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preferred pharmaceuticals inc. - lidocaine (unii: 98pi200987) (lidocaine - unii:98pi200987) - lidocaine ointment usp, 5% is indicated for production of anesthesia of accessible mucous membranes of the oropharynx. it is also useful as an anesthetic lubricant for intubation and for the temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin, and insect bites. lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to other components of lidocaine ointment usp, 5%.

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

taro pharmaceuticals u.s.a., inc. - lidocaine (unii: 98pi200987) (lidocaine - unii:98pi200987) - lidocaine ointment usp, 5% is indicated for production of anesthesia of accessible mucous membranes of the oropharynx. it is also useful as an anesthetic lubricant for intubation and for the temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin, and insect bites. lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to other components of lidocaine ointment usp, 5%.

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

ncs healthcare of ky, llc dba vangard labs - carbamazepine (unii: 33cm23913m) (carbamazepine - unii:33cm23913m) - carbamazepine is indicated for use as an anticonvulsant drug. evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: - partial seizures with complex symptomatology (psychomotor, temporal lobe). patients with these seizures appear to show greater improvement than those with other types. - generalized tonic-clonic seizures (grand mal). - mixed seizure patterns which include the above, or other partial or generalized seizures. absence seizures (petit mal) do not appear to be controlled by carbamazepine (see precautions, general). carbamazepine is indicated in the treatment of the pain associated with true trigeminal neuralgia. beneficial results have also been reported in glossopharyngeal neuralgia. this drug is not a simple analgesic and should not be used for the relief of trivial aches or pains. carbamazepine should not be used in patients with a history of previous bone marrow depression, hype

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

nucare pharmaceuticals,inc. - ciclopirox (unii: 19w019zdrj) (ciclopirox - unii:19w019zdrj) - (to understand fully the indication for this product, please read the entire indications and usage section of the labeling.) ciclopirox topical solution, 8%, (nail lacquer), as a component of a comprehensive management program, is indicated as topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to trichophyton rubrum . the comprehensive management program includes removal of the unattached, infected nails as frequently as monthly, by a health care professional who has special competence in the diagnosis and treatment of nail disorders, including minor nail procedures. - no studies have been conducted to determine whether ciclopirox might reduce the effectiveness of systemic antifungal agents for onychomycosis. therefore, the concomitant use of 8% ciclopirox topical solution and systemic antifungal agents for onychomycosis, is not recommended. - ciclopirox topical solution, 8%, (nail lacquer), should be used

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

aphena pharma solutions - tennessee, llc - carbamazepine (unii: 33cm23913m) (carbamazepine - unii:33cm23913m) - carbamazepine is indicated for use as an anticonvulsant drug. evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: - partial seizures with complex symptomatology (psychomotor, temporal lobe). patients with these seizures appear to show greater improvement than those with other types. - generalized tonic-clonic seizures (grand mal). - mixed seizure patterns which include the above, or other partial or generalized seizures. absence seizures (petit mal) do not appear to be controlled by carbamazepine (see precautions, general). carbamazepine is indicated in the treatment of the pain associated with true trigeminal neuralgia. beneficial results have also been reported in glossopharyngeal neuralgia. this drug is not a simple analgesic and should not be used for the relief of trivial aches or pains. carbamazepine should not be used in patients with a history of previous bone marro

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

preferred pharmaceuticals, inc. - betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - betamethasone dipropionate cream (augmented) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age or older. betamethasone dipropionate cream (augmented), is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation. risk summary there are no available data on betamethasone dipropionate cream (augmented) use in pregnant women to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. observational studies suggest an increased risk of low birthweight infants with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. advise pregnant women that betamethasone dipropionate cream (augmented) may increase the risk of having a low birthweight infant and to use betamethasone dipropionate cream (augmented) on the smallest area of skin and for the shortest duration possible. in animal reproduction studies, increased malformations, including umbilical hernias, cephalocele, and cleft palate, were observed after intramuscular administration of betamethasone dipropionate to pregnant rabbits. the available data do not allow the calculation of relevant comparisons between the systemic exposure of betamethasone dipropionate in animal studies to the systemic exposure that would be expected in humans after topical use of betamethasone dipropionate cream (augmented) (see error! hyperlink reference not valid. ) . the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data betamethasone dipropionate has been shown to cause malformations in rabbits when given by the intramuscular route at doses of 0.05 mg/kg. the abnormalities observed included umbilical hernias, cephalocele, and cleft palate. risk summary there are no data regarding the excretion of betamethasone dipropionate in breast milk, the effects on the breastfed infant, or the effects on milk production after topical application of betamethasone dipropionate cream (augmented) to women who are breastfeeding. it is possible that topical administration of large amounts of betamethasone dipropionate could result in sufficient systemic absorption to produce detectable quantities in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for betamethasone dipropionate cream (augmented) and any potential adverse effects on the breastfed infant from betamethasone dipropionate cream (augmented) or from the underlying maternal condition. clinical considerations to minimize potential exposure to the breastfed infant via breast milk, use betamethasone dipropionate cream (augmented) on the smallest area of skin and for the shortest duration possible while breastfeeding. advise breastfeeding women not to apply betamethasone dipropionate cream (augmented) directly to the nipple and areola to avoid direct infant exposure [see use in specific populations (8.4)] . use of betamethasone dipropionate cream (augmented) in pediatric patients younger than 13 years of age is not recommended due to the potential for hpa axis suppression [see warnings and precautions (5.1)] . in an open-label hpa axis safety trial in subjects 3 months to 12 years of age with atopic dermatitis, betamethasone dipropionate cream (augmented), 0.05% was applied twice daily for 2 to 3 weeks over a mean body surface area of 58% (range 35% to 95%). in 19 of 60 (32%) evaluable subjects, adrenal suppression was indicated by either a ≤5 mcg/dl pre-stimulation cortisol, or a cosyntropin post-stimulation cortisol ≤18 mcg/dl and/or an increase of <7 mcg/dl from the baseline cortisol. out of the 19 subjects with hpa axis suppression, 4 subjects were tested 2 weeks after discontinuation of betamethasone dipropionate cream (augmented), and 3 of the 4 (75%) had complete recovery of hpa axis function. the proportion of subjects with adrenal suppression in this trial was progressively greater, the younger the age group. because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of systemic toxicity when treated with topical drugs. they are, therefore, also at greater risk of hpa axis suppression and adrenal insufficiency upon the use of topical corticosteroids. rare systemic effects such as cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients, especially those with prolonged exposure to large doses of high potency topical corticosteroids. local adverse reactions including skin atrophy have also been reported with use of topical corticosteroids in pediatric patients. avoid use of betamethasone dipropionate cream (augmented) in the treatment of diaper dermatitis. clinical trials of betamethasone dipropionate cream (augmented) included 104 subjects who were 65 years of age and over and 8 subjects who were 75 years of age and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. however, greater sensitivity of some older individuals cannot be ruled out.

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

taro pharmaceuticals u.s.a., inc. - betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - betamethasone dipropionate spray is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. none. risk summary there are no available data on betamethasone dipropionate spray use in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. observational studies suggest an increased risk of low birthweight infants with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. advise pregnant women that betamethasone dipropionate spray may increase the risk of having a low birthweight infant and to use betamethasone dipropionate spray on the smallest area of skin and for the shortest duration possible. in animal reproduction studies, increased malformations, including umbilical hernias, cephalocele, and cleft palate, were observed after intramuscular administration of betamethasone dipropionate to pregnant rabbits during the period of organogenesis (see d

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

taro pharmaceuticals u.s.a., inc. - butalbital (unii: khs0az4jvk) (butalbital - unii:khs0az4jvk), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), caffeine (unii: 3g6a5w338e) (caffeine - unii:3g6a5w338e) - butalbital, acetaminophen, and caffeine capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. caution in this regard is required because butalbital is habit-forming and potentially abusable. this product is contraindicated under the following conditions: tolerance, psychological dependence, and physical dependence may occur especially following prolonged use of high doses of barbiturates. the average daily dose for the barbiturate addict is usually about 1500 mg. as tolerance to barbiturates develops, the amount needed to maintain the same level of intoxication increases; tolerance to a fatal dosage, however, does not increase more than two-fold. as this occurs, the margin between an intoxication dosage and fatal dosage becomes smaller. the lethal dose of a barbiturate is far less if alcohol is also ingested. major withdraw

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

taro pharmaceuticals u.s.a., inc. - clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c) - clindamycin phosphate foam is indicated for topical application in the treatment of acne vulgaris in patients 12 years and older. clindamycin phosphate foam is contraindicated in individuals with a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis (including pseudomembranous colitis). risk summary there are no available data on clindamycin phosphate foam use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. animal reproduction studies have not been conducted with clindamycin phosphate foam. no evidence of fetal harm or malformations was observed in pregnant rats and mice administered daily subcutaneous or oral doses of clindamycin salts during organogenesis at doses that produced exposures up to 84 and 42 times, respectively, the maximum recommended human dose (mrhd) of clindamycin phosphate foam based on body surface area (bsa) comparisons and assuming 100% absorption [see data]. in the u.s. general population, the estimate

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

rpk pharmaceuticals, inc. - phenytoin sodium (unii: 4182431bjh) (phenytoin - unii:6158tkw0c5) - extended phenytoin sodium capsules, usp are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. extended phenytoin sodium capsules are contraindicated in patients with: - a history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins [see warnings and precautions (5.5)] . - a history of prior acute hepatotoxicity attributable to phenytoin [see warnings and precautions (5.7)]. - coadministration with delavirdine because of the potential for loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as extended phenytoin sodium capsules, during pregnancy. physicians are advised to recommend that pregnant patients taking extended phen