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Name:Doxepin

Generic:Oxycodone and Acetaminophen

Strength:PERCOCET 5 mg/325 mg; PERCOCET 7.5 mg/325 mg; PERCOCET 10 mg/325 mg. The usual adult dosage is one tablet every 6 hours as needed for pain. The total daily dose of acetaminophen should not exceed 4 grams.

shape and size:Pill with imprint PERCOCET 7.5/325 is Orange, Capsule-shape and has been identified as Percocet 325 mg / 7.5 mg.

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Description

Doxepin hydrochloride is one of a class of psycho therapeutic agents known as dibenzoxepin tricyclic compounds. The molecular formula of the com pound is C19H21NO • HCl having a molecular weight of 316. It is a white crystalline solid readily soluble in water, lower alcohols and chloroform. Chemically, doxepin hydrochloride is a dibenzoxepin de riva tive and is the first of a fam­ t ily of tricyclic psychotherapeutic a gents. Specifically, it is an isomeric mixture of 1-Pro pana ­ mine, 3-dibenz[b,e]ox epin-11 (6H)ylidene-N,N-dimethyl-hy drochloride. s Each 10 mg, 25 mg, 50 mg, 75 mg and 100 mg doxepin capsule for oral administration n contains doxe pin hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg, 75 mg and 100 mg t
of doxepin, respectively and the following inactive ingredients: colloidal silicon dioxide, li magnesium stearate, microcr ystalline cellulose, pregelatinized starch (corn) and sodium dlauryl sulfate. The empty gelatin capsule shells contain D&C Yellow No. 10, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg, 25 mg and 50 mg empty gela­ d tin capsule shells contain FD&C Yellow No. 6 and the 75 mg and 100 mg empt y gelatin cap­esule shells contain FD&C Green No. 3. d The imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C n Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum
Lake, propylene glycol and shellac glaze.

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INDICATIONS AND USAGE:

Doxepin 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 include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry.
Clinical experience has shown that doxepin is safe and well tolerated even in the elderly patient. Owing to lack of clinical experience in the pediatric population, doxepin is not recommended for use in children under 12 years of age.

COTRAINDICATIONS

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.

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ADVERSE REACTIONS

NOTE: Some of the adverse reactions noted be low have not been specifically re ported with doxepin use. How ever, due to the close pharmacological similarities among the tricyclics, the reactions should be considered when prescribing doxepin.

Anticholinergic Effects: Dry mouth, blurred vision, constipation and urinary retention have been reported. If they do not sub side with continued therapy or be come 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, extra pyramidal symptoms, seizures, tardive dyskinesia and tremor.

Cardiovascular: Cardiovascular effects including hypotension, hypertension and tachycardia have been reported occasion ally.

Allergic: Skin rash, edema, photo sensitization 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 ad verse effects.

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Pregnancy

Reproduction studies have been performed in rats, rabbits, monkeys and dogs and there was no evidence of harm to the animal fetus. The relevance to humans is not Known. Since there is no experience in pregnant women who have received this drug, safety in pregnancy has not been established. There has been a report of apnea and drowsiness occurring in a nursing infant whose mother was taking doxepin.

Pediatric Use: The use of doxepin in children under 12 years of age is not recommended because safe conditions for its use have not been established.

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Drug Inter actions:

Drugs Metabolized by P450 2D6

The biochemical activity of the drug metabolizing isozyme cy to chrome P450 2D6 (debrisoquin hydroxylase) is reduced in a subset of the Caucasian population (about 7% to 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. De pending on the fraction of drug metabolized by P450 2D6, the increase in plasma concentration may be small, or quite large (8-fold in crease 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 propafe none 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.
Never the less, caution is indicated in the co administration 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 anti depressants with drugs that can inhibit cytochrome P450 2D6 may require lower doses than usually prescribed for either the tricyclic antidepressant or the other drug. Further more, 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 in crease 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.

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MAO Inhibitors
Serious side effects and even death have been re ported following the concomitant use of certain drugs with MAO inhibitors. Therefore, MAO inhibitors should be discontinued at least 2 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 ad ministered, 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 se rum levels of tricyclic antidepressant when cimetidine therapy is initiated. Additionally, high er than expected tricyclic antidepressant levels have
been ob served when they are begun in patients al ready taking cimetidine. In patients who have been reported to be well controlled on tricyclic anti depressants 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 t ype II diabetic patient maintained on tolazamide (1 gm/day) 11 days after the addition of doxepin (75 mg/day).

 

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