Amfetamin Actavis Uses

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What is Amfetamin Actavis?

Amphetamine is a central nervous system stimulant that affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control.

Amphetamine is used to treat attention deficit hyperactivity disorder (ADHD).

The Amfetamin Actavis brand of amphetamine is used to treat ADHD and also narcolepsy. Amfetamin Actavis is sometimes used to treat obesity in people who have not lost weight with diets or other treatments.

Amphetamine may also be used for purposes not listed in this medication guide.

Amfetamin Actavis indications

infoAn indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Amfetamin Actavis™ (amphetamine sulfate tablets, USP) is indicated for:

  1. Narcolepsy
  2. Attention Deficit Disorder with Hyperactivity as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of the syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or not be warranted.
  3. Exogenous Obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction for patients refractory to alternative therapy, e.g., repeated diets, group programs, and other drugs. The limited usefulness of amphetamines should be weighed against possible risks inherent in use of the drug, such as those described below.

How should I use Amfetamin Actavis?

Use Amfetamin Actavis as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Amfetamin Actavis comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Amfetamin Actavis refilled.
  • Take Amfetamin Actavis by mouth with or without food.
  • Take your doses of Amfetamin Actavis 4 to 6 hours apart unless your doctor tells you otherwise.
  • Do not drink fruit juice at the same time that you take Amfetamin Actavis. Certain fruit juices (eg, grapefruit, apple, orange) may decrease Amfetamin Actavis's effectiveness.
  • Take Amfetamin Actavis on a regular schedule to get the most benefit from it. Taking Amfetamin Actavis at the same time each day will help you remember to take it.
  • If you miss a dose of Amfetamin Actavis, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Amfetamin Actavis.

Uses of Amfetamin Actavis in details

infoThere are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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This medication is used to treat attention deficit hyperactivity disorder - ADHD. It works by changing the amounts of certain natural substances in the brain. Amphetamine belongs to a class of drugs known as stimulants. It can help increase your ability to pay attention, stay focused on an activity, and control behavior problems. It may also help you to organize your tasks and improve listening skills.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used to treat a certain sleeping disorder (narcolepsy). It should not be used to treat tiredness or to hold off sleep in people who do not have a sleep disorder.

How to use Amfetamin Actavis

Read the Medication Guide provided by your pharmacist before you start taking amphetamine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily in the morning. Taking this medication after noon may cause trouble sleeping (insomnia).

Keep the medication in the original package until you are ready to take a dose. Dry your hands before handling the medication. Peel back the foil layer of the blister pack to remove a tablet. Do not push the tablet through the foil because it may get damaged. Place the tablet on your tongue, allow it to dissolve, and swallow with your saliva. You do not need to take this medication with water or other liquid. Do not crush or chew the tablet.

The dosage is based on your medical condition and response to treatment. Your doctor may adjust your dose to find the dose that is best for you. Follow your doctor's instructions carefully.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

During treatment, your doctor may sometimes stop the medication for a short time to see if the medication is still needed.

This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (including severe tiredness, sleep problems, mental/mood changes such as depression) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away.

When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.

Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction.

Tell your doctor if your condition does not get better or if it gets worse.

Amfetamin Actavis dosage

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Pre-Treatment Screening

Prior to treating patients with Amfetamin Actavis, assess for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam).

Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy. Maintain careful prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and periodically re-evaluate the need for Amfetamin Actavis use.

Dosing Considerations For All Patients

Amfetamin Actavis may be taken with or without food. Individualize the dosage according to the therapeutic needs and response of the patient.

Amfetamin Actavis should be taken as follows:

  • The tablet should remain in the blister pack until the patient is ready to take it.
  • The patient or caregiver should use dry hands to open the blister.
  • Tear along the perforation, bend the blister where indicated and peel back the blister’s labeled backing to take out the tablet. The tablet should not be pushed through the foil.
  • As soon as the blister is opened, the tablet should be removed and placed on the patient’s tongue.
  • The whole tablet should be placed on the tongue and allowed to disintegrate without chewing or crushing.
  • The tablet will disintegrate in saliva so that it can be swallowed.

Pediatric Patients

The recommended starting dosage is 6.3 mg once daily in the morning. Increase in increments of 3.1 mg or 6.3 mg at weekly intervals. The maximum recommended dose is 18.8 mg daily for patients 6 to 12 years, and 12.5 mg daily for patients 13 to 17 years.

Adults

The recommended dose is Amfetamin Actavis 12.5 mg daily.

Switching From Other Amphetamine Products

Patients taking ADDERALL XR may be switched to Amfetamin Actavis at the equivalent dose taken once daily. Refer to Table 1 for equivalent doses of Amfetamin Actavis and ADDERALL XR. ADDERALL XR (dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine aspartate monohydrate, and amphetamine sulfate extended-release capsules) is also referred to as mixed salts of a single-entity amphetamine product extended-release capsules (MAS ER).

Table 1: Equivalent Doses of Amfetamin Actavis and ADDERALL XR (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules

Amfetamin Actavis 3.1 mg 6.3 mg 9.4 mg 12.5 mg 15.7 mg 18.8 mg
Amphetamine extended-release orally disintegrating tablets
ADDERALL XR 5 mg 10 mg 15 mg 20 mg 25 mg 30 mg
Mixed salts of a single-entity amphetamine product extended-release capsules (MAS ER)

If switching from any other amphetamine products, discontinue that treatment, and titrate with Amfetamin Actavis using the titration schedule.

Do not substitute for other amphetamine products on a milligram-per-milligram basis because of different amphetamine base compositions and differing pharmacokinetic profiles.

Dosage Modifications Due To Drug Interactions

Agents that alter urinary pH can impact urinary excretion and alter blood levels of amphetamine. Acidifying agents (e.g., ascorbic acid) decrease blood levels, while alkalinizing agents (e.g., sodium bicarbonate) increase blood levels. Adjust Amfetamin Actavis dosage accordingly.

How supplied

Dosage Forms And Strengths

Amfetamin Actavis 3.1 mg Amphetamine Extended Release

Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A1 on one side)

Amfetamin Actavis 6.3 mg Amphetamine Extended Release

Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A2 on one side)

Amfetamin Actavis 9.4 mg Amphetamine Extended Release

Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A3 on one side)

Amfetamin Actavis 12.5 mg Amphetamine Extended Release

Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A4 on one side)

Amfetamin Actavis 15.7 mg Amphetamine Extended Release

Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A5 on one side)

Amfetamin Actavis 18.8 mg Amphetamine Extended Release

Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A6 on one side)

Storage And Handling

Amfetamin Actavis 3.1 mg Extended Release

Orally Disintegrating Tablet

: round, orange to light orange mottled (debossed A1 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 70165-005-30

Amfetamin Actavis 6.3 mg Extended Release

Orally Disintegrating Tablet

: round, orange to light orange mottled (debossed A2 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 70165-010-30

Amfetamin Actavis 9.4 mg Extended Release

Orally Disintegrating Tablet

: round, orange to light orange mottled (debossed A3 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 70165-015-30

Amfetamin Actavis 12.5 mg Extended Release

Orally Disintegrating Tablet

: round, orange to light orange mottled (debossed A4 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 70165-020-30

Amfetamin Actavis 15.7 mg Extended Release

Orally Disintegrating Tablet

: round, orange to light orange mottled (debossed A5 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 70165-025-30

Amfetamin Actavis 18.8 mg Extended Release

Orally Disintegrating Tablet

: round, orange to light orange mottled (debossed A6 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 70165-030-30

Storage

Store at 20°C to 25° C (68°F to 77° F). Excursions permitted to 15-30° C (59-86° F)

Store Amfetamin Actavis blister packages in the rigid, plastic travel case provided after removal from the carton. To obtain additional travel cases, patients and health care professionals can call Neos Therapeutics, Inc., at 1-XXX-XXX-XXXX.

Disposal

Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining, unused, or expired Amfetamin Actavis at authorized collection sites such as retail pharmacies, hospital or clinic pharmacies, and law enforcement locations. If no take-back program or authorized collector is available, mix Amfetamin Actavis with an undesirable, nontoxic substance to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and discard Amfetamin Actavis in the household trash.

Manufactured by: Neos Therapeutics, LP., Grand Prairie, TX 75050. Made in USA. Revised: Jan 2016

Amfetamin Actavis interactions

See also:
What other drugs will affect Amfetamin Actavis?

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Drugs Having Clinically Important Interactions With Amphetamines

Table 5: Drugs having clinically important interactions with amphetamines.

MAO Inhibitors (MAOI)
Clinical Impact MAOI antidepressants slow amphetamine metabolism, increasing amphetamines effect on the release of norepinephrine and other monoamines from adrenergic nerve endings causing headaches and other signs of hypertensive crisis. Toxic neurological effects and malignant hyperpyrexia can occur, sometimes with fatal results.
Intervention Do not administer Amfetamin Actavis during or within 14 days following the administration of MAOI.
Examples selegiline, isocarboxazid, phenelzine, tranylcypromine
Alkalinizing Agents
Clinical Impact Increase blood levels and potentiate the action of amphetamine.
Intervention Co-administration of Amfetamin Actavis and gastrointestinal alkalinizing agents should be avoided.
Examples Gastrointestinal alkalinizing agents (e.g., sodium bicarbonate).

Urinary alkalinizing agents (e.g., acetazolamide, some thiazides).

Acidifying Agents
Clinical Impact Lower blood levels and efficacy of amphetamines.
Intervention Increase dose based on clinical response.
Examples Gastrointestinal acidifying agents (e.g., guanethidine, reserpine, glutamic acid HCl, ascorbic acid).
Tricyclic Antidepressants
Clinical Impact May enhance the activity of tricyclic or sympathomimetic agents causing striking and sustained increases in the concentration of d-amphetamine in the brain; cardiovascular effects can be potentiated.
Intervention Monitor frequently and adjust or use alternative therapy based on clinical response.
Examples desipramine, protriptyline
Proton Pump Inhibitors
Clinical Impact Time to maximum concentration (Tmax) of amphetamine is increased compared to when administered alone.
Intervention Monitor patients for changes in clinical effect and adjust therapy based on clinical response.
Example omeprazole

Drug/Laboratory Test Interactions

Amphetamines can cause a significant elevation in plasma corticosteroid levels. This increase is greatest in the evening. Amphetamines may interfere with urinary steroid determinations.

Drug Abuse And Dependence

Controlled Substance

Amfetamin Actavis contains amphetamine, which is a Schedule II controlled substance in the U.S. Controlled Substance Act (CSA).

Abuse

Amfetamin Actavis, is a CNS stimulant that contains amphetamine which has a high potential for abuse. Abuse is characterized by impaired control of drug use, compulsive use despite harm, and craving.

Signs and symptoms of amphetamine abuse may include increased heart rate, respiratory rate, blood pressure, and/or sweating, dilated pupils, hyperactivity, restlessness, insomnia, decreased appetite, loss of coordination, tremors, flushed skin, vomiting, and/or abdominal pain. Anxiety, psychosis, hostility, aggression, suicidal or homicidal ideation have also been observed. Abusers of amphetamines may use other unapproved routes of administration which can result in overdose and death.

To reduce the abuse of Amfetamin Actavis, assess the risk of abuse prior to prescribing. After prescribing, keep careful prescription records, educate patients and their families about abuse and proper storage and disposal of CNS stimulants, monitor for signs of abuse while on therapy, and re-evaluate the need for Amfetamin Actavis use.

Dependence

Tolerance

Tolerance (a state of adaptation in which exposure to a drug results in a reduction of the drug’s desired and/or undesired effects over time) may occur during the chronic therapy of CNS stimulants including Amfetamin Actavis.

Dependence

Physical dependence (which is manifested by a withdrawal syndrome produced by abrupt cessation, rapid dose reduction, or administration of an antagonist) may occur in patients treated with CNS stimulants including Amfetamin Actavis. Withdrawal symptoms after abrupt cessation following prolonged high dosage administration of CNS stimulants include dysphoric mood; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation.

Amfetamin Actavis side effects

See also:
What are the possible side effects of Amfetamin Actavis?

The following adverse reactions are discussed in greater detail in other sections of the labeling:

  • Drug Dependence
  • Hypersensitivity to amphetamine, or other components of Amfetamin Actavis
  • Hypertensive Crisis When Used Concomitantly with Monoamine Oxidase Inhibitors
  • Serious Cardiovascular Reactions
  • Blood Pressure and Heart Rate Increases
  • Psychiatric Adverse Reactions
  • Long-Term Suppression of Growth
  • Peripheral Vasculopathy, including Raynaud's phenomenon

6.1 Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Clinical Trials Experience with Other Amphetamine Products in Pediatric Patients and Adults with ADHD

Cardiovascular: Palpitations, tachycardia, elevation of blood pressure, sudden death, myocardial infarction. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use.

Central Nervous System: Psychotic episodes at recommended doses, overstimulation, restlessness, irritability, euphoria, dyskinesia, dysphoria, depression, tremor, tics, aggression, anger, logorrhea.

Eye Disorders: Vision blurred, mydriasis.

Gastrointestinal: Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances. Anorexia and weight loss may occur as undesirable effects.

Allergic: Urticaria, rash, hypersensitivity reactions including angioedema and anaphylaxis. Serious skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported.

Endocrine: Impotence, changes in libido.

Skin: Alopecia.

Clinical Trials Experience with Amfetamin Actavis in Pediatric Patients with ADHD

There is limited experience with Amfetamin Actavis in controlled trials. Based on this limited experience, the adverse reaction profile of Amfetamin Actavis appears similar to other amphetamine extended-release products. The most common (≥2% in the Amfetamin Actavis group and greater than placebo) adverse reactions reported in the Phase 3 controlled study conducted in 108 patients with ADHD (aged 6–12 years) were: epistaxis, allergic rhinitis and upper abdominal pain.

Table 1. Common adverse reactions occurring in ≥2% of Subjects on Amfetamin Actavis and greater than Placebo during the double blind phase.
Preferred Term Amfetamin Actavis

(N=52)

Placebo

(N=48)

Respiratory, thoracic and mediastinal disorders
Epistaxis 3.8% 0%
Rhinitis allergic 3.8% 0%
Gastrointestinal disorders
Abdominal pain upper 3.8% 2.1%

6.2 Postmarketing Experience

The following adverse reactions have been identified during post approval use of other amphetamine products. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Endocrine: frequent or prolonged erections.

Musculoskeletal, Connective Tissue, and Bone Disorders: rhabdomyolysis.

Psychiatric Disorders: dermatillomania.

Amfetamin Actavis contraindications

See also:
What is the most important information I should know about Amfetamin Actavis?

Amfetamin Actavis is contraindicated:

  • In patients known to be hypersensitive to amphetamine, or other components of Amfetamin Actavis. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products.
  • During treatment with MAOIs, and also within 14 days following discontinuation of treatment with a MAOI, because of the risk of hypertensive crisis.

Active ingredient matches for Amfetamin Actavis:

Amfetamine in Iceland.


List of Amfetamin Actavis substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
Adzenys XR-odt tablet, orally disintegrating 12.5 mg/1 (Neos Therapeutics, Lp (US))
Adzenys XR-odt tablet, orally disintegrating 3.1 mg/1 (Neos Therapeutics, Lp (US))
Adzenys XR-odt tablet, orally disintegrating 15.7 mg/1 (Neos Therapeutics, Lp (US))
Adzenys XR-odt tablet, orally disintegrating 6.3 mg/1 (Neos Therapeutics, Lp (US))
Adzenys XR-odt tablet, orally disintegrating 18.8 mg/1 (Neos Therapeutics, Lp (US))
Adzenys XR-odt tablet, orally disintegrating 9.4 mg/1 (Neos Therapeutics, Lp (US))
Almetamin 100 Tablet
Almetamin 1000 Tablet
Dyanavel XR suspension, extended release 2.5 mg/mL (Tris Pharma Inc (US))
Evekeo tablet 5 mg/1 (Arbor Pharmaceuticals, Inc. (US))
Evekeo tablet 10 mg/1 (Arbor Pharmaceuticals, Inc. (US))

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Berché30 Jan 2015 09:28
Bonjour je veut acheter Almetamin 100 Tablet (amfétamine)pouvez vous m'aider ou acheter...merci


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