Doxepin Hydrochloride 50 mg Capsule, 100-count
Other active recalls for Doxepin Hydrochloride (different manufacturers) — 1 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Tricyclic Antidepressant class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Doxepin is used to treat depression and anxiety. Doxepin is in a class of medications called tricyclic antidepressants. It works by increasing the amounts of certain natural substances in the brain that are needed for mental balance. Doxepin is also available as a tablet to treat insomnia. This monograph only gives information about doxepin for depression or anxiety. If you are using this medication for insomnia, read the monograph entitled doxepin (insomnia).
Read the full MedlinePlus article ↗- Good question — doxepin does have a history as an antidepressant, but what you're being prescribed is a much lower-dose version specifically approved for sleep. It's used for peopl...
- What exactly is doxepin being used for here? I thought it was an antidepressant.
- Yes, timing really does matter. You should take doxepin at least 3 hours after your last meal — especially if that meal was high in fat. Eating close to your dose makes the medicat...
- Does it matter when I take it or if I eat first?
Patient education
Supplement & herbal interactions
Doxepin may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
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Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 8PJ61P6TS3
Butyl alcohol is a clear liquid organic solvent derived from petroleum or natural sources. In medicines, it helps dissolve active ingredients and serves as a solvent in liquid formulations and some topical products.
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UNII 35SW5USQ3G
A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
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UNII H3R47K3TBD
FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
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UNII L06K8R7DQK
A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
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UNII WZB9127XOA
A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
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UNII H77VEI93A8
A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
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UNII XM0M87F357
A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
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UNII 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII 46N107B71O
Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
16 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.154 | $15.35 / 100 capsules |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.4302 | $43.02 / 100 capsules |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Doxepin Hydrochloride 50 mg 00378-4250-01 | Mylan | 100 capsules | $0.153 | AB | Availability likely | — |
| Doxepin Hydrochloride 50 mg 00904-7054-61 | Major | 100 capsules | $0.153 | AB | Availability likely | — |
| Doxepin Hydrochloride 50 mg 23155-0796-01 | Heritage | 100 capsules | $0.153 | AB | Availability likely | — |
| Doxepin Hydrochloride 50 mgthis 24658-0795-01 | PURACAP | 100 capsules | $0.153 | AB | Availability likely | — |
| Doxepin hydrochloride 50 mg 27241-0169-01 | Ajanta | 100 capsules | $0.153 | AB | Availability likely | — |
| Doxepin Hydrochloride 50 mg 51079-0438-20 | Mylan | 100 capsules | $0.153 | AB | Availability likely | — |
| Doxepin Hydrochloride 50 mg 59651-0175-01 | Aurobindo | 100 capsules | $0.153 | AB | Availability likely | — |
| Doxepin Hydrochloride 50 mg 62135-0562-90 | Chartwell | 90 capsules | $0.153 | AB | Availability likely | — |
| Doxepin Hydrochloride 50 mg 62332-0645-31 | Alembic | 100 capsules | $0.153 | AB | Availability likely | — |
| Doxepin hydrochloride 50 mg 64980-0596-01 | Rising | 100 capsules | $0.153 | AB | Availability likely | — |
| Doxepin Hydrochloride 50 mg 70756-0426-11 | Lifestar | 100 capsules | $0.153 | AB | Availability likely | — |
| Doxepin Hydrochloride 50 mg 72205-0090-91 | Novadoz | 100 capsules | $0.153 | AB | Availability likely | — |
| Doxepin Hydrochloride 50 mg 72603-0392-01 | NorthStar | 100 capsules | $0.153 | AB | Availability likely | — |
| Doxepin Hydrochloride 50 mg 69315-0160-01 | Leading | 100 capsules | $0.285 | AB | FDA listed | +86% |
| Doxepin Hydrochloride 50 mg 71921-0164-01 | Florida | 100 capsules | $0.285 | AB | FDA listed | +86% |
| Doxepin Hydrochloride 50 mg 69238-1171-01 | Amneal | 1000 capsules | $0.366 | AB | FDA listed | +138% |
| Doxepin Hydrochloride 50 mg 10267-5061-04 | Contract | 1000 capsules | — | AB | FDA listed | — |
| Doxepin Hydrochloride 50 mg 42571-0422-01 | Micro | 100 capsules | — | AB | Discontinued | — |
| Doxepin Hydrochloride 50 mg 42806-0531-01 | Epic | 100 capsules | — | AB | FDA listed | — |
| Doxepin Hydrochloride 50 mg 46708-0645-31 | Alembic | 100 capsules | — | AB | FDA listed | — |
| Doxepin Hydrochloride 50 mg 48433-0037-20 | Safecor | 100 capsules | — | AB | FDA listed | — |
| Doxepin Hydrochloride 50 mg 50090-5286-01 | A-S | 30 capsules | — | — | FDA listed | — |
| Doxepin Hydrochloride 50 mg 50090-7184-01 | A-S | 30 capsules | — | AB | FDA listed | — |
| Doxepin Hydrochloride 50 mg 50090-7819-01 | A-S | 30 capsules | — | AB | FDA listed | — |
| Doxepin Hydrochloride 50 mg 55801-0529-01 | Appco | 100 capsules | — | AB | FDA listed | — |
| Doxepin hydrochloride 50 mg 67046-0394-03 | Coupler | 30 capsules | — | AB | FDA listed | — |
| Doxepin hydrochloride 50 mg 70518-3767-00 | REMEDYREPACK | 30 capsules | — | AB | FDA listed | — |
| Doxepin Hydrochloride 50 mg 70518-4231-00 | REMEDYREPACK | 30 capsules | — | AB | FDA listed | — |
| Doxepin Hydrochloride 50 mg 70518-4282-00 | REMEDYREPACK | 30 capsules | — | AB | FDA listed | — |
| Doxepin Hydrochloride 50 mg 71335-2408-01 | Bryant | 60 capsules | — | AB | FDA listed | — |
| Doxepin Hydrochloride 50 mg 71335-2472-01 | Bryant | 60 capsules | — | AB | FDA listed | — |
| Doxepin Hydrochloride 50 mg 71335-2804-01 | Bryant | 60 capsules | — | AB | FDA listed | — |
| Doxepin hydrochloride 50 mg 71335-9732-01 | Bryant | 60 capsules | — | AB | FDA listed | — |
| Doxepin Hydrochloride 50 mg 81469-0417-01 | First | 100 capsules | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 24658-0795-01 You're viewing this | 100 CAPSULE in 1 BOTTLE (24658-795-01) | $0.1535 / ea | $15.35 | 2023-03-14 | Active |
| 24658-0795-10 | 1000 CAPSULE in 1 BOTTLE (24658-795-10) | $0.1535 / ea | $153.46 | 2023-03-14 | Active |
You're viewing the smallest of 2 pack sizes for this product.
This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.1535 NADAC).
Pack size FAQ
What quantity is in NDC 24658-0795-01?
What is the difference between NDC 24658-0795-01 and NDC 24658-0795-10?
What NDC number is used to bill for this package of Doxepin Hydrochloride 50 mg Capsule?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
Suicidality and Antidepressant Drugs 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 capsules 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 capsule is not approved for use in pediatric patients. ( See Warnings: Clinical Worsening and Suicide Risk , Precautions: Information for Patients , and Precautions: Pediatric Use )
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Doxepin hydrochloride capsule is recommended for the treatment of: 1. Psychoneurotic patients with depression and/or anxiety. 2.
Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol). 3. Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly).
4. Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders. The target symptoms of psychoneurosis that respond particularly well to doxepin hydrochloride include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry.
Clinical experience has shown that doxepin hydrochloride is safe and well tolerated even in the elderly patient. Owing to lack of clinical experience in the pediatric population, doxepin hydrochloride is not recommended for use in children under 12 years of age.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION 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 75 mg/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 to 50 mg/day. The total daily dosage of doxepin hydrochloride capsules 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. The 150 mg capsule strength is intended for maintenance therapy only and is not recommended for initiation of treatment. Anti-anxiety effect is apparent before the antidepressant effect.
Optimal antidepressant effect may not be evident for two to three weeks.
⛔ Contraindications ▾
CONTRAINDICATIONS Doxepin hydrochloride is contraindicated in individuals who have shown hypersensitivity to the drug. Possibility of cross sensitivity with other dibenzoxepines should be kept in mind. Doxepin hydrochloride is contraindicated in patients with glaucoma or a tendency to urinary retention. These disorders should be ruled out, particularly in older patients.
⚠️ Warnings ▾
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 to 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 4,400 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 1,000 patients treated) are provided in Table 1. Table 1 Age Range Drug-Placebo Difference in Number of Cases of Suicidality per 1,000 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 No suicides occurred in any of the pediatric trials. There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide.
It is unknown whether the suicidality risk extends to longer-term use, i.e., beyond several months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with depression that the use of antidepressants can delay the recurrence of depression. All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.
The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality.
Consideration should be given to chan…
🤒 Adverse Reactions ▾
ADVERSE REACTIONS NOTE: Some of the adverse reactions noted below have not been specifically reported with doxepin hydrochloride capsule 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, angle closure glaucoma, mydriasis 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 hydrochloride administration should be borne in mind. These are not indicative of addiction and gradual withdrawal of medication should not cause these symptoms.
🧒 Pediatric Use ▾
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 capsules in a child or adolescent must balance the potential risks with the clinical need.
🧓 Geriatric Use ▾
Geriatric Use A determination has not been made whether controlled clinical studies of doxepin hydrochloride 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 hydrochloride 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 oversedation in the elderly; elderly patients generally should be started on low doses of doxepin hydrochloride and observed closely.
( See WARNINGS .)
🆘 Overdosage ▾
OVERDOSAGE 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 overdoses 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 1A 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 co…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Doxepin hydrochloride capsules, USP are available containing doxepin equivalent to 10 mg, 25 mg, 50 mg, 75 mg and 100 mg. The 10 mg capsule is a #4 capsule with a buff opaque cap and buff opaque body imprinted with "Є529" in black ink on both the cap and body filled with white powder. They are available as follows: 10 mg– 100 count (NDC 24658-793-01) 10 mg– 1000 count (NDC 24658-793-10) The 25 mg capsule is a #3 capsule with an ivory opaque cap and white opaque body imprinted with "Є530" in black ink on both the cap and body filled with white powder.
They are available as follows: 25 mg– 100 count (NDC 24658-794-01) 25 mg– 1000 count (NDC 24658-794-10) The 50 mg capsule is a #2 capsule with an ivory opaque cap and ivory opaque body imprinted with "Є531" in black ink on both the cap and body filled with white powder. They are available as follows: 50 mg– 100 count (NDC 24658-795-01) 50 mg– 1000 count (NDC 24658-795-10) The 75 mg capsule is a #2 capsule with a bright light green opaque cap and bright light green opaque body imprinted with "Є532" in black ink on both the cap and body filled with white powder.
They are available as follows: 75 mg– 100 count (NDC 24658-796-01) 75 mg– 1000 count (NDC 24658-796-10) The 100 mg capsule is a #1 capsule with a bright light green opaque cap and white opaque body imprinted with "Є533" in black ink on both the cap and body filled with white powder. They are available as follows: 100 mg– 100 count (NDC 24658-797-01) 100 mg– 500 count (NDC 24658-797-05) 100 mg– 1000 count (NDC 24658-797-10) Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light.
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure, as required. Dispense with Medication Guide available at: www.puracaplabs.com/medguide/Doxepin-Hydrochloride-Capsule.pdf Distributed by: PuraCap Laboratories, LLC DBA Blu Pharmaceuticals Greenvale, NY 11548 Rev. 12-2022-00 MF529BLUREV12/22 LN0011
📋 Description ▾
DESCRIPTION Doxepin hydrochloride is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. The molecular formula of the compound is C 19 H 21 NOHCl having a molecular weight of 316. It is a white crystalline solid readily soluble in water, lower alcohols and chloroform.
Inert ingredients for the capsule formulations are: microcrystalline cellulose, partially pregelatinized starch (corn), colloidal silicon dioxide, sodium lauryl sulfate, magnesium stearate. The empty gelatin capsule shells contain D&C Yellow No. 10, gelatin, sodium lauryl sulfate, capsule moisture, elemental iron and titanium dioxide.
In addition, the 10 mg, 25 mg and 50 mg empty gelatin capsule shells contain FD&C Yellow No. 6 and the 75 mg and 100 mg empty gelatin capsule shells contain FD&C Green No. 3.
The imprinting ink contains iron oxide black, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No.
2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol, N-Butyl Alcohol and shellac glaze. It meets USP Dissolution Test 3.
💬 Information for Patients ▾
Information for Patients Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with doxepin hydrochloride 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. 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 capsules.
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. Patients should be advised that taking doxepin hydrochloride capsules can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle closure glaucoma.
Pre-existing glaucoma is almost always open-angle glaucoma because angle closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not a risk factor for angle closure glaucoma. Patients may wish to be examined to determine whether they are susceptible to angle closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible.
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 capsules in a child or adolescent must balance the potential risks with the clinical need.
💬 Medication Guide ▾
Medication Guide Dispense with Medication Guide available at: www. puracaplabs.com/medguide/Doxepin-Hydrochloride-Capsule.pdf Doxepin Hydrochloride Capsules, USP (dox' e pin hye'' droe klor' ide) 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: • all risks and benefits of treatment with antidepressant medicines • all treatment choices for depression or other serious mental illness What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions?
1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. 2.
Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.
3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member? • Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed. • Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. • Keep all follow-up visits with the healthcare provider as scheduled.
Call the healthcare provider between visits as needed, especially if you have concerns about symptoms. Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you: • thoughts about suicide or dying • an extreme increase in activity and talking • attempts to commit suicide (mania) other unusual changes in behavior • new or worse depression or mood • new or worse anxiety • Visual problems • feeling very agitated or restless • eye pain • panic attacks • changes in vision • trouble sleeping (insomnia) • swelling or redness in or around • new or worse irritability the eye • acting aggressive, being angry, or violent Only some people are at risk for these • acting on dangerous impulses problems.
You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What else do I need to know about antidepressant medicines? • Never stop an antidepressant medicine without first talking to a healthcare provider . Stopping an antidepressant medicine suddenly can cause other symptoms. • Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it.
Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants. • Antidepressant medicines have other side effects . Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member. • Antidepressant medicines can interact with other medicines . Know all of the medicines that you or your family member takes.
Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider. • Not all antidepressant medicines prescribed for children are FDA approved for use in children . Talk to your child’s hea…