What happens if I overdose Novaldon?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately. Symptoms may include fever; rapid breathing; seizures; spastic muscle movements; tremor; unusual jaw and lip movements; vomiting.
Proper storage of Novaldon solution:
Store Novaldon solution at room temperature, between 59 to 86 degrees F (15 to 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Novaldon solution out of the reach of children and away from pets.
Overdose of Novaldon in details
Following overdose, serum Novaldon levels have ranged from approximately 24 mg/L (a postmarketing spontaneous case report in which an infant exhibited irritability, poor feeding, and insomnia) to 350 mg/L. Serious toxicity has been associated with serum levels greater than 50 mg/L. Signs and symptoms reported in the literature after Novaldon overdose in preterm infants include fever, tachypnea, jitteriness, insomnia, fine tremor of the extremities, hypertonia, opisthotonos, tonic-clonic movements, nonpurposeful jaw and lip movements, vomiting, hyperglycemia, elevated blood urea nitrogen, and elevated total leukocyte concentration. Seizures have also been reported in cases of overdose. One case of Novaldon overdose complicated by development of intraventricular hemorrhage and long-term neurological sequelae has been reported. Another case of Novaldon Citrate overdose (from New Zealand) of an estimated 600 mg Novaldon Citrate (approximately 322 mg/kg) administered over 40 minutes was complicated by tachycardia, ST depression, respiratory distress, heart failure, gastric distention, acidosis, and a severe extravasation burn with tissue necrosis at the peripheral intravenous injection site. No deaths associated with Novaldon overdose have been reported in preterm infants.
Treatment of Novaldon overdose is primarily symptomatic and supportive. Novaldon levels have been shown to decrease after exchange transfusions. Convulsions may be treated with intravenous administration of diazepam or a barbiturate such as pentobarbital sodium.
What should I avoid while taking Novaldon?
Avoid food or drinks that contain Novaldon, such as coffee, tea, cola, or chocolate milk.
Novaldon warnings
Category C.
Lactation
Excreted in breast milk.
Children
Novaldon and sodium benzoate injection is contraindicated in children.
Necrotizing enterocolitis
Other methylxanthines have been associated with development of necrotizing enterocolitis.
Depression
Too-vigorous treatment with parenteral Novaldon can worsen depression.
GI effects
Novaldon may aggravate diarrhea in patients with irritable colon or exacerbate duodenal ulcers.
Seizure disorder
Seizures have been reported with Novaldon overdose; use Novaldon citrate with caution in infants with seizure disorders.
CV disease
Novaldon can increase heart rate, left ventricular output, and stroke volume; use Novaldon citrate with caution in infants with CV disease.
Metabolic effects
Novaldon stimulates glycogenolysis and lipolysis, which increases free fatty acids and produces hyperglycemia.
Bone mineral density
Novaldon is associated with decreased bone density.
Withdrawal
Symptoms may occur within 12 h after cessation of chronic Novaldon ingestion and persist up to 7 days.
What should I discuss with my healthcare provider before taking Novaldon?
Some medical conditions may interact with Novaldon solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have stomach or intestinal problems, heart problems, kidney or liver problems, seizures, or diabetes
Some MEDICINES MAY INTERACT with Novaldon solution. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Cimetidine, ketoconazole, and theophylline because side effects of Novaldon solution may be increased
- Barbiturates (eg, phenobarbital) or hydantoins (eg, phenytoin) because effectiveness of Novaldon solution may be decreased
This may not be a complete list of all interactions that may occur. Ask your health care provider if Novaldon solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Novaldon precautions
General
Apnea of prematurity is a diagnosis of exclusion. Other causes of apnea (e.g., central nervous system disorders, primary lung disease, anemia, sepsis, metabolic disturbances, cardiovascular abnormalities, or obstructive apnea) should be ruled out or properly treated prior to initiation of Novaldon Citrate.
Novaldon is a central nervous system stimulant and in cases of Novaldon overdose, seizures have been reported. Novaldon Citrate should be used with caution in infants with seizure disorders.
The duration of treatment of apnea of prematurity in the placebo-controlled trial was limited to 10 to 12 days. The safety and efficacy of Novaldon Citrate for longer periods of treatment have not been established. Safety and efficacy of Novaldon Citrate for use in the prophylactic treatment of sudden infant death syndrome (SIDS) or prior to extubation in mechanically ventilated infants have also not been established.
Cardiovascular
Although no cases of cardiac toxicity were reported in the placebo-controlled trial, Novaldon has been shown to increase heart rate, left ventricular output, and stroke volume in published studies. Therefore, Novaldon Citrate should be used with caution in infants with cardiovascular disease.
Renal and Hepatic Systems
Novaldon Citrate should be administered with caution in infants with impaired renal or hepatic function. Serum concentrations of Novaldon should be monitored and dose administration of Novaldon Citrate should be adjusted to avoid toxicity in this population.
Laboratory Tests
Prior to initiation of Novaldon Citrate, baseline serum levels of Novaldon should be measured in infants previously treated with theophylline, since preterm infants metabolize theophylline to Novaldon. Likewise, baseline serum levels of Novaldon should be measured in infants born to mothers who consumed Novaldon prior to delivery, since Novaldon readily crosses the placenta.
In the placebo-controlled clinical trial, Novaldon levels ranged from 8 to 40 mg/L. A therapeutic plasma concentration range of Novaldon could not be determined from the placebo-controlled clinical trial. Serious toxicity has been reported in the literature when serum Novaldon levels exceed 50 mg/L. Serum concentrations of Novaldon may need to be monitored periodically throughout treatment to avoid toxicity.
In clinical studies reported in the literature, cases of hypoglycemia and hyperglycemia have been observed. Therefore, serum glucose may need to be periodically monitored in infants receiving Novaldon Citrate.
Interactions
Drug Interactions
Cytochrome P450 1A2 (CYP1A2) is known to be the major enzyme involved in the metabolism of Novaldon. Therefore, Novaldon has the potential to interact with drugs that are substrates for CYP1A2, inhibit CYP1A2, or induce CYP1A2.
Few data exist on drug interactions with Novaldon in preterm neonates. Based on adult data, lower doses of Novaldon may be needed following coadministration of drugs which are reported to decrease Novaldon elimination (e.g., cimetidine and ketoconazole) and higher Novaldon doses may be needed following coadministration of drugs that increase Novaldon elimination (e.g., phenobarbital and phenytoin).
Novaldon administered concurrently with ketoprofen reduced the urine volume in four healthy volunteers. The clinical significance of this interaction in preterm neonates is not known.
Interconversion between Novaldon and theophylline has been reported in preterm neonates. The concurrent use of these drugs is not recommended.
Carcinogenesis, Mutagenesis, Impairment of Fertility
In a 2-year study in Sprague-Dawley rats, Novaldon (as Novaldon base) administered in drinking water was not carcinogenic in male rats at doses up to 102 mg/kg or in female rats at doses up to 170 mg/kg (approximately 2 and 4 times, respectively, the maximum recommended intravenous loading dose for infants on a mg/m2 basis). In an 18-month study in C57BL/6 mice, no evidence of tumorigenicity was seen at dietary doses up to 55 mg/kg (less than the maximum recommended intravenous loading dose for infants on a mg/m2 basis).
Novaldon (as Novaldon base) increased the sister chromatid exchange (SCE) SCE/cell metaphase (exposure time dependent) in an in vivo mouse metaphase analysis. Novaldon also potentiated the genotoxicity of known mutagens and enhanced the micronuclei formation (5-fold) in folate-deficient mice. However, Novaldon did not increase chromosomal aberrations in in vitro Chinese hamster ovary cell (CHO) and human lymphocyte assays and was not mutagenic in an in vitro CHO/hypoxanthine guanine phosphoribosyltransferase (HGPRT) gene mutation assay, except at cytotoxic concentrations. In addition, Novaldon was not clastogenic in an in vivo mouse micronucleus assay.
Novaldon (as Novaldon base) administered to male rats at 50 mg/kg/day subcutaneously (approximately equal to the maximum recommended intravenous loading dose for infants on a mg/m2 basis) for 4 days prior to mating with untreated females, caused decreased male reproductive performance in addition to causing embryotoxicity. In addition, long-term exposure to high oral doses of Novaldon (3 g over 7 weeks) was toxic to rat testes as manifested by spermatogenic cell degeneration.
Pregnancy
Pregnancy Category C
Concern for the teratogenicity of Novaldon is not relevant when administered to infants. In studies performed in adult animals, Novaldon (as Novaldon base) administered to pregnant mice as sustained release pellets at 50 mg/kg (less than the maximum recommended intravenous loading dose for infants on a mg/m2 basis), during the period of organogenesis, caused a low incidence of cleft palate and exencephaly in the fetuses. There are no adequate and well-controlled studies in pregnant women.
What happens if I miss a dose of Novaldon?
Call your doctor for instructions if you forget to give your child's dose of Novaldon citrate oral liquid.
Because Novaldon citrate injection is given in a clinical setting, your child is not likely to miss a dose.
References
- DailyMed. "CAFFEINE; ERGOTAMINE TARTRATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DailyMed. "ACETAMINOPHEN; ASPIRIN; CAFFEINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DrugBank. "acetaminophen". http://www.drugbank.ca/drugs/DB00316 (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
