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nostrum laboratories, inc. - carbamazepine (unii: 33cm23913m) (carbamazepine - unii:33cm23913m) - carbamazepine 100 mg - carbamazepine extended-release capsules are 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 improvements 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 extended-release capsules are 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, hypersensitivity to the drug, or known sensitivity to any of the tricyclic compounds, such as amitriptyline, desipramine, imipramine, protriptyline and nortriptyline. likewise, on theoretical grounds its use with monoamine oxidase inhibitors is not recommended. before administration of carbamazepine, mao inhibitors should be discontinued for a minimum of 14 days, or longer if the clinical situation permits. coadministration of carbamazepine and nefazodone may result in insufficient plasma concentrations of nefazodone and its active metabolite to achieve a therapeutic effect. coadministration of carbamazepine with nefazodone is contraindicated. coadministration of carbamazepine extended-release capsules are contraindicated with delavirdine due to the potential for loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors. no evidence of abuse potential has been associated with carbamazepine, nor is there evidence of psychological or physical dependence in humans.

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

nostrum laboratories, inc. - carbamazepine (unii: 33cm23913m) (carbamazepine - unii:33cm23913m) - carbamazepine 300 mg - carbamazepine extended-release capsules are 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 improvements 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 extended-release capsules are 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

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

nostrum laboratories, inc. - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - oxycodone hydrochloride and acetaminophen oral solution is 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, even at recommended doses (see warnings ), reserve oxycodone hydrochloride and acetaminophen oral solution 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 oxycodone hydrochloride and acetaminophen oral solution is contraindicated in patients with: - significant respiratory depression (see warnings ) significant respiratory depression (see warnings ) - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment (see

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

nostrum laboratories, inc. - piroxicam (unii: 13t4o6vmam) (piroxicam - unii:13t4o6vmam) - piroxicam 10 mg - piroxicam capsules are indicated: piroxicam capsules are contraindicated in the following patients: use of nsaids, including piroxicam capsules, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. avoid use of nsaids, including piroxicam capsules, in pregnant women starting at 30 weeks of gestation (third trimester). there are no adequate and well-controlled studies of piroxicam capsules in pregnant women. data from observational studies regarding potential embryofetal risks of nsaid use in women in the first or second trimesters of pregnancy are inconclusive. in the general u.s. population, all clinically recognized pregnancies, regardless of drug exposure, have a background rate of 2% to 4% for major malformations, and 15% to 20% for pregnancy loss. in animal reproduction studies in rats and rabbits, there was no evidence of teratogenicity at exposures up to 5 and 10 times the maximum recommended human dose (mrhd), respectively. in rat studies with

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

nostrum laboratories, inc. - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine 150 mg - venlafaxine hydrochloride extended-release tablets are indicated for the treatment of major depressive disorder (mdd). efficacy of venlafaxine in mdd was shown in both short-term trials and a longer-term trial in mdd [see clinical studies (14.1) ]. a major depressive episode (dsm-iv) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two-week period: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. venlafaxine hydrochloride extended-release tablets are indicated for the treatment of social an

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nostrum laboratories, inc. - promethazine hydrochloride (unii: r61zeh7i1i) (promethazine - unii:ff28ejq494) - promethazine hydrochloride 6.25 mg in 5 ml - promethazine hcl oral solution is useful for: perennial and seasonal allergic rhinitis. vasomotor rhinitis. allergic conjunctivitis due to inhalant allergens and foods. mild, uncomplicated allergic skin manifestations of urticaria and angioedema. amelioration of allergic reactions to blood or plasma. dermographism. anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. preoperative, postoperative, or obstetric sedation. prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. therapy adjunctive to meperidine or other analgesics for control of postoperative pain. sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. active and prophylactic treatment of motion sickness. antiemetic therapy in postoperative patients. promethazine hcl oral solution is contraindicated for use in pediatric patients less than two years of age. promethazine hcl oral solution is contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines. antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma.

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nostrum laboratories, inc. - morphine sulfate (unii: x3p646a2j0) (morphine - unii:76i7g6d29c) - morphine sulfate 10 mg in 5 ml - morphine sulfate oral solution (10 mg per 5 ml and 20 mg per 5 ml ) are formulations of morphine, an opioid agonist, indicated for the relief of moderate to severe acute and chronic pain where use of an opioid analgesic is appropriate. morphine sulfate is contraindicated in patients with known hypersensitivity to morphine, morphine salts, or any components of the product. morphine sulfate is contraindicated in patients with respiratory depression in the absence of resuscitative equipment. morphine sulfate is contraindicated in patients with acute or severe bronchial asthma or hypercarbia. morphine sulfate is contraindicated in any patient who has or is suspected of having paralytic ileus. no formal studies to assess the teratogenic effects of morphine in animals have been conducted.  it is also not known whether morphine can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.  morphine should be given to a pregnant woman only if clearly needed. in humans, the frequency

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

nostrum laboratories, inc. - morphine sulfate (unii: x3p646a2j0) (morphine - unii:76i7g6d29c) - morphine sulfate 100 mg in 5 ml - morphine sulfate oral solution (10 mg per 5 ml and 20 mg per 5 ml) are formulations of morphine, an opioid agonist, indicated for the relief of moderate to severe acute and chronic pain where use of an opioid analgesic is appropriate. morphine sulfate oral solution 100 mg per 5 ml (20 mg/ml) is an opioid analgesic indicated for the relief of moderate to severe acute and chronic pain in opioid-tolerant patients. morphine sulfate oral solution 100 mg per 5 ml (20 mg/ml) may cause fatal respiratory depression when administered to patients not previously exposed to opioids. patients considered to be opioid tolerant are those who are taking at least 60 mg oral morphine per day, or at least 30 mg of oral oxycodone per day, or at least 12 mg hydromorphone per day, or an equianalgesic dose of another opioid, for a week or longer. morphine sulfate is contraindicated in patients with known hypersensitivity to morphine, morphine salts, or any components of the product. morphine sulfate is contraindicated in patients

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

nostrum laboratories inc. - fluoxetine hydrochloride (unii: i9w7n6b1kj) (fluoxetine - unii:01k63sup8d) - fluoxetine is indicated for the acute and maintenance treatment of major depressive disorder in adult patients and in pediatric patients aged 8 to 18 years [see clinical studies (14.1)] the usefulness of the drug in adult and pediatric patients receiving fluoxetine for extended periods should periodically be re-evaluated [see dosage and administration (2.1)] fluoxetine is indicated for the acute and maintenance treatment of obsessions and compulsions in adult patients and in pediatric patients aged 7 to 17 years with obsessive compulsive disorder (ocd) [see clinical studies (14.2)] the effectiveness of fluoxetine in long-term use, i.e., for more than 13 weeks, has not been systematically evaluated in placebo-controlled trials. therefore, the physician who elects to use fluoxetine for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see dosage and administration (2.2)] fluoxetine is indicated for the acute and maintenance treatment of binge-eatin

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

nostrum laboratories, inc. - promethazine hydrochloride (unii: r61zeh7i1i) (promethazine - unii:ff28ejq494), codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j) - promethazine hydrochloride 6.25 mg in 5 ml - promethazine hydrochloride and codeine phosphate oral solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older. important limitations of use - not indicated for pediatric patients under 18 years of age [see use in specific populations (8.4) ]. - contraindicated in pediatric patients under 12 years of age [see contraindications (4) and use in specific populations (8.4) ]. - contraindicated in pediatric patients 12 to 18 years of age after tonsillectomy or adenoidectomy [see contraindications (4) and use in specific populations (8.4) ]. - because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see warnings and precautions (5.1) ], reserve promethazine hydrochloride and codeine phosphate oral solution for use in adult patients for whom the benefits of cough suppression are expected to outw