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Abixa

Abixa Special Precautions

memantine

Manufacturer:

Lundbeck

Distributor:

Metro Drug
Full Prescribing Info
Special Precautions
As no data are available for patients with severe renal impairment (CrCl <9 mL/min/1.73 m2) therapy is not recommended (see Dosage & Administration).
Based on pharmacological considerations and single case reports, caution is recommended with patients suffering from epilepsy.
Concomitant use of N-methyl-D-aspartate (NMDA)-antagonists eg, amantadine, ketamine or dextromethorphan should be avoided. These compounds act at the same receptor system as memantine, and therefore, adverse drug reactions (mainly CNS-related) may be more frequent or more pronounced (see Interactions).
Some factors that may raise urine pH (see Pharmacokinetics: Elimination under Actions) may necessitate careful monitoring of the patient. These factors include drastic changes in diet eg, from a carnivore to a vegetarian diet, or a massive ingestion of alkalizing gastric buffers. Also, urine pH may be elevated by states of renal tubulary acidosis (RTA) or severe infections of the urinary tract with Proteus bacteria.
In most clinical trials, patients with recent myocardial infarction, uncompensated congestive heart failure (NYHA III-IV) or uncontrolled hypertension were excluded. As a consequence, only limited data are available and patients with these conditions should be closely supervised.
Effects on the Ability to Drive or Operate Machinery: Moderate to severe Alzheimer's disease usually causes impairment of driving performance and compromises the ability to use machinery. Furthermore, memantine may change reactivity such that outpatients should be warned to take special care when driving a vehicle or operating machinery.
Use in pregnancy & lactation: For memantine, no clinical data on exposed pregnancies are available. Animal studies indicate a potential for reducing intrauterine growth at exposure levels which are identical or slightly higher than at human exposure (see Toxicology under Actions). The potential risk for humans is unknown. Memantine should not be used during pregnancy unless clearly necessary.
It is not known whether memantine is excreted in human's breast milk but, taking into consideration the lipophilicity of the substance, this probably occurs. Women taking memantine should not breastfeed.
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