Држава: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
AMPHETAMINE SULFATE (UNII: 6DPV8NK46S) (AMPHETAMINE - UNII:CK833KGX7E)
Solco Healthcare US, LLC
ORAL
PRESCRIPTION DRUG
Amphetamine sulfate tablets, USP, are indicated for: Controlled Substance Amphetamine sulfate tablets contain amphetamine, a Schedule II controlled substance. Abuse Amphetamine sulfate tablets have a high potential for abuse and misuse which can lead to the development of a substance use disorder, including addiction (see WARNINGS ). Amphetamine sulfate tablets can be diverted for non-medical use into illicit channels or distribution. Abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activit
Amphetamine sulfate tablets, USP, are supplied as follows: 5 mg: White, round, convex tablet, uppers scored and debossed "5" on the left side, lowers debossed "S" in bottles of 100 tablets with child-resistant closure, NDC 43547-457-10. 10 mg: White, round, convex tablet, uppers are double crossed scored and debossed "1" on the lower left corner and "0" on the lower right corner, lowers debossed "S" in bottles of 100 tablets with child-resistant closure, NDC 43547-458-10. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15o C and 30o C (59o F and 86o F). [see USP Controlled Room Temperature.] Dispense in a well-closed container, as defined in the USP. Dispense with Medication Guide available at: www.solcohealthcare.com/medguide/amphetamine-tablets.pdf Manufactured by: Prinston Laboratories Charlotte, NC 28206, USA Distributed by: Solco Healthcare US, LLC Somerset, NJ 08873, USA Revised: 09/2023 9040380-06
Abbreviated New Drug Application
Solco Healthcare US, LLC ---------- MEDICATION GUIDE Dispense with Medication Guide available at: www.solcohealthcare.com/medguide/amphetamine-tablets.pdf MEDICATION GUIDE Amphetamine Sulfate Tablets CII (am fet’ a meen sul’ fate) What is the most important information I should know about amphetamine sulfate tablets? Amphetamine sulfate tablets may cause serious side effects, including: • Abuse, misuse, and addiction. Amphetamine sulfate tablets have a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of amphetamine sulfate tablets, other amphetamine-containing medicines, and methylphenidate, can lead to overdose and death. The risk of overdose and death is increased with higher doses of amphetamine sulfate tablets or when it is used in ways that are not approved, such as snorting or injection. o Your healthcare provider should check you or your child’s risk for abuse, misuse, and addiction before starting treatment with amphetamine sulfate tablets and will monitor you your child during treatment. o Amphetamine sulfate tablets may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider. o Do not give amphetamine sulfate tablets to anyone else. See “What are amphetamine sulfate tablets?” for more information. o Keep amphetamine sulfate tablets in a safe place and properly dispose of unused medicine. See “How should I store amphetamine sulfate tablets?” for more information. o Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs. • Risk for people with serious heart disease. • Sudden death has happened in people who have heart defects or other serious heart disease. Your healthcare provider should check you or your child carefully for heart problems before starting amphetamine sulfate tablets. Tell your healthcare provider if you or your child have any heart problems, heart disease, or heart defects. Call Прочитајте комплетан документ
AMPHETAMINE SULFATE- AMPHETAMINE SULFATE TABLET SOLCO HEALTHCARE US, LLC ---------- AMPHETAMINE SULFATE TABLETS, USP, CII WARNING: ABUSE, MISUSE, AND ADDICTION AMPHETAMINE SULFATE TABLETS HAVE A HIGH POTENTIAL FOR ABUSE AND MISUSE, WHICH CAN LEAD TO THE DEVELOPMENT OF A SUBSTANCE USE DISORDER, INCLUDING ADDICTION. MISUSE AND ABUSE OF CNS STIMULANTS, INCLUDING AMPHETAMINE SULFATE, CAN RESULT IN OVERDOSE AND DEATH (SEE OVERDOSAGE), AND THIS RISK IS INCREASED WITH HIGHER DOSES OR UNAPPROVED METHODS OF ADMINISTRATION, SUCH AS SNORTING OR INJECTION. BEFORE PRESCRIBING AMPHETAMINE SULFATE TABLETS, ASSESS EACH PATIENT’S RISK FOR ABUSE, MISUSE, AND ADDICTION. EDUCATE PATIENTS AND THEIR FAMILIES ABOUT THESE RISKS, PROPER STORAGE OF THE DRUG, AND PROPER DISPOSAL OF ANY UNUSED DRUG. THROUGHOUT AMPHETAMINE SULFATE TABLETS TREATMENT, REASSESS EACH PATIENT’S RISK OF ABUSE, MISUSE, AND ADDICTION AND FREQUENTLY MONITOR FOR SIGNS AND SYMPTOMS OF ABUSE, MISUSE, AND ADDICTION (SEE WARNINGS AND DRUG ABUSE AND DEPENDENCE). DESCRIPTION Amphetamine Sulfate is a sympathomimetic amino of the amphetamine group. It is a white, odorless crystalline powder. It has a slightly bitter taste. Its solutions are acid to litmus, having a pH of 5.0 to 6.0. It is freely soluble in water and slightly soluble in alcohol. Each tablet, for oral administration contains 5 mg or 10 mg of amphetamine sulfate, USP. Each tablet also contains the following inactive ingredients: crospovidone, magnesium stearate, silicified microcrystalline cellulose, and stearic acid. Structural Formula: CLINICAL PHARMACOLOGY Amphetamines are non-catecholamine, sympathomimetic amines with CNS stimulant activity. Peripheral actions include elevations of systolic and diastolic blood pressures, and weak bronchodilator, and respiratory stimulant action. Amphetamine, as the racemic form, differs from dextroamphetamine in a number of ways. The l-isomer is more potent than the d-isomer in cardiovascular activity, but much less potent in causing CNS excitatory effects. The racemic m Прочитајте комплетан документ