Adzenys XR-ODT

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Product name: ADZENYS XR-ODT

Active substance: Amphetamine

Other names: Amphetamine extended-release

Strength: 3.1 MG, 6.3 MG, 9.4 MG, 12.5 MG, 15.7 MG, 18.8 MG

$303.00$1,683.00

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Description

BUY ADZENYS XR-ODT ONLINE

BUY ADZENYS XR-ODT ONLINE, ADZENYS XR-ODT (amphetamine extended-release orally disintegrating tablet) contains a 3 to 1 ratio of d- to l-amphetamine, a central nervous system stimulant.

The labeled strengths reflect the amount of amphetamine base in ADZENYS XR-ODT whereas the strengths of the (mixed salts of a single-entity amphetamine) products are in terms of the number of amphetamine salts. Table 1 in Section 2.5 details the equivalent amounts of the active ingredient in these products.

Structural Formula:

ADZENYS XR-ODT (amphetamine extended-release orally disintegrating tablets) ADZENYS XR-ODT is an extended-release orally disintegrating tablet containing 50% immediate-release and 50% delayed-release amphetamine for once-daily dosing.

ADZENYS XR-ODT also contains the following inactive ingredients: Mannitol, Crospovidone, Microcrystalline Cellulose, Methacrylic Acid Copolymer Type A, Sodium Polystyrene Sulfonate, Citric Acid, Fructose, Orange Flavor, Colloidal Silicon Dioxide, Triethyl Citrate, Sucralose, Lake Blend Orange, Magnesium Stearate, and Polyethylene Glycol.

DRUG INDICATIONS

Adults and Children:

Do not substitute for other amphetamine products on an mg-per-mg basis. <6yrs: not established. Individualize. Take in the AM. 6–17yrs: initially 6.3mg once daily; increase in increments of 3.1mg or 6.3mg at weekly intervals; max 18.8mg/day (6–12yrs) or max 12.5mg/day (13–17yrs). 17yrs: 12.5mg once daily. Switching from other amphetamine products: see full labeling.

USES

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.

How to use Adzenys XR-ODT

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 afternoon 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.

Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.

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

DOSAGE AND ADMINISTRATION

Pre-Treatment Screening

Prior to treating patients with ADZENYS XR-ODT, 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 ADZENYS XR-ODT use

Dosing Considerations For All Patients

ADZENYS XR-ODT may be taken with or without food. Individualize the dosage according to the therapeutic needs and response of the patient.

ADZENYS XR-ODT 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 [see Use In Specific Populations, Clinical Studies].

Adults

The recommended dose is ADZENYS XR-ODT 12.5 mg daily.

Switching From Other Amphetamine Products

Patients taking ADDERALL XR may be switched to ADZENYS XR-ODT at the equivalent dose taken once daily . Refer to Table 1 for equivalent doses of ADZENYS XR-ODT and ADDERALL XRADDERALL 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 ADZENYS XR-ODT and ADDERALL XR (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules

ADZENYS XR-ODT 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 ADZENYS XR-ODT 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 ADZENYS XR-ODT dosage accordingly

INTERACTIONS

Avoid drinking alcohol while you are taking this medicine.

Avoid drinking fruit juices or taking vitamin C at the same time you take amphetamine. These can make your body absorb less of the medicine.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Ask your doctor before using stomach acid medicine (including Alka-Seltzer or sodium bicarbonate). Some of these medicines can change the way your body absorbs amphetamine and may increase side effects.

Many drugs can affect amphetamine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

WARNING AND PRECAUTIONS

Serious Cardiovascular Reactions: Sudden death has been reported in association with CNS stimulant treatment at recommended doses in pediatric patients with structural cardiac abnormalities or other serious heart problems. In adults, sudden death, stroke, and myocardial infarction have been reported. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, and other serious heart problems. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during Adzenys XR-ODT treatment.

Blood Pressure and Heart Rate Increases: CNS stimulants can cause an increase in blood pressure (mean increase about 2-4 mm Hg) and heart rate (mean increase about 3-6 bpm). Consider this before prescribing and monitor blood pressure and pulse.

Psychiatric Adverse Reactions: CNS stimulants may cause psychotic or manic symptoms in patients with no prior history, or exacerbate symptoms of behavior disturbance and thought disorder in patients with pre-existing psychosis. Assess for bipolar disorder prior to treatment.

Long-Term Suppression of Growth: Closely monitor weight and height in pediatric patients treated with Adzenys XR-ODT. Treatment may need to be interrupted.

Peripheral Vasculopathy, including Raynaud’s Phenomenon: Signs and symptoms are usually intermittent and mild; very rare sequelae include digital ulceration and/or soft tissue breakdown. Careful observation for digital changes is necessary.

Serotonin Syndrome: Increased risk may occur when amphetamines are co-administered with serotonergic agents (such as MAOIs, selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), or triptans), and during overdosage situations. If it occurs, discontinue Adzenys XR-ODT and initiate supportive treatment.

Potential for Overdose Due to Medication Errors: Substitution and dispensing errors with other amphetamine products could occur, leading to possible overdosage. Do not substitute for other amphetamine products on a milligram-per-milligram basis, because of different amphetamine base compositions and differing pharmacokinetic profiles.

SIDE EFFECTS

Loss of appetite, weight loss, dry mouth, stomach upset/pain, nausea/vomiting, dizziness, headache, diarrhea, fever, nervousness, and trouble sleeping may occur. If any of these effects last or get worse, tell your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, such as: signs of blood flow problems in the fingers or toes (such as coldness, numbness, pain, or skin color changes), unusual wounds on the fingers or toes, mental/mood/behavior changes (such as agitation, aggression, mood swings, depression, abnormal thoughts, thoughts of suicide), uncontrolled movements, continuous chewing movements/teeth grinding, outbursts of words/sounds, change in sexual ability/desire, frequent/prolonged erections (in males).

Get medical help right away if you have any very serious side effects, such as: shortness of breath, chest/jaw/left arm pain, unusual sweating, fainting, severe headache, fast/pounding/irregular heartbeat, seizures, swelling ankles/feet, extreme tiredness, blurred vision, weakness on one side of the body, slurred speech, confusion.

This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take . Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, such as: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Additional information

QUANTITY

90 ODT, 120 ODT, 270 ODT, 750 ODT

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