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

eton pharmaceuticals, inc. - hydrocortisone (unii: wi4x0x7bpj) (hydrocortisone - unii:wi4x0x7bpj) - alkindi sprinkle is indicated as replacement therapy in pediatric patients with adrenocortical insufficiency. alkindi sprinkle is contraindicated in patients with hypersensitivity to hydrocortisone or to any of the ingredients in alkindi sprinkle. anaphylactic reactions have occurred in patients receiving corticosteroids [see adverse reactions (6.2)] . risk summary untreated adrenocortical insufficiency in pregnancy can result in a high rate of complications, including maternal mortality. the use of physiologic doses of hydrocortisone is not expected to cause major birth defects, miscarriage and adverse maternal and fetal outcomes. available data from observational studies with hydrocortisone use in pregnancy have not identified a clear drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes (see data ). the estimated background risk of major birth defects and miscarriage for the indicated population 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 human data available data from observational studies with hydrocortisone use in pregnant women have not identified a clear drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. evidence from published epidemiologic studies suggest that there may be a small increased risk of cleft lip with or without cleft palate associated with first trimester systemic corticosteroid use in pregnant patients. however, the data are limited and report inconsistent findings, and studies have important methodological limitations, including non-randomized design, retrospective data collection, lack of dose-response data and the inability to control for confounders, such as underlying maternal disease and use of concomitant medications. in addition, unlike other corticosteroids, hydrocortisone is enzymatically deactivated by the placenta and therefore, limits fetal exposure. animal data corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. animal studies in which corticosteroids have been given to pregnant mice, rats and rabbits without adrenocortical insufficiency have yielded an increased incidence of cleft palate in the offspring. risk summary cortisol is present in human milk. the use of hydrocortisone at a physiologic dose for adrenocortical insufficiency is not expected to adversely affect the breastfed infant or milk production. there are no data on the presence of hydrocortisone in breast milk, the effect on the breastfed infant or on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for alkindi sprinkle and any potential adverse effects on the breastfed infant from alkindi sprinkle or from the underlying maternal condition. the safety and effectiveness of alkindi sprinkle have been established in pediatric patients for replacement therapy of adrenocortical insufficiency and the information on this use is discussed throughout the labeling. use of alkindi sprinkle in pediatric patients is supported by use in pediatric patients for adrenocortical insufficiency with another hydrocortisone product, along with supportive pharmacokinetic and safety data in 24 pediatric patients with adrenocortical insufficiency. no new adverse reactions were identified [see adverse reactions (6) and clinical pharmacology (12.3)] . alkindi sprinkle are oral granules contained within capsules that must be opened and not swallowed whole to administer the granules. additionally, alkindi sprinkle granules should not be administered via nasogastric or gastric tubes as they may cause tube blockage [see dosage and administration (2.2)] . instructions for use alkindi® sprinkle(ælˈkɪndi spr-en-kle) (hydrocortisone) oral granules read this instructions for use before you start using alkindi sprinkle, and each time you get a refill. there may be new information. this information does not take the place of talking to your healthcare provider about your child's medical condition or treatment. important information you need to know before giving alkindi sprinkle - alkindi sprinkle comes in a capsule that must be opened before use. - do not let your child swallow the capsule. small children may choke. - do not let your child chew or crush the granules in the capsule. - do not let the capsules get wet as this may make some of the granules stick to the capsule. - your healthcare provider will decide the right dose of alkindi sprinkle for your child. follow your healthcare provider's instructions for the dose of alkindi sprinkle to give your child. - ask your healthcare provider or pharmacist if you are not sure how to prepare or give the prescribed dose of alkindi sprinkle to your child. - call your healthcare provider if granules come back up into your child's mouth (regurgitation) or your child has vomiting after swallowing alkindi sprinkle. your child may not have received the full dose of alkindi sprinkle and another dose of alkindi sprinkle may be needed. - your child may sometimes pass the alkindi sprinkle granules in their stools (bowel movement). it does not mean that alkindi sprinkle is not working. do not give your child another dose of alkindi sprinkle. supplies needed to give alkindi sprinkle: - alkindi sprinkle capsule(s) for prescribed dose - 1 spoon - soft food such as yogurt or pureed fruit or sip of fluids such as water, milk, breastmilk or formula preparing and giving alkindi sprinkle: step 1: check the expiration date on the alkindi sprinkle bottle. do not use alkindi sprinkle after the expiration date on the bottle has passed. step 2: remove the prescribed dose of alkindi sprinkle capsules from the bottle. step 6: giving alkindi sprinkle alkindi sprinkle can be given (a) with food onto a spoon, (b) without food onto a spoon, or (c) directly into the child's mouth. do not add the granules to a fluid before giving alkindi sprinkle because it can result in less than the full dose given and it may leave a bitter taste in the mouth. (c) directly onto the child's tongue. pour all granules that make up the prescribed dose directly onto the child's tongue. tap the capsule to make sure all granules are removed. the alkindi sprinkle granules should be given and swallowed within 5 minutes to avoid a bitter taste. step 7: give fluids after giving alkindi sprinkle, give a sip of fluids such as water, milk, breastmilk or formula right away to make sure all granules are swallowed. throwing away (disposal of) alkindi sprinkle: ask your pharmacist how to throw away medicines you no longer use. how should i store alkindi sprinkle? - store alkindi sprinkle at room temperature between 68°f to 77°f (20°c to 25°c). - store in the original bottle to protect from light. - after the bottle has been opened, use the alkindi sprinkle capsules within 60 days. keep alkindi sprinkle and all medicines out of the reach of children. alkindi sprinkle is manufactured for eton pharmaceuticals, inc. by glatt pharmaceutical services gmbh & co. kg werner-glatt-strasse 1, binzen, baden-wuerttemberg, 79589, germany alkindi® is a registered trademark of diurnal limited. alkindi is covered by the following us patents: 9,649,280; 9,675,559; 9,717,740; and other patents in other countries internationally. for more information, go to www.alkindisprinkle.com or call 1-833-343-2500. this instructions for use has been approved by the u.s. food and drug administration. revised: 12/2022

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

akorn - clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c) - clindamycin 300 mg in 50 ml - clindamycin in 5% dextrose injection is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. clindamycin in 5% dextrose injection is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. because of the risk of antibiotic-associated pseudomembranous colitis, as described in the boxed warning , before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. indicated surgical procedures should be performed in conjunction with antibiotic therapy. clindamycin in 5% dextrose injection is indicated in the treatment of serious infections caused b

Australia - English - Department of Health (Therapeutic Goods Administration)

viatris pty ltd - timolol maleate, quantity: 6.83 mg/ml (equivalent: timolol, qty 5 mg/ml); latanoprost, quantity: 50 microgram/ml - eye drops, solution - excipient ingredients: dibasic sodium phosphate; water for injections; monobasic sodium phosphate monohydrate; benzalkonium chloride; sodium chloride; hydrochloric acid; sodium hydroxide - reduction of elevated intraocular pressure in patients with open-angle glaucoma and ocular hypertension who are insufficiently responsive to beta-blockers, prostaglandins or other intraocular pressure lowering medications. xalamol 50/5 should not be used to initiate therapy.

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

aurobindo pharma limited - cefadroxil (unii: 280111g160) (cefadroxil anhydrous - unii:q525pa8jjb) - cefadroxil anhydrous 250 mg in 5 ml - cefadroxil is indicated for the treatment of patients with infection caused by susceptible strains of the designated organisms in the following diseases:   urinary tract infections caused by e. coli, p. mirabilis, and klebsiella species.   skin and skin structure infections caused by staphylococci and/or streptococci.   pharyngitis and/or tonsillitis caused by streptococcus pyogenes (group a beta-hemolytic streptococci).   note: only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. cefadroxil is generally effective in the eradication of streptococci from the oropharynx.  however, data establishing the efficacy of cefadroxil for the prophylaxis of subsequent rheumatic fever are not available.   note: culture and susceptibility tests should be initiated prior to and during therapy.  renal function studies should be performed when indicated.   to reduce the development of drug-resistant bacteria and maintain the effectiveness of cefadroxil and other antibacterial drugs, cefadroxil should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.  when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.  in the absence of such data, local epidemology and susceptibility patterns may contribute to the empiric selection of therapy. cefadroxil is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

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

chartwell rx llc - doxycycline hyclate (unii: 19xts3t51u) (doxycycline anhydrous - unii:334895s862) - doxycycline anhydrous 50 mg - to reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline and other antibacterial drugs, doxycycline should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. doxycycline is indicated for the treatment of the following infections: - rocky mountain spotted fever, typhus fever and the typhus group, q fever, rickettsialpox, and tick fevers caused by rickettsiae. - respiratory tract infections caused by mycoplasma pneumoniae . - lymphogranuloma venereum caused by chlamydia trachomatis . - psittacosis (ornithosis) caused by chlamydophila psittaci . - trachoma caused by chlamydia trachomatis, although the infectious agent is not always eliminated, as j

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

virbac ah, inc. - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9) - amoxicillin anhydrous 50 mg - biomox® (amoxicillin tablets) are indicated for treatment of the following infections in dogs when caused by susceptible strains of organisms: bacterial dermatitis due to staphylococcus aureus, strepto-coccus spp., staphylococcus spp., and escherichia coli . soft tissue infections (abscesses, wounds, lacerations) due to staphylococcus aureus,enterococcus faecalis, escherichia coli, proteus mirabilis, and staphylococcus spp . with all antibiotic therapy, appropriate in vitro cultures and sensitivities should be conducted prior to treatment. use of amoxicillin is contraindicated in animals with a history of an allergic reaction to penicillin.

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

rising pharmaceuticals, inc. - doxercalciferol (unii: 3diz9lf5y9) (doxercalciferol - unii:3diz9lf5y9) - - doxercalciferol capsules are indicated for the treatment of secondary hyperparathyroidism in adult patients with stage 3 or stage 4 chronic kidney disease (ckd) and adult patients with ckd on dialysis. doxercalciferol is contraindicated in patients with: - hypercalcemia [see warnings and precautions (5.1)] - vitamin d toxicity [see warnings and precautions (5.1)] - known hypersensitivity to doxercalciferol or any of the inactive ingredients of doxercalciferol capsules; serious hypersensitivity reactions including anaphylaxis and angioedema have been reported [see warnings and precautions (5.3), adverse reactions (6.2)]. risk summary the limited available data with doxercalciferol in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes. there are risks to the mother and fetus associated with chronic kidney disease in pregnancy [see clinical considerations] . in reproduction studies in r

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

boscia, llc. - titanium dioxide 4.6%, zinc oxide 12.6%, purpose: sunscreen - - helps prevent sunburn - if used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging caused by the sun

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

avkare - risperidone (unii: l6uh7zf8hc) (risperidone - unii:l6uh7zf8hc) - risperidone tablets are indicated for the treatment of schizophrenia. efficacy was established in 4 short-term trials in adults, 2 short-term trials in adolescents (ages 13 to 17 years), and one long-term maintenance trial in adults [see clinical studies (14.1)] . monotherapy risperidone tablets are indicated for the treatment of acute manic or mixed episodes associated with bipolar i disorder. efficacy was established in 2 short-term trials in adults and one short-term trial in children and adolescents (ages 10 to 17 years) [see clinical studies (14.2)] . adjunctive therapy risperidone tablets adjunctive therapy with lithium or valproate is indicated for the treatment of acute manic or mixed episodes associated with bipolar i disorder. efficacy was established in one short-term trial in adults [see clinical studies (14.3)] . risperidone tablets are indicated for the

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

pegasus laboratories, inc. - potassium bromide (unii: osd78555zm) (bromide ion - unii:952902ix06) - kbrovet-ca1 should not be used in animals with a history of hypersensitivity to bromide. not for human use.  keep out of reach of children.  contact a physician in case of accidental ingestion by humans. not for use in cats. keep kbrovet-ca1 in a secured location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.