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

novitium pharma llc - estazolam (unii: 36s3eqv54c) (estazolam - unii:36s3eqv54c) - estazolam is indicated for the short-term management of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings. both outpatient studies and a sleep laboratory study have shown that estazolam administered at bedtime improved sleep induction and sleep maintenance (see clinical pharmacology ). because insomnia is often transient and intermittent, the prolonged administration of estazolam is generally neither necessary nor recommended. since insomnia may be a symptom of several other disorders, the possibility that the complaint may be related to a condition for which there is a more specific treatment should be considered. there is evidence to support the ability of estazolam to enhance the duration and quality of sleep for intervals up to 12 weeks (see clinical pharmacology ). estazolam is contraindicated with ketoconazole and itraconazole, since these medications significantly impair oxidative metabolism mediated by cyp3a (see warnings and precau

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

novitium pharma llc - felbamate (unii: x72rbb02n8) (felbamate - unii:x72rbb02n8) - felbamate oral suspension is not indicated as a first line antiepileptic treatment (see warnings ). felbamate oral suspension is recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use. if these criteria are met and the patient has been fully advised of the risk, and has provided written acknowledgement, felbamate oral suspension can be considered for either monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epilepsy and as adjunctive therapy in the treatment of partial and generalized seizures associated with lennox-gastaut syndrome in children. felbamate oral suspension is contraindicated in patients with known hypersensitivity to felbamate, its ingredients, or known sensitivity to other carbamates. it should not be used in patients with a hi

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

novitium pharma llc - levorphanol tartrate (unii: 04wqu6t9qi) (levorphanol - unii:27618j1n2x) - levorphanol tartrate 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, even at recommended doses [see warnings], reserve levorphanol tartrate tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: - have not been tolerated, or are not expected to be tolerated, - have not provided adequate analgesia, or are not expected to provide adequate analgesia levorphanol tartrate 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 ] - known or suspected gastrointestinal obstruction, including paralytic ileus [see warnings ]  - hypersensitivity to levorphanol or any of the formulation excipients

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

novitium pharma llc - trihexyphenidyl hydrochloride (unii: ao61g82577) (trihexyphenidyl - unii:6rc5v8b7po) - this drug is indicated as an adjunct in the treatment of all forms of parkinsonism (postencephalitic, arteriosclerotic, and idiopathic). it is often useful as adjuvant therapy when treating these forms of parkinsonism with levodopa. additionally, it is indicated for the control of extrapyramidal disorders caused by central nervous system drugs such as the dibenzoxazepines, phenothiazines, thioxanthenes, and butyrophenones.

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

novitium pharma llc - meloxicam (unii: vg2qf83cgl) (meloxicam - unii:vg2qf83cgl) - meloxicam is indicated for management of osteoarthritis pain. meloxicam is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to meloxicam 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 meloxicam, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. because of these risks, limit dose and duration of meloxicam use between about 20 and 30 weeks of gestation, and avoid meloxicam use at about 30 weeks of gestation and later in

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

novitium pharma llc - prazosin hydrochloride (unii: x0z7454b90) (prazosin - unii:xm03yj541d) - prazosin hydrochloride capsules, usp is indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than one drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program's joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihypertensive drugs, from a variety of pharmacologic classes

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

novitium pharma llc - naproxen (unii: 57y76r9atq) (naproxen - unii:57y76r9atq) - naproxen oral suspension is indicated for: the relief of the signs and symptoms of: - rheumatoid arthritis - osteoarthritis - ankylosing spondylitis - polyarticular juvenile idiopathic arthritis - tendonitis - bursitis - acute gout the management of:  - pain. - primary dysmenorrhea naproxen oral suspension is 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 cardiovascular thrombotic events)] risk summary use of nsaids, including naproxen oral suspension, can cause premature closure of the fetal ductus arteriosus a

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

novitium pharma llc - ranitidine hydrochloride (unii: bk76465ihm) (ranitidine - unii:884kt10yb7) - ranitidine is indicated in: - short-term treatment of active duodenal ulcer. most patients heal within 4 weeks. studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks. - maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. no placebo-controlled comparative studies have been carried out for periods of longer than 1 year. - the treatment of pathological hypersecretory conditions (e.g., zollinger-ellison syndrome and systemic mastocytosis). - short-term treatment of active, benign gastric ulcer. most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks. - maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. placebo-controlled studies have been carried out for 1 year. -

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

novitium pharma llc - albuterol sulfate (unii: 021sef3731) (albuterol - unii:qf8svz843e) - albuterol tablets are indicated for the relief of bronchospasm in adults and children 6 years of age and older with reversible obstructive airway disease. albuterol tablets are contraindicated in patients with a history of hypersensitivity to albuterol, or any of its components.

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

novitium pharma llc - acyclovir (unii: x4hes1o11f) (acyclovir - unii:x4hes1o11f) - herpes zoster infections: acyclovir oral suspension, usp is indicated for the acute treatment of herpes zoster (shingles). genital herpes: acyclovir oral suspension, usp is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. chickenpox: acyclovir oral suspension, usp is indicated for the treatment of chickenpox (varicella). acyclovir oral suspension, usp is contraindicated for patients who develop hypersensitivity to acyclovir or valacyclovir.