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kvk-tech, inc. - benzhydrocodone hydrochloride (unii: i894qau7fj) (benzhydrocodone - unii:75ms0aaz9i), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - benzhydrocodone and acetaminophen tablets are indicated for the short-term (no more than 14 days) management of acute 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 and precautions ( 5.1)] , reserve benzhydrocodone and acetaminophen 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. benzhydrocodone and acetaminophen tablets are contraindicated in patients with: - significant respiratory depression [see warnings and precautions ( 5.3)] - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings and precautions ( 5.8)] - known or suspected gastrointestinal obstruct

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kvk-tech, inc. - chlorpheniramine maleate (unii: v1q0o9oj9z) (chlorpheniramine - unii:3u6io1965u) - temporarily relieves the following symptoms due to hay fever or other upper respiratory allergies: sneezing runny nose itchy, watery eyes itching of the nose or throat chlorpheniramine maleate 12 mg is used as an antihistamine. manufactured by: kvk-tech, inc. newtown, pa 18940

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

kvk-tech, inc. - betaxolol hydrochloride (unii: 6x97d2xt0o) (betaxolol - unii:o0zr1r6rz2) - betaxolol hydrochloride 10 mg - betaxolol tablets, usp is indicated in the management of hypertension. it may be used alone or concomitantly with other antihypertensive agents, particularly thiazide-type diuretics. betaxolol tablets, usp is contraindicated in patients with known hypersensitivity to the drug. betaxolol tablets, usp is contraindicated in patients with sinus bradycardia, heart block greater than first degree, cardiogenic shock, and overt cardiac failure (see warnings ).

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kvk-tech, inc. - hydroxyzine dihydrochloride (unii: 76755771u3) (hydroxyzine - unii:30s50ym8og) - hydroxyzine hydrochloride 10 mg - for symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus. as a sedative when used as a premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates , so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. atropine and other belladonna alkaloids are not affected by the drug. hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. the effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. the physician should reassess periodically the usefulness of the drug for the individual patient. oral hydroxyzine h

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kvk-tech, inc. - cyclobenzaprine hydrochloride (unii: 0ve05jys2p) (cyclobenzaprine - unii:69o5wqq5ti) - cyclobenzaprine hydrochloride 5 mg - cyclobenzaprine hydrochloride tablets, usp is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. cyclobenzaprine hydrochloride tablets, usp should be used only for short periods (up to two or three weeks) because adequate  evidence of effectiveness for more prolonged use is not available and because muscle spasm associated  with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. cyclobenzaprine hydrochloride tablets, usp have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy. hypersensitivity to any component of this product. concomitant use of monoamine oxidase (mao) in

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kvk-tech, inc. - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570) - oxycodone hydrochloride 5 mg in 5 ml - oxycodone hydrochloride 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 and precautions ( 5.2)] , reserve oxycodone hydrochloride oral solution 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 risk summary prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome [see warnings and precautions ( 5.4)] . available data with oxycodone hydrochloride oral solution are insufficient to inform a drug-associated risk for major birth defects an

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kvk-tech, inc. - desmopressin acetate (unii: xb13hyu18u) (desmopressin - unii:enr1llb0fp) - central diabetes insipidus desmopressin acetate tablets are indicated as antidiuretic replacement therapy in the management of central diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. desmopressin acetate is ineffective for the treatment of nephrogenic diabetes insipidus. patients were selected for therapy based on the diagnosis by means of the water deprivation test, the hypertonic saline infusion test, and/or response to antidiuretic hormone. continued response to desmopressin acetate can be monitored by measuring urine volume and osmolality. primary nocturnal enuresis desmopressin acetate tablets are indicated for the management of primary nocturnal enuresis. desmopressin acetate may be used alone or as an adjunct to behavioral conditioning or other non-pharmacologic intervention. desmopressin acetate tablets are contraindicated in individuals with known hypersensitivity to desmopressin acetate or to any of the components of desmopressin acetate tablets. desmopressin acetate is contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance below 50ml/min). desmopressin acetate is contraindicated in patients with hyponatremia or a history of hyponatremia.

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kvk-tech, inc. - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), homatropine methylbromide (unii: 68jrs2hc1c) (methylhomatropine - unii:p97ogj7l1l) - hydrocodone bitartrate 5 mg - hydrocodone bitartrate and homatropine methylbromide is indicated for the symptomatic relief of cough 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 less than 6 years of age [ see contraindications (4) ].  - because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [ see warnings and precautions (5.1) ], reserve hydrocodone bitartrate and homatropine methylbromide for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made. hydrocodone bitartrate and homatropine methylbromide is contraindicated for: - all children younger than 6 years of age [ see warnings and precautions (5.2, 5.3), use in specific populations (8.4) ]. hydrocodone

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kvk-tech, inc. - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570) - oxycodone hcl extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate in: - adults; and - opioid-tolerant pediatric patients 11 years of age and older who are already receiving and tolerate a minimum daily opioid dose of at least 20 mg oxycodone orally or its equivalent. limitations of use - because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see warnings and precautions ( 5.1)] , reserve oxycodone hcl extendedrelease tablets for use in patients for whom alternative treatment options (e.g., nonopioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. - oxycodone hcl extended-release tablets are not indicated as an as-needed (prn)

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kvk-tech, inc. - phentermine hydrochloride (unii: 0k2i505otv) (phentermine - unii:c045tql4wp) - phentermine hydrochloride 15 mg - phentermine hydrochloride, usp 15 mg and 30 mg is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index greater than or equal to 30 kg/m 2 , or greater than or equal to 27 kg/m 2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). below is a chart of body mass index (bmi) based on various heights and weights. bmi is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. the limited usefulness of agents of this class, including phentermine hydrochloride, [ see clinical pharmacology ( 12.1 , 12.2 ) ] should be measured against possible risk factors inherent in their use such as those described below. - history of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart failure, uncontrolled hypertension) - during or within 14 days following the administration of monoamine oxidase inhibitors - hyperthyroidism - glaucoma - agitated states - history of drug abuse - pregnancy [see use in specific populations ( 8.1)] - nursing [see use in specific populations ( 8.3)] - known hypersensitivity, or idiosyncrasy to the sympathomimetic amines pregnancy category x phentermine is contraindicated during pregnancy because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm. a minimum weight gain, and no weight loss, is currently recommended for all pregnant women, including those who are already overweight or obese, due to obligatory weight gain that occurs in maternal tissues during pregnancy. phentermine has pharmacologic activity similar to amphetamine (d- and d/l-amphetamine) [ see clinical pharmacology ( 12.1) ]. animal reproduction studies have not been conducted with phentermine. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. it is not known if phentermine is excreted in human milk; however, other amphetamines are present in human milk. because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. safety and effectiveness in pediatric patients have not been established. because pediatric obesity is a chronic condition requiring long-term treatment, the use of this product, approved for short-term therapy, is not recommended. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. this drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. based on the reported excretion of phentermine in urine, exposure increases can be expected in patients with renal impairment [ see clinical pharmacology ( 12.3) ]. use caution when administering phentermine hydrochloride to patients with renal impairment. in patients with severe renal impairment (egfr 15 to 29 ml/min/1.73 m 2 ), limit the dosage of phentermine hydrochloride to 15 mg daily [ see dosage and administration ( 2.2) ]. phentermine hydrochloride has not been studied in patients with egfr less than 15 ml/min/1.73 m 2 , including end-stage renal disease requiring dialysis; avoid use in these populations. phentermine is a schedule iv controlled substance. phentermine is related chemically and pharmacologically to the amphetamines. amphetamines and other stimulant drugs have been extensively abused and the possibility of abuse of phentermine should be kept in mind when evaluating the desirability of including a drug as part of a weight reduction program. abuse of amphetamines and related drugs may be associated with intense psychological dependence and severe social dysfunction. there are reports of patients who have increased the dosage of these drugs to many times that recommended. abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep eeg. manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity and personality changes. a severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia.