this medication at room temperature away from moisture and heat.

What happens if I miss a dose?

Missing a pill increases your risk of becoming pregnant.

If you miss one "active" pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.

If you miss two "active" pills in a row in week one or two, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.

If you miss two "active" pills in a row in week three, or if you miss three pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new one the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.

If you miss three "active" pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new pack on the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.

If you miss two or more pills, you may not have a period during the month. If you miss a period for two months in a row, call your doctor because you might be pregnant.

If you miss any reminder pills, throw them away and keep taking one pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

What should I avoid while taking Triphasil-28 (ethinyl estradiol and levonorgestrel)?

Do not smoke while using birth control pills, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.

Birth control pills will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Triphasil-28 (ethinyl estradiol and levonorgestrel) 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:

• 
  

  sudden numbness or weakness, especially on one side of the body;

  
  


• 
  

  sudden headache, confusion, pain behind the eyes, problems with vision, speech, or balance;

  
  


• 
  

  chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

  
  


• 
  

  a change in the pattern or severity of migraine headaches;

  
  


• 
  

  nausea, stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);

  
  


• 
  

  swelling in your hands, ankles, or feet; or

  
  


• 
  

  symptoms of depression (sleep problems, weakness, mood changes).

  
  

Less serious side effects may include:

• 
  

  mild nausea, vomiting, bloating, stomach cramps;

  
  


• 
  

  breast pain, tenderness, or swelling;

  
  


• 
  

  freckles or darkening of facial skin;

  
  


• 
  

  increased hair growth, loss of scalp hair;

  
  


• 
  

  changes in weight or appetite;

  
  


• 
  

  problems with contact lenses;

  
  


• 
  

  vaginal itching or discharge;

  
  


• 
  

  changes in your menstrual periods, decreased sex drive; or

  
  


• 
  

  headache, nervousness, dizziness, tired feeling.

  
  

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 Triphasil-28 (ethinyl estradiol and levonorgestrel)?

Some drugs can make birth control pills less effective, which may result in pregnancy. Before using birth control pills, tell your doctor if you are using any of the following drugs:

• 
  

  acetaminophen (Tylenol) or ascorbic acid (vitamin C);

  
  


• 
  

  prednisolone (Orapred);

  
  


• 
  

  theophylline (Respbid, Theo-Dur);

  
  


• 
  

  cyclosporine (Neoral, Sandimmune, Gengraf);

  
  


• 
  

  St. John's wort;

  
  


• 
  

  an antibiotic;

  
  


• 
  

  seizure medications;

  
  


• 
  

  a barbiturate sedative such as secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or

  
  


• 
  

  HIV or AIDS medications.

  
  

This list is not complete and there may be other drugs not listed that can affect birth control pills. 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 Triphasil-28 resources

• Triphasil-28 Side Effects (in more detail)
• Triphasil-28 Use in Pregnancy & Breastfeeding
• Drug Images
• Triphasil-28 Drug Interactions
• Triphasil-28 Support Group
• 0 Reviews for Triphasil-28 - Add your own review/rating

• Alesse Prescribing Information (FDA)


• Alesse MedFacts Consumer Leaflet (Wolters Kluwer)


• Alesse Consumer Overview


• Alesse Advanced Consumer (Micromedex) - Includes Dosage Information


• Altavera Prescribing Information (FDA)


• Amethia Prescribing Information (FDA)


• Amethyst Prescribing Information (FDA)


• Aviane Consumer Overview


• Camrese Prescribing Information (FDA)


• Enpresse Prescribing Information (FDA)


• Jolessa Prescribing Information (FDA)


• Jolessa MedFacts Consumer Leaflet (Wolters Kluwer)


• Lessina Prescribing Information (FDA)


• Levlite Prescribing Information (FDA)


• Levora Prescribing Information (FDA)


• LoSeasonique Consumer Overview


• LoSeasonique MedFacts Consumer Leaflet (Wolters Kluwer)


• LoSeasonique Prescribing Information (FDA)


• Lybrel Consumer Overview


• Lybrel MedFacts Consumer Leaflet (Wolters Kluwer)


• Lybrel Prescribing Information (FDA)


• Nordette Prescribing Information (FDA)


• Orsythia Prescribing Information (FDA)


• Portia Prescribing Information (FDA)


• Preven EC Consumer Overview


• Quasense Prescribing Information (FDA)


• Seasonale Prescribing Information (FDA)


• Seasonale Consumer Overview


• Seasonique Prescribing Information (FDA)


• Seasonique Consumer Overview


• Sronyx Prescribing Information (FDA)


• Tri-Levlen Advanced Consumer (Micromedex) - Includes Dosage Information


• Triphasil Prescribing Information (FDA)


• Triphasil Consumer Overview

Compare Triphasil-28 with other medications

• Abnormal Uterine Bleeding
• Birth Control
• Endometriosis
• Gonadotropin Inhibition
• Ovarian Cysts
• Polycystic Ovary Syndrome

Where can I get more information?

• Your pharmacist can provide more information about ethinyl estradiol and levonorgestrel.

See also: Triphasil-28 side effects (in more detail)

Triaz Lotion

Pronunciation: BEN-zoyl per-OX-ide
Generic Name: Benzoyl Peroxide
Brand Name: Examples include Brevoxyl and Triaz

Triaz Lotion is used for:

Treating mild to moderate acne. It may be used with other acne medications.

Triaz Lotion is a keratolytic agent with antibacterial actions. The effectiveness of benzoyl peroxide appears to be due to its antibacterial, peeling (keratolytic), and drying actions.

Do NOT use Triaz Lotion if:

• you are allergic to any ingredient in Triaz Lotion

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

Before using Triaz Lotion:

Some medical conditions may interact with Triaz Lotion. 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

Some MEDICINES MAY INTERACT with Triaz Lotion. However, no specific interactions with Triaz Lotion are known at this time.

Ask your health care provider if Triaz Lotion 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 Triaz Lotion:

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

• Shake well before using.


• To use the lotion wash - Wet the affected area. Use your hands to apply the medicine and gently wash. Rinse with water and pat dry.


• To use the lotion - Wash and completely dry the affected area. Gently rub the medicine in until it is evenly distributed.


• Wash your hands after using Triaz Lotion.


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

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

Important safety information:

• Use on the skin only. Avoid getting Triaz Lotion in your eyes, on the inside of your nose or mouth, on highly inflamed or damaged skin, or on your lips. If you get Triaz Lotion in your eyes, immediately wash them out with cool tap water.


• Avoid applying Triaz Lotion to raw or irritated skin, including sunburns, or to open wounds.


• Several weeks may pass before you see improvement in your acne. Continue to use Triaz Lotion for the full time recommended by your doctor. If your acne does not improve or if it gets worse, check with your doctor.


• Talk with your doctor before you use any other medicines, special cleansers, aftershave, or cosmetics on your skin.


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


• Triaz Lotion may cause bleaching. Avoid contact with hair, fabrics, or carpeting.


• Triaz Lotion should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.


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

Possible side effects of Triaz Lotion:

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; feeling of warmth; irritation; itching; peeling; redness; stinging; swelling of the skin.

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

Severe allergic reactions (rash; hives; itching; dizziness; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); excessive burning, itching, redness, or tenderness of your skin; extreme dryness; severe irritation; sloughing of the skin; swelling in the treated areas.

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: Triaz 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 excessive scaling; flushing; redness; swelling.

Proper storage of Triaz Lotion:

Store at room temperature between 59 and 77 degrees F (15 and 25 degrees C). Store in a tightly closed container, away from fire, flame, heat, and light. Keep Triaz Lotion out of the reach of children and away from pets.

General information:

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


• Triaz Lotion 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 Triaz Lotion. 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 Triaz resources

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

Compare Triaz with other medications

• Acne
• Perioral Dermatitis

Tripohist D

triprolidine hydrochloride and pseudoephedrine hydrochloride

Dosage Form: oral liquid
Tripohist™ D Liquid

Antihistamine/Decongestant

Tripohist D Description

Tripohist™ D Liquid is an alcohol free, sugar free blue liquid for oral administration having an blueberry odor and flavor.

Each teaspoonful (5 mL) contains:

Triprolidine Hydrochloride	1.25 mg
Pseudoephedrine Hydrochloride	45 mg

INACTIVE INGREDIENTS

Sodium Benzoate, Citric Acid, Saccharin Sodium, Glycerin, Sorbitol Solution, Blueberry Flavor, FD&C Blue No. 1 and Purified Water.

Triprolidine Hydrochloride is an antihistamine, chemically it is: Pyridine, 2-[1-(4-methyl-phenyl)-3-(1-pyrrolidinyl)-1-propenyl]-, monohydrochloride, monohydrate, (E)-. It's structure is as follows:

C19H22N2•HCl•H2O    M.W. 332.87

Pseudoephedrine Hydrochloride is a nasal decongestant, chemically it is Benzenemethanol, α-[1-(methylamino)ethyl]-, [S-(R*,R*)]-, hydrochloride. It's structure is as follows:

C10H15NO•HCl    M.W. 201.69

Tripohist D - Clinical Pharmacology

Triprolidine hydrochloride is an antihistamine, which has anticholinergic (drying) and sedative effects. Triprolidine hydrochloride is promptly absorbed and rapidly reaches a therapeutic level which is usually maintained for 4-8 hours. It acts as an antagonist H1 histamine receptor. The serum half-life for triprolidine is 3 to 3.3 hours.

Pseudoephedrine Hydrochloride is an oral sympathomimetic amine that acts as a decongestant to respiratory tract mucous membranes. While its vasoconstrictor action is similar to that of ephedrine, pseudoephedrine has less pressor effect in normotensive adults. Serum half-life for pseudoephedrine is 6-8 hours. Acidic urine is associated with faster elimination of the drug. About one half of the administered dose is excreted in the urine.

Indications and Usage for Tripohist D

Tripohist™ D Liquid is indicated for the symptomatic treatment of perennial and seasonal allergic rhinitis and vasomotor rhinitis.

Contraindications

Tripohist™ D Liquid is contraindicated in patients with hypersensitivity or idiosyncrasy to: triprolidine hydrochloride and other antihistamines of similar chemical structure and/or sympathomimetic amines including pseudoephedrine and/or any of its ingredients; (MAO) inhibitors (or for 14 days after stopping MAOI therapy) and/or beta-adrenergic blocking agents; newborn or premature infants; nursing mothers; patients with severe hypertension or coronary artery disease; patients experiencing asthma attacks.

Warnings

Do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor. If symptoms do not improve within 7 days or are accompanied by a fever, consult a doctor. Tripohist™ D Liquid should be used with considerable caution in patients with glaucoma; stenosing peptic ulcer; pyloroduodenal obstruction; prostatic hypertrophy; bladder neck obstruction; hypertension; diabetes mellitus; ischemic heart disease and hyperthyroidism. Sympathomimetics may produce CNS stimulation and convulsions or cardiovascular collapse with accompanying hypotension. Do not take this product, unless directed by a physician, if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland. May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your physician. Use caution when driving a motor vehicle or operating machinery. Pseudoephedrine is banned and tested for by the U.S. Olympic Committee.

Pediatric Use

See PRECAUTIONS, Pediatric Use

This product may cause excitability especially in children.

Do not give this product to children who have a breathing problem such as chronic bronchitis, or who have glaucoma, without first consulting the child's physician.

This product may cause drowsiness. Sedatives and tranquilizers may increase the drowsiness effect. Do not give this product to children who are taking sedatives or tranquilizers, without first consulting the child's physician.

Precautions

Antihistamines should be used with caution in patients with history of bronchial asthma, increased intraocular pressure; diabetes mellitus; hyperthyroidism; cardiovascular disease and hypertension. Avoid alcohol and other CNS depressants while taking this product. Patients sensitive to antihistamines may experience drowsiness. Patients sensitive to sympathomimetic amines may experience CNS stimulation. While taking this product, exercise care in driving a motorized vehicle or operating machinery.

Drug Interactions

Antihistamines may enhance the effects of tricyclic antidepressants, barbiturates, alcohol, and other CNS depressants. MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines. Sympathomimetic amines may reduce the antihypertensive effects of reserpine, veratrum alkaloids, methyldopa, mecamylamine. Effects of sympathomimetics are increased with MAO inhibitors (or for 14 days after stopping MAOI therapy), beta-adrenergic blocking agents, and thyroid hormones.

Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with this product. It is not known whether it can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. This product should be administered to pregnant women only if clearly needed.

Nursing Mothers

Due to the possible passage of the ingredients into breast milk, this product should not be given to nursing mothers.

Pediatric Use

Safety and effectiveness in the pediatric population, under 6, have not been established.

Geriatric Use

Antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients (approximately 60 years or older). The elderly are also more likely to have adverse reactions to sympathomimetics, including hallucinations, convulsions, CNS depression, and death.

Adverse Reactions

The most frequent adverse reactions to antihistamines are sedation, dizziness, disturbed coordination, epigastric distress, and thickening of bronchial secretions. Others include vomiting, dry mouth, nervousness, nausea, anorexia, diplopia, polyuria, and diarrhea. Sympathomimetic amines may cause convulsions, CNS stimulation, cardiac arrhythmias, respiratory difficulty, tachycardia, palpitations, increased blood pressure, hallucinations, tremors, nervousness, insomnia, weakness, pallor, and dysuria.

Overdosage

No information is available as to specific results of an overdose on this product. The signs, symptoms, and treatment described below are those of H1 antihistamines and ephedrine overdose.

Signs and Symptoms

Should antihistamine effects predominate, central action constitutes the greatest danger. In the small child, symptoms include excitation, hallucination, ataxia, incoordination, tremors, flushing face and fever. Convulsions, fixed and dilated pupils, coma and death may occur in severe cases. In the adult, fever and flushing are uncommon; excitement leading to convulsions and postictal depression is often preceded by drowsiness and coma. Respiration is usually not seriously depressed; blood pressure is usually stable.

Should sympathomimetic symptoms predominate, central effects include restlessness, dizziness, tremor, hyperactive reflexes, talkativeness, irritability and insomnia. Cardiovascular and renal effects include difficulty in micturition, headache, flushing, palpitation, cardiac arrhythmias, hypertension with subsequent hypotension and circulatory collapse. Gastrointestinal effects include dry mouth, metallic taste, anorexia, nausea, vomiting, diarrhea, and abdominal cramps.

Treatment

1) Evacuate stomach as condition warrants. Activated charcoal may be useful. 2) Maintain a non-stimulating environment. 3) Monitor cardiovascular status. 4) Physostigmine may reverse anticholinergic symptoms. 5) Do not give stimulants. 6) Reduce fever with cool sponging. 7) Support respiration. 8) Use sedative or anticonvulsants to control CNS excitation and convulsions. 9) Ammonium chloride may acidify the urine to increase excretion of pseudoephedrine. 10) Further care is symptomatic and supportive.

Tripohist D Dosage and Administration

Adults and children over 12 years of age

1-2 teaspoonfuls every 4 to 6 hours (Do not exceed 240 mg of pseudoephedrine HCI in 24 hours).

Children 6 to 12 years

½-1 teaspoonful every 4 to 6 hours (Do not exceed 120 mg of pseudoephedrine HCI in 24 hours). This product is not indicated for use in children under 6 years of age. (see PRECAUTIONS, Pediatric Use.)

How is Tripohist D Supplied

Tripohist™ D Liquid is supplied as an alcohol free, sugar free, blue liquid having a blueberry odor and flavor, in bottles of 16 fl.oz. (One Pint), NDC 51991-532-16.

WARNING: KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Storage

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature. Protect from freezing.

Pharmacist: Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP/NF.

All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

Rx ONLY

Distributed by:

Breckenridge Pharmaceutical, Inc.

Boca Raton, FL 33487

Manufactured by:

Tri-Med Laboratories, Inc.

Somerset, NJ 08873

Iss. 10/07

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

Breckenridge

Pharmaceutical, Inc.

NDC 51991-532-16

Tripohist™ D

Liquid

Antihistamine/Decongestant

 

• Sugar Free


• Alcohol Free

Description: Each 5 mL (one teaspoonful) for oral

administration contains:

Triprolidine Hydrochloride	1.25 mg
Pseudoephedrine Hydrochloride	45 mg

INACTIVE INGREDIENTS: Sodium Benzoate,

Citric Acid, Saccharin Sodium, Glycerin, Sorbitol

Solution, Blueberry Flavor, FD&C Blue No. 1,

Purified Water.

Rx Only

Net Contents:

16 fl. oz. (One Pint) 473 mL

Tripohist D  triprolidine hydrochloride and pseudoephedrine hydrochloride  liquid

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 51991-532 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Triprolidine Hydrochloride (Triprolidine) Triprolidine Hydrochloride 1.25 mg  in 5 mL Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine Hydrochloride 45 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength Sodium Benzoate   Citric Acid Monohydrate   Saccharin Sodium   Glycerin   Sorbitol   FD&C Blue No. 1   Water

Product Characteristics Color BLUE Score      Shape Size Flavor BLUEBERRY Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 51991-532-16 473 mL In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		01/01/2008	12/31/2011

Labeler - Breckenridge Pharmaceutical, Inc. (150554335)

Establishment
Name	Address	ID/FEI	Operations
Trimed		182050567	MANUFACTURE

Revised: 11/2010Breckenridge Pharmaceutical, Inc.

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