What are the possible side effects of Almetamin?
Almetamin can cause serious side effects, including:
- See Important information for information on reported heart and mental problems.
- slowing of growth (height and weight) in children
Common side effects of amphetamine products include:
- dry mouth
- decreased appetite
- weight loss
- stomach pain
- trouble sleeping
- extreme mood changes
- increased heart rate
Talk to your doctor if you or your child have any side effects that bother you or do not go away.
These are not all the possible side effects of Almetamin. Ask your doctor or pharmacist for more information.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Side effects of Almetamin in details
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- Drug Dependence
- Hypersensitivity to amphetamine, or other components of Almetamin
- 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.
Clinical Trials Experience with Almetamin in Pediatric Patients with ADHD
There is limited experience with Almetamin in controlled trials. Based on this limited experience, the adverse reaction profile of Almetamin appears similar to other amphetamine extended-release products. The most common (≥2% in the Almetamin 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.
|Preferred Term|| Almetamin |
| Placebo |
|Respiratory, thoracic and mediastinal 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.
What is the most important information I should know about Almetamin?
- Tell your doctor or dentist that you take Almetamin before you receive any medical or dental care, emergency care, or surgery.
- Almetamin may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Almetamin 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.
- Almetamin may cause sleeplessness. Do not take Almetamin near your bedtime unless your doctor tells you otherwise.
- Almetamin 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.
- Almetamin may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Almetamin.
- You may need to have some heart tests before starting Almetamin. 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 Almetamin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Almetamin should not be used in CHILDREN younger than 3 years old; safety and effectiveness in these children have not been confirmed.
- Almetamin may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they take Almetamin.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Almetamin while you are pregnant. Almetamin is found in breast milk. Do not breast-feed while taking Almetamin.
When used for long periods of time or at high doses, Almetamin 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 Almetamin stops working well. Do not take more than prescribed.
Some people who use Almetamin 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 Almetamin, you may experience WITHDRAWAL symptoms. These may include severe fatigue and drowsiness.
Almetamin is contraindicated:
- In patients known to be hypersensitive to amphetamine, or other components of Almetamin. 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.
ReviewsThe results of a survey conducted on ndrugs.com for Almetamin 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 Almetamin. 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.
9 consumers reported side effectsDid you experience side effects while taking Almetamin drug?
According to the report by ndrugs.com, the below mentioned statistics discuss the number of people who experienced side effects after taking Almetamin drug. Every drug produces at least minor unwanted effects, which we call side effects. The side effects can be bothersome, or they can be minor so patients do not know they are experiencing them. The side effects of the drug depend on the individual, severity of disease, symptom, and associated conditions in the patient. The most deciding factor is the drug dosage. The higher the dosage, the higher the therapeutic result, and the more side effects. Every patient need not have the same intensity of side effect. When the side effects are greater, immediately consult your health care provider.
|No side effects||6||66.7%|
|It has side effects||3||33.3%|
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Information checked by Dr. Sachin Kumar, MD Pharmacology