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Razadyne ER

"Today, the U.S. Food and Drug Administration issued a proposal designed to assist companies developing new treatments for patients in the early stages of Alzheimer's disease, before the onset of noticeable (overt) dementia.

Alzheimer’"...

Razadyne ER

Razadyne ER Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Razadyne ER (galantamine hydrobromide) is used to treat mild to moderate dementia caused by Alzheimer's disease. It works by restoring the balance of certain natural substances (neurotransmitters) in the brain. This medication is available in generic form. Common side effects include nausea, vomiting, diarrhea, dizziness, loss of appetite, and weight loss.

The recommended starting dose of Razadyne ER is 8 mg/day. The dose should be increased to the initial maintenance dose of 16 mg/day after a minimum of 4 weeks. A further increase to 24 mg/day should be attempted after a minimum of 4 weeks at 16 mg/day. Razadyne ER may interact with atropine, belladonna, clidinium, dicyclomine, glycopyrrolate, hyoscyamine, ketoconazole, mepenzolate, methantheline, methscopolamine, paroxetine, propantheline, or scopolamine. Tell your doctor all medications you use. Razadyne ER should be used only when prescribed during pregnancy. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Our Razadyne ER (galantamine hydrobromide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Razadyne ER in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using galantamine and call your doctor at once if you have a serious side effect such as:

  • chest pain, slow heart rate;
  • feeling like you might pass out;
  • blood in your urine or stool;
  • coughing up blood or vomit that looks like coffee grounds;
  • painful or difficult urination;
  • urinating less than usual or not at all;
  • weakness, confusion, decreased sweating, extreme thirst, hot dry skin; or
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • feeling tired, dizzy, or drowsy;
  • headache, blurred vision, runny nose;
  • depression, sleep problems (insomnia);
  • nausea, vomiting, stomach pain, loss of appetite;
  • weight loss; or
  • unusual or unpleasant taste in your mouth.

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.

Read the entire detailed patient monograph for Razadyne ER (Galantamine HBr ER) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Razadyne ER Overview - Patient Information: Side Effects

SIDE EFFECTS: Nausea, vomiting, diarrhea, dizziness, drowsiness, loss of appetite, and weight loss may occur. If any of these effects persist or worsen, tell your doctor or pharmacist 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.

Tell your doctor right away if you have any serious side effects, including: fainting, unusually slow heartbeat, difficult urination.

Get medical help right away if you have any very serious side effects, including: seizures, black/bloody stools, vomit that looks bloody or like coffee grounds, severe stomach/abdominal pain, irregular heartbeat.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Razadyne ER (Galantamine HBr ER)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Razadyne ER FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following are discussed in more detail in other sections of the labeling:

Clinical Trials 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 practice.

The most common adverse reactions in galantamine-treated subjects from double-blind clinical trials ( ≥ 5%) were nausea, vomiting, diarrhea, dizziness, headache, decreased appetite, and weight decreased.

The most common adverse reactions associated with discontinuation ( ≥ 1%) in galantamine-treated subjects from double-blind clinical trials were nausea (7.7%), vomiting (4.1%), decreased appetite (1.9%), and dizziness (1.6%).

The safety of the extended-release capsule and immediate-release tablet formulations of galantamine was evaluated in 2932 galantamine-treated subjects who participated in 7 placebo-controlled clinical studies and 1454 subjects in 5 open-label clinical studies with mild to moderate dementia of the Alzheimer's type. In clinical studies, the safety profile of once-daily treatment with extended-release galantamine was similar in frequency and nature to that seen with tablets. The information presented in this section was derived from pooled double-blind studies and from pooled open-label data.

Throughout this section, adverse reactions are reported. Adverse reactions are adverse events that were considered to be reasonably associated with the use of galantamine based on the comprehensive assessment of the available adverse event information. A causal relationship with galantamine cannot be reliably established in individual cases.

Commonly-Observed Adverse Reactions in Double-Blind, Placebo-Controlled Clinical Trials

Table 1 lists the adverse drug reactions reported in ≥ 1% of galantamine-treated subjects in 7 placebo-controlled, double-blind clinical trials.

Table 1: Adverse Drug Reactions Reported by ≥ 1% of Galantamine-Treated Subjects in 7 Placebo-Controlled, Double-Blind Clinical Trials

System/Organ Class
Adverse Reaction
Galantamine
(n=2932)
%
Placebo
(n=1525)
%
Metabolism and Nutrition Disorders
  Decreased appetite 5.2 1.4
  Anorexia 3.8 1.0
Psychiatric Disorders
  Depression 4.2 2.9
Nervous System Disorders
  Dizziness 8.9 4.6
  Headache 7.6 5.4
  Tremor 2.0 0.8
  Syncope 1.8 0.7
  Lethargy 1.7 0.7
  Somnolence 1.7 0.8
Cardiac Disorders
  Bradycardia 1.2 0.3
Gastrointestinal Disorders
  Nausea 25.0 7.6
  Vomiting 12.8 3.1
  Diarrhea 9.0 6.3
  Abdominal pain 2.4 0.9
  Abdominal pain upper 2.0 1.4
  Dyspepsia 1.8 1.3
  Stomach discomfort 1.6 0.6
  Abdominal discomfort 1.0 0.4
Skin and Subcutaneous Tissue Disorders
  Hyperhidrosis 1.2 0.7
Musculoskeletal and Connective Tissue Disorders
  Muscle spasms 1.5 0.8
General Disorders and Administration Site Conditions
  Fatigue 4.0 2.2
  Asthenia 2.3 1.7
  Malaise 1.4 0.7
Investigations
  Weight decreased 5.1 1.4

The majority of these adverse events occurred during the dose-escalation period. In those patients who experienced the most frequent adverse event, nausea, the median duration of the nausea was 5-7 days.

Administration of RAZADYNE® ER and RAZADYNE® with food, the use of anti-emetic medication, and ensuring adequate fluid intake may reduce the impact of these events [see DOSAGE AND ADMINISTRATION and PATIENT INFORMATION].

Other Adverse Reactions Observed in Clinical Trials of Galantamine

The following adverse reactions occurred in < 1% of all galantamine-treated subjects (N=2932) in the above double-blind, placebo-controlled clinical trial data sets. In addition, the following also includes all adverse reactions reported at any frequency rate in subjects (N=1454) who participated in open-label studies. Adverse reactions listed in Table 1 above were not included below:

Metabolism and Nutrition Disorders: Dehydration

Nervous System Disorders: Dysgeusia, Hypersomnia, Paresthesia

Eye Disorders: Vision blurred

Cardiac Disorders: Atrioventricular block first degree, Palpitations, Sinus bradycardia, Supraventricular extrasystoles

Vascular Disorders: Flushing, Hypotension

Gastrointestinal Disorders: Retching

Musculoskeletal and Connective Tissue Disorders: Muscular weakness

Injury, Poisoning and Procedural Complications: Fall

Discontinuations Due to Adverse Reactions

In the 7 placebo-controlled studies of adults, 379 (12.9%) galantamine-treated patients (N=2932) and 42 (2.8%) placebo patients (N=1525) discontinued due to an adverse reaction. Those events with an incidence of ≥ 0.5% in the galantamine-treated patients included nausea (225, 7.7%), vomiting (119, 4.1%), decreased appetite (56, 1.9%), dizziness (48, 1.6%), diarrhea (27, 0.9%), headache (26, 0.9%) weight decreased (24, 0.8%), and abdominal pain (15, 0.5%). Those events with an incidence of ≥ 0.5% in placebo patients included nausea (14, 0.9%) and dizziness (8, 0.5%).

In the 5 open-label studies, 103 (7.1%) patients (N=1454) discontinued due to an adverse reaction. Those events with an incidence of ≥ 0.5% included nausea (43, 3.0%), vomiting (23, 1.6%), decreased appetite (13, 0.9%), headache (12, 0.8%), weight decreased (9, 0.6%), dizziness (8, 0.6%), and diarrhea (7, 0.5%).

Postmarketing Experience

The following additional adverse reactions have been identified during post-approval use of RAZADYNE® ER and RAZADYNE®. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency:

Immune System Disorders: Hypersensitivity

Psychiatric Disorders: Hallucination, Hallucination visual, Hallucination auditory

Ear and Labyrinth Disorders: Tinnitus

Vascular Disorders: Hypertension

Hepatobiliary Disorders: Hepatitis, Hepatic enzyme increased

Read the entire FDA prescribing information for Razadyne ER (Galantamine HBr ER) »

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Razadyne ER - User Reviews

Razadyne ER User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Razadyne ER sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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