Dacocilin may be available in the countries listed below.
Dicloxacillin sodium salt (a derivative of Dicloxacillin) is reported as an ingredient of Dacocilin in the following countries:
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Citafan may be available in the countries listed below.
Cytarabine is reported as an ingredient of Citafan in the following countries:
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Vinblastina Filaxis may be available in the countries listed below.
Vinblastine sulfate (a derivative of Vinblastine) is reported as an ingredient of Vinblastina Filaxis in the following countries:
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Comtrex G Frambuesa may be available in the countries listed below.
Benzocaine is reported as an ingredient of Comtrex G Frambuesa in the following countries:
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Zaart may be available in the countries listed below.
Losartan potassium salt (a derivative of Losartan) is reported as an ingredient of Zaart in the following countries:
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Bedozane may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Flunixin meglumine (a derivative of Flunixin) is reported as an ingredient of Bedozane in the following countries:
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Ticlopidina Winthrop may be available in the countries listed below.
Ticlopidine hydrochloride (a derivative of Ticlopidine) is reported as an ingredient of Ticlopidina Winthrop in the following countries:
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Donaren may be available in the countries listed below.
Trazodone hydrochloride (a derivative of Trazodone) is reported as an ingredient of Donaren in the following countries:
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Potassio cloruro B Braun may be available in the countries listed below.
Potassium Chloride is reported as an ingredient of Potassio cloruro B Braun in the following countries:
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In the US, Lanreotide (lanreotide systemic) is a member of the drug class somatostatin and somatostatin analogs and is used to treat Acromegaly.
US matches:
Rec.INN
H01CB03
0108736-35-2
C54-H69-N11-O10-S2
1096
Antineoplastic agent
Growth hormone release inhibiting hormone analogue (analogue of somatostatin)
3-(2-Naphthyl)-D-alanyl-L-cysteinyl-L-tyrosyl-D-tryptophyl-L-lysyl-L-valyl-L-cysteinyl-L-threoninamid, cycl.(2-7)-disulfid (IUPAC)
3-(2-Naphthyl)-D-alanyl-L-cysteinyl-L-tyrosyl-D-tryptophyl-L-lysyl-L-valyl-L-cysteinyl-L-threoninamide, cyclic (2->7)-disulfide (WHO)
L-Threoninamide, 3-(2-naphthalenyl)-D-alanyl-L-cysteinyl-L-tyrosyl-D-tryptophyl-L-lysyl-L-valyl-L-cysteinyl-, cyclic (2->7)-disulfide
International Drug Name Search
Glossary
| BAN | British Approved Name |
| DCF | Dénomination Commune Française |
| IUPAC | International Union of Pure and Applied Chemistry |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
| WHO | World Health Organization |
Restasis is a brand name of cyclosporine ophthalmic, approved by the FDA in the following formulation(s):
No. There is currently no therapeutically equivalent version of Restasis available.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Restasis. 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.
Witcop may be available in the countries listed below.
Aluminium Hydroxide is reported as an ingredient of Witcop in the following countries:
Magnesium Hydroxide is reported as an ingredient of Witcop in the following countries:
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Pepdine may be available in the countries listed below.
Famotidine is reported as an ingredient of Pepdine in the following countries:
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ratio-Fentanyl may be available in the countries listed below.
Fentanyl is reported as an ingredient of ratio-Fentanyl in the following countries:
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Magne-B6 may be available in the countries listed below.
Magnesium Lactate is reported as an ingredient of Magne-B6 in the following countries:
Pyridoxine is reported as an ingredient of Magne-B6 in the following countries:
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Cetirizina Idifarma may be available in the countries listed below.
Cetirizine dihydrochloride (a derivative of Cetirizine) is reported as an ingredient of Cetirizina Idifarma in the following countries:
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Humex toux sèche dextrométhorphane may be available in the countries listed below.
Dextromethorphan hydrobromide (a derivative of Dextromethorphan) is reported as an ingredient of Humex toux sèche dextrométhorphane in the following countries:
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Conaz may be available in the countries listed below.
Fluconazole is reported as an ingredient of Conaz in the following countries:
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Pulibex may be available in the countries listed below.
Aciclovir is reported as an ingredient of Pulibex in the following countries:
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Generic Name: neomycin, polymyxin b, and hydrocortisone (Otic route)
nee-oh-MYE-sin SUL-fate, pol-ee-MIX-in B SUL-fate, hye-droe-KOR-ti-sone
In the U.S.
Available Dosage Forms:
Therapeutic Class: Anti-Infective/Anti-Inflammatory Combination
Pharmacologic Class: Adrenal Glucocorticoid
Chemical Class: Neomycin
Neomycin, polymyxin B, and hydrocortisone is a combination antibiotic and cortisone-like medicine. It is used to treat infections of the ear canal and to help provide relief from redness, irritation, and discomfort of certain ear problems.
Neomycin, polymyxin B, and hydrocortisone preparation 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.
Although there is no specific information comparing use of otic neomycin, polymyxin B, and hydrocortisone preparation in children with use in other age groups, this preparation is not expected to cause different side effects or problems in children than it does in adults.
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. Although there is no specific information comparing use of otic neomycin, polymyxin B, and hydrocortisone preparation in the elderly with use in other age groups, this preparation is not expected to cause different side effects or problems in older people than it does in younger adults.
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | C | Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. |
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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
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.
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:
This section provides information on the proper use of a number of products that contain neomycin, polymyxin b, and hydrocortisone. It may not be specific to Oti-Sone. Please read with care.
You may warm the ear drops to body temperature (37 °C or 98.6 °F), but no higher, by holding the bottle in your hand for a few minutes before using the medicine. If the medicine gets too warm, it may break down and not work at all.
To use:
To help clear up your infection completely, keep using this medicine for the full time of treatment, even if your symptoms have disappeared. 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 1 week, or if they become worse, check with your doctor.
Do not use this medicine for more than 10 days unless otherwise directed by 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:
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: Oti-Sone side effects (in more detail)
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Dimefor may be available in the countries listed below.
Metformin is reported as an ingredient of Dimefor in the following countries:
Metformin hydrochloride (a derivative of Metformin) is reported as an ingredient of Dimefor in the following countries:
International Drug Name Search
Loperamid-Teva may be available in the countries listed below.
Loperamide hydrochloride (a derivative of Loperamide) is reported as an ingredient of Loperamid-Teva in the following countries:
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In some countries, this medicine may only be approved for veterinary use.
Rec.INN
0078771-13-8
C15-H14-Cl-N3-O3
319
Antidote: Benzodiazepine antagonsit
Ethyl 7-chloro-5,6-dihydro-5-methyl-6-oxo-4H-imidazo-[1,5-a][1,4]benzodiazepine-3-carboxylate
International Drug Name Search
Glossary
| IS | Inofficial Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Tizalin may be available in the countries listed below.
Tizanidine hydrochloride (a derivative of Tizanidine) is reported as an ingredient of Tizalin in the following countries:
International Drug Name Search
Paracap may be available in the countries listed below.
Paracetamol is reported as an ingredient of Paracap in the following countries:
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Macrofol Vitamin B12 & Folic Acid may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Cyanocobalamin is reported as an ingredient of Macrofol Vitamin B12 & Folic Acid in the following countries:
Folic Acid is reported as an ingredient of Macrofol Vitamin B12 & Folic Acid in the following countries:
International Drug Name Search
Korzem may be available in the countries listed below.
Diltiazem hydrochloride (a derivative of Diltiazem) is reported as an ingredient of Korzem in the following countries:
International Drug Name Search
Quer-Out may be available in the countries listed below.
Diclofenac sodium salt (a derivative of Diclofenac) is reported as an ingredient of Quer-Out in the following countries:
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Procet may be available in the countries listed below.
Cetirizine dihydrochloride (a derivative of Cetirizine) is reported as an ingredient of Procet in the following countries:
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Generic Name: brompheniramine (brome feh NEER a meen)
Brand Names: BroveX, BroveX CT, Dimetane, Dimetane Extentab, Dimetapp Allergy, Dimetapp Allergy Liquigel, Lodrane 12 Hour
Brompheniramine is an antihistamine. Brompheniramine blocks the effects of the naturally occurring chemical histamine in the body.
Brompheniramine is used to sneezing; runny nose; itching, watery eyes; hives; rashes; itching; and other symptoms of allergies and the common cold.
Brompheniramine may also be used for purposes other than those listed in this medication guide.
Before taking brompheniramine, talk to your doctor if you have
glaucoma or increased pressure in the eye;
a stomach ulcer;
an enlarged prostate, bladder problems or difficulty urinating;
an overactive thyroid (hyperthyroidism);
hypertension or any type of heart problems; or
asthma.
You may not be able to take brompheniramine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
Take brompheniramine exactly as directed on the package or as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
Brompheniramine can be taken with or without food.
To ensure that you get a correct dose, measure the liquid form of brompheniramine with a special dose-measuring spoon or cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.
Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication unless otherwise directed by your doctor.
Symptoms of a brompheniramine overdose may include extreme sleepiness, confusion, weakness, ringing in the ears, blurred vision, large pupils, dry mouth, flushing, fever, shaking, insomnia, hallucinations, and possibly seizures.
Do not take other over-the-counter cough, cold, allergy, diet, pain, or sleep medications while taking brompheniramine without first talking to your pharmacist or doctor. Other medications may also contain brompheniramine or other similar drugs, and you may accidentally take too much of these medicines.
Brompheniramine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if brompheniramine is taken with any of these medications.
Other, less serious side effects may be more likely to occur. Continue to take brompheniramine and talk to your doctor if you experience
sleepiness, fatigue, or dizziness;
headache;
dry mouth; or
difficulty urinating or an enlarged prostate.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Do not take other over-the-counter cough, cold, allergy, diet, pain, or sleep medications while taking brompheniramine without first talking to your pharmacist or doctor. Other medications may also contain brompheniramine or other similar drugs, and you may accidentally take too much of these medicines.
Brompheniramine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if brompheniramine is taken with any of these medications.
Drugs other than those listed here may also interact with brompheniramine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.
See also: Dimetane Extentab side effects (in more detail)
Nekacin may be available in the countries listed below.
Amikacin sulfate (a derivative of Amikacin) is reported as an ingredient of Nekacin in the following countries:
International Drug Name Search
Nurosolv may be available in the countries listed below.
Ibuprofen is reported as an ingredient of Nurosolv in the following countries:
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Thymovar may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Thymol is reported as an ingredient of Thymovar in the following countries:
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Ciflex Ariston may be available in the countries listed below.
Ciprofloxacin hydrochloride (a derivative of Ciprofloxacin) is reported as an ingredient of Ciflex Ariston in the following countries:
International Drug Name Search
Nelio may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Benazepril hydrochloride (a derivative of Benazepril) is reported as an ingredient of Nelio in the following countries:
International Drug Name Search
Milcopen may be available in the countries listed below.
Phenoxymethylpenicillin potassium (a derivative of Phenoxymethylpenicillin) is reported as an ingredient of Milcopen in the following countries:
International Drug Name Search
Afloyan may be available in the countries listed below.
Mirtazapine is reported as an ingredient of Afloyan in the following countries:
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The following drugs and medications are in some way related to, or used in the treatment of Chronic Lymphocytic Leukemia. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
See sub-topics
Medical Encyclopedia:
Harvard Health Guide:
Dehydrocortison may be available in the countries listed below.
Prednisone is reported as an ingredient of Dehydrocortison in the following countries:
International Drug Name Search
Pramipex may be available in the countries listed below.
Pramipexole is reported as an ingredient of Pramipex in the following countries:
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Cefradina La Santé may be available in the countries listed below.
Cefradine is reported as an ingredient of Cefradina La Santé in the following countries:
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Cyproteron PCH may be available in the countries listed below.
Cyproterone 17α-acetate (a derivative of Cyproterone) is reported as an ingredient of Cyproteron PCH in the following countries:
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Amiphos may be available in the countries listed below.
Amifostine is reported as an ingredient of Amiphos in the following countries:
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ratio-Glyburide may be available in the countries listed below.
Glibenclamide is reported as an ingredient of ratio-Glyburide in the following countries:
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Lorazepam Cinfa may be available in the countries listed below.
Lorazepam is reported as an ingredient of Lorazepam Cinfa in the following countries:
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Class: Tricyclics and Other Norepinephrine-reuptake Inhibitors
VA Class: CN601
Chemical Name: 1-Propamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-, hydrochloride
Molecular Formula: C19H21NO HCL
CAS Number: 1229-29-4
Brands: Sinequan
Antidepressants may increase risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (18–24 years of age) with major depressive disorder and other psychiatric disorders; balance this risk with clinical need.h i Doxepin is not approved for use in pediatric patients <12 years of age.a k l (See Pediatric Use under Cautions.)
In pooled data analyses, risk of suicidality was not increased in adults >24 years of age and apparently was reduced in adults ≥65 years of age with antidepressant therapy compared with placebo.h i
Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide.h i j
Appropriately monitor and closely observe all patients who are started on doxepin therapy for clinical worsening, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process.h i j (See Worsening of Depression and Suicidality Risk and Pediatric Use under Cautions.)
REMS:
FDA approved a REMS for doxepin to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of doxepin and consists of the following: medication guide. See the FDA REMS page () or the ASHP REMS Resource Center ().
Dibenzoxepin-derivative tricyclic antidepressant (TCA).a b c k l p
Treatment of depression and/or anxiety in psychoneurotic patients.a k l Psychoneurosis symptoms that respond well to doxepin include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension, and worry.a k l
Treatment of depression and/or anxiety associated with alcoholism.a k l (See Specific Drugs under Interactions.)
Treatment of depression and/or anxiety associated with organic disease; consider possible drug interactions if receiving other drugs concomitantly.a k l
Treatment of psychotic depressive disorders with associated anxiety, including involutional depression and manic-depressive disorders.a k l
Has been effective in the management of chronic idiopathic urticaria† and may be used as an alternative to antihistamines, which are generally considered first-line therapy in patients with this condition.n o v w
Allow at least 2 weeks to elapse between discontinuance of therapy with an MAO inhibitor and initiation of doxepin and vice versa.a c k l Also allow at least 5 weeks to elapse when switching from fluoxetine.a c k l
Monitor for possible worsening of depression, suicidality, or unusual changes in behavior, especially at the beginning of therapy or during periods of dosage adjustments.a h i j k (See Worsening of Depression and Suicidality Risk under Cautions.)
Avoid abrupt discontinuance of therapy in patients receiving high dosages for prolonged periods.a c k l To avoid withdrawal reactions, taper dosage gradually.a k l (See Withdrawal of Therapy under Cautions.)
Administer orally in up to 3 divided doses or as a single daily dose (if ≤150 mg); may administer once-daily doses at bedtime to reduce daytime sedation.a b k l
Dilute each dose of oral concentrate with 120 mL of water, whole or skim milk, or orange, grapefruit, tomato, prune, or pineapple juice just prior to administration; solution is physically incompatible with many carbonated beverages.a b Patients on methadone maintenance may mix doxepin oral concentrate and methadone syrup with Gatorade, lemonade, orange juice, sugar water, Tang, or water but not with grape juice.a b Bulk dilution and storage not recommended by manufacturer.a
Available as doxepin hydrochloride; dosage expressed in terms of doxepin.a b k l
Individualize dosage carefully according to individual requirements and response.a b k l
When administered as a single daily dose, the maximum daily dose recommended is 150 mg.a k l Commercially available 150-mg capsules of doxepin are intended for maintenance therapy only and are not recommended for initial therapy.a b k
Adolescents ≥12 years of age should receive dosage recommended for adults.a k l (See Adults under Dosage.)
Patients with illness of mild to moderate severity: Initially, 75 mg daily.a b k l May adjust dosage as necessary based on response.a k l Usual maintenance dosage: 75–150 mg daily.a k l
More seriously ill patients: Higher dosages may be necessary; gradually increase dosage to ≤300 mg daily, if necessary.a k l
Dosages >300 mg daily rarely provide additional therapeutic effect.a b k l
Patients with very mild symptomatology or emotional symptoms associated with organic brain syndrome: Lower dosages may be adequate; some patients respond to 25–50 mg daily.a b k l
Adolescents ≥12 years of age: Maximum 300 mg daily.a b k l
Maximum 300 mg daily.a b k l
Select dosage at the lower end of recommended range since decreased hepatic, renal, or cardiac function and concomitant illness and medications are more frequent; increase dosage more gradually and monitor closely.a k l May administer before bedtime.a (See Geriatric Use under Cautions.)
Although the manufacturers do not state that doxepin is contraindicated in patients receiving MAO inhibitors, concurrent or recent (i.e., within 2 weeks) therapy with MAO inhibitors generally is contraindicated in patients receiving TCAs. a c k l (See MAO Inhibitors under Interactions.)
Glaucoma or urinary retention.a k l
Known hypersensitivity to doxepin or other dibenzoxepin-derivative TCAs.a k l
Shares the toxic potentials of other TCAs; observe the usual precautions of TCA therapy.a b c k l
Possible worsening of depression and/or emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior in both adult and pediatric patients with major depressive disorder, whether or not they are taking antidepressants; may persist until clinically important remission occurs.g h i j However, suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide.h i j
Appropriately monitor and closely observe patients receiving doxepin for any reason, particularly during initiation of therapy (i.e., the first few months) and during periods of dosage adjustments.h i j (See Boxed Warning and also see Pediatric Use under Cautions.)
Anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and/or mania may be precursors to emerging suicidality.i j Consider changing or discontinuing therapy in patients whose depression is persistently worse or in those with emerging suicidality or symptoms that might be precursors to worsening depression or suicidality, particularly if severe, abrupt in onset, or not part of patient’s presenting symptoms.h i j (See General under Dosage and Administration.)
Prescribe in smallest quantity consistent with good patient management to reduce risk of overdosage.a c d i k l
Observe these precautions for patients with psychiatric (e.g., major depressive disorder, obsessive-compulsive disorder [OCD]) or nonpsychiatric disorders.i
May unmask bipolar disorder.i (See Activation of Mania or Hypomania under Cautions.) Doxepin is not approved for use in treating bipolar depression.k l
Screen for risk of bipolar disorder by obtaining detailed psychiatric history (e.g., family history of suicide, bipolar disorder, depression) prior to initiating therapy.a i k l
Possible sensitivity reactions including skin rash, photosensitization, edema, and pruritus.a k
Possible activation of mania and hypomania, particularly in patients with bipolar disorder; decrease dosage and/or administer an antipsychotic agent concomitantly.a c k l (See Bipolar Disorder under Cautions.)
Mental alertness or physical coordination required for performing hazardous tasks (e.g., driving, operating machinery) may be impaired.a c k l
Response to alcohol may be potentiated.a c k l
Use with caution in patients for whom excess anticholinergic activity could be harmful (e.g., history of urinary retention, increased IOP).a c k l (See Contraindications under Cautions.)
Possibly severe withdrawal reactions; avoid abrupt discontinuance of therapy and taper dosage gradually.a c k l
Possible exacerbation of psychosis in patients with schizophrenia; decrease dosage or administer an antipsychotic agent concomitantly.a c k l
Category C.e
Distributes into milk;100 101 a c e k l r s some clinicians recommend that breast-feeding be avoided during doxepin therapy.e r s
Safety of doxepin in pediatric patients <12 years of age has not been established.a c k l
FDA warns that a greater risk of suicidal thinking or behavior (suicidality) occurred during first few months of antidepressant treatment (4%) compared with placebo (2%) in children and adolescents with major depressive disorder, OCD, or other psychiatric disorders based on pooled analyses of 24 short-term, placebo-controlled trials of 9 antidepressant drugs (SSRIs and others).a i k However, a more recent meta-analysis of 27 placebo-controlled trials of 9 antidepressants (SSRIs and others) in patients <19 years of age with major depressive disorder, OCD, or non-OCD anxiety disorders suggests that the benefits of antidepressant therapy in treating these conditions may outweigh the risks of suicidal behavior or suicidal ideation.g No suicides occurred in these pediatric trials.a g i k
Carefully consider these findings when assessing potential benefits and risks of doxepin in a child or adolescent for any clinical use.a g h i j k l (See Worsening of Depression and Suicidality Risk under Cautions.)
Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.a k l
In pooled data analyses, a reduced risk of suicidality was observed in adults ≥65 years of age with antidepressant therapy compared with placebo.h i (See Boxed Warning and also see Worsening of Depression and Suicidality Risk under Cautions.)
Doxepin generally is well tolerated in geriatric patients.a k l Possible increased sensitivity to anticholinergic (e.g., dry mouth, constipation, vision disturbance), cardiovascular, orthostatic hypotension, and sedative effects of TCAs.k l
Titrate dosage carefully.a k l (See Geriatric Patients under Dosage and Administration.)
Drowsiness, anticholinergic effects (e.g., dry mouth, constipation, blurred vision), GI effects (e.g., nausea, vomiting, diarrhea).a c k l m n o
Metabolized in the liver by various CYP isoenzymes (e.g., CYP1A2, CYP2D6, CYP3A4).a k l
Inhibitors of CYP2D6: potential pharmacokinetic interaction (increased plasma doxepin concentrations) with concomitant use of CYP2D6 inhibitors; use with caution.a k l Consider doxepin dosage adjustment whenever a CYP2D6 inhibitor is added or discontinued.a k l
Drug | Interaction | Comments |
|---|---|---|
Alcohol | Potentiates the effects of alcoholc k l | Avoid concomitant usea k l Increased risks if overdose or suicide attempt occursa k l |
Antiarrhythmics: class 1C (e.g., flecainide, propafenone); quinidine | Potential for decreased doxepin metabolisma c k l | Monitor for TCA toxicity; dosage adjustment may be neededa c k l |
Anticholinergic agents | Hyperthermia, particularly during hot weather, and paralytic ileus possible c | Use with caution; dosage adjustment may be neededc |
Antipsychotics (e.g., phenothiazines) | Potential for decreased doxepin metabolisma c k l | Dosage adjustment may be neededa c k l |
Cimetidine | Possible increased plasma doxepin concentrationsa k l t u Potential for tricyclic toxicity, particularly anticholinergic adverse effectsa c k l t u | Monitor for TCA toxicity; dosage adjustment may be neededc u |
CNS depressants (e.g., analgesics, antihistamines, barbiturates, general anesthetics, opiates) | Potentiates the effects of CNS depressantsc | |
Guanethidine and related compounds | Antagonizes the antihypertensive effects of guanethidine and related compounds at doxepin dosages >150 mg daily; at dosages ≤150 mg daily, antagonism of antihypertensive effects not reporteda c k l | |
Levodopa | May interfere with levodopa absorptionc | Monitor levodopa dosage carefullyc |
MAO inhibitors | Potentially life-threatening serotonin syndrome a c k l | Concomitant use with TCAs generally contraindicateda c k l Allow at least 2 weeks to elapse when switching to or from these drugsa c k l |
Methylphenidate | Potential for decreased metabolism and increased therapeutic efficacy and toxicity of TCAsc | |
SSRIs (e.g., citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline) | Possible serotonin syndromec Potential for decreased doxepin metabolism and increased plasma concentrationsa c k l | Use with caution and monitor for TCA toxicity; dosage adjustment may be neededa c k l Allow at least 5 weeks to elapse when switching from fluoxetinea c k l |
Sympathomimetic agents (e.g., amphetamines, epinephrine, isoproterenol, norepinephrine, phenylephrine) | Increased vasopressor and/or cardiac effectsc | Use with caution; dosage adjustment may be requiredc |
Thyroid agents | Possible cardiac arrhythmiasc | Use with caution c |
Tolazamide | Severe hypoglycemia reported in at least one patienta k l |
Rapidly absorbed from the GI tract following oral administration; bioavailability averages approximately 30%.b c m p q
Peak plasma concentrations usually occur within 2 hours after oral administration.b m p q
Anxiolytic effect occurs prior to antidepressant effect; antidepressant effect usually occurs within 2–3 weeks.a k l
Doxepin and its active N-demethylated metabolite are distributed into milk in concentrations ranging from about 30–140% and 10–115%, respectively, of those in maternal serum.100 101 a c e k l r s Substantial concentrations of the active metabolite have been detected in the serum and urine of nursing infants whose mothers were receiving 75–150 mg of doxepin daily.100 101
Highly bound to plasma protein.c p
Extensively metabolized in the liver by various CYP isoenzymes (principally CYP2D6; also CYP1A2, CYP3A4); undergoes demethylation to pharmacologically active metabolite, N-desmethyldoxepin.a b k m p q Poor metabolizers of CYP2D6 metabolize the drug more slowly than normal metabolizers.a k l
Excreted principally in urine.c
6–24.5 hours.b m n p x
Tight, light-resistant containers at 15–30°C.b k
Tight, light-resistant containers at 20–25°C.b l
Mechanism of action in the management of depressive and anxiety disorders is unknown but may involve inhibition of reuptake of norepinephrine.a k l
Exhibits anticholinergic, antihistaminic, antiserotonergic, and antiadrenergic activity.a c f k l n o
Associated with more frequent anticholinergic, sedative, and cardiovascular effects and weight gain than SSRIs.c
Risk of suicidality; importance of patients, family, and caregivers being alert to and immediately reporting emergence of suicidality, worsening depression, or unusual changes in behavior, especially during the first few months of therapy or during periods of dosage adjustment.a d h i j k l FDA recommends providing written patient information (medication guide) explaining risks of suicidality each time the drug is dispensed.a h i j k l
Importance of avoiding certain activities (e.g., operating machinery, driving a motor vehicle) until effects on the individual are known.a k l
Risk of concomitant use with alcohol.a k l
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.a k l
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses or planned surgery.a k l
Importance of informing patients of other important precautionary information.a k l (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Capsules | 10 mg (of doxepin)* | Sinequan (with parabens) | Pfizer |
Doxepin Hydrochloride Capsules | Watson | |||
25 mg (of doxepin)* | Sinequan (with parabens) | Pfizer | ||
Doxepin Hydrochloride Capsules | Watson | |||
50 mg (of doxepin)* | Sinequan (with parabens) | Pfizer | ||
Doxepin Hydrochloride Capsules | Watson | |||
75 mg (of doxepin)* | Sinequan (with parabens) | Pfizer | ||
Doxepin Hydrochloride Capsules | Watson | |||
100 mg (of doxepin)* | Sinequan (with parabens) | Pfizer | ||
Doxepin Hydrochloride Capsules | Watson | |||
150 mg (of doxepin)* | Sinequan (with parabens) | Pfizer | ||
Solution, concentrate | 10 mg (of doxepin) per mL* | Sinequan Oral Concentrate (with parabens) | Pfizer | |
Doxepin Hydrochloride Oral Solution (Concentrate) (with parabens) | Teva |
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 10/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Doxepin HCl 10MG Capsules (MYLAN): 90/$28.99 or 180/$39.97
Doxepin HCl 10MG/ML Concentrate (TEVA PHARMACEUTICALS USA): 120/$23.99 or 360/$49.97
Doxepin HCl 100MG Capsules (MYLAN): 30/$25.99 or 60/$37.97
Doxepin HCl 150MG Capsules (PAR): 30/$25.99 or 90/$55.96
Doxepin HCl 25MG Capsules (PAR): 60/$13.99 or 120/$19.98
Doxepin HCl 50MG Capsules (MYLAN): 60/$24.99 or 180/$52.97
Doxepin HCl 75MG Capsules (MYLAN): 30/$22.99 or 90/$43.97
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions October 27, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
100. Matheson I, Pande H, Alertsen AR. Respiratory depression caused by N-desmethyldoxepin in breast milk. Lancet. 1985; 2:1124. [IDIS 207267] [PubMed 2865592]
101. Kemp J, Ilett KF, Booth J et al. Excretion of doxepin and N-desmethyldoxepin in human milk. Br J Clin Pharmacol. 1985; 20:497-9. [IDIS 210580] [PubMed 4074620]
102. Pfizer Roerig. Sinequan (doxepin hydrochloride) capsules and oral concentrate prescribing information. New York, NY; 2000 Apr.
103. Food and Drug Administration. Class suicidality labeling language for antidepressants. From the FDA website: ().
104. Food and Drug Administration. Public health advisory: suicidality in children and adolescents being treated with antidepressant medications. Rockville, MD; 2004 Oct 15. From the FDA website: ().
105. Food and Drug Administration. Medication guide: about using antidepressants in children or teenagers. Rockville, MD; 2005 Jan 16. From the FDA website: ().
a. Pfizer Inc. Sinequan(doxepin hydrochloride) capsules and oral concentrate prescribing information. New York, NY; 2005 Jan.
b. AHFS drug information 2007. McEvoy GK, ed. Doxepin hydrochloride. Bethesda, MD: American Society of Health-System Pharmacists; 2007:2373-74.
c. AHFS drug information 2007. McEvoy GK, ed. Tricyclic antidepressant general statement. Bethesda, MD: American Society of Health-System Pharmacists; 2007:2353-60.
d. American Psychiatric Association Practice Guidelines. Practice guideline for the treatment of patients with major depressive disorder, second edition. From the APA website ().
e. Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation. 7th ed. Baltimore, MD: Williams & Wilkins; 2005:513-16.
f. Neittaanmaki H, Myohanen T, Fraki JE. Comparison of cinnarizine, cyproheptadine, doxepin, and hydroxyzine in treatment of idiopathic cold urticaria: usefulness of doxepin. J Am Acad Dermatol. 1984; 11:483-9. [PubMed 6480953]
g. Bridge JA, Iyengar S, Salary CB. Clinical response and risk for reported suicidal ideation and suicide attempts in pediatric antidepressant treatment: a meta-analysis of randomized controlled trials. JAMA. 2007; 297:1683-96. [PubMed 17440145]
h. Food and Drug Administration. FDA news: FDA proposes new warnings about suicidal thinking, behavior in young adults who take antidepressant medications. Rockville, MD; 2007 May 2. From the FDA web site: .
i. Food and Drug Administration. Antidepressant use in children, adolescents, and adults: class revisions to product labeling. Rockville, MD; 2007 May 2. From the FDA web site: .
j. Food and Drug Administration. Revisions to medication guide: antidepressant medicines, depression and other serious mental illnesses and suicidal thoughts or actions. Rockville, MD; 2007 May 2. From the FDA web site:
k. Watson Laboratories, Inc. Doxepin hydrochloride capsule prescribing information. Corona, CA; 2005 May.
l. Teva Pharmaceuticals USA. Doxepin hydrochloride oral concentrate prescribing information. Sellersville, PA; 2005 Jul.
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