Lotrial may be available in the countries listed below.
Enalapril is reported as an ingredient of Lotrial in the following countries:
Enalapril maleate (a derivative of Enalapril) is reported as an ingredient of Lotrial in the following countries:
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Mesatec may be available in the countries listed below.
Mesalazine is reported as an ingredient of Mesatec in the following countries:
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Wanmycin may be available in the countries listed below.
Doxycycline hydrochloride (a derivative of Doxycycline) is reported as an ingredient of Wanmycin in the following countries:
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Ceftriaxon MIP may be available in the countries listed below.
Ceftriaxone is reported as an ingredient of Ceftriaxon MIP in the following countries:
Ceftriaxone disodium salt (a derivative of Ceftriaxone) is reported as an ingredient of Ceftriaxon MIP in the following countries:
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Amlodipino Synthelabo may be available in the countries listed below.
Amlodipine besilate (a derivative of Amlodipine) is reported as an ingredient of Amlodipino Synthelabo in the following countries:
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Paclimedac may be available in the countries listed below.
Paclitaxel is reported as an ingredient of Paclimedac in the following countries:
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Loratadin axcount may be available in the countries listed below.
Loratadine is reported as an ingredient of Loratadin axcount in the following countries:
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Otedram may be available in the countries listed below.
Bromazepam is reported as an ingredient of Otedram in the following countries:
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Spiron may be available in the countries listed below.
Risperidone is reported as an ingredient of Spiron in the following countries:
Spironolactone is reported as an ingredient of Spiron in the following countries:
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Selegilin Sandoz may be available in the countries listed below.
Selegiline hydrochloride (a derivative of Selegiline) is reported as an ingredient of Selegilin Sandoz in the following countries:
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Voltaren Plus may be available in the countries listed below.
Codeine phosphate hemihydrate (a derivative of Codeine) is reported as an ingredient of Voltaren Plus in the following countries:
Diclofenac sodium salt (a derivative of Diclofenac) is reported as an ingredient of Voltaren Plus in the following countries:
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In the US, Nitro-Dur (nitroglycerin systemic) is a member of the following drug classes: antianginal agents, vasodilators and is used to treat Angina, Angina Pectoris Prophylaxis, Heart Attack, Heart Failure and High Blood Pressure.
US matches:
UK matches:
Nitroglycerin is reported as an ingredient of Nitro-Dur in the following countries:
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Glossary
| SPC | Summary of Product Characteristics (UK) |
In the US, Ritodrine (ritodrine systemic) is a member of the drug class tocolytic agents and is used to treat Premature Labor.
US matches:
Rec.INN
G02CA01
0026652-09-5
C17-H21-N-O3
287
ß₂-Sympathomimetic agent
Uterorelaxant
Benzenemethanol, 4-hydroxy-α-[1-[[2-(4-hydroxyphenyl)ethyl]amino]ethyl]-, (R*,S*)-
International Drug Name Search
Glossary
| BAN | British Approved Name |
| BANM | British Approved Name (Modified) |
| DCF | Dénomination Commune Française |
| DCIT | Denominazione Comune Italiana |
| IS | Inofficial Synonym |
| JAN | Japanese Accepted Name |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
Labocne may be available in the countries listed below.
Erythromycin is reported as an ingredient of Labocne in the following countries:
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Pirofel may be available in the countries listed below.
Piroxicam is reported as an ingredient of Pirofel in the following countries:
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Demizolam may be available in the countries listed below.
Midazolam is reported as an ingredient of Demizolam in the following countries:
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Elitos may be available in the countries listed below.
Oxeladin citrate (a derivative of Oxeladin) is reported as an ingredient of Elitos in the following countries:
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Heartcare Aspirin may be available in the countries listed below.
Acetylsalicylic Acid is reported as an ingredient of Heartcare Aspirin in the following countries:
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Metform may be available in the countries listed below.
Metformin hydrochloride (a derivative of Metformin) is reported as an ingredient of Metform in the following countries:
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Lisoril may be available in the countries listed below.
Lisinopril is reported as an ingredient of Lisoril in the following countries:
Lisinopril dihydrate (a derivative of Lisinopril) is reported as an ingredient of Lisoril in the following countries:
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Anprometazina may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Sulfadimidine is reported as an ingredient of Anprometazina in the following countries:
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Squint may be available in the countries listed below.
Benzylpenicillin potassium (a derivative of Benzylpenicillin) is reported as an ingredient of Squint in the following countries:
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Ketzole may be available in the countries listed below.
Ketoconazole is reported as an ingredient of Ketzole in the following countries:
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Mirtazapine Ratiopharm may be available in the countries listed below.
Mirtazapine is reported as an ingredient of Mirtazapine Ratiopharm in the following countries:
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Doxazosina EG may be available in the countries listed below.
Doxazosin mesilate (a derivative of Doxazosin) is reported as an ingredient of Doxazosina EG in the following countries:
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Loratadina Alter may be available in the countries listed below.
Loratadine is reported as an ingredient of Loratadina Alter in the following countries:
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Durabeta may be available in the countries listed below.
Atenolol is reported as an ingredient of Durabeta in the following countries:
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Poslotle may be available in the countries listed below.
Calcitriol is reported as an ingredient of Poslotle in the following countries:
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Penicillin V Billix may be available in the countries listed below.
Phenoxymethylpenicillin potassium (a derivative of Phenoxymethylpenicillin) is reported as an ingredient of Penicillin V Billix in the following countries:
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Apo-Carbamazepine may be available in the countries listed below.
Carbamazepine is reported as an ingredient of Apo-Carbamazepine in the following countries:
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Mirtazapin Orion may be available in the countries listed below.
Mirtazapine is reported as an ingredient of Mirtazapin Orion in the following countries:
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Glucodex may be available in the countries listed below.
Gliclazide is reported as an ingredient of Glucodex in the following countries:
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Preventic-B may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Bendiocarb is reported as an ingredient of Preventic-B in the following countries:
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Pasta Devitalizzante may be available in the countries listed below.
Formaldehyde is reported as an ingredient of Pasta Devitalizzante in the following countries:
Lidocaine is reported as an ingredient of Pasta Devitalizzante in the following countries:
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Nucidol may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Dimpylate is reported as an ingredient of Nucidol in the following countries:
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Lacryvisc may be available in the countries listed below.
Carbomer is reported as an ingredient of Lacryvisc in the following countries:
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Lapicef may be available in the countries listed below.
Cefadroxil monohydrate (a derivative of Cefadroxil) is reported as an ingredient of Lapicef in the following countries:
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Unidox Solutab may be available in the countries listed below.
Doxycycline monohydrate (a derivative of Doxycycline) is reported as an ingredient of Unidox Solutab in the following countries:
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Qutenza is a brand name of capsaicin topical, approved by the FDA in the following formulation(s):
No. There is currently no therapeutically equivalent version of Qutenza available.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Qutenza. 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.
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.
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
Hexidine E may be available in the countries listed below.
Chlorhexidine digluconate (a derivative of Chlorhexidine) is reported as an ingredient of Hexidine E in the following countries:
International Drug Name Search
Ketomax may be available in the countries listed below.
Ketorolac is reported as an ingredient of Ketomax in the following countries:
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Laxadyl may be available in the countries listed below.
Bisacodyl is reported as an ingredient of Laxadyl in the following countries:
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Blocar may be available in the countries listed below.
Carvedilol is reported as an ingredient of Blocar in the following countries:
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Trimethoprim-Sulfadiazine may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Sulfadiazine is reported as an ingredient of Trimethoprim-Sulfadiazine in the following countries:
Trimethoprim is reported as an ingredient of Trimethoprim-Sulfadiazine in the following countries:
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Panfugan may be available in the countries listed below.
Mebendazole is reported as an ingredient of Panfugan in the following countries:
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In the US, Sucraid (sacrosidase systemic) is a member of the drug class digestive enzymes.
US matches:
Sacrosidase is reported as an ingredient of Sucraid in the following countries:
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Latrigil may be available in the countries listed below.
Lamotrigine is reported as an ingredient of Latrigil in the following countries:
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Gen-Naproxen EC may be available in the countries listed below.
Naproxen is reported as an ingredient of Gen-Naproxen EC in the following countries:
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See also: Generic Maxalt-MLT
Maxalt is a brand name of rizatriptan, approved by the FDA in the following formulation(s):
No. There is currently no therapeutically equivalent version of Maxalt available.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Maxalt. 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.
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.
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
Manti Gastop may be available in the countries listed below.
Simeticone is reported as an ingredient of Manti Gastop in the following countries:
International Drug Name Search
Oxfenil may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Oxfendazole is reported as an ingredient of Oxfenil in the following countries:
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Lysotear may be available in the countries listed below.
Lysozyme hydrochloride (a derivative of Lysozyme) is reported as an ingredient of Lysotear in the following countries:
International Drug Name Search
Ketorolac Northia may be available in the countries listed below.
Ketorolac is reported as an ingredient of Ketorolac Northia in the following countries:
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Novo Fosfostilben may be available in the countries listed below.
Diethylstilbestrol is reported as an ingredient of Novo Fosfostilben in the following countries:
International Drug Name Search
Generic Name: chloramphenicol (Ophthalmic route)
klor-am-FEN-i-kol
In the U.S.
In Canada
Available Dosage Forms:
Therapeutic Class: Antibiotic
Chemical Class: Chloramphenicol (class)
Chloramphenicol belongs to the family of medicines called antibiotics. Chloramphenicol ophthalmic preparations are used to treat infections of the eye. This medicine may be given alone or with other medicines that are taken by mouth for eye infections.
Chloramphenicol is available only with your doctor's prescription.
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:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of this medicine in children with use in other age groups.
Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of this medicine in the elderly with use in other age groups.
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.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is 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.
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.
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.
This section provides information on the proper use of a number of products that contain chloramphenicol. It may not be specific to Ocu-Chlor. Please read with care.
For patients using the eye drop form of chloramphenicol:
To use the eye ointment form of chloramphenicol:
To help clear up your infection completely, keep using this medicine for the full time of treatment, even if your symptoms begin to clear up after a few days. If you stop using this medicine too soon, your symptoms may return. Do not miss any doses.
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.
If you miss a dose of this medicine, apply 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.
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.
If your symptoms do not improve within a few days, or if they become worse, check with your doctor.
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:
Check with your doctor as soon as possible if any of the following side effects occur:
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:
After application, eye ointments may be expected to cause your vision to blur for a few minutes.
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.
The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.
Rilménidine Qualimed may be available in the countries listed below.
Rilmenidine dihydrogen phosphate (a derivative of Rilmenidine) is reported as an ingredient of Rilménidine Qualimed in the following countries:
International Drug Name Search
Apo-Ampi may be available in the countries listed below.
Ampicillin is reported as an ingredient of Apo-Ampi in the following countries:
International Drug Name Search
Lazar may be available in the countries listed below.
Betamethasone 17α-valerate (a derivative of Betamethasone) is reported as an ingredient of Lazar in the following countries:
International Drug Name Search
Mentopin may be available in the countries listed below.
Acetylcysteine is reported as an ingredient of Mentopin in the following countries:
International Drug Name Search
Regrow may be available in the countries listed below.
Dextromethorphan hydrobromide (a derivative of Dextromethorphan) is reported as an ingredient of Regrow in the following countries:
Minoxidil is reported as an ingredient of Regrow in the following countries:
International Drug Name Search
Drill toux sèche sans sucre enfant sirop may be available in the countries listed below.
Dextromethorphan hydrobromide (a derivative of Dextromethorphan) is reported as an ingredient of Drill toux sèche sans sucre enfant sirop in the following countries:
International Drug Name Search
Canimax may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Abamectin is reported as an ingredient of Canimax in the following countries:
Oxibendazole is reported as an ingredient of Canimax in the following countries:
Praziquantel is reported as an ingredient of Canimax in the following countries:
International Drug Name Search
Rec.INN
0000056-84-8
C4-H7-N-O4
133
Amino acid
Aspartic acid
L-Asparaginsäure (IUPAC)
L-Aspartic acid (WHO)
International Drug Name Search
Glossary
| DCF | Dénomination Commune Française |
| DCIT | Denominazione Comune Italiana |
| IUPAC | International Union of Pure and Applied Chemistry |
| IS | Inofficial Synonym |
| JAN | Japanese Accepted Name |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
| WHO | World Health Organization |
Rhinophenazol may be available in the countries listed below.
Antazoline sulfate (a derivative of Antazoline) is reported as an ingredient of Rhinophenazol in the following countries:
Naphazoline nitrate (a derivative of Naphazoline) is reported as an ingredient of Rhinophenazol in the following countries:
International Drug Name Search
Bromhexina may be available in the countries listed below.
Bromhexine is reported as an ingredient of Bromhexina in the following countries:
Bromhexine hydrochloride (a derivative of Bromhexine) is reported as an ingredient of Bromhexina in the following countries:
International Drug Name Search
Trolamine salicylate (a derivative of Trolamine) is reported as an ingredient of Mobisyl in the following countries:
International Drug Name Search
Nomégestrol EG may be available in the countries listed below.
Nomegestrol acetate (a derivative of Nomegestrol) is reported as an ingredient of Nomégestrol EG in the following countries:
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Femerital may be available in the countries listed below.
Paracetamol is reported as an ingredient of Femerital in the following countries:
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Laprost may be available in the countries listed below.
Latanoprost is reported as an ingredient of Laprost in the following countries:
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Laxomag may be available in the countries listed below.
Magnesium Hydroxide is reported as an ingredient of Laxomag in the following countries:
International Drug Name Search
Lidocain may be available in the countries listed below.
Lidocaine is reported as an ingredient of Lidocain in the following countries:
Lidocaine hydrochloride (a derivative of Lidocaine) is reported as an ingredient of Lidocain in the following countries:
Lidocaine hydrochloride monohydrate (a derivative of Lidocaine) is reported as an ingredient of Lidocain in the following countries:
International Drug Name Search
H.G. Ciprocap may be available in the countries listed below.
Ciprofloxacin is reported as an ingredient of H.G. Ciprocap in the following countries:
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Tekamlo is a brand name of aliskiren/amlodipine, approved by the FDA in the following formulation(s):
No. There is currently no therapeutically equivalent version of Tekamlo available.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Tekamlo. 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.
There are no current U.S. patents associated with Tekamlo.
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
Benaday may be available in the countries listed below.
Cetirizine dihydrochloride (a derivative of Cetirizine) is reported as an ingredient of Benaday in the following countries:
International Drug Name Search
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Doxepin hydrochloride or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Doxepin Hydrochloride Oral Solution is not approved for use in pediatric patients. (See Warnings: Clinical Worsening and Suicide Risk, Precautions: Information for Patients, and Precautions: Pediatric Use).
Doxepin hydrochloride is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. The molecular formula of the compound is C19H21NO•HCl having a molecular weight of 315.84. It is a white crystalline solid readily soluble in water, lower alcohols and chloroform.
Doxepin hydrochloride oral solution is available as a concentrate for oral administration containing Doxepin hydrochloride equivalent to 10 mg of Doxepin per mL. It also contains the following inactive ingredients: glycerin; methylparaben; peppermint flavor; propylparaben; water. May contain hydrochloric acid and/or sodium hydroxide.
CHEMISTRY
Doxepin hydrochloride is a dibenzoxepin derivative and is the first of a family of tricyclic psychotherapeutic agents. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz[b,e]oxepin-ll(6H)ylidene-N,N-dimethyl-, hydrochloride.
The mechanism of action of Doxepin hydrochloride is not definitely known. It is not a central nervous system stimulant nor a monoamine oxidase inhibitor. The current hypothesis is that the clinical effects are due, at least in part, to influences on the adrenergic activity at the synapses so that deactivation of norepinephrine by reuptake into the nerve terminals is prevented. Animal studies suggest that Doxepin hydrochloride does not appreciably antagonize the antihypertensive action of guanethidine. In animal studies anticholinergic, antiserotonin and antihistamine effects on smooth muscle have been demonstrated. At higher than usual clinical doses, norepinephrine response was potentiated in animals. This effect was not demonstrated in humans.
At clinical dosages up to 150 mg per day, Doxepin can be given to man concomitantly with guanethidine and related compounds without blocking the antihypertensive effect. At dosages above 150 mg per day blocking of the antihypertensive effect of these compounds has been reported.
Doxepin is virtually devoid of euphoria as a side effect. Characteristic of this type of compound, Doxepin has not been demonstrated to produce the physical tolerance or psychological dependence associated with addictive compounds.
Doxepin is recommended for the treatment of:
Doxepin is contraindicated in individuals who have shown hypersensitivity to the drug. Possibility of cross sensitivity with other dibenzoxepines should be kept in mind.
Doxepin is contraindicated in patients with glaucoma or a tendency to urinary retention. These disorders should be ruled out, particularly in older patients.
WARNINGS-Clinical Worsening and Suicide Risk
Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18-24) with major depressive disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction with antidepressants compared to placebo in adults aged 65 and older.
The pooled analyses of placebo-controlled trials in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4400 patients. The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences (drug vs placebo), however, were relatively stable within age strata and across indications. These risk differences (drug-placebo difference in the number of cases of suicidality per 1000 patients treated) are provided in Table 1.
| Age Range | Drug-Placebo Difference in Number of Cases of Suicidality per 1000 Patients Treated |
| Increases Compared to Placebo | |
| < 18 | 14 additional cases |
| 18 to 24 | 5 additional cases |
| Decreases Compared to Placebo | |
| 25 to 64 | 1 fewer case |
| ≥ 65 | 6 fewer cases |
Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with Doxepin Hydrochloride Oral Solution and should counsel them in its appropriate use. A patient Medication Guide about “Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions” is available for Doxepin Hydrochloride Oral Solution. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.
Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking Doxepin Hydrochloride Oral Solution.
Clinical Worsening and Suicide Risk: Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient’s prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient’s presenting symptoms.
Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication.
Pediatric Use: Safety and effectiveness in the pediatric population have not been established (see BOX WARNING and WARNINGS – Clinical Worsening and Suicide Risk). Anyone considering the use of Doxepin Hydrochloride Oral Solution in a child or adolescent must balance the potential risks with the clinical need.
Drug Interactions: Drugs Metabolized by P450 2D6: The biochemical activity of the drug metabolizing isozyme cytochrome P450 2D6 (debrisoquin hydroxylase) is reduced in a subset of the Caucasian population (about 7-10% of Caucasians are so-called “poor metabolizers”); reliable estimates of the prevalence of reduced P450 2D6 isozyme activity among Asian, African and other populations are not yet available. Poor metabolizers have higher than expected plasma concentrations of tricyclic antidepressants (TCAs) when given usual doses. Depending on the fraction of drug metabolized by P450 2D6, the increase in plasma concentration may be small, or quite large (8-fold increase in plasma AUC of the TCA).
In addition, certain drugs inhibit the activity of this isozyme and make normal metabolizers resemble poor metabolizers. An individual who is stable on a given dose of TCA may become abruptly toxic when given one of these inhibiting drugs as concomitant therapy. The drugs that inhibit cytochrome P450 2D6 include some that are not metabolized by the enzyme (quinidine; cimetidine) and many that are substrates for P450 2D6 (many other antidepressants, phenothiazines, and the Type 1C antiarrhythmics propafenone and flecainide). While all the selective serotonin reuptake inhibitors (SSRIs), e.g., citalopram, escitalopram, fluoxetine, sertraline, and paroxetine, inhibit P450 2D6, they may vary in the extent of inhibition. The extent to which SSRI-TCA interactions may pose clinical problems will depend on the degree of inhibition and the pharmacokinetics of the SSRI involved. Nevertheless, caution is indicated in the coadministration of TCAs with any of the SSRIs and also in switching from one class to the other. Of particular importance, sufficient time must elapse before initiating TCA treatment in a patient being withdrawn from fluoxetine, given the long half-life of the parent and active metabolite (at least 5 weeks may be necessary).
Concomitant use of tricyclic antidepressants with drugs that can inhibit cytochrome P450 2D6 may require lower doses than usually prescribed for either the tricyclic antidepressant or the other drug. Furthermore, whenever one of these other drugs is withdrawn from co-therapy, an increased dose of tricyclic antidepressant may be required. It is desirable to monitor TCA plasma levels whenever a TCA is going to be coadministered with another drug known to be an inhibitor of P450 2D6.
Doxepin is primarily metabolized by CYP2D6 (with CYP1A2 & CYP3A4 as minor pathways) inhibitors or substrates of CYP2D6 (i.e., quinidine, selective serotonin reuptake inhibitors [SSRIs]) may increase the plasma concentration of Doxepin when administered concomitantly. The extent of interaction depends on the variability of effect on CYP2D6. The clinical significance of this interaction with Doxepin has not been systematically evaluated.
MAO Inhibitors: Serious side effects and even death have been reported following the concomitant use of certain drugs with MAO inhibitors. Therefore, MAO inhibitors should be discontinued at least two weeks prior to the cautious initiation of therapy with Doxepin. The exact length of time may vary and is dependent upon the particular MAO inhibitor being used, the length of time it has been administered, and the dosage involved.
Cimetidine: Cimetidine has been reported to produce clinically significant fluctuations in steady-state serum concentrations of various tricyclic antidepressants. Serious anticholinergic symptoms (i.e., severe dry mouth, urinary retention and blurred vision) have been associated with elevations in the serum levels of tricyclic antidepressant when cimetidine therapy is initiated. Additionally, higher than expected tricyclic antidepressant levels have been observed when they are begun in patients already taking cimetidine. In patients who have been reported to be well controlled on tricyclic antidepressants receiving concurrent cimetidine therapy, discontinuation of cimetidine has been reported to decrease established steady-state serum tricyclic antidepressant levels and compromise their therapeutic effects.
Alcohol: It should be borne in mind that alcohol ingestion may increase the danger inherent in any intentional or unintentional Doxepin overdosage. This is especially important in patients who may use alcohol excessively.
Tolazamide: A case of severe hypoglycemia has been reported in a type II diabetic patient maintained on tolazamide (1 gm/day) 11 days after the addition of Doxepin (75 mg/day).
Drowsiness: Since drowsiness may occur with the use of this drug, patients should be warned of the possibility and cautioned against driving a car or operating dangerous machinery while taking the drug. Patients should also be cautioned that their response to alcohol may be potentiated.
Sedating drugs may cause confusion and over sedation in the elderly; elderly patients generally should be started on low doses of Doxepin and observed closely (see PRECAUTIONS – Geriatric Use).
Suicide: Since suicide is an inherent risk in any depressed patient and may remain so until significant improvement has occurred, patients should be closely supervised during the early course of therapy. Prescriptions should be written for the smallest feasible amount.
Geriatric Use: A determination has not been made whether controlled clinical studies of Doxepin included sufficient numbers of subjects aged 65 and over to define a difference in response 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.
The extent of renal excretion of Doxepin has not been determined. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selections.
Sedating drugs may cause confusion and over sedation in the elderly; elderly patients generally should be started on low doses of Doxepin and observed closely. (See WARNINGS).
NOTE: Some of the adverse reactions noted below have not been specifically reported with Doxepin use. However, due to the close pharmacological similarities among the tricyclics, the reactions should be considered when prescribing Doxepin hydrochloride.
Anticholinergic Effects: Dry mouth, blurred vision, constipation, and urinary retention have been reported. If they do not subside with continued therapy, or become severe, it may be necessary to reduce the dosage.
Central Nervous System Effects: Drowsiness is the most commonly noticed side effect. This tends to disappear as therapy is continued. Other infrequently reported CNS side effects are confusion, disorientation, hallucinations, numbness, paresthesias, ataxia, extrapyramidal symptoms, seizures, tardive dyskinesia, and tremor.
Cardiovascular: Cardiovascular effects including hypotension, hypertension, and tachycardia have been reported occasionally.
Allergic: Skin rash, edema, photosensitization, and pruritus have occasionally occurred.
Hematologic: Eosinophilia has been reported in a few patients. There have been occasional reports of bone marrow depression manifesting as agranulocytosis, leukopenia, thrombocytopenia, and purpura.
Gastrointestinal: Nausea, vomiting, indigestion, taste disturbances, diarrhea, anorexia, and aphthous stomatitis have been reported. (See Anticholinergic Effects.)
Endocrine: Raised or lowered libido, testicular swelling, gynecomastia in males, enlargement of breasts and galactorrhea in the female, raising or lowering of blood sugar levels, and syndrome of inappropriate antidiuretic hormone secretion have been reported with tricyclic administration.
Other: Dizziness, tinnitus, weight gain, sweating, chills, fatigue, weakness, flushing, jaundice, alopecia, headache, exacerbation of asthma, and hyperpyrexia (in association with chlorpromazine) have been occasionally observed as adverse effects.
Withdrawal Symptoms: The possibility of development of withdrawal symptoms upon abrupt cessation of treatment after prolonged Doxepin administration should be borne in mind. These are not indicative of addiction and gradual withdrawal of medication should not cause these symptoms.
Deaths may occur from overdosage with this class of drugs. Multiple drug ingestion (including alcohol) is common in deliberate tricyclic antidepressant overdose. As the management is complex and changing, it is recommended that the physician contact a poison control center for current information on treatment. Signs and symptoms of toxicity develop rapidly after tricyclic antidepressant overdose; therefore, hospital monitoring is required as soon as possible.
Manifestations: Critical manifestations of overdose include: cardiac dysrhythmias, severe hypotension, convulsions, and CNS depression, including coma. Changes in the electrocardiogram, particularly in QRS axis or width, are clinically significant indicators of tricyclic antidepressant toxicity.
Other signs of overdose may include: confusion, disturbed concentration, transient visual hallucinations, dilated pupils, agitation, hyperactive reflexes, stupor, drowsiness, muscle rigidity, vomiting, hypothermia, hyperpyrexia, or any of the symptoms listed under ADVERSE REACTIONS.
Deaths have been reported involving overdose of Doxepin.
General Recommendations:
General: Obtain an ECG and immediately initiate cardiac monitoring. Protect the patient's airway, establish an intravenous line and initiate gastric decontamination. A minimum of six hours of observation with cardiac monitoring and observation for signs of CNS or respiratory depression, hypotension, cardiac dysrhythmias and/or conduction blocks, and seizures is strongly advised. If signs of toxicity occur at any time during this period, extended monitoring is recommended. There are case reports of patients succumbing to fatal dysrhythmias late after overdose; these patients had clinical evidence of significant poisoning prior to death and most received inadequate gastrointestinal decontamination. Monitoring of plasma drug levels should not guide management of the patient.
Gastrointestinal Decontamination: All patients suspected of tricyclic antidepressant overdose should receive gastrointestinal decontamination. This should include large volume gastric lavage followed by activated charcoal. If consciousness is impaired, the airway should be secured prior to lavage. Emesis is contraindicated.
Cardiovascular: A maximal limb-lead QRS duration of ≥ 0.10 seconds may be the best indication of the severity of the overdose. Intravenous sodium bicarbonate should be used to maintain the serum pH in the range of 7.45 to 7.55. If the pH response is inadequate, hyperventilation may also be used. Concomitant use of hyperventilation and sodium bicarbonate should be done with extreme caution, with frequent pH monitoring. A pH > 7.60 or a pCO2 <20 mm Hg is undesirable. Dysrhythmias unresponsive to sodium bicarbonate therapy/hyperventilation may respond to lidocaine, bretylium or phenytoin. Type lA and 1C antiarrhythmics are generally contraindicated (e.g., quinidine, disopyramide, and procainamide).
In rare instances, hemoperfusion may be beneficial in acute refractory cardiovascular instability in patients with acute toxicity. However, hemodialysis, peritoneal dialysis, exchange transfusions, and forced diuresis generally have been reported as ineffective in tricyclic antidepressant poisoning.
CNS: In patients with CNS depression, early intubation is advised because of the potential for abrupt deterioration. Seizures should be controlled with benzodiazepines, or if these are ineffective, other anticonvulsants (e.g., phenobarbital, phenytoin). Physostigmine is not recommended except to treat life-threatening symptoms that have been unresponsive to other therapies, and then only in consultation with a poison control center.
Psychiatric Follow-up: Since overdosage is often deliberate, patients may attempt suicide by other means during the recovery phase. Psychiatric referral may be appropriate.
Pediatric Management: The principles of management of child and adult overdosages are similar. It is strongly recommended that the physician contact the local poison control center for specific pediatric treatment.
For most patients with illness of mild to moderate severity, a starting daily dose of 75 mg is recommended. Dosage may subsequently be increased or decreased at appropriate intervals and according to individual response. The usual optimum dose range is 75mg/day to 150 mg/day.
In more severely ill patients higher doses may be required with subsequent gradual increase to 300 mg/day if necessary. Additional therapeutic effect is rarely to be obtained by exceeding a dose of 300 mg/day.
In patients with very mild symptomatology or emotional symptoms accompanying organic disease, lower doses may suffice. Some of these patients have been controlled on doses as low as 25-50 mg/day.
The total daily dosage of Doxepin may be given on a divided or once-a-day dosage schedule. If the once-a-day schedule is employed, the maximum recommended dose is 150 mg/day. This dose may be given at bedtime. Anti-anxiety effect is apparent before the antidepressant effect. Optimal antidepressant effect may not be evident for two to three weeks.
Doxepin Hydrochloride Oral Solution USP (Concentrate) is available in 120 mL bottles (NDC 54838-512-40) with an accompanying dropper calibrated at 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg. Each mL contains Doxepin hydrochloride equivalent to 10 mg Doxepin. Just prior to administration, Doxepin Hydrochloride Oral Solution USP (Concentrate) should be diluted with approximately 120 mL of water, whole or skimmed milk, or orange, grapefruit, tomato, prune or pineapple juice. Doxepin Hydrochloride Oral Solution USP (Concentrate) is not physically compatible with a number of carbonated beverages. For those patients requiring antidepressant therapy who are on methadone maintenance, Doxepin Hydrochloride Oral Solution USP (Concentrate) and methadone syrup can be mixed together with Gatorade®, lemonade, orange juice, sugar water, Tang® or water, but not with grape juice. Preparation and storage of bulk dilutions is not recommended.
Recommended Storage Store at 20°-25°C (68°-77°F); excursion permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].
Manufactured by:
Silarx Pharmaceuticals, Inc.
Spring Valley, New York 10977
Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions
Read the Medication Guide that comes with you or your family member's antidepressant medicine. This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. Talk to your, or your family member's, healthcare provider about:
| Doxepin HYDROCHLORIDE Doxepin hydrochloride solution | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA074721 | 12/29/1998 | |
| Labeler - Silarx Pharmaceuticals, Inc (161630033) |
