Cymbalta

Cymbalta

duloxetine

Manufacturer:

Eli Lilly

Distributor:

Zuellig
Full Prescribing Info
Contents
Duloxetine hydrochloride.
Description
The active ingredient in Duloxetine (Cymbalta) is duloxetine hydrochloride.
Each Duloxetine (Cymbalta) hard gastro-resistant capsule contains enteric-coated pellets of duloxetine hydrochloride equivalent to 30 mg or 60 mg of duloxetine.
Hard gastro-resistant capsule. Duloxetine (Cymbalta) is a delayed-release formulation (capsules) for oral administration.
Action
Pharmacology: Pharmacodynamics: Duloxetine is a combined serotonin (5-HT) and noradrenaline (NA) reuptake inhibitor. It weakly inhibits dopamine reuptake with no significant affinity for histaminergic, dopaminergic, cholinergic and adrenergic receptors. Duloxetine dose-dependently increases extracellular levels of serotonin and noradrenaline in various brain areas of animals.
Neurochemical and behavioral studies in laboratory animals showed an enhancement of both serotonin and noradrenaline neurotransmission in the CNS. Duloxetine also normalized pain thresholds in several preclinical models of neuropathic and inflammatory pain and attenuated pain behavior in a model of persistent pain. The presumed mechanism of action of duloxetine in the treatment of both the emotional and somatic symptoms of depression is thought to be due to its inhibition of neuronal uptake of serotonin and noradrenaline, and a resultant increase in serotonergic and noradrenergic neurotransmission in the CNS.
Duloxetine (Cymbalta) was studied in a clinical program involving 2951 patients (1,259 patient-years of exposure) meeting DSM-IV criteria for major depression. The efficacy of Duloxetine (Cymbalta) at the recommended dose of 60 mg once a day was demonstrated in two out of two randomized, double blind, placebo-controlled, fixed dose acute studies in adult outpatients with major depressive disorder. Overall, Duloxetine (Cymbalta) efficacy has been demonstrated at daily doses between 60 and 120 mg in a total of four out of six randomized, double-blind, placebo-controlled, fixed dose acute studies in adult outpatients with major depressive disorder.
Duloxetine (Cymbalta) demonstrated statistical superiority over placebo as measured by improvement in the 17-item Hamilton Depression Rating Scale (HAM-D) total score (including both the emotional and somatic symptoms of depression). Response and remission rates were also statistically significantly higher with Duloxetine (Cymbalta) compared with placebo. Only a small proportion of patients included in pivotal clinical trials had severe depression (baseline HAM-D >25). In a relapse prevention study, patients responding to 12-weeks of acute treatment with open-label Duloxetine (Cymbalta) 60 mg once daily were randomized to either Duloxetine (Cymbalta) 60 mg once daily or placebo for a further 6-months. Duloxetine (Cymbalta) 60 mg once daily demonstrated a statistically significant superiority compared to placebo (p=0.004) on the primary outcome measure, the prevention of depressive relapse, as measured by time to relapse.
The incidence of relapse during the 6-months double-blind follow-up period was 17% and 29% for duloxetine and placebo, respectively.
The pain inhibitory action of duloxetine is believed to be a result of potentiation of descending inhibitory pain pathways within the central nervous system.
Pharmacokinetics: Duloxetine is administered as a single enantiomer. Duloxetine is extensively metabolized by oxidative enzymes (CYP1A2 and the polymorphic CYP2D6), followed by conjugation. The pharmacokinetics of duloxetine demonstrate large intersubject variability (generally 50-60%), partly due to gender, age, smoking status and CYP2D6 metabolizer status.
Duloxetine is well absorbed after oral administration with a Cmax occurring 6 hours post dose. The absolute oral bioavailability of duloxetine ranged from 32% to 80% (mean of 50%). Food delays the time to reach the peak concentration from 6 to 10 hours and it marginally decreases the extent of absorption (approximately 11%). These changes do not have any clinical significance.
Duloxetine is approximately 96% bound to human plasma proteins. Duloxetine binds to both albumin and alpha-l acid glycoprotein. Protein binding is not affected by renal or hepatic impairment Duloxetine is extensively metabolized and the metabolites are excreted principally in urine. Both cytochromes P450-CYP2D6 and P450-CYP1A2 catalyze the formation of the two major metabolites glucuronide conjugate of 4-hydroxy duloxetine and sulphate conjugate of 5-hydroxy, 6-methoxy duloxetine. Based upon in vitro studies, the circulating metabolites of duloxetine are considered pharmacologically inactive. The pharmacokinetics of duloxetine in patients who are poor metabolizers with respect to CYP2D6 has not been specifically investigated. Limited data suggest that the plasma levels of duloxetine are higher in these patients.
The elimination half-life of duloxetine ranges from 8 to 17 hours (mean of 12 hours). After an intravenous dose the plasma clearance of duloxetine ranges from 22 L/hr to 46 L/hr (mean of 36 L/hr). Apparent plasma clearance of duloxetine ranges from 33 to 261 L/hr (mean of 101 L/hr).
Special populations: Gender: Pharmacokinetic differences have been identified between males and females (apparent plasma clearance is approximately 50% lower in females). Based upon the overlap in the range of clearance, gender-based pharmacokinetic differences do not justify the recommendation for using a lower dose for female patients.
Age: Pharmacokinetic differences have been identified between younger and elderly females (≥65 years) (AUC increases by about 25% and half-life is about 25% longer in the elderly), although the magnitude of these changes is not sufficient to justify adjustments to the dose. As a general recommendation, caution should be exercised when treating the elderly (see Dosage & Administration and Precautions).
Renal impairment: End stage renal disease patients receiving dialysis had a 2-fold higher duloxetine Cmax and AUC values compared to healthy subjects. Pharmacokinetic data on duloxetine is limited in patients with mild or moderate renal impairment.
Hepatic impairment: Moderate liver disease (Child Pugh Class B) affected the pharmacokinetics of duloxetine. Compared with healthy subjects, the apparent plasma clearance of duloxetine was 79% lower, the apparent terminal half-life was 2.3 times longer, and the AUC was 3.7 times higher in patients with moderate liver disease. The pharmacokinetics of duloxetine and its metabolites have not been studied in patients with mild or severe hepatic insufficiency.
Toxicology: Preclinical safety data: Duloxetine was not genotoxic in a standard battery of tests and was not carcinogenic in rats.
Multinucleated cells were seen in the liver in the absence of other histopathological changes in the rat carcinogenicity study. The underlying mechanism and the clinical relevance are unknown.
Female mice receiving duloxetine for 2 years had an increased incidence of hepatocellular adenomas and carcinomas at the high dose only (144 mg/kg/day), but these were considered to be secondary to hepatic microsomal enzyme induction. The relevance of this mouse data to humans is unknown.
Reproductive performance was not affected in male rats receiving duloxetine (45 mg/kg/day). Female rats receiving duloxetine (45 mg/kg/day) had a decrease in maternal food consumption and body weight, estrous cycle disruption, decreased live birth indices and progeny survival, and progeny growth retardation at systemic exposure levels estimated to be at the most at maximum clinical exposure (AUC). In an embryo toxicity study in the rabbit, a higher incidence of cardiovascular and skeletal malformations was observed at systemic exposure levels below the maximum clinical exposure (AUC). No malformations were observed in another study testing a higher dose of a different salt of duloxetine. In prenatal/postnatal toxicity studies in the rat, duloxetine induced adverse behavioral effects in the offspring at exposures below maximum clinical exposure (AUC).
Indications/Uses
Duloxetine is indicated for the treatment of major depressive disorder.
Duloxetine is indicated for the treatment of diabetic neuropathic pain.
Duloxetine is indicated for the treatment of generalized anxiety disorder.
Duloxetine is indicated for the treatment of fibromyalgia with or without depression.
Duloxetine is indicated for the treatment of chronic pain (CP) states associated with: Diabetic Peripheral Neuropathic Pain (DPNP); Fibromyalgia (FM); Chronic Lower Back Pain (CLBP); Osteoarthritis (OA).
Dosage/Direction for Use
Duloxetine (Cymbalta) is a hard gastro-resistant capsule formulation for oral use.
The starting and recommended maintenance dose of Duloxetine hydrochloride (Cymbalta) is 60 mg once daily with or without food. Dosages above 60 mg once daily, up to a maximum dose of 120 mg per day administered in evenly divided doses, have been evaluated from a safety perspective in clinical trials. However, there is no clinical evidence suggesting that patients not responding to the initial recommended dose may benefit from dose up titrations.
Hepatic impairment: Duloxetine should not be used in patients with liver disease resulting in hepatic impairment (see Contraindications and Pharmacology: Pharmacokinetics under Actions).
Renal insufficiency: No dosage adjustment is necessary for patients with mild or moderate renal dysfunction (creatinine clearance 30 to 80 mL/min). See Contraindications for severe renal impairment.
Elderly: No dosage adjustment is recommended for elderly patients solely on the basis of age. However, as with any medicine, caution should be exercised when treating the elderly (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Children and adolescents: Duloxetine is not intended for use in children. The safety and efficacy in patients under the age of 18 years have not been established.
Discontinuation of treatment: Abrupt discontinuation should be avoided. When discontinuing duloxetine, it is generally recommended that the dose be tapered of at least one to two weeks before discontinuation in an effort to decrease the risk of discontinuation symptoms. As a general recommendation, the dose should be reduced by half or administered on alternate days during this period. The precise regimen followed should however take into account the individual circumstances of the patient, such as duration of treatment, dose at discontinuation, etc.
Overdosage
In cases of acute ingestions up to 3000 mg, alone or in combination with other drugs, were reported with none being fatal. However, in post marketing experience, fatal outcomes have been reported for acute overdoses, primarily with mixed overdoses, but also with duloxetine only, at doses as low as approximately 1000 mg. Signs and symptoms of overdose (duloxetine alone or with mixed drugs) included somnolence, coma, serotonin syndrome, seizures, vomiting and tachycardia seizures.
In animal studies, the major signs of overdose toxicity are related to the central nervous and gastrointestinal systems. These include central nervous system effects such as tremors, clonic convulsions, ataxia, emesis, and decreased appetite.
No specific antidote is known, but if serotonin syndrome ensues, specific treatment (such as with cyproheptadine and/or temperature control) may be considered. An airway should be established. Monitoring of cardiac and vital signs is recommended, along with appropriate symptomatic and supportive measures. Gastric lavage may be indicated if performed soon after ingestion or in symptomatic patients. Activated charcoal may be useful in limiting absorption. Duloxetine has a large volume of distribution and forced diuresis, hemoperfusion, and exchange perfusion are unlikely to be beneficial.
Contraindications
Hypersensitivity to the active substance or to any of the excipients.
The concomitant use of duloxetine with non-selective irreversible monoamine oxidase inhibitors (MAOIs) is contraindicated (see Interactions for details).
Liver disease resulting in hepatic impairment.
Duloxetine should not be used in combination with fluvoxamine, ciprofloxacin, or enoxacine (i.e. potent CYP1A2 inhibitors) since the combination results in elevated plasma concentrations of duloxetine.
Severe renal impairment (creatinine clearance less than 30 mL/min).
Warnings
Antidepressants increase the risk of suicidal thinking and behavior (suicidality) in children and adolescents with major depressive disorder (MDD) and other psychiatric disorders, and those considering use of these agents must balance the risk with the clinical need.
Special Precautions
As with similar CNS active drugs, duloxetine should be used cautiously in patients with a history of mania or a diagnosis of bipolar disorder, and/or seizures.
Mydriasis has been reported in association with duloxetine, therefore, caution should be used when prescribing duloxetine in patients with raised intraocular pressure, or those at risk of acute narrow-angle glaucoma.
Duloxetine (Cymbalta) hard gastro-resistant capsules contain sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Renal Impairment: Increased plasma concentrations of duloxetine occur in patients with severe renal impairment on hemodialysis (creatinine clearance of less than 30 mL/min). For patients with severe renal impairment, see Contraindications. See Dosage & Administration for information on patients with mild or moderate renal dysfunction.
Increased blood pressure: Duloxetine is associated with an increase in blood pressure in some patients. In patients with known hypertension and/or other cardiac disease, blood pressure monitoring is recommended as appropriate.
Elevated liver enzymes: Elevations in liver enzymes were seen in some patients treated with duloxetine in clinical trials. These were usually transient and self-limiting, or resolved upon discontinuation of duloxetine. Severe elevations of liver enzymes (>10 times the upper limit of normal) or liver injury with a cholestatic or mixed pattern have been rarely reported, in some cases associated with excessive alcohol use or pre-existing liver disease. Duloxetine should be used with caution in patients with substantial alcohol use or pre-existing liver disease.
Use with antidepressants: Cautions should be exercised when using duloxetine in combination with antidepressants. In particular the combination with selective reversible MAOIs is not recommended.
St. John's wort: Undesirable effects may be more common during concomitant use of duloxetine and herbal preparations containing St. John's wort (Hypericum perforatum).
Suicide: The possibility of a suicide attempt is inherent in depression and other psychiatric disorders and may persist until significant remission occurs. Close supervision of high-risk patients should accompany drug therapy.
As with other drugs with similar pharmacological action (inhibitor of serotonin reuptake [SSRI] or inhibitor of serotonin and norepinephrine reuptake [SNRI]), isolated cases of suicidal ideation and suicidal behaviors have been reported during duloxetine therapy or early after treatment discontinuation.
Duloxetine hydrochloride has not been studied in patients under the age of 18 and is not intended for use in this age group. Although a causal role for duloxetine in inducing such events has not been established some analyses from pooled studies of antidepressants in psychiatric disorders found an increased risk for suicidal ideation and/or suicidal behaviors in pediatric and young adult (<25 years of age) patients compared to placebo. Physicians should encourage patients to report any distressing thoughts or feelings at any time.
Hemorrhage: There have been reports of cutaneous bleeding abnormalities, such as ecchymoses and purpura with selective serotonin reuptake inhibitors (SSRIs). Caution is advised in patients taking anticoagulants and/or medicinal products known to affect platelet function, and in patients with known bleeding tendencies.
Hyponatremia: Cases of hyponatremia (some with serum sodium lower than 110 mmol/Liter) have been reported very rarely. The majority of these cases occurred in elderly patients, especially when coupled with a recent history of altered fluid balance or conditions pre-disposing to altered fluid balance. Hyponatremia may present with nonspecific signs and symptoms (such as dizziness, weakness, nausea, vomiting, confusion, somnolence, and lethargy). Signs and symptoms associated with more severe cases have included syncopal episodes, falls, and seizure.
Abnormal Bleeding: SSRIs and SNRIs, including duloxetine, may increase the risk of bleeding events, including gastrointestinal bleeding. Therefore, caution is advised in patients taking duloxetine concomitantly with anticoagulants and/or medicinal products known to affect platelet function (e.g., NSAIDs, aspirin) and in patients with known bleeding tendencies.
Discontinuation of Treatment: Some patients may experience symptoms on discontinuation of duloxetine, particularly if treatment is stopped abruptly (see Dosage & Administration and Adverse Reactions).
Effects on ability to drive and use machines: Duloxetine may be associated with undesirable effects, such as sedation and dizziness. Therefore, patients should be cautioned about operating hazardous machinery, including automobiles, while taking duloxetine.
Use in the Elderly: Only limited clinical data on the use of duloxetine in elderly patients with major depressive disorders is available. Therefore, caution should be exercised when treating the elderly (see Dosage & Administration and Pharmacology: Pharmacokinetics under Actions).
Use In Pregnancy & Lactation
Pregnancy: There are no data on the use of duloxetine in pregnant women. Studies in animals have shown reproductive toxicity at systemic exposure levels (AUC) of duloxetine lower than the maximum clinical exposure (see Pharmacology: Toxicology: Preclinical safety data under Actions).
The potential risk for humans is unknown. As with other serotoninergic drugs, discontinuation symptoms may occur in the neonate after maternal duloxetine use near term. Duloxetine should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Discontinuation symptoms (e.g. hypotonia, tremor, jitteriness, feeding difficulty, respiratory distress and seizures) may occur in the neonate after maternal duloxetine use near term. The majority of cases have occurred either at birth or within a few days of birth. Women should be advised to notify their physician if they become pregnant, or intend to become pregnant, during therapy.
Breastfeeding: Duloxetine is excreted into the milk of lactating women. The estimated daily infant dose on a mg/kg is approximately 0.14% of the maternal dose. Because the safety of duloxetine in infants is not known, breast-feeding while on duloxetine is not recommended.
Adverse Reactions
See Tables A and B.

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

Discontinuation symptoms have been reported when stopping duloxetine. The most commonly reported symptoms following abrupt or tapered discontinuation of duloxetine in clinical trials have included dizziness, nausea, headache, paresthesia, fatigue, vomiting, irritability, nightmares, insomnia, diarrhea, anxiety, hyperhidrosis, vertigo and somnolence.
Duloxetine treatment in clinical trials was associated with numerically significant, but not clinically related increases in ALT, AST, creatinine phosphokinase-CPK, and potassium; transient, abnormal values of these enzymes were infrequently observed in duloxetine-treated patients, compared with placebo-treated patients. Duloxetine is in a class of drugs known to affect urethral resistance. In placebo-controlled trials, urinary hesitation was reported rarely (<1%) in male patients only. If symptoms of urinary hesitation develop during treatment with duloxetine, consideration should be given that they might be drug-related.
Electrocardiograms were obtained from 1139 duloxetine treated patients and 777 placebo-treated patients in 8-week clinical trials. The heart rate-corrected QT interval in duloxetine-treated patients did not differ from that seen in placebo-treated patients.
Cases of suicidal ideation and suicidal behaviors have been reported during duloxetine therapy or early after treatment discontinuation (see Precautions).
Glucose Regulation: In three clinical trials of duloxetine for the treatment of diabetic neuropathic pain, the mean duration of diabetes was approximately 12 years, the mean baseline fasting blood glucose was 176 mg/dL, and the mean baseline hemoglobin A1c (HbA1c) was 7.81%. In the 12 week acute treatment phase of these studies, small increases in fasting blood glucose were observed in duloxetine-treated patients. HbA1c was stable in both duloxetine-treated and placebo-treated patients. In the extension phase of these studies, which lasted up to 52 weeks, there was an increase in HbA1c in both the duloxetine and the routine care groups, but the mean increase was 0.3% greater in the duloxetine-treated group. There was also a small increase in fasting blood glucose and in total cholesterol in duloxetine-treated patients while those laboratory tests showed a slight decrease in the routine care group.
Spontaneous Data: Adverse drug reactions for all indications: The following list of undesirable effects (adverse drug reactions) is based on post-marketing spontaneous reports, and corresponding reporting rates have been provided.
Endocrine disorders: Very rarely (<0.01%): Syndrome of Inappropriate Antidiuretic Hormone (SIADH).
Cardiac disorders: Very rarely (<0.01%): Supraventricular arrhythmia.
Ear and Labyrinth Disorders: Very rarely (<0.01%): Tinnitus upon treatment discontinuation.
Eye disorders: Very rarely (<0.01%): Glaucoma.
Gastrointestinal Disorders: Very rarely (<0.01%): Microscopic colitis.
Hepatobiliary disorders: Very rarely (<0.01%): Hepatitis, jaundice.
Immune system disorders: Very rarely (<0.01%): Anaphylactic reaction, hypersensitivity.
Investigations: Very rarely (<0.01%): Alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, bilirubin increased.
Metabolism and nutrition disorders: Very rarely (<0.01%): Hyponatremia, hyperglycemia (reported especially in diabetic patients).
Musculoskeletal and connective tissue disorders: Very rarely (<0.01%): Trismus.
Nervous system disorders: Very rarely (<0.01%): Extrapyramidal disorder, restless leg syndrome, serotonin syndrome, seizures, seizures upon treatment discontinuation.
Psychiatric disorders: Rarely (≥0.01%-<0.1%): Hallucinations.
Very rarely (<0.01%): Mania, aggression and anger (particularly early in treatment or after treatment discontinuation).
Renal and urinary disorders: Rarely (≥0.01%-<0.1%): Urinary retention.
Reproductive system and breast disorders: Very rarely (<0.01%): Gynecological bleeding, galactorrhea, hyperprolactinemia.
Skin and subcutaneous tissue disorders: Rarely (≥0.01%-<0.1%): Rash.
Very rarely (<0.01%): Angioneurotic edema, contusion, ecchymosis, Stevens-Johnson Syndrome, urticaria.
Vascular disorders: Very rarely (<0.01%): Orthostatic hypotension (especially at the initiation of treatment), syncope (especially at initiation of treatment), hypertensive crisis.
Drug Interactions
MAOIs: Due to the risk of serotonergic syndrome, duloxetine should not be used in combination with non-selective irreversible monoamine oxidase inhibitors (MAOIs), or within at least 14 days of discontinuing treatment with MAOIs. Based on the half-life of duloxetine, at least 5 days should be allowed after stopping duloxetine before starting MAOIs (see Contraindications).
For selective, reversible MAOIs, like moclobemide, the risk of serotonin syndrome is lower. However, the concomitant use of duloxetine with selective, reversible MAOIs is not recommended (see Precautions).
Serotonin Syndrome: In rare cases, serotonin syndrome has been reported in patients using SSRIs (e.g. paroxetine, fluoxetine) concomitantly with serotonergic medicinal products. Caution is advisable if duloxetine is used concomitantly with serotonergic antidepressants like SSRIs, tricyclics like clomipramine or amitriptyline, St. John's wort (Hypericum perforatum), venlafaxine or triptans, tramadol, pethidine and tryptophan.
Drugs metabolized by CYP1A2: In a clinical study, the pharmacokinetics of theophylline, a CYP1A2 substrate, were not significantly affected by co-administration with duloxetine (60 mg twice daily). The study was performed in males and it cannot be excluded that females having a lower CYP1A2 activity and higher plasma concentrations of duloxetine may experience an interaction with CYP1A2 substrate.
Inhibitors of CYP1A2: Because CYP1A2 is involved in duloxetine metabolism, concomitant use of duloxetine with potent inhibitors of CYP1A2 will likely result in higher concentrations of duloxetine. Fluvoxamine (100 mg once daily), a potent inhibitor of CYP1A2, decreased the apparent plasma clearance of duloxetine by about 77% and increased AUC0-t 6-fold. Therefore, duloxetine should not be administered in combination with potent inhibitors of CYP1A2 like fluvoxamine (see Contraindications).
Inducers of CYP1A2: Population pharmacokinetics studies have shown that smokers have almost 50% lower plasma concentrations of duloxetine compared with non-smokers.
Drugs metabolized by CYP2D6: Duloxetine is a moderate inhibitor of CYP2D6. When duloxetine was administered at a dose of 60 mg twice daily with a single dose of desipramine, a CYP2D6 substrate, the AUC of desipramine increased by 3-fold. The co-administration of duloxetine increases steady state AUC of tolterodine (2 mg twice daily) by 71%, but does not affect the pharmacokinetics of its 5-hydroxyl metabolite. Therefore, caution should be used if duloxetine is co-administered with medications that are predominantly metabolized by CYP2D6 and which have a narrow therapeutic index.
Inhibitors of CYP2D6: As CYP2D6 is involved in duloxetine metabolism, concomitant use of duloxetine with potent inhibitors of CYP2D6 may result in higher concentrations of duloxetine.
Paroxetine (20 mg once daily) decreased the apparent plasma clearance of duloxetine by about 37%. Caution is advised if administering duloxetine with inhibitors of CYP2D6 (e.g., SSRIs).
CNS medicinal products: The risk of using duloxetine in combination with other CNS-active medicinal products has not been systematically evaluated, except in the cases described in this section. Consequently, caution is advised when Duloxetine (Cymbalta) is taken in combinations with other centrally acting medicinal products and substances including alcohol and sedative medicinal products (e.g. benzodiazepines, morphinomimetics, antipsychotics, phenobarbital, sedative antihistamines). Concomitant use of other drugs with serotonergic activity (e.g., SNRIs, SSRIs, triptans or tramadol) may result in serotonin syndrome.
Drugs highly bound to plasma protein: Duloxetine is highly bound to plasma proteins (>90%). Therefore, administration of duloxetine to a patient taking another drug that is highly protein bound may cause an increase in free concentrations of either drug.
Antacids and H2 antagonists: Co-administration of duloxetine with aluminium- and magnesium-containing antacids or duloxetine with famotidine had no significant effect on the rate or extent of duloxetine absorption after administration of a 40 mg oral dose.
Oral contraceptives and other steroidal agents: Results of in vitro studies demonstrate that duloxetine does not inhibit or induce the catalytic activity of CYP3A. Specific in vivo drug interaction studies have not been performed.
Caution For Usage
Incompatibilities: Not applicable.
Storage
Store in the original package. Keep the blister strips in the outer carton in order to protect from light and humidity. Do not store above 30°C.
Shelf life: 2 years.
MIMS Class
Antidepressants / Drugs for Neuropathic Pain
ATC Classification
N06AX21 - duloxetine ; Belongs to the class of other antidepressants.
Presentation/Packing
Cap 30 mg (opaque, white bodies, imprinted with '30 mg' and opaque blue caps, imprinted with the numeric identicode '9543') x 28's. 60 mg (opaque, green bodies, imprinted with '60 mg' and opaque, blue caps, imprinted with the numeric identicode '9542') x 28's.
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