DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE (MONOHYDRATE), DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE- dextroampheta

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

DEXTROAMPHETAMINE SACCHARATE (UNII: G83415V073) (DEXTROAMPHETAMINE - UNII:TZ47U051FI), AMPHETAMINE ASPARTATE (UNII: H527KAP6L5) (AMPHETAMINE - UNII:CK833KGX7E), DEXTROAMPHETAMINE SULFATE (UNII: JJ768O327N) (DEXTROAMPHETAMINE - UNII:TZ47U051FI), AMPHETAMINE SULFATE (UNII: 6DPV8NK46S) (AMPHETAMINE - UNII:CK833KGX7E)

থেকে পাওয়া:

Mylan Pharmaceuticals Inc.

INN (International Name):

DEXTROAMPHETAMINE SACCHARATE

রচনা:

DEXTROAMPHETAMINE SACCHARATE 1.25 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV® ) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful.

পণ্য সারাংশ:

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets contain dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, USP and amphetamine sulfate, USP. The 5 mg tablets contain 1.25 mg of dextroamphetamine saccharate, 1.25 mg of amphetamine aspartate monohydrate (equivalent to 1.17 mg of amphetamine aspartate anhydrous), 1.25 mg of dextroamphetamine sulfate, USP and 1.25 mg of amphetamine sulfate, USP. The 5 mg tablets are light blue, round, tablets debossed with M over A5 on one side of the tablet and a quadrisect on the other side. They are available as follows: NDC 0378-4541-01 bottles of 100 tablets The 7.5 mg tablets contain 1.875 mg of dextroamphetamine saccharate, 1.875 mg of amphetamine aspartate monohydrate (equivalent to 1.755 mg of amphetamine aspartate anhydrous), 1.875 mg of dextroamphetamine sulfate, USP and 1.875 mg of amphetamine sulfate, USP. The 7.5 mg tablets are blue, round, tablets debossed with M over A7 on one side of the tablet and a quadrisect on the other side. NDC 0378-4542-01 bottles of 100 tablets The 10 mg tablets contain 2.5 mg of dextroamphetamine saccharate, 2.5 mg of amphetamine aspartate monohydrate (equivalent to 2.34 mg of amphetamine aspartate anhydrous), 2.5 mg of dextroamphetamine sulfate, USP and 2.5 mg of amphetamine sulfate, USP. The 10 mg tablets are dark blue, round, tablets debossed with M over A10 on one side of the tablet and a quadrisect on the other side. NDC 0378-4543-01 bottles of 100 tablets The 12.5 mg tablets contain 3.125 mg of dextroamphetamine saccharate, 3.125 mg of amphetamine aspartate monohydrate (equivalent to 2.925 mg of amphetamine aspartate anhydrous), 3.125 mg of dextroamphetamine sulfate, USP and 3.125 mg of amphetamine sulfate, USP. The 12.5 mg tablets are peach, round, tablets debossed with M over A12 on one side of the tablet and a quadrisect on the other side. NDC 0378-4544-01 bottles of 100 tablets The 15 mg tablets contain 3.75 mg of dextroamphetamine saccharate, 3.75 mg of amphetamine aspartate monohydrate (equivalent to 3.51 mg of amphetamine aspartate anhydrous), 3.75 mg of dextroamphetamine sulfate, USP and 3.75 mg of amphetamine sulfate, USP. The 15 mg tablets are peach, round, tablets debossed with M over A15 on one side of the tablet and a quadrisect on the other side. NDC 0378-4545-01 bottles of 100 tablets The 20 mg tablets contain 5 mg of dextroamphetamine saccharate, 5 mg of amphetamine aspartate monohydrate (equivalent to 4.6 mg of amphetamine aspartate anhydrous), 5 mg of dextroamphetamine sulfate, USP and 5 mg of amphetamine sulfate, USP. The 20 mg tablets are peach, round, tablets debossed with M over A20 on one side of the tablet and a quadrisect on the other side. NDC 0378-4546-01 bottles of 100 tablets The 30 mg tablets contain 7.5 mg of dextroamphetamine saccharate, 7.5 mg of amphetamine aspartate monohydrate (equivalent to 7.03 mg of amphetamine aspartate anhydrous), 7.5 mg of dextroamphetamine sulfate, USP and 7.5 mg of amphetamine sulfate, USP. The 30 mg tablets are peach, round, tablets debossed with M over A30 on one side of the tablet and a quadrisect on the other side. NDC 0378-4547-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription. * The brands listed are trademarks of their respective owners.

অনুমোদন অবস্থা:

Abbreviated New Drug Application

তথ্য লিফলেট

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE
(MONOHYDRATE), DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE-
DEXTROAMPHETAMINE, AMPHETAMINE, DEXTROAMPHETAMINE, AMPHETAMINE TABLET
Mylan Pharmaceuticals Inc.
----------
MEDICATION GUIDE
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine
Sulfate and Amphetamine
Sulfate Tablets
(dex" troe am fet' a meen sac cha rate, am fet' a meen a spar' tate,
dex" troe am fet' a meen sul' fate, am
fet' a meen sul' fate)
Read the Medication Guide that comes with dextroamphetamine
saccharate, amphetamine aspartate,
dextroamphetamine sulfate and amphetamine sulfate tablets before you
or your child starts taking it and
each time you get a refill. There may be new information. This
Medication Guide does not take the place
of talking to your doctor about you or your child’s treatment with
dextroamphetamine saccharate,
amphetamine aspartate, dextroamphetamine sulfate and amphetamine
sulfate tablets.
What is the most important information I should know about
dextroamphetamine saccharate,
amphetamine aspartate, dextroamphetamine sulfate and amphetamine
sulfate tablets?
The following have been reported with use of dextroamphetamine
saccharate, amphetamine
aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets
and other stimulant
medicines.
1. Heart-related problems:
•
sudden death in patients who have heart problems or heart defects
•
stroke and heart attack in adults
•
increased blood pressure and heart rate
Tell your doctor if you or your child have any heart problems, heart
defects, high blood pressure,
or a family history of these problems.
Your doctor should check you or your child carefully for heart
problems before starting
dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine
sulfate and
amphetamine sulfate tablets.
Your doctor should check your or your child’s blood pressure and
heart rate regularly during
treatment with dextroamphetamine saccharate, amphetamine aspartate,
dextroamphetamine
sulfate and amphetamine su

পণ্য বৈশিষ্ট্য

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE
(MONOHYDRATE), DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE-
DEXTROAMPHETAMINE, AMPHETAMINE, DEXTROAMPHETAMINE, AMPHETAMINE TABLET
MYLAN PHARMACEUTICALS INC.
----------
AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF
AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG
DEPENDENCE AND MUST BE AVOIDED. PARTICULAR ATTENTION SHOULD BE
PAID TO THE POSSIBILITY OF SUBJECTS OBTAINING AMPHETAMINES FOR NON-
THERAPEUTIC USE OR DISTRIBUTION TO OTHERS, AND THE DRUGS SHOULD BE
PRESCRIBED OR DISPENSED SPARINGLY.
MISUSE OF AMPHETAMINE MAY CAUSE SUDDEN DEATH AND SERIOUS
CARDIOVASCULAR ADVERSE EVENTS.
DESCRIPTION
A single-entity amphetamine product combining the neutral sulfate
salts of dextroamphetamine and
amphetamine, with the dextro isomer of amphetamine saccharate and d,
l-amphetamine aspartate
monohydrate.
EACH TABLET
CONTAINS
5 MG
7.5 MG
10 MG
12.5 MG
15 MG
20 MG
30 MG
Dextroamphetamine Saccharate
1.25 mg
1.875 mg
2.5 mg
3.125 mg
3.75 mg
5 mg
7.5 mg
Amphetamine Aspartate
Monohydrate
1.25 mg
1.875 mg
2.5 mg
3.125 mg
3.75 mg
5 mg
7.5 mg
Dextroamphetamine Sulfate,
USP
1.25 mg
1.875 mg
2.5 mg
3.125 mg
3.75 mg
5 mg
7.5 mg
Amphetamine Sulfate, USP
1.25 mg
1.875 mg
2.5 mg
3.125 mg
3.75 mg
5 mg
7.5 mg
Total Amphetamine Base
Equivalence
3.13 mg
4.7 mg
6.3 mg
7.8 mg
9.4 mg
12.6 mg 18.8 mg
INACTIVE INGREDIENTS: Colloidal silicon dioxide, compressible sugar,
magnesium stearate,
microcrystalline cellulose and pregelatinized starch (corn).
COLORS: Dextroamphetamine saccharate, amphetamine aspartate,
dextroamphetamine sulfate and
amphetamine sulfate tablets 5 mg, 7.5 mg and 10 mg contain FD&C Blue
No. 1 Aluminum Lake as a
color additive.
Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine
sulfate and amphetamine
sulfate tablets 12.5 mg, 15 mg, 20 mg, and 30 mg contain FD&C Blue No.
1 Aluminum Lake and FD&C
Yellow No. 6 Aluminum Lake as color additives.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Amphetamines are non-catecholamine sympathomimetic ami