Get emergency medical help if you have signs of an allergic reaction to Novydrine: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using Novydrine and call your doctor at once if you have:
chest pain, trouble breathing, feeling like you might pass out;
fast heartbeats, rapid breathing;
confusion, unusual thoughts, paranoia, hallucinations (seeing or hearing things that are not real);
new behavior problems, aggression, anger, feeling irritable;
numbness, pain, cold feeling, unexplained wounds, or skin color changes (pale, red, or blue appearance) in your fingers or toes;
changes in your vision; or
unexplained muscle pain, tenderness, or weakness (especially if you also have fever, unusual tiredness, and dark colored urine).
Novydrine can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.
Common Novydrine side effects may include:
stomach pain, nausea, vomiting, loss of appetite;
diarrhea, constipation;
weight loss;
mood changes, feeling restless or nervous, sleep problems (insomnia);
dry mouth, unusual or unpleasant taste in the mouth;
runny nose, nosebleeds;
increased heart rate;
headache, dizziness;
itching; or
impotence, sexual problems.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Side effects of Novydrine in details
A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.
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The following adverse reactions are discussed in greater detail in other sections of the labeling:
Drug Dependence
Hypersensitivity to Novydrine, or other components of Novydrine
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
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 Novydrine 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 Novydrine 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 Novydrine In Pediatric Patients With ADHD
There is limited experience with Novydrine in controlled trials. Based on this limited experience, the adverse reaction profile of Novydrine appears similar to other Novydrine extended-release products. The most common ( ≥ 2% in the Novydrine 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 Novydrine and greater than Placebo during the double blind phase.
Preferred Term
DYANAVELXR
(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%
Postmarketing Experience
The following adverse reactions have been identified during post approval use of other Novydrine 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.
What is the most important information I should know about Novydrine?
Tell your doctor or dentist that you take Novydrine before you receive any medical or dental care, emergency care, or surgery.
Novydrine may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Novydrine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
Serious effects, including heart attack, stroke, and sudden death, have occurred with the use of stimulant medicines in patients with heart defects or other serious heart problems. If you have a heart defect or other serious heart problem, talk with your doctor about other therapies to treat your condition.
Novydrine may cause sleeplessness. Do not take Novydrine near your bedtime unless your doctor tells you otherwise.
Novydrine may cause circulation problems in the hands and feet. Tell your doctor if you have any numbness, pain, tingling, cold feeling, or skin color change (eg, from pale to blue or red) in your hands or feet. Call your doctor right away if you have any unexplained sores or wounds on your fingers or toes.
Novydrine may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Novydrine.
You may need to have some heart tests before starting Novydrine. Discuss any questions or concerns with your doctor.
Check your blood pressure and heart rate as your doctor has told you. Discuss any questions or concerns with your doctor.
Lab tests may be performed while you use Novydrine. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Novydrine should not be used in CHILDREN younger than 3 years old; safety and effectiveness in these children have not been confirmed.
Novydrine may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they take Novydrine.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Novydrine while you are pregnant. Novydrine is found in breast milk. Do not breast-feed while taking Novydrine.
When used for long periods of time or at high doses, Novydrine may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Novydrine stops working well. Do not take more than prescribed.
Some people who use Novydrine for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you suddenly stop taking Novydrine, you may experience WITHDRAWAL symptoms. These may include severe fatigue and drowsiness.
Novydrine contraindications
Contraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.
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Novydrine extended-release oral suspension is contraindicated:
In patients known to be hypersensitive to Novydrine, or other components of Novydrine extended-release oral suspension. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other Novydrine products.
In patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis.
References
DailyMed. "AMPHETAMINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
DTP/NCI. "AMPHETAMINE: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
European Chemicals Agency - ECHA. "Amphetamine: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Novydrine are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Novydrine. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
User reports
Consumer reported side effects
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