Uses of Uptiva 150 tablet: - Narcolepsy (Uncontrollable daytime sleepiness) Narcolepsy, Obstructive sleep apnoea, Shift Work Sleep Disorder Uncontrolled moderate to severe hypertension or cardiac arrhythmias; history of left ventricular hypertrophy or ischaemic ECG changes, chest pain, any clinical signs of mitral valve prolapse.

CNS stimulant drugs

Armodafinil is an indirect dopamine receptor agonist. This is the R-enantiomer of Modafinil which is a 1:1 mixture of the R- and S-enantiomers. Armodafinil binds to the dopamine transporter and inhibits dopamine reuptake. As a result, increases neuronal activity in the hypothalamus, enhances activity in hypothalamic wakefulness center (TMN, tuberomammillary nucleus) within the hypothalamic sleep wake switch.

How to use Armodafinil: Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Armodafinil may be taken with or without food, but it is better to take it at a fixed time. Administration: May be taken with or without food. Adult Dose: Oral Narcolepsy, Obstructive sleep apnoea Adult: 150-250 mg daily as a single dose in the morning or in 2 divided doses (in the morning and at midday). Shift Work Sleep Disorder 150 mg PO qDay 1 hour prior to patient's work shift Elderly: Consider lower initial dose Hepatic impairment: Reduce dose Child Dose: Safety and efficacy not established Renal Dose: Renal impairment: Safety and efficacy not established

May increase metabolism of ciclosporin, oral contraceptives. May increase the levels/effects of warfarin, TCAs and CYP2C19 substrates (e.g. citalopram, diazepam, methsuximide, phenytoin, propranolol, sertraline). Levels/effects may be reduced with CYP3A4 inducers (e.g. aminoglutethimide, carbamazepine, nafcillin, nevirapine, phenobarbital, phenytoin, rifamycins). Levels/effects may be increased with CYP3A4 inhibitors (e.g. azole antifungals, clarithromycin, diclofenac, doxycycline, erythromycin, imatinib, isoniazid, nefazodone, nicardipine, propofol, protease inhibitors, quinidine, telithromycin, verapamil). Avoid alcohol.

Uncontrolled moderate to severe hypertension or cardiac arrhythmias; history of left ventricular hypertrophy or ischaemic ECG changes, chest pain, any clinical signs of mitral valve prolapse.

Common - Headache - Dizziness - Nausea - Insomnia (difficulty in sleeping) >10% Headache (14-23%) 1-10% Nausea (6-9%),Dry mouth (2-7%),Dizziness (5%),Anxiety (4%),Diarrhea (4%),Insomnia (4%),Rash (1-4%),Depression (1-3%),Dyspepsia (2%),Fatigue (2%),Palpitations (2%),Agitation (1%),Anorexia (1%),Attention disturbances (1%),Contact dermatitis (1%),Dyspnea (1%),Hyperhidrosis (1%),Nervousness (1%),Paresthesia (1%),Pyrexia (1%) <1% Angioedema,Dysphagia,Bronchospasm,Reversible psychosis

Pregnancy: There are no adequate and well controlled studies of Armodafinil in pregnant women. Armodafinil should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.Lactation: It is not known whether Armodafinil or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Armodafinil is administered to a nursing woman.

Precaution: History of psychosis, depression, mania. Discontinue use if there is any sign of rash or hypersensitivity reaction. Increase monitoring in patients with hypertension. Hepatic and renal impairment. Tourette's syndrome. May impair ability to drive or operate machinery. Pregnancy and lactation. Lactation: Unknown if excreted in milk; use caution

There were no overdoses reported in the Armodafinil clinical studies. Symptoms of Armodafinil overdose are likely to be similar to those of Modafinil which included excitation or agitation, insomnia and slight or moderate elevations in hemodynamic parameters. There is no specific antidote for Armodafinil overdose. However, if overdose occurs, it should be managed with primary supportive care.

Store in a cool (below 25°C) and dry place protected from light.

CNS stimulant drugs

The mechanism of armodafinil is unknown but it appears to exert its stimulant effects by reducing GABA-mediated neurotransmission.

Pregnancy Limited available data in pregnant women are insufficient to inform about drug associated risk of adverse pregnancy outcomes; intrauterine growth restriction and spontaneous abortion reported in association with armodafinil and modafinil; although the pharmacology of armodafinil not identical to that of sympathomimetic amines, armodafinil shares some pharmacologic properties with this class; sympathomimetics have been associated with intrauterine growth restriction and spontaneous abortions Effectiveness of hormonal contraceptives may be reduced up to for one month after discontinuation of therapy; advise women who using a hormonal method of contraception to use additional barrier method or alternative non-hormonal method of contraception during treatment and for one month after discontinuation of treatment Lactation There are no data on presence of armodafinil or metabolite in human milk, effects on breastfed infant, or effect of this drug on milk production; modafinil was present in rat milk when animals were dosed during the lactation period; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for armodafinil and any potential adverse effects on breastfed child from armodafinil or from underlying maternal condition