Disclaimer:
Medidex is not a provider of medical services and all information is provided for the convenience of the user. No medical decisions should be made based on the information provided on this website without first consulting a licensed healthcare provider.This website is intended for persons 18 years or older. No person under 18 should consult this website without the permission of a parent or guardian.
RAZADYNE
Overview
What is RAZADYNE?
RAZADYNE ER capsules, RAZADYNEtablets, and RAZADYNE oral solution contain galantamine, a reversible, competitive acetylcholinesterase inhibitor, as the hydrobromide salt. Galantamine hydrobromide is known chemically as (4a,6,8a)-4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6-benzofuro[3a,3,2-][2]benzazepin-6-ol hydrobromide. It has an empirical formula of CHNO •HBr and a molecular weight of 368.27. Galantamine hydrobromide is a white to almost white powder and is sparingly soluble in water. The structural formula for galantamine hydrobromide is:
RAZADYNE ER extended-release capsules contain 8 mg, 16 mg, and 24 mg galantamine as 10.25 mg, 20.51 mg, and 30.76 mg of galantamine hydrobromide, respectively. Inactive ingredients include diethyl phthalate, ethylcellulose, gelatin, hypromellose, polyethylene glycol, sugar spheres (sucrose and starch), and titanium dioxide. The 16 mg capsule also contains red ferric oxide. The 24 mg capsule also contains red ferric oxide and yellow ferric oxide.
RAZADYNE tablets contain 4 mg, 8 mg, and 12 mg galantamine as 5.126 mg, 10.253 mg, and 15.379 mg of galantamine hydrobromide, respectively. Inactive ingredients include colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propylene glycol, talc, and titanium dioxide. The 4 mg tablets contain yellow ferric oxide. The 8 mg tablets contain red ferric oxide. The 12 mg tablets contain red ferric oxide and FD&C yellow #6 aluminum lake.
RAZADYNE oral solution contains 4 mg galantamine (as 5.13 mg galantamine hydrobromide) per mL. The inactive ingredients are methylparaben, propylparaben, purified water, sodium hydroxide, and saccharin sodium.
What does RAZADYNE look like?
What are the available doses of RAZADYNE?
RAZADYNE ER extended-release capsules contain white to off-white pellets and are available in the following strengths:
8 mg white opaque, size 4 hard gelatin capsule with the inscription "GAL 8"
16 mg pink opaque, size 2 hard gelatin capsule with the inscription "GAL 16"
24 mg caramel opaque, size 1 hard gelatin capsule with the inscription "GAL 24"
RAZADYNE tablets are available in the following strengths:
4 mg circular biconvex, off-white tablet imprinted with "JANSSEN" on one side and "G 4" on the other side
8 mg circular biconvex, pink tablet imprinted with "JANSSEN" on one side and "G 8" on the other side
12 mg circular biconvex, orange-brown tablet imprinted with "JANSSEN" on one side and "G 12" on the other side
RAZADYNE 4 mg/mL oral solution is a clear colorless solution supplied in 100 mL bottles with a calibrated (in milligrams and milliliters) pipette. The minimum calibrated volume is 0.5 mL, while the maximum calibrated volume is 4 mL.
What should I talk to my health care provider before I take RAZADYNE?
Pregnancy: Based on animal data may cause fetal harm. ()
How should I use RAZADYNE?
RAZADYNE ER and RAZADYNE are indicated for the treatment of mild to moderate dementia of the Alzheimer's type.
RAZADYNE ER extended-release capsules should be administered once daily in the morning, preferably with food.
The recommended starting dosage of RAZADYNE ER is 8 mg/day. The dosage 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. Dosage increases should be based upon assessment of clinical benefit and tolerability of the previous dose.
The dosage of RAZADYNE ER shown to be effective in a controlled clinical trial is 16–24 mg/day.
Patients currently being treated with RAZADYNE tablets or oral solution can convert to RAZADYNE ER (extended-release capsules) by taking their last dose of RAZADYNE tablets or oral solution in the evening and starting RAZADYNE ER once daily treatment the next morning. Converting from RAZADYNE to RAZADYNE ER should occur at the same total daily dosage.
What interacts with RAZADYNE?
Sorry No Records found
What are the warnings of RAZADYNE?
Sorry No Records found
What are the precautions of RAZADYNE?
Sorry No Records found
What are the side effects of RAZADYNE?
Sorry No records found
What should I look out for while using RAZADYNE?
RAZADYNE ER and RAZADYNE are contraindicated in patients with known hypersensitivity to galantamine hydrobromide or to any excipients used in the formulation.
What might happen if I take too much RAZADYNE?
Because strategies for the management of overdose are continually evolving, it is advisable to contact a poison control center to determine the latest recommendations for the management of an overdose of any drug.
As in any case of overdose, general supportive measures should be utilized. Signs and symptoms of significant overdosing of galantamine are predicted to be similar to those of overdosing of other cholinomimetics. These effects generally involve the central nervous system, the parasympathetic nervous system, and the neuromuscular junction. In addition to muscle weakness or fasciculations, some or all of the following signs of cholinergic crisis may develop: severe nausea, vomiting, gastrointestinal cramping, salivation, lacrimation, urination, defecation, sweating, bradycardia, hypotension, respiratory depression, collapse and convulsions. Increasing muscle weakness is a possibility and may result in death if respiratory muscles are involved.
Tertiary anticholinergics such as atropine may be used as an antidote for RAZADYNE ER and RAZADYNE (galantamine hydrobromide) overdosage. Intravenous atropine sulfate titrated to effect is recommended at an initial dose of 0.5 to 1.0 mg i.v. with subsequent doses based upon clinical response. Atypical responses in blood pressure and heart rate have been reported with other cholinomimetics when co-administered with quaternary anticholinergics. It is not known whether galantamine and/or its metabolites can be removed by dialysis (hemodialysis, peritoneal dialysis, or hemofiltration). Dose-related signs of toxicity in animals included hypoactivity, tremors, clonic convulsions, salivation, lacrimation, chromodacryorrhea, mucoid feces, and dyspnea.
In one postmarketing report, one patient who had been taking 4 mg of galantamine daily for a week inadvertently ingested eight 4 mg tablets (32 mg total) on a single day. Subsequently, she developed bradycardia, QT prolongation, ventricular tachycardia and torsades de pointes accompanied by a brief loss of consciousness for which she required hospital treatment. Two additional cases of accidental ingestion of 32 mg (nausea, vomiting, and dry mouth; nausea, vomiting, and substernal chest pain) and one of 40 mg (vomiting), resulted in brief hospitalizations for observation with full recovery. One patient, who was prescribed 24 mg/day and had a history of hallucinations over the previous two years, mistakenly received 24 mg twice daily for 34 days and developed hallucinations requiring hospitalization. Another patient, who was prescribed 16 mg/day of oral solution, inadvertently ingested 160 mg (40 mL) and experienced sweating, vomiting, bradycardia, and near-syncope one hour later, which necessitated hospital treatment. His symptoms resolved within 24 hours.
How should I store and handle RAZADYNE?
RAZADYNE ER extended-release capsules should be stored at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature].RAZADYNE tablets should be stored at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature].RAZADYNE oral solution should be stored at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. DO NOT FREEZE.Keep out of reach of children.RAZADYNE ER extended-release capsules should be stored at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature].RAZADYNE tablets should be stored at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature].RAZADYNE oral solution should be stored at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. DO NOT FREEZE.Keep out of reach of children.RAZADYNE ER extended-release capsules should be stored at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature].RAZADYNE tablets should be stored at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature].RAZADYNE oral solution should be stored at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. DO NOT FREEZE.Keep out of reach of children.RAZADYNE ER extended-release capsules should be stored at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature].RAZADYNE tablets should be stored at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature].RAZADYNE oral solution should be stored at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. DO NOT FREEZE.Keep out of reach of children.Chlordiazepoxide HCl/Clidinium Bromide is available in light green opaque capsules, each containing 5 mg chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide — bottles of 100 (NDC 42494-409-01), with Librax imprinted on the body of the capsule.Store at 25°C (77°F); excursions permitted to 15°C - 30°C (59°F - 86°F).Keep out of reach of children. Dispense in tight, light-resistant container as defined in USP/NF.Distributed by:Cameron PharmaceuticalsLouisville, KY 40245Manufactured by:Valeant Pharmaceuticals International, Inc.Steinbach, MB R5G 1Z7 Canada9542101-20001587Rev. 08/16Chlordiazepoxide HCl/Clidinium Bromide is available in light green opaque capsules, each containing 5 mg chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide — bottles of 100 (NDC 42494-409-01), with Librax imprinted on the body of the capsule.Store at 25°C (77°F); excursions permitted to 15°C - 30°C (59°F - 86°F).Keep out of reach of children. Dispense in tight, light-resistant container as defined in USP/NF.Distributed by:Cameron PharmaceuticalsLouisville, KY 40245Manufactured by:Valeant Pharmaceuticals International, Inc.Steinbach, MB R5G 1Z7 Canada9542101-20001587Rev. 08/16Chlordiazepoxide HCl/Clidinium Bromide is available in light green opaque capsules, each containing 5 mg chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide — bottles of 100 (NDC 42494-409-01), with Librax imprinted on the body of the capsule.Store at 25°C (77°F); excursions permitted to 15°C - 30°C (59°F - 86°F).Keep out of reach of children. Dispense in tight, light-resistant container as defined in USP/NF.Distributed by:Cameron PharmaceuticalsLouisville, KY 40245Manufactured by:Valeant Pharmaceuticals International, Inc.Steinbach, MB R5G 1Z7 Canada9542101-20001587Rev. 08/16Chlordiazepoxide HCl/Clidinium Bromide is available in light green opaque capsules, each containing 5 mg chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide — bottles of 100 (NDC 42494-409-01), with Librax imprinted on the body of the capsule.Store at 25°C (77°F); excursions permitted to 15°C - 30°C (59°F - 86°F).Keep out of reach of children. Dispense in tight, light-resistant container as defined in USP/NF.Distributed by:Cameron PharmaceuticalsLouisville, KY 40245Manufactured by:Valeant Pharmaceuticals International, Inc.Steinbach, MB R5G 1Z7 Canada9542101-20001587Rev. 08/16Chlordiazepoxide HCl/Clidinium Bromide is available in light green opaque capsules, each containing 5 mg chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide — bottles of 100 (NDC 42494-409-01), with Librax imprinted on the body of the capsule.Store at 25°C (77°F); excursions permitted to 15°C - 30°C (59°F - 86°F).Keep out of reach of children. Dispense in tight, light-resistant container as defined in USP/NF.Distributed by:Cameron PharmaceuticalsLouisville, KY 40245Manufactured by:Valeant Pharmaceuticals International, Inc.Steinbach, MB R5G 1Z7 Canada9542101-20001587Rev. 08/16Chlordiazepoxide HCl/Clidinium Bromide is available in light green opaque capsules, each containing 5 mg chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide — bottles of 100 (NDC 42494-409-01), with Librax imprinted on the body of the capsule.Store at 25°C (77°F); excursions permitted to 15°C - 30°C (59°F - 86°F).Keep out of reach of children. Dispense in tight, light-resistant container as defined in USP/NF.Distributed by:Cameron PharmaceuticalsLouisville, KY 40245Manufactured by:Valeant Pharmaceuticals International, Inc.Steinbach, MB R5G 1Z7 Canada9542101-20001587Rev. 08/16
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Although the etiology of cognitive impairment in Alzheimer's disease (AD) is not fully understood, it has been reported that acetylcholine-producing neurons degenerate in the brains of patients with Alzheimer's disease. The degree of this cholinergic loss has been correlated with degree of cognitive impairment and density of amyloid plaques (a neuropathological hallmark of Alzheimer's disease).
Galantamine, a tertiary alkaloid, is a competitive and reversible inhibitor of acetylcholinesterase. While the precise mechanism of galantamine's action is unknown, it is postulated to exert its therapeutic effect by enhancing cholinergic function. This is accomplished by increasing the concentration of acetylcholine through reversible inhibition of its hydrolysis by cholinesterase. If this mechanism is correct, galantamine's effect may lessen as the disease process advances and fewer cholinergic neurons remain functionally intact. There is no evidence that galantamine alters the course of the underlying dementing process.
Non-Clinical Toxicology
RAZADYNE ER and RAZADYNE are contraindicated in patients with known hypersensitivity to galantamine hydrobromide or to any excipients used in the formulation.No formal drug-drug interaction studies have been performed.
Serious skin reactions (Stevens-Johnson syndrome and acute generalized exanthematous pustulosis) have been reported in patients receiving RAZADYNE ER and RAZADYNE. Inform patients and caregivers that the use of RAZADYNE ER or RAZADYNE should be discontinued at the first appearance of a skin rash, unless the rash is clearly not drug-related. If signs or symptoms suggest a serious skin reaction, use of this drug should not be resumed and alternative therapy should be considered.
Serious adverse reactions are discussed in more detail in the following sections of the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
Review
Read user comments about the side effects, benefits, and effectiveness of losartan oral.
Overall User Ratings
516Total User Reviews
User Reviews
Learn about
User Reviews
Professional
Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
Tips
Interactions
Interactions
A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).