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

actavis pharma, 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, 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. pentazocine and naloxone tablets contains pentazocine, a substance with 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 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 health care 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. parenteral 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 ] .

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

actavis pharma, inc. - amoxapine (unii: r63vq857ot) (amoxapine - unii:r63vq857ot) - amoxapine 25 mg - amoxapine is indicated for the relief of symptoms of depression in patients with neurotic or reactive depressive disorders as well as endogenous and psychotic depressions. it is indicated for depression accompanied by anxiety or agitation. amoxapine is contraindicated in patients who have shown prior hypersensitivity to dibenzoxazepine compounds. it should not be given concomitantly with monoamine oxidase inhibitors. hyperpyretic crises, severe convulsions, and deaths have occurred in patients receiving tricyclic antidepressants and monoamine oxidase inhibitors simultaneously. when it is desired to replace a monoamine oxidase inhibitor with amoxapine, a minimum of 14 days should be allowed to elapse after the former is discontinued. amoxapine should then be initiated cautiously with gradual increase in dosage until optimum response is achieved. the drug is not recommended for use during the acute recovery phase following myocardial infarction.

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

actavis pharma, inc. - primidone (unii: 13afd7670q) (primidone - unii:13afd7670q) - primidone 250 mg - primidone tablets, used alone or concomitantly with other anticonvulsants, are indicated in the control of grand mal, psychomotor, and focal epileptic seizures. it may control grand mal seizures refractory to other anticonvulsant therapy. primidone is contraindicated in: 1) patients with porphyria and 2) patients who are hypersensitive to phenobarbital (see clinical pharmacology).

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

actavis pharma, inc. - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1) - diclofenac sodium 100 mg - carefully consider the potential benefits and risks of diclofenac sodium extended release tablets, usp and other treatment options before deciding to use diclofenac sodium extended-release tablets. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ;   gastrointestinal bleeding, ulceration, and perforation ) . diclofenac sodium extended-release tablets are indicated: - for relief of the signs and symptoms of osteoarthritis - for relief of the signs and symptoms of rheumatoid arthritis diclofenac sodium extended-release tablets, usp are contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product (see warnings ; anaphylactic reactions , serious skin reactions ) .  - history of asthma, urticaria, or allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have b

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

actavis pharma, inc. - lorazepam (unii: o26fzp769l) (lorazepam - unii:o26fzp769l) - lorazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. the effectiveness of lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. the physician should periodically reassess the usefulness of the drug for the individual patient. lorazepam is contraindicated in patients with: - hypersensitivity to benzodiazepines or to any components of the formulation. - acute narrow-angle glaucoma. controlled substance lorazepam tablets contain lorazepam, a schedule iv controlled substance. abuse lorazepam tablets are a benzodiazepine and a cns depressant with a potential for abuse and addiction. abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. misuse is the i

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

actavis pharma, inc. - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), ibuprofen (unii: wk2xyi10qm) (ibuprofen - unii:wk2xyi10qm) - hydrocodone bitartrate 7.5 mg - hydrocodone bitartrate and ibuprofen tablets are indicated for the short-term management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. carefully consider the potential benefits and risks of hydrocodone bitartrate and ibuprofen tablets and other treatment options before deciding to use hydrocodone bitartrate and ibuprofen tablets. use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals ( s e e   warnings: cardiovascular thrombotic events , gastrointestinal bleeding, ulceration, and perforation ) . do not use hydrocodone bitartrate and ibuprofen tablets for the treatment of conditions such as osteoarthritis or rheumatoid arthritis. because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses ( s e e   warnings: addiction, abuse, and misuse ) , reserve hydrocodone bitartrate and ibuprofen tablets for use in patients for whom alternative treatment options (e.g., n

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

actavis pharma, inc. - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570), ibuprofen (unii: wk2xyi10qm) (ibuprofen - unii:wk2xyi10qm) - oxycodone hydrochloride 5 mg - oxycodone hydrochloride and ibuprofen tablets are indicated for the management of short term (no more than 7 days) acute to moderate pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use carefully consider the potential benefits and risks of oxycodone hydrochloride and ibuprofen tablets and other treatment options before deciding to use oxycodone hydrochloride and ibuprofen tablets. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see warnings; cardiovascular thrombotic events, and gastrointestinal bleeding, ulceration, and perforation ]. because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see warnings; addiction, abuse, and misuse ], reserve oxycodone hydrochloride and ibuprofen 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,

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

actavis pharma, inc. - bacitracin zinc (unii: 89y4m234es) (bacitracin - unii:58h6rwo52i), neomycin sulfate (unii: 057y626693) (neomycin - unii:i16qd7x297), polymyxin b sulfate (unii: 19371312d4) (polymyxin b - unii:j2vz07j96k) - bacitracin 400 [iu] in 1 g - first aid antibiotic first aid to help prevent infection in - minor cuts  - scrapes  - burns

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

actavis pharma, inc. - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam 500 mg - levetiracetam extended-release tablets are indicated as adjunctive therapy in the treatment of partial onset seizures in patients 12 years of age and older with epilepsy. levetiracetam extended-release tablets are contraindicated in patients with a hypersensitivity to levetiracetam. reactions have included anaphylaxis and angioedema [see warnings and precautions (5.4) ]. levetiracetam extended-release tablets levels may decrease during pregnancy [see  warnings and precautions (5.9) ]. pregnancy category c there are no adequate and well-controlled studies in pregnant women. in animal studies, levetiracetam produced evidence of developmental toxicity, including teratogenic effects, at doses similar to or greater than human therapeutic doses. levetiracetam extended-release tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. oral administration of levetiracetam to female rats throughout pregnancy and lactation led to increased incidences of minor fetal

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

actavis pharma, inc. - alendronate sodium (unii: 2uy4m2u3ra) (alendronic acid - unii:x1j18r4w8p) - alendronic acid 35 mg - alendronate sodium tablets are indicated for the treatment of osteoporosis in postmenopausal women. in postmenopausal women, alendronate sodium tablets increase bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures). [see clinical studies (14.1) .] alendronate sodium tablets are indicated for the prevention of postmenopausal osteoporosis [see clinical studies (14.2) ].   alendronate sodium tablets are indicated for treatment to increase bone mass in men with osteoporosis [see clinical studies (14.3) ].   alendronate sodium tablets are indicated for the treatment of glucocorticoid-induced osteoporosis in men and women receiving glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who have low bone mineral density [see clinical studies (14.4) ].   alendronate sodium tablets are indicated for the treatment of paget’s disease of bone in men and women. treatment is indicated in patients with paget's disease of bone