phendimetrazine

fen-dye-MET-ra-zeen TAR-trate

Commonly used brand name(s)

In the U.S.

• Bontril


• Bontril PDM


• Bontril Slow-Release


• Melfiat


• Obezine


• Phendiet


• Phendiet-105


• Prelu-2

Available Dosage Forms:

• Tablet


• Capsule


• Capsule, Extended Release

Therapeutic Class: Appetite Suppressant, Centrally Acting

Chemical Class: Phendimetrazine

Uses For phendimetrazine

Phendimetrazine is used as part of a short-term plan, along with a low calorie diet, for weight reduction. It is used in obese patients who have not been able to lose weight with diet and exercise alone. Phendimetrazine belongs to the group of medicines known as appetite suppressants.

phendimetrazine is available only with your doctor's prescription.

Before Using phendimetrazine

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 phendimetrazine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to phendimetrazine 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 phendimetrazine tablets in the pediatric population. Safety and efficacy have not been established.

Use of phendimetrazine slow-release capsules is not recommended in children younger than 12 years of age.

Geriatric

No information is available on the relationship of age to the effects of phendimetrazine in geriatric patients.

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 phendimetrazine, 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 phendimetrazine 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.

• Brofaromine


• Clorgyline


• Furazolidone


• Iproniazid


• Isocarboxazid


• Lazabemide


• Linezolid


• Moclobemide


• Nialamide


• Pargyline


• Phenelzine


• Procarbazine


• Rasagiline


• Selegiline


• Sibutramine


• Toloxatone


• Tranylcypromine

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

• Agitated state or


• Arteriosclerosis (hardening of the arteries), advanced or


• Drug abuse or dependence, history of or


• Glaucoma or


• Heart problems (e.g., heart murmur, valvular heart disease) or


• Hypertension (high blood pressure), moderate to severe or


• Hyperthyroidism (overactive thyroid)—Should not be used in patients with these conditions.

• Hypertension (high blood pressure), mild—Use with caution. May make these conditions worse.

Proper Use of phendimetrazine

Take phendimetrazine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much is taken, it may become habit-forming (causing mental or physical dependence).

phendimetrazine is available in two forms: slow-release capsules and tablets. Ask your doctor which dosage form is right for you.

Carefully follow your doctor's instructions for a reduced-calorie diet plan and regular exercise. Talk with your doctor before starting any exercise program.

Dosing

The dose of phendimetrazine 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 phendimetrazine. 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 treatment of obesity:
  
  • For oral dosage form (slow-release capsules):
    
    • Adults and teenagers—One capsule or 105 milligrams (mg) once a day, taken 30 to 60 minutes before the morning meal.
    
    
    • Children younger than 12 years of age—Use is not recommended.
    
    
  
  
  • For oral dosage form (tablets):
    
    • Adults—One tablet or 35 milligrams (mg) two or three times a day, taken one hour before meals. Your doctor may adjust your dose as needed. However, the dose is usually not more than 2 tablets three times a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of phendimetrazine, 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.

Precautions While Using phendimetrazine

It is very important that your doctor check your progress at regular visits to make sure that phendimetrazine is working properly and does not cause any unwanted effects.

Do not use phendimetrazine if you are also using similar medicines such as benzphetamine, diethylpropion, mazindol, phentermine, Didrex®, or Suprenza™. Also, do not use phendimetrazine if you have used an MAO inhibitor (MAOI) such as Eldepryl®, Marplan®, Nardil®, or Parnate® within the past 14 days. Using these medicines together may cause serious unwanted effects.

Make sure your doctor knows if you are pregnant or planning to become pregnant before using phendimetrazine.

phendimetrazine may be habit-forming. If you think phendimetrazine is not working properly after you have taken it for a few weeks, do not increase the dose. Instead, check with your doctor.

Stop using phendimetrazine and check with your doctor right away if you notice a decrease in your ability to exercise, if you faint, or if you have chest pain, swelling of your feet or lower legs, or trouble with breathing. These may be symptoms of a very serious heart or lung problem.

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

For diabetic patients: phendimetrazine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription and nonprescription (over-the-counter) medicines, dietary supplements, herbal remedies, or medicines for appetite control, asthma, colds, cough, hay fever, and sinus problems.

phendimetrazine 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

• Seeing, hearing, or feeling things that are not there


• severe mental changes

Incidence not known

• Anxiety


• burning while urinating


• difficult or painful urination


• dizziness


• dry mouth


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


• feeling of warmth


• headache


• hyperventilation


• increased need to urinate


• irritability


• nervousness


• numbness or tingling in the arms or legs


• passing urine more often


• redness of the face, neck, arms, and occasionally, upper chest


• restlessness


• shakiness in the legs, arms, hands, or feet


• shortness of breath


• sweating


• trembling or shaking of the hands or feet


• trouble sleeping


• trouble thinking, speaking, or walking


• weakness

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Abdominal or stomach cramps


• blurred vision


• change in consciousness


• convulsions


• diarrhea


• discouragement


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


• fainting


• fast, slow, or irregular heartbeat


• feeling sad or empty


• lack of appetite


• lightheadedness


• loss of consciousness


• loss of interest or pleasure


• nausea


• overactive reflexes


• panic


• physical attempt to injure


• pounding in the ears


• rapid breathing


• sweating


• tiredness


• trouble concentrating


• unusual tiredness or weakness


• violent actions


• vomiting

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

Incidence not known

• Decreased interest in sexual intercourse


• difficulty having a bowel movement (stool)


• inability to have or keep an erection


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


• increased interest in sexual intercourse


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


• sleeplessness


• stomach pain


• 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.

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Phendimetrazine Tartrate

Class: Anorexigenic Agents and Respiratory and Cerebral Stimulants, Miscellaneous
VA Class: GA751
CAS Number: 50-58-8
Brands: Bontril

Introduction

Amphetamine congener;^c anorexigenic agent.^{a b c d f}

Uses for Phendimetrazine Tartrate

Exogenous Obesity

Adjunct to caloric restriction in the short-term management (a few weeks) of exogenous obesity.^{a b c d f}

Use only for short-term monotherapy; not for use in combination with any other drug for weight loss.^{100 120 d}

Phendimetrazine Tartrate Dosage and Administration

General

• 
  

  Teach patient to curtail overeating and consume a suitable diet to help induce and maintain weight loss.^c

  
  

Administration

Oral Administration

Administer conventional tablets orally 2 or 3 times daily, 1 hour before meals.^{b c f}

Administer extended-release capsules orally once daily, 30–60 minutes before the morning meal.^{a c d}

Dosage

Available as phendimetrazine tartrate; dosage expressed in terms of the salt.^{b d f}

Pediatric Patients

Exogenous Obesity

Conventional Tablets

Oral

Children ≥12 years of age: 35 mg 2 or 3 times daily, given 1 hour before meals.^b A dosage of 17.5 mg 2 or 3 times daily may be adequate for some patients.^b

Extended-release Capsules

Oral

Children ≥12 years of age: 105 mg once daily, given 30–60 minutes before the morning meal.^a

Adults

Exogenous Obesity

Conventional Tablets

Oral

35 mg 2 or 3 times daily, given 1 hour before meals.^{b c f} A dosage of 17.5 mg 2 or 3 times daily may be adequate for some patients.^{b f}

Extended-release Capsules

Oral

105 mg once daily, given 30–60 minutes before the morning meal.^{a c d}

Prescribing Limits

Pediatric Patients

Exogenous Obesity

Oral

Children ≥12 years of age: Maximum 70 mg 3 times daily (as conventional tablets).^b

Children ≥12 years of age: Maximum 105 mg once daily (as extended-release capsules).^d

Adults

Exogenous Obesity

Oral

Maximum 70 mg 3 times daily (as conventional tablets).^{b c f}

Maximum 105 mg once daily (as extended-release capsules).^d

Cautions for Phendimetrazine Tartrate

Contraindications

• 
  

  Symptomatic cardiovascular disease, hyperthyroidism, moderate to severe hypertension, pulmonary hypertension, glaucoma, or advanced arteriosclerosis.^{a b c d f}

  
  


• 
  

  Highly nervous or agitated state or history of drug abuse.^{a b c d f}

  
  


• 
  

  Concurrent therapy with other CNS stimulants^{a b c d f} or anorexigenic drugs.^d

  
  


• 
  

  Within 14 days of MAO inhibitor therapy.^c

  
  


• 
  

  Known hypersensitivity or idiosyncrasy to sympathomimetic amines.^{a b c d f}

  
  

Warnings/Precautions

Warnings

Primary Pulmonary Hypertension

Risk of primary pulmonary hypertension (frequently fatal), particularly when used in combination with at least one other anorexigenic agent, or in those with a history of receiving at least one other anorexigenic agent.^{100 d} Risk increased by 23-fold when anorexigenic agents are used for >3 months.^d Increased risk following repeated courses of phendimetrazine cannot be ruled out.^d

Discontinue immediately if new-onset or exacerbation of exertional dyspnea or unexplained symptoms of angina, syncope, or edema of the lower extremities occur, and evaluate for possible pulmonary hypertension.^d

Valvular Heart Disease

Valvular heart disease reported following use of some anorexigenic agents (e.g., fenfluramine, dexfenfluramine [both no longer commercially available in the US]), particularly when used for extended periods of time, at higher than recommended dosages, and/or in combination with other anorexigenic agents.^d

Abnormal heart valve findings have been reported in some patients receiving phendimetrazine.^{c 100 120} Weigh potential risks against benefits of therapy.^d

Consider performing baseline cardiac evaluation to detect preexisting valvular heart diseases prior to initiation of therapy.^d Use not recommended in patients with known heart murmur or valvular heart disease.^d Echocardiogram during and after treatment may be useful for detecting any valvular disorders that may occur.^d

To limit unwarranted exposure and risks, continue therapy only if patient has achieved satisfactory weight loss (e.g., ≥4 pounds [1.8 kg], or as determined by physician and patient) within first 4 weeks of therapy.^d

Tolerance to Anorexigenic Effect

Tolerance to anorexigenic effect usually develops within a few weeks.^{a b d f} When it does, discontinue therapy; do not attempt to increase effect by exceeding recommended dosage.^{a b d f}

CNS Effects

Performance of activities requiring mental alertness or physical coordination may be impaired.^{a b c d f} (See Advice to Patients.)

Abuse Potential

Potential for abuse; habituation or addiction reported with phendimetrazine^c and similar drugs (e.g., amphetamines).^{a b d f}

Manifestations of chronic intoxication may include psychosis resembling schizophrenia, severe dermatoses, marked insomnia, irritability, hyperactivity, and personality changes.^{a b d f}

Abrupt discontinuance following prolonged high dosage may result in extreme fatigue, depression, and sleep EEG changes.^{a b d f}

Sensitivity Reactions

Tartrazine Sensitivity

Some preparations (e.g., 35-mg conventional tablets manufactured by Sandoz) contain tartrazine (FD&C yellow No. 5), which may cause allergic reactions including bronchial asthma in susceptible individuals.^f Incidence of tartrazine sensitivity is low, but it frequently occurs in patients who are sensitive to aspirin.^f

General Precautions

Prescribe and dispense in the smallest feasible quantity to minimize possibility of overdosage.^{a b d f}

Hypertension

Use with caution in patients with mild hypertension;^{a b c d f} monitor BP closely.^c Contraindicated in those with moderate or severe hypertension.^{a b c d f}

Diabetes Mellitus

Use with caution in patients with diabetes mellitus; insulin requirements may decrease in association with phendimetrazine use and the concomitant dietary regimen and weight loss.^c

Specific Populations

Pregnancy

Category C.^{d e}

Whether potential benefits of anorexigenic agents outweigh risks is questionable; use of these agents during pregnancy (especially during the first trimester) probably should be considered a contraindication.^c

Lactation

Not known whether phendimetrazine is distributed into milk;^d however, because of its low molecular weight, the drug is expected to distribute into milk.^e Caution if used in nursing women.^d

Pediatric Use

Use not recommended in children <12 years of age.^{a b c f}

Common Adverse Effects

Palpitation, tachycardia, increased BP, overstimulation, restlessness, dizziness, insomnia, agitation, flushing, tremor, sweating, headache, psychosis, blurred vision, dry mouth, diarrhea, constipation, nausea, stomach pain, changes in libido, urinary frequency, dysuria.^{a b c d f}

Interactions for Phendimetrazine Tartrate

Specific Drugs

Drug	Interaction	Comments
Anorexigenic agents	Risk of serious cardiac problemsd	Avoid concomitant use (including with OTC drugs or herbal preparations) (see Contraindications under Cautions); phendimetrazine not recommended for patients who used any anorexigenic agents within prior yeard
CNS stimulants		Concomitant use contraindicateda b d f
Guanethidine (no longer commercially available in the US)	Decreased hypotensive effecta b c d
Insulin	Possible decrease in insulin requirements in patients with diabetes mellitusc	Use concomitantly with cautionc
MAO inhibitors	Potential for hypertensive crisisa b c d f	Phendimetrazine use during or within 14 days of MAO inhibitor use is contraindicatedc

Phendimetrazine Tartrate Pharmacokinetics

Absorption

Bioavailability

Readily absorbed from the GI tract following oral administration.^c

Duration

Effects persist for about 4 hours.^c

Extended-release capsules produce prolonged therapeutic effect.^a Effects achieved with one 105-mg extended-release capsule are similar to those achieved with three 35-mg conventional tablets administered at 4-hour intervals.^{a d}

Distribution

Extent

Not known whether phendimetrazine is distributed into milk;^d however, because of its low molecular weight, the drug is expected to distribute into milk.^e

Elimination

Metabolism

Undergoes limited biotransformation.^{a d}

Elimination Route

Excreted principally in urine.^{a d}

Half-life

Conventional tablets: Approximately 1.9–3.7 hours.^{a d}

Extended-release capsules: Approximately 3.7–9.8 hours.^{a d}

Stability

Storage

Oral

Conventional Tablets and Extended-release Capsules

Tight, light-resistant containers^f at 20–25°C.^{a b d f} Protect from moisture.^{d f}

ActionsActions

• 
  

  Produces anorexigenic effect and loss of weight.^{a b c d f}

  
  


• 
  

  Like other amphetamine derivatives, has no primary effect on appetite;^{a b c d f} anorexigenic action probably is secondary to CNS stimulation.^c

  
  

Advice to Patients

• 
  

  Potential for drug to impair mental alertness or physical coordination; caution when driving or operating machinery until effects on individual are known.^{a b c d f}

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses (e.g., glaucoma, high BP, cardiac disease).^{a b d f}

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^{a b d f}

  
  


• 
  

  Importance of informing patients of other important precautionary information.^{a b d f} (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Subject to control under the Federal Controlled Substances Act of 1970 as a schedule III (C-III) drug.^{a b c d f}

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Phendimetrazine Tartrate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules, extended-release	105 mg*	Bontril Slow Release (C-III)	Valeant
			Phendimetrazine Tartrate Extended-release Capsules (C-III; with povidone)	Sandoz
	Tablets	35 mg*	Bontril PDM (C-III; with isopropyl alcohol and povidone; scored)	Valeant
			Phendimetrazine Tartrate Tablets (C-III; with povidone)	RLC, Sandoz

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions February 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

Only references cited for selected revisions after 1984 are available electronically.

100. Wyeth-Ayerst. Dear health care professional letter regarding valvular irregularities and primary pulmonary hypertension associated with the use of Plegine. Philadelphia, PA Wyeth-Ayerst; 1998 Jun 15.

101. Deitch MW. Dear health care provider letter: Pondimin and Redux to be voluntarily withdrawn. Philadelphia, PA: Wyeth-Ayerst; 1997 Sep 15.

102. Wyeth-Ayerst. Pondimin and Redux to be voluntarily withdrawn. Philadelphia, PA: 1997 Sep 15. Press release.

103. Lumpkin MM. FDA public health advisory: reports of valvular heart disease in patients receiving concomitant fenfluramine and phentermine. Rockville, MD: Food and Drug Administration; 1997 Jul 8.

104. Connolly HM, Crary JL, McGoon MD et al. Valvular heart disease associated with fenfluramine-phentermine. N Engl J Med. 1997; 337:581-8. [IDIS 391136] [PubMed 9271479]

105. Anon. FDA steps up campaign to discourage off-label “fen/phen” use with public health advisory; agency coordinates message with NEJM, Mayo clinic. FDC Rep. 1997; (Jul 14):4-5.

106. Anon. Knoll Meridia studies continue after Redux, Pondimin withdrawal: lawsuits call for Wyeth to fund medical monitoring of patients exposed to drugs. FDC Rep. 1997; (Sep 22):5.

107. US Food and Drug Administration. Questions and answers about Phen/fen and valvular heart disease. Rockville, MD; 1997 July 8.

108. Plutowski S (Mayo Foundation for Medical Education and Research). Valvular heart disease associated with commonly prescribed diet pills. Rochester, MN; 1997 Jul 8. Press release from website ().

109. Mayo Foundation for Medical Education and Research. Information for physicians regarding pharmacologic therapy for obesity. Rochester, MN; 1997 Jul 7. Press release from website ().

110. Mayo Foundation for Medical Education and Research. Heart valve disease and fen-phen: NEJM waives embargo for Mayo Clinic announcement. Rochester, MN; 1997 Jul 8. Press release from website ().

111. Anon. FDA fenfluramine/Redux epidemiological analysis of HMO records supports findings of valvulopathy in asymptomatic patients reported from five surveys. FDC Rep. 1997; (Sep 15):3-5.

112. Connolly HM, Crary JL, McGoon MD et al. for the Mayo Foundation for Medical Education and Research. Valvular heart disease associated with fenfluramine-phentermine. Rochester, MN; 1997 Jul 8.

113. Mayo Foundation for Medical Education and Research. Information and recommendations for people taking fenfluramine and phentermine. Rochester, MN; 1997 Jul 8.

114. Graham DJ, Green L. Further cases of valvular heart disease associated with fenfluramine-phentermine. N Engl J Med. 1997; 337:635. [IDIS 391141] [PubMed 9280830]

115. Centers for Disease Control and Prevention. Cardiac valvulopathy associated with exposure to fenfluramine or dexfenfluramine: U.S. Department of Health and Human Services interim public health recommendations, November 1997. MMWR Morb Mortal Wkly Rep. 1997; 46:1061-6. [IDIS 395477] [PubMed 9385873]

116. Medeva. Ionamin (C-IV) (phentermine resin capsules) prescribing information. Rochester, NY; 1997 Oct.

117. Coyne CT. Dear health care professional letter regarding labeling changes of Ionamin (phentermine resin capsules). Rochester, NY: Medeva; 1997 Aug 8.

118. Coyne CT. Dear doctor or health care professional letter regarding appropriate use of Ionamin (phentermine resin capsules). Rochester, NY: Medeva; 1997 Sep 18.

119. SoRelle R. Fen-phen and risk of valvular disease. Circulation. 1997; 96:1705-6. [PubMed 9323046]

120. Wyeth-Ayerst. Plegine (phendimetrazine tartrate tablets) prescribing information. In: Physicians’ desk reference. 52nd ed. Montvale, NJ: Medical Economics Company Inc; 1998(Suppl A):A304.

a. Valeant Pharmaceuticals International. Bontril (phendimetrazine tartrate) slow-release capsules prescribing information. Costa Mesa, CA; 2004 Sep.

b. Valeant Pharmaceuticals International. Bontril PDM (phendimetrazine tartrate) tablets prescribing information. Costa Mesa, CA; 2004 Sep.

c. AHFS Drug Information 2007. McEvoy GK, ed. Phendimetrazine tartrate. Bethesda, MD: American Society of Health-System Pharmacists; 2007:2496-7.

d. Sandoz Inc. Phendimetrazine tartrate extended-release capsules prescribing information. Princeton, NJ; 2006 Mar.

e. Phendimetrazine. In: Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation. 7th ed. Philadelphia, PA: Lippincott Williams & Wilkins, 2005:1276.

f. Sandoz Inc. Phendimetrazine tartrate tablets prescribing information. Princeton, NJ; 2006 Mar.

More Phendimetrazine Tartrate resources

• Phendimetrazine Tartrate Side Effects (in more detail)
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• Phendimetrazine Tartrate Support Group
• 87 Reviews for Phendimetrazine Tartrate - Add your own review/rating

• Phendimetrazine Prescribing Information (FDA)


• Adipost Concise Consumer Information (Cerner Multum)


• Bontril PDM Advanced Consumer (Micromedex) - Includes Dosage Information


• Bontril PDM MedFacts Consumer Leaflet (Wolters Kluwer)

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Phenadoz

promethazine hydrochloride

Dosage Form: suppository
Phenadoz®

Promethazine HCl

Suppositories USP

Phenadoz Description

Each rectal suppository of Phenadoz contains 12.5 mg or 25 mg promethazine HCl with ascorbyl palmitate, colloidal silicon dioxide, white wax, and cocoa butter. Phenadoz Suppositories are for rectal administration only.

Promethazine HCl is a racemic compound; the empirical formula is C17H20N2S•HCl and its molecular weight is 320.88.

Promethazine HCl, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride,(±)- with the following structural formula:

Promethazine HCl occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol.

Phenadoz - Clinical Pharmacology

Promethazine is a phenothiazine derivative which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties.

Promethazine is an H1 receptor blocking agent. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects.

Promethazine is well absorbed from the gastrointestinal tract. Clinical effects are apparent within 20 minutes after oral administration and generally last four to six hours, although they may persist as long as 12 hours. Promethazine is metabolized by the liver to a variety of compounds; the sulfoxides of promethazine and N-demethylpromethazine are the predominant metabolites appearing in the urine.

Indications and Usage for Phenadoz

Phenadoz is useful for:

Perennial and seasonal allergic rhinitis.

Vasomotor rhinitis.

Allergic conjuctivitis due to inhalant allergens and foods.

Mild, uncomplicated allergic skin manifestations of urticaria and angioedema.

Amelioration of allergic reactions to blood or plasma.

Dermographism.

Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled.

Preoperative, postoperative, or obstetric sedation.

Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.

Therapy adjunctive to meperidine or other analgesics for control of post-operative pain.

Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused.

Active and prophylactic treatment of motion sickness.

Antiemetic therapy in postoperative patients.

Contraindications

Phenadoz suppositories are contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines.

Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms including asthma.

Warnings

WARNING:

PROMETHAZINE HCL SUPPOSITORIES, USP SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION.

POSTMARKETING CASES OF RESPIRATORY DEPRESSION, INCLUDING FATALITIES, HAVE BEEN REPORTED WITH USE OF PROMETHAZINE HCL SUPPOSITORIES, USP IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HCL SUPPOSITORIES, USP HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS.

CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HCL IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. IT IS RECOMMENDED THAT THE LOWEST EFFECTIVE DOSE OF PROMETHAZINE HCL BE USED IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER AND CONCOMITANT ADMINISTRATION OF OTHER DRUGS WITH RESPIRATORY DEPRESSANT EFFECTS BE AVOIDED.

CNS Depression

Phenadoz Suppositories may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. The impairment may be amplified by concomitant use of other central-nervous-system depressants such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore such agents should either be eliminated or given in reduced dosage in the presence of promethazine HCl (see PRECAUTIONS–Information for Patients and Drug Interactions).

Respiratory Depression

Phenadoz Suppositories may lead to potentially fatal respiratory depression.

Use of Phenadoz Suppositories in patients with compromised respiratory function (e.g. COPD, sleep apnea) should be avoided.

Lower Seizure Threshold

Phenadoz may lower seizure threshold. It should be used with caution in persons with seizure disorders or in persons who are using concomitant medications, such as narcotics or local anesthetics, which may also affect seizure threshold.

Bone-Marrow Depression

Phenadoz Suppositories should be used with caution in patients with bone-marrow depression. Leukopenia and agranulocytosis have been reported, usually when promethazine HCl has been used in association with other known marrow-toxic agents.

Neuroleptic Malignant Syndrome

A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with promethazine HCl alone or in combination with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmias).

The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g. pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology.

The management of NMS should include 1) immediate discontinuation of promethazine HCl, antipsychotic drugs, if any, and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS.

Since recurrences of NMS have been reported with phenothiazines, the reintroduction of promethazine HCl should be carefully considered.

Use in Pediatric Patients

PROMETHAZINE HCL SUPPOSITORIES, USP ARE CONTRAINDICATED FOR THE USE IN PEDIATRIC PATIENTS LESS THAN TWO YEARS OF AGE.

CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HCL SUPPOSITORIES, USP TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. RESPIRATORY DEPRESSION AND APNEA, SOMETIMES ASSOCIATED WITH DEATH, ARE STRONGLY ASSOCIATED WITH PROMETHAZINE PRODUCTS AND NOT FIRMLY WEIGHT-RELATED, WHICH MIGHT OTHERWISE PERMIT SAFE ADMINISTRATION OF INDIVIDUALIZED DOSING. CONCOMITANT ADMINISTRATION OF PROMETHAZINE PRODUCTS WITH OTHER RESPIRATORY DEPRESSANTS HAS AN ASSOCIATION WITH RESPIRATORY DEPRESSION, AND SOMETIMES DEATH, IN PEDIATRIC PATIENTS.

ANTIEMETICS ARE NOT RECOMMENDED FOR TREATMENT OF UNCOMPLICATED VOMITING IN PEDIATRIC PATIENTS, AND THEIR USE SHOULD BE LIMITED TO PROLONGED VOMITING OF KNOWN ETIOLOGY. THE EXTRAPYRAMIDAL SYMPTOMS WHICH CAN OCCUR SECONDARY TO PROMETHAZINE HCL SUPPOSITORIES, USP ADMINISTRATION MAY BE CONFUSED WITH THE CNS SIGNS OF UNDIAGNOSED PRIMARY DISEASE, E.G., ENCEPHALOPATHY OR REYE'S SYNDROME. THE USE OF PROMETHAZINE HCL SUPPOSITORIES, USP SHOULD BE AVOIDED IN PEDIATRIC PATIENTS WHOSE SIGNS AND SYMPTOMS MAY SUGGEST REYE'S SYNDROME OR OTHER HEPATIC DISEASES.

Excessively large dosages of antihistamines, including Phenadoz Suppositories, in pediatric patients may cause sudden death (See OVERDOSAGE). Hallucinations and convulsions have occurred with therapeutic doses and overdoses of promethazine HCl in pediatric patients. In pediatric patients who are acutely ill associated with dehydration, there is an increased susceptibility to dystonias with the use of promethazine HCl.

Other Considerations

Administration of promethazine HCl has been associated with reported cholestatic jaundice.

Precautions

General

Drugs having anticholinergic properties should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, and bladder-neck obstruction.

Phenadoz Suppositories should be used cautiously in persons with cardiovascular disease or with impairment of liver function.

Information for Patients

Phenadoz Suppositories may cause marked drowsiness or impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. The use of alcohol or other central-nervous-system depressants such as sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers, may enhance impairment (see WARNINGS – CNS Depression and PRECAUTIONS – Drug Interactions). Pediatric patients should be supervised to avoid potential harm in bike riding or in other hazardous activities.

Patients should be advised to report any involuntary muscle movements.

Avoid prolonged exposure to the sun.

Drug Interactions

CNS Depressants - Phenadoz Suppositories may increase, prolong, or intensify the sedative action of other central-nervous-system depressants, such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should be avoided or administered in reduced dosage to patients receiving promethazine HCl. When given concomitantly with Phenadoz Suppositories, the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half. Dosage must be individualized. Excessive amounts of promethazine HCl relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control of the pain.

Epinephrine - Because of the potential for Phenadoz to reverse epinephrine's vasopressor effect, epinephrine should NOT be used to treat hypotension associated with Phenadoz Suppositories overdose.

Anticholinergics - Concomitant use of other agents with anticholinergic properties should be undertaken with caution.

Monoamine Oxidase Inhibitors (MAOI) - Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. This possibility should be considered with Phenadoz Suppositories.

Drug/Laboratory Test Interactions

The following laboratory tests may be affected in patients who are receiving therapy with promethazine HCl:

Pregnancy Tests

Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations.

Glucose Tolerance Test

An increase in blood glucose has been reported in patients receiving promethazine HCl.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long term animal studies have not been performed to assess the carcinogenic potential of promethazine, nor are there other animal or human data concerning carcinogenicity, mutagenicity, or impairment of fertility with this drug. Promethazine was nonmutagenic in the Salmonella test system of Ames.

Pregnancy

Teratogenic Effects-Pregnancy Category C

Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of promethazine HCl. These doses are from approximately 2.1 to 4.2 times the maximum recommended total daily dose of promethazine for a 50-kg subject, depending upon the indication for which the drug is prescribed. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats.

Specific studies to test the action of the drug on parturition, lactation, and development of the animal neonate were not done, but a general preliminary study in rats indicated no effect on these parameters. Although antihistamines have been found to produce fetal mortality in rodents, the pharmacological effects of histamine in the rodent do not parallel those in man.There are no adequate and well-controlled studies of Phenadoz Suppositories in pregnant women.

Phenadoz Suppositories should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects

Phenadoz Suppositories administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn.

Labor and Delivery

Promethazine HCl may be used alone or as an adjunct to narcotic analgesics during labor (See DOSAGE AND ADMINISTRATION). Limited data suggest that use of promethazine HCl during labor and delivery does not have an appreciable effect on the duration of labor or delivery and does not increase the risk of need for intervention in the newborn. The effect on later growth and development of the newborn is unknown. (See also Nonteratogenic Effects.)

Nursing Mothers

It is not known whether promethazine HCl 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 Phenadoz Suppositories, 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

Safety and effectiveness in children under 2 years of age have not been established.

Phenadoz Suppositories should be used with caution in pediatric patients 2 years of age and older (see WARNINGS - Use in Pediatric Patients).

Geriatric Use

Clinical studies of promethazine HCl suppositories USP 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.

Sedating drugs may cause confusion and oversedation in the elderly; elderly patients generally should be started on low doses of Phenadoz Suppositories and observed closely.

Adverse Reactions

Central Nervous System

Drowsiness is the most prominent CNS effect of this drug. Sedation, somnolence, blurred vision, dizziness; confusion, disorientation, and extrapyramidal symptoms such as oculogyric crisis, torticollis, and tongue protrusion; lassitude, tinnitus, incoordination, fatigue, euphoria, nervousness, diplopia, insomnia, tremors, convulsive seizures, excitation, catatonic-like states, hysteria. Hallucinations have also been reported.

Cardiovascular–Increased or decreased blood pressure, tachycardia, bradycardia, faintness.

Dermatologic–Dermatitis, photosensitivity, urticaria.

Hematologic-Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis.

Gastrointestinal-Dry mouth, nausea, vomiting, jaundice.

Respiratory–Asthma, nasal stuffiness, respiratory depression (potentially fatal) and apnea (potentially fatal). (See WARNINGS– Respiratory Depression).

Other-Angioneurotic edema. Neuroleptic malignant syndrome (potentially fatal) has also been reported. (See WARNINGS- Neuroleptic Malignant Syndrome.)

Paradoxical Reactions

Hyperexcitability and abnormal movements have been reported in pediatric patients following a single administration of promethazine HCl. Consideration should be given to the discontinuation of promethazine HCl and to the use of other drugs if these reactions occur. Respiratory depression, nightmares, delirium, and agitated behavior have also been reported in some of these patients.

Overdosage

Signs and symptoms of overdosage with promethazine HCl range from mild depression of the central nervous system and cardiovascular system to profound hypotension, respiratory depression, unconsciousness, and sudden death. Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis, and extensor-plantar reflexes (Babinski reflex).

Stimulation may be evident, especially in children and geriatric patients. Convulsions may rarely occur. A paradoxical-type reaction has been reported in children receiving single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares.

Atropine-like signs and symptoms– dry mouth, fixed, dilated pupils, flushing, as well as gastrointestinal symptoms, may occur.

Treatment

Treatment of overdosage is essentially symptomatic and supportive. Only in cases of extreme overdosage or individual sensitivity do vital signs, including respiration, pulse, blood pressure, temperature, and EKG, need to be monitored. Activated charcoal orally or by lavage may be given, or sodium or magnesium sulfate orally as a cathartic. Attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. Diazepam may be used to control convulsions. Acidosis and electrolyte losses should be corrected. Note that any depressant effects of promethazine HCl are not reversed by naloxone. Avoid analeptics which may cause convulsions.

The treatment of choice for resulting hypotension is administration of intravenous fluids, accompanied by repositioning if indicated. In the event that vasopressors are considered for the management of severe hypotension which does not respond to intravenous fluids and repositioning, the administration of norepinephrine or phenylephrine should be considered. EPINEPHRINE SHOULD NOT BE USED, since its use in patients with partial adrenergic blockade may further lower the blood pressure. Extrapyramidal reactions may be treated with anticholinergic antiparkinson agents, diphenhydramine, or barbiturates. Oxygen may also be administered.

Limited experience with dialysis indicates that it is not helpful.

Phenadoz Dosage and Administration

Promethazine HCl Rectal Suppositories, USP are contraindicated for children under 2 years of age (see WARNINGS- Use in Pediatric Patients).

Phenadoz Suppositories are for rectal administration only.

Allergy

The average dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary. Single 25-mg doses at bedtime or 6.25 to 12.5 mg taken three times daily will usually suffice. After initiation of treatment in children or adults, dosage should be adjusted to the smallest amount adequate to relieve symptoms. The administration of promethazine hydrochloride in 25-mg doses will control minor transfusion reactions of an allergic nature.

Motion Sickness

The average adult dose is 25 mg taken twice daily. The initial dose should be taken one-half to one hour before anticipated travel and be repeated 8 to 12 hours later, if necessary. On succeeding days of travel, it is recommended that 25 mg be given on arising and again before the evening meal. For children, Phenadoz Suppositories, 12.5 to 25 mg, twice daily, may be administered.

Nausea and Vomiting

Antiemetics should not be used in vomiting of unknown etiology in children and adolescents (see WARNINGS- Use in Pediatric Patients).

The average effective dose of Phenadoz for the active therapy of nausea and vomiting in children or adults is 25 mg. 12.5- to 25-mg doses may be repeated, as necessary, at 4 to 6 hour intervals.

For nausea and vomiting in children, the usual dose is 0.5 mg per pound of body weight, and the dose should be adjusted to the age and weight of the patient and the severity of the condition being treated.

For prophylaxis of nausea and vomiting, as during surgery and the postoperative period, the average dose is 25 mg repeated at 4- to 6-hour intervals, as necessary.

Sedation

This product relieves apprehension and induces a quiet sleep from which the patient can be easily aroused. Administration of 12.5 to 25 mg Phenadoz by rectal suppository at bedtime will provide sedation in children. Adults usually require 25 to 50 mg for nighttime, presurgical, or obstetrical sedation.

Pre- and Postoperative Use

Phenadoz in 12.5- to 25-mg doses for children and 50-mg doses for adults the night before surgery relieves apprehension and produces a quiet sleep.

For preoperative medication children require doses of 0.5 mg per pound of body weight in combination with an appropriately reduced dose of narcotic or barbiturate and the appropriate dose of an atropine-like drug. Usual adult dosage is 50 mg Phenadoz with an appropriately reduced dose of narcotic or barbiturate and the required amount of a belladonna alkaloid.

Postoperative sedation and adjunctive use with analgesics may be obtained by the administration of 12.5 to 25 mg in children and 25-to 50-mg doses in adults.

Phenadoz Rectal Suppositories are not recommended for children under 2 years of age.

How is Phenadoz Supplied

Phenadoz® (promethazine HCl) Rectal Suppositories USP are available in boxes of 12 as follows:

12.5 mg, ivory, torpedo-shaped suppository contained in plastic packet, NDC 0574-7236-12.

25 mg, ivory, torpedo-shaped suppository contained in plastic packet, NDC 0574-7234-12.

Store refrigerated between 2°C- 8°C (36°F- 46°F).

Dispense in well-closed container.

Manufactured by:

Paddock Laboratories, Inc.

Minneapolis, MN 55427

(07-05)

PRINCIPAL DISPLAY PANEL - 12.5 mg Suppository Packet

Phenadoz®

Promethazine HCl Suppository USP, 12.5 mg

(01)10305747236123

Paddock Laboratories, Inc.

Minneapolis, MN 55427

PRINCIPAL DISPLAY PANEL - 12.5 mg Suppository Carton

NDC 0574-7236-12

Phenadoz®

Promethazine HCl

Suppositories, USP

12.5 mg

FOR RECTAL USE ONLY.

Paddock

Laboratories, Inc.

Rx only

UNIT DOSE

12

RECTAL

SUPPOSITORIES

PRINCIPAL DISPLAY PANEL - 25 mg Suppository Packet

Phenadoz®

Promethazine HCl Suppository USP, 25 mg

(01)10305747234129

Paddock Laboratories, Inc.

Minneapolis, MN 55427

PRINCIPAL DISPLAY PANEL - 25 mg Suppository Carton

NDC 0574-7234-12

Phenadoz®

Promethazine HCl

Suppositories, USP

25mg

FOR RECTAL USE ONLY.

Paddock

Laboratories, Inc.

Rx only

UNIT DOSE

12

RECTAL

SUPPOSITORIES

Phenadoz  promethazine hydrochloride  suppository

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0574-7236 Route of Administration RECTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength promethazine hydrochloride (promethazine) promethazine 12.5 mg

Inactive Ingredients Ingredient Name Strength ascorbyl palmitate   silicon dioxide   white wax   cocoa butter

Product Characteristics Color WHITE (Ivory) Score      Shape BULLET (Torpedo) Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0574-7236-12 12 PACKET In 1 BOX contains a PACKET 1 1 SUPPOSITORY In 1 PACKET This package is contained within the BOX (0574-7236-12)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040479	06/24/2003

Phenadoz  promethazine hydrochloride  suppository

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0574-7234 Route of Administration RECTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength promethazine hydrochloride (promethazine) promethazine 25 mg

Inactive Ingredients Ingredient Name Strength ascorbyl palmitate   silicon dioxide   white wax   cocoa butter

Product Characteristics Color WHITE (Ivory) Score      Shape BULLET (Torpedo) Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0574-7234-12 12 PACKET In 1 BOX contains a PACKET 1 1 SUPPOSITORY In 1 PACKET This package is contained within the BOX (0574-7234-12)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040479	06/24/2003

Labeler - Paddock Laboratories, Inc. (086116803)

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

Revised: 08/2009Paddock Laboratories, Inc.

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Compare Phenadoz with other medications

• Allergic Reactions
• Anaphylaxis
• Hay Fever
• Light Sedation
• Motion Sickness
• Nausea/Vomiting
• Opiate Adjunct
• Sedation
• Urticaria
• Vertigo

Phenobarbital

Class: Barbiturates
VA Class: CN301
CAS Number: 50-06-6
Brands: Luminal

Introduction

Barbiturate;^{a b c d} anxiolytic, sedative, hypnotic, and anticonvulsant.^{a b f}

Uses for Phenobarbital

Insomnia and Anxiety

Relief of anxiety, tension, and apprehension.^{c d} However, barbiturates used infrequently for routine sedation, since there are few clinical situations in which oral barbiturates provide a safety or efficacy advantage over nonbarbiturate sedatives/hypnotics.^f

Short-term treatment of insomnia.^{c d} However, generally not used orally as a hypnotic because several hours are required to achieve maximal effects^a and barbiturates have decreased effectiveness for sleep induction and maintenance after 2 weeks.^d

Drug Withdrawal

Withdrawal of barbiturate or nonbarbiturate hypnotics in patients who are physically dependent on these drugs.^a

Surgery

Preoperatively, to produce sedation and relieve anxiety.^{a c}

Seizure Disorders

Management of tonic-clonic seizures and partial seizures; used alone (particularly in infants and young children) or, more commonly, in combination with phenytoin or other anticonvulsants.^b

Prevention of febrile seizures in infants and young children.^b

Second-line agent in the termination of status epilepticus; may be useful to prevent seizure recurrence after seizures are initially terminated with other anticonvulsants (e.g., diazepam, phenytoin) or for termination of status epilepticus that does not respond to initial therapy with other anticonvulsants.^{b c} Usefulness of parenteral phenobarbital in terminating acute seizure episodes is limited by its slow onset of action.^{a b d}

Prophylactic management of epilepsy.^{c d}

Hyperbilirubinemia in Neonates

Prevention and treatment of hyperbilirubinemia in neonates†.^a

Cholestasis

Has been used to reduce bilirubin concentrations in patients with congenital nonhemolytic unconjugated hyperbilirubinemia† or chronic intrahepatic cholestasis†.^a

Has been used in the management of hyperlipemia associated with intrahepatic and extrahepatic cholestasis†.^a

Phenobarbital Dosage and Administration

General

• 
  

  Adjust dosage carefully and slowly according to individual requirements and response.^{a b}

  
  


• 
  

  Following chronic administration, withdraw phenobarbital slowly to avoid the possibility of precipitating withdrawal symptoms if the patient is physically dependent on the drug.^{a d}

  
  


• 
  

  To prevent rebound in rapid eye movement (REM) sleep, withdrawal of a single therapeutic dose over 5 or 6 days (e.g., reducing dosage from 3 to 2 doses daily for 1 week) has been recommended when barbiturates are discontinued following prolonged use.^a

  
  

Seizures

• 
  

  2–3 weeks of therapy may be required to achieve full anticonvulsant effects.^b

  
  


• 
  

  When transferring a patient to another anticonvulsant drug, reduce phenobarbital dosage gradually over 1 week while, at the same time, instituting therapy with a low dose of the replacement drug.^b

  
  


• 
  

  Withdraw phenobarbital or reduce dosage slowly to avoid precipitating seizures or status epilepticus.^b

  
  

Insomnia

• 
  

  Do not administer for periods >2 weeks.^a

  
  

Administration

Administer orally or by IM or slow IV injection.^{a b c d} Sub-Q injection not recommended.^{a d}

Oral Administration

Frequently administered in 2 or 3 divided doses;^a however, there is no advantage in dividing the daily dosage (because of the long half-life).^{a b}

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Reserve IV administration for emergency treatment of acute seizure states; however, usefulness in these conditions is limited.^{a b} (See Seizure Disorders under Uses.)

Patient should be hospitalized and under close supervision.^a

To minimize the risk of irritation and thrombosis, do not use small veins (e.g., those on the dorsum of the hands or wrist).^d

Avoid intra-arterial injection.^b (See Intra-arterial Injection under Cautions.)

Rate of Administration

≤60 mg/minute.^{a b d}

IM Administration

Maximum volume of single injections is 5 mL; administer deeply into a large muscle to avoid tissue irritation.^d

Dosage

Available as phenobarbital sodium; dosage expressed in terms of the salt.^d

Pediatric Patients

Anxiety

Oral

6 mg/kg daily or 180 mg/m² daily, in 3 equally divided doses.^{a c}

Surgery

Oral

1–3 mg/kg preoperatively.^{a d}

IM

16–100 mg administered 60–90 minutes before surgery;^a alternatively, 1–3 mg/kg preoperatively.^{a d}

Drug Withdrawal

Oral

Infants: 3–10 mg/kg daily.^a After symptoms are relieved, decrease dosage gradually and withdraw drug completely over a 2-week period.^a

Seizure Disorders

Oral

15–50 mg 2 or 3 times daily.^c Alternatively, 3–5 mg/kg or 125 mg/m² daily.^b

IV or IM

4–6 mg/kg daily for 7–10 days to reach therapeutic blood concentrations; alternatively, 10–15 mg/kg daily.^d

Prevention of Febrile Seizures

Oral

3–4 mg/kg daily.^b

Status Epilepticus

IV or IM

15–20 mg/kg IV over 10–15 minutes.^d Alternatively 100–400 mg IM or IV; allow up to 30 minutes for maximum anticonvulsant effect before administering additional doses (to prevent overdosage).^b

Hyperbilirubinemia in Neonates†

Oral

7 mg/kg per day from the first to fifth day of life.^a

IM, then Oral

5 mg/kg IM on the first day of life, followed by 5 mg/kg orally on the second to seventh day.^a

Cholestasis†

Oral

Children <12 years of age: Dosages of 3–12 mg/kg daily in 2 or 3 divided doses have been used.^a

Adults

Insomnia and Anxiety

Anxiety

Oral

30–120 mg daily.^c

Insomnia

Oral

100–320 mg.^c

IM

100–320 mg.^{c d}

Drug Withdrawal

Oral

30-mg dose for each 100- to 200-mg dose of the barbiturate or nonbarbiturate hypnotic that the patient has been taking daily, administered in 3 or 4 divided doses.^a If the patient shows signs of withdrawal on the first day, a loading dose of 100–200 mg of phenobarbital sodium may be administered IM in addition to the oral dose.^a

After stabilization on phenobarbital sodium, decrease the total daily dose of phenobarbital sodium by 30 mg per day.^a After withdrawal symptoms are relieved, gradually decrease dosage and withdraw completely over a 2-week period.^a

Surgery

IM

100–200 mg given 60–90 minutes before surgery.^{a d}

Seizure Disorders

Oral

100–300 mg daily,^{b c} usually at bedtime.^b

Status Epilepticus

IV or IM

20–320 mg; repeat in 6 hours, if necessary.^d Alternatively, 200–600 mg; allow up to 30 minutes for maximum anticonvulsant effect before administering additional doses (to prevent overdosage).^b

Some clinicians administer phenobarbital sodium IV until seizures stop or a total dose of 20 mg/kg has been given.^{a b} Discontinue IV injections as soon as the desired effect is obtained.^b

Cholestasis†

Oral

Dosages of 90–180 mg daily in 2 or 3 divided doses have been used.^a

Special Populations

Hepatic Impairment

Dosage reduction recommended in patients with hepatic impairment;^{c d e} avoid use in patients with marked hepatic impairment.^{c d}

Renal Impairment

Dosage reduction recommended.^{d e}

Geriatric Patients

Dosage reduction recommended.^{d e f}

Cautions for Phenobarbital

Contraindications

• 
  

  Known hypersensitivity to any barbiturates.^{c d}

  
  


• 
  

  Respiratory disease in which dyspnea or obstruction is evident.^{c d}

  
  


• 
  

  Marked impairment of hepatic function.^{c d}

  
  


• 
  

  History of manifest or latent porphyria^{c d} (due to potential for exacerbation of acute intermittent porphyria or porphyria variegata).^f

  
  


• 
  

  Previous addiction to sedative and/or hypnotic drugs.^{c d}

  
  

Warnings/Precautions

Warnings

Pain Reaction

Potential for paradoxical excitement and/or euphoria, restlessness, or delirium in patients with severe pain.^f Barbiturates could mask important symptoms in patients with acute or chronic pain.^{d f} Use with caution in such patients.^{d f} Should not be used to relieve pain or to produce sedation or sleep in the presence of uncontrolled pain.^{c f}

Abuse Potential

Possible tolerance, psychologic dependence, and physical dependence.^{c d} (See Contraindications under Cautions.)

WIthdrawal Effects

Abrupt cessation after prolonged use in dependent individuals may result in withdrawal symptoms (e.g., delirium, convulsions) and potentially be fatal.^{c d} Drug must be withdrawn gradually in patients receiving excessive dosages over extended periods of time.^d

CNS Depression

Performance of activities requiring mental alertness and physical coordination may be impaired.^{c d}

Concurrent use of other CNS depressants may potentiate CNS depression.^{c d} (See Specific Drugs under Interactions.)

Respiratory and Cardiovascular Effects

Possible respiratory depression, apnea, laryngospasm, hypertension, or vasodilation and hypotension, particularly if phenobarbital is administered IV too rapidly.^{d f} Administer slowly; personnel and equipment should be readily available for administration of artificial respiration.^{d f}

Sensitivity Reactions

Dermatologic Effects and Hypersensitivity Reactions

Exfolative dermatitis (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis), sometimes fatal, reported rarely.^{b c d} Because skin eruptions can precede potentially fatal reactions, discontinue phenobarbital whenever dermatologic reactions occur.^{d f}

Hypersensitivity reactions (e.g., localized swelling, particularly of the eyelids, cheeks, or lips; erythematous dermatitis) may occur, particularly in patients with a history of asthma, urticaria, or angioedema.^c

General Precautions

Intra-arterial Injection

Inadvertent intra-arterial administration can cause spasm and severe pain along the affected artery, resulting in local reactions varying in severity from transient pain to gangrene.^d

Discontinue injection if the patient complains of pain or if signs of inadvertent intra-arterial injection (e.g., patches of discolored skin, a white hand with cyanosed skin, delayed onset of action) occur.^{b d} Appropriate therapy for such inadvertent injection has not been fully established; consult manufacturers’ labeling for current recommendations.^{b d}

Suicide

Use with caution, if at all, in depressed patients; potential for suicidal tendencies.^{c d f} Prescribe drug in the smallest feasible quantity.^c

Concomitant Diseases

Use parenterally with extreme caution in debilitated patients or patients with severe hepatic impairment, pulmonary or cardiac disease, status asthmaticus, uremia, or shock.^{d f}

Specific Populations

Pregnancy

Tablets: Category B.^c Injection: Category D.^d

Barbiturates have caused postpartum hemorrhage and hemorrhagic disease in neonates; readily reversible with vitamin K therapy.^{f i}

Possible withdrawal symptoms in neonates born to women who received barbiturates throughout the last trimester of pregnancy.^f Premature neonates are particularly susceptible to the depressant effects of barbiturates.^f

Lactation

Distributed into milk; use with caution.^{c d}

Pediatric Use

May produce paradoxical excitement and hyperactivity or exacerbate existing hyperactivity; if severe, substitute another barbiturate or therapeutic agent.^b

Possible behavioral (e.g., hyperactivity, fussiness, lethargy, disturbed sleep, irritability, disobedience, stubbornness, depressive symptoms) or cognitive effects (e.g., deficits on neuropsychiatric tests, impaired short-term memory and memory concentration tasks) associated with anticonvulsant use.^{d i} If such changes occur and alternative causes are not readily evident, consider the possibility that anticonvulsant therapy may be responsible and the need for dosage reduction or substitution of alternative anticonvulsant(s).ⁱ

Phenobarbital sodium injection contains benzyl alcohol.^d Manufacturer does not recommend use in neonates;^d AAP states that the presence of small amounts of this preservative in a commercially available injection should not proscribe its use when indicated in neonates.^h

Geriatric Use

Possible increased sensitivity to barbiturates.^d Geriatric patients may frequently react to barbiturates with excitement, confusion, or depression.^{c f}

Hepatic Impairment

Use with caution; should not be used in patients with marked hepatic impairment.^{c d} (See Contraindications under Cautions.)

Renal Impairment

Use with extreme caution in patients with nephritis.^{b d} Use parenterally with extreme caution in patients with uremia.^{d f}

Common Adverse Effects

Residual sedation, drowsiness, lethargy, vertigo, nausea, vomiting, headache.^{c d f}

Interactions for Phenobarbital

Metabolized by hepatic microsomal enzymes.^d Induces hepatic microsomal enzymes.^{c d}

Specific Drugs

Drug	Interaction	Comments
Anticoagulants, oral (e.g., warfarin)	Possible decreased plasma warfarin concentrationsc d	Monitor PT; adjust anticoagulant dosage as necessary, especially with initiation or discontinuance of phenobarbitalc f
Antidepressants, tricyclics	Antidepressant may precipitate seizures, resulting in decreased seizure controli Potentiation of respiratory depression following toxic doses of tricyclic antidepressantsi	Monitor epileptic patients for decreased seizure control following initiation of antidepressant therapy; adjust phenobarbital dosage, if necessaryi
CNS depressants (e.g., sedatives, hynotics, antihistamines, tranquilizers, alcohol)	Possible additive depressant effectsc d
Contraceptives, oral	Possible enhanced metabolism of estrogenic and progestinic components; potential for decreased oral contraceptive effectiveness and increased risk of pregnancy with phenobarbital pretreatment or concurrent therapyd	Consider alternate methods of contraceptiond
Corticosteroids	Possible increased corticosteroid metabolismd	Dosage adjustment of corticosteriod may be required;d closely monitor asthmatics receiving corticosteroids when phenobarbital is initiatedi
Doxycycline	Possible decreased half-life of doxycycline; effect may persist up to 2 weeks after discontinuance of phenobarbitald	If possible, avoid concomitant administration;f if administered concomitantly, monitor clinical response to doxycyclined
Griseofulvin	Possible decreased griseofulvin absorption, resulting in decreased blood concentrationsd	Avoid concomitant administration;d if concomitant therapy is necessary, administration of griseofulvin in 3 divided daily doses may improve absorption.f Monitor blood griseofulvin concentrations and increase dosage, if necessaryf
MAO inhibitors	Possible prolongation of phenobarbital effectsd	Dosage adjustment of phenobarbital may be requiredf
Phenytoin	Increased, decreased, or no change in plasma phenytoin concentrations reportedd i	Monitor plasma concentrations of phentoin and phenobarbital; adjust dosages as necessaryd i
Valproic acid	Possible increased plasma phenobarbital concentrationsd	Monitor plasma phenobarbital concentrations and adjust dosage as neededd

Phenobarbital Pharmacokinetics

Absorption

Bioavailability

Slowly absorbed from GI tract following oral administration,^b with peak plasma concentrations usually attained within 8–12 hours and peak brain concentrations in 10–15 hours.^b

Following IV administration, ≥15 minutes may be required to reach peak brain concentrations.^d

Onset

Following oral administration, onset occurs within 30 minutes.^c

Following IV administration, onset occurs within 5 minutes, with maximum CNS depression occurring ≥15 minutes after administration.^{b d} Onset is slower following IM administration.^{b d}

Duration

About 5–6 hours^c or 4–6 hours^d following oral or parenteral administration, respectively.

Plasma Concentrations

Plasma concentrations of 10–25 mcg/mL associated with anticonvulsant activity in most patients.^d Concentrations >50 mcg/mL may produce coma; concentrations >80 mcg/mL are potentially lethal.^b

Distribution

Extent

Rapidly distributed to all tissues and fluids, with high concentrations in the brain, liver, and kidneys.^d

Crosses the placenta and is distributed into milk.^d

Plasma Protein Binding

20–45%.^b

Elimination

Metabolism

Metabolized primarily by hepatic microsomal enzymes.^d

Elimination Route

Excreted prinicipally in urine (25–50% as unchanged drug).^d

Half-life

Adults: 53–118 hours.^d

Children and neonates: 60–180 hours.^d

Stability

Storage

Oral

Tablets

Tight, light-resistant containers at 15–30°C.^c Protect from moisture.^c

Elixir

Tight containers at 20–25°C.^e

Parenteral

Injection

15–30°C.^d

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution Compatibility^HID

Compatible
Dextran 6% in dextrose 5%
Dextran 6% in sodium chloride 0.9%
Dextrose–Ringer’s injection combinations
Dextrose–Ringer’s injection, lactated, combinations
Dextrose–saline combinations
Dextrose 2.5, 5, or 10% in water
Fructose 10% in sodium chloride 0.9%
Fructose 10% in water
Invert sugar 5 and 10% in sodium chloride 0.9%
Invert sugar 5 and 10% in water
Ionosol products
Ringer’s injection
Ringer’s injection, lactated
Sodium chloride 0.45 or 0.9%
Sodium lactate (1/6) M
Incompatible
Alcohol 5%, dextrose 5%

Drug Compatibility

Admixture CompatibilityHID

Compatible
Amikacin sulfate
Aminophylline
Calcium chloride
Calcium gluconate
Colistimethate sodium
Dimenhydrinate
Meropenem
Polymyxin B sulfate
Thiopental sodium
Verapamil HCl
Incompatible
Chlorpromazine HCl
Ephedrine sulfate
Hydralazine HCl
Hydrocortisone sodium succinate
Hydroxyzine HCl
Meperidine HCl
Morphine sulfate
Norepinephrine bitartrate
Pentazocine lactate
Procaine HCl
Prochlorperazine mesylate
Promethazine HCl
Streptomycin sulfate
Vancomycin HCl

Y-site CompatibilityHID

Compatible
Doxapram HCl
Enalaprilat
Fentanyl citrate
Fosphenytoin sodium
Levofloxacin
Linezolid
Meropenem
Methadone HCl
Morphine sulfate
Propofol
Sufentanil citrate
Incompatible
Amphotericin B cholesteryl sulfate complex
Lansoprazole
Variable
Hydromorphone HCl

ActionsActions

• 
  

  CNS effects appear to be related, at least partially, to the drug’s ability to enhance activity of GABA, the principal inhibitory neurotransmitter in the CNS,^{104 105 106 107 108} by altering inhibitory synaptic transmissions that are mediated by GABA_A receptors.^{105 106 108}

  
  


• 
  

  Capable of producing all levels of CNS depression—from mild sedation to hypnosis to deep coma to death.^{c d}

  
  


• 
  

  Anticonvulsant effects of barbiturates are multiple and rather nonselective.ⁱ Principal mechanism of action appears to be reduction of monosynaptic and polysynaptic transmission resulting in decreased excitability of the entire nerve cell; barbiturates also increase the threshold for electrical stimulation of the motor cortex.ⁱ

  
  


• 
  

  Barbiturates lower serum bilirubin concentrations in neonates and patients with congenital nonhemolytic unconjugated hyperbilirubinemia, presumably by induction of glucuronyl transferase, the enzyme that conjugates bilirubin.^f

  
  

Advice to Patients

• 
  

  Potential for phenobarbital to impair mental alertness or physical coordination; do not drive or operate machinery until effects on individual are known.^{c d}

  
  


• 
  

  Importance of taking exactly as prescribed; do not exceed the recommended dosage.^{c d}

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and alcohol consumption.^{c d} Importance of avoiding alcohol while taking the drug.^{c d}

  
  


• 
  

  Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.^{c d}

  
  


• 
  

  Importance of advising patients of other important precautionary information.^{c d} (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Subject to control under the Federal Controlled Substances Act of 1970 as schedule IV (C-IV) drugs.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Phenobarbital

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Elixir	20 mg/5 mL C-IV*
	Tablets	15 mg*
		16 mg C-IV*
		30 mg C-IV*
		32 mg C-IV*
		60 mg C-IV*
		65 mg C-IV*
		100 mg C-IV*

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Phenobarbital Sodium

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injection	30 mg/mL*	Phenobarbital Sodium Injection ( C-IV; with alcohol 10% and propylene glycol 75%)	Wyeth
		60 mg/mL*	Phenobarbital Sodium Injection ( C-IV; with alcohol 10% and propylene glycol 75%)	Wyeth
		65 mg/mL*	Phenobarbital Sodium Injection ( C-IV; with alcohol 10% benzyl alcohol 1.5% and propylene glycol 67.8%)	Baxter
		130 mg/mL*	Luminal Sodium ( C-IV; with alcohol 10% and propylene glycol 67.8%)	Sanofi-Aventis
			Phenobarbital Sodium Injection ( C-IV; with alcohol 10% and propylene glycol 75%)	Wyeth
			Phenobarbital Sodium Injection ( C-IV; with alcohol 10% benzyl alcohol 1.5% and propylene glycol 67.8%)	Baxter

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

PHENobarbital 16.2MG Tablets (QUALITEST): 100/$12.99 or 300/$16.98

PHENobarbital 20MG/5ML Elixir (QUALITEST): 473/$26.96 or 1419/$79.29

PHENobarbital 32.4MG Tablets (QUALITEST): 100/$11.99 or 200/$14.98

PHENobarbital 64.8MG Tablets (QUALITEST): 100/$12.99 or 200/$15.98

PHENobarbital 97.2MG Tablets (QUALITEST): 100/$12.99 or 200/$19.96

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions April 2010. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

Only references cited for selected revisions after 1984 are available electronically.

100. Jones-Pharma. Brevital sodium (methohexital sodium) for injection prescribing information (dated 2001 Mar 28). In: Physicians’ desk reference. 56th ed. Montvale, NJ: Medical Economics Company Inc; 2002:1815-17.

103. Abbott. Pentothal thiopental sodium for injection prescribing information. North Chicago, IL; 1993 Nov.

104. Carmichael FJ, Haas DA. General Anesthetics. In: Kalant H and Roschlau WHE, eds. Principles of Medical Pharmacology. 6th edition. New York: Oxford University Press; 1998:278-92.

105. Evers AS, Crowder CM. General Anesthetics. In: Hardman JG, Gilman AG, Limbird LE, eds Goodman and Gilman’s The pharmacological basis of therapeutics. 10th ed. McGraw-Hill; 2001: 337-44.

106. Donnelly AJ, Shafer AL. Perioperative care. In: Young LL, Koda-Kimble MA, eds. Applied Therapeutics: The clinical use of drugs. 6th ed. Vancouver WA: Applied Therapeutics, Inc.; 1995:8-1-8-24.

107. Tanelian DL, Kosek P, Mody I et al. The role of the GABA_A receptor/chloride channel complex in anesthesia. Anesthesiology. 1993; 78:757-76. [IDIS 316350] [PubMed 8385426]

108. Hales TG, Olsen RW. Basic pharmacology of intravenous induction agents. In: Bowdle TA, Horita A, Kharasch ED, eds. The pharmacologic basis of anesthesiology. New York: Churchill Livingstone; 1994:295-306.

a. AHFS Drug Information 2004. McEvoy GK, ed. Phenobarbital . Bethesda, MD: American Society of Health-System Pharmacists; 2004:2370-1.

b. AHFS Drug Information 2004. McEvoy GK, ed. Phenobarbital. Bethesda, MD: American Society of Health-System Pharmacists; 2004:2108-9.

c. West-ward Pharmaceutical Corp. Phenobarbital tablets prescribing information. Eatontown, NJ; 2001 Jan.

d. Elkins-Sinn, Inc. Phenobarbital Sodium injection prescribing information. Cherry Hill, NJ; 2002 Apr.

e. Pharmaceutical Associates, Inc. Phenobarb elixir prescribing information. Greenville, NC; 2000 Apr.

f. AHFS Drug Information 2004. McEvoy GK, ed. Barbiturate general statement . Bethesda, MD: American Society of Health-System Pharmacists; 2004:2363-6.

HID. Trissel LA. Handbook on injectable drugs. 14th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2007:1331-5.

h. American Academy of Pediatrics Committee on Fetus and Newborn and Committee on Drugs. Benzyl alcohol: toxic agent in neonatal units. Pediatrics. 1983; 72:356 8.

i. AHFS Drug Information 2004. McEvoy GK, ed. Anticonvulsants general statement . Bethesda, MD: American Society of Health-System Pharmacists; 2004:2102-7.

More Phenobarbital resources

• Phenobarbital Side Effects (in more detail)
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• Phenobarbital Prescribing Information (FDA)


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