VYVANSE lisdexamfetamine dimesilate 70mg capsule bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lisdexamfetamine dimesilate, Quantity: 70 mg

Available from:

Takeda Pharmaceuticals Australia Pty Ltd

INN (International Name):

Lisdexamfetamine dimesilate

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: titanium dioxide; croscarmellose sodium; erythrosine; microcrystalline cellulose; magnesium stearate; brilliant blue FCF; Gelatin

Administration route:

Oral

Units in package:

30

Prescription type:

(S8) Controlled Drug

Therapeutic indications:

Attention Deficit Hyperactivity Disorder (ADHD): VYVANSE is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Treatment should be commenced by a specialist. A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before 12 years of age.,Need for comprehensive treatment programme: VYVANSE is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational and social) for patients with this syndrome. Stimulants are not intended for use in the patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician?s assessment of the chronicity and severity of the patient?s symptoms.,Long term use: The physician who elects to use VYVANSE for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.,Binge Eating Disorder (BED): VYVANSE is indicated for the treatment of moderate to severe BED in adults when nonpharmacological treatment is unsuccessful or unavailable. Treatment should be commenced and managed by a psychiatrist.,Need for comprehensive treatment programme: VYVANSE is indicated as part of a total treatment program for BED that optimally includes other measures (nutritional, psychological, and medical) for patients with this disorder. When remedial measures including psychotherapy are insufficient, the decision to prescribe stimulant medication will depend upon the physician?s assessment of the chronicity and severity of the patient?s symptoms.,Limitation of Use: VYVANSE is not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of VYVANSE for the treatment of obesity have not been established. Prescribers should consider that serious cardiovascular events have been reported with this class of sympathomimetic drugs. The BED clinical trials were not designed to assess cardiovascular safety. While there is an accumulation of safety data with VYVANSE use in the ADHD population, this is of limited relevance regarding cardiovascular risk in the BED population. Given the higher cardiovascular risk associated with obesity, the BED population may be at a higher risk. See Sections 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE, Cardiovascular Disease and 4.2 DOSE AND METHOD OF ADMINISTRATION.,Long term use: For BED the initial treatment period is 12 weeks. Patients should then be observed to assess whether further treatment with VYVANSE is required. Periodic re-evaluation of the usefulness of VYVANSE for the individual patient should be undertaken. See Section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical Trials.

Product summary:

Visual Identification: Hard Capsule Size 3: blue opaque body and pink opaque cap, printed 'S489' and '70 mg' in black ink; Container Type: Bottle; Container Material: HDPE; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2013-07-22

Patient Information leaflet

VYVANSE
®
V
Y
V
A
N
S
E
®
C
M
I
V
2
.
0
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
1.
WHY AM I USING VYVANSE?
VYVANSE contains the active ingredient lisdexamfetamine dimesilate.
VYVANSE is used to treat 1) Attention Deficit Hyperactivity
Disorder (ADHD) AND 2) Binge Eating Disorder (BED).
For more information, see Section 1. Why am I using VYVANSE? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE VYVANSE?
Do not use if you: have ever had an allergic reaction to VYVANSE or
any of the ingredients listed at the end of the CMI; taking a
medicine called a ‘monoamine oxidase inhibitor’ (MAOI) or have
taken an MAOI in the last 14 days; have a thyroid problem; feel
unusually excited, over-active, or un-inhibited; have ever had heart
problems.
Talk to your doctor if you have any other medical conditions, take any
other medicines, or are pregnant or plan to become pregnant
or are breastfeeding.
For more information, see Section 2. What should I know before I use
VYVANSE? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with VYVANSE and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE VYVANSE?
•
Take VYVANSE capsule once a day in the morning with or without food.
The usual starting dose is 30 mg once a day, your
doctor may change the dose until it is right for you. If you have
trouble swallowing capsules, you may open your VYVANSE
capsule and pour all of the powder into a soft food such as yogurt,
water or orange juice; mix completely and consume mixed
contents right away.
•
Follow all directions given to you by your doctor or pharmacist
carefully.
More instructions can be found in Section 4. How do I use VYVANSE? in
the full CMI.
5.
WHAT SHOULD

Summary of Product characteristics

VYVANSE PI V3.0 (CCDS V31.1)
1
AUSTRALIAN PRODUCT INFORMATION
VYVANSE
® (LISDEXAMFETAMINE DIMESILATE)
VYVANSE has a potential for abuse, misuse, dependence, or diversion
for non-therapeutic
uses. Physicians should assess the risk of abuse prior to prescribing
and monitor for signs of
abuse and dependence while on therapy. VYVANSE should be prescribed
cautiously to
patients with a history of substance abuse or dependence. Careful
supervision is required
during withdrawal from abusive use since severe depression may occur.
Withdrawal
following chronic therapeutic use may unmask symptoms of the
underlying disorder that may
require follow-up.
1
NAME
OF
THE
MEDICINE
Lisdexamfetamine dimesilate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
VYVANSE capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg or 70 mg of
lisdexamfetamine dimesilate as the active ingredient.
VYVANSE (lisdexamfetamine dimesilate) was developed as a capsule for
once-a-day oral
administration. The chemical designation for lisdexamfetamine
dimesilate is (2S)-2,6-
diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate.
Lisdexamfetamine dimesilate is a white to off-white powder that is
highly soluble in water.
Lisdexamfetamine dimesilate has a 2-octanol/water partition
coefficient (logP) of -1.76;
pKa1 of 10.5 / pKa2 of 7.7; and pH of 4.1 when dissolved in water.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Capsules
APPEARANCE
VYVANSE 20 mg capsule: ivory opaque body and ivory opaque cap, printed
‘S489’ and
‘20 mg’ in black ink.
VYVANSE 30 mg capsule: white opaque body and pink opaque cap, printed
‘S489’ and
‘30 mg’ in black ink.
VYVANSE 40 mg capsule: white opaque body and blue/green opaque cap,
printed ‘S489’
and ‘40 mg’ in black ink.
VYVANSE50 mg capsule: white opaque body and blue opaque cap, printed
‘S489’ and
‘50 mg’ in black ink.
VYVANSE 60 mg capsule: aqua blue opaque body and aqua blue opaque cap,
printed ‘S489’
and ‘60 mg’ in black ink.
VYVANSE 7