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Duloxetine

capsule 20 ,30 & 60 mg

pharmacological class

Selective serotonin Reuptake inhibitors

Antidepressant , Antineuralgic

Indication

Depressive disorder, Major

Pain, peripheral neuropathic, diabetic


Pregnancy Category

Duloxetine crosses the placenta. Adequate and well con­trolled studies in humans have not been done.

Breast-feeding

It is not known whether duloxetine and/or its metabolites are distributed into breast milk. However, duloxetine and/or its metabolites are dis­tributed into the milk of lactating rats. Duloxetine is not recommended for use while breast-feeding.


Precaution

Pediatrics

Safety and efficacy in pediatric patients have not been established. Du­loxetine is not approved for use in pediatric patients.

Geriatrics

Appropriate studies performed to date have not demonstrated geriatric­ specific problems that would limit the usefulness of duloxetine in the elderly. However, greater sensitivity of some elderly cannot be ruled out.

Contraindication & Drug interaction

Contraindications

Except under special circumstances, this medication should not be used when the following medical problem exists:

Hepatic insufficiancy ,Hypersensitivity to duloxetine or any of its inactive ingredient, Narrow-angle glaucoma. Uncontrolled, Renal function impairment, severe

Risk-benefit should be considered when the following medical prob­lems exist:

Alcohol abuse or history of , Bipolar disorder or risk of , Chronic liver disease ,Diabetes mellitus ,Conditions that slow gastric emptying, Seizures, history of  Mania, history of  , Narrow-angle glaucoma. contorolled , Hepatotoxicity

 

Drug interactions

Alcohol, Antidepressants, tricyclic (TCAs) such as Amitriptyline , Imipramine , Nortriptyline,Antiarrhythmics, type 1 C such as Recainide , Propafenone,Cimetidine , Fluvoxamine,Quinolone antimicrobials such as Ciprofioxacin , Enoxacin ,CNS acting drugs ,CYP2D6  inhibitors such as  Desipramine ,Fluoxetine ,Paroxetine , Quinidine'

Drugs that affect gastric acidity ,Highly protein-bound drugs, Monoamine oxidase inhibitors (MAOls), Phenothiazines, Thioridazine

Usual Adult Dose

Antidepressant-

Oral, 40 mg/day (given as 20 mg twice a day) to 60 mg/day (given either once a day or as 30 mg twice a day) without regard to meals

Diabetic peripheral neuropathic pain.

Oral, 60 mg/day once daily, without regard to meals

Note: For patients with diabetes complicated by renal disease, a lower starting dose and gradual increase in dose should be considered.

For all indications, patients with end-stage renal disease (re­quiring dialysis) or in severe renal impairment (estimated cre­atinine clearance <30 ml/min), duloxetine is not recom­mended.

For all indications, it is recommended that duloxetine not be administered to patients with any hepatic insufficiency.

Usual Pediatric Dose

Safety and efficacy have not been established



Side Effects

Those indicating need for medical attention

Incidence not determined

Anaphylactic reaction, angioneuroticedema, glaucoma, hepatitis, hyponatremia, jaundice, orthostatic hypotension, Stevens-Johnson syndrome,syncope

Those indicating need for medical attention only if they continue or are bothersome

Incidence more frequent

Anorexia ,asthenia ,appetite decreased; constipetton, cough; diarrhea; dizziness; dry mouth; fatigue ,headache; hyperhidrosis , insomnia , nasopharyngitis , nau­sea; pharyngolaryngeal pain ,pollalkiuria, somnolence,sweating Increased; vomiting

Incidence less frequent

Anxiety ,dyspepsia, ejac­ulation delayed ,ejaculatory dysfunction ,erectile dysfunction , hot flushes , libido decreasoo ,loose stools; muscle cramp; myalgia , orgasm ab­normal, pyrexia, tremor ,Vision blurred; weight decreased


Storage

Store below 30 oC. Protect from light and moisture.

 

Packaging

Boxes of 60 capsules (Enteric coated) Duloxetine 20 mg

Boxes of 100 capsules (Enteric coated) Duloxetine 30 mg

Boxes of 100 capsules (Enteric coated) Duloxetine 60 mg


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Tel: (+98 ) 21 44504121-3
Email: info@loghman-med.com
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