Dementa® 5 Tablet:Each film coated tablet contains Memantine Hydrochloride INN 5 mg.

Dementa® (Memantine   HCl) is   a   voltage   dependent,   uncompetitive,   with   moderate   affinity,   NMDA    (N-methyl-D-aspartate) receptor antagonist that binds to the NMDA receptor channel and regulates the Calcium
influx  into  the  neurons.  The  chemical  name  of  Memantine  Hydrochloride  is  1-amino-3,  5  -dimethyladamantane  Hydrochloride.
Mode of Action
Persistent  activation  of  N-methyl-D-aspartate  (NMDA)  receptors  in  Central  Nervous  System  by  the  excitatory  amino  acid  glutamate  has  been  hypothesized  to  contribute  to  the  symptomatology  of  Alzheimer's  disease.  
Memantine  is  postulated  to  exert  its  therapeutic  effect  through  its  action  as  a  low  to  moderate  affinity  as  an  uncompetitive   (open-channel)   NMDA   receptor   antagonist   which   binds   preferentially   to   the   NMDA   receptor-operated cation channels.

Pharmacokinetics: Memantine(Dementa®)  is  well  absorbed  after  oral  administration  and  has  linear  pharmacokinetics  over  the therapeutic dose range. It is excreted predominantly unchanged in the urine and has a terminal elimination half life of about 60-80 hours.
Following  oral  administration,  Memantine  (Dementa®)  is  highly  absorbed  with  peak  concentrations  reached  in  about  3-7  hours.  Food  has  no  effect  on  the  absorption  of  Memantine.  The  mean  volume  of  distribution  of  Memantine is 9-11 L/kg and the plasma protein binding is low (45%).
Memantine  (Dementa®)  undergoes  partial  hepatic  metabolism.  About  48%  of  administered  drug  is  excreted  unchanged  in  urine;  the  remainder  is  converted  primarily  to  three  polar  metabolites  which  possess  minimal  
NMDA    receptor    antagonistic    activity:    the    N-glucuronide  conjugate,    6-hydroxy    Memantine    and   1-nitroso-deaminated Memantine. A total of 74% of the administered dose is excreted as the sum of the parent drug  and  the  N-glucuronide  conjugate.  The  hepatic  microsomal  CYP-450  enzyme  system  does  not  play  a significant role in the metabolism of Memantine.

Dementa is indicated for the treatment of all froms of dementia of the Alzheimer's type. Memantine may also be indicated in other types of dementia.

The recommended maintenance dose of Dementa for adults and older patients is 20 mg every day. In order to lower the risk of side effects, the dose should be achieved by upward titration with 5 mg per week over 3 weeks,
achieving the maintenance dose of 20 mg/day from the start of week 4 according to the following dosage
guideline:

Most frequent side effects (frequency of 2% or less) include hallucination, confusion, dizziness, headache and fatigue. Occasional side effects include anxiety, hypertonus (heightened muscle tension), vomiting, bladder infections and increased sexual drive.If there is a history of epileptic seizures, there is a slight chance that Dementa may increase the probability of an attack.

Caregivers should be instructed in the recommended administration (twice per day for doses above 5 mg) and dose escalation (minimum interval of one week between dose increases). If the patients suffer from kidney dysfunction, the kidney function should be monitored at regular basis.

Neurological Conditions Seizures: Memantine has not been systematically evaluated in patients with a seizure disorder. One clinical trial shows that seizures occurred in 0.2% of patients treated with Memantine and 0.5% of patients treated with placebo. 

Carcinogenesis, Mutagenesis and Impairment of Fertility Study shows that no risk of carcinogenesis, mutagenesis and impairment of fertility are caused after Memantine use.

Operating Vehicles or Machinery Taking Memantine may alter the reaction time significantly; therefore safe driving and safe operation of machinery may no longer be possible.

Missed Dose If any dose is missed, just wait and take the next dose at the usual time. Do not double the dose to compensate for the missed dose.

Memantine (Dementa®) is contraindicated in patients with known hypersensitivity to Memantine Hydrochloride or to any excipients used in the formulation.

Pregnancy Category B. Yet there are no adequate and well-controlled studies of Memantine in pregnant women. Memantine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether Memantine is excreted in human breast milk. Because many drugs are excreted in human milk, caution should be exercised when Memantine is administered to a nursing mother.

Dementa® 5 Tablet: Each carton contains 3x10's Tablets in blister pack.
 

Amantadine,     Anticholinergics,     Anticonvulsives,     Baclofen,     Barbiturates,     Cimetidine,     Dantrolene,  Dextromethorphan,  Dopaminergic,  Hydrochlorothiazide,  Ketamine,  Neuroleptics,  Nicotine,  Procainamide,  
Quinidine, Quinine, Ranitidine.

Store in a cool and dry place, protected from light. Keep this medication out of reach of children.