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cameron pharmaceuticals - ribavirin (unii: 49717awg6k) (ribavirin - unii:49717awg6k) - ribavirin for inhalation solution, usp is indicated for the treatment of hospitalized infants and young children with severe lower respiratory tract infections due to rsv. treatment early in the course of severe lower respiratory tract infection may be necessary to achieve efficacy. only severe rsv lower respiratory tract infection should be treated with ribavirin for inhalation solution, usp. the vast majority of infants and children with rsv infection have disease that is mild, self-limited, and does not require hospitalization or antiviral treatment. many children with mild lower respiratory tract involvement will require shorter hospitalization than would be required for a full course of ribavirin for inhalation solution, usp aerosol (3 to 7 days) and should not be treated with the drug. thus the decision to treat with ribavirin for inhalation solution, usp should be based on the severity of the rsv infection. the presence of an underlying condition such as prematurity, immunosuppression or cardiopulmonar

United States - English - NLM (National Library of Medicine)

cameron pharmaceuticals - tetracaine hydrochloride (unii: 5nf5d4opci) (tetracaine - unii:0619f35cgv) - tetracaine hydrochloride is indicated for the production of spinal anesthesia for procedures requiring two to three hours. spinal anesthesia with tetracaine hydrochloride is contraindicated in patients with known hypersensitivity to tetracaine hydrochloride or to drugs of a similar chemical configuration (ester-type local anesthetics), or aminobenzoic acid or its derivatives; and in patients for whom spinal anesthesia as a technique is contraindicated. the decision as to whether or not spinal anesthesia should be used for an individual patient should be made by the physician after weighing the advantages with the risks and possible complications. contraindications to spinal anesthesia as a technique can be found in standard reference texts, and usually include generalized septicemia, infection at the site of injection, certain diseases of the cerebrospinal system, uncontrolled hypotension, etc.

United States - English - NLM (National Library of Medicine)

cameron pharmaceuticals, limited liability company - hydrocortisone acetate (unii: 3x7931po74) (hydrocortisone - unii:wi4x0x7bpj) - hydrocortisone acetate suppositories are indicated for use in inflamed hemorrhoids, post-irradiation (factitial) proctitis, as an adjunct in the treatment of chronic ulcerative colitis, cryptitis, other inflammatory conditions of anorectum, and pruritus ani. hydrocortisone acetate suppositories are contraindicated in those patients having a history of hypersensitivity to hydrocortisone acetate or any of the components. drug abuse and dependence have not been reported in patients treated with hydrocortisone acetate suppositories.

United States - English - NLM (National Library of Medicine)

cameron pharmaceuticals, limited liability company - hydrocortisone acetate (unii: 3x7931po74) (hydrocortisone - unii:wi4x0x7bpj) - hydrocortisone acetate suppositories are indicated for use in inflamed hemorrhoids, post-irradiation (factitial) proctitis, as an adjunct in the treatment of chronic ulcerative colitis, cryptitis, other inflammatory conditions of anorectum, and pruritus ani. hydrocortisone acetate suppositories are contraindicated in those patients having a history of hypersensitivity to hydrocortisone acetate or any of the components. drug abuse and dependence have not been reported in patients treated with hydrocortisone acetate suppositories.

United States - English - NLM (National Library of Medicine)

cameron pharmaceuticals - phenobarbital sodium (unii: sw9m9bb5k3) (phenobarbital - unii:yqe403bp4d) - barbiturates are contraindicated in patients with known barbiturate sensitivity. barbiturates are also contraindicated in patients with a history of manifest or latent porphyria, marked impairment of liver functions or with severe respiratory distress where dyspnea or obstruction is evident. large doses are contraindicated in nephritic subjects. barbiturates should not be administered to persons with known previous addiction to the sedative-hypnotic group since ordinary doses may be ineffectual and may contribute to further addiction. intraarterial administration is contraindicated. its consequences vary from transient pain to gangrene. subcutaneous administration produces tissue irritation, ranging from tenderness and redness to necrosis and is not recommended. (see dosage and administration, treatment of adverse effects due to inadvertent error in administration .) phenobarbital sodium injection contains the preservative benzyl alcohol and is not recommended for use in neonates. there have been reports of f

United States - English - NLM (National Library of Medicine)

cameron pharmaceuticals - metaxalone (unii: 1nma9j598y) (metaxalone - unii:1nma9j598y) - metaxalone tablets is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. the mode of action of this drug has not been clearly identified, but may be related to its sedative properties. metaxalone does not directly relax tense skeletal muscles in man. known hypersensitivity to any components of this product. known tendency to drug induced, hemolytic, or other anemias. significantly impaired renal or hepatic function.

United States - English - NLM (National Library of Medicine)

cameron pharmaceuticals - methylene blue anhydrous (unii: 8nap7826ub) (methylene blue cation - unii:zmz79891zh) - drug-induced methemoglobinemia. methylene blue can cause fetal harm when administered to a pregnant woman. an association exists between the use of methylene blue in amniocentesis and atresia of the ileum and jejunum, ileal occlusions, and other adverse effects in the neonate. (2, 3) methylene blue is contraindicated in women who are or may become pregnant. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. intraspinal and subcutaneous injections are contraindicated. methylene blue is contraindicated in patients with a known hypersensitivity to the drug.

United States - English - NLM (National Library of Medicine)

cameron pharmaceuticals - sodium fluoride (unii: 8zyq1474w7) (fluoride ion - unii:q80vpu408o), vitamin a acetate (unii: 3le3d9d6oy) (vitamin a - unii:81g40h8b0t), sodium ascorbate (unii: s033eh8359) (ascorbic acid - unii:pq6ck8pd0r), cholecalciferol (unii: 1c6v77qf41) (cholecalciferol - unii:1c6v77qf41), .alpha.-tocopherol, d- (unii: n9pr3490h9) (.alpha.-tocopherol, d- - unii:n9pr3490h9), thiamine hydrochloride (unii: m572600e5p) (thiamine ion - unii:4abt0j945j), riboflavin (unii: tlm2976ofr) (riboflavin - unii:tlm2976ofr), n - multi-vit-flor (multivitamin with 0.25 mg, 0.5 mg and 1 mg of fluoride) chewable tablet multivitamin and fluoride supplement ingredients: sucrose, sorbitol, fructose, citric acid, beet root juice, carrageenan, grape flavor, raspberry flavor, stearic acid, cherry flavor, magnesium stearate, sucralose.

United States - English - NLM (National Library of Medicine)

cameron pharmaceuticals - naproxen (unii: 57y76r9atq) (naproxen - unii:57y76r9atq) - naproxen delayed-release tablets are indicated for: the relief of the signs and symptoms of: - rheumatoid arthritis - osteoarthritis - ankylosing spondylitis - polyarticular juvenile idiopathic arthritis naproxen delayed-release tablets are contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to naproxen or any components of the drug product [see warnings and precautions (5.7, 5.9)] . - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [see warnings and precautions (5.7, 5.8)]. - in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions (5.1)] . risk summary use of nsaids, including naproxen delayed-release tablets can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal

United States - English - NLM (National Library of Medicine)

cameron pharmaceuticals - vancomycin hydrochloride (unii: 71wo621tjd) (vancomycin - unii:6q205eh1vu) - vancomycin hydrochloride capsules are indicated for the treatment of c. difficile -associated diarrhea. vancomycin hydrochloride capsules are also used for the treatment of enterocolitis caused by staphylococcus aureus (including methicillin-resistant strains) in adult and pediatric patients less than 18 years of age. limitations of use - parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin hydrochloride capsules must be given orally for these infections. - orally administered vancomycin hydrochloride capsules is not effective for other types of infections. to reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride capsules and other antibacterial drugs, vancomycin hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. vancomycin hydrochloride capsules are contraindicated in patients with known hypersensitivity to vancomycin. risk summary systemic absorption of vancomycin is low following oral administration of vancomycin hydrochloride capsules; however, absorption may vary depending on various factors [see clinical pharmacology (12.3) ]. there are no available data on vancomycin use in pregnant women to assess a risk of major birth defects or miscarriage. available published data on intravenous vancomycin use in pregnancy during the second and third trimesters have not shown an association with adverse maternal or fetal outcomes (see data). vancomycin did not show adverse developmental effects when administered intravenously to pregnant rats and rabbits during organogenesis at doses less than or equal to the recommended maximum human dose (see data). data human data there are no available data on first trimester use of vancomycin in pregnant women to assess a risk of major birth defects or miscarriage. a published study evaluated hearing loss and nephrotoxicity in infants of 10 pregnant intravenous drug users treated with intravenous vancomycin for suspected or documented methicillin-resistant staphylococcal aureus in the second or third trimester. the comparison groups were 10 uninfected non-intravenous drug-dependent patients who received no treatment and 10 uninfected untreated intravenous drug-dependent patients. no infant in the vancomycin exposed group had abnormal sensorineural hearing at 3 months of age or nephrotoxicity. a published prospective study assessed outcomes in 55 pregnant women with a positive group b streptococcus culture and a high-risk penicillin allergy with resistance to clindamycin or unknown sensitivity who were administered intravenous vancomycin at the time of delivery. vancomycin dosing ranged from the standard dose of 1 g intravenously every 12 hours to a dose of 20 mg/kg intravenously every 8 hours (maximum individual dose 2 g). no major adverse reactions were recorded either in the mothers or their newborns. none of the newborns had sensorineural hearing loss. neonatal renal function was not examined, but all of the newborns were discharged in good condition. animal data vancomycin did not cause fetal malformation when administered intravenously during organogenesis to pregnant rats (gestation days 6 to 15) and rabbits (gestation days 6 to 18) at the equivalent recommended maximum human dose of 200 mg/kg/day to rats or 120 mg/kg/day to rabbits. no effects on fetal weight or development were seen in rats at the highest dose tested or in rabbits given 80 mg/kg/day (approximately 1 and 0.8 times the recommended maximum human dose based on body surface area). maternal toxicity was observed in rats (at doses 120 mg/kg and above) and rabbits (at 80 mg/kg and above). risk summary there are no data on the presence of vancomycin in human milk, the effects on the breastfed infant, or the effect on milk production following oral administration. systemic absorption of vancomycin is low following oral administration of vancomycin hydrochloride capsules [see clinical pharmacology (12.3) ]; therefore, it is unlikely to result in clinically relevant exposure in breastfeeding infants. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for vancomycin hydrochloride capsules and any potential adverse effects on the breastfed infant from vancomycin hydrochloride capsules or from the underlying maternal condition. vancomycin hydrochloride capsules are indicated in pediatric patients less than 18 years of age for the treatment of c. difficile associated diarrhea and enterocolitis caused by s. aureus (including methicillin-resistant strains) [see indications and usage (1) and dosage and administration (2.2) ]. in clinical trials, 54% of vancomycin hydrochloride-treated subjects were >65 years of age. of these, 40% were between the ages of >65 and 75, and 60% were >75 years of age. clinical studies with vancomycin hydrochloride in diarrhea associated with clostridium difficile have demonstrated that geriatric subjects are at increased risk of developing nephrotoxicity following treatment with oral vancomycin hydrochloride, which may occur during or after completion of therapy. in patients >65 years of age, including those with normal renal function prior to treatment, renal function should be monitored during and following treatment with vancomycin hydrochloride to detect potential vancomycin induced nephrotoxicity (see warnings and precautions, nephrotoxicity [5.3]; adverse reactions, clinical trials experience [6.1] and clinical studies, diarrhea associated with clostridium difficile [14.1] ). patients >65 years of age may take longer to respond to therapy compared to patients ≤65 years of age (see clinical studies, diarrhea associated with clostridium difficile [14.1] ). clinicians should be aware of the importance of appropriate duration of vancomycin hydrochloride treatment in patients >65 years of age and not discontinue or switch to alternative treatment prematurely.