Diastat

Generic Name: diazepam (Rectal route)

dye-AZ-e-pam

Commonly used brand name(s)

In the U.S.

• Diastat


• Diastat Pediatric

Available Dosage Forms:

• Gel/Jelly


• Kit

Therapeutic Class: Anticonvulsant

Pharmacologic Class: Benzodiazepine, Long Acting

Uses For Diastat

Diazepam rectal gel is used to control certain seizure disorders such as epilepsy.

Diazepam is a benzodiazepine. Benzodiazepines belong to the group of medicines called central nervous system (CNS) depressants, which are medicines that slow down the nervous system.

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

Before Using Diastat

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

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

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

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of diazepam rectal gel in children below 2 years of age. Safety and efficacy have not been established.

Use is not recommended in infants under 6 months of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of diazepam rectal gel in the elderly. However, severe drowsiness, clumsiness, or unsteadiness are more likely to occur in the elderly, which may require an adjustment in the dose for patients receiving diazepam rectal gel.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

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

• Alfentanil


• Amobarbital


• Anileridine


• Aprobarbital


• Buprenorphine


• Butabarbital


• Butalbital


• Carisoprodol


• Chloral Hydrate


• Chlorzoxazone


• Codeine


• Dantrolene


• Ethchlorvynol


• Etravirine


• Fentanyl


• Fospropofol


• Hydrocodone


• Hydromorphone


• Itraconazole


• Ketorolac


• Levorphanol


• Meperidine


• Mephenesin


• Mephobarbital


• Meprobamate


• Metaxalone


• Methocarbamol


• Methohexital


• Morphine


• Morphine Sulfate Liposome


• Naproxen


• Oxycodone


• Oxymorphone


• Pentobarbital


• Phenobarbital


• Primidone


• Propoxyphene


• Remifentanil


• Secobarbital


• Sodium Oxybate


• Sufentanil


• Tapentadol


• Thiopental


• Zolpidem

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amitriptyline


• Amprenavir


• Clarithromycin


• Dalfopristin


• Disulfiram


• Erythromycin


• Fluvoxamine


• Ginkgo


• Isoniazid


• Mirtazapine


• Phenytoin


• Quinupristin


• Rifapentine


• Roxithromycin


• St John's Wort


• Theophylline


• Troleandomycin

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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:

• Alcohol abuse, or history of, or


• Drug abuse or dependence, or history of—Dependence on diazepam may develop.

• Breathing problems or lung diseases (e.g., asthma, pneumonia)—Use with caution. May make this condition worse.

• Glaucoma, acute narrow angle—Should not be used in patients with this condition.

• Kidney disease or


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

Proper Use of diazepam

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

Apply this medicine only as directed by your doctor. Do not apply more of it, do not apply it more often, and do not apply it for a longer time than your doctor ordered. Never take rectal medicine by mouth.

This medicine is not for daily use. After you use the medicine, it is best to wait at least 5 days before using it again. Do not use this medicine more than 5 times per month, unless your doctor tells you to.

This medicine will need to be given to you while you are having a seizure. A family member or other caregiver will give the medicine to you since you will most likely be unable to give it to yourself.

For caregivers administering this medicine:

• Discuss with the patient's medical doctor exactly when and how to use diazepam rectal gel.


• Discuss with the patient's medical doctor when you should call for emergency help.


• Read the instructions that you received with the medicine before you need to use it.


• Stay with the patient after administering diazepam rectal gel to check his or her condition as instructed by the doctor.

This medicine comes in a prefilled plastic applicator. Remove the cap from the prefilled applicator before inserting it. To make the applicator easier to insert, use the lubricating gel that came with the medicine.

Dosing

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

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

• For rectal dosage form (gel):
  
  • For control of seizures:
    
    • Adults, teenagers, and children 2 years of age and older—Dose is based on body weight and must be determined by your doctor.
    
    
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.
    
    
  
  

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.

Destroy any medicine that you do not need by flushing it down the toilet.

Precautions While Using Diastat

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates (used for seizures); muscle relaxants; or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you stop taking this medicine. Check with your doctor before taking any of the above while you are using this medicine.

This medicine may cause some people, especially older persons, to become drowsy, dizzy, lightheaded, clumsy, unsteady, or less alert than they are normally. Make sure you know how you react to diazepam before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to think or see well.

Diastat 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:

Less common

• Anxiety


• blurred vision


• changes in patterns and rhythms of speech


• confusion


• cough


• crying


• delusions


• dementia


• depersonalization


• difficulty breathing


• difficulty in speaking


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


• dry mouth


• dysphoria


• euphoria


• false or unusual sense of well-being


• feeling of warmth or heat


• flushing or redness of skin, especially on face and neck


• headache


• hyperventilation


• irregular heartbeats


• irritability


• lack of coordination


• mental depression


• mood or mental changes


• nervousness


• noisy breathing


• paranoia


• quick to react or overreact emotionally


• rapidly changing moods


• restlessness


• seizures


• shakiness and unsteady walk


• shortness of breath


• slurred speech


• sweating


• tightness in chest


• trouble in speaking


• trouble sleeping


• unsteadiness, trembling, or other problems with muscle control or coordination


• unusual tiredness or weakness


• wheezing

Rare

• Bladder pain


• bloody or cloudy urine


• difficult, burning, or painful urination


• fever or chills


• frequent urge to urinate


• increase in body movements


• lower back or side pain


• painful or difficult urination


• pale skin


• swollen, painful, or tender lymph glands in neck, armpit, or groin


• unusual bleeding or bruising

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

• Sleepiness or unusual drowsiness

Less common

• Diarrhea


• feeling of constant movement of self or surroundings


• hiccups


• lack or loss of strength


• rash


• runny nose


• sensation of spinning


• sneezing


• stuffy nose

Rare

• Bigger, dilated, or enlarged pupils (black part of eye)


• increased sensitivity of eyes to light


• itching skin


• loss of appetite


• vomiting


• weight loss

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: Diastat 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 Diastat resources

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

• Diastat Prescribing Information (FDA)


• Diastat Gel MedFacts Consumer Leaflet (Wolters Kluwer)


• Diazepam Monograph (AHFS DI)


• Diazepam Professional Patient Advice (Wolters Kluwer)


• Diazepam MedFacts Consumer Leaflet (Wolters Kluwer)


• Diastat AcuDial Gel MedFacts Consumer Leaflet (Wolters Kluwer)


• Valium Prescribing Information (FDA)


• Valium MedFacts Consumer Leaflet (Wolters Kluwer)


• Valium Consumer Overview

Compare Diastat with other medications

• Alcohol Withdrawal
• Anxiety
• Endoscopy or Radiology Premedication
• ICU Agitation
• Light Anesthesia
• Light Sedation
• Muscle Spasm
• Seizure Prevention
• Seizures
• Status Epilepticus
• Temporomandibular Joint Disorder
• Tetanus

Endomina

Endomina may be available in the countries listed below.

Ingredient matches for Endomina

Estradiol

Estradiol is reported as an ingredient of Endomina in the following countries:

• Spain

International Drug Name Search

Fido's Hydrobath

Fido's Hydrobath may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Fido's Hydrobath

Benzalkonium Chloride

Benzalkonium chloride (a derivative of Benzalkonium) is reported as an ingredient of Fido's Hydrobath in the following countries:

• Australia

International Drug Name Search

Ebastine

In some countries, this medicine may only be approved for veterinary use.

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

R06AX22

CAS registry number (Chemical Abstracts Service)

0090729-43-4

Chemical Formula

C32-H39-N-O2

Molecular Weight

469

Therapeutic Categories

Antiallergic agent

Histamine, H₁-receptor antagonist

Chemical Name

1-Butanone, 1-[4-(1,1-dimethylethyl)phenyl]-4-[4-(diphenylmethoxy)-1-piperidinyl]-

Foreign Names

• Ebastinum (Latin)
• Ebastin (German)
• Ebastine (French)
• Ebastina (Spanish)

Generic Names

• Ebastine (OS: USAN, BAN)
• LAS W-090 (IS: Almirall)
• Ebastine (PH: BP 2010, Ph. Eur. 6)
• Ebastinum (PH: Ph. Eur. 6)

Brand Names

• Alastina
  Alacan, Spain



• Aleva
  OEP, Philippines



• Bactil
  Omega, Spain



• Clever
  Chiesi, Italy



• Durfin
  Orifarm, Denmark



• Ebast
  Micro Labs, Myanmar



• Ebastel Forte
  Almirall, Spain



• Ebastel OD
  Dainippon Sumitomo, Japan



• Ebastel
  Almirall, Austria; Almirall, Spain; Almirall Hermal, Germany; Dainippon Sumitomo, Japan; Elmor, Venezuela; Orient Europharma, Taiwan



• Ebastin Aristo
  Aristo Pharma, Germany



• Ebastin Lindopharm
  Lindopharm, Germany



• Ebastina Acost
  Acost, Spain



• Ebastina Alprofarma
  Alprofarma, Spain



• Ebastina Alter
  Alter, Spain



• Ebastina Bexal
  Bexal, Spain



• Ebastina Cinfa
  Cinfa, Spain



• Ebastina Davur
  Davur, Spain



• Ebastina Merck
  Merck Genericos, Spain



• Ebastina Normon
  Normon, Spain



• Ebastina Qualitec
  Qualitec, Spain



• Ebastina Sandoz
  Sandoz, Spain



• Ebastina Stada
  Stada, Spain



• Ebastina Teva
  Teva, Spain



• Ebastina Toll Pharma
  Toll, Spain



• Ebastina Ur
  Uso Racional, Spain



• Ebastina Winthrop
  Sanofi-Aventis S.A., Spain



• Erostin-DC (Ebastine and Phenylephrine)
  Micro Eros, India



• Estivan
  Almirall, Belgium; Almirall, Luxembourg



• Evastel
  Almirall, Mexico



• Kestin
  Almirall, France



• Kestine
  Almirall, China; Almirall, Iceland; Almirall, Italy; Almirall, Latvia; Almirall, Netherlands; Almirall, Norway; Almirall, Poland; Almirall, Portugal; Almirall, Singapore; Aspen Pharmacare, South Africa; Eczacibasi, Turkey; Eisai, Hong Kong; Leiras, Finland; Novis Pharmaceutical, Greece; Nycomed, Estonia; Nycomed, Georgia; Nycomed, Lithuania; Nycomed, Russian Federation; Nycomed, Sweden; Rhône-Poulenc Rorer, Slovakia; Stephar, Netherlands; Almirall Prodesfarma S.AES, Denmark



• Kestinlyo
  Almirall, France



• Ketamine (veterinary use)
  IFET, Greece



• Rino Ebastel (Ebastine and Pseudoephedrine)
  Almirall, Spain



• Rinobactil (Ebastine and Pseudoephedrine)
  Omega, Spain

International Drug Name Search

Glossary

BAN	British Approved Name
IS	Inofficial Synonym
OS	Official Synonym
PH	Pharmacopoeia Name
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name

Click for further information on drug naming conventions and International Nonproprietary Names.

Intrizin

Intrizin may be available in the countries listed below.

Ingredient matches for Intrizin

Cetirizine

Cetirizine dihydrochloride (a derivative of Cetirizine) is reported as an ingredient of Intrizin in the following countries:

• Indonesia

International Drug Name Search

Griseo

Griseo may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Griseo

Griseofulvin

Griseofulvin is reported as an ingredient of Griseo in the following countries:

• Netherlands

International Drug Name Search

Aknefug Mino

Aknefug Mino may be available in the countries listed below.

Ingredient matches for Aknefug Mino

Minocycline

Minocycline hydrochloride dihydrate (a derivative of Minocycline) is reported as an ingredient of Aknefug Mino in the following countries:

• Germany

International Drug Name Search

Ketotilon

Ketotilon may be available in the countries listed below.

Ingredient matches for Ketotilon

Ketotifen

Ketotifen fumarate (a derivative of Ketotifen) is reported as an ingredient of Ketotilon in the following countries:

• Japan

International Drug Name Search

Arthricream

In the US, Arthricream is a member of the drug class miscellaneous topical agents and is used to treat Back Pain, Bursitis, Osteoarthritis, Pain, Period Pain, Raynaud's Syndrome, Rheumatoid Arthritis and Tendonitis.

Ingredient matches for Arthricream

Trolamine

Trolamine salicylate (a derivative of Trolamine) is reported as an ingredient of Arthricream in the following countries:

• United States

International Drug Name Search

Sulfacel

Ingredient matches for Sulfacel

Sulfacetamide Sodium

Sulfacetamide sodium salt (a derivative of Sulfacetamide) is reported as an ingredient of Sulfacel in the following countries:

• United States

International Drug Name Search

Roxigrün

Roxigrün may be available in the countries listed below.

Ingredient matches for Roxigrün

Roxithromycin

Roxithromycin is reported as an ingredient of Roxigrün in the following countries:

• Germany

International Drug Name Search

Cephazer

Cephazer may be available in the countries listed below.

Ingredient matches for Cephazer

Cefapirin

Cefapirin sodium salt (a derivative of Cefapirin) is reported as an ingredient of Cephazer in the following countries:

• Taiwan

International Drug Name Search

Sabril

In the US, Sabril (vigabatrin systemic) is a member of the drug class gamma-aminobutyric acid analogs and is used to treat Epilepsy, Seizure Prevention and Seizures.

US matches:

• Sabril


• Sabril Solution


• Sabril Tablets

UK matches:

• Sabril Sachets 0.5g and Tablets 500mg (SPC)

Ingredient matches for Sabril

Vigabatrin

Vigabatrin is reported as an ingredient of Sabril in the following countries:

• Argentina


• Australia


• Austria


• Belgium


• Brazil


• Chile


• Czech Republic


• France


• Germany


• Greece


• Hong Kong


• Hungary


• Ireland


• Italy


• Luxembourg


• Malta


• Mexico


• Netherlands


• New Zealand


• Oman


• Peru


• Poland


• Portugal


• Singapore


• Slovakia


• Slovenia


• South Africa


• Switzerland


• Taiwan


• Tunisia


• Turkey


• United Kingdom


• United States

International Drug Name Search

Glossary

SPC	Summary of Product Characteristics (UK)

Click for further information on drug naming conventions and International Nonproprietary Names.

Pantacid

Pantacid may be available in the countries listed below.

Ingredient matches for Pantacid

Pantoprazole

Pantoprazole sodium (a derivative of Pantoprazole) is reported as an ingredient of Pantacid in the following countries:

• Hungary

International Drug Name Search

SK-40

SK-40 may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for SK-40

Chlortetracycline

Chlortetracycline hydrochloride (a derivative of Chlortetracycline) is reported as an ingredient of SK-40 in the following countries:

• Switzerland

Sulfadimidine

Sulfadimidine sodium salt (a derivative of Sulfadimidine) is reported as an ingredient of SK-40 in the following countries:

• Switzerland

Tylosin

Tylosin tartrate (a derivative of Tylosin) is reported as an ingredient of SK-40 in the following countries:

• Switzerland

International Drug Name Search

Rinelon

Rinelon may be available in the countries listed below.

Ingredient matches for Rinelon

Mometasone

Mometasone 17-(2-furoate) (a derivative of Mometasone) is reported as an ingredient of Rinelon in the following countries:

• Italy


• Mexico


• Peru


• Philippines

International Drug Name Search

Streptomycin Sulphate Meiji

Streptomycin Sulphate Meiji may be available in the countries listed below.

Ingredient matches for Streptomycin Sulphate Meiji

Streptomycin

Streptomycin sulfate (a derivative of Streptomycin) is reported as an ingredient of Streptomycin Sulphate Meiji in the following countries:

• Indonesia


• Malaysia

International Drug Name Search

Alleton

Alleton may be available in the countries listed below.

Ingredient matches for Alleton

Oxatomide

Oxatomide is reported as an ingredient of Alleton in the following countries:

• Japan

International Drug Name Search

Mucoform Syrup

Mucoform Syrup may be available in the countries listed below.

Ingredient matches for Mucoform Syrup

Ambroxol

Ambroxol hydrochloride (a derivative of Ambroxol) is reported as an ingredient of Mucoform Syrup in the following countries:

• Georgia

International Drug Name Search

Nimustine Hydrochloride

Nimustine Hydrochloride may be available in the countries listed below.

Ingredient matches for Nimustine Hydrochloride

Nimustine

Nimustine Hydrochloride (JAN) is also known as Nimustine (Rec.INN)

International Drug Name Search

Glossary

JAN	Japanese Accepted Name
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.

Apsamix Colistina

Apsamix Colistina may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Apsamix Colistina

Colistin Sulfate

Colistin sulfate (a derivative of Colistin) is reported as an ingredient of Apsamix Colistina in the following countries:

• Poland

International Drug Name Search

Slow-Apresoline

Slow-Apresoline may be available in the countries listed below.

Ingredient matches for Slow-Apresoline

Hydralazine

Hydralazine hydrochloride (a derivative of Hydralazine) is reported as an ingredient of Slow-Apresoline in the following countries:

• Ghana


• Kenya


• Nigeria


• Sudan


• Tanzania


• Zimbabwe

International Drug Name Search

Albyl-E

Albyl-E may be available in the countries listed below.

Ingredient matches for Albyl-E

Aspirin

Acetylsalicylic Acid is reported as an ingredient of Albyl-E in the following countries:

• Norway

International Drug Name Search

Seeco

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Seeco

Tylosin

Tylosin phosphate (a derivative of Tylosin) is reported as an ingredient of Seeco in the following countries:

• United States

International Drug Name Search

Miacalcic

Miacalcic may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

UK matches:

• Miacalcic 50 IU/ml and 100 IU/ml Ampoules and 400 IU/2ml Solution for Injection and Infusion
• MIACALCIC 200 IU Nasal Spray (SPC)
• Miacalcic 400 IU/2ml Solution for Injection and Infusion (SPC)
• Miacalcic 50 IU/ml and 100 IU/ml Ampoules (SPC)

Ingredient matches for Miacalcic

Calcitonin

Calcitonin is reported as an ingredient of Miacalcic in the following countries:

• Australia


• Bangladesh


• Belgium


• Bosnia & Herzegowina


• Brazil


• Chile


• China


• Colombia


• Croatia (Hrvatska)


• Czech Republic


• Denmark


• Finland


• France


• Georgia


• Ghana


• Greece


• Hong Kong


• Hungary


• Iceland


• India


• Indonesia


• Israel


• Kenya


• Latvia


• Libya


• Luxembourg


• Malaysia


• Malta


• Mexico


• New Zealand


• Nigeria


• Norway


• Oman


• Peru


• Philippines


• Poland


• Portugal


• Romania


• Russian Federation


• Serbia


• Singapore


• Slovakia


• Slovenia


• South Africa


• Spain


• Sudan


• Sweden


• Switzerland


• Taiwan


• Tanzania


• Thailand


• Turkey


• United Kingdom


• Vietnam


• Zimbabwe

International Drug Name Search

Glossary

SPC	Summary of Product Characteristics (UK)

Click for further information on drug naming conventions and International Nonproprietary Names.

Ketoprofen Vramed

Ketoprofen Vramed may be available in the countries listed below.

Ingredient matches for Ketoprofen Vramed

Ketoprofen

Ketoprofen is reported as an ingredient of Ketoprofen Vramed in the following countries:

• Bulgaria


• Russian Federation

International Drug Name Search

Antihist

Antihist may be available in the countries listed below.

Ingredient matches for Antihist

Mepyramine

Mepyramine maleate (a derivative of Mepyramine) is reported as an ingredient of Antihist in the following countries:

• South Africa

International Drug Name Search

Solodyn

Solodyn is a brand name of minocycline, approved by the FDA in the following formulation(s):

SOLODYN (minocycline hydrochloride - tablet, extended release; oral)

• 
  Manufacturer: MEDICIS
  
  Approval date: May 8, 2006
  
  Strength(s): EQ 135MG BASE ^[RLD][AB], EQ 45MG BASE ^[AB], EQ 90MG BASE ^[AB]


• 
  Manufacturer: MEDICIS
  
  Approval date: July 23, 2009
  
  Strength(s): EQ 115MG BASE, EQ 65MG BASE
  


• 
  Manufacturer: MEDICIS
  
  Approval date: August 27, 2010
  
  Strength(s): EQ 105MG BASE, EQ 55MG BASE, EQ 80MG BASE
  

Has a generic version of Solodyn been approved?

A generic version of Solodyn has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Solodyn and have been approved by the FDA:

minocycline hydrochloride tablet, extended release; oral

• 
  Manufacturer: BARR
  
  Approval date: March 17, 2009
  
  Strength(s): EQ 135MG BASE ^[AB], EQ 45MG BASE ^[AB], EQ 90MG BASE ^[AB]


• 
  Manufacturer: IMPAX LABS INC
  
  Approval date: February 3, 2009
  
  Strength(s): EQ 135MG BASE ^[AB], EQ 45MG BASE ^[AB], EQ 90MG BASE ^[AB]


• 
  Manufacturer: LUPIN LTD
  
  Approval date: November 30, 2011
  
  Strength(s): EQ 135MG BASE ^[AB], EQ 45MG BASE ^[AB], EQ 90MG BASE ^[AB]


• 
  Manufacturer: MATRIX LABS LTD
  
  Approval date: July 20, 2010
  
  Strength(s): EQ 135MG BASE ^[AB], EQ 45MG BASE ^[AB], EQ 90MG BASE ^[AB]


• 
  Manufacturer: SANDOZ
  
  Approval date: August 13, 2009
  
  Strength(s): EQ 135MG BASE ^[AB], EQ 45MG BASE ^[AB], EQ 90MG BASE ^[AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Solodyn. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

• 
  Method for the treatment of acne
  Patent 5,908,838
  Issued: June 1, 1999
  Inventor(s): Gans; Eugene H.
  Assignee(s): Medics Pharmaceutical Corporation
  A method for the treatment of acne is provided which results in the reduction of vestibular side effects following administration of oral tetracycline antibiotics.
  
  Patent expiration dates:
  
  
  • February 19, 2018
    
    ✓ 
    Patent use: TREATMENT OF INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS
  
  



• 
  Minocycline oral dosage forms for the treatment of acne
  Patent 7,541,347
  Issued: June 2, 2009
  Inventor(s): Wortzman; Mitchell & Plott; R. Todd & Bhatia; Kuljit & Patel; Bhiku
  Assignee(s): Medicis Pharmaceutical Coropration
  Minocycline oral dosage forms containing a controlled release carrier are useful for the treatment of acne.
  
  Patent expiration dates:
  
  
  • April 2, 2027
    
    ✓ 
    Patent use: TREATMENT OF INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS
  
  



• 
  Minocycline oral dosage forms for the treatment of acne
  Patent 7,544,373
  Issued: June 9, 2009
  Inventor(s): Wortzman; Mitchell & Plott; R. Todd & Bhatia; Kuljit & Patel; Bhiku
  Assignee(s): Medicis Pharmaceutical Corporation
  Minocycline oral dosage forms containing a controlled release carrier are useful for the treatment of acne.
  
  Patent expiration dates:
  
  
  • April 2, 2027
    
    ✓ 
    Drug product
  
  



• 
  Minocycline oral dosage forms for the treatment of acne
  Patent 7,790,705
  Issued: September 7, 2010
  Inventor(s): Wortzman; Mitchell & Plott; R. Todd & Bhatia; Kuljit & Patel; Bhiku
  Assignee(s): Medicis Pharmaceutical Corporation
  Minocycline oral dosage forms containing a controlled release carrier are useful for the treatment of acne.
  
  Patent expiration dates:
  
  
  • June 24, 2025
    
    ✓ 
    Patent use: TREATMENT OF ACNE
  
  



• 
  Method for the treatment of acne
  Patent 7,919,483
  Issued: April 5, 2011
  Inventor(s): Wortzman; Mitchell & Plott; R. Todd & Bhatia; Kuljit & Patel; Bhiku
  Assignee(s): Medicis Pharmaceutical Corporation
  A method for treatment of acne with tetracyclines is provided. A lower sustained dose and no loading dose is employed, with an optional once-a-day dosing regimen.
  
  Patent expiration dates:
  
  
  • March 7, 2027
    
    ✓ 
    Patent use: TREATMENT OF ACNE
  
  

See also...

• Solodyn Consumer Information (Drugs.com)
• Solodyn Extended-Release Tablets Consumer Information (Wolters Kluwer)
• Solodyn Consumer Information (Cerner Multum)
• Minocycline Consumer Information (Drugs.com)
• Minocycline Consumer Information (Wolters Kluwer)
• Minocycline Capsules Consumer Information (Wolters Kluwer)
• Minocycline Extended-Release Tablets Consumer Information (Wolters Kluwer)
• Minocycline Injection Consumer Information (Wolters Kluwer)
• Minocycline Pellet-Filled Capsules Consumer Information (Wolters Kluwer)
• Minocycline Consumer Information (Cerner Multum)
• Arestin eent AHFS DI Monographs (ASHP)
• Minocycline Hydrochloride AHFS DI Monographs (ASHP)
• Minocycline Hydrochloride eent AHFS DI Monographs (ASHP)

Doxycycline Hyclate Tablets

Dosage Form: tablet, film coated
DOXYCYCLINE HYCLATE

TABLETS USP

Rx only

Doxycycline Hyclate Tablets Description

Doxycycline hyclate is available as a 20 mg tablet formulation of doxycycline for oral administration.

The structural formula of doxycycline hyclate is:

with an emperical formula of (C22H24N2O8•HCl)2•C2H6O•H2O and a molecular weight of 1025.89. The chemical designation for doxycycline is 4-(dimethylamino)-1, 4, 4a, 5, 5a, 6, 11, 12a-octahydro-3, 5, 10, 12, 12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate.

Doxycycline hyclate is a yellow to light-yellow crystalline powder which is soluble in water.

Each tablet for oral administration contains 23 mg doxycycline hyclate equivalent to 20 mg of doxycycline. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, carnauba wax, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, titanium dioxide, and triacetin.

Doxycycline Hyclate Tablets - Clinical Pharmacology

After oral administration, doxycycline hyclate is rapidly and nearly completely absorbed from the gastrointestinal tract. Doxycycline is eliminated with a half-life of approximately 18 hours by renal and fecal excretion of unchanged drug.

Mechanism of Action

Doxycycline has been shown to inhibit collagenase activity in vitro.1 Additional studies have shown that doxycycline reduces the elevated collagenase activity in the gingival crevicular fluid of patients with adult periodontitis.2,3 The clinical significance of these findings is not known.

Microbiology

Doxycycline is a member of the tetracycline class of antibiotics. The dosage of doxycycline achieved with this product during administration is well below the concentration required to inhibit microorganisms commonly associated with adult periodontitis. Clinical studies with this product demonstrated no effect on total anaerobic and facultative bacteria in plaque samples from patients administered this dose regimen for 9 to 18 months. This product should not be used for reducing the numbers of or eliminating those microorganisms associated with periodontitis.

Pharmacokinetics

The pharmacokinetics of doxycycline following oral administration of doxycycline hyclate were investigated in 4 volunteer studies involving 107 adults. Additionally, doxycycline pharmacokinetics have been characterized in numerous scientific publications.4 Pharmacokinetic parameters for doxycycline hyclate following single oral doses and at steady-state in healthy subjects are presented as follows:

Pharmacokinetic Parameters for Doxycycline Hyclate Tablets

	n	Cmax* (ng/mL)	Tmax† (hr)	CI/F* (L/hr)	t1/2* (hr)
* Mean ± SD † Mean and range ‡ Steady-State data were obtained from normal volunteers administered a bioequivalent formulation.
Single dose 20 mg (tablet)	20	362 ± 101	1.4 (1.0–2.5)	3.85 ± 1.3	18.1 ± 4.85
Steady-State 20 mg BID‡	30	790 ± 285	2 (0.98–12.0)	3.76 ± 1.06	Not Determined

Absorption

Doxycycline is well absorbed after oral administration. In a single-dose study, concomitant administration of doxycycline hyclate with a 1000 calorie, high-fat, high-protein meal which included dairy products, in healthy volunteers, resulted in a decrease in the rate and extent of absorption and delay in the time to maximum concentrations.

Distribution

Doxycycline is greater than 90% bound to plasma proteins. Its apparent volume of distribution is variously reported as between 52.6 and 134 L.4,6

Metabolism

Major metabolites of doxycycline have not been identified. However, enzyme inducers such as barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline.

Excretion

Doxycycline is excreted in the urine and feces as unchanged drug. It is variously reported that between 29% and 55.4% of an administered dose can be accounted for in the urine by 72 hours.5,6 Half-life averaged 18 hours in subjects receiving a single 20 mg doxycycline dose.

Special Populations

Geriatric

Doxycycline pharmacokinetics have not been evaluated in geriatric patients.

Pediatric

Doxycycline pharmacokinetics have not been evaluated in pediatric patients (See WARNINGS section).

Gender

Doxycycline pharmacokinetics were compared in 9 men and 11 women under fed and fasted conditions. While female subjects had a higher rate (Cmax) and extent of absorption (AUC), these differences are thought to be due to differences in body weight/lean body mass. Differences in other pharmacokinetic parameters were not significant.

Race

Differences in doxycycline pharmacokinetics among racial groups have not been evaluated.

Renal Insufficiency

Studies have shown no significant difference in serum half-life of doxycycline in patients with normal and severely impaired renal function. Hemodialysis does not alter the half-life of doxycycline.

Hepatic Insufficiency

Doxycycline pharmacokinetics have not been evaluated in patients with hepatic insufficiency.

Drug Interactions

(See PRECAUTIONS section).

Clinical Study

In a randomized, multi-centered, double-blind, 9-month Phase 3 study involving 190 adult patients with periodontal disease [at least two probing sites per quadrant of between 5 and 9 mm pocket depth (PD) and attachment level (ALv)], the effects of oral administration of 20 mg twice a day of doxycycline hyclate (using a bioequivalent capsule formulation) plus scaling and root planing (SRP) were compared to placebo control plus SRP. Both treatment groups were administered a course of scaling and root planing in 2 quadrants at Baseline. Measurements of ALv, PD and bleeding-on-probing (BOP) were obtained at Baseline, 3, 6, and 9 months from each site about each tooth in the two quadrants that received SRP using the UNC-15 manual probe. Each tooth site was categorized into one of three strata based on Baseline PD: 0–3 mm (no disease), 4–6 mm (mild/moderate disease), ≥ 7 mm (severe disease). For each stratum and treatment group, the following were calculated at month 3, 6, and 9: mean change in ALv from baseline, mean change in PD from baseline, mean percentage of tooth sites per patient exhibiting attachment loss of ≥ 2 mm from baseline, and percentage of tooth sites with bleeding on probing. The results are summarized in the following table.

Clinical Results at Nine Months of Doxycycline Hyclate Capsules, 20 mg, as an Adjunct to SRP (Bioequivalent to Doxycycline Hyclate Tablets, 20 mg)

Parameter	Baseline Pocket Depth
	0–3 mm	4–6 mm	≥ 7 mm
* SD = Standard Deviation † ALv = Clinical Attachment Level ‡ p<0.050 vs. the placebo control group. § PD = Pocket Dept ¶ p<0.010 vs. the placebo control group. # BOP = Bleeding on Probing
Number of Patients
(Doxycycline Hyclate Tablets   20 mg BID)	90	90	79
Number of Patients
(Placebo)	93	93	78
Mean Gain (SD*) in ALv†
Doxycycline Hyclate Tablets   20 mg BID	0.25 (0.29) mm	1.03 (0.47) mm‡	1.55 (1.16) mm‡
Placebo	0.20 (0.29) mm	0.86 (0.48) mm	1.17 (1.15) mm
Mean Decrease (SD*) in PD§
Doxycycline Hyclate Tablets   20 mg BID	0.16 (0.19) mm¶	0.95 (0.47) mm¶	1.68 (1.07) mm¶
Placebo	0.05 (0.19) mm	0.69 (0.48) mm	1.20 (1.06) mm
% of Sites (SD*) with loss of ALv† ≥ 2 mm
Doxycycline Hyclate Tablets   20 mg BID	1.9 (4.2)%	1.3 (4.5)%	0.3 (9.4)%
Placebo	2.2 (4.1)%	2.4 (4.4)%	3.6 (9.4)%
% of Sites (SD*) with BOP#
Doxycycline Hyclate Tablets   20 mg BID	39 (19)%¶	64 (18)%‡	75 (29)%
Placebo	46 (19)%	70 (18)%	80 (29)%

Indications and Usage for Doxycycline Hyclate Tablets

Doxycycline hyclate is indicated for use as an adjunct to scaling and root planing to promote attachment level gain and to reduce pocket depth in patients with adult periodontitis.

Contraindications

This drug is contraindicated in persons who have shown hypersensitivity to doxycycline or any of the other tetracyclines.

Warnings

THE USE OF DRUGS OF THE TETRACYCLINE CLASS DURING TOOTH DEVELOPMENT (LAST HALF OF PREGNANCY, INFANCY AND CHILDHOOD TO THE AGE OF 8 YEARS) MAY CAUSE PERMANENT DISCOLORATION OF THE TEETH (YELLOW-GRAY-BROWN). This adverse reaction is more common during long-term use of the drugs but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. TETRACYCLINE DRUGS, THEREFORE, SHOULD NOT BE USED IN THIS AGE GROUP AND IN PREGNANT OR NURSING MOTHERS UNLESS THE POTENTIAL BENEFITS MAY BE ACCEPTABLE DESPITE THE POTENTIAL RISKS.

All tetracyclines form a stable calcium complex in any bone forming tissue. A decrease in fibula growth rate has been observed in premature infants given oral tetracyclines in doses of 25 mg/kg every 6 hours. This reaction was shown to be reversible when the drug was discontinued.

Doxycycline can cause fetal harm when administered to a pregnant woman. Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can have toxic effects on the developing fetus (often related to retardation of skeletal development). Evidence of embryotoxicity has also been noted in animals treated early in pregnancy. If any tetracyclines are used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

The catabolic action of the tetracyclines may cause an increase in BUN. Previous studies have not observed an increase in BUN with the use of doxycycline in patients with impaired renal function.

Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Patients apt to be exposed to direct sunlight or ultraviolet light should be advised that this reaction can occur with tetracycline drugs, and treatment should be discontinued at the first evidence of skin erythema.

Precautions

While no overgrowth by opportunistic microorganisms such as yeast were noted during clinical studies, as with other antimicrobials, doxycycline hyclate therapy may result in overgrowth of nonsusceptible microorganisms including fungi.

The use of tetracyclines may increase the incidence of vaginal candidiasis.

Doxycycline hyclate should be used with caution in patients with a history or predisposition to oral candidiasis. The safety and effectiveness of doxycycline hyclate has not been established for the treatment of periodontitis in patients with coexistant oral candidiasis.

If superinfection is suspected, appropriate measures should be taken.

Laboratory Tests

In long term therapy, periodic laboratory evaluations of organ systems, including hematopoietic, renal, and hepatic studies should be performed.

Drug Interactions

Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.

Since bacterial antibiotics, such as the tetracycline class of antibiotics, may interfere with the bactericidal action of members of the β-lactam (e.g., penicillin) class of antibiotics, it is not advisable to administer these antibiotics concomitantly.

Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, and iron-containing preparations, and by bismuth subsalicylate.

Barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline.

The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity.

Concurrent use of tetracyclines may render oral contraceptives less effective.

Drug/Laboratory Test Interactions

False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Doxycycline hyclate was assessed for potential to induce carcinogenesis in a study in which the compound was administered to Sprague-Dawley rats by gavage at dosages of 20, 75, and 200 mg/kg/day for two years. An increased incidence of uterine polyps was observed in female rats that received 200 mg/kg/day, a dosage that resulted in a systemic exposure to doxycycline approximately nine times that observed in female humans that used doxycycline hyclate (exposure comparison based upon AUC values). No impact upon tumor incidence was observed in male rats at 200 mg/kg/day, or in either gender at the other dosages studied. Evidence of oncogenic activity was obtained in studies with related compounds, i.e., oxytetracycline (adrenal and pituitary tumors), and minocycline (thyroid tumors).

Doxycycline hyclate demonstrated no potential to cause genetic toxicity in an in vitro point mutation study with mammalian cells (CHO/HGPRT forward mutation assay) or in an in vivo micronucleus assay conducted in CD-1 mice. However, data from an in vitro assay with CHO cells for potential to cause chromosomal aberrations suggest that doxycycline hyclate is a weak clastogen.

Oral administration of doxycycline hyclate to male and female Sprague-Dawley rats adversely affected fertility and reproductive performance, as evidenced by increased time for mating to occur, reduced sperm motility, velocity, and concentration, abnormal sperm morphology, and increased pre-and post-implantation losses. Doxycycline hyclate induced reproductive toxicity at all dosages that were examined in this study, as even the lowest dosage tested (50 mg/kg/day) induced a statistically significant reduction in sperm velocity. Note that 50 mg/kg/day is approximately 10 times the amount of doxycycline hyclate contained in the recommended daily dose of doxycycline hyclate for a 60 kg human when compared on the basis of body surface area estimates (mg/m2). Although doxycycline impairs the fertility of rats when administered at sufficient dosage, the effect of doxycycline hyclate on human fertility is unknown.

Pregnancy

Teratogenic Effects

Pregnancy Category D

(See WARNINGS Section). Results from animal studies indicate that doxycycline crosses the placenta and is found in fetal tissues.

Nonteratogenic effects

(See WARNINGS Section).

Labor and Delivery

The effect of tetracyclines on labor and delivery is unknown.

Nursing Mothers

Tetracyclines are excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from doxycycline, the use of doxycycline hyclate in nursing mothers is contraindicated. (See WARNINGS Section).

Pediatric Use

The use of Doxycycline Hyclate Tablets in infancy and childhood is contraindicated. (See WARNINGS section).

Adverse Reactions

Adverse Reactions in Clinical Trials of a bioequivalent form of doxycycline hyclate capsules

In clinical trials of adult patients with periodontal disease 213 patients received 20 mg BID over a 9 – 12 month period. The most frequent adverse reactions occurring in studies involving treatment with a bioequivalent form of doxycycline hyclate capsules or placebo are listed below:

Incidence (%) of Adverse Reactions in Clinical Trials of Doxycycline Hyclate Capsules, 20 mg (Bioequivalent to Doxycycline Hyclate Tablets, 20 mg) vs. Placebo

Adverse Reaction	Doxycycline Hyclate Capsules 20 mg BID (n=213)	Placebo (n=215)
Note: Percentages are based on total number of study participants in each treatment group.
Headache	55 (26%)	56 (26%)
Common Cold	47 (22%)	46 (21%)
Flu Symptoms	24 (11%)	40 (19%)
Tooth Ache	14 (7%)	28 (13%)
Periodontal Abscess	8 (4%)	21 (10%)
Tooth Disorder	13 (6%)	19 (9%)
Nausea	17 (8%)	12 (6%)
Sinusitis	7 (3%)	18 (8%)
Injury	11 (5%)	18 (8%)
Dyspepsia	13 (6%)	5 (2%)
Sore Throat	11 (5%)	13 (6%)
Joint Pain	12 (6%)	8 (4%)
Diarrhea	12 (6%)	8 (4%)
Sinus Congestion	11 (5%)	11 (5%)
Coughing	9 (4%)	11 (5%)
Sinus Headache	8 (4%)	8 (4%)
Rash	8 (4%)	6 (3%)
Back Pain	7 (3%)	8 (4%)
Back Ache	4 (2%)	9 (4%)
Menstrual Cramp	9 (4%)	5 (2%)
Acid Indigestion	8 (4%)	7 (3%)
Pain	8 (4%)	5 (2%)
Infection	4 (2%)	6 (3%)
Gum Pain	1 (<1%)	6 (3%)
Bronchitis	7 (3%)	5 (2%)
Muscle Pain	2 (1%)	6 (3%)

Adverse Reactions for Tetracyclines

The following adverse reactions have been observed in patients receiving tetracyclines:

Gastrointestinal: anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, and inflammatory lesions (with vaginal candidiasis) in the anogenital region. Hepatotoxicity has been reported rarely. Rare instances of esophagitis and esophageal ulcerations have been reported in patients receiving the capsule forms of the drugs in the tetracycline class. Most of these patients took medications immediately before going to bed. (See DOSAGE AND ADMINISTRATION Section).

Skin: maculopapular and erythematous rashes. Exfoliative dermatitis has been reported but is uncommon. Photosensitivity is discussed above. (See WARNINGS Section).

Renal toxicity: Rise in BUN has been reported and is apparently dose related. (See WARNINGS Section).

Hypersensitivity reactions: urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, serum sickness, pericarditis, and exacerbation of systemic lupus erythematosus.

Blood: Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia have been reported.

Overdosage

In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures. Dialysis does not alter serum half-life and thus would not be of benefit in treating cases of overdose.

Doxycycline Hyclate Tablets Dosage and Administration

THE DOSAGE OF Doxycycline Hyclate Tablets DIFFERS FROM THAT OF DOXYCYCLINE USED TO TREAT INFECTIONS. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS INCLUDING THE DEVELOPMENT OF RESISTANT MICROORGANISMS.

Doxycycline Hyclate Tablets 20 mg twice daily as an adjunct following scaling and root planing may be administered for up to 9 months. Doxycycline Hyclate Tablets should be taken twice daily at 12 hour intervals, usually in the morning and evening. It is recommended that if Doxycycline Hyclate Tablets are taken close to meal times, allow at least one hour prior to or two hours after meals. Safety beyond 12 months and efficacy beyond 9 months have not been established.

Administration of adequate amounts of fluid along with the tablets is recommended to wash down the drug and reduce the risk of esophageal irritation and ulceration. (See ADVERSE REACTIONS Section).

How is Doxycycline Hyclate Tablets Supplied

Doxycycline Hyclate Tablets USP equivalent to 20 mg of doxycycline, round, white, unscored, film coated tablet, debossed MP 573 on one side and blank on the other side.

Bottles of 30	NDC 53489-647-07
Bottles of 60	NDC 53489-647-06
Bottles of 90	NDC 53489-647-90
Bottles of 100	NDC 53489-647-01
Bottles of 250	NDC 53489-647-03
Bottles of 500	NDC 53489-647-05
Bottles of 1000	NDC 53489-647-10

Store at 20° to 25°C (68° to 77°F).

[See USP Controlled Room Temperature]

DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

REFERENCES

1. Golub L.M., Sorsa T., Lee H-M, Ciancio S., Sorbi D., Ramamurthy N.S., Gruber B., Salo T., Konttinen Y.T.: Doxycycline Inhibits Neutrophil (PMN)-type Matrix Metalloproteinases in Human Adult Periodontitis Gingiva. J. Clin. Periodontol 1995; 22: 100–109.


2. Golub L.M., Ciancio S., Ramamurthy N.S., Leung M., McNamara T.F.: Low-dose Doxycycline Therapy: Effect on Gingival and Crevicular Fluid Collagenase Activity in Humans. J. Periodont Res 1990; 25: 321–330.


3. Golub L.M., Lee H.M., Greenwald R.A., Ryan M.E., Salo T., Giannobile W.V.: A Matrix Metalloproteinase Inhibitor Reduces Bone-type Collagen Degradation Fragments and Specific Collegenases in Gingival Crevicular Fluid During Adult Periodontitis. Inflammation Research 1997; 46: 310–319.


4. Saivain S., Houin G.: Clinical Pharmacokinetics of Doxycycline and Minocycline. Clin. Pharmacokinetics 1988; 15: 355–366.


5. Schach von Wittenau M., Twomey T.: The Disposition of Doxycycline by Man and Dog. Chemotherapy 1971; 16: 217–228.


6. Campistron G., Coulais Y., Caillard C., Mosser J., Pontagnier H., Houin G.: Pharmacokinetics and Bioavailability of Doxycycline in Humans. Arzneimittel Forschung 1986; 36: 1705–1707.

Manufactured by:

MUTUAL PHARMACEUTICAL COMPANY, INC.

Philadelphia, PA 19124 USA

Rev 01, April 2009

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

MP

NDC 53489-647-01

DOXYCYCLINE HYCLATE

TABLETS USP

20 mg

100 TABLETS

Rx only

MUTUAL PHARMACEUTICAL CO., INC.

PHILADELPHIA, PA 19124 USA

DOXYCYCLINE HYCLATE  doxycycline hyclate  tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 53489-647 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Doxycycline Hyclate (Doxycycline Anhydrous) Doxycycline Anhydrous 20 mg

Inactive Ingredients Ingredient Name Strength anhydrous lactose   carnauba wax   croscarmellose sodium   hypromelloses   magnesium stearate   cellulose, microcrystalline   polydextrose   polyethylene glycols   titanium dioxide   triacetin

Product Characteristics Color WHITE Score no score Shape ROUND Size 9mm Flavor Imprint Code MP;573 Contains

Packaging # NDC Package Description Multilevel Packaging 1 53489-647-07 30 TABLET In 1 BOTTLE, PLASTIC None 2 53489-647-06 60 TABLET In 1 BOTTLE, PLASTIC None 3 53489-647-90 90 TABLET In 1 BOTTLE, PLASTIC None 4 53489-647-01 100 TABLET In 1 BOTTLE, PLASTIC None 5 53489-647-03 250 TABLET In 1 BOTTLE, PLASTIC None 6 53489-647-05 500 TABLET In 1 BOTTLE, PLASTIC None 7 53489-647-10 1000 TABLET In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA065134	05/13/2005

Labeler - Mutual Pharmaceutical Company, Inc. (121735955)

Revised: 01/2012Mutual Pharmaceutical Company, Inc.

Definity

In the US, Definity (perflutren systemic) is a member of the drug class ultrasound contrast media.

US matches:

• Definity

Ingredient matches for Definity

Perflutren

Perflutren is reported as an ingredient of Definity in the following countries:

• Canada


• Chile


• United States

International Drug Name Search

Neo Vet-Cillin

Neo Vet-Cillin may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Neo Vet-Cillin

Amoxicillin

Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Neo Vet-Cillin in the following countries:

• Italy

International Drug Name Search

Oxytetracyclin

Oxytetracyclin may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Oxytetracyclin

Oxytetracycline

Oxytetracycline hydrochloride (a derivative of Oxytetracycline) is reported as an ingredient of Oxytetracyclin in the following countries:

• Germany

International Drug Name Search

Fébuprol

Fébuprol may be available in the countries listed below.

Ingredient matches for Fébuprol

Febuprol

Fébuprol (DCF) is also known as Febuprol (Rec.INN)

International Drug Name Search

Glossary

DCF	Dénomination Commune Française
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.

Menorox

Menorox may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Menorox

Norfloxacin

Norfloxacin is reported as an ingredient of Menorox in the following countries:

• South Africa

International Drug Name Search

BroveX PSE

Generic Name: brompheniramine and pseudoephedrine (BROM fen EER a meen and SOO doe ed FED rin)

Brand Names: Andehist NR Syrup, Bidhist-D, Bromaline, Bromhist Pediatric Drops, Bromhist-NR, BroveX PD, BroveX PSE, Brovex SR, Di-Bromm, Histex SR, J-TanD PD, Lodrane 12D, Lodrane 24D, Lodrane D, Lodrane Liquid, LoHist-12D, LoHist-PD, Q-Tapp, Sildec, Touro Allergy, Ultrabrom, Ultrabrom PD

What is BroveX PSE (brompheniramine and pseudoephedrine)?

Brompheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of brompheniramine and pseudoephedrine is used to treat sneezing, cough, runny or stuffy nose, itchy or watery eyes, hives, skin rash, itching, and other symptoms of allergies and the common cold.

Brompheniramine and pseudoephedrine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about BroveX PSE (brompheniramine and pseudoephedrine)?

There are many brands and forms of this medicine available and not all brands are listed on this leaflet.

Do not give this medication to a child younger than 2 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not use any other over-the-counter cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains an antihistamine or decongestant. Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body. Brompheniramine and pseudoephedrine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of this medication.

What should I discuss with my healthcare provider before taking BroveX PSE (brompheniramine and pseudoephedrine)?

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

Ask a doctor or pharmacist if it is safe for you to take brompheniramine and pseudoephedrine if you have:

• kidney disease;


• 
  

  diabetes;

  
  


• 
  

  glaucoma;

  
  


• 
  

  heart disease or high blood pressure;

  
  


• 
  

  diabetes;

  
  


• 
  

  a thyroid disorder;

  
  


• 
  

  an enlarged prostate; or

  
  


• 
  

  problems with urination.

  
  

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Brompheniramine and pseudoephedrine 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.

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

How should I take BroveX PSE (brompheniramine and pseudoephedrine)?

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

Do not give this medication to a child younger than 2 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Take this medicine with a full glass of water. Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time.

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

Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

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

This medication can cause you to have unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.

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

What happens if I miss a dose?

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

What happens if I overdose?

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

Overdose symptoms may include feeling restless or nervous, nausea, vomiting, stomach pain, dizziness, drowsiness, dry mouth, warmth or tingly feeling, or seizure (convulsions).

What should I avoid while taking BroveX PSE (brompheniramine and pseudoephedrine)?

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

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

Do not use any other over-the-counter cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains an antihistamine or decongestant.

BroveX PSE (brompheniramine and pseudoephedrine) 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:

• 
  

  fast, pounding, or uneven heartbeat;

  
  


• 
  

  confusion, hallucinations, unusual thoughts or behavior;

  
  


• 
  

  severe dizziness, anxiety, restless feeling, or nervousness;

  
  


• 
  

  increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);

  
  


• 
  

  confusion, hallucinations, unusual thoughts or behavior;

  
  


• 
  

  easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or

  
  


• 
  

  urinating less than usual or not at all.

  
  

Less serious side effects may include:

• 
  

  blurred vision;

  
  


• 
  

  dry mouth;

  
  


• 
  

  nausea, stomach pain, constipation;

  
  


• 
  

  mild loss of appetite, stomach upset;

  
  


• 
  

  warmth, tingling, or redness under your skin;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  restless or excitability (especially in children);

  
  


• 
  

  skin rash or itching;

  
  


• 
  

  dizziness, drowsiness;

  
  


• 
  

  problems with memory or concentration; or

  
  


• 
  

  ringing in your ears.

  
  

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 BroveX PSE (brompheniramine and pseudoephedrine)?

Sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by brompheniramine. Tell your doctor if you regularly use any of these medicines, or any other cold or allergy medications..

Tell your doctor about all other medications you use, especially:

• 
  

  medicines to treat high blood pressure;

  
  


• 
  

  a diuretic (water pill);

  
  


• 
  

  medication to treat irritable bowel syndrome;

  
  


• 
  

  bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol) or tolterodine (Detrol);

  
  


• 
  

  aspirin or salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others);

  
  


• 
  

  a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others; or

  
  


• 
  

  antidepressants such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others.

  
  

This list is not complete and there may be other drugs that can interact with brompheniramine and pseudoephedrine. 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 BroveX PSE resources

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

• Bidhist-D Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Bromfenex Controlled-Release and Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Lodrane D MedFacts Consumer Leaflet (Wolters Kluwer)

Compare BroveX PSE with other medications

• Hay Fever
• Nasal Congestion

Where can I get more information?

• Your pharmacist can provide more information about brompheniramine and pseudoephedrine.

See also: BroveX PSE side effects (in more detail)