Description

Galantamine 4mg  Tablets USP
60 Tablets

COMPOSITION
Each Tablet contains:
Galantamine HBr USP      4mg
Excipients                          q.s.

THERAPEUTIC INDICATION:
Galantamine is used to treat mild to moderate Alzheimer’s type dementia, Improve Memory and Recall, Increase Dream Intensity.

DOSAGE AND ADMINISTRATION
Usual Adult Dose for Alzheimer’s Disease

Immediate release tablet and oral solution:
Initial dose: 4 mg orally twice a day, preferably with morning and evening meals
-After a minimum of four weeks, increase to 8 mg twice a day, then after an additional 4 weeks, may increase to 12 mg twice a day
Maintenance dose: 16 to 24 mg per day given in 2 divided doses
Maximum dose: 24 mg/day

Extended release capsule:
Initial dose: 8 mg orally once a day, preferably with the morning meal
-After 4 weeks, dose should be increased to 16 mg once a day, a further increase to 24 mg once a day may be considered after a minimum of 4 weeks of taking 16 mg/day
Maintenance dose: 16 to 24 mg orally once a day based on clinical benefit and tolerability
Maximum dose: 24 mg/day

Conversion from Immediate-Release (IR) Tablets or Oral Solution to Extended-Release (ER) Capsules:
-Take the last dose of IR formulation n in the evening prior to starting ER capsule; start ER capsule following morning at once a day dosing
-Converting from IR to ER should occur at the same total daily dosage

Comments:
-During clinical trials, an immediate-release dose of 32 mg per day was found to be less well tolerated and did not increase clinical benefit; dosing at 24 mg/day was not found to provide statistically significant increased clinical benefit from 16 mg/day; however, it might provide additional benefit for some patients.
-Dose increases should be based upon assessment of clinical benefit and tolerability of the previous dose.
-If therapy is interrupted for more than 3 days, the patient should be restarted at the lowest dosage and the dosage escalated to current dose.

Use: For the treatment of mild to moderate dementia of the Alzheimer’s type.

Renal Dose Adjustments

Moderate renal impairment (CrCl 9 to 59 mL/min: Maximum daily dose should generally not exceed 16 mg/day
Severe renal impairment (CrCl less than 9 mL/min): Not recommended

Liver Dose Adjustments

Moderately Impaired Hepatic Function (Child-Pugh score of 7 to 9): Maximum daily dose should generally not exceed 16 mg/day
Severe Hepatic Impairment (Child-Pugh score of 10 to 15): Not recommended

GALANTAMINE

Galantamine improves the function of nerve cells in the brain. It works by preventing the breakdown of a chemical called acetylcholine. People with dementia usually have lower levels of this chemical, which is important for the processes of memory, thinking, and reasoning.

Galantamine is used to treat mild to moderate Alzheimer’s type dementia.

HEALTH BENEFITS
1) Treating Alzheimer’s Disease

Galantamine is an effective treatment for Alzheimer’s disease, and has been officially approved by the FDA for this medical use.

Many Alzheimer’s patients report benefitting from galantamine therapy that is initiated early, soon after diagnosis, and continued for at least 1 year.

Galantamine is believed to act by increasing the concentration and overall activity of acetylcholine in the brain, which has been preposed to account for its effects on the symptoms of Alzheimer’s disease.

2) May Help Treat Mild Cognitive Impairment (MCI)

Mild cognitive impairment (MCI) is a condition that involves a gradual loss of cognitive function over time. MCI sufferers often complain of memory failure. One study administered galantamine (4 mg twice per day) to sufferers of MCI for 7 days. These patients were reported to show a subsequent improvement in performance on memory tasks (episodic face-encoding and working memory tasks).

3) May Reduce Inflammation

According to some early reports, galantamine may help decrease brain inflammation.

Although the exact mechanisms responsible for this potential effect are not yet known, some preliminary evidence suggests that galantamine may exert anti-inflammatory effects by modifying NF-κB, TNF-α, visfatin & adiponectin.

Galantamine has also been reported to activate the cholinergic anti-inflammatory pathway, one of the fundamental anti-inflammatory pathways in human biology, which protects the body from prolonged exposure to systemic inflammation. This pathway is activated by through α7 nicotinic acetylcholine receptors (α7 nAChR), which therefore may account for some of galantamine’s reported anti-inflammatory effects

4) May Act as an Antioxidant

Oxidative stress can cause a lot of health issues in the human body, and has been reported to be especially relevant to a number of significant health conditions such as Alzheimer’s, Parkinson’s, Huntington’s, Down’s syndrome, cancer, and diabetes.

Some early evidence suggests that galantamine may act as an antioxidant, and could therefore potentially protect cells from oxidative stress.

5)  May Treat Diabetes

Some early evidence suggests that galantamine may have anti-diabetic effects by improving insulin signaling pathways (specifically by acting on p-insulin, p-Akt, GLUT4, and GLUT2 receptors).

6) May Induce Lucid Dreaming

A lucid dream is a dream in which an individual is aware that they are dreaming, and often has some control over their dreams.

Some researchers have suggested that galantamine may enhance lucidity in dreams by altering the cholinergic system and increasing the levels of acetylcholine in the brain.

However, this interesting effect could come with significant downsides. For example, the increases in acetylcholine and other cholinergic mechanisms could cause impairments in overall sleep quality – specifically, by increasing the amount of time spent in the REM stage of sleep.

SAFETY RELATED INFORMATION:

Galantamine can interact with other medications, herbs, or vitamins you might be taking. That’s why your doctor should manage all of your medications carefully. If you’re curious about how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.

Note: You can reduce your chances of drug interactions by having all of your prescriptions filled at the same pharmacy. That way, a pharmacist can check for possible drug interactions.

Medications that might interact with this drug

Drugs used to treat depression

• amitriptyline
• desipramine
• doxepin
• nortriptyline

These drugs can cause problems with how galantamine works. If you take them together, galantamine may not work as well.

Allergy drugs

• chlorpheniramine
• diphenhydramine
• hydroxyzine

These drugs can cause problems with how galantamine works. If you take them together, galantamine may not work as well.

Motion sickness drugs

• dimenhydrinate
• meclizine

These drugs can cause problems with how galantamine works. If you take them together, galantamine may not work as well.

Overactive bladdar medications

• darifenacin
• oxybutynin
• tolterodine
• trospium

These drugs can cause problems with how galantamine works. If you take them together, galantamine may not work as well.

Stomach medications

• dicyclomine
• hyoscyamine
• loperamide

These drugs can cause problems with how galantamine works. If you take them together, galantamine may not work as well.

Alzheimer’s disease medications

• donepezil
• rivastigmine

These medications work similarly to galantamine. Taking them together can increase your risk of side effects.

Neuromuscular blockers

• succinylcholine

This medicine works similarly to galantamine. Taking them together can increase your risk of side effects.

Urinary retention medications

• bethanechol

This medicine works similarly to galantamine. Taking them together can increase your risk of side effects.

GALANTAMINE WARNINGS

People with heart problems
Let your doctor know if you have heart problems, especially issues with irregular, slow, or fast heart rate. You have a higher risk for experiencing a slow heart rate and fainting while taking galantamine.

People with stomach ulcers or bleeding
Talk to your doctor if you have a history of stomach problems, ulcers, or bleeding. Also mention if you are currently taking any non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or naproxen. Galantamine may increase the amount of acid in your stomach. This may put you at risk of having more stomach ulcers or bleeding.

People with lung problems
Talk to your doctor if you have asthma or other lung diseases. Galantamine may make these conditions worse, so it needs to be used with caution.

People with bladder problems
Galantamine may block your bladder, making it difficult to urinate. Talk to your doctor if you’ve had any bladder problems in the past.

People with seizures or epilepsy
Galantamine may cause seizures. Tell your doctor if you’ve ever had seizures. People with Alzheimer’s disease may also be more likely to have seizures.

People with liver problems
Tell your doctor if you have a history of liver problems. If your liver isn’t working well, more of this drug may stay in your body longer. This puts you at greater risk for side effects.

People with kidney problems
Tell your doctor if you have a history of kidney problems. If your kidneys aren’t working well, more of this drug may stay in your body longer. This puts you at greater risk for side effects.

Pregnant women
Galantamine is a category C pregnancy drug. That means two things:

1. Research in animals has shown adverse effects to the fetus when the mother takes the drug.
2. There haven’t been enough studies done in humans to be certain how the drug might affect the fetus.

Tell your doctor if you’re pregnant or plan to become pregnant. Galantamine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Women who are breast-feeding
It isn’t known if galantamine passes into breastmilk. If it does, it could cause serious side effects in a child who is breastfed.

If you are breastfeeding or thinking about it, talk to your doctor about whether you should take galantamine.

For seniors
You may process this drug more slowly. A normal adult dose may cause the levels of this drug to be higher than normal in your body. You may need a lower dose or a different schedule.

For children
This medicine hasn’t been studied in children and shouldn’t be used in children younger than 18 years.

DIETARY  SUPPLEMENT

fssai approved

OUR PRODUCT:

• Dairy-free
• Gluten-free
• Non-GMO
• Soy-Free

MANUFACTURED BY:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,Fort,
Mumbai – 400001
at:Gujarat, INDIA.

Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com