Yhdysvallat - englanti - NLM (National Library of Medicine)

rebel distributors corp - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam 250 mg - levetiracetam tablets are indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy. this product should not be administered to patients who have previously exhibited hypersensitivity to levetiracetam or any of the inactive ingredients in levetiracetam tablets. the abuse and dependence potential of levetiracetam has not been evaluated in human studies.

Yhdysvallat - englanti - NLM (National Library of Medicine)

actavis mid atlantic llc - chlorhexidine gluconate (unii: mor84mud8e) (chlorhexidine - unii:r4ko0dy52l) - rinse - 0.12 mg in 1 ml - chlorhexidine gluconate oral rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. chlorhexidine gluconate has not been tested among patients with acute necrotizing ulcerative gingivitis (anug). for patients having coexisting gingivitis and periodontitis, see precautions. this product should not be used by persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients.

Yhdysvallat - englanti - NLM (National Library of Medicine)

preferred pharmaceuticals, inc. - orphenadrine citrate (unii: x0a40n8i4s) (orphenadrine - unii:al805o9og9) - orphenadrine citrate 100 mg - orphenadrine citrate extended-release tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions. orphenadrine citrate extended-release tablets are contraindicated in patients with glaucoma, pyloric or duodenal obstruction, stenosing peptic ulcers, prostatic hypertrophy or obstruction of the bladder neck, cardio-spasm (mega-esophagus) and myasthenia gravis. orphenadrine citrate tablets are contraindicated in patients who have demonstrated a previous hypersensitivity to the drug. orphenadrine has been chronically abused for its euphoric effects. the mood elevating effects may occur at therapeutic doses of orphenadrine.

Yhdysvallat - englanti - NLM (National Library of Medicine)

golden state medical supply, inc. - nifedipine (unii: i9zf7l6g2l) (nifedipine - unii:i9zf7l6g2l) - nifedipine 10 mg - i. vasospastic angina nifedipine is indicated for the management of vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by st segment elevation, 2) angina or coronary artery spasm provoked by ergonovine, or 3) angiographically demonstrated coronary artery spasm. in those patients who have had angiography, the presence of significant fixed obstructive disease is not incompatible with the diagnosis of vasospastic angina, provided that the above criteria are satisfied. nifedipine may also be used where the clinical presentation suggests a possible vasospastic component but where vasospasm has not been confirmed, e.g., where pain has a variable threshold on exertion or when angina is refractory to nitrates and/or adequate doses of beta blockers. ii. chronic stable angina (classical effort-associated angina) nifedipine is indicated for the management of chronic stable angina (effort-associated angina) without evidence of vasospasm in patients who remain

Yhdysvallat - englanti - NLM (National Library of Medicine)

lupin pharmaceuticals,inc. - pentazocine hydrochloride (unii: a36bxo4ppx) (pentazocine - unii:rp4a60d26l), naloxone hydrochloride (unii: f850569pqr) (naloxone - unii:36b82amq7n) - pentazocine 50 mg - pentazocine and naloxone tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration [see warnings], reserve pentazocine and naloxone tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] - have not been tolerated or are not expected to be tolerated, - have not provided adequate analgesia or are not expected to provide adequate analgesia pentazocine and naloxone tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate. pentazocine and naloxone tablets are contraindicated in patients with: - significant respiratory depression [see warnings ] - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings ]. patients with known or suspected gastrointestinal obstruction, including paralytic ileus [see warnings ] - patients with hypersensitivity to either pentazocine, naloxone, or any of the formulation excipients (e.g., anaphylaxis) [see warnings ]. pentazocine and naloxone tablets contain pentazocine, a schedule iv controlled substance. controlled substance pentazocine and naloxone tablets contain pentazocine, a schedule iv controlled substance. abuse pentazocine and naloxone tablets contain pentazocine, a substance with a high potential for misuse and abuse, which can lead to the development of substance use disorder, including addiction [see warnings]. misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed. abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. misuse and abuse of pentazocine and naloxone tablets increases a risk of overdose, which may lead to central nervous system and respiratory depression, hypotension, seizures, and death. the risk is increased with concurrent abuse of pentazocine and naloxone tablets with alcohol and other cns depressants. abuse of and addiction to opioids in some individuals may not be accompanied by concurrent tolerance and symptoms of physical dependence. in addition, abuse of opioids can occur in the absence of addiction. all patients treated with opioids require careful and frequent reevaluation for signs of misuse, abuse, and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use. patients at high risk of pentazocine and naloxone tablets abuse include those with a history of prolonged use of any opioid, including products containing pentazocine, those with a history of drug or alcohol abuse, or those who use pentazocine and naloxone tablets in combination with other abused drugs. "drug-seeking" behavior is very common in persons with substance use disorders. drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated "loss" of prescriptions, tampering with prescriptions, and reluctance to provide prior medical records or contact information for other treating healthcare provider(s). "doctor shopping" (visiting multiple prescribers to obtain additional prescriptions) is common among people who abuse drugs and people with substance use disorder. preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with inadequate pain control. pentazocine and naloxone tablets, like other opioids, can be diverted for nonmedical use into illicit channels of distribution. careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised. proper assessment of the patient, proper prescribing practices, periodic reevaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. risks specific to abuse of pentazocine and naloxone tablets abuse of pentazocine and naloxone tablets poses a risk of overdose and death. the risk is increased with concurrent use of pentazocine and naloxone tablets with alcohol and/or other cns depressants. parental drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and hiv. both tolerance and physical dependence can develop during use of opioid therapy. tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). physical dependence is a state that develops as a result of a physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. withdrawal may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone), mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). physical dependence may not occur to a clinically significant degree until after several days to weeks of continued use. do not abruptly discontinue pentazocine and naloxone tablets in a patient physically dependent on opioids. rapid tapering of pentazocine and naloxone tablets in a patient physically dependent on opioids may lead to serious withdrawal symptoms, uncontrolled pain, and suicide. rapid discontinuation has also been associated with attempts to find other sources of opioid analgesics, which may be confused with drug-seeking for abuse. when discontinuing pentazocine and naloxone tablets, gradually taper the dosage using a patient-specific plan that considers the following: the dose of pentazocine and naloxone tablets the patient has been taking, the duration of treatment, and the physical and psychological attributes of the patient. to improve the likelihood of a successful taper and minimize withdrawal symptoms, it is important that the opioid tapering schedule is agreed upon by the patient. in patients taking opioids for an extended period of time at high doses, ensure that a multimodal approach to pain management, including mental health support (if needed), is in place prior to initiating an opioid analgesic taper [see dosage and administration, warnings ]. infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs [see pregnancy].

Yhdysvallat - englanti - NLM (National Library of Medicine)

lupin pharmaceuticals,inc. - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - clobetasol propionate 0.5 mg in 1 ml - clobetasol propionate topical solution, usp is indicated for short-term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp. treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 ml/week because of the potential for the drug to suppress the hpa axis. this product is not recommended for use in pediatric patients under 12 years of age. clobetasol propionate topical solution is contraindicated in patients with primary infections of the scalp, or in patients who are hypersensitive to clobetasol propionate, other corticosteroids, or any ingredient in this preparation.

Yhdysvallat - englanti - NLM (National Library of Medicine)

a-s medication solutions - sertraline hydrochloride (unii: uti8907y6x) (sertraline - unii:quc7nx6wmb) - sertraline 100 mg - sertraline hydrochloride tablets are indicated for the treatment of the following [see clinical studies (14)] : - major depressive disorder (mdd) - obsessive-compulsive disorder (ocd) - panic disorder (pd) - posttraumatic stress disorder (ptsd) - social anxiety disorder (sad) - premenstrual dysphoric disorder (pmdd) sertraline hydrochloride tablets are contraindicated in patients: - taking, or within 14 days of stopping, maois, (including the maois linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [see warnings and precautions (5.2), drug interactions (7.1)] . - taking pimozide [see drug interactions (7.1)]. - with known hypersensitivity to sertraline (e.g., anaphylaxis, angioedema) [see adverse reactions (6.1, 6.2)] . risk summary overall, available published epidemiologic studies of pregnant women exposed to sertraline in the first trimester suggest no difference in major birth defect risk compared to the background rate for major birth defects in comparator popu

Yhdysvallat - englanti - NLM (National Library of Medicine)

preferred pharmaceuticals, inc. - lovastatin (unii: 9lhu78oqfd) (lovastatin - unii:9lhu78oqfd) - lovastatin 20 mg - therapy with lovastatin tablets usp should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. lovastatin tablets usp should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-c and ldl-c to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk. primary prevention of coronary heart disease in individuals without symptomatic cardiovascular disease, average to moderately elevated total-c and ldl-c and below average hdl-c, lovastatin tablets usp are indicated to reduce the risk of: -myocardial infarction -unstable angina -coronary revascularization procedures (see clinical pharmacology, clinical studies). coronary heart disease lovastatin tablets usp are indicated to slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment strategy to lower t

Yhdysvallat - englanti - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - testosterone (unii: 3xmk78s47o) (testosterone - unii:3xmk78s47o) - testosterone 30 mg in 1.5 ml - testosterone topical solution usp is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone: - primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. these men usually have low serum testosterone concentrations and gonadotropins (fsh, lh) above the normal range. - hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (lhrh) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. these men have low testosterone serum concentrations but have gonadotropins in the normal or low range. limitations of use: - safety and efficacy of testosterone topical solution usp in men with "age-related hypogonadism" (als

Yhdysvallat - englanti - NLM (National Library of Medicine)

lake erie medical dba quality care products llc - quetiapine fumarate (unii: 2s3pl1b6uj) (quetiapine - unii:bgl0jsy5si) - quetiapine 25 mg - quetiapine tablets usp are indicated for the treatment of schizophrenia. the efficacy of quetiapine tablets usp in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). the effectiveness of quetiapine tablets usp for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see clinical studies (14.1 )]. quetiapine tablets usp are indicated for the acute treatment of manic episodes associated with bipolar i disorder, both as monotherapy and as an adjunct to lithium or divalproex. efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10 to 17 years) [see clinical studies (14.2 )]. quetiapine tablets usp are indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. efficacy was established in two 8-week monotherapy trials in adult p