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

berlin-chemie ag - ambroxol (ambroxol hydrochloride) - tablets effervescent - 60mg

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

berlin-chemie a.g. - ambroxol (ambroxol hydrochloride) - tablets effervescent - 60mg

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

berlin-chemie ag - ambroxol (ambroxol hydrochloride) - tablets effervescent - 60mg

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

akorn operating company llc - cimetidine hydrochloride (unii: wf10491673) (cimetidine - unii:80061l1wgd) - cimetidine 300 mg in 5 ml - cimetidine hydrochloride oral solution is indicated in: (1) short-term treatment of active duodenal ulcer. most patients heal within 4 weeks and there is rarely reason to use cimetidine at full dosage for longer than 6 to 8 weeks (see dosage and administration-duodenal ulcer). concomitant antacids should be given as needed for relief of pain. however, simultaneous administration of oral cimetidine and antacids is not recommended, since antacids have been reported to interfere with the absorption of oral cimetidine. (2) maintenance therapy for duodenal ulcer patients at reduced dosage after healing of active ulcer. patients have been maintained on continued treatment with cimetidine 400 mg h.s. for periods of up to 5 years. (3) short-term treatment of active benign gastric ulcer. there is no information concerning usefulness of treatment periods of longer than 8 weeks. (4) erosive gastroesophageal reflux disease (gerd). erosive esophagitis diagnosed by endoscopy. treatment is indicated for 12 weeks for hea

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

mikart, llc - butalbital (unii: khs0az4jvk) (butalbital - unii:khs0az4jvk), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), caffeine (unii: 3g6a5w338e) (caffeine - unii:3g6a5w338e) - butalbital 50 mg in 15 ml - butalbital, acetaminophen and caffeine oral solution is indicated for the relief of the symptom complex of tension (or muscle contraction) headache. evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. caution in this regard is required because butalbital is habit‑forming and potentially abusable. this product is contraindicated under the following conditions: - hypersensitivity or intolerance to any component of this product. - patients with porphyria. butalbital : barbiturates may be habit-forming: tolerance, psychological dependence, and physical dependence may occur especially following prolonged use of high doses of barbiturates. the average daily dose for the barbiturate addict is usually about 1500 mg. as tolerance to barbiturates develops, the amount needed to maintain the same level of intoxication increases; tolerance to a fatal dosage, however, does not increase more than two-fold. as this occurs

Kenya - English - Pharmacy and Poisons Board

hetero labs ltd 7-2-a2 hetero corporate industrial estates sanath - zidovudine - oral solution - each 5ml (1 teaspoonful) contains zidovudine usp… - antivirals for systemic use:

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

cipla ltd. - stavudine (unii: bo9le4qfzf) (stavudine - unii:bo9le4qfzf) - stavudine 1 mg in 1 ml - stavudine in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (hiv)-1 infection [see clinical studies (14) ]. stavudine is contraindicated in patients with clinically significant hypersensitivity to stavudine or to any of the components contained in the formulation. co-administration of stavudine with didanosine is contraindicated due to the potential for serious and/or life-threatening events notably lactic acidosis, hepatotoxicity, peripheral neuropathy, and pancreatitis [see warnings and precautions (5.1, 5.2, 5.3, 5.4 )]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to stavudine for oral solution during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary fatal lactic acidosis has been reported in pregnant individuals who received the combination of stavudine and didano

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

lupin pharmaceuticals,inc. - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride 5 mg in 5 ml - methylphenidate hydrochloride oral solution is indicated for the treatment of: -   attention deficit hyperactivity disorder (adhd) in adults and pediatric patients 6 years of age and older -   narcolepsy methylphenidate hydrochloride oral solution is contraindicated in patients: - with known hypersensitivity to methylphenidate or other components of methylphenidate hydrochloride oral solution. hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [see adverse reactions (6)]. - receiving concomitant treatment with monoamine oxidase inhibitors (maois), or within 14 days following discontinuation of treatment with an maoi, because of the risk of hypertensive crises [see drug interactions (7)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to adhd medications, including methylphenidate hydrochloride oral solution, during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for psychostimulants at 1-866-961-2388. risk summary published studies and postmarketing reports on methylphenidate use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. there may be risks to the fetus associated with the use of cns stimulants use during pregnancy (see clinical considerations ). no effects on morphological development were observed in embryo-fetal development studies with oral administration of methylphenidate to pregnant rats and rabbits during organogenesis at doses up to 12 and 19 times, respectively, the maximum recommended human dose (mrhd) of 60 mg/day given to adults on a mg/m2 basis. however, spina bifida was observed in rabbits at a dose 65 times the mrhd given to adults. a decrease in pup body weight was observed in a pre- and post-natal development study with oral administration of methylphenidate to rats throughout pregnancy and lactation at doses 7 times the mrhd given to adults (see data ). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations fetal/neonatal adverse reactions cns stimulants, such as methylphenidate hydrochloride oral solution, can cause vasoconstriction and thereby decrease placental perfusion. no fetal and/or neonatal adverse reactions have been reported with the use of therapeutic doses of methylphenidate during pregnancy; however, premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers. data animal data in embryo-fetal development studies conducted in rats and rabbits, methylphenidate was administered orally at doses of up to 75 and 200 mg/kg/day, respectively, during the period of organogenesis. malformations (increased incidence of fetal spina bifida) were observed in rabbits at the highest dose, which is approximately 65 times the mrhd of 60 mg/day given to adults on a mg/m2 basis. the no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (19 times the mrhd given to adults on a mg/m2 basis). there was no evidence of morphological development effects in rats, although increased incidences of fetal skeletal variations were seen at the highest dose level (12 times the mrhd of 60 mg/day given to adults on a mg/m2 basis), which was also maternally toxic. the no effect level for embryo-fetal development in rats was 25 mg/kg/day (4 times the mrhd on a mg/m2 basis). when methylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 45 mg/kg/day, offspring body weight gain was decreased at the highest dose (7 times the mrhd of 60 mg/day given to adults on a mg/m2 basis), but no other effects on postnatal development were observed. the no effect level for pre- and postnatal development in rats was 15 mg/kg/day (~2 times the mrhd given to adults on a mg/m2 basis). risk summary limited published literature, based on milk sampling from seven mothers reports that methylphenidate is present in human milk, which resulted in infant doses of 0.16% to 0.7% of the maternal weight- adjusted dosage and a milk/plasma ratio ranging between 1.1 and 2.7. there are no reports of adverse effects on the breastfed infant and no effects on milk production. long-term neurodevelopmental effects on infants from stimulant exposure are unknown. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for methylphenidate hydrochloride oral solution and any potential adverse effects on the breastfed infant from methylphenidate hydrochloride oral solution or from the underlying maternal condition. clinical considerations monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain. the safety and effectiveness of methylphenidate hydrochloride oral solution for the treatment of adhd have been established in pediatric patients six years of age and older. the safety and effectiveness of methylphenidate hydrochloride oral solution in pediatric patients under six years of age have not been established. the long-term efficacy of methylphenidate in pediatric patients has not been established. long-term suppression of growth growth should be monitored during treatment with stimulants, including methylphenidate hydrochloride oral solution. pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted [see warnings and precautions (5.6)]. juvenile animal toxicity data in a study conducted in young rats, methylphenidate was administered orally at doses of up to 100 mg/kg/day for 9 weeks, starting early in the postnatal period (postnatal day 7) and continuing through sexual maturity (postnatal week 10). when these animals were tested as adults (postnatal weeks 13 -14), decreased spontaneous locomotor activity was observed in males and females previously treated with 50 mg/kg/day (approximately 4 times the mrhd of 60 mg/day given to children on a mg/m2 basis) or greater, and a deficit in the acquisition of a specific learning task was seen in females exposed to the highest dose (8 times the mrhd given to children on a mg/m2 basis). the no effect level for juvenile neurobehavioral development in rats (5 mg/kg/day) is less than the mrhd given to children on a mg/m2 basis. the clinical significance of the long-term behavioral effects observed in rats is unknown. methylphenidate hydrochloride oral solution has not been studied in the geriatric population. methylphenidate hydrochloride oral solution contains methylphenidate hydrochloride, a schedule ii controlled substance. methylphenidate hydrochloride oral solution has a high potential for abuse and misuse which can lead to the development of a substance use disorder, including addiction [see warnings and precautions (5.1)]. methylphenidate hydrochloride oral solution can be diverted for nonmedical use into illicit channels or distribution. abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect. 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. 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 methylphenidate may cause increased heart rate, respiratory rate, or blood pressure; sweating; dilated pupils; hyperactivity; restlessness; insomnia; decreased appetite; loss of coordination; tremors; flushed skin; vomiting; and/or abdominal pain. anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation have also been observed with cns stimulants abuse and/or misuse. misuse and abuse of cns stimulants, including methylphenidate hydrochloride oral solution, can result in overdose and death [see overdosage (10)] , and this risk is increased with higher doses and or unapproved methods of administration, such as snorting or injection. physical dependence methylphenidate hydrochloride oral solution may produce physical dependence. 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. withdrawal signs and symptoms after abrupt discontinuation or dose reduction following prolonged use of cns stimulants including methylphenidate hydrochloride oral solution include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation. tolerance methylphenidate hydrochloride oral solution may produce tolerance. 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).

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

prasco laboratories - dextroamphetamine sulfate (unii: jj768o327n) (dextroamphetamine - unii:tz47u051fi) - dextroamphetamine sulfate oral solution is indicated in:  narcolepsy  attention deficit disorder with hyperactivity: as an integral part of a total treatment program that typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 years to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotionally lability, and impulsivity. the diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. nonlocalizing (soft) neurological signs, learning disability, and abnormal eeg may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.  known hypersensitivity to amphetamine products.  during or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crisis may resu