Advertisement

Topics

Tiagabine Hydrochloride Tablets | TIAGABINE HYDROCHLORIDE

13:56 EDT 24th July 2014 | BioPortfolio
Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.
IMAGE chemical-structure.jpgIMAGE figure-1.jpgIMAGE figure-2.jpgIMAGE figure-3.jpgIMAGE figure-4.jpg
Table 1 Median Reduction and Median Percent Reduction from Baseline in 4-Week Seizure Rates in Study 1
Placebo (N=91)
Tiagabine Hydrochloride 16 mg/day
(N=61)
Tiagabine Hydrochloride 32 mg/day
(N=87)
Tiagabine Hydrochloride 56 mg/day
(N=56)
Combined 32 + 56 mg/day (N=143)
Complex
Partial
Median
Reduction
0.6
0.8
2.2p <0.05
2.9
2.6
Median %
ReductionStatistical significance was not assessed for median % reduction.
9%
13%
25%
32%
29%
All
Partial
Median
Reduction
0.2
1.2
2.7
3.5
2.9
Median %
Reduction
3%
12%
24%
36%
27%
Table 2 Median Reduction and Median Percent Reduction from Baseline in 4-Week Seizure Rates in Study 2
Placebo (N=107)
Tiagabine Hydrochloride 16 mg BID
(N=106)
Tiagabine Hydrochloride 8 mg QID
(N=104)
Complex
Partial
Median Reduction
0.3
1.6
1.3p <0.027, necessary for statistical significance due to multiple comparisons.
Median % ReductionStatistical significance was not assessed for median % reduction.
4%
22%
15%
All
Partial
Median Reduction
0.5
1.6
1.3
Median % Reduction
5%
19%
13%
Table 3 Median Reduction and Median Percent Reduction from Baseline in 4-Week Seizure Rates in Study 3
    Placebo (N=77)
 
Tiagabine Hydrochloride 30 mg/day
(N=77)
Complex PartialN=72 and 75 for placebo and tiagabine hydrochloride, respectively.
Median Reduction
-0.1
1.3p <0.05
Median % ReductionStatistical significance was not assessed for median % reduction.
-1%
14%
All Partial
Median Reduction
-0.5
1.1
Median % Reduction
-7%
11%
Table 4: Risk by Indication for Antiepileptic Drugs in the Pooled Analysis
Indication
Placebo Patients with Events per 1000 Patients
Drug Patients with Events per 1000 Patients
Relative Risk: Incidence of Events in Drug Patients/Incidence in Placebo Patients
Risk Difference: Additional Drug Patients with Events per 1000 Patients
Epilepsy
1
3.4
3.5
2.4
Psychiatric
5.7
8.5
1.5
2.9
Other
1
1.8
1.9
0.9
Total
2.4
4.3
1.8
1.9
Table 5: Treatment-Emergent Adverse EventPatients in these add-on studies were receiving one to three concomitant enzyme-inducing antiepilepsy drugs in addition to tiagabine hydrochloride or placebo. Patients may have reported multiple adverse experiences; thus, patients may be included in more than one category. Incidence in Parallel-Group, Placebo-Controlled, Add-On Trials (events in at least 1% of patients treated with Tiagabine Hydrochloride and numerically more frequent than in the placebo group)
Body System/
COSTART
Tiagabine Hydrochloride
N=494
%
Placebo
N=275
%
Body as a Whole
Abdominal Pain
7
3
Pain (unspecified)
5
3
Cardiovascular
Vasodilation
2
1
Digestive
Nausea
11
9
Diarrhea
7
3
Vomiting
7
4
Increased Appetite
2
0
Mouth Ulceration
1
0
Musculoskeletal
Myasthenia
1
0
Nervous System
Dizziness
27
15
Asthenia
20
14
Somnolence
18
15
Nervousness
10
3
Tremor
9
3
Difficulty with Concentration/AttentionCOSTART term substituted with a more clinically descriptive term.
6
2
Insomnia
6
4
Ataxia
5
3
Confusion
5
3
Speech Disorder
4
2
Difficulty with Memory
4
3
Paresthesia
4
2
Depression
3
1
Emotional Lability
3
2
Abnormal Gait
3
2
Hostility
2
1
Nystagmus
2
1
Language Problems
2
0
Agitation
1
0
Respiratory System
Pharyngitis
7
4
Cough Increased
4
3
Skin and Appendages
Rash
5
4
Pruritus
2
0
Table 6: Treatment-Emergent Adverse Event Incidence in Study 1Patients in this study were receiving one to three concomitant enzyme-inducing antiepilepsy drugs in addition to tiagabine hydrochloride or placebo. Patients may have reported multiple adverse experiences; thus, patients may be included in more than one category. (events in at least 5% of patients treated with Tiagabine Hydrochloride 32 or 56 mg and numerically more frequent than in the placebo group)
Body System/
COSTART Term
Tiagabine Hydrochloride 56 mg
(N=57)
%
Tiagabine Hydrochloride 32 mg
(N=88)
%
Placebo
(N=91)
%
Body as a Whole
Accidental Injury
21
15
20
Infection
19
10
12
Flu Syndrome
9
6
3
Pain
3
7
2
Abdominal Pain
5
7
4
Digestive System
Diarrhea
2
10
6
Hemic and Lymphatic System
Ecchymosis
0
6
1
Musculoskeletal System
Myalgia
5
2
3
Nervous System
Dizziness
28
31
12
Asthenia
23
18
15
Tremor
21
14
1
Somnolence
19
21
17
Nervousness
14
11
6
Difficulty with Concentration/AttentionCOSTART term substituted with a more clinically descriptive term.
14
7
3
Ataxia
9
6
6
Depression
7
1
0
Insomnia
5
6
3
Abnormal Gait
5
5
3
Hostility
5
5
2
Respiratory System
Pharyngitis
7
8
6
Special Senses
Amblyopia
4
9
8
Urogenital System
Urinary Tract Infection
5
0
2
Table 7: Typical Dosing Titration Regimen for Patients Already Taking Enzyme-Inducing AEDs
  Initiation and Titration Schedule Total Daily Dose
Week 1
Initiate at 4 mg once daily
4 mg/day
Week 2
Increase total daily dose by 4 mg
8 mg/day
(in two divided doses)
Week 3
Increase total daily dose by 4 mg
12 mg/day
(in three divided doses)
Week 4
Increase total daily dose by 4 mg
16 mg/day
(in two to four divided doses)
Week 5
Increase total daily dose by 4 to 8 mg
20 to 24 mg/day
(in two to four divided doses)
Week 6
Increase total daily dose by 4 to 8 mg
24 to 32 mg/day
(in two to four divided doses)
Usual Adult Maintenance Dose in Induced Patients:
32 to 56 mg/day in two to four divided doses

Do not stop tiagabine hydrochloride tablets without first talking to a healthcare provider.

IMAGE label-2mg.jpgIMAGE label-4mg.jpg

Manufacturer

Sun Pharmaceutical Industries Limited

Active Ingredients

Source

Drugs and Medications [567 Associated Drugs and Medications listed on BioPortfolio]

Donepezil hydrochloride [Sun Pharmaceutical Industries Limited ]

These highlights do not include all the information needed to use donepezil hydrochloride safely and effectively. See full prescribing information for donepezil hydrochloride tablets Donepezil Hydroch...

Donepezil hydrochloride [Aurobindo Pharma Limited]

These highlights do not include all the information needed to use donepezil hydrochloride safely and effectively. See full prescribing information for donepezil hydrochloride tablets.Donepezil Hydroch...

Donepezil hydrochloride [WOCKHARDT USA LLC]

These highlights do not include all the information needed to use donepezil hydrochloride tablets safely and effectively. See full prescribing information for donepezil hydrochloride tablets. Donepezi...

Donepezil hydrochloride [Major Pharmaceuticals]

These highlights do not include all the information needed to use donepezil hydrochloride tablets safely and effectively. See full prescribing information for donepezil hydrochloride tablets. Donepezi...

Donepezil hydrochloride [WOCKHARDT LIMITED]

These highlights do not include all the information needed to use donepezil hydrochloride tablets safely and effectively. See full prescribing information for donepezil hydrochloride tablets. Donepezi...

Clinical Trials [1892 Associated Clinical Trials listed on BioPortfolio]

Tiagabine for the Treatment of Cocaine Dependence - 1

The purpose of this study is to assess tiagabine for the treatment of cocaine dependence.

Tiagabine, Sertraline, or Donepezil for the Treatment of Cocaine Dependence - 9

The purpose of this CREST (Clinical Rapid Evaluation Screening Trial) study is the use of tiagabine, sertraline, or donepezil for the treatment of cocaine dependence using a modified place...

Switching From an SSRI to Tiagabine(GABITRIL) in Order to Alleviate SSRI Induced Sexual Dysfunction

Anxious patients are now treated with Selective Serotonin Reuptake Inhibitor medications (common antidepressants) which elevate serotonin and thus alleviate anxiety. These medications hav...

A Prospective, Observational Study On The Effectiveness Of New Antiepileptic Drugs As First Bitherapy In The Daily Clinical Practice

Assessment of the efficacy under daily clinical conditions of the new antiepileptic drugs (AEDs) gabapentin, lamotrigine, levetiracetam, oxcarbazepine, pregabalin, tiagabine and topiramate...

Treating Schizophrenia by Correcting Abnormal Brain Development

The purpose of this study is to determine whether treatment with tiabagine (Gabitril) during the early course of schizophrenia can fundamentally correct the brain deficits associated with ...

PubMed Articles [214 Associated PubMed Articles listed on BioPortfolio]

Inhibition of GABA transporters fails to afford significant protection following focal cerebral ischemia.

Brain ischemia triggers excitotoxicity and cell death, yet no neuroprotective drugs have made it to the clinic. While enhancing GABAergic signaling to counterbalance excitotoxicity has shown promise i...

Neurotropic effect of B vitamins in the complex treatment of pain syndrome.

Combined vitamin preparations in therapeutic doses are used, along with simple analgesics, nonsteroidal anti-inflammatory drugs (NSAIDs), muscle and epidural blockade, for the relief of acute pain. It...

Effects of oxycodone on immune function in patients undergoing radical resection of rectal cancer under general anesthesia.

This study aims to explore the effect of oxycodone hydrochloride injection on the immune function of patients who underwent radical resection of rectal cancer under general anesthesia.Eighty patients ...

The Effects of Systemic Alfuzosin and Tamsulosin Hydrochloride on Choroidal Thickness and Pupil Diameter Sizes in Cases with Benign Prostatic Hyperplasia.

To compare the effects of alfuzosin hydrochloride and tamsulosin hydrochloride on choroidal thickness (CT) and pupil diameter (PD) sizes in patients with benign prostatic hyperplasia.

The effectiveness of the combination of azelastine hydrochloride and mometasone furoate for the intranasal application in the patients presenting with seasonal allergic rhinitis.

The objective of the present work was to evaluate the effectiveness of the combination of azelastine hydrochloride and mometasone furoate for the intranasal application to treat the patients presentin...

Quick Search
Advertisement
 

Relevant Topics

Drug Discovery
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...

Pharmacy
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...


Drugs and Medication Quicklinks


Searches Linking to this Drug Record