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Azstarys (Generic Serdexmethylphenidate and Dexmethylphenidate)

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WARNING

Serdexmethylphenidate and dexmethylphenidate together have the potential to become habit-forming. Never exceed the dosage, frequency, or duration of treatment recommended by your doctor. If you consume excessive amounts of serdexmethylphenidate and dexmethylphenidate, you can continue to feel the desire to take big doses of the drug and might exhibit strange behavioural changes. Any of the following signs should be reported to your doctor right away by you or a carer: heartbeat that is quick, hammering, or irregular; perspiration; dilated pupils; an unusually ecstatic mood; restlessness; irritability; trouble going asleep or staying asleep; anger; aggression; worry; lack of appetite; Loss of coordination, uncontrollable bodily movements, flushed skin, nausea, stomach ache, or thoughts of injuring or killing oneself or others, as well as planning or acting on such thoughts.

Inform your doctor if you or any members of your family regularly use excessive amounts of alcohol, use street drugs, or abuse prescription pharmaceuticals.

Without first seeing your doctor, do not discontinue taking serdexmethylphenidate or dexmethylphenidate, especially if you have taken too much of the medicine. Your dose will likely be gradually reduced by your doctor, who will also closely watch you during this period. If you abruptly quit using serdexmethylphenidate and dexmethylphenidate after abusing it, you could experience severe depression and exhaustion. Even if you haven’t misused the medicine, your doctor may need to keep a close eye on you when you stop using serdexmethylphenidate and dexmethylphenidate because your symptoms could get worse.

Avoid sharing, selling, or allowing others to use your medication. Serdexmethylphenidate and dexmethylphenidate are illegal to sell or give away because they may injure other people. Serdexmethylphenidate and dexmethylphenidate should be kept in a secure location to prevent accidental or intentional consumption by others. Count the remaining capsules so you’ll know if any are missing.

When you start receiving therapy with serdexmethylphenidate and dexmethylphenidate as well as each time you need a prescription refill, your doctor or pharmacist will provide you the manufacturer’s patient information sheet (Medication Guide). If you have any questions, thoroughly read the material, then consult your physician or pharmacist. The Medication Guide is also available on the Food and Drug Administration (FDA) website or the manufacturer’s website.

Why is this medication prescribed?

Serdexmethylphenidate and dexmethylphenidate are used together as part of a treatment programme to manage the signs and symptoms of attention deficit hyperactivity disorder (ADHD; more difficulty focusing, controlling actions, and remaining still or quiet than other people their age). This condition affects both adults and children 6 years of age and older. In a group of drugs known as central nervous system stimulants, serdexmethylphenidate and dexmethylphenidate are combined. The level of a few natural chemicals in the brain is altered by these drugs.

How should this medicine be used?

Serdexmethylphenidate and dexmethylphenidate are sold as a capsule to be swallowed. It is often taken in the morning, with or without meals, once day. Dexmethylphenidate and serdexmethylphenidate should be taken at roughly the same time each day. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Dexmethylphenidate and serdexmethylphenidate should be taken exactly as prescribed. Never take it in larger or less amounts or more frequently than directed by your doctor.

Avoid chewing or crushing the pills; simply swallow them whole. If you are unable to take the capsule, you can open it and sprinkle the entire contents onto 2 teaspoons of applesauce or roughly 50 millilitres (2 oz) of water. After mixing for 10 minutes, immediately swallow or consume the concoction. Don’t keep the drug mixture on hand for later use.

Serdexmethylphenidate and dexmethylphenidate will likely be prescribed to you at a low starting dose by your doctor, who will then progressively raise it up to once per week.

Throughout your treatment, your condition ought to become better. If your symptoms get worse at any point while you’re receiving therapy or if they don’t get better after a month, call your doctor.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before taking serdexmethylphenidate and dexmethylphenidate,

  • If you have any allergies, including to methylphenidate, dexmethylphenidate, serdexmethylphenidate, other drugs, or any of the substances in serdexmethylphenidate and dexmethylphenidate capsules, notify your doctor right away. For a list of the ingredients, consult the Medication Guide or speak with your pharmacist.
  • Inform your physician if you are currently taking any of the following drugs or have stopped taking them within the previous 14 days: monoamine oxidase (MAO) inhibitors such as isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate). Most likely, your doctor will advise you to wait at least 14 days after your last MAO inhibitor dose before taking methylphenidate.
  • Inform your doctor and pharmacist about any additional prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products you are now taking or intend to use. Incorporate any of the following: alpha blockers like tamsulosin (Flomax, in Jalyn), alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), and terazosin; Benazepril (Lotensin, Lotrel), captopril, enalapril (Vasotec, Vaseretic), fosinopril, lisinopril (in Prinzide, Zestoretic), moexipril (Univasc, Uniretic), perindopril (Aceon, Prestalia), and quinapril are examples of ACE inhibitors (Accupril, in Quinaretic), angiotensin receptor blockers (ARBs) include ramipril (Altace), trandolapril (in Tarka), olmesartan (in Benicar, in Azor, in Benicar HCT, in Tribenzor), and telmisartan (in Micardis, in Micardis HCT, in Twynsta). Other examples include candesartan (in Atacand, in Atacand HCT), beta blockers such atenolol (Tenormin, in Tenoretic), metoprolol (Lopressor, Toprol XL, in Dutoprol), nadolol (Corgard, in Corzide), propranolol (Inderal, Innopran, in Inderide), and timolol (Blocadren, in Timolide); calcium channel blockers like diltiazem (Cardizem), venlafaxine (Effexor), paroxetine (Paxil), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), sertraline (Zoloft), and risperidone are examples of selective serotonin reuptake inhibitors (SSRIs) (Risperdal). Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • Inform your doctor if anyone in your family has ever experienced a sudden death or has an abnormal heartbeat. Additionally, let your doctor know if you have or have had had a heart defect, high blood pressure, an irregular heartbeat, artery hardening, heart illness, blood vessel disease, or any other cardiac issues. Your heart and blood vessels will be checked by your doctor during the examination. Serdexmethylphenidate and dexmethylphenidate should not be taken if you have a heart condition or if there is a significant chance you might develop one, according to your doctor.
  • Inform your doctor if you or anyone in your family is currently experiencing or has ever experienced depression, mania (frenzied, unusually exuberant mood), bipolar disorder (mood fluctuations from depressed to excited), or has attempted or thought about attempting suicide. Inform your doctor if you currently or in the past have mental illness, circulation issues in your fingers or toes, or both.
  • If you are pregnant or plan to become pregnant, let your doctor know. Call your doctor if you become pregnant while taking serdexmethylphenidate or dexmethylphenidate.
  • If you are breastfeeding, let your doctor know. If you are using serdexmethylphenidate and dexmethylphenidate when you are breastfeeding, watch out for signs of agitation, weight loss, or poor feeding in the breastfed child. If the breastfed child displays any of these signs, contact your doctor right away.
  • Inform your doctor or dentist that you are taking serdexmethylphenidate and dexmethylphenidate if you are having surgery, including dental surgery.
  • You should be aware that dexmethylphenidate and serdexmethylphenidate should be taken in conjunction with other therapies for ADHD, such as counselling and specialised instruction. Ensure that you adhere to all recommendations from your therapist or doctor.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

If you miss a dosage, take it as soon as you recall. If the next dose is soon due, skip the missed one and carry on with your regular dosing plan. To make up for a missing dose, do not take a second one.

What side effects can this medication cause?

Dexmethylphenidate and serdexmethylphenidate could also have negative side effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Slim down
  • Nausea
  • Heartburn
  • Zizziness

Some adverse effects can be very harmful. Call your doctor right away or seek emergency medical attention if you develop any of these signs or any of the ones detailed in the IMPORTANT WARNING section:

  • Rash
  • Hives
  • Itching
  • Depression
  • Assuming falsehoods to be true
  • Feeling unusually wary about other people
  • Hallucinating (seeing objects or hearing sounds that do not exist)
  • Mania (frenzied or overly exuberant emotion)
  • Fingers or toes are pale or have a bluish tint
  • Tingling, burning, numbness, or pain in the hands or feet
  • Unidentified cuts on the fingers or toes
  • Skin that is swollen or peeling
  • Regular, uncomfortable erections
  • Longer than four-hour erection

Dexmethylphenidate and serdexmethylphenidate, particularly in children or teenagers with significant heart conditions, can result in abrupt death in children and teenagers. Adults taking this medicine, particularly those with major cardiac conditions or heart abnormalities, are at risk for sudden death, heart attacks, and stroke. If you or your child has chest pain, breathlessness, or fainting while taking this medication, contact your doctor straight away. The dangers of using this drug should be discussed with your doctor.

Dexmethylphenidate and serdexmethylphenidate may inhibit children’s ability to grow or put on weight. The physician for your child will keep a close eye on their development. If you are worried about your child’s weight gain or growth while taking this medicine, talk to your child’s doctor. The hazards of providing serdexmethylphenidate and dexmethylphenidate to your child should be discussed with their doctor.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. Store it away from excessive heat and moisture at room temperature (not in the bathroom).

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medicines website at http://goo.gl/c4Rm4p for additional information.

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

Symptoms of overdose may include:

  • Nausea
  • Vomiting
  • Diarrhea
  • Restlessness
  • Anxiety
  • Agitation
  • Tremors
  • Twitching muscles
  • Convulsions
  • Extreme joy
  • Confusion
  • Hallucinating (seeing things or hearing voices that do not exist)
  • Delirium
  • Sweating
  • Flushing
  • Headache
  • Fever
  • Rapid or erratic heartbeat
  • Dilated eyes
  • Blurry eyesight
  • Aching and weakened muscles

What other information should I know?

Keep all of your appointments with your physician and the lab. To determine how well your body is responding to serdexmethylphenidate and dexmethylphenidate, your doctor will examine your blood pressure, heart rate, and request a few lab tests.

No one else should take your medication. Any queries you may have regarding medication refills should be directed to your pharmacist.

This medication cannot be renewed. In order to prevent running out of medication, make sure you plan regular doctor’s appointments.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Azstarys®
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