Gabapentin Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, Gabapentin Dosage & Rx Info | Gabapentin Uses, Side Effects -: Indications, Side Effects, Warnings, Gabapentin - Drug Information - Taj Pharma, Gabapentin dose Taj pharmaceuticals Gabapentin interactions, Taj Pharmaceutical Gabapentin contraindications, Gabapentin price, Gabapentin Taj Pharma Gabapentin 300mg capsules SMPC- Taj Pharma . Stay connected to all updated on Gabapentin Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.
Gabapin 400 mg Tablet is manufactured in India by Intas Pharmaceuticals Limited. Gabapin 400 mg Tablet is is basically an anticonvulsant normally prescribed for epilepsy and postherpetic neuralgia.
This document summarizes information about the anti-seizure medications gabapentin and pregabalin. It discusses gabapentin's mechanism of action, approved uses, dosing, pharmacokinetics, interactions, adverse effects and overdose treatment. It then summarizes a clinical study comparing the dose-response relationship of pregabalin and gabapentin in patients with partial seizures, finding that pregabalin was more potent and effective at reducing seizure frequency.
Drug Monitoring and Pharmacokinetics of Gabapentin, Clinical Pharmacyİsa Badur
This document summarizes the pharmacokinetics and dosing of gabapentin. It discusses:
1) Gabapentin's mechanism of action involves binding to voltage-gated calcium channels containing the alpha-2-delta-1 subunit, which may modulate the release of excitatory neurotransmitters involved in epilepsy and pain.
2) Gabapentin has variable oral bioavailability that is inversely related to dose due to saturable absorption. It has a half-life of 5-7 hours in adults that increases with renal impairment.
3) Gabapentin is excreted unchanged in the urine, with 76-81% of the dose excreted renally. Dosing should be
Gabapentin capsules are used to treat postherpetic neuralgia in adults and as an adjunctive therapy for partial onset seizures in adults and pediatric patients aged 3 and older. The capsules contain 300mg of gabapentin as the active ingredient and are manufactured by Sun Pharmaceutical Industries Limited. Common side effects include dizziness, somnolence, and peripheral edema. Gabapentin capsules should be stored at room temperature and used with caution during pregnancy.
Extended-release gabapentin was approved in 2011 for the treatment of postherpetic neuralgia. A clinical trial compared once daily and twice daily dosing of extended-release gabapentin to placebo. While the primary endpoint was not statistically significant, secondary endpoints showed benefits for pain, sleep interference, and global impression of change with gabapentin. Further studies are needed to definitively establish efficacy and identify optimal dosing for postherpetic neuralgia.
Nilotinib Capsules 50mg/150mg/200mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Nilotinib Dosage & Rx Info | Nilotinib Uses, Side Effects Nilotinib: Indications, Side Effects, Warnings, Nilotinib -Drug Information –Taj Pharma, Nilotinib dose Taj pharmaceuticals Nilotinib interactions, Taj Pharmaceutical Nilotinib contraindications, Nilotinib price, Nilotinib Taj Pharma Nilotinib SmPC-Taj Pharma Stay connected to all updated on Nilotinib Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
Topiramate tablets are available in 15mg and 100mg strengths from Taj Pharma. Topiramate is indicated as monotherapy for partial seizures in adults and children over 6, and as adjunctive therapy for partial seizures, primary generalized tonic-clonic seizures, and Lennox-Gastaut syndrome in children and adults. It is also indicated for migraine prophylaxis in adults. Common side effects include mood disturbances, depression, and kidney stones. Dosage should be titrated slowly from low starting doses and monitored based on clinical response and tolerability. Special precautions are needed in patients with renal or hepatic impairment.
Gabapin 400 mg Tablet is manufactured in India by Intas Pharmaceuticals Limited. Gabapin 400 mg Tablet is is basically an anticonvulsant normally prescribed for epilepsy and postherpetic neuralgia.
This document summarizes information about the anti-seizure medications gabapentin and pregabalin. It discusses gabapentin's mechanism of action, approved uses, dosing, pharmacokinetics, interactions, adverse effects and overdose treatment. It then summarizes a clinical study comparing the dose-response relationship of pregabalin and gabapentin in patients with partial seizures, finding that pregabalin was more potent and effective at reducing seizure frequency.
Drug Monitoring and Pharmacokinetics of Gabapentin, Clinical Pharmacyİsa Badur
This document summarizes the pharmacokinetics and dosing of gabapentin. It discusses:
1) Gabapentin's mechanism of action involves binding to voltage-gated calcium channels containing the alpha-2-delta-1 subunit, which may modulate the release of excitatory neurotransmitters involved in epilepsy and pain.
2) Gabapentin has variable oral bioavailability that is inversely related to dose due to saturable absorption. It has a half-life of 5-7 hours in adults that increases with renal impairment.
3) Gabapentin is excreted unchanged in the urine, with 76-81% of the dose excreted renally. Dosing should be
Gabapentin capsules are used to treat postherpetic neuralgia in adults and as an adjunctive therapy for partial onset seizures in adults and pediatric patients aged 3 and older. The capsules contain 300mg of gabapentin as the active ingredient and are manufactured by Sun Pharmaceutical Industries Limited. Common side effects include dizziness, somnolence, and peripheral edema. Gabapentin capsules should be stored at room temperature and used with caution during pregnancy.
Extended-release gabapentin was approved in 2011 for the treatment of postherpetic neuralgia. A clinical trial compared once daily and twice daily dosing of extended-release gabapentin to placebo. While the primary endpoint was not statistically significant, secondary endpoints showed benefits for pain, sleep interference, and global impression of change with gabapentin. Further studies are needed to definitively establish efficacy and identify optimal dosing for postherpetic neuralgia.
Nilotinib Capsules 50mg/150mg/200mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Nilotinib Dosage & Rx Info | Nilotinib Uses, Side Effects Nilotinib: Indications, Side Effects, Warnings, Nilotinib -Drug Information –Taj Pharma, Nilotinib dose Taj pharmaceuticals Nilotinib interactions, Taj Pharmaceutical Nilotinib contraindications, Nilotinib price, Nilotinib Taj Pharma Nilotinib SmPC-Taj Pharma Stay connected to all updated on Nilotinib Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
Topiramate tablets are available in 15mg and 100mg strengths from Taj Pharma. Topiramate is indicated as monotherapy for partial seizures in adults and children over 6, and as adjunctive therapy for partial seizures, primary generalized tonic-clonic seizures, and Lennox-Gastaut syndrome in children and adults. It is also indicated for migraine prophylaxis in adults. Common side effects include mood disturbances, depression, and kidney stones. Dosage should be titrated slowly from low starting doses and monitored based on clinical response and tolerability. Special precautions are needed in patients with renal or hepatic impairment.
Gemcitabine 200mg, 1g powder for solution for infusion smpc taj pharmaceuticalsTaj Pharma
GEMCITABINE Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, GEMCITABINE Dosage & Rx Info | GEMCITABINE Uses, Side Effects -: Indications, Side Effects, Warnings, GEMCITABINE - Drug Information - Taj Pharma, GEMCITABINE dose Taj pharmaceuticals GEMCITABINE interactions, Taj Pharmaceutical GEMCITABINE contraindications, GEMCITABINE price, GEMCITABINE Taj Pharma Cancer, oncologyGemcitabine 200mg, 1g Powder for Solution for Infusion. SMPC- Taj Pharma
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This document provides information on the treatment of Kala-azar (visceral leishmaniasis) and post-kala-azar dermal leishmaniasis (PKDL). It discusses the clinical features, case definitions, objectives of treatment, and drug treatment options for primary kala-azar, treatment failure, and relapse cases. The first-line drugs recommended are liposomal amphotericin B, miltefosine, and paromomycin. For PKDL, first-line treatment is oral miltefosine for 12 weeks, and second-line options include amphotericin B deoxycholate or sodium stibogluconate. Special considerations for treatment in pregnancy, co-
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.
Carbamazepine 200 mg tablets smpc taj pharmaceuticalsTaj Pharma
Carbamazepine Uses, Side Effects -: Indications, Side Effects, Warnings, Carbamazepine - Drug Information - Taj Pharma, Carbamazepine dose Taj pharmaceuticals Carbamazepine interactions, Taj Pharmaceutical Carbamazepine contraindications, Carbamazepine price, Carbamazepine Taj Pharma Carbamazepine 200 mg tablets SMPC- Taj Pharma . Stay connected to all updated on Carbamazepine Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.
Carboplatin Injection BP 50mg/5ml, 150mg/15ml, 450mg/45ml, 600mg/60ml Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Carboplatin Dosage & Rx Info | Carboplatin Uses, Side Effects Carboplatin: Indications, Side Effects, Warnings, Carboplatin -Drug Information –Taj Pharma, Carboplatin dose Taj pharmaceuticals Carboplatin interactions, Taj Pharmaceutical Carboplatin contraindications, Carboplatin price, Carboplatin Taj Pharma Carboplatin SmPC-Taj Pharma Stay connected to all updated on Carboplatin Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SMPC.
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Quetiapine Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, Quetiapine Dosage & Rx Info | Quetiapine Uses, Side Effects -: Indications, Side Effects, Warnings, Quetiapine - Drug Information - Taj Pharma, Quetiapine dose Taj pharmaceuticals Quetiapine interactions, Taj Pharmaceutical Quetiapine contraindications, Quetiapine price, Quetiapine Taj Pharma Cancer, oncologyQuetiapine 25mg Film Coated Tablets SMPC- Taj Pharma . Stay connected to all updated on Quetiapine Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.
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IMATINIB Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, IMATINIB Dosage & Rx Info | IMATINIB Uses, Side Effects -: Indications, Side Effects, Warnings, IMATINIB - Drug Information - Taj Pharma, IMATINIB dose Taj pharmaceuticals IMATINIB interactions, Taj Pharmaceutical IMATINIB contraindications, IMATINIB price, IMATINIB Taj Pharma Cancer, oncologyImatinib 100 mg capsules. SMPC- Taj Pharma . Stay connected to all updated on IMATINIB Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.
Imatinib Capsules 100mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Imatinib Dosage & Rx Info | Imatinib Uses, Side Effects Imatinib: Indications, Side Effects, Warnings, Imatinib -Drug Information –Taj Pharma, Imatinib dose Taj pharmaceuticals Imatinib interactions, Taj Pharmaceutical Imatinib contraindications, Imatinib price, Imatinib Taj Pharma Imatinib SmPC-Taj Pharma Stay connected to all updated on Imatinib Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SMPC.
Everolimus Tablets 5mg, 10mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Everolimus Dosage & Rx Info | Everolimus Uses, Side Effects Everolimus: Indications, Side Effects, Warnings, Everolimus -Drug Information –Taj Pharma, Everolimus dose Taj pharmaceuticals Everolimus interactions, Taj Pharmaceutical Everolimus contraindications, Everolimus price, Everolimus Taj Pharma Everolimus SmPC-Taj Pharma Stay connected to all updated on Everolimus Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SMPC.
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Lapatinib Tablets USP 250mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Lapatinib Dosage & Rx Info | Lapatinib Uses, Side Effects Lapatinib: Indications, Side Effects, Warnings, Lapatinib -Drug Information –Taj Pharma, Lapatinib does Taj pharmaceuticals Lapatinib interactions, Taj Pharmaceutical Lapatinib contraindications, Lapatinib price, Lapatinib Taj Pharma Lapatinib SmPC-Taj Pharma Stay connected to all updated on Lapatinib Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SMPC.
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Ketoconazole Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, Ketoconazole Dosage & Rx Info | Ketoconazole Uses, Side Effects -: Indications, Side Effects, Warnings, Ketoconazole - Drug Information - Taj Pharma, Ketoconazole dose Taj pharmaceuticals Ketoconazole interactions, Taj Pharmaceutical Ketoconazole contraindications, Ketoconazole price, Ketoconazole Taj Pharma Ketoconazole 200 mg tablets SMPC- Taj Pharma . Stay connected to all updated on Ketoconazole Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.
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Busulfan Tablets USP 2mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Busulfan Dosage & Rx Info | Busulfan Uses, Side Effects Busulfan: Indications, Side Effects, Warnings, Busulfan -Drug Information –Taj Pharma, Busulfan dose Taj pharmaceuticals Busulfan interactions, Taj Pharmaceutical Busulfan contraindications, Busulfan price, Busulfan Taj Pharma Busulfan SmPC-Taj Pharma Stay connected to all updated on Busulfan Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SMPC.
Ramipril Tablets BP 5mg, 10mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Ramipril Dosage & Rx Info | Ramipril Uses, Side Effects Ramipril: Indications, Side Effects, Warnings, Ramipril-Drug Information –Taj Pharma, Ramipril dose Taj pharmaceuticals Ramipril interactions, Taj Pharmaceutical Ramipril contraindications, Ramipril price, Ramipril Taj Pharma Ramipril SmPC-Taj Pharma Stay connected to all updated on Ramipril Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SMPC.
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Dexamethasone Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, Dexamethasone Dosage & Rx Info | Dexamethasone Uses, Side Effects -: Indications, Side Effects, Warnings, Dexamethasone - Drug Information - Taj Pharma, Dexamethasone dose Taj pharmaceuticals Dexamethasone interactions, Taj Pharmaceutical Dexamethasone contraindications, Dexamethasone price, Dexamethasone Taj Pharma Dexamethasone 4 mg tablets SMPC- Taj Pharma . Stay connected to all updated on Dexamethasone Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.
Paracetamol and ibuprofen 500 mg and 150 mg film coated tablets smpc taj pha...Taj Pharma
Paracetamol and Ibuprofen - Drug Information - Taj Pharma, Paracetamol and Ibuprofen dose Taj pharmaceuticals Paracetamol and Ibuprofen interactions, Taj Pharmaceutical Paracetamol and Ibuprofen contraindications, Paracetamol and Ibuprofen price, Paracetamol and Ibuprofen Taj Pharma Paracetamol and Ibuprofen 500 mg/150 mg film coated tablets SMPC- Taj Pharma . Stay connected to all updated on Paracetamol and Ibuprofen Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.
Escitalopram 10 mg film coated tablets smpc- taj pharmaceuticalsTaj Pharma
This document is the summary of product characteristics for Escitalopram 10 mg film-coated tablets produced by Taj Pharmaceuticals. It provides information on the therapeutic uses, posology, contraindications, warnings/precautions, interactions, and adverse effects of the drug. Escitalopram is indicated for the treatment of major depressive disorder, panic disorder, social anxiety disorder, generalized anxiety disorder, and obsessive-compulsive disorder. The recommended starting dose is 10 mg daily, which can be increased to a maximum of 20 mg based on individual patient response and tolerability. Cautions are advised regarding risk of suicide, seizures, QT prolongation and interactions with other serotonergic drugs.
Metformin hydrochloride Tablets Taj Pharma SmPCTajPharmaQC
Metformin hydrochloride ER tablets 500mg/750mg/1000mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Metformin hydrochloride Dosage & Rx Info | Metformin hydrochloride Uses, Side Effects Metformin hydrochloride: Indications, Side Effects, Warnings, Metformin hydrochloride-Drug Information –Taj Pharma, Metformin hydrochloride dose Taj pharmaceuticals Metformin hydrochloride interactions, Taj Pharmaceutical Metformin hydrochloride contraindications, Metformin hydrochloride price, Metformin hydrochloride Taj Pharma Metformin hydrochloride SmPC- Taj Pharma Stay connected to all updated on Metformin hydrochloride Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SMPC.
Glimepiride Tablets USP Taj Pharma SmPCTajPharmaQC
Glimepiride Tablets USP 1mg, 2mg, 3mg, 4mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Glimepiride Dosage & Rx Info | Glimepiride Uses, Side Effects Glimepiride: Indications, Side Effects, Warnings, Glimepiride-Drug Information –Taj Pharma, Glimepiride dose Taj pharmaceuticals Glimepiride interactions, Taj Pharmaceutical Glimepiride contraindications, Glimepiride price, Glimepiride Taj Pharma Glimepiride SmPC- Taj Pharma Stay connected to all updated on Glimepiride Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SMPC.
Gabapentin is an anticonvulsant used to treat partial seizures in adults and children over 12 years old. It is also used to treat postherpetic neuralgia and pain associated with diabetic neuropathy. Common side effects include somnolence, dizziness, and fatigue. Special populations like those with renal impairment require dosage adjustments. Abrupt withdrawal may cause increased seizure frequency so gabapentin should be tapered off slowly over at least a week.
Pregabalin SR Capsules Sustained Release 100mg/150mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Pregabalin Dosage & Rx Info | Pregabalin Uses, Side Effects Vecuronium bromide: Indications, Side Effects, Warnings, Pregabalin-Drug Information –Taj Pharma, Pregabalin dose Taj pharmaceuticals Pregabalin interactions, Taj Pharmaceutical Pregabalin contraindications, Pregabalin price, Pregabalin Taj Pharma Pregabalin SmPC-Taj Pharma Stay connected to all updated on Pregabalin Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
Gemcitabine 200mg, 1g powder for solution for infusion smpc taj pharmaceuticalsTaj Pharma
GEMCITABINE Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, GEMCITABINE Dosage & Rx Info | GEMCITABINE Uses, Side Effects -: Indications, Side Effects, Warnings, GEMCITABINE - Drug Information - Taj Pharma, GEMCITABINE dose Taj pharmaceuticals GEMCITABINE interactions, Taj Pharmaceutical GEMCITABINE contraindications, GEMCITABINE price, GEMCITABINE Taj Pharma Cancer, oncologyGemcitabine 200mg, 1g Powder for Solution for Infusion. SMPC- Taj Pharma
Gentamicin 40 mg per ml injection smpc taj pharmaceuticalsTaj Pharma
Gentamicin - Drug Information - Taj Pharma, Gentamicin dose Taj pharmaceuticals Gentamicin interactions, Taj Pharmaceutical Gentamicin contraindications, Gentamicin price, Gentamicin Taj Pharma Gentamicin 40 mg/ml Injection SMPC- Taj Pharma . Stay connected to all updated on Gentamicin Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.
This document provides information on the treatment of Kala-azar (visceral leishmaniasis) and post-kala-azar dermal leishmaniasis (PKDL). It discusses the clinical features, case definitions, objectives of treatment, and drug treatment options for primary kala-azar, treatment failure, and relapse cases. The first-line drugs recommended are liposomal amphotericin B, miltefosine, and paromomycin. For PKDL, first-line treatment is oral miltefosine for 12 weeks, and second-line options include amphotericin B deoxycholate or sodium stibogluconate. Special considerations for treatment in pregnancy, co-
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.
Carbamazepine 200 mg tablets smpc taj pharmaceuticalsTaj Pharma
Carbamazepine Uses, Side Effects -: Indications, Side Effects, Warnings, Carbamazepine - Drug Information - Taj Pharma, Carbamazepine dose Taj pharmaceuticals Carbamazepine interactions, Taj Pharmaceutical Carbamazepine contraindications, Carbamazepine price, Carbamazepine Taj Pharma Carbamazepine 200 mg tablets SMPC- Taj Pharma . Stay connected to all updated on Carbamazepine Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.
Carboplatin Injection BP 50mg/5ml, 150mg/15ml, 450mg/45ml, 600mg/60ml Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Carboplatin Dosage & Rx Info | Carboplatin Uses, Side Effects Carboplatin: Indications, Side Effects, Warnings, Carboplatin -Drug Information –Taj Pharma, Carboplatin dose Taj pharmaceuticals Carboplatin interactions, Taj Pharmaceutical Carboplatin contraindications, Carboplatin price, Carboplatin Taj Pharma Carboplatin SmPC-Taj Pharma Stay connected to all updated on Carboplatin Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SMPC.
Quetiapine 25mg film coated tablets smpc- taj pharmaceuticalsTaj Pharma
Quetiapine Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, Quetiapine Dosage & Rx Info | Quetiapine Uses, Side Effects -: Indications, Side Effects, Warnings, Quetiapine - Drug Information - Taj Pharma, Quetiapine dose Taj pharmaceuticals Quetiapine interactions, Taj Pharmaceutical Quetiapine contraindications, Quetiapine price, Quetiapine Taj Pharma Cancer, oncologyQuetiapine 25mg Film Coated Tablets SMPC- Taj Pharma . Stay connected to all updated on Quetiapine Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.
Imatinib 100 mg capsules smpc taj pharmaceuticalsTaj Pharma
IMATINIB Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, IMATINIB Dosage & Rx Info | IMATINIB Uses, Side Effects -: Indications, Side Effects, Warnings, IMATINIB - Drug Information - Taj Pharma, IMATINIB dose Taj pharmaceuticals IMATINIB interactions, Taj Pharmaceutical IMATINIB contraindications, IMATINIB price, IMATINIB Taj Pharma Cancer, oncologyImatinib 100 mg capsules. SMPC- Taj Pharma . Stay connected to all updated on IMATINIB Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.
Imatinib Capsules 100mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Imatinib Dosage & Rx Info | Imatinib Uses, Side Effects Imatinib: Indications, Side Effects, Warnings, Imatinib -Drug Information –Taj Pharma, Imatinib dose Taj pharmaceuticals Imatinib interactions, Taj Pharmaceutical Imatinib contraindications, Imatinib price, Imatinib Taj Pharma Imatinib SmPC-Taj Pharma Stay connected to all updated on Imatinib Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SMPC.
Everolimus Tablets 5mg, 10mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Everolimus Dosage & Rx Info | Everolimus Uses, Side Effects Everolimus: Indications, Side Effects, Warnings, Everolimus -Drug Information –Taj Pharma, Everolimus dose Taj pharmaceuticals Everolimus interactions, Taj Pharmaceutical Everolimus contraindications, Everolimus price, Everolimus Taj Pharma Everolimus SmPC-Taj Pharma Stay connected to all updated on Everolimus Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SMPC.
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Lapatinib Tablets USP 250mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Lapatinib Dosage & Rx Info | Lapatinib Uses, Side Effects Lapatinib: Indications, Side Effects, Warnings, Lapatinib -Drug Information –Taj Pharma, Lapatinib does Taj pharmaceuticals Lapatinib interactions, Taj Pharmaceutical Lapatinib contraindications, Lapatinib price, Lapatinib Taj Pharma Lapatinib SmPC-Taj Pharma Stay connected to all updated on Lapatinib Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SMPC.
Ketoconazole 200 mg tablets smpc taj pharmaceuticalsTaj Pharma
Ketoconazole Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, Ketoconazole Dosage & Rx Info | Ketoconazole Uses, Side Effects -: Indications, Side Effects, Warnings, Ketoconazole - Drug Information - Taj Pharma, Ketoconazole dose Taj pharmaceuticals Ketoconazole interactions, Taj Pharmaceutical Ketoconazole contraindications, Ketoconazole price, Ketoconazole Taj Pharma Ketoconazole 200 mg tablets SMPC- Taj Pharma . Stay connected to all updated on Ketoconazole Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.
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Busulfan Tablets USP 2mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Busulfan Dosage & Rx Info | Busulfan Uses, Side Effects Busulfan: Indications, Side Effects, Warnings, Busulfan -Drug Information –Taj Pharma, Busulfan dose Taj pharmaceuticals Busulfan interactions, Taj Pharmaceutical Busulfan contraindications, Busulfan price, Busulfan Taj Pharma Busulfan SmPC-Taj Pharma Stay connected to all updated on Busulfan Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SMPC.
Ramipril Tablets BP 5mg, 10mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Ramipril Dosage & Rx Info | Ramipril Uses, Side Effects Ramipril: Indications, Side Effects, Warnings, Ramipril-Drug Information –Taj Pharma, Ramipril dose Taj pharmaceuticals Ramipril interactions, Taj Pharmaceutical Ramipril contraindications, Ramipril price, Ramipril Taj Pharma Ramipril SmPC-Taj Pharma Stay connected to all updated on Ramipril Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SMPC.
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Dexamethasone Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, Dexamethasone Dosage & Rx Info | Dexamethasone Uses, Side Effects -: Indications, Side Effects, Warnings, Dexamethasone - Drug Information - Taj Pharma, Dexamethasone dose Taj pharmaceuticals Dexamethasone interactions, Taj Pharmaceutical Dexamethasone contraindications, Dexamethasone price, Dexamethasone Taj Pharma Dexamethasone 4 mg tablets SMPC- Taj Pharma . Stay connected to all updated on Dexamethasone Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.
Paracetamol and ibuprofen 500 mg and 150 mg film coated tablets smpc taj pha...Taj Pharma
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Escitalopram 10 mg film coated tablets smpc- taj pharmaceuticalsTaj Pharma
This document is the summary of product characteristics for Escitalopram 10 mg film-coated tablets produced by Taj Pharmaceuticals. It provides information on the therapeutic uses, posology, contraindications, warnings/precautions, interactions, and adverse effects of the drug. Escitalopram is indicated for the treatment of major depressive disorder, panic disorder, social anxiety disorder, generalized anxiety disorder, and obsessive-compulsive disorder. The recommended starting dose is 10 mg daily, which can be increased to a maximum of 20 mg based on individual patient response and tolerability. Cautions are advised regarding risk of suicide, seizures, QT prolongation and interactions with other serotonergic drugs.
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Metformin hydrochloride ER tablets 500mg/750mg/1000mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Metformin hydrochloride Dosage & Rx Info | Metformin hydrochloride Uses, Side Effects Metformin hydrochloride: Indications, Side Effects, Warnings, Metformin hydrochloride-Drug Information –Taj Pharma, Metformin hydrochloride dose Taj pharmaceuticals Metformin hydrochloride interactions, Taj Pharmaceutical Metformin hydrochloride contraindications, Metformin hydrochloride price, Metformin hydrochloride Taj Pharma Metformin hydrochloride SmPC- Taj Pharma Stay connected to all updated on Metformin hydrochloride Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SMPC.
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Gabapentin is an anticonvulsant used to treat partial seizures in adults and children over 12 years old. It is also used to treat postherpetic neuralgia and pain associated with diabetic neuropathy. Common side effects include somnolence, dizziness, and fatigue. Special populations like those with renal impairment require dosage adjustments. Abrupt withdrawal may cause increased seizure frequency so gabapentin should be tapered off slowly over at least a week.
Pregabalin SR Capsules Sustained Release 100mg/150mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Pregabalin Dosage & Rx Info | Pregabalin Uses, Side Effects Vecuronium bromide: Indications, Side Effects, Warnings, Pregabalin-Drug Information –Taj Pharma, Pregabalin dose Taj pharmaceuticals Pregabalin interactions, Taj Pharmaceutical Pregabalin contraindications, Pregabalin price, Pregabalin Taj Pharma Pregabalin SmPC-Taj Pharma Stay connected to all updated on Pregabalin Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
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Newer antiepileptic drugs (AEDs) such as eslicarbazepine, vigabatrin, lacosamide, clobazam, levetiracetam, lamotrigine, topiramate, zonisamide, oxcarbazepine have been introduced as adjunctive therapies for refractory epilepsy. These newer AEDs have fewer drug interactions and side effects than older AEDs. They target specific epilepsy syndromes in children. However, most are only used as adjunctive rather than monotherapy due to a lack of superiority trials compared to conventional AEDs. Dosing and use of the newer AEDs varies based on age, renal function
Betamethasone 0.5 mg soluble tablets smpc taj pharmaceuticalsTaj Pharma
Betamethasone Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, Betamethasone Dosage & Rx Info | Betamethasone Uses, Side Effects -: Indications, Side Effects, Warnings, Betamethasone - Drug Information - Taj Pharma, Betamethasone dose Taj pharmaceuticals Betamethasone interactions, Taj Pharmaceutical Betamethasone contraindications, Betamethasone price, Betamethasone Taj Pharma Betamethasone 500 microgram Soluble Tablets SMPC- Taj Pharma . Stay connected to all updated on Betamethasone Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.
This document summarizes several medications used to treat obesity and related comorbidities such as diabetes. It describes the mechanism of action, efficacy, dosing, and adverse effects of medications including metformin, pramlintide, exenatide, liraglutide, bupropion, topiramate, phentermine, lorcaserin, phentermine/topiramate, orlistat, and naltrexone/bupropion. Clinical trials have shown these medications can promote weight loss ranging from 2-10% of initial body weight when used as an adjunct to diet and exercise. Common adverse effects include nausea, vomiting, diarrhea, constipation, and changes in
Carbamazepine Controlled-release Tablets USP SmPC Taj PharmaceuticalsTajPharmaQC
Carbamazepine CR Tablets USP 200mg, 400mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Carbamazepine Dosage & Rx Info | Carbamazepine Uses, Side Effects Carbamazepine: Indications, Side Effects, Warnings, Carbamazepine -Drug Information –Taj Pharma, Carbamazepine dose Taj pharmaceuticals Carbamazepine interactions, Taj Pharmaceutical Carbamazepine contraindications, Carbamazepine price, Carbamazepine Taj Pharma Carbamazepine SmPC- Taj Pharma Stay connected to all updated on Carbamazepine Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SMPC.
Deflazacort 6mg tablets smpc taj pharmaceuticalsTaj Pharma
Deflazacort Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, Deflazacort Dosage & Rx Info | Deflazacort Uses, Side Effects -: Indications, Side Effects, Warnings, Deflazacort - Drug Information - Taj Pharma, Deflazacort dose Taj pharmaceuticals Deflazacort interactions, Taj Pharmaceutical Deflazacort contraindications, Deflazacort price, Deflazacort Taj Pharma Deflazacort 6mg Tablets SMPC- Taj Pharma . Stay connected to all updated on Deflazacort Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.
Gemcitabine for Injection USP Taj Pharma SmPCTajPharmaQC
Gemcitabine for Injection USP 200mg, 1000mg Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Gemcitabine Dosage & Rx Info | Gemcitabine Uses, Side Effects Gemcitabine: Indications, Side Effects, Warnings, Gemcitabine -Drug Information –Taj Pharma, Gemcitabine dose Taj pharmaceuticals Gemcitabine interactions, Taj Pharmaceutical Gemcitabine contraindications, Gemcitabine price, Gemcitabine Taj Pharma Gemcitabine SmPC-Taj Pharma Stay connected to all updated on Gemcitabine 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.
Ranitidine 150mg film coated tablets smpc- taj pharmaceuticalsTaj Pharma
Ranitidine Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, Ranitidine Dosage & Rx Info | Ranitidine Uses, Side Effects -: Indications, Side Effects, Warnings, Ranitidine - Drug Information - Taj Pharma, Ranitidine dose Taj pharmaceuticals Ranitidine interactions, Taj Pharmaceutical Ranitidine contraindications, Ranitidine price, Ranitidine Taj Pharma Ranitidine 150mg Film-coated TabletsSMPC- Taj Pharma . Stay connected to all updated on Ranitidine Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.
Lamotrigine Dispersible Tablets Taj Pharma SmPCTajPharmaQC
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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.
Lamotrigine Tablets 25mg, 50mg, 100mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Lamotrigine Dosage & Rx Info | Lamotrigine Uses, Side Effects Lamotrigine: Indications, Side Effects, Warnings, Lamotrigine-Drug Information –Taj Pharma, Lamotrigine dose Taj pharmaceuticals Lamotrigine interactions, Taj Pharmaceutical Lamotrigine contraindications, Lamotrigine price, Lamotrigine Taj Pharma Lamotrigine SmPC- Taj Pharma Stay connected to all updated on Lamotrigine Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SMPC.
Daptomycin for Injection Taj Pharma SmPCTajPharmaQC
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Deferasirox Dispersible Tablets SmPC Taj PharmaceuticalsTajPharmaQC
Deferasirox Dispersible Tablets 125mg, 250mg, 400mg, 500mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Deferasirox Dosage & Rx Info | Deferasirox Uses, Side Effects Deferasirox: Indications, Side Effects, Warnings, Deferasirox -Drug Information –Taj Pharma, Deferasirox dose Taj pharmaceuticals Deferasirox interactions, Taj Pharmaceutical Deferasirox contraindications, Deferasirox price, Deferasirox Taj Pharma Deferasirox SmPC- Taj Pharma Stay connected to all updated on Deferasirox Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SMPC.
Aprepitant 80mg, 125 mg hard capsules smpc taj pharmaceuticalsTaj Pharma
Aprepitant - Drug Information - Taj Pharma, Aprepitant dose Taj pharmaceuticals Aprepitant interactions, Taj Pharmaceutical Aprepitant contraindications, Aprepitant price, Aprepitant Taj Pharma Cancer, oncologyAprepitant 80mg, 125 mg hard capsules SMPC- Taj Pharma . Stay connected to all updated on Aprepitant Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.
Imatinib, 400mg, 100mg, film coated tablets smpc- taj pharmaceuticalsTaj Pharma
IMATINIB Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, IMATINIB Dosage & Rx Info | IMATINIB Uses, Side Effects -: Indications, Side Effects, Warnings, IMATINIB - Drug Information - Taj Pharma, IMATINIB dose Taj pharmaceuticals IMATINIB interactions, Taj Pharmaceutical IMATINIB contraindications, IMATINIB price, IMATINIB Taj Pharma Cancer, oncologyImatinib, 400mg, 100mg, film-coated tablets. SMPC- Taj Pharma . Stay connected to all updated on IMATINIB Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.
Gabapentin 300mg capsules pil, taj pharmaceuticals.Taj Pharma
Gabapentin 300mg Capsules, Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, Gabapentin Dosage & Rx Info | Gabapentin Uses, Side Effects Gabapentin 300mg Capsules: Indications, Side Effects, Warnings, Gabapentin - Drug Information - Taj Pharma, Gabapentin dose Taj pharmaceuticals Gabapentin interactions, Taj Pharmaceutical Gabapentin contraindications, Gabapentin price, Gabapentin , Taj Pharma Gabapentin 300mg Capsules, - Taj Pharma . Stay connected to all updated on Gabapentin Taj Pharmaceuticals Taj pharmaceuticals Hyderabad. Patient Information Leaflets, PIL.
Dasatinib film coated tablets smpc- taj pharmaceuticalsTaj Pharma
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Zolpiderm tartrate 5mg and 10mg tablets pil, taj pharmaceuticals.Taj Pharma
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.
Zolpidem tartrate 5 mg tablets smpc taj pharmaceuticalsTaj Pharma
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Paracetamol 10 mg per ml solution for infusion smpc taj pharmaceuticalsTaj Pharma
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Oxytetracycline 250mg tablets smpc taj pharmaceuticalsTaj Pharma
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Gastrointestinal Infections
GASTROINTESTINAL INFECTIONS result from the ingestion of pathogens that cause infections at the level of this tract, generally being transmitted by food, water and hands contaminated by microorganisms such as E. coli, Salmonella, Shigella, Vibrio cholerae, Campylobacter, Staphylococcus, Rotavirus among others that are generally contained in feces, thus configuring a FECAL-ORAL type of transmission.
Among the factors that lead to the occurrence of gastrointestinal infections are the hygienic and sanitary deficiencies that characterize our markets and other places where raw or cooked food is sold, poor environmental sanitation in communities, deficiencies in water treatment (or in the process of its plumbing), risky hygienic-sanitary habits (not washing hands after major and/or minor needs), among others.
These are generally consequences (signs and symptoms) resulting from gastrointestinal infections: diarrhea, vomiting, fever and malaise, among others.
The treatment consists of replacing lost liquids and electrolytes (drinking drinking water and other recommended liquids, including consumption of juicy fruits such as papayas, apples, pears, among others that contain water in their composition).
To prevent this, it is necessary to promote health education, improve the hygienic-sanitary conditions of markets and communities in general as a way of promoting, preserving and prolonging PUBLIC HEALTH.
Gastritis and Gastric Health
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In addition to bacterial infections, gastritis and gastric ulcers are associated with several factors, with emphasis on prolonged fasting, chemical substances including drugs, alcohol, foods with strong seasonings including chilli, which ends up causing inflammation of the stomach walls and/or corrosion. of the same, resulting in the appearance of wounds and consequent gastritis or ulcers, respectively.
Among patients with gastritis and/or ulcers, one of the dilemmas is associated with the foods to consume in order to minimize the sensation of pain and discomfort.
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Academy of Oriental Medicine at Austin
Academy of Oriental Medicine at Austin
Academy of Oriental Medicine at Austin
About AOMA: The Academy of Oriental Medicine at Austin offers a masters-level graduate program in acupuncture and Oriental medicine, preparing its students for careers as skilled, professional practitioners. AOMA is known for its internationally recognized faculty, award-winning student clinical internship program, and herbal medicine program. Since its founding in 1993, AOMA has grown rapidly in size and reputation, drawing students from around the nation and faculty from around the world. AOMA also conducts more than 20,000 patient visits annually in its student and professional clinics. AOMA collaborates with Western healthcare institutions including the Seton Family of Hospitals, and gives back to the community through partnerships with nonprofit organizations and by providing free and reduced price treatments to people who cannot afford them. The Academy of Oriental Medicine at Austin is located at 2700 West Anderson Lane. AOMA also serves patients and retail customers at its south Austin location, 4701 West Gate Blvd. For more information see www.aoma.edu or call 512-492-303434.
- Video recording of this lecture in English language: https://youtu.be/RvdYsTzgQq8
- Video recording of this lecture in Arabic language: https://youtu.be/ECILGWtgZko
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PGx Analysis in VarSeq: A User’s PerspectiveGolden Helix
Since our release of the PGx capabilities in VarSeq, we’ve had a few months to gather some insights from various use cases. Some users approach PGx workflows by means of array genotyping or what seems to be a growing trend of adding the star allele calling to the existing NGS pipeline for whole genome data. Luckily, both approaches are supported with the VarSeq software platform. The genotyping method being used will also dictate what the scope of the tertiary analysis will be. For example, are your PGx reports a standalone pipeline or would your lab’s goal be to handle a dual-purpose workflow and report on PGx + Diagnostic findings.
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Discuss and demonstrate the approaches with array and NGS genotyping methods for star allele calling to prep for downstream analysis.
Following genotyping, explore alternative tertiary workflow concepts in VarSeq to handle PGx reporting.
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Gabapentin 300mg capsules smpc taj pharmaceuticals
1. Gabapentin 300mg capsules SMPC, Taj Pharmaceuticals
Gabapentin Taj Phar ma : Uses, Side Effects, Interactions, Pictures, Warnings, Gabapentin Dosage & Rx Info | Gabapentin Uses, Side Effects -: Indications, Side Effects, Warnings, Gabapentin - Drug Information - Taj Phar ma, Gabapentin dose Taj pharmaceuticals Gabapentin interactions, TajPhar maceutical Gabapentin contraindications, Gabapentin price, Gabapentin Taj Pharma Gabapentin 300mg capsules SMPC- Taj Phar ma . Stay connected to all updated on Gabapentin Taj Pharmaceuticals Taj phar maceuticals Hyderabad.
RX
GABAPENTIN
CAPSULES
300MG
1.NAME OF THE MEDICINAL PRODUCT
Gabapentin 300mg capsules
2. QUALITATIVE AND QUANTITATIVE
COMPOSITION
Each capsule contains 300mg of gabapentin
Excipients with known effect:
Each 300 mg hard capsule contains 50.5mg
lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Capsules,hard
Size 1, yellow-yellow, hard gelatin capsules
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Epilepsy
Gabapentin is indicated as adjunctive therapy in
the treatment of partial seizures with and without
secondary generalisation in adults and children
aged 6 years and above (see section 5.1).
Gabapentin is indicated as monotherapy in the
treatment of partial seizures with and without
secondary generalisation in adults and
adolescents aged 12 years and above.
Treatment of peripheral neuropathic pain
Gabapentin is indicated for the treatment of
peripheral neuropathic pain such as painful
diabetic neuropathy and post-herpetic neuralgia
in adults.
4.2 Posology and method of administration
Posology
For all indications a titration scheme for the
initiation of therapy is described in Table 1,
which is recommended for adults and
adolescents aged 12 years and above. Dosing
instructions for children under 12 years of age
are provided under a separate sub-heading later
in this section.
Discontinuation of gabapentin
In accordance with current clinical practice, if
gabapentin has to be discontinued it is
recommended this should be done gradually
over a minimum of 1 week independent of the
indication.
Epilepsy
Epilepsy typically requires long-term therapy.
Dosage is determined by the treating physician
according to individual tolerance and efficacy.
Adults and adolescents:
In clinical trials, the effective dosing range was
900 to 3600mg/day. Therapy may be initiated by
titrating the dose as described in Table 1 or by
administering 300mg three times a day (TID) on
Day 1. Thereafter, based on individual patient
response and tolerability, the dose can be further
increased in 300mg/day increments every 2-3
days up to a maximum dose of 3600mg/day.
Slower titration of gabapentin dosage may be
appropriate for individual patients. The
minimum time to reach a dose of 1800mg/day is
one week, to reach 2400mg/day is a total of 2
weeks, and to reach 3600mg/day is a total of 3
weeks.
Dosages up to 4800mg/day have been well
tolerated in long-term open-label clinical
studies. The total daily dose should be divided in
three single doses, the maximum time interval
between the doses should not exceed 12 hours to
prevent breakthrough convulsions.
Children aged 6 years and above:
Table 1
DOSING CHART – INITIAL TITRATION
Day 1 Day 2 Day 3
300mg once a
day
300mg two times
a day
300mg three
times a day
2. Gabapentin 300mg capsules SMPC, Taj Pharmaceuticals
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The starting dose should range from 10 to
15mg/kg/day and the effective dose is reached
by upward titration over a period of
approximately three days. The effective dose of
gabapentin in children aged 6 years and older is
25 to 35mg/kg/day. Dosages up to 50mg/kg/day
have been well tolerated in a long term clinical
study. The total daily dose should be divided in
three single doses, the maximum time interval
between doses should not exceed 12 hours.
It is not necessary to monitor gabapentin plasma
concentrations to optimize gabapentin therapy.
Further, gabapentin may be used in combination
with other antiepileptic medicinal products
without concern for alteration of the plasma
concentrations of gabapentin or serum
concentrations of other antiepileptic medicinal
products.
Peripheral neuropathic pain
Adults
The therapy may be initiated by titrating the
dose as described in Table 1. Alternatively, the
starting dose is 900mg/day given as three
equally divided doses. Thereafter, based on
individual patient response and tolerability, the
dose can be further increased in 300mg/day
increments every 2-3 days up to a maximum
dose of 3600mg/day. Slower titration of
gabapentin dosage may be appropriate for
individual patients. The minimum time to reach
a dose of 1800mg/day is one week, to reach
2400mg/day is a total of 2 weeks, and to reach
3600mg/day is a total of 3 weeks.
In the treatment of peripheral neuropathic pain
such as painful diabetic neuropathy and post-
herpetic neuralgia, efficacy and safety have not
been examined in clinical studies for treatment
periods longer than 5 months. If a patient
requires dosing longer than 5 months for the
treatment of peripheral neuropathic pain, the
treating physician should assess the patient's
clinical status and determine the need for
additional therapy.
Instruction for all areas of indication
In patients with poor general health, i.e., low
body weight, after organ transplantation etc., the
dose should be titrated more slowly, either by
using smaller dosage strengths or longer
intervals between dosage increases.
Elderly (over 65 years of age)
Elderly patients may require dosage adjustment
because of declining renal function with age (see
Table 2). Somnolence, peripheral oedema and
asthenia may be more frequent in elderly
patients.
Renal impairment
Dosage adjustment is recommended in patients
with compromised renal function as described in
Table 2 and/or those undergoing haemodialysis.
Gabapentin capsules can be used to follow
dosing recommendations for patients with renal
insufficiency.
Table 2
DOSAGE OF GABAPENTIN IN ADULTS BASED ON RENAL
Creatinine Clearance (ml/min) Total D
≥80 900-36
50-79 600-18
30-49 300-90
15-29 150b
-6
<15c
150b
-3
a Total daily dose should be administered as
three divided doses. Reduced dosages are for
patients with renal impairment (creatinine
clearance < 79ml/min).
b The 150mg daily dose to be administered as
300mg every other day.
c For patients with creatinine clearance
<15ml/min, the daily dose should be reduced in
proportion to creatinine clearance (e.g., patients
with a creatinine clearance of 7.5ml/min should
receive one-half the daily dose that patients with
a creatinine clearance of 15ml/min receive).
Use in patients undergoing haemodialysis
For anuric patients undergoing haemodialysis
who have never received gabapentin, a loading
dose of 300 to 400mg, then 200 to 300mg of
gabapentin following each 4 hours of
haemodialysis, is recommended. On dialysis-
free days, there should be no treatment with
gabapentin.
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For renally impaired patients undergoing
haemodialysis, the maintenance dose of
gabapentin should be based on the dosing
recommendations found in Table 2. In addition
to the maintenance dose, an additional 200 to
300mg dose following each 4-hour
haemodialysis treatment is recommended.
Method of administration
For oral use.
Gabapentin can be given with or without food
and should be swallowed whole with sufficient
fluid intake (e.g. a glass of water).
4.3 Contraindications
Hypersensitivity to the active substance or to
any of the excipients listed in section 6.1.
4.4 Special Warnings and precautions for use
Drug Rash with Eosinophilia and Systemic
Symptoms (DRESS)
Severe, life-threatening, systemic
hypersensitivity reactions such as Drug rash
with eosinophilia and systemic symptoms
(DRESS) have been reported in patients taking
antiepileptic drugs including gabapentin (see
section 4.8).
It is important to note that early manifestations
of hypersensitivity, such as fever or
lymphadenopathy, may be present even though
rash is not evident. If such signs or symptoms
are present, the patient should be evaluated
immediately. Gabapentin should be discontinued
if an alternative etiology for the signs or
symptoms cannot be established.
Anaphylaxis
Gabapentin can cause anaphylaxis. Signs and
symptoms in reported cases have included
difficulty breathing, swelling of the lips, throat,
and tongue, and hypotension requiring
emergency treatment. Patients should be
instructed to discontinue gabapentin and seek
immediate medical care should they experience
signs or symptoms of anaphylaxis (see section
4.8).
Suicidal ideation and behaviour
Suicidal ideation and behaviour have been
reported in patients treated with anti-epileptic
agents in several indications. A meta-analysis of
randomised placebo controlled trials of anti-
epileptic drugs has also shown a small increased
risk of suicidal ideation and behaviour. The
mechanism of this risk is not known and the
available data do not exclude the possibility of
an increased risk for Gabapentin.
Therefore patients should be monitored for signs
of suicidal ideation and behaviours and
appropriate treatment should be considered.
Patients (and caregivers of patients) should be
advised to seek medical advice should signs of
suicidal ideation or behaviour emerge.
Acute pancreatitis
If a patient develops acute pancreatitis under
treatment with gabapentin, discontinuation of
gabapentin should be considered (see section
4.8).
Seizures
Although there is no evidence of rebound
seizures with gabapentin, abrupt withdrawal of
anticonvulsants in epileptic patients may
precipitate status epilepticus (see section 4.2).
As with other antiepileptic medicinal products,
some patients may experience an increase in
seizure frequency or the onset of new types of
seizures with gabapentin.
As with other anti-epileptics, attempts to
withdraw concomitant anti-epileptics in
treatment refractory patients on more than one
anti-epileptic, in order to reach gabapentin
monotherapy have a low success rate.
Gabapentin is not considered effective against
primary generalized seizures such as absences
and may aggravate these seizures in some
patients. Therefore, gabapentin should be used
with caution in patients with mixed seizures
including absences.
Gabapentin treatment has been associated with
dizziness and somnolence, which could increase
the occurrence of accidental injury (fall). There
have also been post-marketing reports of loss of
consciousness, confusion and mental
impairment. Therefore, patients should be
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advised to exercise caution until they are
familiar with the potential effects of the
medicinal product.
Concomitant use with opioids
Patients who require concomitant treatment with
opioids should be carefully observed for signs of
central nervous system (CNS) depression, such
as somnolence, sedation and respiratory
depression. Patients who use gabapentin and
morphine concomitantly may experience
increases in gabapentin concentrations. The dose
of gabapentin or opioids should be reduced
appropriately (see section 4.5).
Respiratory depression
Gabapentin has been associated with severe
respiratory depression. Patients with
compromised respiratory function, respiratory or
neurological disease, renal impairment,
concomitant use of CNS depressants and the
elderly might be at higher risk of experiencing
this severe adverse reaction. Dose adjustments
might be necessary in these patients.
Use in elderly patients (over 65 years of age)
No systematic studies in patients 65 years or
older have been conducted with gabapentin. In
one double blind study in patients with
neuropathic pain, somnolence, peripheral
oedema and asthenia occurred in a somewhat
higher percentage in patients aged 65 years or
above, than in younger patients. Apart from
these findings, clinical investigations in this age
group do not indicate an adverse event profile
different from that observed in younger patients.
Paediatric population
The effects of long-term (greater than 36 weeks)
gabapentin therapy on learning, intelligence, and
development in children and adolescents have
not been adequately studied. The benefits of
prolonged therapy must therefore be weighed
against the potential risks of such therapy.
Abuse and Dependence
Cases of abuse and dependence have been
reported in the post-marketing database.
Carefully evaluate patients for a history of drug
abuse and observe them for possible signs of
gabapentin abuse e.g. drug-seeking behaviour,
dose escalation, development of tolerance.
Laboratory tests
False positive readings may be obtained in the
semi-quantitative determination of total urine
protein by dipstick tests. It is therefore
recommended to verify such a positive dipstick
test result by methods based on a different
analytical principle such as the Biuret method,
turbidimetric or dye-binding methods, or to use
these alternative methods from the beginning.
Gabapentin Accord-UK capsules contain lactose
Patients with rare hereditary problems of
galactose intolerance, the total lactase deficiency
or glucose galactose malabsorption should not
take this medicine.
4.5 Interaction with other medicinal
products and other forms of interaction
There are spontaneous and literature case reports
of respiratory depression and/or sedation
associated with gabapentin and opioid use. In
some of these reports, the authors considered
this a particular concern with the combination of
gabapentin and opioids, especially in elderly
patients.
In a study involving healthy volunteers (N=12),
when a 60mg controlled-release morphine
capsule was administered 2 hours prior to a
600mg gabapentin capsule, mean gabapentin
AUC increased by 44% compared to gabapentin
administered without morphine. Therefore,
patients who require concomitant treatment with
opioids should be carefully observed for signs of
CNS depression, such as somnolence, sedation
and respiratory depression and the dose of
gabapentin or opioid should be reduced
appropriately.
No interaction between gabapentin and
phenobarbital, phenytoin, valproic acid, or
carbamazepine has been observed.
Gabapentin steady-state pharmacokinetics are
similar for healthy subjects and patients with
epilepsy receiving these antiepileptic agents.
Coadministration of gabapentin with oral
contraceptives containing norethindrone and/or
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ethinyl estradiol, does not influence the steady-
state pharmacokinetics of either component.
Coadministration of gabapentin with antacids
containing aluminium and magnesium, reduces
gabapentin bioavailability up to 24%. It is
recommended that gabapentin be taken at the
earliest two hours following antacid
administration.
Renal excretion of gabapentin is unaltered by
probenecid.
A slight decrease in renal excretion of
gabapentin that is observed when it is
coadministered with cimetidine is not expected
to be of clinical importance.
4.6 Fertility, Pregnancy and lactation
Pregnancy
Pregnancy
Risk related to epilepsy and antiepileptic
medicinal products in general
The risk of birth defects is increased by a factor
of 2 – 3 in the offspring of mothers treated with
an antiepileptic medicinal product. Most
frequently reported are cleft lip, cardiovascular
malformations and neural tube defects. Multiple
antiepileptic drug therapy may be associated
with a higher risk of congenital malformations
than monotherapy, therefore it is important that
monotherapy is practiced whenever possible.
Specialist advice should be given to women who
are likely to become pregnant or who are of
childbearing potential and the need for
antiepileptic treatment should be reviewed when
a woman is planning to become pregnant. No
sudden discontinuation of antiepileptic therapy
should be undertaken as this may lead to
breakthrough seizures, which could have serious
consequences for both mother and child.
Developmental delay in children of mothers
with epilepsy has been observed rarely.
It is not possible to differentiate if the
developmental delay is caused by genetic, social
factors, maternal epilepsy or the antiepileptic
therapy.
Risk related to gabapentin
Gabapentin crosses the human placenta.
There are no adequate data from the use of
gabapentin in pregnant women.
Studies in animals have shown reproductive
toxicity (see section 5.3). The potential risk for
humans is unknown. Gabapentin should not be
used during pregnancy unless the potential
benefit to the mother clearly outweighs the
potential risk to the foetus.
No definite conclusion can be made as to
whether gabapentin is associated with an
increased risk of congenital malformations when
taken during pregnancy, because of epilepsy
itself and the presence of concomitant
antiepileptic medicinal products during each
reported pregnancy.
Breast-feeding
Gabapentin is excreted in human milk. Because
the effect on the breast-fed infant is unknown,
caution should be exercised when gabapentin is
administered to a breast-feeding mother.
Gabapentin should be used in breast-feeding
mothers only if the benefits clearly outweigh the
risks.
Fertility
There is no effect on fertility in animal studies
(see section 5.3).
4.7 Effects on ability to drive and use
machines
Gabapentin may have minor or moderate
influence on the ability to drive and use
machines. Gabapentin acts on the central
nervous system and may cause drowsiness,
dizziness or other related symptoms.
Even, if they were only of mild or moderate
degree, these undesirable effects could be
potentially dangerous in patients driving or
operating machinery. This is especially true at
the beginning of the treatment and after increase
in dose.
4.8 Undesirable Effects
The adverse reactions observed during clinical
studies conducted in epilepsy (adjunctive and
monotherapy) and neuropathic pain have been
provided in a single list below by class and
frequency (very common (> 1/10); common
(>1/100, <1/10); uncommon (>1/1000, <1/100);
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rare (>1/10,000; <1/1,000); very rare
(<1/10,000). Where an adverse reaction was
seen at different frequencies in clinical studies, it
was assigned to the highest frequency reported.
Additional reactions reported from the post-
marketing experience are included as frequency
'Not known' (cannot be estimated from the
available data) in italics in the list below. Within
each frequency grouping, undesirable effects are
presented in order of decreasing seriousness.
Infections and infestations
Very Common: Viral infection
Common: Pneumonia, respiratory infection,
urinary tract infection, infection, otitis media
Blood and the lymphatic system disorders
Common: leucopenia
Not known: thrombocytopenia
Immune system disorders
Uncommon: allergic reactions (e.g. urticaria)
Not known: anaphylaxis, Hypersensitive
syndrome, a systemic reaction with a variable
presentation that can include fever, rash,
hepatitis lymphadenopathy, eosinophilia and
sometimes other signs and symptoms (see
section 4.4).
Metabolism and Nutrition Disorders
Common: anorexia, increased appetite
Uncommon: hyperglycaemia (most often
observed in patients with diabetes)
Rare: hypoglycaemia (most often observed in
patients with diabetes)
Not known: hyponatraemia
Psychiatric disorders
Common: hostility, confusion and emotional
lability, depression, anxiety, nervousness,
thinking abnormal
Uncommon: agitation
Not known: hallucinations
Nervous system disorders
Very common: somnolence, dizziness, ataxia,
Common: convulsions, hyperkinesias,
dysarthria, amnesia, tremor, insomnia, headache,
sensations such as paresthesia, hypaesthesia,
coordination abnormal, nystagmus, increased,
decreased, or absent reflexes
Uncommon: hypokinesia, mental impairment
Rare: loss of consciousness
Not known: other movement disorders (e.g.
choreoathetosis, dyskinesia, dystonia),
Eye disorders
Common: visual disturbances such as
amblyopia, diplopia
Ear and Labyrinth disorders
Common: vertigo
Not known: tinnitus
Cardiac disorders
Uncommon: palpitations
Vascular disorder
Common: hypertension, vasodilatation
Respiratory, thoracic and mediastinal
disorders
Common: dyspnoea, bronchitis, pharyngitis,
cough, rhinitis
Rare: Respiratory depression
Gastrointestinal disorders
Common: vomiting, nausea, dental
abnormalities, gingivitis, diarrhoea, abdominal
pain, dyspepsia, constipation, dry mouth or
throat, flatulence
Uncommon: dysphagia
Not known: pancreatitis
Hepatobiliary disorders
Not known: hepatitis, jaundice
Skin and subcutaneous tissue disorders
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Common: facial oedema, purpura most often
described as bruises resulting from physical
trauma, rash, pruritus, acne
Not known: Stevens-Johnson syndrome,
angioedema, erythema multiforme,
alopecia, drug rash with eosinophilia and
systemic symptoms (see section 4.4)
Musculoskeletal, connective tissue and bone
disorders
Common: arthralgia, myalgia, back pain,
twitching
Not known: rhabdomyolysis, myoclonus
Renal and urinary disorders
Not known: acute renal failure, incontinence
Reproductive system and breast disorders
Common: impotence
Not known: breast hypertrophy, gynaecomastia,
sexual dysfunction (including changes in libido,
ejaculation disorders and anorgasmia)
General disorders and administration site
conditions
Very Common: fatigue, fever
Common: peripheral oedema, abnormal gait,
asthenia, pain, malaise, flu syndrome
Uncommon: generalized oedema
Not known: withdrawal reactions (mostly
anxiety, insomnia, nausea, pains, sweating),
chest pain. Sudden unexplained deaths have
been reported where a causal relationship to
treatment with gabapentin has not been
established.
Investigations
Common: WBC (white blood cell count)
decreased, weight gain
Uncommon: elevated liver function tests SGOT
(AST), SGPT (ALT) and bilirubin
Not known: blood creatine phosphokinase
increased
Injury and poisoning
Common: accidental injury, fracture, abrasion
Uncommon: fall
Under treatment with gabapentin cases of acute
pancreatitis were reported. Causality with
gabapentin is unclear (see section 4.4).
In patients on haemodialysis due to end-stage
renal failure, myopathy with elevated creatine
kinase levels has been reported.
Respiratory tract infections, otitis media,
convulsions and bronchitis were reported only in
clinical studies in children.
Additionally, in clinical studies in children,
aggressive behaviour and hyperkinesias were
reported commonly.
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
Acute, life-threatening toxicity has not been
observed with gabapentin overdoses of up to
49g. Symptoms of the overdoses included
dizziness, double vision, slurred speech,
drowsiness, loss of consciousness, lethargy and
mild diarrhoea.
All patients recovered fully with supportive care.
Reduced absorption of gabapentin at higher
doses may limit drug absorption at the time of
overdosing and, hence, minimize toxicity from
overdoses.
Overdoses of gabapentin, particularly in
combination with other CNS depressant
medications, may result in coma.
Although gabapentin can be removed by
haemodialysis, based on prior experience it is
usually not required.
However, in patients with severe renal
impairment, haemodialysis may be indicated.
An oral lethal dose of gabapentin was not
identified in mice and rats given doses as high as
8000mg/kg.
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Signs of acute toxicity in animals included
ataxia, laboured breathing, ptosis, hypoactivity,
or excitation.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic groups: Other
antiepileptics
Mechanism of action
Gabapentin readily enters the brain and prevents
seizures in a number of animal models of
epilepsy. Gabapentin does not possess affinity
for either GABAA or GABAB receptor nor does
it alter the metabolism of GABA. It does not
bind to other neurotransmitter receptors of the
brain and does not interact with sodium
channels. Gabapentin binds with high affinity to
the α2δ (alpha-2-delta) subunit of voltage-gated
calcium channels and it is proposed that binding
to the α2δ subunit may be involved in
gabapentin's anti-seizure effects in animals.
Broad panel screening does not suggest any
other drug targets other than α2δ.
Evidence from several pre-clinical models
inform that the pharmacological activity of
gabapentin may be mediated via binding to α2δ
through a reduction in release of excitatory
neurotransmitters in regions of the central
nervous system. Such activity may underlie
gabapentin's anti-seizure activity. The relevance
of these actions of gabapentin to the
anticonvulsant effects in humans remains to be
established.
Gabapentin also displays efficacy in several pre-
clinical animal pain models. Specific binding of
gabapentin to the α2δ subunit is proposed to
result in several different actions that may be
responsible for analgesic activity in animal
models. The analgesic activities of gabapentin
may occur in the spinal cord as well as at higher
brain centres through interactions with
descending pain inhibitory pathways. The
relevance of these pre-clinical properties to
clinical action in humans is unknown.
Clinical efficacy and safety
A clinical trial of adjunctive treatment of partial
seizures in paediatric subjects, ranging in age
from 3 to 12 years, showed a numerical but not
statistically significant difference in the 50%
responder rate in favour of the gabapentin group
compared to placebo. Additional post-hoc
analyses of the responder rates by age did not
reveal a statistically significant effect of age,
either as a continuous or dichotomous variable
(age groups 3-5 and 6-12 years). The data from
this additional post-hoc analysis are summarised
in the table below:
*The modified intent to treat population was
defined as all patients randomised to study
medication who also had evaluable seizure
diaries available for 28 days during both the
baseline and double-blind phases.
5.2 Pharmacokinetic properties
Absorption
Following oral administration, peak plasma
gabapentin concentrations are observed within 2
to 3 hours.
Gabapentin bioavailability (fraction of dose
absorbed) tends to decrease with increasing
dose. Absolute bioavailability of a 300mg
capsule is approximately 60%. Food, including a
high-fat diet, has no clinically significant effect
on gabapentin pharmacokinetics.
Gabapentin pharmacokinetics are not affected by
repeated administration. Although plasma
gabapentin concentrations were generally
between 2µg/ml and 20µg/ml in clinical studies,
such concentrations were not predictive of safety
or efficacy. Pharmacokinetic parameters are
given in Table 3.
Table 3
Response (≥ 50% Improved) by Treatment and Age
MITT* Population
Age Category Placebo Gabapentin P-Value
< 6 Years Old 4/21
(19.0%)
4/17
(23.5%)
0.7362
6 to 12 Years
Old
17/99
(17.2%)
20/96
(20.8%)
0.5144
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Summary of gabapentin mean (%CV) steady-
state pharmacokinetic parameters following
every eight hours administration
Pharmacokine
tic parameter
300mg
(N = 7)
400mg
(N = 14)
800mg
(N=14)
Mea
n
%C
V
Mea
n
%C
V
Mea
n
%C
V
Cmax (μg/ml) 4.02 (24) 5.74 (38) 8.71 (29)
tmax (hr) 2.7 (18) 2.1 (54) 1.6 (76)
T1/2 (hr) 5.2 (12) 10.8 (89) 10.6 (41)
AUC (0-8)
μg•hr/ml)
24.8 (24) 34.5 (34) 51.4 (27)
Ae% (%) NA NA 47.2 (25) 34.4 (37)
Cmax = Maximum steady state plasma
concentration
tmax = Time for Cmax
T1/2 = Elimination half-life
AUC(0-8) = Steady state area under plasma
concentration-time curve from time 0 to 8 hours
postdose
Ae% = Percent of dose excreted unchanged into
the urine from time 0 to 8 hours postdose
NA = Not available
Distribution
Gabapentin is not bound to plasma proteins and
has a volume of distribution equal to 57.7 litres.
In patients with epilepsy, gabapentin
concentrations in cerebrospinal fluid (CSF) are
approximately 20% of corresponding steady-
state trough plasma concentrations. Gabapentin
is present in the breast milk of breast-feeding
women.
Biotransformation
There is no evidence of gabapentin metabolism
in humans. Gabapentin does not induce hepatic
mixed function oxidase enzymes responsible for
drug metabolism.
Elimination
Gabapentin is eliminated unchanged solely by
renal excretion. The elimination half-life of
gabapentin is independent of dose and averages
5 to 7 hours.
In elderly patients, and in patients with impaired
renal function, gabapentin plasma clearance is
reduced.
Gabapentin elimination-rate constant, plasma
clearance, and renal clearance are directly
proportional to creatinine clearance.
Gabapentin is removed from plasma by
haemodialysis. Dosage adjustment in patients
with compromised renal function or undergoing
haemodialysis is recommended (see section 4.2).
Gabapentin pharmacokinetics in children were
determined in 50 healthy subjects between the
ages of 1 month and 12 years. In general, plasma
gabapentin concentrations in children > 5 years
of age are similar to those in adults when dosed
on a mg/kg basis.
In a pharmacokinetic study in 24 healthy
paediatric subjects aged between 1 month and 48
months, an approximately 30% lower exposure
(AUC), lower Cmax and higher clearance per
body weight have been observed in comparison
to available reported data in children older than
5 years.
Linearity/Non-linearity
Gabapentin bioavailability (fraction of dose
absorbed) decreases with increasing dose which
imparts non-linearity to pharmacokinetic
parameters which include the bioavailability
parameter (F) e.g. Ae%, CL/F, Vd/F.
Elimination pharmacokinetics (pharmacokinetic
parameters which do not include F such as CLr
and T1/2), are best described by linear
pharmacokinetics. Steady state plasma
gabapentin concentrations are predictable from
single-dose data.
5.3 Preclinical safety data
Carcinogenesis
Gabapentin was given in the diet to mice at 200,
600, and 2000mg/kg/day and to rats at 250,
1000, and 2000mg/kg/day for two years. A
statistically significant increase in the incidence
of pancreatic acinar cell tumours was found only
in male rats at the highest dose. Peak plasma
drug concentrations in rats at 2000mg/kg/day are
10 times higher than plasma concentrations in
humans given 3600mg/day. The pancreatic
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acinar cell tumours in male rats are low-grade
malignancies, did not affect survival, did not
metastasize or invade surrounding tissue, and
were similar to those seen in concurrent
controls. The relevance of these pancreatic
acinar cell tumours in male rats to carcinogenic
risk in humans is unclear.
Mutagenesis
Gabapentin demonstrated no genotoxic
potential. It was not mutagenic in vitro in
standard assays using bacterial or mammalian
cells. Gabapentin did not induce structural
chromosome aberrations in mammalian cells in
vitro or in vivo, and did not induce micronucleus
formation in the bone marrow of hamsters.
Impairment of Fertility
No adverse effects on fertility or reproduction
were observed in rats at doses up to 2000mg/kg
(approximately five times the maximum daily
human dose on a mg/m2 of body surface area
basis).
Teratogenesis
Gabapentin did not increase the incidence of
malformations, compared to controls, in the
offspring of mice, rats, or rabbits at doses up to
50, 30 and 25 times respectively, the daily
human dose of 3600mg, (four, five or eight
times, respectively, the human daily dose on a
mg/m2 basis).
Gabapentin induced delayed ossification in the
skull, vertebrae, forelimbs, and hind limbs in
rodents, indicative of foetal growth retardation.
These effects occurred when pregnant mice
received oral doses of 1000 or 3000mg/kg/day
during organogenesis and in rats given
2000mg/kg prior to and during mating and
throughout gestation. These doses are
approximately 1 to 5 times the human dose of
3600mg on a mg/m2 basis.
No effects were observed in pregnant mice given
500mg/kg/day (approximately 1/2 of the daily
human dose on a mg/m2 basis).
An increased incidence of hydroureter and/or
hydronephrosis was observed in rats given
2000mg/kg/day in a fertility and general
reproduction study, 1500mg/kg/day in a
teratology study, and 500, 1000, and
2000mg/kg/day in a perinatal and postnatal
study. The significance of these findings is
unknown, but they have been associated with
delayed development. These doses are also
approximately 1 to 5 times the human dose of
3600 mg on a mg/m2 basis.
In a teratology study in rabbits, an increased
incidence of post-implantation foetal loss,
occurred in pregnant rabbits given 60, 300, and
1500mg/kg/day during organogenesis. These
doses are approximately 0.3 to 8 times the daily
human dose of 3600mg on a mg/m2 basis.
The margins of safety are insufficient to rule out
the risk of these effects in humans.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Lactose Monohydrate
Maize Starch
Talc
Capsule shell
Titanium dioxide, E171
Yellow iron oxide, E172
Gelatin
Printing ink
Shellac, E904
Propylene glycol, E1520
Black iron oxide, E172
Potassium hydroxide, E525
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Do not store above 25°C.
Store in the original package in order to protect
from moisture
6.5 Nature and contents of container
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Aluminium/transparent PVC blisters
Each pack will contain either 30, 50, 60, 100 or
120 capsules.
Each blister strip will contain 10 capsules.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and
other handling
No special requirements.
7. MANUFACTURER:
Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
At: 615, GIDC, Kerala, Bavla, Dist. Ahmedabad
438225, Gujarat, INDIA
This leaflet was last revised in October 2019