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Tramadol hydrochloride 37.5 mg and paracetamol 325 mg film coated tablets smp...Taj Pharma
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Tramadol hydrochloride 37.5 mg and paracetamol 325 mg film coated tablets smp...Taj Pharma
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Valsartan 80mg, 160mg film coated tablets smpc- taj pharmaceuticalsTaj Pharma
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Amiloride hydrochloride 2.5mg and 25mg hydrochlorothiazide tablets smpc taj ...Taj Pharma
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Irbesartan 150 mg film coated tablets smpc- taj pharmaceuticalsTaj Pharma
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Telmisartan/HCTZ Tablets Taj Pharma PILTajPharmaQC
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Artemether and lumefantrine Tablets Taj Pharma SmPCTajPharmaQC
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Captopril Tablets SmPC Taj PharmaceuticalsTajPharmaQC
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Valsartan and HCTZ Tablets USP 80mg/12.5mg, 160mg/12.5mg, 320mg/12.5mg Taj Ph...TajPharmaQC
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Valsartan 80mg, 160mg film coated tablets smpc- taj pharmaceuticalsTaj Pharma
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Irbesartan 150 mg film coated tablets smpc- taj pharmaceuticalsTaj Pharma
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Telmisartan/HCTZ Tablets Taj Pharma PILTajPharmaQC
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Valsartan/Hydroclororthiazide 80mg/12.5mg, 160mg/12.5mg Film Coated Tablets Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, Valsartan-Hydroclororthiazide Dosage & Rx Info | Valsartan-Hydroclororthiazide Uses, Side Effects - Valsartan-Hydroclororthiazide : Indications, Side Effects, Warnings, Valsartan-Hydroclororthiazide - Drug Information - Taj Pharma, Valsartan-Hydroclororthiazide dose Taj pharmaceuticals Valsartan-Hydroclororthiazide interactions, Taj Pharmaceutical Valsartan-Hydroclororthiazide contraindications, Valsartan-Hydroclororthiazide price, Valsartan-Hydroclororthiazide Taj Pharma hypertension Valsartan/Hydroclororthiazide 80mg/12.5mg, 160mg/12.5mg Film Coated Tablets PIL- Taj Pharma . Stay connected to all updated on Valsartan-Hydroclororthiazide Taj Pharmaceuticals Taj pharmaceuticals Hyderabad. Patient Information Leaflets, PIL.
Artemether and lumefantrine Tablets Taj Pharma SmPCTajPharmaQC
Artemether and lumefantrine Tablets 20mg/120mg, 40mg/240mg, 80mg/480mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Artemether and lumefantrine Dosage & Rx Info | Artemether and lumefantrine Uses, Side Effects Artemether and lumefantrine: Indications, Side Effects, Warnings, Artemether and lumefantrine -Drug Information –Taj Pharma, Artemether and lumefantrine dose Taj pharmaceuticals Artemether and lumefantrine interactions, Taj Pharmaceutical Artemether and lumefantrine contraindications, Artemether and lumefantrine price, Artemether and lumefantrine Taj Pharma Artemether and lumefantrine SmPC-Taj Pharma Stay connected to all updated on Artemether and lumefantrine Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
Olmesartan medoxomil and Amlodipine Tablets Taj Pharma SmPCTajPharmaQC
Olmesartan medoxomil and Amlodipine Tablets 20mg/5mg, 40mg/5mg, 40mg/10mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Olmesartan medoxomil and Amlodipine Dosage & Rx Info | Olmesartan medoxomil and Amlodipine Uses, Side Effects Vecuronium bromide: Indications, Side Effects, Warnings, Olmesartan medoxomil and Amlodipine-Drug Information –Taj Pharma, Olmesartan medoxomil and Amlodipine dose Taj pharmaceuticals Olmesartan medoxomil and Amlodipine interactions, Taj Pharmaceutical Olmesartan medoxomil and Amlodipine contraindications, Olmesartan medoxomil and Amlodipine price, Olmesartan medoxomil and Amlodipine Taj Pharma Olmesartan medoxomil and Amlodipine SmPC-Taj Pharma Stay connected to all updated on Olmesartan medoxomil and Amlodipine Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
Trazodone Hydrochloride Tablets IP 25mg; 50mg; 100mg (Sesyrin) Taj Pharma SmPCTajPharmaQC
Trazodone Hydrochloride Tablets IP 25mg; 50mg; 100mg (Sesyrin) Taj Pharma Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, Trazodone Hydrochloride Tablets IP 25mg; 50mg; 100mg (Sesyrin) Taj Pharma Dosage & Rx Info | Trazodone Hydrochloride Tablets IP 25mg; 50mg; 100mg (Sesyrin) Taj Pharma Uses, Side Effects, Trazodone Hydrochloride Tablets IP 25mg; 50mg; 100mg (Sesyrin) Taj Pharma Indications, Side Effects, Warnings, Trazodone Hydrochloride Tablets IP 25mg; 50mg; 100mg SmPC
Captopril Tablets SmPC Taj PharmaceuticalsTajPharmaQC
Captopril Tablets USP 25mg, 50mg, 100mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Captopril Dosage & Rx Info | Captopril Uses, Side Effects Captopril: Indications, Side Effects, Warnings, Captopril -Drug Information –Taj Pharma, Captopril dose Taj pharmaceuticals Captopril interactions, Taj Pharmaceutical Captopril contraindications, Captopril price, Captopril Taj Pharma Captopril SmPC- Taj Pharma Stay connected to all updated on Captopril Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SMPC.
Valsartan and HCTZ Tablets USP 80mg/12.5mg, 160mg/12.5mg, 320mg/12.5mg Taj Ph...TajPharmaQC
Valsartan and HCTZ Tablets USP 80mg/12.5mg, 160mg/12.5mg, 320mg/12.5mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Valsartan and HCTZ Dosage & Rx Info | Valsartan and HCTZ Uses, Side Effects Valsartan and HCTZ: Indications, Side Effects, Warnings, Valsartan and HCTZ-Drug Information –Taj Pharma, Valsartan and HCTZ dose Taj pharmaceuticals Valsartan and HCTZ interactions, Taj Pharmaceutical Valsartan and HCTZ contraindications, Valsartan and HCTZ price, Valsartan and HCTZ Taj Pharma Valsartan and HCTZ SmPC-Taj Pharma Stay connected to all updated on Valsartan and HCTZ Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SMPC.
Furosemide Injection USP Taj Pharma SmPCTajPharmaQC
Furosemide Injection USP 20mg/2ml, 40mg/4ml, 100mg/10ml Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Furosemide Dosage & Rx Info | Furosemide Uses, Side Effects Furosemide: Indications, Side Effects, Warnings, Furosemide -Drug Information –Taj Pharma, Furosemide dose Taj pharmaceuticals Furosemide interactions, Taj Pharmaceutical Furosemide contraindications, Furosemide price, Furosemide Taj Pharma Furosemide SmPC-Taj Pharma Stay connected to all updated on Furosemide Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
Telmisartan 40 mg tablets smpc taj pharmaceuticalsTaj Pharma
Telmisartan Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, Telmisartan Dosage & Rx Info | Telmisartan Uses, Side Effects -: Indications, Side Effects, Warnings, Telmisartan - Drug Information - Taj Pharma, Telmisartan dose Taj pharmaceuticals Telmisartan interactions, Taj Pharmaceutical Telmisartan contraindications, Telmisartan price, Telmisartan Taj Pharma Telmisartan 40mg Tablets SMPC- Taj Pharma . Stay connected to all updated on Telmisartan Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.
Telmisartan Tablets USP Taj Pharma SmPCTajPharmaQC
Telmisartan Tablets USP 20mg/40mg/80mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Telmisartan Dosage & Rx Info | Telmisartan Uses, Side Effects Telmisartan: Indications, Side Effects, Warnings, Telmisartan-Drug Information –Taj Pharma, Telmisartan dose Taj pharmaceuticals Telmisartan interactions, Taj Pharmaceutical Telmisartan contraindications, Telmisartan price, Telmisartan Taj Pharma Telmisartan SmPC-Taj Pharma Stay connected to all updated on Telmisartan Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SMPC.
Flutamide Tablets USP 250mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Flutamide Dosage & Rx Info | Flutamide Uses, Side Effects Flutamide: Indications, Side Effects, Warnings, Flutamide -Drug Information –Taj Pharma, Flutamide dose Taj pharmaceuticals Flutamide interactions, Taj Pharmaceutical Flutamide contraindications, Flutamide price, Flutamide Taj Pharma Flutamide SmPC-Taj Pharma Stay connected to all updated on Flutamide Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SMPC.
Tolterodine Tartrate2mg and 4mg Prolonged-release Capsules (Dezrol La) Taj Ph...TajPharmaQC
Tolterodine Tartrate2mg and 4mg Prolonged-release Capsules (Dezrol La) Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Tolterodine Tartrate2mg and 4mg Prolonged-release Capsules (Dezrol La) Taj Pharma Dosage & Rx Info | Tolterodine Tartrate2mg and 4mg Prolonged-release Capsules (Dezrol La) Taj Pharma Uses, Side Effects, Tolterodine Tartrate2mg and 4mg Prolonged-release Capsules (Dezrol La) Taj Pharma : Indications, Side Effects, Warnings, Tolterodine Tartrate2mg and 4mg Prolonged-release Capsules (Dezrol La) Taj Pharma - Drug Information - Taj Pharma, Tolterodine Tartrate2mg and 4mg Prolonged-release Capsules (Dezrol La) Taj Pharma dose Taj pharmaceuticals Tolterodine Tartrate2mg and 4mg Prolonged-release Capsules (Dezrol La) Taj Pharma interactions, Taj Pharmaceutical Tolterodine Tartrate2mg and 4mg Prolonged-release Capsules (Dezrol La) Taj Pharma contraindications, Tolterodine Tartrate2mg and 4mg Prolonged-release Capsules (Dezrol La) Taj Pharma price, SmPC
Sartel H Tablets (Generic Telmisartan and Hydrochlorothiazide Tablets)Clearsky Pharmacy
Sartel H Tablets (Generic Telmisartan and Hydrochlorothiazide Tablets) is combination of an angiotensin II receptor blocker (ARB) and a thiazide diuretic indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure.
Lowering blood pressure decreases the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. This medicine is not prescribed for initial therapy of hypertension.
Hydroxyzine hydrochloride 10mg film coated tablets smpc- taj pharmaceuticalsTaj Pharma
Hydroxyzine hydrochloride Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, Hydroxyzine hydrochloride Dosage & Rx Info | Hydroxyzine hydrochloride Uses, Side Effects -: Indications, Side Effects, Warnings, Hydroxyzine hydrochloride - Drug Information - Taj Pharma, Hydroxyzine hydrochloride dose Taj pharmaceuticals Hydroxyzine hydrochloride interactions, Taj Pharmaceutical Hydroxyzine hydrochloride contraindications, Hydroxyzine hydrochloride price, Hydroxyzine hydrochloride Taj Pharma Hydroxyzine hydrochloride 10mg Film-coated Tablets SMPC- Taj Pharma . Stay connected to all updated on Hydroxyzine hydrochloride Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.
Atorvastatin 40 mg film coated tablets smpc- taj pharmaceuticalsTaj Pharma
Atorvastatin 40mg Tablets Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, Atorvastatin Dosage & Rx Info | Atorvastatin Uses, Side Effects - Atorvastatin : Indications, Side Effects, Warnings, Atorvastatin - Drug Information - Taj Pharma, Atorvastatin dose Taj pharmaceuticals Atorvastatin interactions, Taj Pharmaceutical Atorvastatin contraindications, Atorvastatin price, Atorvastatin Taj Pharma anti-arrhythmics Atorvastatin 40 mg film-coated tablets SMPC- Taj Pharma . Stay connected to all updated on Atorvastatin Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.
Duloxetine 20 mg gastro resistant capsules smpc- taj pharmaceuticalsTaj Pharma
Duloxetine Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, Duloxetine Dosage & Rx Info | Duloxetine Uses, Side Effects -: Indications, Side Effects, Warnings, Duloxetine - Drug Information - Taj Pharma, Duloxetine dose Taj pharmaceuticals Duloxetine interactions, Taj Pharmaceutical Duloxetine contraindications, Duloxetine price, Duloxetine Taj Pharma Duloxetine 20 mg gastro-resistant capsules SMPC- Taj Pharma . Stay connected to all updated on Duloxetine Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.
Tadalafil 20 mg film coated tablets smpc- taj pharmaceuticalsTaj Pharma
Drug Information - Taj Pharma, Tadalafil dose Taj pharmaceuticals Tadalafil interactions, Taj Pharmaceutical Tadalafil contraindications, Tadalafil price, Tadalafil Taj Pharma Tadalafil 20 mg film-coated tablets SMPC- Taj Pharma . Stay connected to all updated on Tadalafil Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.
Telbivudine Tablet 600mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Telbivudine Dosage & Rx Info | Telbivudine Uses, Side Effects Telbivudine: Indications, Side Effects, Warnings, Telbivudine -Drug Information –Taj Pharma, Telbivudine dose Taj pharmaceuticals Telbivudine interactions, Taj Pharmaceutical Telbivudine contraindications, Telbivudine price, Telbivudine Taj Pharma Telbivudine SmPC-Taj Pharma Stay connected to all updated on Telbivudine Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
Raltegravir Tablets USP Taj Pharma SmPCTajPharmaQC
Raltegravir Tablet USP 25mg/100mg/400mg/600mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Raltegravir Dosage & Rx Info | Raltegravir Uses, Side Effects Raltegravir: Indications, Side Effects, Warnings, Raltegravir -Drug Information –Taj Pharma, Raltegravir dose Taj pharmaceuticals Raltegravir interactions, Taj Pharmaceutical Raltegravir contraindications, Raltegravir price, Raltegravir Taj Pharma Raltegravir SmPC-Taj Pharma Stay connected to all updated on Raltegravir Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
Linezolid Tablets USP 600mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Linezolid Dosage & Rx Info | Linezolid Uses, Side Effects Linezolid: Indications, Side Effects, Warnings, Linezolid -Drug Information –Taj Pharma, Linezolid dose Taj pharmaceuticals Linezolid interactions, Taj Pharmaceutical Linezolid contraindications, Linezolid price, Linezolid Taj Pharma Linezolid SmPC-Taj Pharma Stay connected to all updated on Linezolid Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
Lacosamide Tablets 50mg/100mg/150mg/200mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Lacosamide Dosage & Rx Info | Lacosamide Uses, Side Effects Lacosamide : Indications, Side Effects, Warnings, Lacosamide-Drug Information –Taj Pharma, Lacosamide dose Taj pharmaceuticals Lacosamide interactions, Taj Pharmaceutical Lacosamide contraindications, Lacosamide price, Lacosamide Taj Pharma Lacosamide SmPC-Taj Pharma Stay connected to all updated on Lacosamide Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
Digoxin Tablets USP 62.5mcg/125mcg/250mcg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Digoxin Dosage & Rx Info | Digoxin Uses, Side Effects Digoxin : Indications, Side Effects, Warnings, Digoxin -Drug Information –Taj Pharma, Digoxin dose Taj pharmaceuticals Digoxin interactions, Taj Pharmaceutical Digoxin contraindications, Digoxin price, Digoxin Taj Pharma Digoxin SmPC-Taj Pharma Stay connected to all updated on Digoxin Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
Digoxin Tablets USP 62.5mcg/125mcg/250mcg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Digoxin Dosage & Rx Info | Digoxin Uses, Side Effects Digoxin : Indications, Side Effects, Warnings, Digoxin -Drug Information –Taj Pharma, Digoxin dose Taj pharmaceuticals Digoxin interactions, Taj Pharmaceutical Digoxin contraindications, Digoxin price, Digoxin Taj Pharma Digoxin SmPC-Taj Pharma Stay connected to all updated on Digoxin Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
Ciprofloxacin Tablets USP 250mg/500mg/750mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Ciprofloxacin Dosage & Rx Info | Ciprofloxacin Uses, Side Effects Ciprofloxacin : Indications, Side Effects, Warnings, Ciprofloxacin -Drug Information –Taj Pharma, Ciprofloxacin dose Taj pharmaceuticals Ciprofloxacin interactions, Taj Pharmaceutical Ciprofloxacin contraindications, Ciprofloxacin price, Ciprofloxacin Taj Pharma Ciprofloxacin SmPC-Taj Pharma Stay connected to all updated on Ciprofloxacin Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
Azithromycin Tablets USP 250mg/500mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Azithromycin Dosage & Rx Info | Azithromycin Uses, Side Effects Azithromycin: Indications, Side Effects, Warnings, Azithromycin -Drug Information –Taj Pharma, Azithromycin dose Taj pharmaceuticals Azithromycin interactions, Taj Pharmaceutical Azithromycin contraindications, Azithromycin price, Azithromycin Taj Pharma Azithromycin SmPC-Taj Pharma Stay connected to all updated on Azithromycin Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
Atomoxetine Capsules USP Taj Pharma SmPCTajPharmaQC
Atomoxetine Capsules USP 10mg/18mg/25mg/40mg/60mg/80mg/100mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Atomoxetine Dosage & Rx Info | Atomoxetine Uses, Side Effects Atomoxetine: Indications, Side Effects, Warnings, Atomoxetine -Drug Information –Taj Pharma, Atomoxetine dose Taj pharmaceuticals Atomoxetine interactions, Taj Pharmaceutical Atomoxetine contraindications, Atomoxetine price, Atomoxetine Taj Pharma Atomoxetine SmPC-Taj Pharma Stay connected to all updated on Atomoxetine Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
Vildagliptin Tablets 50mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Vildagliptin Dosage & Rx Info | Vildagliptin Uses, Side Effects Vildagliptin: Indications, Side Effects, Warnings, Vildagliptin -Drug Information –Taj Pharma, Vildagliptin dose Taj pharmaceuticals Vildagliptin interactions, Taj Pharmaceutical Vildagliptin contraindications, Vildagliptin price, Vildagliptin Taj Pharma Vildagliptin SmPC-Taj Pharma Stay connected to all updated on Vildagliptin Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
Theophylline Extended-Release Tablets 100mg, 200mg, 300mg, 400mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Theophylline Dosage & Rx Info | Theophylline Uses, Side Effects Theophylline: Indications, Side Effects, Warnings, Theophylline -Drug Information –Taj Pharma, Theophylline dose Taj pharmaceuticals Theophylline interactions, Taj Pharmaceutical Theophylline contraindications, Theophylline price, Theophylline Taj Pharma Theophylline SmPC-Taj Pharma Stay connected to all updated on Theophylline Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
Sofosbuvir/Velpatasvir Tablets Taj Pharma SmPCTajPharmaQC
Sofosbuvir/Velpatasvir Tablets 400mg/100mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Sofosbuvir/Velpatasvir Dosage & Rx Info | Sofosbuvir/Velpatasvir Uses, Side Effects Sofosbuvir/Velpatasvir: Indications, Side Effects, Warnings, Sofosbuvir/Velpatasvir -Drug Information –Taj Pharma, Sofosbuvir/Velpatasvir dose Taj pharmaceuticals Sofosbuvir/Velpatasvir interactions, Taj Pharmaceutical Sofosbuvir/Velpatasvir contraindications, Sofosbuvir/Velpatasvir price, Sofosbuvir/Velpatasvir Taj Pharma Sofosbuvir/Velpatasvir SmPC-Taj Pharma Stay connected to all updated on Sofosbuvir/Velpatasvir Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
Sofosbuvir Tablets 400mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Sofosbuvir Dosage & Rx Info | Sofosbuvir Uses, Side Effects Sofosbuvir: Indications, Side Effects, Warnings, Sofosbuvir -Drug Information –Taj Pharma, Sofosbuvir dose Taj pharmaceuticals Sofosbuvir interactions, Taj Pharmaceutical Sofosbuvir contraindications, Sofosbuvir price, Sofosbuvir Taj Pharma Sofosbuvir SmPC-Taj Pharma Stay connected to all updated on Sofosbuvir Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
Nicorandil Tablets BP 10mg, 20mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Nicorandil Dosage & Rx Info | Nicorandil Uses, Side Effects Nicorandil: Indications, Side Effects, Warnings, Nicorandil -Drug Information –Taj Pharma, Nicorandil dose Taj pharmaceuticals Nicorandil interactions, Taj Pharmaceutical Nicorandil contraindications, Nicorandil price, Nicorandil Taj Pharma Nicorandil SmPC-Taj Pharma Stay connected to all updated on Nicorandil Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
Ledipasvir and Sofosbuvir Tablets Taj Pharma SmPCTajPharmaQC
Ledipasvir and Sofosbuvir Tablets 90mg/400mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Ledipasvir and Sofosbuvir Dosage & Rx Info | Ledipasvir and Sofosbuvir Uses, Side Effects Ledipasvir and Sofosbuvir: Indications, Side Effects, Warnings, Ledipasvir and Sofosbuvir -Drug Information –Taj Pharma, Ledipasvir and Sofosbuvir dose Taj pharmaceuticals Ledipasvir and Sofosbuvir interactions, Taj Pharmaceutical Ledipasvir and Sofosbuvir contraindications, Ledipasvir and Sofosbuvir price, Ledipasvir and Sofosbuvir Taj Pharma Ledipasvir and Sofosbuvir SmPC-Taj Pharma Stay connected to all updated on Ledipasvir and Sofosbuvir Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
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Losartan potassium/HCTZ Tablets USP Taj Pharma SmPC
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Losartan
Potassium/Hydrochlorothiazide
tablets USP 50mg/12.5
mg/100mg/12.5mg/100mg/25mg
1. Name of the medicinal
product
Losartan Potassium/Hydrochlorothiazide
50mg/12.5mg tablets USP Taj Pharma
Losartan Potassium/Hydrochlorothiazide
100mg/12.5mg tablets USP Taj Pharma
Losartan Potassium/Hydrochlorothiazide
100mg/25mg tablets USP Taj Pharma
2. Qualitative and quantitative
composition
a) Each film-coated tablet contains:
Losartan potassium USP 50mg
Hydrochlorothiazide USP 12.5mg
Excipients q.s.
Colour: Yellow Oxide of Iron & Titanium
Dioxide USP.
b) Each film-coated tablet contains:
Losartan potassium USP 100mg
Hydrochlorothiazide USP 12.5mg
Excipients q.s.
Colour: Yellow Oxide of Iron & Titanium
Dioxide USP.
c) Each film-coated tablet contains:
Losartan potassium USP 100mg
Hydrochlorothiazide USP 25mg
Excipients q.s.
Colour: Yellow Oxide of Iron & Titanium
Dioxide USP.
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Film-coated tablet.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of essential hypertension in patients
whose blood pressure has not been adequately
controlled by losartan or hydrochlorothiazide
alone.
4.2 Posology and method of administration
Losartan Potassium/Hydrochlorothiazide may be
administered with other antihypertensive agents.
Losartan Potassium/Hydrochlorothiazide tablets
should be swallowed with a glass of water.
Losartan Potassium/Hydrochlorothiazide may be
administered with or without food.
Hypertension
Losartan and hydrochlorothiazide is not for use
as initial therapy, but in patients whose blood
pressure is not adequately controlled by losartan
potassium or hydrochlorothiazide alone.
Dose titration with the individual components
(losartan and hydrochlorothiazide) is
recommended.
When clinically appropriate direct change from
monotherapy to the fixed combination may be
considered in patients whose blood pressure is
not adequately controlled.
The usual maintenance dose of Losartan
Potassium/Hydrochlorothiazide is one tablet of
Losartan Potassium/Hydrochlorothiazide 50
mg/12.5 mg (losartan 50 mg/HCTZ 12.5 mg)
once daily. For patients who do not respond
adequately to Losartan
Potassium/Hydrochlorothiazide 50 mg/12.5 mg,
the dosage may be increased to one tablet of
Losartan Potassium/Hydrochlorothiazide 100
mg/25 mg (losartan 100 mg/ HCTZ 25 mg) once
daily. The maximum dose is one tablet of
Losartan Potassium/Hydrochlorothiazide 100
mg/25 mg once daily. In general, the
antihypertensive effect is attained within three to
four weeks after initiation of therapy. Losartan
Potassium/Hydrochlorothiazide 100/12.5
(losartan 100 mg/ HCTZ 12.5 mg) is available
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for those patients titrated to 100 mg of losartan
who require additional blood pressure control.
Use in patients with renal impairment and
haemodialysis patients
No initial dosage adjustment is necessary in
patients with moderate renal impairment (i.e.
creatinine clearance 30-50 ml/min). Losartan
and hydrochlorothiazide tablets are not
recommended for haemodialysis patients.
Losartan/HCTZ tablets must not be used in
patients with severe renal impairment (i.e.
creatinine clearance <30 ml/min) (see section
4.3).
Use in patients with hepatic impairment
Losartan Potassium/Hydrochlorothiazide is
contraindicated in patients with severe hepatic
impairment (see section 4.3.).
Use in patients with intravascular volume
depletion
Volume and /or sodium depletion should be
corrected prior to administration of
Losartan/HCTZ tablets.
Use in the elderly
Dosage adjustment is not usually necessary for
the elderly.
Use in children and adolescents (< 18 years)
There is no experience in children and
adolescents. Therefore,
losartan/hydrochlorothiazide should not be
administered to children and adolescents.
4.3 Contraindications
- Hypersensitivity to losartan, sulphonamide-
derived substances (as hydrochlorothiazide), or
to any of the excipients.
- Therapy resistant hypokalaemia or
hypercalcaemia
- Severe hepatic impairment; cholestasis and
biliary obstructive disorders
- Refractory hyponatraemia
- Symtomatichyperuricaemia/gout
- 2nd
and 3rd
trimester of pregnancy (see section
4.4 and 4.6)
- Severe renal impairment (i.e. creatinine
clearance < 30 ml/min).
- Anuria
4.4 Special warnings and precautions for use
Losartan
Angiooedema
Patients with a history of angiooedema (swelling
of the face, lips, throat, and/or tongue) should be
closely monitored (see section 4.8).
Hypotension and Intravascular volume depletion
Symptomatic hypotension, especially after the
first dose, may occur in patients who are volume
and/or sodium-depleted by vigorous diuretic
therapy, dietary salt restriction, diarrhoea or
vomiting.
Such conditions should be corrected before the
administration of Losartan
Potassium/Hydrochlorothiazide (see sections
4.2. and 4.3.).
Electrolyte imbalances
Electrolyte imbalances are common in patients
with renal impairment, with or without diabetes,
and should be addressed. Therefore, the plasma
concentrations of potassium and creatinine
clearance values should be closely monitored;
especially patients with heart failure and a
creatinine clearance between 30-50 ml/ min
should be closely monitored.
The concomitant use of potassium sparing
diuretics, potassium supplements and potassium
containing salt substitutes with losartan/
hydrochlorothiazide is not recommended (see
section 4.5).
Liver function impairment
Based on pharmacokinetic data which
demonstrate significantly increased plasma
concentrations of losartan in cirrhotic patients,
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Losartan Potassium/Hydrochlorothiazide should
be used with caution in patients with a history of
mild to moderate hepatic impairment. There is
no therapeutic experience with losartan in
patients with severe hepatic impairment.
Therefore Losartan
Potassium/Hydrochlorothiazide is
contraindicated in patients with severe hepatic
impairment (see sections 4.2, 4.3 and 5.2).
Renal function impairment
As a consequence of inhibiting the renin-
angiotensin-aldosterone system, changes in renal
function, including renal failure, have been
reported (in particular, in patients whose renal
function is dependent on the renin-angiotensin-
aldosterone system, such as those with severe
cardiac insufficiency or pre-existing renal
dysfunction). As with other drugs that affect the
renin-angiotensin-aldosterone system, increases
in blood urea and serum creatinine have also
been reported in patients with bilateral renal
artery stenosis or stenosis of the artery to a
solitary kidney; these changes in renal function
may be reversible upon discontinuation of
therapy. Losartan should be used with caution in
patients with bilateral renal artery stenosis or
stenosis of the artery to a solitary kidney.
Renal transplantation
There is no experience in patients with recent
kidney transplantation.
Primary hyperaldosteronism
Patients with primary aldosteronism generally
will not respond to antihypertensive drugs acting
through inhibition of the renin-angiotensin
system. Therefore, the use of Losartan
Potassium/Hydrochlorothiazide is not
recommended.
Coronary heart disease and cerebrovascular
disease:
As with any antihypertensive agents, excessive
blood pressure decrease in patients with
ischaemic cardiovascular and cerebrovascular
disease could result in a myocardial infarction or
stroke.
Heart failure:
In patients with heart failure, with or without
renal impairment, there is - as with other drugs
acting on the renin-angiotensin system - a risk of
severe arterial hypotension, and (often acute)
renal impairment.
Aortic and mitral valve stenosis, obstructive
hypertrophic cardiomyophathy
As with other vasodilators, special caution is
indicated in patients suffering from aortic or
mitral stenosis, or obstructive hypertrophic
cardiomyopathy.
Ethnic differences
As observed for angiotensin converting enzyme
inhibitors, losartan and the other angiotensin
antagonists are apparently less effective in
lowering blood pressure in black people than in
nonblacks, possibly because of higher
prevalence of low-renin states in the black
hypertensive population.
Pregnancy
AIIRAs should not be initiated during
pregnancy. Unless continued AIIRA therapy is
considered essential, patients planning
pregnancy should be changed to alternative anti-
hypertensive treatments which have an
established safety profile for use in pregnancy.
When pregnancy is diagnosed, treatment with
AIIRAs should be stopped immediately, and, if
appropriate, alternative therapy should be started
(see sections 4.3 and 4.6).
Hydrochlorothiazide
Hypotension and electrolyte/fluid imbalance
As with all antihypertensive therapy,
symptomatic hypotension may occur in some
patients. Patients should be observed for clinical
signs of fluid or electrolyte imbalance, e.g.,
volume depletion, hyponatremia, hypochloremic
alkalosis, hypomagnesemia or hypokalemia
which may occur during intercurrent diarrhea or
vomiting. Periodic determination of serum
electrolytes should be performed at appropriate
intervals in such patients.
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Dilutionalhyponatraemia may occur in
oedematous patients in hot weather.
Metabolic and endocrine effects
Thiazide therapy may impair glucose tolerance.
Dosage adjustment of antidiabetic agents,
including insulin, may be required (see section
4.5). Latent diabetes mellitus may become
manifest during thiazide therapy.
Thiazides may decrease urinary calcium
excretion and may cause intermittent and slight
elevation of serum calcium. Marked
hypercalcemia may be evidence of hidden
hyperparathyroidism. Thiazides should be
discontinued before carrying out tests for
parathyroid function.
Increases in cholesterol and triglyceride levels
may be associated with thiazide diuretic therapy.
Thiazide therapy may precipitate hyperuricemia
and/or gout in certain patients. Because losartan
decreases uric acid, losartan in combination with
hydrochlorothiazide attenuates the diuretic-
induced hyperuricemia.
Hepatic impairment
Thiazides should be used with caution in
patients with impaired hepatic function or
progressive liver disease, as it may cause
intrahepatic cholestasis, and since minor
alterations of fluid and electrolyte balance may
precipitate hepatic coma.
Losartan Potassium/Hydrochlorothiazide is
contraindicated for patients with severe hepatic
impairment (see section 4.3 and 5.2).
In patients receiving thiazides, hypersensitivity
reactions may occur with or without a history of
allergy or bronchial asthma. Exacerbations or
activation of systemic lupus erythematosus was
reported after the use of thiazides.
Excipient
The product contains lactose. Patients with rare
congenital intolerance of galactose, Lapp lactase
insufficiency and glucose-
galactosemalabsorption should not take this
medicine (see section 6.1).
4.5 Interaction with other medicinal products
and other forms of interaction
Losartan
Rifampicin and fluconazole have been reported
to lower levels of active metabolites. The
clinical consequences of these interactions have
not been evaluated.
As with other drugs that block angiotensin II or
its effects, concomitant use of potassium-
sparing diuretics (e.g., spironolactone,
triamterene, amiloride), potassium supplements,
or salt substitutes containing potassium may lead
to increases in serum potassium. Co-medication
is not advisable.
As with other medicines which affect the
excretion of sodium, lithium excretion may be
reduced.
Therefore, serum lithium levels should be
monitored carefully if lithium salts are to be
coadministered with angiotensin II receptor
antagonists.
When angiotensin II antagonists are
administered simultaneously with NSAIDs (i.e.
selective COX-2 inhibitors, acetylsalicylic acid
at anti-inflammatory doses) and non-selective
NSAIDs, attenuation of the antihypertensive
effect may occur. Concomitant use of
angiotensin II antagonists or diuretics and
NSAIDs may lead to an increased risk of
worsening of renal function, including possible
acute renal failure, and an increase in serum
potassium, especially in patients with poor pre-
existing renal function. The combination should
be administered with caution, especially in the
elderly. Patients should be adequately hydrated
and consideration should be given to monitoring
renal function after initiation of concomitant
therapy, and periodically thereafter.
In some patients with compromised renal
function who are being treated with non-
steroidal antiinflammatory drugs, including
selective cyclooxygenase-2 inhibitors, the co-
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administration of angiotensin II receptor
antagonists may result in a further deterioration
of renal function. These effects are usually
reversible.
Other substances inducing hypotension like
tricyclic antidepressants, antipsychotics,
baclofene, amifostine: Concomitant use with
these drugs that lower blood pressure, as main or
side-effect, may increase the risk of
hypotension.
Hydrochlorothiazide
When given concurrently, the following drugs
may interact with thiazide diuretics:
Alcohol, barbiturates, narcotics or
antidepressants:
Potentiation of orthostatic hypotension may
occur.
Antidiabetic drugs (oral agents and insulin):
The treatment with a thiazide may influence the
glucose tolerance. Dosage adjustment of the
antidiabetic drug may be required. Metformin
should be used with caution because of the risk
of lactic acidosis induced by possible functional
renal failure linked to hydrochlorothiazide.
Other antihypertensive drugs
Additive effect.
Cholestyramine and colestipol resins:
Absorption of hydrochlorothiazide is impaired in
the presence of anionic exchange resins. Single
doses of either cholestyramine or colestipol
resins bind the hydrochlorothiazide and reduce
its absorption from the gastrointestinal tract by
up to 85 and 43 percent, respectively.
Corticosteroids, ACTH
Intensified electrolyte depletion, particularly
hypokalemia.
Pressor amines (e.g., adrenaline)
Possible decreased response to pressor amines
but not sufficient to preclude their use.
Skeletal muscle relaxants, nondepolarizing (e.g.,
tubocurarine)
Possible increased responsiveness to the muscle
relaxant.
Lithium
Diuretic agents reduce the renal clearance of
lithium and add a high risk of lithium toxicity;
concomitant use is not recommended.
Medicinal products used in the treatment of gout
(probenecid, sulfinpyrazone and allopurinol)
Dosage adjustment of uricosuric medicinal
products may be necessary since
hydrochlorothiazide may raise the level of serum
uric acid. Increase in dosage of probenecid or
sulfinpyrazone may be necessary.
Coadministration of a thiazide may increase the
incidence of hypersensitivity reactions to
allopurinol.
Anticholinergic agents (e.g. atropine, biperiden)
Increase of the bioavailability to thiazide-type
diuretics by decreasing gastrointestinal motility
and stomach emptying rate.
Cytotoxic agents (eg cyclophosphamide,
methotrexate)
Thiazides may reduce the renal excretion of
cytotoxic medicinal products and potentiate their
myelosuppressive effects.
Salicylates
In case of high dosages of salicylates
hydrochlorothiazide may enhance the toxic
effect of the salicylates on the central nervous
system.
Methyldopa
There have been isolated reports of
haemolyticanaemia occurring with concomitant
use of hydrochlorothiazide and methyldopa.
Cyclosporine
Concomitant treatment with cyclosporine may
increase the risk of hyperuricaemia and gout-
type complications.
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Digitalis glycosides
Thiazide-induced hypokalaemia or
hypomagnesaemia may favour the onset of
digitalis- induced cardiac arrhythmias.
Medicinal products affected by serum potassium
disturbances
Periodic monitoring of serum potassium and
ECG is recommended when
losartan/hydrochlorothiazide is administered
with medicinal products affected by serum
potassium disturbances (e.g. digitalis glycosides
and antiarrhythmics) and with the following
torsades de pointes(ventricular tachycardia)-
inducing medicinal products (including some
antiarrhythmics), hypokalaemia being a
predisposing factor to torsades de pointes
(ventricular tachycardia):
- Class Iaantiarrythmics (eg quinidine,
hydroquinidine, disopyramide).
- Class III antiarrythmics (egamiodarone,
sotalol, dofetilide, ibutilide).
- Some antipsychotics (egthioridazine,
chlorpromazine, levomepromazine,
trifluoperazine, cyamemazine, sulpiride,
sultopride, amisulpride, tiapride, pimozide,
haloperidol, droperidol).
- Others (egbepridil, cisapride, diphemanil,
erythromycin IV, halofantrin, mizolastine,
pentamidine, terfenadine, vincamine IV).
Calcium salts
Thiazide diuretics may increase serum calcium
levels due to decreased excretion. If calcium
supplements must be prescribed, serum calcium
levels should be monitored and calcium dosage
should be adjusted accordingly.
Laboratory Test Interactions
Because of their effects on calcium metabolism,
thiazides may interfere with tests for parathyroid
function (see section 4.4).
Carbamazepine
Risk of symptomatic hyponatremia. Clinical and
biological monitoring is required.
Iodine Contrast Media
In case of diuretic-induced dehydration, there is
an increased risk of acute renal failure,
especially with high doses of the iodine product.
Patients should be rehydrated before the
administration.
Amphotericin B (parenteral), corticosteroids,
ACTH or stimulant laxatives
Hydrochlorothiazide may intensify electrolyte
imbalance, particularly hypokalaemia.
4.6 Pregnancy and lactation
Pregnancy
The use of AIIRAs is not recommended during the first trimester
is contra-indicated during the 2nd and 3rd trimester of pregnancy
Epidemiological evidence regarding the risk of
teratogenicity following exposure to ACE
inhibitors during the first trimester of pregnancy
has not been conclusive; however a small
increase in risk cannot be excluded. Whilst there
is no controlled epidemiological data on the risk
with Angiotensin II Receptor Inhibitors
(AIIRAs), similar risks may exist for this class
of drugs. Unless continued AIIRAs therapy is
considered essential, patients planning
pregnancy should be changed to alternative
antihypertensive treatments which have an
established safety profile for use in pregnancy.
When pregnancy is diagnosed, treatment with
Losartan Potassium/Hydrochlorothiazide should
be stopped immediately and, if appropriate,
alternative therapy should be started.
Losartan Potassium/Hydrochlorothiazide
therapy exposure during the second and third
trimesters is known to induce human fetotoxicity
(decreased renal function, oligohydramnios,
skull ossification retardation) and neonatal
toxicity (renal failure, hypotension,
hyperkalaemia) (see also 5.3 'Preclinical safety
data').
Should exposure to Losartan
Potassium/Hydrochlorothiazide have occurred
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from the second trimester of pregnancy,
ultrasound check of renal function and skull is
recommended.
Infants whose mothers have taken Losartan
Potassium/Hydrochlorothiazide should be
closely observed for hypotension (see also
section 4.3 and 4.4).
There is limited experience with
hydrochlorothiazide during pregnancy,
especially during the first trimester. Animal
studies are insufficient.
Hydrochlorothiazide crosses the placenta. Based
on the pharmacological mechanism of action of
hydrochlorothiazide its use during the second
and third trimester may compromise foeto-
placental perfusion and may cause foetal and
neonatal effects like icterus, disturbance of
electrolyte balance and thrombocytopenia.
Hydrochlorothiazide should not be used for
gestational oedema, gestational hypertension or
preeclampsia due to the risk of decreased plasma
volume and placental hypoperfusion, without a
beneficial effect on the course of the disease.
Hydrochlorothiazide should not be used for
essential hypertension in pregnant women
except in rare situations where no other
treatment could be used.
Lactation
No information is available regarding the use of
Losartan Potassium/Hydrochlorothiazide during
breastfeeding. Hydrochlorothiazide is excreted
in human milk. Therefore, the use of Losartan
Potassium/Hydrochlorothiazide during
breastfeeding is not recommended. Alternative
treatments with better established safety profiles
during breastfeeding are preferable, especially
while nursing a newborn or preterm infant.
4.7 Effects on ability to drive and use
machines
No studies on the reactions on the ability to
drive and use machines have been performed.
However, when driving vehicles or operating
machinery it must be borne in mind that
dizziness or drowsiness may occasionally occur
when taking antihypertensive therapy, in
particular during initiation of treatment or when
the dose is increased.
4.8 Undesirable effects
The adverse reactions below are classified where
appropriate by system organ class and frequency
according to the following convention:
Very common: ≥1/10
Common: ≥1/100, <1/10
Uncommon: ≥1/1,000, ≤1/100
Rare: ≥1/10,000, ≤1/1,000
Very rare: ≤ 1/10,000
Not known: ≤ 1/10,000
(cannot be estimated from the available data)
In clinical trials with losartan potassium salt and
hydrochlorothiazide, no adverse reactions
peculiar to this combination of substances were
observed.
The adverse reactions were restricted to those
which were formerly observed with losartan
potassium and/or hydrochlorothiazide.
In controlled clinical trials of essential
hypertension, dizziness was the only adverse
reaction reported as substance-related that
occurred with an incidence greater than placebo
in 1% or more of patients treated with losartan
and hydrochlorothiazide.
Next to these effects, there are further adverse
reactions reported after the introduction of the
product to the market as follows:
Hepato-biliary disorders
Rare: hepatitis.
Investigations
Rare: hyperkalaemia, elevated ALT.
Additional adverse reactions that have been seen
with one of the individual components and may
be potential adverse reactions with Losartan
Potassium/Hydrochlorothiazide are the
following:
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Losartan
Blood and lymphatic system disorders
Uncommon: Anaemia, Henoch-
Schönleinpurpura, ecchymosis, haemolysis.
Immune system disorders
Rare: Anaphylactic reaction, angiooedema,
urticaria.
Metabolism and nutrition disorders
Uncommon: Anorexia, gout.
Psychiatric disorders
Common: Insomnia.
Uncommon: Anxiety, anxiety disorder, panic
disorder, confusion, depression, abnormal
dreams, sleep disorder, somnolence, memory
impairment.
Nervous system disorders
Common: Headache, dizziness.
Uncommon: Nervousness, paraesthesia,
peripheral neuropathy, tremor, migraine,
syncope.
Eye disorders
Uncommon: Blurred vision, burning/stinging in
the eye, conjunctivitis, decrease in visual acuity.
Ear and labyrinth disorders
Uncommon: Vertigo, tinnitus.
Cardiac disorders
Uncommon: Hypotension, orthostatic
hypotension, sternalgia, angina pectoris, grade
II-AV block, cerebrovascular event, myocardial
infarction, palpitation, arrhythmias (atrial
fibrillations, sinus bradycardia, tachycardia,
ventricular tachycardia, ventricular fibrillation).
Vascular disorders
Uncommon: Vasculitis.
Respiratory, thoracic and mediastinal disorders
Common: Cough, upper respiratory infection,
nasal congestion, sinusitis, sinus disorder
Uncommon: Pharyngeal discomfort, pharyngitis,
laryngitis, dyspnoea, bronchitis, epistaxis,
rhinitis, respiratory congestion
Gastrointestinal disorders
Common: Abdominal pain, nausea, diarrhoea,
dyspepsia
Uncommon: Constipation, dental pain, dry
mouth, flatulence, gastritis, vomiting
Hepato-biliary disorders
Not known: Liver function abnormalities
Skin and subcutaneous tissue disorders
Uncommon: Alopecia, dermatitis, dry skin,
erythema, flushing, photosensitivity, pruritus,
rash, urticaria, sweating
Musculoskeletal and connective tissue disorders
Common: Muscle cramp, back pain, leg pain,
myalgia
Uncommon: Arm pain, joint swelling, knee pain,
musculoskeletal pain, shoulder pain, stiffness,
arthralgia, arthritis, coxalgia, fibromyalgia,
muscle weakness
Not known: Rhabdomyolysis
Renal and urinary disorders
Uncommon: Nocturia, urinary frequency,
urinary tract infection
Reproductive system and breast disorders
Uncommon: Decreased libido, impotence
General disorders and administration site
conditions
Common: Asthenia, fatigue, chest pain.
Uncommon: facial oedema, fever.
Investigations
Common: Hyperkalaemia, mild reduction of
haematocrit and haemoglobin
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Uncommon: Mild increase in urea and creatinine
serum levels
Very rare: Increase in hepatic enzymes and
bilirubin.
Hydrochlorothiazide
Blood and lymphatic system disorders
Uncommon: Agranulocytosis, aplastic anaemia,
haemolyticanaemia, leukopenia, purpura,
thrombocytopenia.
Immune system disorders
Rare: Anaphylactic reaction
Metabolism and nutrition disorders
Uncommon: Anorexia, hyperglycaemia,
hyperuricaemia, hypokalaemia, hyponatraemia
Psychiatric disorders
Uncommon: Insomnia
Nervous system disorders
Common: Cephalalgia.
Eye disorders
Uncommon: transient blurred vision, xanthopsia.
Vascular disorders
Uncommon: Necrotizing angiitis (vasculitis,
cutaneous vasculitis)
Respiratory, thoracic and mediastinal disorders
Uncommon: Respiratory disturbances including
pneumonitis and pulmonaryoedema.
Gastrointestinal disorders
Uncommon: Sialoadenitis, spasms, stomach
irritation, nausea, vomiting, diarrhoea,
constipation.
Hepato-biliary disorders
Uncommon: Icterus (intrahepatic cholestatis),
pancreatitis
Skin and subcutaneous tissue disorders
Uncommon: Photosensitivity, urticaria, toxic
epidermal necrolysis.
Musculoskeletal and connective tissue disorders
Uncommon: Muscle cramps.
Renal and urinary disorders
Uncommon: Glycosuria, interstitial nephritis,
renal dysfunction, renal failure
General disorders and administration site
conditions
Uncommon: Fever, dizziness.
4.9 Overdose
No specific information is available on the
treatment of overdosage with Losartan
Potassium/Hydrochlorothiazide. Treatment is
symptomatic and supportive. Therapy with
Losartan Potassium/Hydrochlorothiazide should
be discontinued and the patient observed closely.
Suggested measures include induction of emesis
if ingestion is recent, and correction of
dehydration, electrolyte imbalance, hepatic
coma and hypotension by established
procedures.
Losartan
Limited data are available in regard to
overdosage in humans. The most likely
manifestation of overdosage would be
hypotension and tachycardia; bradycardia could
occur from parasympathetic (vagal) stimulation.
If symptomatic hypotension should occur,
supportive treatment should be instituted.
Neither losartan nor the active metabolite can be
removed by hemodialysis.
Hydrochlorothiazide
The most common signs and symptoms
observed are those caused by electrolyte
depletion (hypokalemia, hypochloremia,
hyponatremia) and dehydration resulting from
excessive diuresis. If digitalis has also been
administered, hypokalemia may accentuate
cardiac arrhythmias.
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The degree to which hydrochlorothiazide is
removed by hemodialysis has not been
established.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Angiotensin II
antagonists and diuretics.
Losartan-Hydrochlorothiazide
The components of Losartan
Potassium/Hydrochlorothiazide have been
shown to have an additive effect on blood
pressure reduction, reducing blood pressure to a
greater degree than either component alone. This
effect is thought to be a result of the
complimentary actions of both components.
Further, as a result of its diuretic effect,
hydrochlorothiazide increases plasma renin
activity, increases aldosterone secretion,
decreases serum potassium, and increases the
levels of angiotensin II. Administration of
losartan blocks all the physiologically relevant
actions of angiotensin II and through inhibition
of aldosterone could tend to attenuate the
potassium loss associated with the diuretic.
Losartan has been shown to have a mild and
transient uricosuric effect. Hydrochlorothiazide
has been shown to cause modest increases in
uric acid; the combination of losartan and
hydrochlorothiazide tends to attenuate the
diuretic- induced hyperuricemia.
The antihypertensive effect of Losartan
Potassium/Hydrochlorothiazide is sustained for
a 24-hour period. In clinical studies of at least
one year's duration, the antihypertensive effect
was maintained with continued therapy. Despite
the significant decrease in blood pressure,
administration of Losartan
Potassium/Hydrochlorothiazide had no clinically
significant effect on heart rate. In clinical trials,
after 12 weeks of therapy with losartan 50
mg/hydrochlorothiazide 12.5 mg, trough sitting
diastolic blood pressure was reduced by an
average of up to 13.2 mmHg.
Losartan Potassium/Hydrochlorothiazide is
effective in reducing blood pressure in males
and females, blacks and non-blacks and in
younger (<65 years) and older (≥65 years)
patients and is effective in all degrees of
hypertension.
Losartan
Losartan is a synthetically produced oral
angiotensin-II receptor (type AT1) antagonist.
Angiotensin II, a potent vasoconstrictor, is the
primary active hormon of the renin-angiotensin
system and an important determinant of the
pathophysiology of hypertension. Angiotensin II
binds to the AT1 receptor found in many tissues
(e.g. vascular smooth muscle, adrenal gland,
kidneys and the heart) and elicits several
important biological actions, including
vasoconstriction and the release of
aldosterone.Angiotensin II also stimulates
smooth-muscle cell proliferation.
Losartan selectively blocks the AT1 receptor. In
vitro and in vivo losartan and its
pharmacologically active carboxylic acid
metabolite E-3174 block all physiologically
relevant actions of angiotensin II, regardless of
the source or route of its synthesis.
Losartan does not have an agonist effect nor
does it block other hormone receptors or ion
channels important in cardiovascular regulation.
Furthermore, losartan does not inhibit ACE
(kininase II), the enzyme that degrades
bradykinin. Consequently, there is thus no
increase in bradykinin-mediated undesirable
effects.
During the administration of losartan the
removal of the angiotensin II negative feedback
on rennin secretion leads to increased plasma-
renin activity (PRA). Increase in the PRA leads
to an increase in angiotensin II in plasma.
Despite these increases, antihypertensive activity
and suppression of the plasma aldosterone
concentration are maintained, indicating
effective angiotensin II receptor blockade. After
the discontinuation of losartan,PRA and
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angiotensin II values fell within 3 days to the
baseline values.
Both losartan and its principal active metabolite
have a far greater affinity for the AT1 receptor
than for the AT2 receptor. The active metabolite
is 10- to 40-times more active than losartan on a
weight for weight basis.
In a study specifically designed to assess the
incidence of cough in patients treated with
losartan as compared to patients treated with
ACE inhibitors, the incidence of cough reported
by patients receiving losartan or
hydrochlorothiazide was similar and was
significantly less than in patients treated with an
ACE inhibitor. In addition, in an overall analysis
of 16 double-blind clinical trials in 4131
patients, the incidence of spontaneously reported
cough in patients treated with losartan was
similar (3.1%) to that of patients treated with
placebo (2.6%) or hydrochlorothiazide (4.1%),
whereas the incidence with ACE inhibitors was
8.8%.
In nondiabetic hypertensive patients with
proteinuria, the administration of losartan
potassium significantly reduces proteinuria,
fractional excretion of albumin and IgG.
Losartan maintains glomerular filtration rate and
reduces filtration fraction. Generally losartan
causes a decrease in serum uric acid (usually
<0.4 mg/dL) which was persistent in chronic
therapy.
Losartan has no effect on autonomic reflexes
and no sustained effect on plasma
norepinephrine.
In patients with left ventricular failure, 25 mg
and 50 mg doses of losartan produced positive
hemodynamic and neurohormonal effects
characterized by an increase in cardiac index and
decreases in pulmonary capillary wedge
pressure, systemic vascular resistance, mean
systemic arterial pressure and heart rate and a
reduction in circulating levels of aldosterone and
norepinephrine, respectively.
The occurrence of hypotension was dose related
in these heart failure patients.
Hypertension Studies
In controlled clinical studies, once-daily
administration of Losartan to patients with mild
to moderate essential hypertension produced
statistically significant reductions in systolic and
diastolic blood pressure. Measurements of blood
pressure 24 hours post-dose relative to 5 – 6
hours post-dose demonstrated blood pressure
reduction over 24 hours; the natural diurnal
rhythm was retained. Blood pressure reduction
at the end of the dosing interval was 70 – 80 %
of the effect seen 5-6 hours postdose.
Discontinuation of Losartan in hypertensive
patients did not result in an abrupt rise in blood
pressure (rebound). Despite the marked decrease
in blood pressure, Losartan had no clinically
significant effects on heart rate.
Losartan is equally effective in males and
females, and in younger (below the age of 65
years) and older hypertensive patients.
LIFE Study
The Losartan Intervention For Endpoint
reduction in hypertension (LIFE) study was a
randomised, triple-blind, active-controlled study
in 9193 hypertensive patients aged 55 to 80
years with ECGdocumented left ventricular
hypertrophy. Patients were randomised to once
daily losartan 50 mg or once daily atenolol 50
mg. If goal blood pressure (<140/90 mmHg) was
not reached, hydrochlorothiazide (12.5 mg) was
added first and, if needed, the dose of losartan or
atenolol was then increased to 100 mg once
daily. Other antihypertensives, with the
exception of ACE inhibitors, angiotensin II
antagonists or beta-blockers were added if
necessary to reach the goal blood pressure.
The mean length of follow up was 4.8 years.
The primary endpoint was the composite of
cardiovascular morbidity and mortality as
measured by a reduction in the combined
incidence of cardiovascular death, stroke and
myocardial infarction. Blood pressure was
significantly lowered to similar levels in the two
groups. Treatment with losartan resulted in a
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13.0% risk reduction (p=0.021, 95 % confidence
interval 0.77-0.98) compared with atenolol for
patients reaching the primary composite
endpoint. This was mainly attributable to a
reduction of the incidence of stroke. Treatment
with losartan reduced the risk of stroke by 25%
relative to atenolol (p=0.001 95% confidence
interval 0.63-0.89). The rates of cardiovascular
death and myocardial infarction were not
significantly different between the treatment
groups.
Hydrochlorothiazide
Hydrochlorothiazide is a thiazide diuretic. The
mechanism of the antihypertensive effect of
thiazide diuretics is not fully known. Thiazides
affect the renal tubular mechanisms of
electrolyte reabsorption, directly increasing
excretion of sodium and chloride in
approximately equivalent amounts. The diuretic
action of hydrochlorothiazide reduces plasma
volume, increases plasma renin activity and
increases aldosterone secretion, with consequent
increases in urinary potassium and bicarbonate
loss, and decreases in serum potassium. The
renin-aldosterone link is mediated by
angiotensin II and therefore coadministration of
an angiotensin II receptor antagonist tends to
reverse the potassium loss associated with
thiazide diuretics.
After oral use, diuresis begins within 2 hours,
peaks in about 4 hours and lasts about 6 to 12
hours the antihypertensive effect persists for up
to 24 hours.
5.2 Pharmacokinetic properties
Absorption
Losartan
Following oral administration, losartan is well
absorbed and undergoes first-pass metabolism,
forming an active carboxylic acid metabolite and
other inactive metabolites. The systemic
bioavailability of losartan tablets is
approximately 33%. Mean peak concentrations
of losartan and its active metabolite are reached
in 1 hour and in 3-4 hours, respectively. There
was no clinically significant effect on the plasma
concentration profile of losartan when the drug
was administered with a standardized meal.
Distribution
Losartan
Both losartan and its active metabolite are ≥99%
bound to plasma proteins, primarily albumin.
The volume of distribution of losartan is 34
liters. Studies in rats indicate that losartan
crosses the bloodbrain barrier poorly, if at all.
Hydrochlorothiazide
Hydrochlorothiazide crosses the placental but
not the blood-brain barrier and is excreted in
breast milk.
Biotransformation
Losartan
About 14% of an intravenously- or orally-
administered dose of losartan is converted to its
active metabolite. Following oral and
intravenous administration of 14C-labeled
losartan potassium, circulating plasma
radioactivity primarily is attributed to losartan
and its active metabolite. Minimal conversion of
losartan to its active metabolite was seen in
about one percent of individuals studied.
In addition to the active metabolite, inactive
metabolites are formed, including two major
metabolites formed by hydroxylation of the
butyl side chain and a minor metabolite, an N-2
tetrazoleglucuronide.
Elimination
Losartan
Plasma clearance of losartan and its active
metabolite is about 600 mL/min and 50 mL/min,
respectively. Renal clearance of losartan and its
active metabolite is about 74 mL/min and 26
mL/min, respectively. When losartan is
administered orally, about 4% of the dose is
excreted unchanged in the urine, and about 6%
of the dose is excreted in the urine as active
metabolite. The pharmacokinetics of losartan
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and its active metabolite are linear with oral
losartan potassium doses up to 200 mg.
Following oral administration, plasma
concentrations of losartan and its active
metabolite decline polyexponentially with a
terminal half-life of about 2 hours and 6-9 hours,
respectively. During oncedaily dosing with 100
mg, neither losartan nor its active metabolite
accumulates significantly in plasma.
Both biliary and urinary excretion contribute to
the elimination of losartan and its metabolites.
Following an oral dose of 14C-labeled losartan
in man, about 35% of radioactivity is recovered
in the urine and 58% in the feces.
Hydrochlorothiazide
Hydrochlorothiazide is not metabolized but is
eliminated rapidly by the kidney. When plasma
levels have been followed for at least 24 hours,
the plasma half-life has been observed to vary
between 5.6 and 14.8 hours. At least 61 percent
of the oral dose is eliminated unchanged within
24 hours.
Characteristics in Patients
Losartan-Hydrochlorothiazide
The plasma concentrations of losartan and its
active metabolite and the absorption of
hydrochlorothiazide in elderly hypertensives are
not significantly different from those in young
hypertensives.
Losartan
Following oral administration in patients with
mild to moderate alcoholic cirrhosis of the liver,
plasma concentrations of losartan and its active
metabolite were, respectively, 5-fold and 1.7-
fold greater than those seen in young male
volunteers.
Neither losartan nor the active metabolite can be
removed by hemodialysis.
5.3 Preclinical safety data
Preclinical data reveal no special hazard for
humans based on conventional studies of general
pharmacology, genotoxicity and carcinogenic
potential. The toxic potential of the combination
of losartan/hydrochlorothiazide was evaluated in
chronic toxicity studies for up to six months
duration in rats and dogs after oral
administration, and the changes observed in
these studies with the combination were mainly
produced by the losartan component. The
administration of the
losartan/hydrochlorothiazide combination
induced a decrease in the red blood cell
parameters (erythrocytes, haemoglobin,
haematocrit), a rise in urea-N in the serum, a
decrease in heart weight (without a histological
correlate) and gastrointestinal changes (mucous
membrane lesions, ulcers, erosions,
haemorrhages). There was no evidence of
teratogenicity in rats or rabbits treated with the
losartan/hydrochlorothiazide combination.
Foetal toxicity in rats, as evidenced by a slight
increase in supernumerary ribs in the F1
generation, was observed when females were
treated prior to and throughout gestation. As
observed in studies with losartan alone, adverse
foetal and neonatal effects, including renal
toxicity and foetal death, occurred when
pregnant rate were treated with the
losartan/hydrochlorothiazide combination during
late gestation and/or lactation.
6. Pharmaceutical particulars
6.1 List of excipients
Maize starch, pregelatinised, Cellulose,
microcrystalline, Lactose monohydrate,
Magnesium stearate
Hypromellose, Macrogol, Quinoline yellow,
Talc, Titanium dioxide.
6.2 Incompatibilities
Not applicable
6.3 Shelf life
3 years
6.4 Special precautions for storage
Do not store above 30°C. Store in the original
blister in order to protect from moisture.
6.5 Nature and contents of container
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Al/PVC/Blister Packing.
Pack sizes: 7, 14, 28, 30, 50, 90, 100 and 500
film-coated tablets
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other
handling
No special requirements.
7. Manufactured In India By:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of Commerce Lane,
Fort, Mumbai - 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-
222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m.
EST
E-mail: tajgroup@tajpharma.com