What are the precautions and potential side effects of using Pro Plus (caffeine) tablets?

From the Guidelines

Pro Plus tablets, containing caffeine, should be used with caution, not exceeding 400mg of caffeine per day, to minimize the risk of side effects such as insomnia, nervousness, and stomach upset, as evidenced by recent studies 1. When considering the use of Pro Plus tablets, it's essential to be aware of the potential precautions and side effects associated with caffeine consumption.

• Key points to consider include:
  • Adults should limit their caffeine intake to 400mg per day, approximately 4-5 cups of coffee or 8 Pro Plus tablets 1.
  • Children, pregnant or breastfeeding women, and individuals with certain medical conditions, such as heart problems or anxiety disorders, should avoid or limit caffeine intake due to potential adverse effects 1.
  • Caffeine can interact with certain medications, including antibiotics and psychiatric medications, so individuals taking these drugs should consult a healthcare provider before using Pro Plus tablets 1.
  • People sensitive to caffeine should start with a lower dose to assess their tolerance and minimize the risk of adverse effects 1. The central nervous system stimulation caused by caffeine can lead to increased alertness but also potentially cause adverse effects, such as agitation, anxiety, or sleep disturbance, especially when consumed excessively or by vulnerable individuals 1.
• Regular use of caffeine can result in tolerance and mild physical dependence, potentially leading to withdrawal symptoms like headaches and fatigue when stopping 1. Overall, a cautious approach to using Pro Plus tablets, considering individual sensitivity and medical conditions, is crucial to minimize the risk of side effects and ensure safe consumption 1.

From the FDA Drug Label

PRECAUTIONS General Caffeine is a central nervous system stimulant and in cases of caffeine over­dose, seizures have been reported Caffeine citrate should be used with caution in infants with seizure disorders. Although no cases of cardiac toxicity were reported in the placebo-controlled trial, caffeine has been shown to increase heart rate, left ventricular output, and stroke volume in published studies. Therefore, caffeine citrate should be used with caution in infants with cardiovascular disease Caffeine citrate should be administered with caution in infants with impaired renal or hepatic function.

ADVERSE REACTIONS Overall, the reported number of adverse events in the double-blind period of the controlled trial was similar for the caffeine citrate and placebo groups. The following table shows adverse events that occurred in the double-blind period of the controlled trial and that were more frequent in caffeine citrate treated patients than placebo Adverse events described in the published literature include: central nervous system stimulation (i.e., irritability, restlessness, jitteriness), cardiovascular effects (i.e., tachycardia, increased left ventricular output, and increased stroke volume), gastrointestinal effects (i.e., increased gastric aspirate, gastrointesti­nal intolerance), alterations in serum glucose (hypoglycemia and hyper­glycemia) and renal effects (increased urine flow rate, increased creatinine clearance, and increased sodium and calcium excretion).

OVERDOSAGE Following overdose, serum caffeine levels have ranged from approximately 24 mg/L (a post marketing spontaneous case report in which an infant exhibited irritability, poor feeding and insomnia) to 350 mg/L. Serious toxicity has been associated with serum levels greater than 50 mg/L Signs and symptoms reported in the literature after caffeine overdose in preterm infants include fever, tachypnea, jitteriness, insomnia, fine tremor of the extremities, hypertonia, opisthotonos, tonic-clonic movements, nonpurposeful jaw and lip movements, vomiting, hyperglycemia, elevated blood urea nitrogen, and ele­vated total leukocyte concentration Seizures have also been reported in cases of overdose.

The precautions and potential side effects of using Pro Plus (caffeine) tablets include:

• Central Nervous System Stimulation: irritability, restlessness, jitteriness
• Cardiovascular Effects: tachycardia, increased left ventricular output, and increased stroke volume
• Gastrointestinal Effects: increased gastric aspirate, gastrointestinal intolerance
• Alterations in Serum Glucose: hypoglycemia and hyperglycemia
• Renal Effects: increased urine flow rate, increased creatinine clearance, and increased sodium and calcium excretion
• Seizures: have been reported in cases of overdose
• Serious Toxicity: has been associated with serum levels greater than 50 mg/L Key points to consider when using caffeine tablets:
• Use with caution in infants with seizure disorders or cardiovascular disease
• Use with caution in infants with impaired renal or hepatic function
• Monitor serum caffeine levels to avoid toxicity
• Monitor serum glucose to avoid hypoglycemia or hyperglycemia 2, 2, 2

From the Research

Precautions and Potential Side Effects of Pro Plus (Caffeine) Tablets

• Caffeine is a mild stimulant that can be used safely in moderate amounts, but excessive consumption (1~1.5 g/day) can cause caffeine poisoning, leading to symptoms such as anxiety, agitation, insomnia, and gastrointestinal disorders 3.
• Long-term or excessive caffeine consumption can lead to addiction, insomnia, migraine, and other side effects, and children, adolescents, pregnant women, and people sensitive to caffeine should restrict or reduce their intake to avoid potential adverse effects 4.
• Caffeine can disrupt sleep and wake function, and regular daily dietary caffeine intake is associated with disturbed sleep and daytime sleepiness, with risks greatly underestimated by the general population and physicians 5.
• Caffeine can interact with many psychiatric medications, including antidepressant agents, antipsychotic agents, antimanic agents, antianxiety agents, and sedative agents, leading to caffeine-related or medication-related side effects that may complicate psychiatric treatment 6.
• High doses of caffeine may induce side effects such as hypothermia and reduced locomotor activity, and paraxanthine, a metabolite of caffeine, may be a better wake-promoting agent for hypersomnia associated with neurodegenerative diseases due to its lower toxicity and lesser anxiogenic effects 7.

Special Considerations

• Pregnant women, children, and adolescents should be cautious when consuming Pro Plus tablets due to the potential risks associated with caffeine consumption 4, 5.
• Individuals with psychiatric conditions or those taking psychiatric medications should be aware of the potential interactions between caffeine and their medications 6.
• People sensitive to caffeine or those who experience side effects such as anxiety, agitation, or insomnia should consider reducing their caffeine intake or switching to alternative stimulants 3, 7.