Central Pharmacy

Upper Govind Nagar, Mumbai, Maharashtra

The FDA has approved duloxetine for the treatment of depression and the management of the pain associated with diabetic peripheral neuropathy. The drug is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) similar to venlafaxine (Effexor). Duloxetine is marketed by Eli Lilly and Company as Cymbalta.

Indications : Duloxetine is indicated for the treatment of major depressive disorder (MDD). Effectiveness has not been studied in hospitalized patients with MDD.1 Duloxetine is also indicated for the management of pain associated with diabetic peripheral neuropathy.

Dosage :

• The recommended dose for depression is 40 mg (20 mg twice daily) to 60 mg daily (60 mg once daily or 30 mg twice daily). It may be taken without regard to meals. The recommended dose for neuropathy is 60 mg daily. The capsule contains enteric-coated pellets therefore it should be swallowed whole, not chewed or crushed nor sprinkle on food or liquid. It is not recommended for patients with liver dysfunction or patients with end stage renal disease.
• Duloxetine supplied as 20 mg, 30 mg, and 60 mg capsules.

Potential Advantages : Duloxetine is the first drug approved for the management of diabetic peripheral neuropathy. It is also reported to be effective in relieving painful physical symptoms in depressed patients. Improvements in pain severity were associated with higher remission rates.

Potential Disadvantages : Duloxetine has been associated with increased risk of mydriasis. Therefore it should be avoid in patients with uncontrolled narrow angle glaucoma. Common side effects associated with duloxetine are nausea, somnolence, insomnia, headache, dry mouth, constipation, dizziness, and diarrhea. These tend to be more common earlier in therapy. Increase in blood pressure, symptoms of urinary hesitation, sexual dysfunction in males, and elevation of serum transaminase levels have also been reported. Other frequent (at least 1/100) side effects observed during premarketing evaluations include gastritis, irritability, lethargy, nervousness, nightmare, restlessness, dysuria, night sweats, pruritus, and rash. Duloxetine is metabolized by CYP1A2 and CYP2D6. Potent inhibitors of these isoenzymes result in increase levels of duloxetine. Duloxetine is also a moderate inhibitor of CYP2D6 and intermediate between paroxetine and sertraline. Due to the risk of serious ventricular arrhythmias and sudden death the co-administration of thioridazine and duloxetine in contraindicated.

Clinical Implications :

• Duloxetine is the first drug to be approved for the management of diabetic peripheral neuropathy. It is not known how it compares with other drugs (ie, antidepressant, anticonvulsants) currently being used for this condition with limited success.
• Duloxetine joins the crowded antidepressant market with several SSRIs and one other SSNRI. It is most similar to venlafaxine with no clear clinical advantage over other antidepressants.

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Details :

• Active Ingredient And Chemical structure - The active ingredient contained in Isotroin Capsules is Isotretinoin. Isotretinoin, a retinoid, is a yellow to orange crystalline powder with a molecular weight of 300.44. It is available as Isotroin Capsules (Generic Accutane) in 10 mg and 20 mg capsules for oral administration.
• Uses - Accutane in the form of Isotroin Capsules is used for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic.
• Generic Forms and Brand names of Accutane - Isotroin Capsules manufactured by Cipla Ltd., India is an effective treatment for moderate to severe acne that has failed other therapies. Accutane which has the active ingredient Isotretinoin is also sold as Sotret, Claravis, Amnesteem, Roaccutane, Clarus, Decutan, Isotane, Izotek, Oratane, Isotret and under various other brand names.
• Preparations - Isotroin Capsules (Generic Accutane) is available as tablets of 10 mg and 20 mg.
• Storage Requirements - Isotroin Capsules are to be stored at controlled room temperature (15^oC to 30^oC). Protect from light. Store away from heat and moisture.

• Warnings :
  • Isotroin Capsules (Generic Accutane) must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking Accutane in any amount, even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining whether an exposed fetus has been affected.
  • As there are significant adverse effects associated with its use, Isotroin Capsules should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.

• Dosage :
  • Generic Accutane should always be administered with a meal. The recommended dosage range for Isotroin Capsules is 0.5 to 1.0 mg/kg/day given in two divided doses with food for 15 to 20 weeks.
  • In studies which compared 0.1, 0.5, and 1.0 mg/kg/day, it was found that all dosages provided initial clearing of the disease, but there was a greater need for retreatment with the lower dosages. During treatment, the Generic Accutane dose may be adjusted according to response of the disease and/or the appearance of clinical side effects — some of which may be dose related.

Side Effects Of Isotroin Capsules (Generic Accutane)The most common side effects of Isotroin Capsules are listed below :

• Body as a Whole - Allergic reactions, including vasculitis, systemic hypersensitivity, edema, fatigue, lymphadenopathy, weight loss
• Cardiovascular - Palpitation, tachycardia, vascular thrombotic disease, stroke
• Endocrine/Metabolic - Hypertriglyceridemia, alterations in blood sugar levels
• Gastrointestinal - Inflammatory bowel disease, hepatitis, pancreatitis, bleeding and inflammation of the gums, colitis, esophagitis/esophageal ulceration, ileitis, nausea, other nonspecific gastrointestinal symptoms
• Hematologic - Allergic reactions, anemia, thrombocytopenia, neutropenia, rare reports of agranulocytosis.
• Musculoskeletal - Skeletal hyperostosis, calcification of tendons and ligaments, premature epiphyseal closure, decreases in bone mineral density, musculoskeletal symptoms including back pain, myalgia, and arthralgia, transient pain in the chest, arthritis, tendonitis, other types of bone abnormalities, elevations of CPK/rare reports of rhabdomyolysis.
• Neurological - Pseudotumor cerebri, dizziness, drowsiness, headache, insomnia, lethargy, malaise, nervousness, paresthesias, seizures, stroke, syncope, weakness
• Psychiatric - Suicidal ideation, suicide attempts, suicide, depression, psychosis, aggression, violent behaviors, emotional instability
• Reproductive System - Abnormal menses
• Respiratory - Bronchospasms (with or without a history of asthma), respiratory infection, voice alteration
• Skin and Appendages - Acne fulminans, alopecia (which in some cases persists), bruising, cheilitis (dry lips), dry mouth, dry nose, dry skin, epistaxis, eruptive xanthomas, erythema multiforme, flushing, fragility of skin, hair abnormalities, hirsutism, hyperpigmentation and hypopigmentation, infections (including disseminated herpes simplex), nail dystrophy, paronychia, peeling of palms and soles, photoallergic/photosensitizing reactions, pruritus, pyogenic granuloma, rash (including facial erythema, seborrhea, and eczema), Stevens-Johnson syndrome, sunburn susceptibility increased, sweating, toxic epidermal necrolysis, urticaria, vasculitis (including Wegener’s granulomatosis), abnormal wound healing
• Hearing - Hearing impairment, tinnitus.
• Vision - Corneal opacities, decreased night vision which may persist, cataracts, color vision disorder, conjunctivitis, dry eyes, eyelid inflammation, keratitis, optic neuritis, photophobia, visual disturbances
• Urinary System - Glomerulonephritis, nonspecific urogenital findings

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