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

natco pharma usa llc - testosterone (unii: 3xmk78s47o) (testosterone - unii:3xmk78s47o) - testosterone topical solution 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 cryptor chidism, 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 concentrations and gonadotropins (fsh, lh) above the normal range. - hypogonadotropic hypogonadism (congenital or acquired): gonadotropic 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 in men with “age-related hypogonadism' (also referred to as “late-onset hypogonadism”) have not been established. - safety and efficacy of testosterone topical solution in males < 18 years old have not been established [see use in specific populations (8.4)] . - testosterone topical solution is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate [see warnings and precaution (5.1)] . - testosterone topical solution is contraindicated in women who are, or who may become pregnant, or who are breastfeeding. testosterone topical solution may cause fetal harm when administered to a pregnant woman. testosterone topical solution may cause serious adverse reactions in nursing infants. if a pregnant woman is exposed to testosterone topical solution, she should be apprised of the potential hazard to the fetus. [see use in specific populations (8.1, 8.3)] . pregnancy category x [see contraindications (4)] — testosterone topical solution is contraindicated during pregnancy or in women who may become pregnant. testosterone is teratogenic and may cause fetal harm. exposure of a female fetus to androgens may result in varying degrees of virilization. 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. although it is not known how much testosterone transfers into human milk, testosterone topical solution is contraindicated in nursing women because of the potential for serious adverse reactions in nursing infants. testosterone and other androgens may adversely affect lactation. [see contraindications (4)] . safety and efficacy of testosterone topical solution has not been established in males <18 years of age. improper use may result in acceleration of bone age and premature closure of epiphyses. there have not been sufficient numbers of geriatric patients involved in controlled clinical studies utilizing testosterone topical solution to determine whether efficacy in those over 65 years of age differs from younger patients. of the 155 patients enrolled in the pivotal clinical study utilizing testosterone topical solution, 21 were over 65 years of age. additionally, there were insufficient long-term safety data in these patients utilizing testosterone topical solution to assess a potential incremental risk of cardiovascular disease and prostate cancer. no formal studies were conducted involving patients with renal impairment. no formal studies were conducted involving patients with hepatic impairment. safety and efficacy of testosterone topical solution in males with bmi >35 kg/m2 has not been established. testosterone topical solution contains testosterone, a schedule iii controlled substance in the controlled substances act. drug abuse is intentional non-therapeutic use of a drug, even once, for its rewarding psychological and physiological effects. abuse and misuse of testosterone are seen in male and female adults and adolescents. testosterone, often in combination with other anabolic androgenic steroids (aas), and not obtained by prescription through a pharmacy, may be abused by athletes and bodybuilders. there have been reports of misuse by men taking higher doses of legally obtained testosterone than prescribed and continuing testosterone despite adverse events or against medical advice. abuse-related adverse reactions serious adverse reactions have been reported in individuals who abuse anabolic androgenic steroids and include cardiac arrest, myocardial infarction, hypertrophic cardiomyopathy, congestive heart failure, cerebrovascular accident, hepatotoxicity, and serious psychiatric manifestations, including major depression, mania, paranoia, psychosis, delusions, hallucinations, hostility and aggression. the following adverse reactions have also been reported in men: transient ischemic attacks, convulsions, hypomania, irritability, dyslipidemias, testicular atrophy, subfertility, and infertility. the following additional adverse reactions have been reported in women: hirsutism, virilization, deepening of voice, clitoral enlargement, breast atrophy, male-pattern baldness and menstrual irregularities. the following adverse reactions have been reported in male and female adolescents: premature closure of bony epiphyses with termination of growth, and precocious puberty. because these reactions are reported voluntarily from a population of uncertain size and may include abuse of other agents, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. behaviors associated with addiction continued abuse of testosterone and other anabolic steroids, leading to addiction is characterized by the following behaviors: - taking greater dosages than prescribed - continued drug use despite medical and social problems due to drug use - spending significant time to obtain the drug when supplies of the drug are interrupted - giving a higher priority to drug use than other obligations - having difficulty in discontinuing the drug despite desires and attempts to do so - experiencing withdrawal symptoms upon abrupt discontinuation of use physical dependence is characterized by withdrawal symptoms after abrupt drug discontinuation or a significant dose reduction of a drug. individuals taking supratherapeutic doses of testosterone may experience withdrawal symptoms lasting for weeks or months which include depressed mood, major depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido and hypogonadotropic hypogonadism. drug dependence in individuals using approved doses of testosterone for approved indications has not been documented. instructions for use testosterone (tes-tos-te-rone) topical solution, for topical use ciii read this instructions for use for testosterone topical solution before you start using it and each time you get a refill. there may be new information. this leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment. applying testosterone topical solution - testosterone topical solution is to be applied to the armpits only. do not apply testosterone topical solution to any other parts of your body such as your stomach area (abdomen), penis, scrotum, shoulders or upper arms. - do not apply testosterone topical solution with your fingers or hands. - apply testosterone topical solution at about the same time each morning. testosterone topical solution should be applied after showering and bathing. - avoid swimming or bathing for at least 2 hours after you apply testosterone topical solution. - you can use an antiperspirant or deodorant before applying testosterone topical solution. if you use antiperspirant or deodorant, then it should be applied at least 2 minutes before you apply testosterone topical solution. - testosterone topical solution is flammable until dry. let testosterone topical solution dry before smoking or going near an open flame. - avoid splashing in the eyes. in case of contact with eyes, flush thoroughly with water. if irritation persists, seek medical advice. testosterone topical solution figure 1 - before using a new bottle of testosterone topical solution for the first time, you will need to prime the pump. to prime the testosterone topical solution pump gently push down on the pump 3 times. do not use any testosterone topical solution that came out while priming. wash it down the sink to avoid accidental exposure to others. your testosterone topical solution pump is now ready to use. - use testosterone topical solution exactly as your healthcare provider tells you to use it. your healthcare provider will tell you the dose of testosterone topical solution that is right for you. apply your dose correctly by following the application instructions in the table below. - before applying testosterone topical solution, make sure that your armpit is clean, dry and that there is no broken skin. figure 2 remove the cap and the applicator cup from the pump. then, position the nozzle over the applicator cup and gently press down on (depress) the pump (see figure 2). figure 3 - to apply the testosterone topical solution, keep the applicator upright, place it up into the armpit application site and wipe steadily down and up. (see figure 3). - if testosterone topical solution drips or runs, wipe it back up with the applicator cup. do not rub in the solution with your fingers or hand after it has been applied. - let the application site dry completely for 3 minutes before putting on a shirt. - after you have finished applying testosterone topical solution, rinse the applicator cup with room temperature running water, and then pat it dry with a tissue. carefully replace the applicator cup and cap back onto the bottle and make sure you store the bottle safely. - clean up any spilled solution from surfaces such as the sink or floor to make sure others do not come into contact with it. - wash your hands with soap and water right away. how should i store testosterone topical solution? - store testosterone topical solution upright at room temperature between 68ºf to 77ºf (20ºc to 25ºc). - when it is time to throw away the bottle, safely throw away all parts of the testosterone topical solution dispenser including the bottle applicator cup and cap into the household trash. - be careful to prevent accidental exposure of children or pets. - keep testosterone topical solution away from fire. keep testosterone topical solution and all medicines out of the reach of children. this instructions for use has been approved by the u.s. food and drug administration. revised: 04/2021

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

natco pharma usa llc - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam oral solution is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. levetiracetam oral solution is indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy. levetiracetam oral solution is indicated as adjunctive therapy for the treatment of primary generalized tonic- clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy. levetiracetam oral solution is contraindicated in patients with a hypersensitivity to levetiracetam. reactions have included anaphylaxis and angioedema [see warnings and precautions (5.4)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), including levetiracetam, during pregnancy. encourage women who are taking levetiracetam during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

natco pharma limited, india - carfilzomib - injection - 60 mg/vial

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

atco laboratories limited, pakistan - sitaglipin - film coated tablets - 50

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

natco pharma limited-pharma division - sofosbuvir, velpatasvir - tablets film-coated - 400mg+ 100mg

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

natco pharma usa llc - armodafinil (unii: v63xwa605i) (armodafinil - unii:v63xwa605i) - armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (osa), narcolepsy, or shift work disorder (swd). limitations of use in osa, armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. if continuous positive airway pressure (cpap) is the treatment of choice for a patient, a maximal effort to treat with cpap for an adequate period of time should be made prior to initiating armodafinil tablets for excessive sleepiness. armodafinil tablets are contraindicated in patients with known hypersensitivity to modafinil or armodafinil or its inactive ingredients [see warnings and precautions (5.1, 5.2, 5.3)]. risk summary limited available data on armodafinil use in pregnant women are insufficient to inform a drug associated risk of adverse pregnancy outcomes. intrauterine growth restriction and spontaneous abortion have been reported in association with armodafinil and modafinil. although the pharmacology of armodafinil is not identical to that of the sympathomimetic amines, armodafinil shares some pharmacologic properties with this class [see clinical pharmacology (12.1)]. some sympathomimetics have been associated with intrauterine growth restriction and spontaneous abortions. in animal reproduction studies of armodafinil (r-modafinil) and modafinil (a mixture of r-and s-modafinil) conducted in pregnant rats (armodafinil, modafinil) and rabbits (modafinil) during organogenesis, evidence of developmental toxicity (increased embryofetal and offspring mortality, decreased fetal growth) was observed at clinically relevant plasma exposures. all pregnancies have a background risk of birth defects, loss, or other adverse outcomes. the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data oral administration of armodafinil (60, 200, or 600 mg/kg/day) to pregnant rats throughout organogenesis resulted in decreased fetal body weight and increased incidences of fetal variations indicative of growth delay at the highest dose, which was also maternally toxic. the highest no-effect dose for embryofetal developmental toxicity in rat (200 mg/kg/day) was associated with a plasma armodafinil exposure (auc) less than that in humans at the maximum recommended human dose (mrhd) of armodafinil (250 mg/day). modafinil (50, 100, or 200 mg/kg/day) administered orally to pregnant rats throughout organogenesis produced an increase in resorptions and an increased incidence of fetal variations at the highest dose tested. the higher no-effect dose for embryofetal developmental toxicity (100 mg/kg/day) was associated with a plasma armodafinil auc less than that in humans at the mrhd of armodafinil tablets. however, in a subsequent rat study of up to 480 mg/kg/day of modafinil, no adverse effects on embryofetal development were observed. in a study in which modafinil (45, 90, or 180 mg/kg/day) was orally administered to pregnant rabbits during organogenesis, embryofetal death was increased at the highest dose. the highest no-effect dose for developmental toxicity (100 mg/kg/day) was associated with a plasma armodafinil auc less than that in humans at the mrhd of armodafinil tablets. modafinil administration to rats throughout gestation and lactation at oral doses of up to 200 mg/kg/day resulted in decreased viability in the offspring at doses greater than 20 mg/kg/day, a dose resulting in a plasma armodafinil auc less than that in humans at the mrhd of armodafinil tablets. no effects on postnatal developmental and neurobehavioral parameters were observed in surviving offspring. risk summary there are no data on the presence of armodafinil or its metabolites in human milk, the effects on the breastfed infant, or the effect of this drug on milk production. modafinil was present in rat milk when animals were dosed during the lactation period. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for armodafinil and any potential adverse effects on the breastfed child from armodafinil or from the underlying maternal condition. the effectiveness of hormonal contraceptives may be reduced when used with armodafinil tablets and for one month after discontinuation of therapy. advise women who are using a hormonal method of contraception to use an additional barrier method or an alternative non-hormonal method of contraception during treatment with armodafinil tablets and for one month after discontinuation armodafinil tablets  of treatment [see drug interactions (7) and clinical pharmacology (12.3)]. safety and effectiveness in pediatric patients have not been established. serious rash has been seen in pediatric patients receiving modafinil [see warnings and precautions (5.1)]. in elderly patients, elimination of armodafinil and its metabolites may be reduced as a consequence of aging. therefore, consideration should be given to the use of lower doses and close monitoring in this population [see dosage and administration (2.4)and clinical pharmacology (12.3)]. the dosage of armodafinil tablets should be reduced in patients with severe hepatic impairment [see dosage and administration (2.3)and clinical pharmacology (12.3)]. armodafinil tablets contain armodafinil, a schedule iv controlled substance. abuse of armodafinil tablets has been reported in patients treated with  armodafinil tablets. patterns of abuse have included euphoric mood and use of increasingly large doses or recurrent use of  armodafinil tablets  for a desired effect. drug diversion has also been noted. during the postmarketing period, misuse of  armodafinil tablets has been observed (e.g., taking  armodafinil tablets   against a physician’s advice, and obtaining  armodafinil tablets from multiple physicians). abuse of armodafinil, the active ingredient of  armodafinil tablets, poses a risk of overdosage similar to that seen for modafinil, which may lead to tachycardia, insomnia, agitation, dizziness, anxiety, nausea, headache, dystonia, tremor, chest pain, hypertension, seizures, delirium, or hallucinations. other signs and symptoms of cns stimulant abuse include tachypnea, sweating, dilated pupils, hyperactivity, restlessness, decreased appetite, loss of coordination, flushed skin, vomiting, and abdominal pain. in humans, modafinil produces psychoactive and euphoric effects, alterations in mood, perception, thinking and feelings, typical of other cns stimulants. in in vitro binding studies, modafinil binds to the dopamine reuptake site and causes an increase in extracellular dopamine, but no increase in dopamine release. modafinil is reinforcing, as evidenced by its self-administration in monkeys previously trained to self-administer cocaine. in some studies, modafinil was also partially discriminated as stimulant-like. physicians should follow patients closely, especially those with a history of drug and/or stimulant (e.g., methylphenidate, amphetamine, or cocaine) abuse. patients should be observed for signs of misuse or abuse (e.g., incrementation of doses or drug-seeking behavior). the abuse potential of modafinil (200, 400, and 800 mg) was assessed relative to methylphenidate (45 and 90 mg) in an inpatient study in individuals experienced with drugs of abuse. results from this clinical study demonstrated that modafinil produced psychoactive and euphoric effects and feelings consistent with other scheduled cns stimulants (methylphenidate). physical dependence is a state that develops as a result of 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. physical dependence can occur in patients treated with armodafinil tablets. abrupt cessation or dose reduction following chronic use can result in withdrawal symptoms, including shaking, sweating, chills, nausea, vomiting, confusion, aggression, and atrial fibrillation. drug withdrawal convulsions, suicidality, fatigue, insomnia, aches, depression and headache have also been observed during the postmarketing period. also, abrupt withdrawal has caused deterioration of psychiatric symptoms such as depression. 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). multiple cases of development of tolerance to armodafinil tablets have been reported during the postmarketing period.

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

natco pharma limited - trihexyphenidyl hydrochloride (unii: ao61g82577) (trihexyphenidyl - unii:6rc5v8b7po) - trihexyphenidyl hydrochloride 2 mg - trihexyphenidyl hcl 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.  trihexyphenidyl hcl is contraindicated in patients with hypersensitivity to trihexyphenidyl hcl or to any of the tablet ingredients. trihexyphenidyl hcl is also contraindicated in patients with narrow angle glaucoma. blindness after long-term use due to narrow angle glaucoma has been reported. although trihexyphenidyl hcl is not classified as a controlled substance, the possibility of abuse should be borne in mind due to its stimulant and euphoriant properties.

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

natco pharma usa llc - alprazolam (unii: yu55mq3izy) (alprazolam - unii:yu55mq3izy) - alprazolam tablets are indicated for the:  - acute treatment of generalized anxiety disorder (gad) in adults.  - treatment of panic disorder (pd), with or without agoraphobia in adults.  alprazolam tablets are contraindicated in patients:  - with known hypersensitivity to alprazolam or other benzodiazepines. angioedema has been reported [see adverse reactions (6.2)].  - taking strong cytochrome p450 3a (cyp3a) inhibitors (e.g., ketoconazole, itraconazole), except ritonavir [see dosage and administration (2.6), warnings and precautions (5.5), drug interactions (7.1)]  pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to psychiatric medications, including alprazolam tablets, during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for psychiatric medications at 1-866-961-2388 or visiting online at  https://womensmentalhealth.org/research/pregnancyregistry/. risk summary

Nigeria - English - NAFDAC (National Agency for Food and Drugs Administration and Control)

zinc phosphide 755

Kenya - English - Pharmacy and Poisons Board

national pharmacy ltd p.o box 17843-00500 nairobi. - mometasone furoate cream 0.1% w/w - cream - mometasone furoate cream 0.1% w/w - mometasone