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

hospira, inc. - bupivacaine hydrochloride (unii: 7tqo7w3vt8) (bupivacaine - unii:y8335394ro) - bupivacaine hydrochloride anhydrous 2.5 mg in 1 ml - bupivacaine hydrochloride injection/bupivacaine hydrochloride and epinephrine injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. specific concentrations and presentations of bupivacaine hydrochloride injection/bupivacaine hydrochloride and epinephrine injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see dosage and administration (2.2)]. limitations of use not all blocks are indicated for use with bupivacaine hydrochloride injection/bupivacaine hydrochloride and epinephrine injection given clinically significant risks associated with use [see dosage and administration (2.2), contraindications (4), warnings and precautions (5.1, 5.4, 5.5, 5.7, 5.9)] . bupivacaine hydrochloride injection/bupivacaine hydrochloride and epinephrine injection is contraindicated in: risk summary bupivacaine hydrochloride injection/bupivacaine hydrochloride and epinephrine injection is contraindicated for obstetrical paracervical block anesthesia. its use in this technique has resulted in fetal bradycardia and death [see contraindications (4), warnings and precautions (5.1)]. there are no available data on use of bupivacaine hydrochloride injection/bupivacaine hydrochloride and epinephrine injection in pregnant women to inform a drug-associated risk of adverse developmental outcomes. in animal studies, embryo-fetal lethality was noted when bupivacaine was administered subcutaneously to pregnant rabbits during organogenesis at clinically relevant doses. decreased pup survival was observed in a rat pre- and post-natal developmental study (dosing from implantation through weaning) at a dose level comparable to the daily maximum recommended human dose (mrhd) on a body surface area (bsa) basis. based on animal data, advise pregnant women of the potential risks to a fetus (see data). local anesthetics rapidly cross the placenta, and when used for epidural, caudal, or pudendal block anesthesia, can cause varying degrees of maternal, fetal, and neonatal toxicity [see clinical pharmacology (12.3)]. the incidence and degree of toxicity depend upon the procedure performed, the type, and amount of drug used, and the technique of drug administration. adverse reactions in the parturient, fetus, and neonate involve alterations of the cns, peripheral vascular tone, and cardiac function. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, inform the patient of the potential hazard to the fetus. the estimated background risk of major birth defects and miscarriage for the indicated populations are 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. clinical considerations maternal adverse reactions maternal hypotension has resulted from regional anesthesia. local anesthetics produce vasodilation by blocking sympathetic nerves. the supine position is dangerous in pregnant women at term because of aortocaval compression by the gravid uterus. therefore, during treatment of systemic toxicity, maternal hypotension or fetal bradycardia following regional block, the parturient should be maintained in the left lateral decubitus position if possible, or manual displacement of the uterus off the great vessels be accomplished. elevating the patient's legs will also help prevent decreases in blood pressure. the fetal heart rate also should be monitored continuously and electronic fetal monitoring is highly advisable. labor or delivery epidural, caudal, or pudendal anesthesia may alter the forces of parturition through changes in uterine contractility or maternal expulsive efforts. epidural anesthesia has been reported to prolong the second stage of labor by removing the parturient's reflex urge to bear down or by interfering with motor function. the use of obstetrical anesthesia may increase the need for forceps assistance. the use of some local anesthetic drug products during labor and delivery may be followed by diminished muscle strength and tone for the first day or two of life. this has not been reported with bupivacaine. it is extremely important to avoid aortocaval compression by the gravid uterus during administration of regional block to parturients. to do this, the patient must be maintained in the left lateral decubitus position or a blanket roll or sandbag may be placed beneath the right hip and gravid uterus displaced to the left. data animal data bupivacaine hydrochloride produced developmental toxicity when administered subcutaneously to pregnant rats and rabbits at clinically relevant doses. bupivacaine hydrochloride was administered subcutaneously to rats at doses of 4.4, 13.3, & 40 mg/kg and to rabbits at doses of 1.3, 5.8, & 22.2 mg/kg during the period of organogenesis (implantation to closure of the hard palate). the high doses are comparable to the daily mrhd of 400 mg/day on a mg/m2 bsa basis. no embryo-fetal effects were observed in rats at the high dose which caused increased maternal lethality. an increase in embryo-fetal deaths was observed in rabbits at the high dose in the absence of maternal toxicity with the fetal no observed adverse effect level representing approximately 0.3 times the mrhd on a bsa basis. in a rat pre- and post-natal developmental study (dosing from implantation through weaning) conducted at subcutaneous doses of 4.4, 13.3, & 40 mg/kg, decreased pup survival was observed at the high dose. the high dose is comparable to the daily mrhd of 400 mg/day on a bsa basis. risk summary lactation studies have not been conducted with bupivacaine. bupivacaine has been reported to be excreted in human milk suggesting that the nursing infant could be theoretically exposed to a dose of the drug. bupivacaine hydrochloride injection/bupivacaine hydrochloride and epinephrine injection should be administered to lactating women only if clearly indicated. studies assessing the effects of bupivacaine hydrochloride injection/bupivacaine hydrochloride and epinephrine injection in breastfed children have not been performed. studies to assess the effect of bupivacaine hydrochloride injection/bupivacaine hydrochloride and epinephrine injection on milk production or excretion have not been performed. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for bupivacaine and any potential adverse effects on the breastfed child from bupivacaine or from the underlying maternal condition. bupivacaine hydrochloride injection/bupivacaine hydrochloride and epinephrine injection is approved for use in adults. administration of bupivacaine hydrochloride injection/bupivacaine hydrochloride and epinephrine injection in pediatric patients younger than 12 years is not recommended. continuous infusions of bupivacaine in pediatric patients have been reported to result in high systemic levels of bupivacaine and seizures; high plasma levels may also be associated with cardiovascular abnormalities. patients 65 years and over, particularly those with hypertension, may be at increased risk for developing hypotension while undergoing anesthesia with bupivacaine hydrochloride injection/bupivacaine hydrochloride and epinephrine injection. in clinical studies of bupivacaine, elderly patients reached the maximal spread of analgesia and maximal motor blockade more rapidly than younger adult patients. differences in various pharmacokinetic parameters have been observed between elderly and younger adult patients [see clinical pharmacology (12.3)]. this product is known to be substantially excreted by the kidney, and the risk of adverse 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. elderly patients may require lower doses of bupivacaine hydrochloride injection/bupivacaine hydrochloride and epinephrine injection. amide-type local anesthetics, such as bupivacaine, are metabolized by the liver. patients with severe hepatic impairment, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations, and potentially local anesthetic systemic toxicity. therefore, consider reduced dosing and increased monitoring for local anesthetic systemic toxicity in patients with moderate to severe hepatic impairment treated with bupivacaine hydrochloride injection/bupivacaine hydrochloride and epinephrine injection, especially with repeat doses [see warnings and precautions (5.10)] . bupivacaine is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with renal impairment. this should be considered when selecting the bupivacaine hydrochloride injection/bupivacaine hydrochloride and epinephrine injection dosage [see use in specific populations (8.5)] .

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

baxter healthcare pty ltd - bupivacaine hydrochloride, quantity: 5 mg/ml (equivalent: bupivacaine hydrochloride monohydrate, qty 5.28 mg/ml) - injection, solution - excipient ingredients: hydrochloric acid; sodium chloride; water for injections; sodium hydroxide - indications ,bupivacaine-claris is indicated for the production of local or regional anaesthesia and analgesia in individuals as follows: ,surgical anaesthesia ,epidural block for surgery ,field block (minor and major nerve blocks and infiltration). ,analgesia ,continuous epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain. ,field block (minor nerve block and infiltration).

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

baxter healthcare pty ltd - bupivacaine hydrochloride, quantity: 5 mg/ml (equivalent: bupivacaine hydrochloride monohydrate, qty 5.28 mg/ml) - injection, solution - excipient ingredients: hydrochloric acid; sodium chloride; sodium hydroxide; water for injections - indications ,bupivacaine-baxter is indicated for the production of local or regional anaesthesia and analgesia in individuals as follows: ,surgical anaesthesia ,epidural block for surgery ,field block (minor and major nerve blocks and infiltration). ,analgesia ,continuous epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain. ,field block (minor nerve block and infiltration).

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

hospira, inc. - bupivacaine hydrochloride (unii: 7tqo7w3vt8) (bupivacaine - unii:y8335394ro) - bupivacaine hydrochloride anhydrous 7.5 mg in 1 ml - bupivacaine spinal is indicated for subarachnoid injection in adults for the production of subarachnoid block (spinal anesthesia). bupivacaine spinal is contraindicated in: risk summary the available data on the use of bupivacaine spinal in pregnant women do not establish the presence or absence of developmental toxicity related to the use of bupivacaine spinal. in animal studies, embryo-fetal lethality was noted when bupivacaine was administered subcutaneously to pregnant rabbits during organogenesis and decreased pup survival was observed in a rat pre- and post-natal developmental study (dosing from implantation through weaning). these effects were observed at dose levels approximately 30 times the daily maximum recommended human dose (mrhd) on a body surface area (bsa) basis. based on animal data, advise pregnant women of the potential risk to a fetus (see data ). local anesthetics rapidly cross the placenta, and when used for epidural, caudal, or pudendal block anesthesia, can cause varying degrees of maternal, fetal, and neonatal toxicity [see clinical pharmacology (12.3)]. the incidence and degree of toxicity depend upon the procedure performed, the type, and amount of drug used, and the technique of drug administration. adverse reactions in the parturient, fetus, and neonate involve alterations of the cns, peripheral vascular tone, and cardiac function. if this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, inform the patient of the potential hazard to the fetus. the estimated background risk of major birth defects and miscarriage for the indicated populations are 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. clinical considerations maternal adverse reactions maternal hypotension has resulted from regional and neuraxial anesthesia. local anesthetics produce vasodilation by blocking sympathetic nerves. the supine position is dangerous in pregnant women at term because of aortocaval compression by the gravid uterus. therefore, during treatment of systemic toxicity, maternal hypotension, or fetal bradycardia following regional or neuraxial block, the parturient should be maintained in the left lateral decubitus position if possible, or manual displacement of the uterus off the great vessels be accomplished. elevating the patient’s legs and right-side-up positioning will help prevent decreases in blood pressure. the fetal heart rate also should be monitored continuously and electronic fetal monitoring is highly advisable. labor or delivery spinal anesthesia is commonly used during labor and delivery. bupivacaine hydrochloride, when administered properly, via the epidural route in doses 10 to 12 times the amount used in spinal anesthesia has been used for obstetrical analgesia and anesthesia without evidence of adverse effects on the fetus. spinal anesthesia may alter the forces of parturition through changes in uterine contractility or maternal expulsive efforts. spinal anesthesia has also been reported to prolong the second stage of labor by removing the parturient’s reflex urge to bear down or by interfering with motor function. the use of obstetrical anesthesia may increase the need for forceps assistance. the use of some local anesthetic drug products during labor and delivery may be followed by diminished muscle strength and tone for the first day or two of life. this has not been reported with bupivacaine. it is extremely important to avoid aortocaval compression by the gravid uterus during administrations of regional or neuraxial block to parturients. to do this, the patient must be maintained in the left lateral decubitus position or a blanket roll or sandbag may be placed beneath the right hip and the gravid uterus displaced to the left. data animal data bupivacaine hydrochloride produced developmental toxicity when administered subcutaneously to pregnant rats and rabbits at doses 30-times the mrhd. bupivacaine hydrochloride was administered subcutaneously to rats at doses of 4.4, 13.3, and 40 mg/kg and to rabbits at doses of 1.3, 5.8, and 22.2 mg/kg during the period of organogenesis (implantation to closure of the hard palate). the high doses are approximately 30-times the daily mrhd of 12 mg/day on a mg dose/m2 bsa basis. no embryo-fetal effects were observed in rats at the high dose which caused increased maternal lethality. an increase in embryo-fetal deaths was observed in rabbits at the high dose in the absence of maternal toxicity with the fetal no observed adverse effect level being approximately 8-times the mrhd on a bsa basis. in a rat pre- and post-natal development study (dosing from implantation through weaning) conducted at subcutaneous doses of 4.4, 13.3, and 40 mg/kg, decreased pup survival was observed at the high dose. the high dose is approximately 30-times the daily mrhd of 12 mg/day on a bsa basis. risk summary lactation studies have not been conducted with bupivacaine. bupivacaine has been reported to be excreted in human milk suggesting that the nursing infant could be theoretically exposed to a dose of the drug. bupivacaine spinal should be administered to lactating women only if clearly indicated. studies assessing the effects of bupivacaine spinal in breastfed children have not been performed. studies to assess the effect of bupivacaine spinal on milk production or excretion have not been performed. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for bupivacaine and any potential adverse effects on the breastfed child from bupivacaine or from the underlying maternal condition. bupivacaine spinal is approved for use in adults only. administration of bupivacaine spinal in patients younger than 18 is not recommended. patients 65 years and over, particularly those with hypertension, may be at increased risk for developing hypotension while undergoing spinal anesthesia with bupivacaine spinal. in clinical studies of bupivacaine, elderly patients exhibited a greater spread and higher maximal level of anesthesia than younger patients. elderly patients also reached the maximal level of anesthesia more rapidly than younger patients, and exhibited a faster onset of motor blockade. differences in various pharmacokinetic parameters have been observed between elderly and younger patients [see clinical pharmacology (12.3)] . this product is known to be substantially excreted by the kidney, and the risk of adverse 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. elderly patients may require lower doses of bupivacaine spinal. amide-type local anesthetics, such as bupivacaine, are metabolized by the liver. patients with severe hepatic impairment, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations, and potentially local anesthetic systemic toxicity. therefore, consider reduced dosing and increased monitoring for local anesthetic systemic toxicity in patients with moderate to severe hepatic impairment treated with bupivacaine spinal [see warnings and precautions (5.10)] . bupivacaine is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with renal impairment. this should be considered when selecting the bupivacaine spinal dosage [see use in specific populations (8.5)] .

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

general injectables & vaccines, inc - bupivacaine hydrochloride (unii: 7tqo7w3vt8) (bupivacaine - unii:y8335394ro) - bupivacaine hydrochloride anhydrous 2.5 mg in 1 ml - bupivacaine hydrochloride injection/bupivacaine hydrochloride and epinephrine injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. specific concentrations and presentations of bupivacaine hydrochloride injection/bupivacaine hydrochloride and epinephrine injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see dosage and administration (2.2)]. limitations of use not all blocks are indicated for use with bupivacaine hydrochloride injection/bupivacaine hydrochloride and epinephrine injection given clinically significant risks associated with use [see dosage and administration (2.2), contraindications (4), warnings and precautions (5.1, 5.4, 5.5, 5.7, 5.9)]. bupivacaine hydrochloride injection/bupivacaine hydrochloride and epinephrine injection is contraindicated in: - obstetrical paracervical

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

baxter healthcare pty ltd - bupivacaine hydrochloride, quantity: 2.5 mg/ml (equivalent: bupivacaine hydrochloride monohydrate, qty 2.64 mg/ml) - injection, solution - excipient ingredients: water for injections; hydrochloric acid; sodium chloride; sodium hydroxide - indications ,bupivacaine-baxter is indicated for the production of local or regional anaesthesia and analgesia in individuals as follows: ,surgical anaesthesia ,epidural block for surgery ,field block (minor and major nerve blocks and infiltration). ,analgesia ,continuous epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain. ,field block (minor nerve block and infiltration).

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

general injectables & vaccines, inc - bupivacaine hydrochloride (unii: 7tqo7w3vt8) (bupivacaine - unii:y8335394ro), epinephrine bitartrate (unii: 30q7ki53ak) (epinephrine - unii:ykh834o4bh) - bupivacaine hydrochloride anhydrous 2.5 mg in 1 ml - bupivacaine hydrochloride is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia. (see warnings .) experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of 0.75% concentration of bupivacaine hydrochloride in these patients. bupivacaine hydrochloride is not recommended for intravenous regional anesthesia (bier block). (see warnings .) the routes of administration and indicated bupivacaine hydrochloride concentrations are: (see dosage and administration for additional information.) standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of bupivacaine hydrochloride. bupivacaine hydrochloride is contraindicated in obstetrical paracervical block anesthesia. its use in this technique ha

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

hf acquisition co llc, dba healthfirst - bupivacaine hydrochloride (unii: 7tqo7w3vt8) (bupivacaine - unii:y8335394ro) - bupivacaine hydrochloride is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia (see warnings). experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of 0.75% concentration of bupivacaine hydrochloride in these patients. bupivacaine hydrochloride is not recommended for intravenous regional anesthesia (bier block) (see warnings). the routes of administration and indicated bupivacaine hydrochloride concentrations are: (see dosage and administration for additional information.) standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of bupivacaine hydrochloride. bupivacaine hydrochloride is contraindicated in obstetrical paracervical block anesthesia. its use in this technique has resulted in fetal bradycardia and death. bupivacaine hydrochloride is contraindicated in patients with a known hypersensitivity to it or to any local anesthetic agent of the amide-type or to other components of bupivacaine hydrochloride solutions.

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

boucher & muir pty ltd - bupivacaine hydrochloride monohydrate, quantity: 5.28 mg/ml (equivalent: bupivacaine hydrochloride, qty 5 mg/ml) - injection, solution - excipient ingredients: glucose; water for injections; sodium hydroxide - bupivacaine spinal heavy bnm is indicated for the production of spinal anaesthesia.,bupivacaine spinal heavy bnm is suitable for abdominal surgery lasting 45 - 60 minutes and urological and lower limb surgery lasting 2 - 3 hours.

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

cardinal health - bupivacaine hydrochloride (unii: 7tqo7w3vt8) (bupivacaine - unii:y8335394ro) - bupivacaine hydrochloride is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia. (see warnings .) experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of 0.75% concentration of bupivacaine hydrochloride in these patients. bupivacaine hydrochloride is not recommended for intravenous regional anesthesia (bier block). (see warnings .) the routes of administration and indicated bupivacaine hydrochloride concentrations are: •local infiltration 0.25% •peripheral nerve block 0.25% and 0.5% •retrobulbar block 0.75% •sympathetic block 0.25% •lumbar epidural 0.25%, 0.5%, and 0.75% (0.75% not for obstetrical anesthesia) •caudal 0.25% and 0.5% •epidural test dose 0.5% with epinephrine 1:200,000 •dental blocks 0.5% with epinephrine 1:200,000 (see