natgillin/translations-raw huggingface dataset:
(Hypericum perforatum),
However, the majority of the most frequent adverse events were mild to moderate and resolved within 30 days of occurrence (e. g. nausea).
ARICLAIM
Table 1:
CYP2D6: * 60 mg
Adverse reactions Frequency estimate:
24 '
24
INR
Very
'% 40 mg
Common
CYP1A2:
Uncommon
CYP1A2 ARICLAIM
Very Common Uncommon Rare Very
CYP1A2, $
Frequency not known
CYP1A2,
common
(100 mg
Rare
),
Investigations Cardiac Disorders
77%
Weight decrease Weight increase Blood cholesterol increased
AUC0- t 6
Creatinine phosphokinase increase
. '
Palpitations Nervous System Disorders
, ARICLAIM
Tachycardia
$
Supra-ventricular arrhythmia, mainly atrial fibrillation
$
Headache Dizziness Tremor Lethargy Somnolence Paraesthesia
CYP1A2,
Dyskinesia Myoclonus
%
Serotonin syndrome Psychomotor restlessness Convulsions AkathisiaExtrapyramidal symptoms
4. 3).
Eye Disorders
CYP1A2:, 50%
Blurred vision
-
Visual disturbance Mydriasis
(
Glaucoma
+
Ear and Labyrinth Disorders
(AUC)
Vertigo
. ($/
Tinnitus1 Ear pain
(
Respiratory, thoracic and mediastinal disorders Gastrointestinal Disorders
5. 3).
Yawning
ARICLAIM
Epistaxis Throat tightness
$
Nausea (23.3%) Dry mouth (11.9%) Constipation (10.3%)
. 3
Diarrhoea Vomiting Dyspepsia
$
Gastroenteritis Haematochezia Stomatitis Gastritis Flatulence Eructation Breath odour
$
Gastrointestinal haemorrhage
,
Urinary hesitation Dysuria Nocturia Urine odour abnormal
$$
Urine flow decreased Polyuria
5. 2). +
Urinary retention
$
Skin and Subcutaneous Tissue Disorders
ARICLAIM
Sweating increased
ARICLAIM, $
Rash Increased tendency to
25
Photo- sensitivity reactions 25
-
Stevens-Johnson Syndrome Angioneurotic oedema
12 -
Very
958
Common
955
Uncommon
,
Very Common Uncommon Rare Very
.)
Frequency not known
- 30
common
(
bruise Night sweats Cold sweat
.,
Dermatitis contact Urticaria
1: - "
Rare
)
Muscoskeletal and connective tissue disorders
:
Muscle spasm Muscle tightness Musculo- skeletal pain Trismus
(≥1/ 10),
Muscle twitching
(≥1/ 100
Endocrine disorders
(≥1/ 1 000
Hypo- thyroidism Metabolism and Nutrition Disorders
(≥ 1/ 10 000
Appetite decreased
< 1/ 1 000),
Dehydration
(< 1/ 10 000),
Hyperglycemia (reported especially in diabetic patients) SIADH Hyponatremia
)..
Flushing
%
Syncope2 Blood pressure increase
+
Hypertensive crisis Orthostatic hypotension2 Peripheral coldness
,
Hypertension
+
General Disorders and Administration Site Conditions Fatigue (10.9%)
+
Abdominal pain Pruritus Weakness Chills
+,
Malaise Feeling hot Feeling abnormal Thirst
&
Gait disturbance Feeling cold
! + +
Chest pain
4 + #
Immune system
(, '
disorders
4
Anaphylactic reaction
.
Hepato-biliary disorders
- (
Hepatitis3 Elevated liver enzymes (ALT, AST, alkaline phosphatase) Acute liver injury
5 1
Hepatic failure Jaundice
6
Reproductive System and Breast Disorders Menopausal
26 0
26
* 4
Common
-
Uncommon
(23, 3%) * 4 (11, 9%) ((10, 3%)
Very Common Uncommon Rare Very
Stevens - Johnson
Frequency not known
0
common
27 + #
Rare
1 & "(10, 9%)
Psychiatric Disorders 1
($
Insomnia AnxietySlee p disorder Agitation Libido decreased
SSRIs
Hallucinations
SNRIs, $
Suicidal behaviour Suicidal ideation 4 Mania Aggression and anger 5
/ $
2 Cases of orthostatic hypotension and syncope have been reported especially at the initiation of treatment 3 See section 4.4 4 Cases of suicidal ideation and suicidal behaviours have been reported during duloxetine therapy or early after treatment discontinuation (see section 4.4) 5 Cases of aggression and anger have been reported particularly early in treatment of after treatment discontinuation.
.
It is therefore advised that when duloxetine treatment is no longer required, gradual discontinuation by dose tapering should be carried out (see sections 4.2 and 4.4).
755
Electrocardiograms were obtained from 755 duloxetine-treated patients with SUI and 779 placebo- treated patients in 12-week clinical trials.
,
There was also a small increase in fasting blood glucose and in total cholesterol in duloxetine-treated patients while those laboratory tests showed a slight decrease in the routine care group.
2
27 Table 2:
$/
Very
$-
Common
1 964
Uncommon
$).
Rare
5 253
Very Rare
, 3 289
Frequency not
$/
common
$.
known
ARICLAIM,
Investigations
/ 2: - ")
Weight decrease
:
Weight increase Creatinine phosphokinase increase
(≥1/ 10), (≥1/ 10
Blood cholesterol increased
< 1/ 10),
Cardiac Disorders
(≥1/ 1 000
Palpitations
< 1/ 100),
Tachycardia
(≥ 1/ 10 000 < 1/ 1 000), $
Supra- ventricular arrhythmia, mainly atrial fibrillation
)..
Nervous System
(< 1/ 10 000),
Disorders
(13, 8%)
Headache (13.8%) Somnolence (10.7%) Eye Disorders
+ #
Dizziness Tremor Lethargy Paraesthesia
#
Dyskinesia Poor quality sleep Nervousness Myoclonus Disturbance in attention Dysgeusia
(
Serotonin syndrome Convulsions Akathisia Psychomotor restlessness Extra- pyramidal symptoms
(10, 7%)
Blurred vision
.
Visual disturbance Mydriasis
,
Glaucoma
$
Ear and Labyrinth Disorders
5 1 6 0
Tinnitus 1
(21, 7%) (
Vertigo Ear pain
Stevens - Johnson,
Respiratory, thoracic and mediastinal disorders
0
Yawning
-
Epistaxis Throat tightness
31 # - 3
Gastrointestinal
(ALT,
Disorders
%%)
Nausea (21.7%) Dry mouth (13.2%)
$
Diarrhoea Constipation Vomiting Dyspepsia Flatulence
)
Gastroenteritis Stomatitis Gastritis Eructation
-
Haematochezia Breath odour
'
Gastrointestinal haemorrhage
%
Renals and Urinary Disorders
%
Urinary Retention Urinary hesitation Dysuria Nocturia
7
Urine odour abnormal
0 /
28
4. 4)
Very
SNRIs
Uncommon
HbA1
Frequency not
0, 3% -
common
QT, PR, QRS
Polyuria Urine flow decreased
QTcB
known
1 000 mg.
Skin and Subcutaneous Tissue Disorders
,
Rash Sweating increased Night sweats
)
Photo- sensitivity reactions Increased tendency to bruise Dermatitis contact Urticaria Cold sweat
/
Stevens- Johnson Syndrome Angio-neurotic oedema
.
Muscoskeletal and connective tissue disorders
,
Musculo- skeletal pain Muscle tightness Muscle spasm
N06AX21
Muscle twitching
(5- HT)
Trismus
%
Endocrine disorders Hypo- thyroidism Metabolism and Nutrition Disorders
(NE). +
Decreased Appetite
,
Dehydration SIADH Hypo-natremia
$$
Infections and infestations Laryngitis Vascular Disorders
(! ").
Flushing
* $
Syncope2 Orthostatic hypotension2 Blood pressure increase Peripheral coldness
$$$
Hypertensive crisis Hypertension
33: '% 40 mg
Fatigue Abdominal pain
-
Feeling hot Malaise Gait disturbance Feeling abnormal Feeling cold Thirst Chills
83 955 -
Chest pain
(IEF)
Immune system disorders
(I- QOL).
Hyper- sensitivity
$22%), 8
Anaphylactic reaction
(52% 29%)
29
12
Very
(52% 33%)
Common
ARICLAIM
Uncommon
$-
Rare
. (
Very Rare
ARICLAIM,
Frequency not
< 14
common
, ARICLAIM
disorder
.
known
-
Hepatitis3 Elevated liver enzymes (ALT, AST, alkaline phosphatase)
%
Hepatic failure Jaundice
"
Acute liver injury
: &
Reproductive System and Breast Disorders
(I- QOL)
Erectile dysfunction
$
Sexual dysfunction Ejaculation disorder Ejaculation delayed Gynaecological haemorrhage
,
Menopausal symptoms
$
Psychiatric Disorders
9, 2
Insomnia
5, 9,
Aggression
p < 0, 001).
Suicidal
,
Abnormal dreams Anxiety
$
Sleep disorder Apathy Disorientation
(PGI),
and anger 5 Mania
$p < 0, 001).
behaviour4 Suicidal ideation4
50, 1%,
1
ARICLAIM
AgitationLibid Bruxism o decreased Orgasm abnormal
&
Hallucinations
"
3 See section 4.4 4 Cases of suicidal ideation and suicidal behaviours have been reported during duloxetine therapy or early after treatment discontinuation (see section 4.4) 5 Cases of aggression and anger have been reported particularly early in treatment of after treatment discontinuation.
:
It is therefore advised that when duloxetine treatment is no longer required, gradual discontinuation by dose tapering should be carried out (see sections 4.2 and 4.4).
,
There was also a small increase in fasting blood glucose and in total cholesterol in
,.
30 duloxetine-treated patients while those laboratory tests showed a slight decrease in the routine care group.
,
No clinically significant differences were observed for QT, PR, QRS, or QTcB measurements between duloxetine- treated and placebo-treated patients.
ARICLAIM
4.9 Overdose
ARICLAIM
Signs and symptoms of overdose (duloxetine alone or in combination with other medicinal products) included somnolence, coma, serotonin syndrome, seizures, vomiting and tachycardia.
$
Duloxetine has a large volume of distribution and forced diuresis, haemoperfusion, and exchange perfusion are unlikely to be beneficial.
12 -
5.
,
5.1 Pharmacodynamic properties
,
Other antidepressants.
, ARICLAIM $
ATC code:
$$
N06AX21
(
It weakly inhibits dopamine reuptake with no significant affinity for histaminergic, dopaminergic, cholinergic and adrenergic receptors.
+
A similar mechanism in women is believed to result in stronger urethral closure during urine storage with physical stress that could explain the efficacy of duloxetine in the treatment of women with SUI.
)
The pain inhibitory action of duloxetine is believed to be a result of potentiation of descending inhibitory pain pathways within the central nervous system.
.
Differences were observed
:
31 at each visit after 4 weeks (duloxetine 54%, and placebo 22%), 8 weeks (52% and 29%), and 12 weeks (52% and 33%) of medication.
2
In an additional study limited to patients with severe SUI, all responses with duloxetine were achieved within 2 weeks.
6
In these women, ARICLAIM may provide no benefit beyond that afforded by more conservative behavioural interventions.
, 12 - (22,
Quality of Life:
88
ARICLAIM and Prior Continence Surgery: there are limited data that suggest that the benefits of ARICLAIM are not diminished in women with stress urinary incontinence who have previously undergone continence surgery.
,
Combined therapy (duloxetine + PFMT) showed greater improvement in both pad use and condition-specific quality of life measures than ARICLAIM alone or PFMT alone.
,
The primary outcome measure was the weekly mean of 24-hour average pain, which was collected in a daily diary by patients on an 11-point Likert scale.
)
The difference in mean improvement between the two active treatment arms was not significant.
, 27%
For patients not experiencing somnolence, clinical response was observed in 47% of patients receiving duloxetine and 27% patients on placebo.
30%
Patients not demonstrating a pain reduction of 30% within 60 days of treatment were unlikely to reach this level during further treatment.
$., 30% $
Although data from a one-year open label study offer some evidence for longer-term efficacy, no conclusive efficacy data for treatments longer than 12 weeks duration are available from placebo- controlled studies.
32%
32 5.2 Pharmacokinetic properties
80% (
The pharmacokinetics of duloxetine demonstrate large intersubject variability (generally 50-60%), partly due to gender, age, smoking status and CYP2D6 metaboliser status.
50%; N=8
The absolute oral bioavailability of duloxetine ranged from 32% to 80% (mean of 50%; N=8 subjects).
CYP2D6
Special populations:
$
As a general recommendation, caution should be exercised when treating the elderly (see sections 4.2 and 4.4).
.) -
Pharmacokinetic data on duloxetine is limited in patients with mild or moderate renal impairment.
.
The pharmacokinetics of duloxetine and its metabolites have not been studied in patients with mild or severe hepatic insufficiency.
22 l /
Nursing mothers:
33
33 5.3 Preclinical safety data
261 l /
The underlying mechanism and the clinical relevance are unknown.
(
In pre/ postnatal toxicity study in the rat, duloxetine induced adverse behavioural effects in the offspring at systemic exposures levels below maximum clinical exposure (AUC).
$$
6.
Pugh Class B)
PHARMACEUTICAL PARTICULARS
, AUC 3. 7 - $
6.1 List of excipients
: & 12 -
Capsule content:
(AUC).
Hypromellose.
+ / / $(: &
Capsule shell:
(E132) 4.
Gelatin Sodium Lauryl Sulfate Titanium Dioxide (E171) Indigo Carmine (E132) Edible Black Ink.
4:
Edible Ink:
(E172)
Black Iron Oxide-Synthetic (E172) Propylene glycol Shellac
5
6.2 Incompatibilities
.
Not applicable.
6. 3, & +
6.3 Shelf life
3.
3 years.
6. 4
6.4 Special precautions for storage
% #
Store in the original package in order to protect from moisture.
(PCTFE) $
34 6.5 Nature and contents of container
28
Packs of 28 and 56 capsules.
56
Not all pack sizes may be marketed.
EU/ 1/ 04/ 283/ 001 EU/ 1/ 04/ 283/ 007
EU/ 1/ 04/ 283/ 001 EU/ 1/ 04/ 283/ 007
37 1.
35 1.
ARICLAIM 30 mg
ARICLAIM 30 mg hard gastro-resistant capsules
30 mg
Each capsule contains 30 mg of duloxetine (as hydrochloride)
8, 6 mg.
Excipients: sucrose 8.6 mg.
‘ 9543 ’
PHARMACEUTICAL FORM
$$5. 2).
Hard gastro-resistant capsule.
30
Opaque white body, imprinted with ‘ 30 mg’ and an opaque blue cap, imprinted with ‘ 9543’.
4. 4
4.
ARICLAIM, $
CLINICAL PARTICULARS
ARICLAIM
4.1 Therapeutic indications
$
4.2 Posology and method of administration
-.,) - $
For oral use.
(.
Hence, some patients that respond insufficiently to 60 mg may benefit from a higher dose.
5. 2).
The medicinal product response should be evaluated after 2 months’ of treatment.
ARICLAIM (
Additional response after this time is unlikely (see 5.1).
.,
The therapeutic benefit should regularly (at least every three months) be reassessed.
$
Elderly No dosage adjustment is recommended for elderly patients solely on the basis of age.
$CYP1A2),
However, caution should be exercised when treating the elderly (see section 5.2).
%
Hepatic impairment ARICLAIM should not be used in patients with liver disease resulting in hepatic impairment (see sections 4.3 and 5.2).
(
Renal insufficiency No dosage adjustment is necessary for patients with mild or moderate renal dysfunction (creatinine clearance 30 to 80 ml/ min).
< 30 ml /
ARICLAIM should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/ min; see section 4.3)..
) (
Subsequently, the physician may continue decreasing the dose, but at a more gradual rate.
ARICLAIM, (
4.3 Contraindications
.
Hypersensitivity to the active substance or to any of the excipients.
4. 4
Concomitant use of ARICLAIM with nonselective, irreversible Monoamine Oxidase Inhibitors (MAOIs) is contraindicated (see section 4.5).
4. 8).
Liver disease resulting in hepatic impairment (see section 5.2).
4. 4
ARICLAIM should not be used in combination with fluvoxamine, ciprofloxacin or enoxacine (i. e. potent CYP1A2 inhibitors) since the combination results in elevated plasma concentrations of duloxetine (see section 4.5).
< 30 ml /
Severe renal impairment (creatinine clearance < 30 ml/ min) (see section 4.4).
).
The initiation of treatment with ARICLAIM is contraindicated in patients with uncontrolled hypertension that could expose patients to a potential risk of hypertensive crisis (see sections 4.4 and 4.8).
ARICLAIM $
4.4 Special warnings and precautions for use
$MAO -
Mania and seizures ARICLAIM should be used with caution in patients with a history of mania or a diagnosis of bipolar disorder, and/ or seizures.
$
Mydriasis Mydriasis has been reported in association with duloxetine, therefore, caution should be used when prescribing ARICLAIM to patients with increased intraocular pressure, or those at risk of acute narrow-angle glaucoma.
%
For patients who experience a sustained increase in blood pressure while receiving duloxetine either dose reduction or gradual discontinuation should be considered (see section 4.8).
,
For patients with severe renal impairment, see section 4.3. ee section 4.2 for information on patients with mild or moderate renal dysfunction.
ARICLAIM,,
Use with antidepressants
.,
In particular the combination with selective reversible MAOIs is not recommended.
ARICLAIM (
St John’ s wort Undesirable effects may be more common during concomitant use of ARICLAIM and herbal preparations containing St John’ s wort (Hypericum perforatum).
.
If a decision to initiate antidepressant pharmacological therapy is taken, the gradual discontinuation of ARICLAIM is recommended (see section 4.2).
18
ARICLAIM should not be used in the treatment of children and adolescents under the age of 18 years.
.
Caution is advised in patients taking anticoagulants and/ or medicinal products known to affect platelet function, and in patients with known bleeding tendencies.
-
Hyponatremia may be due to a syndrome of inappropriate anti-diuretic hormone secretion (SIADH).
(
It is therefore advised that duloxetine should be gradually tapered when discontinuing treatment over a period of no less than 2 weeks, according to the patient’ s needs (see section 4.2).
)
In patients who develop these symptoms, increasing the dose may be detrimental.
$,
The use of more than one of these products concomitantly should be avoided.
/
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.
$-,
4.5 Interaction with other medicinal products and other forms of interaction
)
Consequently, caution is advised when ARICLAIM is taken in combination with other centrally acting medicinal products and substances including alcohol and sedative medicinal products (e. g. benzodiazepines, morphinomimetics, antipsychotics, phenobarbital, sedative antihistamines).
,
Based on the half-life of duloxetine, at least 5 days should be allowed after stopping ARICLAIM before starting an MAOI (see section 4.3).
$($.,
However, the concomitant use of ARICLAIM with selective, reversible MAOIs is not recommended (see section 4.4).
/ $
Caution is advisable if ARICLAIM is used concomitantly with serotonergic antidepressants like SSRIs, tricyclics like clomipramine or amitriptyline, St John’ s wort (Hypericum perforatum), venlafaxine or triptans, tramadol, pethidine and tryptophan.
,
Caution is advised if ARICLAIM is co-administered with medicinal products that are predominantly metabolised by CYP2D6 (risperidone, tricyclic antidepressants [TCAs] such as nortriptyline, amitriptyline, and imipramine) particularly if they have a narrow therapeutic index (such as flecainide, propafenone and metoprolol).
$/
Furthermore, increases in INR values have been reported when duloxetine was co-administered with warfarin.
. (
Effects of other medicinal products on duloxetine Antacids and H2 antagonists: co-administration of duloxetine with aluminium- and magnesium- containing antacids or duloxetine with famotidine had no significant effect on the rate or extent of duloxetine absorption after administration of a 40 mg oral dose.
$
Therefore ARICLAIM should not be administered in combination with potent inhibitors of CYP1A2 like fluvoxamine (see section 4.3).
(SSRIs)
Inducers of CYP1A2:
(SNRIs).
4.6 Pregnancy and lactation
,
Studies in animals have shown reproductive toxicity at systemic exposure levels (AUC) of duloxetine lower than the maximum clinical exposure (see section 5.3).
40 # $0 ARICLAIM.
The potential risk for humans is unknown.
$
As the safety of duloxetine in infants is not known, the use of ARICLAIM while breast-feeding is not recommended.
$. 0
40 4.7 Effects on ability to drive and use machines
,
Patients should be instructed that if they experience sedation or dizziness they should avoid potentially hazardous tasks such as driving or operating machinery.
4. 8).
4.8 Undesirable effects
, $/
The most commonly observed adverse reactions in patients with diabetic neuropathic pain treated with ARICLAIM were: nausea; headache, dry mouth and somnolence.
ARICLAIM,
Table 1:
, ARICLAIM, 23%,
Adverse reactions Frequency estimate:
, $/
Very
SSRI’ s
Common
SRNI’ s,
Uncommon
$/
Rare
4. 8.) $$
Very Rare
. + $,
Frequency not
(2- 3
common
4. 2).
known
$(> 10
Investigations
4. 8).
Weight decrease
$
Weight increase Creatinine phosphokinase increase
. 0
Blood cholesterol increased
ARICLAIM
Cardiac Disorders
(& * +
Palpitations
+ & '#
Tachycardia
,
Supra- ventricular arrhythmia, mainly atrial fibrillation
& '- (,
Nervous System
(& * +
Disorders
%
Headache (13.8%) Somnolence (10.7%) Eye Disorders
,
Dizziness Tremor Lethargy Paraesthesia
,
Dyskinesia Poor quality sleep Nervousness Myoclonus Disturbance in attention Dysgeusia
$
Serotonin syndrome Convulsions Akathisia Psychomotor restlessness Extra- pyramidal symptoms
)
Blurred vision
&
Visual disturbance Mydriasis
(, -:
Glaucoma
1
Tinnitus 1
-
Vertigo Ear pain
,
Respiratory, thoracic and mediastinal disorders
ARICLAIM
Yawning
$
Epistaxis Throat tightness
41
41
, $,%,
Very
(MAO - (
Common
MAO -
Rare
-.,) -
Very Rare
ARICLAIM 4. 4).
Frequency not
SSRIs (
common
SSRIs,
known
(Hypericum perforatum),
Gastrointestinal Disorders Nausea (21.7%) Dry mouth (13.2%)
%
Diarrhoea Constipation Vomiting Dyspepsia Flatulence
,
Gastroenteritis Stomatitis Gastritis Eructation
2
Haematochezia Breath odour
(
Gastrointestinal haemorrhage
CYP2D6: * 60 mg
Renals and Urinary Disorders
$
Urinary Retention Urinary hesitation Dysuria Nocturia Polyuria Urine flow decreased
CYP2D6 $
Urine odour abnormal
, AUC
Skin and Subcutaneous Tissue Disorders
3
Rash Sweating increased Night sweats
.
Photo- sensitivity reactions Increased tendency to bruise Dermatitis contact Urticaria Cold sweat
(40 mg
Stevens- Johnson Syndrome Angio-neurotic oedema
AUC
Musculo- skeletal pain Muscle tightness Muscle spasm
(2 mg 5 -
Muscle twitching
71%,,
Trismus
ARICLAIM
Decreased Appetite
in vitro
Hyperglycemia (reported especially in diabetic patients)
CYP1A2
Dehydration SIADH Hypo-natremia
/
Infections and infestations Laryngitis Vascular Disorders
CYP1A2,
Flushing
,
Syncope2 Orthostatic hypotension2 Blood pressure increase Peripheral coldness
ARICLAIM
Hypertensive crisis Hypertension
42
42
(
Very
(AUC)
Common
5. 3).
Uncommon
. (,
Rare
ARICLAIM
Very Rare
mg/ kg $0, 14% (.
Frequency not
$mg/ kg $
common
0, 14%
known
(
General Disorders and Administration Site Conditions
ARICLAIM
Fatigue Abdominal pain
.
Feeling hot Malaise Gait disturbance Feeling abnormal Feeling cold Thirst Chills
ARICLAIM
Chest pain
, $
Immune system disorders Hepato-biliary disorders
ARICLAIM,
Hyper- sensitivity disorder
/ 1: - ")
Anaphylactic reaction
(≥1/ 10),
Hepatitis3 Elevated liver enzymes (ALT, AST, alkaline phosphatase)
(≥1/ 100
Hepatic failure Jaundice
(≥1/ 1 000
Acute liver injury
(≥ 1/ 10 000 < 1/ 1 000), $
Reproductive System and Breast Disorders
(< 1/ 10 000),
Erectile dysfunction
%
Sexual dysfunction Ejaculation disorder Ejaculation delayed Gynaecological haemorrhage
(13, 8%)
Menopausal symptoms
(10, 7%)
Psychiatric Disorders
5 1 6 0
Insomnia
(21, 7%) (
Aggression
(13,
Suicidal
Stevens - Johnson,
Abnormal dreams Anxiety
(
Sleep disorder Apathy Disorientation
0
and anger 5 Mania
-
behaviour4 Suicidal ideation4
1 &
1
"($
AgitationLibid Bruxism o decreased Orgasm abnormal
SNRIs
Cases of tinnitus have also been reported after treatment discontinuation.
4. 2
2 Cases of orthostatic hypotension and syncope have been reported especially at the initiation of treatment.
4. 4).
Discontinuation of duloxetine (particularly when abrupt) commonly leads to withdrawal symptoms.
46
It is therefore advised that when duloxetine treatment is no longer required, gradual discontinuation by dose tapering should be carried out (see sections 4.2 and 4.4).
12 -
There was also a small increase in fasting blood glucose and in total cholesterol in duloxetine-treated patients while those laboratory tests showed a slight decrease in the routine care group.
205
Electrocardiograms were obtained from 528 duloxetine-treated and 205 placebo-treated patients with diabetic neuropathic pain in clinical trials lasting up to 13-weeks.
QT, PR, QRS
4.9 Overdose
$.
Signs and symptoms of overdose (duloxetine alone or in combination with other medicinal products) included somnolence, coma, serotonin syndrome, seizures, vomiting and tachycardia.
QTcB
No specific antidote is known for duloxetine but if serotonin syndrome ensues, specific treatment (such as with cyproheptadine and/ or temperature control) may be considered.
4 800 mg.!
A free airway should be established.
%
5.
,
Pharmacotherapeutic group:
1 000 mg.
Other antidepressants.
ATC
ATC code:
N06AX21.
N06AX21.
*
Duloxetine dose-dependently increases extracellular levels of serotonin and noradrenaline in various brain areas of animals.
$$$
The pain inhibitory action of duloxetine is believed to be a result of potentiation of descending inhibitory pain pathways within the central nervous system.
(5- HT)
The primary outcome measure was the weekly mean of 24-hour average pain, which was collected in a daily diary by patients on an 11-point Likert scale.