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Zolpidem Tartrate - Drug Information - Taj Pharma, Zolpidem Tartrate dose Taj pharmaceuticals Zolpidem Tartrate interactions, Taj Pharmaceutical Zolpidem Tartrate contraindications, Zolpidem Tartrate price, Zolpidem Tartrate Taj Pharma Zolpidem Tartrate 5 mg Tablets SMPC- Taj Pharma . Stay connected to all updated on Zolpidem Tartrate Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.
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Tolterodine Tartrate2mg and 4mg Prolonged-release Capsules (Dezrol La) Taj Ph...TajPharmaQC
This document describes Tolterodine Tartrate 2mg and 4mg prolonged-release capsules produced by Taj Pharma for the treatment of overactive bladder. It includes information on uses, dosages, side effects and interactions. The capsules contain either 2mg or 4mg of Tolterodine Tartrate as the active ingredient. Common side effects include dry mouth. It should be used with caution in patients with conditions like QT prolongation, renal or hepatic impairment. The document provides the full patient information leaflet and prescribing information for this medication.
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Tramadol Hydrochloride and Paracetamol Tablets IP 37.5mg/325mg; 50mg/325mg (Tramataj-A) Taj PharmaTaj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, Tramadol Hydrochloride and Paracetamol Tablets IP 37.5mg/325mg; 50mg/325mg (Tramataj-A) Taj PharmaDosage & Rx Info | Tramadol Hydrochloride and Paracetamol Tablets IP 37.5mg/325mg; 50mg/325mg (Tramataj-A) Taj PharmaUses, Side Effects, Tramadol Hydrochloride and Paracetamol Tablets IP 37.5mg/325mg; 50mg/325mg (Tramataj-A) Taj PharmaIndications, Side Effects, Warnings, Tramadol Hydrochloride and Paracetamol Tablets IP 37.5mg/325mg; 50mg/325mg (Tramataj-A) Taj Pharma- Drug Information – Taj Pharma, Tramadol Hydrochloride and Paracetamol Tablets IP 37.5mg/325mg; 50mg/325mg (Tramataj-A) Taj Pharmadose Taj pharmaceuticals Tramadol Hydrochloride and Paracetamol Tablets IP 37.5mg/325mg; 50mg/325mg (Tramataj-A) Taj Pharmainteractions, Taj Pharmaceutical Tramadol Hydrochloride and Paracetamol Tablets IP 37.5mg/325mg; 50mg/325mg (Tramataj-A) Taj Pharma SmPC
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This document provides information on Furosemide 20mg/2ml Solution for Injection Taj Pharma, including its uses, dosage, side effects and interactions. It is used as a potent diuretic to treat conditions like cardiac, pulmonary and renal edema. The dosage varies based on the condition, ranging from 20-50mg initially for adults administered via intramuscular or intravenous injection. Special precautions must be taken for patients with renal or liver impairment, electrolyte imbalances, or who are elderly or dehydrated. Laboratory monitoring of sodium, potassium and renal function is recommended during treatment.
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Tolterodine Tartrate2mg and 4mg Prolonged-release Capsules (Dezrol La) Taj Ph...TajPharmaQC
This document describes Tolterodine Tartrate 2mg and 4mg prolonged-release capsules produced by Taj Pharma for the treatment of overactive bladder. It includes information on uses, dosages, side effects and interactions. The capsules contain either 2mg or 4mg of Tolterodine Tartrate as the active ingredient. Common side effects include dry mouth. It should be used with caution in patients with conditions like QT prolongation, renal or hepatic impairment. The document provides the full patient information leaflet and prescribing information for this medication.
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Tramadol Hydrochloride and Paracetamol Tablets IP 37.5mg/325mg; 50mg/325mg (Tramataj-A) Taj PharmaTaj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, Tramadol Hydrochloride and Paracetamol Tablets IP 37.5mg/325mg; 50mg/325mg (Tramataj-A) Taj PharmaDosage & Rx Info | Tramadol Hydrochloride and Paracetamol Tablets IP 37.5mg/325mg; 50mg/325mg (Tramataj-A) Taj PharmaUses, Side Effects, Tramadol Hydrochloride and Paracetamol Tablets IP 37.5mg/325mg; 50mg/325mg (Tramataj-A) Taj PharmaIndications, Side Effects, Warnings, Tramadol Hydrochloride and Paracetamol Tablets IP 37.5mg/325mg; 50mg/325mg (Tramataj-A) Taj Pharma- Drug Information – Taj Pharma, Tramadol Hydrochloride and Paracetamol Tablets IP 37.5mg/325mg; 50mg/325mg (Tramataj-A) Taj Pharmadose Taj pharmaceuticals Tramadol Hydrochloride and Paracetamol Tablets IP 37.5mg/325mg; 50mg/325mg (Tramataj-A) Taj Pharmainteractions, Taj Pharmaceutical Tramadol Hydrochloride and Paracetamol Tablets IP 37.5mg/325mg; 50mg/325mg (Tramataj-A) Taj Pharma SmPC
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This document provides information on Furosemide 20mg/2ml Solution for Injection Taj Pharma, including its uses, dosage, side effects and interactions. It is used as a potent diuretic to treat conditions like cardiac, pulmonary and renal edema. The dosage varies based on the condition, ranging from 20-50mg initially for adults administered via intramuscular or intravenous injection. Special precautions must be taken for patients with renal or liver impairment, electrolyte imbalances, or who are elderly or dehydrated. Laboratory monitoring of sodium, potassium and renal function is recommended during treatment.
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Flutamide Taj Pharma is a medication used to treat advanced prostate cancer. It works by blocking the effects of testosterone on prostate cancer cells. Common side effects include nausea, vomiting, diarrhea, breast tenderness and gynecomastia. When used with an LHRH agonist, it can help reduce side effects from the flare reaction that sometimes occurs with LHRH agonist treatment alone. Regular monitoring of liver function is required due to potential for hepatotoxicity. Other potential side effects include cardiovascular effects like fluid retention and increased risk of blood clots.
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This document provides information on Escitalopram 5mg, 10mg and 20mg tablets manufactured by Taj Pharma, including uses, dosage, side effects and interactions. Escitalopram is indicated for major depressive disorder, panic disorder, social anxiety disorder, generalized anxiety disorder and obsessive-compulsive disorder. It should be administered at 5-20mg daily depending on the condition and individual patient response. Special warnings are provided for pediatric use, risk of suicide and serotonin syndrome when taken with other serotonergic drugs.
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This document is a patient information leaflet for Zolpidem Tartrate 5mg and 10mg tablets produced by Taj Pharmaceuticals. It provides information on:
- What zolpidem is and what it is used for, which is the short-term treatment of insomnia.
- Contraindications and warnings for its use, including not taking it if you have breathing problems or a history of substance abuse.
- How to take zolpidem, including only taking it at bedtime for 2-4 weeks as prescribed by your doctor.
- Possible side effects and drug interactions to be aware of when taking zolpidem with other medications.
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Flutamide Taj Pharma is a medication used to treat advanced prostate cancer. It works by blocking the effects of testosterone on prostate cancer cells. Common side effects include nausea, vomiting, diarrhea, breast tenderness and gynecomastia. When used with an LHRH agonist, it can help reduce side effects from the flare reaction that sometimes occurs with LHRH agonist treatment alone. Regular monitoring of liver function is required due to potential for hepatotoxicity. Other potential side effects include cardiovascular effects like fluid retention and increased risk of blood clots.
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This document provides information on Escitalopram 5mg, 10mg and 20mg tablets manufactured by Taj Pharma, including uses, dosage, side effects and interactions. Escitalopram is indicated for major depressive disorder, panic disorder, social anxiety disorder, generalized anxiety disorder and obsessive-compulsive disorder. It should be administered at 5-20mg daily depending on the condition and individual patient response. Special warnings are provided for pediatric use, risk of suicide and serotonin syndrome when taken with other serotonergic drugs.
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Telmisartan/HCTZ Tablets 40mg/12.5 and 80mg/12.5mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Telmisartan/HCTZ Dosage & Rx Info | Telmisartan/HCTZ Uses, Side Effects Vecuronium bromide: Indications, Side Effects, Warnings, Telmisartan/HCTZ -Drug Information –Taj Pharma, Telmisartan/HCTZ dose Taj pharmaceuticals Telmisartan/HCTZ interactions, Taj Pharmaceutical Telmisartan/HCTZ contraindications, Telmisartan/HCTZ price, Telmisartan/HCTZ Taj Pharma Telmisartan/HCTZ SmPC-Taj Pharma Stay connected to all updated on Telmisartan/HCTZ Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
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Telmisartan Tablets IP 20mg; 40mg; 80mg (Telmisar) Taj PharmaTaj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, Telmisartan Tablets IP 20mg; 40mg; 80mg (Telmisar) Taj PharmaDosage & Rx Info | Telmisartan Tablets IP 20mg; 40mg; 80mg (Telmisar) Taj PharmaUses, Side Effects, Telmisartan Tablets IP 20mg; 40mg; 80mg (Telmisar) Taj PharmaIndications, Side Effects, Warnings, Telmisartan Tablets IP 20mg; 40mg; 80mg (Telmisar) Taj Pharma- Drug Information – Taj Pharma, Telmisartan Tablets IP 20mg; 40mg; 80mg (Telmisar) Taj Pharmadose Taj pharmaceuticals Telmisartan Tablets IP 20mg; 40mg; 80mg (Telmisar) Taj Pharmainteractions, Taj Pharmaceutical Telmisartan Tablets IP 20mg; 40mg; 80mg (Telmisar) Taj Pharmacontraindications, Telmisartan Tablets IP 20mg; 40mg; 80mg (Telmisar) Taj Pharmaprice, Telmisartan Tablets IP 20mg; 40mg; 80mg (Telmisar) Taj PharmaTaj Pharma Telmisartan Tablets IP 20mg; 40mg; 80mg (Telmisar) Taj PharmaSMPC- Taj Pharma Stay connected to all updated on Telmisartan Tablets IP 20mg; 40mg; 80mg (Telmisar) Taj PharmaTaj Pharmaceuticals Taj pharmaceuticals Hyderabad. Summary of Product Characteristics, SmPC.
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Aprepitant Capsules 80mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Aprepitant Dosage & Rx Info | Aprepitant Uses, Side Effects Aprepitant : Indications, Side Effects, Warnings, Aprepitant -Drug Information –Taj Pharma, Aprepitant dose Taj pharmaceuticals Aprepitant interactions, Taj Pharmaceutical Aprepitant contraindications, Aprepitant price, Aprepitant Taj Pharma Aprepitant SmPC-Taj Pharma Stay connected to all updated on Aprepitant Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SMPC.
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Cyclophosphamide Tablets USP 25mg/50mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Cyclophosphamide Dosage & Rx Info | Cyclophosphamide Uses, Side Effects Cyclophosphamide: Indications, Side Effects, Warnings, Cyclophosphamide -Drug Information –Taj Pharma, Cyclophosphamide dose Taj pharmaceuticals Cyclophosphamide interactions, Taj Pharmaceutical Cyclophosphamide contraindications, Cyclophosphamide price, Cyclophosphamide Taj Pharma Cyclophosphamide SmPC-Taj Pharma Stay connected to all updated on Cyclophosphamide Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SMPC.
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This document is a patient information leaflet for Zolpidem Tartrate 5mg and 10mg tablets produced by Taj Pharmaceuticals. It provides information on:
- What zolpidem is and what it is used for, which is the short-term treatment of insomnia.
- Contraindications and warnings for its use, including not taking it if you have breathing problems or a history of substance abuse.
- How to take zolpidem, including only taking it at bedtime for 2-4 weeks as prescribed by your doctor.
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Haloperidol - Drug Information - Taj Pharma, Haloperidol dose Taj pharmaceuticals Haloperidol interactions, Taj Pharmaceutical Haloperidol contraindications, Haloperidol price, Haloperidol Taj Pharma Haloperidol Injection 5mg/ml SMPC- Taj Pharma . Stay connected to all updated on Haloperidol Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.
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This document provides information on Tapentadol ER 50mg, 100mg, 150mg, 200mg extended-release tablets produced by Taj Pharma, including its uses, dosages, side effects and interactions. It describes Tapentadol ER as indicated for the management of severe chronic pain in adults that requires opioid analgesics. Information is provided on dosing, administration, contraindications, warnings and precautions, interactions with other medications, and adverse effects.
Desloratadine Tablets 5mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Desloratadine Dosage & Rx Info | Desloratadine Uses, Side Effects Vecuronium bromide: Indications, Side Effects, Warnings, Desloratadine-Drug Information –Taj Pharma, Desloratadine dose Taj pharmaceuticals Desloratadine interactions, Taj Pharmaceutical Desloratadine contraindications, Desloratadine price, Desloratadine Taj Pharma Desloratadine SmPC-Taj Pharma Stay connected to all updated on Desloratadine Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
Etoposide Injection USP 100mg/5ml Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Etoposide Dosage & Rx Info | Etoposide Uses, Side Effects Etoposide: Indications, Side Effects, Warnings, Etoposide -Drug Information –Taj Pharma, Etoposide dose Taj pharmaceuticals Etoposide interactions, Taj Pharmaceutical Etoposide contraindications, Etoposide price, Etoposide Taj Pharma Etoposide SmPC-Taj Pharma Stay connected to all updated on Etoposide Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SMPC.
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Paliperidone 3mg/6mg/9mg/12mg Extended-release Tablets Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Paliperidone Dosage & Rx Info | Paliperidone Uses, Side Effects Vecuronium bromide: Indications, Side Effects, Warnings, Paliperidone-Drug Information –Taj Pharma, Paliperidone dose Taj pharmaceuticals Paliperidone interactions, Taj Pharmaceutical Paliperidone contraindications, Paliperidone price, Paliperidone Taj Pharma Paliperidone SmPC-Taj Pharma Stay connected to all updated on Paliperidone Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
Paliperidone 3mg/6mg/9mg/12mg Extended-release Tablets Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Paliperidone Dosage & Rx Info | Paliperidone Uses, Side Effects Vecuronium bromide: Indications, Side Effects, Warnings, Paliperidone-Drug Information –Taj Pharma, Paliperidone dose Taj pharmaceuticals Paliperidone interactions, Taj Pharmaceutical Paliperidone contraindications, Paliperidone price, Paliperidone Taj Pharma Paliperidone SmPC-Taj Pharma Stay connected to all updated on Paliperidone Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
Lorazepam Injection USP 2mg/1ml, 20mg/10ml, 40mg/10ml Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Lorazepam Dosage & Rx Info | Lorazepam Uses, Side Effects Lorazepam: Indications, Side Effects, Warnings, Lorazepam -Drug Information –Taj Pharma, Lorazepam dose Taj pharmaceuticals Lorazepam interactions, Taj Pharmaceutical Lorazepam contraindications, Lorazepam price, Lorazepam Taj Pharma Lorazepam SmPC-Taj Pharma Stay connected to all updated on Lorazepam Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
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Aripiprazole Tablets 10mg, 15mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Aripiprazole Dosage & Rx Info | Aripiprazole Uses, Side Effects Aripiprazole: Indications, Side Effects, Warnings, Aripiprazole -Drug Information –Taj Pharma, Aripiprazole dose Taj pharmaceuticals Aripiprazole interactions, Taj Pharmaceutical Aripiprazole contraindications, Aripiprazole price, Aripiprazole Taj Pharma Aripiprazole SmPC- Taj Pharma Stay connected to all updated on Aripiprazole Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SMPC.
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Aripiprazole 10mg, 15mg Tablets Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, Aripiprazole Dosage & Rx Info | Aripiprazole Uses, Side Effects - Aripiprazole : Indications, Side Effects, Warnings, Aripiprazole - Drug Information - Taj Pharma, Aripiprazole dose Taj pharmaceuticals Aripiprazole interactions, Taj Pharmaceutical Aripiprazole contraindications, Aripiprazole price, Aripiprazole Taj Pharma antipsychotics Aripiprazole 10mg, 15mg Tablets SMPC- Taj Pharma . Stay connected to all updated on Aripiprazole Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.
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Alprazolam Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, Alprazolam Dosage & Rx Info | Alprazolam Uses, Side Effects -: Indications, Side Effects, Warnings, Alprazolam - Drug Information - Taj Pharma, Alprazolam dose Taj pharmaceuticals Alprazolam interactions, Taj Pharmaceutical Alprazolam contraindications, Alprazolam price, Alprazolam Taj Pharma Alprazolam 250 microgram Tablets SMPC- Taj Pharma . Stay connected to all updated on Alprazolam Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.
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Paroxetine Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, Paroxetine Dosage & Rx Info | Paroxetine Uses, Side Effects -: Indications, Side Effects, Warnings, Paroxetine - Drug Information - Taj Pharma, Paroxetine dose Taj pharmaceuticals Paroxetine interactions, Taj Pharmaceutical Paroxetine contraindications, Paroxetine price, Paroxetine Taj Pharma Paroxetine 20 mg film-coated tablets SMPC- Taj Pharma . Stay connected to all updated on Paroxetine Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.
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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.
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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.
Perindopril Arginine Tablets USP Taj Pharma PILTajPharmaQC
This document provides information on Perindopril Arginine Tablets produced by Taj Pharma, including its uses, side effects, dosage, interactions and warnings. It is used to treat high blood pressure, heart failure and reduce cardiac risks. Common side effects include severe stomach/abdominal pain. It should not be used in pregnancy or by those allergic to its ingredients. Caution is advised when taking it with other medications due to potential interactions.
This document provides information on lacosamide tablets produced by Taj Pharma, including:
- It describes the composition, pharmaceutical form, clinical uses, dosages, and administration details for lacosamide tablets in 50mg, 100mg, 150mg, and 200mg strengths.
- The tablets are indicated as monotherapy or adjunctive therapy for partial-onset seizures. Common side effects include nausea and vomiting. Special populations may require adjusted dosages.
- Detailed posology and dosage adjustment recommendations are provided for various patient populations including children, elderly patients, and those with renal or hepatic impairment.
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This document provides information on enalapril maleate/hydrochlorothiazide tablets produced by Taj Pharma for treating hypertension. It contains dosing instructions and lists side effects like dizziness and headache. Contraindications include hypersensitivity, severe renal impairment, pregnancy, and a history of angioedema from ACE inhibitors. Warnings include risks of hypotension, electrolyte imbalances, and renal impairment. The document provides details on administration, interactions, and special patient populations.
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.
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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.
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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.
This document provides information on Sofosbuvir Tablets 400mg by Taj Pharma, including its uses, dosage, administration instructions, and safety information. Key details include:
- Sofosbuvir is used in combination with other medications to treat chronic hepatitis C in adults and adolescents aged 12-18.
- The recommended dosage for adults is one 400mg tablet taken orally once daily with food. Dosage recommendations are also provided for adolescents aged 12-18.
- Special populations like renal impairment patients may use Sofosbuvir but dosage adjustments are not required, though safety data is limited in severe renal impairment. No dose adjustments are needed for hepatic impairment.
- Sofosbuvir should not be
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.
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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.
Rasamanikya is a excellent preparation in the field of Rasashastra, it is used in various Kushtha Roga, Shwasa, Vicharchika, Bhagandara, Vatarakta, and Phiranga Roga. In this article Preparation& Comparative analytical profile for both Formulationon i.e Rasamanikya prepared by Kushmanda swarasa & Churnodhaka Shodita Haratala. The study aims to provide insights into the comparative efficacy and analytical aspects of these formulations for enhanced therapeutic outcomes.
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The UK is currently facing a Adhd Medication Shortage Uk, which has left many patients and their families grappling with uncertainty and frustration. ADHD, or Attention Deficit Hyperactivity Disorder, is a chronic condition that requires consistent medication to manage effectively. This shortage has highlighted the critical role these medications play in the daily lives of those affected by ADHD. Contact : +1 (747) 209 – 3649 E-mail : sales@trinexpharmacy.com
Integrating Ayurveda into Parkinson’s Management: A Holistic ApproachAyurveda ForAll
Explore the benefits of combining Ayurveda with conventional Parkinson's treatments. Learn how a holistic approach can manage symptoms, enhance well-being, and balance body energies. Discover the steps to safely integrate Ayurvedic practices into your Parkinson’s care plan, including expert guidance on diet, herbal remedies, and lifestyle modifications.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the 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 lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
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. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
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Histololgy of Female Reproductive System.pptxAyeshaZaid1
Dive into an in-depth exploration of the histological structure of female reproductive system with this comprehensive lecture. Presented by Dr. Ayesha Irfan, Assistant Professor of Anatomy, this presentation covers the Gross anatomy and functional histology of the female reproductive organs. Ideal for students, educators, and anyone interested in medical science, this lecture provides clear explanations, detailed diagrams, and valuable insights into female reproductive system. Enhance your knowledge and understanding of this essential aspect of human biology.
- Video recording of this lecture in English language: https://youtu.be/kqbnxVAZs-0
- Video recording of this lecture in Arabic language: https://youtu.be/SINlygW1Mpc
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Cell Therapy Expansion and Challenges in Autoimmune DiseaseHealth Advances
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
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Zolpidem Tartrate Tablets USP 5mg/10mg
1. Name of the medicinal product
Zolpidem Tartrate Tablets USP 5mg Taj Pharma
Zolpidem Tartrate Tablets USP 10mg Taj Pharma
2. Qualitative and quantitative composition
Each film coated tablet contains:
Zolpidem tartrate USP 5mg
Excipients qs
Each film coated tablet contains:
Zolpidem tartrate USP 10mg
Excipients qs
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Coated tablets for oral administration.
4. Clinical particulars
4.1 Therapeutic indications
Zolpidem tartrate is indicated for the short-term treatment of
insomnia in adults in situations where the insomnia is debilitating or
is causing severe distress for the patient.
4.2 Posology and method of administration
Posology
The treatment should be taken in a single intake and not be re-
administered during the same night.
The recommended daily dose for adults is 10mg to be taken
immediately at bedtime. The lowest effective daily dose of zolpidem
tartrate should be used and must not exceed 10mg.
The duration of treatment should usually vary from a few days to
two weeks with a maximum of four weeks including tapering off
where clinically appropriate.
Treatment should be as short as possible. It should not exceed four
weeks including the period of tapering off. In certain cases extension
beyond the maximum treatment period may be necessary; if so,
extension beyond the maximum treatment period should not take
place without re-evaluation of the patient's status, since the risk of
abuse and dependence increases with the duration of treatment (see
section 4.4).
Special populations
Paediatric population
Zolpidem tartrate is not recommended for use in children and
adolescents below 18 years of age, due to a lack of data to support
use in this age group. The available evidence from placebo-
controlled clinical trials is presented in section 5.1.
Elderly
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Elderly or debilitated patients may be especially sensitive to the
effects of zolpidem tartrate therefore a 5mg/10mg dose is
recommended. These recommended doses should not be exceeded.
Hepatic impairment
As clearance and metabolism of zolpidem tartrate is reduced in
hepatic impairment, dosage should begin at 5mg/10mg in these
patients with particular caution being exercised in elderly patients. In
adults (under 65 years) dosage may be increased to 10mg only where
the clinical response is inadequate and the drug is well tolerated.
Zolpidem must not be used in patients with severe hepatic
impairment as it may contribute to encephalopathy (see section 4.3).
Method of administration
Oral administration.
4.3 Contraindications
• Zolpidem tartrate is contraindicated in patients with a
hypersensitivity to zolpidem tartrate or any of the excipients listed in
section 6.1.
• Obstructive sleep apnoea.
• Myasthenia gravis.
• Severe hepatic insufficiency.
• Acute and/or severe respiratory depression.
In the absence of data, zolpidem tartrate should not be prescribed for
children or patients with psychotic illness.
4.4 Special warnings and precautions for use
The cause of insomnia should be identified wherever possible and
the underlying factors treated before a hypnotic is prescribed. The
failure of insomnia to remit after a 7 – 14 day course of treatment
may indicate the presence of a primary psychiatric or physical
disorder, and the patient should be carefully re-evaluated at regular
intervals.
Next-day psychomotor impairment
Like other sedative/hypnotic drugs, Zolpidem tartrate has CNS-
depressant effects. The risk of next-day psychomotor impairment,
including impaired driving ability, is increased if:
• zolpidem tartrate is taken within less than 8 hours before
performing activities that require mental alertness (see section 4.7);
• a dose higher than the recommended dose is taken;
• zolpidem tartrate is co-administered with other CNS depressants or
with other drugs that increase the blood levels of zolpidem tartrate,
or with alcohol or illicit drugs (see section 4.5).
Zolpidem tartrate should be taken in a single intake immediately at
bedtime and not be re-administered during the same night.
Specific patient groups
Respiratory insufficiency:
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As hypnotics have the capacity to depress respiratory drive,
precautions should be observed if Zolpidem tartrate is prescribed to
patients with compromised respiratory function.
Hepatic insufficiency:
See section 4.2.
Elderly:
See section 4.2 for dose recommendations.
Risk from concomitant use of opioids:
Concomitant use of Zolpidem tartrate and opioids may result in
sedation, respiratory depression, coma and death. Because of these
risks, concomitant prescribing of sedative medicines such as
benzodiazepines or related drugs such as Zolpidem tartrate with
opioids should be reserved for patients for whom alternative
treatment options are not possible.
If a decision is made to prescribe Zolpidem tartrate concomitantly
with opioids, the lowest effective dose should be used, and the
duration of treatment should be as short as possible (see also general
dose recommendation in section 4.2).
The patients should be followed closely for signs and symptoms of
respiratory depression and sedation. In this respect, it is strongly
recommended to inform patients and their environment to be aware
of these symptoms (see section 4.5).
Use in patients with a history of drug or alcohol abuse:
Extreme caution should be exercised when prescribing for patients
with a history of drug or alcohol abuse. These patients should be
under careful surveillance when receiving zolpidem tartrate or any
other hypnotic, since they are at risk of habituation and
psychological dependence.
Psychotic illness:
Hypnotics such as Zolpidem tartrate are not recommended for the
primary treatment of psychotic illness.
Suicidal ideation, suicide attempt, suicide and depression:
Some epidemiological studies suggest an increased incidence of
suicidal ideation, suicide attempt and suicide in patients with or
without depression, and treated with benzodiazepines and other
hypnotics, including zolpidem. However, a causal relationship has
not been established.
As with other sedative/hypnotic drugs, zolpidem tartrate should be
administered with caution in patients exhibiting symptoms of
depression. Suicidal tendencies may be present therefore the least
amount of Zolpidem tartrate that is feasible should be supplied to
these patients to avoid the possibility of intentional overdose by the
patient. Pre-existing depression may be unmasked during use of
Zolpidem tartrate . Since insomnia may be a symptom of depression,
the patient should be re-evaluated if insomnia persists.
General information relating to effects seen following administration
of benzodiazepines and other hypnotic agents which should be taken
into account by the prescribing physician are described below.
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Tolerance:
Some loss of efficacy to the hypnotic effects of short-acting
benzodiazepines and benzodiazepine-like agents like Zolpidem
tartrate may develop after repeated use for a few weeks.
Dependence:
Use of zolpidem may lead to the development of abuse and/or
physical and psychological dependence. The risk of dependence
increases with dose and duration of treatment. The risk of abuse and
dependence is also greater in patients with a history of psychiatric
disorders and/or alcohol, substance or drug abuse. Zolpidem should
be used with extreme caution in patients with current or a history of
alcohol, substance or drug abuse or dependence.
If physical dependence is developed, a sudden discontinuation of
treatment will be accompanied by withdrawal symptoms. These may
consist of headaches, muscle pain, extreme anxiety, tension,
restlessness, confusion and irritability. In severe cases the following
symptoms may occur: derealisation, depersonalisation, hyperacusis,
numbness and tingling of the extremities, hypersensitivity to light,
noise and physical contact, hallucinations or epileptic seizures.
Rebound insomnia:
A transient syndrome whereby the symptoms that led to treatment
with a benzodiazepine or benzodiazepine-like agent recur in an
enhanced form may occur on withdrawal of hypnotic treatment. It
may be accompanied by other reactions including mood changes,
anxiety and restlessness.
It is important that the patient should be aware of the possibility of
rebound phenomena, thereby minimising anxiety over such
symptoms should they occur when the medicinal product is
discontinued. Since the risk of withdrawal phenomena or rebound
has been shown to be greater after abrupt discontinuation of
treatment, it is recommended that the dosage is decreased gradually
where clinically appropriate.
There are indications that, in the case of benzodiazepines and
benzodiazepine-like agents with a short duration of action,
withdrawal phenomena can become manifest within the dosage
interval, especially when the dosage is high.
Amnesia:
Benzodiazepines or benzodiazepine-like agents such as Zolpidem
tartrate may induce anterograde amnesia. The condition occurs most
often several hours after ingesting the product. In order to reduce the
risk, patients should ensure that they will be able to have an
uninterrupted sleep of 8 hours (see section 4.8).
Other psychiatric and “paradoxical” reactions:
Other psychiatric and paradoxical reactions like restlessness,
exacerbated insomnia, agitation, irritability, aggression, delusion,
anger, nightmares, hallucinations, psychosis, abnormal behaviour
and other adverse behavioural effects are known to occur when using
benzodiazepines or benzodiazepine-like agents. Should this occur,
use of the product should be discontinued. These reactions are more
likely to occur in the elderly.
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Somnambulism and associated behaviours:
Sleep walking and other associated behaviours such as “sleep
driving”, preparing and eating food, making phone calls or having
sex, with amnesia for the event, have been reported in patients who
had taken Zolpidem tartrate and were not fully awake. The use of
alcohol and other CNS-depressants with Zolpidem tartrate appears
to increase the risk of such behaviours, as does the use of Zolpidem
tartrate at doses exceeding the maximum recommended dose.
Discontinuation of Zolpidem tartrate should be strongly considered
for patients who report such behaviours (for example, sleep driving),
due to the risk to the patient and others (see sections 4.5 and 4.8).
Severe injuries:
Due to its pharmacological properties, zolpidem can cause
drowsiness and a decreased level of consciousness, which may lead
to falls and consequently to severe injuries.
4.5 Interaction with other medicinal products and other forms of
interaction
Not recommended
Concomitant intake with alcohol:
The sedative effect may be enhanced when the product is used in
combination with alcohol. This affects the ability to drive or use
machines.
Take into account
Combination with CNS depressants:
Enhancement of the central depressive effect may occur in cases of
concomitant use with antipsychotics (neuroleptics), hypnotics,
anxiolytics/sedatives, antidepressant agents, narcotic analgesics,
antiepileptic drugs, anaesthetics and sedative antihistamines.
Therefore, concomitant use of Zolpidem tartrate with these drugs
may increase drowsiness and next-day psychomotor impairment,
including impaired driving ability (see sections 4.4 and 4.7). Also,
isolated cases of visual hallucinations were reported in patients
taking Zolpidem tartrate with antidepressants including bupropion,
desipramine, fluoxetine, sertraline and venlafaxine.
Co-administration of fluvoxamine may increase blood levels of
zolpidem tartrate, concurrent use is not recommended.
In the case of narcotic analgesics enhancement of euphoria may also
occur leading to an increase in psychological dependence.
Opioids:
The concomitant use of sedative medicines such as benzodiazepines
or related drugs such as Zolpidem tartrate with opioids increases the
risk of sedation, respiratory depression, coma and death because of
additive CNS depressant effect. The dosage and duration of
concomitant use should be limited (see section 4.4).
CYP450 inhibitors and inducers:
Co- administration of ciprofloxacin may increase blood levels of
zolpidem tartrate, concurrent use is not recommended.
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Compounds which inhibit certain hepatic enzymes (particularly
cytochrome P450) may enhance the activity of benzodiazepines and
benzodiazepine-like agents.
Zolpidem tartrate is metabolised via several hepatic cytochrome
P450 enzymes, the main enzyme being CYP3A4 with the
contribution of CYP1A2. The pharmacodynamic effect of zolpidem
tartrate is decreased when it is administered with a CYP3A4 inducer
such as rifampicin and St. John's Wort. St. John's Wort has been
shown to have a pharmacokinetic interaction with zolpidem. Mean
Cmax and AUC were decreased (33.7 and 30.0% lower, respectively)
for zolpidem administered with St. John's Wort compared to
zolpidem administered alone. Co-administration of St. John's Wort
may decrease blood levels of zolpidem, concurrent use is not
recommended.
However when zolpidem tartrate was administered with itraconazole
(a CYP3A4 inhibitor) its pharmacokinetics and pharmacodynamics
were not significantly modified. The clinical relevance of these
results is unknown. Co-administration of Zolpidem tartrate with
ketoconazole (200mg twice daily), a potent CYP3A4 inhibitor,
prolonged Zolpidem tartrate elimination half-life, increased total
AUC, and decreased apparent oral clearance when compared to
Zolpidem tartrate plus placebo. The total AUC for Zolpidem tartrate
, when co-administered with ketoconazole, increased by a factor of
1.83 when compared to Zolpidem tartrate alone. A routine dosage
adjustment of Zolpidem tartrate is not considered necessary, but
patients, should be advised that use of Zolpidem tartrate with
ketoconazole may enhance the sedative effects.
Since CYP3A4 plays an important role in zolpidem tartrate
metabolism, possible interactions with drugs that are substrates or
inducers of CYP3A4 should be considered.
Other drugs:
When zolpidem tartrate was administered with ranitidine, no
significant pharmacokinetic interactions were observed.
4.6 Fertility, pregnancy and lactation
Pregnancy
The use of zolpidem is not recommended during pregnancy.
Animal studies do not indicate direct or indirect harmful effects with
respect to reproductive toxicity.
Zolpidem crosses the placenta.
A large amount of data on pregnant women (more than 1000
pregnancy outcomes) collected from cohort studies has not
demonstrated evidence of the occurrence of malformations following
exposure to benzodiazepines or benzodiazepine-like substances
during the first trimester of pregnancy. However, certain case-control
studies reported an increased incidence of cleft lip and palate
associated with use of benzodiazepines during pregnancy.
Cases of reduced fetal movement and fetal heart rate variability have
been described after administration of benzodiazepines or
benzodiazepine-like substances during the second and/or third
trimester of pregnancy.
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Administration of zolpidem during the late phase of pregnancy or
during labour has been associated with effects on the neonate, such
as hypothermia, hypotonia, feeding difficulties ('floppy infant
syndrome') and respiratory depression due to the pharmacological
action of the product. Cases of severe neonatal respiratory depression
have been reported.
Moreover, infants born to mothers who took sedative/hypnotic
agents chronically during the latter stages of pregnancy may have
developed physical dependence and may be at risk of developing
withdrawal symptoms in the postnatal period. Appropriate
monitoring of the newborn in the postnatal period is recommended.
If Zolpidem tartrate is prescribed to a woman of childbearing
potential, she should be warned to contact her physician about
stopping the product if she intends to become or suspects that she is
pregnant.
Breast-feeding
Small quantities of zolpidem tartrate appear in breast milk. The use
of zolpidem tartrate in nursing mothers is therefore not
recommended.
4.7 Effects on ability to drive and use machines
Zolpidem tartrate has major influence on the ability to drive and use
machines.
Vehicle drivers and machine operators should be warned that, as
with other hypnotics, there may be a possible risk of drowsiness,
prolonged reaction time, dizziness, sleepiness, blurred/double vision
and reduced alertness and impaired driving the morning after therapy
(see section 4.8). In order to minimise this risk a resting period of at
least 8 hours is recommended between taking zolpidem tartrate and
driving, using machinery and working at heights.
Driving ability impairment and behaviours such as 'sleep-driving'
have occurred with zolpidem tartrate alone at therapeutic doses.
Furthermore, the co-administration of zolpidem tartrate with alcohol
and other CNS depressants increases the risk of such behaviours (see
sections 4.4 and 4.5). Patients should be warned not to use alcohol or
other psychoactive substances when taking zolpidem tartrate.
4.8 Undesirable effects
The following CIOMS frequency rating is used, when applicable:
Very common ≥ 10%
Common ≥ 1 and < 10%
Uncommon ≥ 0.1 and < 1%
Rare ≥ 0.01 and < 0.1%
Very rare < 0.01%
Not known: cannot be estimated based on available data.
There is evidence of a dose-relationship for adverse effects
associated with zolpidem tartrate use, particularly for certain CNS
and gastrointestinal events. As recommended in section 4.2, they
should in theory be less if zolpidem tartrate is taken immediately
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before retiring, or in bed. They occur most frequently in elderly
patients.
Immune system disorders
Not known: angioneurotic oedema
Psychiatric disorders
Common: hallucination, agitation, nightmare, depression (see section
4.4)
Uncommon: confusional state, irritability, restlessness, aggression,
somnambulism (see section 4.4), euphoric mood
Rare: libido disorder
Very rare: delusion, dependence (withdrawal symptoms, or rebound
effects may occur after treatment discontinuation)
Not known: anger, psychosis, abnormal behaviour
Most of these psychiatric undesirable effects are related to
paradoxical reactions
Nervous system disorders
Common: somnolence, headache, dizziness, exacerbated insomnia,
cognitive disorders such as anterograde amnesia (amnestic effects
may be associated with inappropriate behaviour)
Uncommon: paraesthesia, tremor, disturbance in attention, speech
disorder
Rare: depressed level of consciousness
Eye disorders
Uncommon: diplopia, vision blurred
Very rare: visual impairment
Respiratory, thoracic and mediastinal disorders
Very rare: respiratory depression (see section 4.4)
Gastrointestinal disorders
Common: diarrhea, nausea, vomiting, abdominal pain
Hepatobiliary disorders
Uncommon: liver enzymes elevated
Rare: hepatocellular, cholestatic or mixed liver injury (see sections
4.2, 4.3 and 4.4)
Metabolism and nutrition disorders
Uncommon: appetite disorder
Skin and subcutaneous tissue disorders
Uncommon: rash, pruritus, hyperhidrosis
Rare: urticaria
Musculoskeletal and connective tissue disorders
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Common: back pain
Uncommon: myalgia, muscle spasms, muscular weakness
Infections and infestations
Common: upper respiratory tract infection, lower respiratory tract
infection
General disorders and administration site conditions
Common: fatigue
Rare: gait disturbance, fall (predominantly in elderly patients and
when zolpidem was not taken in accordance with prescribing
recommendation) (see section 4.4).
Not known: drug tolerance
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the
medicinal product is important. It allows continued monitoring of the
benefit/risk balance of the medicinal product.
4.9 Overdose
Signs and symptoms:
In cases of overdose involving zolpidem tartrate alone or with other
CNS-depressant agents (including alcohol), impairment of
consciousness ranging from somnolence to coma, and more severe
symptomatology, including fatal outcomes have been reported.
Management:
General symptomatic and supportive measures should be used. If
there is no advantage in emptying the stomach, activated charcoal
should be given to reduce absorption. Sedating drugs should be
withheld even if excitation occurs.
Use of flumazenil may be considered where serious symptoms are
observed. Flumazenil is reported to have an elimination half-life of
about 40 – 80 minutes. Patients should be kept under close
observation because of this short duration of action; further doses of
flumazenil may be necessary. However, flumazenil administration
may contribute to the appearance of neurological symptoms
(convulsions).
Zolpidem is not dialyzable. The value of dialysis in the treatment of
an overdose has not been determined. Dialysis in patients with renal
failure receiving therapeutic doses of zolpidem have demonstrated
no reduction in levels of zolpidem.
In the management of overdose with any medicinal product, it should
be borne in mind that multiple agents may have been taken.
5. Pharmacological properties
5.1 Pharmacodynamic properties
(GABA-A receptor modulator selective for omega-1 receptor
subtype hypnotic agent).
Zolpidem tartrate is an imidazopyridine which preferentially binds
the omega-1 receptor subtype (also known as the benzodiazepine-1
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subtype) which corresponds to GABA-A receptors containing the
alpha-1 sub-unit, whereas benzodiazepines non-selectively bind both
omega-1 and omega-2 subtypes. The modulation of the chloride
anion channel via this receptor leads to the specific sedative effects
demonstrated by zolpidem tartrate. These effects are reversed by the
benzodiazepine antagonist flumazenil.
In animals: The selective binding of zolpidem tartrate to omega-1
receptors may explain the virtual absence at hypnotic doses of
myorelaxant and anti-convulsant effects in animals which are
normally exhibited by benzodiazepines which are not selective for
omega-1 sites.
In man: zolpidem tartrate decreases sleep latency and the number of
awakenings, and increases sleep duration and sleep quality. These
effects are associated with a characteristic EEG profile, different
from that of the benzodiazepines. In studies that measured the
percentage of time spent in each sleep stage, zolpidem tartrate has
generally been shown to preserve sleep stages. At the recommended
dose, zolpidem tartrate has no influence on the paradoxical sleep
duration (REM). The preservation of deep sleep (stages 3 and 4 -
slow-wave sleep) may be explained by the selective omega-1 binding
by zolpidem tartrate. All identified effects of zolpidem tartrate are
reversed by the benzodiazepine antagonist flumazenil.
The randomized trials only showed convincing evidence of efficacy
of 10mg zolpidem tartrate.
In a randomized double-blind trial in 462 non-elderly healthy
volunteers with transient insomnia, zolpidem tartrate 10mg
decreased the mean time to fall asleep by 10 minutes compared to
placebo, while for 5mg/10mg zolpidem tartrate this was 3 minutes.
In a randomized double-blind trial in 114 non-elderly patients with
chronic insomnia, zolpidem tartrate 10mg decreased the mean time
to fall asleep by 30 minutes compared to placebo, while for
5mg/10mg zolpidem tartrate this was 15 minutes.
In some patients, a lower dose of 5mg/10mg could be effective.
Paediatric population
Safety and efficacy of zolpidem tartrate have not been established in
children aged less than 18 years. A randomized placebo-controlled
study in 201 children aged 6 – 17 years with insomnia associated
with Attention Deficit Hyperactivity Disorder (ADHD) failed to
demonstrate efficacy of zolpidem tartrate 0.25mg/10mg/kg/day (with
a maximum of 10mg/day) as compared to placebo. Psychiatric and
nervous system disorders comprised the most frequent treatment
emergent adverse events observed with zolpidem tartrate versus
placebo and included dizziness (23.5% versus 1.5%), headache
(12.5% versus 9.2%), and hallucinations (7.4% versus 0%) (see
sections 4.2 and 4.3).
5.2 Pharmacokinetic properties
Zolpidem tartrate has both a rapid absorption and onset of hypnotic
action. Bioavailability is 70% following oral administration and
demonstrates linear kinetics in the therapeutic dose range. Peak
plasma concentration is reached at between 0.5 and 3 hours.
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The elimination half-life is short, with a mean of 2.4 hours (± 0.2 h)
and a duration of action of up to 6 hours.
Protein binding amounts to 92.5% ± 0.1%. First pass metabolism by
the liver amounts to approximately 35%. Repeated administration
has been shown not to modify protein binding indicating a lack of
competition between zolpidem tartrate and its metabolites for
binding sites.
The distribution volume in adults is 0.54 ± 0.02 L/kg and decreases
to 0.34 ± 0.05 L/kg in the very elderly.
All metabolites are pharmacologically inactive and are eliminated in
the urine (56%) and in the faeces (37%).
Zolpidem tartrate has been shown in trials to be non-dialysable.
Plasma concentrations in elderly subjects and those with hepatic
impairment are increased. In patients with renal insufficiency,
whether dialysed or not, there is a moderate reduction in clearance.
The other pharmacokinetic parameters are unaffected.
Zolpidem tartrate is metabolised via several hepatic cytochrome
P450 enzymes, the main enzyme being CYP3A4 with the
contribution of CYP1A2. Since CYP3A4 plays an important role in
zolpidem tartrate metabolism, possible interactions with drugs that
are substrates or inducers of CYP3A4 should be considered.
5.3 Preclinical safety data
No data of therapeutic relevance.
6. Pharmaceutical particulars
6.1 List of excipients
Tablet core:
Lactose monohydrate, Microcrystalline cellulose, Hypromellose,
Sodium starch glycollate, Magnesium stearate
Film coating:
Hypromellose, Titanium dioxide, Polyethylene glycol 400
6.2 Incompatibilities
None known
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Store in a dry place below 30°C
6.5 Nature and contents of container
Cartons of 4, 14, 28 or 56 tablets in PVC/foil blister strips of 7 or 14
tablets.
6.6 Special precautions for disposal and other handling
Please consult the package insert before use. Do not use after the
stated expiry date on the carton and blister.
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KEEP OUT OF THE REACH OF CHILDREN
7. Manufactured By:
Taj Pharmaceuticals Ltd.
at: Plot. No. 220, Mahagujarat
Industrial Estate, At & Post-Moraiya,
Tal-Sanand, Dist- Ahmedabad Gujarat (India)