FDA-Approved Drugs in August 2015: Spritam, Keveyis, Addyi, and More
Explore the FDA-approved drugs in August 2015, including Spritam (Levetiracetam) for seizures, Keveyis (Diclorphenamide) for periodic paralysis, and Addyi (Flibanserine) for women. Learn about indications, mechanisms of action, side effects, precautions, and more.
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Presentation Transcript
Drugs approved by US-FDA in Aug. 2015 Dr. Amit Birajdar
Spritam (Levetiracetam) Date of Approval:August 3, 2015 Brand name :- Keppra Indication :- 1. Myoclonic seizures 2. Partial onset seizures 3. Tonic-clonic seizures Mechnism of action:- Modify synaptic release of glutamate or GABA by binding to specific synaptc protein labelled SV2A. 23-04-2025 3
Side Effect:- Dizziness,drowsiness,weakness,infection. Nervous system:- Somnolence (15%), dizziness (9%), vertigo (up to 5%), depression (4%), nervousness (4%), ataxia (3%), amnesia (2%), anxiety (2%), emotional lability (2%), hostility (2%), and paresthesia (2%). Somnolence (8%) and dizziness (5%) have been reported with extended release tablets. 23-04-2025 4
Psychiatric system:- Depression (5.7%) including suicidal depression (0.7%), irritability (6%), and mood swings (5%) Respiratory system:- Pharyngitis (7%), rhinitis (4%), cough (2%), and sinusitis (2%). Other:- neck pain (8%), anorexia (3%), diplopia (2%) 23-04-2025 5
Keveyis (Diclorphenamide) Generic Name: dichlorphenamide Date of Approval: August 7, 2015 Brand Name: Daranide Indication:- Primary hyperkalemic and hypokalemic periodic paralysis 23-04-2025 6
Mechanism of action:- Maintain potassium balance of body serum. Carbonic anhydrase inhibitors are used as prophylaxis 23-04-2025 7
Precaution:- High-dose aspirin regimen Allergic to sulfa-based drugs Liver, kidney, or certain lung conditions Pregnant, planning to become pregnant, or nursing Younger than 18 yr Side effect:- Tingling or pricking sensation, Difficulty thinking & paying attention, Changes in taste & confusion 23-04-2025 8
Addyi (Flibanserine) Generic Name: flibanserin Date of Approval: August 18, 2015 Company: Sprout Pharmaceuticals, Inc. Half life :- 11 HOUR Indication:- Once-daily, non-hormonal, multifunctional serotonin agonist antagonist (MSAA) HSDD have low sexual desire excluding :- Medical or Mental, Relationship problem, Drug side effect. 23-04-2025 9
Mecahnism of action:- Flibanserin acts full agonist of 5-HT1Areceptor in prefrontal cortex, demonstrating regional selectivity Excitatory activity - dopamine and norepinephrine, Inhibitory activity - serotonin. Modulation 23-04-2025 10
Side effect:- Mild to moderate and resolved itself. Most common - dizziness, nausea, fatigue, sleepiness, and trouble sleep. Precaution:- Avoid alcohol Take at bed time Interaction with many drug 23-04-2025 11
Repatha (Evolocumab) Generic Name: Evolocumab (Inj) Date of Approval: August 27, 2015 Company: Amgen Inc. Indication:- Diet and maximally tolerated statin therapy in adults with heterozygous familial hypercholesterolemia Atherosclerotic heart or blood vessel disease 23-04-2025 12
Precaution:- Allergic to rubber or latex Pregnant OR Breastfeeding or plan Heart problems such as heart attacks, stroke, Normal physiology of LDL . 23-04-2025 13
Mechanism of action:- 23-04-2025 14
GAUSS-2 The GAUSS-2 trial evaluated safety, tolerability and efficacy statins due to muscle-related side effects. Most common adverse event headache (7.8%) muscle spasms (6.3%) Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects With Elevated Risk (FOURIER) Lowering cholesterol by an additional 50% might reduce this risk even further. myalgia (7.8%) pain in extremity (6.8%) 23-04-2025 15
Synjardy Generic Name: empagliflozin and metformin hydrochloride Date of Approval: August 27, 2015 Company: Boehringer Ingelheim Pharmaceuticals & Eli Lilly Indication:- Type 2 Dibates mellitus 23-04-2025 16
Mechanism of action:- Inhibitor of SGLT-2 Exclusively in proximal tubules of nephron SGLT-2 accounts for about 90 percent of glucose reabsorption into the blood. Approved in Europe in May 2014 & by FDA in August 2014 Contraindication:- Type 1 DM, Below 18 yr, Diabetic Ketoacidosis 23-04-2025 17
Side effect:- dehydration hypoglycaemia kidney problems vaginal yeast infection yeast infection of the penis (balanitis) urinary tract infection low vitamin B12 (vitamin B12 deficiency) increased fats in your blood (cholesterol) 23-04-2025 18
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