LOXX 60 Duloxetine Hydrochloride 60mg Delayed-Release Capsule 1's
RXDRUG-DRP-9403-30-1pc
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Features
Brand
LOXX 60
Full Details
Dosage Strength
60 mg
Drug Ingredients
- Duloxetine
Drug Packaging
Delayed-Release Capsule 1's
Generic Name
Duloxetine Hydrochloride
Dosage Form
Delayed-Release Capsule
Registration Number
DRP-9403
Drug Classification
Prescription Drug (RX)
Description
Indications/Uses
Duloxetine (Loxx 30/Loxx 60) delayed-release capsules is advocated for treating adults who have major depressive disorder, generalized anxiety disorder, fibromyalgia and in relief of diabetic peripheral neuropathic pain.
Dosage/Direction for Use
Duloxetine (Loxx 30/Loxx 60) delayed-release capsule should be swallowed whole and should not be chewed or crushed, nor should the capsule be opened and its contents sprinkled on food or mixed with liquids. Duloxetine (Loxx 30/Loxx 60) Delayed Release Capsules should be given without regard to meals.
Major Depressive Disorder: 1 LOXX 30 once daily or 1 LOXX 60 once daily. Dose can be increased by 30 mg/day up to a maximum 120 mg duloxetine per day.
Generalized Anxiety Disorder/Fibromyalgia/Diabetic Peripheral Neuopathy Pain: Initially 1 LOXX 30 once daily for a week and then 1 LOXX 60 once daily. Dose can be increased by 30 mg/day up to a maximum 120 mg duloxetine per day.
Major Depressive Disorder: 1 LOXX 30 once daily or 1 LOXX 60 once daily. Dose can be increased by 30 mg/day up to a maximum 120 mg duloxetine per day.
Generalized Anxiety Disorder/Fibromyalgia/Diabetic Peripheral Neuopathy Pain: Initially 1 LOXX 30 once daily for a week and then 1 LOXX 60 once daily. Dose can be increased by 30 mg/day up to a maximum 120 mg duloxetine per day.
Overdosage
In postmarketing experience, fatal outcomes have been reported for acute overdoses, primarily with mixed overdoses, but also with duloxetine only, at doses as low as 1000 mg. Signs and symptoms of overdose (duloxetine alone or with mixed drugs) included somnolence, coma, serotonin syndrome, seizures, syncope, tachycardia, hypotension, hypertension, and vomiting.
There is no specific antidote to Duloxetine (Loxx 30/Loxx 60) Delayed Release Capsules, but if serotonin syndrome ensues, specific treatment (such as with cyproheptadine and/or temperature control) may be considered. In case of acute overdose, treatment should consist of those general measures employed in the management of overdose with any drug.
An adequate airway, oxygenation, and ventilation should be assured and cardiac rhythm and vital signs should be monitored. Induction of emesis is not recommended. Gastric lavage with a large-bore orogastric tube with appropriate airway protection, if needed, may be indicated if performed soon after ingestion or in symptomatic patients.
Activated charcoal may be useful in limiting absorption of duloxetine from the gastrointestinal tract. Administration of activated charcoal has been shown to decrease AUC and Cmax by an average of one-third, although some subjects had a limited effect of activated charcoal. Due to the large volume of distribution of this drug, forced diuresis, dialysis, hemoperfusion, and exchange transfusion are unlikely to be beneficial.
In managing overdose, the possibility of multiple drug involvement should be considered. A specific caution involves patients who are taking or have recently taken Duloxetine (Loxx 30/ Loxx 60) Delayed Release Capsules and might ingest excessive quantities of tricyclic antidepressants. In such a case, decreased clearance of the parent tricyclic and/or its active metabolite may increase the possibility of clinically significant sequelae and extend the time needed for dose medical observation.
There is no specific antidote to Duloxetine (Loxx 30/Loxx 60) Delayed Release Capsules, but if serotonin syndrome ensues, specific treatment (such as with cyproheptadine and/or temperature control) may be considered. In case of acute overdose, treatment should consist of those general measures employed in the management of overdose with any drug.
An adequate airway, oxygenation, and ventilation should be assured and cardiac rhythm and vital signs should be monitored. Induction of emesis is not recommended. Gastric lavage with a large-bore orogastric tube with appropriate airway protection, if needed, may be indicated if performed soon after ingestion or in symptomatic patients.
Activated charcoal may be useful in limiting absorption of duloxetine from the gastrointestinal tract. Administration of activated charcoal has been shown to decrease AUC and Cmax by an average of one-third, although some subjects had a limited effect of activated charcoal. Due to the large volume of distribution of this drug, forced diuresis, dialysis, hemoperfusion, and exchange transfusion are unlikely to be beneficial.
In managing overdose, the possibility of multiple drug involvement should be considered. A specific caution involves patients who are taking or have recently taken Duloxetine (Loxx 30/ Loxx 60) Delayed Release Capsules and might ingest excessive quantities of tricyclic antidepressants. In such a case, decreased clearance of the parent tricyclic and/or its active metabolite may increase the possibility of clinically significant sequelae and extend the time needed for dose medical observation.
Administration
May be taken with or without food: Swallow whole, do not chew/crush/open cap.
Contraindications
Duloxetine (Loxx 30/Loxx 60) delayed-release capsule is contraindicated in those with known hypersensitivity to duloxetine or any of its ingredients. It is not advocated in hepatic insufficiency, end-stage renal disease, or severe renal impairment (creatinine clearance <30 ml/minute), uncontrolled narrow-angle glaucoma and during lactation if breast-feeding is to be persisted with.
Duloxetine (Loxx 30/Loxx 60) Delayed Release Capsules is not advocated along with MAOIs, serotonin precursors such as tryptophan and thioridazine.
Duloxetine (Loxx 30/Loxx 60) Delayed Release Capsules is not advocated along with MAOIs, serotonin precursors such as tryptophan and thioridazine.
Warnings
Symptoms associated with discontinuation of Duloxetine (Loxx 30/Loxx 60) Delayed Release Capsules and other selective serotonin reuptake inhibitors (SSRIs) and SSNRIs have been reported. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. At least 14 days should elapse between discontinuation of a MAOI and initiation of therapy with Duloxetine (Loxx 30/Loxx 60) Delayed Release Capsules. In addition, at least 5 days should be allowed after stopping Duloxetine Delayed Release Capsules before starting MAOI. All patients being treated with antidepressants like Duloxetine (Loxx 30/Loxx 60) delayed-release capsule 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.
Duloxetine (Loxx 30/Loxx 60) Delayed Release Capsules should be discontinued in patients who develop jaundice or other evidence of clinically significant liver dysfunction, symptomatic orthostatic hypotension and/or syncope, symptomatic hyponatremia, or urinary hesitancy and retention. Blood pressure should be measured prior to initiating treatment and periodically measured throughout the duration for which Duloxetine (Loxx 30/Loxx 60) Delayed Release Capsules is taken.
Treatment with Duloxetine (Loxx 30/Loxx 60) Delayed Release Capsules and any concomitant serotonengic or antidoperninergic agents, including antipsychotics, should be discontinued immediately serotonin syndrome or NMS-like reactions occur and supportive symptomatic treatment should be initiated.
Duloxetine (Loxx 30/Loxx 60) Delayed Release Capsules should ordinarily not be prescribed to patients with substantial alcohol use. Smoking can reduce bioavailability of Duloxetine (Loxx 30/Loxx 60) Delayed Release Capsules by about one-third. It should be advocated with due precaution along with aspirin, NSAIDs, warfarin and other anti-coagulants.
Duloxetine (Loxx 30/Loxx 60) Delayed Release Capsules should be discontinued in patients who develop jaundice or other evidence of clinically significant liver dysfunction, symptomatic orthostatic hypotension and/or syncope, symptomatic hyponatremia, or urinary hesitancy and retention. Blood pressure should be measured prior to initiating treatment and periodically measured throughout the duration for which Duloxetine (Loxx 30/Loxx 60) Delayed Release Capsules is taken.
Treatment with Duloxetine (Loxx 30/Loxx 60) Delayed Release Capsules and any concomitant serotonengic or antidoperninergic agents, including antipsychotics, should be discontinued immediately serotonin syndrome or NMS-like reactions occur and supportive symptomatic treatment should be initiated.
Duloxetine (Loxx 30/Loxx 60) Delayed Release Capsules should ordinarily not be prescribed to patients with substantial alcohol use. Smoking can reduce bioavailability of Duloxetine (Loxx 30/Loxx 60) Delayed Release Capsules by about one-third. It should be advocated with due precaution along with aspirin, NSAIDs, warfarin and other anti-coagulants.
Special Precautions
Duloxetine (Loxx 30/Loxx 60) delayed release capsule must be given with due precaution in those with history of mania, seizures, narrow angle glaucoma and liver dysfunction. Patients who are greatly prone to suicide must be given the smallest possible dose of Duloxetine (Loxx 30/ Loxx 60) delayed-release capsules with care.
Use In Pregnancy & Lactation
Duloxetine (Loxx 30/Loxx 60) Delayed Release Capsules must be given during pregnancy (category: C) if strictly necessary.
Safety and efficacy of Duloxetine (Loxx 30/Loxx 60) Delayed Release Capsules in children are not established.
Safety and efficacy of Duloxetine (Loxx 30/Loxx 60) Delayed Release Capsules in children are not established.
Adverse Reactions
Significant adverse reactions (>5%) which can even result in withdrawal of duloxetine include nausea, vomiting, dizziness, somnolence, headache, dry mouth, constipation, diarrhea, decreased appetite, hyperhidrosis and fatigue. Duloxetine can cause the following adverse reactions: Cardiac Disorders: Frequent: palpitations. Infrequent: myocardial infarction and tachycardia.
Ear and Labyrinth Disorders: Frequent: vertigo. Infrequent: ear pain and tinnitus.
Endocrine Disorders: Infrequent: hypothyroidism.
Eye Disorders: Frequent vision blurred; Infrequent: diplopia and visual disturbance.
Gastrointestinal Disorders: Frequent: flatulence, dyspepsia, loose stools; Infrequent: eructation, gastritis, halitosis, abdominal pain and stomatitis; Rare: gastric ulcer, hematochezia and melena.
General Disorders and Administration Site Conditions: Frequent: chills/rigors, anorexia, appetite and weight decrease; Infrequent: feeling abnormal, asthenia, wrests, feeling hot and/or cold, seasonal allergy, malaise and thirst; Rare: gait disturbance.
Infections and Infestations: Infrequent: gastroenteritis, laryngitis, nasopharyngitis, respiratory tract infection, urinary tract infection, influenza and viral gastroenteritis.
Investigations: Frequent: weight increased; Infrequent: blood cholesterol increased.
Metabolism and Nutrition Disorders: Infrequent: dehydration and hyperlipidemia; Rare: dyslipidemia.
Musculoskeletal and Connective Tissue Disorders: Frequent: musculoskeletal pain, muscle cramp. musculoskeletal spasms and myalgia; Infrequent: muscle tightness and muscle twitching.
Nervous System Disorders: Frequent dysgeusia, lethargy, tremor, migraine and parasthesia/hypoesthesia; Infrequent: disturbance in attention.
Psychiatric Disorders: Frequent: abnormal dreams, decreased libido and sleep disorder; Infrequent: apathy, bruxism, disorientation/confusional state, irritability, mood swings, agitation, anxiety and suicide attempt; Rare: completed suicide.
Renal and Urinary Disorders: Infrequent: dysuria, micturition urgency, nocturia, polyuria, pollakiuria and urine odor abnormal.
Reproductive System and Breast Disorders: Frequent: anorgasmia/orgasm abnormal, erectile dysfunction, ejaculation delayed or ejaculation disorder and penis disorder; Infrequent: menopausal symptoms and sexual dysfunction.
Respiratory, Thoracic and Mediastinal Disorders: Frequent: cough, pharyngolaryngeal pain and yawning; Infrequent: throat tightness.
Skin and Subcutaneous Tissue Disorders: Infrequent: cold sweat, dermatitis contact, erythema, increased tendency to bruise, night sweats, and photosensitivity reaction; Rare: ecchymosis.
Vascular Disorders: Frequent: hot flush; Infrequent: flushing, orthostatic hypotension, and peripheral coldness.
Ear and Labyrinth Disorders: Frequent: vertigo. Infrequent: ear pain and tinnitus.
Endocrine Disorders: Infrequent: hypothyroidism.
Eye Disorders: Frequent vision blurred; Infrequent: diplopia and visual disturbance.
Gastrointestinal Disorders: Frequent: flatulence, dyspepsia, loose stools; Infrequent: eructation, gastritis, halitosis, abdominal pain and stomatitis; Rare: gastric ulcer, hematochezia and melena.
General Disorders and Administration Site Conditions: Frequent: chills/rigors, anorexia, appetite and weight decrease; Infrequent: feeling abnormal, asthenia, wrests, feeling hot and/or cold, seasonal allergy, malaise and thirst; Rare: gait disturbance.
Infections and Infestations: Infrequent: gastroenteritis, laryngitis, nasopharyngitis, respiratory tract infection, urinary tract infection, influenza and viral gastroenteritis.
Investigations: Frequent: weight increased; Infrequent: blood cholesterol increased.
Metabolism and Nutrition Disorders: Infrequent: dehydration and hyperlipidemia; Rare: dyslipidemia.
Musculoskeletal and Connective Tissue Disorders: Frequent: musculoskeletal pain, muscle cramp. musculoskeletal spasms and myalgia; Infrequent: muscle tightness and muscle twitching.
Nervous System Disorders: Frequent dysgeusia, lethargy, tremor, migraine and parasthesia/hypoesthesia; Infrequent: disturbance in attention.
Psychiatric Disorders: Frequent: abnormal dreams, decreased libido and sleep disorder; Infrequent: apathy, bruxism, disorientation/confusional state, irritability, mood swings, agitation, anxiety and suicide attempt; Rare: completed suicide.
Renal and Urinary Disorders: Infrequent: dysuria, micturition urgency, nocturia, polyuria, pollakiuria and urine odor abnormal.
Reproductive System and Breast Disorders: Frequent: anorgasmia/orgasm abnormal, erectile dysfunction, ejaculation delayed or ejaculation disorder and penis disorder; Infrequent: menopausal symptoms and sexual dysfunction.
Respiratory, Thoracic and Mediastinal Disorders: Frequent: cough, pharyngolaryngeal pain and yawning; Infrequent: throat tightness.
Skin and Subcutaneous Tissue Disorders: Infrequent: cold sweat, dermatitis contact, erythema, increased tendency to bruise, night sweats, and photosensitivity reaction; Rare: ecchymosis.
Vascular Disorders: Frequent: hot flush; Infrequent: flushing, orthostatic hypotension, and peripheral coldness.
Drug Interactions
Duloxetine (Loxx 30/Loxx 60) Delayed Release Capsules should be advocated with due precaution along with tricyclic antidepressants, phenothiazines, thioridazine, Type 1C antiarrhythmic, and other CNS agents.
Storage
Store at temperatures not exceeding 25°C.
Shelf life: 24 months.
Shelf life: 24 months.
Action
Pharmacology: Pharmacokinetics: Orally administered duloxetine is well absorbed but there is a median 2 hours lag until absorption begins. Food does not affect the peak plasma concentrations (Cmax) of duloxetine, but delays the time to reach peak concentration (Tmax) from 6 to 10 hours and it marginally decreases the extent of absorption [area under the curve (AUC)] by about 10%. Steady-state plasma concentrations are typically achieved after 3 days of dosing. There is a 3 hour delay in absorption of immediate release duloxetine, and a one-third increase in apparent clearance of duloxetine after an evening dose as compared to a morning dose.
The apparent volume of distribution averages about 1640 L. Duloxetine (Loxx 30/Loxx 60) is highly bound (>90%) to proteins and binding is primarily to albumin and a1-acid glycoprotein.
Duloxetine (Loxx 30/Loxx 60) undergoes extensive metabolism and only about 3% of the total absorbed occurs as unchanged drug in plasma. The major biotransformation pathways for duloxetine involve oxidation of the naphthyl ring followed by conjugation and further oxidation. Both CYP1A2 and CYP2D6 catalize the oxidation of the naphthyl ring. Metabolites found in plasma include 4-hydroxy duloxetine glucuronide and 5-hydroxy, 6-methoxy duloxetine sulfate.
Duloxetine (Loxx 30/Loxx 60) has an elimination half-life of about 12 hours (range 8 to 17 hours) and its pharmacokinetics is dose proportional over the therapeutic range. Elimination of duloxetine is mainly through hepatic metabolism involving two P450 isozymes, CYP1A2 and CYP2D6. Many additional metabolites have been identified in urine, some representing only minor pathways of elimination. Only trace (<1% of the dose) amounts of unchanged duloxetine are present in the urine. Most (about 70%) of the duloxetine dose appears in the urine as metabolites of duloxetine; about 20% is excreted in the feces. Duloxetine (Loxx 30/Loxx 60) undergoes extensive metabolism, but the major circulating metabolites have not been shown to contribute significantly to the pharmacologic activity of duloxetine.
The apparent volume of distribution averages about 1640 L. Duloxetine (Loxx 30/Loxx 60) is highly bound (>90%) to proteins and binding is primarily to albumin and a1-acid glycoprotein.
Duloxetine (Loxx 30/Loxx 60) undergoes extensive metabolism and only about 3% of the total absorbed occurs as unchanged drug in plasma. The major biotransformation pathways for duloxetine involve oxidation of the naphthyl ring followed by conjugation and further oxidation. Both CYP1A2 and CYP2D6 catalize the oxidation of the naphthyl ring. Metabolites found in plasma include 4-hydroxy duloxetine glucuronide and 5-hydroxy, 6-methoxy duloxetine sulfate.
Duloxetine (Loxx 30/Loxx 60) has an elimination half-life of about 12 hours (range 8 to 17 hours) and its pharmacokinetics is dose proportional over the therapeutic range. Elimination of duloxetine is mainly through hepatic metabolism involving two P450 isozymes, CYP1A2 and CYP2D6. Many additional metabolites have been identified in urine, some representing only minor pathways of elimination. Only trace (<1% of the dose) amounts of unchanged duloxetine are present in the urine. Most (about 70%) of the duloxetine dose appears in the urine as metabolites of duloxetine; about 20% is excreted in the feces. Duloxetine (Loxx 30/Loxx 60) undergoes extensive metabolism, but the major circulating metabolites have not been shown to contribute significantly to the pharmacologic activity of duloxetine.
MedsGo Class
Antidepressants / Drugs for Neuropathic Pain
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