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

direct_rx - carisoprodol (unii: 21925k482h) (carisoprodol - unii:21925k482h) - carisoprodol tablets, usp is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. carisoprodol tablets, usp should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [see dosage and administration (2)]. carisoprodol tablets, usp is contraindicated in patients with a history of acute intermittent porphyria or a hypersensitivity reaction to a carbamate such as meprobamate. 8.1 pregnancy: pregnancy category c. there are no data on the use of carisoprodol during human pregnancy. animal studies indicate that carisoprodol crosses the placenta and results in adverse effects on fetal growth and postnatal survival. the primary metabolite of carisoprodol, meprobamate, is an approved anxiolytic. retrospective, post-marketing studies do not show a consistent association between maternal use of meprobamate and an increased risk for particular congenital malformations. teratogenic effects: animal studies have not adequately evaluated the teratogenic effects of carisoprodol. there was no increase in the incidence of congenital malformations noted in reproductive studies in rats, rabbits, and mice treated with meprobamate. retrospective, post-marketing studies of meprobamate during human pregnancy were equivocal for demonstrating an increased risk of congenital malformations following first trimester exposure. across studies that indicated an increased risk, the types of malformations were inconsistent. nonteratogenic effects: in animal studies, carisoprodol reduced fetal weights, postnatal weight gain, and postnatal survival at maternal doses equivalent to 1 to 1.5 times the human dose (based on a body surface area comparison). rats exposed to meprobamate in-utero showed behavioral alterations that persisted into adulthood. for children exposed to meprobamate in-utero, one study found no adverse effects on mental or motor development or iq scores. carisoprodol should be used during pregnancy only if the potential benefit justifies the risk to the fetus. 8.2 labor and delivery there is no information about the effects of carisoprodol on the mother and the fetus during labor and delivery. 8.3 nursing mothers very limited data in humans show that carisoprodol is present in breast milk and may reach concentrations two to four times the maternal plasma concentrations. in one case report, a breast-fed infant received about 4 to 6% of the maternal daily dose through breast milk and experienced no adverse effects. however, milk production was inadequate and the baby was supplemented with formula. in lactation studies in mice, female pup survival and pup weight at weaning were decreased. this information suggests that maternal use of carisoprodol may lead to reduced or less effective infant feeding (due to sedation) and/or decreased milk production. caution should be exercised when carisoprodol is administered to a nursing woman. 8.4 pediatric use the efficacy, safety, and pharmacokinetics of carisoprodol in pediatric patients less than 16 years of age have not been established. 8.5 geriatric use the efficacy, safety, and pharmacokinetics of carisoprodol in patients over 65 years old have not been established. 8.6 renal impairment the safety and pharmacokinetics of carisoprodol in patients with renal impairment have not been evaluated. since carisoprodol is excreted by the kidney, caution should be exercised if carisoprodol is administered to patients with impaired renal function. carisoprodol is dialyzable by hemodialysis and peritoneal dialysis. 8.7 hepatic impairment the safety and pharmacokinetics of carisoprodol in patients with hepatic impairment have not been evaluated. since carisoprodol is metabolized in the liver, caution should be exercised if carisoprodol is administered to patients with impaired hepatic function. 8.8 patients with reduced cyp2c19 activity patients with reduced cyp2c19 activity have higher exposure to carisoprodol. therefore, caution should be exercised in administration of carisoprodol to these patients [see clinical pharmacology (12.3)]. 9.1 controlled substance carisoprodol tablets, usp contains carisoprodol, usp a schedule iv controlled substance. carisoprodol has been subject to abuse, misuse, and criminal diversion for nontherapeutic use [see warnings and precautions (5.2)]. 9.2 abuse abuse of carisoprodol poses a risk of overdosage which may lead to death, cns and respiratory depression, hypotension, seizures and other disorders .[seewarnings and precautions (5.2) and over dosage(10)].patients at high risk of carisoprodol abuse may include those with prolonged use of carisoprodol, with a history of drug abuse, or those who use carisoprodol in combination with other abused drugs. prescription drug abuse is the intentional non-therapeutic use of a drug, even once, for its rewarding psychological effects. drug addiction, which develops after repeated drug abuse, is characterized by a strong desire to take a drug despite harmful consequences, difficulty in controlling its use, giving a higher priority to drug use than to obligations, increased tolerance, and sometimes physical withdrawal. drug abuse and drug addiction are separate and distinct from physical dependence and tolerance (for example, abuse or addiction may not be accompanied by tolerance or physical dependence) [see drug abuse and dependance(9.3)] 9.3 dependence tolerance is when a patient’s reaction to a specific dosage and concentration is progressively reduced in the absence of disease progression, requiring an increase in the dosage to maintain the same. physical dependence is characterized by withdrawal symptoms after abrupt discontinuation or a significant dose reduction of a drug. both tolerance and physical dependence have been reported with the prolonged use of carisoprodol. reported withdrawal symptoms with carisoprodol include insomnia, vomiting, abdominal cramps, headache, tremors, muscle twitching, anxiety, ataxia, hallucinations, and psychosis. instruct patients taking large doses of carisoprodol or those taking the drug for a prolonged time to not abruptly stop carisoprodol. [see warnings and precautions (5.2)].

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

proficient rx lp - carisoprodol (unii: 21925k482h) (carisoprodol - unii:21925k482h) - there are no data on the use of carisoprodol during human pregnancy. animal studies indicate that carisoprodol crosses the placenta and results in adverse effects on fetal growth and postnatal survival. the primary metabolite of carisoprodol, meprobamate, is an approved anxiolytic. retrospective, post-marketing studies do not show a consistent association between maternal use of meprobamate and an increased risk for particular congenital malformations. teratogenic effects: animal studies have not adequately evaluated the teratogenic effects of carisoprodol. there was no increase in the incidence of congenital malformations noted in reproductive studies in rats, rabbits, and mice treated with meprobamate. retrospective, post-marketing studies of meprobamate during human pregnancy were equivocal for demonstrating an increased risk of congenital malformations following first trimester exposure. across studies that indicated an increased risk, the types of m

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

novartis pharmaceuticals australia pty ltd - norethisterone acetate; oestradiol -

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

novartis pharmaceuticals australia pty ltd - oestradiol; norethisterone acetate -

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

novartis pharmaceuticals australia pty ltd - oestradiol -

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

novartis pharmaceuticals australia pty ltd - oestradiol; oestradiol hemihydrate -

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

novartis pharmaceuticals australia pty ltd - oestradiol -

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

aspen pharmacare australia pty ltd - oestradiol -

New Zealand - English - Medsafe (Medicines Safety Authority)

sandoz new zealand limited - estradiol hemihydrate 1.56mg equivalent to 100 µg per 24 hours - transdermal patch - 100 mcg/24h - active: estradiol hemihydrate 1.56mg equivalent to 100 µg per 24 hours excipient: acrylic adhesive dipropylene glycol oleyl alcohol povidone silicone adhesive - the estradot regimen is indicated for the following: - oestrogen replacement therapy for the treatment of the symptoms of natural or surgically induced menopause. - prevention of postmenopausal osteoporosis (see dosage and administration and warnings and precautions).

New Zealand - English - Medsafe (Medicines Safety Authority)

sandoz new zealand limited - estradiol hemihydrate 0.39mg equivalent to oestradiol 25 µg/24hour - transdermal patch - 25 mcg/24h - active: estradiol hemihydrate 0.39mg equivalent to oestradiol 25 µg/24hour excipient: acrylic adhesive dipropylene glycol oleyl alcohol povidone silicone adhesive - the estradot regimen is indicated for the following: - oestrogen replacement therapy for the treatment of the symptoms of natural or surgically induced menopause. - prevention of postmenopausal osteoporosis. in women with an intact uterus, oestrogens should always be supplemented by administration of a progestogen.