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Side Effects & Adverse Reactions

WARNINGS: [PSYCHIATRY] Caution is recommended in patients with a history of bipolar illness. Mood elevation is possible in this population.

[ANTICONVULSANT] Caution is also recommended in patients taking anticonvulsant medications as folate may interfere with anticonvulsant medication, and may lower seizure threshold. Furthermore, it has been reported that anticonvulsant medications interfere with folate metabolism, but the exact action is unclear; therefore caution is recommended with patients in this therapeutic group.

[GENERAL] Folinic acid may enhance the toxicity of fluorouracil. Deaths from severe enterocolitis, diarrhea, and dehydration have been reported in elderly patients receiving weekly formyl-THF and fluorouracil. Concomitant granulocytopenia and fever were present in some but not all of the patients. The concomitant use of formyl-THF with trimethoprim-sulfamethoxazole for the acute treatment of Pneumocystis carinii pneumonia in patients with HIV infection was associated with increased rates of treatment failure and mortality in a placebo controlled study.7

Individuals taking nitrates for the treatment of angina may experience severe headaches when taking NAC/NAC derivatives. Carbamazepine levels may be reduced when NAC is used with that drug.8 Patients at risk of developing renal stones, particularly cysteine stones, should avoid this product. Acetylcysteine clearance is reduced in preterm newborns as well as those with chronic liver disease. Do not administer to critically ill patients. Acetylcysteine and its sulfhydryl metabolites could produce a false-positive result in the nitroprusside test for ketone bodies used in diabetes. Acetylcysteine should be used with caution in those with a history of peptic ulcer disease since acetylcysteine may disrupt the gastric mucosal barrier.9

[ONCOLOGY] Patients undergoing cancer treatment should consult their licensed medical practitioner for advice.

Puralor® Ci may also be administered by manually crushing a tablet, and then adding the contents to a thick juice or soft food - such as applesauce or yogurt. Puralor® Ci may be chewed. Chewable tablets can be a choking hazard to those who cannot chew, such as elderly persons.

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Legal Issues

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Manufacturer Warnings

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Uses

INDICATIONS AND USAGE: Puralor® Ci is indicated for the distinct nutritional requirements of individuals who have suboptimal folates levels in the cerebrospinal fluid, plasma and/or red blood cells, and require a maintenance level. Folate is effective in the treatment of hyperhomocysteinemia and/or megaloblastic anemias40 (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin41, pregnancy, infancy, childhood or other related folate-malabsorption complications of an inborn or environmental origin.

Puralor® Ci is not a drug, but may be used as monotherapy (“rescue” therapy) or adjunctive therapy as determined by your licensed medical practitioner. The adjunctive use of Puralor® Ci enables medical practitioners to combine therapeutic modalities (dietary management and drug therapy). In patients with suboptimal folate levels - and as determined by your licensed medical practitioner, Puralor® Ci may be administered as rescue or adjunctive folate-therapy to provide a protective effect in reducing the risk of secondary/endpoints and/or disease-states of a hyperhomocysteinemia and/or vascular nature20 such as may be found with generalized and age-related cognitive decline, cognitive impairment, Vascular Dementia and/or Alzheimer's Disease (AD).

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History

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Other Information

DESCRIPTION: Puralor® Ci* is an orally-administered prescription folate-containing product for the clinical dietary management of mild-to-moderate cognitive impairment disorders related to suboptimal folate levels associated with metabolic imbalances in transformylation and/or methylation biochemistry with particular emphasis on hyperhomocysteinemia and/or neurovascular oxidative stress.1

The protective effect of DeltaFolateTM in Puralor®Ci comes in supplying an array of folate-derivatives in combination with folate coenzymes, cofactors and co-metabolites that decrease the risk of bioavailability-interference such as might occur with inborn or environmental folate-malabsorption. This allows the folate substrate, THF, to be utilized in transformylation and/or methylation biochemistry.2,3,4

* Puralor® Ci may be taken by women of child bearing age. Puralor® Ci does not contain vitamin B6, and therefore has less risk of excessive dopamine production and antagonizing/agonizing dopamine-targeting drug therapies such as LevoDopa/CarbiDopa Parkinson’s Disease (PD). Furthermore, vitamin B12 and folate therapy have been shown to lower plasma homocysteine in L-DOPA-treated PD patients.5 Puralor® Ci also does not contain iron, and therefore has less risk of iron overload - a concern for elderly populations with or without neurodegenerative disorders.6

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