Phrenilin with Caffeine and Codeine and Tobramycin Sulfate

• Generic Name: acetaminophen / butalbital / caffeine / codeine
• Dosage Forms: capsules
• Other Brand Names: Fioricet with Codeine, Phrenilin with Caffeine and Codeine

Butalbital, acetaminophen, caffeine, and codeine combination is used to relieve symptoms of tension (or muscle contraction) headaches. Extended and repeated use of this product is not recommended.

Butalbital belongs to the group of medicines called barbiturates. They act in the central nervous system (CNS) to produce their effects.

Acetaminophen is used to relieve pain and reduce fever in patients. It does not become habit-forming when taken for a long time. But acetaminophen may cause other unwanted effects when taken in large doses, including serious liver damage. Although rare, use of acetaminophen has been reported to lead to liver transplantation and death, usually at high doses and when multiple acetaminophen-containing products have been used.

Caffeine is a CNS stimulant that is used with pain relievers to increase their effect. It has also been used for migraine headaches. Codeine belongs to the group of medicine called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.

When butalbital or codeine is used for a long time or in large doses, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics or barbiturates are used for this purpose. Physical dependence may lead to withdrawal side effects when you suddenly stop taking the medicine. In patients who get headaches, the first symptom of withdrawal may be new (rebound) headaches.

This medicine is available only under a restricted distribution program called the Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy) program.

• Generic Name: tobramycin
• Dosage Forms: n.a.
• Other Brand Names: Bethkis, Kitabis Pak, Tobi, TOBI Podhaler

Treatment of serious bone and joint infections caused by susceptible Staphylococcus aureus, Enterobacter, Escherichia coli, Klebsiella, Proteus, or Pseudomonas aeruginosa. Used as an adjunct to other appropriate anti-infectives.

Treatment of serious intra-abdominal infections (including peritonitis) caused by susceptible Enterobacter, E. coli, or Klebsiella. Used as an adjunct to other appropriate anti-infectives.

Treatment of CNS infections (meningitis) caused by susceptible gram-negative bacteria.

Aminoglycosides should not be used alone for treatment of meningitis; usually used as an adjunct to other anti-infectives in initial treatment. Used in conjunction with ampicillin for initial empiric treatment of neonatal Streptococcus agalactiae (group B streptococci) meningitis or for Listeria monocytogenes meningitis.

Treatment of serious respiratory tract infections caused by susceptible S. aureus, Enterobacter, E. coli, Klebsiella, Serratia, or Ps. aeruginosa. Used as an adjunct to an appropriate β-lactam (e.g., ceftriaxone, cefotaxime, cefepime, piperacillin and tazobactam, ticarcillin and clavulanate) or carbapenem (e.g., imipenem, meropenem) for empiric treatment of nosocomial pneumonia.

Administered by oral inhalation via nebulization for management of bronchopulmonary Ps. aeruginosa infections in cystic fibrosis patients ≥6 years of age. Safety and efficacy not established in pediatric patients < 6 years of age, in patients with forced expiratory volume in 1 second (FEV1) <25% or >75% of the predicted value, or in patients colonized with Burkholderia cepacia (formerly Ps. cepacia).

Treatment of septicemia caused by susceptible E. coli, Klebsiella, or Ps. aeruginosa.

Used as an adjunct to an appropriate β-lactam (e.g., ceftriaxone, cefotaxime, cefepime, piperacillin and tazobactam, ticarcillin and clavulanate) or carbapenem (e.g., imipenem, meropenem) for empiric treatment of life-threatening septicemia.

Treatment of serious skin and skin structure infections caused by susceptible S. aureus, Enterobacter, E. coli, Klebsiella, Proteus, or Ps. aeruginosa. Used as an adjunct to other appropriate anti-infectives.

Treatment of serious complicated and recurrent UTIs caused by susceptible S. aureus, Citrobacter, Enterobacter, E. coli, Klebsiella, Proteus, Providencia, Serratia, or Ps. aeruginosa. Used as an adjunct to other appropriate anti-infectives.

Not indicated for uncomplicated UTIs unless causative organism is resistant to other less-toxic alternatives.

Empiric anti-infective therapy of presumed bacterial infections in febrile neutropenic patients. Used in conjunction with an appropriate antipseudomonal cephalosporin (e.g., ceftazidime, ceftriaxone), extended-spectrum penicillin (e.g., ticarcillin, piperacillin and tazobactam, ticarcillin and clavulanate), or carbapenem (e.g., imipenem, meropenem).

Consult published protocols for the treatment of infections in febrile neutropenic patients for specific recommendations regarding selection of the initial empiric regimen, when to change the initial regimen, possible subsequent regimens, and duration of therapy in these patients. Consultation with an infectious disease expert knowledgeable about infections in immunocompromised patients also is advised.